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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 December 31, 2025


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

Commission File Number: 001-40782

_________________________________________________

ROIVANT SCIENCES LTD.

(Exact name of Registrant as specified in its Charter)

_________________________________________________


Bermuda			98-1173944
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)


7th Floor 50 Broadway London SW1H 0DB United Kingdom			Not Applicable
1 Pennsylvania Plaza Floor 54 New York, NY1			10119
Viaduktstrasse 8 4051 Basel Switzerland1			Not Applicable
(Addresses of principal executive offices)			(Zip Code)

+44 207 400 3347

(Registrant’s telephone number, including area code)

Not Applicable

(Former Name, former address and former fiscal year, if changed since last report)

_________________________________________________

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 Shares, $0.0000000341740141 per share

ROIV

The Nasdaq Global Select 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 February 2, 2026, the registrant had 715,701,137 common shares, par value $0.0000000341740141 per share, outstanding (the “Common Shares”).

1 Addresses of wholly-owned subsidiaries of the Registrant.

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		Page
PART I—FINANCIAL INFORMATION

Item 1.	Financial Statements (Unaudited)	6

	Condensed Consolidated Balance Sheets as of December 31 , 2025 and March 31, 2025	6

	Condensed Consolidated Statements of Operations for the Three and Nine Months Ended D e cember 31 , 2025 and 2024	7

	Condensed Consolidated Statements of Comprehensive (Loss) Income for the Three and Nine Months Ended December 31, 2025 and 2024	9

	Condensed Consolidated Statements of Shareholders’ Equity for the Three and Nine Months Ended December 3 1 , 2025 and 2024	10

	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended December 3 1 , 2025 and 2024	11

	Notes to Condensed Consolidated Financial Statements	13

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	32

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	47

Item 4.	Controls and Procedures	48

PART II—OTHER INFORMATION

Item 1.	Legal Proceedings	49

Item 1A.	Risk Factors	49

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	121

Item 3.	Defaults Upon Senior Securities	121

Item 4.	Mine Safety Disclosures	121

Item 5.	Other Information	121

Item 6.	Exhibits	122

SIGNATURES		123

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Where You Can Find More Information

Investors and others should note that we may announce material business and financial information to our investors using our investor relations website (https://investor.roivant.com), filings we make with the Securities and Exchange Commission (the “SEC”), our corporate account on the social media platform X (formerly Twitter) (@Roivant), other social media platforms, webcasts, press releases and conference calls. Similarly, Immunovant, Inc., as well as our other subsidiaries, may announce material business and financial information to its investors and others using its investor relations website (https://immunovant.com/investors), filings it makes with the SEC, social media platforms, webcasts, press releases and conference calls. We and our subsidiaries use these mediums to communicate with our and our subsidiaries’ shareholders and the public about our company, our subsidiaries, our product candidates and other matters. It is possible that the information that we make available in this manner may be deemed to be material information. We therefore encourage investors and others interested in our company and our subsidiaries to review this information.

The above-referenced information is not incorporated by reference into this filing and the website addresses and X account name are provided only as inactive textual references.

Summary Risk Factors

You should consider carefully the risks described under “Risk Factors” in Part II, Item 1A. of this Quarterly Report on Form 10-Q. Unless the context otherwise requires, references in this section to “we,” “us,” “our,” “Roivant” and the “Company” refer to Roivant Sciences Ltd. and its consolidated subsidiaries and affiliates, as the context requires. A summary of the risks that could materially and adversely affect our business, financial condition, operating results and prospects include the following:

Risks Related to Our Business and Industry

•Our relatively limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development and commercialization may make it difficult for us to execute on our business model and for you to assess our future prospects.

•We may not be successful in our efforts to acquire or in-license new product candidates, and newly acquired or in-licensed product candidates may not perform as expected in clinical trials or be successful in eventually achieving marketing approvals.

•Immunovant relies on the HanAll Agreement to provide the rights to the core intellectual property relating to IMVT-1402 and batoclimab. Any termination or loss of significant rights under the HanAll Agreement would adversely affect Immunovant’s development and commercialization of IMVT-1402 and batoclimab.

•We will likely incur significant operating losses for the foreseeable future and may never achieve sustained profitability.

•We face risks associated with the allocation of capital and personnel across our businesses.

•We face risks associated with the Vant structure.

•We face risks associated with potential future payments we may owe in connection with our product candidates.

•We face risks associated with acquisitions, divestitures and other strategic transactions.

•We face risks associated with the use of our cash, cash equivalents and marketable securities.

•We are exposed to risks related to our significant holdings of cash, cash equivalents and marketable securities.

•While we do not have a need for additional capital under our current operating plans as a result of our current liquidity position, we may in the future require additional capital to fund our operations. In that case, if we fail to obtain necessary financing when needed, we may not be able to successfully acquire or in-license new

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product candidates, complete the development and commercialization of our product candidates following regulatory approval and continue to pursue our drug discovery efforts.

•Our business strategy and potential for future growth rely on a number of assumptions, some or all of which may not be realized.

•Our drug discovery efforts may not be successful in identifying new product candidates.

•Unfavorable, uncertain and rapidly changing global and regional economic, political and public health conditions could adversely affect our business, financial condition and results of operations.

•A portion of our or certain of our Vants’ manufacturing, laboratory research or clinical trial activities takes place in Asia. A significant disruption in that region, such as a trade war or political unrest, could materially adversely affect our business, financial condition and results of operations.

•Inadequate or uncertain funding levels for the FDA, U.S. Patent and Trademark Office (“USPTO”), SEC or other government agencies could hinder, delay or result in the suspension of those agencies’ operations, which could harm our business.

•Clinical trials and preclinical studies are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials or preclinical studies on the expected timelines, if at all.

•We may encounter difficulties enrolling and retaining patients in clinical trials, and clinical development activities could thereby be delayed or otherwise adversely affected.

•The results of our preclinical studies and clinical trials may not support our proposed claims for our product candidates or regulatory approvals on a timely basis or at all, and the results of earlier studies and trials may not be predictive of future trial results.

•Interim, preliminary or topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

•Changes in methods of product manufacturing or formulation may result in additional costs or delays.

•Obtaining approval of a new drug is an extensive, lengthy, expensive and inherently uncertain process, and the FDA or another regulatory authority may delay, limit or deny approval. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized. If we are unable to obtain regulatory approval in one or more jurisdictions for any of our product candidates, our business will be substantially harmed.

•Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of product candidates that we may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization.

•Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, delay or prevent their regulatory approval, limit the scope of any approved label or market acceptance following regulatory approval or result in significant negative consequences.

•The regulatory approval processes of the FDA and comparable non-U.S. regulatory authorities are lengthy, time consuming and inherently unpredictable, and gaining approval for a product candidate in one country or jurisdiction does not guarantee that we will be able to obtain approval for or commercialize it in any other jurisdiction, which would limit our ability to realize our full market potential.

•We rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner or fail to comply with applicable requirements, it may harm our business.

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•We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of our product candidates.

•We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

•The use of artificial intelligence (“AI”) could expose us to liability or adversely affect our business.

•If we are unable to obtain and maintain patent and other intellectual property protection for our technology and product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

Risks Related to Our Securities, Our Jurisdiction of Incorporation and Certain Tax Matters

•If our performance does not meet market expectations, the price of our securities may decline.

•We have incurred and will continue to incur increased costs as a result of operating as a public company and our management has devoted and will continue to devote a substantial amount of time to new compliance initiatives.

•If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common shares may decline.

•Anti-takeover provisions in our memorandum of association and bye-laws, as well as provisions of Bermuda law, could delay or prevent a change in control, limit the price investors may be willing to pay in the future for our common shares and could entrench management.

•Our largest shareholders own a significant percentage of our common shares and are able to exert significant control over matters subject to shareholder approval.

•Future sales and issuances of our or the Vants’ equity securities or rights to purchase equity securities, including pursuant to our or the Vants’ equity incentive and other compensatory plans, will result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall.

•Future sales, or the perception of future sales, of our common shares by us or our existing shareholders could cause the market price for our common shares to decline and impact our ability to raise capital in the future.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains statements, including matters discussed under Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” Part II, Item 1. “Legal Proceedings,” Part II, Item 1A. “Risk Factors” and in other sections of this report, that are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements contained in this Quarterly Report on Form 10-Q are based on our current expectations and beliefs concerning future developments and their potential effects on us taking into account information currently available to us. There can be no assurance that future developments affecting us will be those that we have anticipated. Should one or more of these risks or uncertainties materialize, they could cause our actual results to differ materially from the forward-looking statements. Some factors that could cause actual results to differ include, but are not limited to risk associated with:

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•our relatively limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development and commercialization;

•our ability to acquire or in-license new product candidates;

•the allocation of capital and personnel across our businesses;

•our Vant structure;

•potential future payments we may owe in connection with our product candidates;

•acquisitions, divestitures and other strategic transactions;

•the use of our cash, cash equivalents and marketable securities;

•the potential future need for additional capital to fund our operations;

•unfavorable, uncertain and rapidly changing global and regional economic, political and public health conditions;

•the fact that designing and implementing clinical trials and preclinical studies is very expensive, time-consuming and difficult;

•difficulties we may encounter enrolling and retaining patients in clinical trials, which could adversely affect or otherwise delay clinical development activities;

•the results of our preclinical studies and clinical trials not supporting our proposed claims for a product candidate or regulatory approval;

•interim, preliminary or topline data from our clinical trials changing as more data become available or data being delayed due to audit or verification procedures;

•changes in product candidate manufacturing or formulation that could result in additional costs or delays;

•the fact that obtaining approval of a new drug is an extensive, lengthy, expensive and inherently uncertain process and the FDA or another regulatory authority may delay, limit or deny approval;

•the failure of our clinical trials to demonstrate substantial evidence of the safety and efficacy of our product candidates;

•undesirable side effects caused by our product candidates that halt their clinical development, delay or prevent their regulatory approval, limit the scope of any approved label or market acceptance or result in negative consequences;

•our inability to obtain regulatory approval for a product candidate in certain jurisdictions, even if we are able to obtain approval in certain other jurisdictions;

•the failure of any third-party we rely upon to conduct, supervise and monitor our clinical trials to perform in a satisfactory manner or to comply with applicable legal, regulatory or other requirements;

•our reliance on third parties to produce clinical and commercial supplies of our product candidates;

•our dependence on key personnel and our ability to attract, motivate and retain highly qualified personnel;

•the potential that our use of AI could expose us to liability;

•our ability to obtain and maintain patent and other intellectual property protection for our technology and product candidates;

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•the failure to issue (or the threatening of their validity, patentability, enforceability, breadth or strength of protection) or provide meaningful exclusivity for our product candidates of our patent applications that we own or have in-licensed;

•the inadequacy of patent terms and their scope to protect our competitive position;

•the fact that our largest shareholders own a significant percentage of our stock and will be able to exert significant control over matters subject to shareholder approval;

•dilution of ownership caused by future sales and issuances of our or the Vants’ equity securities or rights to purchase equity securities;

•future sales, or the perception of future sales, of our common shares by us or our existing shareholders, and the impact thereof on the price of our common shares;

•the outcome of any pending or potential litigation, including but not limited to our expectations regarding the outcome of any such litigation and costs and expenses associated with such litigation;

•changes in applicable laws or regulations;

•the possibility that we may be adversely affected by other economic, business or competitive factors; and

•any other risks and uncertainties, including those described under Part II, Item IA. “Risk Factors.”

These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. References to our “product candidates” include our current and any future products or product candidates. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These forward-looking statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

ROIVANT SCIENCES LTD.

Condensed Consolidated Balance Sheets

(unaudited, in thousands, except share and per share amounts)


	December 31, 2025		March 31, 2025
Assets
Current assets:
Cash and cash equivalents	$	1,478,270	$	2,715,411
Marketable securities (held at fair value as of December 31, 2025)	3,051,708		2,171,480
Other current assets	129,912		113,173
Total current assets	4,659,890		5,000,064
Property and equipment, net	13,447		12,056
Operating lease right-of-use assets	83,561		89,021
Investments measured at fair value	433,907		302,939
Other assets	34,563		32,860
Total assets	$	5,225,368	$	5,436,940
Liabilities and Shareholders’ Equity
Current liabilities:
Accounts payable	$	13,294	$	23,691
Accrued expenses	117,991		114,294
Operating lease liabilities	10,436		9,842
Other current liabilities	10,243		1,584
Total current liabilities	151,964		149,411
Liability instruments measured at fair value	—		9,981
Operating lease liabilities, noncurrent	98,503		90,328
Other liabilities	677		22
Total liabilities	251,144		249,742
Commitments and contingencies (Note 11)
Shareholders’ equity:
Common shares, par value $0.0000000341740141 per share, 7,000,000,000 shares authorized and 709,689,411 and 695,938,323 shares issued and outstanding at December 31, 2025 and March 31, 2025, respectively	—		—
Additional paid-in capital	4,943,643		4,562,107
(Accumulated deficit) / retained earnings	(694,998)		116,060
Accumulated other comprehensive income	20,610		9,438
Shareholders’ equity attributable to Roivant Sciences Ltd.	4,269,255		4,687,605
Noncontrolling interests	704,969		499,593
Total shareholders’ equity	4,974,224		5,187,198
Total liabilities and shareholders’ equity	$	5,225,368	$	5,436,940

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

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ROIVANT SCIENCES LTD.

Condensed Consolidated Statements of Operations

(unaudited, in thousands, except share and per share amounts)


	Three Months Ended December 31,				Nine Months Ended December 31,
	2025		2024		2025		2024
Revenue	$	1,999	$	9,018	$	5,740	$	21,483
Operating expenses:
Cost of revenues	700		259		965		706
Research and development (includes $18,123 and $9,685 of share-based compensation expense for the three months ended December 31, 2025 and 2024 and $40,218 and $30,128 for the nine months ended December 31, 2025 and 2024, respectively)	165,380		141,595		482,867		405,175
General and administrative (includes $86,874 and $69,386 of share-based compensation expense for the three months ended December 31, 2025 and 2024 and $228,778 and $165,670 for the nine months ended December 31, 2025 and 2024, respectively)	175,072		141,545		452,216		444,318
Total operating expenses	341,152		283,399		936,048		850,199
Gain on sale of Telavant net assets	—		—		—		110,387
Loss from operations	(339,153)		(274,381)		(930,308)		(718,329)
Change in fair value of investments	(21,592)		21,314		(130,968)		(42,287)
Change in fair value of liability instruments	24,416		(2,147)		47,704		(1,632)
Interest income	(43,266)		(61,851)		(136,929)		(203,751)
Other (income) expense, net	(8,342)		2,816		8,560		7,877
Loss from continuing operations before income taxes	(290,369)		(234,513)		(718,675)		(478,536)
Income tax expense (benefit)	23,332		(25,568)		34,976		(1,147)
Loss from continuing operations, net of tax	(313,701)		(208,945)		(753,651)		(477,389)
Income from discontinued operations, net of tax	—		327,020		—		373,030
Net (loss) income	(313,701)		118,075		(753,651)		(104,359)
Net loss attributable to noncontrolling interests	(47,810)		(51,306)		(150,886)		(138,853)
Net (loss) income attributable to Roivant Sciences Ltd.	$	(265,891)	$	169,381	$	(602,765)	$	34,494

Amounts attributable to Roivant Sciences Ltd.:
Loss from continuing operations, net of tax	$	(265,891)	$	(157,639)	$	(602,765)	$	(338,691)
Income from discontinued operations, net of tax	—		327,020		—		373,185
Net (loss) income attributable to Roivant Sciences Ltd.	$	(265,891)	$	169,381	$	(602,765)	$	34,494

Basic and diluted net (loss) income per common share:
Basic and diluted loss from continuing operations	$	(0.38)	$	(0.22)	$	(0.88)	$	(0.46)
Basic and diluted income from discontinued operations	$	—	$	0.45	$	—	$	0.51
Basic and diluted net (loss) income per common share	$	(0.38)	$	0.23	$	(0.88)	$	0.05

Weighted average shares outstanding:
Basic	696,859,682		722,716,168		686,052,379		731,318,202
Diluted	696,859,682		722,716,168		686,052,379		731,318,202

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

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ROIVANT SCIENCES LTD.

Condensed Consolidated Statements of Comprehensive (Loss) Income

(unaudited, in thousands)


	Three Months Ended December 31,				Nine Months Ended December 31,
	2025		2024		2025		2024
Net (loss) income	$	(313,701)	$	118,075	$	(753,651)	$	(104,359)
Other comprehensive income:
Change in fair value of debt due to change in subsidiary credit risk	—		2,300		—		(1,200)
Unrealized gains on available-for-sale securities	1,213		—		4,264		—
Foreign currency translation adjustment	76		3,941		7,552		(6,185)
Amounts reclassified from accumulated other comprehensive income	(347)		19,869		(347)		19,869
Total other comprehensive income	942		26,110		11,469		12,484
Comprehensive (loss) income	(312,759)		144,185		(742,182)		(91,875)
Comprehensive loss attributable to noncontrolling interests	(47,920)		(51,289)		(150,589)		(138,509)
Comprehensive (loss) income attributable to Roivant Sciences Ltd.	$	(264,839)	$	195,474	$	(591,593)	$	46,634

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

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ROIVANT SCIENCES LTD.

Condensed Consolidated Statements of Shareholders’ Equity

(unaudited, in thousands, except share data)


	Shareholders’ Equity
	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Income		Retained Earnings / (Accumulated Deficit)		Noncontrolling Interests		Total Shareholders’ Equity
	Shares	Amount
Balance at March 31, 2025	695,938,323	$	—	$	4,562,107	$	9,438	$	116,060	$	499,593	$	5,187,198
Issuance of the Company’s common shares in connection with equity incentive plans, net of forfeitures, and tax withholding payments	6,560,959	—		16,912		—		—		—		16,912
Exercise and vesting of subsidiary share awards	—	—		2,325		—		—		1,288		3,613
Cash contributions to majority-owned subsidiaries	—	—		(290)		—		—		290		—
Unrealized gains on available-for-sale securities	—	—		—		470		—		—		470
Repurchase of the Company’s common shares	(20,269,450)	—		—		—		(208,293)		—		(208,293)
Share-based compensation	—	—		63,031		—		—		19,147		82,178
Foreign currency translation adjustment	—	—		—		7,229		—		510		7,739
Net loss	—	—		—		—		(223,355)		(50,556)		(273,911)
Balance at June 30, 2025	682,229,832	$	—	$	4,644,085	$	17,137	$	(315,588)	$	470,272	$	4,815,906
Issuance of the Company’s common shares in connection with equity incentive plans, net of forfeitures, and tax withholding payments	7,386,746	—		45,569		—		—		—		45,569
Exercise and vesting of subsidiary share awards	—	—		14,110		—		—		10,999		25,109
Cash contributions to majority-owned subsidiaries	—	—		(503)		—		—		503		—
Unrealized gains on available-for-sale securities	—	—		—		2,581		—		—		2,581
Issuance of the Company’s common shares under employee stock purchase plan	80,792	—		774		—		—		—		774
Share-based compensation	—	—		67,845		—		—		13,976		81,821
Foreign currency translation adjustment	—	—		—		(160)		—		(103)		(263)
Net loss	—	—		—		—		(113,519)		(52,520)		(166,039)
Balance at September 30, 2025	689,697,370	$	—	$	4,771,880	$	19,558	$	(429,107)	$	443,127	$	4,805,458
Issuance of the Company’s common shares in connection with equity incentive plans and tax withholding payments	19,992,041	—		65,422		—		—		—		65,422
Vesting of Earn-Out Shares	—	—		57,685		—		—		—		57,685
Issuance of subsidiary common shares, net of issuance costs	—	—		108,902		—		—		84,703		193,605
Contribution from minority interest holder to subsidiary	—	—		—		—		—		39,250		39,250
Exercise and vesting of subsidiary share awards	—	—		8,063		—		—		13,522		21,585
Issuance of subsidiary common shares to the Company and cash contributions to majority-owned subsidiaries	—	—		(160,357)		—		—		160,357		—
Repurchase of subsidiary common shares	—	—		(1,318)		—		—		(82)		(1,400)
Issuance of the Company’s common shares under employee stock purchase plan	—	—		381		—		—		—		381
Share-based compensation	—	—		92,985		—		—		12,012		104,997
Amounts reclassified from accumulated other comprehensive income	—	—		—		(347)		—		—		(347)
Unrealized gains on available-for-sale securities	—	—		—		1,213		—		—		1,213
Foreign currency translation adjustment	—	—		—		186		—		(110)		76
Net loss	—	—		—		—		(265,891)		(47,810)		(313,701)
Balance at December 31, 2025	709,689,411	$	—	$	4,943,643	$	20,610	$	(694,998)	$	704,969	$	4,974,224


	Shareholders’ Equity
	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive (Loss) Income		Retained Earnings		Noncontrolling Interests		Total Shareholders’ Equity
	Shares	Amount
Balance at March 31, 2024	806,677,954	$	—	$	5,396,492	$	(4,083)	$	576,172	$	479,948	$	6,448,529
Issuance of the Company’s common shares in connection with equity incentive plans and tax withholding payments	3,626,235	—		(11,147)		—		—		—		(11,147)
Issuance of subsidiary common shares, net	—	—		11,647		—		—		—		11,647
Exercise and vesting of subsidiary share awards	—	—		433		—		—		312		745
Cash contributions to majority-owned subsidiaries	—	—		(69)		—		—		69		—
Repurchase of common shares	(71,251,083)	—		(648,385)		—		—		—		(648,385)
Share-based compensation	—	—		32,817		—		—		17,422		50,239
Change in fair value of debt due to change in subsidiary credit risk	—	—		—		(10,600)		—		—		(10,600)
Foreign currency translation adjustment	—	—		—		(3,265)		—		33		(3,232)
Net income (loss)	—	—		—		—		95,297		(37,807)		57,490
Balance at June 30, 2024	739,053,106	$	—	$	4,781,788	$	(17,948)	$	671,469	$	459,977	$	5,895,286
Issuance of the Company’s common shares in connection with equity incentive plans and tax withholding payments	3,226,784	—		(2,597)		—		—		—		(2,597)
Exercise and vesting of subsidiary share awards	—	—		430		—		—		332		762
Issuance of the Company’s common shares under employee stock purchase plan	72,143	—		648		—		—		—		648
Cash contributions to majority-owned subsidiaries	—	—		(119)		—		—		119		—
Repurchase of common shares	(9,023,658)	—		(60,349)		—		(45,705)		—		(106,054)
Share-based compensation	—	—		55,610		—		—		16,105		71,715
Change in fair value of debt due to change in subsidiary credit risk	—	—		—		7,100		—		—		7,100
Foreign currency translation adjustment	—	—		—		(7,188)		—		294		(6,894)
Net loss	—	—		—		—		(230,184)		(49,740)		(279,924)
Balance at September 30, 2024	733,328,375	$	—	$	4,775,411	$	(18,036)	$	395,580	$	427,087	$	5,580,042
Issuance of the Company’s common shares in connection with equity incentive plans and tax withholding payments	7,055,968	—		16,915		—		—		—		16,915
Sale of interests in subsidiary	—	—		—		—		—		(48,079)		(48,079)
Exercise and vesting of subsidiary share awards	—	—		1,444		—		—		1,129		2,573
Issuance of subsidiary common shares to the Company and cash contributions to majority-owned subsidiaries	—	—		(280)		—		—		280		—
Repurchase of common shares	(20,751,976)	—		(138,785)		—		(104,563)		—		(243,348)
Share-based compensation	—	—		66,312		—		—		17,370		83,682
Change in fair value of debt due to change in subsidiary credit risk	—	—		—		2,300		—		—		2,300
Foreign currency translation adjustment	—	—		—		3,924		—		17		3,941
Amounts reclassified from accumulated other comprehensive (loss) income	—	—		—		19,869		—		—		19,869
Net income (loss)	—	—		—		—		169,381		(51,306)		118,075
Balance at December 31, 2024	719,632,367	$	—	$	4,721,017	$	8,057	$	460,398	$	346,498	$	5,535,970

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

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ROIVANT SCIENCES LTD.

Condensed Consolidated Statements of Cash Flows

(unaudited, in thousands)


	Nine Months Ended December 31,
	2025		2024
Cash flows from operating activities:
Net loss	$	(753,651)	$	(104,359)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation	268,996		205,541
Change in fair value of investments	(130,968)		(42,287)
Change in fair value of debt and liability instruments	47,704		(98,954)
Gain on sale of subsidiary interests	—		(376,506)
Gain on sale of Telavant net assets	—		(110,387)
Impairment loss on operating lease right-of-use assets	15,594		—
Accretion of discount and amortization of premium on marketable securities, net	(29,606)		(54,304)
Realized gain from sales of marketable securities	(347)		—
Loss on extinguishment of debt	—		8,848
Depreciation and amortization	2,710		12,646
Non-cash lease expense	6,412		4,871
Other	7,344		(465)
Changes in assets and liabilities, net of effects from acquisition and divestiture:
Other current assets	(6,995)		(53,922)
Accounts payable	(12,737)		(18,003)
Accrued expenses	(3,900)		(19,507)
Operating lease liabilities	(2,110)		(5,459)
Other	5,023		(14,639)
Net cash used in operating activities	(586,531)		(666,886)
Cash flows from investing activities:
Purchases of marketable securities	(3,792,124)		(4,061,521)
Proceeds from maturities of marketable securities	2,745,000		960,000
Proceeds from sales of marketable securities	200,766		—
Purchase of property and equipment	(6,948)		(3,788)
Proceeds from sale of subsidiary interests	—		185,586
Proceeds from sale of Telavant net assets, net	—		110,387
Cash decrease upon deconsolidation of subsidiaries	—		(31,149)
Other	(2,518)		—
Net cash used in investing activities	(855,824)		(2,840,485)
Cash flows from financing activities:
Proceeds from issuance of subsidiary common shares, net of issuance costs paid	193,605		—

Contribution from minority interest holder to subsidiary	39,250		—
Repayment of debt by subsidiary	—		(51,979)
Payments on principal portion of finance lease obligations	—		(774)
Proceeds from exercise of the Company’s and subsidiary stock options	217,165		37,006
Taxes paid related to net settlement of equity awards	(39,869)		(29,755)
Repurchase of the Company’s common shares	(208,293)		(997,787)

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Proceeds from issuance of the Company’s common shares under employee stock purchase plan	1,155		648
Net cash provided by (used in) financing activities	203,013		(1,042,641)
Effect of exchange rate changes on cash, cash equivalents, and restricted cash	2,451		1,236
Net change in cash, cash equivalents and restricted cash	(1,236,891)		(4,548,776)
Cash, cash equivalents and restricted cash at beginning of period	2,725,661		6,550,450
Cash, cash equivalents and restricted cash at end of period	$	1,488,770	$	2,001,674
Non-cash investing and financing activities:
Issuance of subsidiary shares in connection with Debt Renegotiation	$	—	$	11,647
Operating lease right-of-use assets obtained and exchanged for operating lease liabilities	$	9,141	$	51,266
Reclassification of earn-out shares liability to additional paid-in capital upon vesting	$	57,685	$	—
Other	$	9,909	$	159

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

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ROIVANT SCIENCES LTD.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Note 1—Description of Business and Liquidity

(A) Description of Business

Roivant Sciences Ltd. (inclusive of its consolidated subsidiaries, the “Company” or “RSL”) aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. The Company does this by creating nimble subsidiaries or “Vants” to develop and commercialize its medicines and technologies. Beyond therapeutics, the Company also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. The Company was founded on April 7, 2014 as a Bermuda exempted limited company.

The Company’s subsidiaries are wholly owned subsidiaries and majority-owned or controlled subsidiaries. Refer to Note 4, “Equity Method Investments” for further discussion of the Company’s investments in unconsolidated entities.

(B) Liquidity

Historically, the Company has incurred significant operating losses and negative cash flows from operations since its inception. In December 2023, the Company sold its entire equity interest in its majority-owned subsidiary Telavant Holdings, Inc. (“Telavant”). At closing, the Company received approximately $5.2 billion in cash. As of December 31, 2025, the Company had cash, cash equivalents, and marketable securities of approximately $4.5 billion and its accumulated deficit was $695.0 million. For the nine months ended December 31, 2025 and 2024, the Company incurred net losses from continuing operations of $753.7 million and $477.4 million, respectively. The Company has historically financed its operations primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements.

The Company is subject to risks common to companies in the biopharmaceutical industry including, but not limited to, uncertainties related to commercialization of products, regulatory approvals to market its product candidates, dependence on key products, dependence on third-party service providers, such as contract research organizations, and protection of intellectual property rights. Management expects to incur additional losses in the future to fund its operations and conduct product research and development and may require additional capital to fully implement its business plan.

Note 2—Summary of Significant Accounting Policies

(A) Basis of Presentation and Principles of Consolidation

The Company’s fiscal year ends on March 31, and its fiscal quarters end on June 30, September 30, and December 31.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and follow the requirements of the United States Securities and Exchange Commission (“SEC”) for interim financial reporting. Accordingly, these unaudited condensed consolidated financial statements do not include all of the information and disclosures required by U.S. GAAP for complete financial statements as certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. The unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements.

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These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2025 filed with the SEC. The unaudited condensed consolidated balance sheet at March 31, 2025 has been derived from the audited consolidated financial statements at that date. In the opinion of management, the unaudited condensed consolidated financial statements include all adjustments, which include only normal recurring adjustments, that are considered necessary to present fairly the financial position of the Company and its results of operations and cash flows for the interim periods presented. Operating results for the three and nine months ended December 31, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending March 31, 2026, for any other interim period, or for any other future year.

Any references in these notes to applicable accounting guidance are meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The unaudited condensed consolidated financial statements include the accounts of RSL and the subsidiaries in which it has a controlling financial interest, most often through a majority voting interest. All intercompany balances and transactions have been eliminated in consolidation.

For consolidated entities where the Company owns or is exposed to less than 100% of the economics, the Company records net loss attributable to noncontrolling interests in its unaudited condensed consolidated statements of operations equal to the noncontrolling interest’s proportionate share of the respective operations. The Company presents noncontrolling interests as a component of shareholders’ equity on its unaudited condensed consolidated balance sheets.

The Company accounts for changes in its ownership interest in its subsidiaries while control is retained as equity transactions. The carrying amount of the noncontrolling interest is adjusted to reflect the change in the ownership interest in the subsidiary. Any difference between the fair value of the consideration received or paid and the amount by which the noncontrolling interest is adjusted is recognized within shareholders’ equity attributable to RSL.

In September 2024, the Company’s subsidiary, Dermavant Sciences Ltd. (“Dermavant”), entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Organon & Co. (“Organon”), Organon Bermuda Ltd., an indirect wholly owned subsidiary of Organon (“Merger Sub”), and the Company, solely in its capacity as the representative of the securityholders of Dermavant. Organon’s acquisition of Dermavant (the “Dermavant Transaction”) was completed in October 2024 and the Company determined the acquisition met the discontinued operations accounting criteria. As the Dermavant Transaction closed in October 2024, no Dermavant assets or liabilities were recognized on the balance sheet as of March 31, 2025 or December 31, 2025. The Company classified the results of Dermavant as discontinued operations in its condensed consolidated statements of operations for the three and nine months ended December 31, 2024. The cash flows related to discontinued operations have not been segregated and are included in the condensed consolidated statements of cash flows. The discussions in these notes to the condensed consolidated financial statements relate solely to the Company’s continuing operations, unless otherwise noted. For further information on the discontinued operations related to Dermavant, refer to Note 6, “Discontinued Operations.”

(B) Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company regularly evaluates estimates and assumptions related to assets, liabilities, costs, expenses, contingent liabilities, share-based compensation and research and development costs. The Company bases its estimates and assumptions on historical experience and on various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates.

Financial instruments that potentially subject the Company to credit risk concentration include cash, cash equivalents, and marketable securities. The Company maintains cash deposits, cash equivalents, and marketable securities in highly-rated, federally-insured financial institutions in excess of federally insured limits. The Company has established guidelines relative to diversification and maturities to maintain safety and liquidity. The Company has not experienced any credit losses related to these financial instruments and does not believe that it is exposed to any significant credit risk related to these instruments.

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The Company has long-lived assets in different geographic locations. As of December 31, 2025 and March 31, 2025, a majority of the Company’s long-lived assets were located in the United States (“U.S.”).

(D) Segment Reporting

Operating segments are defined as components of an entity about which separate, discrete information is available for evaluation by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker views the operations and manages the business in a single operating and reportable segment focused on the discovery, development and commercialization of medicines and technologies. The accounting policies of the segment are the same as those described in this Note 2, “Summary of Significant Accounting Policies.” See Note 15, “Segment Information” for further detail.

(E) Cash, Cash Equivalents, and Restricted Cash

Cash and cash equivalents include cash deposits in banks and all highly liquid investments that are readily convertible to cash. The Company considers all highly liquid investments purchased with original maturities of three months or less to be cash equivalents. Cash equivalents consist of amounts invested in money market funds.

Cash as reported in the accompanying condensed consolidated statements of cash flows includes the aggregate amounts of cash, cash equivalents, and restricted cash as presented on the accompanying condensed consolidated balance sheets as follows (in thousands):


	December 31, 2025		March 31, 2025
Cash and cash equivalents	$	1,478,270	$	2,715,411
Restricted cash (included in “Other current assets”)	2,608		2,358
Restricted cash (included in “Other assets”)	7,892		7,892
Cash, cash equivalents and restricted cash	$	1,488,770	$	2,725,661

(F) Marketable Securities

The Company considers all highly liquid investments in securities with original maturities of greater than three months at the time of purchase to be marketable securities. As of December 31, 2025, marketable securities consist of amounts invested in U.S. Treasury securities and are classified as available-for-sale and carried at fair value. Prior to December 31, 2025, a portion of the Company’s marketable securities were classified as held-to-maturity and carried at amortized cost. Unrealized holding gains and losses, net of income taxes, on available-for-sale debt securities are reflected as a separate component of shareholders’ equity until realized. The cost of available-for-sale securities sold and the amount reclassified out of accumulated other comprehensive income into earnings is determined using the specific identification method. Interest income is recorded as earned within “Interest income” in the condensed consolidated statements of operations.

(G) Contingencies

The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company continually assesses any litigation or other claims it may confront to determine if an unfavorable outcome would lead to a probable loss or reasonably possible loss which could be estimated. The Company accrues for all contingencies at the earliest date at which the Company deems it probable that a liability has been incurred and the amount of such liability can be reasonably estimated. If the estimate of a probable loss is a range and no amount within the range is more likely than another, the Company accrues the minimum of the range. In the cases where the Company believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the contingent loss, including an estimable range, if possible.

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(H) Investments

Investments in equity securities for which the Company does not have control or significant influence may be accounted for using (i) the fair value option, if elected, (ii) fair value through earnings, if fair value is readily determinable or (iii) for equity investments without readily determinable fair values, the measurement alternative to measure at cost adjusted for any impairment and observable price changes, as applicable. The election to use the measurement alternative is made for each eligible investment.

The Company has elected the fair value option to account for certain investments over which the Company has significant influence. The Company believes the fair value option best reflects the underlying economics of the investment. See Note 4, “Equity Method Investments.”

(I) Fair Value Measurements

The Company utilizes fair value measurement guidance prescribed by U.S. GAAP to value its financial instruments. The guidance establishes a fair value hierarchy for financial instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. Fair value is defined as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the reporting date. As a basis for considering market participant assumptions in fair value measurements, the guidance establishes a three-tier fair value hierarchy that distinguishes among the following:

•Level 1-Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities.

•Level 2-Valuations are based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly.

•Level 3-Valuations are based on inputs that are unobservable (supported by little or no market activity) and significant to the overall fair value measurement.

To the extent the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

The Company’s financial instruments include shares of common stock of Arbutus Biopharma Corporation (“Arbutus”) and Class A units of Heracles Parent, L.L.C. (“Datavant”). The Company’s financial instruments also include liability instruments issued, including the earn-out shares liabilities (prior to vesting during the quarter ended December 31, 2025) issued in connection with the Company’s business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”) (as discussed in Note 12, “Earn-Out Shares”); its investments in other entities; cash; cash equivalents, consisting of money market funds; marketable securities, consisting of U.S. Treasury securities; and accounts payable.

The shares of Arbutus common stock are classified as Level 1, and their fair value is determined based upon quoted market prices in active markets. The Class A units of Datavant and liability instruments issued are classified as Level 3 within the fair value hierarchy as the assumptions and estimates used in the valuations are unobservable in the market. Cash and accounts payable are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature. Money market funds are included in Level 1 of the fair value hierarchy and are valued at the closing price reported by an actively traded exchange. Marketable securities are included in Level 2 of the fair value hierarchy, are classified as available-for-sale (or held-to-maturity prior to December 31, 2025), and are carried at fair value or amortized cost, respectively.

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(J) Share-Based Compensation

Share-based awards to employees, directors, and consultants include stock options, restricted stock units (“RSUs”), performance options, performance restricted stock units (“PSUs”) and capped value appreciation rights (“CVARs”).

The Company measures the fair value of its stock options that only have service vesting requirements or performance-based options without market conditions using the Black-Scholes option pricing model. Certain assumptions need to be made with respect to utilizing the Black-Scholes option pricing model, including the expected life of the award, volatility of the underlying shares, the risk-free interest rate and the fair value of the Company’s shares of common stock. Since the Company has limited option exercise history, it has generally elected to estimate the expected life of an award based upon the “simplified method” with the continued use of this method extended until such time the Company has sufficient exercise history. In prior fiscal years, because the Company did not have sufficient trading history to rely on the volatility of its common stock, volatility was estimated by taking the average historical price volatility for comparable publicly traded peer companies. Beginning on April 1, 2025, the Company began using a blend of its historical and implied volatility to estimate the expected share price volatility assumption. Due to changes in the Company’s capital position, the Company believes this methodology better reflects its expected future volatility. The risk-free interest rate is based on the rates paid on securities issued by the U.S. Treasury with a term approximating the expected life of the equity award. The Company accounts for pre-vesting award forfeitures when they occur. As RSL’s common shares are publicly traded, the Company determines the fair value of each common share underlying share-based awards based on the closing price of its common shares as reported by Nasdaq on the date of grant. For privately held Vants, the fair value of the shares of common stock underlying share-based awards on each grant date is estimated, given the absence of a public trading market.

(K) Foreign Currency

The Company’s functional and reporting currency is the U.S. dollar. For the Company’s subsidiaries whose functional currency is other than the U.S. dollar, assets and liabilities are translated into U.S. dollars at the exchange rates in effect at the balance sheet date, while their revenue and expenses are translated at the average exchange rates for the reporting period. The cumulative foreign currency translation adjustments are recorded as a component of “Accumulated other comprehensive income” in the accompanying condensed consolidated statement of shareholders’ equity.

Transaction gains and losses that arise from exchange rate fluctuations on transactions denominated in a currency other than the functional currency are included in “Other (income) expense, net” in the accompanying condensed consolidated statements of operations. For the nine months ended December 31, 2025, foreign currency transaction losses were $7.1 million. Foreign currency transaction losses were de minimis for the nine months ended December 31, 2024.

(L) Significant Accounting Policies

There were no significant changes to the Company’s significant accounting policies from those disclosed in the Company’s Form 10-K for the year ended March 31, 2025.

(M) Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of their specified effective dates.

In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which requires updates to the income tax disclosures related to the rate reconciliation and disaggregation of income taxes paid by jurisdiction. The amendments are effective for fiscal years beginning after December 15, 2024 and are applicable to the Company’s fiscal year beginning April 1, 2025, with early adoption permitted. The amendments should be applied prospectively, however retrospective application is permitted. The Company expects adoption of this ASU will result in expanded disclosures in line with the requirements of ASU 2023-09.

In November 2024, the FASB issued ASU 2024-03, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses,” which requires disclosure of certain costs and expenses on an interim and annual basis in the notes to the financial statements. The amendments are effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. This ASU is applicable to the Company’s Annual Report on Form 10-K for the fiscal

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year ended March 31, 2028, and subsequent interim periods, with early adoption permitted. The amendments can be adopted either (i) prospectively to financial statements issued for reporting periods after the effective date of this ASU or (ii) retrospectively to any or all prior periods presented in the financial statements. The Company expects adoption of this ASU will result in additional disclosures in line with the requirements of ASU 2024-03.

In September 2025, the FASB issued ASU 2025-07, “Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract,” which refines the scope of the guidance on derivatives in ASC 815 and clarifies the guidance on share-based payments from a customer in ASC 606. This guidance is effective for fiscal years and interim periods beginning after December 15, 2026, with early adoption permitted. These requirements may be applied prospectively or on a modified retrospective basis through a cumulative-effect adjustment to the opening balance of retained earnings. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements.

Note 3—Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents, and marketable securities consisted of the following (in thousands):


	December 31, 2025		March 31, 2025
Cash and cash equivalents
Cash	$	91,940	$	93,954
Money market funds	1,386,330		2,621,457
Total cash and cash equivalents	$	1,478,270	$	2,715,411
Marketable securities
U.S. Treasury securities, available-for-sale	$	3,051,708	$	—
U.S. Treasury securities, held-to-maturity	—		2,171,480
Total marketable securities	$	3,051,708	$	2,171,480

Total cash, cash equivalents, and marketable securities	$	4,529,978	$	4,886,891

The following table summarizes the unrealized positions for the Company’s marketable securities (in thousands):


	As of December 31, 2025
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value
U.S. Treasury securities, available-for-sale	$	3,047,791	$	3,917	$	—	$	3,051,708

Total marketable securities	$	3,047,791	$	3,917	$	—	$	3,051,708


	As of March 31, 2025
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value
U.S. Treasury securities, held-to-maturity	$	2,171,480	$	1,267	$	(463)	$	2,172,284
Total marketable securities	$	2,171,480	$	1,267	$	(463)	$	2,172,284

The Company classified its marketable securities as Level 2 measurements within the fair value hierarchy. As of December 31, 2025, the contractual maturities of all marketable securities were less than 12 months.

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Note 4—Equity Method Investments

The Company maintains equity method investments in certain entities. As of December 31, 2025 and March 31, 2025, the most significant of these were the Company’s investments in Arbutus and Datavant, which are accounted for using the fair value option.

The Company determined that it does not control these entities and as a result does not consolidate these entities. Due to the Company’s significant influence over operating and financial policies of these entities, the entities are considered related parties of the Company.

Investment in Arbutus

The Company holds an investment in Arbutus in the form of 38,847,462 common shares of Arbutus. As of December 31, 2025, RSL held approximately 20% of the issued and outstanding shares of Arbutus.

At December 31, 2025 and March 31, 2025, the aggregate fair value of the Company’s investment in Arbutus was $186.9 million and $135.6 million, respectively. The fair value of the Company’s investment was determined using the closing price of Arbutus’s common stock on December 31, 2025 and March 31, 2025 of $4.81 and $3.49, respectively. During the three and nine months ended December 31, 2025, the Company recognized unrealized gains of $10.5 million and $51.3 million on its investment in Arbutus, respectively, in the accompanying condensed consolidated statements of operations. During the three and nine months ended December 31, 2024, the Company recognized an unrealized loss of $22.5 million and an unrealized gain of $26.8 million on its investment in Arbutus, respectively, in the accompanying condensed consolidated statements of operations.

Investment in Datavant

The Company holds an investment in Class A units of Datavant. As of December 31, 2025, the Company’s minority equity interest represented approximately 9% of the outstanding Class A units in Datavant. Datavant’s capital structure includes several classes of preferred units that, among other features, have liquidation preferences and conversion rights. Upon conversion of such preferred units into Class A units, the Company’s ownership interest would be diluted.

As of December 31, 2025 and March 31, 2025, the fair value of the Company’s investment was $247.1 million and $167.4 million, respectively. During the three and nine months ended December 31, 2025, the Company recognized unrealized gains of $11.1 million and $79.7 million on its investment in Datavant, respectively, in the accompanying condensed consolidated statements of operations. During the three and nine months ended December 31, 2024, the Company recognized unrealized gains of $1.2 million and $15.5 million on its investment in Datavant, respectively, in the accompanying condensed consolidated statements of operations.

The fair value of the Company’s investment was determined using valuation models that incorporate significant unobservable inputs and is classified as a Level 3 measurement within the fair value hierarchy. Refer to Note 13, “Fair Value Measurements” for more information.

Note 5—Recent Transactions and Developments

Telavant Disposition

On December 14, 2023, the Company completed the sale of its entire equity interest in its majority-owned subsidiary Telavant to Roche Holdings, Inc. (“Roche”) (the “Roche Transaction”). The Roche Transaction was made pursuant to a Stock Purchase Agreement dated October 22, 2023 among the Company, Telavant, Pfizer Inc. (“Pfizer”), and Roche (the “Stock Purchase Agreement”). Prior to the Roche Transaction, the Company held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer owned the remaining 25%, in each case on an as-converted basis. Refer to Note 5, “Recent Transactions and Developments” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2025 for further information regarding the Roche Transaction.

Pursuant to the Stock Purchase Agreement, the Company was due its pro rata portion of a one-time milestone payment of $150 million, following the initiation of a Phase 3 trial in ulcerative colitis. In June 2024, the one-time milestone was achieved. The milestone payment was paid to all of Telavant’s equity holders, including holders of Telavant RSUs, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction.

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Accordingly, the Company recognized a gain on sale of Telavant net assets of $110.4 million for its pro rata portion during the nine months ended December 31, 2024 in the accompanying condensed consolidated statements of operations.

Note 6—Discontinued Operations

On October 28, 2024, the Company completed the sale of its entire equity interest in its majority-owned subsidiary, Dermavant, to Organon. The Dermavant Transaction was made pursuant to the Merger Agreement between Dermavant, Organon, Merger Sub, and the Company. Pursuant to the Merger Agreement, Organon agreed to acquire Dermavant for cash consideration comprising an upfront payment, regulatory and sales milestones, and royalties. Refer to Note 6, “Discontinued Operations” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2025 for further information regarding the Dermavant Transaction.

The Company concluded that Dermavant met the discontinued operations accounting criteria in the second fiscal quarter of 2024. As the Dermavant Transaction closed in October 2024, no Dermavant assets or liabilities were recognized on the balance sheet as of March 31, 2025 or December 31, 2025. Financial results of Dermavant through closing of the Dermavant Transaction are presented as “Income from discontinued operations, net of tax” in the accompanying consolidated statements of operations for the three and nine months ended December 31, 2024. As a result of the Dermavant Transaction, the Company recognized a gain of $376.5 million for the three and nine months ended December 31, 2024, of which $301.5 million was recognized upon the deconsolidation of Dermavant and $75.0 million was subsequently recognized upon achievement of the first milestone.

The following table presents components of discontinued operations included in “Income from discontinued operations, net of tax” (in thousands):


	Three Months Ended December 31, 2024		Nine Months Ended December 31, 2024
Product revenue, net	$	2,296	$	41,599
License, milestone and other revenue	1,212		33,838
Revenue, net	3,508		75,437
Operating expenses:
Cost of revenues	1,695		12,116
Research and development	3,210		24,307
Selling, general and administrative	25,750		119,879
Total operating expenses	30,655		156,302
Loss from operations	(27,147)		(80,865)
Gain on sale of subsidiary interests(1)	(376,506)		(376,506)
Change in fair value of debt	5,330		(97,322)
Interest expense(2)	10,688		30,556
Other expense (income), net	7,183		(11,257)
Income from discontinued operations before income taxes	326,158		373,664
Income tax (benefit) expense	(862)		634
Income from discontinued operations, net of tax	$	327,020	$	373,030

Loss from discontinued operations before income taxes attributable to noncontrolling interests	$	—	$	(155)
Income from discontinued operations before income taxes attributable to Roivant Sciences Ltd.	326,158		373,819
Income from discontinued operations before income taxes	$	326,158	$	373,664

(1)Gain on sale of subsidiary interests includes the release of accumulated other comprehensive loss of $19.9 million primarily associated with the realization of Dermavant’s cumulative translation adjustments.

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(2)Interest expense consists of interest payments related to outstanding debt held by Dermavant as well as the associated non-cash amortization of debt discounts and issuance costs. Additionally, for the three and nine months ended December 31, 2024, interest expense includes an $8.8 million loss on extinguishment of the Credit Facility.

In the accompanying condensed consolidated statements of cash flows, the cash flows from discontinued operations are not separately classified. The following table summarizes significant non-cash operating and investing items from discontinued operations (in thousands):


	Nine Months Ended December 31, 2024
Gain on sale of subsidiary interests	$	(376,506)
Share-based compensation	$	9,666
Change in fair value of debt	$	(97,322)
Loss on extinguishment of debt	$	8,848
Depreciation and amortization	$	6,739

Note 7—Certain Balance Sheet Components

(A) Accrued Expenses

Accrued expenses at December 31, 2025 and March 31, 2025 consisted of the following (in thousands):


	December 31, 2025		March 31, 2025
Research and development expenses	$	55,716	$	45,813
Compensation-related expenses	38,112		53,928
Other expenses	24,163		14,553
Total accrued expenses	$	117,991	$	114,294

(B) Other Current Liabilities

Other current liabilities at December 31, 2025 and March 31, 2025 consisted of the following (in thousands):


	December 31, 2025		March 31, 2025
Income tax payable	$	7,167	$	416
Deferred revenue	3,050		1,168
Other	26		—
Total other current liabilities	$	10,243	$	1,584

Note 8—Shareholders’ Equity

(A) At-the-Market Equity Offering Program

On September 19, 2022, the Company entered into a sales agreement with Cowen and Company, LLC (“Cowen”) to sell its common shares having an aggregate offering price of up to $400.0 million from time to time through an “at-the-market” equity offering program under which Cowen acts as the Company’s agent (the “ATM Facility”).

As of December 31, 2025, the Company had $400.0 million of remaining capacity available under the ATM Facility.

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(B) Share Repurchase Program

On June 24, 2025, the Company’s board of directors authorized a common share repurchase program allowing for repurchases of the Company’s common shares in an aggregate amount of up to $500 million (excluding fees and expenses). No purchases have been made as of December 31, 2025 pursuant to this repurchase program.

The Company’s board of directors previously had authorized a common share repurchase program, allowing for repurchases of common shares in an aggregate amount of up to $1.5 billion (excluding fees and expenses), which was completed in June 2025. In April 2024, pursuant to this share repurchase program, the Company entered into a share repurchase agreement with Sumitomo Pharma Co., Ltd. (“Sumitomo”) and repurchased all 71,251,083 common shares held by Sumitomo at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million. Subsequent to the repurchase of the common shares held by Sumitomo, additional repurchases of 57,110,703 shares were made in open market transactions under the share repurchase program during the year ended March 31, 2025 for an aggregate purchase price of approximately $644.8 million. During the three months ended June 30, 2025, repurchases of 20,269,450 shares were made for an aggregate purchase price of approximately $208.3 million.

Immunovant

In December 2025, the Company’s subsidiary, Immunovant, Inc. (“Immunovant”), completed an underwritten offering of 26,200,000 shares of its common stock (including 16,666,666 shares of common stock purchased by RSL) at a price of $21.00 per share, for net proceeds to Immunovant of approximately $543.6 million after deducting underwriting discounts and commissions and offering expenses. Following the purchase of shares by RSL, the Company’s ownership interest in Immunovant increased to approximately 56%, and the Company continues to consolidate Immunovant.

Note 9—Share-Based Compensation and Other Compensation Plans

(A) RSL Equity Incentive Plans

RSL has three equity incentive plans: the Roivant Sciences Ltd. 2021 Equity Incentive Plan (the “RSL 2021 EIP”), the Roivant Sciences Ltd. Amended and Restated 2015 Equity Incentive Plan, and the Roivant Sciences Ltd. Amended and Restated 2015 Restricted Stock Unit Plan (collectively, the “RSL Equity Plans”). The RSL 2021 EIP was approved and adopted in connection with the Business Combination and became effective immediately prior to closing. At December 31, 2025, a total of 24,970,629 common shares were available for future grants under the RSL 2021 EIP.

Stock Options and Performance Stock Options

Activity for stock options and performance stock options under the RSL Equity Plans for the nine months ended December 31, 2025 was as follows:


			Number of Options
Options outstanding at March 31, 2025			139,412,098
Granted			2,264,315
Exercised			(43,081,547)
Forfeited/Canceled			(1,189,703)
Options outstanding at December 31, 2025			97,405,163
Options exercisable at December 31, 2025			85,840,056

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Restricted Stock Units

Activity for RSUs under the RSL Equity Plans for the nine months ended December 31, 2025 was as follows:


			Number of RSUs
Non-vested balance at March 31, 2025			14,119,949
Granted			6,454,080
Vested			(3,782,085)
Forfeited			(1,905,609)
Non-vested balance at December 31, 2025			14,886,335

Performance Restricted Stock Units

Activity for PSUs under the RSL Equity Plans for the nine months ended December 31, 2025 was as follows:


			Number of PSUs
Non-vested balance at March 31, 2025			36,872,465
Granted			11,900,000
Vested			—
Forfeited			—
Non-vested balance at December 31, 2025			48,772,465

In July 2025, the Company’s board of directors appointed Frank Torti as an executive officer of the Company with the title President and Vant Chair. In connection with this appointment, the Compensation Committee approved a compensation package for Dr. Torti consisting of (i) a one-time cash retention award, (ii) a grant of PSUs with both performance- and time-vesting components and (iii) a grant of time-vesting RSUs. A summary of the incentive equity awards approved is as follows:

Executive

Title

Performance Restricted Stock Units (at max) #

Restricted Stock Units (#)

Frank Torti

President and Vant Chair

11,900,000

1,836,547

The PSU and RSU awards were approved on the same terms and conditions as the awards granted to the Company’s Chief Executive Officer, Matthew Gline, as part of the 2024 Senior Executive Compensation Program (as defined below). The grant date fair values of the PSU and RSU awards to Dr. Torti set forth in the tables above are $85.1 million and $20.9 million, respectively.

During the three months ended December 31, 2025, the share price hurdles for the first three of the six vesting tranches of the PSUs granted pursuant to the 2024 Senior Executive Compensation Program, including Dr. Torti’s PSU award approved in July 2025, were met as a result of the Company’s trailing 30-day volume weighted average trading price per share exceeding the specified share price hurdles of $15.00, $17.50, and $20.00. As a result, the “Performance Condition” (as defined in the 2024 Senior Executive Compensation Program) was satisfied for 13,386,480 PSUs. Vesting is contingent upon the satisfaction of the “Service Condition” (as defined in the 2024 Senior Executive Compensation Program), which will be deemed satisfied on the first anniversary of the date on which the Performance Condition is first satisfied with respect to such tranche, subject to the executive’s continuous service through such anniversary. Following the achievement of the Service Condition and the vesting of any tranche of the PSUs, the common shares underlying the applicable vested tranche of PSUs are subject to a further two-year holding period before such common shares may be sold by the executive (subject to certain customary exceptions).

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Capped Value Appreciation Rights

March 2020 CVAR Grants

As of December 31, 2025, 17,548,368 CVARs granted in March 2020 remain outstanding. These CVARs had met the service vesting condition as of December 31, 2025 but have not satisfied their applicable hurdle price on an applicable hurdle measurement date. Such CVARs will be earned if the hurdle price is satisfied on a hurdle measurement date, being annually on March 30, prior to the expiration date of March 31, 2026.

November 2021 CVAR Grants

Activity for CVARs granted in November 2021 under the RSL 2021 EIP for the nine months ended December 31, 2025 was as follows:


			Number of CVARs
Non-vested balance at March 31, 2025			348,527
Vested			(297,795)
Forfeited			(50,732)
Non-vested balance at December 31, 2025			—

During the nine months ended December 31, 2025, 297,795 common shares were issued upon their settlement.

(B) Subsidiary Equity Incentive Plans

Certain subsidiaries of RSL adopt their own equity incentive plan (“EIP”). Each EIP is generally structured so that the applicable subsidiary and its affiliates’ employees, directors, officers, and consultants are eligible to receive non-qualified and incentive stock options, stock appreciation rights, restricted share awards, RSUs, and other share awards under their respective EIP. The Company recorded share-based compensation expense of $38.4 million and $72.1 million for the three and nine months ended December 31, 2025, respectively, and $13.5 million and $42.1 million for the three and nine months ended December 31, 2024, respectively, related to subsidiary EIPs.

In November 2025, the Company offered certain holders of vested equity of the Company’s subsidiary, Priovant Holdings, Inc. (“Priovant”), the opportunity to exchange a portion of their vested equity granted under the Priovant 2021 Equity Incentive Plan for RSL common shares granted under the RSL 2021 EIP (the “Exchange Offer”). The Exchange Offer expired on December 23, 2025. On December 23, 2025, immediately following the expiration of the Exchange Offer, the exchanged Priovant equity instruments were canceled, and the Company granted 1,746,194 RSL common shares, under the RSL 2021 EIP, to the individuals participating in the Exchange Offer. The Exchange Offer was treated as a modification for accounting purposes and resulted in incremental share-based compensation expense of $25.2 million, of which $8.3 million was recognized to research and development expense and $16.9 million was recognized to general and administrative expense. This incremental expense was recognized in full on December 23, 2025.

(D) Cash Bonus Program

During the year ended March 31, 2024, the Company approved a special one-time cash retention bonus award to its employees in the aggregate amount of $79.7 million (the “Cash Bonus Program”).

The Company recognized general and administrative expense of $5.5 million for the three months ended December 31, 2024, and $4.5 million and $19.0 million for the nine months ended December 31, 2025 and 2024, respectively, relating to the Cash Bonus Program. The Company recognized research and development expense of $1.7 million for the three months ended December 31, 2024, and $0.9 million and $5.4 million for the nine months ended December 31, 2025 and 2024, respectively, relating to the Cash Bonus Program. There was no related expense recognized during the three months ended December 31, 2025.

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(E) 2024 Senior Executive Compensation Program Cash Awards

In July 2024, the Compensation Committee of the board of directors approved a multi-year incentive compensation program for each of Matthew Gline, Chief Executive Officer; Mayukh Sukhatme, President and Chief Investment Officer; and Eric Venker, President and Immunovant CEO (the “2024 Senior Executive Compensation Program”). In July 2025, the Compensation Committee also approved a one-time cash retention award for Frank Torti in connection with his appointment as an executive officer of the Company. Pursuant to the 2024 Senior Executive Compensation Program, including Dr. Torti’s one-time cash retention award approved in July 2025, the Company paid the following one-time cash retention awards to the officers listed in the table below:


Executive	Title	Cash Awards (in thousands)

Matthew Gline	Chief Executive Officer	$	5,725
Mayukh Sukhatme	President and Chief Investment Officer	$	80,550
Eric Venker	President and Immunovant CEO	$	7,465
Frank Torti	President and Vant Chair	$	7,500

As a result of the cash retention rewards, the Company recognized general and administrative expense of $14.8 million during the nine months ended December 31, 2025 and $3.7 million and $82.8 million, respectively, during the three and nine months ended December 31, 2024. There was no related expense recognized during the three months ended December 31, 2025.

Note 10—Income Taxes

The Company’s effective tax rate for the three and nine months ended December 31, 2025 was (8.0)% and (4.9)%, respectively, and the effective tax rate for the three and nine months ended December 31, 2024 was 10.9% and 0.2%, respectively. The effective tax rates for the three and nine months ended December 31, 2025 are driven by the Company’s earnings by jurisdiction and a valuation allowance that eliminates the Company’s global net deferred tax assets, as well as the impacts of taxable intercompany income and non-deductible executive compensation. The effective tax rates for the three and nine months ended December 31, 2024 are driven by the Company’s earnings by jurisdiction and a valuation allowance that eliminates the Company’s global net deferred tax assets.

The Company assesses the realizability of its deferred tax assets at each balance sheet date based on available positive and negative evidence in order to determine the amount which is more likely than not to be realized and records a valuation allowance as necessary.

On July 4, 2025, H.R. 1, 119th Cong. (2025), also referred to as the “One Big Beautiful Bill Act” (the “2025 Tax Act” or “OBBBA”) was signed into law in the U.S., which includes a broad range of tax reform provisions. The impact of the OBBBA on the Company’s accompanying condensed consolidated financial statements is not material.

Note 11—Commitments and Contingencies

(A) Commitments

Lease Commitments

The Company has leases, consisting primarily of real estate leases. Refer to Note 11, “Leases” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2025 for further information regarding the Company’s lease commitments.

During the three months ended December 31, 2025, in connection with the relocation of the U.S. corporate headquarters of Roivant Sciences, Inc. and the execution of a sublease agreement, the Company identified a triggering event for the associated operating lease right-of-use asset and leasehold improvements (the asset group) for the former U.S. corporate headquarters. The Company determined that the asset group was not recoverable as its carrying amount exceeded the future net undiscounted cash flows expected under the sublease agreement. The Company measured the fair value of the asset group using an income approach based on a discounted cash flow methodology using significant Level 3 inputs.

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Key inputs used in the valuation included contractual and market-based sublease rental rates, estimated lease commencement date, transaction costs, and a discount rate of 8.5%.

As the carrying amount of the asset group exceeded its fair value, the Company recognized a total pre-tax impairment charge of $17.1 million during the three and nine months ended December 31, 2025, which is included in general and administrative expenses in the condensed consolidated statements of operations.

Other Commitments

The Company has entered into commitments under various asset acquisition and license agreements. Under these agreements, the Company is required to make milestone payments upon successful completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events, such as the achievement of specified development, regulatory and commercial milestones, and the Company will be required to make milestone payments and royalty payments in connection with the sale of products developed under these agreements. Refer to Note 12, “Commitments and Contingencies” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2025 for further information regarding certain key asset acquisition and license agreements. There have been no material changes to the key asset acquisition and license agreements relating to continuing operations during the nine months ended December 31, 2025. The Company has further commitments relating to other asset acquisition and license agreements that it has entered into and expects to enter into additional asset acquisition and license agreements in the future, which may require upfront payments and long-term commitments of capital resources.

Additionally, the Company enters into agreements with contract service providers to assist in the performance of its research and development activities. Expenditures to contract research organizations and contract manufacturing organizations represent significant costs in the clinical development of its product candidates. Subject to required notice periods and certain obligations under binding purchase orders, the Company can elect to discontinue the work under these agreements at any time. The Company expects to enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and long-term commitments of capital resources.

As of December 31, 2025, the Company’s subsidiary, Immunovant, has a remaining minimum obligation for the contract manufacturing of batoclimab drug substance of approximately $39.1 million, of which $0.3 million, $0.8 million, $10.0 million, $14.0 million and $14.0 million is expected to be paid, subject to the terms of such contract manufacturing agreement, during the remainder of the fiscal year ending March 31, 2026, and for the fiscal years ending March 31, 2027, 2028, 2029 and 2030, respectively.

(B) Loss Contingencies

The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company accrues for loss contingencies when available information indicates that it is probable that a liability has been incurred and the amount of such loss can be reasonably estimated, and if the Company believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the litigation or claim, including an estimable range, if possible.

The Company is a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate the Company to indemnify the other parties to such agreements upon the occurrence of certain events. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain. The Company also indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits. The maximum amount of potential future indemnification is unlimited; however, the Company currently maintains director and officer liability insurance, which may cover certain liabilities arising from the Company’s obligation to indemnify its directors and officers. To date, the Company has not incurred any material costs related to these indemnification obligations and has not accrued any liabilities related to such obligations in the accompanying condensed consolidated financial statements as of December 31, 2025 and March 31, 2025.

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Note 12—Earn-Out Shares

In connection with the Business Combination, the Company issued the following restricted common shares on September 30, 2021:

a.2,033,591 common shares issued to Patient Square Capital LLC (the “MAAC Sponsor”) and 10,000 common shares issued to each of MAAC’s independent directors (collectively, the “20% Earn-Out Shares”), subject to vesting if the closing price of the Company’s common shares is greater than or equal to $15.00 over any 20 out of 30 trading day period between November 9, 2021 and September 30, 2026 (the “Vesting Period”); and

b.1,016,796 common shares issued to the MAAC Sponsor and 5,000 common shares issued to each of MAAC’s independent directors (collectively, the “10% Earn-Out Shares” and, together with the 20% Earn-Out Shares, the “Earn-Out Shares”), subject to vesting if the closing price of the Company’s common shares is greater than or equal to $20.00 over any 20 out of 30 trading day period during the Vesting Period.

During the quarter ended December 31, 2025, both of the 20% Earn-Out Shares and the 10% Earn-Out Shares, which were already included in the Company’s issued and outstanding share count, vested and therefore are no longer subject to forfeiture. Certain of the Earn-Out Shares remain subject to a lock-up and may not be sold until the one-year anniversary of the applicable vesting date.

Prior to vesting, the Earn-Out Shares required liability classification and were classified as “Liability instruments measured at fair value” on the accompanying condensed consolidated balance sheets. The Earn-Out Shares liability was subject to remeasurement at each balance sheet date with changes in fair value recognized in the Company’s statements of operations. The Earn-Out Shares were remeasured upon their vesting, and these remeasurements were recognized in “Change in fair value of liability instruments” in the accompanying condensed consolidated statements of operations. The resulting liabilities upon remeasurement, totaling $57.7 million, were reclassified to additional paid-in capital.

During the three and nine months ended December 31, 2025, the Company recognized losses of $24.4 million and $47.7 million, respectively, due to changes in the fair value of the Earn-Out Shares in the accompanying condensed consolidated statements of operations. During the three and nine months ended December 31, 2024, the Company recognized gains of $2.1 million and $0.4 million, respectively, due to changes in fair value of the Earn-Out Shares in the accompanying condensed consolidated statements of operations.

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Note 13—Fair Value Measurements

Recurring Fair Value Measurements

The following table sets forth the Company’s assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2025 and March 31, 2025, by level, within the fair value hierarchy (in thousands):


	As of December 31, 2025								As of March 31, 2025
	Level 1		Level 2		Level 3		Balance as of December 31, 2025		Level 1		Level 2		Level 3		Balance as of March 31, 2025
Assets:
Money market funds	$	1,386,330	$	—	$	—	$	1,386,330	$	2,621,457	$	—	$	—	$	2,621,457
Available-for-sale marketable securities	—		3,051,708		—		3,051,708		—		—		—		—
Investment in Datavant Class A units	—		—		247,051		247,051		—		—		167,361		167,361
Investment in Arbutus common shares	186,856		—		—		186,856		135,578		—		—		135,578
Total assets at fair value	$	1,573,186	$	3,051,708	$	247,051	$	4,871,945	$	2,757,035	$	—	$	167,361	$	2,924,396
Liabilities:
Liability instruments measured at fair value(1)	—		—		—		—		—		—		9,981		9,981
Total liabilities at fair value	$	—	$	—	$	—	$	—	$	—	$	—	$	9,981	$	9,981

(1)At March 31, 2025, Level 3 includes the fair value of the Earn-Out Shares of $10.0 million.

There were no transfers into or out of Level 3 during the nine months ended December 31, 2025.

Level 3 Disclosures

The Company measures its Level 3 assets and liabilities at fair value based on significant inputs not observable in the market, which causes them to be classified as a Level 3 measurement within the fair value hierarchy. The valuation of the Level 3 assets and liabilities uses assumptions and estimates the Company believes would be made by a market participant in making the same valuation. The Company evaluates these assumptions and estimates on an ongoing basis as additional data impacting the assumptions and estimates is obtained. Changes in the fair value related to updated assumptions and estimates are recorded within the statements of operations at the end of each reporting period.

The fair value of Level 3 assets and liabilities may change significantly as additional data is obtained, impacting the Company’s assumptions regarding probabilities of potential scenarios used to estimate fair value. In evaluating this information, considerable judgment is required to interpret the data used to develop the assumptions and estimates. Accordingly, the use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts, and such changes could materially impact the Company’s results of operations in future periods.

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The changes in fair value of the Level 3 assets during the nine months ended December 31, 2025 and 2024 were as follows (in thousands):


Balance at March 31, 2024	$	147,526
Change in fair value of investment in Datavant, included in net loss	15,483
Balance at December 31, 2024	$	163,009

Balance at March 31, 2025	$	167,361
Change in fair value of investment in Datavant, included in net loss	79,690
Balance at December 31, 2025	$	247,051

The changes in fair value of the Level 3 liabilities during the nine months ended December 31, 2025 and 2024 were as follows (in thousands):


Balance at March 31, 2024	$	25,737
Changes in fair value of liability instruments, included in net loss	(1,632)
Balance at December 31, 2024	$	24,105

Balance at March 31, 2025	$	9,981
Changes in fair value of liability instruments, included in net loss	47,704
Reclassification to additional paid-in capital upon vesting of Earn-Out Shares	(57,685)
Balance at December 31, 2025	$	—

Investment in Datavant

The Company elected the fair value option to account for its investment in Datavant. The estimate of fair value for this investment was determined using the income approach, market approach, and implementation of the option pricing method (“OPM”). The OPM allows for the allocation of a company’s equity value among the various equity capital owners (preferred and common shareholders). The OPM uses the preferred shareholders’ liquidation preferences, participation rights, dividend policy, and conversion rights to determine how proceeds from a liquidity event shall be distributed among the various ownership classes at a future date. The fair value was calculated using significant unobservable inputs including the following:


	Point Estimate Used
Input	As of December 31, 2025	As of March 31, 2025
Volatility	95.0%	110.0%
Discount rate	11.8%	13.0%

Earn-Out Shares

Prior to vesting during the quarter ended December 31, 2025, the fair value of the Earn-Out Shares issued as part of the Business Combination was calculated using the Monte Carlo simulation method under the income approach. Refer to Note 12, “Earn-Out Shares” for additional details. Significant unobservable inputs used to calculate the fair value of the Earn-Out Shares included the following:

Point Estimate Used

Input

As of March 31, 2025

Volatility

38.4%

Risk-free rate

3.96%

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As of March 31, 2025, the Company began using a blend of its historical and implied volatility, rather than exclusively relying on historical volatility, to estimate the expected volatility assumption of various equity instruments issued by the Company. Due to changes in the Company’s capital position, the Company believes this methodology better reflects its expected future volatility.

As of March 31, 2025, the fair value of the Earn-Out Shares was $10.0 million, which was included in “Liability instruments measured at fair value” in the accompanying condensed consolidated balance sheets.

Note 14—Net (Loss) Income per Common Share

Basic net (loss) income per common share is computed by dividing net (loss) income attributable to Roivant Sciences Ltd. by the weighted-average number of common stock outstanding during the period. Diluted net (loss) income per common share is computed by dividing the net (loss) income attributable to Roivant Sciences Ltd. by the diluted weighted-average number of common stock outstanding during the period.

For periods of loss from continuing operations, diluted loss per share is calculated similar to basic loss per share as the effect of including all potentially dilutive common stock equivalents is anti-dilutive. For the three and nine months ended December 31, 2025 and 2024, all outstanding common stock equivalents have been excluded from the computation of diluted loss per share because their effect was anti-dilutive due to the net loss from continuing operations.

As of December 31, 2025 and 2024, the following potentially dilutive common stock equivalents were excluded from the computation of diluted net (loss) income per common share:


	December 31, 2025	December 31, 2024
Stock options and performance stock options	97,405,163	141,783,273
Restricted stock units and performance stock units (non-vested)	63,658,800	51,484,611
March 2020 CVARs(1)	17,548,368	17,548,368
November 2021 CVARs (non-vested)	—	710,060
Restricted common stock (non-vested)	—	169,422
Earn-Out Shares (non-vested)	—	3,080,387
Other stock based awards and instruments issued	3,674,484	5,031,399

(1)Refer to Note 9, “Share-Based Compensation and Other Compensation Plans” for details regarding settlement of CVARs.

Note 15—Segment Information

The Company is operated and managed as a single operating and reportable segment which focuses on the discovery, development and commercialization of medicines and technologies. The Company’s Chief Operating Decision Maker (“CODM”) is its chief executive officer.

The CODM assesses performance for the Company based on net (loss) income, which is reported on the condensed consolidated statements of operations and comprehensive (loss) income as net (loss) income. The measure of segment assets is reported on the condensed consolidated balance sheets as total assets.

The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seeks regulatory approval. As such, the CODM uses cash forecast models and budgeted versus actual results to assess performance, make operating decisions and allocate resources across the Company including to various Vants and research and development projects.

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The Company’s significant segment expenses are as follows (in thousands):


	Three Months Ended December 31,				Nine Months Ended December 31,
	2025		2024		2025		2024
Revenue	$	1,999	$	9,018	$	5,740	$	21,483
Less:
Cost of revenues	700		259		965		706
Program-specific research and development expenses:
Anti-FcRn franchise—endocrine diseases	19,806		15,479		64,030		46,279
Anti-FcRn franchise—neurological diseases	17,688		24,978		61,712		73,071
Anti-FcRn franchise—rheumatology diseases	14,129		8,180		35,949		17,225
Anti-FcRn franchise—dermatology diseases	3,037		4,951		16,134		9,894
Anti-FcRn franchise—other clinical and nonclinical	463		44		3,174		7,579
Brepocitinib	16,201		10,940		45,936		32,051
Mosliciguat	10,398		4,701		26,250		13,865
Other development and discovery programs	13,399		14,557		34,819		43,751
Research and development share-based compensation	18,123		9,685		40,218		30,128
Research and development personnel-related expenses	41,403		38,292		124,591		103,414
Other research and development expenses	10,733		9,788		30,054		27,918
General and administrative share-based compensation	86,874		69,386		228,778		165,670
General and administrative personnel-related expenses	28,246		33,572		96,307		173,082
Other general and administrative expenses	59,952		38,587		127,131		105,566
Gain on sale of Telavant net assets	—		—		—		(110,387)
Change in fair value of investments	(21,592)		21,314		(130,968)		(42,287)
Change in fair value of liability instruments	24,416		(2,147)		47,704		(1,632)
Interest income	(43,266)		(61,851)		(136,929)		(203,751)
Other (income) expense, net	(8,342)		2,816		8,560		7,877
Income tax expense (benefit)	23,332		(25,568)		34,976		(1,147)
Income from discontinued operations, net of tax	—		(327,020)		—		(373,030)
Net (loss) income	$	(313,701)	$	118,075	$	(753,651)	$	(104,359)

Note 16—Subsequent Events

In January 2026, the Company’s subsidiary, Immunovant, completed an internal reorganization and transfer of intellectual property rights related to Immunovant’s product candidates between two wholly-owned subsidiaries of Immunovant. The Company is still assessing the impact of this transfer, but expects a reduction in its current income tax expense for the year ending March 31, 2026, and expects a reduction in its foreign net operating losses and corresponding valuation allowance in Switzerland. Ownership and rights to such intellectual property remain with the Company and its subsidiaries.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our (1) unaudited condensed consolidated financial statements and notes to those statements included in this Quarterly Report on Form 10-Q (“Quarterly Report”) and (2) audited consolidated financial statements and notes to those statements and management’s discussion and analysis of financial condition and results of operations for the fiscal year ended March 31, 2025, included in our Annual Report on Form 10-K, filed with the SEC on May 29, 2025 (the “Form 10-K”). Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Roivant’s actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see “Forward-Looking Statements” and “Risk Factors” in this Quarterly Report. Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31.

Overview

Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.

Pipeline

The following table summarizes selected product candidates from our pipeline:

Product Candidate

Indication

Vant

Modality

Phase

Brepocitinib

Dermatomyositis

Priovant

Small Molecule

NDA Filed

Brepocitinib

Non-Infectious Uveitis

Priovant

Small Molecule

Phase 3*

Brepocitinib

Cutaneous Sarcoidosis

Priovant

Small Molecule

Phase 3*

IMVT-1402

Graves’ Disease

Immunovant

Biologic

Phase 2/3*

IMVT-1402

Difficult-to-Treat
Rheumatoid Arthritis

Immunovant

Biologic

Phase 2/3*

IMVT-1402

Myasthenia Gravis

Immunovant

Biologic

Phase 2/3*

IMVT-1402

Sjögren’s Disease

Immunovant

Biologic

Phase 2/3*

IMVT-1402

Chronic Inflammatory Demyelinating Polyneuropathy

Immunovant

Biologic

Phase 2/3*

IMVT-1402

Cutaneous Lupus Erythematosus

Immunovant

Biologic

Phase 2

Batoclimab

Thyroid Eye Disease

Immunovant

Biologic

Phase 3*

Mosliciguat

Pulmonary Hypertension associated with Interstitial Lung Disease

Pulmovant

Inhaled

Phase 2

Note: All product candidates in our current pipeline are investigational and subject to health authority approval. The “Phase” for a specific product candidate referenced above reflects both ongoing clinical trials and expected upcoming trials.

*Indicates registrational or potentially registrational trials.

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Vant Ownership

The following table summarizes our ownership of certain of our subsidiary companies and affiliates as of December 31, 2025.


	Roivant Ownership
Vant	Basic1			Fully Diluted2
Priovant	73	%		66	%
Immunovant	56	%	3	52	%	3
Pulmovant	98	%		91	%
Genevant	83	%		64	%
Covant	95	%		91	%
Arbutus	20	%	3	19	%	3

Note: In addition to the subsidiary companies and affiliates listed in the table above, Roivant continues to maintain ownership interests in certain other entities as previously disclosed, including Proxima (formerly VantAI), PsiThera (formerly Psivant) and Datavant, as well as the right to receive future milestones and royalties related to the sale of our subsidiary Dermavant in 2024.

1.Basic ownership refers to Roivant’s percentage ownership of the issued and outstanding common and preferred shares (if applicable) of the entity.

2.Fully diluted ownership refers to Roivant’s percentage ownership of all outstanding equity interests of the entity, including unvested RSUs, options and warrants, in each case whether vested or unvested.

3.Denotes entities that are publicly traded.

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Upcoming Catalysts

In the upcoming year, we have a robust set of expected near-term catalysts, including the items set forth in the table below. In addition, we plan to in-license multiple potentially category-leading drugs per year.


Program	Vant	Catalyst	Expected Timing
Roivant pipeline growth	Roivant	New mid/late-stage in-licensing announcements	Ongoing
LNP platform	Genevant	Summary judgment phase in U.S. Moderna case	Ongoing
LNP platform	Genevant	Jury trial in U.S. Moderna case	March 2026
Batoclimab	Immunovant	Topline data from both Phase 3 trials in thyroid eye disease	1H 2026
LNP platform	Genevant	First major hearings in ex-U.S. Moderna cases	1H 2026
Mosliciguat	Pulmovant	Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease	2H 2026
Brepocitinib	Priovant	Topline data from Phase 3 trials in non-infectious uveitis	2H 2026
IMVT-1402	Immunovant	Topline data from Phase 2 trial in cutaneous lupus erythematosus	2H 2026
IMVT-1402	Immunovant	Topline data from potentially registrational trial in ACPA+ difficult-to-treat rheumatoid arthritis	2H 2026
IMVT-1402	Immunovant	Topline data from potentially registrational trials in Graves’ disease	2027
IMVT-1402	Immunovant	Topline data from potentially registrational trial in myasthenia gravis	2027
IMVT-1402	Immunovant	Topline data from potentially registrational trial in chronic inflammatory demyelinating polyneuropathy	2028
IMVT-1402	Immunovant	Topline data from potentially registrational trial in Sjögren’s disease	2028

Note: References under “Expected Timing” are to calendar years. All catalyst timings are based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. The timing of the litigation-related events noted above is subject to change, including at the discretion of the court.

Recent Developments

•Priovant: In February 2026, Priovant announced positive Phase 2 results for brepocitinib in cutaneous sarcoidosis ("CS"). Brepocitinib 45 mg significantly improved CS disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 p<0.0001). Brepocitinib demonstrated rapid, deep and sustained improvements across all other efficacy endpoints measured with consistent safety profile. New Drug Application was submitted to the FDA for brepocitinib in dermatomyositis (DM). Topline data from Phase 3 studies in non-infectious uveitis are expected in the second half of calendar year 2026.

•Immunovant: Potentially registrational trial for IMVT-1402 in difficult-to-treat rheumatoid arthritis fully enrolled, with topline data expected in the second half of calendar year 2026. All other clinical development timelines remain on track for IMVT-1402 across announced indications, including potentially registrational trials in Graves’ disease ("GD"), myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease, and a proof-of-concept trial in cutaneous lupus erythematosus. Roivant-led Immunovant financing alongside key institutional investors generated gross proceeds to Immunovant of approximately $550 million, extending Immunovant’s cash runway to the launch of IMVT-1402 in GD.

•Pulmovant: Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease fully enrolled, with topline data expected in the second half of calendar year 2026.

•Genevant: Favorable summary judgment decision in U.S. Moderna case affirms Genevant's view of section 1498: the significant majority of liability belongs in the current case against Moderna. Jury trial in U.S. Moderna case

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scheduled for March 2026 and international proceedings continue with first major hearings expected in the first half of calendar year 2026.

•Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.5 billion as of December 31, 2025, supporting cash runway into profitability.

Components of Results of Operations

Revenue

Revenue primarily relates to amounts earned in connection with license agreements, as well as revenue generated by subscription and service-based fees.

Cost of revenues

Our cost of revenues primarily relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting and third-party data costs.

Research and development expenses

Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates. Research and development expenses primarily include the following:

•Program-specific costs, including direct third-party costs, which include expenses incurred under agreements with contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research and any other third-party expenses directly attributable to the development of our product candidates.

•Unallocated internal costs, including:

•employee-related expenses, such as salaries, share-based compensation and benefits, for research and development personnel; and

•other research and development related expenses that are not allocated to a specific program.

Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we advance our product candidates and our in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates.

The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following:

•the scope, rate of progress, expense and results of our preclinical development activities, any future clinical trials of our product candidates and other research and development activities that we may conduct;

•the number and scope of preclinical and clinical programs we decide to pursue;

•the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates;

•the number of doses that patients receive;

•the countries in which the trials are conducted;

•our ability to secure and leverage adequate CRO support for the conduct of clinical trials;

• our ability to establish an appropriate safety and efficacy profile for our product candidates;

• the timing, receipt and terms of any approvals from applicable regulatory authorities;

• the potential additional safety monitoring or other studies requested by regulatory agencies;

• the significant and changing government regulation and regulatory guidance;

• our ability to establish clinical and commercial manufacturing capabilities, or make arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make product successfully; and

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• our ability to maintain a continued acceptable safety profile of our product candidates following regulatory approval of our product candidates.

The successful development of our product candidates is highly uncertain, and we cannot reasonably estimate the costs that will be necessary to complete the remainder of the development of our product candidates. In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability.

General and administrative expenses

General and administrative (“G&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation and benefits, for employees engaged in G&A activities. G&A employees include those responsible for the identification and acquisition or in-license of new drug candidates, as well as for managing Vant operations and facilitating the use of our platform and technologies at the Vants. G&A expenses also consist of legal and accounting fees, consulting services and other operating costs relating to corporate matters and daily operations.

We expect G&A expenses to increase in future periods to support our potential commercialization efforts. These increases will likely include additional costs related to the hiring of new personnel and fees to outside consultants, as well as other expenses. If any of our current or future product candidates receives regulatory approval in the U.S. or another jurisdiction, we expect that we would incur significantly increased expenses associated with building a sales and marketing team. Additionally, in July 2024, the Compensation Committee of the board of directors approved a multi-year incentive compensation program for each of Matthew Gline, Chief Executive Officer; Mayukh Sukhatme, President and Chief Investment Officer; and Eric Venker, President and Immunovant CEO (the “2024 Senior Executive Compensation Program”). In July 2025, the Compensation Committee also approved a multi-year incentive compensation program for Frank Torti in connection with his appointment as an executive officer of the Company. The long-term equity incentive awards granted pursuant to this program will result in significant share-based compensation expense over the vesting period of the awards. Refer to Note 9, “Share-Based Compensation and Other Compensation Plans” of our financial statements for further details.

Gain on sale of Telavant net assets

Gain on sale of Telavant net assets reflects a gain resulting from the achievement of a one-time milestone in June 2024 at Telavant Holdings, Inc. (“Telavant”) for our pro rata portion of the consideration. Refer to Note 5, “Recent Transactions and Developments” for further information.

Change in fair value of investments

Change in fair value of investments includes the unrealized (gain) loss on equity investments, including Arbutus Biopharma Corporation (“Arbutus”) and Heracles Parent, L.L.C. (“Datavant”). We have elected the fair value option to account for these investments.

Change in fair value of liability instruments

Change in fair value of liability instruments primarily includes the loss (gain) relating to the measurement and recognition of fair value on a recurring basis of certain liabilities, including the earn-out share liabilities (prior to vesting) (the “Earn-Out Shares”) issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”), a special purpose acquisition company. Refer to Note 12, “Earn-Out Shares” for further information.

Interest income

Interest income consists of interest earned on our cash equivalents and marketable securities.

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Income tax expense (benefit)

Income tax expense is recorded for the jurisdictions in which we do business. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded when, after consideration of all positive and negative evidence, it is not more likely than not that our deferred tax assets will be realizable. When uncertain tax positions exist, we recognize the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position and consideration of the available facts and circumstances.

Income from discontinued operations, net of tax

Income from discontinued operations, net of tax consists of the gain on sale of subsidiary interests resulting from the sale of our entire equity interest in our majority-owned subsidiary, Dermavant Sciences Ltd. (“Dermavant”), to Organon & Co. (“Organon”) in October 2024 and the financial results of Dermavant. In September 2024, Dermavant entered into an Agreement and Plan of Merger with Organon, Organon Bermuda Ltd., an indirect wholly owned subsidiary of Organon, and us, solely in our capacity as the representative of the securityholders of Dermavant. Organon’s acquisition of Dermavant (the “Dermavant Transaction”) was completed in October 2024. Refer to Note 6, “Discontinued Operations” of our financial statements for further information.

Net loss attributable to noncontrolling interests

Net loss attributable to noncontrolling interests consists of the portion of net loss of those consolidated entities that is not allocated to us. We record net loss attributable to noncontrolling interests equal to the noncontrolling interest’s proportionate share of the respective operations.

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Results of Operations

Comparison of the three and nine months ended December 31, 2025 and 2024

The following table sets forth our results of operations for the three months ended December 31, 2025 and 2024:


	Three Months Ended December 31,
	2025		2024		Change
	(in thousands)
Revenue	$	1,999	$	9,018	$	(7,019)
Operating expenses:
Cost of revenues	700		259		441
Research and development	165,380		141,595		23,785
General and administrative	175,072		141,545		33,527
Total operating expenses	341,152		283,399		57,753
Loss from operations	(339,153)		(274,381)		(64,772)
Change in fair value of investments	(21,592)		21,314		(42,906)
Change in fair value of liability instruments	24,416		(2,147)		26,563
Interest income	(43,266)		(61,851)		18,585
Other (income) expense, net	(8,342)		2,816		(11,158)
Loss from continuing operations before income taxes	(290,369)		(234,513)		(55,856)
Income tax expense (benefit)	23,332		(25,568)		48,900
Loss from continuing operations, net of tax	(313,701)		(208,945)		(104,756)
Income from discontinued operations, net of tax	—		327,020		(327,020)
Net (loss) income	(313,701)		118,075		(431,776)
Net loss attributable to noncontrolling interests	(47,810)		(51,306)		3,496
Net (loss) income attributable to Roivant Sciences Ltd.	$	(265,891)	$	169,381	$	(435,272)

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The following table sets forth our results of operations for the nine months ended December 31, 2025 and 2024:


	Nine Months Ended December 31,
	2025		2024		Change
	(in thousands)
Revenue	$	5,740	$	21,483	$	(15,743)
Operating expenses:
Cost of revenues	965		706		259
Research and development	482,867		405,175		77,692
General and administrative	452,216		444,318		7,898
Total operating expenses	936,048		850,199		85,849
Gain on sale of Telavant net assets	—		110,387		(110,387)
Loss from operations	(930,308)		(718,329)		(211,979)
Change in fair value of investments	(130,968)		(42,287)		(88,681)
Change in fair value of liability instruments	47,704		(1,632)		49,336
Interest income	(136,929)		(203,751)		66,822
Other expense, net	8,560		7,877		683
Loss from continuing operations before income taxes	(718,675)		(478,536)		(240,139)
Income tax expense (benefit)	34,976		(1,147)		36,123
Loss from continuing operations, net of tax	(753,651)		(477,389)		(276,262)
Income from discontinued operations, net of tax	—		373,030		(373,030)
Net loss	(753,651)		(104,359)		(649,292)
Net loss attributable to noncontrolling interests	(150,886)		(138,853)		(12,033)
Net (loss) income attributable to Roivant Sciences Ltd.	$	(602,765)	$	34,494	$	(637,259)

Variance analysis for three and nine months ended December 31, 2025 and 2024

Revenue


	Three Months Ended December 31,						Nine Months Ended December 31,
	2025		2024		Change		2025		2024		Change
	(in thousands)						(in thousands)
Revenue	$	1,999	$	9,018	$	(7,019)	$	5,740	$	21,483	$	(15,743)

Revenue decreased by $7.0 million to $2.0 million for the three months ended December 31, 2025, compared to $9.0 million for the three months ended December 31, 2024. During both the three months ended December 31, 2025 and 2024, revenue was primarily driven by amounts earned in connection with license agreements at Genevant.

Revenue decreased by $15.7 million to $5.7 million for the nine months ended December 31, 2025, compared to $21.5 million for the nine months ended December 31, 2024. During both the nine months ended December 31, 2025 and 2024, revenue was primarily driven by amounts earned in connection with license agreements at Genevant.

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Research and development expenses

For the three months ended December 31, 2025 and 2024, our research and development expenses consisted of the following:


	Three Months Ended December 31,
	2025		2024(1)		Change
	(in thousands)
Program-specific costs:
Anti-FcRn franchise—endocrine diseases	$	19,806	$	15,479	$	4,327
Anti-FcRn franchise—neurological diseases	17,688		24,978		(7,290)
Anti-FcRn franchise—rheumatology diseases	14,129		8,180		5,949
Anti-FcRn franchise—dermatology diseases	3,037		4,951		(1,914)
Anti-FcRn franchise—other clinical and nonclinical	463		44		419
Brepocitinib	16,201		10,940		5,261
Mosliciguat	10,398		4,701		5,697
Other development and discovery programs(2)	13,399		14,557		(1,158)
Total program-specific costs	95,121		83,830		11,291

Unallocated internal costs:
Share-based compensation	18,123		9,685		8,438
Personnel-related expenses	41,403		38,292		3,111
Other expenses	10,733		9,788		945
Total research and development expenses	$	165,380	$	141,595	$	23,785
(1) Certain prior year amounts have been reclassified to conform to current year presentation.
(2) For the three months ended December 31, 2024, terminated program expenses included $3.1 million for namilumab. There were no terminated program expenses for the three months ended December 31, 2025.

Research and development expenses increased by $23.8 million to $165.4 million for the three months ended December 31, 2025, compared to $141.6 million for the three months ended December 31, 2024. This increase was primarily driven by an increase in program-specific costs of $11.3 million and share-based compensation of $8.4 million.

The $11.3 million increase in program-specific costs was primarily driven by increases of $5.7 million related to mosliciguat and $5.3 million related to brepocitinib, reflecting the progression of our programs.

The $8.4 million increase in share-based compensation expense, which is an unallocated internal cost, was primarily driven by incremental share-based compensation expense as a result of the exchange of certain vested equity granted under the Priovant Holdings, Inc. (“Priovant”) 2021 Equity Incentive Plan for RSL common shares (the “Exchange Offer”). Refer to Note 9, “Share-Based Compensation and Other Compensation Plans” of our financial statements for further details.

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For the nine months ended December 31, 2025 and 2024, our research and development expenses consisted of the following:


	Nine Months Ended December 31,
	2025		2024(1)		Change
	(in thousands)
Program-specific costs:
Anti-FcRn franchise—endocrine diseases	$	64,030	$	46,279	$	17,751
Anti-FcRn franchise—neurological diseases	61,712		73,071		(11,359)
Anti-FcRn franchise—rheumatology diseases	35,949		17,225		18,724
Anti-FcRn franchise—dermatology diseases	16,134		9,894		6,240
Anti-FcRn franchise—other clinical and nonclinical	3,174		7,579		(4,405)
Brepocitinib	45,936		32,051		13,885
Mosliciguat	26,250		13,865		12,385
Other development and discovery programs(2)	34,819		43,751		(8,932)
Total program-specific costs	288,004		243,715		44,289

Unallocated internal costs:
Share-based compensation	40,218		30,128		10,090
Personnel-related expenses	124,591		103,414		21,177
Other expenses	30,054		27,918		2,136
Total research and development expenses	$	482,867	$	405,175	$	77,692
(1) Certain prior year amounts have been reclassified to conform to current year presentation.
(2) For the nine months ended December 31, 2025, terminated program expenses consisted of $1.9 million for namilumab. For the nine months ended December 31, 2024, terminated program expenses consisted of $11.0 million for namilumab and $1.9 million for RVT-2001.

Research and development expenses increased by $77.7 million to $482.9 million for the nine months ended December 31, 2025, compared to $405.2 million for the nine months ended December 31, 2024. This increase was primarily driven by an increase in program-specific costs of $44.3 million, personnel-related expenses of $21.2 million, and share-based compensation of $10.1 million.

The $44.3 million increase in program-specific costs was primarily driven by an increase of $27.0 million related to the anti-FcRn franchise, $13.9 million related to brepocitinib, and $12.4 million related to mosliciguat, reflecting the progression of our programs. The increase was partially offset by a $11.0 million decrease in expenses related to terminated programs.

The $21.2 million increase in personnel-related expenses, which is an unallocated internal cost, was primarily driven by higher headcount to support additional clinical studies for the anti-FcRn franchise activities at Immunovant. The $10.1 million increase in share-based compensation expense was primarily driven by the Priovant Exchange Offer. Refer to Note 9, "Share-Based Compensation and Other Compensation Plans" of our financial statements for further details.

General and administrative expenses


	Three Months Ended December 31,						Nine Months Ended December 31,
	2025		2024		Change		2025		2024		Change
	(in thousands)						(in thousands)
General and administrative	$	175,072	$	141,545	$	33,527	$	452,216	$	444,318	$	7,898

General and administrative expenses increased by $33.5 million to $175.1 million for the three months ended December 31, 2025, compared to $141.5 million for the three months ended December 31, 2024. This increase was primarily due to an impairment loss of $17.1 million related to the relocation of the United States (“U.S.”) corporate headquarters of Roivant Sciences, Inc. (refer to Note 11, “Commitments and Contingencies” of our financial statements for

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further details) and an increase of $17.5 million in share-based compensation expense, primarily driven by the Priovant Exchange Offer (refer to Note 9, “Share-Based Compensation and Other Compensation Plans” of our financial statements for further details). These increases were partially offset by a decrease of $5.3 million in personnel-related expense, primarily due to the conclusion of one-time cash retention awards under the Cash Bonus Program (as defined below).

General and administrative expenses increased by $7.9 million to $452.2 million for the nine months ended December 31, 2025, compared to $444.3 million for the nine months ended December 31, 2024. This increase was primarily due to an increase in share-based compensation expense of $63.1 million, primarily due to the long-term equity incentive awards from the 2024 Senior Executive Compensation Program and incremental share-based compensation expense resulting from the Priovant Exchange Offer, as well as an impairment loss of $17.1 million related to the relocation of the U.S. corporate headquarters of Roivant Sciences, Inc. These increases were partially offset by a decrease of $76.8 million in personnel-related expense, which largely resulted from higher expense for the nine months ended December 31, 2024 related to the one-time cash retention awards from the 2024 Senior Executive Compensation Program and the Cash Bonus Program (as defined below).

A summary of general and administrative expense relating to the special one-time cash retention bonus award to its employees awarded during the year ended March 31, 2024 (the “Cash Bonus Program”) and 2024 Senior Executive Compensation Program is as follows:


	Three Months Ended December 31,				Nine Months Ended December 31,				Remaining Expense as of December 31, 2025
	2025		2024		2025		2024
	(in thousands)
Cash Bonus Program	$	—	$	5,516	$	4,510	$	19,055	$	—
2024 Senior Executive Compensation Program:
Cash awards	—		3,660		14,819		82,762		—
Performance restricted stock units	36,515		30,488		103,076		52,360		178,071
Restricted stock units	3,916		2,328		9,624		4,133		56,692
Stock options	185		171		542		474		1,750
Total	$	40,616	$	42,163	$	132,571	$	158,784	$	236,513

Gain on sale of Telavant net assets


	Three Months Ended December 31,						Nine Months Ended December 31,
	2025		2024		Change		2025		2024		Change
	(in thousands)						(in thousands)
Gain on sale of Telavant net assets	$	—	$	—	$	—	$	—	$	110,387	$	(110,387)

Gain on sale of Telavant net assets was approximately $110.4 million for the nine months ended December 31, 2024 and resulted from the achievement of a one-time milestone in June 2024. Refer to Note 5, “Recent Transactions and Developments” of our financial statements for further information.

Change in fair value of investments


	Three Months Ended December 31,						Nine Months Ended December 31,
	2025		2024		Change		2025		2024		Change
	(in thousands)						(in thousands)
Change in fair value of investments	$	(21,592)	$	21,314	$	(42,906)	$	(130,968)	$	(42,287)	$	(88,681)

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Changes in fair value of investments were an unrealized gain of $21.6 million and an unrealized loss of $21.3 million for the three months ended December 31, 2025 and 2024, respectively. The change of $42.9 million was driven by changes in the public share price of Arbutus, as well as the change in the fair value of our investment in Datavant.

Changes in fair value of investments were unrealized gains of $131.0 million and $42.3 million for the nine months ended December 31, 2025 and 2024, respectively. The increase of $88.7 million was driven by changes in the public share price of Arbutus, as well as the change in the fair value of our investment in Datavant, which was driven by growth in forecasted financial performance.

Change in fair value of liability instruments


	Three Months Ended December 31,						Nine Months Ended December 31,
	2025		2024		Change		2025		2024		Change
	(in thousands)						(in thousands)
Change in fair value of liability instruments	$	24,416	$	(2,147)	$	26,563	$	47,704	$	(1,632)	$	49,336

Change in fair value of liability instruments was a loss of $24.4 million and a gain of $2.1 million for the three months ended December 31, 2025 and 2024, respectively. The change in fair value of liability instruments for the three months ended December 31, 2025 consisted of a loss relating to the Earn-Out Shares issued as part of the Business Combination. The Earn-Out Shares vested during the quarter ended December 31, 2025. Accordingly, the Earn-Out Shares were remeasured upon their vesting, and these final remeasurements were recognized in the change in fair value of liability instruments. No further liability remains related to the Earn-Out Shares.

Changes in fair value of liability instruments was a loss of $47.7 million and a gain of $1.6 million for the nine months ended December 31, 2025 and 2024, respectively. The change in fair value of liability instrument for the nine months ended December 31, 2025 consisted of a loss relating to the Earn-Out Shares issued as part of the Business Combination. The Earn-Out Shares vested during the quarter ended December 31, 2025. Accordingly, the Earn-Out Shares were remeasured upon their vesting, and these final remeasurements were recognized in the change in fair value of liability instruments. No further liability remains related to the Earn-Out Shares.

Interest income


	Three Months Ended December 31,						Nine Months Ended December 31,
	2025		2024		Change		2025		2024		Change
	(in thousands)						(in thousands)
Interest income	$	(43,266)	$	(61,851)	$	18,585	$	(136,929)	$	(203,751)	$	66,822

Interest income decreased by $18.6 million to $43.3 million for the three months ended December 31, 2025, compared to $61.9 million for the three months ended December 31, 2024. The decrease is primarily due to lower cash equivalents and marketable securities balances in our interest-bearing accounts and lower interest rates.

Interest income decreased by $66.8 million to $136.9 million for the nine months ended December 31, 2025, compared to $203.8 million for the nine months ended December 31, 2024. The decrease is primarily due to lower cash equivalents and marketable securities balances in our interest-bearing accounts and lower interest rates.

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Income tax expense (benefit)


	Three Months Ended December 31,						Nine Months Ended December 31,
	2025		2024		Change		2025		2024		Change
	(in thousands)						(in thousands)
Income tax expense (benefit)	$	23,332	$	(25,568)	$	48,900	$	34,976	$	(1,147)	$	36,123

Income tax expense (benefit) changed by $48.9 million to an expense of $23.3 million for the three months ended December 31, 2025, compared to an income tax benefit of $25.6 million for the three months ended December 31, 2024. The increase is primarily due to our fluctuating earnings by legal entity in various jurisdictions over the periods, as well as the impacts of taxable intercompany income and non-deductible executive compensation.

Income tax expense (benefit) changed by $36.1 million to an expense of $35.0 million for the nine months ended December 31, 2025, compared to an income tax benefit of $1.1 million for the nine months ended December 31, 2024. The increase is primarily due to the impacts of taxable intercompany income and non-deductible executive compensation, as well as our fluctuating earnings by legal entity in various jurisdictions over the periods.

Income from discontinued operations, net of tax


	Three Months Ended December 31,						Nine Months Ended December 31,
	2025		2024		Change		2025		2024		Change
	(in thousands)						(in thousands)
Income from discontinued operations, net of tax	$	—	$	327,020	$	(327,020)	$	—	$	373,030	$	(373,030)

Income from discontinued operations, net of tax was $327.0 million and $373.0 million for the three and nine months ended December 31, 2024, respectively, and reflects the gain on sale of subsidiary interests resulting from the sale of our entire equity interest in our majority-owned subsidiary, Dermavant, to Organon in October 2024, partially offset by Dermavant’s net losses. Refer to Note 6, “Discontinued Operations” of our financial statements for further information.

Liquidity and Capital Resources

For the nine months ended December 31, 2025 and 2024, we incurred net losses from continuing operations of $753.7 million and $477.4 million, respectively. As of December 31, 2025, we had cash, cash equivalents and marketable securities of approximately $4.5 billion and our accumulated deficit was $695.0 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditures for the foreseeable future. However, projections of future cash flows and operating expenses are inherently uncertain and subject to changes, as described under “Risk Factors” in Part II, Item 1A. of this Quarterly Report on Form 10-Q. As a result, our existing cash, cash equivalents and marketable securities may not be sufficient to fund our operating expenses as anticipated, and we may need to raise additional capital to fund our operations.

Our short-term and long-term liquidity requirements as of December 31, 2025 included:

•obligations under our leases (refer to Note 11, “Leases” in our Annual Report on Form 10-K for the year ended March 31, 2025 for further information regarding our lease commitments); and

•certain commitments related to the contract manufacturing of batoclimab drug substance. As of December 31, 2025, our subsidiary, Immunovant, has a remaining minimum obligation for the contract manufacturing of batoclimab drug substance of approximately $39.1 million, of which $0.3 million, $0.8 million, $10.0 million, $14.0 million and $14.0 million is expected to be paid, subject to the terms of such contract manufacturing agreement, during the remainder of the fiscal year ending March 31, 2026, and for the fiscal years ending March 31, 2027, 2028, 2029 and 2030, respectively.

The above purchase commitments do not represent all of our anticipated purchases, but instead represent only the contractually obligated minimum purchases or firm commitments of non-cancelable minimum amounts.

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Additionally, we have certain payment obligations under various asset acquisition and license agreements. Under these agreements we are required to make milestone payments upon successful completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events, such as the achievement of specified development, regulatory and commercial milestones, and the amount, timing and likelihood of such payments are not known. We will also be required to make milestone payments and royalty payments in connection with the sale of products developed under these agreements. We expect to enter into additional asset acquisition and license agreements in the future, which may require upfront payments and long-term commitments of capital resources.

We enter into agreements with contract service providers to assist in the performance of our research and development activities. Expenditures to contract research organizations and contract manufacturing organizations represent significant costs in the clinical development of our product candidates. Subject to required notice periods and certain obligations under binding purchase orders, we can elect to discontinue the work under these agreements at any time. We expect to enter into additional collaborative research, contract research, manufacturing and supplier agreements in the future, which may require upfront payments and long-term commitments of capital resources.

On June 24, 2025, our board of directors authorized a common share repurchase program allowing for repurchases of our common shares in an aggregate amount of up to $500 million (excluding fees and expenses). No purchases have been made as of December 31, 2025 pursuant to this repurchase program.

Our board of directors previously had authorized a common share repurchase program, allowing for repurchases of our common shares in an aggregate amount of up to $1.5 billion (excluding fees and expenses), which was completed in June 2025. In April 2024, pursuant to this share repurchase program, we entered into a share repurchase agreement with Sumitomo Pharma Co., Ltd. (“Sumitomo”) and repurchased all 71,251,083 common shares held by Sumitomo at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million. Subsequent to the repurchase of the common shares held by Sumitomo, additional repurchases of 57,110,703 shares were made in open market transactions under the share repurchase program during the fiscal year ended March 31, 2025 for an aggregate purchase price of approximately $644.8 million. During the three months ended June 30, 2025, repurchases of 20,269,450 shares were made for an aggregate purchase price of approximately $208.3 million.

Funding Requirements

We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the discovery efforts, preclinical activities, clinical trials and potential commercialization of our product candidates. Our operating results, including our net losses, may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials, our expenditures on other research and development activities and our commercialization efforts. We anticipate our expenses will increase substantially as we:

•fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future;

•fund the manufacturing of drug substance and drug product of our product candidates in development;

•seek to identify, acquire, develop and commercialize additional product candidates;

•invest in activities related to the discovery of novel drugs and advancement of our internal programs;

•integrate acquired product candidates or technologies into a comprehensive regulatory and product development strategy;

•maintain, expand and protect our intellectual property portfolio;

•hire scientific, clinical, quality control and administrative personnel;

•add operational, financial and management information systems and personnel, including personnel to support our drug development efforts;

•achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties;

•seek regulatory approvals for any product candidates that successfully complete clinical trials;

•build out our sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain regulatory approval; and

•operate as a public company.

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While we do not have a need for additional capital to continue our operations as a result of our current liquidity position, we may in the future require additional capital to fund our operations, pursue business opportunities or strategic transactions or respond to challenges, competition or unforeseen circumstances. In that case, until such time, if ever, that we can generate substantial revenues, we may finance future cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements or other collaborations at Roivant and the Vants. To the extent that we raise additional capital by issuing equity securities at Roivant or the Vants, our existing shareholders’ ownership, or our ownership in the Vants, may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that could harm the rights of our shareholders. Additionally, any agreements for future debt or preferred equity financings, if available, may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations or strategic alliances or through marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or technologies or grant licenses on terms that may not be favorable to us. The foregoing restrictions associated with potential sources of additional capital may make it more difficult for us to raise additional capital, if needed, or to pursue business opportunities, including potential acquisitions.

While we do not have a near-term need for additional capital as a result of our current liquidity position, we may in the future require additional capital, and if adequate funds are not available to us, in that case, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery programs, or be unable to expand operations or otherwise capitalize on business opportunities, which could materially affect our business, prospects, financial condition and results of operations.

Finally, as part of our ongoing business strategy we regularly evaluate new acquisition and in-licensing opportunities, as well as our capital structure. We may from time to time use our existing cash to fund such opportunities or to return capital to shareholders though share repurchases or the issuance of cash dividends on our common shares to optimize our capital structure. See “Risk Factors—Risks Related to Our Business and Industry—We face risks associated with acquisitions, divestitures and other strategic transactions.” for more information.

Cash Flows

The following table sets forth a summary of our cash flows for the nine months ended December 31, 2025 and 2024:


	Nine Months Ended December 31,
	2025		2024
	(in thousands)
Net cash used in operating activities	$	(586,531)	$	(666,886)
Net cash used in investing activities	$	(855,824)	$	(2,840,485)
Net cash provided by (used in) financing activities	$	203,013	$	(1,042,641)

Operating Activities

Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash flow from operating activities is derived from adjusting our net loss for non-cash items and changes in working capital.

For the nine months ended December 31, 2025, cash used in operating activities decreased by $80.4 million to $586.5 million compared to $666.9 million for the nine months ended December 31, 2024. This decrease was primarily due to certain cost savings during the nine months ended December 31, 2025 as a result of the sale of Dermavant and termination of namilumab and RVT-2001 programs along with lower cash compensation during the nine months ended December 31, 2025 as a result of higher one-time cash awards made pursuant to the 2024 Senior Executive Compensation Program during the nine months ended December 31, 2024. These decreases were partially offset by lower cash receipts from revenues in part as a result of the sale of Dermavant, less interest income received and greater cash requirements to advance our existing research and development programs, including the anti-FcRn franchise and brepocitinib, during the nine months ended December 31, 2025.

Investing Activities

For the nine months ended December 31, 2025, cash used in investing activities decreased by approximately $2.0 billion to $855.8 million compared to approximately $2.8 billion for the nine months ended December 31, 2024, primarily

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related to the maturities of certain marketable securities along with a decrease in purchases of marketable securities during the nine months ended December 31, 2025.

Financing Activities

For the nine months ended December 31, 2025, cash provided by financing activities was $203.0 million and cash used in financing activities was approximately $1.0 billion for the nine months ended December 31, 2024. This change is primarily due to a decrease in cash used for the repurchase of our common shares, an increase in cash proceeds from exercise of stock options, and an increase in cash proceeds from the issuance of subsidiary common shares, net of issuance costs paid, during the nine months ended December 31, 2025.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingencies as of the dates of the unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts or experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known.

We define our critical accounting policies as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles.

There have been no significant changes to our critical accounting policies and use of estimates from those disclosed under Management’s Discussion and Analysis of Financial Condition and Results of Operations for the year ended March 31, 2025 in our Form 10-K.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are exposed to market risks in the ordinary course of our business, primarily related to interest rate and foreign currency sensitivities and equity price risk.

Interest Rate Sensitivity

As of December 31, 2025, we had cash, cash equivalents and marketable securities of approximately $4.5 billion. Our management team has broad discretion in respect of use of our cash, cash equivalents and marketable securities. The primary objective of our investment activities is to preserve capital to fund our operations. We may use all or a portion of such proceeds for one or more strategic transactions, including acquisitions of companies, asset purchases or sales or in-licensing of intellectual property, products or product candidates or technologies, as described above. We also seek to maximize income from our investments without assuming significant risk. To achieve our objectives, we maintain a portfolio of investments in a variety of securities of high credit quality and average short-term duration, according to our board-approved investment policy. Interest income is sensitive to changes in the general level of interest rates; however, due to the nature of our account portfolio, a hypothetical 10% change in interest rates would not have a material effect on our financial condition or unaudited condensed consolidated financial statements.

Foreign Currency Sensitivity

Our employees and our operations are currently primarily located in the U.S., and our expenses are generally denominated in U.S. dollars. We therefore are not currently exposed to significant market risk related to changes in foreign currency exchange rates. However, we are exposed to fluctuations in foreign currency exchange rate risk as a result of entering into transactions denominated in currencies other than U.S. dollars as we have contracted with and may continue to contract with foreign vendors and counterparties. A hypothetical 10% change in exchange rates during any of the periods

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presented would not have a material effect on our financial condition or unaudited condensed consolidated financial statements.

Equity Price Risk

As of December 31, 2025, we were exposed to price risk on equity securities included in our portfolio of investments, the most significant of which were our investments in Arbutus and Datavant. Our investments in Arbutus and Datavant are measured at fair value with any changes in fair value recognized in our statements of operations, which therefore may increase the volatility of our earnings. A hypothetical 10% increase or decrease in the fair value of our investments in Arbutus and Datavant would have increased or decreased their fair value as of December 31, 2025 by approximately $43.4 million.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures.

We maintain “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), that are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.

Our management, with the participation of our Principal Executive Officer and our Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025, the end of the period covered by this Quarterly Report. Based on this evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2025 at the reasonable assurance level.

Changes in Internal Control Over Financial Reporting.

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended December 31, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitation on the Effectiveness of Internal Control.

Our management, including our Principal Executive Officer and Principal Financial Officer, does not expect that our disclosure controls and procedures, or our internal controls, will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected.

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PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in legal or regulatory proceedings arising in the ordinary course of our business. We do not currently, however, expect such legal proceedings to have a material adverse effect on our business, operating results or financial condition. However, depending on the nature and timing of a given dispute, an unfavorable resolution could materially affect our current or future results of operations or cash flows.

Item 1A. Risk Factors.

Our business involves a high degree of risk. You should carefully consider the risks described below, together with the other information contained in this Quarterly Report, including our unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report, as well as the risks, uncertainties and other information set forth in the reports and other materials filed or furnished by us and our majority-controlled subsidiary, Immunovant, Inc. (“Immunovant”), with the SEC. We cannot assure you that any of the events discussed in the risk factors below will not occur. These risks could have a material and adverse impact on our business, prospects, results of operations, financial condition and cash flows. If any such events were to happen, the trading shares of our common shares could decline, and you could lose all or part of your investment.

Unless the context otherwise requires, references in this section to “we,” “us,” “our,” “Roivant” and the “Company” refer to Roivant Sciences Ltd. and its subsidiaries and affiliates, as the context requires. References to our “product candidates” include our current and any future products or product candidates. Approval from the U.S. Food and Drug Administration (“FDA”) or other applicable international regulatory authority is required before a product or product candidate may be marketed and sold in the relevant jurisdiction.

Risks Related to Our Business and Industry

Risks Related to Our Strategy and Financial Position

Our relatively limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development and commercialization may make it difficult for us to execute on our business model and for you to assess our future prospects.

We are a clinical-stage biopharmaceutical and healthcare technology company with a relatively limited operating history upon which you can evaluate our business and prospects. We were formed in April 2014, and our operations to date have primarily been limited to acquiring or in-licensing product candidates, pursuing the clinical development and commercialization of those product candidates, managing and operating our subsidiaries, which we refer to as “Vants,” financing activities, efforts to discover new product candidates and the creation or acquisition of healthcare technology companies and products. Following the acquisition of our subsidiary Dermavant by Organon (the “Dermavant Transaction”), completed in October 2024, we no longer have a commercial-stage product and we do not expect to generate product revenues from the commercial sale of our product candidates in the near term. Drug development is an inherently uncertain undertaking that involves significant upfront investments and a substantial degree of risk. If we do not successfully address and manage these risks, our business and prospects will suffer.

Our ability to execute on our business model, successfully develop and commercialize product candidates and eventually generate revenues from the sales of our product candidates following regulatory approvals depends on a number of factors, including our ability to:

•successfully progress and complete our ongoing and future clinical trials;

•identify and consummate new acquisition or in-licensing opportunities, and then advance the acquired or in-licensed product candidates through clinical trials;

•obtain regulatory approvals for our current and future product candidates;

•successfully launch commercial sales of our product candidates following regulatory approvals, whether alone or in collaboration with others, including establishing sales, marketing and distribution systems;

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•set acceptable prices for our product candidates following regulatory approvals and obtain coverage and adequate reimbursement from third-party payors;

•achieve market acceptance of our product candidates following regulatory approvals in the medical community and with third-party payors and consumers;

•make milestone, royalty or other payments due under any licenses or agreements;

•obtain, maintain, expand, protect and enforce our intellectual property portfolio, including intellectual property obtained through license agreements;

•realize the benefits of our strategic partnerships and other collaborations, including the Dermavant Transaction;

•attract, hire and retain experienced management teams and qualified personnel to support our ongoing clinical development efforts, including at existing and newly-formed Vants, and successfully prepare for the commercialization of our product candidates following regulatory approvals;

•initiate and maintain relationships with third-party suppliers and manufacturers and have commercial quantities of product candidates, following regulatory approvals, manufactured at acceptable cost and quality levels and in compliance with FDA and other regulatory requirements;

•negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter;

•raise additional funds when needed and on terms acceptable to us;

•successfully grow our healthcare technology Vants and market the products and services offered by those Vants;

•defend against any product liability claims or other lawsuits related to our product candidates; and

•continue to meet the requirements of being a public company, including requirements under the Sarbanes-Oxley Act of 2002 (“SOX”) and continue to protect our business operations and systems from cybersecurity threats.

Because of the numerous risks and uncertainties associated with biopharmaceutical product development and commercialization, we are unable to predict when and if our product candidates will achieve various milestones in their clinical development, including marketing approval from the FDA or other regulatory authorities, the timing or amount of increased expenses related to these activities or when we will be able to generate revenues from the sale of those product candidates following regulatory approvals or achieve or maintain profitability. Our expenses could increase beyond expectations if we are required by the FDA or other regulatory authorities to perform studies or clinical trials in addition to those that are currently anticipated or to otherwise provide data beyond that which we currently believe is necessary to support an application for marketing approval in the U.S. or another jurisdiction, or if there are any delays in any of our current or future clinical trials or the development of our product candidates. Our inability to successfully execute on the objectives described herein would have a material adverse effect on our business, financial condition, results of operations and prospects.

We may not be successful in our efforts to acquire or in-license new product candidates, and newly acquired or in-licensed product candidates may not perform as expected in clinical trials or be successful in eventually achieving marketing approvals.

The success of our business depends in large part on our ability to successfully identify new product candidates, generally through acquisitions or in-licensing transactions. Our acquisition and in-licensing efforts focus on identifying assets in development by third parties across a diverse range of therapeutic areas that, in our view, are underserved or undervalued. Once identified, we typically seek to in-license these assets from partners for low or no upfront payment, with future royalty or milestone payments to the licensor tied to the successful achievement of pre-specified development or commercialization benchmarks. From time to time, we also use joint venture structures for our Vants, where the licensor receives a minority equity ownership stake in the Vant formed around an in-licensed asset. Certain potential licensors may be unwilling or unable to pursue these types of transaction structures, which could have the effect of limiting the number of available in-licensing candidates or make us a less attractive partner for a given asset, relative to other potential acquirors.

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Following the acquisition or in-licensing, our strategy often entails designing low-cost studies for a product candidate that result in a quick “go/no-go” decision on whether or how to proceed with future development for a given asset. In the event a product candidate fails to demonstrate a meaningful clinical effect or presents potential safety or tolerability issues in these early-stage studies, we may decide to discontinue development of the product candidate. In these cases, we generally will be unable to recoup any of the expenses associated with the acquisition or in-licensing of the product candidate or the costs associated with the studies. We may decide to proceed with the development of a product candidate on the basis of that study and later determine that the more costly and time intensive trials required for regulatory approvals do not support the initial value the product candidate was thought to hold or demonstrate the product profile required for a marketing approval. Even if a product candidate does prove to be valuable or successful in receiving marketing approval, its value may be less than we anticipated at the time of the investment, including after payments of applicable royalty and milestone payments to the licensor, and we may not be able to recover the investment we made in developing the product candidate.

We also face significant competition for attractive investment opportunities. A number of companies compete with us for such opportunities, some of which may possess greater financial or technical resources. If we are unable to identify a sufficient number of potential product candidates for acquisition or in-licensing, or if the product candidates that we identify do not prove to be as valuable as anticipated, we will not be able to successfully develop or receive marketing approval for those product candidates, and our business and results of operations may suffer materially as a result. Any such failure to in-license or acquire new product candidates from third parties, or the failure of those product candidates to succeed in clinical trials and eventually receive marketing approval, would have a material adverse effect on our business, financial condition, results of operations and prospects.

Immunovant relies on the HanAll Agreement to provide the rights to the core intellectual property relating to IMVT-1402 and batoclimab. Any termination or loss of significant rights under the HanAll Agreement would adversely affect Immunovant’s development and commercialization of IMVT-1402 and batoclimab.

Our subsidiary Immunovant holds the intellectual property rights to IMVT-1402 and batoclimab under a license agreement with HanAll Biopharma Co., Ltd. (“HanAll”) (the “HanAll Agreement”). The HanAll Agreement imposes a variety of obligations on Immunovant, including those relating to exclusivity, territorial rights, development, commercialization, funding, payment, diligence, sublicensing, insurance, intellectual property protection and other matters. If Immunovant materially breaches any of its obligations under the HanAll Agreement and is unable to cure that breach within the time frame specified under the HanAll Agreement, Immunovant may be required to pay damages to HanAll and HanAll may have the right to terminate the HanAll Agreement, which would result in Immunovant being unable to develop or manufacture its products. Immunovant has commenced discussions with HanAll regarding the potential return to HanAll of certain rights for batoclimab.

Biotechnology and pharmaceutical license agreements are complex and certain provisions in the HanAll Agreement may be susceptible to multiple interpretations. The resolution of any dispute or disagreement involving contract interpretation that may arise in relation to the HanAll Agreement or other agreements, including those related to the development and commercialization of product candidates could affect the scope of Immunovant’s rights, or affect financial or other obligations, under the HanAll Agreement, either of which could harm our business, financial condition, results of operations and prospects.

Immunovant continues to anticipate sharing top-line results from the two batoclimab Phase 3 TED studies concurrently in the first half of calendar year 2026. HanAll has a variety of interests in the licensed products under the HanAll Agreement and outside of Immunovant’s licensed territories, and may, as a result of those interests, disagree with, or initiate a dispute with respect to, Immunovant’s development or commercialization plans for batoclimab. While the HanAll Agreement gives Immunovant final control over development and regulatory decisions relating to batoclimab in our licensed territories, HanAll may disagree with future development plans for batoclimab, and Immunovant may not reach an agreement with respect to batoclimab, which could result in HanAll initiating a dispute for alleged breach of the HanAll Agreement and such a dispute could result in arbitration or litigation. In the event that HanAll asserts a breach, we and Immunovant do not believe there would be any basis for such a claim, and would vigorously contest such a claim if made. Any potential dispute with HanAll could be very expensive and time-consuming, may divert management’s attention from core business functions and may result in unfavorable results that materially impact Immunovant’s business. In addition, discontinuing further development of and regulatory submissions for batoclimab could impact and result in disputes with third parties, such as with respect to the contract manufacturing of batoclimab, which may be time consuming and expensive to resolve.

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We will likely incur significant operating losses for the foreseeable future and may never achieve sustained profitability.

Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to gain regulatory approval or become commercially viable. Following the Dermavant Transaction we do not have any product candidates that have received marketing approval anywhere in the world and we do not expect to generate product revenues from the commercial sale of our product candidates in the near term. As a result, we cannot estimate with precision the extent of our future losses. Since inception, we have incurred significant losses and negative cash flows from operations. As of December 31, 2025, we had cash, cash equivalents and marketable securities of approximately $4.5 billion and our accumulated deficit was approximately $695.0 million.

We may never be able to successfully develop, achieve regulatory approvals for or commercialize our product candidates. Even if approved, our product candidates may not generate meaningful product revenues or enable us to achieve or maintain profitability. We expect to incur substantial operating losses for the foreseeable future, through the projected commercialization of our product candidates. Our ability to generate meaningful product revenues and achieve and sustain profitability depends on our ability to complete the development of our product candidates, obtain necessary regulatory approvals for our product candidates and manufacture and successfully market our product candidates alone or in collaboration with others. Revenues from the sale of any product candidate for which regulatory approval is obtained will depend, in part, upon the size of the markets in the territories for which we may gain regulatory approval, the accepted price for the product candidate, the ability to obtain reimbursement at any price, the strength and term of patent exclusivity for the product candidate and the overall competitive landscape. Even if we achieve profitability from product revenues in the future, we may not be able to sustain profitability in subsequent periods. Our failure to achieve and sustain profitability could depress the market value of our company and impair our ability to raise capital, expand our business and pipeline and market any product candidates following regulatory approval.

We face risks associated with the allocation of capital and personnel across our businesses.

Because we have finite financial and management resources, we must make challenging decisions regarding the allocation of capital and personnel across our businesses. We face certain risks associated with these decisions and may fail to capitalize on viable commercial product candidates or profitable market opportunities as a result. For example, we may decide not to pursue a particular in-licensing or acquisition opportunity, or a potential target indication for a product candidate, that later proves to have greater commercial potential than our current and planned development programs and product candidates. Similarly, decisions to delay or terminate certain programs may subsequently also prove to be suboptimal and could cause us to miss valuable opportunities. In addition, our management’s attention to one product candidate or target indication may divert their attention from another opportunity or indication that ultimately might have proven more successful. If we do not accurately evaluate the commercial potential or target market for a particular product candidate or indication, or misinterpret trends in the biopharmaceutical industry more generally, we may relinquish valuable rights to a product candidate through collaboration, licensing or other royalty arrangements, or fail to pursue a target indication, which would have been more advantageous, and our business, financial condition, results of operations and growth prospects could be materially adversely affected. In addition, our spending on current and future research and development programs and other future product candidates may not yield any commercially viable future product candidates.

We may pursue additional in-licenses or acquisitions of product candidates or programs, which entail additional risk to us. Identifying, selecting and acquiring promising product candidates requires substantial technical, financial, legal and human resources expertise. Our efforts may not result in the actual acquisition or in-license of a successful product candidate, potentially resulting in a diversion of our management’s time and the expenditure of our resources with no resulting benefit. If we are unable to identify programs that ultimately result in approved products, we may spend material amounts of our capital and other resources evaluating, acquiring and developing product candidates that ultimately do not provide a return on our investment, which would have a material adverse effect on our business, financial condition, results of operations and prospects.

We face risks associated with the Vant structure.

Our product candidates are developed at our Vants, which operate similarly to independent biopharmaceutical companies with their own management teams and equity incentive structures. While we believe that there are significant competitive advantages to this structure, as compared to traditional pharmaceutical companies or smaller biopharma companies, the Vant structure also poses certain risks for our business.

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Operating the Vants independently, rather than under a centralized, consolidated management team, may result in increased costs at Roivant and the Vants, as certain functions or processes, including sales and marketing, clinical and nonclinical personnel, business development, finance, accounting, human resources and legal functions, are replicated at Roivant and at multiple Vants. There may also be certain start-up costs associated with the establishment of a new Vant or integration of a newly acquired business into a Vant, which are greater under the Vant model than they would be under a centralized model. The use of the Vant model may also entail increased costs for us, including the time and expenses associated with hiring Vant CEOs and management teams, overseeing Vant equity incentive arrangements and managing compliance-related risks, including the internal controls, accounting systems and other policies and procedures necessary for us to operate as a public company. We may also be exposed to increased “key employee” risks in the event a Vant CEO were to depart, including the loss of other senior Vant personnel, potentially resulting in adverse impacts to commercialization or development work at the Vant. These increased expenses, complexities and other challenges may make using and scaling the Vant model more challenging and costly than it would be for a traditional pharmaceutical company to both operate and expand the number of product candidates under development, which could have a material adverse effect on our consolidated business, financial condition, results of operations or prospects. This decentralized model could also make compliance with applicable laws and regulations more challenging to monitor and may expose us to increased costs that could, in turn, harm our business, financial condition, results of operations or prospects.

In addition, a single or limited number of the Vants may, now or in the future, comprise a large proportion of our value. Similarly, in the future, a large proportion of our consolidated revenues could be derived from one or a small number of Vants. Any adverse development at a key Vant, including the loss of key members of management, the termination of a key license agreement or other loss of the intellectual property underlying a product candidate or the failure of a clinical trial for a product candidate under development at the Vant, could have a material adverse effect on our consolidated business, financial condition, results of operations or prospects.

We do not wholly own certain of our Vants, including our publicly traded subsidiary, Immunovant. By virtue of Immunovant being a publicly traded company, our operational control of Immunovant is also limited in certain respects and certain transactions between us and Immunovant may require the prior approval of a special committee of independent directors, which we do not control. This structure could result in delays in certain financing or other transactions at Immunovant, or prevent us from taking certain actions with respect to Immunovant that we think are in our best interests as a majority shareholder of Immunovant. In addition, certain of our Vants have issued equity securities senior to our ownership interests, which dilutes our economic interest in the Vants and can in certain cases limit our operational control of the Vant.

Our Vants also have equity incentive plans, which can result in the dilution of our ownership interest in the Vant as the awards issued under those plans vest and are exercised. The vesting and exercise of incentive equity awards at the Vants, as well as future capital needs at the Vants – which may be financed through senior debt or equity securities or common equity – may further dilute or subordinate our ownership and economic interests in the Vants or reduce our operational control of the Vants. In addition, recipients of Vant equity awards may have economic alignment with a Vant that incentivizes them to act in ways that prioritize the success of a Vant over the success of the Company as a whole, which could adversely impact our consolidated business, financial condition, results of operations or prospects. For more information on our ownership of our Vants, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview.”

We manage the Vants in part through our designees who serve on the Vant boards of directors. Additionally, certain officers or employees of Roivant may from time to time serve as officers or employees of the Vants. Such service by Roivant officers or employees may take away time or focus from such individuals’ work at Roivant. Further, in their capacities as officers or directors of the Vants, those individuals may owe fiduciary duties to the Vants and their shareholders under applicable law, which may at times require them to take actions that are not directly in our interest as a shareholder. To the extent any such actions have an adverse effect on the value of our ownership interest in the Vant, it could further adversely impact our consolidated business, financial condition, results of operations or prospects.

We face risks associated with potential future payments we may owe in connection with our product candidates.

The in-licensing transactions for our product candidates typically involve zero or low upfront payments combined with milestone and royalty payments. These arrangements generally involve a payment or payments upon the achievement of certain development or regulatory milestones, including regulatory approval, and then royalty payments upon the achievement of specified levels of sales, which can extend for up to the life of a product. Some of these payments may become due before a product is generating sufficient funds to enable us to meet our obligations. If this were to occur, we

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would default on our payment obligations and could face penalties, delays in commercialization or development activities, the termination of a license agreement or reputational damage. Even for a product that is commercialized and generating revenue, payments could become due that are so large that the investment is not profitable or is less profitable than anticipated. For example, this could occur if at the time of the initial investment, we overestimated the value of the product and agreed to a payment schedule using these inflated estimates. If we are unable to make milestone and royalty payments related to our product candidates when due, our business and prospects could suffer and our ability to in-license future product candidates could be impaired.

We face risks associated with acquisitions, divestitures and other strategic transactions.

We have in the past engaged in acquisitions, divestitures and other strategic transactions, and we may in the future pursue similar opportunities. For example, in October 2024 we completed the Dermavant Transaction, the consideration for which consisted of an upfront payment of $183.6 million and a milestone payment of $75 million upon FDA approval of VTAMA for the treatment of atopic dermatitis (the “AD Approval Milestone”). We received the AD Approval Milestone in January 2025. In addition, at closing, all former Dermavant equity holders, including Roivant, received the right to receive their pro rata portion of (i) milestone payments of up to $950 million for the achievements of certain tiered net sales amounts with respect to VTAMA, each less than or equal to $1 billion and (ii) tiered royalties of (x) low-to-mid single digit percentages with respect to annual net sales of VTAMA up to $1 billion and (y) 30% with respect to annual net sales of VTAMA above $1 billion. There can be no assurance that we will receive any of the future milestone or royalty payments owed in connection with the Dermavant Transaction, or that the proceeds from the Dermavant Transaction will exceed the profits that we could have generated if we had continued to own and operate Dermavant as one of our Vants. For more information on the Dermavant Transaction, please refer to Note 6, “Discontinued Operations” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Any such future strategic transactions will entail numerous risks, including:

•in connection with divestiture or other sale or partnering transactions:

•the failure to realize the expected benefits from the transaction, including receiving milestone and royalty payments owed in connection with the transaction; and

•risks and uncertainties associated with the counterparty to any such transaction, including their ability to successfully develop and commercialize a product candidate such that milestone and royalty payments are triggered or their ability to make milestone and royalty payments when such payments are due;

•in connection with acquisition or in-licensing transactions:

•the risks generally applicable to biopharmaceutical drug development, including that the acquired or in-licensed program does not generate the expected clinical outcomes, that the expected timelines for the clinical program are delayed or otherwise slower than expected, that safety or tolerability issues arise in the clinical trials or that other regulatory issues arise, including the inability to receive regulatory approvals on the expected timelines or at all;

•the ability following applicable regulatory approvals to generate revenues from an acquired product candidate or program sufficient to meet our objectives or offset the associated transaction and maintenance costs;

•risks associated with the transfer or integration of the operations of an acquired entity or program, including difficulties associated with integrating any new personnel; and

•increased operating expenses and cash requirements, the assumption of indebtedness or contingent liabilities or the issuance of our equity securities in connection with such a transaction, which would result in dilution to our shareholders;

•the diversion of our management’s attention from existing programs and other operational matters; and

•the loss of key employees and other uncertainties, including our ability to maintain key business relationships at the acquired entity, that may arise in connection with a given transaction.

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In addition, the integration or separation of any business that we may acquire in the future may disrupt our existing business and may be a complex, risky and costly endeavor for which we may never realize the full benefits. For any alliances or joint ventures that we enter into in the biopharmaceutical industry, we may encounter numerous difficulties in discovering, developing, manufacturing and marketing any new products or product candidates related to such businesses, which may delay or prevent us from realizing the expected benefits or enhancing our business. Divestiture transactions such as the Dermavant Transaction may adversely impact the price of our common shares, to the extent investors believe the value of the consideration received in the transaction is not equivalent to the value of the asset or program divested. Accordingly, there can be no assurance that transactions of the nature described above will be undertaken or successfully completed, and that any transaction we do complete will not have a material adverse effect on our business, results of operations, financial condition and prospects.

We face risks associated with the use of our cash, cash equivalents and marketable securities.

As of December 31, 2025, we had cash, cash equivalents and marketable securities of approximately $4.5 billion. Our management team has broad discretion in respect of use of our cash, cash equivalents and marketable securities. We may use all or a portion of such proceeds for one or more strategic transactions, including acquisitions of companies, asset purchases or the in-licensing of intellectual property, products, product candidates or technologies, as described above. We may not be able to find a suitable strategic transaction that we deem sufficiently attractive to pursue, and even if such a transaction is identified, may not be able to complete a strategic transaction in the future. Our ability to complete a strategic transaction may be negatively impacted by general macroeconomic and market trends and conditions, including volatility in the capital markets, and the other risks described herein.

As previously disclosed, in June 2025, our board of directors authorized a new common share repurchase program, allowing for repurchases of common shares in an aggregate amount of up to $500 million (excluding fees and expenses) (the “2025 Repurchase Authorization”). The 2025 Repurchase Authorization is in addition to the previously disclosed common share repurchase program allowing for repurchase of common shares in an aggregate amount of up to $1.5 billion (excluding fees and expenses), which was fully exhausted as of June 30, 2025.

The timing and total amount of repurchases under the 2025 Repurchase Authorization, or any future repurchase authorization from our board of directors, will depend on several factors, including the market price of our common shares, general business, macroeconomic and market conditions and other investment opportunities, as well as the discretion of our board of directors, or its delegees, that any such activity would be in the best interests of our shareholders and in compliance with all applicable laws and our contractual obligations. In the event that we decide to pursue further repurchases of common shares, we may be limited in our ability to repurchase our common shares by various governmental laws, rules and regulations which prevent us from purchasing our common shares during periods when we are in possession of material non-public information. We may also use our discretion to repurchase common shares from certain shareholders without offering the opportunity to all shareholders to have their common shares repurchased at that time and price. In addition, our ability to pay dividends may be limited by covenants of any existing and future outstanding indebtedness we or our subsidiaries incur.

The amount of cash available to return to shareholders, if any, can vary significantly from period to period for a number of reasons, including, among other things, our results of operations, financial condition, cash requirements, contractual restrictions, applicable law and other factors that our board of directors may deem relevant. The returns of capital to shareholders may change in form, amount, value and frequency from time to time, and we cannot guarantee that any such future returns of capital will take place. The trading price of our common shares may decline, possibly materially, if we are unable to meet investor expectations with respect to the timing and total amount of future capital returns to shareholders. There is no guarantee that our significant balance of cash, cash equivalents and marketable securities will be used to increase our operating results, return capital to shareholders or enhance the value of our common shares.

We are exposed to risks related to our significant holdings of cash, cash equivalents and marketable securities.

Our significant holdings of cash, cash equivalents and marketable securities can be negatively affected by a variety of factors, including market and economic conditions and volatility, political risk, trade policy, including the imposition of additional tariffs, currency risk, credit risk, sovereign risk, interest rate fluctuations or other market or macroeconomic factors. Our investments consist primarily of money market funds and other debt securities, including investment-grade corporate bonds. Any fixed-income securities we hold now or in the future are subject to external factors that may adversely affect their market value or liquidity, such as interest rate, liquidity, market and issuer credits risks, including actual or anticipated changes in credit ratings. Additionally, we may from time to time have balances in bank

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accounts that are in excess of insured deposit limits and could be subject to risks of bank failures. As a result, the value and liquidity of our cash, cash equivalents and marketable securities may fluctuate substantially. Therefore, although we have not incurred any significant losses on our cash, cash equivalents and marketable securities, future fluctuations in their value could result in significant losses and could have a material adverse impact on our results of operations and financial condition.

While we do not have a need for additional capital under our current operating plans as a result of our current liquidity position, we may in the future require additional capital to fund our operations. In that case, if we fail to obtain necessary financing when needed, we may not be able to successfully acquire or in-license new product candidates, complete the development and commercialization of our product candidates following regulatory approval and continue to pursue our drug discovery efforts.

Acquiring or in-licensing, discovering, developing, commercializing and marketing biopharmaceutical product candidates is expensive and time consuming, and we expect to continue to spend substantial amounts to fund our clinical development and other research and development activities, and to commercialize our product candidates following regulatory approvals. While we do not have a near-term need for additional capital under our current operating plan as a result of our current liquidity position, we may in the future require additional capital to pursue these activities. We are also responsible for payments to third parties under our license and acquisition agreements, including milestone and royalty payments. Because of the inherent uncertainties in these activities – including the outcome of preclinical and clinical trials and the regulatory approval process – we cannot reasonably estimate the actual amounts necessary to successfully complete the development, regulatory approval process and commercialization of our product candidates. Our estimate as to how long we expect our existing cash, cash equivalents and marketable securities to be available to fund our operations is based on assumptions that may be proven inaccurate, and we could exhaust our available capital resources sooner than we currently expect.

If adequate funds are not available to us in the future when we need it, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery programs or be unable to expand operations or otherwise capitalize on business opportunities, which could materially affect our business, prospects, financial condition and results of operations.

Our business strategy and potential for future growth rely on a number of assumptions, some or all of which may not be realized.

Our business strategy and plans for future growth rely on a number of assumptions, including, in the case of our product candidates, assumptions related to approval and adoption of a particular therapy, incidence and prevalence of an indication, use of a product candidate versus competitor therapies and size of the addressable patient populations. Some or all of these assumptions may be incorrect due to errors or mistaken assumptions in our analysis or the inherent uncertainties in the drug development process, among other reasons. We cannot accurately predict whether, following regulatory approvals, our product candidates will achieve significant market acceptance in line with these assumptions or whether there will be a market for our product candidates that reaches the anticipated size. If any of these assumptions are incorrect or overstated, our results and future prospects will be materially and adversely affected.

Our drug discovery efforts may not be successful in identifying new product candidates.

Our drug discovery efforts are centered on our discovery Vants, including PsiThera and Covant, which employ a variety of approaches to the drug discovery process, including quantitative proteomics, induced proximity and covalency. As a company, we have relatively limited experience in drug discovery generally and with certain of the computational tools that are employed in those efforts. Our future success depends, in part, on our ability to successfully use these approaches and technologies to identify promising new product candidates and eventually advance those product candidates through preclinical studies and clinical trials. We have not yet succeeded and may not succeed in advancing any product candidates developed through these discovery efforts into clinical trials, demonstrating the efficacy and safety of such product candidates or obtaining regulatory approval thereafter. As a result, it is difficult to predict the time and cost of product candidate development from our discovery Vants and we cannot predict whether the application of these approaches will result in the development and regulatory approval of any products. In addition, many of the active drug discovery efforts at our discovery Vants are being conducted pursuant to collaboration agreements with third parties, in which the third parties are either owed milestone and royalty payments tied to the successful development and commercialization of successfully identified drug candidates, or have been granted exclusive or shared development and commercialization rights with respect to successfully identified drug candidates in exchange for upfront payments, shared

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expenses, and certain milestone and royalty payments owed to the discovery Vants. Any problems that we or our third-party partners experience in the future related to this platform or any of our related development programs may cause significant delays or unanticipated costs or may prevent the development of a commercially viable product. Any of these factors may prevent us from completing our preclinical studies or any clinical trials that we may initiate or commercializing any internally discovered product candidates we may develop on a timely or profitable basis, if at all. Even if successful, as a result of our collaboration agreements, our rights to commercialize any successfully discovered product candidates may be limited.

Unfavorable, uncertain and rapidly changing global and regional economic, political and public health conditions could adversely affect our business, financial condition and results of operations.

Our business could be adversely affected by changes in global or regional economic, political and public health conditions. Various macroeconomic factors could adversely affect our business, financial condition and results of operations, including changes in inflation levels, interest rates, international trade policies and tariffs and overall economic conditions and the current and future conditions in the global financial markets, including global or regional economic instability. For example, if sustained high rates of inflation or other factors were to significantly increase our expenses, we may be unable to manage such increased expenses or pass through price increases. During a severe or prolonged economic downturn, patients may prioritize other items over certain or all of their treatments and medications, which could have a negative impact on our commercial sales. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which economic climate and financial market conditions could adversely impact our business.

Additionally, uncertainties resulting from political instability, international hostilities and geopolitical tensions (including the current military conflict between Russia and Ukraine and the conflict in the Middle East), trade disputes between nations (including current trade disputes with China), a global financial crisis, wars, terrorism and civil unrest could adversely affect our business. In particular, given the new administration in the United States, there is currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, tariffs, treaties, taxes and other limitations on cross-border operations. The U.S. government has made and continues to make significant additional changes in U.S. trade policies and tariffs and may take actions in the future actions that could negatively impact U.S. trade. For example, legislation has been enacted to limit certain U.S. biotechnology companies from using equipment or services produced or provided by select Chinese biotechnology companies in the performance of federal contracts, and others in Congress have advocated for the use of existing executive branch authorities to limit those Chinese service providers’ ability to engage in business in the U.S. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions or what actions may be taken by the other countries in retaliation. If we are unable to obtain or import goods or use services from existing service providers or become unable to export or, if approved, sell our products, our business, liquidity, financial condition and results of operations would be materially and adversely affected.

Further, outbreaks of disease and other unexpected public health events may cause extreme volatility in the capital and credit markets and other disruptions to our business. Business disruptions could include, among others, disruptions to our clinical development activities, including due to supply chain or distribution constraints or challenges, clinical enrollment, clinical site availability, patient accessibility and conduct of our clinical trials, as well as temporary closures of the facilities of suppliers or contract manufacturers in the biotechnology supply chain. Adverse health conditions could result in a variety of risks to our business, including our ability to raise capital when needed on acceptable terms, if at all.

A portion of our or certain of our Vants’ manufacturing, laboratory research or clinical trial activities takes place in Asia. A significant disruption in that region, such as a trade war or political unrest, could materially adversely affect our business, financial condition and results of operations.

We and certain of our Vants engage in contract manufacturing, conduct clinical trials and perform laboratory research activities outside the U.S., including in Asia. Any disruption in production or inability of contracted manufacturers in Asia to produce adequate quantities to meet our or the Vants’ needs could impair our or the Vants’ ability to operate on a day-to-day basis and to continue development of certain product candidates. In particular, trade tensions and conflict between the United States and China remain high, and could result in changes to the laws, rules, regulations and policies of the governments of the United States or China that impact the ability of U.S. biotechnology companies to partner with entities in China. For example, starting in February 2025 the U.S. imposed additional tariffs on Chinese imports, and China has responded with tariffs on U.S. products. We or certain of our Vants also conduct certain laboratory research and expect to have clinical trial sites in Asia. We are exposed to the possibility of product supply disruption, clinical trial delays and

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increased costs in the event of changes in governmental policies, political unrest or unstable economic conditions in Asia. Any disruption of these activities could materially and adversely affect our business and results of operations.

Inadequate or uncertain funding levels for the FDA, USPTO, SEC or other government agencies could hinder, delay or result in the suspension of those agencies’ operations, which could harm our business.

The ability of the FDA and other government agencies to review and approve new pharmaceutical products can be affected by a variety of factors, including budgets and funding levels, its ability to hire and retain key personnel and accept the payment of user fees and statutory, regulatory and policy changes. Review times at the FDA have fluctuated in recent years as a result of changes in these factors. In addition, government funding of the SEC, USPTO and other government agencies on which our operations may rely or be dependent is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other government agencies may slow the time required for new drugs to be reviewed and approved, which could adversely affect our business. For example, over the last several years, including as recently as February 2026, the U.S. government has shut down several times and certain regulatory agencies, including the FDA, have had to furlough employees and suspend certain activities. The Trump administration’s freeze on hiring and new return-to-office policy may disrupt normal operations of federal agencies, including the FDA. If another funding or other disruption occurs, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, or to provide feedback on our clinical development plans, which could have a material adverse effect on our business. There is substantial uncertainty as to how, if at all, the new administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates. The impending uncertainty could present new challenges or potential opportunities as we navigate the clinical development and regulatory approval process for our product candidates. Further, future government shutdowns or other disruptions to normal operations could impact our ability to access the public markets and obtain the funding necessary to properly capitalize and continue our operations.

Risks Related to the Development of Our Product Candidates

Clinical trials and preclinical studies are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials or preclinical studies on the expected timelines, if at all.

Our biopharmaceutical product candidates that are in clinical development or preclinical studies will require, as applicable, extensive clinical testing before a New Drug Application (“NDA”) or other similar application for regulatory approval, such as a Biologics License Application (“BLA”) or an application for marketing authorization in the European Union (“E.U.”) or United Kingdom (“U.K.”), may be submitted, or extensive preclinical testing before an Investigational New Drug application (“IND”) or an application for authorization to conduct a clinical trial in the E.U. or U.K. may be submitted, a Clinical Trial Application (“CTA”). We cannot provide any assurance that we will submit an IND, NDA, CTA or other similar application for regulatory approval for our product candidates within projected timeframes or whether any such application will be accepted for review or ultimately approved by the relevant regulatory authorities.

We cannot provide any assurance that any clinical trials will be conducted as planned or completed on schedule, if it all. Clinical trials and preclinical studies are very expensive, time-consuming and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time-consuming and costly and is dependent upon collaboration with many contract research organizations (“CROs”) and clinical trial sites. For instance, the FDA, an institutional review board (“IRB”), an Ethics Committee (“EC”) or other regulatory authorities may not agree with the proposed analysis plans or trial design for the clinical trials of our product candidates, and during any such review, may identify unexpected efficacy or safety concerns, which may delay the effective date of an IND or approval of an NDA, BLA or similar application. The FDA, the European Medicines Agency (“EMA”), the European Commission, the Medicines and Healthcare products Regulatory Agency (“MHRA”) or other relevant regulatory authority may also find that the benefits of any product candidate in any applicable indication do not outweigh its risks in a manner sufficient to grant regulatory approval.

The FDA or other regulatory authorities may also not agree with the scope of our proposed investigational plan. For example, they may find that our proposed development program is not sufficient to support a marketing authorization application, or that the proposed indication is considered to be too broad. Moreover, the FDA or other regulatory authorities may also refuse or impose certain restrictions on our reliance on data supporting our clinical trial application or

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marketing authorization application should such data originate from studies outside of the relevant jurisdiction or be affected by regulatory non-compliance, including issues of data integrity. In the E.U., data derived from clinical trials that were conducted outside the E.U. cannot be used to support a CTA unless the clinical trial was registered on a relevant database. In each case, this could delay the clinical development and authorization timeline for a given product candidate.

Failures can occur at any stage of development, including clinical trials or preclinical studies, and we could encounter problems that cause us to abandon or repeat clinical trials or preclinical studies. In addition, results from clinical trials or preclinical studies may require further evaluation, delaying the next stage of development or submission of an IND or an NDA or similar application in the U.S. or another jurisdiction. Further, product candidates in later stages of clinical trials may fail to show the desired safety and efficacy results despite having successfully progressed through preclinical and earlier stage clinical trials. Such product candidates may exhibit safety signals in later stage clinical trials that they did not exhibit in earlier studies or trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in, or the discontinuation of, advanced clinical trials with a product candidate due to lack of efficacy or adverse safety findings, despite having promising results in earlier trials or studies. Likewise, the results of early clinical trials or preclinical studies of our product candidates may not be predictive of the results of current or future development programs. There can also be no assurance that the results of studies conducted by collaborators or other third parties with similar product candidates in similar indications will be viewed favorably or indicative of our own future trial results.

The commencement and completion of clinical trials and other studies may be delayed by several factors, including:

•the inability to generate sufficient data to support the initiation or continuation of clinical trials;

•difficulty identifying patients and enrolling them in clinical trials and other studies, including as a result of competing trials run by other pharmaceutical companies;

•the failure to add, or delays in activating, a sufficient number of clinical trial sites;

•the inability to reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

•the failure by our CROs or other third parties to adhere to clinical trial agreements;

•the failure to manufacture or release sufficient quantities of our product candidates or failure to obtain sufficient quantities of active comparator medications for our clinical trials, if applicable, that in each case meet our quality standards, for use in clinical trials;

•the inability or unwillingness of clinical investigators or study participants to follow our clinical and other applicable protocols or applicable regulatory requirements;

•unforeseen safety issues, or subjects experiencing severe or unexpected adverse events;

•a lack of clinical benefit or effectiveness being demonstrated during clinical trials;

•the occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors;

•premature discontinuation of study participants from clinical trials or missing data;

•the inability to monitor patients adequately during or after treatment;

•inappropriate unblinding of trial results;

•changes in the market that render continued development of a product candidate no longer reasonable or commercially attractive;

•the cost of clinical trials of our product candidates being greater than we anticipated;

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•unanticipated impact from changes in or modifications to protocols or clinical trial design, including those that may be required by the FDA or other regulatory authorities;

•the failure to obtain regulatory authorization to commence a clinical trial or reach consensus with regulatory authorities regarding the design or implementation of our studies;

•resolving any dosing issues, including those raised by the FDA or other regulatory authorities;

•changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

•changes in the approval policies or regulations of the FDA or other regulatory authorities;

•an IRB or EC refusing to approve, suspending, or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; or

•other regulatory issues, including the receipt of any inspectional observations on FDA’s Form-483, Warning or Untitled Letters, clinical holds or complete response letters or similar communications/objections by other regulatory authorities.

We, the FDA or other regulatory authorities may suspend our clinical trials in an entire country at any time, or an IRB/EC may suspend our clinical trial sites within any country, if it appears that we or our collaborators, or the principal investigator, are failing to conduct a trial in accordance with the protocol, applicable regulatory requirements, including Good Clinical Practice (“GCP”) regulations, that we are exposing participants to unacceptable health risks, or if the FDA or other regulatory authority finds deficiencies in our IND or equivalent applications for other countries or in the manner in which clinical trials are conducted. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, the competent authorities of the E.U. Member States and the U.K. or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a clinical benefit from using a product candidate, changes in governmental regulations or administrative actions, developments on trials conducted by us or our competitors for related technology that raises regulatory concerns about risk to patients of the technology broadly, or lack of adequate funding to continue the clinical trial. Therefore, we cannot predict with any certainty the schedule for commencement and completion of future clinical trials.

If we experience delays in the commencement or completion of our clinical trials, or if we terminate a clinical trial prior to completion, the commercial prospects of our product candidates could be harmed, and our ability to generate product revenue from any of our product candidates, if approved, may be delayed. In addition, any delays in our clinical trials could increase our costs, cause a decline in our share price, slow down the approval process, and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may harm our business, financial condition and results of operations. In addition, many of the factors that cause or lead to a termination or suspension of, or delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. We may make formulation or manufacturing changes to our product candidates, in which case we may need to conduct additional preclinical or clinical studies to bridge our modified product candidates to earlier versions. Any delays to our clinical trials that occur as a result could shorten any period during which we may have the exclusive right to commercialize our product candidates and our competitors may be able to bring product candidates to market before we do, and the commercial viability of our product candidates could be significantly reduced.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or other regulatory authorities. The FDA or other regulatory authorities may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected the integrity of the study. The FDA or other regulatory authorities may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing and authorization applications by the FDA or other regulatory authorities, as the case may be, and may ultimately lead to the denial of marketing approval of any of our product candidates.

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In addition, for our product candidates that are in clinical development, prior to our acquisition of the rights to those product candidates we had no involvement with or control over the preclinical or clinical development of those product candidates. We are therefore dependent on our licensing and other transaction partners having conducted such research and development in accordance with the applicable protocols and legal, regulatory and scientific standards, having used appropriately regulated and compliant equipment and devices during the preclinical or clinical development, having accurately reported the results of all clinical trials and other research they conducted prior to our acquisition of the rights to those product candidates, having correctly collected and interpreted the data from these trials and other research and having supplied us with complete information, data sets and reports required to adequately demonstrate the results reported through the date of our acquisition of these product candidates. Problems associated with the pre-acquisition development of our product candidates could result in increased costs and delays in the commercialization or development of our product candidates, which could harm our ability to generate any future revenue from sales of our product candidates following regulatory approval.

We may encounter difficulties enrolling and retaining patients in clinical trials, and clinical development activities could thereby be delayed or otherwise adversely affected.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may experience difficulties in patient enrollment and retention in our clinical trials for a variety of reasons, including:

•the size and characteristics of the patient population;

•the patient eligibility criteria defined in the protocol, including biomarker-driven identification and certain highly-specific criteria related to stage of disease progression, which may limit the patient populations eligible for our clinical trials to a greater extent than competing clinical trials for the same indication that do not have biomarker-driven patient eligibility criteria;

•the design of the trial, including the size of the study population required for analysis of the trial’s primary endpoints;

•the number and location of clinical trials sites, including the proximity of patients to trial sites;

•our ability to recruit clinical trial investigators with the appropriate competencies and experience;

•competing clinical trials for similar therapies or targeting patient populations meeting our patient eligibility criteria;

•clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies and product candidates;

•our ability to obtain and maintain patient consents; and

•the risk that patients enrolled in clinical trials will not complete such trials, for any reason, including the risk of higher drop-out rates if participants become infected with a virus or other infectious disease that impacts their participation in our trials.

Our inability to enroll and retain a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment delays and retention challenges in our clinical trials may result in increased development costs for our product candidates, delay our ability to obtain clinical data, and jeopardize our ability to obtain marketing approval for the sale of our product candidates. For certain of our product candidates, including brepocitinib and IMVT-1402, which target various autoimmune indications, there are limited patient pools from which to draw in order to complete our clinical trials in a timely and cost-effective manner. In addition, for certain of our early-stage development programs, there may be a limited number of sites where it is feasible to run clinical trials, making such programs particularly susceptible to delays caused by issues at those sites.

Furthermore, any negative results or new safety signals we may report in clinical trials of our product candidates may make it difficult or impossible to recruit and retain patients in other clinical trials we are conducting or to resume enrolling patients once a paused clinical trial has been resumed. Similarly, negative results reported by our competitors

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about their drug candidates may negatively affect patient recruitment in our clinical trials. Also, marketing authorization of competitors in this same class of drugs may impair our ability to enroll patients into our clinical trials, delaying or potentially preventing us from completing recruitment of one or more of our trials.

Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop our product candidates, or could render further development impracticable. In addition, we expect to rely on CROs and clinical trial sites to ensure proper and timely conduct of our future clinical trials, and, while we intend to enter into agreements governing their services, we will be limited in our ability to compel their actual performance. Any such delays in our current or future clinical trials could have a material adverse impact on our operations and financial condition and results.

The results of our preclinical studies and clinical trials may not support our proposed claims for our product candidates or regulatory approvals on a timely basis or at all, and the results of earlier studies and trials may not be predictive of future trial results.

Success in preclinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior preclinical studies and earlier clinical trials. For example, we cannot assure you that the reductions in IgG antibodies and favorable analyte profile observed in our Phase 1 trial of IMVT-1402 will be observed in future clinical trials, including pivotal trials necessary for regulatory approvals, or that such reductions in IgG antibodies will result in clinical benefits sufficient to demonstrate that the efficacy endpoints of the study are met. Similarly, promising interim results or other preliminary analyses do not ensure that the clinical trial as a whole will be successful and may lack statistical significance, which would further limit the reliability of such interim or preliminary data. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in, or the discontinuation of, clinical trials, even after promising results were seen with their product candidates in earlier preclinical studies or clinical trials. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unobserved adverse events.

The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. Product candidates in later stage clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical and initial clinical trials. A future failure of a clinical trial to meet its pre-specified endpoints may cause us to abandon development of the product candidate in question. Any delay in, or termination of, our clinical trials will prevent or delay the submission of an NDA or other similar applications to the FDA or other relevant comparable non-U.S. regulatory authorities and, ultimately, our ability to commercialize our product candidates following regulatory approval, and generate product revenues. Even if our clinical trials are completed as planned, we cannot be certain that their results will support our claims for differentiation or the effectiveness or safety of our product candidates. The FDA and other regulatory authorities, including the European Commission, the EMA and the MHRA, have substantial discretion in the review and approval process and may disagree that our data support the differentiated claims we propose. In addition, only a small percentage of product candidates under development result in the submission of an NDA or other similar application to the FDA and other comparable non-U.S. regulatory authorities and even fewer are approved for commercialization.

Interim, preliminary or topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose interim, preliminary or topline data from our clinical trials, which are based on a preliminary analysis of then-available data. These results and related findings and conclusions are subject to change following a full analysis of all data related to the particular trial.

We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, preliminary and topline results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the topline data we previously reported. As a result, interim, preliminary and topline data should be viewed with caution until the final data are available. Interim data are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse differences between interim, preliminary or topline

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data and final data could significantly harm our business prospects. Further, disclosure of preliminary or interim data by us or by our competitors could result in increased volatility in the price of our shares.

Further, other parties, including our collaborators or regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of a particular product candidate and our business in general. In addition, the information we choose or are required to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure. Any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate or our business. If the interim, preliminary or topline data that we report differ from later, final or actual results, or if others, including our collaborators or regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for and commercialize our product candidates and our business, operating results, prospects or financial condition may be harmed.

Changes in methods of product manufacturing or formulation may result in additional costs or delays.

As our product candidates proceed through the development process, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. Such changes may also require additional testing, FDA notification or FDA approval, or another regulatory authority’s notification or approval, as applicable, since similar requirements apply in other jurisdictions. This could delay the completion, or result in the abandonment, of clinical trials, require the conduct of bridging clinical trials, the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commence sales and generate revenues.

Risks Related to Regulatory Approval and Commercialization of Our Product Candidates

Obtaining approval of a new drug is an extensive, lengthy, expensive and inherently uncertain process, and the FDA or another regulatory authority may delay, limit or deny approval. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized. If we are unable to obtain regulatory approval in one or more jurisdictions for any of our product candidates, our business will be substantially harmed.

We cannot commercialize a product candidate until the appropriate regulatory authorities have reviewed and approved the product candidate for commercial sale. Following the completion of the Dermavant Transaction in October 2024, we no longer have any approved products in the U.S. or any other jurisdiction and there can be no assurance that we will be successful in obtaining regulatory approval in the U.S. and other jurisdictions for any of our product candidates. In addition, we cannot be certain that any product candidates that receive regulatory approval will be successfully commercialized.

The time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials, and depends upon numerous factors, including the type, complexity and novelty of the product candidate involved. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary between jurisdictions, which may cause delays in the approval or the decision not to approve an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies.

Changes to the leadership at the FDA and other federal agencies under the Trump administration, as well as executive orders and other executive actions, such as a freeze on hiring, the implementation of new regulations and certain external communications, may impact our clinical development and timelines. In particular, ongoing efforts by the Trump Administration to reduce the size of the FDA and other branches of the Department of Health and Human Services (“HHS”), including through reductions in staff, may further increase the unpredictability in approval timelines for our product candidates. For example, on February 11, 2025, President Trump issued an executive order on workforce optimization, seeking to reduce the size of the federal workforce through large-scale reductions in force and by placing

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limitations on the number of new employee hires. Pursuant to this executive order, on March 27, 2025, HHS announced that it was initiating a restructuring of the department, including reducing the FDA’s workforce by approximately 3,500 full-time employees, which began on April 1, 2025. On July 8, 2025, the U.S. Supreme Court granted an application for a stay pertaining to an injunction entered by the U.S. District Court for the Northern District of California regarding the HHS reduction in staff, and on July 14, 2025, HHS emailed certain employees to notify them of their separation from HHS effective the same day. The termination of these employees has been preceded and accompanied by the resignation of senior leaders within the FDA, resulting in the loss of institutional knowledge and experience. Terminations and resignations at the FDA have continued and there has been notable turnover and instability in key leadership positions. Although the full impact of these events remains unclear, we expect there will be an adverse effect on the FDA’s ability to efficiently carry out its functions, including conducting inspections and timely reviewing drug and biologic product applications, and a potential impact on how it interprets and enforces its authorities. Further, the Trump Administration’s ongoing deregulation and transparency efforts, as well as its efforts intended to ensure that the science underlying agency decisions is sound, could create regulatory uncertainty for biopharmaceutical companies. Additionally, uncertainty remains as to how the FDA’s agency-wide implementation of ELSA, a generative artificial intelligence tool, including for review of drug product applications, as well as its deployment of agentic artificial intelligence capabilities, will impact the outcomes and timeliness of FDA reviews and other activities. In addition, the future of the currently applicable Prescription Drug User Fee Act construct to ensure timely FDA review of applications may be impacted due to expressed concerns about the effect on industry-FDA relations, and staffing shortages.

Contributing to this uncertainty, in June 2024, the U.S. Supreme Court overruled the Chevron doctrine, which gave deference to regulatory agencies’ statutory interpretations in litigation against federal government agencies, including the FDA, where the law is ambiguous. This landmark decision may invite more companies and other stakeholders to bring lawsuits against the FDA to challenge longstanding decisions and policies, including the FDA’s statutory interpretations of market exclusivities and the “substantial evidence” requirements for drug approvals, which could undermine the FDA’s authority, lead to greater uncertainty about the regulatory process in the pharmaceutical industry and disrupt the FDA’s normal operations, any of which could delay the FDA’s review of our regulatory submissions. We cannot predict the full impact of this decision, future judicial challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative action. Further, we cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action or as a result of legal challenges, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, our business could be materially harmed.

Obtaining marketing approval of a new drug is an extensive, lengthy, expensive and inherently uncertain process and the FDA or other regulatory authorities may delay, limit or deny approval of a product candidate for many reasons, including:

•we may not be able to demonstrate that a product candidate is safe and effective as a treatment for the targeted indications, and in the case of our product candidates regulated as biological products, that the product candidate is safe, pure and potent for use in its targeted indication, to the satisfaction of the FDA or other relevant regulatory authorities;

•a product candidate may be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;

•the FDA or other relevant regulatory authorities may require additional pre-approval studies or clinical trials, which would increase costs and prolong development timelines;

•the results of clinical trials may not meet the level of statistical or clinical significance required by the FDA or other relevant regulatory authorities for marketing approval;

•the FDA or other relevant regulatory authorities may disagree with the number, design, size, conduct or implementation of clinical trials, including the design of proposed preclinical and early clinical trials of any future product candidates;

•the CROs that we retain to conduct clinical trials may take actions outside of our control, or otherwise commit errors or breaches of protocols, that adversely impact the clinical trials and ability to obtain marketing approvals;

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•the FDA or other relevant regulatory authorities may not find the data from nonclinical, preclinical studies or clinical trials sufficient to demonstrate that the clinical and other benefits of a product candidate outweigh its safety risks;

•the FDA or other relevant regulatory authorities may disagree with an interpretation of data or significance of results from nonclinical, preclinical studies or clinical trials or may require additional studies;

•the FDA or other relevant regulatory authorities may not accept data generated at clinical trial sites, including in situations where the authorities deem that the data was not generated in compliance with GCP, ethical standards or applicable data protection laws;

•if an NDA, BLA or a similar application is referred for review by an advisory committee, the FDA or other relevant regulatory authority, as the case may be, may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the FDA or other relevant regulatory authorities, as the case may be, require, as a condition of approval, additional nonclinical, preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;

•the FDA or other relevant regulatory authorities may require development of a risk evaluation and mitigation strategy (“REMS”) drug safety program or its equivalent, as a condition of approval;

•the FDA or other relevant regulatory authorities may require additional post-marketing studies and patient registries for product candidates;

•the FDA or other relevant regulatory authorities may find the chemistry, manufacturing and controls data insufficient to support the quality of our product candidates;

•the FDA or other relevant regulatory authorities may identify deficiencies in the manufacturing processes or facilities of third-party manufacturers; or

•the FDA or other relevant regulatory authorities may change their approval policies or adopt new regulations.

Our future success depends significantly on our ability to successfully complete clinical trials for our product candidates, obtain regulatory approval and then successfully commercialize those product candidates. Any inability to successfully initiate, conduct or complete clinical trials could result in additional costs to us or impair our ability to generate revenue. In addition, if we make manufacturing or formulation changes to our product candidates, we may be required to or we may elect to conduct additional nonclinical studies or clinical trials to bridge data obtained from our modified product candidates to data obtained from nonclinical and clinical research conducted using earlier versions of these product candidates. Clinical trial delays could also shorten any periods during which our product candidates have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize product candidates and may harm our business and results of operations.

Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of product candidates that we may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization.

Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive nonclinical studies, preclinical studies and clinical trials that the applicable product candidate is both safe and effective for use in each target indication, and in the case of our product candidates regulated as biological products, that the product candidate is safe, pure, and potent for use in its targeted indication. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical development process. The results of preclinical studies of our product candidates may not be predictive of the results of early-stage or later-stage clinical trials, and results of early-stage clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. The results of clinical trials in one set of patients or disease indications may not be predictive of those obtained in another set of patients or disease indications. In

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some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the dosing regimen and other clinical trial protocols and the rate of dropout among clinical trial participants. Open-label extension studies may also extend the timing and increase the cost of clinical development substantially. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and earlier stage clinical trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization.

We cannot be certain that our current clinical trials or any other future clinical trials will be successful. Additionally, any safety concerns observed in any one of our clinical trials in our targeted indications could limit the prospects for regulatory approval of our product candidates in those and other indications, which could have a material adverse effect on our business, financial condition and results of operations. In addition, even if such clinical trials are successfully completed, we cannot guarantee that the FDA or comparable non-U.S. regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval. Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that other jurisdiction. To the extent that the results of the trials are not satisfactory to the FDA or comparable non-U.S. regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates. Even when regulatory approval is secured for a product candidate, the terms of such approval may limit the scope and use of the specific product candidate, which may also limit its commercial potential.

Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, delay or prevent their regulatory approval, limit the scope of any approved label or market acceptance following regulatory approval or result in significant negative consequences.

Adverse events caused by or associated with our product candidates have caused us and could, in the future, cause us, our collaborators, other reviewing entities, clinical trial sites or regulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval. Treatment-related side effects arising from, or those perceived to arise from, our product candidates or those from other companies targeting similar diseases, could also affect patient recruitment or the ability of enrolled patients to complete their participation in our clinical trials or result in potential product liability claims. We cannot predict whether our product candidates will cause toxicities in humans that would preclude or delay successful completion of clinical trials. Additionally, these side effects may not be appropriately recognized or managed by the treating medical staff. If an unacceptable frequency or severity of adverse events or new safety signals are reported in our clinical trials for our product candidates or any future product candidates, our ability to obtain regulatory approval for such product candidates may be negatively impacted.

If one or more of our product candidates receives marketing approval, and we or others, including our collaborators, later identify undesirable side effects or adverse events caused by such products, a number of potentially significant negative consequences could result, including but not limited to:

•regulatory authorities may withdraw, revoke, suspend, vary or limit their approval of the product candidate or require a REMS (or equivalent outside the U.S.) to impose restrictions on its distribution or other risk management measures;

•regulatory authorities may request or require that we recall a product candidate;

•additional restrictions being imposed on the distribution, marketing or manufacturing processes of our product candidates or any components thereof, including a “black box” warning or contraindication on product labels or communications containing warnings or other safety information about the product candidate;

•regulatory authorities may require the addition of labeling statements, such as warnings or contraindications, require other labeling changes of a product candidate or require field alerts or other communications to physicians, pharmacies or the public;

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•we may be required to change the way a product candidate is administered or distributed, conduct additional clinical trials, change the labeling of a product candidate or conduct additional post-marketing studies or surveillance;

•we may be required to repeat preclinical studies or clinical trials or terminate programs for a product candidate, even if other studies or trials related to the program are ongoing or have been successfully completed;

•we may be sued and held liable for harm caused to patients, or may be subject to fines, restitution or disgorgement of profits or revenues;

•physicians may stop prescribing a product candidate;

•reimbursement may not be available for a product candidate;

•we may elect to discontinue the sale of a product candidate;

•our product candidates may become less competitive; and

•our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, substantially increase the costs of commercializing our product candidates in the future following regulatory approval, and could significantly harm our business, financial condition, results of operations and growth prospects. We cannot predict whether our product candidates will cause toxicities in humans that would preclude or lead to the revocation of regulatory approval based on nonclinical studies or clinical trials.

The regulatory approval processes of the FDA and comparable non-U.S. regulatory authorities are lengthy, time consuming and inherently unpredictable, and gaining approval for a product candidate in one country or jurisdiction does not guarantee that we will be able to obtain approval for or commercialize it in any other jurisdiction, which would limit our ability to realize our full market potential.

Prior to obtaining approval to commercialize a product candidate in any jurisdiction, we or our collaborators must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA or comparable non-U.S. regulatory authorities, that such product candidate is safe and effective and, as applicable, pure and potent for its intended use. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe the nonclinical or clinical data for a product candidate are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities. In order to market any products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements on a country-by-country basis regarding safety and efficacy. Approval of a product candidate by the FDA does not ensure approval by regulatory authorities in any other country or jurisdiction outside the U.S. In addition, clinical trials conducted in one country, and the data generated therefrom, may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country. Approval processes vary among countries and can involve additional product testing and validation, as well as additional administrative review periods. Seeking regulatory approval could result in difficulties and costs for us and require additional nonclinical studies or clinical trials, which could be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our products in those countries. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of any product we develop will be unrealized.

FDA approval for a product candidate in the United States does not guarantee that we will be able to or that we will make efforts to obtain approval for or commercialize our product candidates in any other jurisdiction, which would limit our ability to realize the product candidate’s full market potential.

In order to market any of our product candidates outside of the U.S., we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional or different administrative review periods from those in the

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U.S., including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the U.S., a product candidate must be approved for reimbursement before it can be sold in that jurisdiction. In some cases, the price that we intend to charge for our product candidates is also subject to approval.

Seeking regulatory approval outside of the U.S. could result in difficulties and costs and require additional nonclinical studies or clinical trials which could be costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates in those countries. The regulatory approval process outside of the U.S. may include all of the risks associated with obtaining FDA approval. We do not have any product candidates approved for sale in any jurisdiction, including international markets, and we do not have significant experience in obtaining regulatory approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approval in international markets is delayed, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

Following regulatory approvals, our products will remain subject to extensive regulatory scrutiny.

Any product candidate for which we obtain marketing approval will be subject to extensive and ongoing regulatory requirements, including for manufacturing processes, post-approval clinical data, labeling, packaging, distribution, continuous supply, adverse event reporting, storage, recordkeeping, traceability, conduct of potential post-marketing studies and post-marketing submission requirements, export, import, advertising and promotional activities for such product, among other things, will be subject to extensive and ongoing requirements of and review by the FDA and other regulatory authorities.

While healthcare professionals are free to use and prescribe drug products for off-label uses, the FDA and other foreign competent authorities strictly regulate manufacturers’ promotion of drug products. In particular, a product may not be promoted for uses that are not approved by the FDA as reflected in the FDA-approved labeling. A company that is found to have improperly promoted off-label uses may be subject to large civil and criminal fines, penalties and enforcement actions. The same rules on off-label promotion apply in the E.U. and the U.K. Further, in the U.S., we expect that direct-to-consumer (“DTC”) advertisements will be subject to increased scrutiny and enforcement by the FDA based on its aggressive enforcement posture with respect to DTC prescription drug advertisements. The FDA has also increased its scrutiny of the data used to substantiate prescription drug and biologic advertising and promotional claims more generally, which may also lead to additional industry enforcement. In the E.U. and the U.K., the promotion of prescription-only medicinal products to any audience, other than licensed healthcare professionals, is prohibited. If we cannot successfully manage the promotion of our approved product candidates, we could become subject to significant liability, which could materially adversely affect our business and financial condition.

Any regulatory approvals that we receive for our product candidates will be subject to limitations on the approved indicated uses for which the product may be marketed and promoted or to the conditions of approval or contain requirements for potentially costly post-marketing testing. We will be required to report certain adverse reactions and production problems, if any, to the FDA and comparable foreign regulatory authorities. Any new legislation addressing drug safety issues could result in delays in product development or commercialization, or increased costs to assure compliance. The FDA and other agencies, including the Department of Justice, closely regulate and monitor the post-approval marketing and promotion of products to ensure that they are manufactured, marketed, and distributed only for the approved indications and in accordance with the provisions of the approved labeling. We will have to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. In certain indications, regulatory approval may limit the market of a product candidate to target patient populations when patient selection biomarkers are used. In these indications, regulatory authorities may require us to run additional clinical trials prior to expanding the label for approval that includes a broader patient population. As such, we may not promote our products for indications or uses for which they do not have approval. The holder of an approved NDA, BLA or MAA must submit new or supplemental applications and obtain approval for certain changes to the approved product, product labeling, or manufacturing process. We could also be asked to conduct post-marketing clinical trials to verify the safety and efficacy of our non-biologic products or the safety, purity and potency of our biologic products, in general or in specific patient subsets. The Food and Drug Omnibus Reform Act reformed the accelerated approval pathway, such that the FDA is now required to specify conditions for post-approval study requirements and set forth procedures for the FDA to withdraw a product on an expedited basis for non-compliance with

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post-approval requirements. An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing approval.

If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things, issue warning letters, impose penalties, suspend regulatory approvals or require a product recall. Any of these actions by a regulatory agency could require us to expend significant time and resources, generate negative publicity and adversely affect the value of our company.

We may develop product candidates for the treatment of conditions for which there is little clinical experience and, in some cases, use new endpoints or methodologies, and the FDA or other regulatory authorities may not consider the endpoints of these clinical trials to provide clinically meaningful results.

There may not be any pharmacologic therapies approved to treat certain conditions that we attempt to address, and there may be few clinical trials attempted and no approved treatments for these conditions. As a result, the design and conduct of clinical trials of product candidates for the treatment of these conditions may take longer, be more costly or be more complicated to design due to the novelty of development in these conditions; and even if the FDA or other regulatory authorities do find our success criteria to be sufficiently validated and clinically meaningful, we may not achieve the pre-specified endpoint to a degree of statistical significance in our pivotal or other clinical trials. Further, even if we achieve the pre-specified criteria, our clinical trials may produce unpredictable or inconsistent results compared to the more traditional efficacy endpoints in the trial. As a result, achieving regulatory approval for such product candidates could be more uncertain, more costly and more time-consuming, which could adversely affect our business.

Our failure to maintain or continuously improve our quality management program could have an adverse effect upon our business, subject us to regulatory actions and cause patients to lose confidence in us or our product candidates, among other negative consequences.

Quality management plays an essential role in the manufacturing of drugs or drug products, conducting clinical trials, preventing defects, improving our product candidates and services and assuring the safety and efficacy of our product candidates. We seek to maintain a robust quality management program which includes the following broad pillars of quality:

•monitoring and assuring regulatory compliance for clinical trials, manufacturing and testing of good applicable practice (“GxP”) (e.g., GCP, Good Laboratory Practices (“GLP”) and Good Manufacturing Practices (“GMP”) regulated) products;

•monitoring and providing oversight of all GxP suppliers (e.g., contract development manufacturing organizations and CROs);

•establishing and maintaining an integrated, robust quality management system for clinical, manufacturing, supply chain and distribution operations; and

•cultivating a proactive, preventative quality culture and employee and supplier training to ensure quality.

Our future success depends on our ability to maintain and continuously improve our quality management program. A quality or safety issue may result in adverse inspection reports, warning letters, monetary sanctions, injunctions to halt manufacture and distribution of drugs or drug products, civil or criminal sanctions, costly litigation, refusal of a government to grant approvals and licenses, restrictions on operations or withdrawal, suspension or variation of existing approvals and licenses. An inability to address a quality or safety issue in an effective and timely manner may also cause negative publicity, or a loss of patient confidence in us or our product candidates, which may result in difficulty in successfully launching product candidates following regulatory approval and the loss of potential future sales, which could have an adverse effect on our business, financial condition and results of operations.

Breakthrough Therapy Designation, Fast Track Designation or Orphan Drug Designation by the FDA or similar status granted by other relevant regulatory authorities, even if granted for any product candidate, may not lead to a faster

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development, regulatory review or approval process, and does not necessarily increase the likelihood that any product candidate will receive marketing approval in the United States or other jurisdictions.

We have sought, or may in the future seek, Breakthrough Therapy Designation, Fast Track Designation or Orphan Drug Designation for certain of our product candidates. For example, in July 2021, Immunovant was granted orphan drug designation in the U.S. by the FDA for batoclimab for the treatment of MG and, in August 2022, it received orphan drug designation from the European Commission for batoclimab for the treatment of MG. Immunovant plans to seek orphan drug designation from the FDA for IMVT-1402 where there is a medically plausible basis for IMVT-1402’s use. Immunovant may also seek orphan drug designation for IMVT-1402 for the treatment of other indications in the E.U. In addition, in September 2024, Priovant announced that brepocitinib has been granted Fast Track Designation from the FDA for NIU. We may seek similar designations for other of our product candidates in the future where there is a basis for doing so.

A breakthrough therapy is defined as a therapy that is intended, alone or in combination with one or more other therapies, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For therapies that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed on potentially less efficacious control regimens. Therapies designated as breakthrough therapies by the FDA may also be eligible for priority review and accelerated approval. Designation as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe a product candidate meets the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a Breakthrough Therapy Designation for a product candidate may not result in a faster development process, review or approval compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if a product candidate qualifies as a breakthrough therapy, the FDA may later decide that such product candidate no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Recently, there has been heightened scrutiny of the accelerated approval pathway, with some stakeholders advocating for reform. The HHS Office of Inspector General has completed an assessment of how the FDA implements the accelerated approval pathway. In addition, Section 3210 of the Consolidated Appropriations Act, 2023, revised the accelerated approval pathway. Although this legislation did not change the standard for accelerated approval, it, among other things, requires the FDA to specify the conditions for required post-marketing trials, permits the FDA to require such trials to be underway prior to, or within a specific period after, approval, requires sponsors to provide reports on post-marketing trial progress no later than 180 days after approval and every 180 days thereafter until such trials are completed, makes the failure to conduct required post-marketing trials with due diligence and the failure to submit the required reports prohibited acts, and details procedures the FDA must follow to withdraw an accelerated approval on an expedited basis. We understand that FDA approval letters to products granted accelerated approval subsequent to passage of this legislation are including language that informs the sponsor that they are required to submit status reports of the progress of each requirement no later than 180 days post-approval and every 180 days thereafter and that the FDA is otherwise exercising its new authorities. The FDA has also been issuing guidance documents regarding the accelerated approval pathway. At this time, it is not clear what impact, if any, these developments may have on our business, financial condition results of operations or prospects.

If a therapy is intended for the treatment of a serious or life-threatening condition and the therapy demonstrates the potential to address unmet medical needs for this condition, the therapy sponsor may apply for Fast Track Designation. The FDA has broad discretion whether or not to grant this designation, so even if we believe a particular product candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it. Even if we do receive Fast Track Designation, we may not necessarily experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw Fast Track Designation if it believes that the designation is no longer supported by data from our clinical development program. Fast Track Designation alone does not guarantee qualification for the FDA’s priority review procedures.

The FDA also recently announced the Commissioner’s National Priority Voucher (“CNPV”) and pilot program, designed to accelerate the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and to enhance the health interests of Americans. Specific priorities include addressing a U.S. public health crisis, addressing a large unmet need and increasing affordability, among others. Companies selected for the program will be issued a voucher entitling the company to benefits including enhanced communications and rolling review

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to allow for a shortened review time. On October 16, 2025, the FDA announced the initial nine CNPV recipients under the program and has announced additional recipients since then.

The FDA also recently introduced the Rare Disease Evidence Principles (“RDEP”) to help provide greater speed and predictability in the review of therapies intended to treat rare diseases driven by a known, in-born genetic defect with very small populations or subpopulations (generally fewer than 1,000 patients in the United States) facing progressive deterioration in function leading to rapid or significant disability or death in a relatively short period of time and for whom there are no adequate alternative therapies that alter the course of the disease. Sponsors of eligible investigational therapies intended to address the genetic defect that is the major driver of the pathophysiology for such rare disease may apply to the RDEP process prior to the launch of a pivotal trial. Approval under the process may be based on one adequate and well-controlled study together with robust confirmatory evidence and may result in additional post-marketing requirements to further ensure safety and effectiveness. The RDEP process is separate from and independent of requests for orphan drug designation discussed below and does not bear on the FDA’s determination of whether a drug may be eligible for orphan drug designation. The FDA also released a plausible mechanism concept as part of its efforts to streamline and facilitate the development of rare disease and bespoke therapies for which a randomized trial is not feasible.

Regulatory authorities in some jurisdictions, including the U.S., the U.K. and the European Economic Area (the “EEA”), may designate drugs and biologics for relatively small patient populations as orphan drugs. In the U.S., the FDA may designate a drug or biologic as an orphan drug if it is intended to treat a rare disease or condition, which is defined as a disease or condition that affects fewer than 200,000 individuals annually in the U.S. or for which there is no reasonable expectation that costs of research and development of the drug for the disease or condition can be recovered by sales of the drug in the U.S. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug or biologic for the same orphan indication for that time period. In the U.S., in order for a product to receive orphan drug exclusivity, the FDA must not have previously approved a drug considered the same drug for the same orphan indication, or the subsequent drug must be shown to be clinically superior to such a previously approved same drug. The applicable period of marketing exclusivity is seven years in the U.S. A similar market exclusivity scheme exists in the EEA. The European Commission, on the basis of a scientific opinion by the EMA’s Committee for Orphan Medicinal Products grants Orphan Drug Designation to promote the development of products that are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the E.U. Additionally, designation is granted for products intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition when, without incentives, it is unlikely that sales of the drug in the E.U. would be sufficient to justify the necessary investment in developing the drug or biological product. In any event, Orphan Drug Designation is granted only if there is no satisfactory method of diagnosis, prevention or treatment, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. Orphan designation in the E.U. entitles a party to certain benefits, such as scientific assistance (protocol assistance), financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product approval. This orphan market exclusivity period prevents the European Commission, EMA and the competent authorities of the E.U. Member States from accepting an application or granting marketing authorization for any similar medicinal product intended for the same orphan indication. The orphan market exclusivity applies in parallel to the “normal” data and market exclusivity in the EEA, whereby no company can make reference to (rely on) the innovator drug company’s preclinical and clinical data in order to obtain a marketing authorization for eight years from the date of the first approval of the innovator drug in the EEA and no generic or biosimilar drug can be marketed for ten years from the first approval of the innovator drug in the EEA; the innovator drug may qualify for an extra year’s protection. This additional one year of marketing exclusivity may be obtained where the innovator company is granted, during the first eight years of the ten years market exclusivity, a marketing authorization for a significant new indication for the relevant medicinal product. In such a situation, the generic or biosimilar company can only market their product after 11 years from the first grant of the innovator company’s marketing authorization for the product in the EEA.

Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug or biologic to meet the needs of patients with the rare disease or condition. In the EEA, orphan drug designation, and the related benefits, may be lost if it is established before the market authorization is granted that the designation criteria are no longer met. Further, in response to Catalyst Pharms., Inc. v. Becerra, a 2021 decision from the U.S. Court of Appeals for the Eleventh Circuit, the FDA clarified in a January 2023 notice that the FDA intends to continue to apply its longstanding interpretation of the regulations to matters outside of the scope of the Catalyst order – that is, the agency will continue tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is approved, which permits other sponsors to obtain

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approval of a drug for new uses or indications within the same orphan designated disease or condition that have not yet been approved. It is unclear how future litigation, legislation, agency decisions and administrative actions will impact the scope of the orphan drug exclusivity.

Moreover, the ten year orphan market exclusivity in the EEA may be reduced to six years if the orphan drug designation criteria are no longer met at the end of the fifth year since grant of the approval, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.

In April 2023, as part of the E.U. Pharmaceutical Strategy, the European Commission published a proposal for a comprehensive revision of the E.U. pharmaceutical legislation (which will not apply in the U.K.). The new legislation is expected to be adopted by the European Parliament and the Council in early 2026 and it will significantly change the regulatory regime applicable to both the “normal” data and market exclusivity and the orphan exclusivities and reduce/modulate the exclusivities and rewards that could be granted to medicinal products. In addition, the proposal envisages changes to the concept of unmet medical need and considers introducing novel rewards for orphan medicinal products addressing a high unmet medical need. The new legislation is expected to start to apply in 2028.

In June 2016, the electorate in the United Kingdom voted in favor of leaving the European Union (commonly referred to as Brexit). Thereafter, in March 2017, the country formally notified the European Union of its intention to withdraw pursuant to Article 50 of the Lisbon Treaty. The United Kingdom formally left the European Union in January 2020. A transition period began under the Withdraw Agreement in February 2020, during which time E.U. law, including pharmaceutical law, remained applicable in the United Kingdom. However, this ended in December 2020. In December 2020, the United Kingdom and European Union signed the Trade and Cooperation Agreement which included an agreement on free trade between the two parties, although it provided minimal provisions on medicinal products. Since that time, Great Britain has operated an independent regulatory regime for medicinal products, although Northern Ireland continued to follow E.U. law under the Northern Ireland Protocol. Further, in March 2023, an agreement was reached by the U.K. and E.U. (the “Windsor Agreement”), relating to post-Brexit trade issues in Northern Ireland, which has applied from January 1, 2025. This adjusts how the Northern Ireland protocol operates and, amongst other things, seeks to simplify the supply of medicines between Great Britain and Northern Ireland and means E.U. legislation does not apply in all cases in Northern Ireland. Since the regulatory framework in the United Kingdom covering the quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorizations, commercial sales, and distribution of pharmaceutical products is derived from E.U. Directives and Regulations, Brexit could materially impact the future regulatory regime which applies to products and the approval of product candidates in the United Kingdom, as the U.K. legislation now has the potential to diverge from E.U. legislation. This continues to impact regulatory requirements for medicinal products and devices in the United Kingdom. The MHRA continues to publish detailed guidance for industry and organizations on the position in the United Kingdom, and continues to update this as the United Kingdom’s regulatory position on medicinal products and medical devices evolves. There have been a number of public consultations on the future legislation in the U.K., in particular in relation to the clinical trials and medical devices frameworks in the U.K. The legislation on medical devices is currently being amended on a rolling basis with additional changes due in 2026, and a new regulatory regime on clinical trials will come into effect in the U.K. in April 2026.

Following Brexit, a separate process for orphan drug designation applies to the U.K. There is no pre-marketing authorization orphan designation step required (as there is in the EEA), and the application for orphan designation will be reviewed by the MHRA at the time of the marketing authorization application. The criteria are the same as in the EEA, save that they apply to the U.K. only (e.g., there must be no satisfactory method of diagnosis, prevention or treatment of the condition concerned in the U.K.). Following the application of the Windsor Agreement on January 1, 2025, authorization of orphan products by the MHRA covers the whole of the U.K.

If we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA or the European Commission or MHRA can subsequently approve the same drug for a different condition or the same condition if the FDA or the EMA or the MHRA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In the EEA and U.K., a marketing authorization may also be granted, for the same therapeutic indication, to a competitor with a similar medicinal product during the exclusivity period if we are unable to supply sufficient quantities of the medicinal product for which we received marketing authorization. Moreover, our orphan exclusivity and “normal” data and market exclusivities will be modulated and likely shortened if we submit an application for marketing authorization for an orphan medicinal product after the start of application of the new E.U. pharmaceutical legislation in 2028, as discussed above.

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Receipt of marketing approval for our product candidates does not guarantee that they will achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.

The commercial success of our product candidates, once regulatory approval has been received, will depend upon their degree of market acceptance by physicians, patients, third-party payors and others in the medical community. Receipt of marketing approval for our product candidates does not guarantee that they will gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical community. The degree of market acceptance for our product candidates will depend on a number of factors, including:

•the efficacy and potential advantages compared to alternative treatments;

•the ability to offer these products for sale at competitive prices;

•the ability to offer appropriate patient financial assistance programs, such as commercial insurance co-pay assistance;

•convenience and ease of dosing and administration compared to alternative treatments;

•the clinical indications for which the product candidate is approved by the FDA or comparable non-U.S. regulatory agencies;

•product labeling or product insert requirements of the FDA or other comparable non-U.S. regulatory authorities, including any limitations, contraindications or warnings contained in a product’s approved labeling;

•restrictions on how the product candidate is dispensed or distributed;

•the timing of market introduction of competitive products;

•publicity and health authority communications concerning our product candidates or competing products and treatments;

•the strength of marketing and distribution support;

•product cost and sufficient third-party insurance coverage or reimbursement, and patients’ willingness to pay out-of-pocket in the absence of third-party coverage or adequate reimbursement; and

•safety and the prevalence and severity of any side effects or adverse events.

Even if a product candidate displays a favorable efficacy and safety profile in clinical trials, market acceptance will be unknown until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of our products may require significant resources and may never be successful.

If approved, our product candidates regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.

The Affordable Care Act includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”), which created an abbreviated approval pathway under section 351(k) of the PHSA for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, a section 351(k) application for a biosimilar or interchangeable product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar or interchangeable product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product submitted under section 351(a) of the PHSA containing the competing sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of the other company’s product. The law is complex and is still being interpreted and implemented by the FDA and the FDA only approved the first interchangeable biosimilar in July 2021. As a result, its ultimate impact, implementation and meaning are subject to uncertainty. In addition, the Further Consolidated Appropriations Act, 2020, which incorporated the framework from the Creating and Restoring Equal Access To Equivalent

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Samples legislation, purports to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products, including by allowing generic drug, 505(b)(2) NDA or biosimilar developers to obtain access to branded drug and biological product samples. Its provisions do have the potential to facilitate the development and future approval of biosimilar versions of our product candidates, introducing biosimilar competition that could have a material adverse impact on our business, financial condition and results of operations. The FDA has also issued guidance eliminating the need for data from comparative clinical efficiency studies to demonstrate biosimilarity in many circumstances, which may accelerate biosimilar market entry.

Whether approval of a biological product qualifies for reference product exclusivity turns on whether the FDA consider the approval a “first licensure.” Not every licensure of a biological product is considered a “first licensure” that gives rise to its own exclusivity period. Our product candidates approved as a biological product under a BLA may qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise. The extent to which a biosimilar, once licensed, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological products is variable, and will depend on a number of marketplace and regulatory factors. If competitors are able to obtain marketing approval for biosimilars referencing our product candidates, our products may become subject to competition from such biosimilars, with the attendant competitive pressure and consequences.

Any future commercialization efforts will be dependent on sales, marketing and distribution capabilities, including agreements with third parties to sell, market and distribute our product candidates.

In order to effectively market our product candidates following regulatory approval, we must successfully employ our sales, distribution, marketing and related capabilities or make arrangements with third parties to perform these services. Our Vants with product candidates in late-stage clinical development, including Immunovant and Priovant, do not currently have a sales, marketing and distribution infrastructure, and would expect to build such a function, or make arrangements with third parties to perform these services in connection with the commercialization of one of their product candidates following regulatory approval.

There are risks involved with both establishing and maintaining internal commercial capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force or reimbursement specialists is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and other commercialization capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition commercialization personnel. The costs associated with a sales, marketing and distribution infrastructure may exceed the net revenues we are able to generate from the sale of a product candidate following regulatory approval.

Factors that may inhibit our efforts to commercialize a product candidate, if approved, on our own include:

•the inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs and other support personnel;

•the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future approved products;

•the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement and other acceptance by payors;

•the inability to price products at a sufficient price point to ensure an adequate and attractive level of profitability;

•restricted or closed distribution channels that make it difficult to distribute our products to segments of the patient population;

•the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

•unforeseen costs and expenses associated with creating an independent commercialization organization.

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If we or the Vants are unable to build an internal sales force or negotiate a collaborative relationship for the commercialization of a product candidate following regulatory approval, it could result in a delay to, or reduce the effectiveness of, our commercialization efforts. This could adversely impact the product revenues generated from a product candidate following regulatory approval.

If we decide to fund commercialization activities ourselves, we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all. If we do not have sufficient funds, we will not be able to bring a product candidate to market or generate product revenues. We could enter into arrangements with collaborative partners at an earlier stage than otherwise would be ideal and we may be required to relinquish certain rights to a product candidate or otherwise agree to terms unfavorable to us, any of which may have an adverse effect on our business, operating results and prospects. If we enter into arrangements with third parties to perform sales, marketing, commercial support and distribution services, our product revenues, including net revenues, may be lower than if we were to market and sell a product candidate through an internal sales force. In addition, we may not be successful in entering into arrangements with third parties to commercialize our product candidates or may be unable to do so on terms that are favorable to us. We may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our product candidates effectively or may expose us to legal and regulatory risk by not adhering to regulatory requirements and restrictions governing the sale and promotion of prescription drug products, including those restricting off-label promotion. If we do not establish commercialization capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates following regulatory approvals, which could have an adverse effect on our business, financial condition and results of operations.

Our current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient support, charitable organizations, customers, and others are subject to applicable healthcare regulatory laws, which could expose us to penalties and other risks.

Our business operations and current and potential future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient support, charitable organizations, customers and others, expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws regulate the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our product candidates following regulatory approvals. Such laws include, without limitation:

•the federal Anti-Kickback Statute, which is a criminal law that prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under a federal healthcare program (such as Medicare and Medicaid). The term “remuneration” has been broadly interpreted by the federal government to include anything of value. Although there are a number of statutory exceptions and regulatory safe harbors protecting certain activities from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all elements of an available exception or safe harbor. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Violations of the federal Anti-Kickback Statute may result in civil monetary penalties up to $100,000 for each violation. Civil penalties for such conduct can further be assessed under the federal False Claims Act. Violations can also result in criminal penalties, including criminal fines and imprisonment of up to 10 years. Similarly, violations can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid;

•the federal false claims laws, including the False Claims Act, which imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent; knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim; or knowingly making or causing to be made, a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. The False Claims Act provides for suit by the federal government or private parties (qui tam relator) and when an entity is determined to have violated the federal civil False Claims Act, the government may impose significant civil fines and penalties for each false claim or statement for penalties assessed after January

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30, 2023, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

•the federal health care fraud statute (established by HIPAA), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false or fraudulent statements relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

•the Administrative Simplification provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations, which impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security, and transmission of individually identifiable health information on health plans, health care clearinghouses, and most healthcare providers (collectively, “covered entities”), and such covered entities’ “business associates,” defined as independent contractors or agents of covered entities that create, receive or obtain personally identifiable health information in connection with providing a service for or on behalf of the covered entity;

•various privacy, cybersecurity and data protection laws, rules and regulations at the international, federal, state and local level, which impose obligations with respect to safeguarding the privacy, security, and cross-border transmission of personally identifiable data, including personal health information;

•the federal Civil Monetary Penalties Law, which authorizes the imposition of substantial civil monetary penalties against an entity that engages in activities including, among others (1) knowingly presenting, or causing to be presented, a claim for services not provided as claimed or that is otherwise false or fraudulent in any way; (2) arranging for or contracting with an individual or entity that is excluded from participation in federal health care programs to provide items or services reimbursable by a federal health care program; (3) violations of the federal Anti-Kickback Statute; or (4) failing to report and return a known overpayment;

•the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to payments or other “transfers of value” made to physicians, certain other healthcare providers and teaching hospitals, and requires applicable manufacturers and group purchasing organizations to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other “transfers of value” to such physician owners (covered manufacturers are required to submit reports to the government by the 90th day of each calendar year);

•analogous state and E.U. and foreign national laws and regulations, such as state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, and state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;

•U.S. federal drug price reporting and government contracting statutes and regulations, the violation of which can lead to civil penalties, debarment and enforcement under the federal False Claims Act, and certain local and state laws that require disclosures to state agencies or boards and commercial purchasers, for example, with respect to certain price increases, some of which contain ambiguous requirements that government officials have not yet clarified; and

•E.U. and foreign national laws prohibiting promotion of prescription-only medicinal products to individuals other than healthcare professionals, governing strictly all aspects of interactions with healthcare professionals and healthcare organizations, including prior notification, review and approval of agreements with healthcare professionals, and requiring public disclosure of transfers of value made to a broad range of stakeholders, including healthcare professionals, healthcare organizations, medical students, physicians associations, patient organizations and editors of specialized press.

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Efforts to ensure that our current and future business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable healthcare laws. If our operations are found to be in violation of any of these or any other applicable health regulatory laws that may apply to us, we may be subject to significant penalties, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal or state healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Even the mere issuance of a subpoena, civil investigative demand or the fact of an investigation alone, regardless of the merit, may result in negative publicity, a drop in our share price and other harm to our business, financial condition and our results of operations. Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

Healthcare legislative and regulatory measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.

The U.S. and many other jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could restrict or regulate post-approval activities for our product candidates, affect our ability to profitably sell our product candidates following regulatory approval and prevent or delay marketing approval of our product candidates. Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. Moreover, as discussed above, the removal of the Richardson Waiver may impact our ability to meaningfully engage in any rulemaking for which HHS does not engage in the notice-and-comment process.

Additionally, the Trump Administration may pursue new or different drug pricing, trade and tariff, social and other policy objectives from prior administrations, which introduces further uncertainty as to how future legislative or regulatory changes may impact our business. For example, within his initial days in office, President Trump issued an executive order repealing former President Biden’s executive order 14087, which directed the Centers for Medicare and Medicaid Services (“CMS”) Center for Medicare and Medicaid Innovation to test new payment models that would lower drug costs and promote access to innovative drug therapies for Medicare and Medicaid beneficiaries. In addition, the Trump Administration published an executive order 14273 titled “Lowering Drug Prices by Once Again Putting Americans First.” Generally, this executive order instructs HHS to recommend ways to lower drug prices. The Trump Administration also renewed the idea of international reference pricing through the May 2025 executive order 14297 titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” Among other things, this executive order directs the Secretary of HHS to communicate most-favored-nation (“MFN”) price targets to manufacturers and propose a rulemaking plan to impose MFN pricing if “significant progress” is not made towards achieving such pricing. It also states that the Administration will take additional aggressive action should manufacturers fail to offer American consumers the MFN lowest price. It is not clear if and how these executive orders will impact our business. In addition, several manufacturers have publicly announced confidential MFN agreements with the U.S., which per public Trump Administration statements would, among other things, “provide every State Medicaid program in the country access to MFN drug prices on products made by the [signing] companies”; “guarantee[] MFN prices on all new innovative medicines the [signing] companies bring to market”; “require the [signing] companies to repatriate increased foreign revenue on existing products that they realize as a result of . . . U.S. trade policies”; and require “the [signing] companies to offer medicines at a deep discount off the list price when selling directly to American patients through TrumpRx.” The Trump Administration has also called on Congress to codify the Trump Administration’s Most-Favored-Nation deals. It is uncertain if such legislation will be enacted, and if it is, how it could affect our business. Furthermore, in November 2025, CMS announced a new, voluntary program called the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model, under which manufacturers can offer MFN rebates to State Medicaid Programs. Also, as explained in more detail below, in December 2025, CMS issued two proposed rules related to MFN pricing. Additionally, President Trump also took executive action to end diversity, equity and inclusion initiatives among public-sector contractors and grantees. Moreover, the Trump Administration is prioritizing efforts to restructure HHS, including substantial reductions in workforce. It is not clear how this restructuring of HHS will impact our business. Finally, the Trump Administration has imposed broad tariffs on foreign imports, which in some cases has caused other nations to levy reciprocal tariffs on goods

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manufactured in the United States. The Trump Administration also has stated several times it intends to impose national security related tariffs of 100% on brand name pharmaceutical drug imports if current negotiations on drug pricing and U.S. investments by drug manufacturers are not satisfactory. Trump Administration officials have stated any tariff action will be held in abeyance for now, while the Trump Administration negotiates agreements with manufacturers that may permit them to avoid the tariffs by investing in the U.S. and taking other actions. As explained above, agreements with several manufacturers to avoid any national security tariffs for three years have been publicly announced so far. Certain U.S. trading partners, including the E.U., Switzerland and Japan, have also negotiated deals with the Trump Administration that promise that any national security tariffs on pharmaceuticals or pharmaceutical raw materials will be forthcoming. These measures could impact our costs for raw materials and manufacturing as well as the market for our future products. Some of these policy changes may be subject to litigation, increasing the uncertainty of their effects on our business.

There has been increasing legislative and enforcement interest in the U.S. with respect to drug pricing practices. Notably, the U.S. government enacted the Inflation Reduction Act of 2022 (the “IRA”), the implementation and scope of which is subject to change through ongoing and future regulatory processes and rulemaking, and which could result in additional rebate payments for certain products, adversely affect the pricing of healthcare products and services in the U.S. and implement price limitations or otherwise restrict the amount of reimbursement available from governmental agencies or third-party payors. In addition, the IRA includes provisions that generally require manufacturers of Medicare Part B and Part D rebatable drugs to pay inflation rebates to the Medicare program if pricing metrics associated with their products increase faster than the rate of inflation. The impact of the IRA on research and development, the pharmaceutical supply chain and other aspects of our business and industry remains uncertain and difficult to predict. There are several ongoing legal challenges to the IRA’s drug price negotiation program, and we cannot predict the outcome of these cases or the impact they could have on implementation of the law. Over time, the IRA could increase our government discount and rebate liabilities, reduce the revenues we are able to collect from sales of our products as well as present challenges for payor negotiations and formulary access. However, the degree of impact that the IRA will ultimately have upon our business remains unclear at this time. Various industry stakeholders, including pharmaceutical companies, the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the IRA are unconstitutional. The impact of these judicial changes, future litigation brought in view of the Supreme Court’s overrule of the Chevron doctrine, legislative, executive and administrative actions and any future healthcare measures and agency rules implemented by the government on us and the pharmaceutical industry as a whole is unclear.

There also have been and continue to be a number of other federal and state legislative and regulatory initiatives to contain healthcare costs, including costs for pharmaceuticals. For example, as discussed in detail above, the ACA substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S. pharmaceutical industry.

Individual states in the U.S. have also increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures. One notable example includes Colorado, where the state Prescription Drug Affordability Board set the first upper payment limit on a drug based on the IRA’s maximum fair price. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our product candidates following regulatory approval or put pressure on the pricing of our product candidates.

Additionally, U.S. regulators continue to pursue policies designed to lower drug costs for federal programs and patients. In May 2019, the CMS, issued a final rule to allow Medicare Advantage Plans the option of using step therapy, a type of prior authorization, for Part B drugs beginning January 1, 2020. Additionally, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. This rulemaking also created a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. However, Congress has adopted various delays on the implementation or enforcement of the rule, including a postponement until January 2032 under the IRA.

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On December 31, 2020, CMS enacted a final rule that, among other things, expanded the scope of drug products that may be considered “line extensions” subject to inflationary rebates under the Medicaid Drug Rebate Program. On September 26, 2024, CMS published a Medicaid Drug Rebate Program final rule, which, among other things, amends the definitions of a “covered outpatient drug,” adds regulations and penalties for drug product misclassifications, including failure to report pricing and product information in a timely manner, and limits the period for manufacturers to initiate disputes concerning state-invoiced utilization data. These changes have generally taken effect since November 2024 and could significantly increase manufacturer rebate liability, expand the scope of products subject to Medicaid rebates, and subject manufacturer drug pricing practices to further scrutiny. On November 5, 2025, CMS issued a Medicare Physician Fee Schedule final rule, which increases bona fide service fee documentation requirements, defines “bundled arrangement,” addresses “unbundling” of both contingent and non-contingent discounts and include sales of Part B units at the Maximum Fair Price in average sales price calculations. These changes could lower reimbursement for Medicare Part B utilization and require manufacturers to comply with new, uncertain or complex reporting obligations and drug pricing documentation practices.

Furthermore, on December 23, 2025, CMS published two proposed rules to create new drug pricing models: the Global Benchmark for Efficient Drug Pricing Model (“GLOBE”) and the Guarding U.S. Medicare Against Rising Drug Costs Model (“GUARD”). If finalized, these rules would require "Most Favored Nation" pricing by requiring manufacturers to pay additional rebates for certain drugs based on the difference between the drug’s Medicare price and the drug’s price in market basket countries. CMS proposes that the agency would apply the new rebate requirement to utilization by approximately 25% of Medicare Part D enrollees (under GUARD) and 25% of Medicare Part B fee-for-service enrollees (under GLOBE). Assuming these proposed rules are finalized and withstand any legal challenge, it is uncertain how they could affect Roivant and its subsidiaries.

Moreover, upcoming legislative and policy changes in the E.U. and the U.K., some of which may materialize in the near term, are aimed at increasing accessibility and affordability of medicinal products, as well as at increased cooperation between the E.U. Member States. Such initiatives may further impact the price and reimbursement status of our products in the future.

There have been, and likely will continue to be, legislative and regulatory proposals at the national and state levels in jurisdictions around the world directed at containing or lowering the cost of healthcare, including prescription drugs. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability through product revenue or commercialize our product candidates following regulatory approval. Such reforms could have an adverse effect on anticipated revenue from our product candidates following regulatory approval and may affect our overall financial condition and ability to develop future product candidates and obtain marketing approval for those product candidates. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and impose price controls may adversely affect:

•the demand for our product candidates following regulatory approval;

•our ability to receive or set a price that we believe is fair for our product candidates following regulatory approval;

•our ability to generate revenue and achieve sustained profitability; and

•the amount of taxes that we are required to pay.

We expect that healthcare reform measures that may be adopted in the future, may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, lower reimbursement and new payment methodologies. This could lower the price that we receive for our product candidates following regulatory approval. Any denial in coverage or reduction in reimbursement from Medicare or other government-funded programs may result in a similar denial or reduction in payments from private payors, which may prevent us from being able to generate sufficient revenue, attain sustained profitability or successfully commercialize our product candidates following regulatory approval.

Coverage and adequate reimbursement may not be available for our product candidates following regulatory approval, which could make it difficult for us to profitably sell our product candidates.

Market acceptance and sales of our product candidates following regulatory approval will depend in part on the extent to which coverage and adequate reimbursement for these product candidates will be available from third-party

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payors, including government health administration authorities and private health insurers. The pricing and reimbursement of our product candidates following regulatory approval must be adequate to support the costs associated with commercialization efforts. If we are unable to obtain adequate levels of reimbursement, our ability to successfully market and sell our product candidates following regulatory approval, will be adversely affected. The manner and level at which reimbursement is provided for services related to our product candidates (e.g., for administration of our products to patients) is also important. Inadequate reimbursement for such services may lead to physician resistance and adversely affect our ability to market or sell our product candidates following regulatory approval. There is no assurance that our product candidates will achieve adequate coverage and reimbursement levels.

In the U.S., no uniform policy of coverage and reimbursement exists among third-party payors. Third-party payors decide which drugs they will pay for and establish reimbursement levels. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for any product candidate following regulatory approval will be made on a plan-by-plan basis. For example, one payor’s determination to provide coverage does not assure that other payors will also provide coverage and adequate reimbursement for the same product candidate, and payors may periodically review and change their coverage and reimbursement rates. Additionally, a third-party payor’s decision to provide coverage does not imply that an adequate reimbursement rate will be approved. Each plan determines whether or not it will provide coverage, what amount it will pay the manufacturer, on what tier of its formulary the drug will be placed and whether to require step therapy. The position of a drug on a formulary generally determines the co-payment that a patient will need to make to obtain the drug and can strongly influence the adoption of a drug by patients and physicians. Patients who are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients are unlikely to use our product candidates following regulatory approval unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of the product candidate. Further, from time to time, typically on an annual basis, payment rates are updated and revised by third-party payors. Such updates could impact the demand for our product candidates to the extent that patients who are prescribed our product candidates following regulatory approval are not separately reimbursed for the cost of the product candidate.

The process for determining whether a third-party payor will provide coverage for a drug may be separate from the process for setting the price or for establishing the reimbursement rate that such a payor will pay. Even if we obtain adequate levels of reimbursement, third-party payors, such as government or private healthcare insurers, carefully review and increasingly question the coverage of, and challenge the prices charged for, products. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Many payors continue to adopt benefit plan changes that shift a greater portion of prescription costs to patients, including more limited benefit plan designs, higher patient co-pay or co-insurance obligations and limitations on patients’ use of commercial manufacturer co-pay payment assistance programs. Significant consolidation in the health insurance industry has resulted in a few large insurers and pharmacy benefit managers exerting greater pressure in pricing and usage negotiations with drug manufacturers, significantly increasing discounts and rebates required of manufacturers and limiting patient access and usage. Further consolidation among insurers, pharmacy benefit managers and oth

Roivant Sciences Ltd. 10-Q