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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

(Mark One)


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

For the quarterly period ended March 31, 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: 001-36544

Sage Therapeutics, Inc.

(Exact name of registrant as specified in its Charter)

     Delaware

     27-4486580

     (State or other jurisdiction of
incorporation or organization)

     (I.R.S. Employer
Identification No.)

55 Cambridge Parkway

Cambridge, Massachusetts 02142

(Address of principal executive office) (Zip Code)

Registrant’s telephone number, including area code: (617) 299-8380

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	SAGE	The Nasdaq Global Market

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, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of April 22, 2025, there were 62,620,694 shares of the registrant’s common stock, $0.0001 par value per share, outstanding.

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “intends”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

•

our expectations and goals for commercialization of ZURZUVAE® in the U.S. for the treatment of women with postpartum depression, or PPD, including our beliefs in the potential benefit and profile of ZURZUVAE for the treatment of women with PPD; our estimates as to the number of women with PPD; the potential market opportunity for ZURZUVAE for the treatment of women with PPD; our market access, sales and marketing, customer support, investment, and distribution strategies for ZURZUVAE and related expectations, goals, and assumptions, including our goals to establish ZURZUVAE as the standard of care for women with PPD, expand market growth in PPD, accelerate topline revenue growth, and ultimately help more women with PPD; our market access goal of helping all women with PPD who are prescribed ZURZUVAE gain access to ZURZUVAE as quickly as possible with minimal restrictions; and the potential future results of our commercialization efforts and investment in the U.S.;

•

our expectations and estimates regarding: the level of expenses we may incur in connection with our activities, including the cost savings we may realize as a result of our October 2024 corporate reorganization and pipeline prioritization efforts; use of cash, cash runway and projected cash balance at any given time; timing of future cash needs; capital requirements; funding from potential revenue; anticipated funding from ongoing collaborations; sources of future financing; and our ability to obtain additional financing, including on acceptable terms, when needed to fund future operations;

•

our plans for the development of our product candidates for the treatment of brain health diseases and disorders, and potentially for other indications, including for SAGE-319 as a potential treatment for behavioral symptoms associated with certain neurodevelopmental disorders; our plans to announce data from a Phase 1 multiple ascending dose study of SAGE-319 by late 2025 and to evaluate next steps, if any, based on these data; our plans to evaluate other potential indications for SAGE-324, including seizures in developmental and epileptic encephalopathies and to provide an update on next steps, if any, in mid-2025; our plans with respect to other research and development activities, including continuing to explore targeted work within our NMDA receptor negative allosteric modulator platform with SAGE-817 and SAGE-039; and expected timelines for our planned activities;

•

our expectations regarding our plans to explore strategic alternatives;

•

our ability, within the expected time frames, to initiate clinical trials and non-clinical studies of existing or future product candidates, including pivotal clinical trials, and to successfully enroll, complete and announce the results of ongoing or future clinical trials;

•

our belief as to potential outcomes of our clinical development and commercialization activities;

•

our plans and potential outcomes with respect to interactions with regulatory authorities;

•

our plans for and the potential costs, benefits and outcomes of our existing collaborations with Biogen MA Inc., or BIMA, and Biogen International GmbH, or, together with BIMA, Biogen, and Shionogi & Co., Ltd., or Shionogi, and our plans for and potential outcomes of any additional business development efforts;

•

our plans and expectations with respect to the potential development of any product or product candidate for markets outside the U.S.;

•

our expectations with respect to the availability of supplies of ZURZUVAE and our product candidates, and the expected performance of our third-party manufacturers, including conformity with applicable regulatory requirements;

•

our ability to obtain and maintain intellectual property protection for our proprietary assets and other forms of exclusivity relevant to our business;

•

the estimated number of patients with diseases or disorders of interest to us and the potential size of the market for our products and product candidates in the indications we are pursuing or plan to study;

•

the potential for our current products and current or future product candidates, if successfully developed and approved, for the indications and in the markets for which they are approved and our ability to serve those markets;

•

the potential for success of competing products that are or become available for the treatment of PPD or any of the other indications that we are pursuing or may pursue in the future with our products and our product candidates;

•

the impact of changes to the macroeconomic environment and geopolitical events on our activities, business and results of operations, and the potential success of our efforts to address or mitigate such impact; and

•

other risks and uncertainties, including those listed under Part II, Item 1A, Risk Factors.

Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events and with respect to our business and future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part II, Item 1A, Risk Factors and elsewhere in this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

We may from time to time provide estimates, projections and other information concerning, among other things, our industry, the general business environment, and the markets for certain diseases, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information we provide in this Quarterly Report. Unless otherwise expressly stated, we obtained this industry and business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties; industry, medical and general publications; government data; and similar sources, in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate.

This Quarterly Report on Form 10-Q contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Quarterly Report on Form 10-Q and the documents incorporated by reference herein may appear without the ® or ™ 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 rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Summary of Risks Related to our Business

Our business, prospects, financial condition, and operating results are subject to numerous risks and uncertainties that you should be aware of before making an investment decision, as more fully described under Part II, Item 1A, Risk Factors and elsewhere in this Quarterly Report. These risks may include, but are not limited to, the following:

•

Our future business prospects depend heavily on our ability, with our collaborator Biogen, to successfully continue to commercialize ZURZUVAE for the treatment of women with PPD. We and Biogen may not be successful in our commercialization efforts for ZURZUVAE for the treatment of women with PPD. ZURZUVAE may not achieve, or, even if achieved, maintain, broad market acceptance. We also may encounter other limitations or issues related to the commercialization of ZURZUVAE, including as a result of its price or competition in the market. ZURZUVAE may not achieve brand awareness and adoption among healthcare professionals, including OBGYNs, and our beliefs about the potential for OBGYNs to utilize ZURZUVAE at the forefront of postpartum care may prove to be incorrect. As a result, we may not generate revenues at the levels or on the timing we expect. The number of women with PPD, the unmet need for additional treatment options, and the potential market for ZURZUVAE in this indication may be significantly smaller than we expect. Any setback or delay in our ability to market ZURZUVAE for the treatment of women with PPD may have a material adverse effect on our business and prospects.

•

Our plans to explore strategic alternatives and our rejection of an unsolicited, non-binding acquisition proposal from Biogen to acquire all of our outstanding shares not owned by Biogen may have a material adverse effect on our business. Our rejection of the unsolicited, nonbinding acquisition proposal from Biogen, our enforcement of the terms of the stock purchase agreement we entered into with Biogen, and our strategic alternatives review process may adversely impact our relationship with Biogen, including our efforts to commercialize ZURZUVAE for the treatment of women with PPD. We cannot be certain that our efforts to date with Biogen, including regarding sales force coordination, engagement with payors, and education efforts related to PPD, will not be adversely impacted or that Biogen will continue to make investments related to ZURZUVAE. Any disruption of our relationship with Biogen under the Biogen collaboration agreement may have an adverse impact on sales of ZURZUVAE and may in turn materially adversely affect our business, results of operations, financial condition and prospects. We have not set a timetable for the strategic alternatives review process, nor have we made any decisions related to any potential strategic alternatives at this time. There can be no assurance that our strategic alternatives review process will result in any transaction or other strategic outcome.

•

Our future business prospects also depend heavily on our ability to successfully develop and gain regulatory approval of our product candidates. We cannot be certain that the results of our development programs will be positive or sufficient to file for regulatory approval. Any setback or delay in obtaining regulatory approval for any of our product candidates or in our ability to commence marketing of our products, if approved, may have a material adverse effect on our business and prospects.

•

If the affected populations for indications our products and product candidates are targeting, including the addressable markets within such populations, or the number of patients within such markets who are actually treated with our products, are smaller than we anticipate, or our other assumptions with respect to the potential markets for our products and product candidates are incorrect, our ability to achieve profits from the commercialization of such products, if approved, at the levels or on the timing we expect could be materially adversely impacted.

•

If serious adverse events or other undesirable side effects are identified during the use of any of our marketed products or product candidates, such events may adversely affect market acceptance or result in other significant negative consequences for an approved product; delay or prevent further development or regulatory approval with respect to product candidates; or cause regulatory authorities to require labeling statements, such as boxed warnings, or a Risk Evaluation and Mitigation Strategy, on approved products.

•

We, or our collaboration partners, may not achieve positive results in clinical trials and non-clinical studies of our product candidates. The results of non-clinical studies or clinical trials of our product candidates at any stage may not support further development or may not be sufficient to file for and obtain regulatory approval.

•

We may not generate revenues from our existing products, or any of our product candidates if successfully developed, at the levels we expect. We may not achieve events tied to cash milestone payments or other payments from our collaboration partners on the timelines we expect or at all. Our expenses may also be higher than we expect, including as a result of unexpected events or changes in plans. Also, we may not achieve anticipated cost savings from our October 2024 corporate reorganization at the levels we expect. As a result, our expectations as to our cash runway and the sufficiency of cash to fund our future operations may prove to be incorrect. We will need to raise additional funding, which may not be available on acceptable terms, or at all.

•

Any impairment of the ability of our third-party suppliers to supply product or to meet applicable regulatory standards may significantly negatively impact our ability to achieve our goals and plans and to meet the expectations for our business.

•

Competing therapies may exist or could be approved that adversely affect the amount of revenue we are able to generate from the sale of ZURZUVAE for the treatment of women with PPD or any of our other current or future product candidates, if successfully developed and approved.

•

Our existing collaborations with Biogen and Shionogi, and any future collaborations, may not lead to the successful development or regulatory approval of product candidates or commercialization of products in the territories covered by the applicable collaboration. Our collaborators may have competing priorities, conflicting incentives, or different views than us on key decisions, that may hamper or delay our development and commercialization efforts or increase our costs. Our business may be adversely affected, and we may be subject to delays, disputes, or litigation if we disagree significantly with any of our collaborators, or any of our collaborators fails to perform its obligations or terminates our collaboration.

•

If we are unable to adequately protect our proprietary technology or obtain and maintain issued patents sufficient to protect our products or product candidates, others could compete against us more directly, which would have a material adverse impact on our business, results of operations, financial condition and prospects.

•

If we were to lose our rights to certain licensed intellectual property, or if we are not able to obtain licenses to intellectual property, we may determine we need in the future, we may not be able to continue developing or commercializing certain of our products or product candidates, if approved.

•

Existing or future laws, regulations, executive orders, policies aimed at reducing healthcare costs, or other governmental or regulatory actions may have a material adverse effect on our business or results of operations. Existing, pending or future federal and state reforms aimed at reducing healthcare costs, including pricing and reimbursement of pharmaceutical products, may in the future result in reduced reimbursement and access for our products or cause us to curtail certain development plans due to concerns about commercial viability, any of which could adversely affect our ability to generate revenue and negatively impact our business, results of operations, financial condition, and prospects.

•

We are subject to healthcare laws and regulations, which could expose us to the risk of criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings if we or our employees are alleged or determined not to have complied with such laws and regulations.

•

Our stock price may fluctuate in response to a number of factors.

Sage Therapeutics, Inc.

INDEX


		Page
PART I – FINANCIAL INFORMATION

Item 1.	Financial Statements (Unaudited)	7
	Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024	7
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2025 and 2024	8
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024	9
	Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three months ended March 31, 2025 and 2024	10
	Notes to Condensed Consolidated Financial Statements	11
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	35
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	53
Item 4.	Controls and Procedures	53

PART II – OTHER INFORMATION

Item 1.	Legal Proceedings	54
Item 1A.	Risk Factors	55
Item 5.	Other Information	102
Item 6.	Exhibits	103
	Signatures	104

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

Sage Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(Unaudited)


	March 31, 2025			December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	45,224		$	81,021
Marketable securities		378,630			423,397
Prepaid expenses and other current assets		19,893			17,749
Collaboration receivable - related party		10,729			9,134
Total current assets		454,476			531,301
Property and equipment, net		778			890
Restricted cash		1,450			1,450
Right-of-use operating asset		10,357			10,753
Other long-term assets		2,608			2,828
Total assets	$	469,669		$	547,222
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	5,435		$	12,699
Accrued expenses		42,531			57,598
Operating lease liability, current portion		1,812			1,318
Total current liabilities		49,778			71,615
Operating lease liability, net of current portion		10,043			10,518
Total liabilities		59,821			82,133
Commitments and contingencies (Note 6)
Stockholders’ equity:
Preferred stock, $0.0001 par value per share; 5,000,000 shares authorized at March 31, 2025 and December 31, 2024; no shares issued or outstanding at March 31, 2025 and December 31, 2024		—			—
Common stock, $0.0001 par value per share; 120,000,000 shares authorized at March 31, 2025 and December 31, 2024; 62,543,751 and 61,359,242 shares issued at March 31, 2025 and December 31, 2024, respectively; 62,540,718 and 61,356,209 shares outstanding at March 31, 2025 and December 31, 2024, respectively		6			6
Treasury stock, at cost, 3,033 shares at March 31, 2025 and December 31, 2024		(400	)		(400	)
Additional paid-in capital		3,442,639			3,435,564
Accumulated deficit		(3,032,539	)		(2,970,325	)
Accumulated other comprehensive income		142			244
Total stockholders’ equity		409,848			465,089
Total liabilities and stockholders’ equity	$	469,669		$	547,222

The accompanying notes are an integral part of these condensed consolidated financial statements.

Sage Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(Unaudited)


	Three Months Ended March 31,
	2025			2024
Product revenue, net	$	—		$	1,690
Collaboration revenue - related party		13,827			6,212
Other revenue(1)		236			—
Total revenues		14,063			7,902
Operating costs and expenses:
Cost of revenues		655			1,269
Research and development		22,759			71,734
Selling, general and administrative		57,591			52,574
Restructuring		513			—
Total operating costs and expenses		81,518			125,577
Loss from operations		(67,455	)		(117,675	)
Interest income, net		5,223			9,204
Other income (expense), net		18			(12	)
Net loss	$	(62,214	)	$	(108,483	)
Net loss per share—basic and diluted	$	(1.01	)	$	(1.80	)
Weighted average number of common shares outstanding—basic and diluted		61,857,573			60,136,198
Comprehensive loss:
Net loss	$	(62,214	)	$	(108,483	)
Other comprehensive items:
Unrealized gain (loss) on marketable securities		(102	)		27
Total comprehensive loss	$	(62,316	)	$	(108,456	)

(1) Consists of related-party amounts of $0.2M for the quarter ended March 31, 2025 (see Note 7).

The accompanying notes are an integral part of these condensed consolidated financial statements.

Sage Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)


	Three Months Ended March 31,
	2025			2024
Cash flows from operating activities
Net loss	$	(62,214	)	$	(108,483	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		6,927			13,698
Premium on marketable securities		(137	)		(23	)
Amortization of discount on marketable securities		(981	)		(1,554	)
Depreciation expense		112			336
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(2,144	)		5,237
Collaboration receivable - related party		(1,595	)		72,500
Other long-term assets		220			332
Right-of-use operating asset		396			1,601
Operating lease liabilities, current		494			(1,859	)
Operating lease liabilities, non-current		(475	)		—
Accounts payable		(7,264	)		(3,839	)
Accrued expenses and other liabilities		(15,067	)		(15,778	)
Net cash used in operating activities		(81,728	)		(37,832	)
Cash flows from investing activities
Proceeds from sales and maturities of marketable securities		133,756			201,054
Purchases of marketable securities		(87,973	)		(61,618	)
Net cash provided by investing activities		45,783			139,436
Cash flows from financing activities
Proceeds from stock option exercises and employee stock purchase plan issuances		242			1,559
Payment of employee tax obligations related to vesting of restricted stock units		(94	)		(2	)
Net cash provided by financing activities		148			1,557
Net increase (decrease) in cash, cash equivalents and restricted cash		(35,797	)		103,161
Cash, cash equivalents, and restricted cash at beginning of period		82,471			72,324
Cash, cash equivalents, and restricted cash at end of period	$	46,674		$	175,485
Reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheets
Cash and cash equivalents		45,224			172,653
Restricted cash		1,450			2,832
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows	$	46,674		$	175,485

The accompanying notes are an integral part of these condensed consolidated financial statements.

Sage Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(in thousands, except share data)

(Unaudited)


													Accumulated
										Additional			Other						Total
	Common Stock				Treasury Stock					Paid-in			Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Shares		Amount			Capital			Income (Loss)			Deficit			Equity

Balances at December 31, 2023		60,043,643	$	6		3,033	$	(400	)	$	3,370,397		$	(814	)	$	(2,569,659	)	$	799,530
Issuance of common stock from exercises of stock options		7,142		—		—		—			52			—			—			52
Issuance of common stock under the employee stock purchase plan		61,402		—		—		—			1,507			—			—			1,507
Vesting of restricted stock units, net of employee tax obligations		69,844		—		—		—			(2	)		—			—			(2	)
Stock-based compensation expense		—		—		—		—			13,170			—			—			13,170
Change in unrealized loss on available-for-sale securities		—		—		—		—			—			27			—			27
Net loss		—		—		—		—			—			—			(108,483	)		(108,483	)
Balances at March 31, 2024		60,182,031		6		3,033		(400	)		3,385,124			(787	)		(2,678,142	)		705,801

Balances at December 31, 2024		61,356,209	$	6		3,033	$	(400	)	$	3,435,564		$	244		$	(2,970,325	)	$	465,089
Issuance of common stock under the employee stock purchase plan		52,436		—		—		—			242			—			—			242
Vesting of restricted stock units, net of employee tax obligations		1,132,073		—		—		—			(94	)		—			—			(94	)
Stock-based compensation expense		—		—		—		—			6,927			—			—			6,927
Change in unrealized gain on available-for-sale securities		—		—		—		—			—			(102	)		—			(102	)
Net loss		—		—		—		—			—			—			(62,214	)		(62,214	)
Balances at March 31, 2025		62,540,718		6		3,033		(400	)		3,442,639			142			(3,032,539	)		409,848

The accompanying notes are an integral part of these condensed consolidated financial statements.

SAGE THERAPEUTICS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Nature of the Business

Sage Therapeutics, Inc. (“Sage” or the “Company”) is a biopharmaceutical company with a mission to pioneer solutions to deliver life-changing brain health medicines, so every person can thrive.

The Company’s product ZURZUVAE® (zuranolone) was approved by the U.S. Food and Drug Administration (the “FDA”) on August 4, 2023, for the treatment of postpartum depression (“PPD”) in adults. ZURZUVAE is a neuroactive steroid that is a positive allosteric modulator of GABAA receptors, targeting both synaptic and extrasynaptic GABAA receptors, and is the first oral, once-daily, 14-day treatment specifically indicated for adults with PPD. ZURZUVAE became commercially available for women with PPD in December 2023.

The Company has a portfolio of product candidates with a current focus on modulating two critical central nervous system (“CNS”) receptor systems, GABA and NMDA. The GABA receptor family, which is recognized as the major inhibitory neurotransmitter in the CNS, mediates downstream neurologic and bodily function via activation of GABAA receptors. The NMDA-type receptors of the glutamate receptor system are a major excitatory receptor system in the CNS. Dysfunction in these systems is implicated in a broad range of CNS disorders. The Company is targeting diseases and disorders of the brain across its pipeline.

The Company’s product ZULRESSO® (brexanolone) CIV injection was previously approved in the U.S. for the treatment of PPD in individuals 15 years old and older. The Company discontinued commercial availability of ZULRESSO as of December 31, 2024.

In October 2024, the Company executed a plan to reorganize its business operations, including a reduction of approximately 33% of the Company’s total workforce and approximately 55% of the Company’s research and development workforce. See Note 11, Restructuring, for further details.

On January 10, 2025, the Company received an unsolicited, non-binding acquisition proposal from Biogen MA Inc. (“BIMA”) and Biogen International GmbH (together with BIMA, “Biogen”) to acquire all outstanding shares of the Company not already owned by Biogen for $7.22 per share. On January 27, 2025, the Board of Directors of the Company (the “Board”) unanimously rejected the unsolicited, non-binding acquisition proposal received from Biogen. The Company further announced that the Board has initiated a process to explore strategic alternatives for the Company. The strategic review process is ongoing. The Company has not set a timetable for the review process nor have any decisions related to any potential strategic alternatives been made at this time. There can be no assurance that the strategic alternatives review process will result in any transaction or other strategic outcome.

The Company was incorporated under the laws of the State of Delaware on April 16, 2010, and commenced operations on January 19, 2011, as Sterogen Biopharma, Inc. On September 13, 2011, the Company changed its name to Sage Therapeutics, Inc.

Risks and Uncertainties

The Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including, but not limited to, the risks associated with developing product candidates at each stage of non-clinical and clinical development; the challenges associated with gaining regulatory approval of such product candidates; the risks associated with the marketing and sale of pharmaceutical products; the potential for development by third parties of new technological innovations that may compete with the Company’s products and product candidates; the dependence on key personnel; the challenges of protecting proprietary technology; the need to comply with government regulations; the high costs of drug development; the uncertainty of being able to secure additional capital

when needed to fund operations; and the direct or indirect impacts of the macroeconomic environment and geopolitical events on its development activities, operations and financial condition.

The product candidates developed by the Company require approvals from the FDA or foreign regulatory authorities prior to commercial sales. There can be no assurance that the current and future product candidates of the Company will receive, or that ZURZUVAE will maintain, the necessary approvals. If the Company fails to successfully complete clinical development and generate results sufficient to file for regulatory approval or is denied approval or approval is delayed for any of its product candidates, such occurrences may have a material adverse impact on the Company’s business and its financial condition.

The Company is also subject to additional risks and uncertainties arising from changes to the macroeconomic environment and geopolitical events. U.S. and global financial markets have experienced volatility and disruption due to macroeconomic and geopolitical events such as the implementation of tariffs, inflation, the risk of a recession and ongoing conflicts in other countries. In addition, if equity and credit markets deteriorate, it may make any future debt or equity financing more difficult to obtain on favorable terms, and potentially more dilutive to existing stockholders. The Company cannot predict at this time to what extent it and its collaborators, employees, suppliers, contract manufacturers and/or vendors could potentially be negatively impacted by these events.

Going Concern

Under Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40), the Company has the responsibility to evaluate whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date that the financial statements are issued. The Company has incurred losses and negative cash flows from operations in each year since its inception, except for net income of $606.1 million for the year ended December 31, 2020, reflecting revenue recognized under a collaboration and license agreement with Biogen (the “Biogen Collaboration Agreement”). As of March 31, 2025, the Company had an accumulated deficit of $3.0 billion. Until such time, if ever, as the Company can generate substantial product revenue and/or collaboration revenue and achieve sustained profitability, the Company expects to finance its cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other sources of funding. If the Company is unable to raise additional funds through equity or debt financings or other sources of funding when needed, the Company may need to delay, limit, reduce or terminate product development or future commercialization efforts or grant rights to develop and market products or product candidates that the Company would otherwise prefer to develop and market itself.

The Company expects that, based on its current operating plans, the Company’s existing cash, cash equivalents and marketable securities will be sufficient to fund its currently planned operations for at least the next 12 months from the filing date of these unaudited interim condensed consolidated financial statements (“condensed consolidated financial statements”). The Company anticipates it will require additional financing to fund its future operations. Even if the Company believes it has sufficient funds for its current or future operating plans, the Company may seek to raise additional capital if market conditions are favorable or in light of other strategic considerations.

Summary of Significant Accounting Policies

The following is a summary of significant accounting policies followed in the preparation of these condensed consolidated financial statements.

Basis of Presentation

The condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be

read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

The condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of the Company’s management, the accompanying condensed consolidated financial statements contain all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of its financial position as of March 31, 2025, its results of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, its cash flows for the three months ended March 31, 2025 and 2024, and its statements of changes in stockholders’ equity for the three months ended March 31, 2025 and 2024. The consolidated balance sheet at December 31, 2024, was derived from audited financial statements, but does not include all disclosures required by GAAP. The results for the three months ended March 31, 2025, are not necessarily indicative of the results for the year ending December 31, 2025, or for any future period.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies, within the “Notes to Consolidated Financial Statements” accompanying its Annual Report on Form 10-K for the year ended December 31, 2024. Intercompany accounts and transactions have been eliminated.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period.

Research and Development Costs and Accruals

Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries and benefits, overhead costs, depreciation, contract services and other related costs. Research and development costs are expensed to operations as the related obligation is incurred.

The Company has entered into various research and development contracts with research institutions and other companies both inside and outside of the U.S. These agreements are generally cancelable, and related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations to those third parties as of the end of the reporting period. Any accrual estimates are based on a number of factors, including the Company’s knowledge of the progress towards completion of the research and development activities, invoicing to date under the contracts, communication from the research institution or other companies of any actual costs incurred during the period that have not yet been invoiced, and the costs included in the contracts. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the estimates made by the Company. The historical accrual estimates made by the Company have not been materially different from the actual costs.

Revenue Recognition

Under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“Topic 606”), an entity recognizes revenue when or as performance obligations are satisfied by transferring control of promised goods or services to a customer, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price,

including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right may be accounted for as a contract modification or as a continuation of the contract for accounting purposes.

Topic 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as collaboration arrangements.

For contracts determined to be within the scope of Topic 606, the Company assesses whether the goods or services promised within each contract are distinct to identify those that are performance obligations. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract.

The Company allocates the transaction price (the amount of consideration it expects to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which the Company expects to be entitled.

Product Revenue, Net

Until the discontinuation of commercial availability of ZULRESSO as of December 31, 2024, the Company generated product revenue from the sale of ZULRESSO to a limited number of specialty distributors and specialty pharmacy providers in the U.S. The Company recognized product revenue, net of variable consideration related to certain allowances and accruals that are determined using the expected value method, in its consolidated financial statements at the point in time when control transfers to the customer, which was typically when the product has been delivered to the customer’s location. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. The Company’s only performance obligation identified for ZULRESSO was to deliver the product to the location specified by the customer’s order.

The Company recorded shipping and handling costs associated with delivery of product to its customers within selling, general and administrative expenses on its condensed consolidated statements of operations and comprehensive loss. The Company expensed incremental costs of obtaining a contract as incurred if the expected amortization period of the asset would be less than one year. If the Company were to incur incremental costs with an amortization period greater than a year, such costs would be capitalized as contract assets, as they are expected to be recovered, and would be expensed by amortizing on a systematic basis that is consistent with the transfer to the customer of the goods or services to which the asset relates. The Company did not have any contract assets (unbilled receivables) at March 31, 2025. The Company did not have any contract liabilities at March 31, 2025, as the Company did not receive any payments in advance of satisfying its performance obligations to its customers. Amounts billed or invoiced that are considered trade accounts receivable are included in prepaid expenses and other current assets on the condensed consolidated balance sheets.

As of March 31, 2025 and December 31, 2024, the Company had not provided any allowance for bad debts against the trade accounts receivable, and the amount of trade accounts receivable was not significant.

The Company recorded reserves, based on contractual terms, for the following components of variable consideration related to ZULRESSO sold by the Company during the reporting period, as well as its estimate of product that remains in the distribution channel inventory of its customers at the end of the reporting period. On a quarterly basis, the Company updated its estimates, if necessary, and recorded any material adjustments in the period they are identified.

Chargebacks: The Company estimated chargebacks from its customers who directly purchased the product from the Company for discounts resulting from contractual commitments to sell products to eligible healthcare settings at prices lower than the list prices charged to its customers. Customers charged the Company for the difference between what they paid to the Company for the product and the selling price to the eligible healthcare settings. Reserves for chargebacks consisted of credits that the Company expected to issue for units that remain in the distribution channel inventories at the end of each reporting period that the Company expected would be sold to eligible healthcare settings, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit.

Government Rebates: The Company was subject to discount obligations under government programs, including Medicaid. The Company recorded reserves for rebates in the same period the related product revenue was recognized, resulting in a reduction of ZULRESSO product revenue and a current liability that is included in accrued expenses on its condensed consolidated balance sheets. The Company’s liability for these rebates consisted of invoices received for claims from prior quarters that have not been paid or for which an invoice had not yet been received, estimates of claims for the current quarter, and estimates of future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel at the end of each reporting period.

Trade Discounts and Allowances: The Company generally provided customary invoice discounts on ZULRESSO sales to its customers for prompt payment and the Company paid fees for sales order management, data, and distribution services. The Company estimated its customers would earn these discounts and fees and deduct in full these discounts and fees from gross ZULRESSO revenue and accounts receivable at the time the Company recognized the related revenue.

Financial Assistance: The Company provided voluntary financial assistance programs for ZULRESSO to patients with commercial insurance that had coverage and resided in states that allowed financial assistance. The Company estimated the financial assistance amounts for ZULRESSO and records any such amounts within accrued expenses on its condensed consolidated balance sheets. The calculation of the accrual for financial assistance was based on an estimate of claims and the cost per claim that the Company expected to receive using demographics for patients who had registered and been approved for assistance. Any adjustments were recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which was included as a component of accrued expenses on the condensed consolidated balance sheets.

Product Returns: Consistent with industry practice, the Company offered product return rights with respect to ZULRESSO to customers for damaged, defective or expiring product, provided it is within a specified period around the product expiration date as set forth in the Company’s return goods policy. The Company estimated the amount of its product sales that may be returned by its customers and recorded this estimate as a reduction of revenue in the period the related product revenue was recognized, as well as a reserve within accrued expenses on the condensed consolidated balance sheets. Product returns have not been significant to date and are not expected to be significant in the future.

License, Milestone, and Collaboration Revenue

In assessing whether a promised good or service is distinct in the evaluation of a collaboration or license arrangement subject to Topic 606, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, the Company is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.

The transaction price is then determined and allocated to the identified performance obligations in proportion to their standalone selling prices (“SSP”) on a relative SSP basis. SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied.

Determining the SSP for performance obligations requires significant judgment. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. In certain circumstances, the Company may apply the residual method to determine the SSP of a good or service if the SSP is considered highly variable or uncertain. The Company validates the SSP for performance obligations by evaluating whether changes in the key assumptions used to determine the SSP will have a significant effect on the allocation of arrangement consideration between multiple performance obligations.

If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer. The Company determines the amount of variable consideration by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the period of adjustment.

If an arrangement includes development and regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received.

In determining the transaction price, the Company adjusts consideration for the effects of the time value of money if the timing of payments provides the Company with a significant benefit of financing. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less. The Company assessed its arrangements with Shionogi & Co., Ltd. (“Shionogi”) and Biogen and concluded that a significant financing component does not exist for either arrangement. For arrangements with licenses of intellectual property that include sales-based royalties or milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties or milestone payments relate, the Company recognizes royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty or milestone payment has been allocated has been satisfied.

The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method. Revenue from the Company’s collaboration agreement with Shionogi has come from initial, upfront consideration upon execution of the agreement and for the supply of drug product for Shionogi’s clinical trials. Revenue from the Company’s collaboration agreement with Biogen has come from initial, upfront consideration related to the execution of the Biogen Collaboration Agreement, milestone payments and the Company’s share of ZURZUVAE revenues under the elements of the arrangement accounted for under ASC Topic 808, Collaborative Arrangements (“Topic 808”). For additional information, see the Collaborative Arrangements section below and refer to Note 7, Collaboration Agreements.

Collaborative Arrangements

The Company analyzes its collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and therefore within the scope of Topic 808. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of Topic 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of Topic 808 and which elements of the collaboration are more reflective of a vendor-customer relationship and

therefore within the scope of Topic 606. For elements of collaboration arrangements that are accounted for pursuant to Topic 808, an appropriate recognition method is determined and applied consistently, either by analogy to authoritative accounting literature or by applying a reasonable and rational policy election. For those elements of the arrangement that are accounted for pursuant to Topic 606, the Company applies the five-step model described above and presents the arrangement as license and milestone revenue or other collaboration revenue in the condensed consolidated statements of operations and comprehensive loss.

For collaboration arrangements that are within the scope of Topic 808, the Company evaluates the income statement classification for presentation of amounts due from or owed to other participants associated with multiple activities in a collaboration arrangement based on the nature of each separate activity. Payments or reimbursements that are the result of a collaborative relationship instead of a vendor-customer relationship are recorded as an increase to collaboration revenue, an increase to or reduction of cost of revenues, research and development expense, or selling, general and administrative expense, depending on the nature of the activity. For additional information relating to the accounting for the co-commercialization of ZURZUVAE in the U.S. with Biogen under Topic 808, refer to Note 7, Collaboration Agreements.

Fair Value Measurements

Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial assets and liabilities carried at fair value are classified and disclosed in one of the following three categories:

Level 1 — Quoted market prices in active markets for identical assets or liabilities.

Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The Company’s cash equivalents and marketable securities at March 31, 2025 and December 31, 2024 were carried at fair value, determined according to the fair value hierarchy; see Note 3, Fair Value Measurements.

The carrying amounts reflected in the condensed consolidated balance sheets for the collaboration receivable – related party, accounts payable, and accrued expenses approximate their fair values due to their short-term maturities at March 31, 2025 and December 31, 2024, respectively.

Recently Issued Accounting Pronouncements

In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). ASU 2023-09 modifies the rules on income tax disclosures to enhance the transparency and decision-usefulness of income tax disclosures, particularly in the rate reconciliation table and disclosures about income taxes paid. The amendments are intended to address investors’ requests for income tax disclosures that provide more information to help them better understand an entity’s exposure to potential changes in tax laws and the ensuing risks and opportunities and to assess income tax information that affects cash flow forecasts and capital allocation decisions. The guidance also eliminates certain existing disclosure requirements related to uncertain tax positions and unrecognized deferred tax liabilities. The guidance is effective for all entities for annual periods beginning after December 15, 2024. All entities should apply the guidance prospectively but have the option to apply it retrospectively. The Company will adopt ASU 2023-09 retrospectively for the annual period beginning after December 15, 2024. The Company expects ASU 2023-09 to only impact certain limited disclosures with no material impact to the condensed consolidated financial statements.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40) (“ASU 2024-03”). ASU 2024-03 modifies the rules on income statement disclosures to enhance the transparency of and include more detailed information about the types

of expenses, including purchases of inventory, employee compensation, depreciation, amortization, and depletion, in commonly presented expense captions such as cost of sales, research and development, and selling, general and administrative expenses. The amendments are intended to address investors’ requests for income statement expense disclosures that provide more information to help them better understand the components of an entity’s expenses, make their own judgments about the entity’s performance, and more accurately forecast expenses, and enable investors to better assess an entity’s prospects for future cash flows. It will also provide contextual information for an entity’s presentation and consideration of management’s discussion and analysis of financial position and results of operations. The guidance is effective for all entities for annual periods beginning after December 15, 2026. All entities should apply the guidance prospectively but have the option to apply it retrospectively. Early adoption is permitted. The Company is continuing to assess the timing of adoption and the potential impacts of ASU 2024-03 on the consolidated financial statements and related disclosures.

Fair Value Measurements

The Company’s cash equivalents are classified within Level 1 and Level 2 of the fair value hierarchy. The Company’s investments in marketable securities are classified within Level 2 of the fair value hierarchy.

The fair values of the Company’s marketable securities are based on prices obtained from independent pricing sources. Consistent with the fair value hierarchy described in Note 2, Summary of Significant Accounting Policies, marketable securities with validated quotes from pricing services are reflected within Level 2, as they are primarily based on observable pricing for similar assets or other market observable inputs. Typical inputs used by these pricing services include, but are not limited to, reported trades, benchmark yields, issuer spreads, bids, offers or estimates of cash flow, prepayment spreads and default rates. The Company performs validation procedures to ensure the reasonableness of this data. The Company performs its own review of prices received from the independent pricing services by comparing these prices to other sources. After completing the validation procedures, the Company did not adjust or override any fair value measurements provided by the pricing services as of March 31, 2025 and December 31, 2024.

The following tables summarize the Company’s cash equivalents and marketable securities as of March 31, 2025 and December 31, 2024:


	March 31, 2025
	Total		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
	(in thousands)
Cash equivalents:
Money market funds	$	42,139	$	42,139	$	—	$	—
Total cash equivalents		42,139		42,139		—		—
Marketable securities:
U.S. government securities		17,916		—		17,916		—
U.S. corporate bonds		253,414		—		253,414		—
International corporate bonds		51,931		—		51,931		—
U.S. commercial paper		19,824		—		19,824		—
International commercial paper		28,358		—		28,358		—
U.S. certificates of deposit		2,097		—		2,097		—
U.S. municipal securities		5,090		—		5,090		—
Total marketable securities		378,630		—		378,630		—
	$	420,769	$	42,139	$	378,630	$	—


	December 31, 2024
	Total		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
	(in thousands)
Cash equivalents:
Money market funds	$	73,845	$	73,845	$	—	$	—
U.S. government securities		5,397		—		5,397		—
U.S. commercial paper		997		—		997		—
Total cash equivalents		80,239		73,845		6,394		—
Marketable securities:
U.S. government securities		36,457		—		36,457		—
U.S. corporate bonds		269,013		—		269,013		—
International corporate bonds		52,461		—		52,461		—
U.S. commercial paper		30,373		—		30,373		—
International commercial paper		24,144		—		24,144		—
U.S. certificates of deposit		900		—		900		—
U.S. municipal securities		10,049		—		10,049		—
Total marketable securities		423,397		—		423,397		—
	$	503,636	$	73,845	$	429,791	$	—

During the three months ended March 31, 2025 and 2024, there were no transfers among the Level 1, Level 2 and Level 3 categories.

4. Investments

The following tables summarize the fair value and amortized cost of the Company’s available-for-sale securities by major security type including gross unrealized gains and losses and credit losses as of March 31, 2025 and December 31, 2024:


	March 31, 2025
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Credit Losses		Fair Value
	(in thousands)
Assets:
U.S. government securities	$	17,917	$	3	$	(4	)	$	—	$	17,916
U.S. corporate bonds		253,296		174		(56	)		—		253,414
International corporate bonds		51,911		42		(22	)		—		51,931
U.S. commercial paper		19,824		—		—			—		19,824
International commercial paper		28,358		—		—			—		28,358
U.S. certificates of deposit		2,097		—		—			—		2,097
U.S. municipal securities		5,085		5		—			—		5,090
	$	378,488	$	224	$	(82	)	$	—	$	378,630


	December 31, 2024
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Credit Losses		Fair Value
	(in thousands)
Assets:
U.S. government securities	$	36,444	$	18	$	(5	)	$	—	$	36,457
U.S. corporate bonds		268,841		305		(133	)		—		269,013
International corporate bonds		52,411		65		(15	)		—		52,461
U.S. commercial paper		30,373		—		—			—		30,373
International commercial paper		24,144		—		—			—		24,144
U.S. certificates of deposit		900		—		—			—		900
U.S. municipal securities		10,040		9		—			—		10,049
	$	423,153	$	397	$	(153	)	$	—	$	423,397

As of March 31, 2025 and December 31, 2024, the Company had $2.7 million and $3.4 million, respectively, of accrued interest receivable relating to the Company’s available-for-sale securities, which is included within prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets.

No accrued interest receivable was written off during the three months ended March 31, 2025 and 2024. Realized gains or losses were immaterial for the three months ended March 31, 2025 and 2024.

The following tables summarize the fair value and the unrealized losses of the Company’s marketable securities that have been in a loss position for either less than twelve months or greater than twelve months as of March 31, 2025 and December 31, 2024:


	March 31, 2025
	Less than 12 months					Greater than 12 months				Total
	Fair Value		Unrealized Losses			Fair Value		Unrealized Losses		Fair Value		Unrealized Losses
	(in thousands)
U.S. government securities	$	8,194	$	(4	)	$	—	$	—	$	8,194	$	(4	)
U.S. corporate bonds		75,160		(56	)		4,218		—		79,378		(56	)
International corporate bonds		19,488		(22	)		—		—		19,488		(22	)
	$	102,842	$	(82	)	$	4,218	$	—	$	107,060	$	(82	)


	December 31, 2024
	Less than 12 months					Greater than 12 months					Total
	Fair Value		Unrealized Losses			Fair Value		Unrealized Losses			Fair Value		Unrealized Losses
	(in thousands)
U.S. government securities	$	11,032	$	(5	)	$	—	$	—		$	11,032	$	(5	)
U.S. corporate bonds		83,946		(129	)		10,197		(4	)		94,143		(133	)
International corporate bonds		7,312		(15	)		—		—			7,312		(15	)
	$	102,290	$	(149	)	$	10,197	$	(4	)	$	112,487	$	(153	)

As of March 31, 2025 and December 31, 2024, the unrealized losses on the Company’s investments in U.S. government securities, U.S. corporate bonds, and international corporate bonds were caused by interest rate increases. The Company purchased those investments at a premium relative to their face amount. The current credit ratings are all within the guidelines of the investment policy of the Company and the Company does not expect the issuers to settle any security at a price less than the amortized cost basis of the investment. As of March 31, 2025, the Company does not intend to sell those investments, and it is not probable that the Company will be required to sell the investments before recovery of their amortized cost basis.

As of March 31, 2025, all marketable securities held by the Company had remaining contractual maturities of one year or less, except for U.S. corporate bonds and international corporate bonds with a fair value of $40.0 million and maturities of one to two years.

As of December 31, 2024, all marketable securities held by the Company had remaining contractual maturities of one year or less, except for U.S. corporate bonds and international corporate bonds with a fair value of $30.7 million and maturities of one to two years.

All marketable securities, including those with remaining contractual maturities of more than one year, are classified as current assets on the balance sheet because they are considered to be “available-for-sale” and the Company can convert them into cash to fund current operations.

There have been no impairments of the Company’s assets measured and carried at fair value during the three months ended March 31, 2025 and the year ended December 31, 2024.

5. Accrued Expenses

The following table summarizes accrued expenses as of March 31, 2025 and December 31, 2024:


	March 31,		December 31,
	2025		2024
	(in thousands)
Accrued research and development costs	$	15,123	$	19,758
Restructuring		6,778		15,307
Employee-related		5,965		14,840
Professional services		13,821		7,114
Other		844		579
	$	42,531	$	57,598

6. Commitments and Contingencies

Legal Proceedings

On August 28, 2024, named plaintiff Darren Korver filed a purported federal securities class action lawsuit in the Southern District of New York against the Company and individuals, Barry E. Greene and Kimi Iguchi (the “Securities Class Action”). Pursuant to a statutorily prescribed process, the court appointed two new class representatives, Steamfitters Local 449 Pension & Retirement Security Funds and Trust of the Retirement System of the UPR, who filed an amended complaint on March 3, 2025, against the original defendants and five additional former officers of the Company. The amended complaint in the Securities Class Action alleges violations of U.S. securities laws under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Rule 10b-5 promulgated thereunder and seeks an as-yet unspecified amount of damages allegedly sustained by parties who purchased the Company’s stock between April 12, 2021 and July 23, 2024, as well as applicable attorneys’ fees and costs. On April 17, 2025, the Company, along with all of the individual defendants, filed a motion to dismiss the Securities Class Action in the Southern District of New York. The Company denies any allegations of wrongdoing and intends to vigorously defend against the Securities Class Action.

On October 16, 2024, the Company received a subpoena from the Enforcement Division of the SEC requesting documents and information related to the Company’s NDA for zuranolone for the treatment of MDD, including communications with the FDA and any communications containing material nonpublic information. The Company is cooperating with the SEC and intends to continue to provide information responsive to the SEC’s requests.

On March 26, 2025, plaintiff shareholder Qingping Zhu commenced derivative litigation in the Southern District of New York, purportedly on behalf of the Company, against fifteen current and former officers and

directors of the Company (the “Derivative Litigation”). Based significantly on the allegations underlying the Securities Class Action, the Derivative Litigation alleges violations of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder, breaches of fiduciary duty, unjust enrichment, and waste of corporate assets, and seeks unspecified damages and various equitable relief. On April 14, 2025, the Southern District of New York granted a stay of the Derivative Litigation pending the resolution of the motion to dismiss the amended complaint in the Securities Class Action.

At this time, the Company is unable to predict the outcome of the Securities Class Action, the SEC investigation, or the Derivative Litigation, or reasonably estimate a range of possible losses.

7. Collaboration Agreements

Shionogi

In June 2018, the Company entered into a strategic collaboration with Shionogi for the clinical development and commercialization of zuranolone for the treatment of MDD and other potential indications in Japan, Taiwan and South Korea (the “Shionogi Territory”). In October 2018, the Company entered into a supply agreement with Shionogi for the Company to supply zuranolone clinical material to Shionogi.

Under the terms of the collaboration and license agreement, Shionogi is responsible for all clinical development and regulatory filings for zuranolone in MDD and other indications in the Shionogi Territory and would be responsible for commercialization of zuranolone in the Shionogi Territory, if zuranolone is successfully developed and obtains marketing approval in any of the countries within the Shionogi Territory. Shionogi was required to make an upfront payment to the Company of $90.0 million, and the Company was originally eligible to receive additional payments of up to $485.0 million if certain regulatory and commercial milestones were achieved by Shionogi. The potential future milestone payments originally included up to $70.0 million for the achievement of specified regulatory milestones, up to $30.0 million for the achievement of specified commercialization milestones, and up to $385.0 million for the achievement of specified net sales milestones. The potential future milestone payments for achievement of specified regulatory milestones were reduced to $55.0 million upon failure to receive FDA approval of zuranolone for the treatment of MDD in the U.S. prior to December 31, 2023. The Company is eligible to receive tiered royalties on sales of zuranolone in the Shionogi Territory, if development efforts are successful, with tiers averaging in the low to mid-twenty percent range, subject to other terms of the agreement. As between the Company and Shionogi, the Company maintains exclusive rights to develop and commercialize zuranolone outside of the Shionogi Territory. The upfront cash payment and any payments for milestones and royalties are non-refundable and non-creditable. Due to the uncertainty of pharmaceutical development and the high historical failure rates generally associated with drug development, the Company may not receive any milestone payments or any royalty payments from Shionogi.

The Company concluded that Shionogi meets the definition of a customer because the Company is delivering intellectual property and know-how rights for the zuranolone program in support of territories in which the parties are not jointly sharing the risks and rewards. In addition, the Company determined that the Shionogi collaboration met the requirements to be accounted for as a contract, including that it is probable that the Company will collect the consideration to which the Company is entitled in exchange for the goods or services that will be delivered to Shionogi.

The Company determined that the performance obligations in the Shionogi collaboration agreement included the license to zuranolone and the supply of certain materials during the clinical development phase, which includes the supply of active pharmaceutical ingredient (“API”). The performance obligation related to the license to zuranolone was determined to be distinct from other performance obligations and therefore was a separate performance obligation for which control was transferred upon signing. The obligation to provide certain clinical materials, including API for use during the development period, was determined to be a separate performance obligation. Given that Shionogi is not obligated to purchase any minimum amount or quantities of commercial API, the supply of API to Shionogi for commercial use was determined to be an option for Shionogi, rather than a performance obligation of the Company at contract inception and will be accounted for if and when exercised. The

Company also determined that there was no separate material right in connection with the supply of API for commercial use as the expected pricing was not at a discount. Given this fact pattern, the Company has concluded the agreement has two performance obligations.

Under the clinical supply agreement, the Company is obligated to manufacture and supply to Shionogi (i) clinical quantities of API reasonably required by Shionogi for the development of licensed products in the Shionogi Territory under the collaboration and license agreement and (ii) quantities of drug product reasonably required for use by Shionogi in Phase 1 clinical trials of zuranolone in the Shionogi Territory under the collaboration and license agreement, in the quantities agreed to by the parties. Collaboration revenue from the clinical supply agreement, which excludes the $90.0 million upfront payment, pertains to the clinical material sold under the terms of the clinical supply agreement. The Company records the costs related to the clinical supply agreement in research and development expense on its condensed consolidated statements of operations and comprehensive loss. For the three months ended March 31, 2025 and 2024 the Company did not recognize any collaboration revenue from the Company’s agreement with Shionogi.

The Company completed the evaluation of the SSP of each of the performance obligations and determined that the SSP of the license performance obligation was $90.0 million. The Company recognized the transaction price allocated to the license performance obligation of $90.0 million as revenue during the quarter upon delivery of the license to Shionogi and resulting ability of Shionogi to use and benefit from the license, which was in the three months ended June 30, 2018. The remaining transaction price related to the performance obligation for the supply of certain clinical material is not significant. The potential milestone payments that the Company is eligible to receive were excluded from the transaction price, as all milestone amounts were fully constrained based on the probability of achievement. The Company will re-evaluate the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, and, if necessary, adjust its estimate of the transaction price.

Biogen

In November 2020, the Company entered into the Biogen Collaboration Agreement to jointly develop and commercialize SAGE-217 products and SAGE-324 products. Concurrently, the Company also entered into a stock purchase agreement with BIMA (the “Biogen Stock Purchase Agreement”) under which BIMA purchased shares of the Company’s common stock. The Biogen Collaboration Agreement became effective on December 28, 2020 (the “Effective Date”).

Under the terms of the Biogen Collaboration Agreement, the Company granted Biogen co-exclusive licenses to develop and commercialize SAGE-217 products and SAGE-324 products (each, a “Product Class” and together, the “Licensed Products”) in the U.S., an exclusive license to develop and commercialize SAGE-217 products in all countries of the world other than the U.S. and the Shionogi Territory, and an exclusive license to develop and commercialize SAGE-324 products in all countries of the world other than the U.S. The Company refers to the territories outside the U.S. to which Biogen has rights under the Biogen Collaboration Agreement with respect to the applicable Licensed Product as the “Biogen Territory”.

In September 2024, Biogen notified the Company of its termination of the Biogen Collaboration Agreement solely with respect to products containing the Company’s SAGE-324 products on a worldwide basis, effective February 17, 2025 (the “SAGE-324 Termination”), in accordance with the required notice period. As a result of the SAGE-324 Termination, as of February 17, 2025 (the “SAGE-324 Termination effective date”), all licenses granted by the Company to Biogen or by Biogen to the Company regarding the SAGE-324 products expired with respect to the SAGE-324 products on a worldwide basis. Biogen granted to the Company an irrevocable, perpetual license for any Biogen background technology, Biogen collaboration technology or joint collaboration technology that existed as of February 17, 2025 with respect to the SAGE-324 products, in each case in accordance with the terms of the Biogen Collaboration Agreement.

In connection with the effectiveness of the Biogen Collaboration Agreement and the closing of the sale of shares to BIMA in December 2020, the Company received $1.5 billion in consideration, comprised of an upfront payment of $875.0 million and the $650.0 million purchase price for 6,241,473 newly issued shares of the

Company’s common stock (the “Biogen Shares”). As a result of the purchase of the Biogen Shares, Biogen is a related party of the Company.

The Company was initially eligible to receive additional payments of up to $1.6 billion from Biogen if certain regulatory and commercial milestones were achieved. The potential future milestone payments for SAGE-217 products included up to $475.0 million for the achievement of specified regulatory and commercial milestones, including a milestone payment of $75.0 million for the first commercial sale of ZURZUVAE for the treatment of women with PPD in the U.S. and, if approved, a milestone payment of $150.0 million for the first commercial sale of ZURZUVAE for the treatment of MDD in the U.S., and up to $300.0 million for the achievement of specified net sales milestones. In the fourth quarter of 2023, the Company achieved the $75.0 million milestone for the first commercial sale of ZURZUVAE for the treatment of women with PPD in the U.S. Because the Company and Biogen have agreed not to pursue further development of zuranolone for the treatment of MDD in the U.S., the Company will not receive the $150.0 million milestone payment for the first commercial sale of ZURZUVAE for the treatment of MDD in the U.S.

The potential future milestone payments for SAGE-324 products initially included up to $520.0 million for the achievement of specified regulatory and commercial milestones and up to $300.0 million for the achievement of specified net sales milestones. As a result of the SAGE-324 Termination, the Company will not receive any milestone payments for SAGE-324 products under the Biogen Collaboration Agreement.

The Company is also eligible to receive tiered royalties on net sales of SAGE-217 products in the Biogen Territory at percentage rates ranging from the high teens to low twenties.

Due to the uncertainty of pharmaceutical development and the high historical failure rates generally associated with drug development, and the challenges of launching and commercializing a product, if approved, the Company may never receive any additional milestone payments or any royalty payments under the Biogen Collaboration Agreement.

Development and commercialization activities in the U.S. under the Biogen Collaboration Agreement are conducted pursuant to plans agreed to by the Company and Biogen and overseen by a joint steering committee that consists of an equal number of representatives of each party. The Company and Biogen share equally in the costs for development and commercialization, as well as the profits and losses upon FDA approval and commencement of product sales, in the U.S., subject to the Company’s opt-out right described below. Biogen is solely responsible for all development activities and costs related to any development and commercialization of SAGE-217 products and, prior to the SAGE-324 Termination, SAGE-324 products, for the Biogen Territory, and the Company will receive royalties on any sales in the Biogen Territory, as mentioned above. Biogen is the principal and records sales of SAGE-217 products globally.

The Company is obligated to supply API and bulk drug product for the Biogen Territory and API, bulk drug product and final drug product for the U.S. to support development and commercialization activities. Biogen has the right to assume manufacturing responsibilities for API for the Biogen Territory at any time during the term of the Biogen Collaboration Agreement, and the Biogen Collaboration Agreement further provides that Biogen will, within a reasonable period of time after the Effective Date, assume manufacturing responsibility for bulk drug product for the Biogen Territory.

Unless terminated earlier, the Biogen Collaboration Agreement will continue on a Licensed Product-by-Licensed Product and country-by-country basis until the date on which (a) in any country in the Biogen Territory, the royalty term has expired for all Licensed Products in a Product Class in such country, and (b) for the U.S., the parties agree to permanently cease to commercialize all Licensed Products in a Product Class. Biogen also has the right to terminate the Biogen Collaboration Agreement for convenience in its entirety, on a Product Class-by-Product Class basis (such as the SAGE-324 Termination) or as to a particular region, upon advance written notice. The Company has an opt-out right to convert the co-exclusive licenses in the U.S. to an exclusive license to Biogen on a Product Class-by-Product Class basis. Following the exercise of the opt-out right, the Company would no longer share

equally in the profits and losses in the U.S. and would be entitled to receive certain royalty payments at percentage rates ranging from the low to high twenties and additional sales milestones.

The Company concluded that the Biogen Collaboration Agreement and the Biogen Stock Purchase Agreement should be combined and treated as a single arrangement for accounting purposes as the agreements were entered into contemporaneously and in contemplation of one another. The Company determined that the combined agreements had elements that were within the scope of Topic 606 and Topic 808.

As of the Effective Date, the Company identified the following promises in the Biogen Collaboration Agreement that were evaluated under the scope of Topic 606: delivery of (i) a co-exclusive license for SAGE-217 products in the U.S.; (ii) an exclusive license for SAGE-217 products in the Biogen Territory; (iii) a co-exclusive license for SAGE-324 products in the U.S.; (iv) an exclusive license for SAGE-324 products in the Biogen Territory; (v) the clinical manufacturing supply of API and bulk drug product for SAGE-217 products in the Biogen Territory; and (vi) the clinical manufacturing supply of API and bulk drug product for SAGE-324 products in the Biogen Territory.

The Company also evaluated whether certain options outlined within the Biogen Collaboration Agreement represented material rights that would give rise to a performance obligation and concluded that none of the options convey a material right to Biogen and therefore are not considered separate performance obligations within the Biogen Collaboration Agreement.

The Company assessed the above promises at contract inception and determined that the co-exclusive licenses for SAGE-217 products and SAGE-324 products in the U.S. are reflective of a vendor-customer relationship and therefore represent performance obligations within the scope of Topic 606. The co-exclusive license for SAGE-217 products and SAGE-324 products in the U.S. are considered functional intellectual property and distinct from other promises under the contract. The exclusive licenses for SAGE-217 products and SAGE-324 products in the Biogen Territory are considered functional licenses that are distinct in the context of the Biogen Collaboration Agreement as Biogen can benefit from the licenses on its own or together with other readily available resources. As the co-exclusive licenses in the U.S. and the exclusive licenses in the Biogen Territory are delivered at the same time, they are considered one performance obligation at contract inception. The clinical manufacturing supply of API and bulk drug product for SAGE-217 products and SAGE-324 products for the Biogen Territory are considered distinct in the context of the Biogen Collaboration Agreement as Biogen can benefit from the manufacturing services together with the licenses transferred by the Company at the inception of the Biogen Collaboration Agreement. Therefore, each represents a separate performance obligation within a contract with a customer under the scope of Topic 606 at contract inception.

The Company determined the transaction price under Topic 606 at the inception of the Biogen Collaboration Agreement to be $1.1 billion, consisting of the upfront payment of $875.0 million plus $232.5 million in excess proceeds from the equity investment under the Biogen Stock Purchase Agreement, when measured at fair value, plus future variable consideration for manufacturing supply of clinical API and bulk drug product for the Biogen Territory. The amount of variable consideration related to the future manufacturing services was not material. At inception, the Company determined that any variable consideration related to clinical development and regulatory or commercial milestones is deemed to be fully constrained and therefore excluded from the transaction price due to the high degree of uncertainty and risk associated with these potential payments, as the Company determined that it could not assert that it was probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company also determined that royalties and sales milestones relate solely to the licenses of intellectual property and are therefore excluded from the transaction price under the sales- or usage-based royalty exception of Topic 606. Revenue related to these royalties and sales milestones will only be recognized when the associated sales occur, and relevant thresholds are met. As such, the entirety of the $1.1 billion transaction price was allocated to the transfer of the co-exclusive licenses for SAGE-217 products and SAGE-324 products in the U.S. and the exclusive licenses for SAGE-217 products and SAGE-324 products in the Biogen Territory and was recognized as license revenue during the year ended December 31, 2020.

In the fourth quarter of 2023, the Company achieved a milestone for the first commercial sale of ZURZUVAE for the treatment of women with PPD in the U.S. and recognized license and milestone revenue – related party of $75.0 million during the fourth quarter of the year ended December 31, 2023. Payment of the $75.0 million milestone was received during January 2024. During the three months ended March 31, 2025 and 2024, no license and milestone revenue – related party was recognized related to the Biogen Collaboration Agreement.

The Company considers the collaborative activities associated with the co-development, co-commercialization, and co-manufacturing of SAGE-217 products and, through the SAGE-324 Termination effective date, SAGE-324 products in the U.S., to be separate units of account within the scope of Topic 808 as the Company and Biogen are both active participants in the development and commercialization activities and are exposed to significant risks and rewards that are dependent on the development and commercial success of the activities in the arrangement.

While Biogen is considered the principal in transactions with customers for the sale of ZURZUVAE globally, the Company is also engaged in significant commercialization activities, including maintaining its own U.S. direct sales force. The Company presents its proportionate share of Biogen’s ZURZUVAE sales to customers in the U.S. as collaboration revenue - related party. Payments to or reimbursements from Biogen related to the agreement of the parties to share equally in all revenue and costs are accounted for as an increase to collaboration revenue, an increase to or reduction of cost of revenues, research and development expenses, or selling, general and administrative expenses, in the consolidated statements of operations and comprehensive loss, depending on the nature of the activity.

To record its proportionate share of collaboration revenue from Biogen’s sales of ZURZUVAE to customers in the U.S., the Company utilizes certain information from Biogen, including revenue from the sale of the product and associated reserves on revenue.

The following table summarizes the Company’s proportionate share of the activity under the Biogen Collaboration Agreement accounted for under Topic 808, including activities associated with the sale of ZURZUVAE in the U.S., as well as costs during the periods related to the development of SAGE-217 products and SAGE-324 products, through February 17, 2025, the SAGE-324 Termination effective date, as reflected in our condensed consolidated statement of operations and comprehensive loss:


	Three Months Ended March 31,
	2025		2024
	(in thousands)
Collaboration revenue - related party	$	13,827	$	6,212
Cost of revenues		725		1,201
Research and development expenses		1,296		7,031
Selling, general and administrative expenses		20,594		12,983

The revenue, cost of revenues, and expense categories in the table below reflect the following reimbursement amounts to (from) Biogen to account for the sharing of economics under the Biogen Collaboration Agreement:


	Three Months Ended March 31,
	2025			2024
	(in thousands)
Collaboration revenue - related party	$	(13,827	)	$	(6,212	)
Cost of revenues		(130	)		(562	)
Research and development expenses		(239	)		(5,657	)
Selling, general and administrative expenses		4,786			2,306

As of March 31, 2025, the Company recorded a collaboration receivable - related party of $10.7 million in the condensed consolidated balance sheet, representing net reimbursement for the amounts due for the three months ended March 31, 2025 and other collaboration revenue for the three months ended March 31, 2025 and three months ended December 31, 2024. As of December 31, 2024, the Company recorded a collaboration receivable – related

party of $9.1 million, representing net reimbursement for the amounts due for the three months ended December 31, 2024.

During the three months ended March 31, 2025, no payments were made to Biogen and the Company received $7.8 million from Biogen for the amounts due for the three months ended December 31, 2024. During the three months ended March 31, 2024, no payments were made to Biogen and the Company received $82.6 million from Biogen for the amounts due for the three months ended December 31, 2023.

During the three months ended March 31, 2025, the Company recorded $0.2 million of other collaboration revenue related to providing development and regulatory support to Biogen in the Biogen Territory under the Biogen Collaboration Agreement. During the three months ended March 31, 2024, no other collaboration revenue was recognized related to the Biogen Collaboration Agreement.

Accounting for the Biogen Stock Purchase Agreement

In connection with the execution of the Biogen Collaboration Agreement, the Company and BIMA entered into the Biogen Stock Purchase Agreement. Pursuant to the Biogen Stock Purchase Agreement, the Company sold the Biogen Shares to BIMA at a price of approximately $104.14 per share for aggregate consideration of $650.0 million. The sale of the shares to BIMA closed on December 31, 2020.

The Biogen Stock Purchase Agreement includes certain standstill provisions that terminate on the earliest of (i) a specified regulatory milestone under the Biogen Collaboration Agreement, (ii) the date one year following the termination of the Biogen Collaboration Agreement and (iii) the seventh anniversary of the Effective Date.

The Company determined the fair value of the common shares was $417.5 million, which was $232.5 million less than the proceeds received from BIMA for the issuance of the Company’s common stock under the Biogen Stock Purchase Agreement. As such, the $232.5 million in excess proceeds was included in the $1.1 billion transaction price of the Biogen Collaboration Agreement determined above.

8. Common Stock

As of March 31, 2025 and December 31, 2024, the Company had 120,000,000 authorized shares of common stock, par value $0.0001 per share.

Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the Board, if any. As of March 31, 2025 and December 31, 2024, no dividends have been declared.

As of March 31, 2025, the Company had received 3,033 shares of the Company’s common stock from an employee as consideration for exercises of stock options. The total cost of shares held in treasury at March 31, 2025 was $0.4 million.

Sales Agreement

On September 16, 2024, the Company entered into a Sales Agreement (the “ATM Sales Agreement”) with TD Securities (USA) LLC, as sales agent (“TD Cowen”), with respect to an “at the market offering” program pursuant to which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $250.0 million (the “Shares”), from time to time through TD Cowen (the “ATM Offering”). Upon the Company’s entry into the ATM Sales Agreement, the prior sales agreement with Cowen and Company, LLC, an affiliate of TD Cowen, dated November 7, 2023 (the “Original Sales Agreement”) was terminated. At the time of such termination, $241.7 million out of an aggregate of $250.0 million of shares remained unsold under the Original Sales Agreement.

Upon delivery of a placement notice, and subject to the terms and conditions of the ATM Sales Agreement, TD Cowen may sell the Shares by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4)

promulgated under the Securities Act of 1933, as amended. The Company may sell the Shares in amounts and at times to be determined by the Company from time to time subject to the terms and conditions of the ATM Sales Agreement, but the Company has no obligation to sell any of the Shares in the ATM Offering.

The Company or TD Cowen may suspend or terminate the ATM Offering upon notice to the other parties and subject to other conditions. TD Cowen will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices, applicable state and federal laws, rules and regulations, and the rules of The Nasdaq Global Market.

The Company has agreed to pay TD Cowen commission for its service in acting as agent in the sale of the Shares in the amount of up to 3.0% of the gross proceeds from the sale of the Shares pursuant to the ATM Sales Agreement.

During the three months ended March 31, 2025, the Company did not sell any shares under the ATM Sales Agreement. During the three months ended March 31, 2024, the Company did not sell any shares under the Original Sales Agreement. As of March 31, 2025, $250.0 million of shares remained available for issuance and sale under the ATM Sales Agreement.

9. Stock-Based Compensation

Equity Plans

On July 2, 2014, the stockholders of the Company approved the 2014 Stock Option and Incentive Plan (the “2014 Plan”), which became effective immediately prior to the completion of the Company’s initial public offering. The 2014 Plan provided for the grant of restricted stock awards, restricted stock units, incentive stock options and non-statutory stock options. The 2014 Plan replaced the Company’s 2011 Stock Option and Grant Plan (the “2011 Plan”).

On June 10, 2024, the stockholders of the Company approved the 2024 Equity Incentive Plan (the “2024 Plan”), which had been previously approved by the Board. Upon stockholder approval, the 2024 Plan became effective immediately and replaced the 2014 Plan. The 2024 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, other stock-based awards, and cash awards. The total number of shares initially reserved for issuance under the 2024 Plan is equal to the sum of (i) 5,500,000 shares of the Company’s common stock and (ii) such additional number of shares of the Company’s common stock (up to 11,002,166 shares) as is equal to the number of shares of common stock subject to awards granted under the 2014 Plan that were outstanding as of June 10, 2024, and which awards expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right (subject, however, in the case of incentive stock options, to any limitations under the Internal Revenue Code of 1986, as amended, and any regulations thereunder).

The Company no longer grants stock options or other awards under either its 2014 Plan or its 2011 Plan, and there are no stock options or other awards outstanding under the 2011 Plan. Any stock options and other awards outstanding under the 2014 Plan remain outstanding and effective in accordance with their terms.

On December 15, 2016, the Board approved the 2016 Inducement Equity Plan (as amended and restated, the “2016 Plan”). The 2016 Plan provides for the grant of equity awards to individuals who have not previously been an employee or a non-employee director of the Company to induce them to accept employment and to provide them with a proprietary interest in the Company. On September 20, 2018, the Board amended the 2016 Plan to increase the total number of shares reserved for issuance by 1,200,000 shares. On April 16, 2024, the Board amended the 2016 Plan to reduce the number of shares reserved for issuance thereunder to 428,074 shares and provide that no further grants may be made under the 2016 Plan after April 16, 2024.

Terms of equity grants, including vesting requirements, are determined by the Board or the Compensation Committee of the Board, subject to the provisions of the applicable plan. Stock options granted by the Company that are not performance-based are considered time-based because they vest based on the continued service of the grantee

with the Company during a specified period following grant. These awards, when granted to employees, generally vest ratably over four years, with 25% vesting at the one-year anniversary, and generally expire 10 years after the date of grant.

As of March 31, 2025, the total number of shares underlying outstanding awards under the 2024 Plan, the 2014 Plan, and the 2016 Plan was 8,782,994, and the total number of shares available for future issuance under the 2024 Plan was 6,214,108 shares.

On June 16, 2022, the Company’s stockholders approved an amendment to the amended 2014 Employee Stock Purchase Plan (the “ESPP”), which had been previously approved by the Board, to add 300,000 shares of common stock to the ESPP. On June 15, 2023, the Company’s stockholders approved another amendment to the ESPP, which had been previously approved by the Board, to add an additional 500,000 shares of common stock to the ESPP. As amended, a total of 1,082,000 shares of common stock have been authorized for issuance under the ESPP. As of March 31, 2025, 715,242 shares have been issued and 366,758 shares are available for future issuance under the ESPP.

Option Exchange Program

On January 23, 2024, the Company initiated a tender offer related to a one-time stock option exchange program pursuant to which eligible non-executive officer employees were given the opportunity to exchange certain outstanding stock options (the “Eligible Options”) to purchase shares of the Company’s common stock for replacement options to purchase a lesser number of shares of common stock (the “Option Exchange”) upon the terms and subject to the conditions set forth in the Offer to Exchange Eligible Options for Replacement Options dated January 23, 2024 (the “Offer to Exchange”). Stock options eligible for exchange had an exercise price per share of $35.00 or greater, in addition to certain other requirements, and were exchanged for replacement options with an exercise price per share equal to the fair market value of the Company’s common stock on the date of grant of the replacement options, which was February 21, 2024. The consummation of the Option Exchange was subject to approval by the Company’s stockholders, which approval was received at the special meeting of stockholders held on January 31, 2024. The Company accepted for exchange Eligible Options to purchase a total of 3,079,608 shares of the Company’s common stock. All tendered Eligible Options were cancelled effective as of February 21, 2024, and promptly thereafter, in exchange thereof, the Company granted replacement options for a total of 1,483,113 shares of the Company’s common stock, pursuant to the terms of the Offer to Exchange and the 2014 Plan. The exercise price per share of the replacement options was $22.20 per share, which was the closing price per share of the Company’s common stock on the Nasdaq Global Market on February 21, 2024. The replacement options vest over 18 months from the date of grant and have a term of seven years.

The Company expects to incur a total of $1.7 million of additional stock-based compensation expense as a result of the Option Exchange, to be recognized over the 18-month vesting period of the replacement options.

Restricted Stock Units

The following table summarizes activity relating to time-based restricted stock units and performance restricted stock units:


	Shares			Weighted Average Grant Date Fair Value
Outstanding as of December 31, 2024		3,000,390		$	30.04
Granted		1,905,452		$	7.43
Vested		(1,144,903	)	$	21.17
Forfeited		(549,248	)	$	29.15
Outstanding as of March 31, 2025		3,211,691		$	19.93

Time-based restricted stock units

During the three months ended March 31, 2025 and 2024, the Company granted 1,493,452 and 857,084 time-based restricted stock units, respectively, to its employees.

During the three months ended March 31, 2025 and 2024, there were 1,144,903 and 69,943 time-based restricted stock units that vested, respectively. The fair value on the date of vesting for the three months ended March 31, 2025 and 2024, was $8.5 million and $1.6 million, respectively.

At March 31, 2025, 1,933,359 time-based restricted stock units were both outstanding and unvested, and the total unrecognized stock-based compensation expense related to these awards was $15.8 million, which is expected to be recognized over the remaining weighted average vesting period of 3.57 years.

Performance restricted stock units

During the three months ended March 31, 2025 and 2024, the Company granted 412,000 and 395,055 performance restricted stock units, respectively, to its employees.

The majority of the performance restricted stock units vest upon the achievement of certain clinical and regulatory development milestones related to product candidates and certain commercial milestones. Certain performance restricted stock units vest upon the Company reaching specified measures of total stockholder return.

Recognition of stock-based compensation expense associated with performance restricted stock units, except for those with milestones that are measures of total stockholder return, commences when the performance condition is considered probable of achievement, using management’s best estimates, which consider the inherent risk and uncertainty regarding the future outcomes of the milestones. Recognition of stock-based compensation expense associated with performance restricted stock units with milestones that are measures of total stockholder return commences on the grant date and is recorded independently of the vesting outcomes of the grants.

As of March 31, 2025, the criteria for one vesting milestone for outstanding performance restricted stock units was considered probable. The Company recognized stock-based compensation expense related to the probable vesting of this performance restricted stock unit of $3.5 million. There remains an estimated $29,000 of expense to be recognized as of March 31, 2025.

No performance restricted stock units vested during the three months ended March 31, 2025 and 2024.

During the three months ended March 31, 2025 and 2024, the Company recorded $0.2 million and $0.3 million, respectively, of stock-based compensation expense, related to performance restricted stock units for which vesting is tied to total stockholder return.

As of March 31, 2025, 1,278,332 performance restricted stock units were both outstanding and unvested, and the total unrecognized stock-based compensation expense related to these awards was $34.4 million.

Stock Option Rollforward

The following table summarizes activity related to time-based and performance-based stock options:


	Shares			Weighted Average Exercise Price		Weighted Average Remaining Life (in years)		Aggregate Intrinsic Value (in thousands)
Outstanding as of December 31, 2024		5,757,824		$	52.52		5.34	$	—
Granted		792,315		$	6.94
Forfeited		(577,884	)	$	58.94
Expired		(400,952	)	$	38.26
Outstanding as of March 31, 2025		5,571,303		$	46.40		6.20	$	910
Exercisable as of March 31, 2025		3,509,054		$	55.73		5.03	$	—

As of March 31, 2025, the Company had unrecognized stock-based compensation expense related to its outstanding and unvested time-based stock option awards of $21.3 million, which is expected to be recognized over the remaining weighted average vesting period of 3.58 years.

There were no stock options exercised during the three months ended March 31, 2025. The intrinsic value of stock options exercised during the three months ended March 31, 2024 was $0.1 million.

Performance-Based Stock Options

Recognition of stock-based compensation expense associated with performance-based stock options commences when the performance condition is considered probable of achievement, using management’s best estimates, which consider the inherent risk and uncertainty regarding the future outcomes of the milestones.

As of March 31, 2025 and 2024, for performance-based stock option grants that were outstanding, the achievement of the milestones that had not been met was considered not probable, and therefore no expense has been recognized related to these awards during the three months ended March 31, 2025 and 2024, respectively.

During the three months ended March 31, 2025 and 2024, the Company granted no stock options to purchase shares of common stock that contain performance-based vesting criteria.

During the three months ended March 31, 2025 and 2024, no milestones were achieved under performance-based stock options.

As of March 31, 2025, 455,000 performance-based stock options were both outstanding and unvested, the total unrecognized stock-based compensation expense related to these awards was $24.9 million before the application of the forfeiture rate and the timing of recognition of this stock-based compensation expense is subject to judgment of the Company as to when the performance conditions are considered probable of being achieved.

Stock-Based Compensation Expense

The following table summarizes stock-based compensation expense recognized during the three months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025		2024
	(in thousands)
Research and development	$	2,056	$	4,965
Selling, general and administrative		4,871		8,733
	$	6,927	$	13,698

The following table summarizes stock-based compensation expense by award type recognized during the three months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025		2024
	(in thousands)
Stock options	$	3,355	$	7,451
Restricted stock units		3,395		5,719
Employee stock purchase plan		177		528
	$	6,927	$	13,698

For stock option awards, the fair value is estimated at the grant date using the Black-Scholes option-pricing model, taking into account the terms and conditions upon which stock options are granted. The fair value of the stock

options is amortized on a straight-line basis for stock option awards to employees, non-employee directors and non-employee consultants over the requisite service period of the awards.

The weighted average grant date fair value per share of stock options granted under the Company’s stock option plans during the three months ended March 31, 2025 and 2024 was $4.85 and $15.11, respectively.

10. Net Loss Per Share

The following table shows the calculation of basic and diluted net loss per share for the three months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025			2024
Basic net loss per share:
Numerator:
Net loss (in thousands)	$	(62,214	)	$	(108,483	)
Denominator:
Weighted average common stock outstanding - basic and diluted		61,857,573			60,136,198
Net loss per share - basic and diluted	$	(1.01	)	$	(1.80	)

The following table summarizes potential dilutive securities outstanding at the end of each reporting period that were excluded from the calculation of diluted net loss per share because including them would have been anti-dilutive as of three months ended March 31, 2025 and 2024:


	Three Months Ended March 31,
	2025		2024
Stock options		5,116,303		6,520,634
Restricted stock units		1,933,359		2,399,564
Employee stock purchase plan		90,352		52,975
		7,140,014		8,973,173

Stock options and restricted stock units that are outstanding and contain performance-based vesting criteria for which the performance conditions have not been met are excluded from the calculation of potential dilutive securities above.

11. Restructuring

In August 2023, the Company implemented a strategic corporate reorganization and reprioritization of its pipeline (the “2023 Restructuring”). The 2023 Restructuring included a reduction of the Company’s workforce by approximately 40%, designed to right-size the organization as the Company worked to achieve sustained growth and support the commercialization of ZURZUVAE to treat women with PPD. During the three months ended March 31, 2025, the Company did not record any related expense. During the three months ended March 31, 2024, the Company recorded a $0.6 million reversal of related expense.

As of March 31, 2025, the Company had paid all 2023 Restructuring charges. Total restructuring charges incurred through March 31, 2025 are $32.9 million, which is the total amount to be incurred.

In October 2024, the Company implemented a plan to reorganize its business operations (the “2024 Restructuring”), including to focus investment on the ongoing launch of ZURZUVAE for the treatment of women with PPD and its prioritized pipeline development efforts. As part of the 2024 Restructuring, the Company implemented a reduction of approximately 33% of the Company’s total workforce and approximately 55% of the Company’s research and development workforce. During the three months ended March 31, 2025, the Company recorded $0.5 million of expense for the 2024 Restructuring, primarily for one-time termination benefits to the

affected employees, primarily consisting of cash payments of severance, healthcare benefits and outplacement assistance.

The Company expects that substantially all of the accrued 2024 Restructuring charges as of March 31, 2025, will be paid in cash by June 30, 2025. Total charges related to the 2024 Restructuring incurred through March 31, 2025 are $22.8 million which is the total expected amount to be incurred.

The following table summarizes activity related to the restructuring accrual inclusive of both the 2023 Restructuring and the 2024 Restructuring:


	Three Months Ended March 31,
	2025			2024
	(in thousands)
Balance as of December 31	$	15,307		$	10,589
Restructuring expenses incurred, net		513			(597	)
Cash paid		(9,042	)		(7,424	)
Non-cash activity		—			—
Balance as of March 31	$	6,778		$	2,568

12. Segment Information

Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company operates as a single reporting segment, focused on discovering, developing and delivering brain health medicines. The Company’s measure of segment profit or loss is net loss. The CODM is the chief executive officer. The CODM manages and allocates resources to the operations of the Company on a total company basis. Managing and allocating resources on a consolidated basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions, therapeutic areas and research and development projects that are in line with the Company’s long-term company-wide strategic goals. Consistent with this decision-making process, the CODM uses consolidated financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Operating expenses are used to monitor budget versus actual results. The CODM also uses net loss in competitive analysis by benchmarking to the Company’s peer group. The competitive analysis along with the monitoring of budgeted versus actual results are used in assessing performance of the segment. All the Company’s long-lived assets are held in the United States and all the Company’s revenues are derived from the United States.

The following table is representative of the significant expense categories regularly provided to the CODM when managing the Company’s single reporting segment. A reconciliation to the consolidated net loss for the three months ended March 31, 2025 and 2024 is included at the bottom of the table below.


		Three Months Ended March 31,

Sage Therapeutics, Inc. 10-Q