ROIV 10-K & 10-Q changes, risk factors and insider trading

Our business involves a high degree of risk. You should carefully consider the risks described below, together with the other information contained in this Annual Report on Form 10-K, including the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and theour audited consolidated financial statements and the related notes, 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,affiliates. as References to our “product candidates” include our current product candidates and any future products or product candidates. Approval from the contextU.S. requires.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.

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 andcandidates, the creation or acquisition of healthcare technology companies and products.products Followingand theefforts acquisitionto ofenforce and defend our subsidiary Dermavantintellectual byproperty. OrganonWe (thedo “Dermavantnot Transaction”), completed in October 2024, we no longercurrently have aany commercial-stagecommercial productstage products and we do not expect to generate product revenues from the commercial sale of our product candidates until we receive applicable regulatory approvals for the foreseeableone future.of our product candidates. Drug development and commercialization is ana challenging and 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, including to 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:

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 thethese objectives described herein would have a material adverse effect on our business, financial condition, results of operations and prospects.

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 stakeinterest in the Vant formed aroundto develop 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.

Following the acquisition or in-licensing,in-licensing of a product candidate, 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,opportunities. someThese of whichcompanies may possess greater financial or technical resources.resources than we do. If we are unable to identify a sufficient number of potential product candidates for acquisition or in-licensing, are unsuccessful in completing those acquisition or in-licensing transactions or if the product candidates that we identifyare able to acquire or in-license 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.

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 weWe do not currently have any productcommercial candidatesstage that have received marketing approval anywhere in the worldproducts and we do not expect to generate product revenues from the commercial sale of our product candidates inuntil thewe nearreceive term.applicable regulatory approvals for one of our product candidates. As a result, we cannot estimate with precision the extent of ourany future profits or losses. Since inception, we have incurred significant losses and negative cash flows from operations. As of March 31, 2025,2026, we had cash, cash equivalents and marketable securities of approximately $4.9$4.3 billion and retainedour earningsaccumulated ofdeficit was approximately $116.1$501.8 million.

Because we have finite financial and managementmanagerial 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.

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 expensesexpense 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 and certain of our Vants to operate as a public company.companies. We may also be exposed to increased “key employee” risks,risks in the event a Vant CEO were to depart, including the loss of other senior Vant personnel, potentially resulting in adverse impacts to commercializationdevelopment or developmentcommercialization 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 make us less competitive relative to our peers that operate in that manner or 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 for us and our Vants and may expose us and our Vants to increased costs that could, in turn, harm our consolidated 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.Vants that have commercial stage products. 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 or impairment 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.Immunovant, and our private majority controlled subsidiary, Priovant, and may be limited in our ability to direct or control the business and the development of the product candidates or technologies at such Vants. In addition, for certain other Vants, including Immunovant, we may in the future come to hold less than a majority ownership interest in the Vant. 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. InFurthermore, addition,even certainif ofwe our Vantsown havea issued equity securities senior to ourmajority ownership interests, which dilutes our economic interest in a Vant, we may not necessarily be able to control the outcome of certain corporate actions. In addition, we may face limitations on our ability to control or direct actions at privately owned Vants and can in certainwhich caseswe limithave ourminority operationalequity control of the Vant.partners.

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. For example, Eric Venker currently serves as both an executive officer of Roivant and the chief executive officer of our subsidiary, Immunovant. 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.

The acquisition or in-licensing transactions for our product candidates typically involve zero or low dollar-value upfront payments combined with milestone and royalty payments. These arrangements transactions 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 commercial 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.milestone and royalty payment obligations related to these products. If this were to occur, and we are not otherwise able to fund or raise the capital necessary to fund these obligations, we 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 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 sale of our entire equity interest in our majority-owned subsidiary Dermavant Transaction,Sciences Ltd. to Organon & Co. (the “Dermavant Transaction”), the consideration for which consisted of an upfront payment of $183.6 million and thea ADmilestone Approval Milestone Paymentpayment of $75 million upon FDA approval of VTAMA for the treatment of atopic dermatitis.dermatitis 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 Roivant’s condensedour consolidated financial statements included in this Annual Report on Form 10-K.

In addition, theThe 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.

As of March 31, 2025,2026, we had cash, cash equivalents and marketable securities of approximately $4.9$4.3 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.candidates.

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 TYK2JAK1 and JAK1TYK2 currently under review at the FDA for the treatment of dermatomyositis and also in late stage development for the treatment of dermatomyositis, non-infectious uveitis anduveitis, cutaneous sarcoidosis; IMVT-1402 and batoclimab,lichen planopilaris; IMVT-1402, a fully human monoclonal antibodiesantibody 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.

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 with additional studies and our in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates.

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 ChiefImmunovant OperatingCEO. OfficerIn (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. Collectively, these compensation arrangements are referred to herein as the “2024 Senior Executive Compensation ProgramProgram.”). The long-term equity incentive awards granted pursuant to this program will continue to 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 audited financial statements for further details.

Change in fair value of liability instruments primarily includes the loss (gain) loss 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”) and warrant liabilities,liabilities (prior to their redemption,redemption) issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”), a special purpose acquisition company. Refer to Note 13, “Earn-Out Shares, Public Warrants and Private Placement Warrants” of our audited financial statements for further information regarding the redemption of our warrants.

Income (loss) from discontinued operations, net of tax consists of the gain on sale of subsidiary interests for the year ended March 31, 2025 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 (the “Dermavant Transaction”) and the financial results of Dermavant through the closing of the Dermavant TransactionTransaction. (asRefer definedto below).Note In September6, 2024,“Discontinued Dermavant entered into an Agreement and PlanOperations” of Merger (the “Merger Agreement”) with Organon, Organon Bermuda Ltd., an indirect wholly owned subsidiary of Organon (“Merger Sub”), and us, solely in our capacityaudited asfinancial the representativestatements offor thefurther securityholders of Dermavant, pursuant to which Organon agreed to acquire Dermavant (the “Dermavant Transaction”). The Dermavant Transaction was completed in October 2024.information.

Revenue decreased by $20.8 million to $8.3 million for the year ended March 31, 2026, compared to $29.1 million for the year ended March 31, 2025. Revenue decreased by $3.7 million to $29.1 million for the year ended March 31, 2025, compared to $32.7 million for the year ended March 31, 2024. Revenue increased by $1.2 million to $32.7 million for the year ended March 31, 2024, compared to $31.5 million for the year ended March 31, 2023. During the years ended March 31, 2025,2026, 2024,2025 and 2023,2024, revenue was primarily driven by amounts earned in connection with license agreements at Genevant.

Research and development expenses increased by $110.5$131.4 million to $681.8 million for the year ended March 31, 2026, compared to $550.4 million for the year ended March 31, 2025,2025. comparedThis toincrease $439.9 million for the year ended March 31, 2024,was primarily due todriven increasesby an increase in program-specific costs of $78.5$101.1 million, personnel-related expenses of $22.9$21.6 million,million and share-based compensation of $7.4 million and other expenses of $1.7$8.1 million.

The increase of $22.9 million in personnel-related expenses was primarily driven by higher personnel-related expenses at Immunovant as a result of higher headcount and enhancement of capabilities to support Immunovant’s strategic objectives as clinical activities progress. Included in personnel-related expenses is a special one-time cash retention bonus award granted to employees in December 2023 (the “Cash Bonus Program”). During the years ended March 31, 2025 and 2024, we recognized additional research and development expense of $5.8 million and $9.9 million, respectively, relating to the Cash Bonus Program. The remaining research and development expense of $0.9 million as of March 31, 2025 will be recognized over the applicable service period of the award.

There were no acquired in-process research and development expenses for the years ended March 31, 2026 and 2025. Acquired in-process research and development expenses decreased by $71.3 million toof $26.5 million for the year ended March 31, 2024, compared to $97.7 million for the year ended March 31, 2023. The decrease was primarily due to higher consideration for the purchase of IPR&D during the year ended March 31, 2023 as a result of consideration for the purchase of IPR&D of $87.7 million relating to the acquisition of RVT-3101 in November 2022 and the achievement of a development milestone relating to batoclimab, which resulted in a one-time milestone expense of $10.0 million. Acquired in-process research and development expenses for the year ended March 31, 2024 was driven by $14.0 million of consideration for the purchase of IPR&D relating to the asset acquisition of mosliciguat completed by our subsidiary, Pulmovant, Inc. (“Pulmovant”) and $12.5 million relating to the achievement of development and regulatory milestones for batoclimab.

General and administrative expenses increased by $32.7$19.1 million to $416.1$610.5 million for the year ended March 31, 2024,2026, compared to $383.4$591.4 million for the year ended March 31, 2023.2025. This increase was primarily due to an increase in personnel-relatedshare-based expensescompensation expense of $27.0$58.8 million, whichprimarily largelydue resultedto the long-term equity incentive awards from the CashSenior BonusExecutive Program,Compensation Program and incremental share-based compensation expense resulting from the Priovant Exchange Offer, an impairment loss of $17.1 million related to the relocation of the U.S. corporate headquarters of Roivant Sciences, Inc. and an increase of $9.1 million in professional feesfees, ofreflecting $19.6higher million.litigation-related costs incurred. These increases were partially offset by a decrease of $69.9 million in share-based compensationpersonnel-related expense, which largely resulted from higher expense offor $20.1the million.year ended March 31, 2025 related to the one-time cash retention awards from the Senior Executive Compensation Program and the Cash Bonus Program (as defined below).

GainGeneral onand saleadministrative ofexpenses Telavant net assets decreasedincreased by $5.2$175.3 billionmillion to $110.4$591.4 million for the year ended March 31, 2025, compared to $5.3$416.1 billionmillion for the year ended March 31, 2024. TheThis gainincrease forwas theprimarily yeardue endedto Marchincreases 31,in 2025share-based resultedcompensation expense of $84.6 million and personnel-related expenses of $79.6 million, largely as a result of long-term equity and one-time cash retention awards from the achievementSenior ofExecutive aCompensation one-time milestone in June 2024. The gain for the year ended March 31, 2024 resulted from the sale of our entire equity interest in Telavant to Roche in December 2023.Program. Refer to Note 5,9, “RecentShare-Based TransactionsCompensation and DevelopmentsOther Compensation Plans” of our audited financial statements for further information.

ChangeGain inon fair valuesale of investmentsTelavant net assets was an unrealized gain of $55.2 million and an unrealized loss of $48.0$110.4 million for the yearsyear ended March 31, 2025 and 2024,$5.3 respectively.billion for the year ended March 31, 2024. The changegain for the year ended March 31, 2025 resulted from the achievement of $103.2 milliona wasone-time primarily driven by changesmilestone in theJune public2024. shareThe pricesgain of Arbutus and infor the fairyear valueended March 31, 2024 resulted from the sale of our investmententire equity interest in Datavant.Telavant to Roche in December 2023. Refer to Note 4,5, “EquityRecent MethodTransactions Investmentsand Developments” of our audited financial statements for further information.

Change in fair value of investments were unrealized lossesgains of $48.0$105.0 million and $20.8$55.2 million for the years ended March 31, 20242026 and 2023,2025, respectively. The change of $27.2$49.9 million was primarily driven by changes in the public share pricesprice of our equity investments, including Arbutus, as well as the change in fair value of our investment in Datavant.Datavant, which was driven by growth in forecasted financial performance.

Our business involves a high degree of risk. You should carefully consider the risks described below,in “Part I, Item 1A. Risk Factors” of our Annual Report, together with the other information contained in this Quarterly Report, including the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and 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 sharesprice 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. References to our “product candidates” include our current product candidates 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. During the quarter ended June 30, 2026, our risk factors have not changed materially from those described in the Annual Report, except for the risk factors noted below.

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, 2025,2026, included in our Annual Report on Form 10-K, filed with the SEC on May 29,20, 20252026 (the “FormAnnual 10-KReport”). 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 “Cautionary Note Regarding 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.

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 TYK2JAK1 and JAK1TYK2 currently under review at the FDA for the treatment of dermatomyositis and also in late stage development for the treatment of dermatomyositis, non-infectious uveitis anduveitis, cutaneous sarcoidosis; IMVT-1402 and batoclimab,lichen planopilaris; IMVT-1402, a fully human monoclonal antibodiesantibody 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.

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

The following table summarizes our ownership of certain of our subsidiary companies and affiliates as of DecemberJune 31,30, 2025.2026.

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.

•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,gravis (“MG”), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (“D2T RA”) and Sjögren’s disease,disease (“SjD”), and a proof-of-concept trial in cutaneous lupus erythematosus.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.(“CLE”).

•Pulmovant: Phase 2 trialstudy of mosliciguat in pulmonary hypertension associated with interstitial lung disease fully(“PH-ILD”) enrolled,remains withon topline data expected in the second half of calendar year 2026.track.

•Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.5$3.9 billion as of DecemberJune 31,30, 2025,2026, excluding the cash payment received from Moderna in July, supporting cash runway into profitability. For the three months ended June 30, 2026, Roivant repurchased 7.3 million common shares for an aggregate repurchase price of approximately $208.7 million.

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 with additional studies and our in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates.

• 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

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

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”).CEO. 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. Collectively, these compensation arrangements are referred to herein as the “Senior Executive Compensation Program.” The long-term equity incentive awards granted pursuant to this program will continue to result in significant share-based compensation expense over the vesting period of the awards. Refer to Note 9,8, “Share-Based Compensation and Other Compensation Plans” of our financial statements for further details.

Income tax (benefit) 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.

Comparison of the three and nine months ended DecemberJune 31,30, 20252026 and 20242025

The following table sets forth our results of operations for the three months ended DecemberJune 31,30, 20252026 and 20242025:

Variance analysis for three and nine months ended DecemberJune 31,30, 20252026 and 20242025

For the three months ended DecemberJune 31,30, 20252026 and 2024,2025, our research and development expenses consisted of the following:

Research and development expenses increased by $23.8$49.1 million to $165.4$202.0 million for the three months ended DecemberJune 31,30, 2025,2026, compared to $141.6$152.9 million for the three months ended DecemberJune 31,30, 2024.2025. This increase was primarily driven by an increase in program-specific costs of $11.3$49.4 million and share-basedpersonnel-related compensationexpenses of $8.4$3.8 million.

The $44.3increase of $49.4 million increase in program-specific costs was primarily driven by an increaseincreases of $27.0$44.8 million related to the anti-FcRn franchise, $13.9 million related to brepocitinib,franchise and $12.4$4.7 million related to mosliciguat, reflecting the progression of our programs. The increase of $3.8 million in personnel-related expenses was partiallyprimarily offsetdriven by a $11.0$4.1 million decrease in expensesemployee bonuses related to terminatedthe programs.global settlement reached with Moderna in March 2026.

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 (in thousands):

Changes in fair value of investments were an unrealized gain of $21.6$36.6 million and an unrealized loss of $21.3$19.1 million for the three months ended DecemberJune 31,30, 20252026 and 2024,2025, respectively. The change of $42.9$55.8 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.

Interest income decreased by $66.8$11.4 million to $136.9$36.9 million for the ninethree months ended DecemberJune 31,30, 2025,2026, compared to $203.8$48.3 million for the ninethree months ended DecemberJune 31,30, 2024.2025. The decrease iswas primarily due to lower cash equivalents and marketable securities balances in our interest-bearing accounts andas well as lower interest rates.