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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, ~~2024~~2025

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE TRANSITION PERIOD FROM TO

Commission File Number 001-36754

EVOFEM BIOSCIENCES, INC.

(Exact name of Registrant as specified in its Charter)

Delaware		20-8527075
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

7770 Regents Rd, Suite 113-618 San Diego, CA		92122
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (858) 550-1900

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		EVFM		OTCQB

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
None

Securities registered pursuant to Section 12(g) of the Act: ~~None~~Common Stock, par value $0.0001 per share.

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definition of “large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The aggregate market value of the ~~common~~Common ~~stock~~Stock held by non-affiliates of the registrant was approximately $01.9 2 million as of June 30, ~~2024~~2025, based upon the closing sale price on the ~~OTCQB~~OTCID ~~Venture~~Basic Market reported for such date. Shares of ~~common~~Common Stock ~~stock~~ held by each executive officer and director and certain holders of more than 10% of the outstanding shares of the registrant’s ~~common~~Common ~~stock~~Stock have been excluded in that such persons may be deemed to be affiliates. Shares of ~~common~~Common ~~stock~~Stock held by other persons, including certain other holders of more than 10% of the outstanding shares of ~~common~~Common ~~stock~~Stock, have not been excluded in that such persons are not deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.

The number of shares of Registrant’s Common Stock outstanding as of March 149, ~~2025~~2026 was ~~113~~132,~~356~~530,~~354~~081.

DOCUMENTS INCORPORATED BY REFERENCE

None.

Table of Contents

		Page
PART I
Item 1.	Business	32
Item 1A.	Risk Factors	3132
Item 1B.	Unresolved Staff Comments	7579
Item 1C.	Cybersecurity	7579
Item 2.	Properties	7680
Item 3.	Legal Proceedings	7680
Item 4.	Mine Safety Disclosures	7680
PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	7781
Item 6.	[RESERVED]	7782
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	7882
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	9294
Item 8.	Financial Statements and Supplementary Data	9294
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	9294
Item 9A.	Controls and Procedures	9295
Item 9B.	Other Information	9396
Item 9C.	Disclosure Regarding Foreign Jurisdictions That Prevent Inspections	9396
PART III
Item 10.	Directors, Executive Officers and Corporate Governance	9496
Item 11.	Executive Compensation	99105
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	~~114~~121
Item 13.	Certain Relationships and Related Transactions, and Director Independence	~~115~~124
Item 14.	Principal Accounting Fees and Services	~~117~~127
PART IV
Item 15.	Exhibits and Financial Statement Schedules	~~118~~127
Item 16.	Form 10-K Summary	~~124~~131
SIGNATURES		~~125~~132

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This annual report on Form 10-K (Annual Report), contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” All statements, other than statements of historical facts, contained in this Annual Report, including statements regarding our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. Words such as, but not limited to, “anticipate,” “aim,” “believe,” “contemplate,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “suggest,” “strategy,” “target,” “will,” “would,” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, among other things, statements about:

● our ability to regain compliance with listing standards of the OTCQB® Venture Market to maintain the listing of our shares thereon; ● the possibility and effects of our common stock being traded on OTC Pink Current in the event we fail to regain compliance with OTCQB® Venture Market; ● the consummation of the transactions contemplated by the Merger Agreement and documents related thereto; ● our ability to continue as a going concern; ● the Notice of Default and cancellation of Forbearance Agreement received by Future Pak, LLC and any potential legal action(s) against the Company, including that its assets that could be taken and potential negative outcome(s) thereof; ● our ability to ~~successfully integrate and commercialize SOLOSEC® (secnidazole) 2g oral granules (SOLOSEC); ● our ability to~~ remediate the material weaknesses in our internal controls and procedures identified by management; ● our ability to obtain necessary approvals of any corporate action(s) needing stockholder, FINRA, Nasdaq, or other approvals; ● our ability to file Annual and Quarterly Reports on a timely basis; ● our ability to raise additional capital to fund our operations if and as needed; ● our ability to achieve and sustain profitability; ● our estimates regarding ~~our~~expenses, ~~future~~revenues, ~~performance~~financial ~~including~~performance, ~~without~~and ~~limitation~~capital requirements, ~~any~~including ~~estimates~~the length of ~~potential~~time ~~future~~our ~~revenues;~~capital ●resources ~~estimates~~will ~~regarding~~sustain ~~market~~our ~~size~~operations; ● ~~our~~the ~~estimates~~Notices ~~regarding~~of ~~expenses,~~Default ~~revenues,~~and ~~financial~~cancellation ~~performance~~of Forbearance Agreement received from Future Pak, LLC and ~~capital~~any ~~requirements~~potential legal action(s) against the Company related thereto, including ~~the~~that ~~length~~its ofassets ~~time~~that ~~our~~could ~~capital~~be ~~resources~~taken ~~will~~and ~~sustain~~potential ~~our~~negative ~~operations~~outcome(s) thereof; ● our ability to comply with the provisions and requirements of our debt arrangements, to avoid future defaults pursuant to our debt arrangements, and to pay amounts owed, including any amounts that may be accelerated, pursuant to our debt arrangements; ● ~~estimates~~our ~~regarding~~ability ~~health~~to ~~care~~successfully ~~providers’~~commercialize ~~(HCPs’) recommendations of PHEXXI~~PHEXX® (lactic acid, citric acid, and potassium bitartrate) vaginal gel (PHEXX) (formerly known as PHEXXI®) toand ~~patients~~SOLOSEC® (secnidazole) 2g oral granules (SOLOSEC); ● estimates regarding ~~HCPs~~market ~~recommendations~~size; of● ~~SOLOSEC~~estimates toregarding ~~patients~~health ~~suffering~~care ~~from~~providers’ ~~the~~(HCPs’) ~~sexual~~recommendations ~~health~~of ~~infections~~PHEXX ~~for~~and ~~which~~SOLOSEC itto ~~is indicated~~patients; ● the rate and degree of market acceptance of ~~our~~PHEXX ~~products~~and SOLOSEC; ● our ability to successfully commercialize and distribute our products and continue to develop our sales and marketing capabilities~~, particularly after any product rebrand~~; ● ~~The requirement to change the name of PHEXXI and~~ our ~~estimates regarding the timing and cost thereof; ● our estimates regarding the effectiveness of our marketing campaigns; ● our~~ strategic plans for our business, including the commercialization of our products; ● the potential for changes to current regulatory mandates requiring health insurance plans to cover U.S. Food and Drug Administration (FDA) -cleared or -approved contraceptive products ~~or testing for sexually transmitted infections (STIs)~~ without cost sharing; ● our ability to obtain or maintain third-party payer coverage and adequate reimbursement, and our reliance on the willingness of patients to pay out-of-pocket for our products absent full or partial third-party payer reimbursement; ● our ability to protect and defend our intellectual property position and our reliance on third party licensors; ● our ability to obtain additional patent protection for our products; ● our dependence on third parties for the manufacture of our products; ● our ability to expand our organization to accommodate potential growth; and ● our ability to retain and attract key personnel.

Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that these statements are based on our projections of the future which are subject to known and unknown risks and uncertainties and other factors that may cause our actual results, level of activity, performance, or achievements to differ from those expressed or implied by these forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement. Forward-looking statements should be regarded solely as our current plans, estimates and beliefs. You should read this Annual Report and the documents that we have filed as exhibits to this Annual Report and incorporated by reference herein completely and with the understanding that our actual results may be materially different from the plans, intentions and expectations disclosed in the forward-looking statements we make. Moreover, we operate in a very competitive and rapidly changing environment and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. The forward-looking statements contained in this Annual Report are made as of the date of this Annual Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.

This Annual Report contains estimates and other statistical data made by independent parties and by the Company relating to market size and growth and other data about its industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

Our first commercial product, PHEXXI, was approved by the FDA on May 22, 2020, for the prevention of pregnancy and launched in the U.S. in September 2020. PHEXXI is the first and only non-hormonal prescription contraceptive vaginal gel. Women use it when they have sex, applying PHEXXI 0-60 minutes prior to intercourse. Because PHEXXI is hormone-free and non-systemic, it is not associated with side effects of hormonal contraceptive methods, such as depression, weight gain, headaches, loss of libido, mood swings and irritability. Taking hormones may not be right for some women, especially those with certain medical conditions including clotting disorders, hormone-sensitive cancers, diabetes or a BMI over 30, as well as women who are breast feeding, and / or smoke. Per the NCHS-published data from the chart below, more than 23.3 million women in the U.S. do not want to get pregnant and will not use a hormonal contraceptive.

In July 2024 we acquired global rights to SOLOSEC. This FDA-approved single-dose oral antimicrobial agent provides a complete course of therapy for the treatment of two common sexual health infections – bacterial vaginosis (BV) and trichomoniasis (Trich). The SOLOSEC acquisition aligns with and advances our mission to improve access to innovative and differentiated options that impact women’s daily lives. We re-launched SOLOSEC in the U.S. in November 2024 and expect commercialization of SOLOSEC will benefit from our commercial infrastructure and strong physician relationships.

Outside the U.S., our strategy is to commercialize our products in global markets through commercial partnerships and/or license agreements. PHEXXI was approved in Nigeria on October 6, 2022, as Femidence™ by the National Agency for Food and Drug Administration and Control. PHEXXI has been submitted for approval in Mexico, Ethiopia and Ghana. In July 2024, we licensed commercial rights to PHEXXI in the Middle East to Pharma 1 Drug Store, LLC, an emerging Emirati health care company (Pharma 1). Pharma 1 is expected to file for regulatory approval of PHEXXI in the United Arab Emirates (UAE) in the first half of 2025.

Unless the context requires otherwise, references in this Annual Report to “Evofem,” “Company,” “we,” “us” and “our” refer to Evofem Biosciences, Inc. and its subsidiaries.

This Annual Report includes our trademarks, trade names and service marks, including “EVOFEM®” , “~~PHEXXI~~PHEXX®”, “FEMIDENCE™”, and “SOLOSEC®”, which are protected under applicable intellectual property laws and are the property of Evofem Biosciences, Inc. or its subsidiaries. Solely for convenience, trademarks, trade names and service marks referred to in this Annual Report may appear without the ®, ™ or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.

PART I

Item 1. Business.

Overview

We are a San Diego-based commercial-stage biopharmaceutical company ~~with~~committed ato ~~strong~~commercializing ~~focus~~innovative onproducts ~~innovation~~to address unmet needs in women’s sexual and reproductive health.

Our first commercial product, ~~PHEXXI~~PHEXX®, was approved by the FDA on May 22, 2020, for the prevention of pregnancy and launched in the U.S. ~~PHEXXI~~in September 2020. PHEXX is the first and only ~~FDA~~non-~~approved,~~hormonal ~~hormone-free~~ prescription contraceptive vaginal gel. ItWomen ~~comes~~use init awhen ~~pre~~they have sex, inserting PHEXX 0-~~filled~~60 ~~applicator~~minutes prior to intercourse. Because PHEXX is hormone-free and non-systemic, it is ~~applied~~not ~~within~~associated ~~one~~with side ~~hour~~effects ~~before~~of ~~intercourse~~hormonal contraceptive methods, ~~empowering~~which include depression, weight gain, headaches, loss of libido, mood swings and irritability. Taking hormones may not be right for some women, especially those with certain medical conditions including clotting disorders, hormone-sensitive acancers, ~~convenient~~diabetes, ~~discreet~~or a BMI over 30, ~~and~~as ~~flexible~~well ~~contraception~~as ~~method~~women ~~that~~who ~~puts~~are ~~control~~breast infeeding, ~~their~~and ~~hands~~/ or who smoke. WePer ~~commercially~~the ~~launched~~National ~~PHEXXI~~Center infor ~~September~~Health ~~2020~~Statistics in(NCHS), based on data from the 2022-2023 National Survey of Family Growth, approximately 15.9 million women1 in the U.S. ~~and~~do ~~have~~not ~~reported~~want ~~increased~~to ~~net~~get ~~product~~pregnant ~~sales~~and ~~for~~will ~~each~~not ~~successive~~use ~~year~~a hormonal contraceptive.

InWe ~~November~~acquired ~~2024,~~global werights ~~re-launched~~to SOLOSEC® inon ~~the~~July ~~U.S.~~14, ~~following~~2024 ~~the~~and ~~acquisition~~relaunched ~~of global rights to~~ the ~~product~~brand in ~~July~~November 2024. ~~This~~SOLOSEC ~~oral~~is an FDA-approved single-dose oral antimicrobial agent that provides a complete course of therapy for ~~two common sexual health infections with just one dose. SOLOSEC is FDA-approved for~~ the treatment of two common sexual health ~~diseases:~~infections – bacterial vaginosis (BV), aand ~~common~~trichomoniasis. ~~vaginal~~This ~~infection,~~acquisition inaligns ~~females~~with ~~12 years of age~~ and ~~older,~~advances ~~and~~our ~~Trichomonas~~mission ~~vaginalis,~~to acommercialize ~~common sexually transmitted infection (STI), in people 12 years of age~~innovative and ~~older.~~differentiated ~~SOLOSEC~~products ~~has~~for ~~the~~women’s ~~same~~sexual ~~call point as PHEXXI, enabling us to leverage our commercial infrastructure~~ and ~~strong~~reproductive ~~physician relationships~~health.

We1 ~~intend~~Daniels toK ~~commercialize~~and ~~our~~Abma ~~products~~J. inCurrent ~~all~~Contraceptive ~~other~~Status ~~global~~Among ~~markets~~Females ~~through~~Ages ~~partnerships~~15–49: orUnited ~~licensing agreements~~States, ~~such~~2022–2023. asNCHS ~~the~~Data ~~July 2024~~Brief ~~licensing~~No. of539. ~~commercial~~August ~~rights~~2025. toData ~~PHEXXI~~table infor ~~the~~Figure ~~Middle East to Pharma~~ 1 ~~Drug Store~~, ~~LLC,~~sourced anfrom ~~emerging~~National ~~Emirati~~Survey ~~health~~of ~~care~~Family ~~company~~Growth (~~Pharma 1~~NSFG) 2022–2023. https://www.cdc.gov/nchs/data/databriefs/db539.pdf

While our pipeline includes multiple candidates that are designed to address critical unmet needs in women’s health, we halted all clinical development in October 2022 to focus resources on growing sales of PHEXXI for the prevention of pregnancy.2

~~Aditxt~~Outside ~~Merger~~the U.S., our strategy is to commercialize our products in global markets through commercial partnerships and/or license agreements. We licensed commercial rights to PHEXX and SOLOSEC in the Middle East and North Africa (MENA) to Pharma 1 Drug Store, LLC (Pharma 1), an emerging Emirati health care company, in July 2024 and May 2025, respectively. Pharma 1 filed for regulatory approval of PHEXX in the United Arab Emirates (UAE) in June 2025 and of SOLOSEC in the UAE in September 2025

On December 11, 2023, the Company entered into an Agreement and Plan of Merger, as amended, (the Merger Agreement) with Aditxt, Inc., a Delaware corporation (Aditxt or Parent), Adifem, Inc., a Delaware corporation and wholly-owned Subsidiary of Aditxt (Merger Sub), pursuant to which, and on the terms and subject to the conditions thereof, Merger Sub will merge with and into the Company, with the Company surviving as a wholly owned subsidiary of Aditxt (the Merger).

On January 10, 2024, the Company, Parent and Merger Sub entered into the first amendment to the Merger Agreement (the First Amendment) to change the filing date for the Joint Proxy Statement (as defined in the Merger Agreement) to February 14, 2024.

On January 30, 2024, the Company, Parent and Merger Sub entered into the second amendment to the Merger Agreement (the Second Amendment) to:

(i) Change the date of the Parent Loan (as defined in the Merger Agreement) to the Company to be February 29, 2024; (ii) Change the date by which the Company may terminate the Merger Agreement for failure to receive the Loan from Parent to be February 29, 2024; and, (iii) Change the filing date for the Joint Proxy Statement (as defined in the Merger Agreement) to April 1, 2024.

On February 26, 2024, Aditxt and the Holders entered into an Assignment Agreement (the February Assignment Agreement), pursuant to which the Company consented to the assignment of all remaining amounts due under the Notes from Aditxt back to the Holders.

On February 29, 2024, the Company, Parent and Merger Sub entered into the third amendment to the Merger Agreement (the Third Amendment) to:

(i) Amend and restate Section 6.10 in its entirety as follows: “Parent Equity Investment. On or prior to (a) April 1, 2024, Parent shall purchase 2,000 shares of the Company’s Series F-1 Preferred Shares, par value $0.0001 per share for an aggregate purchase price of $2.0 million (the Initial Parent Equity Investment) and (b) April 30, 2024, Parent shall purchase 1,500 shares of F-1 Preferred Shares for an aggregate purchase price of $1.5 million (the Subsequent Parent Equity Investment).”; (ii) Delete in its entirety the provision in Section 6.16; (iii) Extend the date to file a Joint Proxy Statement to April 30, 2024; (iv) Add new Section 7.2(i) as follows: “(i) Repurchase Price. No defaults shall have occurred and be continuing under the Loan Documents and the Outstanding Balance (as defined in the Securities Purchase Agreement) plus all accrued and unpaid interest thereon, in an amount not to exceed the Repurchase Price (as defined in the Securities Purchase Agreement) shall have been paid in full.”; and, (v) Amend and restate Section 8.1(f) to allow for termination of the Merger Agreement by the Company if either (a) the Initial Parent Equity Investment has not been made by April 1, 2024, or (b) the Subsequent Parent Equity Investment has not been made by April 30, 2024.

The aforementioned numbers of shares of F-1 Preferred Shares shall be equitably adjusted for any stock split, reverse stock split, stock dividend (including any dividend or other distribution of securities convertible into F-1 Preferred Shares), subdivision, reorganization, reclassification, recapitalization, combination, exchange of shares or other like change with respect to the number of shares of F-1 Preferred Shares outstanding after the date hereof and prior to the Effective Time or any change to the Stated Value thereof as set forth in that certain Certificate of Designations of Series F-1 Convertible Preferred Stock of the Company.

On February 29, 2024, as part of the Third Amendment, Aditxt agreed to have, as a condition of closing, that the outstanding balance, plus all accrued and unpaid interest thereon, in an amount not to exceed the Repurchase Price, shall have been paid in full. The A&R Merger Agreement, as amended, entered into on July 12, 2024, maintains the same condition to closing. As discussed above, the A&R Merger Agreement was amended on August 16, 2024, September 6, 2024, October 2, 2024, November 19, 2024, and March 22, 2025; none of the amendments modified this closing condition.

On April 26, 2024, the Company delivered a termination notice to Aditxt notifying it that the Company was exercising its right to terminate the Merger Agreement effective April 26, 2024 (the Termination Notice), in accordance with Section 8.1(f) of the Merger Agreement, as revised in the third amendment to the Merger Agreement, made on February 29, 2024.

On May 2, 2024, the Company, the Merger Sub and Aditxt entered into the Reinstatement and Fourth Amendment to the Merger Agreement (the Fourth Amendment) in order to waive and amend, among other things, the several provisions listed below. In consideration of the Fourth Amendment, Aditxt agreed to pay the Company $1.0 million, which the Company received during the three months ended June 30, 2024.

Amendments to Article VI: Covenants and Agreement

Article VI of the Merger Agreement was amended to:

i. reinstate the Merger Agreement, as amended by the Fourth Amendment, as if never terminated; ii. reflect Aditxt’s payment to the Company, in the amount of $1.0 million (the Initial Payment), via wire initiated by May 2, 2024; iii. delete Section 6.3, which effectively eliminates the “no shop” provision, and the several defined terms used therein; iv. add a new defined term, “Company Change of Recommendation”; and v. revise section 6.10 of the Merger Agreement such that, after the Initial Payment, and upon the closing of each subsequent capital raise by Aditxt (each a Parent Subsequent Capital Raise), Aditxt shall purchase that number of shares of the Company’s Series F-1 Preferred Stock, par value $0.0001 per share (the Series F-1 Preferred Stock), equal to forty percent (40%) of the gross proceeds of such Parent Subsequent Capital Raise divided by 1,000, up to a maximum aggregate amount of $2.5 million or 2,500 shares of Series F-1 Preferred Stock. A maximum of $1.5 million shall be raised prior to June 17, 2024 and $1.0 million prior to July 1, 2024 (the Parent Capital Raise).

Amendments to Article VIII: Termination

Article VIII of the Merger Agreement is amended to:

i.	extend the date after which either party may terminate from May 8, 2024 to July 15, 2024;
ii.	revise Section 8.1(d) in its entirety to allow Company to terminate at any time after there has been a Company Change of Recommendation, provided that Aditxt must receive ten day written notice and have the opportunity to negotiate a competing offer in good faith; and
iii.	amend and restate Section 8.1(f) in its entirety, granting the Company the right to terminate the agreement if:
		(a)	the full $1.0 million Initial Payment required by the Fourth Amendment has not been paid in full by May 3, 2024
		(b)	$1.5 million of the Parent Capital Raise Amount has not been paid to the Company by June 17, 2024,
		(c)	$1.0 million of the Parent Capital Raise Amount has not been paid to the Company by July 1, 2024, or,
		(d)	Aditxt does not pay any portion of the Parent Equity Investment within five calendar days after each closing of a Parent Subsequent Capital Raise.

On July 12, 2024, the Company, the Merger Sub and Aditxt entered into the Amended and Restated Merger Agreement (the A&R Merger Agreement) which amends and restates in its entirety the Agreement and Plan of Merger (as amended January 10, 2024, January 30, 2024, February 29, 2024, and May 2, 2024 (collectively, the Original Merger Agreement)). Except as described below, the terms and provisions of the A&R Merger Agreement are consistent with the terms and provisions of the Original Merger Agreement.

	●	As consideration for the Merger, Parent will (i) pay $1.8 million less an amount equal to the product of (x) the number of Dissenting Shares represented by Company Common Stock and (y) the Common Exchange Ratio (as defined in the A&R Merger Agreement) (the Common Consideration)
	●	Each share of the Company’s Series E-1 Preferred Stock, par value $0.0001 (the Series E-1), issued and outstanding as of the Effective Time (as defined in the A&R Merger Agreement) shall automatically be converted into the right to receive from Aditxt one share Parent Preferred Stock (the Preferred Merger Consideration)

At the Effective Time of the Merger:

(i) The Company Convertible Note Holders will enter into an Exchange Agreement, pursuant to which these Note Holders exchange the value of their then-outstanding Company Convertible Notes and purchase rights for an aggregate of not more than 88,161 shares of Parent Preferred Stock. (ii) Each stock option of the Company (the Options), that was outstanding and unexercised immediately prior to the Effective Time will be cancelled without the right to receive any consideration. (iii) all shares of Company Common Stock or Company Preferred Stock held by Parent or Merger Sub or by any wholly-owned Subsidiary thereof, shall be automatically cancelled and retired and shall cease to exist and no consideration shall be delivered or deliverable in exchange therefore;

Further, Aditxt agreed to, on or prior to: (a) July 12, 2024, purchase 500 shares of the Company’s Series F-1 Preferred Shares for an aggregate purchase price of $0.5 million (the July Purchase) (b) August 9, 2024, purchase an additional 500 shares of F-1 Preferred Shares for an aggregate purchase price of $0.5 million (the August Purchase), (c) the earlier of August 30, 2024 or within five business days of the closing of a public offering by Aditxt resulting in aggregate net proceeds to Aditxt of no less than $20.0 million, purchase an additional 2,000 shares of F-1 Preferred Shares for an aggregate purchase price of $2.0 million (the Third Parent Equity Investment); and (d) September 30, 2024, purchase an additional 1,000 shares of F-1 Preferred Stock at an aggregate purchase price of $1.0 million (the Fourth Parent Equity Investment). The July Purchase and subsequent August Purchase of 500 shares of the Company’s Series F-1 Preferred Shares in each respective purchase were completed as scheduled.

On August 16, 2024, the Company, Parent and Merger Sub entered into the first amendment to the A&R Merger Agreement (the First Amendment), to change the funding date for the Third Parent Equity Investment Date (as defined in the A&R Merger Agreement) from August 30, 2024 to the earlier of (i) September 6, 2024 or (ii) within five (5) business days of the closing of a public offering by Parent resulting in aggregate net proceeds to Parent of no less than $20.0 million.

On September 6, 2024, the Company, Parent and Merger Sub entered into the second amendment to the A&R Merger Agreement (the Second Amendment), to (i) change the date of the Third Parent Equity Investment Date and Fourth Parent Equity Investment Date (as defined in the A&R Merger Agreement) from September 6, 2024 and September 30, 2024 to September 30, 2024 and October 31, 2024, respectively and (ii) to change the required consummation date to November 29, 2024.

On October 2, 2024, the Company, Parent and Merger Sub entered into the third amendment to the A&R Merger Agreement (the Third Amendment), to (i) change the date of the Third Parent Equity Investment Date (as defined in the A&R Merger Agreement) from September 30, 2024 to October 2, 2024, (ii) change the Third Parent Equity Investment from 1,500 shares of Series F-1 Preferred Shares to 720 shares of Series F-1 Preferred Shares, and (iii) amend the Fourth Parent Equity Investment (as defined in the A&R Merger Agreement) from 1,500 shares of Series F-1 Preferred Shares to 2,280. The Third and Fourth Parent Equity Investments were timely completed on October 2 and October 28, 2024, respectively.

On November 19, 2024, the Company, Parent and Merger Sub entered into the fourth amendment to the A&R Merger Agreement (the Fourth Amendment) to change the required consummation date to January 31, 2025.

On March 22, 2025, the Company, Parent and Merger Sub entered into the fifth amendment to the A&R Merger Agreement (the Fifth Amendment), to (i) change the required consummation date to September 30, 2025; (ii) add a Parent investment of $1.5 million to be completed by April 7, 2025 (the Fifth Parent Investment); and (iii) add a special meeting consummation date being on or prior to September 26, 2025.

The accompanying consolidated financial statements in this Annual Report do not reflect the potential impact of the A&R Merger Agreement.

The A&R Merger Agreement, as amended, is subject to certain closing conditioned and contains customary representations, warranties and covenants and indemnifications provisions.

The consummation of the Merger is conditioned upon, among other things: (i) the Company Shareholder approval shall having been obtained in accordance with applicable Law; (ii) no governmental entity having jurisdiction over any party shall have issue any order, decree, ruling injunction or other action that is in effect restraining the Merger; (iii) a voting agreement shall have been executed and delivered by the parties thereto; (iv) all Company preferred stock shall have been converted to Company common stock except for the Unconverted Company Preferred Stock (as defined by the A&R Merger Agreement); (v) the Company shall have received agreements from all of the holders of the Company’s warrants, duly executed, containing waivers with respect to any fundamental transaction, change in control or other similar rights that such warrant holders may have under any such Company warrants and exchange such Company warrants as they hold for an aggregate of not more than 930,336 shares of Parent Preferred Stock (as defined in the A&R Merger Agreement); (vi) the Company shall have cashed out any other warrant holder who has not provided a warrant holder agreement, provided, however, that the aggregate amount of such cash out for any and all other warrant holders who have not provided a warrant holder agreement shall not exceed $0.15 million; (vii) the Company shall have obtained waivers from holders of Company convertible notes of the original principal amount thereof with respect to any fundamental transaction rights such Company convertible note holders may have under any such Company convertible notes, including any right to vote, consent or otherwise approve or veto any of the transaction contemplated by this A&R Merger Agreement; (viii) Aditxt shall have received sufficient financing to satisfy its payment obligations under the A&R Merger Agreement; (ix) the requisite stockholder approval shall have been obtained by Aditxt at a special meeting of its stockholders to approve the Parent Stock Issuance (as defined in the A&R Merger Agreement); (x) Aditxt shall have received a compliance certificate from the Company certifying Company complied with all reps and warranties in the A&R Merger Agreement; (xi) Aditxt shall have received waivers from the parties to the agreements listed in Section 7.2(f) of the A&R Merger Agreement Parent Disclosure Letter of the issuance of securities in a “Variable Rate Transaction” (as such term in defined in such agreements); (xii) Parent shall have received a certificate certifying that no interest in the Company is a U.S. real property interest, as required under U.S. treasury regulation section 1.897-2(h) and 1.1445-3(c); (xiii) Aditxt shall have paid, in full, the Repurchase Price, as defined in the Fourth Amendment to the Securities Purchase and Security Agreement dated as of September 8, 2023, by and among the Company, Baker Brothers Life Sciences, L.P., 667, L.P. and Bakers Bros. Advisors LP, which was assigned to Future Pak, LLC in 2024; (xv) there shall be no more than 4,141,434 dissenting shares that are Company common stock or 98 dissenting shares that are Company preferred stock; (xiv) Company shall have received from Aditxt a compliance certificate certifying that Parent has complied with all representations and warranties; and (xv) that Aditxt shall be incompliance with stockholders’ equity requirements in Nasdaq listing rule 5550(b)(1).

In connection with the Merger Agreement, Aditxt, the Company and the holders (the Holders) of certain senior indebtedness of Evofem (the Notes) entered into an Assignment Agreement dated December 11, 2023 (the December Assignment Agreement), pursuant to which the Holders assigned the Notes to Aditxt in consideration for the issuance by Aditxt of (i) an aggregate principal amount of $5.0 million in secured notes of Aditxt due on January 2, 2024 (the January 2024 Secured Notes), (ii) an aggregate principal amount of $8.0 million in secured notes of Aditxt due on September 30, 2024 (the September 2024 Secured Notes), (iii) an aggregate principal amount of $5.0 million in ten-year unsecured notes (the Unsecured Notes), and (iv) payment of $0.2 million in respect of net sales of PHEXXI in respect of the calendar quarter ended September 30, 2023.

Our Leadership Team

We have assembled a world-class team with industry-recognized expertise in women’s sexual and reproductive health.

The team is led by Saundra Pelletier, an expert in women’s health from puberty to menopause. She has served as Chief Executive Officer, President and Executive Director of Evofem Biosciences since February 2015, and as interim Chair of the Board since November 2021. She has been responsible for the Company’s growth and evolution, ~~led~~from clinical-stage ~~Evofem’s~~private ~~transition~~company to ~~the~~a ~~public~~publicly-listed ~~market~~commercial instage ~~January~~company ~~2018, and~~generating ~~led~~revenue ~~multiple~~from ~~equity~~two ~~financing~~FDA-approved ~~rounds which have raised over $500 million~~assets.

During her more than 2526 years of experience in the pharmaceutical industry, Ms. Pelletier has launched pharmaceutical brands worldwide and expanded indications of female healthcare brands in multiple countries. Her experience includes a comprehensive range of women’s healthcare products, cardiovascular drugs, pain management agents, sleep therapeutics and medical devices. She has had oversight and accountability for Sales, Marketing, Operations, Medical Affairs, Regulatory Affairs, Manufacturing, Customer Service, Business Development and Strategic Partnerships.

Our Chief Financial Officer, Ivy Zhang, is a trusted leader and a seasoned finance executive who is dedicated to advancing our mission of addressing the unmet sexual and reproductive health needs of women. She joined Evofem as Chief Financial Officer on April 13, 2023 and leads our finance organization and financial activities including financial planning and analysis, accounting, external audit, tax, controllership, and treasury functions. Ms. Zhang has more than 1617 years of financial and accounting experience spanning diverse industries, including pharmaceuticals and medical devices. Most recently she was Vice President Corporate Controller of HUYABIO International. From March 2018 to November 2022, she held increasingly senior leadership roles in Evofem’s finance team, ultimately serving as Controller. Earlier in her career, Ms. Zhang served in finance positions for more than two and a half years at SeaSpine Holdings Corporation (a public medical and therapeutic technology and device company) and approximately seven years at Ernst & Young LLP. On April 13, 2023, the Board of Directors appointed her Secretary.

Our Strategy

Key elements of our strategy include:

● ~~Successfully~~ Successfully commercialize ~~PHEXXI~~PHEXX. Currently, our primary focus is the successful commercialization of ~~PHEXXI~~PHEXX in the U.S. Outside the U.S., we intend to commercialize ~~PHEXXI~~PHEXX through strategic partnerships or license agreements, such as ~~the~~our licensing agreement with Pharma 1 for the Gulf Cooperative Commission (GCC) and MENA, under which Pharma 1 is expected to launch PHEXX in the UAE in 2026. We believe this approach will allow us to effectively deploy our capital to maximize the inherent value of ~~PHEXXI~~PHEXX for the benefit of all stakeholders.

● Successfully commercialize SOLOSEC. In July 2024, we expanded our commercial portfolio by acquiring global rights to SOLOSEC, an oral antimicrobial agent that provides a complete course of therapy for the treatment of two common sexual health infections with just one dose. SOLOSEC is FDA-approved for the treatment of bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and Trichomonas vaginalis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC has the same call point as PHEXXI, enabling us to leverage our commercial infrastructure and strong physician relationships. We relaunched SOLOSEC in November 2024 and our continued focus will be on ensuring the success of the commercialization efforts.3

● ~~Leverage~~ ~~our~~Successfully Ucommercialize SOLOSEC.S. ~~sales~~In ~~force~~July ~~through~~2024, ~~business~~we ~~development.~~expanded Weour ~~intend~~commercial toportfolio ~~opportunistically~~by ~~acquire,~~acquiring ~~in-license~~global ~~additional~~rights ~~commercial~~to SOLOSEC, oran ~~launch-ready~~oral ~~products~~antimicrobial toagent ~~enhance~~that ~~our~~provides ~~offerings~~a ~~and~~complete ~~complement~~course ~~our~~of ~~core~~therapy ~~competencies~~for inthe ~~women’s~~treatment of two common sexual health infections with just one dose. InSOLOSEC ~~addition~~is ~~to increasing~~FDA-approved ~~revenues,~~for the ~~addition~~treatment of ~~other~~bacterial ~~commercial~~vaginosis ~~assets~~(BV), ~~would~~a ~~diversify~~common ~~our~~vaginal ~~revenue~~infection, ~~stream~~in females 12 years of age and older, and Trichomonas vaginalis, a common sexually transmitted infection (STI), in people 12 years of age and older. We relaunched ~~may~~SOLOSEC ~~also~~in ~~defray~~November ~~sales~~2024 ~~force~~and our continued focus will be on ensuring the success of the commercialization efforts. As with ~~costs~~PHEXX, bywe ~~promoting~~aim ~~synergistic~~to ~~products~~commercialize ~~for~~SOLOSEC ~~other~~outside ~~companies~~the onU.S. athrough ~~fee-for-service~~strategic ~~basis~~partnerships or license agreements, such as our licensing agreement with Pharma 1.

7● Reduce Manufacturing Costs / COGS. Our goal is to improve margins by lowering the cost to manufacture our products. In 2027, when we are selling product made under new manufacturing contracts, we hope to reduce both PHEXX and SOLOSEC COGS by approximately 55% to 60% from current levels.

● Leverage our U.S. sales force through business development. We intend to opportunistically acquire or in-license additional commercial or launch-ready products to enhance our offerings and complement our core competencies in women’s health. In addition to increasing revenues, the addition of other commercial assets would diversify our revenue stream.

Contraceptive Market Overview

U.S. Contraceptive Market

The U.S. is the largest commercial market worldwide and presents the greatest opportunity for ~~PHEXXI~~PHEXX and other women’s health products. The total U.S. contraceptive market was valued at $8.78 billion in 2024 and is expected to reach approximately $12 billion by 2030 with a compound annual growth rate of 4.7% ~~(source: Grand View Research, U.S. Contraceptive Market Size, Share & Trends Analysis Report By Product and Segment Forecasts, 2023 – 2030.)~~3

In the U.S., ~~current~~an ~~contraceptive~~estimated ~~options~~54.3% ~~include~~of women of reproductive age 15-49 use contraception2 including:

● ~~devices~~Non-hormonal ~~designed~~contraceptives: toprescription ~~prevent~~methods ~~pregnancy~~including ~~through~~PHEXX, ~~physical~~the ~~means~~female condom, and diaphragms, and non-prescription methods such as ~~condoms~~the male condom, withdrawal, periodic abstinence, and ~~diaphragms~~cycle tracking; ● Short-acting hormone-based prescription pharmaceutical products: oral contraceptives (OCs), vaginal rings, transdermal patches, and intramuscular injections – all prescription products; and, ● Long-acting removable contraceptives (LARCs): hormonal intrauterine devices (IUDs), a hormone-free copper IUD, and hormonal implants – all prescription products.

~~● hormone-based pharmaceutical products, including oral~~ Hormonal contraceptives ~~(OCs), vaginal rings, transdermal patches, intramuscular injections, subcutaneous implants and intrauterine devices (IUDs). These~~ can be associated with undesirable side effects such as weight gain, loss of libido and mood changes that may lead women to discontinue their use and seek alternative contraceptive methods. Hormonal birth control is also associated with a slight increase in the risk of breast cancer, as published in the peer-reviewed journal PLOS Medicine in March 2023;

	●	a hormone-free copper IUD; and
	●	PHEXXI, a prescription vaginal pH modulator that was introduced to the market in September 2020.

The vast majority of contraceptive products require a prescription in the U.S. Besides condoms and a progestin-only OC that was converted to over-the-counter (OTC) status in 2024, the only currently available OTC contraceptive products in the U.S. are spermicides that contain nonoxynol-9 (N-9), a surfactant (detergent).

As shown in the chart below, which is based on data from the ~~2017~~2022–~~2019~~2023 National Survey of Family Growth, of the 7274.79 million ~~women~~ women of reproductive age (15-49) in the U.S., 136.01 million women use no method of birth control, putting them at risk of unintended pregnancy. An additional 109.38 million women in the U.S,. rely on ~~condoms~~a orshort-acting ~~some~~hormone-free ~~other~~method; ~~form~~methods ofin ~~non-hormonal~~this ~~OTC~~category ~~birth~~include PHEXX, ~~control~~male ~~(e.g.~~and female condoms, the rhythm method, diaphragms, cervical cap, spermicides, and withdrawal). Another 2010.03 million women in the U.S. use ~~prescription~~short-acting ~~birth control methods; these are predominantly~~ hormone-based ~~with~~contraceptives ~~the~~including ~~sole exception of~~ the ~~copper~~oral ~~IUD.~~contraceptive ~~This~~pill, ~~study~~patch, ~~predated~~vaginal ~~the~~ring ~~FDA-approval~~ and Ushot.S. ~~launch of PHEXXI~~ Women in ~~2020~~each ~~as well as the 2024 switch~~ of ~~Opill~~these ~~from~~groups ~~prescription to~~are ~~OTC~~potential ~~status~~PHEXX users.

~~Source:~~2 Daniels- K~~-and-~~, Abma- J.- Current- Contraceptive- Status- Among~~-Women-Aged-~~ Females Ages 15~~-49_NCHS-~~–49: United States, 2022–2023. NCHS Data- Brief- Number~~-388-October-2020~~ 539.~~pdf~~ ~~(evofem~~August 2025.~~com)~~ Accessed Jan. 9, 2026, via https://www.cdc.gov/nchs/data/databriefs/db539.pdf

83 Grand View Research, U.S. Contraceptive Market Size, Share & Trends Analysis Report By Product and Segment Forecasts, 2023 – 2030

Per the NCHS-published data, an aggregate 23.3 million women who are currently at risk for pregnancy are not using hormone-based contraceptives as their primary form of contraception. Evofem hopes that PHEXXI will grow the prescription birth control market through adoption by women in these groups.4

~~Through~~Source: ~~the~~Daniels ~~growing utilization of GLP-1 prescription medications like Ozempic~~K, ~~Mounjaro~~Abma ~~and Zepbound, a new opportunity for PHEXXI has emerged~~J. ~~GLP-1s~~ ~~may~~Current ~~make~~Contraceptive ~~oral~~Status ~~birth~~Among ~~control~~Females ~~pills~~Ages ~~less~~15–49: ~~effective~~United atStates, ~~certain points in the dosing schedule~~2022–2023. ~~Per~~NCHS ~~the~~Data ~~USPI,~~Brief ~~prescribers are instructed~~Number to539. ~~“advise~~August ~~patients using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method” to prevent unintended pregnancy during these times~~2025. ~~PHEXXI~~Accessed ~~can be prescribed to prevent unintended pregnancy in these patients~~Jan. We9, ~~aim to~~2026, ~~increase~~via ~~awareness among GLP-1 users and prescribers to build adoption of PHEXXI among women concurrently taking GLP-1s and oral birth control pills~~https://www.cdc.gov/nchs/data/databriefs/db539.pdf.

Per the NCHS-published data, an aggregate 15.9 million women who are currently at risk for unintended pregnancy are not using hormone-based contraceptives or a LARC as their primary form of contraception. These women are key targets for PHEXX.

Through the growing utilization of GLP-1 prescription medications like Ozempic, Mounjaro and Zepbound, we believe a new opportunity for PHEXX has emerged. GLP-1s may make oral birth control pills less effective at certain points in the dosing schedule⁴. Per the United States Prescribing Information (USPI) for Mounjaro and Zepbound, prescribers are instructed to “advise patients using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method” to prevent unintended pregnancy during these times.⁵ The USPI for Ozempic similarly advises that the drug “may impact absorption of concomitantly administered oral medications”.⁶ We believe PHEXX can be prescribed to help prevent unintended pregnancy in these patients.

⁴ Washington State Health Care Authority. Bulletin 28 Jan. 2025. Accessed 10 Feb. 2026 via https://content.govdelivery.com/accounts/WAHCA/bulletins/3ce3574

⁵ Zepbound Prescribing Information: “Use in Specific Populations”. Accessed 10 Feb. 2026 via https://uspl.lilly.com/zepbound/zepbound.html#pi

Mounjaro Prescribing Information: “Use in Specific Populations”. Accessed 10 Feb. 2026 via https://uspl.lilly.com/mounjaro/mounjaro.html#pi

⁶ Ozempic Prescribing Information: “Drug Interactions”. Accessed 10 Feb. 2026 via https://www.novo-pi.com/ozempic.pdf

In the U.S., an estimated 15.77 million women of reproductive age (ages 18-49) report GLP-1 use⁷. Factoring published data from the 2024 KFF Women’s Health Survey on use of oral contraceptives in women ages 18-49⁸, we estimate that in the U.S. alone there are 3.55 million women on GLP-1s who also use oral contraceptives. This translates to a $904 million total addressable market in the U.S. We aim to increase awareness among these women and their healthcare providers to drive adoption of PHEXX and expand sales into this sub-market.

Market Opportunity: Contraception

Hundreds of millions of women worldwide seek sexual and reproductive health products that provide them with their self-defined control of their individual needs during their (on average) 30+ years of fertility. However, an estimated 218 million women who want to avoid pregnancy are not using safe, modern methods of contraception and nearly half of all pregnancies – 112 million each year - are unintended according to the United Nations 2024 State of World Population report.

According to the CDC, reducing the percentage of all unintended pregnancies has been one of the National Health Promotion Objectives since its establishment in 1980. ~~Approximately~~Despite ~~two~~this, ~~million~~approximately ~~unintended~~41.6% ~~pregnancies~~of ~~occur~~all inpregnancies ~~the~~are ~~U.S. annually~~unintended; ~~36%,~~there orare ~~1.97~~approximately ~~million of the 5~~2.513 million ~~total~~ unintended pregnancies in the U.S., ~~were~~each ~~unintended~~year.9 inBy ~~2019.~~successfully ~~(CDC~~commercializing ~~National~~PHEXX, ~~Center~~a ~~for~~hormone-free, ~~Health~~on-demand ~~Statistics~~contraceptive ~~(NCHS).~~gel ~~National~~controlled by ~~Pregnancy~~women, ~~Rate~~we ~~Estimates released~~believe ~~April~~we ~~12,~~can ~~2023)~~help address this need.

Our Commercial Products: ~~PHEXXI~~PHEXX and SOLOSEC

~~PHEXXI~~PHEXX

~~PHEXXI~~PHEXX® (lactic acid, citric acid and potassium bitartrate) vaginal gel is the only FDA-approved, hormone-free, on-demand, woman-controlled prescription contraceptive drug product available in the U.S. We believe ~~PHEXXI~~PHEXX’s attributes address significant gaps and ~~underserved and~~ unmet needs in the contraceptive market, ~~and~~making ~~make~~ it an attractive contraceptive choice for women.

~~PHEXXI~~PHEXX key benefits:

● Hormone-free: ~~PHEXXI~~PHEXX is an innovative, ~~gel~~hormone-free ~~that~~contraceptive ~~works~~gel. toBy ~~prevent~~avoiding ~~pregnancy without the use of~~ hormones., ~~Because~~it ~~PHEXXI~~offers isan ~~completely~~alternative ~~hormone-free,~~for women who are ~~less~~concerned ~~likely~~about toside ~~worry~~effects ~~about~~commonly ~~the~~associated ~~hormone-related~~with ~~side~~hormonal ~~effects~~birth control, ~~like~~such as weight ~~gain~~changes, mood ~~swings~~effects, or ~~blood~~increased ~~clots~~risk ~~which~~of ~~are~~blood ~~associated with hormonal birth control methods~~clots. ● Only when you need it: With ~~PHEXXI~~PHEXX, women no longer need to have birth control in their bodies 24/7. ~~PHEXXI~~PHEXX is used in the moment, 0-60 minutes before each and every act of sex, so no daily commitment is required. This also makes ~~PHEXXI~~PHEXX easily reversible, providing women with a flexible option for family planning. ● First in class: ~~PHEXXI~~PHEXX is the first and only hormone-free prescription birth control gel that women control. ~~PHEXXI~~PHEXX works to prevent pregnancy by maintaining the vaginal pH, which reduces sperm motility, and lowers the chance of sperm reaching the egg. This revolutionary mechanism of action is unique to ~~PHEXXI~~PHEXX, meaning we know of no other products like it in the market. ● Woman-controlled: ~~PHEXXI~~PHEXX puts women in control of their bodies and their pregnancy prevention. With ~~PHEXXI~~PHEXX, there is no need to rely on a partner to bring a condom, to take a pill at the same time every day, and no need for an in-office injection or procedure to prevent pregnancy. The quick and easy pre-sex application is designed with spontaneity and convenience in mind.

97 Bozick et al. New Weight Loss Drugs: GLP-1 Agonist Use and Side Effects in the United States. Analysis of RAND American Life Panel survey data, April–May 2025. (n = 8,793). Pub. Aug 6, 2025. Accessed Jan. 7, 2026, via https://www.rand.org/pubs/research_reports/RRA4153-1.html)

~~PHEXXI~~8 isFrederiksen ~~designed~~B, toDiep ~~address~~K, ~~underserved~~Salganicoff A. Contraceptive Experiences, Coverage, and ~~unmet~~Preferences: ~~needs~~Findings infrom the ~~birth~~2024 ~~control~~KFF ~~market~~Women’s Health Survey. Nov 22, as2024. ~~seen~~Accessed inJan ~~the~~7, ~~table~~2026, ~~below~~via https://www.kff.org/womens-health-policy/contraceptive-experiences-coverage-and-preferencesfindings-from-the-2024-kff-womens-health-survey/#:~:text=Eight%20in%20ten%20(82%25)%20women,Almost%20half%20(48%25)%20of%20contraceptive.

Prescription Contraceptive Products and Associated Benefits

Product Class

Non-Hormonal

No Systemic Side Effects

Non-invasive

Convenient

Vaginal pH Modulator (i.e., PHEXXI)

✔

28 Day OCs

✔

Extended Regimen OCs

✔

Hormone Releasing IUDs

✔

Copper IUD

✔

Implant

✔

Vaginal Ring

✔

Transdermal Patch

✔

⁹ Rossen LM et al. Updated methodology to estimate overall and unintended pregnancy rates in the United States. National Center for Health Statistics. Vital Health Stat 2(201). 2023. DOI: https://dx.doi.org/10.15620/cdc:124395.

PHEXX is designed to address underserved and unmet needs in the birth control market, as highlighted in the table below.

Prescription Contraceptive Products and Associated Benefits
Product Class	Non-Hormonal	No Systemic Side Effects	Non-invasive	Convenient
Vaginal pH Modulator (i.e., PHEXX)	✔	✔	✔	✔
28 Day OCs			✔
Extended Regimen OCs			✔
Hormone Releasing IUDs				✔
Copper IUD	✔	✔		✔
Implant				✔
Vaginal Ring			✔	✔
Transdermal Patch			✔

Vaginal pH Modulator Mechanism of Action

A normal vaginal pH of 3.5 to 4.5 is important for maintaining good vaginal health. At this optimal pH level, the ~~vagina~~vaginal ~~contains~~biome ~~a balance~~supports of necessary healthy bacteria. ~~Additionally,~~while aremaining ~~vaginal pH in this range is~~ inhospitable to sperm asand ~~well as~~ certain viral and bacterial pathogens.

10PHEXX was developed to have acid-buffering (pH 3.5), lubricating, and viscosity-retaining properties to acidify the male ejaculate in the vagina. Typically, the introduction of semen (pH = 7.2-8.0) into the vagina causes a rise in pH to above 6.0 due to the alkalinity of the ejaculate, which neutralizes the normally acidic vaginal environment and allows for the survival of sperm. The active ingredients in PHEXX produce a normal vaginal pH (3.5-4.5) even in the presence of semen, creating an inhospitable environment for sperm. The maintenance of the acidic vaginal pH reduces the availability of calcium ions which are needed to drive sperm tail movement. In vitro studies show immediate sperm motility reduction10. PHEXX prevents pregnancy by reducing sperm motility, inhibiting sperm from reaching the ovum to form a zygote. Other properties contributing to PHEXX’s mechanism of action are its capacity to 1) maintain sufficient viscosity even when diluted by the introduction of semen into the vagina, 2) impede cervical mucus penetration by sperm, and 3) form a protective layer over the vaginal and cervical epithelium.

PHEXXI was developed to have acid-buffering (pH 3.5), lubricating and viscosity-retaining properties to provide effective acidification of the male ejaculate in the vagina. Typically, the introduction of semen (pH = 7.2-8.0) into the vagina causes a rise in pH above 6.0 due to the alkalinity of the ejaculate, which neutralizes the normally acidic vaginal environment and allows for the survival of sperm. The active ingredients in PHEXXI produce a normal vaginal pH (3.5-4.5) even in the presence of semen, creating an inhospitable environment for sperm. The maintenance of the acidic vaginal pH reduces the availability of calcium ions which are needed to drive sperm tail movement. In vitro studies show immediate sperm motility reduction. PHEXXI prevents pregnancy by reducing sperm motility, inhibiting sperm from reaching the ovum to form a zygote. Other properties contributing to PHEXXI’s mechanism of action are its capacity to maintain sufficient viscosity even upon dilution with the introduction of semen into the vagina, impede cervical mucus penetration by sperm, and form a protective layer over the vaginal and cervical epithelium.

SOLOSEC

In July 2024, we expanded our commercial portfolio by acquiring global rights to SOLOSEC® (secnidazole) 2g2 g oral granules, a single-dose oral antimicrobial agent that provides a complete course of therapy with just one dose for the treatment of two common sexual health infections. SOLOSEC is FDA-approved for the treatment of ~~two sexual health diseases~~: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and Trichomonas vaginalis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC has the same call point as PHEXXI, enabling us to leverage our commercial infrastructure and strong physician relationships.

	1)	Bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and
	2)	Trichomonas vaginalis, a common sexually transmitted infection (STI), in people 12 years of age and older.

SOLOSEC has the same call point as PHEXX, enabling us to leverage our commercial infrastructure and strong physician relationships. We re-launched the brand in November 2024.

¹⁰ Amaral E, et al. Postcoital testing after the use of a bio-adhesive acid buffering gel (ACIDFORM) and a 2% nonoxynol-9 product. Contraception. 2004 Dec;70(6):492-7. doi: 10.1016/j.contraception.2004.06.007. PMID: 15541412.

Bacterial Vaginosis

Bacterial vaginosis (BV) affects an estimated 21 million women in the U.S., approximately 29% of the U.S. population, making it the most common vaginal condition in women ages 15-44. It results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms including odor and discharge. Of interest, BV raises the pH of the vagina, making it a more friendly environment for trichomoniasis and other STIs; approximately 20% of BV patients also have trichomoniasis.

If left untreated, BV can have serious health consequences. Untreated or improperly treated BV is associated with increased risk of infection with STIs like HPV, herpes, trichomoniasis, chlamydia, gonorrhea, and HIV, as well as transmission of STIs to a partner. Additional risks include developing pelvic inflammatory disease (PID), which can threaten a ~~women~~woman’s fertility, and complications with gynecological surgery.

~~There~~In ~~are~~May ~~several~~2025, ~~currently~~an ~~available~~investigator-led ~~treatments~~clinical trial entitled ‘Once Weekly Secnidazole Granules for BVthe Treatment of Recurrent Bacterial Vaginosis’ was presented at the 2025 ACOG Annual Clinical and Scientific Meeting; the abstract was subsequently published in Obstetrics & Gynecology. ~~SOLOSEC~~In isthis ~~uniquely~~focused ~~designed~~clinical ~~for~~study ~~convenient,~~of ~~safe~~24 women with recurrent BV, ~~single~~once-~~dose~~weekly ~~oral~~dosing ~~administration~~with SOLOSEC demonstrated efficacy inmatching or potentially surpassing outcomes of current CDC-recommended suppressive treatments. These promising results underscore SOLOSEC’s potential to redefine the standard of care for recurrent BV ~~treatment~~by ~~market,~~offering asa ~~seen~~simpler intreatment ~~the~~option ~~table~~for ~~below~~long-term symptom control.

~~The~~There ~~comparative~~are ~~efficacy~~several ofcurrently ~~SOLOSEC~~available ~~vs. these~~ treatments ~~has~~for ~~not~~BV. ~~been~~We ~~adequately~~believe ~~studied.~~SOLOSEC ~~This~~ is ~~not~~uniquely adesigned ~~complete~~for ~~list~~convenient, ofsafe, ~~attributes~~single-dose ~~for each~~oral ~~product~~administration ~~that~~in ~~may be important to a clinical decision. For~~ the ~~most~~BV ~~updated~~treatment ~~information~~market, ~~consult~~as ~~the~~seen PIin ~~for~~the ~~each~~table ~~product~~below.

~~While~~The ~~oral~~comparative ~~metronidazole~~efficacy ~~is the current standard~~ of ~~care~~SOLOSEC tovs. ~~treat~~these ~~BV,~~treatments ~~research~~ has ~~shown~~not ~~that~~been asadequately ~~many~~studied. asThis ~~50%~~is ~~of patients with BV do~~ not ~~adhere to~~ a ~~full~~complete ~~course~~list of ~~metronidazole~~attributes ~~treatment~~for ~~(500mg~~each product 2xthat ~~per~~may ~~day~~be ximportant 7to ~~days). 58% of women who do not complete therapy will have~~ a ~~recurrence within~~clinical ~~one year~~decision. ~~Noncompliance~~For tothe amost ~~multiple-day~~updated ~~metronidazole~~information, ~~regimen~~consult isthe aPrescribing ~~contributing~~Information ~~factor~~(PI) tofor ~~persistent~~each BVproduct.

11Research has shown that as many as 50% of patients with BV do not adhere to a full course of metronidazole treatment (500mg BID x 7d) 14 doses. 58% of women who do not complete therapy will have a recurrence within one year. Noncompliance to a multiple-day metronidazole regimen is a contributing factor to persistent BV.

In clinical trials, SOLOSEC demonstrated clinically and statistically significant efficacy in the treatment of BV with just one dose; 68% of patients treated with SOLOSEC did not require any additional treatment for BV. Guidelines ~~for~~from the American College of Obstetricians and Gynecologists (ACOG) in 2020 and the U.S. Centers for Disease Control (CDC) in 2021 each include single dose SOLOSEC for the treatment of BV.

Trichomoniasis

Trichomoniasis (Trich) is the most common non-viral STI in the world. It is caused by a parasite called Trichomonas vaginalis and affects both women and men. All sexual partners of an infected person must be treated to prevent reinfection with the parasite. In 2018, there were an estimated 6.9 million new T. vaginalis infections in the U.S. According to the CDC, the U.S. prevalence of T. vaginalis is 2.1% among females and 0.5% among males, with the highest rates among Black females (9.6%) and Black males (3.6%). A study of STD clinic attendees in Birmingham, Alabama, identified a prevalence of 27% among women and 9.8% among men. Approximately 70% of women with trichomoniasis are also infected with the bacteria that cause BV.

In clinical trials, a single dose of SOLOSEC demonstrated a cure rate of 92.2% for Trich in women, while reported cure rates in males range from 91.7%-100%.

SOLOSEC’s one-and-done dosing and the resulting high level of compliance is believed to be a significant differentiator. Non-compliance to a multi-day metronidazole regimen is a contributing factor to persistent Trich or BV; and ACOG and the CDC no longer recommend single dose metronidazole to treat Trich in women.

A Phase 4 investigator-led randomized, open-label, parallel arm clinical trial is underway to evaluate the efficacy and cost-effectiveness of secnidazole (SOLOSEC 2 g, one dose administered one time) versus metronidazole (Flagyl^® 500 mg, administered twice daily for seven days) for the treatment of trichomoniasis in men and women. Study investigators hypothesize that, in the current clinical trial, the rate of repeat infections with T. vaginalis will be 1.75 lower in the SOLOSEC arm versus the multi- dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. This trial is funded by the National Institutes of Health (NIH).

Commercialization Strategy

Evofem’s commercial operations are focused on the U.S., which is the largest commercial market worldwide and which we believe presents the greatest opportunity for ~~PHEXXI~~PHEXX, SOLOSEC, and other women’s health products. Our strategy is to commercialize ~~PHEXXI~~PHEXX, SOLOSEC, and ~~potentially~~ potentially other innovative women’s health products in the U.S. through our dedicated sales team, supported by a telehealth platform.

Outside the U.S., the Company’s strategy is to commercialize our products in global markets through commercial partnerships and/or license agreements. ~~PHEXXI~~Our ~~was~~first ~~approved~~licensed interritory ~~Nigeria~~is ~~on October 6, 2022, as Femidence™ by~~ the ~~National~~Middle ~~Agency~~East ~~for Food~~ and ~~Drug~~North ~~Administration and~~Africa ~~Control.~~(MENA); ~~PHEXXI has been submitted for approval in Mexico, Ethiopia and Ghana. In July 2024,~~ we licensed commercial rights to ~~PHEXXI~~PHEXX and inSOLOSEC ~~the Middle East~~ to Pharma 1 Drug Store, LLC, an emerging Emirati health care company (Pharma 1), in July 2024 and May 2025, respectively. ~~The~~For each product, the licensed territory includes the United Arab Emirates (UAE), Kuwait, Saudi Arabia, Qatar and certain other countries in the region. Pharma 1 is responsible for obtaining and maintaining any regulatory approvals required to market and sell ~~PHEXXI,~~each product, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. ~~Evofem will supply PHEXXI to~~ Pharma 1 atfiled ~~cost-plus. Pharma 1 is expected to file~~ for regulatory approval of ~~PHEXXI~~PHEXX in the ~~UAE~~United inArab ~~the~~Emirates ~~first~~(UAE) ~~half~~in ofJune 2025 and isof ~~contractually~~SOLOSEC ~~obligated~~in tothe ~~launch~~UAE ~~within~~in ~~60 days of approval~~September 2025.

129

Commercialization of ~~PHEXXI~~PHEXX and SOLOSEC in the U.S.

The U.S. is the largest commercial market worldwide and presents the greatest opportunity for ~~PHEXXI~~PHEXX, SOLOSEC, and other women’s ~~health~~ health products. Our sales force promotes ~~PHEXXI~~PHEXX and SOLOSEC directly to obstetrician/gynecologists and their affiliated health professionals, who collectively write the majority of prescriptions for contraceptive products and treatments for bacterial vaginosis (BV) and trichomoniasis. As of March 14, 2025, our sales force consisted of 16 regional sales representatives, who have on average 14 years in the Pharma industry and 12 years in women’s health. They are supported by two business directors and an SVP of Commercial Operations. The sales team is geographically focused on territories with most favorable PHEXXI coverage, targeting HCPs with an abundance of the PHEXXI patient type and/or who are likely prescribers of SOLOSEC.

We also offer women direct access to ~~PHEXXI~~PHEXX via a telehealth platform. Using this platform, women can directly meet with a ~~healthcare~~an ~~provider (~~HCP) to determine if they are eligible for a prescription and, if so, have the prescription written by the HCP, then filled and ~~mailed~~ mailed directly to them by a third-party pharmacy or by utilizing their pharmacy of choice.

Our commercial strategy for ~~PHEXXI~~PHEXX includes targeting women of reproductive potential in the U.S., We focus our efforts on 1) the approximately 15.911 23 million sexually active women who are ~~not~~ currently using ~~hormonal~~a hormone-free method (non-LARC) or no contraception ~~and~~at all, and 2) the approximately 2010.3 million women who are using a ~~prescription~~hormonal contraceptive (non-LARC), some of whom, particularly pill users, may be ready to move to an FDA-approved, non-invasive, hormone-free contraceptive. An important subset of this population is contraceptive pill users who also take GLP-1s and who may benefit from concurrent use of ~~PHEXXI~~PHEXX to prevent unintended pregnancy during GLP-1 dose ~~evaluation~~ escalation periods. Additionally, we target certain identified target HCP segments.

Our commercial strategy for SOLOSEC is directed towards approximately 3,000 HCPs within the OB/GYN space, with a particular focus on current SOLOSEC. Weprescribers ~~aim to build advocates through national initiatives~~ and ~~Key Opinion Leader (KOL) development while leveraging the~~ established relationships of our experienced sales team.

BV is the most common vaginal condition in women of reproductive age in the United States, affecting an estimated 21 million women. The condition results from an overgrowth of certain bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and/or discharge. The CDC, in its 2021 STI Treatment Guidelines, recommends treatment for bacterial vaginosis in women with symptoms. Our commercial strategy for SOLOSEC reflects the coverage reality that SOLOSEC is best for women who have had BV previously.

Of interest, BV raises the pH of the vagina, increasing the likelihood of concomitant infection with trichomoniasis and other STIs; approximately 20% of BV patients also have trichomoniasis.

There are an estimated 6.9 million new trichomoniasis infections in the U.S. each year. Up to 70% of people infected with this STI are unaware that they are infected and may unwittingly pass the parasite to sexual partners. Untreated infections might last from months to years. Undiagnosed infections and lack of compliance with multi-day treatment regimens are critical contributing factors to the prevalence of this parasitic STI. All sexual partners of people infected with trichomoniasis should be treated with the same dose and at the same time to prevent reinfection.

SOLOSEC is designed to be easy to take; one oral dose contains a complete course of treatment for BV and trichomoniasis, which appeals to patients and HCPs alike.

Payer and Reimbursement Strategy in the U.S.

Pricing Strategy

Our pricing strategy for ~~PHEXXI~~PHEXX was informed by extensive pre-approval payer research including discussions with decision makers at ~~major~~ major health plans and pharmacy benefit managers (PBMs) across the U.S. who at the time controlled nearly 83 million commercial lives. Based on this gathered intelligence, we initially priced ~~PHEXXI~~PHEXX at $267.50 per box of 12 applicators upon its launch in 2020 and each year we update the pricing to account for changes to the consumer price index and other considerations. Our pricing, when annualized, is comparable to all other commercially available branded prescription contraceptives.

~~PHEXXI~~PHEXX is classified in the databases and pricing compendia of Medi-Span and First Databank, two major drug information databases that payers can consult for pricing and product information, as the first and only “vaginal pH modulator.”

Our pricing strategy for SOLOSEC is a continuance of legacy pricing established by ~~Lupin,~~the company from which we acquired the asset in July 2024. While SOLOSEC is positioned at a different price point compared to ~~some~~ other products available for similar indications, ~~its~~ its convenient one-time oral dosing supports better patient compliance, which could contribute to cost benefits from a health economics perspective. As legacy payor contracts expire, we are re-evaluating the strategy and making adjustments.

¹¹Daniels K and Abma J. Current Contraceptive Status Among Females Ages 15–49: United States, 2022–2023. NCHS Data Brief No. 539. August 2025. Data table for Figure 1, sourced from National Survey of Family Growth (NSFG) 2022–2023. https://www.cdc.gov/nchs/data/databriefs/db539.pdf

Third-party Payers

Market acceptance and sales of ~~PHEXXI~~PHEXX and SOLOSEC depend, in part, on the extent to which reimbursement is available from third-party payers, which include government health administration authorities, managed care organizations, private health insurers and PBMs. Third-party payers decide which therapies they will pay for and establish reimbursement levels for those therapies. Decisions regarding the extent of coverage and amount of reimbursement to be provided for any product are made on a payer-by-payer basis. One payer’s determination to provide coverage for a drug does not assure that other payers will also provide coverage and adequate reimbursement for that drug.

Managed care organizations and other private insurers frequently adopt their own payment or reimbursement reductions. The continued integration between commercial health plans and PBMs has increased the negotiating power of these entities. Third-party payers increasingly employ formularies to control costs; they negotiate discounted prices in exchange for formulary inclusion. These formularies often do not include all products approved for any particular indication. We continue to work with health plans and PBMs to improve and secure additional formulary positioning for ~~PHEXXI~~PHEXX and SOLOSEC.

In the second quarter of 2022, we successfully negotiated a contract with one of the largest PBMs in the nation, which added ~~PHEXXI~~PHEXX to ~~its~~ its formulary with no restrictions for most women covered by the plan. The agreement was ~~retroactive~~effective ~~and took effect~~ January 1, 2022 and expired on isJanuary ~~representative~~1, of2026, ~~approximately~~at 46which ~~million~~time ~~lives~~we made the strategic decision not to renew. An additional 13.7 million lives are covered under our December 2020 ~~PHEXXI~~PHEXX contract award from the U.S. Department of Veterans Affairs.

For SOLOSEC, ~~Third~~third-~~Party~~party coverage generally involves ~~more~~greater ~~barriers~~utilization ~~to patient access~~management, ~~such~~ asincluding prior ~~authorizations~~authorization requirements, ~~because~~due ~~there~~in ~~are~~part ~~less~~to ~~expensive~~the ~~generics~~availability ~~available~~of inlower-cost generic therapies for the ~~class~~same indications. However, ~~the~~SOLOSEC’s ~~one~~single-~~and-done~~dose regimen ~~dosing~~ and ~~improved~~ associated compliance ~~makes~~benefits ~~getting~~can ~~SOLOSEC~~support ~~approved~~prior ~~with~~authorization aapproval ~~prior~~in ~~authorization~~appropriate ~~easier~~patients. As a result, our ~~sales~~commercial efforts ~~team~~are ~~focuses~~focused on ~~the~~ patient ~~type~~populations with ~~repeated~~ recurrent or persistent BVbacterial vaginosis.

We also participate in government programs including the 340B and the Medicaid Drug Rebate Program, which ~~took effect January 1, 2021, and~~ affords access to ~~PHEXXI~~PHEXX and SOLOSEC for the U.S. Medicaid population.

Affordable Care Act

The Affordable Care Act (ACA) guarantees coverage of women’s preventive services, including free birth control and contraceptive counseling, for all individuals and covered dependents with reproductive capacity. This includes all contraceptives approved, granted, or cleared by the FDA. The ACA also requires most health plans to cover STI screenings and counseling, for certain populations, at no cost.

History

Under section 2713 of the Public Health Service (PHS) Act, group health plans and health insurers are required to cover preventive care and screenings under guidelines issued by the Health Resources and Services Administration (HRSA). PHS Act section 2713 took effect when added by the Affordable Care Act (ACA) in 2010.

HRSA guidelines issued in 2019 required broad coverage of contraceptive care and services for women. HRSA issued updated guidelines in late 2021, under which:

	a.	The full range of FDA- approved, -granted, or -cleared contraceptives, effective family planning practices, and sterilization procedures should be available as part of contraceptive care.

	b.	The full range of contraceptives includes those currently listed in the FDA’s Birth Control Guide and any additional contraceptives approved, granted, or cleared by the FDA.

On January 1, 2023, the current HRSA Women’s Preventive Services Guidelines took effect for calendar year plans.

Separately, on January 10, 2022, the U.S. Department of Health and Human Services (HHS), alongside the Departments of Labor and of the Treasury (the Departments) issued updated guidance related to contraceptive access. Specific directives to healthcare plans under the Departments’ FAQ Update include that:

	a.	Plans are required to cover an FDA- approved, cleared, or granted contraceptive, if a provider deems it medically necessary, at $0 cost share, whether or not it is specifically identified in the current FDA Birth Control Guide.

	b.	Plans may not require patients to try and fail multiple options within a method, or force trying and failing other methods, if a provider deems a product medically necessary.

The Departments also established clear communications channels for consumers with concerns about their plan’s compliance with ~~HSRA~~HRSA requirements.

Collectively, this new guidance specifies that most insurers and pharmacy benefit managers (PBMs) must provide coverage, with no out-of-pocket costs to women, for FDA-approved contraceptive products, like ~~PHEXXI~~PHEXX® (lactic acid, citric acid and potassium bitartrate), prescribed by healthcare providers.

In July 2022 after the fall of Roe v. Wade and in the wake of action in many states to restrict access to emergency contraception, the Departments released further guidance regarding birth control coverage. Key points of this guidance include:

	–	Most private health plans and health insurance issuers must cover contraceptives at no additional cost to individuals under the Affordable Care Act no matter where they live or work.

	–	Violators of the preventive care coverage requirements may be subject to the $100 per person per day excise tax under section 4980D of the Internal Revenue Code or a civil monetary penalty under PHS Act section 2723.

	–	The Departments “will take enforcement action as warranted.”

14As of and since January 1, 2023, most insurers and PBMs must provide coverage, with no out-of-pocket costs (e.g. $0 copay) to the subscriber or dependent, for FDA-approved contraceptive products, like PHEXX, prescribed by healthcare providers.

As ofa ~~and since January 1~~result, ~~2023,~~to ~~most~~comply ~~insurers and pharmacy benefit managers (PBMs) must provide coverage,~~ with nothese ~~out-of-pocket costs (e.g. $0 copay) to the subscriber or dependent~~Guidelines, ~~for~~payers ~~FDA-approved~~are ~~contraceptive~~increasingly ~~products,~~covering ~~like~~PHEXX ~~PHEXXI, prescribed~~ by ~~healthcare providers.~~:

~~As a~~– ~~result,~~Adding PHEXX to ~~comply~~formulary ~~with~~(commercial ~~these~~insurers) ~~Guidelines,~~or ~~payers~~preferred ~~are~~drug ~~increasingly~~list ~~covering~~(Medicaid) ~~PHEXXI~~– ~~by:~~Removing the requirement for a Prior Authorization letter from the HCP (commercial insurers) – Moving PHEXX to $0 copay (commercial insurers)

– Adding PHEXXI to formulary (commercial insurers) or preferred drug list (Medicaid) – Removing the requirement for a Prior Authorization letter from the HCP (commercial insurers) – Moving PHEXXI to $0 copay (commercial insurers)

Birth Control Guide

The FDA Birth Control Guide (the Guide) was developed and is used as an educational tool by many obstetrician/gynecologists to assist in counseling patients on their contraceptive options and to help them find the method that best suits their needs. It was developed more than a decade ago has not been undated since and therefore, does not reflect subsequent changes to the contraceptive landscape including methods that were subsequently approved by the FDA, notably the vaginal pH modulator (~~PHEXXI~~PHEXX).

Methods not on the current, outdated Guide may be underrepresented in contraceptive counseling dialogues. Evofem therefore believes the Guide should include all FDA-approved methods of birth control. However, while the updated HSRA Guidelines discussed above are highly favorable to PHEXXI, they remove the impetus for the FDA to update the Guide.12

~~Further,~~Methods ~~even~~not ~~though~~on the ~~FDA~~current, outdated Guide ~~was~~may ~~intended~~be asunderrepresented anin ~~educational~~contraceptive ~~tool,~~counseling ~~certain~~dialogues. ~~insurers~~Evofem ~~have~~therefore ~~used~~believes itthe toGuide should ~~block~~include ~~coverage~~all ofFDA-approved methods ~~not~~of ~~included in~~birth ~~the Guide~~control. ~~While~~However, ~~this~~while ~~is explicitly prohibited by~~ the ~~current~~updated ~~HSRA~~HRSA Guidelines, ~~and~~discussed ~~there~~above ~~has~~are ~~been~~highly ~~considerable~~favorable to ~~progress~~PHEXX, ~~since~~they ~~January 1,~~remove ~~2023,~~the ~~two~~impetus ~~notable~~for ~~plans~~the ~~continue~~FDA to ~~flout~~update the ~~law~~Guide.

ToFurther, ~~proactively~~even ~~address~~though ~~this~~the ~~conundrum,~~FDA inGuide ~~2022~~was ~~Evofem~~intended ~~developed~~as ~~and~~an ~~introduced~~educational atool, ~~new~~certain ~~educational~~insurers ~~chart~~have ~~that~~used ~~provides~~it ~~high-level~~to ~~information about~~block ~~birth~~coverage ~~control~~of methods ~~that~~not ~~are~~included in ~~currently~~the ~~available~~Guide. toWhile ~~women~~this inis explicitly prohibited by the ~~U.S.~~current HRSA Guidelines, ~~adding~~and ~~new~~there ~~categories~~has ~~including~~been ~~vaginal~~considerable pHprogress ~~modulator~~since January 1, 2023, two notable plans continue to flout the law.

~~This~~To ~~educational~~proactively ~~tool~~address isthis ~~intended~~conundrum, toin ~~facilitate~~2022 ~~patient-centric~~Evofem ~~contraceptive~~developed ~~counseling by focusing first~~ and ~~foremost~~introduced onits ~~whether~~own ornew ~~not a~~educational ~~woman~~chart isthat ~~willing~~provides ~~and/or~~high-level ~~able~~information about tobirth ~~take~~control ~~exogenous~~methods ~~hormones;~~that ~~for those who~~ are ~~not,~~currently ~~hormone-free~~available ~~options~~to ~~including~~women ~~PHEXXI~~in ~~are~~the ~~prominently displayed and discussed~~U.S., ~~The~~adding ~~Evofem-developed~~new ~~chart~~categories ~~has~~including ~~been~~vaginal ~~extremely~~pH ~~well received and has had a positive impact with HCPs and patients alike~~modulator.

15This educational tool is intended to facilitate patient-centric contraceptive counseling by focusing first and foremost on whether or not a woman is willing and/or able to take exogenous hormones; for those who are not, hormone-free options including PHEXX are prominently displayed and discussed. We believe the Evofem-developed chart has been well received and has been useful to HCPs and patients alike.

Contraceptive Market Landscape

The modern contraception market was established in 1960 with the introduction of “the pill,” the first oral contraceptive widely available to women in the U.S. Innovation and new product introductions in the women’s reproductive and sexual health care arena have been limited when compared to other therapeutic categories. As shown in the timeline below, there was no notable innovation providing additional options in women’s reproductive health until almost 30 years after the introduction of “the pill,” when pharmaceutical companies introduced the non-hormonal copper IUD and synthetic hormonal products with different ~~hormonal~~ delivery systems, including the hormonal IUD, implants, the patch, and vaginal ring.

While several new contraceptive category entrants have been introduced in recent years, Evofem believes ~~PHEXXI~~PHEXX is the first innovative contraceptive method introduced in the U.S. since NuvaRing ~~was~~in 2001. We do not include Miudella, a new type of copper IUD approved by the FDA in ~~2001~~early 2025, because it is not yet commercially available.

U.S. Market

In the U.S. today, commercially available contraceptive options include:

● ~~devices~~Devices designed to prevent pregnancy through physical means, such as condoms and diaphragms. ● Short-Acting Reversible hormone-based pharmaceutical products, including ~~oral contraceptives (~~OCs), vaginal rings, transdermal patches, and intramuscular injections,. ~~subcutaneous~~● ~~implants~~LARCs, ~~and~~comprised of intrauterine devices (IUDs). ~~These~~– ~~can~~hormonal ~~be associated with undesirable side effects such as weight gain, loss of libido~~ and ~~mood changes that may lead women to discontinue their use and seek alternative contraceptive methods. Further,~~ a ~~peer~~hormone-~~reviewed~~free ~~analysis~~copper ~~published~~IUD in– ~~the~~and ~~journal~~subcutaneous ~~PLOS Medicine in March 2023 found that the use of all kinds of~~ hormonal ~~birth control is associated with a slight increase in the risk of breast cancer~~implants. ● ~~a hormone-free copper IUD; and ● PHEXXI~~PHEXX, a prescription vaginal pH modulator that was introduced to the market in September 2020.

AsWhile ~~shown~~Evofem’s inmarket ~~the~~research ~~“U.S.~~has ~~Market~~indicated bythat ~~Contraceptive~~the ~~Method”~~hormone-free, ~~chart above~~on-demand, ofwoman-controlled ~~the~~aspect ~~72.7 million women~~ of ~~reproductive~~PHEXX ~~age~~makes ~~(15-49)~~it inan ~~the~~attractive ~~U.S.,~~option ~~13.0~~across ~~million~~the ~~women~~entire ~~use~~competitive ~~no method of birth control~~set, ~~putting~~we ~~them~~are atfocused ~~risk~~on ofthe ~~unintended pregnancy~~26.2 ~~An additional 10.3~~ million women in ~~the~~who ~~U.S.~~fall ~~rely~~into onthree ~~condoms~~contraceptive oruse ~~some~~groups ~~other form of non-hormonal OTC birth control (e.g. rhythm, withdrawal). Another 20.0 million women~~ in the “U.S. ~~use~~Market ~~prescription~~by ~~birth~~Contraceptive ~~control~~Method” ~~methods,~~chart ~~which are predominantly hormone-based with the sole exception of the copper IUD. Note~~above: ~~this study and its data predate the commercial availability in 2020 of PHEXXI as well as the 2024 switch of Opill from prescription to OTC status.~~

~~An aggregate~~1. 23The approximately 6.31 million sexually active women ~~who~~use ~~are~~no ~~currently~~method of birth control, putting them at risk ~~for~~of unintended pregnancy; ~~and~~2. ~~are~~The ~~not~~approximately ~~using~~9.8 ~~hormone-based~~million ~~contraceptives~~women asin ~~their~~the ~~primary form of contraception~~U.S. ~~Evofem~~who ~~expects~~already ~~that~~rely ~~PHEXXI~~on ~~will~~a ~~grow~~form ~~the~~of ~~prescription~~non-hormonal birth control ~~market~~(e.g., ~~through~~condoms, ~~adoption~~rhythm, bywithdrawal); and, 3. The approximately 10.3 million women in ~~these groups~~the U.S. who use a short-acting hormonal birth control method.

AsCombining groups 1 and 2, there are an aggregate 15.912 million women’s ~~expectations~~who ~~change~~are ~~throughout~~not ~~their~~seeking ~~contraceptive~~to ~~journey,~~become wepregnant and do not use hormonal contraceptives. We expect ~~PHEXXI~~that toPHEXX ~~compete~~will ~~for~~grow both its market share inand atthe ~~least~~prescription ~~three~~birth control market through adoption by women ~~categories:~~in these two groups.

1.Additionally, as women’s expectations change throughout their contraceptive journey, we expect PHEXX to compete for market share in two additional categories: Hormonal short-acting reversible contraceptives consisting of oral contraceptive pills, patches, injectables and rings;, 2. and Long-Acting Reversible Contraception, comprising IUDs, ~~implants,~~ and ~~injectables; and 3~~implants. ~~OTC methods, dominated primarily by the male condom.~~

¹²Daniels K and Abma J. Current Contraceptive Status Among Females Ages 15–49: United States, 2022–2023. NCHS Data Brief No. 539. August 2025. Data table for Figure 1, sourced from National Survey of Family Growth (NSFG) 2022–2023. https://www.cdc.gov/nchs/data/databriefs/db539.pdf

1. Short-Acting, Reversible Hormonal Contraceptives (Predominantly Prescription)

Oral contraceptives

~~Oral contraceptives (~~OCs), also known as the pill, are the most commonly used form of birth control in the U.S. today. There are two main ~~kinds~~ kinds of hormonal OCs: combination birth control pills, which contain both estrogen and progestin, and the progestin only pill (POP). In 2024 the POP brand Opill (Perrigo) became commercially available OTC. Combination OCs remain prescription products. Use of either kind is associated with a slight increase in the risk of breast cancer. OCs typically must be taken at the same time every day to be the most effective. If the POP is taken more than three hours late (or missed entirely), the user is advised to use supplemental non-hormonal contraception, like ~~Phexxi~~PHEXX, for the next two days to prevent unintended pregnancy.

Contraceptive Patch

The weekly contraceptive patch was introduced in 2000 by Johnson & Johnson’s Janssen division; however, deaths resulting from venous thromboembolism due to hormonal exposure had a significant negative impact on the patch and led to label changes restricting utilization.13 Following the loss of exclusivity, Johnson & Johnson’s Janssen division exited women’s health care and contraception as a promotional category. A new branded patch was launched in late 2020 under the brand name Twirla (Agile Therapeutics) and is competing against a generic entrant Xulane (Mylan).

Vaginal Ring

The hormonal vaginal ring was introduced to the market in 2001 by Merck & Co.; generic versions are now available. The ring is used for three weeks and then removed for a week during menses and a new hormonal vaginal ring is inserted. The efficacy of the vaginal ring is similar to hormonal oral contraception. A meta-analysis of 18 studies found that users of the vaginal ring reported more vaginal irritation and discharge than combination pill users, but less nausea, acne, irritability, depression, and emotional changes ~~(source: Lopez et al~~. ~~Skin patch and vaginal ring versus combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD003552. doi: 10.1002/14651858.CD003552.pub4).~~14

An annual hormonal vaginal ring was launched in the U.S. in 2020 under the brand name Annovera (Mayne Pharma).

Injectables

The primary injectable hormonal contraceptive on the market is Depo-Provera offered by Pfizer Inc. Each injection provides protection for up to 12 to 14 weeks, but patients must receive injections once every 12 weeks to get optimal contraceptive protection. Depo-Provera was introduced to the market in 1992.

2. Long-Acting Reversible Contraception (Prescription)

~~Long-acting~~LARCs ~~reversible~~are ~~contraception (LARC) is~~ not dependent on user adherence, which appeals to those who benefit from a passive form of birth control ~~with no daily requirement to take a pill~~. LARC methods include the Intrauterine Device (IUD) and the Contraceptive Implant.

IUDs

The copper IUD was introduced to the market in 1988 and provides protection by disrupting sperm motility and damaging sperm so that they are prevented from joining with an ovum. Today, the copper IUD is principally marketed by Cooper Surgical, Inc. as Paragard.

A nitinol-frame copper IUD was approved by the FDA in 2025 under the brand name Miudella (Sebella). It is not yet commercially available.

The hormonal IUD is principally offered under the brand names Kyleena, Skyla and Mirena, a family of products from Bayer Pharmaceuticals. All IUDs must be inserted and removed by a physician.

~~Many~~13 ~~women~~Bell ~~have~~J. ~~opted~~New ~~against~~Risk ~~the~~Data ~~IUD~~Added ~~for 1) fear of a bad insertion experience; a peer-reviewed study published in 2015 found that “all women had a high expectation of pain prior~~ to ~~IUD~~Contraceptive ~~insertion.”~~Patch ~~(source: Brima et al~~Label. AFamily ~~comparison of the expected and actual~~Practice ~~pain experienced by women during insertion of an intrauterine contraceptive device~~News. ~~Open~~15 ~~Access J Contracept~~Oct. ~~2015 Feb 16;6:21-26~~2006. ~~doi~~https: ~~10.2147~~/~~OAJC~~/cdn.~~S74624~~mdedge.) and 2) concern over having something in them (i.e. a “foreign body effect”), which has been frequently demonstrated in medical literature. (source: Ferguson et al. Patient Opinions About Foreign Body Contraceptives. Women’s Health Rep (New Rochelle). 2020 Oct 8;1(1):451com/files/s3fs-~~458. doi: 10.1089~~public/~~whr~~issues/articles/74033_main.~~2020.0048.). Among women who opt-in to the insertion procedure, many decide to remove their IUD due to the hormonal and other side effects that they experience.~~pdf

¹⁴ Lopez et al. Skin patch and vaginal ring versus combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD003552. doi: 10.1002/14651858.CD003552.pub4

Many women have opted against the IUD for 1) fear of a bad insertion experience; a peer-reviewed study published in 2015 found that “all women had a high expectation of pain prior to IUD insertion,”¹⁵ and 2) concern over having something in them (i.e. a “foreign body effect”), which has been frequently demonstrated in medical literature¹⁶. Among women who opt-in to the insertion procedure, many decide to remove their IUD due to the hormonal and other side effects that they experience.

Implants

The contraception implant must be implanted under the skin and removed by a qualified HCP, requiring a medical procedure. It provides contraception by releasing hormones over a three-year period. The implant is marketed in the U.S. as Nexplanon (Organon).

~~Injectables~~3. Short-Acting Hormone-Free Methods

~~The~~As ~~primary~~noted ~~injectable~~in ~~hormonal contraceptive on~~ the ~~market~~“US isMarket ~~Depo-Provera offered~~ by ~~Pfizer~~Contraceptive ~~Inc.~~Method” ~~Each~~chart ~~injection~~above, ~~provides~~in ~~protection~~the ~~for up to 12 to 14 weeks~~U.S., ~~but~~an ~~patients~~estimated ~~must~~9.8 ~~receive~~million ~~injections~~women ~~once~~rely ~~every~~on ~~12 weeks to get optimal contraceptive protection. Depo~~short-~~Provera~~acting ~~was~~hormone-free ~~introduced~~methods tofor ~~the~~their ~~market~~contraceptive ~~in 1992~~needs.

~~3. OTC Methods (Non~~Hormone-~~prescription)~~free Prescription Products

AsThese ~~noted~~contraceptive indevices ~~the~~are ~~“US~~applied ~~Market~~or byworn ~~Contraceptive~~inside ~~Method”~~the ~~chart~~vagina ~~above,~~and inused ~~the U~~on-demand.~~S.,~~ anThey ~~estimated~~are ~~10.3~~available ~~million~~by ~~women~~prescription ~~rely~~and onmust ~~OTC~~be ~~products~~inserted ~~for~~into ~~their~~the ~~contraceptive~~vagina ~~needs~~prior to each act of intercourse.

~~Condoms~~Vaginal ~~are~~pH ~~the~~Modulator. ~~dominant~~The ~~product~~first ~~offering~~and inonly ~~OTC~~Vaginal ~~sales,~~pH ~~with~~Modulator ~~estimated~~- ~~domestic~~PHEXX ~~sales~~- ofwas ~~approximately~~FDA ~~$480~~approved ~~million~~and launched by Evofem in ~~2023~~2020. ~~(Fortune~~PHEXX is a hormone-free, ~~Business~~prescription ~~Insights).~~contraceptive ~~Approximately~~vaginal ~~14.2~~gel ~~million~~that women ~~use~~apply ~~condoms~~0-60 minutes before intercourse. It is used on-demand, ~~either~~only ~~alone~~when needed, and comes in a box of 12 pre-filled applicators. It was evaluated and approved as a stand-alone contraceptive. PHEXX can also be used in conjunction with, ormost ~~interchangeably~~other birth control methods to provide additional protection against unintended pregnancy. Supplementing with ~~other~~PHEXX ~~forms~~appeals to women who have been placed on drugs like GLP-1s and Paxlovid, which can reduce efficacy of hormonal birth control., ~~The~~and ~~predominant~~women ~~brands~~who ~~are~~need ~~Trojan~~supplemental ~~(Church~~protection &after ~~Dwight)~~taking ~~and~~an ~~Durex~~OC ~~(Reckitt~~late ~~Benckiser)~~or missing a day entirely.

17Diaphragm. A diaphragm prevents pregnancy by covering the cervix, thus preventing sperm from entering the uterus. Diaphragms must be used with PHEXX or a spermicide to work. Diaphragms come in different sizes, so a doctor will fit the user for one, show her how to insert and remove it, and give her a prescription. FDA approved diaphragms available in the U.S. include Caya®.

~~Besides~~Cervical ~~condoms~~Cap. ~~and~~A ~~the~~cervical ~~POP~~cap ~~discussed~~is ~~above,~~made ~~the~~from ~~only~~soft ~~currently~~silicone ~~available~~and ~~OTC~~shaped ~~contraceptive~~like ~~products~~a insailor’s ~~the U~~hat.S. ~~are~~It ~~nonoxynol-9~~prevents ~~containing~~pregnancy ~~(N-9) spermicides,~~by ~~which~~covering ~~are~~the ~~available~~cervix, thus inpreventing ~~sponges,~~sperm ~~jelly/creams~~from ~~and~~entering ~~foams,~~the ~~and~~uterus. ~~have~~Concurrent ~~very~~use ~~limited~~of ~~utilization.~~PHEXX ~~These~~or ~~surfactant-based~~spermicide ~~products can~~makes ~~potentially~~the ~~cause~~cervical ~~genital~~cap ~~irritation~~much ~~and~~more ~~inflammation~~effective. ~~that~~The only ~~may~~brand ~~increase~~of ~~the~~cervical ~~risk~~cap ofthat ~~contracting~~is ~~human~~FDA ~~immunodeficiency~~approved ~~virus~~and ~~(HIV) or~~available ~~other~~in ~~STIs~~the ~~from~~U.S. anis ~~infected~~called ~~partner~~FemCap®.

4Female Condoms. ~~Vaginal~~Female pHcondoms ~~Modulator~~prevent ~~(Prescription)~~pregnancy by stopping sperm from meeting an egg. The only brand of internal condom that is FDA approved and available in the U.S. is the FC2 Female Condom®.

~~The first and only Vaginal pH Modulator~~ Over- ~~PHEXXI~~ the- ~~was launched by Evofem in 2020. PHEXXI is a hormone-free, prescription contraceptive vaginal~~Counter ~~gel that women apply 0~~Non-60hormonal ~~minutes~~Products ~~before intercourse. It is used on-demand, only when needed,~~ and ~~comes in a box of 12 pre-filled applicators.~~Methods

~~Data~~Male onCondoms. ~~PHEXXI~~Male iscondoms ~~not~~also ~~reflected~~prevent inpregnancy ~~the “U.S. Market~~ by ~~Contraceptive~~stopping ~~Method”~~sperm ~~chart~~from ~~above,~~meeting ~~since~~an ~~the underlying study predates its commercial availability~~egg. ~~New adopters of PHEXXI are expected to come equally from each category discussed~~Collectively, asthey ~~interest in PHEXXI falls into three distinct segments: (1) those women who~~ are ~~not~~the ~~currently~~dominant ~~using~~ hormone-~~based contraceptives; (2) those women seeking an alternative~~free toproduct ~~hormonal~~offering, ~~contraception;~~with ~~and~~estimated ~~(3)~~domestic ~~those~~sales ~~women~~of ~~who~~approximately ~~are~~$480 ~~expected~~million toin ~~utilize~~2023 ~~PHEXXI~~(Fortune asBusiness ~~added~~Insights). ~~protection~~Approximately ~~to their current form~~ 7.1% of ~~birth control. This last group includes~~ women ~~who~~in ~~have~~the ~~been~~U.S. ~~placed~~use oncondoms, ~~drugs~~either ~~like~~alone, ~~GLP-1s~~in ~~and~~conjunction ~~Paxlovid~~with, ~~which~~or ~~can~~interchangeably ~~reduce~~with ~~efficacy~~other forms of ~~hormonal~~ birth control ~~and women who need supplemental protection after taking an OC late or missing a day entirely~~. ~~Evofem’s market research~~17 ~~has~~The ~~indicated~~predominant ~~that~~brands ~~the~~are ~~hormone-free,~~Trojan ~~on-demand,~~(Church ~~woman-controlled~~& ~~aspect~~Dwight) ofand ~~PHEXXI~~Durex ~~makes~~(Reckitt ~~it an attractive option across the entire competitive set~~Benckiser).

Spermicides. All spermicides in the U.S. rely on nonoxynol-9 (N-9), a surfactant associated with genital irritation and inflammation that may increase the risk of contracting human immunodeficiency virus (HIV) or other STIs from an infected partner. Spermicides are available in sponges, jelly/creams and foams, and have very limited utilization.

¹⁵ Brima et al. A comparison of the expected and actual pain experienced by women during insertion of an intrauterine contraceptive device. Open Access J Contracept. 2015 Feb 16;6:21-26. doi: 10.2147/OAJC.S74624

¹⁶ Ferguson et al. Patient Opinions About Foreign Body Contraceptives. Women’s Health Rep (New Rochelle). 2020 Oct 8;1(1):451-458. doi: 10.1089/whr.2020.0048.

¹⁷ Daniels K, Abma J. Current Contraceptive Status Among Females Ages 15–49: United States, 2022–2023. NCHS Data Brief Number 539. August 2025. Accessed Jan. 9, 2026, via https://www.cdc.gov/nchs/data/databriefs/db539.pdf

Other Methods. Fertility tracking, withdrawal, and periodic abstinence are among the other non-hormonal methods used by women in the U.S.

Ex-U.S. Markets

The conditions addressed by our products are not unique to the United States; they affect women around the world.

Contraception. ~~According~~ According to the United Nations Department of Economic and Social Affairs, nearly 1.1 billion women worldwide desire contraception including “172 million women (who are) are using no method at all, despite their desire to avoid pregnancy, and thus are considered to have an unmet need for family planning.”18 This demand is reflected by the significant market growth projections for non-hormonal birth control;. Growth Plus Reports forecasts global sales of non-hormonal contraceptives will increase from $27.7 billion in 2022 to $52.2 billion by 2031.19

Trichomoniasis. Trichomonas vaginalis is the most common non-viral STI, globally. The World Health Organization (WHO) cites an estimated 156 ~~million~~ million new cases of T. vaginalis infection among people aged 15–49 years old in 2020 (73.7 million in females, 82.6 million in males).20 Approximately one third of new infections in this age group occur in the WHO African Region, followed by the Region of the Americas.

Bacterial vaginosis. A recent systematic review and meta-analysis reported that the prevalence of BV among women of reproductive age ranges from 23% to 29%, with the following regional prevalence estimates: 23% in Europe and Central Asia; 24% in East Asia and Pacific, Latin America and the Caribbean; 25% in the Middle East and North Africa (MENA) and sub-Saharan Africa; 27% in North America; and 29% in South ~~Asia (Peebles~~ ~~K et al~~Asia. ~~High global burden and costs of bacterial vaginosis: a systematic review and meta-analysis. Sex Transm Dis. 2019;46(5):304-11 (https://doi.org/10.1097/ OLQ.0000000000000972)).~~21

In markets outside of the U.S., our strategy is to establish regional and/or global partnerships by either sublicensing the ~~commercialization~~ commercialization rights or entering into distribution agreements with one or more third parties for the commercialization of ~~PHEXXI~~ PHEXX and/or SOLOSEC in that market. We believe this approach will afford access to women whose lives we aim to positively impact while allowing us to maximize the inherent value of our products for the benefit of all stakeholders.

~~PHEXXI~~We licensed ~~was~~commercial ~~approved~~rights into ~~Nigeria~~PHEXX onand ~~October~~SOLOSEC 6,in ~~2022, as Femidence™ by~~ the ~~National~~Middle ~~Agency~~East ~~for Food~~ and ~~Drug~~North ~~Administration~~Africa ~~and~~(MENA) ~~Control. PHEXXI has been submitted for approval in Mexico, Ethiopia and Ghana. In July 2024, we licensed commercial rights~~ to ~~PHEXXI in the Middle East to~~ Pharma 1 Drug Store, LLC (Pharma 1), an emerging Emirati health care company, ~~(Pharma~~in ~~1).~~July ~~Pharma~~2024 1and isMay ~~expected~~2025, torespectively. ~~file~~Pharma 1 filed for regulatory approval of ~~PHEXXI~~ PHEXX in the United Arab Emirates (UAE) in ~~the~~June ~~first~~2025 ~~half~~and of SOLOSEC in the UAE in September 2025.

Manufacturing

We outsource the manufacturing of ~~PHEXXI~~PHEXX to a third party. We are currently contracted with a leading US-based gel manufacturer to manufacture ~~PHEXXI~~PHEXX in accordance with all applicable current good manufacturing practices (cGMP) regulations, as well as in compliance with all applicable laws and other relevant regulatory agency requirements for manufacture of pharmaceutical drug products and combination drug-device products. As of December 31, ~~2024~~2025, we estimated that we had manufactured inventory on hand to support approximately three months of anticipated demand for ~~PHEXXI~~PHEXX. ~~and~~Additional ~~additional~~ manufacturing of ~~PHEXXI~~PHEXX is ongoing to support ~~further~~future sales.

We ~~are~~currently ~~committed~~sell ~~to purchasing~~ finished goods inventory that was purchased from the SOLOSEC seller ~~through a transition period ending in November 2026~~ at a pre-defined unit price. ~~After~~We ~~the~~intend ~~transition period, we expect~~ to outsource ~~the~~future manufacturing of SOLOSEC to a third party, similar to our handling of ~~PHEXXI~~PHEXX.

~~Our~~18 United ~~Pipeline~~Nations Department of Economic and Social Affairs. World Family Planning 2020. https://www.un.org/development/desa/pd/sites/www.un.org.development.desa.pd/files/files/documents/2020/Sep/unpd_2020_worldfamilyplanning_highlights.pdf

~~While~~19 ~~Evofem’s~~Growth ~~pipeline~~Plus ~~includes~~Market ~~multiple~~Reports. ~~candidates~~Non-Hormonal ~~that~~Birth ~~are~~Control ~~designed~~Market toby ~~address~~Type ~~critical~~(Contraceptive ~~unmet~~Devices, ~~needs~~Sterilization), inGender ~~women’s health~~(Male, ~~the~~Female) ~~Company~~– ~~halted~~Global ~~all~~Outlook ~~clinical~~& ~~development~~Forecast in2023-2031. ~~October~~May ~~2022~~5, ~~due~~2023. ~~to financial constraints~~https://www.growthplusreports.com/report/nonhormonal-birth-control-market/8914

~~EVO100~~20 ~~for~~Peebles ~~STI~~K ~~Prevention~~et al. High global burden and costs of bacterial vaginosis: a systematic review and meta-analysis. Sex Transm Dis. 2019;46(5):304-11. https://doi.org/10.1097/ OLQ.0000000000000972

~~EVO100~~ 21 World ~~vaginal~~Health ~~gel was in development for the prevention of urogenital chlamydia and gonorrhea in women~~Organization. ~~Chlamydia~~Fact ~~and~~Sheet: ~~gonorrhea are among the many bacterial and viral pathogens that require a higher pH environment to thrive~~Trichomoniasis. ~~The~~21 ~~CDC~~November ~~reported that infections with these two sexually transmitted pathogens cost the U~~2025.S. ~~healthcare system $1~~https://www.~~0 billion, in aggregate direct and indirect costs~~who. ~~There are no FDA~~int/news-~~approved drugs to prevent these sexually transmitted diseases (STIs). The FDA granted EVO100 Fast Track Designation for the prevention of chlamydia and gonorrhea~~room/fact-sheets/detail/trichomoniasis#:~:text=Trichomoniasis%20is%20a%20common%20sexually, ~~and designated EVO100 a Qualified Infectious Disease Product (QIDP) for~~ the ~~prevention of infection these pathogens~~%20Region%20of%20the%20Americas.

The Phase 2B/3 trial (AMPREVENCE) achieved its primary and secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in chlamydia and gonorrhea infections of 50% and 78%, respectively, in women receiving EVO100 vs. placebo. Based on these highly positive clinical outcomes we initiated a Phase 3 clinical trial (EVOGUARD) to evaluate EVO100 for these potential indications in 2020. On October 11, 2022, we reported that EVOGUARD did not meet its primary efficacy endpoint. We and our advisors believe the public health response to the COVID pandemic caused changes in clinical site operations and subject behavior and actions, including deviations from following the clinical study protocol requirements related to STI acquisition, detection, and prevention, which contributed to this outcome.17

EVO200 Vaginal Gel for Recurrent Bacterial Vaginosis

Our investigational candidate for the reduction of recurrent bacterial vaginosis (BV), EVO200 vaginal gel, uses the same proprietary vaginal pH modulator platform as PHEXXI. In a Phase 1 dose-finding trial for this indication, the highest dose formulation of the study drug demonstrated reduced vaginal pH for up to seven days following a single administration. The FDA has designed EVO200 as a Qualified Infectious Disease Product (QIDP) for this indication, which provides several important potential advantages including, but not limited to, longer market exclusivity.

MPT Vaginal Gel for HIV Prevention

In December 2021, we launched a collaboration with Orion Biotechnology Canada Ltd. (Orion) to evaluate the compatibility and stability of Orion’s novel CCR5 antagonist, OB-002, in PHEXXI with the goal of developing a Multipurpose Prevention Technology (MPT) product candidate for indications including the prevention of HIV in women. Assuming positive preclinical results, Evofem and Orion may seek government and philanthropic funding for subsequent clinical trials of any resulting MPT vaginal gel product candidate.

Thin Film Project

In February 2020, we contracted with the University of South Australia to develop a vaginally applied thin film as a second-generation vaginal pH modulator product. The lead thin film candidates have been selected, and stability data has been generated with positive results. Next steps are to optimize the lead candidates and identify funding to proceed.

Rush License Agreement

In 2014, wethe Company entered into an amended and restated license agreement (the Rush License Agreement) with Rush University Medical Center (Rush University), pursuant to which Rush University granted usthe Company an exclusive, worldwide license of ~~certain~~a ~~patents~~patent and certain know-how related to its vaginal pH modulator technology (US6706276, the Rush Patent). Pursuant to the Rush License Agreement, until the expiration of the Rush Patent, the Company was obligated to pay Rush University ~~submitted~~an aearned ~~patent~~royalty ~~term~~during ~~extension~~the ~~(PTE)~~patent ~~application~~term, ~~requesting~~calculated as a ~~five~~ mid-~~year~~single digit ~~PTE~~percentage ~~for~~of PHEXX net sales (the URush Royalty).S. ~~patent~~In ~~and~~September ~~received~~2020, ~~multiple~~the ~~Orders~~Company ~~Granting~~entered ~~Interim~~into ~~Extension~~the ~~(OGIE)~~first ~~which~~amendment ~~extended~~to the ~~expiration~~Rush ofLicense Agreement, pursuant to which the ~~licensed~~Company ~~patent~~agreed to ~~March~~pay 6,a ~~2025.~~minimum Noannual ~~further~~royalty ~~OGIE~~amount ~~has~~of ~~been~~$0.1 ~~received~~million ~~and~~to ~~thus~~the extent the ~~patent~~earned isroyalties did ~~believed~~not toequal beor ~~expired~~exceed $0.1 ~~PHEXXI~~million ~~remains protected~~commencing inJanuary 1, 2021 until the ~~U.S.~~expiration byof ~~four~~the ~~additional~~patent, ~~Orange~~including ~~Book~~any ~~patents~~granted ~~solely-owned~~Patent byTerm Extensions ~~Evofem~~(PTEs).

~~Pursuant to the~~ The Rush ~~License~~Patent ~~Agreement,~~would ~~the~~have ~~Company~~expired ~~was~~on ~~obligated~~March to6, ~~pay~~2021 ~~Rush~~(the ~~University an~~Original ~~earned~~Expiration ~~royalty~~Date) ~~based~~if ~~upon~~no aPTE ~~percentage~~was ofobtained. ~~net~~Rush ~~sales~~University infiled ~~the~~an application ~~range~~for ofPTE ~~mid-single~~in ~~digits~~July ~~until the expiration of this patent. In September~~ 2020, ~~the~~which ~~Company~~would ~~entered~~extend ~~into~~ the ~~first~~expiration ~~amendment~~date toof the Rush ~~License~~Patent ~~Agreement, pursuant~~ to ~~which~~March ~~the~~6, ~~Company~~2026 ~~was~~if ~~also~~granted. ~~obligated to~~Multiple ~~pay~~Orders aGranting ~~minimum~~Interim ~~annual~~Extension ~~royalty~~(OGIEs) ~~amount~~were ofreceived ~~$0.1~~from ~~million to~~ the ~~extent the earned royalties did not equal or exceed $0~~U.~~1 million commencing January 1, 2021~~S. ~~Such~~Patent ~~royalty~~and ~~costs,~~Trademark ~~included~~Office in(USPTO) ~~cost~~while ofthe ~~goods~~PTE ~~sold,~~was ~~were $0~~under evaluation.8 ~~million~~The ~~and~~last ~~$0.7~~OGIE ~~million~~expired ~~for~~on ~~the~~March ~~years ended December 31~~6, ~~2024 and 2023, respectively~~2025. ~~No further royalties will be due to Rush University after the patent expiration.~~

19Because the USPTO had granted multiple OGIEs to Rush University, between the date of the original PTE application (July 2020) and the final OGIE expiration (March 2025), the Company determined it was probable that the PTE extending the expiration to March 6, 2026 would be granted. Therefore, the Company accrued a total of $2.8 million related to the Rush Royalty as a contingent liability after the Original Expiration Date in accordance with Accounting Standards Codification (ASC) 450, of which $0.9 million was paid in good faith and $1.9 million was unpaid and included in accrued expenses in the consolidated balance sheet as of December 31, 2024.

WeDuring ~~also~~the ~~have~~first ~~the~~quarter ~~right~~of to2025, ~~sub-license~~the ~~our~~Company’s ~~rights~~legal tocounsel ~~affiliates~~ascertained ~~(without~~that ~~the~~no ~~prior~~further ~~approval~~OGIEs ofwere ~~Rush~~granted ~~University)~~after ~~and~~March to6, ~~third~~2025 ~~parties~~and ~~(with~~ the PTE ~~prior~~had ~~written~~also ~~approval~~still ofnot ~~Rush~~been ~~University)~~granted. ToAs ~~the extent Rush University approves of~~ a ~~third-party sub-license~~result, inthe ~~lieu~~Company ofdiscontinued ~~any~~accruing ~~royalty payment obligation under~~ the Rush ~~License~~Royalty ~~Agreement~~since, webased ~~would~~on ~~then~~the benew ~~under~~information, the anCompany ~~obligation~~deemed toit ~~pay~~remote ~~Rush~~that ~~University~~the aPTE ~~sub-license~~would ~~fee~~ultimately ~~equal to~~be agranted. ~~percentage~~Amounts ofpreviously ~~any~~accrued ~~sublicensing~~under ~~revenue~~the ~~received from any third-party sub-licensee.~~ Rush ~~University~~License ~~retained~~Agreement ~~a royalty free, non-exclusive~~were ~~license~~still ~~from~~being usassessed ~~for~~at ~~the~~that ~~Rush~~time ~~License~~and IPas ~~for~~such, ~~non-commercial~~no ~~research~~adjustments ~~purposes~~were made.

~~The~~Furthermore, in August 2025 the FDA confirmed that the relevant active ingredient covered by the Rush ~~License~~Patent ~~Agreement~~had ~~contains~~previously ~~additional~~been ~~customary~~used ~~representations~~in other FDA-approved products and, ~~warranties~~as such, ~~covenants~~no PTE should be granted. On October 28, ~~indemnification~~2025, ~~and~~the ~~insurance~~USPTO ~~and~~issued ~~confidentiality~~a final decision officially denying ~~provisions~~the ~~for~~PTE ~~agreements~~application of(the ~~its~~Final ~~type~~PTE Decision). The Final PTE Decision also vacated all Interim Extensions ab initio. Based on the Final PTE Decision, the Company and its legal counsel determined that the Rush ~~License~~Patent ~~Agreement~~expired ~~may~~on the Original Expiration Date and as such it is no longer probable that the Company will be ~~terminated~~required ~~upon~~to ~~mutual~~pay ~~written~~any ~~consent~~expenses ofrelated ~~both~~to ~~parties~~the orRush byRoyalty aaccrued ~~non-breaching~~after ~~party~~that ifdate. ~~the~~The ~~other~~Company ~~party~~reversed ~~commits~~the aoutstanding ~~breach~~accrued orRush ~~default~~Royalty contingent liability of ~~any~~$1.9 ~~covenant~~million induring the ~~agreement~~year ended ~~and~~December ~~fails~~31, 2025. Because the gain was material to ~~cure~~cost ~~this~~of ~~breach~~goods ~~within 30~~sold, ~~days~~the ~~after~~amount ~~receiving~~was ~~written~~presented ~~notice~~separately ofon the ~~breach~~consolidated statement orof ~~default~~operations as a gain on change in accounting estimates on contingent royalty liability.

~~Unless~~If ~~terminated~~the inCompany ~~accordance~~determines ~~with~~to ~~its~~pursue ~~terms,~~a refund of the ~~Rush~~estimated ~~License~~royalties ~~Agreement~~paid ~~continues~~but ~~until~~not ~~the~~earned ~~expiration,~~per ~~revocation~~its orcurrent ~~invalidation~~analysis, ofit ~~the~~could potentially ~~last~~receive a refund of $0.9 million from Rush University (the ~~patents~~amount orpaid for royalties accrued after the ~~abandonment~~Original Expiration Date). Conversely, if Rush University pursues payment of the ~~last~~amounts ~~patent~~accrued ~~application~~but ~~included~~not ~~within~~paid for the ~~licensed~~time ~~patents~~covered ~~and~~by ~~technology~~the OGIEs, ~~including~~the maximum liability that ~~any~~the ~~patent~~Company ~~claiming~~could anincur ~~improvement~~is ~~made~~approximately ~~during~~$2.3 million. Based on the ~~term~~current ofanalysis, the ~~Rush~~Company ~~License~~could ~~Agreement~~have inan ~~the~~additional ~~course~~gain of ~~research~~up to ~~supported~~$0.9 million or ~~developed by~~a ~~Rush~~loss ~~University~~of ~~utilizing~~up ~~the~~to ~~technology~~$2.3 million.

Our vaginal pH modulator (PHEXX) remains protected in the U.S. by four Orange Book-listed patents which are solely-owned by Evofem.

Intellectual Property

We strive to protect the proprietary vaginal pH modulator gel technology both internationally and domestically. We seek and maintain patents intended to cover ~~PHEXXI~~PHEXX and its methods of use, as well as any other inventions that are commercially important to the development of our business. We endeavor to properly file patent applications for new inventions we believe may have commercial value. We also may rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.

Our success will depend on our ability, in part: to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how related to our business; to defend and enforce our patents and other intellectual property rights; and to preserve the confidentiality of our trade secrets and operate without infringing the valid and enforceable patents and other proprietary rights of third parties. We will also rely on continuing technological innovation and in-licensing opportunities to develop and maintain our proprietary position.

Related to PHEXXI, as of March 14, 2025, we owned or had exclusive license to approximately 36 issued patents and allowed applications in the U.S. and other countries and jurisdictions, and had approximately seven patent applications pending in the U.S. and other countries and jurisdictions. This includes four U.S. patents which cover PHEXXI and its labeled indication that are listed in the U.S. FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book): 18

●Related to ~~U.S.~~PHEXX, ~~Patent~~as ~~No.~~of 11February 28,~~992~~ 2026,~~472:~~ ~~Method~~we ofowned ~~use~~or ~~patent~~had ~~covering~~exclusive ~~contraception~~license ~~using~~to ~~PHEXXI~~approximately ●35 issued patents and allowed applications in the U.S. ~~Patent~~and ~~No.~~other ~~11,337,989:~~countries ~~Method~~and ofjurisdictions ~~use~~and ~~patent~~had ~~covering~~approximately ~~contraception~~six ~~using~~patent ~~PHEXXI~~applications ●pending in the U.S. ~~Patent~~and ~~No.~~other ~~11,439,610:~~countries ~~Composition~~and jurisdictions. ofThis ~~matter~~includes ~~patent~~four ~~covering PHEXXI ●~~ U.S. ~~Patent~~patents ~~No.~~which ~~10,568,855:~~cover ~~Method~~PHEXX ofand ~~use~~its ~~patent~~labeled ~~covering~~indication ~~contraception~~that ~~using~~are ~~PHEXXI~~listed in the Orange Book:

~~We solely~~● ~~own~~U.S. ~~several~~Patent ~~patent~~No. ~~families~~11,992,472: ~~relating~~Method toof ~~the~~use ~~composition~~patent ~~and~~covering ~~therapeutic~~contraception ~~use~~using ofPHEXX ~~our~~● ~~vaginal~~U.S. pHPatent ~~modulator~~No. ~~gel~~11, ~~which~~337,989: ~~upon issue,~~Method ~~would~~of ~~expire~~use atpatent ~~the~~covering ~~earliest~~contraception inusing ~~2033.~~PHEXX We● ~~believe~~U.S. ~~that~~Patent ~~our~~No. ~~licensed~~11,439,610: ~~and~~Composition ~~solely~~of ~~owned~~matter ~~non-hormonal contraceptive gel patents and pending~~ patent ~~applications,~~covering ~~combined~~PHEXX ~~with~~● ~~our~~U.S. ~~substantial~~Patent ~~know-how~~No. ~~in this field~~10,568,855: ~~will~~Method ~~continue~~of touse ~~provide~~patent ~~opportunities~~covering ~~for~~contraception ~~us to~~using ~~establish a significant barrier to competitor entry into the market.~~PHEXX

~~Related~~We solely toown ~~SOLOSEC,~~several aspatent ~~of March~~families ~~14,~~relating ~~2025,~~to wethe ~~owned~~composition orand ~~had~~therapeutic ~~exclusive~~use ~~license~~of toour ~~approximately~~vaginal 19pH ~~issued~~modulator ~~patents~~gel, ~~and~~which, ~~allowed~~upon ~~applications~~issue, would inexpire at the Uearliest in 2033.S. ~~and~~We ~~other countries~~believe ~~and~~that ~~jurisdictions,~~our ~~and~~solely ~~had~~owned ~~approximately~~non-hormonal ~~three~~contraceptive ~~patent~~gel ~~applications~~patents and pending patent inapplications, ~~the~~combined ~~U.S.~~with ~~and~~our ~~other~~substantial ~~countries~~know-how ~~and jurisdictions.~~in ~~This~~this ~~includes~~field, ~~ten~~will ~~U.S.~~continue ~~patents~~to ~~which~~provide ~~cover~~opportunities ~~SOLOSEC~~for ~~and~~us ~~its~~to ~~labeled~~establish a ~~indication~~significant ~~that~~barrier ~~are~~to ~~listed~~competitor inentry into the ~~Orange Book:~~ market.

·Related to ~~U.S. Patent No. 11,684,607: Composition of matter and method of use patent covering~~ SOLOSEC ~~and use thereof for the treatment of BV · U.S. Patent No. 11~~,~~602,522:~~ ~~Composition~~as of ~~matter~~February ~~and method of use patent covering SOLOSEC and use thereof for the treatment of trichomoniasis · U.S. Patent No. 11~~28,~~324,721:~~ ~~Method of use patent covering SOLOSEC for the treatment of trichomoniasis · U.S. Patent No. 11~~2026,~~020,377:~~ ~~Composition~~we ofowned ~~matter~~or ~~patent~~had ~~covering~~exclusive ~~SOLOSEC~~license ~~for~~to ~~the~~approximately ~~treatment~~20 ofissued BVpatents ·and ~~U.S.~~allowed ~~Patent~~applications ~~No.~~in ~~11,000,508: Method of use patent covering SOLOSEC for~~ the ~~treatment of trichomoniasis ·~~ U.S. ~~Patent~~and ~~No.~~other ~~11,000,507:~~countries ~~Method~~and ~~of use patent covering SOLOSEC for the treatment of BV · U.S. Patent No. 10~~jurisdictions,~~857,133:~~ ~~Composition of matter~~ and ~~method~~had ofapproximately ~~use~~four patent ~~covering~~applications ~~SOLOSEC~~pending ~~and~~in ~~use thereof for~~ the ~~treatment of BV ·~~ U.S. ~~Patent No. 10,849,884: Composition of matter~~ and ~~method~~other ~~of use patent covering SOLOSEC~~ countries and ~~use~~jurisdictions. ~~thereof~~This ~~for~~includes ~~the~~eleven ~~treatment of BV and trichomoniasis ·~~ U.S. ~~Patent~~patents ~~No.~~which ~~10,682,338:~~cover ~~Method of use patent covering~~ SOLOSEC ~~for~~and ~~the~~its ~~treatment~~labeled ofindications BVthat ·are ~~U.S.~~listed ~~Patent~~in ~~No. 10,335,390: Method of use patent covering SOLOSEC for~~ the ~~treatment~~Orange ~~of BV~~Book:

In● ~~February~~U.S. ~~2025~~Patent No. 12,280,037: ~~the~~Method ~~USPTO~~of ~~issued to~~use patent covering SOLOSEC for the ~~Company~~treatment aof ~~Notice~~trichomoniasis ● U.S. Patent No. 11,684,607: Composition of ~~Allowance~~matter ~~for~~and method of use patent ~~application~~covering ~~17/028~~SOLOSEC and use thereof for the treatment of BV ● U.S. Patent No. 11,~~838~~602,522: ~~entitled~~Composition ~~“Method~~of matter and ~~Pharmaceutical~~method ~~Composition~~of ~~for~~use ~~Treating or~~patent ~~Preventing~~covering ~~Trichomoniasis~~SOLOSEC and ~~Uses~~use ~~Thereof~~thereof for the treatment of trichomoniasis ● U.”S. ~~This~~Patent ~~Notice~~No. 11,324,721: Method of ~~Allowance~~use ispatent ~~expected~~covering toSOLOSEC ~~result~~for inthe treatment of trichomoniasis ● U.S. Patent No. 11,020,377: Composition of matter patent covering SOLOSEC for the ~~issuance~~treatment of aBV ● U.S. Patent No. 11,000,508: Method of use patent ~~that~~ ~~will~~covering ~~extend~~SOLOSEC for the treatment of trichomoniasis ● U.S. Patent No. 11,000,507: Method of use patent covering SOLOSEC’s IPfor ~~protection~~the bytreatment aof ~~full~~BV ~~five~~● ~~years~~U.S. Patent No. 10,857,133: ~~from~~Composition ~~2035~~of tomatter ~~2040~~and method of use patent covering SOLOSEC and use thereof for the treatment of BV ● U.S. Patent No. 10,849,884: ~~which~~Composition ~~Evofem~~of ~~expects~~matter ~~will~~and ~~be Orange~~method ~~Book-listable~~of use patent covering SOLOSEC and use thereof for the treatment of BV and trichomoniasis ● U. S. Patent No. 10,682,338: Method of use patent covering SOLOSEC for the treatment of BV ● U.S. Patent No. 10,335,390: Method of use patent covering SOLOSEC for the treatment of BV

In addition to patents, we rely, and expect to rely, on trade secrets and know-how to develop and maintain our competitive positions. ~~For~~ For example, certain aspects of the composition, manufacturing, and use of ~~PHEXXI~~PHEXX and SOLOSEC are protected by unpatented trade secrets and know-how. Although trade secrets and know-how can be difficult to protect, we seek to protect our proprietary technology and processes, in part, through confidentiality agreements with our employees, consultants, scientific advisors, collaborators, and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached and we may not have adequate remedies for these incidents. In addition, our trade secrets and know-how may otherwise become known or may be independently discovered by competitors. To the extent our consultants, contractors or collaborators use intellectual property owned by third parties in their work for us, disputes may arise as to the rights in related or resulting intellectual property, including trade secret, know-how and inventions.

2019

Trademark Basics and Strategy

We own or have rights to various trademarks, copyrights and trade names used in our business, including EVOFEM, ~~PHEXXI~~PHEXX, SOLOSEC and FEMIDENCE. All of our logos and trademarks appearing in this Annual Report are the property of Evofem Biosciences, Inc. All other third-party trademarks appearing in this Annual Report are the property of their respective holders. Our use or display of other parties’ trademarks, trade dress, or products in this Annual Report is not intended to, and does not, imply a relationship with, or endorsement or sponsorship of us, by the trademark, trade dress, or product owner.

Government Regulation and Product Approval

The research, development, testing, manufacture, labeling, promotion, advertising, distribution, and marketing, among other things, of our products are subject to extensive regulation by governmental authorities in the U.S. and other countries. The processes for obtaining regulatory approvals in the U.S. and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory requirements, require the expenditure of substantial time and financial resources.

In the U.S., the FDA regulates drugs and other medical products under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations. Failure to comply with the applicable U.S. requirements may subject us to administrative or judicial sanctions, such as FDA refusal to approve pending New Drug Applications (NDAs), warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution.

Post-Approval Requirements in the U.S.

Following approval of a new product or indication, the manufacturer and the approved product are subject to continuing regulation by the FDA, including, among other things: monitoring and record-keeping activities, reporting of adverse experiences, and complying with promotion and advertising requirements, which include restrictions on promoting approved drugs for unapproved uses or patient populations (known as “off-label use”). Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such uses. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including adverse publicity, enforcement action by the FDA, corrective advertising, consent decrees and the full range of civil and criminal penalties available to the FDA. Prescription drug promotional materials also must be submitted to the FDA in conjunction with their first use. Further, if there are any modifications to the approved drug, including changes in indications, labeling, or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require the applicant to develop additional data or conduct additional preclinical studies or clinical trials.

Any limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur while the product is on the market.

FDA regulations require that products be manufactured in specific approved facilities and in accordance with cGMPs. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products. The manufacturing facilities for any of our products must meet cGMP requirements and satisfy the FDA or comparable foreign regulatory authorities’ satisfaction before it is approved and can be manufactured. Evofem relies, and expects to continue to rely, on third parties for the production of commercial quantities of PHEXXI and SOLOSEC in accordance with cGMPs. These manufacturers must also comply with cGMPs that require, among other things, quality control and quality assurance, the maintenance of records and documentation, and the obligation to investigate and correct any deviations from cGMP. Manufacturers and other entities involved in the manufacture and distribution of approved drugs or combination products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. The discovery of violative conditions, including failure to conform to cGMPs, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved NDA, including recall.20

FDA regulations require that products be manufactured in specific approved facilities and in accordance with cGMPs. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products. The manufacturing facilities for any of our products must meet cGMP requirements and satisfy the FDA or comparable foreign regulatory authorities’ satisfaction before it is approved and can be manufactured. Evofem relies, and expects to continue to rely, on third parties for the production of commercial quantities of PHEXX and SOLOSEC in accordance with cGMPs. These manufacturers must also comply with cGMPs that require, among other things, quality control and quality assurance, the maintenance of records and documentation, and the obligation to investigate and correct any deviations from cGMP. Manufacturers and other entities involved in the manufacture and distribution of approved drugs or combination products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. The discovery of violative conditions, including failure to conform to cGMPs, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved NDA, including recall.

After approval of a drug is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information, or imposition of additional post-market surveillance or clinical trials to assess new safety risks. Other potential consequences include, among other things:

	●	restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

	●	fines, warning letters or other enforcement-related letters or clinical holds on investigational or post-approval clinical trials;

	●	refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals;

	●	product seizure or detention, or refusal to permit the import or export of products;

	●	injunctions or the imposition of civil or criminal penalties; and

	●	consent decrees, corporate integrity agreements, debarment, or exclusion from federal health care programs; or mandated modification of promotional materials and labeling and the issuance of corrective information.

In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (PDMA), which regulates the distribution of drugs and drug samples at the federal level and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution. In 2013, the Drug Supply Chain Security Act (DSCSA) was enacted with the aim of building an electronic system to identify and trace certain prescription drugs distributed in the U.S., including most biological products. The DSCSA mandated obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers were phased in over a 10-year period and effective November 27, 2024, all authorized trading partners, including dispensers and manufacturers, are required to incorporate serial numbers into their DSCSA processes, providing enhanced unit-level tracking.

From time to time, new legislation and regulations may be implemented that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA. It is impossible to predict whether further legislative or regulatory changes will be enacted, or FDA regulations, guidance or interpretations will be changed or what the impact of such changes, if any, may be.

Hatch-Waxman Act and Marketing Exclusivity

Under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Amendments) to the Federal Food, Drug, and Cosmetic Act (FDCA), Congress authorized the FDA to approve generic drugs that are the same as drugs previously approved by the FDA under the NDA provisions of the statute and also enacted Section 505(b)(2) of the FDCA. To obtain approval of a generic drug, an applicant must submit an abbreviated new drug application (ANDA), to the agency. In support of such applications, a generic manufacturer may rely on the preclinical and clinical testing conducted for a drug product previously approved under an NDA, known as the reference listed drug (RLD). Specifically, in order for an ANDA to be approved, the FDA must find that the generic version is identical to the RLD with respect to the active ingredients, the route of administration, the dosage form, and the strength of the drug. In contrast, Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. A Section 505(b)(2) applicant may eliminate the need to conduct certain preclinical or clinical studies, if it can establish that reliance on studies conducted for a previously-approved product is scientifically appropriate. Unlike the ANDA pathway used by developers of bioequivalent versions of innovator drugs, which does not allow applicants to submit new clinical data other than bioavailability or bioequivalence data, the 505(b)(2) regulatory pathway does not preclude the possibility that a follow-on applicant would need to conduct additional clinical trials or nonclinical studies; for example, they may be seeking approval to market a previously approved drug for new indications or for a new patient population that would require new clinical data to demonstrate safety or effectiveness. The FDA may then approve the new product for all or some of the label indications for which the RLD has been approved, or for any new indication sought by the Section 505(b)(2) applicant, as applicable.

Upon approval of an NDA or a supplement thereto, NDA sponsors are required to list with the FDA each patent with claims that cover the applicant’s product or an approved method of using the product. Each of the patents listed by the NDA sponsor is published in the Orange Book. The Orange Book listing for the ~~PHEXXI~~PHEXX vaginal gel NDA includes five patents covering the product’s composition of matter and its method of use in prevention of pregnancy. The Orange Book listing for the SOLOSEC NDA includes ten patents covering the product’s composition of matter and its methods of use in treatment of BV, trichomoniasis and sexually transmitted infection. Except for patents covering methods of use for which the follow-on applicant is not seeking approval, the applicant is required to certify to the FDA concerning any patents listed in the Orange Book for the RLD, when an ANDA applicant submits its application to the FDA. To the extent the Section 505(b)(2) applicant is relying on studies conducted for an already approved product, such an applicant is also required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would.

Specifically, an ANDA or 505(b)(2) applicant for a follow-on drug product with respect to each patent must certify that: (i) the required patent information has not been filed by the original applicant; (ii) the listed patent already has expired; (iii) the listed patent has not expired, but will expire on a specified date and approval is sought after patent expiration; or (iv) the listed patent is invalid, unenforceable or will not be infringed by the manufacture, use or sale of the new product.

If a Paragraph I or II certification is filed, the FDA may make approval of the application effective immediately upon completion of its review. If a Paragraph III certification is filed, the approval may be made effective on the patent expiration date specified in the application, although a tentative approval may be issued before that time. If an application contains a Paragraph IV certification, a series of events will be triggered, the outcome of which will determine the effective date of approval of the ANDA or 505(b)(2) application.

A certification that the new product will not infringe the RLD’s listed patents or that such patents are invalid is called a Paragraph IV certification. If the follow-on applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders for the RLD once the applicant’s NDA has been accepted for filing by the FDA. The NDA and patent holders may then initiate a legal challenge to the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of their receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA or 505(b)(2) NDA until the earlier of 30 months after the receipt of the Paragraph IV notice, expiration of the patent or a decision in the infringement case that is favorable to the ANDA or 505(b)(2) applicant. Alternatively, if the listed patent holder does not file a patent infringement lawsuit within the required 45-day period, the follow-on applicant’s ANDA or 505(b)(2) NDA will not be subject to the 30-month stay.

In addition, under the Hatch-Waxman Amendments, the FDA may not approve an ANDA or 505(b)(2) NDA until any applicable period of non-patent exclusivity for the referenced RLD has expired. These market exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications. The FDCA provides a five-year period of non-patent marketing exclusivity within the U.S. to the first applicant to gain approval of an NDA for a drug containing a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an ANDA or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement.

The FDCA also provides three years of marketing exclusivity for a NDA, 505(b)(2) NDA, or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving follow-on applications for drugs containing the original active agent. Five-year and three-year exclusivity also will not delay the submission or approval of a traditional NDA filed under Section 505(b)(1) of the FDCA. However, an applicant submitting a traditional NDA would be required to either conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

The three-year new product exclusivity for the ~~PHEXXI~~PHEXX NDA expired on May 22, 2023. The product’s intellectual property currently includes ~~five~~four U.S. patents which cover ~~PHEXXI~~PHEXX and its labeled indication that are listed in the Orange Book; these patents are expected to protect ~~PHEXXI~~PHEXX into 2033.

SOLOSEC’s intellectual property includes ~~ten~~eleven U.S. patents which cover the product and its labeled indication that are listed in the Orange ~~Book,~~ ~~and one allowed patent~~Book; these patents ~~and allowed patent~~ are expected to protect SOLOSEC into ~~2040~~2041. SOLOSEC is also protected by NCE-GAIN Exclusivity until September 15, 2027.

Designation of and Exclusivity for Qualified Infectious Disease Products

In 2012 as part of the Food Drug Administration Safety and Innovation Act, Congress passed legislation known as the Generating Antibiotic Incentives Now Act (GAIN Act), which amended the FDCA to encourage the development of antibacterial and antifungal drug products that treat pathogens that cause serious and life-threatening infections. The law grants an additional five years of marketing exclusivity upon the approval of an NDA for a drug product previously designated by FDA as a Qualified Infectious Disease Product (QIDP). As a result, if applicable to a designated QIDP, upon approval the periods of five-year new chemical entity exclusivity (NCE) and three-year new clinical investigation exclusivity would become ten years and eight years, respectively.

A QIDP is defined in the GAIN Act to mean “an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by: (1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens;” or (2) certain “qualifying pathogens.” A “qualifying pathogen” is a pathogen that has the potential to pose a serious threat to public health (e.g., resistant gram positive pathogens, multi-drug resistant gram negative bacteria, multi-drug resistant tuberculosis and Clostridium difficile) and that is included in a list established and maintained by FDA. A drug sponsor may request FDA to designate its product as a QIDP any time before the submission of an NDA for that indication. FDA must make a QIDP determination within 60 days of the designation request. A product designated as a QIDP may be granted priority review by FDA upon submission and can also qualify for “Fast Track” status, described further below.

We have received two QIDP designations from the FDA for EVO100 for the prevention of urogenital infection in women with both chlamydia and gonorrhea and one for EVO200 for BV. SOLOSEC was designated a QIDP for the treatment of BV and was granted fast-track designation. SOLOSEC is protected by NCE-GAIN Exclusivity until September 15, 2027.

Fast Track and Priority Review Designations

The FDA is authorized to designate certain products for expedited development or review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition. These programs include Fast Track designation and priority review designation.

To be eligible for a Fast Track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need by providing a therapy where none exists or a therapy that may be potentially superior to existing therapy based on efficacy or safety factors. Fast Track designation provides opportunities for more frequent interactions with the FDA review team to expedite development and review of the product. The FDA may also review sections of the NDA for a Fast Track product on a rolling basis before the complete application is submitted, if the sponsor and the FDA agree on a schedule for the submission of the application sections, and the sponsor pays any required user fees upon submission of the first section of the NDA. Fast Track designation may be withdrawn by the sponsor or rescinded by the FDA if the designation is no longer supported by data emerging in the clinical trial process. A product candidate designated as a QIDP is eligible for Fast Track designation under the provisions of the GAIN Act, but the NDA sponsor must specifically request Fast Track designation from the agency as with non-infectious disease product candidates. Fast Track designation may be requested concurrent with or at any time after the QIDP designation. In addition, although QIDP designation may be requested prior to submission of an Investigational New Drug Application (IND), a request for Fast Track designation may only be made concurrently with, or any time after, submission of an IND.

The FDA also may designate a product for priority review if it is a drug or biologic that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. The FDA determines at the time that the marketing application is submitted, on a case- by-case basis, whether the proposed drug represents a significant improvement in treatment, prevention or diagnosis of disease when compared with other available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting drug reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes, or evidence of safety and effectiveness in a new subpopulation. A priority review designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for acting on a marketing application from ten months to six months for an original new molecular entity NDA from the date of filing. Although the FDA automatically gives priority review designation to the first application submitted for a specific drug product and indication for which a QIDP designation was granted, a subsequent application from the same sponsor for the same product and indication will receive priority review designation only if it otherwise meets the criteria for priority review.

Finally, even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. Furthermore, Fast Track designation and priority review do not change the standards for approval and may not ultimately expedite the development or approval process.

We have received two Fast Track designations from the FDA for EVO100 for the prevention of urogenital chlamydia and gonorrhea infection in women.

Patent Term Restoration in the U.S.

Depending upon the timing, duration and specifics of FDA approval of our drug candidates, some of our U.S. patents may be eligible for limited PTE under other provisions of the Hatch-Waxman Amendments. These PTEs permit a patent restoration term of up to five years as compensation for any patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND, and the submission date of an NDA, plus the time between the submission date of an NDA and the approval of that application. Only one patent applicable to an approved drug is eligible for the extension, and the extension must be applied for prior to expiration of the patent. The U.S. Patent and Trademark Office (USPTO) in consultation with the FDA, reviews and approves the application for any PTE or restoration.

Other U.S. Governmental Regulations and Environmental Matters

As we have now established international contracts, we are subject to compliance with the U.S. Foreign Corrupt Practices Act of 1977, as amended (the FCPA), which prohibits corporations and individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff member, political party, or political candidate to obtain or retain business or to otherwise influence a person working in an official capacity. We also may be implicated under the FCPA for activities by our partners, collaborators, contract research organizations, vendors, or other agents.

While enforcement of the FCPA was paused on February 10, 2025, following an executive order signed by President Trump, we continue to comply with the FCPA, and the position held by the Department of Justice and other U.S. authorities that previously enforced the FCPA, which collectively deem most health care professionals and other employees of foreign hospitals, clinics, research facilities and medical schools in countries with public health care or public education systems to be “foreign officials” under the FCPA. If and when we interact with foreign health care professionals and researchers in testing and marketing our products abroad, we have policies and procedures in place sufficient to prevent us and agents acting on our behalf from providing any bribe, gift or gratuity, including excessive or lavish meals, travel or entertainment in connection with marketing our products and services or securing required permits and approvals such as those needed to initiate clinical trials in foreign jurisdictions. The FCPA also obligates companies whose securities are listed in the U.S. to comply with accounting provisions requiring the maintenance of books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and the development and maintenance of an adequate system of internal accounting controls for international operations.

Our present and future business has been and will continue to be subject to various other laws and regulations. Various laws, regulations and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement, import and export and use and disposal of hazardous or potentially hazardous substances used in connection with our research work are or may be applicable to our activities. Certain agreements involving exclusive license rights, if any, or acquisitions, if any, may be subject to national or supranational antitrust regulatory control, the effect of which cannot be predicted. The extent of government regulation, which might result from future legislation or administrative action, cannot accurately be predicted.

Review and Approval of Drug Products in the European Union

In addition to regulations in the U.S., we are and will be subject, either directly or through our distribution partners, to a variety of regulations in other jurisdictions governing, among other things, clinical trials and future commercial sales and distribution of our products, if approved in those markets.

We must obtain the requisite approvals from regulatory authorities in non-U.S. countries prior to the commencement of clinical trials or marketing of a product in those countries. Moreover, the time required to obtain approval in other countries and jurisdictions might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in others.

As of January 31, 2020, the United Kingdom (UK) is no longer a member state of the European Union (EU), and therefore a separate marketing authorization application (MAA) and approval will be required to market a medicinal product in the UK.

We are assessing the optimal regulatory legal basis for the ~~PHEXXI~~PHEXX and SOLOSEC MAAs in the EU and the UK. As in the U.S., medicinal ~~products~~ products can be marketed in the EU only if a marketing authorization from the competent regulatory agencies has been obtained. Similar to the U.S., the various phases of preclinical and clinical research in the EU are subject to significant regulatory controls.

Pursuant to the European Clinical Trials Directive, a system for the approval of clinical trials in the EU has been implemented through national legislation of the member states. Under this system, an applicant must obtain approval from the competent national authority of an EU member state in which the clinical trial is to be conducted. Furthermore, the applicant may only start a clinical trial after a competent ethics committee has issued a favorable opinion. Clinical trial applications must be accompanied by an investigational medicinal product dossier with supporting information prescribed by the European Clinical Trials Directive and corresponding national laws of the member states and further detailed in applicable guidance documents. In April 2014, the new Clinical Trials Regulation, Regulation EU No 536/2014 (Clinical Trials Regulation) was adopted and it came into application on January 31, 2022. The Clinical Trials Regulation will be directly applicable in all the EU member states, repealing the current Clinical Trials Directive 2001/20/EC. Conduct of all clinical trials performed in the EU will continue to be bound by currently applicable provisions until the new Clinical Trials Regulation becomes applicable. The extent to which ongoing clinical trials will be governed by the Clinical Trials Regulation will depend on when the Clinical Trials Regulation becomes applicable and on the duration of the individual clinical trial. If a clinical trial continues for more than three years from the day on which the Clinical Trials Regulation becomes applicable, the Clinical Trials Regulation will at that time begin to apply to the clinical trial.

The new Clinical Trials Regulation aims to simplify and streamline the approval of clinical trials in the EU. The main characteristics of the regulation include: a streamlined application procedure via a single entry point; a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is assessed by the competent authorities of all EU member states in which an application for authorization of a clinical trial has been submitted. Part II is assessed separately by each EU member state concerned. Strict deadlines have been established for the assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure will continue to be governed by the national law of the concerned EU member state. However, overall related timelines will be defined by the Clinical Trials Regulation.

To obtain marketing approval of a drug in the EU, an applicant must submit an MAA either under a centralized or decentralized procedure. The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for all EU member states, Iceland, Lichtenstein, and Norway. The centralized procedure is compulsory for specific products, including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy products (such as gene-therapy, somatic cell-therapy or tissue-engineered medicines) and products with a new active substance indicated for the treatment of certain diseases. For products with a new active substance indicated for the treatment of certain diseases and products that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure may be optional. Under the centralized procedure the maximum timeframe for the evaluation of an MAA by the EMA is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the Committee for Medicinal Products for Human Use (CHMP). Accelerated assessment might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest, particularly from the point of view of therapeutic innovation. The timeframe for the evaluation of an MAA under the accelerated assessment procedure is 150 days, excluding stop-clocks.

The decentralized procedure is available to applicants who wish to market a product in specific EU member states where such product has not received marketing approval in any EU member states before. The decentralized procedure provides for an applicant to apply to one-member state to assess the application (the reference member state) and specifically list other member states in which it wishes to obtain approval (concerned member states). Under this procedure, an applicant submits an application based on identical dossiers and related materials, including a draft summary of product characteristics, and draft labeling and package leaflet, to the reference member state and each concerned member state. The reference member state prepares a draft assessment report and drafts of the related materials within 210 days after receipt of a valid application which is then reviewed and approved commented on by the concerned member states. Within 90 days of receiving the reference member state’s assessment report and related materials, each concerned member state must decide whether to approve the assessment report and related materials.

In the EU, only products for which marketing authorizations have been granted may be promoted. A marketing authorization is valid for five years in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the authorizing member state. To this end, the marketing authorization holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to be valid. Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal. Any authorization which is not followed by the actual placing of the drug on the EU market (in case of centralized procedure) or on the market of the authorizing member state within three years after authorization ceases to be valid (the so-called sunset clause). Even if authorized to be marketed in the EU, prescription-only medicines may only be promoted to health care professionals, not the general public. All promotion should be in accordance with the particulars listed in the summary of product characteristics. Promotional materials must also comply with various laws, and codes of conduct developed by pharmaceutical industry bodies in the EU which govern (among other things) the training of sales staff, promotional claims and their justification, comparative advertising, misleading advertising, endorsements, and (where permitted) advertising to the general public. Failure to comply with these requirements could lead to the imposition of penalties by the competent authorities of the EU member states. The penalties could include warnings, orders to discontinue the promotion of the drug product, seizure of promotional materials, fines and possible imprisonment.

In the EU, only products for which marketing authorizations have been granted may be promoted. A marketing authorization is valid for five years in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the authorizing member state. To this end, the marketing authorization holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety, and efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to be valid. Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal. Any authorization which is not followed by the actual placing of the drug on the EU market (in case of centralized procedure) or on the market of the authorizing member state within three years after authorization ceases to be valid (the so-called sunset clause). Even if authorized to be marketed in the EU, prescription-only medicines may only be promoted to health care professionals, not the general public. All promotion should be in accordance with the particulars listed in the summary of product characteristics. Promotional materials must also comply with various laws, and codes of conduct developed by pharmaceutical industry bodies in the EU which govern (among other things) the training of sales staff, promotional claims and their justification, comparative advertising, misleading advertising, endorsements, and (where permitted) advertising to the general public. Failure to comply with these requirements could lead to the imposition of penalties by the competent authorities of the EU member states. The penalties could include warnings, orders to discontinue the promotion of the drug product, seizure of promotional materials, fines, and possible imprisonment.

EU Regulatory Exclusivity

In the EU, new products authorized for marketing (i.e., reference products) qualify for eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization. The data exclusivity period prevents generic applicants from relying on the pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic marketing authorization in the EU during a period of eight years from the date on which the reference product was first authorized in the EU. The market exclusivity period prevents a successful generic applicant from commercializing its product in the EU until ten years have elapsed from the initial authorization of the reference product in the EU. The ten-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.

Rest of the World Regulation

For other countries outside of the EU and the U.S., ~~such~~including as countries in the ~~CGG~~GCC, Eastern Europe, Latin America, Asia, orand Africa, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from jurisdiction to jurisdiction. Additionally, the clinical trials must be conducted in accordance with cGCP requirements and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

Other U.S. Health Care Laws and Regulations

We must comply with various U.S. federal and state laws, rules and regulations pertaining to health care fraud and abuse, including anti-kickback laws. HCPs and third-party payers play a primary role in the recommendation and prescription of drug products and medical devices. Our current and future arrangements with health care professionals, principal investigators, consultants, third-party payers and customers may expose us to broadly applicable fraud and abuse and other health care laws and regulations. Such restrictions under applicable federal and state health care laws and regulations, include but are not limited to the following:

Anti-Kickback Statute – the Federal Anti-Kickback Statute, among other things, prohibits persons from knowingly and willfully soliciting, offering, receiving, or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federally funded health care programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate the statute in order to have committed a violation. In addition, the government may assert that a claim that includes items or services resulting from a violation of the Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

Civil and Criminal False Claims Laws – the federal civil and criminal false claims laws, including the federal False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government.

Health Insurance Portability and Accountability Act of 1996 – the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibits, among other things, individuals or entities from executing a scheme to defraud any health care benefit program or making any false statements relating to health care matters; as in the case of the Federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate the statute in order to have committed a violation. Additionally, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and its implementing regulations impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization, on entities subject to the law, such as certain HCPs, health plans, and health care clearinghouses and their respective business associates that perform services for them that involve the creation, use, maintenance or disclosure of, individually identifiable health information.

False Statements Statute – the federal False Statements Statutes prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statement to the federal government, including executive or administrative agencies.

Sunshine Act – the federal transparency or “sunshine” requirements of the ACA requires certain manufacturers of drugs, devices, biologics, and medical supplies to annually report to the Department of Health and Human Services (the DHHS) information related to payments and other transfers of value made to physicians, teaching hospitals and certain advanced non-physician health care practitioners, as well as ownership and investment interests held by physicians and their immediate family members.

State Transparency Laws – some U.S. state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to HCPs and other HCPs or marketing expenditures; some state laws require pharmaceutical companies to implement compliance programs and to track and report gifts, compensation and other remuneration provided to physicians, in addition to requiring drug manufacturers to report information related to payments to physicians and other HCPs or marketing expenditures and pricing information; and some state and local laws require the registration of pharmaceutical sales representatives.

State and Foreign Regulatory Concerns – there are analogous State and foreign laws and regulations, such as State Anti-Kickback and False Claims laws, which may apply to sales or marketing arrangements and claims involving health care items or services reimbursed by non-governmental third-party payers, including private insurers. State and foreign laws also govern the privacy and security of health and personal information. These laws differ from each other in significant ways and may conflict, while applying simultaneously with HIPAA, thus complicating compliance efforts.

The scope and enforcement of these laws is uncertain and subject to rapid change. Notably, in November 2020, DHHS finalized significant changes to the regulations implementing the Anti-Kickback Statute, as well as the civil monetary penalty rules regarding beneficiary inducements, with the goal of offering the health care industry more flexibility and reducing the regulatory burden associated with those fraud and abuse laws, particularly with respect to value-based arrangements among industry participants. Regulatory authorities might challenge our current or future activities under these laws, regulations, and safe harbors. Any such challenge could have a material adverse effect on our reputation, business, results of operations and financial condition. In addition, efforts to ensure that our business arrangements with third parties will comply with these laws will involve substantial costs. Any investigation of us or the third parties with whom we contract, regardless of the outcome, would be costly and time consuming. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, monetary fines, imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal health care programs, debarment under the FDCA, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations.

Health Care Reform and Potential Changes to Laws and Regulations

In the U.S. and some foreign jurisdictions, there have been, and continue to be, legislative and regulatory changes both enacted and proposed related to the health care system, which could prevent or delay marketing approval of our products, restrict or regulate post-approval activities, and affect our ability to profitably sell our current products or any other approved product we may seek to commercialize. In particular, the FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted. For example, in December 2016, the 21st Century Cures Act (Cures Act), was passed by Congress and signed into law. The Cures Act, among other things, is intended to modernize the regulation of drugs and devices and to spur innovation, but its ultimate implementation is uncertain. In addition, in August 2017, the FDA Reauthorization Act was signed into law, which reauthorized the FDA’s user fee programs and included additional drug and device provisions that build on the Cures Act. A subsequent FDA reauthorization package was finalized by Congress on September 30, 2022; several other FDA-related changes have been proposed in Congress, including several within the “Cures 2.0” bill. While the bill as a whole has not passed, some components have been signed into law through various other legislative vehicles or otherwise addressed by executive action.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition, and results of operations.

Among policy makers and payers in the U.S. and elsewhere, there is significant interest in promoting changes in health care systems with the stated goals of containing health care costs, improving quality and/or expanding access. In the U.S., the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. For example, in March 2010, the ACA was enacted, which, among other things, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care plans; imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs coverage under Medicare Part D; and established a Center for Medicare Innovation at the U.S. Centers for Medicare and Medicaid Services (CMS) to test innovative payment and service delivery models to lower Medicare and Medicaid spending. As another example, the 2021 Consolidated Appropriations Act, signed into law on December 27, 2020, incorporated extensive health care provisions and amendments to existing laws, including a requirement that all manufacturers of drug products covered under Medicare Part B report the product’s average sales price (ASP) to DHHS beginning on January 1, 2022, subject to enforcement via civil money penalties.

Since its enactment, there have been judicial and congressional challenges to certain aspects of the ACA, and as a result certain sections of the ACA have not been fully implemented or effectively repealed. However, following several years of litigation in the federal courts, in June 2021, the U.S. Supreme Court upheld the ACA when it dismissed a legal challenge to the ACA’s constitutionality. Further legislative and regulatory changes under the ACA remain possible. It is unknown what form any such changes or any law would take, and how or whether it may affect the pharmaceutical industry as a whole or our business in the future. We expect that changes or additions to the ACA, the Medicare and Medicaid programs, such as changes allowing the federal government to directly negotiate drug prices, and changes stemming from other health care reform measures, especially with regard to health care access, financing or other legislation in individual states, could have a material adverse effect on the health care industry in the U.S.

Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013 and will remain in effect through 2030 unless additional congressional action is taken. The Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), which was signed into law on March 27, 2020, and was designed to provide financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended the 2% Medicare sequester from May 1, 2020 through December 31, 2020, and extended the sequester by one year, through 2030, in order to offset the added expense of the 2020 cancellation. The suspension was subsequently extended through March 31, 2022, with a reduction of the suspension to 1% sequester through June 30, 2022. The suspension was lifted in steps during 2022 and for 2023, the 2% sequester rate established on July 1, 2022 was in effect for the entire year.

As another example, on December 20, 2019, the Further Consolidated Appropriations Act for 2020 was signed into law (P.L. 116-94), which includes a piece of bipartisan legislation called the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (the CREATES Act). The CREATES Act aims to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products to deny generic product developers access to samples of brand products. Because generic product developers need samples to conduct certain comparative testing required by the FDA, some have attributed the inability to timely obtain samples as a cause of delay in the entry of generic products. To remedy this concern, the CREATES Act establishes a private cause of action that permits a generic product developer to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Whether and how generic product developers will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on our future commercial products are unknown. Other new laws may result in additional reductions in Medicare and other health care funding, which could have an adverse effect on customers for our approved product and, accordingly, our financial operations.

Additionally, there has been heightened governmental scrutiny in the U.S. of manufacturers’ pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. DHHS has solicited feedback on various measures intended to lower drug prices and reduce the out-of-pocket costs of drugs and has implemented others under its existing authority. For example, in 2020, the FDA finalized a rulemaking to establish a system whereby state governmental entities could lawfully import and distribute prescription drugs sourced from Canada. More recently, in July 2021, then- President Biden issued a sweeping executive order on promoting competition in the American economy that includes several mandates pertaining to the pharmaceutical and health care insurance industries. Among other things, the executive order directs the FDA to work towards implementing a system for importing drugs from Canada (following on the first Trump Administration notice-and-comment rulemaking on Canadian drug importation which was finalized in October 2020). The Biden order also called on DHHS to release a comprehensive plan to combat high prescription drug prices, and it includes several directives regarding the Federal Trade Commission’s oversight of potentially anticompetitive practices within the pharmaceutical industry. The drug pricing plan released by DHHS in September 2021 in response to the executive order makes clear that the former Biden Administration supported aggressive action to address rising drug prices, including allowing DHHS to negotiate the cost of Medicare Part B and D drugs, but such significant changes will require either new legislation to be passed by Congress or time-consuming administrative actions. Additionally, the former Biden administration announced new lower prices, to be in effect beginning in 2026, for the first ten drugs selected for Medicare price negotiation in August 2024. The future of these executive orders and prior Administration actions is unclear under the current Trump Administration.

Coverage, Pricing, and Reimbursement

Sales of Evofem’s products approved for marketing by the FDA and foreign regulatory authorities depend, in part, on the extent to which such products will be covered by third-party payers, such as government health programs, commercial insurance and managed care organizations. In the U.S., no uniform policy of coverage and reimbursement for drug or biological products exists. Accordingly, decisions regarding the extent of coverage and amount of reimbursement to be provided for any of Evofem’s FDA-approved products will be made on a payer-by-payer basis. Prescriptions generated through the telehealth platform may be subject to additional payer requirements. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our approved products to each payer separately, with no assurance that coverage and adequate reimbursement will be obtained.

The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost containment programs to limit the growth of government-paid health care costs, including price-controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs. For example, the ACA contains provisions that may reduce the profitability of drug products through increased rebates for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, and mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal health care programs. Adoption of general controls and measures, coupled with the tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for pharmaceutical drugs. The Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the Secretary of the DHHS as a condition for states to receive federal matching funds for the manufacturer’s outpatient drugs furnished to Medicaid patients. The ACA made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers’ rebate liability by raising the minimum basic Medicaid rebate on most branded prescription drugs from 15.1% of average manufacturer price (AMP), to 23.1% of AMP and adding a new rebate calculation for “line extensions” (i.e., new formulations, such as extended release formulations) of solid oral dosage forms of branded products, as well as potentially impacting their rebate liability by modifying the statutory definition of AMP. The ACA also expanded the universe of Medicaid utilization subject to drug rebates by requiring pharmaceutical manufacturers to pay rebates on Medicaid managed care utilization and by enlarging the population potentially eligible for Medicaid drug benefits. Congress has expressed its intention to repeal or repeal and replace the ACA. If that is done, many if not all of the provisions of the ACA may no longer apply to prescription drugs.

The marketability of any products for which Evofem has or will receive regulatory approval for commercial sale may suffer if the government and third-party payers fail to provide adequate coverage and reimbursement. Emphasis on cost containment measures in the U.S. has increased, and Evofem expects will continue to increase, the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

In addition, in most foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The ~~requirements~~ requirements governing drug pricing and reimbursement vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of ~~PHEXXI~~PHEXX or SOLOSEC to currently available therapies (so called health technology assessment) in order to obtain reimbursement or pricing approval. For example, the EU provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product, or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of Evofem’s approved drug products. Historically, products launched in the EU do not follow price structures of the U.S. and generally prices tend to be significantly lower.

Corporate Information

Our corporate headquarters are located at 7770 Regents Rd, Suite 113-618, San Diego, CA 92122-1967, and our telephone number is (858) 550-1900. Our website is located at www.evofem.com. Our Annual Report, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act) will be made available free of charge on our website as soon as reasonably practicable after we electronically file these materials with, or furnish it to, the Securities and Exchange Commission (SEC) on their website located at www.sec.gov. The contents of our website are not incorporated into this Annual Report, and our reference to the URL for our website is intended to be an inactive textual reference only. The information contained on, or that can be accessed through, our website is not a part of this Annual Report.

Employees

As of ~~March~~February 1428, ~~2025~~2026, we had a total of 3229 full-time employees. We also engage consultants and contract workers on an as-needed basis. We believe that relations with our employees and consultants are good.

Item 1A. Risk Factors.

Summary of Risk Factors

The risk factors described below are a summary of the principal risk factors associated with an investment in Evofem. These are not the only risks we face. You should carefully consider the following risk factors, together with all other information included in this Annual report, including the consolidated financial statements and related notes, when deciding to invest in us. You should be aware that the occurrence of any of the events described in this Risk Factors section and elsewhere in this Annual Report could have a material adverse effect on our business, financial position, results of operations and cash flows and the trading price of our securities could decline and you could lose all or part of your investment.

Risks Related to Our Financial Condition and Capital Requirements

● We are currently over 90 days past due on a significant amount of vendor obligations. We may not be able to refinance, extend or repay our substantial indebtedness owed to our secured and unsecured lenders, which would have a material adverse effect on our financial condition and ability to continue as a going concern. ● Our audited consolidated financial statements include a statement that there is a substantial doubt about our ability to continue as a going concern. ● We have incurred significant losses and negative cash flows since our inception and anticipate we will continue to incur significant losses and negative cash flow for the foreseeable future. We may never be profitable and our operating results may differ from any guidance we may announce. ● We must raise significant additional funds to finance our operations and to remain a going concern. If we are unable to raise additional capital when needed or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our business initiatives. ● We are solely focused in women’s health and may be unfavorably impacted by weak investor sentiment and a lack of interest in the category. Our ability to access capital and to advance our candidates could be adversely impacted. ● We have certain obligations pursuant to our issued and outstanding senior secured notes, promissory notes, convertible notes and related note purchase agreements, and our failure to comply with these obligations could have a material adverse effect on our business, intellectual property, financial condition, or results of operations. ● We have a limited number of shares of ~~common~~Common ~~stock~~Stock available for future issuance which could adversely affect our ability to raise capital or consummate strategic transactions. ● Use of net operating loss carryforwards may be limited and U.S. federal income tax reform could adversely affect us.

Risks Related to the Aditxt Merger

● Failure to complete the merger could negatively impact our stock price and the future business and financial results of the Company. ● We may not be able to effect the merger pursuant to the Merger Agreement and we could incur substantial costs. ● While the Merger Agreement is in effect, we are subject to certain interim covenants. ● The announcement and pendency of the merger could cause disruptions in our business, which could have an adverse effect on our business and financial results. ● Certain provisions of the Merger Agreement may discourage third parties from submitting alternative acquisition proposals. ● We may be subject to litigation relating to the Merger.

Risks Related to Potential Bankruptcy

● We are subject to risks and uncertainties associated with potential bankruptcy proceedings including a long and protracted restructuring, from which our business could suffer. ● As of December 31, 2025, we have negative stockholders’ equity. If we are unable to raise additional capital, or otherwise become unable to satisfy our obligations as they become due, we may become insolvent and face the risk of bankruptcy. ● Our financial results may be volatile and may not reflect historical trends.

Risks Related to Commercialization ~~and~~of ~~sales~~PHEXX, ~~expansion~~SOLOSEC, ofand ~~our~~Any Other Approved Products

● Our success will depend heavily on whether we can successfully commercialize PHEXX for prevention of pregnancy, and SOLOSEC, for the treatment of bacterial vaginosis (BV) and trichomoniasis (Trich). ● If we are unable to maintain effective internal sales and marketing capabilities, or to enter into agreements with third parties to market and sell our products, our ability to continue to successfully commercialize our products and generate revenue would be adversely affected. ● Our use of social media platforms to market and promote our prescription products, presents risks and operational challenges. ● We face competition from other medical device, biotechnology, and biopharmaceutical companies and our operating results will suffer if we are unable to compete effectively. ● PHEXX, SOLOSEC, and any other approved products we promote may not gain sufficient market acceptance among physicians, patients or the medical community, thereby limiting our potential to generate revenue, which will undermine our future growth prospects. ● The telehealth market continues to develop. If the telehealth industry encounters negative publicity over privacy issues, fails to engage sufficient numbers of providers, or if limitations on reimbursement or new state law regulatory requirements impede our ability to implement our telehealth strategy, the growth of our business may be harmed. ● The success of PHEXX will depend on the availability of competitive products and women’s preferences. ● The commercial success of PHEXX, SOLOSEC and/or any future products we promote will depend in significant measure on the label claims that the FDA or other regulatory authorities approve for those products. ● The FDA and other regulatory agencies actively enforce laws and regulations prohibiting the promotion of off-label uses for prescription drugs and medical devices. If we are found or alleged to have improperly promoted our commercial product for off-label uses, we may become subject to significant liability. ● If we suffer negative publicity concerning the safety or efficacy of our products, our reputation and the commercialization of such products could be harmed. ● We rely, and expect to continue to rely, on market research conducted internally to evaluate the potential commercial acceptance of PHEXX for the prevention of pregnancy. ● There can be no assurance on the accuracy or completeness of certain facts, forecasts and other statistics obtained from various government publications, market data providers and other independent third-party sources, including industry expert reports, contained in this Annual Report or other statements we may make from time to time. ● The proportion of the contraceptive market that is made up of generic products continues to increase, making the introduction of a branded contraceptive difficult and expensive. ● Even though we have received approval from the FDA in the U.S. to market PHEXX for the prevention of pregnancy, and, as Femidence, by the National Agency for Food and Drug Administration and Control of Nigeria, and to market SOLOSEC for the treatment of BV and Trich, we may fail to receive similar approvals in other territories outside the U.S.

Risks Related to Regulatory Approval of our Products

● We may fail to receive approval to market our products outside the U.S.

Risks Related to Our Post-Marketing Legal and Regulatory Compliance

● ~~Developments~~Even ~~after~~though awe ~~product~~have ~~reaches~~obtained ~~the~~FDA ~~market~~approval ~~may~~for ~~adversely~~PHEXX ~~affect~~for ~~sales~~prevention of ~~the~~pregnancy ~~product.~~and ●of ~~Product~~SOLOSEC ~~liability~~for ~~lawsuits~~the ~~against~~treatment usof ~~could~~BV ~~cause~~and usTrich, towe ~~incur~~remain ~~substantial~~subject ~~liabilities~~to ~~and~~ongoing ~~limit~~regulatory ~~commercialization of our Products~~requirements. ● ~~The~~Developments ~~FDA~~after ~~and~~a ~~other~~product ~~regulatory~~reaches ~~agencies actively enforce~~ the ~~laws~~market ~~and~~may ~~regulations~~adversely ~~relating~~affect tosales ~~the promotion~~ of ~~our~~the ~~products~~product.

	●	Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of our Products.
	●	If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business, financial condition or results of operations.
	●	The FDA and other regulatory agencies actively enforce the laws and regulations relating to the promotion of our products.

Risks Related to Our Intellectual Property

● ~~Our~~ThereapeuticsMD ~~rights~~may totake ~~develop~~adverse ~~and~~action ~~commercialize~~against ~~PHEXXI are subject, in part, to~~ the ~~terms~~Company and ~~conditions~~its ofuse ~~licenses granted to us by third parties. The patent protection and patent prosecution~~ of ~~PHEXXI~~the ~~are~~PHEXX ~~dependent on third parties~~mark. ● If we are unable to obtain and maintain patent protection for ~~PHEXXI~~PHEXX or SOLOSEC, or if the scope of the patent protection we have or will obtain is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to our products and technology, and our ability to successfully commercialize ~~PHEXXI~~PHEXX and/or SOLOSEC may be adversely affected. ● We may not be able to protect our intellectual property and proprietary rights throughout the world. ● IfObtaining weand domaintaining ~~not~~our ~~obtain~~patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent ~~term~~agencies, ~~extensions~~and ~~(PTE)~~our patent protection could be reduced or eliminated for ~~PHEXXI~~non-compliance with these requirements. ● Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ~~business~~ability ~~may~~to protect our products. ● Issued patents covering PHEXX or SOLOSEC could be ~~materially~~found ~~harmed~~invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad. ● An Event of Default under the secured notes issued pursuant to the Baker Bros. Purchase Agreement, as amended, could allow the secured creditor to take possession of all assets owned by us, including any directly owned intellectual property pertaining to ~~PHEXXI~~PHEXX. ● The Company received two Notice of Defaults from their largest creditor, Future Pak, LLC, alleging a number of Events of Default, accelerating the Principal due and payable and declaring the termination of the existing Forbearance Agreement. ● We may be subject to claims challenging the inventorship of our patents and other intellectual property. ● If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed. ● We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. ● We may be at risk that our former employees may wrongfully use or disclose our trade secrets. ● We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property. ● Third-party claims of intellectual property infringement induced intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the commercialization of our product. ● In the ordinary course of business, we have been and again may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming, and unsuccessful. ● If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected. ● Intellectual property rights do not necessarily address all potential threats.

Risks Related to Our Reliance on Third Parties

● Our success relies on third-party suppliers and two contract manufacturers,. ~~one~~● ~~each~~We have no significant internal distribution capabilities. ● We rely on third parties for ~~PHEXXI~~the delivery of telehealth services through the PHEXX telehealth platform. ● If we are unable to enter into or maintain strategic relationships or collaborations with respect to PHEXX for the prevention of pregnancy, or if we are unable to realize the potential benefits from such collaborations, our business, financial condition, commercialization prospects and ~~SOLOSEC~~results of operations may be materially adversely affected. ● We enter into various contracts in the normal course of our business in which we indemnify the other party to the contract. In the event we must perform under these indemnification provisions, it could have noa ~~significant~~material ~~internal~~adverse ~~distribution~~effect ~~capabilities~~on our business, financial condition and results of operations.

Risks Related to Our Commercialization of Health Care Products

● Our products may face follow-on competition sooner than anticipated. ● Changes in health care laws and regulations may eliminate current requirements for health insurance plans to cover and reimburse FDA-cleared or FDA-approved contraceptive products without cost sharing, which could reduce demand for products such as ~~PHEXXI~~PHEXX. ● ~~Increasing~~Despite ~~scrutiny~~FDA-approval offor ~~healthcare~~our ~~economics~~products and even if we are successful in obtaining additional products to commercialize in the U.S., revenues may ~~influence~~be ~~prescribing~~adversely affected if our products do not obtain coverage and ~~utilization~~adequate ~~practices~~reimbursement from third-party payers in the U.S. ● The pharmaceutical and medical device industries are highly regulated and subject to various fraud and abuse, ~~which~~data ~~could~~privacy, ~~reduce~~transparency, ~~demand~~and ~~for~~other ~~branded~~health ~~products~~care ~~such~~laws, asincluding, ~~PHEXXI~~without limitation, the U.S. Federal Anti-Kickback Statute, the U.S. Federal False Claims Act and ~~SOLOSEC~~the FCPA. ● Health care legislative reform measures may have a negative impact on our business and results of operations.

Risks Related to Our Business Operations

	●	As we mature and expand our sales and marketing infrastructure, we will need to expand the size of our organization. If we experience difficulties in managing this growth or are unable to attract and retain management and other key personnel, we may be unable to successfully commercialize our products or otherwise implement our business plan.
	●	Our current or future employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with legal requirements or regulatory standards.
	●	We may be vulnerable to disruption, damage and financial obligations as a result of information technology system failures, cybersecurity breaches, loss of data or other disruptions that could compromise our proprietary information or other sensitive information.
	●	We expect to continue to incur increased costs as a result of operating as a public company and our management will be required to devote substantial time to compliance initiatives and corporate governance practices.
	●	The inability to attract and retain qualified key management personnel would impair our ability to implement our business plan.
	●	In connection with the departure of key personnel, we may be subject to certain separation payments, legal actions or other claims.
	●	We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations which can harm our business.
	●	We or the third parties upon whom we depend may be adversely affected by earthquakes, medical epidemics or pandemics, or other natural disasters including wildfires. These natural disasters may be exacerbated by the effects of climate change.

Risks Related to Our Common and Preferred Stock

● ~~Our~~There ~~management~~can ~~has~~be ~~identified~~no ~~material~~assurance ~~weakness~~that inwe ~~our~~will ~~internal~~be ~~controls~~able ~~and~~to ~~procedures~~comply with the continued listing standards of OTCID. ● Our stock price is and may continue to be volatile. ● There may not be an active, liquid trading market for our equity securities. ● Because our Common Stock is subject to the “penny stock” rules, brokers cannot generally solicit the purchase of our Common Stock, which adversely affects its liquidity and market price. ● We may ~~not~~need ~~obtain shareholder approval~~ to ~~approve an~~ increase in ~~the~~our authorized capital, effectuate a reverse split or ~~other~~obtain ~~corporate~~effective ~~action~~waivers ~~relating~~from toderivative ~~the common stock when and if needed~~securityholders. ● Our ~~common~~Common ~~stock~~Stock could be further diluted as the result of the issuance of additional shares of ~~common~~Common ~~stock~~Stock, convertible securities, warrants or options. ● A significant portion of our total outstanding shares of Common Stock may be sold into the public market at any time, which could cause the market price of our Common Stock to drop significantly, even if our business is performing well. ● We are and may continue to be subject to short-selling strategies. ● We identified material weaknesses in our internal controls over financial reporting as of December 31, 2025 and 2024 and these or other material weaknesses could continue to materially impair our ability to report accurate financial information in a timely manner. ● We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our Common Stock less attractive to investors. ● We do not anticipate paying any cash dividends on our Common Stock in the foreseeable future; capital appreciation, if any, will be your sole source of gain as a holder of our Common Stock. ● Provisions in our amended and restated certificate of incorporation, our bylaws or Delaware law might discourage, delay or prevent a change in control of the Company or changes in our management and, therefore, depress the trading price of our Common Stock. ● Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us. ● Our business could be negatively affected as a result of the actions of activist stockholders. ● We may become a defendant in one or more stockholder derivative or class-action litigation(s), and any such future lawsuit(s) may adversely affect our business, financial condition, results of operations and cash flows.

Risks Related to Our Financial Condition and Capital Requirements

We are currently over 90 days past due on a significant amount of vendor obligations. We may not be able to refinance, extend or repay our substantial indebtedness owed to our secured and unsecured lenders, which would have a material adverse effect on our financial condition and ability to continue as a going concern.

As of February 28, ~~2025~~2026, we had approximately $1112.27 million in accounts payable with approximately $910.54 million that is over 90 days past due. If we are unable to repay these amounts, as well as our existing debt obligations at maturity, and we are otherwise unable to extend the maturity dates or refinance these obligations, we ~~would~~will be in default. We cannot provide any assurances that we will be able to raise the necessary amount of capital to repay these obligations or that we will be able to extend the maturity dates or otherwise refinance these obligations. Upon a default, our secured lenders would have the right to exercise their rights and remedies to collect, which would include foreclosing on our assets. Accordingly, a default would have a material adverse effect on our business, and we would likely be forced to seek bankruptcy protection.

Our audited consolidated financial statements ~~included~~include a statement that there is a substantial doubt about our ability to continue as a going concern and a continuation of negative financial trends could result in our inability to continue as a going concern.

Our management has determined that there is substantial doubt about our ability to continue as a going concern over the next 12 months from the filing date of March 2411, ~~2025~~2026. Our independent auditors have included a “going concern” explanatory paragraph in their report on our consolidated financial statements as of and for the year ended December 31, ~~2024~~2025 as filed in this Annual Report on Form 10-K. The reaction of investors to the inclusion of a going concern statement by our independent auditors, and our potential inability to continue as a going concern, could materially adversely affect the price of our ~~common~~Common ~~stock~~Stock.

33Additionally, if our operating results fail to improve, we could violate additional debt covenants, our liquidity could be further adversely impacted, and we may need to seek additional sources of funding. There is no assurance that we will be able to raise additional capital to fund our operations or that debt or equity financings will be available in sufficient amounts or on acceptable terms. If our operating results fail to improve, then our financial condition could render us unable to continue as a going concern.

Additionally, if our operating results fail to improve, we could violate additional debt covenants, our liquidity could be further adversely impacted and we may need to seek additional sources of funding. There is no assurance that we will be able to raise additional capital to fund our operations or that debt or equity financing will be available in sufficient amounts or on acceptable terms. If our operating results fail to improve, then our financial condition could render us unable to continue as a going concern.

We have incurred significant losses and negative cash flows since our inception and anticipate we will continue to incur significant losses and negative cash flow for the foreseeable future.

We have incurred yearly losses and negative cash flows since our inception, other than net income of $0.4 million (excluding deemed dividends) for the year ended December 31, 2025, primarily attributable to a non-cash gain on change in accounting estimates on contingent royalty liability and settlement of a portion of its trade payables with vendors, and net income of $53.0 million (excluding deemed dividends) for the year ended December 31, 2023, which was primarily attributable to a non-cash gain on debt extinguishment. As of December 31, ~~2024~~2025, we had an accumulated deficit of $897.74 million. Negative cash flows from our operations are expected to continue for the foreseeable future. To date, we have devoted substantially all our financial resources to the development and commercialization of ~~PHEXXI~~ PHEXX for hormone-free contraception, ~~and~~ to clinical trials investigating the ~~development~~potential utility of ~~EVO100~~PHEXX for the prevention of chlamydia and gonorrhea, and development of our other product candidates, as well as providing general and administrative support for our operations. Our utilization of cash has historically been highly dependent on these development programs and the commercialization of ~~PHEXXI~~PHEXX in the U.S. In October 2022, we discontinued ~~development~~our ~~of EVO100 and have no plans to advance~~ clinical ~~development of this program or to significantly invest in other clinical~~ programs ~~or product candidates for the foreseeable future. We plan~~ to allocate capital to fund our continued commercialization efforts. Our cash expenses will also continue to be dependent on the terms and conditions of our contracts with service providers and any license partners.

To date, we have financed our operations primarily through the sale of equity securities, promissory notes, warrants, convertible notes, convertible preferred stock and through other debt arrangements. The amount of our future net losses will depend, in large part, on our ability to generate revenue from the sale of ~~PHEXXI~~PHEXX and SOLOSEC, the rate of our future expenditures and our ability to obtain additional funding through equity or debt financings, strategic collaborations or grants which may be particularly challenging or impossible in light of market conditions. The commercialization and development of biopharmaceutical products involves a substantial degree of risk.

We expect to continue to incur significant operating expenses and to continue to incur significant losses for the foreseeable future as we:

● incur sales, marketing, and distribution costs to commercialize PHEXXI and SOLOSEC; ● incur costs associated with the commercial manufacturing of PHEXXI and SOLOSEC; ● implement post-approval changes and process improvements to manufacturing; ● seek regulatory and marketing approvals for PHEXXI and/or SOLOSEC outside the US; ● seek reimbursement for PHEXXI, SOLOSEC, or any product(s) we may commercialize in the future ● continue our efforts to identify, assess, acquire, and/or commercialize other products; ● make milestone, royalty or other payments under third-party license agreements; ● make payments related to debt agreements; ● seek to maintain, protect, and expand our intellectual property portfolio; and ● seek to attract and retain skilled personnel.

The net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. Due to the recurring losses, negative cash flows from operating activities since inception, and net working capital at December 31, 2024, the report of our independent registered public accountant on our consolidated financial statements as of and for the year ended December 31, 2024 filed with this Annual Report on Form 10-K for the year ended December 31, 2024 includes explanatory language describing the existence of substantial doubt about our ability to continue as a going concern. In addition, our management has further determined that there is a substantial doubt about our ability to continue as a going concern over the next 12 months from the filing date of March 24, 2025.

~~Although~~We weexpect ~~have~~to ~~generated~~continue ~~revenue~~to ~~from~~incur ~~product~~significant ~~sales,~~operating weexpenses ~~may~~and ~~never~~to becontinue ~~profitable.~~to ~~Our~~incur ~~operating~~significant ~~results~~losses ~~may~~for ~~differ~~the ~~from~~foreseeable ~~any~~future ~~guidance~~ as we ~~may announce.~~:

~~Our current~~● ~~business~~incur issales, ~~substantially~~marketing, ~~dependent~~and ondistribution ~~the~~costs ~~commercial~~to ~~success~~commercialize ofPHEXX ~~PHEXXI,~~ and toSOLOSEC; a● ~~lesser~~incur ~~extent,~~costs ~~SOLOSEC.~~associated ~~The~~with the commercial ~~launch~~ manufacturing of ~~PHEXXI~~PHEXX ~~took~~and ~~place~~SOLOSEC; on● ~~September~~implement 8,post-approval ~~2020,~~changes and ~~although~~process weimprovements ~~have~~to ~~generated~~manufacturing; ~~revenue~~● ~~from~~seek ~~sales~~regulatory ofand ~~PHEXXI,~~marketing weapprovals ~~may~~for ~~never~~PHEXX ~~achieve~~ and/or ~~sustain~~SOLOSEC ~~profitability,~~outside ~~even~~the ~~with~~US; ~~the~~● ~~addition~~seek ofreimbursement ~~revenue~~for ~~from~~PHEXX, SOLOSEC, ~~since~~or weany ~~acquired~~product(s) ~~global~~we ~~rights~~may tocommercialize in the ~~product~~future in● ~~July 2024.~~continue ~~Our~~our ~~ability~~efforts to ~~generate~~identify, ~~revenue~~assess, ~~and~~acquire, ~~achieve~~ and/or ~~sustain~~commercialize ~~profitability~~other ~~depends~~products; on● ~~our~~make ~~ability~~milestone, ~~alone~~royalty or ~~with~~other ~~strategic collaborators,~~payments tounder ~~successfully~~third-party ~~commercialize~~license ~~PHEXXI~~agreements; ~~and~~● ~~SOLOSEC~~make ~~and,~~payments related to adebt ~~lesser~~agreements; ~~extent,~~● ~~any~~seek ~~future~~to ~~products~~maintain, ~~we may license~~protect, ~~acquire,~~ orand ~~otherwise~~expand ~~commercialize.~~our ~~Our~~intellectual ~~ability~~property toportfolio; ~~generate~~and ~~future~~● ~~revenue~~seek ~~from~~to ~~product~~attract ~~sales~~and ~~depends~~retain ~~heavily~~skilled ~~on our success in many areas, including, but not limited to:~~personnel.

●The net ~~the~~losses ~~rate~~we ~~and~~incur ~~degree~~may offluctuate ~~market~~significantly ~~acceptance~~from ~~for~~quarter ~~PHEXXI,~~to ~~SOLOSEC~~quarter and ~~any~~year ~~other~~to ~~products in our commercial portfolio; ● the effectiveness of our commercialization strategies~~year, ~~either~~such directly or with distribution partners, including the effectiveness of our sales force, the PHEXXI telehealth platform, media and digital campaigns, and contracted tele-sales vendor; ● reimbursement and pricing for PHEXXI, SOLOSEC and any other approved products in our commercial portfolio in amounts that ~~support~~a profitability; ● successfully competing against other products; ● manufacturing PHEXXI and SOLOSEC and establishing and maintaining supply and manufacturing relationships with third parties that are commercially feasible, as well as complying with applicable regulatory requirements and meeting our supply needs in sufficient quantities period-to-period ~~meet~~comparison ~~market demand for~~ of our ~~products;~~results ~~● obtaining regulatory approval~~ of ~~PHEXXI~~operations ~~(Femidence)~~may ~~and/or~~not ~~SOLOSEC~~be ina ~~territories~~good ~~outside~~indication of ~~the U.S.; ● protecting, maintaining and enforcing~~ our ~~intellectual~~future property rights, including patents, trade secrets and know-how; ● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; and ● attracting, hiring and retaining qualified personnelperformance.

~~From~~Due ~~time~~ to ~~time,~~the werecurring ~~may~~losses, ~~provide~~negative ~~guidance~~cash asflows tofrom ~~our~~operating ~~anticipated~~activities ~~future~~since ~~performance and certain unit shipment information~~inception, ~~prescription~~ and ~~prescriber~~ ~~statistics,~~a ~~website~~net ~~and~~working ~~search~~deficit ~~statistics~~at ~~and~~December ~~other metrics. We may fail to achieve the performance described in any such~~31, ~~guidance~~2025, ~~and~~the ~~any~~report ~~information or metrics we may provide may be not be indicative~~ of ~~future~~our ~~results.~~independent Inregistered ~~addition,~~public weaccountant ~~provide~~on ~~co-pay~~our ~~assistance to~~consolidated ~~commercially~~financial ~~insured~~statements ~~patients~~as ~~with~~of ~~an approved PHEXXI or SOLOSEC prescription~~ and ~~utilize a sample program to promote demand~~ for ~~our products. While~~ the ~~co-pay~~year ended ~~program~~December ~~reduces~~31, ~~the~~2025 ~~amount~~filed ofwith ~~profit~~this weAnnual ~~realize~~Report ~~per~~on ~~unit~~Form ~~sold, it is a value~~10-~~add~~K ~~program~~for ~~to patients that we aim to continue in 2025. Because of~~ the ~~expense~~year toended ~~run~~December ~~the program~~31, we2025 ~~will~~includes ~~look to modify the business rules surrounding the co-pay~~explanatory ~~program~~language indescribing the ~~future,~~existence ~~particularly~~of assubstantial ~~payers~~doubt ~~increasingly~~about ~~cover~~our ~~PHEXXI~~ability ~~at $0 co-pay~~ to ~~comply~~continue ~~with~~as ~~HRSA~~a ~~guidelines;~~going ~~compliance~~concern. ~~was~~In ~~mandated beginning January 1~~addition, ~~2023~~our ~~and enforcement action is anticipated. If we are not able to generate sufficient net sales~~management ofhas ~~our~~further ~~products,~~determined ~~the~~that ~~net~~there ~~sales of our products~~ is ~~not~~a ~~sufficiently~~substantial ~~profitable,~~doubt weabout ~~fail to meet~~ our ~~guidance,~~ability orto ~~our information~~continue oras ~~metrics~~a isgoing ~~not~~concern ~~indicative~~over ofthe ~~our~~next ~~future~~12 ~~results of operations, this could materially and adversely affect our business~~months ~~results~~from ~~of operations,~~ the ~~price~~filing date of ~~our~~March ~~common stock~~11, ~~our financial condition and our ability to raise additional capital~~2026.

We ~~will~~ ~~need~~may tonever ~~raise~~be ~~significant additional funds to finance our operations, including the commercialization of PHEXXI and SOLOSEC, and to remain a going concern~~profitable. IfOur weoperating ~~are~~results ~~unable~~may todiffer ~~raise~~from ~~additional~~any ~~capital~~guidance ~~when needed or on acceptable terms,~~ we may ~~be forced to delay, reduce and/or eliminate one or more of our business initiatives or to cease our operations entirely~~announce.

WeOur ~~have~~current ~~incurred~~business ~~significant~~is ~~losses~~substantially ~~and~~dependent ~~negative~~on ~~cash~~the ~~flows~~commercial ~~since~~success ~~our inception. We believe our existing capital resources as~~ of ~~the~~PHEXX, ~~filing of~~and ~~this Annual Report are sufficient~~ to ~~fund~~a ~~our~~lesser ~~planned~~extent, ~~operations~~SOLOSEC. ~~into~~The ~~the~~commercial ~~first half~~ launch of ~~2025.~~PHEXX ~~Our~~took ~~ability~~place toon ~~raise~~September ~~additional funds will depend~~8, ~~in part~~2020, ~~on our ability to successfully commercialize PHEXXI~~ and ~~SOLOSEC~~although ~~(collectively~~we ~~our~~have ~~Products)~~generated inrevenue ~~the~~from ~~U.S.~~sales ~~If,~~of ~~for whatever reason~~PHEXX, we ~~are unsuccessful in these efforts, it~~ may ~~make~~never ~~any~~achieve ~~necessary debt, equity~~ or ~~alternative financing more difficult,~~sustain ~~more~~profitability, ~~costly~~even ~~and~~with ~~more~~the ~~dilutive.~~addition ~~Attempting~~of torevenue ~~secure additional financing will divert our management~~ from ~~our~~SOLOSEC ~~day-to-day~~since ~~activities, which may adversely affect our ability to commercialize our Products. In addition,~~ we ~~cannot~~acquired ~~guarantee~~global ~~that~~rights ~~future financing will be available in sufficient amounts or on terms acceptable~~ to ~~us, if at all. Furthermore,~~ the ~~global~~product ~~credit and financial markets have experienced extreme volatility and disruptions~~ in ~~recent~~July ~~history, particularly for life science companies~~2024. IfOur ~~the equity and credit markets deteriorate,~~ability itto ~~may~~generate ~~make~~revenue ~~any~~and ~~necessary~~achieve ~~debt or equity financing more difficult, more costly~~ and ~~more~~sustain ~~dilutive.~~profitability Ifdepends ~~we are unable to raise additional funds when needed or~~ on ~~acceptable~~our ~~terms~~ability, wealone ~~may~~or bewith ~~unable~~strategic ~~to continue commercializing our products. In addition~~collaborators, ~~we may be required~~ to ~~delay, scale back or eliminate some~~successfully orcommercialize ~~all~~PHEXX ofand ~~our~~SOLOSEC ~~business~~and, ~~initiatives or be forced~~ to ~~cease~~a ~~operations~~lesser ~~entirely. To the~~ extent ~~we raise additional capital through the sale of equity~~, ~~convertible~~any ~~debt~~future orproducts ~~other~~we ~~securities~~may ~~convertible into equity~~license, ~~the ownership interest of our stockholders will be diluted~~acquire, ~~and~~ ~~the terms of these new securities may include liquidation~~ or ~~other~~otherwise ~~preferences that adversely affect the rights of our stockholders~~commercialize. ~~Future~~ ~~debt financings, if available at all, would likely involve agreements with additional covenants limiting or restricting our ability~~Our ability to ~~take~~generate ~~specific~~future ~~actions,~~revenue ~~such~~from ~~as incurring additional debt, making capital expenditures, making additional~~ product ~~acquisitions,~~sales ~~or declaring~~depends ~~dividends.~~heavily Ifon weour ~~raise~~success ~~additional~~in ~~funds~~many ~~through strategic collaborations~~areas, ~~alternative non-dilutive financing~~including, ~~such~~but ~~as royalty-based financing, or licensing arrangements with third parties, we may have to relinquish valuable rights to our products, or future revenue streams or grant licenses on terms that are~~ not ~~favorable to~~limited ~~us.~~to:

	●	the rate and degree of market acceptance for PHEXX, SOLOSEC and any other products in our commercial portfolio;
	●	the effectiveness of our commercialization strategies, either directly or with distribution partners, including the effectiveness of our sales force, the PHEXX telehealth platform, media and digital campaigns, and contracted tele-sales vendor;
	●	reimbursement and pricing for PHEXX, SOLOSEC and any other approved products in our commercial portfolio in amounts that support profitability;
	●	successfully competing against other products;
	●	manufacturing PHEXX and SOLOSEC and establishing and maintaining supply and manufacturing relationships with third parties that are commercially feasible, as well as complying with applicable regulatory requirements and meeting our supply needs in sufficient quantities to meet market demand for our products;
	●	obtaining and maintaining regulatory approval of PHEXX (Femidence) and/or SOLOSEC in territories outside of the U.S.;
	●	protecting, maintaining and enforcing our intellectual property rights, including patents, trade secrets and know-how;
	●	negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; and
	●	attracting, hiring and retaining qualified personnel.

From time to time, we may provide guidance as to our anticipated future performance and certain unit shipment information, prescription and prescriber statistics, website and search statistics and other metrics. We may fail to achieve the performance described in any such guidance, and any information or metrics we may provide, may be not be indicative of future results. In addition, we provide co-pay assistance to commercially insured patients with an approved PHEXX or SOLOSEC prescription and utilize a sample program to promote demand for our products. While the co-pay program reduces the amount of profit we realize per unit sold, it is a value-add program to patients that we aim to continue in 2026. Because of the expense to run the program, we will look to modify the business rules surrounding the co-pay program in the future, particularly as payers increasingly cover PHEXX at $0 co-pay to comply with HRSA guidelines; compliance was mandated beginning January 1, 2023 and enforcement action is anticipated. If we are not able to generate sufficient net sales of our products, the net sales of our products are not sufficiently profitable, we fail to meet our guidance, or our information or metrics is not indicative of our future results of operations, this could materially and adversely affect our business results of operations, the price of our Common Stock, our financial condition and our ability to raise additional capital.

~~Women’s~~We ~~health~~will ~~has~~need ~~historically~~to ~~been~~raise ansignificant ~~underfunded~~additional ~~sector.~~funds ~~Recently,~~to afinance ~~number~~our ofoperations, ~~public~~including ~~companies~~the ~~focused~~commercialization inof ~~women’s~~PHEXX ~~health~~and ~~have~~SOLOSEC, ~~failed~~and to ~~achieve~~remain ~~expected~~a ~~commercial~~going ~~success~~concern. ~~and~~If ~~struggled~~we are unable to ~~access~~raise ~~sufficient~~additional capital. Wewhen ~~are~~needed ~~solely~~or ~~focused~~on inacceptable ~~women’s~~terms, ~~health~~we ~~and~~ may be ~~unfavorably~~forced ~~impacted~~to bydelay, reduce ~~weak~~and/or ~~investor~~eliminate ~~sentiment~~one ~~and~~or amore ~~lack~~ of ~~interest~~our inbusiness ~~the~~initiatives ~~category.~~or ~~Our ability~~ to ~~access~~cease ~~capital and to advance~~ our ~~candidates~~operations ~~could be adversely impacted~~entirely.

We have incurred ~~are~~significant ~~solely~~losses ~~focused~~and innegative ~~women’s~~cash ~~health,~~flows since our inception and ~~primarily~~have approximately $10.4 million in ~~the~~over ~~areas~~90 days past due payables as of ~~contraception~~February 28, ~~vaginal~~2026. ~~health,~~We ~~reproductive~~believe ~~health,~~our ~~and~~existing ~~sexual~~capital resources as of the filing of this Annual Report are sufficient to ~~health.~~fund ~~The~~our ~~sector~~planned ~~has~~operations ~~historically~~for ~~been~~a ~~underfunded~~limited period, ~~with~~likely ~~only~~not ~~about~~past ~~one~~the ~~percent~~first half of ~~healthcare~~2026. ~~research~~Our ability to raise additional funds will depend, in part, on our ability to successfully commercialize PHEXX and ~~innovation~~SOLOSEC (collectively our Products) in the U.S. ~~invested~~If we are unsuccessful in ~~female~~these efforts, it may make any necessary debt, equity or alternative financing more difficult, more costly and more dilutive. Attempting to secure additional financings will divert our management team from our day-~~specific~~to-day ~~conditions~~activities, ~~beyond~~which ~~oncology~~may adversely ~~according~~affect our ability to ~~market~~commercialize ~~research~~our Products. ~~The~~In ~~failure~~addition, ofwe ~~the~~cannot ~~women’~~guarantee that future financing(s) ~~health~~will ~~sector~~be available in sufficient amounts or on terms acceptable to ~~receive consistent~~us, ~~and~~if ~~committed~~at ~~investment~~all. ~~fuels~~Furthermore, ~~investor~~the ~~sentiment~~global ~~that~~credit ~~market~~and ~~opportunities~~financial ~~for~~markets ~~new~~have experienced ~~products~~extreme volatility and disruptions in ~~women’s~~recent ~~health~~history, ~~are~~particularly ~~limited~~for life science companies. If the equity and credit ~~Our~~markets ~~stock~~deteriorate, ~~price~~it may make any necessary debt or equity financing(s) more difficult, more costly and ~~our~~more ~~ability~~dilutive. If we are unable to ~~access~~raise additional ~~capital~~funds when needed or on acceptable terms, ~~when~~we ~~needed~~may be unable to continue commercializing our products. In addition, we may be ~~adversely~~required ~~impacted~~to bydelay, ~~unfavorable~~scale back or eliminate some or all of our business initiatives or be forced to cease ~~investor~~operations ~~perception~~entirely. To the extent we raise additional capital through the sale of ~~market~~equity, ~~opportunities~~convertible ~~for~~debt ~~women’s~~or ~~health~~other ~~products~~securities convertible into equity, the ownership interest of our stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our ~~business~~stockholders. Future debt financings, ~~operating~~if ~~results~~available at all, ~~financial~~would ~~condition~~likely involve agreements with additional covenants limiting or restricting our ability to take specific actions, such ~~and~~as ~~prospects~~incurring ~~could~~additional ~~suffer~~debt, making capital expenditures, making additional product acquisitions, or declaring dividends. If we raise additional funds through strategic collaborations, alternative non-dilutive financing, such as royalty-based financing, or licensing arrangements with third parties, we may have to relinquish valuable rights to our products, or future revenue streams or grant licenses on terms that are not favorable to us.

We are solely focused in women’s health and may be unfavorably impacted by weak investor sentiment and a lack of interest in the category. Our ability to access capital and to advance our candidates could be adversely impacted.

Women’s health has historically been an underfunded sector. Recently, a number of public companies focused in women’s health have failed to achieve expected commercial success and struggled to access sufficient capital. We are solely focused in women’s health, and primarily in the areas of contraception, vaginal health, reproductive health, and sexual health. The sector has historically been underfunded, with only about one percent of healthcare research and innovation in the U.S. invested in female-specific conditions beyond oncology according to market research²². The failure of the women’s health sector to receive consistent and committed investment fuels investor sentiment that market opportunities for new products in women’s health are limited. Our stock price and our ability to access additional capital on acceptable terms when needed may be adversely impacted by unfavorable investor perception of market opportunities for women’s health products, and our business, operating results, financial condition, and prospects could suffer.

We have certain obligations pursuant to our issued and outstanding senior secured notes, promissory notes, convertible notes and related note purchase agreements, and our failure to comply with these obligations could have a material adverse effect on our business, intellectual property, financial condition, or results of operations.

In April 2020, we entered into a Securities Purchase and ~~Securities~~Security Agreement (the Baker Bros. Purchase Agreement) with certain institutional investors and their designated agent pursuant to which we issued and sold secured convertible promissory notes in an aggregate principal amount of $25.0 million and warrants to purchase shares of our ~~common~~Common ~~stock~~Stock. InThe ~~November 2021, we entered into the first amendment to the~~ Baker Bros. Purchase Agreement, which ~~extended~~is ~~the~~secured ~~affirmative~~by substantially ~~covenant~~all toof ~~achieve~~our ~~$100.0~~assets, ~~million~~was inamended ~~cumulative~~from ~~net~~time ~~sales of PHEXXI by June 30, 2022~~ to ~~June~~time ~~30,~~as ~~2023~~disclosed herein. On ~~March~~July 723, ~~2023~~2024, Baker Bros. ~~Advisors~~assigned the Baker Notes to Future Pak, LPLLC (the ~~Designated~~Assignee) ~~Agent~~(the July 2024 Assignment) ~~provided~~. aThe ~~Notice~~terms of ~~Event~~the ofBaker ~~Default~~Notes ~~and~~were ~~Reservation~~not ofchanged ~~Rights~~in (connection with the ~~Notice~~assignment offrom ~~Default)~~Baker ~~relating~~ to the ~~Baker Bros~~Assignee. ~~Purchase Agreement.~~

~~In March~~22 ~~2023,~~Evaluate ~~the~~Pharma ~~Company received a Notice of Event of Default and Reservation of Rights~~ (~~the Notice of Default~~2025) ~~from Baker Bros~~. ~~claiming~~Kearney ~~that~~analysis. ~~the~~https://www.evaluate.com/ ~~Company failed to maintain the required shares reserved amount per the Third Baker Amendment~~ as ~~defined~~cited in ~~Note 4 – Debt. In addition,~~ the ~~Notice of Default resulted in a cross default under all outstanding debt, which became~~ ~~currently~~World ~~due~~Economic ~~and~~Forum ~~which~~white ~~the~~paper ~~Company~~Prescription ~~did~~for ~~not~~Change: ~~have~~Policy ~~sufficient~~Recommendations ~~capital~~for toWomen’s ~~repay~~Health ~~such~~Research ~~obligations during the period of default. However, in~~ (May ~~2023 the Company effectuated a Reverse Stock Split, and thereby had a sufficient number of shares reserved as required under the Third Baker Amendment~~2025). ~~As of June 30, 2023, the Company had not met the affirmative covenant requiring achievement of $100~~https://reports.~~0 million in cumulative net sales of PHEXXI by such date as per the First Baker Amendment (as defined in Note 4 – Debt)~~weforum.org/docs/WEF_Prescription_for_Change_2025.pdf

In September 2023, the Company entered into a Fourth Baker Amendment (as defined in Note 4 – Debt), upon which the cumulative net sales covenant was removed and all defaults existing at the time of signing were cured.

The Fourth Baker Amendment amends certain provisions within the Baker Bros. Purchase Agreement including:

(i) the rescission of the Notice of Default delivered to the Company on March 7, 2023 and waiving the Events of Default named therein; (ii) The waiver of any and all other Events of Default existing as of the Fourth Baker Amendment date; (iii) the removal of the conversion feature into shares of Company common stock, including the removal of any requirement to reserve shares of common stock for conversion of the Baker Notes as well as any registration rights related thereto; (iv) the clarification that for the sole purpose of enabling an ex-U.S. license agreement for such assets, any Patents, Trademarks or Copyrights acquired after the Effective Date shall be excluded from the definition of Collateral; and, (v) the removal of the requirement for the Company to obtain $100 million in cumulative net PHEXXI sales in the specified timeframe.

~~The current~~On ~~outstanding~~September ~~balance~~27, of2024, ~~the~~Assignee, ~~Baker~~as ~~Notes~~agent ~~will~~for ~~continue~~the topurchasers ~~accrue~~(in ~~interest~~such ~~at 10% per annum and~~capacity, in the ~~event~~Designated ofAgent) provided a ~~default~~Notice inof ~~the agreement~~Event orof aDefault ~~failure~~and toReservation ~~pay~~of ~~the~~Rights ~~Repurchase Price~~ (asthe ~~defined below) on or before~~ September 8,2024 ~~2028~~Notice ~~(the~~of ~~Maturity Date~~Default), ~~the Baker Purchasers~~relating ~~may~~to ~~collect on~~ the ~~full~~Baker ~~principal amount then outstanding~~Bros. ~~Additionally,~~Purchase ~~the Company was required to make a $1~~Agreement.0 ~~million~~The ~~upfront payment by October 1, 2023 (which payment was made in late~~ September ~~2023)~~2024 asNotice ~~well~~of asDefault ~~quarterly~~claims ~~cash~~that ~~payments~~by ~~based~~entering ~~upon~~into aarrangements ~~percentage~~to ofrepay ~~the~~certain ~~Company’s~~existing ~~global~~obligations, ~~net~~including ~~product~~obligations ~~revenue.~~owed ~~The~~to ~~cash payments will be determined based upon~~ the ~~quarterly~~U.S. ~~global~~Department ~~net revenue~~ of ~~PHEXXI such~~Health ~~that~~and ifHuman ~~the~~Services ~~global net revenue is less than or equal to $5.0 million~~(HHS), ~~the~~an ~~Company~~Event ~~will~~of ~~pay~~Default ~~3%;~~has ~~if the global net revenue is over~~occurred ~~$5.0~~under ~~million~~Section ~~and less than or equal to $7~~9.01(e) ~~million,~~of the ~~Company~~Baker ~~will continue to pay 3% on net revenue up to $5~~Bros.0 ~~million~~Purchase ~~and 4% on the net revenue over $5~~Agreement.0 ~~million;~~According ~~and~~to if the ~~global~~September ~~net~~2024 ~~revenue~~Notice isof ~~over $7.0 million~~Default, the ~~Company~~Designated ~~will~~Agent ~~pay~~accelerated repayment 3%of on the ~~net~~outstanding ~~revenue~~principal ~~up to~~balance ~~$5.0~~owed ~~million,~~by ~~4% on~~ the ~~net~~Company ~~revenue~~under ~~over~~the ~~$5.0~~Baker ~~million up to $7~~Bros.0 ~~million,~~Purchase ~~and 5% on net revenue over $7~~Agreement.0 ~~million.~~ The ~~cash~~Designated ~~payments~~Agent provided ~~will~~two beadditional ~~payable~~notices ~~beginning~~asserting inadditional ~~the~~events ~~fourth quarter~~ of ~~2023.~~default ~~Regardless~~under of the ~~percentage~~relevant ~~paid,~~governing ~~the quarterly cash payment amounts, along with the $1~~documents.~~0 million upfront payment, will be deducted from the Repurchase Price as Applicable Reductions.~~

The ~~Fourth~~ ~~Baker~~Company ~~Amendment~~disputes ~~also~~the ~~granted~~allegations and intends to contest any attempt by the ~~Company~~Designated Agent and the ~~ability~~purchasers to ~~repurchase~~exercise ~~the~~their ~~principal~~default ~~amount~~rights and ~~accrued~~remedies ~~and~~under ~~unpaid~~the ~~interest~~Baker ofBros. ~~the~~Purchase Agreement, however there can be no assurances that we will prevail. If the notes under the Baker ~~Notes~~Bros. ~~for~~Purchase upAgreement are deemed to abe ~~five-year~~in ~~period~~default ~~for~~and accelerated, we could be required to repay amounts that exceed our available liquidity. Our debt agreements, including but not limited to the Baker Bros. Purchase Agreement, convertible notes other instruments contain covenants that restrict our ability to incur additional indebtedness, engage in certain transactions, and take other corporate actions. A default under one agreement may trigger cross-~~time~~default provisions ~~Repurchase~~under ~~Price~~other ~~designated~~agreements. ~~below:~~If we are unable to cure any default or obtain waivers, our secured lenders may exercise remedies, including foreclosure on substantially all of our assets. Certain provisions of the notes provide for redemption premiums and other enhanced remedies upon default.

Date of Notes’ Repurchase		Repurchase Price
On or prior to September 8, 2024		$14,000,000 (less Applicable Reductions)
September 9, 2024-September 8, 2025		$16,750,000 (less Applicable Reductions)
September 9, 2025-September 8, 2026		$19,500,000 (less Applicable Reductions)
September 9, 2026-September 8, 2027		$22,250,000 (less Applicable Reductions)
September 9, 2027-September 8, 2028		$25,000,000 (less Applicable Reductions)

Any acceleration of our indebtedness, enforcement of remedies by creditors, or inability to refinance or restructure our obligations could materially adversely affect our business, financial condition, results of operations, and may force us to seek protection under applicable bankruptcy laws. In such event, holders of our Common Stock could lose all or substantially all of their investment.

OnWe ~~December~~have ~~11,~~a ~~2023,~~limited ~~Baker~~number ~~Bros~~of ~~assigned~~shares ~~to Aditxt, Inc. all remaining amounts due under the Securities Purchase and Security Agreement by and among Borrower, Baker and Designated Agent, dated as~~ of ~~April~~Common ~~23,~~Stock ~~2020,~~available asfor ~~amended~~future onissuance ~~November~~which ~~20,~~could ~~2021,~~adversely ~~March~~affect ~~21,~~our ~~2022,~~ability ~~September 15, 2022 and September 8, 2023 (the Agreement). Upon such assignment, Aditxt was the Company’s senior secured debtholder and the Company was obligated~~ to ~~make~~raise ~~all payments under the Fourth Baker Amendment to the Assignee as of December 31, 2023. On February 26,~~capital ~~2024,~~or ~~the~~consummate ~~notes~~strategic ~~were re-assigned back to Baker~~transactions.

OnWe ~~July~~are 23currently authorized to issue 3,000,000,000 ~~2024~~shares of Common Stock under our amended and restated certificate of incorporation. As of February 28, ~~the~~2026, ~~Company~~we ~~consented~~have toissued ~~the~~126,685,925 ~~transfer~~shares of ~~ownership~~Common Stock and 1,395,303,768 shares of ~~the~~Common ~~Baker~~Stock were ~~Notes~~committed ~~from~~for ~~Baker~~issuance ~~Brothers~~giving ~~Life~~effect ~~Sciences~~to the assumed exercise of all outstanding warrants, ~~667~~options, purchase rights and the ~~L.P.,~~assumed conversion of all issued and ~~Baker~~outstanding ~~Bros.~~convertible ~~Advisors,~~notes ~~LP,~~after ~~each~~accounting afor ~~Delaware~~the ~~limited~~security ~~partnership~~holders ~~(collectively,~~who ~~Baker)~~have waived the requirement for shares to ~~Future~~be ~~Pak,~~reserved ~~LLC~~for ~~(the~~conversion ~~Assignee)~~of their instruments. ~~The~~Certain ~~terms~~outstanding ofconvertible ~~the~~securities ~~Baker~~contain ~~Notes~~price ~~were~~adjustment ~~not~~provisions that ~~changed~~may result in ~~connection~~the ~~with~~issuance of additional shares if we complete future financings at prices below the ~~assignment~~applicable ~~from~~conversion ~~Baker~~or exercise price. As a result, the number of authorized but unissued shares of Common Stock available for future issuance may be insufficient to support additional equity financings or strategic transactions without first obtaining stockholder approval to increase the ~~Assignee~~number of authorized shares. There can be no assurance that stockholders would approve such an amendment to our certificate of incorporation. If we are unable to increase our authorized share capital when needed, our ability to raise capital, refinance indebtedness, or consummate a merger or other strategic transaction could be materially adversely affected.

On September 27, 2024, the Assignee, as agent for the Purchasers (in such capacity, the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the September 2024 Notice of Default) relating to the Securities Purchase and Security Agreement dated April 23, 2020, as amended, by and among the Company, Designated Agent, as certain guarantors and the purchasers (each a Purchaser and collectively Purchasers). The September 2024 Notice of Default claims that by entering into arrangements to repay certain existing obligations, including obligations owed to the U.S. Department of Health and Human Services (HHS), an Event of Default has occurred under Section 9.1(e) of the SPA. According to the Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Purchase Agreement. If all Purchasers exercise the Section 5.7 Option (as defined below), the repurchase price would be equal to the total outstanding balance, including principal and accrued interest. Pursuant to Section 5.7(b) of the SPA, upon the occurrence of an Event of Default, each Purchaser may elect, at its option, to require the Company to repurchase the Note held by such Purchaser (or any portion thereof) at a repurchase price equal to two times the sum of the outstanding principal balance and all accrued and unpaid interest thereon, due within three business days after such Purchaser delivers a notice of such election (the Section 5.7 Option).

On October 27, 2024, the Designated Agent sent an amended and supplemented notice to the Initial Notice of Default (the Amended Notice of Default) which adds new claims of default based on the Company’s current repayment agreements of existing obligations, including obligations owed to HHS, an Event of Default has occurred under Section 9.1(e) of the Baker Bros. Purchase Agreement, as amended. Furthermore, the Amended Notice stated that, because the events of default described in the Amended Notice of Default are not the certain prior events of default listed in the Forbearance Agreement (Specified Defaults), the Designated Agent and the holders of the senior secured promissory notes described in the SPA thereby provided notice to the Company that the Forbearance Agreement is terminated as of October 27, 2024.

On November 8, 2024, the Designated Agent sent an amended and supplemented notice to the Notices (the Third Amended Notice of Default) which adds new claims of default based on (i) the Company’s failure to maintain a cash position of $1.0 million or greater, as required under Section 5(b) of the Forbearance Agreement (ii) the Company’s failure to deliver financial and operating reports in accordance with the timeline required under the Section 8.1(n) of the Baker Stock Purchase Agreement, and (iii) to clarify the outstanding balance under the notes of the Baker Stock Purchase Agreement plus all accrued and unpaid interest thereon, in the sum of approximately is $107.0 million as opposed to the Repurchase Price as defined in the Fourth Amendment.

Evofem strongly disagrees with the Designated Agent’s claim that an Event of Default has occurred. The Company intends to vigorously contest any attempt by the Designated Agent and the Purchasers to exercise their default rights and remedies under the SPA.

In October 2020, we entered into a Securities Purchase Agreement (the Adjuvant Purchase Agreement) pursuant to which we issued and sold to certain institutional investors unsecured convertible promissory notes in an aggregate principal amount of $25.0 million. On April 4, 2022, we entered into the first amendment to the Adjuvant Purchase Agreement (the First Adjuvant Amendment). The First Adjuvant Amendment extended, effective as of the date on which we achieved the Qualified Financing Threshold upon the closing of the May 2022 Public Offering, the affirmative covenant to achieve $100.0 million in cumulative net sales of PHEXXI by June 30, 2022 to June 30, 2023. The First Adjuvant Amendment also provided for an adjustment to the conversion price of the Adjuvant Notes such that the conversion price for these Notes, effective as of the reverse stock split the conversion price will now be the lesser of (i) $678.49, and (ii) 100% of the lowest price per share of common stock (or with respect to securities convertible into common stock, 100% of the applicable conversion price) sold in any equity financing until we have met the Qualified Financing Threshold.

Between December 2022 and September 2023, we entered into various securities purchase agreements (SPAs), with certain investors (the Investors) providing for the sale and issuance of senior secured convertible notes due in the aggregate gross cash receipt of $5.6 million (the Notes), warrants to purchase an aggregate 25,956,854 shares of common stock (Warrants), pre-funded warrants to purchase an aggregate 6,432,306 shares of common stock (Pre-funded Warrants), and an aggregate 70 shares of Series D Preferred Stock (the Preferred Shares) (collectively, the Senior Subordinate Notes). Each Investor paid approximately $650 for each $1,000 of principal amount of Notes, Preferred Shares and Warrants.

These debt arrangements limit our ability to incur debt, merge, or declare dividends and, in certain circumstances. The Baker Notes are secured by substantially all of our assets. Our failure to make payments as due under any of the Notes could be an event of default under all of the Notes. Events of default under these arrangements could also include, but are not limited to, a material breach of representations, our failure to comply with our obligation to convert convertible notes, our failure to perform or observe, and in certain instances, cure, certain covenants, including, but not limited to, a covenant requiring us to maintain the listing of shares of our common stock on the OTCQB. In the event of a default and depending on the terms of each Note, a holder of the Notes may be entitled to redemption premiums, treble amounts and other remedies described in their respective agreements. Any default could materially and adversely impact our business, results of operations and financial condition, as well as increase our need to raise additional capital, cause us to cease our operations entirely and may result in the holders of our common stock not receiving any value for their investment.

We have a limited number of shares of common stock available for future issuance which could adversely affect our ability to raise capital or consummate strategic transactions.

We are currently authorized to issue 3,000,000,000 shares of common stock under our amended and restated certificate of incorporation. As of March 14, 2025 we have issued 113,356,354 shares of common stock and approximately 964 million shares of common stock were committed for issuance giving effect to the assumed exercise of all outstanding warrants, options, purchase rights and the assumed conversion of all issued and outstanding convertible notes after accounting for the security holders who have waived the requirement for shares to be reserved for conversion of their instruments. The conversion prices of the Adjuvant Convertible Notes (as amended) and Senior Subordinate Notes may also be subject to adjustment depending on the price of issuances in future financings as described above. These adjustments would further increase the number of shares of common stock to be reserved as a result of these adjustments. Due to the limited number of authorized shares common stock available for future issuance, we may not be able to raise additional equity capital or complete a merger or other business combination unless we increase the number of shares we are authorized to issue. We would need to seek stockholder approval to increase the number of our authorized shares of Common Stock, and we can provide no assurance that we would succeed in amending our amended and restated certificate of incorporation to increase the number of shares of Common Stock we are authorized to issue which could negatively impact our business, prospects, and results of operations.

Use of net operating loss carryforwards may be limited and U.S. federal income tax reform could adversely affect us.

Our ability to utilize our net operating loss (NOL) carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes. Corresponding rules may apply under state tax laws. Even if there is no limitation on utilization of our NOL carryforwards as the result of an ownership change, the utilization of NOL carryforwards may be limited by other applicable laws. Pursuant to the ~~TCJA~~Tax Cuts and Jobs Act passed in December 2017, carryforwards originating from a loss incurred in a year after 2017 are limited and may reduce taxable income in any post-2020 year by no more than 80% of the pre-NOL taxable income in such year. The Coronavirus Aid, Relief and Economic Security Act (the CARES Act) temporarily suspended this 80% taxable income limitation, allowing an NOL carryforward to fully offset taxable income in tax years beginning before January 1, 2021. Additional legislation or regulation which could affect our tax burden could be enacted by any governmental authority. We cannot predict the timing or extent of such tax-related developments which could have a negative impact on our financial results, including a potential increase in federal corporate tax rates generally. We cannot estimate how the changes in tax law from this legislation will affect our tax liability in future years, but we have recorded a valuation allowance related to our NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits from those assets. We have established a full valuation allowance for our deferred tax assets due to uncertainties as to their utilization. While we use our best judgment in attempting to quantify and reserve for our tax obligations, there is no guarantee that our estimates are accurate. A challenge by a taxing authority, our ability to utilize tax benefits such as carryforwards or tax credits, or a deviation from other tax-related assumptions may cause actual results to deviate from previous estimates.

Risks Related to the Aditxt Merger

The Merger may not be completed on the terms or timeline currently contemplated, or at all. Our stockholders will be subject to a number of material risks if the Merger is not completed.

The consummation of the Merger is subject to certain closing conditions, including:

	(1)	adoption of the Merger Agreement by the holders of a majority of our outstanding common stock and Series E-1 Shares (shares of which vote on an as-converted basis, and thus have greater voting power than shares of our common stock) at a meeting of our stockholders at which a quorum is present;
	(2)	no governmental entity having jurisdiction over any party shall have issue any order, decree, ruling injunction or other action that is in effect restraining the Merger;
	(3)	a voting agreement shall have been executed and delivered by the parties thereto;
	(4)	all Company preferred stock shall have been converted to Company common stock except for the Unconverted Company Preferred Stock (as defined by the A&R Merger Agreement);
	(5)	the Company shall have received agreements from all of the holders of the Company’s warrants, duly executed, containing waivers with respect to any fundamental transaction, change in control or other similar rights that such warrant holders may have under any such Company warrants and exchange such Company warrants as they hold for an aggregate of not more than 930,336 shares of Parent Preferred Stock (as defined in the A&R Merger Agreement);
	(6)	the Company shall have cashed out any other warrant holder who has not provided a warrant holder agreement, provided, however, that the aggregate amount of such cash out for any and all other warrant holders who have not provided a warrant holder agreement shall not exceed $0.15 million;
	(7)	the Company shall have obtained waivers from holders of Company convertible notes of the original principal amount thereof with respect to any fundamental transaction rights such Company convertible note holders may have under any such Company convertible notes, including any right to vote, consent or otherwise approve or veto any of the transaction contemplated by this A&R Merger Agreement;
	(8)	Aditxt shall have received sufficient financing to satisfy its payment obligations under the A&R Merger Agreement;
	(9)	the requisite stockholder approval shall have been obtained by Aditxt at a special meeting of its stockholders to approve the Parent Stock Issuance (as defined in the A&R Merger Agreement);
	(10)	Aditxt shall have received a compliance certificate from the Company certifying Company complied with all reps and warranties in the A&R Merger Agreement;
	(11)	Aditxt shall have received waivers from the parties to the agreements listed in Section 7.2(f) of the A&R Merger Agreement Parent Disclosure Letter of the issuance of securities in a “Variable Rate Transaction” (as such term in defined in such agreements);
	(12)	Parent shall have received a certificate certifying that no interest in the Company is a U.S. real property interest, as required under U.S. treasury regulation section 1.897-2(h) and 1.1445-3(c);
	(13)	Aditxt shall have paid, in full, the Repurchase Price, as defined in the Fourth Amendment to the Securities Purchase and Security Agreement dated as of September 8, 2023, by and among the Company, Baker Brothers Life Sciences, L.P., 667, L.P. and Bakers Bros. Advisors LP (as assigned to Future Pak, LLC in 2024);
	(14)	there shall be no more than 4,141,434 dissenting shares that are Company common stock or 98 dissenting shares that are Company preferred stock;
	(15)	Company shall have received from Aditxt a compliance certificate certifying that Parent has complied with all representations and warranties; and
	(16)	that Aditxt shall be in compliance with stockholders’ equity requirements in Nasdaq listing rule 5550(b)(1).

If the Merger is not completed for any reason, the price of our common stock may decline to the extent that the market price of our common stock, as applicable, reflects or previously reflected positive market assumptions that the Merger would be completed and the related benefits would be realized. In addition, the Company and Aditxt have expended significant management time and resources and have incurred and will continue to incur significant expenses due to legal, advisory, printing and financial services fees related to the Merger. These expenses must be paid regardless of whether the Merger is consummated.

There is no assurance that the Merger will be consummated. If the Merger is not timely completed, we may have to materially alter our respective business plans.

We may not be able to effect the Merger pursuant to the Merger Agreement. If we are unable to do so, we will incur substantial costs associated with withdrawing from the transaction.

In connection with the Merger Agreement and its amendments, we have incurred substantial costs planning and negotiating the transaction. These costs include, but are not limited to, costs associated with employing and retaining third-party advisors who perform financial, auditing and legal services required before we were able to enter into the Merger Agreement and which services will continue to be utilized as we seek to complete the transaction. If, for whatever reason, the transactions contemplated by the Merger Agreement fail to close, we will still be responsible for these costs, which could adversely affect our liquidity and financial results.

While the Merger Agreement is in effect, we are subject to certain interim covenants.

The Merger Agreement generally requires us to operate our business in the ordinary course, subject to certain exceptions, including as required by applicable law, pending consummation of the Merger, and subjects us to customary interim operating covenants that restrict us, without approval (such approval not to be unreasonably conditioned, withheld, or delayed), from taking certain specified actions until the Merger is completed or the Merger Agreement is terminated in accordance with its terms. These restrictions could prevent us from pursuing certain business opportunities that may arise prior to the consummation of the Merger and may affect our ability to execute our business strategies and attain financial and other goals and may impact our financial condition, results of operations and cash flows.

The announcement and pendency of the Merger could cause disruptions in our business, which could have an adverse effect on our business and financial results.

We have operated and, until the completion of the Merger, will continue to operate independently. Uncertainty about the effect of the Merger on employees, customers, distributors and vendors may have an adverse effect on us. These uncertainties may impair our ability to retain and motivate key personnel and could cause customers, distributors, vendors and others with whom we deal to seek to change existing business relationships which may materially and adversely affect our business. Moreover, integration efforts will also divert management attention and resources. These integration matters could have an adverse effect on the Company.

Certain provisions of the Merger Agreement may discourage third parties from submitting alternative acquisition proposals.

The terms of the Merger Agreement prohibit us from soliciting alternative acquisition proposals or cooperating with persons making alternative acquisition proposals, except in limited circumstances when our Board of Directors determines in good faith that an alternative acquisition proposal is or is reasonably likely to result in a superior proposal and that failure to cooperate with the proponent of the proposal is reasonably likely to be inconsistent with our Board of Directors’ fiduciary duties.

We may be subject to litigation relating to the Merger.

We may be subject to legal claims, including stockholder claims, related to the Merger. Litigation is distracting and costly and subject to inherent uncertainties, and unfavorable rulings could occur. An unfavorable ruling could include monetary damages or other adverse effects. Were an unfavorable ruling to occur, there exists the possibility of a material adverse impact on our business, financial position, and results of operations, and the Merger may not be completed and our stock price could decline significantly.

Risks Related to Potential Bankruptcy

Given our current financial condition, we have considered and may continue to consider filing for bankruptcy protection. While we have not initiated bankruptcy proceedings, we caution that trading in our securities is highly speculative and poses substantial risks ~~relating~~ relating to the potential of bankruptcy proceedings ~~should we fail to consummate a strategic transaction such as the Merger (as defined in Note 1 - Business)~~. Trading prices for our securities may bear little or no relationship to the actual recovery, if any, by holders of our securities in Bankruptcy proceedings, if any.

We are subject to risks and uncertainties associated with potential bankruptcy proceedings.

~~Our~~If we were to seek bankruptcy protection, our operations and ability to develop and execute our business plan, our financial condition, our liquidity, and our continuation as a going concern, are subject to risks and uncertainties associated potential or actual bankruptcy. Bankruptcy proceedings are complex, costly, and time-consuming and may disrupt our business. In such proceedings, holders of secured and unsecured indebtedness would have priority over holders of our Common Stock and other equity securities. As a result, equity holders could lose all or substantially all of their investment. The commencement of bankruptcy proceedings could adversely affect our relationships with suppliers, service providers, customers, employees, and other third parties, and could limit our ability to operate our business in the ordinary course. ~~These~~In ~~risks~~addition, ~~include~~trading prices for our securities may be highly volatile and may bear little or no relationship to the ~~following:~~actual recovery, if any, realized by security holders in a bankruptcy proceeding.

● our ability to prosecute, confirm and consummate a plan of reorganization with respect to the Chapter 11 proceedings; ● the high costs of bankruptcy proceedings and related fees; ● our ability to obtain sufficient financing to allow us to emerge from bankruptcy and execute our business plan post emergence; ● our ability to maintain our current relationships with or attract new suppliers, service providers, customers, employees, and other third parties; ● our ability to maintain contracts that are critical to our operations; ● our ability to execute our business plan in the current depressed commodity price environment; ● our ability to attract, motivate and retain key employees; ● the ability of third parties to seek and obtain court approval to terminate contracts and other agreements with us or make other third-party motions in the proceedings; ● the ability of third parties to seek and obtain court approval to convert Chapter 11 proceedings to Chapter 7 proceedings, if applicable; and ● the actions and decisions of our creditors and other third parties who have interests in proceedings that may be inconsistent with our plans.38

~~Delays~~As inof ~~filing~~December ~~for~~31, or2025, ~~moving~~we ~~forward~~have ~~with~~negative ~~the~~stockholders’ ~~proceedings~~equity. ~~increase~~If ~~the~~we ~~risks~~are ofunable ~~our~~to ~~being~~raise additional capital, or otherwise become unable to ~~reorganize~~satisfy our ~~business~~obligations ~~and~~as ~~emerge~~they ~~from bankruptcy~~become ~~and~~due, ~~increase~~we ~~our~~may ~~costs~~become ~~associated~~insolvent ~~with~~and face the ~~bankruptcy~~risk ~~process~~of bankruptcy.

~~These~~Since ~~risks~~inception, ~~and~~we ~~uncertainties~~have ~~could~~incurred ~~affect~~significant ~~our~~operating ~~business~~losses. ~~and~~As ~~operations~~of inDecember ~~various~~31, ~~ways.~~2025, ~~For~~we ~~example,~~had ~~negative~~a ~~events~~working ~~associated~~capital ~~with~~deficit ~~either Chapter~~of 11$69.5 ormillion ~~Chapter~~and 7an ~~proceedings~~accumulated ~~could~~deficit ~~adversely~~of ~~affect~~$897.4 ~~our~~million. ~~relationships~~We ~~with~~have financed our ~~suppliers,~~operations ~~service~~to ~~providers,~~date ~~customers,~~primarily ~~employees, and~~through ~~other~~the ~~third~~issuance ~~parties,~~of ~~which~~preferred instock, Common ~~turn~~Stock ~~could~~and ~~adversely~~warrants, ~~affect~~cash ~~our~~received ~~operations~~from ~~and~~private ~~financial~~placement ~~condition. Also~~transactions, ~~we need~~ the ~~prior~~issuance ~~approval~~ of ~~the~~convertible ~~Bankruptcy~~notes ~~Court~~and, ~~for~~to ~~transactions~~a ~~outside~~lesser ~~the~~extent, product ~~ordinary~~sales. ~~course of business~~Accordingly, ~~which~~if ~~may~~we ~~limit~~are ~~our~~unable ~~ability~~ to ~~respond~~raise ~~timely~~additional ~~to certain events~~capital, ~~take advantage of certain opportunities~~ or ~~pursue~~if ~~our~~we ~~business~~otherwise ~~strategies.~~become ~~Because~~unable ofto ~~the~~satisfy ~~risks~~our ~~and uncertainties associated~~obligations ~~with~~as ~~potential~~they ~~proceedings~~become due, we ~~cannot~~may ~~accurately~~become ~~predict~~insolvent orand ~~quantify~~face the ~~ultimate~~risk ~~impact~~of ~~that~~bankruptcy ~~events~~and ~~that~~other ~~may~~adverse ~~occur~~action ~~during~~by ~~the proceedings will have on~~ our ~~business,~~existing ~~financial condition~~ and ~~results~~future ~~of operations~~creditors.

AsFurther, we may currently, or in the future, be operating in the “zone of ~~December~~insolvency” 31as described under Delaware law, ~~2024~~which is our jurisdiction of incorporation. Generally, wea ~~have~~corporation’s ~~negative~~directors ~~stockholders~~owe a fiduciary duty to the corporation’s shareholders ~~equity~~and not to its creditors. IfHowever, wewhen ~~are~~a ~~unable~~corporation tois ~~raise~~operating ~~additional~~in ~~capital~~the “zone of insolvency,” orsome ~~otherwise~~courts have ~~become~~concluded that the fiduciary duty of directors may shift to include creditors. Delaware courts have taken the position that ~~unable~~directors of a corporation operating in the zone of insolvency continue to ~~satisfy~~owe ~~our~~a ~~obligations~~fiduciary asduty ~~they~~to ~~become~~the ~~due~~corporation’s stockholders but also owe such duty to its creditors. Accordingly, weour management and directors may ~~become~~be ~~insolvent~~required to consider their duties with regard to both stockholders and ~~face~~creditors ~~the~~in ~~risk~~their ofdecision ~~bankruptcy~~making processes.

Since inception, we have incurred significant operating losses. As of December 31, 2024, we had a working capital deficit of $66.8 million and an accumulated deficit of $897.7 million. We have financed our operations to date primarily through the issuance of preferred stock, common stock and warrants, cash received from private placement transactions, the issuance of convertible notes and, to a lesser extent, product sales. Accordingly, if we are unable to raise additional capital, or if we otherwise become unable to satisfy our obligations as they become due, we may become insolvent and face the risk of bankruptcy and other adverse action by our existing and future creditors.

Further, we may currently, or in the future, be operating in the “zone of insolvency” as described under Delaware law, which is our jurisdiction of incorporation. Generally, a corporation’s directors owe a fiduciary duty to the corporation’s shareholders and not to its creditors. However, when a corporation is operating in the “zone of insolvency,” some courts have concluded that the fiduciary duty of directors shifts to include creditors. Delaware courts have taken the position that directors of a corporation operating in the zone of insolvency continue to owe a fiduciary duty to the corporation’s stockholders but also owe such duty to its creditors. Accordingly, our management and directors may be required to consider their duties with regard to both stockholders and creditors in their decision making processes.

Our businesses could suffer from a long and protracted restructuring.

Our future results could be dependent upon the successful confirmation and implementation of a bankruptcy plan or other alternative restructuring transaction, including a sale of all or substantially all of our assets. A long period of operations under Bankruptcy Court protection could have a material adverse effect on our business, financial condition, results of operations and liquidity. Failure to obtain confirmation of a ~~Chapter 11~~ plan or approval and consummation of an alternative restructuring transaction in a timely manner may harm our ability to obtain financing to fund our operations, and there is a significant risk that the value of our securities and assets would be substantially eroded to the detriment of all stakeholders. If a ~~Chapter 11~~ plan that complies with the applicable provisions of the Bankruptcy Code cannot be agreed upon, it is possible that we would have to liquidate our assets, in which case it is likely that holders of claims would receive substantially less favorable treatment than they would receive if we were to emerge as a viable, reorganized entity.

If filed, as long as bankruptcy proceedings continue, we will be required to incur substantial costs for professional fees and other expenses associated with the administration of the ~~Chapter~~bankruptcy ~~11 or Chapter 7~~ proceedings. ~~Chapter~~Such 11 proceedings may also require us to seek debtor-in-possession financing to fund operations. If we are unable to obtain such financing on favorable terms or at all, our chances of successfully reorganizing our business may be seriously jeopardized, the likelihood that we instead will be required to liquidate our assets may be enhanced, and, as a result, any securities in us could become further devalued or become worthless.

In the event we decide to initiate bankruptcy proceedings, there can be no assurance that we will successfully reorganize and emerge from Chapter 11 proceedings or, if we do successfully reorganize, as to when we would emerge from ~~the~~bankruptcy ~~Chapter 11~~ proceedings. Even after a ~~Chapter~~bankruptcy 11 plan is confirmed and implemented, our operating results may be adversely affected by the possible reluctance of prospective lenders, suppliers, and other counterparties to do business with a company that recently emerged from bankruptcy proceedings.

In certain instances, a Chapter 11 case may be converted to a case under Chapter 7 of the Bankruptcy Code.

We have not filed for bankruptcy and therefore have not yet decided upon Chapter 11 or Chapter 7. However, should we choose to pursue Chapter 11, upon a showing of cause, the Bankruptcy Court may convert our Chapter 11 case to a case under Chapter 7 of the Bankruptcy Code. In such event, a Chapter 7 trustee would be appointed or elected to liquidate our assets for distribution in accordance with the priorities established by the Bankruptcy Code. We believe that liquidation under Chapter 7 ~~would~~could possibly result in significantly smaller distributions being made to our creditors because of (i) the likelihood that the assets would have to be sold or otherwise disposed of in a distressed fashion over a short period of time rather than in a controlled manner and as a going concern, (ii) additional administrative expenses involved in the appointment of a Chapter 7 trustee, and (iii) additional expenses and claims, some of which would be entitled to priority, that would be generated during the liquidation and from the rejection of leases and other executory contracts in connection with a cessation of operations.

If we choose to file under Chapter 11, we may be subject to claims that will not be discharged in the bankruptcy proceedings, which could have a material adverse effect on our financial condition and results of operations.

The Bankruptcy Code provides that the confirmation of a plan of reorganization discharges a debtor from substantially all debts arising prior to confirmation. With few exceptions, all claims that arose prior to confirmation of the plan of reorganization (i) would be subject to compromise and/or treatment under the plan of reorganization and/or (ii) would be discharged in accordance with the Bankruptcy Code and the terms of the plan of reorganization. Any claims not ultimately discharged through a plan of reorganization could be asserted against the reorganized entities and may have an adverse effect on our financial condition and results of operations on a post-reorganization basis.

Our financial results may be volatile and may not reflect historical trends.

~~During~~If we were to seek protection under applicable bankruptcy ~~proceedings~~laws, ~~we expect~~ our financial results tocould ~~continue~~become tosignificantly bemore volatile. asBankruptcy ~~asset~~proceedings ~~impairments,~~could result in asset ~~dispositions~~impairments, restructuring ~~activities~~ ~~and~~charges, ~~expenses~~asset dispositions, contract terminations and rejections, and/or claims assessments ~~occur~~, which may significantly impact our consolidated financial statements. AsIn asuch ~~result~~circumstances, our historical financial performance iswould ~~likely~~ not be indicative of ~~our~~future ~~financial performance after the date of a bankruptcy filing~~results.

In addition, if we ~~emerge~~were ~~from Chapter 11, the amounts reported in subsequent consolidated financial statements may materially change relative~~ to ~~historical~~emerge ~~consolidated~~from ~~financial statements, including as~~ a ~~result~~bankruptcy ofproceeding, ~~revisions to~~ our capital structure, operating plans, ~~pursuant~~and tofinancial areporting ~~plan~~could ofchange ~~reorganization~~materially. We ~~also~~ may be required to adopt fresh start accounting, in which could ~~case~~result in our assets and liabilities ~~will~~being be recorded at fair value as of the ~~fresh~~emergence ~~start reporting~~ date, ~~which may differ materially from the recorded values of assets~~ and ~~liabilities on~~ our ~~consolidated balance sheets. Our~~ financial ~~results~~statements after ~~the~~emergence could ~~application~~differ ofsignificantly ~~fresh start accounting also may be different~~ from our historical ~~trends~~financial statements.

Risks Related to Commercialization of ~~PHEXXI~~PHEXX, SOLOSEC, and Any Other Approved Products

Our success will depend heavily on whether we can successfully commercialize ~~PHEXXI~~ PHEXX for prevention of pregnancy, and ~~our newly acquired product,~~ SOLOSEC, for the treatment of bacterial vaginosis (BV) and trichomoniasis (Trich). ~~Failure~~ ~~to successfully commercialize our products would likely cause our business to fail.~~

Our ~~overall~~ success ~~will~~depends ~~rely~~ heavily on the commercial ~~success~~performance of ~~PHEXXI~~PHEXX, ~~vaginal~~our ~~gel~~hormone-free ~~for~~contraceptive ~~prevention~~vaginal ofgel, ~~pregnancy~~and ~~as well as of~~ SOLOSEC, ~~for the~~our treatment offor BVbacterial vaginosis and ~~Trich~~trichomoniasis. ~~Failure~~We tohave ~~successfully~~no ~~commercialize~~other ~~our~~approved products ~~would~~generating ~~likely~~meaningful ~~cause our business to fail~~revenue.

The successful commercialization of PHEXX and SOLOSEC depends on numerous factors, including market acceptance by healthcare providers and patients, reimbursement and pricing support from payors, the effectiveness of our sales and marketing efforts, competition from alternative products, our ability to maintain adequate manufacturing and supply arrangements, and our ability to comply with applicable regulatory requirements.

If PHEXX and SOLOSEC do not achieve sufficient market adoption, generate adequate reimbursement, or produce sustainable margins, we may be unable to generate sufficient revenue to fund our operations. Given our current financial condition and limited product portfolio, failure to successfully commercialize these products would materially adversely affect our business, financial condition, and results of operations and could threaten our ability to continue as a going concern.

If we are unable to maintain effective internal sales and marketing capabilities, or to enter into agreements with third parties to market and sell our products, our ability to continue to successfully commercialize our products and generate revenue would be adversely affected.

We may not be able to maintain the requisite sales force to market our products and we may face difficulties recruiting and hiring sales representatives and otherwise obtaining marketing capabilities. In the fourth quarter of 2022 and first quarter of 2023, we completed two reductions in workforce (RIFs) which reduced overall headcount, ~~and~~including ~~notably the total number of sales employees; this negatively impacted~~ our ~~ability to maintain our~~ sales ~~and marketing capabilities~~force. Any failure or future delay in the timely development of our internal commercialization capabilities could adversely impact the potential for commercial success of our products. We expect to continue to expend significant time and resources to train our sales consultants in marketing our products. In addition, we must train our sales force to ensure that an appropriate and compliant message about our products is being delivered. If we are unable to effectively train our sales force and equip them with compliant and effective materials, including medical and sales literature to help them appropriately inform and educate physicians regarding the potential benefits of our products, our efforts to successfully commercialize our products could be put in jeopardy, which would negatively impact our ability to generate product revenues.

Our use of social media platforms to market and promote our prescription products, presents risks and operational challenges.

We believe that our customer base and potential patient populations for our products are active on social media, and we have engaged and intend to continue to engage through those platforms to conduct direct-to-consumer marketing. Social media practices in the pharmaceutical, biotechnology and medical device industries are evolving, which creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media platforms to comment on the effectiveness of, or adverse experiences with, our products, which could result in regulatory reporting obligations or the need for us to conduct an investigation. The use of influencers and patient ambassadors to promote our products also may be subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (FTC), as well as comparable state consumer protection laws, and we are responsible for training those influencers on the compliant messages they can deliver to consumers about our products. Any actual or perceived non-compliance by our influencers and patient ambassadors with those requirements could lead to an investigation by the FTC or a comparable state agency or could lead to allegations of misleading advertising by private plaintiffs. In addition, there is a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us or our products on any social networking website. If any of these events were to occur or we otherwise fail to comply with any applicable regulations, we could incur liability, face restrictive regulatory actions, or incur other harm to our business such as reputational damage.

We face competition from other medical device, biotechnology and biopharmaceutical companies and our operating results will suffer if we are unable to compete effectively.

The medical device, biotechnology and biopharmaceutical industries, and the women’s health sector, are intensely competitive. Significant competition among various contraceptive products already exists. Existing products have name recognition, are marketed by companies with established commercial infrastructures, and are marketed with greater financial, technical and personnel resources than we have. To compete and gain market share, any new product must demonstrate advantages in efficacy, convenience, tolerability, and/or safety, among other things. In addition, new products developed by others could emerge as competitors to ~~PHEXXI~~PHEXX. These products could potentially offer an alternative form of non-hormonal contraception that is more convenient, is more effective, and/or provides protection over longer periods of time as compared to ~~PHEXXI~~PHEXX. We also compete with these organizations to recruit management and sales and marketing personnel. Any ~~failure~~ failure to attract and retain such personnel could negatively affect our level of expertise and our ability to execute our business plan. We We also face competition in connection with identifying and engaging in strategic transactions. If we are not able to compete effectively against our current and future competitors, our business will not grow and our financial condition and operations will suffer.

With respect to SOLOSEC, there are many FDA-approved products for the treatment of bacterial vaginosis, and many are generic. SOLOSEC competes with those products. Current therapies for the treatment of bacterial vaginosis primarily consist of oral and vaginal formulations of antibiotics delivered as a single dose or through multiple doses over consecutive days. If health care providers do not view the prescribing information for SOLOSEC as compelling compared with other products available for the treatment of bacterial vaginosis, or if competitive products have better insurance coverage or reimbursement levels than SOLOSEC, health care providers may opt to continue to prescribe existing treatments rather than recommend or prescribe SOLOSEC to their patients.

Our potential competitors include large, well-established pharmaceutical companies and specialty pharmaceutical companies who have significantly more resources than Evofem. These companies include Merck & Co., Inc., Organon, Allergan PLC, Pfizer Inc., Bayer AG, Johnson & Johnson, CooperSurgical Inc. and Mylan Inc. Additionally, several generic manufacturers currently market and continue to introduce new generic contraceptives.

~~PHEXXI,~~Our ~~SOLOSEC,~~potential ~~and~~competitors ~~any~~include ~~other~~large, ~~approved~~well-established ~~products~~pharmaceutical wecompanies ~~promote~~and ~~may~~specialty ~~not~~pharmaceutical ~~gain~~companies ~~sufficient~~who ~~market~~have ~~acceptance~~significantly more ~~among~~resources ~~physicians,~~than ~~patients~~Evofem. ~~or the medical community~~Additionally, ~~thereby~~several ~~limiting~~generic ~~our~~manufacturers ~~potential~~currently tomarket ~~generate~~and ~~revenue,~~continue ~~which~~to ~~will~~introduce ~~undermine~~new generic ~~our future growth prospects~~contraceptives.

~~Even~~PHEXX, ~~though~~SOLOSEC, ~~PHEXXI~~and ~~has~~any ~~been~~other approved byproducts ~~the~~we ~~FDA~~promote ~~for~~may ~~commercial~~not ~~sale~~gain ~~for~~sufficient ~~the~~market ~~prevention~~acceptance ofamong ~~pregnancy~~physicians, ~~and~~patients ~~SOLOSEC~~or ~~has been approved by~~ the ~~FDA~~ ~~for commercial sale for the treatment of BV and trichomoniasis~~medical community, ~~the~~thereby ~~degree~~limiting ofour ~~market~~potential ~~acceptance~~to ofgenerate ~~any new product by physicians~~revenue, ~~patients~~ ~~and~~which ~~the medical community~~ will ~~depend~~undermine onour afuture ~~number~~growth ~~of factors, including:~~prospects.

Even though PHEXX has been approved by the FDA for commercial sale for the prevention of pregnancy, and SOLOSEC has been approved by the FDA for commercial sale for the treatment of BV and trichomoniasis, the degree of market acceptance of any new product by physicians, patients and the medical community will depend on a number of factors, including:

	●	demonstrated evidence of efficacy and safety and potential advantages compared to competing products;
	●	perceptions by the medical community, physicians, and patients, regarding the safety and effectiveness of the product and the willingness of the target patient population to try it and of physicians to prescribe it;
	●	relative convenience and ease of administration compared to other products approved for the same indication;
	●	the regulatory label requirements for the product, including any potential restrictions on use or precautionary statements;
	●	sufficient third-party insurance coverage and adequate reimbursement;
	●	the terms of any approvals, such as any restrictions on the use of our product together with other medications;
	●	the willingness of wholesalers and pharmacies to stock the products;
	●	the prevalence and severity of any adverse side effects;
	●	the ability to sufficiently educate physicians with respect to the product’s safety and efficacy; and
	●	availability of alternative products and the cost-effectiveness of our product relative to competing products.

If any approved product that we may license, acquire or sell, including ~~PHEXXI~~PHEXX and SOLOSEC, does not provide a benefit over currently available options, that product is unlikely to achieve market acceptance, and we will not generate sufficient revenues to achieve profitability.

~~The telehealth~~Our ~~market~~commercial ~~continues~~strategy toincludes positioning ~~develop.~~PHEXX Iffor itwomen ~~encounters~~using ~~negative~~GLP-1 ~~publicity~~receptor ~~over privacy issues~~agonists, ~~fails~~and toif ~~engage~~clinical ~~sufficient numbers of providers~~guidance, orprescribing ifpatterns ~~limitations on reimbursement~~ or ~~new~~regulatory ~~state~~interpretations do ~~law~~not ~~regulatory~~support ~~requirements~~this ~~impede~~positioning, our ~~ability~~anticipated tomarket ~~implement~~opportunity ~~our~~and ~~telehealth strategy,~~sales ~~the~~ growth ofcould ~~our business may~~ be ~~harmed~~adversely affected.

We believe that women who use glucagon-like ~~utilize~~peptide-1 a(GLP-1) ~~telehealth~~receptor ~~platform~~agonists, ~~where~~including ~~women~~products ~~can~~such ~~directly~~as ~~meet~~Ozempic®, ~~with~~Mounjaro® ~~HCPs~~and toZepbound®, ~~determine~~may ~~their~~represent ~~eligibility~~a potential growth opportunity for ~~PHEXXI~~PHEXX, ~~and~~particularly ~~potentially~~because ~~have~~certain prescribing information for these products advises caution regarding the use ~~prescriptions~~of ~~written.~~oral ~~Our~~contraceptives ~~success~~during ~~will~~dose ~~depend~~escalation toor aotherwise ~~substantial~~notes ~~extent~~potential impacts on ~~the~~absorption ~~willingness~~of oral medications. However, this positioning is based on currently available prescribing information, published guidance and our interpretation of ~~women~~market todata, ~~use~~all ~~the~~of ~~telehealth~~which ~~platform.~~may ~~Negative~~evolve. ~~publicity~~Future ~~concerning~~clinical ~~our~~data, ~~telehealth~~regulatory ~~platform~~guidance, labeling updates, or ~~the~~professional ~~telehealth~~society ~~industry~~recommendations asmay aclarify, ~~whole~~limit, ~~could~~or ~~limit~~contradict current ~~market~~assumptions ~~acceptance~~regarding any interaction between GLP-1 receptor agonists and ~~utilization~~oral ofcontraceptives. If the medical community determines that GLP-1 products do not meaningfully reduce the ~~PHEXXI~~effectiveness ~~telehealth~~of ~~platform.~~oral ~~Additionally~~contraceptives, ~~telehealth~~or ~~laws~~if ~~are~~prescribers ~~rapidly~~do ~~changing.~~not ~~There~~view isPHEXX noas ~~guarantee~~an ~~that~~appropriate supplemental ~~telehealth~~or ~~will~~alternative becontraceptive ~~permitted in~~option ~~the~~for ~~same~~such ~~way~~patients, demand for PHEXX in ~~perpetuity.~~this ~~Changes~~segment bymay ~~state~~not ~~professional~~materialize. ~~licensing~~In ~~boards~~addition, our ability to promote PHEXX in connection with GLP-1 use is limited by the ~~standards~~product’s ofFDA-approved ~~care~~labeling. If regulatory authorities determine that our promotional materials, educational efforts, or ~~other~~digital ~~requirements~~marketing ~~governing~~related to GLP-1 users are inconsistent with approved ~~the~~labeling ~~practice~~or ofotherwise ~~telehealth~~misleading, ~~including~~we ~~the~~could ~~imposition~~be ofsubject ~~new~~to ~~requirements~~regulatory ~~for~~scrutiny, ~~prescriptions~~warning ~~from~~letters, ~~state~~fines, ~~and~~or ~~federal~~other ~~regulatory~~enforcement ~~bodies~~actions, and ~~could~~we ~~impact~~may ~~the~~be ~~success~~required ofto modify our ~~telehealth~~marketing ~~solution~~practices. ~~Similarly~~Further, ~~individual~~utilization ~~and~~trends ~~health~~for ~~care~~GLP-1 ~~industry~~receptor agonists may change due to safety concerns, supply constraints, pricing pressures, reimbursement limitations, competitive entrants, or ~~negative~~shifts ~~publicity~~in ~~regarding~~prescribing patterns. Any ~~patient~~decline ~~confidentiality~~in ~~and~~GLP-1 ~~privacy~~prescribing inor reduced patient persistence could reduce the ~~context~~size of ~~telehealth~~the ~~could~~potential ~~limit~~target ~~market~~population ~~acceptance~~we ~~and~~have ~~utilization~~identified. If of our ~~platform.~~assumptions Ifregarding ~~any of~~the ~~these~~GLP-1 ~~events~~market ~~occur~~opportunity prove inaccurate, itor ~~could~~if ~~have~~we aare ~~material~~unable ~~adverse~~to ~~effect~~effectively onand ~~our~~compliantly ~~business~~reach this patient population, ~~financial~~our ~~condition~~expected growth prospects, orrevenues, results of operations and financial condition could be materially adversely affected.

The ~~success~~telehealth ofmarket ~~PHEXXI~~continues ~~will~~to ~~depend~~develop. onIf the ~~availability~~telehealth ofindustry ~~competitive~~encounters ~~products~~negative ~~and~~publicity ~~women’s~~over ~~preferences~~privacy issues, infails ~~addition~~to engage sufficient numbers of providers, or if limitations on reimbursement or new state law regulatory requirements impede our ability to ~~the~~implement ~~market’s~~our telehealth ~~acceptance~~strategy, the growth of ~~the~~our ~~vaginal~~business pHmay ~~modulator~~be harmed.

~~The~~We ~~commercial~~utilize ~~success~~a telehealth platform where women can directly meet with HCPs to determine their eligibility of ~~PHEXXI~~PHEXX and potentially have prescriptions written. Our success will depend ~~upon~~to a substantial extent on the ~~contraceptive~~willingness ~~market~~of aswomen ~~well~~to asuse ~~market~~the ~~acceptance~~telehealth ofplatform. ~~PHEXXI~~Negative publicity concerning our telehealth platform, patient privacy, data security, or the telehealth industry as a ~~new~~whole, ~~form~~could ofreduce ~~contraception~~patient utilization. Additionally, federal and state laws governing telehealth, professional licensing, prescribing practices, reimbursement and standards aof ~~vaginal~~care pHare ~~modulator~~rapidly evolving. ~~Risks~~Changes ~~related~~in these laws or regulations, including new requirements imposed by state licensing boards, federal or state healthcare regulators, or prescribing authorities, could limit our ability to ~~market~~operate ~~acceptance~~or ~~include~~expand our telehealth platform. If telehealth utilization declines, ~~among~~regulatory ~~other~~requirements ~~things:~~become more restrictive, reimbursement policies change adversely, or concerns regarding confidentiality and data privacy increase, our telehealth strategy may be impaired, which could materially adversely affect our business, financial condition, and results of operations.

● minimum acceptable contraceptive efficacy rates and the related regulatory label requirements, including any potential restrictions on use or precautionary statements; ● perceived safety differences of hormonal and/or non-hormonal contraceptive options; ● changing women’s preferences; ● the effect of the Affordable Care Act (ACA) on pharmaceutical coverage, reimbursement and pricing, and the coverage of preventable services (including contraception under certain conditions); and ● new generic contraceptive options including the possibility of a future potential generic version of PHEXXI.

For example, the pregnancy rate with typical use of PHEXXI in the FDA-approved label is higher than that of hormonal contraceptives, and we cannot be certain that the associated risk of unintended pregnancy will not deter adoption of PHEXXI as a method of pregnancy prevention. In addition, PHEXXI’s label contains a warning related to use by women with a history of recurrent urinary tract infections, which could limit the willingness of HCPs to prescribe or certain women to use PHEXXI. These risks could reduce the market potential for PHEXXI or any future contraceptive product we may seek to develop, and place pressure on our business, financial condition, results of operations and prospects.

The ~~commercial~~ success of ~~PHEXXI,~~PHEXX ~~SOLOSEC and/or any future products we promote~~ will depend ~~in significant measure~~ on the ~~label~~availability ~~claims~~of ~~that the~~competitive ~~FDA~~products orand ~~other~~women’s ~~regulatory authorities approve for those products~~preferences.

The commercial success of ~~our~~PHEXX ~~products~~ will depend ~~in significant measure~~ upon the ~~prescribing~~overall ~~information~~contraceptive market and the ~~patient-directed~~degree ~~labeling describing~~of ~~the~~market ~~product’s~~acceptance ~~features,~~of ~~benefits,~~PHEXX as a form of contraception and ~~risks~~a vaginal pH modulator. Adoption of PHEXX is influenced by many factors, including:

~~We are~~● ~~required~~minimum toacceptable ~~submit~~contraceptive ~~all~~efficacy ~~revisions~~rates toand ~~approved~~the ~~product~~related ~~labeling~~regulatory ~~for~~label ~~our~~requirements, ~~products~~including asany ~~part~~potential ofrestrictions aon ~~supplemental~~use ~~NDA~~or toprecautionary ~~the~~statements; ~~FDA~~● ~~for~~perceived ~~review and~~safety ~~approval.~~differences ~~Failure~~of tohormonal ~~achieve~~and/or ~~approval~~non-hormonal ~~from~~contraceptive ~~the~~options; ~~FDA~~● orchanging ~~other~~women’s ~~regulatory~~preferences; ~~authorities~~● ofthe ~~product~~effect ~~labeling~~of ~~revisions~~the ~~could~~Affordable ~~have~~Care aAct ~~material adverse~~(ACA) ~~impact~~ on ~~our~~pharmaceutical ~~business~~coverage, ~~financial~~reimbursement ~~condition~~and pricing, ~~results~~and the coverage of ~~operations~~preventable services (including contraception under certain conditions); and ~~prospects~~● new generic contraceptive options including the possibility of a future potential generic version of PHEXX.

The pregnancy rate associated with typical use of PHEXX, as reflected in its FDA-approved labeling is higher than that of many hormonal contraceptives. We cannot be certain that the associated risk of unintended pregnancy will not deter adoption of PHEXX as a method of pregnancy prevention. In addition, PHEXX’s label contains a warning related to use by women with a history of recurrent urinary tract infections, which could limit the willingness of HCPs to prescribe or certain women to use PHEXX. These risks could reduce the market potential for PHEXX or any future contraceptive product we may seek to develop, and place pressure on our business, financial condition, results of operations and prospects.

The commercial success of PHEXX, SOLOSEC and/or any future products we promote will depend in significant measure on the label claims that the FDA or other regulatory authorities approve for those products.

We are prohibited from promoting our products for uses not described in the approved labeling, and our ability to communicate the benefits of our products is limited by the language approved by regulatory authorities. If the approved labeling contains significant limitations, precautionary statements, or warnings, or if we are unable to obtain approval for expanded indications or revised labeling through supplemental NDA submissions, our ability to effectively market our products could be materially adversely affected.

In addition, regulatory authorities may require changes to product labeling based on post-marketing safety data, including the addition of new warnings or other restrictions. Any such changes could negatively affect physician prescribing behavior, patient acceptance, reimbursement coverage, and our overall commercial performance.

The FDA and other regulatory agencies actively enforce laws and regulations prohibiting the promotion of off-label uses for prescription drugs and medical devices. If we are found or alleged to have improperly promoted our commercial product for off-label uses, we may become subject to significant liability.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products such as ~~PHEXXI~~ PHEXX and SOLOSEC. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory ~~agencies~~ agencies as reflected in the product’s approved labeling. Promotional labeling for ~~PHEXXI~~PHEXX, SOLOSEC and for any other products that we may promote, must be submitted to FDA at the time of first use. The agency actively solicits reports from health care professionals about improper drug manufacturer promotional claims or activities. If we are found or alleged to have improperly promoted our products for any off-label use, we may become subject to significant liability and potentially reputational harm. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of our products to ensure compliance with these legal and regulatory requirements, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

If we suffer negative publicity concerning the safety or efficacy of our products, our reputation and the commercialization of such products could be harmed.

If concerns should arise about the safety or efficacy of our products, such concerns could adversely affect the market’s perception which could lead to a decline in investors’ expectations, adverse effects on our results of operations, and a decline in the price of our common stock.

WeIf ~~rely,~~we ~~and~~suffer ~~expect~~negative topublicity ~~continue~~concerning tothe ~~rely,~~safety onor ~~market~~efficacy ~~research~~of ~~conducted~~our ~~internally~~products, toour ~~evaluate~~reputation and the ~~potential~~commercialization ~~commercial acceptance~~ of ~~PHEXXI~~such ~~for~~products could ~~the~~be ~~prevention of pregnancy~~harmed.

WeReports ~~expect~~of toadverse ~~continue~~events, towhether ~~perform~~accurate ~~internal~~or ~~market~~not, ~~research~~could ~~and~~lead ~~our research~~to ~~findings~~increased ~~may~~regulatory ~~not~~scrutiny, beproduct ~~indicative~~label orchanges, ~~predictive~~additional ofwarnings, product ~~actual~~withdrawals, or ~~overall~~litigation. ~~market~~Media ~~acceptance~~coverage, ~~and~~social ~~any~~media ~~future~~commentary, ~~market~~or ~~research~~other ~~may~~public ~~not be~~discussion ~~indicative~~ of ~~the~~safety ~~acceptance~~or ~~for~~efficacy ~~PHEXXI for contraception. Moreover, our internal research that has informed our~~concerns ~~views~~may ~~with~~amplify ~~respect~~these toeffects ~~our sales~~ and ~~marketing~~reduce ~~strategy,~~patient ~~payer coverage, pricing~~ and ~~reimbursement~~healthcare ~~with~~provider ~~respect~~confidence toin ~~PHEXXI~~our ~~may prove to be incorrect~~products. ~~For~~Any ~~example,~~perceived weor ~~believe~~actual ~~that~~safety ~~women~~or ~~who are most likely to use PHEXXI as their primary method of preventing~~efficacy ~~pregnancy~~issues ~~are~~could ~~those~~adversely ~~who~~affect ~~are~~prescribing ~~unwilling~~patterns, toreimbursement ~~use~~coverage, ~~hormone-based~~investor ~~contraceptives~~confidence, and ~~are~~our ~~unsatisfied~~stock ~~with~~price, ~~other~~and ~~commercially~~could ~~available~~materially ~~non-hormonal~~adversely ~~alternatives.~~affect If our ~~market~~business, ~~research~~financial ~~has overestimated the size of this population or the willingness of these women to try PHEXXI~~condition, ~~the~~and ~~commercialization~~results of ~~PHEXXI may be less successful than we or others expect~~operations.

We rely, and expect to continue to rely, on market research conducted internally to evaluate the potential commercial acceptance of PHEXX for the prevention of pregnancy.

We expect to continue to perform internal market research and our research findings may not be indicative or predictive of actual or overall market acceptance and any future market research may not be indicative of the acceptance for PHEXX for contraception. Moreover, our internal research that has informed our views with respect to our sales and marketing strategy, payer coverage, pricing and reimbursement with respect to PHEXX may prove to be incorrect. For example, we believe that women who are most likely to use PHEXX as their primary method of preventing pregnancy are those who are unwilling to use hormone-based contraceptives and are unsatisfied with other commercially available non-hormonal alternatives. If our market research has overestimated the size of this population or the willingness of these women to try PHEXX, the commercialization of PHEXX may be less successful than we or others expect.

There can be no assurance on the accuracy or completeness of certain facts, forecasts and other statistics obtained from various government publications, market data providers and other independent third-party sources, including industry expert reports, contained in this Annual Report or other statements we may make from time to time.

Certain facts, forecasts and other statistics contained herein and that we may discuss from time to time have been derived from various government publications, market data providers and other third-party sources. While we have no reason to believe that this information is false or misleading or that any fact has been omitted that would render this information false or misleading, we cannot guarantee the accuracy and completeness of this information. While we have taken reasonable care to ensure that these facts, forecasts and other statistics have been accurately reproduced from their respective sources, these facts, forecasts and other statistics have not been independently verified by us, our directors, advisers or any other parties and none of us make any representation as to the accuracy or completeness of such information. Due to possibly flawed or ineffective collection methods or discrepancies between published information and market practice and other problems, the facts, forecasts and statistics contained herein may be inaccurate or may not be comparable to information produced by other parties. Therefore, you should give consideration as to how much weight or importance you should attach to or place on these facts, forecasts or statistics and in all cases, but particularly with respect to market size, this information should not be unduly relied upon.

The proportion of the contraceptive market that is made up of generic products continues to increase, making the introduction of a branded contraceptive difficult and expensive.

The proportion of the U.S. market that is made up of generic products has increased over time. This trend is occurring in the women’s health segment as well, where many of the most popular oral contraceptive ~~pills~~pill brands have experienced genericization. Assuming this trend continues, it may be more challenging to commercialize ~~PHEXXI~~PHEXX at a price that will maximize our revenue and profits. Also, there may be additional marketing costs to commercialize ~~PHEXXI~~PHEXX in order to overcome the trend towards generics and to gain access to reimbursement by payers. If we are unable to gain or maintain favorable reimbursement from payers for ~~PHEXXI~~ PHEXX, or if patients are unwilling to pay any price differential between ~~PHEXXI~~PHEXX and a generic contraceptive product, our revenues will be limited. We are covering the cost of initial fills of ~~PHEXXI~~PHEXX at a $0 co-pay and subsequent refills at $25 co-pay up to a reduction of $75 per box. However, we cannot be certain that these initiatives will be successful in overcoming general inclinations of physicians and their patients to avoid branded contraceptives and these initiatives may become prohibitively expensive. If we choose to curtail our co-pay programs, demand for ~~PHEXXI~~PHEXX may decrease. In addition, if health care plans do not add ~~PHEXXI~~PHEXX to their covered formularies within the timelines we expect, or continue to include it on their covered formularies, or impose a more restrictive co-pay than we expect, our costs of providing these incentive programs will increase beyond our expectations and reduce our product margins and net revenues from sales of ~~PHEXXI~~PHEXX.

Even though we have received approval from the FDA in the U.S. to market PHEXXI for the prevention of pregnancy, and, as Femidence, by the National Agency for Food and Drug Administration and Control of Nigeria, and to market SOLOSEC for the treatment of BV and Trich, we may fail to receive similar approvals in other territories outside the U.S.44

Even though we have received approval from the FDA in the U.S. to market PHEXX for the prevention of pregnancy, and, as Femidence, by the National Agency for Food and Drug Administration and Control of Nigeria, and to market SOLOSEC for the treatment of BV and Trich, we may fail to receive similar approvals in other territories outside the U.S.

To market a new product outside the U.S., we must obtain separate marketing approvals in each jurisdiction and comply with numerous and varying regulatory requirements of other countries, including clinical trials, commercial sales, pricing manufacture distribution and safety requirements. The time required to obtain approval in other countries might differ from, and be longer than, that required to obtain FDA approval. The marketing approval process in other countries may include all the risks associated with obtaining FDA approval in the U.S., as well as other risks. In addition, in many countries outside the U.S., a new product must receive pricing and reimbursement approval prior to commercialization. This can result in substantial delays in these countries. Additionally, the product labeling requirements outside the U.S. are different and may be inconsistent with the U.S. labeling requirements, negatively affecting our ability to market our products in countries outside the U.S.

In addition, if we are unable to comply with applicable foreign regulatory requirements, we may be subject to fines, suspension or withdrawal of marketing approvals, product recalls, seizure of products, operating restrictions and criminal prosecution. In such an event, our ability to market to our full target market will be reduced and our ability to realize the full market potential of the approved products will be harmed, which could have a materially adverse effect on our business, financial condition, results of operations and prospects.

Risks Related to Our Post-Marketing Legal and Regulatory Compliance

Even though we have obtained FDA approval for ~~PHEXXI~~PHEXX for prevention of pregnancy and of SOLOSEC for the treatment of BV and Trich, we remain subject to ongoing regulatory requirements.

Even though ~~PHEXXI~~PHEXX vaginal gel has been approved by the FDA for the prevention of pregnancy and SOLOSEC has been approved by the FDA for the treatment of BV and Trich, we are and will be subject to ongoing regulatory requirements with respect to manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing clinical trials and submission of safety, efficacy and other post-approval information, including both federal and state requirements in the U.S. and requirements of comparable foreign ~~regulatory~~ regulatory authorities.

In addition, manufacturers and manufacturers’ facilities are required to continuously comply with FDA and comparable foreign regulatory authority requirements, including ensuring quality control and manufacturing procedures conform to cGMP regulations and corresponding foreign regulatory manufacturing requirements. Accordingly, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any NDA submission to the FDA or any other type of domestic or foreign MAA.

Any regulatory approvals we have received and may in future receive for our products may be subject to limitations on the approved indicated uses for which it may be marketed, and usual and customary surveillance to monitor its safety and efficacy. We will be required to report adverse reactions and production problems, if any, to the FDA and comparable foreign regulatory authorities. Any new legislation addressing drug safety issues could result in delays in commercialization, or increased costs to ensure compliance.

If a regulatory agency discovers previously unknown problems with our products, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or it disagrees with the promotion, marketing or labeling of a product, the regulatory agency may impose restrictions on that product or on us, including requiring withdrawal of the product from the market. If we are unable to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

	●	issue warning letters or untitled letters;
	●	impose civil or criminal penalties;
	●	suspend or withdraw regulatory approval;
	●	suspend any of our ongoing clinical trials;
	●	refuse to approve pending applications or supplements to approved applications submitted by us;
	●	impose restrictions on our operations, including closing our contract manufacturers’ facilities; or
	●	require a product recall.

Any government investigation of alleged violations of law would require us to expend significant time and resources in response and could generate adverse publicity. Any inability to comply with ongoing regulatory requirements may significantly and adversely affect our ability to develop and commercialize our products and the value of our business and our operating results would be adversely affected.

Developments after a product reaches the market may adversely affect sales of the product.

Even though ~~PHEXXI~~PHEXX has been approved in the U.S. for the prevention of pregnancy and SOLOSEC for the treatment of BV and Trich, certain developments could decrease market demand for it, including the following:

	●	the re-review of a product that is already marketed;
	●	new scientific information and evolution of scientific theories;
	●	the recall or loss of marketing approval of a product that is already marketed;
	●	changing government standards or public expectations regarding safety, efficacy or labeling changes; and
	●	greater examination of advertising and promotion.

In the past, clinical trials and post-marketing surveillance of certain marketed drugs have raised concerns that have led to recalls, withdrawals, or the addition of restrictive labeling of marketed products. If previously unknown side effects are discovered with one of the active ingredients in, or if there is an increase in negative publicity regarding known side effects related to ~~PHEXXI~~PHEXX, SOLOSEC, or any other product we may commercialize, this could significantly reduce demand for the product or require us to take actions that could negatively affect sales, including removing the product from the market, restricting its distribution or applying for labeling changes.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our products. If we are unable to obtain adequate insurance or are required to pay for liabilities resulting from a claim excluded from, or beyond the limits of, our insurance coverage, a material liability claim could adversely affect our financial condition.

We face an inherent risk of product liability exposure in commercializing our products. If serious adverse events or undesirable side effects occur, the following events could occur which would materially and adversely affect our business:

	●	regulatory authorities may require the addition of specific warnings or contraindications to product labeling or the issuance of alerts to physicians, pharmacies, and the general public;
	●	we may be required to change the way our products are administered or to revise the labeling of our products;
	●	we may be subject to promotional and marketing limitations on our products;
	●	sales of our products may decrease significantly;
	●	regulatory authorities may require us to take one or more of our products off the market;
	●	we may be required to conduct additional clinical trials with more patients or over longer periods of time than anticipated;
	●	we may be required to implement risk evaluation and mitigation strategies (REMS), which could result in substantial cost increases and have a negative impact on our ability to commercialize our products;
	●	we may be required to limit the patients who can receive our products;
	●	we may be subject to litigation or product liability claims; and
	●	our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of our products, or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from our products. Serious adverse events or side effects could require one or more of our products to be taken off the market, may require it to be packaged with safety warnings, or may otherwise limit our sales.

Further, if we cannot successfully defend ourselves against these product liability claims, we may incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in decreased demand for our products, injury to our reputation, negative media attention and the diversion of our management’s time and attention from our commercialization efforts to address claim related matters.

We will need to maintain liability insurance coverage as we continue to commercialize our products. This insurance may become increasingly expensive and difficult to procure. In the future, this insurance may not be available to us at all or may only be available at a very high cost and, if available, may not be adequate to cover all liabilities we may incur. In addition, while we have increased our liability insurance coverage in connection with the commercialization of our products, we cannot be certain our coverage limits will be sufficient to cover liability claims we may face. We will also need to increase liability coverage if we promote any other product. If we are not able to obtain and maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise, our business could be harmed, possibly materially.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business, financial condition or results of operations.

The activities of our third-party manufacturers and suppliers may involve the controlled storage, use, and disposal of hazardous materials. We and our manufacturers and suppliers, and our potential future manufacturers and suppliers, are and will be subject to laws and regulations governing the use, manufacture, storage, handling, and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use may be stored at our and our current and potential future manufacturers’ facilities pending their use and disposal. We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts and business operations; environmental damage resulting in costly clean-up; and liabilities under applicable laws and regulations governing the use, storage, handling, and disposal of these materials and specified waste products. Although we believe the safety procedures utilized by us and our current third-party manufacturers for handling and disposing of materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of specified materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently, and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. We do not currently carry biological or hazardous waste insurance coverage.

The FDA and other regulatory agencies actively enforce the laws and regulations relating to the promotion of our products.

If we are found to have improperly promoted uses of our products in the U.S., we may become subject to significant liability. Such enforcement has become more common in the industry. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription drug and device products. In particular, a product may not be promoted in a manner that results in the company making false or misleading claims. If the FDA determines that our or our partners’ public disclosures, promotional materials or training constitutes promotion of false or misleading claims, it could request modifications to disclosure policies, training or promotional materials or subject us or our partners to regulatory or enforcement actions, including the issuance of an untitled letter, a Warning Letter, injunction, seizure, civil fine or criminal penalties and a requirement for corrective advertising, including “Dear Doctor” letters. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our or our partners’ promotional or training materials to constitute promotion of false or misleading claims which could result in significant civil, criminal and/or administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government-funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, increased losses and diminished profits and the curtailment or restructuring of operations, any of which could adversely affect our or our partners’ ability to operate and, thus, adversely impact our business and our financial results. The FDA or other enforcement authorities could also request that we enter into a consent decree or a corporate integrity agreement or seek a permanent injunction against us under which specified promotional conduct is monitored, changed, or curtailed. If we cannot successfully manage the promotion of our product in the U.S., we could become subject to significant liability, which would materially adversely affect our business and financial condition.

Risks Related to Our Intellectual Property

~~Our~~TherapeuticsMD ~~rights~~may totake ~~develop~~adverse ~~and~~action ~~commercialize~~against ~~PHEXXI are subject, in part, to~~ the ~~terms~~Company and ~~conditions~~its ofuse ~~licenses granted to us by third parties. The patent protection and patent prosecution~~ of ~~PHEXXI~~the isPHEXX ~~dependent on third parties~~mark.

WeOn ~~are~~December ~~reliant~~14, ~~upon~~2020, ~~licenses~~a totrademark ~~certain~~dispute ~~patent~~captioned ~~rights~~TherapeuticsMD, ~~and~~Inc. ~~proprietary~~v ~~technology~~Evofem ~~from~~Biosciences, ~~third~~Inc., ~~parties~~was ~~that~~filed ~~are~~in ~~important~~the orU.S. ~~necessary~~District Court tofor the ~~commercialization~~ Southern District of ~~PHEXXI.~~Florida ~~For~~against ~~example~~the Company, ~~the~~alleging ~~Rush~~trademark ~~License~~infringement ~~Agreement~~of ~~includes~~certain ~~intellectual~~trademarks ~~property~~owned ~~rights~~by TherapeuticsMD tounder ~~PHEXXI~~federal and state law (Case No. ~~This~~9:20-cv-82296). ~~agreement currently~~On ~~requires~~July us18, as2022, athe ~~condition~~Company tosettled the ~~maintenance~~lawsuit ofwith TherapeuticsMD, ~~our~~with ~~license~~certain ~~and~~requirements ~~other~~which ~~rights,~~were required to ~~make~~be ~~milestone~~performed ~~and~~by ~~royalty~~July ~~payments~~2024 ~~and satisfy~~(the ~~certain~~Settlement ~~performance~~Timeline), ~~obligations~~including changing ~~through~~the ~~March~~name ~~2025~~of PHEXXI. AsOn ofJuly ~~December 31~~29, 2024, wethe ~~have~~Company ~~accrued~~received ~~all~~a ~~such~~cease ~~obligations~~and ~~pursuant~~desist letter from TherapeuticsMD, demanding that the toCompany change the ~~Rush~~name ~~License~~of ~~Agreement~~PHEXXI. In September 2024, wethe ~~have~~Company ~~obtained~~filed an application for a ~~waiver~~new name of ~~any~~PHEXX, ~~potential~~which ~~claim~~was ofapproved by ~~breach~~the ~~based~~FDA onin ~~any~~April ~~provisions~~2025. ~~requiring~~In usaccordance towith ~~timely exploit~~ASC 450, the ~~licensed~~Company ~~patent~~has oraccrued ~~make~~the ~~minimum~~present ~~royalty~~value ~~payments~~of the probable settlement amounts remaining payable over the next several years.

In addition, with respect to PHEXXI, Rush University has the right, in certain instances, to control the defense against any infringement litigation arising from the manufacture or development (but not the sale) of PHEXXI. While the Rush License Agreement requires Rush University to indemnify us for certain losses arising from these claims, this indemnification may not be sufficient to adequately compensate us for any related losses or the potential loss of our ability to manufacture and develop PHEXXI. In general, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations, and prospects. Moreover, if disputes over intellectual property we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize PHEXXI, which could have a material adverse effect on our business, financial conditions, results of operations, and prospects.47

Our licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not the sole and exclusive owners of the patents we in-license. If other third parties have ownership rights to our in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

TherapeuticsMD may take adverse action against the Company and its use of the PHEXXI mark.

On December 14, 2020, a trademark dispute captioned TherapeuticsMD, Inc. v Evofem Biosciences, Inc., was filed in the U.S. District Court for the Southern District of Florida against the Company, alleging trademark infringement of certain trademarks owned by TherapeuticsMD under federal and state law (Case No. 9:20-cv-82296). On July 18, 2022, the Company settled the lawsuit with TherapeuticsMD, with certain requirements which were required to be performed by July 2024 (the Settlement Timeline), including changing the name of PHEXXI. On July 29, 2024 the Company received a cease and desist letter from TherapeuticsMD, demanding that the Company change the name of PHEXXI. The Company is currently finalizing plans to re-brand PHEXXI in connection with the settlement reached with TherapeuticsMD in 2022.

If we are unable to obtain and maintain patent protection for our products and their underlying technologies, or if the scope of the patent protection we have or will obtain is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to our product and technology, and our ability to successfully commercialize our products may be adversely affected.

Our success depends in large part on our ability to obtain and maintain patent protection in the U.S. and other countries with respect to ~~our~~ our product and proprietary. We seek to protect our proprietary position by in-licensing intellectual property and filing patent applications in the U.S. and abroad relating to our products and their underlying technologies. If we ~~or our licensors~~ are unable to obtain or maintain ~~patent~~ patent protection with respect to our products and their underlying technologies, our business, financial condition, results of operations, and prospects could be materially harmed.

46Changes in either the patent laws or their interpretation in the U.S. and other countries may diminish our ability to protect our inventions, obtain, maintain, and enforce our intellectual property rights and, more generally, could affect the value of our intellectual property or narrow the scope of our patents. With respect to our owned intellectual property, we cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient protection from competitors or other third parties. Our pending and issued patent claims for PHEXX are not broad, and it is possible that a competitor may seek to make modifications to their product in an effort to design around our patent claims and avoid infringement. Furthermore, if any such competitor or third party is able to demonstrate bioequivalence without infringing our patents, then such a competitor or third party would then be able to introduce a competitive generic product onto the market once any available regulatory exclusivity has expired. The FDA has broad discretion in determining whether a potential competitive product demonstrates bioequivalence; we are not able to predict the extent to which a competitor or third party might be able to demonstrate bioequivalence without infringing our patents.

~~Changes~~The ~~in either the~~ patent ~~laws~~prosecution orprocess ~~their~~is ~~interpretation~~expensive, intime-consuming, ~~the~~and ~~U.S.~~complex, and ~~other~~we ~~countries~~ may ~~diminish~~not ~~our~~be ~~ability~~able to ~~protect~~file, ~~our~~prosecute, ~~inventions~~maintain, ~~obtain~~enforce, or ~~maintain,~~license ~~and~~all ~~enforce~~necessary ~~our~~or ~~intellectual~~desirable ~~property~~patent ~~rights~~applications ~~and,~~at ~~more~~a ~~generally,~~reasonable ~~could~~cost ~~affect~~or ~~the~~in ~~value~~a oftimely ~~our~~manner. ~~intellectual~~It ~~property~~is oralso ~~narrow~~possible we will be unsuccessful ~~the~~in ~~scope~~our efforts to identify patentable aspects of our ~~owned~~research and ~~licensed~~development ~~patents.~~output ~~With~~in ~~respect~~time to ~~both~~obtain ~~in-licensed~~patent ~~and~~protection. ~~owned~~Although ~~intellectual~~we enter ~~property,~~into wenon-disclosure ~~cannot~~and ~~predict~~confidentiality ~~whether the~~agreements ~~patent~~with ~~applications~~parties wewho ~~and~~have ~~our~~access ~~licensors~~to ~~are~~confidential ~~currently~~or ~~pursuing~~patentable ~~will~~aspects ~~issue~~of asour ~~patents~~research and indevelopment ~~any~~output, ~~particular~~such ~~jurisdiction~~as orour ~~whether~~employees, ~~the claims~~corporate ofcollaborators, ~~any~~outside ~~issued~~scientific ~~patents~~collaborators, ~~will~~Contract ~~provide~~Research ~~sufficient~~Organizations ~~protection~~(CROs), ~~from~~contract ~~competitors~~manufacturers, consultants, oradvisors, and other third parties., ~~Our~~any ~~pending~~of ~~and~~these ~~issued~~parties ~~patent claims~~may ~~for~~breach ~~PHEXXI~~the ~~are~~agreements ~~not broad,~~ and itdisclose issuch ~~possible~~output ~~that~~before a ~~competitor~~patent application ~~may~~is ~~seek~~filed, tothereby ~~make~~jeopardizing ~~modifications~~our ability to ~~their~~seek ~~product~~patent inprotection. anIn ~~effort~~addition, our ability to obtain and maintain valid ~~design~~and ~~around~~enforceable ~~our~~patents ~~patent~~depends ~~claims~~on ~~and~~whether ~~avoid~~the ~~infringement.~~differences ~~Furthermore,~~between ifour ~~any~~inventions ~~such~~and ~~competitor~~the orprior ~~third~~art ~~party~~allow isour ~~able~~inventions to ~~demonstrate~~be ~~bioequivalence~~patentable ~~without~~over ~~infringing~~the ~~our~~prior ~~patents~~art. Furthermore, ~~then~~publications ~~such~~of adiscoveries ~~competitor~~in orthe ~~third~~scientific ~~party~~literature ~~would~~often ~~then~~lag bethe ~~able~~actual todiscoveries, ~~introduce~~and apatent applications ~~competitive~~in ~~generic product onto~~ the ~~market~~U.S. ~~once~~and ~~any~~other ~~available~~jurisdictions ~~regulatory~~are ~~exclusivity~~typically ~~has~~not ~~expired.~~published ~~The~~until ~~FDA~~18 ~~has~~months ~~broad~~after ~~discretion~~filing, or in ~~determining~~some ~~whether~~cases anot ~~potential~~at ~~competitive~~all. ~~product~~Therefore, ~~demonstrates~~we ~~bioequivalence;~~cannot be certain that we ~~are~~were ~~not~~the ~~able~~first to ~~predict~~make the ~~extent~~inventions toclaimed ~~which~~in aany ~~competitor~~of our patents or ~~third~~pending ~~party~~patent ~~might~~applications, beor ~~able~~that we were the first to ~~demonstrate bioequivalence~~file ~~without~~for ~~infringing~~patent ~~our~~protection ~~patents~~of such inventions.

The patent ~~prosecution~~position ~~process~~of isbiotechnology ~~expensive, time-consuming,~~ and ~~complex,~~biopharmaceutical ~~and~~companies wegenerally ~~may~~is ~~not~~highly beuncertain, ~~able~~involves tocomplex ~~file,~~legal ~~prosecute,~~and ~~maintain,~~factual ~~enforce~~questions, or ~~license~~and ~~all~~has ~~necessary~~been orthe ~~desirable~~subject ~~patent applications at a reasonable cost or in a timely manner. It is also possible we will be unsuccessful in our efforts to identify patentable aspects~~ of ~~our~~much ~~research~~litigation ~~and development output~~ in ~~time~~recent ~~to obtain patent protection~~years. ~~Although~~As ~~we enter~~a ~~into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output~~result, ~~such~~the ~~as our employees~~issuance, ~~corporate collaborators~~scope, ~~outside scientific collaborators~~validity, ~~CROs~~enforceability, ~~contract~~and ~~manufacturers,~~commercial ~~consultants,~~value ~~advisors, and other third parties, any~~ of ~~these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing~~ our ~~ability to seek~~ patent ~~protection.~~rights Inare ~~addition,~~highly ~~our ability to obtain and maintain valid and enforceable patents depends on whether the differences between our inventions and the prior art allow our inventions to be patentable over the prior art~~uncertain. ~~Furthermore,~~Our ~~publications~~pending ~~of discoveries in the scientific literature often lag the actual discoveries,~~ and future patent applications inmay ~~the U.S. and other jurisdictions are typically~~ not ~~published~~result ~~until 18 months after filing, or~~ in ~~some cases not at all.~~patents ~~Therefore,~~being weissued ~~cannot~~which beprotect ~~certain that we or~~ our ~~licensors were the first to make the inventions claimed in any of our owned or licensed patents or pending patent applications~~products, or ~~that~~which weeffectively orprevent ~~our~~others ~~licensors~~from ~~were~~commercializing ~~the~~competitive ~~first~~technologies toand ~~file for patent protection of such inventions~~product candidates.

The patent position of biotechnology and biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. Our owned or in-licensed pending and future patent applications may not result in patents being issued which protect our products, or which effectively prevent others from commercializing competitive technologies and product candidates.

Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications we license or own currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents we own or in-license may be challenged, narrowed, circumvented, or invalidated by third parties. Consequently, we do not know whether our products and other proprietary technology will be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner which could materially adversely affect our business, financial condition, results of operations and prospects.

The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability, and our patents may be challenged in the courts or patent offices in the U.S. and abroad. We ~~or our licensors~~ may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant and inter partes review, or or interference proceedings or other similar proceedings challenging our ~~owned or licensed~~ patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, our ~~owned or in-licensed~~ patent rights, allow third parties to commercialize generic versions of our products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. Moreover, we, ~~or one of our licensors,~~ may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant ~~challenge~~ challenge proceedings, such as oppositions in a foreign patent office, that challenge our ~~or our licensor’s~~ priority of invention or or other features of patentability with respect to our ~~owned or in-licensed~~ patents and patent applications. Such challenges may result in loss of patent rights, loss of exclusivity, or in patent claims being narrowed, invalidated, or held unenforceable, which could ~~limit~~ limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our products. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us.

The patent rights licensed to us under the Rush University License are believed to have expired in March 2025. Upon expiration, these patent rights will no longer protect PHEXXI, and we now rely solely on our directly owned patent formulas and patent application families for patent protection for PHEXXI. Moreover, some of our owned and in-licensed patents and patent applications may in the future be co-owned with third parties. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us. Furthermore, our owned and in-licensed patents may be subject to a reservation of rights by one or more third parties. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.48

We may not be able to protect our intellectual property and proprietary rights throughout the world.

Filing, prosecuting, and defending patents on ~~PHEXXI~~PHEXX (Femidence) and SOLOSEC in all countries throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the U.S. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S. or other jurisdictions. Competitors may use our technology in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection but enforcement is not as strong as that in the U.S. These products may compete with our products, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary rights generally. In addition, some jurisdictions, such as Europe, Japan, and China, may have a higher standard for patentability than in the U.S., including for example the requirement of claims having literal support in the original patent filing and the limitation on using supporting data that is not in the original patent filing. Under those heightened patentability requirements, we may not be able to obtain sufficient patent protection in certain jurisdictions even though the same or similar patent protection can be secured in U.S. and other jurisdictions.

Proceedings to enforce our intellectual property and proprietary rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property and proprietary rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property we develop or license.

Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we ~~or any of our licensors~~ are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations, and prospects may be adversely affected.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and applications will be due to be paid to the USPTO and various government patent agencies outside of the U.S. over the lifetime of our ~~owned or licensed~~ patents and applications. In certain circumstances, we rely on our licensing partners to pay these fees due to U.S. and non-U.S. patent agencies. The USPTO and various non-U.S. government agencies require compliance with several procedural, documentary, fee payment, and other similar provisions during the patent application process. ~~We are also dependent on our licensors to take the necessary action to comply with these requirements with respect to our licensed intellectual property.~~ In some cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in a partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

Changes in either the patent laws or interpretation of the patent laws in the U.S. could increase the uncertainties and costs surrounding the ~~prosecution~~ prosecution of patent applications and the enforcement or defense of issued patents. Assuming other requirements for patentability are met, prior to March 2013, in the U.S., the first to invent the claimed invention was entitled to the patent, while outside the U.S., the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act (the America Invents Act) enacted in September 2011, the U.S. transitioned to a first inventor to file system in which, assuming other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before we do could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us to be cognizant going forward of the time from invention to filing of a patent application. Since patent applications in the U.S. and most other countries are confidential for a period after filing or until issuance, we cannot be certain that we ~~or our licensors~~ were the first to either (i) file any patent application related to ~~PHEXXI~~PHEXX or (ii) invent any of the inventions claimed in our ~~or our licensor’s~~ patents or patent applications.

The America Invents Act also includes a number of significant changes that affect the way patent applications will be prosecuted and also may affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our ~~owned or in-licensed~~ patent applications and the enforcement or defense of our ~~owned or in-licensed~~ issued patents, all which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

In addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained. Depending on future actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future.

~~Issued patents covering PHEXXI or SOLOSEC could be found invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad.~~50

IfIssued wepatents ~~or one of our licensors initiated legal proceedings against a third party to enforce a patent~~ covering ~~PHEXXI~~PHEXX or SOLOSEC, ~~the defendant~~ could ~~counterclaim~~be ~~that~~found ~~such patent is~~ invalid or unenforceable. Inif ~~patent~~challenged ~~litigation~~ in ~~the~~court ~~U.S., defendant counterclaims alleging invalidity~~ or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may raise claims challenging the validity or enforceability of our owned or in-licensed patents before administrative bodies in the U.S. or abroad~~, even outside the context of litigation~~. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our products. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we or our licensing partners and the patent examiner were unaware during prosecution. If a third party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our products. Such a loss of patent protection would have a material adverse impact on our business, financial condition, results of operations, and prospects.

49If we initiated legal proceedings against a third party to enforce a patent covering PHEXX or SOLOSEC, the defendant could counterclaim that such patent is invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may raise claims challenging the validity or enforceability of our patents before administrative bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our products. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we or our licensing partners and the patent examiner were unaware during prosecution. If a third party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our products. Such a loss of patent protection would have a material adverse impact on our business, financial condition, results of operations, and prospects.

If we do not obtain a Patent Term Extension (PTE) for PHEXXI, our business may be materially harmed.

One or more of our owned or in-licensed U.S. patents covers PHEXXI for the prevention of pregnancy, and our patents may be eligible for limited PTE under the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a PTE of up to 5 years as compensation for patent term lost during the FDA regulatory review process. A PTE cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended, and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar patent term restoration provisions to compensate for commercialization delay caused by regulatory review are also available in certain foreign jurisdictions, such as in Europe under Supplemental Protection Certificate (SPC). Further, if the FDA determines that the PHEXXI does not represent the first permitted commercial marketing or use of the product, or the active ingredients, we may fail to satisfy applicable requirements which could materially harm us and our operations.

In 2020, Rush University submitted a PTE application for the U.S. patent which we licensed from them, requesting a five-year PTE to 2026. Two Orders Granting Interim Extension (OGIEs) were received from the USPTO, extending the expiration of this patent to 2023. An additional request for interim patent term extension was granted, extending the exclusivity through March 2025. No further extensions have been received to date in the U.S., and we may not be granted a similar extension outside the U.S., such as SPC for the European patents, because of, for example, our inability to exercise due diligence during the testing phase or regulatory review process, our inability to apply within applicable deadlines, our inability to apply prior to expiration of relevant patents, or if we are otherwise unable to satisfy applicable requirements. Moreover, the applicable time or the scope of patent protection afforded could be less than our or Rush University’s request. If we or Rush University are unable to obtain PTE, or the term of any such extension is shorter than what we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations, and prospects could be materially harmed.

The patent protection and patent prosecution for our products is dependent on third parties, including Rush University.

While we normally seek to obtain the right to control prosecution, maintenance and enforcement of the patents relating to our products, as we do with our four solely owned Orange Book-listed U.S. patents, there may be times, such as with respect to our agreement with Rush University for PHEXXI, when the filing and prosecution activities for patents relating to certain products is controlled by our licensors or collaboration partners. If any of our current or future licensing or collaboration partners fail to prosecute, maintain and enforce such patents and patent applications in a manner consistent with the best interests of our business, including by payment of all applicable fees for patents covering PHEXXI, we could lose our rights to the intellectual property or our exclusivity with respect to those rights, our ability to develop and commercialize PHEXXI for the prevention of pregnancy may be adversely affected, and we may not be able to prevent competitors from making, using and selling competing products. In addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution.

An Event of Default under the secured notes issued pursuant to the Baker Bros. Purchase Agreement, as amended, could allow the secured creditor to take possession of all assets owned by us, including any directly owned intellectual property.

On March 7, 2023, Baker Bros. Advisors, LP (the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the Notice of Default) relating to the ~~Securities~~Baker Bros. Purchase ~~and Security~~ Agreement dated April 23, 2020, and subsequently amended ~~(SPA)~~, by and among Evofem, Designated Agent, the Guarantors and Baker Purchasers. The Notice of Default claimed that the Company failed to maintain the “Required Reserve Amount” as required by Section 2.7 of the Third Amendment to the Securities Purchase Agreement and Section 8.1(e) of the SPA. The Designated Agent claims such failure constitutes an immediate Event of Default pursuant to Section 9.1(e) of the SPA. The Designated Agent, at the direction of the Baker Purchasers, accelerated repayment of the outstanding balance payable and elected its remedies pursuant to Section 5.07(b) of the Securities Purchase Agreement. As a result, approximately $92.7 million, representing two times the sum of the outstanding balance and all accrued and unpaid interest thereon and all other amounts due under the SPA and other documents, was due and payable within three business days of receipt of the Notice of Default.

In September 2023, the Company and Baker entered into the Fourth Amendment, which, as described in more detail in Note 4 - Debt, waived the Notice of Default, cured all existing defaults, and removed the Company’s need to reserve enough equity to cover the value of the note and allowed the company to repurchase the note at a discounted price.

On December 11, 2023, Baker Bros assigned to Aditxt, Inc. (Assignee) all remaining amounts due under the ~~Securities~~Baker Bros. Purchase ~~and Security~~ Agreement. The notes were transferred back to Baker Bros on February 26, 2024 and then assigned to Future Pak, LLC on July 23, 2024. Given our current inability to pay any amounts ~~due~~ due under the Purchase Agreement or under the convertible notes, the designated agent of these note holders has the right to take ~~possession~~ possession of all of our assets and/or pursue any available legal remedies against us.

The Company received two Notice of Defaults (on September 27, 2024 and October 27, 2024) from their largest creditor, Future Pak, LLC, alleging a number of Events of Default, accelerating the Principal due and payable and declaring the termination of the existing Forbearance Agreement.

On September 27, 2024, Future Pak, LLC, as agent for the Purchasers (in such capacity, the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the Notice of Default) relating to the ~~Securities~~Baker Bros. Purchase ~~and Security~~ Agreement dated April 23, 2020, as amended (SPA), by and among the Company, Designated Agent, as certain guarantors and the purchasers (each a Purchaser and collectively Purchasers). The Notice of Default claims that by entering into arrangements to repay certain existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the SPA.

50According to the Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Purchase Agreement. If all Purchasers exercise the Section 5.7 Option (as defined below), the repurchase price would be equal to $106.8 million. Pursuant to Section 5.7(b) of the SPA, upon the occurrence of an Event of Default, each Purchaser may elect, at its option, to require the Company to repurchase the Baker Notes held by such Purchaser (or any portion thereof) at a repurchase price equal to two times the sum of the outstanding principal balance and all accrued and unpaid interest thereon, due within three business days after such Purchaser delivers a notice of such election (the Section 5.7 Option).

According to the Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Purchase Agreement. If all Purchasers exercise the Section 5.7 Option (as defined below), the repurchase price would be equal to $106.8 million. Pursuant to Section 5.7(b) of the SPA, upon the occurrence of an Event of Default, each Purchaser may elect, at its option, to require the Company to repurchase the Note held by such Purchaser (or any portion thereof) at a repurchase price equal to two times the sum of the outstanding principal balance and all accrued and unpaid interest thereon, due within three business days after such Purchaser delivers a notice of such election (the Section 5.7 Option).51

On October 27, 2024, the Designated Agent sent an amended and supplemented notice to the Notice of Default which adds additional claims of default based on the Company’s current repayment agreements of existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the ~~Securities~~Baker Bros. Purchase ~~and Security~~ Agreement dated April 23, 2020, as amended. Furthermore, the Amended Notice stated that, because the events of default described in the Amended Notice of Default are not the certain prior events of default listed in the Forbearance Agreement (the Specified Defaults), the Designated Agent and the holders of the senior secured promissory notes described in the SPA thereby provided notice to the Company that the Forbearance Agreement is terminated as of October 27, 2024.

Subsequently, on November 8, 2024, the Designated Agent sent an amended and supplemented notice to the Notices (the Third Amended Notice of Default) which adds new claims of default based on (i) the Company’s failure to maintain a cash position of $1.0 million or greater, as required under Section 5(b) of the Forbearance Agreement (ii) the Company’s failure to deliver financial and operating reports in accordance with the timeline required under the Section 8.1(n) of the Baker Stock Purchase Agreement, and (iii) to clarify the outstanding balance under the notes of the Baker Stock Purchase Agreement plus all accrued and unpaid interest thereon, in the sum of approximately is $107.0 million as opposed to the Repurchase Price as defined in the Fourth Amendment.

Evofem strongly disagrees with Future Pak LLC’s claim that an Event of Default has occurred. We intend to vigorously contest any attempt by Future Pak, LLC to exercise its default rights and remedies under the SPA. We further maintain that the Repurchase Price as defined in the Fourth Amendment remains in effect; this amount is currently approximately $1517.13 million.

If an Event of Default were to occur, the Designated Agent could take significant, adverse action against the Company, its assets and its accounts. There can be no assurances that the Company would be able to cure any Event(s) of Default or otherwise stop or mitigate any adverse action(s) taken by the Designated Agent.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

We or ~~our licensors~~ may be subject to claims that former employees, collaborators or other third parties have an interest in our ~~owned or in-licensed~~ patents, trade secrets, or other intellectual property as an inventor or co-inventor. For example, we ~~or our licensors~~ may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing ~~PHEXXI~~PHEXX. Litigation may be necessary to defend against these and other claims challenging inventorship or our ~~or our licensor’s~~ ownership of our ~~owned or in-licensed~~ patents, trade secrets or other intellectual property. If we ~~or our licensors~~ fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our product. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking and maintaining patents for our products, we also rely on trade secrets and confidentiality agreements to protect our unpatented know-how, technology, and other proprietary information and to maintain our competitive position. With respect to ~~PHEXXI~~PHEXX, we consider trade secrets and know-how to be one of our important sources of intellectual property. Trade secrets and know-how can be difficult to protect. In particular, our trade secrets and know-how in connection with ~~PHEXXI~~PHEXX may be disseminated within the industry through independent development, the publication of journal articles describing the methodology, and the movement of personnel with scientific ~~positions~~ positions in academic and industry.

We seek to protect these trade secrets and other proprietary technology, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors, and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. We cannot guarantee we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the U.S. are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third party, our competitive position would be materially and adversely harmed.

We may be subject to claims that third parties have an ownership interest in our trade secrets. For example, we may have disputes arise from conflicting obligations of our employees, consultants or others who are involved in developing ~~PHEXXI~~PHEXX. Litigation may be necessary to defend against these and other claims challenging ownership of our trade secrets. If we fail in defending any such claims, in addition to paying monetary damages, it may lose valuable trade secret rights, such as exclusive ownership of, or right to use, trade secrets that are important to ~~PHEXXI~~PHEXX. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we have no knowledge of any claims against us, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. To date, none of our employees have been subject to such claim.

We may be at risk that our former employees may wrongfully use or disclose our trade secrets.

In addition to patent protection, we rely heavily upon know-how and trade secret protection, as well as non-disclosure agreements and invention assignment agreements with our employees, consultants, and third parties, to protect our confidential and proprietary information, especially where we do not believe patent protection is appropriate or obtainable. In addition to contractual measures, we try to protect the confidential nature of our proprietary information using physical and technological security measures. Such measures may not, for example, in the case of misappropriation of a trade secret by an employee, former employee, consultant, former consultant or third party with authorized access, provide adequate protection for our proprietary information. Our security measures may not prevent an employee or consultant from misappropriating our trade secrets and providing them to a competitor, and recourse we take against such misconduct may not provide an adequate remedy to protect our interests fully. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive, and time-consuming, and the outcome is unpredictable. In addition, trade secrets may be independently developed by others in a manner that could prevent legal recourse by us. If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any such information was independently developed by a competitor, our competitive position could be harmed.

We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.

Many of our employees, consultants and advisors are currently or were previously employed at universities or other biotechnology or biopharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants, and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. Litigation may be necessary to defend against these claims. If we fail to defend any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to our management.

In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that it regards as its own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Third-party claims of intellectual property infringement, induced intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the commercialization of our product.

The contraceptive market is competitive and dynamic. Due to the significant research and development activities being conducted by ~~several~~ several companies in this field, including us and our competitors, the intellectual property landscape is in flux, and it may remain ~~uncertain~~ uncertain in the future. There may be significant intellectual property related litigation and proceedings relating to our ~~owned~~ and ~~in-licensed~~ ~~and~~ other third-party’s intellectual property and proprietary rights in the future.

Our commercial success depends in part on our and our collaborators’ ability to avoid infringing, inducing infringement, misappropriating and otherwise violating the patents and other intellectual property rights of third parties. There is a substantial amount of complex litigation involving patents and other intellectual property rights in the biotechnology and biopharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation, and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. As discussed above, recently, due to changes in U.S. law referred to as patent reform, new procedures including inter partes review and post-grant review have been implemented. As stated above, this reform adds uncertainty to the possibility of a challenge to our patents in the future.

52Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the fields in which we intend to commercialize PHEXX. We cannot assure you that PHEXX will not infringe patents owned by third parties. We may not be aware of patents that have already been issued and that a third party, for example, a competitor in the fields in which we are commercializing our product, might assert are infringed by PHEXX, including claims to compositions, formulations, methods of manufacture or methods of use or treatment that cover our product. It is also possible that patents owned by third parties of which we are aware, but which we do not believe are relevant to PHEXX, could be found to be infringed by our product. In addition, because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our product may infringe.

~~Numerous~~Third ~~U.S.~~parties ~~and~~may ~~foreign~~currently ~~issued~~have patents ~~and~~or ~~pending~~obtain ~~patent~~patents ~~applications~~in ~~owned~~the byfuture ~~third~~and ~~parties~~may ~~exist~~claim inthat ~~the~~use ~~fields~~of inour ~~which~~technology weinfringes ~~intend~~upon tothese ~~commercialize PHEXXI~~patents. In Wethe ~~cannot~~event ~~assure~~a ~~you~~third ~~that~~party ~~PHEXXI~~claims ~~will~~we ~~not~~infringed ~~infringe~~their patents ~~owned~~or bythat ~~third~~we ~~parties.~~are Weotherwise ~~may~~employing ~~not~~their beproprietary ~~aware~~technology ofwithout authorization ~~patents~~and ~~that~~initiates ~~have~~litigation ~~already been~~against ~~issued~~us, ~~and~~even ~~that~~if awe ~~third~~believe ~~party,~~such ~~for~~claims ~~example~~are without merit, a ~~competitor~~court inof ~~the~~competent ~~fields~~jurisdiction could inhold ~~which~~that wesuch patents are ~~commercializing~~valid, enforceable and infringed by our technology or product. In this case, ~~might~~the ~~assert~~holders of such patents ~~are~~may ~~infringed~~be byable ~~PHEXXI,~~to ~~including~~block ~~claims~~our ability to ~~compositions,~~commercialize ~~formulations,~~PHEXX ~~methods~~unless ofwe ~~manufacture~~obtain ora ~~methods~~license ofunder ~~use~~the applicable patents, or ~~treatment~~until ~~that~~such ~~cover~~patents ~~our~~expire ~~product~~or are finally determined to be held invalid or unenforceable. ItSuch isa ~~also~~license ~~possible~~may ~~that~~not ~~patents~~be ~~owned~~available byon ~~third~~commercially ~~parties~~reasonable terms ofor ~~which~~at all. Even if we are ~~aware,~~able ~~but~~to ~~which~~obtain wea dolicense, ~~not~~the ~~believe~~license ~~are~~would ~~relevant~~ likely obligate us to ~~PHEXXI~~pay license fees or royalties or both, and ~~could~~the berights ~~found~~granted to us might be ~~infringed~~nonexclusive, bywhich could result in our ~~product.~~competitors Ingaining ~~addition,~~access ~~because~~to ~~patent~~the ~~applications~~same ~~can~~intellectual ~~take~~property. If ~~many~~we ~~years~~are unable to ~~issue~~obtain a necessary license to a third-party patent on commercially reasonable terms, ~~there~~ we may be ~~currently~~unable ~~pending~~to ~~patent~~commercialize PHEXX ~~applications~~or ~~that~~such commercialization efforts may ~~later~~be ~~result~~significantly indelayed, ~~issued~~which ~~patents~~could ~~that~~in ~~our~~turn ~~product~~significantly ~~may~~harm ~~infringe~~our business.

Third parties may currently have patents or obtain patents in the future and may claim that use of our technology infringes upon these patents. In the event a third party claims we infringed their patents or that we are otherwise employing their proprietary technology without authorization and initiates litigation against us, even if we believe such claims are without merit, a court of competent jurisdiction could hold that such patents are valid, enforceable and infringed by our technology or product. In this case, the holders of such patents may be able to block our ability to commercialize PHEXXI unless we obtain a license under the applicable patents, or until such patents expire or are finally determined to be held invalid or unenforceable. Such a license may not be available on commercially reasonable terms or at all. Even if we are able to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectual property. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, we may be unable to commercialize PHEXXI or such commercialization efforts may be significantly delayed, which could in turn significantly harm our business.54

Defense of infringement claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from our business, and may impact our reputation. In the event of a successful claim of infringement against us, we may be enjoined from further developing or commercializing our infringing products or technology. In addition, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties and/or redesign our infringing products or technology, which may be impossible or require substantial time and monetary expenditure. In that event, we would be unable to further develop and commercialize our product, which could harm our business significantly. Further, we cannot predict whether any required license would be available at all or whether we would be available on commercially reasonable terms. In the event we could not obtain a license, we may be unable to further commercialize our product, which could harm our business significantly. Even if we are able to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be forced to cease some aspect of our business operations such as the commercialization of ~~PHEXXI~~PHEXX, if, as a result of actual or threatened patent infringement claims, we are unable to enter licenses on acceptable terms.

Engaging in litigation defending us against third parties alleging infringement of patent and other intellectual property rights is very expensive, particularly for a company of our size, and time-consuming. Some of our competitors may be able to sustain the costs of litigation or administrative proceedings more effectively than we can because of greater financial resources. Patent litigation and other proceedings may also absorb significant management time. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace. The occurrence of any of the foregoing could have a material adverse effect on our business, financial condition or results of operations.

In the ordinary course of business, we have been and again may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming, and unsuccessful.

Competitors or other third parties may infringe our patents or the patents of our licensing partners. We have and may again be required to defend against claims of infringement or otherwise engage in legal action to protect our intellectual property. Any commercial success we may achieve with ~~PHEXXI~~PHEXX for the prevention of pregnancy may incentivize third parties to challenge or infringe our intellectual property. In addition, our patents or the patents of our licensing partners also may become involved in inventorship, priority or validity disputes. To counter or defend against these claims is expensive and time consuming. In an infringement proceeding, a court may decide a patent owned ~~or in-licensed~~ by us is invalid or unenforceable or may refuse to stop the other party from using the technology at issue on the grounds our ~~owned and in-licensed~~ patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our owned ~~or in-licensed~~ patents at risk of being invalidated or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions, or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our ~~common~~Common ~~stock~~Stock. These litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

Some intellectual property that we have in-licensed may have been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S. manufacturers.

Intellectual property rights we have licensed or may in the future license are generated through the use of U.S. government funding and are therefore subject to certain federal regulations. As a result, the U.S. government may have certain rights to intellectual property embodied in our current product pursuant to the Bayh-Dole Act of 1980 (Bayh-Dole Act) and implementing regulations. These U.S. government rights in certain inventions developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right to require us or our licensors to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). The U.S. government also has the right to take title to these inventions if we, or the applicable licensor, fail to disclose the invention to the government and fail to file an application to register the intellectual property within specified time limits. These time limits have recently been changed by regulation and may change in the future. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us or the applicable licensor to expend substantial resources. In addition, the U.S. government requires that any products embodying the subject invention or produced through the use of the subject invention be manufactured substantially in the U.S. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the U.S. or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. manufacturers may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property. To the extent any of our current or future intellectual property is generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our registered or unregistered trademarks or trade names have, in the ordinary course of our business, been challenged and may again be challenged by third parties. These trademarks and trade names may also be infringed, circumvented or may not be registered with the USPTO or determined to be infringing on other marks. During trademark registration proceedings, we may receive rejections of our applications by the USPTO or in other foreign jurisdictions. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. Moreover, any name we have proposed to use with our product in the U.S. must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark. Similar requirements exist in Europe. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark.

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We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, we may be subject to potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names or that allege we have infringed on their trademarks and trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights or to defend ourselves in suits related to our trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and prospects.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

● others may be able to make products that are similar to our product or utilize similar technology but that are not covered by the claims of the patents that we license or may own; ● we, or our current or future licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future; ● we, or our current or future licensors or collaborators, might not have been the first to file patent applications covering certain of our or their inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technology without infringing our ~~owned or licensed~~ intellectual property rights; ● it is possible that our current or future pending ~~owned or licensed~~ patent applications will not lead to issued patents; ● issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors or other third parties; ● our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we may not develop additional proprietary technologies that are patentable; ● the patents of others may harm our business; and ● we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Risks Related to Our Reliance on Third Parties

Our success relies on third-party suppliers and two contract manufacturers. Any failure by these third parties, including their inability to successfully perform and comply with regulatory requirements, could negatively impact our business and our ability to develop and market our products, and our business could be substantially harmed.

We have a small number of employees and no internal manufacturing capability. Our management does not expect to manufacture any ~~products~~ products and expects to rely solely on third parties to manufacture our products, including our FDA-approved commercial products ~~PHEXXI~~ PHEXX and SOLOSEC, and as such we will be subject to inherent uncertainties related to product safety, availability, and security. We currently have only one contract manufacturer for each of our drug products.

~~PHEXXI~~PHEXX is manufactured by DPT Laboratories, Ltd. (DPT), with whom we entered into a supply and manufacturing agreement in November 2019 (the PHEXX ~~PHEXXI~~ Manufacturing Agreement). Pursuant to the ~~PHEXXI~~PHEXX Manufacturing Agreement, subject only to a supply failure, we are obligated to purchase all of our requirements with respect to ~~PHEXXI~~PHEXX from DPT. We expect to rely on DPT to increase the manufacturing of ~~PHEXXI~~PHEXX in amounts needed to support commercialization including anticipated demand in the CGG under our agreement with Pharma 1, assuming regulatory approvals in the UAE and subsequent countries. If DPT does not perform as agreed, is unable to increase manufacturing of ~~PHEXXI~~PHEXX as needed to support ongoing commercialization, or terminates our agreement, we will be required to replace them as our manufacturer, and we may be unable to do so on a timely basis, on similar terms or at all. Furthermore, we have only a single source of supply for some of the key raw materials and components of ~~PHEXXI~~PHEXX, and while we believe we would be able to obtain supplies through alternative sources if needed, alternate sources of supply may not be readily available.

Our current supply of SOLOSEC comes from its former owner, which has an existing finished goods supply. We inherited the former owner’s manufacturing agreement with Catalent, which will ensure uninterrupted commercial supply of SOLOSEC.

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We do not control the manufacturing processes for the production of either of our products, which must be made in accordance with relevant regulations including, among other things, quality control, quality assurance, compliance with cGMP and the maintenance of records and documentation. In the future, it is possible that our suppliers or manufacturers may fail to comply with FDA regulations, the requirements of other regulatory bodies or our own requirements, any of which would result in suspension or prevention of commercialization and/or manufacturing of ~~PHEXXI~~PHEXX; suspension of ongoing research; disqualification of data or other enforcement actions such as product recall, injunctions, civil penalties or criminal prosecutions against us. Furthermore, we may be unable to replace any supplier or manufacturer with an alternate supplier or manufacturer on a commercially reasonable or timely basis, or at all.

If we were to experience an unexpected loss of supply of, or if any supplier or manufacturer were unable to meet demand for our products, we could experience delays in commercialization. We might be unable to find alternative suppliers or manufacturers with FDA approval, of acceptable quality, and that are able to supply products/ingredients in the appropriate volumes and at an acceptable cost. The long transition periods necessary to switch manufacturers and suppliers would significantly delay our timelines, including our commercialization timeline, which would materially adversely affect our business, financial conditions, results of operations and prospects.

In addition, our reliance on DPT and anticipated future third-party manufacturers exposes us to the following additional risks:

	●	we may be unable to identify other manufacturers on acceptable terms or at all;
	●	our third-party manufacturers might be unable to timely formulate and manufacture our product or produce the quantity and quality required to meet our clinical and commercial needs, if any;
	●	DPT and anticipated future third-party manufacturers may not be able to execute our manufacturing procedures appropriately;
	●	our anticipated future third-party manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to successfully produce, store and distribute our products;
	●	manufacturers are subject to ongoing periodic unannounced inspections by the FDA and corresponding state agencies to ensure strict compliance with cGMPs and other government regulations and corresponding foreign standards, and we do not have control over third-party manufacturers’ compliance with these regulations and standards;
	●	we may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing process for our product; and,
	●	our third-party manufacturers could breach or terminate their agreements with us.

Each of these risks could impact the continued availability of our products or could result in higher costs or deprive us of potential ~~product~~ product revenue. In addition, we rely on third parties to perform release testing on ~~PHEXXI~~PHEXX and SOLOSEC prior to delivery to patients. If these tests are not appropriately conducted and test data are not reliable, patients could be put at risk of serious harm, which could result in product liability suits.

The manufacture of medical products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of medical products often encounter difficulties in production, particularly in scaling up and validating initial production and absence of contamination. These problems include difficulties with production costs and yields, quality control, including stability of the product, quality assurance testing, operator error, shortages of qualified personnel, timely availability of raw materials, lot consistency, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if contaminants are discovered in our supply of our product or in the manufacturing facilities, such manufacturing facilities may need to be closed for an extended period to investigate and remedy the contamination. We cannot be assured that any stability or other issues relating to the manufacture of our products will not occur in the future. Additionally, our manufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments. If our manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, our ability to distribute our products would be harmed. There is no assurance that our manufacturers will be successful in establishing a larger-scale commercial ~~manufacturing~~ manufacturing process for ~~PHEXXI~~PHEXX that achieves our objectives for manufacturing capacity and cost of goods. There is no assurance that our manufacturers will be able to manufacture or continue to manufacture our products to specifications acceptable to the FDA or other regulatory authorities, or to produce it in sufficient quantities to meet future demand. Any delay or failure in the production of our products would impair our ability to commercialize and obtain revenue therefrom. These circumstances would materially harm our business, results of operations, financial conditions and prospects.

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We have no significant internal distribution capabilities. We intend to engage third-party distributors for distribution of products outside the U.S., if approved, and have engaged additional third-party wholesale distributors for the distribution of our products in the U.S. Our inability to identify, or enter into an agreement with, any such third-party distributor, would likely have a material adverse effect on our business and operations.

If we are unable to engage additional wholesale distributors and/or maintain our relationship with our wholesale distributors within the U.S., our domestic commercialization activities may be disrupted. If we are able to identify and enter into additional strategic relationships with one or more third party collaborators for the development of our products outside of the U.S., beyond our commercial agreement with Pharma 1 Drug Store for the GCC we intend to work with that third party or third parties to obtain marketing approval for our products in each relevant jurisdiction and to enter into distribution agreements with such third party or parties for distribution of our products in each relevant jurisdiction outside the U.S. We cannot guarantee that we will be able to enter into any such additional wholesale distribution agreements on commercially reasonable terms, or at all, or that we will be able to identify additional third party collaborators for the development and commercialization of our products outside the U.S. or that we will be able to enter into any such distribution agreement with any such third party for the distribution of our products outside the U.S. For our current distribution agreements and for any future distribution agreements we may enter into, we would be subject to uncertainties related to such distribution services, including the quality of such distribution services. For example, distributors may not have the capacity to supply sufficient product if demand increases rapidly. Further, we would be dependent on the distributors to ensure that the distribution process accords with applicable foreign and U.S. regulations, which include, among other things, compliance with current good documentation practices, the maintenance of certain records, and compliance with other regulations, including, without limitation, the Foreign Corrupt Practices Act (FCPA) and the Drug Supply Chain Security Act (DSCSA) in the U.S. Failure to comply with these requirements could result in significant remedial action, including enforcement action requiring distributors to implement physical changes or improvements to their facilities, suspension of distribution or recall product. Additionally, any failure by us to forecast demand for finished product and failure by us to ensure our distributors have appropriate capacity to distribute such quantities of finished product, could result in an interruption in the supply of certain products and a decline in sales of that product. If we grant any such third-party distributor the right to manufacture any applicable product, we would also be subject to the risk factors set forth above with respect to third-party manufacturing of our product as well as the requirement to have any such additional manufacturer pre-approved by FDA or other relevant regulatory authorities. Further, third-party distributors may not perform as agreed or may terminate their agreements with us. Any significant problem or disruption that our distributors experience could delay or interrupt our sale of products in the applicable jurisdiction until the applicable distributor cures the problem or until we identify and negotiate an acceptable agreement with an alternative distributor, if one is available. Any failure or delay in distributing products would likely have a negative impact on our business and operations.

We rely on third parties for the delivery of telehealth services through the ~~PHEXXI~~PHEXX telehealth platform. Failure of these third parties to to provide services of a suitable quality, in accordance with applicable regulations and within acceptable time frames may cause the ~~delay~~ delay or failure of our telehealth strategy.

We employ a business model that relies on the outsourcing of certain functions, tests and services to CROs, medical institutions and other specialist providers, including, without limitation, quality assurance, clinical monitoring, and regulatory expertise. There is no assurance that such organizations or individuals will be able to provide the functions, tests or services as agreed upon, or to the requisite quality. We rely on the efforts of these organizations and individuals and could suffer significant delays in our processes should they fail to perform as expected.

There is also no assurance that these third parties will not make errors in, or simply fail to be effective in, the design, management or retention of our data or data systems. Any failures by such third parties could lead to a loss of data or data integrity, which in turn could lead to delays in clinical development and obtaining regulatory approval. Third parties may not pass FDA or other regulatory audits. In addition, the cost of such services could significantly increase over time.

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The ~~PHEXXI~~PHEXX telehealth platform is designed to provide physicians with on-demand educational support, and to remove certain barriers to women’s access to ~~PHEXXI~~PHEXX by removing the need for an in-office visit. With the ~~PHEXXI~~PHEXX telehealth platform, women can directly meet with an HCP to determine their eligibility for a ~~PHEXXI~~PHEXX prescription and potentially have it written by the HCP, filled, and mailed directly to them by a third-party pharmacy. These telehealth platform services are not core to our business of developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health. These services are also subject to complex federal and state laws and regulations and professional practice standards, and we do not have the resources to provide these telehealth services internally. Any pharmacy that fills ~~PHEXXI~~PHEXX prescriptions will be fully independent from us. We do not control or own or possess any ownership stake in any pharmacy that we expect may fill prescriptions for ~~PHEXXI~~PHEXX or in any telehealth service provider. All prescriptions will be be routed through our independent third-party telehealth service providers. If our telehealth service providers fail to perform or fail to perform in compliance with applicable laws, regulations and standards of care, our business, financial condition, commercial launch of ~~PHEXXI~~PHEXX and results of operation would be adversely affected.

If we are unable to enter into or maintain strategic relationships or collaborations with respect to ~~PHEXXI~~PHEXX for the prevention of pregnancy, or if we are unable to realize the potential benefits from such collaborations, our business, financial condition, commercialization prospects and results of operations may be materially adversely affected.

We do not presently expect to commercialize ~~PHEXXI~~PHEXX or SOLOSEC outside of the U.S., assuming international marketing approval is obtained, unless we enter into a strategic relationship or collaboration with a third party, such as our July 2024 agreement with Pharma 1. We face significant competition in seeking appropriate collaborators. Collaborations are complex and time-consuming arrangements to negotiate and document.

Our success in entering into a definitive agreement for any collaboration will depend upon, among other things, our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design and outcomes of any clinical trials that may be required by relevant foreign regulatory authorities, the collaborator’s history of regulatory compliance, the likelihood of approval by regulatory authorities, the potential market for the product, the costs and complexities of manufacturing and delivering such products to customers, the potential of competing products, the strength of the intellectual property and industry and market conditions generally. The collaborator may also consider alternative products or technologies for similar indications on which they might collaborate with one of our competitors and whether such collaboration could be more attractive than the one with us for our products.

Any potential collaboration agreement into which we might enter may call for licensing or cross-licensing of potentially blocking patents, know-how or other intellectual property. Due to the potential overlap of data, know-how and intellectual property rights, there can be no assurance that one of our collaborators will not dispute our right to use, license or distribute such data, know-how or other intellectual property rights, and this may potentially lead to disputes, liability or termination of the collaboration.

We may also be restricted under existing and future collaboration agreements from entering into agreements on certain terms with other potential collaborators and may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If that were to occur, we may have to curtail the development of a particular product, reduce or delay our development program, delay commercialization, reduce the scope of sales or marketing activities, or increase expenditures and undertake commercialization activities at our own expense.

If we were to elect to fund commercialization activities on our own, we would need to obtain additional capital, which may not be available to us on acceptable terms or at all.

If we enter into a collaboration agreement regarding a product, we could be subject to, among other things, the following risks, each of which may materially harm our business, commercialization prospects and financial condition:

	●	we may not be able to control the amount and timing of resources that the collaborator devotes to the product development program;
	●	we may experience financial difficulties and thus not commit sufficient financial resources to the product development program;
	●	we may be required to relinquish important rights to the collaborator such as marketing, distribution and intellectual property rights;
	●	a collaborator could move forward with a competing product developed either independently or in collaboration with third parties, including our competitors;
	●	a collaborator could terminate the agreement either for convenience, if permitted, or for our breach; or
	●	business combinations or significant changes in a collaborator’s business strategy may adversely affect our willingness to complete our obligations under any arrangement.

As a result, a collaboration may not result in the successful development or commercialization of our product. In addition, actions taken by a collaborator within its licensed territory, many of which we may not be able to control, could negatively impact our commercialization of the product in the U.S.

We enter into various contracts in the normal course of our business in which we indemnify the other party to the contract. In the event we must perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations.

In the normal course of business, we periodically enter into or will enter into manufacturing, distribution, wholesale, academic, commercial, service, collaboration, licensing, consulting, and other agreements that contain indemnification provisions. With respect to our academic and other research agreements, including the Rush License Agreement, we typically indemnify the institution and related parties from losses arising from claims relating to the products, processes or services made, used, sold or performed pursuant to the agreements for which we have secured licenses, and from claims arising from our or our sublicensees’ exercise of rights under the agreement. With respect to collaboration agreements, we may have to indemnify our collaborators from any third-party product liability claims that could result from the production, use or consumption of the product, as well as for alleged infringements of any patent or other intellectual property right owned by a third party. With respect to consultants, we indemnify them from claims arising from performance of their services in accordance with legal and contractual requirements.

If our obligations under an indemnification provision exceed applicable insurance coverage or if we were denied insurance coverage, our business, financial condition, and results of operations could be adversely affected. Similarly, if we are relying on a collaborator to indemnify us and the collaborator is denied insurance coverage or the indemnification obligation exceeds the applicable insurance coverage, and if the collaborator does not have other assets available to indemnify us, our business, financial condition, and results of operations could be adversely affected.

Risks Related to Our Commercialization of Health Care Products

Our products may face follow-on competition sooner than anticipated.

Although ~~PHEXXI~~PHEXX and SOLOSEC are FDA-approved for commercialization in the U.S., they and any other product we may commercialize may face competition from generic products earlier or more aggressively than anticipated, depending upon how well such approved products perform in the U.S. prescription drug market. In addition to creating the 505(b)(2) NDA pathway, the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) authorized the FDA to approve generic drugs that are the same as drugs previously approved for marketing under the NDA provisions of the statute pursuant to an Abbreviated New Drug Application (ANDA). An ANDA relies on the preclinical and ~~clinical~~ clinical testing conducted for a previously approved reference listed drug (RLD) and must demonstrate to the FDA that the generic drug ~~product~~ product is identical to the RLD with respect to the active ingredients, the route of administration, the dosage form, and the strength of the drug and also that it is “bioequivalent” to the RLD. The FDA is prohibited by statute from approving an ANDA when ~~certain~~ certain marketing or data exclusivity protections apply to the RLD. If any such competitor or third party is able to demonstrate bioequivalence without infringing our patents, then this competitor or third party may then be able to introduce a competing generic product onto the market.

PHEXXI is indicated for the prevention of pregnancy and was granted three (3) years of data exclusivity that expired on May 22, 2023, and it has been designated as an RLD by the FDA. We cannot predict the future PHEXXI market, whether someone will attempt to force the FDA to take other actions, or how quickly others may seek to come to market with competing products now that the three-year data exclusivity period has ended. 60

PHEXX is indicated for the prevention of pregnancy and was granted three (3) years of data exclusivity that expired on May 22, 2023, and it has been designated as an RLD by the FDA. We cannot predict the future PHEXX market, whether someone will attempt to force the FDA to take other actions, or how quickly others may seek to come to market with competing products now that the three-year data exclusivity period has ended.

SOLOSEC is indicated for the treatment of bacterial vaginosis in females 12 years of age and trichomoniasis in people 12 years of age and older. It was granted was granted three (3) years of NCE exclusivity that expired on September 15, 2022 and ten years of exclusivity under GAIN that will expire on September 15, 2027.

If the FDA approves generic versions of our products, it could negatively impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on our investments in those products.

59Changes in health care laws and regulations may eliminate current requirements for health insurance plans to cover and reimburse FDA-cleared or FDA-approved contraceptive products without cost sharing, which could reduce demand for products such as PHEXX. Our management expects our success will be dependent on the willingness or ability of patients to pay out-of-pocket for our products should they not be able to obtain third-party reimbursement or should such reimbursement be limited.

Changes in health care laws and regulations may eliminate current requirements for health insurance plans to cover and reimburse FDA-cleared or FDA-approved contraceptive products without cost sharing, which could reduce demand for products such as PHEXXI. Our management expects our success will be dependent on the willingness or ability of patients to pay out-of-pocket for our products should they not be able to obtain third-party reimbursement or should such reimbursement be limited.

We cannot be certain that third-party reimbursement will remain available for our products, or if reimbursement is available, that the amount of any such reimbursement would not change. We provide a financial assistance program for patients to offset any co-pay or patient out of pocket costs, but we do not know if this program will be successful in increasing market acceptance or that such program will not prove to be prohibitively costly. Demand for our products may decrease if we elect to discontinue our co-pay programs. The ACA and subsequent regulations enacted by the U.S. Department of Health and Human Services (DHHS) require, under certain conditions, health plans to provide coverage for women’s preventive care, including all forms of FDA-cleared or FDA-approved contraception, without imposing any cost sharing on the plan beneficiary. These regulations ensure that women who wish to use an approved form of contraception may request it from their doctors and their health insurance plan must cover all costs associated with such products, under certain conditions. In January 2022, the DHHS, Department of Labor, and Treasury Department jointly issued guidance on implementation of this ACA mandate, among other things. The recently issued federal guidance makes clear that all FDA-approved or cleared contraceptive products that are determined by an individual’s medical provider to be medically appropriate for such individual must be covered without-cost sharing, regardless of whether the product is specifically identified in the FDA’s Birth Control Guide.

However, certain members of Congress and other stakeholders may attempt to repeal or repeal and replace the ACA and corresponding regulations, as more fully described below, which could eliminate the requirement for health plans to cover women’s preventive care without cost sharing. Even if the ACA is not repealed, the DHHS regulations to specifically enforce the preventive health coverage mandate could be repealed or modified; for example, the Trump administration in 2017 altered the mandate to allow certain employers and insurers to opt-out of birth control coverage for religious or moral reasons, which was partially upheld by the Supreme Court in July 2020. We cannot predict the timing or impact of any future rulemaking or changes in the law. Any repeal or elimination of the preventive care coverage rules would mean that women seeking to use prescribed forms of contraceptives may have to pay some portion of the cost for such products out-of-pocket, which could deter some women from using prescription contraceptive products, such as ~~PHEXXI~~PHEXX, at all. We expect that health care reform measures that may be adopted in the future may result in more rigorous coverage criteria and lower reimbursement, and in additional downward pressure on the price that may be charged for ~~PHEXXI~~PHEXX or any other product we commercialize. Even with coverage for any approved product, the resulting reimbursement payment rates might not be adequate or may require a co-pay that patients find unacceptably high. Patients are unlikely to use any products we may market unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of those products. As a result, we expect that our success, to some degree, will be dependent on the willingness of patients to pay out-of-pocket for our products in the event that their third-party payer either does not cover and reimburse or requires payment of a portion of the cost of our products by the patient, thus increasing the patient’s overall cost to use them. This could reduce market demand for our products, which would have a material adverse effect on our business, financial conditions, and prospects.

We may also experience pressure from payers as well as state and federal government authorities concerning certain promotional approaches that we may implement, such as our co-pay programs. Certain state and federal enforcement authorities and members of Congress have initiated inquiries about co-pay programs. Some state legislatures have been considering proposals that would restrict or ban co-pay coupons. For example, legislation was recently signed into law in California that would limit the use of co-pay coupons in cases where a lower cost generic drug is available and if individual ingredients in combination therapies are available over the counter at a lower cost. It is possible that similar legislation could be proposed and enacted in additional states. If we are unsuccessful with or discontinue our co-pay programs, or we are unable to secure adequate coverage from third-party payers, we may experience financial pressure which would have a material adverse effect on our business and make it difficult to commercialize successfully.

Despite FDA-approval for our products and even if we are successful in obtaining additional products to commercialize in the U.S., revenues may be adversely affected if our products do not obtain coverage and adequate reimbursement from third-party payers in the U.S.

Market acceptance and sales of ~~PHEXXI~~PHEXX, SOLOSEC, or any other product we may commercialize will depend in part on the extent to which ~~reimbursement~~ reimbursement for these products will be available from third-party payers, including government health administration authorities, managed care organizations and private health insurers. Third-party payers decide which therapies they will pay for and establish reimbursement levels. Third-party payers in the U.S. often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for any product that we commercialize will be made on a payer-by-payer basis. One payer’s determination to provide coverage for a drug does not assure that other payers will also provide coverage and adequate reimbursement for the drug. Additionally, a third-party payer’s decision to provide coverage for a therapy does not imply that an adequate reimbursement rate will be approved.

60Third-party payers are increasingly challenging the prices charged for pharmaceutical and medical device products. The U.S. government and other third-party payers are increasingly limiting both coverage and the level of reimbursement for new drugs and medical devices, in addition to questioning their safety and efficacy. Coverage decisions can depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. We may incur significant costs to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our future products, in addition to the costs required to obtain the necessary FDA marketing approvals. Third-party payer coverage may not be available to patients for PHEXX, SOLOSEC, or any future product we may seek to commercialize. If third-party payers do not provide coverage and adequate reimbursement for PHEXX or other products we may commercialize, if approved, HCPs may not prescribe them or patients may ask their HCPs to prescribe competing products with more favorable reimbursement.

Third-party payers are increasingly challenging the prices charged for pharmaceutical and medical device products. The U.S. government and other third-party payers are increasingly limiting both coverage and the level of reimbursement for new drugs and medical devices, in addition to questioning their safety and efficacy. Coverage decisions can depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available. We may incur significant costs to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our future products, in addition to the costs required to obtain the necessary FDA marketing approvals. Third-party payer coverage may not be available to patients for PHEXXI, SOLOSEC, or any future product we may seek to commercialize. If third-party payers do not provide coverage and adequate reimbursement for PHEXXI or other products we may commercialize, if approved, HCPs may not prescribe them or patients may ask their HCPs to prescribe competing products with more favorable reimbursement.

Managed care organizations and other private insurers frequently adopt their own payment or reimbursement reductions. Consolidation among managed care organizations has increased the negotiating power of these entities. Third-party payers increasingly employ formularies to control costs by negotiating discounted prices in exchange for formulary inclusion. Failure to obtain timely or adequate pricing or formulary placement for our products or obtaining such pricing or placement at unfavorable pricing levels, could materially adversely affect our business, financial conditions, results of operations and prospects.

The pharmaceutical and medical device industries are highly regulated and subject to various fraud and abuse, data privacy, transparency, and other health care laws, including, without limitation, the U.S. Federal Anti-Kickback Statute, the U.S. Federal False Claims Act and the FCPA.

HCPs and third-party payers play a primary role in the recommendation and prescription of drug products and medical devices that are granted marketing approval. Our current and future arrangements with health care professionals, principal investigators, consultants, third-party payers, customers and other organizations may expose us to broadly applicable fraud and abuse and other health care laws and regulations in the U.S. These regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. The laws that may affect our ability to operate include, among others:

● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal health care program, such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws, including the False Claims Act, which can be enforced by private individuals through civil whistleblower or qui tams actions, and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payers that are false or fraudulent; ● the Health Insurance Portability and Accountability Act (HIPAA) which, among other things, created new federal criminal statutes that prohibit executing a scheme to defraud any health care benefit program and making false statements relating to health care matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH), and its implementing regulations, which imposes certain requirements on certain covered HCPs, health plans, and health care clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security, and transmission of individually identifiable health information; ● the Physician Payments Sunshine Act, enacted as part of the ACA, which requires manufacturers of drugs, devices, biologics, and medical supplies to report annually to the Centers for Medicare & Medicaid Services (CMS) information related to payments and other transfers of value to physicians, as defined by such law, teaching hospitals, and certain advanced non-physician health care practitioners and ownership and investment interests held by physicians and their immediate family members; and, ● foreign and state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to HCPs and other potential referral sources; state laws that require product manufacturers to report information related to payments and other transfers of value to physicians and other HCPs or marketing expenditures; state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and which may conflict, thus complicating compliance efforts.

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	●	federal civil and criminal false claims laws, including the False Claims Act, which can be enforced by private individuals through civil whistleblower or qui tams actions, and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payers that are false or fraudulent;

	●	the Health Insurance Portability and Accountability Act (HIPAA) which, among other things, created new federal criminal statutes that prohibit executing a scheme to defraud any health care benefit program and making false statements relating to health care matters;

	●	HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH), and its implementing regulations, which imposes certain requirements on certain covered HCPs, health plans, and health care clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security, and transmission of individually identifiable health information;

	●	the Physician Payments Sunshine Act, enacted as part of the ACA, which requires manufacturers of drugs, devices, biologics, and medical supplies to report annually to the Centers for Medicare & Medicaid Services (CMS) information related to payments and other transfers of value to physicians, as defined by such law, teaching hospitals, and certain advanced non-physician health care practitioners and ownership and investment interests held by physicians and their immediate family members; and,

	●	foreign and state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to HCPs and other potential referral sources; state laws that require product manufacturers to report information related to payments and other transfers of value to physicians and other HCPs or marketing expenditures; state and local laws that require the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and which may conflict, thus complicating compliance efforts.

The scope and enforcement of these laws and regulations is uncertain and subject to rapid change. Notably, in November 2020, DHHS finalized significant changes to the regulations implementing the Anti-Kickback Statute, as well as the civil monetary penalty rules regarding beneficiary inducements, with the goal of offering the health care industry more flexibility and reducing the regulatory burden associated with those fraud and abuse laws, particularly with respect to value-based arrangements among industry participants. Regulatory authorities might challenge our current or future activities under these laws. Any such challenge could have a material adverse effect on our reputation, business, results of operations and financial condition. These risks may be increased where there are evolving interpretations of applicable regulatory requirements, such as those applicable to manufacturer co-pay programs. Pharmaceutical manufacturer co-pay programs, including pharmaceutical manufacturer donations to patient assistance programs offered by charitable foundations, are the subject of ongoing litigation, enforcement actions and settlements (involving other manufacturers and to which we are not a party) and evolving interpretations of applicable regulatory requirements and certain state laws, and any change in the regulatory or enforcement environment regarding such programs could impact our ability to offer such programs. In addition, efforts to ensure that our business arrangements with third parties will comply with these laws will involve substantial costs. Any investigation of us or the third parties with whom we contract, regardless of the outcome, would be costly and time-consuming. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, monetary fines, imprisonment, disgorgement of profits, possible exclusion and debarment from participation in Medicare, Medicaid and other federal health care programs, debarment under the FDCA, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations.

Health care legislative reform measures may have a negative impact on our business and results of operations.

In the U.S. and some foreign jurisdictions, there have been, and continue to be, ~~several~~ legislative and regulatory changes and proposed changes regarding the health care system that could restrict or regulate post-approval activities and affect our ability to profitably sell any product.

~~There remain~~The ~~judicial and Congressional challenges to certain aspects of the~~ ACA,’s ~~and~~core ~~as a result certain sections of the ACA have not been~~constitutionality ~~fully~~was ~~implemented~~upheld orby ~~effectively repealed. However, following several years of litigation in~~ the ~~federal courts, in June 2021, the~~ U.S. Supreme Court ~~upheld~~in ~~the~~2021, ~~ACA when it dismissed a legal challenge to the ACA’s constitutionality. Further legislative~~ and ~~regulatory changes~~there ~~under~~is ~~the~~no ~~ACA~~longer ~~remain~~a ~~possible,~~live ~~although the new~~ federal ~~administration~~constitutional ~~under President Biden has signaled that it plans~~ challenge to ~~build on~~ the ~~ACA~~law ~~and~~itself ~~expand~~ (the ~~number~~Court ofdismissed ~~people~~the ~~who~~last ~~are~~major ~~eligible for health insurance subsidies under it~~case). ItHowever, isthere ~~unknown~~are ~~what~~ongoing ~~form~~legal ~~any such~~challenges ~~changes~~focused oron ~~any~~new ~~law~~federal ~~would~~regulatory ~~take, and how or whether it may affect the biopharmaceutical industry as a whole or our business in the future. We expect that~~ changes ~~or additions~~ to ~~the~~ ACA, ~~the Medicare and Medicaid~~ programs, ~~such as changes allowing the federal government to directly negotiate drug prices~~(e.g., eligibility and ~~changes~~marketplace ~~stemming~~enrollment ~~from other health care reform measures~~rules), ~~especially~~ with ~~regard~~at toleast ~~health~~one ~~care access,~~multistate ~~financing,~~lawsuit orpending ~~other~~that ~~legislation~~argues inrecent ~~individual~~HHS ~~states,~~and ~~could~~CMS ~~have~~ACA arule ~~material~~changes ~~adverse~~are ~~effect on the health care industry in the U~~unlawful.S.

~~Additionally,~~In ~~the~~mid-2025 ~~2020~~Congress ~~federal~~passed ~~spending~~and ~~package~~the ~~permanently~~President ~~eliminated,~~signed ~~effective January 1, 2020,~~ the ~~ACA~~so-~~mandated~~called “~~Cadillac”~~One ~~tax~~Big onBeautiful ~~high-cost employer-sponsored~~Bill ~~health~~Act,” ~~coverage~~which ~~and~~made ~~medical~~significant ~~device~~changes to ~~tax~~federal ~~and,~~health ~~effective~~policy ~~January~~and 1,did ~~2021,~~not ~~also~~extend ~~eliminated~~ the ~~health~~enhanced ~~insurer~~premium tax. ~~Further, the~~credits ~~Bipartisan~~previously ~~Budget~~in ~~Act~~place ofthrough ~~2018, among other things, amended~~ the ~~ACA,~~American ~~effective~~Rescue ~~January~~Plan ~~1, 2019, to close the coverage gap in most~~Act ~~Medicare~~and ~~drug~~Inflation ~~plans,~~Reduction ~~commonly referred to as the “donut hole”~~Act. InAs ~~addition, CMS published~~ a ~~final rule that would give states greater flexibility~~result, ~~effective~~the ~~January~~enhanced 1,subsidies ~~2020,~~that inhad ~~setting~~reduced ~~benchmarks~~costs for ~~insurers~~millions inof ~~the~~Americans ~~individual~~expired ~~and~~at ~~small group marketplaces, which may have~~ the ~~effect~~ end of ~~relaxing the essential health benefits required under the ACA for plans sold through such marketplaces~~2025.

~~The~~Efforts ~~uncertainty~~by ~~around~~congressional ~~the~~negotiators ~~future~~in oflate ~~the~~2025 ~~ACA,~~ and inearly ~~particular~~2026 ~~the impact~~ to ~~reimbursement~~extend ~~levels,~~or ~~may~~reinstate ~~lead~~those toenhanced ~~uncertainty~~subsidies orhave ~~delay~~collapsed indue ~~the purchasing~~to ~~decisions of our customers~~partisan disagreements, ~~which~~leaving ~~may~~the inACA ~~turn~~marketplace ~~negatively~~subsidy ~~impact~~structure ~~our~~at ~~product~~its ~~sales.~~original Ifstatutory ~~there~~level ~~are~~for ~~not adequate reimbursement levels, our business and results of operations could be adversely affected~~2026.

62Further legislative activity and negotiation over health care legislation remains highly uncertain, and any future changes; including expansions of subsidies, Medicare drug price negotiation authority, or major structural reforms, could occur but have not yet been enacted.

InCMS ~~addition,~~and ~~other~~HHS ~~legislative changes~~ have ~~been~~continued ~~proposed~~to ~~and~~issue ~~adopted~~new ~~since the~~ ACA-related ~~was~~rules ~~enacted.~~under ~~These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to~~ the ~~Budget~~current ~~Control~~federal ~~Act~~administration ~~of 2011, which began in 2013~~ and ~~will remain in effect through 2030 unless additional Congressional action is taken. However,~~ the ~~Medicare~~subsequent ~~sequester reductions under the Budget Control Act of 2011 will be suspended from May 1~~administration, ~~2020 through December 31, 2020 due to the COVID-19 pandemic, pursuant to provisions~~affecting ~~of the CARES Act which also extended the sequester by one year~~eligibility, ~~through~~enrollment ~~2030~~processes, inEssential ~~order~~Health ~~to offset the added expense of the 2020 cancellation. The suspension was subsequently extended through March 31~~Benefits, ~~2022,~~and ~~with~~marketplace ~~a reduction of the suspension to 1% sequester through June 30, 2022.~~ operations:

In addition, in 2013, the Drug Supply Chain Security Act (DSCSA) enacted imposed obligations on manufacturers of pharmaceutical products related to product tracking and tracing. On December 20, 2019, President Trump signed the Further Consolidated Appropriations Act for 2020 into law (P.L. 116-94) that includes a piece of bipartisan legislation called the CREATES Act. The CREATES Act aims to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking the existence of a REMS for certain products, to deny generic and biosimilar product developers access to samples of brand products. The CREATES Act establishes a private cause of action that permits a generic or biosimilar product developer to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Whether and how generic and biosimilar product developments will use this new pathway, as well as the likely outcome of any legal challenges to provisions of the CREATES Act, remain highly uncertain and its potential effects on our future commercial products are unknown. Other legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We are unsure whether additional legislative changes will be enacted, or whether the current regulations, guidance or interpretations will be changed, or whether such changes will have any impact on our business.

	●	Marketplace Integrity and Affordability Final Rule (2025): CMS finalized changes strengthening income and eligibility verification, tightening reenrollment rules, modifying automatic reenrollment premiums, changing special enrollment period availability, and revising plan standards. Some of these changes are temporary or set to sunset pending further rulemaking or litigation.

	●	New Proposed Rules for 2027 ACA Coverage: CMS also proposed additional changes in early 2026 aimed at expanding consumer choice and accountability, which are open for public comment.

	●	Essential Health Benefits and Coverage Definitions: Recent regulations have revised or narrowed coverage definitions, including excluding specific benefits from mandatory coverage under ACA exchanges, which has led to lawsuits by state attorneys general.

	●	No judicial decision has yet invalidated the ACA’s foundational framework; instead, disputes now center on how new regulations are implemented and whether they comport with statute.

	Other federal health program changes continue to affect the broader health care landscape:

	●	Budget reconciliation and federal spending laws enacted in 2025 affect Medicaid work and verification requirements, and are being tracked for implementation.

	●	Congressional policy on Medicare payments and other provider reimbursement mechanisms, including sequestration under the Budget Control Act, remains in effect and continues to create uncertainty in payment levels through 2030 absent further action.

The future of drug pricing policy, including direct Medicare negotiation for drug prices, remains a major area of debate. While the Inflation Reduction Act currently provides some negotiation authority, additional legislative changes aimed at expanding price negotiation or modifying rebate rules could materially affect industry economics, but such changes have not yet been enacted.

In addition, in 2013, the Drug Supply Chain Security Act (DSCSA) established obligations on manufacturers of pharmaceutical products related to product tracking and tracing.

On December 20, 2019, the Further Consolidated Appropriations Act for 2020 was signed into law (P.L. 116-94); this legislation includes a piece of bipartisan legislation called the CREATES Act. The CREATES Act aims to address the concern articulated by both the FDA and others in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking the existence of a Risk Evaluation and Mitigation Strategies (REMS) program for certain products, to deny generic and biosimilar product developers access to samples of brand products. The CREATES Act establishes a private cause of action that permits a generic or biosimilar “eligible product developer” to sue the brand manufacturer to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” The first lawsuit under the CREATED Act was Teva Pharmaceuticals v. Amicus Therapeutics (2021), in which Teva sued Amicus for its refusal to timely provide necessary drug samples for generic development of Galafold, Amicus’ oral medication used to treat Fabry disease. Teva eventually dismissed the suit after Amicus agreed to provide requested quantities. The quick resolution of the complaint illustrates the success of the CREATES Act in halting the drug supply dispute.

Other legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We are unsure whether additional legislative changes will be enacted, or whether the current regulations, guidance or interpretations will be changed, or whether such changes will have any impact on our business.

Additionally, there has been heightened governmental scrutiny in the U.S. of pharmaceutical pricing practices considering the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. For example, state legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In December 2020, the U.S. Supreme Court unanimously held that federal law does not preempt the states’ ability to regulate PBMs or other members of the health care and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area.

At the federal level, DHHS has solicited feedback on various measures intended to lower drug prices and reduce the out of pocket costs of drugs and has implemented others under its existing authority. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage plans the option to use step therapy for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019. In addition, in 2020, the FDA finalized a rulemaking to establish a system whereby state governmental entities could lawfully import and distribute prescription drugs sourced from Canada. In July 2021, former President Biden issued a sweeping executive order on promoting competition in the American economy that includes several mandates pertaining to the pharmaceutical and health care insurance industries. Among other things, the executive order directed the FDA to work towards implementing a system for importing drugs from Canada (following on the Trump administration notice-and-comment rulemaking on Canadian drug importation finalized in October 2020). The Biden order also called on DHHS to release a comprehensive plan to combat high prescription drug prices, and it includes several directives regarding the Federal Trade Commission’s oversight of potentially anticompetitive practices within the pharmaceutical industry. The drug pricing plan released by DHHS in September 2021 in response to the executive order makes clear that the Biden Administration supports aggressive action to address rising drug prices, including allowing DHHS to negotiate the cost of Medicare Part B and D drugs, but such significant changes will require either new legislation to be passed by Congress or time-consuming administrative actions. The implementation of cost containment measures or other health care reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products.

Current and future health care legislation could have a significant impact on our business. There is uncertainty with respect to the impact these changes, if any, may have, and any changes likely will take time to unfold. Any additional federal or state health care reform measures could limit the amounts that third-party payers will pay for health care products and services, and, in turn, could significantly reduce the projected value of certain development projects and reduce our profitability.

6365

We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage.

We and our third-party service providers are subject to laws and regulations covering data privacy and the protection of personal information including health information. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues which may affect our business. In the U.S., we and our third-party ~~service~~ service providers may be subject to state security breach notification laws, state health information privacy laws and federal and state ~~consumer~~ consumer protections laws which impose requirements for the collection, use, disclosure and transmission of personal information. These laws overlap and often conflict and each of these laws are subject to varying interpretations by courts and government agencies, creating ~~complex~~ complex compliance issues for us and our third-party service providers. In particular, our ~~PHEXXI~~PHEXX telehealth platform and our online, ~~digital~~ digital and media marketing strategies are required to comply with these laws and regulations. If we fail to comply with applicable laws ~~and~~ and regulations, we could be subject to penalties or sanctions, including criminal penalties if we knowingly obtain information that is protected by HIPAA (protected health information) from a covered entity or business associate in a manner that is not authorized or permitted by HIPAA or for aiding and abetting a violation of HIPAA.

The regulatory environment surrounding information security, data collection, and privacy is increasingly demanding. We are subject to numerous U.S. federal and state laws and regulations governing the protection of health, personal information, and financial information of our customers, clinical subjects, clinical investigators, employees, and vendors/business contacts. For example, California has implemented the California Confidentiality of Medical Information Act that imposes restrictive requirements regulating the use and disclosure of health information and other personally identifiable information, and California has recently adopted the CCPA, which went into effect in January of 2020. The CCPA mirrors a number of the key provisions of the EU General Data Protection Regulation (GDPR) described below. The CCPA establishes a new privacy framework for covered businesses by creating an expanded definition of personal information, establishing new data privacy rights for consumers in the State of California, imposing special rules on the collection of consumer data from minors, and creating a new and potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches. Additionally, a new privacy law, the California Privacy Rights Act (CPRA), was a ballot measure approved by California voters in the election on November 3, 2020, and certain provisions are effective as of January 1, 2022 with full effectiveness as of January 1, 2023. The CPRA modifies and expands the CCPA significantly, and among other things, creates the California Privacy Protection Agency with full administrative power, authority and jurisdiction to implement and enforce CCPA. CPRA transferred rulemaking authority from the California attorney General to the California Privacy Protection Agency effective July 1, 2021 with final CPRA regulations due by July 1, 2022. CPRA enforcement began July 1, 2023. The CCPA creates the potential for further uncertainty, additional costs and expenses in our efforts to comply with California privacy requirements and additional potential for harm and liability for failure to comply. Virginia and Colorado enacted similar data protection laws in 2021, and other U.S. states have proposals under consideration, increasing the regulatory compliance risk.

Numerous other countries have, or are developing, laws governing the collection, use and transmission of personal information as well. EU member states and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations.

On May 25, 2018, the GDPR went into effect, implementing a broad data protection framework that expanded the scope of EU data protection law, including to non-EU entities that process, or control the processing of, personal data relating to individuals located in the EU, including clinical trial data. The GDPR sets out a number of requirements that must be complied with when handling the personal data of EU based data subjects, including: providing expanded disclosures about how their personal data will be used; higher standards for organizations to demonstrate that they have obtained valid consent or have another legal basis in place to justify their data processing activities; the obligation to appoint data protection officers in certain circumstances; new rights for individuals to be “forgotten” and rights to data portability, as well as enhanced current rights (e.g. access requests); the principal of accountability and demonstrating compliance through policies, procedures, training and audit; and a new mandatory data breach regime. In particular, medical or health data, genetic data and biometric data where the latter is used to uniquely identify an individual are all classified as “special category” data under the GDPR and afford greater protection and require additional compliance obligations. Further, EU member states have a broad right to impose additional conditions—including restrictions—on these data categories. This is because the GDPR allows EU member states to derogate from the requirements of the GDPR mainly in regard to specific processing situations (including special category data and processing for scientific or statistical purposes). As the EU states continue to reframe their national legislation to harmonize with the GDPR, we will need to monitor compliance with all relevant EU member states’ laws and regulations, including where permitted derogation from the GDPR are introduced.

6466

We will also be subject to evolving EU laws on data export if we transfer data outside the EU to ourselves or third parties. The GDPR only permits exports of data outside the EU where there is a suitable data transfer solution in place to safeguard personal data (e.g. the EU Commission approved Standard Contractual Clauses). On July 16, 2020, the Court of Justice of the EU (CJEU) issued a landmark opinion in the case Maximilian Schrems vs. Facebook (Case C-311/18) (Schrems II). This decision calls into question certain data transfer mechanisms as between the EU member states and the U.S. The CJEU is the highest court in Europe and the Schrems II decision heightens the burden on data importers to assess U.S. national security laws on their business future actions of EU data protection authorities are difficult to predict at the early date. Consequently, there is some risk of any data transfers from the EU being halted. If we have to rely on third parties to carry out services for us, including processing personal data on our behalf, we are required under GDPR to enter into contractual arrangements to help ensure that these third parties only process such data according to our instructions and have sufficient security measures in place. Any security breach or non-compliance with our contractual terms or breach of applicable law by such third parties could result in enforcement actions, litigation, fines and penalties or adverse publicity and could cause customers to lose trust in us, which would have an adverse impact on our reputation and business. Any contractual arrangements requiring the processing of personal data from the EU to us in the U.S. will require greater scrutiny and assessments as required under Schrems II and may have an adverse impact on cross-border transfers of personal data or increase costs of compliance. The GDPR provides an enforcement authority to impose large penalties for noncompliance, including the potential for fines of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. We will be subject to GDPR when we have a EU presence or “establishment” (e.g. EU based subsidiary or operations), when conducting clinical trials with EU based data subjects, whether the trials are conducted directly by us or through a vendor or partner, or offering approved products or services to EU based data subjects, regardless of whether involving a EU based subsidiary or operations.

Applicable data privacy and data protection laws may conflict with each other, and by complying with the laws or regulations of one jurisdiction, we may find that we are violating the laws or regulations of another jurisdiction. Despite our efforts, we may not have fully complied in the past and may not in the future. If we become liable under laws or regulations applicable to us, we may be required to pay significant fines and penalties, our reputation may be harmed, and we may be forced to change the way we operate. That could require us to incur significant expenses, which could significantly affect our business.

Our business may be adversely affected by unfavorable macroeconomic conditions, including potential future pandemics, geopolitical conflicts and other factors.

Various macroeconomic factors could adversely affect our business, our results of operations and our financial condition, including changes in inflation, interest rates and foreign currency exchange rates and overall economic conditions and uncertainties, including those resulting from political instability (including workforce uncertainty), trade disputes between nations and the current and future conditions in the global financial markets. For example, if inflation or other factors were to significantly increase our business costs, we may be unable to pass through price increases to patients. The cost of importing similar products from foreign markets may affect our sales in any domestic market.

In addition, U.S. and global financial markets have experienced disruption due to various macroeconomic and geopolitical events. These include, but are not limited to, rising inflation, rising interest rates, the risk of a recession and other ongoing global conflicts. We cannot predict at this time to what extent our or our collaborators, employees, suppliers, contract manufacturers and/or vendors could be negatively impacted by these and other macroeconomic and geopolitical events.

Interest rates and the ability to access credit markets could also adversely affect the ability of patients, payers and distributors to purchase, pay for and effectively distribute our products. Similarly, these macroeconomic factors could affect the ability of our current or potential future third-party manufacturers, sole source or single source suppliers, licensors or licensees to remain in business, or otherwise manufacture or supply our product. Failure by any of them to remain in business could affect our ability to manufacture our products.

Some physician offices appear to have been negatively impacted by restrictions on elective procedures and office visits during the pandemic. To the extent physician offices are again closed or visits are again reduced, patients could be less likely to be prescribed PHEXXI. Even with our ongoing telehealth efforts through channels such as the PHEXXI telehealth platform, we may not be able to effectively commercialize PHEXXI for the prevention of pregnancy as a result of our reduced sales force, any reduction in physician office visits, or other circumstances related to a public health emergency. Any such emergency may adversely affect us and our business in manner we may be unable to reliably predict or quantify.67

65Some physician offices appear to have been negatively impacted by restrictions on elective procedures and office visits during the pandemic. To the extent physician offices are again closed or visits are again reduced, patients could be less likely to be prescribed PHEXX. Even with our ongoing telehealth efforts through channels such as the PHEXX telehealth platform, we may not be able to effectively commercialize PHEXX for the prevention of pregnancy as a result of our reduced sales force, any reduction in physician office visits, or other circumstances related to a public health emergency. Any such emergency may adversely affect us and our business in manner we may be unable to reliably predict or quantify.

Ongoing geopolitical tensions, conflict between Russia and Ukraine, the Israel-Hamas wars, and any escalations thereof may result in adverse impacts on the global economy which may in turn negatively impact our business. These and any additional sanctions and export controls, as well as any counter responses by the governments of the countries in conflict or at war, or other jurisdictions, could adversely affect, directly or indirectly, the global supply chain, with negative implications on the availability and prices of raw materials, energy prices, and our customers, as well as the global financial markets and financial services industry.

Risks Related to Our Business Operations

As we mature and expand our sales and marketing infrastructure, we will need to expand the size of our organization. If we experience difficulties in managing this growth or are unable to attract and retain management and other key personnel, we may be unable to successfully commercialize our products or otherwise implement our business plan.

As of ~~March~~February 1428, ~~2025~~2026, we had a total of 3229 full-time employees. In addition, we use third-party consultants to assist with finance, including regulatory filings, sales, marketing and market access research and programs, as well as general and administrative activities. As our development and commercialization plans and strategies continue to develop, we expect that we will expand the size of our employee base for managerial, operational, sales, marketing, financial, regulatory affairs and other resources. Future growth would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain, motivate and integrate additional employees. In addition, management may have to divert a disproportionate amount of its attention away from day-to-day activities and devote a substantial amount of time to managing these growth activities, which would lead to disruptions in our operations. We cannot provide assurance that we will be able to retain adequate staffing levels to run our operations and/or to accomplish all the objectives that we otherwise would seek to accomplish, or that our staffing levels may turn out to be too robust for our actual business activity.

Our ability to compete in the highly competitive pharmaceutical industry depends upon our ability to attract and retain highly qualified managerial and key personnel. We are highly dependent on our senior management, and the loss of the services of any members of our senior management team could impede, delay or prevent the development and commercialization of our product, hurt our ability to raise additional funds and negatively impact our ability to implement our business plan. If we lose the services of any of these individuals, we might not be able to find suitable replacements on a timely basis or at all, and our business could be harmed as a result. We do not maintain “key man” insurance policies on the lives of these individuals.

We might not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for qualified personnel among biotechnology, medical device, biopharmaceutical and other businesses, particularly in the San Diego area where we are headquartered. As a result, we may be required to expend significant financial resources in our employee recruitment and retention efforts, including the grant of significant equity incentive awards which would be dilutive to stockholders. Many of the other companies within the contraceptive industry with whom we compete for qualified personnel have greater financial and other resources, different risk profiles and longer histories in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. If we are not able to attract and retain the necessary personnel to accomplish our business objectives or if we are not able to effectively manage any future growth, we may experience constraints that will harm our ability to implement our business strategy and achieve our business objectives.

Our current or future employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with legal requirements or regulatory standards.

We may become exposed to the risk of employees, independent contractors, principal investigators, consultants, suppliers, commercial partners or vendors engaging in fraud or other misconduct. Misconduct by employees, independent contractors, principal investigators, consultants, suppliers, commercial partners and vendors could include intentional conduct such as failures: (i) to comply with FDA or other regulators’ regulations; (ii) to provide accurate information to such regulators; or (iii) to comply with manufacturing standards established by us and/or required by law. In particular, sales, marketing and business arrangements in the health care industry are subject to extensive laws, regulations and industry guidance intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct by current or future employees, independent contractors, principal investigators, consultants, suppliers, commercial partners and vendors could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory or civil sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct by employees, independent contractors, principal investigators, consultants, suppliers, commercial partners and vendors, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending or asserting our rights, those actions could have a significant adverse impact on our business and we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, monetary fines, individual imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal health care programs, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations.

We may be vulnerable to disruption, damage and financial obligations as a result of information technology system failures, cybersecurity breaches, loss of data or other disruptions that could compromise our proprietary information or other sensitive information.

Despite the implementation of security measures and internal policies and controls, any of the internal computer systems belonging to us or our third-party service providers are vulnerable to damage from computer viruses, unauthorized access, natural disasters, malicious attack, human error, and telecommunication and electrical failure. Cybersecurity risks continue to increase for our industry, including for our third-party vendors, who may hold some of our data, and the proliferation of new technologies and the increased sophistication and activities of the actors behind such attacks present risks for compromised or lost data, which could result in substantial costs and harm to our reputation. Any system failure, accident, security breach or data breach that causes interruptions in our own or in third-party service vendors’ operations could result in a material disruption of our commercialization or product development programs. For example, the loss of clinical study data from future clinical trials could result in liability, delays in our or our partners’ regulatory approval efforts and significantly increase our costs to recover or reproduce the lost data. Further, our information technology and other internal infrastructure systems, including firewalls, servers, leased lines and connection to the Internet, face the risk of systemic failure, which could disrupt our operations. In addition, our commercialization of ~~PHEXXI~~PHEXX is partially reliant on the use of the ~~PHEXXI~~PHEXX telehealth platform and our other digital or media marketing strategies. We are in turn reliant on third parties and limited internal resources to ensure the ~~PHEXXI~~PHEXX telehealth platform and these other digital and marketing resources function appropriately. Our commercialization of ~~PHEXXI~~PHEXX may be adversely affected to the extent the ~~PHEXXI~~PHEXX telehealth platform and our other online marketing resources do not work ~~properly~~ properly or are disrupted. To the extent any disruption or security breach results in a loss or damage to our data or applications, sensitive information or inappropriate disclosure of confidential or proprietary information, we may incur resulting liability and reputation damage, our product development programs and competitive position may be adversely affected and the further commercialization or development of our products may be delayed. Furthermore, we may incur additional costs to remedy the damage caused by these disruptions or security breaches and these costs could be significant.

The U.S. federal and various state and foreign governments have adopted or proposed requirements regarding the collection, distribution, use, security, and storage of personally identifiable information and other data relating to individuals, and federal and state consumer protection laws are being applied to enforce regulations related to the collection, use, and dissemination of data. Some of these federal, state and foreign government requirements include obligations of companies to notify individuals and others of security breaches involving health information or particular personally identifiable information, which could result from breaches experienced by us or by our vendors, contractors, or organizations with which we have formed strategic relationships. Even though we may have contractual protections with such vendors, contractors, or other organizations, notifications and follow-up actions related to a security breach could impact our reputation, cause us to incur significant costs, including legal expenses, harm customer confidence, hurt our expansion into new markets, cause us to incur remediation costs, or cause us to lose existing customers.

The techniques used by criminal elements to attack computer systems are sophisticated, change frequently and may originate from less regulated or remote areas of the world. For example, there may be an increased risk of cybersecurity attacks by state actors due to the current conflict between either Russia and Ukraine or between Israel and Hamas. Additionally, Russian ransomware gangs have threatened to increase hacking activity against critical infrastructure of any nation or organization that retaliates against Moscow for its invasion of Ukraine. Any such increase in such attacks on our third-party provider or other systems could adversely affect our network systems or other operations. We may not be able to address these techniques proactively or implement adequate preventative measures. There can be no assurance that we will promptly detect any such disruption or security breach, if at all. If our computer systems are compromised, we could be subject to fines, damages, reputational harm, litigation and enforcement actions, and we could lose trade secrets, the occurrence of which could harm our business, in addition to possibly requiring substantial expenditures of resources to remedy. For example, any such event that leads to unauthorized access, use or disclosure of personal information, including personal information regarding our patients or employees, could harm our reputation, require us to comply with federal and/or state breach notification laws and foreign law equivalents, and otherwise subject us to liability under laws and regulations that protect the privacy and security of personal information. In addition, a cybersecurity breach could adversely affect our reputation and could result in other negative consequences, including disruption of our internal operations, increased cyber security protection costs, lost revenues or litigation. Despite precautionary measures to prevent unanticipated problems that could affect our IT systems, sustained or repeated system failures that interrupt our ability to generate and maintain data could adversely affect our ability to operate our business.

Any such security breach may compromise information stored on our networks and may result in significant data losses or theft of our intellectual property or proprietary business information, it may also subject us to significant fines, penalties or liabilities for any noncompliance with certain privacy and security laws. In addition, our liability insurance may not be sufficient in type or amount to cover us against claims related to security breaches, cyber-attacks and other related breaches. A cybersecurity breach could adversely affect our reputation and could result in other negative consequences, including disruption of our internal operations, increased cybersecurity protection costs, lost revenue or litigation.

We expect to continue to incur increased costs as a result of operating as a public company and our management will be required to devote substantial time to compliance initiatives and corporate governance practices.

As a public company, we incur and expect to continue to incur additional significant legal, accounting and other expenses in relation to our status as a public reporting company. Now that we are no longer an emerging growth company, we expect these expenses will further increase. We may need to hire additional accounting, finance and other personnel in connection with our continuing efforts to comply with the requirements of being a public company, and our management and other personnel will need to continue to devote a substantial amount of time towards maintaining compliance with these requirements. In addition, the Sarbanes-Oxley Act of 2002 and rules subsequently implemented by the SEC and the OTC Markets have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly.

While we remain a smaller reporting company and have revenues of less than $100 million per year, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. If and when we are required to achieve compliance with regulatory auditor attestation report requirements within the prescribed period, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. As described herein, we have identified one or more material weaknesses. This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our consolidated financial statements.

The inability to attract and retain qualified key management personnel would impair our ability to implement our business plan.

~~Our team is lean and highly focused, and has been largely stable since 2023.~~ The loss of one or more members of our key employees or advisors could hinder our commercialization efforts and have a material adverse effect on our business, financial condition, results of operations and prospects. Our continued ability to attract and retain highly qualified management, advisors and other specialized personnel is tantamount to our future success. Key members of management include Saundra Pelletier our Chief Executive Officer and Ivy Zhang, our Chief Financial Officer and Secretary, both of whom are employed at-will and for whom we do not have “key man” insurance coverage. We face competition for personnel, notably those with expertise in women’s health care, drug development, governmental regulation and commercialization, from other companies, universities, public and private research institutions, government entities and other organizations (many of whom have substantially greater financial resources than us). As a result of this competition, we might not be able to attract or retain these key employees on conditions that are economically acceptable. Our inability to attract and retain these key employees could prevent us from achieving our objectives and implementing our business strategy, which could have a material adverse effect on our business and prospects.

Our continued ability to attract and retain highly qualified management, advisors and other specialized personnel is tantamount to our future success. Key members of management include Saundra Pelletier our Chief Executive Officer and Ivy Zhang, our Chief Financial Officer and Secretary, both of whom are employed at-will and for whom we do not have “key man” insurance coverage.

We face competition for personnel, notably those with expertise in women’s health care, drug development, governmental regulation and commercialization, from other companies, universities, public and private research institutions, government entities and other organizations (many of whom have substantially greater financial resources than us). As a result of this competition, we might not be able to attract or retain these key employees on conditions that are economically acceptable. Our inability to attract and retain these key employees could prevent us from achieving our objectives and implementing our business strategy, which could have a material adverse effect on our business and prospects.

In connection with the departure of key personnel, we may be subject to certain separation payments, legal actions or other claims.

We are and may continue to be responsible for the payment of all earned and unpaid wages, vacation, bonuses and other forms of compensation due to certain employees. Our failure to pay such may result in claims being filed against us and us being subject to further penalties for any violations. The failure to successfully remediate any such disputes or pay any amounts payable could negatively impact our business, financial conditions, results of operations and prospects.

We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations which can harm our business.

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the FCPA, the U.S. domestic bribery statute contained in 18 U.S. Code (U.S.C.) § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other partners from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. We may engage third parties for clinical trials outside of the U.S., to sell our products abroad once we enter a commercialization phase, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other partners, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

We or the third parties upon whom we depend may be adversely affected by earthquakes, medical epidemics or pandemics, or other natural disasters including wildfires. These natural disasters may be exacerbated by the effects of climate change.

Our principal offices are located in San Diego, California. Any unplanned event, such as flood, fire, explosion, earthquake, wildfires, extreme weather condition, medical epidemics or pandemics, power shortage, telecommunication failure or other natural or man-made accidents or incidents that results in us being unable to fully utilize our facilities, effects the ability of our employees working remotely to communicate with us and our systems, or that affects the operations of our third party manufacturers, distributors, service providers or consultants may have a material and adverse effect on our ability to operate our business and have significant negative consequences on our financial and operating conditions. These natural events may become worse over time due to the ongoing effects of climate change. Any business interruption may have a material and adverse effect on our business, financial condition, results of operations and prospects.

Risks Related to Our Common Stock

69There can be no assurance that we will be able to comply with the continued listing standards of OTCID.

~~There~~The Company’s Common Stock was moved to and began trading on the ~~can~~Over-the-Counter beIntegrated noDisclosure ~~assurance~~(OTCID), ~~that~~the wenew ~~will~~basic bereporting ~~able~~market totier ~~comply~~launched ~~with~~by the OTC Markets Group, at market open on July 1, 2025. OTC Markets has certain continued listing standards ofthat ~~OTCQB~~we must meet to maintain our listing on the OTCID.

~~OTC~~There ~~Markets~~can ~~has~~be ~~certain~~no ~~continued~~assurance ~~listing~~that ~~standards~~there ~~that~~will webe ~~must~~an ~~meet~~active tomarket ~~maintain~~for our ~~listing~~shares of Common Stock either now or in the future. Market liquidity will depend on the ~~OTCQB~~perception ~~exchange~~of our operating business and any steps that our management might take to bring us to the awareness of investors. There can be no assurance given that there will be any awareness generated. Consequently, investors may not be able to liquidate their investment or liquidate it at a price that reflects the value of the business. As a result, holders of our securities may not find purchasers for our securities should they to desire to sell them.

On January 6, 2025, the Company received a written notice (the OTC Markets Notice) from the OTC notifying the Company that, because the closing bid price for the Company’s common stock was below $0.01 per share for 30 consecutive calendar days, the Company is not currently in compliance with the minimum bid price requirement for continued listing on the OTCQB, as set forth in the OTCQB listing standards, section 2.3 (the Minimum Bid Price Requirement).

In accordance with OTCQB Listing Standards, Section 4.1 the Company has a compliance period of 90 calendar days, or until April 6, 2025, to regain compliance with the Minimum Bid Price Requirement. Compliance may be achieved if the Company’s closing bid price is equal to or greater than $0.01 for ten consecutive trading days at any time during the 90-day compliance period, in which case OTC Markets will notify the Company of its compliance and the matter will be closed.

If we are unable to comply with these continued listing standards by April 6, 2025, our common stock will be delisted from the OTCQB, and will begin trading on the OTC Pink Current.

Our Common Stock may become quoted only on the OTC Pink Current Information Marketplace (OTC Pink), which may have an unfavorable impact on our stock price and liquidity.

Our common stock may become listed on the OTC Pink if the Company does not regain compliance with the Minimum Bid Price Requirement. The OTC Pink is a more limited market than the OTCQB or NASDAQ. The quotation of our shares on the OTC Pink may result in a less liquid market available for existing and potential stockholders to trade shares of our common stock, could depress the trading price of our common stock and could have a long-term adverse impact on our ability to raise capital in the future.

There can be no assurance that there will be an active market for our shares of common stock either now or in the future. Market liquidity will depend on the perception of our operating business and any steps that our management might take to bring us to the awareness of investors. There can be no assurance given that there will be any awareness generated. Consequently, investors may not be able to liquidate their investment or liquidate it at a price that reflects the value of the business. As a result, holders of our securities may not find purchasers for our securities should they to desire to sell them. Consequently, our securities should be purchased only by investors having no need for liquidity in their investment and who can hold our securities for an indefinite period of time.

Our stock price is and may continue to be volatile.

Our Common Stock is currently quoted for public trading on the ~~OTCQB~~OTCID under the symbol “EVFM”. The market price for our ~~common~~Common ~~stock~~Stock is volatile and may fluctuate significantly in response to a number of factors, many of which we cannot control, such as potential irregularity in financial results from quarter to quarter, political developments related to women’s reproductive rights and contraception, the content and tone of media coverage and commentary, or changes in securities analysts’ recommendations, any of which could cause the price of our ~~common~~Common ~~stock~~Stock to fluctuate substantially. Each of these factors, among others, could harm your investment in our securities and could result in your being unable to resell any of our securities that you purchase at a price equal to or above the price you paid.

In addition, the stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to companies operating performance. The market price for our common stock may be influenced by many factors, including:72

●In addition, the ~~potential delisting of our common~~ stock ~~from~~market OTCQB, should we not comply with continued listing standards; ● the adverse effects resulting from a potential delisting; ● failure to timely file future required filings; ● the loss of key personnel; ● the results of our efforts to commercialize PHEXXI, SOLOSEC, or any other products, particularly in ~~the~~general ~~event~~and ~~of a rebrand; ●~~ the ~~results~~market of our efforts to acquire or in-license products; ● commencement or termination of any collaboration or licensing arrangement; ● disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for ~~our~~biopharmaceutical ~~technology;~~companies ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures and capital commitments; ● additions or departures of key management personnel; ● variations in ~~our~~particular ~~financial~~have ~~results~~experienced orextreme ~~those of companies~~ volatility that ~~are~~has ~~perceived~~often tobeen beunrelated ~~similar~~ to ~~us;~~companies ●operating ~~new~~performance. ~~products,~~The ~~product~~market ~~candidates~~price ~~or new uses~~ for ~~existing products introduced or announced by~~ our ~~competitors,~~Common ~~and~~Stock ~~the timing of these introductions or announcements; ● results of clinical trials of product candidates of our competitors; ● general economic and market conditions and other factors that~~ may be ~~unrelated~~influenced to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies, wars, terrorism and political unrest, outbreak of major disease, boycotts and other business restrictions; ● regulatory or legal developments in the U.S. and other countries; ● changes in the structure of healthcare payment systems; ● conditions or trends in the biotechnology and biopharmaceutical industries; ● actual or anticipated changes in earnings estimates, development timelines or recommendations by ~~securities~~many analysts; ● announcement or expectation of additional financing efforts and related debt and equity issuances; ● sales of common stock by us or our stockholders in the future, as well as the overall trading volume of our common stock; ● stockholder activism; ● any stockholder derivative actions; and ● other factors ~~described in this “Risk Factors” section.~~, including:

70● failure to timely file future required filings; ● the loss of key personnel; ● the results of our efforts to commercialize PHEXX, SOLOSEC, or any other products, particularly in the event of a rebrand; ● the results of our efforts to acquire or in-license products; ● commencement or termination of any collaboration or licensing arrangement; ● disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technology; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures and capital commitments; ● additions or departures of key management personnel; ● variations in our financial results or those of companies that are perceived to be similar to us; ● new products, product candidates or new uses for existing products introduced or announced by our competitors, and the timing of these introductions or announcements; ● results of clinical trials of product candidates of our competitors; ● general economic and market conditions and other factors that may be unrelated to our operating performance or the operating performance of our competitors, including changes in market valuations of similar companies, wars, terrorism and political unrest, outbreak of major disease, boycotts and other business restrictions; ● regulatory or legal developments in the U.S. and other countries; ● changes in the structure of healthcare payment systems; ● conditions or trends in the biotechnology and biopharmaceutical industries; ● actual or anticipated changes in earnings estimates, development timelines or recommendations by securities analysts; ● announcement or expectation of additional financing efforts and related debt and equity issuances; ● sales of Common Stock by us or our stockholders in the future, as well as the overall trading volume of our Common Stock; ● stockholder activism; ● any stockholder derivative actions; and ● other factors described in this “Risk Factors” section.

~~Upon~~Broad ~~being listed on the OTCQB Marketplace on October 10, 2022 the closing sales price started at $21.25, was $0.0099 as of December 31, 2024, and was $0.008 as of March 14, 2025. These broad~~ market fluctuations may adversely affect the trading price or liquidity of our ~~common~~Common ~~stock~~Stock. In the past, following periods of volatility in companies’ stock prices, securities class-action litigation has often been instituted against such companies. Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources, which could materially and adversely affect our business and financial condition.

There may not be an active, liquid trading market for our equity securities.

Our ~~common~~ ~~stock~~Common Stock trades exclusively on OTCID. Securities quoted on ~~the~~OTC ~~OTCQB~~markets ~~Marketplace.~~generally ~~Trading~~have lower trading volumes, fewer market makers, and greater price volatility than securities listed on ~~the~~national ~~OTCQB~~securities ~~Marketplace~~exchanges. ~~can~~As ~~fluctuate~~a ~~significantly~~result, ~~which~~the market for our Common Stock may be less liquid and more volatile. ~~could~~Limited trading volume and liquidity may make it difficult for investors to ~~execute~~buy ~~transactions~~or insell ~~our~~shares ~~securities~~at ~~and~~desired ~~could~~times ~~cause~~or ~~declines~~prices orand ~~volatility~~may result in wider bid-ask spreads. Reduced liquidity may also increase the ~~prices~~risk of significant price fluctuations in response to relatively small trades or news events. In addition, limited market liquidity and the absence of exchange listing may adversely affect our ~~equity~~ability ~~securities~~to raise additional capital and may result in reduced analyst coverage and institutional investor interest.

Because our Common Stock is subject to the “penny stock” rules, brokers cannot generally solicit the purchase of our Common Stock, which adversely affects its liquidity and market price.

The SEC has adopted regulations which generally define “penny stock” to be an equity security that has a market price of ~~less~~ less than $5.00 per share, subject to specific exemptions. The market price of our Common Stock on the ~~OTCQB~~OTCID ~~Marketplace~~ is presently less ~~than~~ than $5.00 per share and therefore we are considered a “penny stock” company according to SEC rules. ~~Further, we do not expect our stock price to rise above $5.00 in the foreseeable future.~~ The “penny stock” designation requires any broker-dealer selling our securities to disclose certain information concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable to purchase the securities. These rules limit the ability of broker-dealers to solicit purchases of our Common Stock and therefore reduce the liquidity of the public market for our shares. Moreover, as a result of apparent regulatory pressure from the SEC and the Financial Industry Regulatory Authority (FINRA), a growing number of broker-dealers decline to permit investors to purchase and sell or otherwise make it difficult to sell shares of penny stocks. The “penny stock” designation may have a depressive effect upon our Common Stock price.

~~Moreover,~~Because aswe ado ~~result~~not ofhave ~~apparent~~sufficient ~~regulatory~~authorized ~~pressure~~capital ~~from~~on ~~the~~a ~~SEC~~fully ~~and~~diluted ~~the Financial Industry Regulatory Authority (FINRA)~~basis, athe ~~growing~~excess ~~number of~~outstanding ~~broker-dealers~~capital ~~decline~~exposes tous ~~permit investors~~ to ~~purchase~~liability, and ~~sell~~we ormay ~~otherwise~~need ~~make it difficult~~ to ~~sell~~increase ~~shares~~our ofauthorized ~~penny~~capital, ~~stocks.~~effectuate ~~The “penny stock” designation may have~~ a ~~depressive~~reverse ~~effect~~split ~~upon~~or ~~our~~obtain ~~Common~~effective waivers ~~Stock~~from ~~price~~derivative securityholders.

~~Because we~~As doof ~~not~~December ~~have~~31, ~~sufficient~~2025, and February 28, 2026, our authorized capital consists onof a3,000,000,000 ~~fully~~shares ~~diluted~~of ~~basis~~Common Stock and 5,000,000 shares of Preferred Stock. As of December 31, 2025, of the ~~excess~~authorized Common Stock, 126,685,925 shares were issued and outstanding and 1,380,978,452 shares were reserved for issuance under potential conversions ~~capital~~of ~~exposes~~convertible usnotes, topurchase ~~liability~~rights, preferred shares, warrants and all other derivatives. As of February 28, 2026, of the authorized Common Stock, 126,685,925 shares were issued and outstanding and 1,395,303,768 shares were reserved for issuance under potential conversions of convertible notes, purchase rights, preferred shares, warrants and all other derivatives, exclusive of instruments for which the reservation requirement was waived by the respective holders. As such, our fully diluted capital structure is more than the amount of Common Stock we ~~will~~are authorized to issue. Therefore, we may need to either increase our authorized ~~capital~~Common Stock, effectuate a reverse split, or ~~obtain~~effectuate ~~effective~~another manner of reducing the number of instruments convertible to Common Stock. In addition, we may need to obtain requisite approvals or waivers ~~from~~and ~~derivative~~the ~~securityholders~~current waivers may be rescinded relating to such.

AsOur ofCommon ~~December 31, 2024, and March 14, 2025, our authorized capital consists of 3,000,000,000 shares of common stock and 5,000,000 shares of Preferred~~ Stock. Ascould ofbe ~~December~~further ~~31,~~diluted ~~2024,~~as of the ~~authorized~~result ~~common stock, 113,356,354 shares were issued and outstanding and 958,185,542 shares were reserved for issuance under potential conversions~~ of ~~convertible notes, purchase rights, preferred shares, warrants and all other derivatives. As of March 14, 2025, of~~ the ~~authorized common stock, 113,356,354 shares were issued and outstanding and approximately 963,564,509 shares were reserved for~~ issuance ~~under potential conversions~~ of ~~convertible~~additional ~~notes, purchase rights, preferred~~ shares, ~~warrants and all other derivatives, exclusive~~ of ~~instruments~~Common ~~for which the reservation requirement was waived by the respective holders. As such~~Stock, ~~our~~ fully diluted capital structure is more than the amount of common stock we are authorized to issue. Therefore, until we either increase our authorized common stock, effectuate a reverse split, or another manner of reducing the number of instruments convertible ~~to common stock, we are exposed to the risk of liability arising from the excess fully diluted capitalization. In addition to the dilutive effect any exercises of the derivative~~ securities ~~would have~~, ~~in the event we are unable to obtain the requisite approvals or the current waivers~~warrants ~~are rescinded,~~ or ~~we are delayed in those efforts, the Company and your investment in us would be at risk~~options.

71In the past, we have issued Common Stock, convertible securities (such as convertible notes) and warrants in order to raise capital. We have also issued Common Stock as compensation for services and incentive compensation for our employees, directors and certain vendors. We have shares of Common Stock reserved for issuance upon the exercise of certain of these securities and may increase the shares reserved for these purposes in the future. Our issuance of additional Common Stock, convertible securities, options and warrants could affect the rights of our stockholders, could reduce the market price of our Common Stock or could result in adjustments to exercise prices of outstanding warrants (resulting in these securities becoming exercisable for, as the case may be, a greater number of shares of our Common Stock), or could obligate us to issue additional shares of Common Stock to certain of our stockholders.

~~Our~~A ~~common~~significant ~~stock~~portion ~~could~~of beour ~~further~~total ~~diluted~~outstanding asshares of Common Stock may be sold into the ~~result~~public ofmarket at any time, which could cause the ~~issuance~~market price of ~~additional~~our ~~shares~~Common ofStock ~~common~~to ~~stock~~drop significantly, ~~convertible~~even ~~securities,~~if ~~warrants or~~our ~~options~~business is doing well.

InSales ~~the~~of ~~past,~~a wesubstantial ~~have~~number ~~issued~~of ~~common~~shares ~~stock,~~of ~~convertible~~our ~~securities~~Common ~~(such~~Stock asin ~~convertible~~the ~~notes)~~public ~~and~~market ~~warrants~~could inoccur. ~~order~~These tosales, ~~raise~~or ~~capital.~~the ~~We have~~perception ~~also~~in ~~issued~~the ~~common~~market that ~~stock~~holders asof ~~compensation~~a ~~for~~large ~~services~~number ~~and~~of ~~incentive~~shares ~~compensation~~intend ~~for~~to ~~our~~sell ~~employees~~shares, ~~directors~~could ~~and~~reduce ~~certain~~the ~~vendors~~market price of our Common Stock. We ~~have~~Future ~~shares~~issuances of our ~~common~~securities ~~stock~~may ~~reserved~~cause ~~for~~additional ~~issuance~~reduction ~~upon~~in the ~~exercise~~percentage ofinterests ~~certain~~ of ~~these~~our ~~securities~~current ~~and~~stockholders ~~may~~in ~~increase~~ the ~~shares~~voting ~~reserved~~power, liquidation ~~for~~value, ~~these~~our ~~purposes~~book and market value, and in ~~the~~any future earnings. ~~Our~~As ~~issuance~~ of ~~additional~~February ~~common~~28, ~~stock~~2026, ~~convertible~~there ~~securities~~were approximately 3,324 shares of our Common Stock subject to outstanding options ~~and~~which ~~warrants~~have ~~could~~been ~~affect the~~registered ~~rights~~on ofregistration ~~our~~statements ~~stockholders~~on Form S-8. Furthermore, ~~could~~as ~~reduce~~of ~~the~~February 28, ~~market~~2026, ~~price~~there were an aggregate of ~~our~~1,395,303,768 ~~common~~shares ~~stock~~reserved orfor ~~could~~issuance ~~result~~under inpotential conversions ~~adjustments~~of toconvertible ~~exercise~~notes, ~~prices~~purchase ~~of outstanding~~rights, preferred shares, warrants ~~(resulting~~and inall ~~these~~other ~~securities~~derivatives, ~~becoming~~exclusive ~~exercisable~~of instruments for, which asthe reservation requirement was waived by the ~~case~~respective ~~may~~holders. ~~be,~~We ahave ~~greater~~granted ~~number~~(or ofare ~~shares~~required to grant) certain of our ~~common~~security ~~stock)~~holders registration rights pursuant to our agreements with these holders, orincluding ~~could~~agreements ~~obligate~~requiring us to ~~issue~~register ~~additional~~for resale the shares of ~~common~~our ~~stock~~Common toStock ~~certain~~issued upon the conversion or exercise of our ~~stockholders~~convertible notes and related warrants.

A significant portion of our total outstanding shares of common stock may be sold into the public market at any point, which could cause the market price of our common stock to drop significantly, even if our business is doing well.74

~~Sales~~The ofissuance aor ~~substantial~~resale ~~number~~ of ~~shares of~~ our ~~common~~Common ~~stock~~Stock inissued ~~the~~to ~~public~~our ~~market~~security ~~could occur. These sales, or the perception in the market that~~ holders ofupon aconversion ~~large number~~ of ~~shares~~convertible ~~intend~~notes toor ~~sell~~upon ~~shares,~~exercise ~~could reduce the market price~~ of our ~~common stock. Future issuances of~~warrants ~~our~~or ~~securities~~options ~~may~~could cause ~~additional reduction in~~ the ~~percentage~~market ~~interests~~price of our ~~current~~Common ~~stockholders~~Stock into ~~the~~decline. ~~voting~~In ~~power~~addition, ~~liquidation value,~~the ~~our~~increase ~~book and market value, and~~ in ~~any~~the ~~future~~number ~~earnings. As~~ of ~~March~~issued ~~14, 2025, there were approximately 3,372~~ shares of our ~~common~~ ~~stock~~Common ~~subject~~Stock toissuable ~~outstanding~~upon ~~options~~conversion ~~which~~of ~~have~~our ~~been~~convertible ~~registered~~notes onor ~~registration~~upon ~~statements~~exercise ~~on Form S-8. Furthermore, as~~ of ~~March~~our ~~14, 2024,~~warrants ~~there~~may ~~were~~have an ~~aggregate~~incidental ofanti-takeover effect ~~approximately~~in ~~and~~that ~~approximately~~these ~~964~~additional ~~million~~ shares ~~were~~could ~~reserved~~be ~~for~~used ~~issuance~~to ~~under~~dilute ~~potential~~the ~~conversions of~~stock ~~convertible~~ownership ~~notes,~~of ~~purchase~~parties ~~rights,~~seeking ~~preferred~~to ~~shares,~~obtain ~~warrants~~control ~~and~~of ~~all~~us. ~~other~~The ~~derivatives,~~resulting increased ~~exclusive~~number of ~~instruments~~issued ~~for~~shares ~~which~~could ~~the~~discourage ~~reservation requirement was waived by~~ the ~~respective~~possibility ~~holders.~~of, ~~We have granted (~~or ~~are~~render ~~required~~more todifficult, ~~grant)~~ certain ofmergers, ~~our~~tender ~~security~~offers, ~~holders registration~~proxy ~~rights~~contests ~~pursuant~~or toother ~~our~~change ~~agreements with these holders, including agreements requiring us to register for resale the shares~~ of ~~our~~control ~~common stock issued upon the conversion~~ or ~~exercise~~ownership ~~of our convertible notes and related warrants~~transactions.

The issuance or resale of our common stock issued to our security holders upon conversion of convertible notes or upon exercise of our warrants or options could cause the market price of our common stock to decline. In addition, the increase in the number of issued shares of our common stock issuable upon conversion of our convertible notes or upon exercise of our warrants may have an incidental anti-takeover effect in that these additional shares could be used to dilute the stock ownership of parties seeking to obtain control of us. The resulting increased number of issued shares could discourage the possibility of, or render more difficult, certain mergers, tender offers, proxy contests or other change of control or ownership transactions.

We are and may continue to be subject to short-selling strategies.

Short sellers of our stock may be manipulative and may attempt to drive down the market price of shares of our Common Stock. Short selling is the practice of selling securities that the seller does not own but rather has, borrowed from a third party with the intention of buying identical securities back at a later date to return to the lender. The short seller hopes to profit from a decline in the value of the securities between the sale of the borrowed securities and the purchase of the replacement shares, as the short seller expects to pay less in that purchase than it received in the sale. As it is therefore in the short seller’s best interests for the price of the stock to decline, many short sellers (sometime known as “disclosed shorts”) publish, or arrange for the publication of, negative opinions regarding the relevant issuer and its business prospects to create negative market momentum and generate profits for themselves after selling a stock short. Although traditionally these disclosed shorts were limited in their ability to access mainstream business media or to otherwise create negative market rumors, the rise of the Internet and technological advancements regarding document creation, videotaping and publication by weblog (blogging) have allowed many disclosed shorts to publicly attack a company’s credibility, strategy and veracity by means of so-called “research reports” that mimic the type of investment analysis performed by large Wall Street firms and independent research analysts. These short attacks have, in the past, led to selling of shares in the market, on occasion in large scale and broad base. Issuers who have limited trading volumes and are susceptible to higher volatility levels than large-cap stocks, can be particularly vulnerable to such short seller attacks. These short seller publications are not regulated by any governmental, self-regulatory organization or other official authority in the U.S., are not subject to certification requirements imposed by the SEC and, accordingly, the opinions they express may be based on distortions or omissions of actual facts or, in some cases, fabrications of facts. In light of the limited risks involved in publishing such information, and the enormous profit that can be made from running a successful short attack, unless the short sellers become subject to significant penalties, it is more likely than not that disclosed short sellers will continue to issue such reports.

72Significant short selling of a company’s stock creates an incentive for market participants to reduce the value of that company’s Common Stock. Short selling may lead to the placement of sell orders by short sellers without commensurate buy orders because the shares borrowed by short sellers do not have to be returned by any fixed period of time. If a significant market for short selling our Common Stock develops, the market price of our Common Stock could be significantly depressed.

Significant short selling of a company’s stock creates an incentive for market participants to reduce the value of that company’s common stock. Short selling may lead to the placement of sell orders by short sellers without commensurate buy orders because the shares borrowed by short sellers do not have to be returned by any fixed period of time. If a significant market for short selling our common stock develops, the market price of our common stock could be significantly depressed.75

~~Continued~~We ~~failure~~identified ~~to remediate current~~ material weaknesses ~~and~~in ~~establish~~our ~~and maintain effective~~ internal controls inover ~~accordance~~financial ~~with~~reporting ~~Section~~as ~~404~~ of ~~the~~December ~~Sarbanes-Oxley~~31, ~~Act~~2025 ~~could~~and ~~have~~2024 aand these or other material weaknesses ~~adverse~~could ~~effect~~continue onto materially impair our ~~business~~ability ~~and~~to ~~stock~~report ~~price~~accurate financial information in a timely manner.

As aof ~~publicly~~December ~~traded company~~31, we2025 ~~are~~(the ~~required~~period tocovered ~~comply~~by ~~with~~this Annual Report), the ~~SEC~~Company’s ~~rules~~management, ~~implementing~~with ~~Sections~~the ~~302~~participation ~~and 404~~ of ~~the~~its ~~Sarbanes-Oxley~~principal ~~Act,~~executive ~~which~~officer ~~requires~~and ~~management~~principal ~~to certify~~ financial ~~and~~officer, ~~other~~has ~~information~~evaluated inthe ~~our~~effectiveness ~~quarterly~~of ~~and~~its ~~annual~~disclosure ~~reports~~controls and ~~provide~~procedures anas ~~annual management~~defined ~~report~~in onRules ~~the~~13a-15(e) ~~effectiveness~~and of15d-15(e) ~~controls~~under ~~over~~the ~~financial~~Exchange ~~reporting~~Act. AsBased ~~discussed~~on ~~below~~such evaluation, wethe ~~have~~principal ~~identified~~executive ~~internal~~officer ~~control weaknesses,~~ and ~~need~~principal tofinancial officer ~~undertake~~have ~~various~~concluded ~~actions,~~that ~~such~~the asCompany’s ~~implementing~~disclosure ~~new internal~~ controls, ~~new systems~~ and procedures ~~and~~were ~~hiring~~not ~~additional~~effective ~~accounting or~~as ~~internal~~of ~~audit~~December ~~staff~~31, ~~which~~2025 ~~could~~due ~~increase~~to the ~~our~~identified ~~operating~~material ~~expenses.~~weaknesses ~~In addition, we may identify additional deficiencies~~ in ~~our~~ internal control over financial reporting ~~as part of that process~~.

InManagement ~~addition,~~identified ifmaterial weweaknesses in the Company’s internal control over financial reporting primarily related to limited finance and accounting staffing levels that are ~~unable~~not commensurate with the Company’s complexity and its financial accounting and reporting requirements. The Company continued to ~~resolve~~operate ~~internal~~with ~~control~~a ~~deficiencies~~very lean finance and accounting department throughout 2025. Despite performing some remediation activities in a2024 ~~timely~~and ~~manner~~2025, ~~investors~~bringing ~~could~~new ~~lose~~staff ~~confidence~~up into ~~the~~speed ~~accuracy~~with key processes, including some very complicated financial instruments and ~~completeness~~transactions, ofthe ~~our~~Company ~~financial~~continued ~~reports~~to lack the resources to fully monitor and operate internal controls of financial reporting. As such, the ~~market~~Company ~~price~~did not fully implement components of ~~our~~the ~~common~~COSO ~~stock~~framework, ~~could~~including elements of the control environment, risk assessment, control activities, information and communication, and monitoring activities components. Management cannot assure that the measures that have been taken to date, and are continuing to be ~~negatively~~implemented, ~~affected~~will be sufficient to remediate the material weaknesses identified or to avoid potential future material weaknesses.

We ~~identified~~are ~~material~~a ~~weaknesses~~“smaller ~~in our internal control over financial~~ reporting ~~as of December 31~~company”, ~~2024~~ and ~~2023~~the ~~and~~reduced ~~these~~disclosure orrequirements ~~other~~applicable ~~material weaknesses~~to ~~could~~smaller ~~continue~~reporting tocompanies ~~materially~~may make ~~impair~~ our ~~ability~~Common toStock ~~report~~less ~~accurate~~attractive ~~financial~~to ~~information in a timely manner~~investors.

As of December 31, 2024 (the period covered by this Annual Report), the Company’s management, with the participation of its principal executive officer and principal financial officer, has evaluated the effectiveness of its disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on such evaluation, the principal executive officer and principal financial officer have concluded that the Company’s disclosure controls and procedures were not effective as of December 31, 2024 due to the identified material weaknesses in internal control over financial reporting as discussed below.

Management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act). Management, under the supervision and with the participation of the principal executive officer and principal financial officer, conducted an assessment of the effectiveness of internal control over financial reporting as of December 31, 2024, based on the framework and criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO framework). Based on this assessment, management concluded that, as of December 31, 2024, its internal control over financial reporting was not effective due to the existence of material weaknesses described below.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that a reasonable possibility exists that a material misstatement of the annual or interim financial statements would not be prevented or detected on a timely basis.

Management identified material weaknesses in the Company’s internal control over financial reporting primarily related to limited finance and accounting staffing levels that are not commensurate with the Company’s complexity and its financial accounting and reporting requirements. The Company continued to operate with a very lean finance and accounting department throughout 2024. Despite performing some remediation activities in 2023 and 2024, bringing new staff up to speed with key processes, including some very complicated financial instruments and transactions, caused the Company to lack the resources to fully monitor and operate internal controls of financial reporting.

Based on the above, the Company did not fully implement components of the COSO framework, including elements of the control environment, risk assessment, control activities, information and communication, and monitoring activities components.

Management continues to evaluate the material weaknesses discussed above and is implementing its remediation plan. However, assurance as to when the remediation efforts will be complete cannot be provided and the material weaknesses cannot be considered remedied until the applicable controls have operated for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. Management cannot assure readers that the measures that have been taken to date, and are continuing to be implemented, will be sufficient to remediate the material weaknesses identified or to avoid potential future material weaknesses.

We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

We are a “smaller reporting company” under SEC regulations. For so long as we remain a smaller reporting company, we will be permitted to and intend to rely on exemptions from certain disclosure requirements applicable to other public companies that are not smaller reporting companies. These exemptions include:

	●	for so long as we remain a smaller reporting company with annual revenues of less than $100 million per year and a public float value as of our most recently completed second fiscal quarter of less than $700 million, not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting; and
	●	reduced disclosure obligations regarding executive compensation.

We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and the price of our common stock price may be more volatile.76

73We cannot predict whether investors will find our Common Stock less attractive if we rely on these exemptions. If some investors find our Common Stock less attractive as a result, there may be a less active trading market for our Common Stock and the price of our Common Stock price may be more volatile.

We do not anticipate paying any cash dividends on our ~~common~~Common ~~stock~~Stock in the foreseeable future; capital appreciation, if any, will be your sole source of gain as a holder of our ~~common~~Common ~~stock~~Stock.

We have never declared or paid cash dividends on shares of our ~~common~~Common ~~stock~~Stock. As noted above, we are also restricted from paying cash ~~dividends~~ dividends pursuant to our debt arrangements. Except as may be required to redeem our issued and outstanding promissory notes or shares of Series E-1 Shares, Series F-1 Shares, or Series G-1 Shares (each as defined herein; see Item 13), we currently plan to retain all our future earnings, if any, and any cash received through future financings to finance the growth and development of our business. Accordingly, capital appreciation, if any, of our ~~common~~Common ~~stock~~Stock will be the sole source of gain for our common stockholders for the foreseeable future.

Provisions in our amended and restated certificate of incorporation, our bylaws or Delaware law might discourage, delay or prevent a change in control of the Company or changes in our management and, therefore, depress the trading price of our ~~common~~Common ~~stock~~Stock.

Provisions in our amended and restated certificate of incorporation, our bylaws or Delaware law may discourage, delay, or prevent a merger, acquisition or other change in control stockholders may consider favorable, including transactions in which our stockholders might otherwise receive a premium for their shares. These provisions could also limit the price investors might be willing to pay in the future for shares of our ~~common~~Common ~~stock~~Stock, thereby depressing the market price of our ~~common~~Common ~~stock~~Stock. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions might frustrate or prevent any attempts by our stockholders to replace or remove the current management by making it more difficult for our stockholders to replace members of our board of directors. These provisions include the following:

	●	a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;
	●	prohibiting our stockholders from calling a special meeting of stockholders or acting by written consent other than unanimous written consent;
	●	permitting our board of directors to issue additional shares of our preferred stock, with such rights, preferences, and privileges as they may designate, including the right to approve an acquisition or other changes in control;
	●	establishing an advance notice procedure for stockholder proposals to be brought before an annual meeting, including proposed nominations of persons for election to our board of directors;
	●	providing that our directors may be removed only for cause;
	●	providing that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum; and
	●	requiring the approval of our board of directors or the holders of a supermajority of our outstanding shares of capital stock to amend our bylaws and certain provisions of our certificate of incorporation.

Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.

Our amended and restated certificate of incorporation and amended and restated bylaws provides that we will indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law. In addition, as permitted by Section 145 of the DGCL, our amended and restated bylaws and our indemnification agreements that we have entered with our directors and officers provide that:

	●	We will indemnify our directors and officers for serving us in those capacities, or for serving other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.
	●	We may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law.
	●	We are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
	●	We will not be obligated pursuant to our amended and restated bylaws to indemnify a person with respect to proceedings initiated by that person against us or our other indemnities, except with respect to proceedings authorized by our board of directors or brought to enforce a right to indemnification.
	●	The rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons.
	●	We may not retroactively amend our bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.

If securities analysts cease publishing research or reports about our business, or if they publish negative evaluations of our common stock, the price of our common stock could decline.

The trading market for our common stock relies in part on the research and reports industry or financial analysts publish about us or our business. We do not have any control over these analysts. If one or more of the analysts covering our business downgrade their evaluations of our common stock, the price of our common stock could decline. In addition, if one or more of these analysts cease coverage or cease regularly publishing reports on our business, we could lose visibility in the financial markets, which in turn could cause our common stock price or trading volume to decline.

Our business could be negatively affected as a result of the actions of activist stockholders.

It is possible that one or more of our stockholders may publicly voice opposition to our financing strategy, ~~the A&R Merger Agreement,~~ and/or certain aspects of our corporate governance and strategy, or undertake a proxy contest to reconstitute our board. Proxy contests have been waged against many companies in the biopharmaceutical industry over the last several years. If faced with a proxy contest or other type of stockholder activism, we may not be able to respond successfully to the contest or other type of activism which would be disruptive to our business. Even if we are successful, our reputation and/or business could be adversely affected by a proxy contest or other form of stockholder activism because:

	●	responding to proxy contests and other actions by activist stockholders can be costly and time-consuming, disrupting operations and diverting the attention of management and employees;
	●	perceived uncertainties as to our company and future strategic direction may result in the loss of potential financing, acquisitions, collaboration, in-licensing or other business opportunities, and may make it more difficult to attract and retain qualified personnel and business partners; and
	●	if individuals are elected to our board of directors with a specific agenda, it may adversely affect our ability to effectively and timely implement our strategic plan and create additional value for our stockholders.

Any or all of these activities could cause our stock price to decline or experience periods of volatility, and could be particularly problematic as our company seeks to establish itself as a profitable a commercial enterprise in a challenging environment.

We may become a defendant in one or more stockholder derivative or class-action litigations, and any such future lawsuit may adversely affect our business, financial condition, results of operations and cash flows.

We and certain of our officers and directors may become defendants in one or more future stockholder derivative actions or other class-action lawsuits. These lawsuits would divert our management’s attention and resources from our ordinary business operations, and we would likely incur significant expenses associated with their defense (including, without limitation, substantial attorneys’ fees and other fees of professional advisors and potential obligations to indemnify current and former officers and directors who are or may become parties to such actions). If these lawsuits do arise, we may be required to pay material damages, consent to injunctions on future conduct and/or suffer other penalties, remedies or sanctions. In addition, any such future stockholder lawsuits could adversely impact our reputation and/or to launch and commercialize our products, thereby harming our ability to generate revenue. Accordingly, the ultimate resolution of these matters could have a material adverse effect on our business, financial condition, results of operation and cash flow and, consequently, could negatively impact the trading price of our ~~common~~Common ~~stock~~Stock.

Item 1B. Unresolved Staff Comments.

None.

Item 1C. Cybersecurity.

We recognize the importance cybersecurity has to the success of our business. We also recognize the need to continually assess cybersecurity risk and evolve our response in the face of a rapidly and ever-changing environment. Accordingly, we aim to protect our business operations, including customer records and information, against known and evolving cybersecurity threats.

Risk Management and Strategy

We have established policies and processes for assessing, identifying, and managing material risk from cybersecurity threats, and have integrated these processes into our overall risk management systems and processes. We routinely assess material risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through our information systems that may result in adverse effects on the confidentiality, integrity, or availability of our information systems or any information residing therein.

We conduct periodic risk assessments to identify cybersecurity threats, as well as assessments in the event of a material change in our business practices that may affect information systems that are vulnerable to such cybersecurity threats. These risk assessments include identification of reasonably foreseeable internal and external risks, the likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems, and safeguards in place to manage such risks.

75Following these risk assessments, we re-design, implement, and maintain reasonable safeguards to minimize identified risks; reasonably address any identified gaps in existing safeguards; and regularly monitor the effectiveness of our safeguards. Primary responsibility for assessing, monitoring and managing our cybersecurity risks rests with the Information Technology Consultant, who reports to our Director of Human Resources and the Chief Executive Officer, to manage the risk assessment and mitigation process.

Following these risk assessments, we re-design, implement, and maintain reasonable safeguards to minimize identified risks; reasonably address any identified gaps in existing safeguards; and regularly monitor the effectiveness of our safeguards. Primary responsibility for assessing, monitoring and managing our cybersecurity risks rests with the Director, Information Technology who reports to our Head of Human Resources and the Chief Executive Officer, to manage the risk assessment and mitigation process.

As part of our overall risk management system, we monitor and test our safeguards and train our employees on these safeguards, in collaboration with Information Technology and management. Personnel at all levels and departments are made aware of our cybersecurity policies through trainings.

We engage consultants, or other third parties in connection with our risk assessment processes if required. These service providers assist us in designing and implementing our cybersecurity policies and procedures. We require each third-party service provider to certify that it has the ability to implement and maintain appropriate security measures, consistent with all applicable laws, to implement and maintain reasonable security measures in connection with their work with us, and to promptly report any suspected breach of its security measures that may affect our company.

We have not encountered cybersecurity challenges that have materially impaired our operations or financial standing. For additional information regarding risks from cybersecurity threats, please refer to Item 1A, “Risk Factors,” in this annual report on Form 10-K.

Governance

One of the key functions of our board of directors is informed oversight of our risk management process, including risks from cybersecurity threats. Our board of directors is responsible for monitoring and assessing strategic risk exposure, and our executive officers are responsible for the day-to-day management of the material risks we face. Our board of directors administers its cybersecurity risk oversight function directly as a whole, as well as through the audit committee.

Our management team is primarily responsible for assessing and managing our material risks from cybersecurity threats with assistance from third-party service providers as needed.

Our management team oversees our cybersecurity policies and processes, including those described in the “Risk Management and Strategy” above. The cybersecurity risk management program includes tools and activities to prevent, detect, and analyze current and emerging cybersecurity threats, and plans and strategies to address threats and incidents.

Our management team will also provide periodic briefings to the audit committee regarding our Company’s cybersecurity risks and activities, including any recent cybersecurity incidents and related responses, cybersecurity systems testing, activities of third parties, and the like. Our audit committee will then provide updates to the Board on such reports.

Item 2. Properties.

Our corporate headquarters are now virtual and are located at 7770 Regents Rd, Suite 113-618, San Diego, California. We maintain this address for mail service.

We believe that our existing facilities are adequate for our current needs.

Item 3. Legal Proceedings.

From time to time, we may be involved in various actual and threatened legal proceedings, claims, investigations and government inquiries arising in the ordinary course of our business, including intellectual property, securities, stockholder derivative claims, employment, governance, workplace culture, contractual rights, false or misleading advertising, or other legal claims relating to our products and operations. Any proceedings, claims or inquiries involving us, whether successful or not, may be time consuming, result in costly litigation, unfavorable outcomes, increased costs of business, may require us to change our business practices or products, require significant amount of management’s time, may harm our reputation or otherwise harm our business and future financial results.

Item 4. Mine Safety Disclosures.

Not applicable.

7680

PART II

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Market Information

Our ~~common~~ ~~stock~~Common ~~began~~Stock current ~~trading~~trades on the ~~Nasdaq~~OTCID ~~Global~~tier Market on November 20, 2014 under the ticker symbol “NEOT” and corporate name Neothetics, Inc. (Neothetics). Prior to November 20, 2014, there was no public market for our common stock. On January 17, 2018, we completed a merger (the Merger) with privately-held Evofem Biosciences Operations, Inc. (Private Evofem) where Private Evofem survived as our wholly owned subsidiary. In connection with the Merger, we changed our name from “Neothetics, Inc.” to “Evofem Biosciences, Inc.” and changed the ticker symbol for our common stock to “EVFM.” Shares of ~~our common stock began trading on~~ the ~~Nasdaq~~OTC ~~Capital~~Markets ~~Market (Nasdaq)~~ under the ~~ticker~~ symbol “EVFM ~~on January 18, 2018~~”.

On August 11, 2022, our stock was suspended from trading on the Nasdaq due to noncompliance with its minimum bid price requirement. On October 26, 2022, our common stock was formally delisted from Nasdaq. The delisting of our shares from Nasdaq made our common stock less liquid and makes it more difficult for us to raise funds when and as needed to fund operations. Our common stock began trading on the OTCQB® Venture Market (the OTCQB) of the OTC Markets Group, Inc., (the OTC Markets) a centralized electronic quotation service for over-the-counter securities, effective October 3, 2022 under the symbol “EVFM.”

On January 6, 2025, the Company received a written notice (the OTC Markets Notice) from the OTC Markets notifying the Company that, because the closing bid price for the Company’s common stock was below $0.01 per share for 30 consecutive calendar days, the Company is not currently in compliance with the minimum bid price requirement for continued listing on the OTCQB, as set forth in the OTCQB listing standards, section 2.3 (the Minimum Bid Price Requirement).

The OTC Markets Notice has no immediate effect on the listing of the Company’s common stock on OTCQB, and, therefore, the Company’s listing remains fully effective. In accordance with OTCQB Listing Standards, Section 4.1 the Company has a compliance period of 90 calendar days, or until April 6, 2025, to regain compliance with the Minimum Bid Price Requirement. Compliance may be achieved if the Company’s closing bid price is equal to or greater than $0.01 for ten consecutive trading days at any time during the 90-day compliance period, in which case OTC Markets will notify the Company of its compliance and the matter will be closed.

If the Company does not regain compliance with the Minimum Bid Price Requirement by April 6, 2025, OTC Markets will provide written notification to the Company that its common stock will be removed from OTCQB and will begin trading on the OTC’s Pink Current tier.

The Company intends to continue actively monitoring the closing bid price for the Company’s common stock between now and April 6, 2025, and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement, however there can be no assurance that the Company can regain compliance.

Holders of Common Stock

As of ~~March~~February 1428, ~~2025~~2026, there were ~~113~~126,~~356~~685,~~354~~925 shares of our ~~common~~Common ~~stock~~Stock outstanding and 14 holders of record of our ~~common~~Common ~~stock~~Stock. This number was derived from our stockholder records and does not include beneficial owners of our ~~common~~Common ~~stock~~Stock whose shares are held in the name of various dealers, clearing agencies, banks, brokers and other fiduciaries.

Recent Sales of Unregistered Securities

WeDuring ~~had~~the fiscal year ended December 31, 2025, there were no unregistered sales of ~~unregistered~~our ~~equity~~ securities ~~during~~that ~~the~~were ~~three~~not reported ~~months~~in ~~ended~~a ~~December~~Current ~~31,~~Report ~~2024~~on Form 8-K or our Quarterly Reports on Form 10-Q.

Dividend Policy

We have never declared or paid any cash dividend on our ~~common~~Common ~~stock~~Stock. We currently anticipate that we will retain future earnings, if any, for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any future determination related to our dividend policy will be made at the discretion of our board of directors.

Our ~~series~~Series E-1 Shares ~~does~~ earn shares dividends payable in either shares of ~~common~~Common ~~stock~~Stock or as additional shares of Series E-1 Shares, at a rate of 10% per annum. On the 18-month anniversary of the initial issuance date for the Series E-1 ~~convertible preferred stock~~Shares, the dividend rate increased ~~shall further increase~~ by 30% on the first calendar day of each calendar quarter thereafter until no shares of Series E-1 Shares remain outstanding. Our Series G-1 Shares earn shares dividends payable in either shares of Common Stock or as additional shares of Series G-1 Shares, at a rate of 8% per annum.

Equity Compensation Plan Information

Information about our equity compensation plans is incorporated herein by reference to Part III, Item 12 of this Annual Report.

Issuer Repurchases of Equity Securities

For the quarter ended December 31, ~~2024~~2025, we did not repurchase any equity securities.

Item 6. [RESERVED]

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes appearing elsewhere in this Annual Report. Some of the information contained in this discussion and analysis is set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Annual Report, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.

Overview

We are a San Diego-based commercial-stage biopharmaceutical company with a strong focus on innovation in women’s health. ~~Our~~We ~~first~~currently ~~commercial~~commercialize ~~product,~~two ~~PHEXXI, was~~ FDA-approved byproducts: ~~the~~PHEXX® ~~FDA~~(lactic ~~on May 22~~acid, ~~2020.~~citric ~~PHEXXI~~acid ~~is the first~~ and ~~only~~potassium ~~non-hormonal~~bitartrate) ~~prescription~~vaginal ~~contraceptive~~ gel. ~~It is locally acting, with no systemic activity,~~ and ~~used on-demand by women only when they have sex. Because PHEXXI is a non-hormonal~~SOLOSEC® ~~contraceptive,~~(secnidazole) it2 isg ~~not~~oral ~~associated with side effects of exogenous hormone use like depression, weight gain, headaches, loss of libido, mood swings and irritability~~granules. Taking hormones may not be right for some women, especially those with certain medical conditions, including clotting disorders hormone-sensitive cancer, diabetes or a BMI over 30, or those who are breast feeding or smoke. More than 23.3 million women in the U.S. will not use a hormonal contraceptive.

~~Evofem~~Approved ~~has~~by ~~delivered~~the ~~PHEXXI~~FDA ~~net~~on ~~sales~~May ~~growth~~22, in2020, ~~each~~PHEXX ~~consecutive~~is ~~year~~the ~~since~~first itand ~~was~~only ~~launched~~non-hormonal inprescription ~~Sept~~contraceptive ~~2020~~gel. ~~Key~~It ~~growth~~is ~~drivers~~locally ~~for~~acting, ~~2025~~with ~~include~~no systemic ~~expanded~~activity, ~~use~~and ofused ~~PHEXXI~~on-demand inby women ~~who~~only ~~take~~when ~~oral~~they ~~birth~~have ~~control~~sex. ~~pills~~Because inPHEXX ~~conjunction~~is ~~with~~a ~~GLP~~non-1hormonal ~~prescription~~contraceptive, ~~medications~~it ~~like~~is ~~Ozempic,~~not ~~Mounjaro~~associated with ~~and~~side ~~Zepbound~~effects ~~for~~of exogenous hormone use. In some women, these side effects may include depression, weight gain, headaches, loss of libido, mood swings and irritability. ~~These~~Taking ~~drugs~~hormones may ~~make~~not ~~oral~~be ~~birth~~right ~~control~~for ~~pills~~some ~~less~~women, ~~effective~~especially atthose with certain ~~points~~medical inconditions, ~~the~~including clotting ~~dosing~~disorders ~~schedule. Per~~hormone-sensitive ~~the~~cancer, ~~USPI~~diabetes, ~~prescribers~~or ~~are~~a ~~instructed~~BMI toover ~~“advise~~30, ~~patients~~or ~~using~~those ~~oral~~who ~~contraceptives~~are tobreast ~~switch~~feeding toor awho ~~non-oral~~smoke. ~~contraceptive~~Per ~~method~~the National orCenter ~~add~~for aHealth ~~barrier~~Statistics ~~method”~~(NCHS), tomore ~~prevent~~than ~~unintended~~15.923 ~~pregnancy~~million ~~during~~women ~~these~~in ~~times~~the U.S. will not use a hormonal contraceptive.

~~Outside~~Evofem ~~the~~has ~~U.S.,~~delivered ~~PHEXXI~~PHEXX ~~was~~net ~~approved~~sales growth in ~~Nigeria~~each onconsecutive ~~October~~year 6,since ~~2022,~~it aswas ~~Femidence™~~launched byin ~~the~~September ~~National~~2020. ~~Agency~~Key growth drivers for ~~Food~~2025 included ~~and~~social ~~Drug~~media ~~Administration and~~campaigns, ~~Control.~~participation ~~To-date~~in strategic medical conferences, ~~PHEXXI~~and ~~has~~initiatives ~~been~~to ~~submitted~~expand ~~for~~use ~~approval~~of PHEXX in ~~Mexico~~women who take oral birth control pills in conjunction with GLP-1 prescription medications like Ozempic, ~~Ethiopia~~Mounjaro and ~~Ghana~~Zepbound for weight loss. WeThese ~~intend~~drugs tomay ~~commercialize~~make ~~PHEXXI~~oral birth control pills less effective at certain points in ~~all~~the dosing schedule. Per the products’ ~~other~~USPIs, ~~global~~prescribers ~~markets~~are ~~through~~instructed ~~partnerships~~to “advise patients using oral contraceptives to switch to a non-oral contraceptive method or add ~~licensing~~a ~~agreements~~barrier method” to prevent unintended pregnancy during these times.

On July 17, 2024, we licensed exclusive commercial rights to PHEXXI in the Middle East to Pharma 1 Drug Store, an emerging Emirati health care company. The licensed territory includes the United Arab Emirates (UAE), Kuwait, Saudi Arabia, Qatar and certain other countries in the region. Pharma 1 is responsible for obtaining and maintaining any regulatory approvals required to market and sell PHEXXI, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. Evofem will supply PHEXXI to Pharma 1 at cost-plus. Pharma 1 is expected to file for regulatory approval of PHEXXI in the UAE in the first half of 2025.

In July 2024 we acquired global rights to SOLOSEC. This FDA-approved single-dose oral antimicrobial agent provides a complete course of therapy for the treatment of two common sexual health infections – bacterial vaginosis (BV) and trichomoniasis. The SOLOSEC acquisition aligns with and advances our mission to improve access to innovative and differentiated options that impact women’s daily lives. We expect commercialization of SOLOSEC will benefit from our commercial infrastructure and strong physician relationships.

We intend ~~halted~~to ~~clinical~~expand ~~development of~~the ~~our~~global ~~investigational~~reach ~~product~~of ~~candidates~~our inproducts ~~October~~and ~~2022~~further toincrease ~~focus~~our ~~resources~~global onpotential ~~growing~~through ~~domestic~~ex-U.S. ~~sales~~partnerships ofor ~~PHEXXI~~licensing agreements for ~~the~~PHEXX ~~prevention~~and ~~of pregnancy~~SOLOSEC.

~~Recent~~We ~~Developments~~licensed exclusive commercial rights for PHEXX in MENA to Pharma 1 Drug Store, an emerging Emirati health care company. Under the License and Supply Agreement dated on July 17, 2024, as amended on May 3, 2025, the licensed territory includes the UAE, Kuwait, Saudi Arabia, Qatar, Oman, and Jordan, with potential to expand into 15 other countries in the region. Pharma 1 is responsible for obtaining and maintaining any regulatory approvals required to market and sell PHEXX, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. Evofem will supply product to Pharma 1 at cost-plus. Pharma 1 filed for regulatory approval of PHEXX in the UAE in June 2025.

~~Notice~~23Daniels ofK ~~Default~~ and ~~Termination~~Abma J. Current Contraceptive Status Among Females Ages 15–49: United States, 2022–2023. NCHS Data Brief No. 539. August 2025. Data table for Figure 1, sourced from National Survey of ~~Forbearance~~Family ~~Agreement~~Growth (NSFG) 2022–2023. https://www.cdc.gov/nchs/data/databriefs/db539.pdf

On September 27, 2024, Future Pak, LLC, as agent for the Purchasers (in such capacity, the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the Notice of Default) relating to the Securities Purchase and Security Agreement dated April 23, 2020, as amended (SPA), by and among the Company, Designated Agent, as certain guarantors and the purchasers (each a “Purchaser” and collectively Purchasers). The Notice of Default claims that by entering into arrangements to repay certain existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the SPA.

On October 27, 2024, the Designated Agent sent an amended and supplemented notice to the Notice of Default which adds additional claims of default based on the Company’s current repayment agreements of existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the Securities Purchase and Security Agreement dated April 23, 2020, as amended. Furthermore, the Amended Notice stated that, because the events of default described in the Amended Notice of Default are not the certain prior events of default listed in the Forbearance Agreement (the Specified Defaults), the Designated Agent and the holders of the senior secured promissory notes described in the SPA thereby provided notice to the Company that the Forbearance Agreement is terminated as of October 27, 2024.

The Company strongly disagrees with the Designated Agent’s claim that any Event of Default has occurred. The Company intends to vigorously contest any attempt by the Designated Agent and the Purchasers to exercise their default rights and remedies under the SPA.

Aditxt Merger

On December 11, 2023, the Company entered into an Agreement and Plan of Merger, as amended, (the Merger Agreement) with Aditxt, Inc., a Delaware corporation (Aditxt), Adifem, Inc., a Delaware corporation and wholly-owned Subsidiary of Aditxt (Merger Sub), pursuant to which, and on the terms and subject to the conditions thereof, Merger Sub will merge with and into the Company, with the Company surviving as a wholly owned subsidiary of Aditxt (the Merger).

	●	As consideration for the Merger, Parent will (i) pay $1.8 million less an amount equal to the product of (x) the number of Dissenting Shares represented by Company Common Stock and (y) the Common Exchange Ratio (as defined in the A&R Merger Agreement) (the Common Consideration)
	●	Each share of the Company’s Series E-1 Preferred Stock, par value $0.0001 (the Series E-1), issued and outstanding as of the Effective Time (as defined in the A&R Merger Agreement) shall automatically be converted into the right to receive from Aditxt one share Parent Preferred Stock (the Preferred Merger Consideration)

At the Effective Time of the Merger:

On March 22, 2025, the Company, Parent and Merger Sub entered into the fifth amendment to the A&R Merger Agreement (the Fifth Amendment), to (i) change the required consummation date to September 30, 2025; (ii) add a Parent Investment of $1.5 million to be completed by April 7, 2025; and (iii) add a special meeting consummation date being on or prior to September 26, 2025.

On September 23, 2024, the Company filed a preliminary proxy statement with the SEC. Subject to certain exceptions, the Company’s Board of Directors will recommend that the A&R Merger Agreement be adopted by the Company’s stockholders at a special meeting of the Company’s stockholders (the Company Board Recommendation). However, subject to the satisfaction of certain terms and conditions, the Company and the Board are permitted to take certain actions which may, as more fully described in the A&R Merger Agreement, include changing the Company Board Recommendation and entering into a definitive agreement with respect to a Company Change of Recommendation (as defined in the A&R Merger Agreement) if the Company Board or any committee thereof determines in good faith, after consultation with the Company’s outside legal and financial advisors and after taking into account relevant legal, financial, regulatory, estimated timing of consummation and other aspects of such proposal that the Company Board considers in good faith and the Person or group making such proposal, would, if consummated in accordance with its terms, result in a transaction more favorable to the Company Shareholders than the Merger. If the Company has a Company Change of Recommendation, the Company must provide Aditxt with a ten (10) calendar day written notice thereof and negotiate with Aditxt in good faith to provide a competing offer.

On December 23, 2024, Evofem announced its decision to cancel its special meeting and the withdrawal from consideration by the stockholders of the Company the proposals set forth in its preliminary proxy statement.

PHEXXI as a Contraceptive; Commercial Strategies

In September 2020, we commercially launched PHEXXI in the United States. Our sales force promotes PHEXXI directly to obstetrician/gynecologists and their affiliated health professionals, who collectively write the majority of prescriptions for contraceptive products. Our sales force comprises approximately 16 regional sales representatives, two business directors and an SVP of Commercial Operations, supported by a self-guided virtual health care provider (HCP) learning platform. Additionally, we offer women direct access to PHEXXI via a telehealth platform. Using this platform, women can directly meet with an HCP to determine their eligibility for a PHEXXI prescription and, if eligible, have the prescription written by the HCP, then filled and mailed directly to them by a third-party pharmacy.

Our comprehensive commercial strategy for PHEXXI includes marketing and product awareness campaigns targeting women of reproductive potential in the U.S., including the approximately 23.3 million women who are not using hormonal contraception and the approximately 20.0 million women who are using a prescription contraceptive, some of whom, particularly oral birth control pill users, may be ready to move to an FDA-approved, non-invasive, non-systemic hormone-free contraceptive, as well as certain identified target HCP segments. In addition to marketing and product awareness campaigns, our commercial strategy includes payer outreach and execution of our consumer digital and media strategy.

Key growth drivers for 2025 include expanded use of PHEXXI in women who take oral birth control pills in conjunction with GLP-1 prescription medications like Ozempic, Mounjaro and Zepbound for weight loss. These drugs may make oral birth control pills less effective at certain points in the dosing schedule. Per the USPI, prescribers are instructed to “advise patients using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method” to prevent unintended pregnancy during these times.

We continue working to increase the number of lives covered and to gain a preferred formulary position for PHEXXI.

Payer wins in 2024 include the removal of the Prior Authorization requirement for PHEXXI by the Washington State Health Care Authority effective January 1, 2024, and, as a result of the Company’s successful renegotiation, a 7.4% reduction in the rebate paid by the Company to Medi-Cal on PHEXXI prescriptions dispensed to Medi-Cal members. The approval rate was over 80% for all of 2024.

Since the second quarter of 2022, we have been under contract with one of the largest pharmacy benefit managers (PBMs) in the nation, which added PHEXXI to its formulary with no restrictions for most women covered by the plan. The agreement was retroactive and took effect January 1, 2022 and is representative of approximately 46 million lives.

An additional 13.7 million lives are covered under our December 2020 contract award from the U.S. Department of Veterans Affairs.

We also participate in government programs, including the 340B and the Medicaid Drug Rebate Program. As a result of our participation in the Medicaid National Drug Rebate Program, the U.S. Medicaid population gained access to PHEXXI on January 1, 2021. As of May 2024, Medicaid provides health coverage to approximately 73.8 million members; nearly two-thirds of adult women enrolled in Medicaid are in their reproductive years (19-44). Additionally, we recently began participating in a 340B Group Purchasing Organization (GPO) that serves safety-net clinics throughout the U.S. This GPO has over 6,500 members, which expands our reach among safety-net providers.

Approximately 83% of commercial and Medicaid PHEXXI prescriptions are being approved by payers.

PHEXXI is classified in the databases and pricing compendia of Medi-Span and First Databank, two major drug information databases that payers can consult for pricing and product information, as the first and only “Vaginal pH Modulator.”

Effective as of January 1, 2023, most insurers and PBMs must provide coverage, with no out-of-pocket costs (e.g. $0 copay) to the subscriber or dependent, for FDA-approved contraceptive products, like PHEXXI, prescribed by healthcare providers.

As a result, to comply with these Guidelines, payers are increasingly covering PHEXXI by:

In 2022, Evofem developed and introduced a new contraceptive educational chart for patients and HCPs that details high-level information about birth control methods currently available to women in the U.S., including the vaginal pH modulator. This new contraceptive educational tool has been extremely well received and has had a positive impact with HCPs and patients alike.

The Company also licensed commercial rights to SOLOSEC in MENA to Pharma 1 on May 19, 2025. Under this agreement, the licensed territory includes the UAE, Kuwait, Saudi Arabia, Qatar, Oman, and Jordan, with potential to expand into 15 other countries in the region. Pharma 1 is responsible for obtaining and maintaining any regulatory approvals required to market and sell SOLOSEC, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. Evofem will supply product to Pharma 1 at a specified cost per unit. Pharma 1 filed for regulatory approval of SOLOSEC in the UAE in September 2025.

Under the 2020 Global Health Agreement with Adjuvant Capital, the Company has also submitted marketing applications for PHEXX under the trademark Femidence™ in Nigeria, Ethiopia, and Ghana. Femidence was approved in Nigeria on October 6, 2022, by the National Agency for Food and Drug Administration and Control. In October 2021, the Company submitted Femidence for approval in Mexico. The Company has not allocated resources to follow up with these regulatory bodies or advance commercialization in Nigeria due to fiscal constraints since October 2022.

We halted clinical development of our investigational product candidates in October 2022 to focus resources on growing domestic sales of PHEXX for the prevention of pregnancy.

In the second quarter of 2025, enrollment commenced in an investigator-led randomized, open-label, parallel Phase 4 clinical trial to evaluate the efficacy and cost-effectiveness of secnidazole (SOLOSEC® 2 g, one dose administered one time) versus metronidazole (Flagyl® 500 mg, administered twice daily for seven days) for the treatment of trichomoniasis in men and women. Study investigators hypothesize that, in the current clinical trial, the rate of repeat infections with T. vaginalis will be 1.75 lower in the SOLOSEC arm versus the multi-dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. This trial is funded directly by the National Institutes of Health (NIH).

In an investigator-led clinical study of SOLOSEC in 24 women with recurrent bacterial vaginosis (BV), once-weekly dosing with demonstrated efficacy matching or potentially surpassing outcomes of current CDC-recommended suppressive treatments. These promising results underscore SOLOSEC’s potential to redefine the standard of care for recurrent BV – offering a simpler treatment option for long-term symptom control. The study was presented at the 2025 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting.

PHEXX as a Contraceptive; Commercial Strategies

In September 2020, we commercially launched PHEXX in the United States. Our sales force promotes PHEXX directly to obstetrician/gynecologists (OB/GYNs) and their affiliated health professionals, who collectively write the majority of prescriptions for contraceptive products. Our sales force comprises regional sales representatives, sales managers, business directors, and a Senior Vice President of Commercial Operations. Additionally, we offer women direct access to PHEXX via a telehealth platform. Using this platform, women can directly meet with an HCP to determine their eligibility for a PHEXX prescription and, if eligible, have the prescription written by the HCP, then filled and mailed directly to them by a third-party pharmacy.

Our comprehensive commercial strategy for PHEXX includes marketing and product awareness campaigns targeting HCPs and women of reproductive potential in the U.S., including the approximately 15.9²⁴ million women who are not using hormonal contraception and the approximately 10.3 million women who are using a short-acting hormonal contraceptive, some of whom, particularly oral birth control pill users, may be ready to move to an FDA-approved, non-invasive, non-systemic hormone-free contraceptive, as well as certain identified target HCP segments. In addition to marketing and product awareness campaigns, our commercial strategy includes payer outreach and execution of our consumer digital and media strategy.

Key growth drivers for 2025 included social media campaigns, participation in strategic medical conferences, and initiatives to expand use of PHEXX in women who take oral birth control pills in conjunction with GLP-1 prescription medications like Ozempic, Mounjaro and Zepbound for weight loss. These drugs may make oral birth control pills less effective at certain points in the dosing schedule. Per the USPI, prescribers are instructed to “advise patients using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method” to prevent unintended pregnancy during these times.

²⁴Daniels K and Abma J. Current Contraceptive Status Among Females Ages 15–49: United States, 2022–2023. NCHS Data Brief No. 539. August 2025. Data table for Figure 1, sourced from National Survey of Family Growth (NSFG) 2022–2023. https://www.cdc.gov/nchs/data/databriefs/db539.pdf

We continue working to increase the number of lives covered and to gain a preferred formulary position for PHEXX.

Previous contracting efforts have validated our access strategy. With PHEXX approval rates consistently above 80%, the Company has shifted from broad payer contracting to strengthening pharmacy partnerships. In 2025, we expanded our network in two of our highest-volume markets — California and the Northeast — by adding new partners in California and a regional distributor with more than 90 pharmacies in the Northeast. These targeted partnerships represent low-hanging fruit in high-demand areas, improving patient access while supporting more cost-effective and scalable pull-through.

Approximately 13.7 million lives are covered under our December 2020 contract award from the U.S. Department of Veterans Affairs.

We also participate in government programs, including the 340B and the Medicaid Drug Rebate Program. As a result of our participation in the Medicaid National Drug Rebate Program, the U.S. Medicaid population gained access to PHEXX on January 1, 2021. As of May 2025, Medicaid provides health coverage to approximately 70.5 million members; nearly two-thirds of adult women enrolled in Medicaid are in their reproductive years (19-44). Additionally, we began participating in a 340B Group Purchasing Organization (GPO) that serves safety-net clinics throughout the U.S. in June 2024. This GPO has over 6,500 members, which expands our reach among safety-net providers.

As of December 2025, approximately 83% of commercial and Medicaid PHEXX prescriptions were being approved by payers.

PHEXX is classified in the databases and pricing compendia of Medi-Span and First Databank, two major drug information databases that payers can consult for pricing and product information, as the first and only “Vaginal pH Modulator.”

Effective as of January 1, 2023, most insurers and PBMs must provide coverage, with no out-of-pocket costs (e.g., $0 copay) to the subscriber or dependent, for FDA-approved contraceptive products, like PHEXX, prescribed by healthcare providers.

To comply with these federal guidelines, payers are increasingly covering PHEXX by:

	–	Adding PHEXX to formulary (commercial insurers) or preferred drug list (Medicaid)
	–	Removing the requirement for a Prior Authorization letter from the HCP (commercial insurers)
	–	Moving PHEXX to $0 copay (commercial insurers)

SOLOSEC

	1)	Bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and
	2)	Trichomonas vaginalis, a common sexually transmitted infection (STI), in people 12 years of age and older.

~~SOLOSEC has the same call point as PHEXXI, enabling us to leverage our commercial infrastructure and strong physician relationships. We re-launched the brand in November 2024.~~84

SOLOSEC has the same call point as PHEXX, enabling us to leverage our commercial infrastructure and strong physician relationships. We re-launched the brand in November 2024.

Bacterial Vaginosis

If left untreated, BV can have serious health consequences. Untreated or improperly treated BV is associated with increased risk of infection with STIs like HPV, herpes, ~~trichomoniasis~~Trich, chlamydia, gonorrhea, and HIV, as well as transmission of STIs to a partner. Additional risks include developing pelvic inflammatory disease (PID), which can threaten a ~~women~~woman’s fertility, and complications with gynecological surgery.

~~Research~~In ~~has~~May ~~shown~~2025, ~~that~~an asinvestigator-led ~~many~~clinical astrial ~~50%~~entitled ‘Once Weekly Secnidazole Granules for the Treatment of ~~patients~~Recurrent ~~with~~Bacterial Vaginosis’ BVwas dopresented ~~not~~at ~~adhere~~the to2025 aACOG ~~full~~Annual ~~course~~Clinical ofand ~~metronidazole~~Scientific ~~treatment~~Meeting; ~~(500mg~~the ~~BID~~abstract xwas ~~7d)~~subsequently 14published ~~doses.~~in Obstetrics ~~58%~~& Gynecology. In this focused clinical study of 24 women ~~who~~with dorecurrent ~~not~~BV, ~~complete~~once-weekly ~~therapy~~dosing ~~will~~with ~~have~~SOLOSEC ademonstrated ~~recurrence~~efficacy matching ~~within~~or ~~one~~potentially ~~year.~~surpassing ~~Noncompliance~~outcomes toof acurrent ~~multiple~~CDC-~~day~~recommended ~~metronidazole~~suppressive ~~regimen is~~treatments. aThese ~~contributing~~promising ~~factor~~results underscore SOLOSEC’s potential to ~~persistent~~redefine the standard of care for recurrent BV by offering a simpler treatment option for long-term symptom control.

In clinical trials, SOLOSEC demonstrated clinically and statistically significant efficacy in the treatment of BV with just one dose; 68% of patients treated with SOLOSEC did not require any additional treatment for BV. Guidelines for the American College of Obstetricians and Gynecologists (ACOG) in 2020 and the U.S. Centers for Disease Control (CDC) in 2021 each include single dose SOLOSEC for the treatment of BV.

Trichomoniasis

In clinical trials, a single dose of SOLOSEC demonstrated a cure rate of 92.2% for Trich in women, while reported cure rates in males range from 91.7%-100%.

SOLOSEC’s one-and-done dosing and the resulting high level of compliance is believed to be a significant differentiator. Non-compliance to a multi-day metronidazole regimen is a contributing factor to persistent Trich or BV; ~~and~~both ACOG and the CDC no longer recommend single dose metronidazole to treat Trich in women.

83A Phase 4 investigator-led randomized, open-label, parallel arm clinical trial is underway to evaluate the efficacy and cost-effectiveness of secnidazole (SOLOSEC 2 g, one dose administered one time) versus metronidazole (Flagyl® 500 mg, administered twice daily for seven days) for the treatment of Trich in men and women. Study investigators hypothesize that, in the current clinical trial, the rate of repeat infections with T. vaginalis will be 1.75 lower in the SOLOSEC arm versus the multi- dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. This trial is directly funded by the National Institutes of Health (NIH).

Financial Operations Overview

Net Product Sales

Our revenue recognition is based on unit shipments from our third-party logistics warehouse to our customers, which consist of wholesale distributors, retail pharmacies, telehealth companies, and a mail-order specialty ~~pharmacy~~pharmacies. We have recognized net product sales in the U.S. since the commercial launch of ~~PHEXXI~~PHEXX in September 2020; SOLOSEC net product sales were added to our revenue beginning in July 2024. Gross revenues, as discussed in Note 3 - Revenue, were adjusted for variable consideration, including our patient support programs.

For the year ended December 31, 2024, there was an approximate 7% increase in net product sales as a result of an increase to the PHEXXI wholesale acquisition cost (WAC) in January 2024, more favorable PHEXXI payer coverage despite a single digit decrease in unit shipments to customers compared to the year ended December 31, 2023, and the addition of SOLOSEC net revenue in the current year. Gross revenues, as discussed in Note 3 - Revenue, were adjusted for variable consideration, including our patient support programs.

Cost of Goods Sold

Inventory costs include all purchased materials, direct labor, and manufacturing overhead. In addition, wein ~~are~~prior ~~obligated~~years towe ~~pay~~accrued quarterly royalty ~~payments~~amounts that would have been due pursuant to our license agreement with Rush University, inhad their application for patent term extension (PTE) been granted. The royalty expenses accrued were amounts equal to a single-digit percentage of ~~the~~our gross ~~amounts we receive on a~~ quarterly ~~basis~~receipts, less certain deductions incurred in the quarter based on a sliding scale. WeDue ~~are~~to ~~also~~the ~~obligated~~patent toexpiration, ~~pay~~no royalty costs were recorded for the year aended ~~minimum~~December ~~annual~~31, ~~royalty~~2025. ~~amount~~For ofthe year ended December 31, 2024, $0.18 million towas ~~the~~included ~~extent~~in ~~these~~the ~~earned~~costs ~~royalties~~of dogoods sold ~~not~~in ~~equal~~the orconsolidated ~~exceed~~statement $0of operations.1 ~~million~~As described in aNote ~~given~~7 ~~year.~~– Commitments and Contingencies, no further ~~Such~~royalties ~~royalty~~are ~~costs~~payable ~~were~~to ~~$0.8~~Rush ~~million~~University ~~and~~now $0that the patent has expired.7 ~~million~~The ~~for~~amounts ~~the~~that ~~years~~had ~~ended~~been previously accrued but were unpaid as of December 31, 2024 ~~and~~were ~~2023,~~reversed ~~respectively~~in the current period, ~~and~~which ~~were~~had ~~included in~~a ~~the~~favorable ~~costs~~impact ofon ~~goods~~the ~~sold~~total inoperating expenses during the year ~~consolidated~~ended ~~financial~~December ~~statements~~31, 2025 of approximately $1.9 Nomillion ~~further~~that ~~royalties~~is ~~will~~not expected to be ~~due~~repeated in future periods. Due to ~~Rush~~the ~~University~~materiality and ~~after~~the one-time nature of the reversal, the amount was included in the gain on change in accounting estimates on contingent royalty liability in the ~~patent~~consolidated ~~expiration~~statement of operations.

We are ~~also~~ obligated to pay quarterly ~~royalty~~royalties under the SOLOSEC Asset Purchase Agreement dated July 14, 2024; this royalty is based on a percentage of SOLOSEC net sales, adjusted for co-pay program costs. There are no minimum quarterly or annual royalty amounts. Such royalty costs were approximately $0.1 million and immaterial for the ~~year~~years ended December 31, 2025 and 2024, respectively.

84In the year ended December 31, 2025, cost of goods sold also included a loss on inventory write-down for excess and obsolescence as well as a loss on inventory purchase commitment of approximately $1.0 million. Less than $0.1 million was recorded related to inventory write-down for excess and obsolescence in the year ended December 31, 2024.

Operating Expenses

Research and Development Expenses

Our research and development expenses primarily consist of costs associated with ongoing improvements related to our products. These expenses include:

● ~~continuous~~ongoing improvements of manufacturing and analytical efficiency; ● ongoing product characterization and process optimization; ● alternative raw material evaluation to secure an uninterrupted supply chain and reduce cost of goods sold; ● employee-related expenses, including salaries, benefits, travel and noncash stock-based compensation expense; and ● facilities, depreciation, and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold imp

Filing Compare · Evofem Biosciences, Inc.