Reworded10-Q Nov 9, 2026 vs 10-K May 20, 2026
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/10-K filed May 20, 2026, compared with May 29, 2025
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Health care · Pharmaceuticals
Roivant Sciences Ltd. ROIV
New risk paragraphs, branching off last year
Each branch is a paragraph in Risk Factors with nothing like it in the 10-K filed May 29, 2025. A box jumps to the paragraph as filed, below.
Paragraphs with nothing like them in last year's 10-K
65 paragraphs in Risk Factors of the 10-K filed May 20, 2026 with nothing like them in the 10-K filed May 29, 2025. Quoted exactly. Paragraphs that were only edited are under 10-K change.
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. 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.
•make milestone, royalty or other payments due under any licenses or agreements;
We also face significant competition for investment opportunities. A number of companies compete with us for such opportunities. These companies may possess greater financial or technical resources than we do. If we are unable to
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 could adversely affect Immunovant’s development or commercialization of IMVT-1402.
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 product candidates. Immunovant has commenced discussions with HanAll regarding the potential return to HanAll of certain rights for batoclimab.
Immunovant shared top-line results from the two batoclimab Phase 3 TED studies concurrently in April 2026. Neither study achieved its primary endpoint, leading Immunovant to make a decision to discontinue further development of batoclimab across all indications to focus fully on IMVT-1402. 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 plans for batoclimab. While the HanAll Agreement gives Immunovant final decision-making authority over development and regulatory matters for licensed products in Immunovant's licensed territories, and Immunovant believes it has satisfied its obligations under the HanAll Agreement, including with respect to batoclimab, HanAll may disagree with Immunovant's interpretation of the agreement or Immunovant's actions thereunder, and Immunovant may be unable to reach an agreement with HanAll regarding the future of batoclimab. This could result in a dispute with HanAll involving 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 could 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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Changes in tariffs and other governmental trade policies could negatively affect our business and results of operations.
Recent governmental actions and proposals relating to tariffs and other trade policies have created uncertainty about future trading arrangements and the possibility of jurisdictions imposing or increasing tariffs on certain goods. For example, certain governments (including the U.S. and other countries where we do business) have imposed or may impose tariffs on a wide range of products, raw materials and intermediate goods. The U.S. Supreme Court has invalidated some of the U.S. tariffs, but additional tariffs are anticipated to be imposed pursuant to the Trump Administration's ongoing U.S. trade investigation. Additional tariffs, or retaliatory measures by other countries in response, may be implemented at any time. Should these or similar tariffs remain in place (or be re-imposed or increased), or if additional tariffs or trade restrictions are enacted in the future, they could cause us or our future customers to face higher supply costs, delays or require us to switch suppliers. These actions could adversely affect our future margins, profitability, financial condition and results of operations.
In addition, the pharmaceutical industry faces specific and evolving tariff-related risks. On April 2, 2026, the United States announced significant tariffs on certain pharmaceutical products, active pharmaceutical ingredients and key starting materials. These tariffs, which were imposed pursuant to a national security investigation under Section 232 of the Trade Expansion Act of 1962, will generally go into effect in September 2026. The tariffs, which range from 10% to 100% depending on type of product and country of origin, are also subject to a number of exemptions and exclusions. There is still significant uncertainty about implementation and application of the tariffs and the exemptions and exclusions as various elements of the tariff action remain to be determined in subsequent agency actions. These new U.S. tariffs may raise costs for drug products and inputs used in our clinical development programs or that our contract manufacturers and suppliers may procure in connection with manufacturing our product candidates.
We cannot predict future changes in trade policy or the terms of any renegotiated trade agreements, nor can we determine the impact they may have on our business. Any such changes could have a material adverse effect on our business, financial condition and results of operations.
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 increased political instability, international hostilities and geopolitical tensions (such as the current conflicts between Russia and Ukraine and hostilities involving Iran, including direct military actions and proxy conflicts across the Middle East), trade disputes between nations (including trade disputes with China), a global financial crisis, wars, terrorism and civil unrest could adversely affect our business. In particular, the foregoing factors have resulted in significant volatility in global financial markets. If such volatility persists or deepens, we may be unable to access additional capital on terms that are favorable, or at all, which could negatively affect our capacity for certain strategic transactions or our ability to make other important investments. In addition, high levels of inflation and interest rate fluctuations may increase our financing costs or restrict our access to potential sources of future liquidity. Additional funds may not be available when we need them on terms that are acceptable to us. If adequate funds are not available to us on a timely basis, we may be required to delay, limit, reduce or terminate one or more of our product development or commercialization efforts.
Legislation targeting biotechnology companies with ties to certain foreign adversaries, including the BIOSECURE Act, could materially adversely affect our business, supply chain and results of operations.
We and certain of our Vants rely on third-party contract manufacturing organizations (“CMOs”) to manufacture drug substance and drug product for our product candidates. The BIOSECURE Act, enacted in December 2025 as Section 851 of the FY2026 National Defense Authorization Act, prohibits U.S. government agencies from procuring or obtaining biotechnology equipment or services from designated “biotechnology companies of concern,” and restricts agencies from entering into, extending, or renewing contracts with entities that use such covered equipment or services (the “BIOSECURE Act”). The statute relies on two designation mechanisms: (1) automatic designation through the Department of Defense’s Section 1260H list of “Chinese military companies”; and (2) a criteria-based pathway administered through an interagency process led by the Office of Management and Budget, which is required to publish a list of biotechnology companies of concern within one year.
The prohibitions under the BIOSECURE Act take effect following revisions to the Federal Acquisition Regulation, with the timing depending on the basis for a company’s designation as a “biotechnology company of concern.” Although the statute includes a five-year rule of construction that protects legacy agreements from being invalidated by the new restrictions, a safe harbor for items no longer produced or provided by a biotechnology company of concern and limited case-by-case waivers in the national security interest, there can be no assurance that we will be able to fully avail ourselves of such provisions or that they will adequately mitigate the impact of the statute’s prohibitions on our operations.
In such an event, we or our Vants may be required to transition manufacturing activities then performed by CMOs receiving the designation to alternative CMOs, which could be costly, time-consuming and disruptive to our supply chain and clinical development programs.
In addition to the BIOSECURE Act, the introduction or passage of other federal or state legislation, executive orders or regulatory actions further restricting U.S. biotechnology companies’ use of certain foreign-based CMOs could impose additional constraints on our Vants' manufacturing operations and supply chain. There can be no assurance that our Vants would be able to identify and qualify alternative manufacturers on commercially reasonable terms or in a timeframe sufficient to avoid material disruption to their businesses, which could have a material adverse effect on our business, financial condition and results of operations.
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.
•competing clinical trials for similar therapies, and clinicians’ and participants’ perceptions of the relative advantages, risks and side effects of our product candidates compared to other available therapies, including any new drugs or treatments;
•our ability to monitor trial participants adequately during and after treatment;
•adverse results or other safety signals in our trials or related to other product candidates, and any resulting negative publicity which could discourage potential participants and their physicians from participating in our trials; and
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.
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 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 as further described in draft guidance issued in February 2026.
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 that can benefit from orphan drug market exclusivities when approved if certain conditions are met.
It is also possible that current or future litigation or action by Congress could change the scope of available orphan exclusivity. Any changes to the orphan drug provisions could change our opportunities for, or likelihood of success in obtaining, orphan drug exclusivity and could materially adversely affect our business, financial condition, results of operations, cash flows and prospects.
There are significant expenses and risks involved with establishing sales, marketing and distribution capabilities, including the ability to hire, retain and appropriately incentivize qualified individuals, develop an appropriate and effective compliance function, provide adequate training to sales and marketing personnel and effectively manage geographically dispersed sales and marketing teams to generate sufficient demand. Any failure or delay in the development in our sales,
•the inability of sales personnel to appropriately inform and educate healthcare providers regarding the potential benefits and proper administration of our products;
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.
Products approved for rare or orphan indications, such as brepocitinib if approved for dermatomyositis, may be subject to heightened public, media and legislative scrutiny with respect to their pricing. Because orphan drugs are often priced at a premium to reflect the relatively small patient populations, high unmet medical need and significant costs of development and commercialization, they have attracted particular attention from Congress, government agencies, patient advocacy groups and the press. Government authorities and third-party payors are increasingly attempting to limit or regulate drug prices and reimbursement for orphan drugs specifically. These dynamics may give rise to heightened attention and potential negative reactions to our pricing decisions for any product candidate that we commercialize, including brepocitinib, even where we believe such pricing reflects the clinical value of the therapy and the investment required to develop it. Such attention could pressure us to reduce prices, offer discounts beyond those required by law, limit our ability to negotiate adequate reimbursement rates with payors or otherwise adversely affect our ability to generate sufficient revenue to sustain commercialization of our product candidates.
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 manufactured in the United States.
On April 2, 2026, the United States announced significant tariffs on certain pharmaceutical products, active pharmaceutical ingredients and key starting materials. These tariffs, which were imposed pursuant to a national security investigation under Section 232 of the Trade Expansion Act of 1962, will generally go into effect in September 2026. The tariffs, which range from 10% to 100% depending on type of product and country of origin, are also subject to a number of exemptions and exclusions. There is still significant uncertainty about implementation and application of the tariffs and the exemptions and exclusions as various elements of the tariff action remain to be determined in subsequent agency actions. These new U.S. tariffs may raise costs for drug products and inputs used in our clinical development programs or that our contract manufacturers and suppliers may procure in connection with manufacturing our product candidates.
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.
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 MFN 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. Additionally, legislative proposals have been introduced in Congress that would mandate MFN pricing for particular healthcare programs if enacted. However, we cannot be certain whether any of these proposals will be enacted and if they are, how they could impact our business.
The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles and resulting regulatory updates and changes in policy priorities.
On June 28, 2024, the U.S. Supreme Court issued an opinion holding that courts reviewing agency action pursuant to the Administrative Procedure Act (the “APA”) “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision has had and will have a significant impact on how lower courts evaluate challenges to agency interpretations of law, including those by the Department of Health and Human Services, CMS, FDA and other agencies with significant oversight of the biopharmaceutical industry. The new framework is likely to increase both the frequency of such challenges and their odds of success by eliminating one way in which the government previously prevailed in such cases. As a result, significant regulatory policies will be subject to increased litigation and judicial scrutiny.
In addition, federal agency priorities, leadership, policies, rulemaking, communications, spending and staffing may be significantly impacted by election cycles and legislative developments. For example, the Trump Administration has committed to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agencies, such as HHS, FDA and CMS. Efforts by the current administration to limit federal agency budgets or personnel may result in reductions to agency budgets, employees and operations. The administration and agencies have also made abrupt announcements about new or changed regulatory policies, such as policies related to the use of AI to review product applications. And, the recent federal government shutdown may prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, and may significantly impact the ability of the FDA to timely review and process our regulatory submissions. These developments may lead to greater uncertainty regarding FDA policies, slower response times and longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval for our product candidates. Any resulting changes in regulation may result in unexpected delays, increased costs or other negative impacts on our business that are difficult to predict.
Moreover, as a result of projected supply constraints for certain materials used in the production of our product candidates, we have in the past and may in the future reserve manufacturing capacity in advance of receiving required efficacy or safety results from our clinical trials, which may involve committing substantial financial resources to product
In the U.S., legislative proposals and certain enacted legislation could negatively impact U.S. funding for certain biotechnology providers that have relationships with certain foreign governments or which pose a threat to national security. Currently, the potential downstream adverse impacts on entities having commercial relationships with any impacted biotechnology provider is unknown but may include supply chain disruptions or delays. If any of our suppliers become subject to any such laws, including those yet to be enacted, this may result in material delays or other disruptions to our development and, if approved, commercial activities, add significant additional cost, require that we move our non-clinical or clinical development and manufacturing activities to alternative suppliers, in each case, which may materially and adversely impact our ability to develop and manufacture our product candidates, conduct our clinical trials and, if approved, commercialize our products in a timely manner, or at all, or result in unacceptable additional costs.
mid-level and senior managers as well as junior, mid-level and senior scientific and medical personnel. Negative business developments and changes in immigration laws, policies or enforcement patterns, or announcements thereof, that make it more difficult or less desirable for immigrants to work in the U.S. or introduce greater uncertainty into the immigration system and changes in immigration laws, policies or enforcement patterns, or announcements thereof, that make it more difficult or less desirable for immigrants to work in the U.S. or introduce greater uncertainty into the immigration system may make it difficult to recruit and retain qualified personnel. If we are unable to attract and incentivize quality personnel on acceptable terms, or at all, it may cause our business and operating results to suffer.
Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages or claims related to our privacy and data security obligations. Any disruption or security breach or incident that results in or is perceived to have resulted in
a loss of, or damage to, our data or systems, or inappropriate disclosure, use, acquisition, transfer, modification, unavailability or other processing of confidential or proprietary information, including data related to our personnel, could result in the loss, unauthorized modification, use, unavailability, disclosure or other unauthorized processing of critical or sensitive data, and could cause us to incur liability. Further, in any such event, the development and commercialization of our product candidates following regulatory approval could be delayed and our business and operations could be adversely affected. Any of the foregoing could result in significant financial, legal or reputational harm to us and our business.
competitive harm, legal liability, brand or reputational harm or other adverse impacts on our business and financial results. If we do not have sufficient rights to use the data or other material or content on which our AI solutions or other AI tools we use rely, we also may incur liability through the violation of applicable laws, third-party intellectual property, privacy or other rights or contracts to which we are a party. In addition, the use of generative AI models in our internal or third-party systems may create new attack surfaces or methods for adversaries, which could impact us and the third parties with whom we work. These AI-specific risks include, among others, model poisoning attacks in which adversaries corrupt or manipulate training data to cause AI models to produce incorrect or biased outputs, adversarial input attacks designed to manipulate model outputs in ways that are difficult to detect and model extraction attacks in which competitors or other bad actors seek to reconstruct or steal proprietary AI models by probing their outputs. These risks are of particular relevance to our drug discovery activities, where compromised AI models could undermine target identification, compound screening or other critical research processes. Furthermore, the data used to train our AI models, which may include proprietary research data, licensed third-party data or data derived from patients or clinical studies, may itself be subject to privacy regulations, third-party intellectual property claims or contractual restrictions. If our use of such training data is found to be inconsistent with applicable law, license terms or data subject rights, we could face legal claims, regulatory action, ownership disputes or restrictions on our ability to use or further develop the affected AI models. Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations and adversely impact our business. The integration of AI into our and third parties’ systems (potentially without the third party disclosing such use to us) subjects us to the risk that the providers of AI technologies may not meet existing or evolving legal, regulatory or industry standards relating to privacy, data protection, cybersecurity, intellectual property, product safety, human oversight or algorithmic accountability. Compliance with these requirements may require substantial investments in governance, documentation, monitoring, testing or operational controls, and may limit our ability to deploy or scale certain AI-enabled tools or features. If we do not adopt AI or other machine-learning technologies effectively or at an appropriate pace, we may also be less competitive relative to peers who do.
In the United States, over the past year, states have advanced, and in some cases passed, dozens of laws focusing on AI governance and regulation, including on deployment of AI technologies in healthcare settings. At the same time, the Trump Administration has endorsed a federal moratorium on the enforcement of state AI laws, including through an executive order on “Ensuring a National Policy Framework for Artificial Intelligence.” So far, these efforts have not been successful at curtailing state action on AI regulation, contributing to a complicated legislative patchwork, which may be litigated in state and federal courts. Moreover, the FDA has advanced guidance and proposed frameworks for regulating AI technologies in drug discovery, marketing submissions and medical device development.
Cross-border transfers of personal data and compliance with international data protection regulations, including the GDPR, create legal and operational risks for our business.
We conduct clinical trials and other activities in the European Union and other jurisdictions that impose stringent data protection requirements. The GDPR imposes obligations with respect to the collection, storage, transfer and other processing of personal data relating to individuals in the E.U., including clinical trial participants, employees and other data subjects, and provides for fines of up to the greater of €20 million or 4% of total worldwide annual turnover for violations. The transfer of personal data from the E.U. to the U.S. and other countries is subject to specific legal mechanisms and ongoing legal uncertainty, including as a result of legal challenges to applicable transfer frameworks. In addition, the interaction between GDPR requirements and E.U. AI Act obligations, including requirements around the use of personal data in AI training and automated decision-making, creates further compliance complexity for our AI-enabled drug
discovery and clinical operations. If we or our third-party processors fail to comply with applicable data protection laws, or if the legal mechanisms on which we rely for cross-border data transfers are invalidated or become unavailable, we could face regulatory enforcement, significant fines, restrictions on our data processing activities or other adverse consequences that could materially affect our operations and development programs.
Compliance with FDA electronic records and data integrity requirements creates cybersecurity-adjacent regulatory risk that could adversely affect our business.
As a biopharmaceutical company, we are subject to FDA regulations governing electronic records and electronic signatures, including 21 CFR Part 11, as well as data integrity expectations applicable to regulated clinical and manufacturing systems. These regulations require that electronic records used in connection with FDA-regulated activities be trustworthy, reliable and generally equivalent to paper records. A cyberattack, breach, system failure or unauthorized modification affecting our regulated electronic records or systems, or those of our CROs, CMOs or other third parties conducting regulated activities on our behalf, could compromise the integrity, authenticity or availability of required records in a manner that triggers FDA scrutiny, warning letters, clinical hold or other regulatory action. Remediation of data integrity findings can be time-consuming and costly, and in severe cases could result in delays to or rejection of regulatory submissions, invalidation of clinical data, or restrictions on our operations. We may not be able to prevent all such events, and the consequences of a data integrity failure in a regulated context could be disproportionately severe relative to the underlying cybersecurity incident.
could adversely affect our results of operations and business, including preventing or limiting the commercialization of our product candidates following regulatory approval.
as constituting prohibited promotion of prescription-only medicinal products if it reaches an EEA/U.K.-audience and could trigger enforcement and penalties. This is an area of increased scrutiny in both the EEA and the U.K.and trigger enforcements and penalties. This is an area of increased scrutiny in both the EEA and the U.K.
could harm our business, financial condition, results of operations and prospects. For example, disputes may arise with respect to our current or future licensing agreement include disputes relating to:
• the right to enforce patent rights against third party infringers under the license agreement;
Our subsidiary Immunovant has licensed certain intellectual property rights covering IMVT-1402 and batoclimab from HanAll. We and Immunovant depend, and will continue to depend, on the HanAll Agreement for the rights to develop, manufacture and commercialize certain product candidates. If, for any reason, the rights granted to Immunovant under the HanAll Agreement are terminated or Immunovant otherwise loses those rights, it would adversely affect our and Immunovant’s business. The HanAll Agreement also imposes, and any future collaboration agreements or license agreement we enter into are likely to impose, various development, commercialization, funding, milestone payment, royalty, diligence, sublicensing, insurance, patent prosecution and enforcement or other obligations on us or our Vants. For more information regarding the risks associated with the HanAll Agreement, please see the risk factor above entitled “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.”
to obtain, maintain, defend, protect or enforce any patents or patent applications licensed to us, our rights to such patents and patent applications may be reduced or eliminated and our right to develop and, following regulatory approval, commercialize product candidates that are the subject of such licensed rights could be adversely affected.
as to the rights in related or resulting know-how and inventions, which could be time-consuming and divert the attention of senior management.
In February 2022, Roivant’s subsidiary GSG and Roivant’s affiliate Arbutus filed a lawsuit in the U.S. District Court for the District of Delaware against Moderna and an affiliate seeking damages for infringement of certain patents, including U.S. Patent Nos. 8,492,359, 9,364,435, 9,504,651 and 11,141,378, in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19 (the “Moderna Action”). In 2025, GSG and Arbutus filed five international lawsuits against Moderna targeting alleged infringing activity with respect to Moderna’s vaccine for COVID-19 in 30 countries (the “Moderna International Cases”). On March 3, 2026, GSG and, solely for certain purposes, Genevant, and Arbutus entered into a settlement agreement with Moderna Inc. and Moderna TX, Inc. (the “Settlement Agreement”) to resolve the Moderna Action and the Moderna International Cases. Under the Settlement Agreement, Moderna agreed to make a $950 million noncontingent lump sum payment to GSG and Arbutus on or before July 8, 2026. In addition, as described in more detail below, Moderna agreed to make an additional contingent lump sum payment of up to $1.3 billion (the “Contingent Payment”) to GSG and Arbutus, depending on the outcome of Moderna’s appeal of the District Court’s rejection of Moderna’s affirmative defense under 28 U.S.C. § 1498 (“§ 1498”). In March 2026, Moderna filed a notice of its appeal (the “§ 1498 Appeal”) with the U.S. Court of Appeals for the Federal Circuit (the “Federal Circuit”). Briefing of the § 1498 Appeal is expected to be completed in July 2026, with oral arguments before the Federal Circuit expected to take place in 2027.
Under the terms of the Settlement Agreement, Moderna will make the Contingent Payment to GSG and Arbutus (i) if the Federal Circuit affirms, or if there is a final non-appealable judgment that affirms, the rejection of Moderna’s affirmative defense pursuant to § 1498 by the District Court in its entirety or otherwise holds that § 1498 does not bar GSG’s and Arbutus’s claim against Moderna as to either or both of direct infringement and indirect infringement with respect to all of the doses subject to Moderna’s appeal, or (ii) upon a voluntary dismissal of Moderna’s appeal (any of the foregoing under (i) or (ii), a “GSG/Arbutus § 1498 Victory”).
The receipt of the Contingent Payment is subject to a number of risks and uncertainties that could impact the amount and timing of any proceeds received by GSG and Arbutus. If the Federal Circuit determines that § 1498 bars GSG’s and Arbutus’s direct and indirect infringement claims with respect to all doses subject to Moderna’s appeal, no Contingent Payment will be owed to GSG and Arbutus. If § 1498 is found to bar claims only with respect to some of such doses, the Contingent Payment will be prorated and the precise amount of the Contingent Payment could be subject to dispute if the Federal Circuit’s ruling does not clearly articulate the number of affected doses, potentially requiring binding arbitration to resolve. We cannot predict the timing or outcome of the § 1498 Appeal. Even if GSG and Arbutus receive the Contingent Payment following a favorable appellate outcome, as described above, GSG and Arbutus would be required to return the Contingent Payment to Moderna, plus interest, if the favorable outcome were to be subsequently overturned in Moderna’s favor in a final non-appealable decision. The obligation to potentially return the Contingent Payment, together with interest, could have a material adverse effect on our consolidated financial condition if such a repayment obligation were to arise after the proceeds are deployed or distributed.
More broadly, litigation settlement agreements involve inherent risks and uncertainties. For example, Moderna could default on, or otherwise fail to make, the Contingent Payment under certain circumstances. In addition, the terms of the Settlement Agreement represent a final resolution of the Moderna Action and the Moderna International Cases. GSG and Arbutus will have no further ability to seek additional damages from Moderna in connection with the licensed products and activities covered by the Settlement Agreement, even if circumstances change or additional infringing activities are discovered that fall within the scope of the license. The mutual releases contained in the Settlement Agreement extinguish claims that might otherwise have been available to GSG and Arbutus. In addition, the Settlement Agreement resolves only
the disputes between GSG and Arbutus, on the one hand, and Moderna and its affiliates, on the other, and does not affect other pending litigation, including the Pfizer Action described below, which remains ongoing and subject to its own risks and uncertainties.
manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants.
could create liability for us and damage our reputation, which could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.
Paragraphs in the 10-Q filed Nov 9, 2026 that were not in the one before
New in the latest 10-Q
59 paragraphs in the 10-Q filed Nov 9, 2026 with nothing like them in the 10-Q filed Aug 6, 2026 (at least half the words must differ; new numbers alone do not count). Quoted exactly, grouped by the item heading above them. This is text that changed, not a judgement of how serious it is.
10-Q
LISRAYA™ is a trademark of our subsidiary, Priovant Therapeutics, Inc. Other brands, names and trademarks contained in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
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Financial statements and notes
Income (Loss) Shares Amount Balance at March 31, 2026 720,352,386 $ $ 5,024,826 $ 4,358 $ (501,814) $ 765,042 $ 5,292,412 Issuance of the Company’s common shares in connection with equity incentive plans, net of tax withholding payments 9,208,139 — 24,596 — — — 24,596 Exercise and vesting of subsidiary share awards — — 13,470 — — 10,164 23,634 Issuance of subsidiary shares to the Company and cash contributions to majority-owned subsidiaries — — (1,265) — — 1,265 — Repurchase of the Company’s common shares (6,892,463) — — — (208,703) — (208,703) Issuance of the Company’s common shares under employee stock purchase plan — — 635 — — — 635 Share-based compensation — — 68,664 — — 14,678 83,342 Unrealized losses on available-for-sale securities — — — (2,987) — — (2,987) Foreign currency translation adjustment — — — (670) — 216 (454) Net loss — — — — (189,837) (100,769) (290,606) Balance at June 30, 2026 722,668,062 $ $ 5,130,926 $ 701 $ (900,354) $ 690,596 $ 4,921,869 Issuance of the Company’s common shares in connection with equity incentive plans, net of tax withholding payments 3,452,317 — (5,595) — — — (5,595) Exercise and vesting of subsidiary share awards — — 3,719 — — 2,647 6,366 Cash contributions to majority-owned subsidiaries — — (1,003) — — 1,003 — Distribution by subsidiary — — — — — (186,567) (186,567) Repurchase of the Company’s common shares (2,467,035) — — — (72,500) — (72,500) Issuance of the Company’s common shares under employee stock purchase plan 34,062 — — — — — — Share-based compensation — — 65,672 — — 13,625 79,297 Amounts reclassified from accumulated other comprehensive income (loss) — — — 10 — — 10 Unrealized losses on available-for-sale securities — — — (9,751) — — (9,751) Foreign currency translation adjustment — — — 109 — (307) (198) Net (loss) income — — — — (191,619) 54,408 (137,211) Balance at September 30, 2026 723,687,406 $ $ 5,193,719 $ (8,931) $ (1,164,473) $ 575,405 $ 4,595,720
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LISRAYA™ (brepocitinib) was approved by the United States Food and Drug Administration (“FDA”) in August 2026 for the treatment of adults with dermatomyositis.
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The Company sells LISRAYA to specialty pharmacies, which constitute the Company’s only customers for product revenue. The following table summarizes customers who individually accounted for 10% or more of the Company’s total gross product revenue:
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As of September 30, 2026, these customers accounted for 82 % and 18 % of the Company’s gross accounts receivable balance related to product revenue. The Company did not have product revenue during the six months ended September 30, 2025. The Company monitors the creditworthiness of its customers and has not experienced any credit losses to date.
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Show the other 54
Inventory is recorded at the lower of cost or net realizable value, with cost determined using a standard cost approach, which approximates actual cost determined on a first-in, first-out basis. Inventory consists of raw materials, work-in-process and finished goods and consists primarily of the cost for raw materials and third-party contract manufacturing costs.
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The Company assesses recoverability of inventory during each reporting period and writes down any excess and obsolete inventories to their net realizable value in the period in which the impairment is first identified. Such impairment charges are recorded as a component of cost of revenue in the condensed consolidated statements of operations.
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Inventory is recognized as cost of product revenue when the related product revenue is recognized (i.e., upon delivery to the specialty pharmacy). Inventory deployed for clinical operations is recognized as research and development expense.
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Prior to regulatory approval, the Company records costs incurred to manufacture the Company’s drug product as research and development expense. Once the product receives regulatory approval, the Company capitalizes inventory costs related to the product. Following FDA approval of LISRAYA in August 2026, the Company began capitalizing qualifying manufacturing costs as inventory.
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The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for its arrangements, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as the Company satisfies a performance obligation.
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The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606, Revenue from Contracts with Customers at contract inception, the Company reviews the contract to determine which performance obligations it must deliver and which performance obligations are distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.
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The Company’s product revenue, net relates entirely to the sale of LISRAYA in the U.S. The Company began recognizing product revenues after the approval by the FDA in August 2026 of LISRAYA for the treatment of adults with dermatomyositis.
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The Company enters into agreements with specialty pharmacies (each a “Customer” and collectively the “Customers”) to sell LISRAYA in the U.S. Revenues from product sales are recognized when the Customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery of the product to the Customer.
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Revenues from product sales are recorded net of variable consideration, which includes: (a) prompt payment discounts, (b) government rebates, (c) chargebacks, (d) product returns and (e) co-pay assistance for patients. The reserves for variable consideration are classified as reductions of accounts receivable or accrued expenses.
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Variable consideration is estimated based on contractual terms as well as management assumptions and historical data. The amount of variable consideration is calculated using the expected value method, which is the sum of probability weighted amounts in a range of possible outcomes, or the most likely amount method, which is the single most likely amount in a range of possible outcomes. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results vary from estimates, the Company adjusts these estimates, which affects net product revenue and earnings in the period such variances become known.
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a.Prompt Payment Discounts: Customers receive a prompt payment discount for payments made within a contractually agreed number of days before the due date. The Company estimates that its Customers will earn these discounts. These discounts are recorded as a reduction of gross product revenue and accounts receivable at the time revenue is recognized.
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b.Government Rebates: Allowances for government rebates include mandated discounts under Medicaid, Medicare, and other government programs. The Company’s estimate for these rebates is based on contractual or statutory discount rates, estimated patient mix, and expected utilization. Rebates are recorded as a reduction of gross product revenue and an accrued expense is established at the time revenue is recognized.
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c.Chargebacks: Chargebacks for statutory discounts to qualified government healthcare providers represent the estimated obligations resulting from contractual commitments to sell product to qualified U.S. Department of Veterans Affairs hospitals and 340B entities at discounted prices. The Customer charges the Company for the difference between what it pays to the Company for the product and the selling price to the qualified healthcare provider. Chargebacks are recorded as a reduction of gross product revenue and accounts receivable at the time revenue is recognized.
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d.Product Returns: The Company offers its Customers limited product return rights for damages and product within an eligible expiry window. The Company currently estimates product return reserves using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The reserve for returns is recorded as a reduction of gross product revenue and an accrued expense is established at the time revenue is recognized.
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e.Co-pay Assistance: The Company offers a co-pay assistance program, which is intended to provide financial assistance to qualified patients. The Company uses a third-party to administer the co-pay assistance program. Co-pay assistance is recorded as a reduction of gross product revenue and an accrued expense is established at the time revenue is recognized.
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The Company makes estimates and judgments that affect the recognition of net product revenues. The Company adjusts the estimated discounts, rebates, chargebacks, returns and co-pay assistance based on new information, including information regarding actual discounts, rebates, chargebacks, returns and co-payments for the product, as it becomes available. Claims by third-party payors for certain variable consideration may be submitted to the Company significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known.
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The Company applies judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating the transaction price to performance obligations within a contract, determining when performance obligations have been satisfied, assessing the recognition and likelihood of reversal of variable consideration and determining and applying appropriate methods of measuring progress for performance obligations satisfied over time. These judgments are discussed in more detail below.
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• Licenses of intellectual property: If a license to intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from the portion of the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are not distinct from other promises, the Company applies judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the related revenue recognition accordingly.
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• Milestone payments: At the inception of each arrangement that includes research, development or regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price on a cumulative catch-up basis in earnings in the period of the adjustment.
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• Royalties and commercial milestone payments: For arrangements that include sales-based royalties, including commercial milestone payments based on a pre-specified level of sales, the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Achievement of these royalties and commercial milestones may solely depend upon performance of the licensee.
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Revenue is also generated from certain technology-focused contracts from subscription and service-based fees recognized for the use of certain internally developed technology. Subscription revenue is recognized ratably over the contract period.
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The Company’s accounts receivable primarily consist of amounts due from the Company’s customers related to product sales and are recorded net of prompt payment discounts, chargebacks, and any allowance for credit losses. The Company evaluates the collectability of its accounts receivable by monitoring the financial condition and creditworthiness of its customers, and the Company considers economic factors or trends expected to affect future collections. As of September 30, 2026, the Company did not have an allowance for credit losses. Accounts receivable, net is included in “Other current assets” on the accompanying condensed consolidated balance sheets.
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In October 2024, the Company completed the sale of its entire equity interest in its majority-owned subsidiary, Dermavant Sciences Ltd., to Organon & Co. (“Organon”). The consideration paid was subject to post-closing adjustments, which were resolved in July 2026. As a result, the Company received $ 20.9 million from Organon in August 2026, of which $ 5.1 million was released from escrow. The incremental $ 15.8 million represents an additional gain on the sale of Dermavant and is presented as “Income from discontinued operations, net of tax” in the accompanying condensed consolidated statements of operations for the three and six months ended September 30, 2026.
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In the accompanying condensed consolidated statement of cash flows, the cash flows from discontinued operations are not separately classified. The significant cash flow items from discontinued operations were as follows (in thousands):
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Following the approval of LISRAYA by the FDA in August 2026, the Company began incurring a tiered, sub-teens royalty payable to Pfizer, Inc. (“Pfizer”) on net sales of LISRAYA pursuant to the terms of the license and collaboration agreement entered into between Priovant and Pfizer in September 2021. Priovant is also obligated to pay Pfizer a one-time mid-tens-of-million dollars sales milestone payment if net sales of LISRAYA in a given year exceed a mid-hundreds-of-millions dollars amount.
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In September 2026, the Company was named as a defendant in a purported stockholder derivative action filed in the Court of Chancery of the State of Delaware on behalf of Immunovant, the Company’s majority-owned subsidiary. The complaint asserts claims against the Company, as Immunovant’s controlling stockholder, and certain of Immunovant’s current and former directors for alleged breaches of fiduciary duty relating to Immunovant’s private placement transaction completed in January 2025 with the Company and certain institutional accredited investors. Immunovant is named as a nominal defendant. The stockholder seeks unspecified damages and costs on behalf of Immunovant. The Company believes the claims are without merit and intends to vigorously defend against them. The litigation is at an early stage, and the Company cannot reasonably predict its outcome or estimate any potential loss or range of loss.
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During the three months ended September 30, 2026, Genevant’s parent, GSL, declared a dividend funded by the Fixed Payment received from Moderna. The related settlement gain was recognized during the year ended March 31, 2026 (see Note 5).
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The following table summarizes selected commercial and development-stage product candidates from our pipeline:
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5. In October 2026, following quarter-end, Roivant participated in a modified Dutch auction tender offer by Arbutus. Roivant tendered and had accepted by Arbutus a number of shares proportionate to its ownership interest in Arbutus and therefore continued to own approximately 19% of Arbutus on an issued and outstanding basis following the tender offer.
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• Priovant: LISRAYA became commercially available in the U.S. in August 2026 and generated net product revenue of $31.0 million in its first 5 weeks of launch.
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Brepocitinib 45 mg once-daily achieved statistically significant benefit compared to placebo on the primary and all key secondary endpoints for each of CLARITY-1 and CLARITY-2, the two identical Phase 3 trials comprising the CLARITY program in non-infectious uveitis (“NIU”). Median time to treatment failure for brepocitinib patients was greater than 48 weeks in both studies, compared with ~12 weeks on placebo in each study (p<0.0001 in both studies), including 40 weeks of steroid-free treatment, setting a new bar for time to failure and steroid-sparing benefit in NIU. Pooled across the CLARITY studies, 62% of patients on brepocitinib achieved steroid-free quiescence at Week 48, compared with 20% on placebo (p<0.0001), with similar results in each study. Of patients that entered the CLARITY studies (pooled) with macular edema, 42% of eyes on brepocitinib achieved resolution of macular edema at Week 48, compared with 4.8% on placebo (p<0.0001), with similar results in each study. The magnitude and breadth of benefit observed across every ranked endpoint, compared with results reported in registrational trials of existing NIU therapies, suggest brepocitinib has the potential to be the most effective systemic, non-steroid treatment option for NIU. Safety data consistent with prior brepocitinib clinical trials; no new safety signals or findings. Priovant intends to file a supplemental New Drug Application (“sNDA”) for brepocitinib for the treatment of NIU in the first half of calendar year 2027.
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• Immunovant: Following the open-label lead-in in Period 1 of the potentially registrational trial in patients with difficult-to-treat rheumatoid arthritis (“D2T RA”), where a total of 170 participants were enrolled to receive IMVT-1402 600 mg for 16 weeks, study participants meeting the criteria for an ACR20 response at Weeks 14 and 16 were eligible to advance to Period 2 of the trial. A total of 117 participants were included in the Period 2 efficacy analysis and randomized to IMVT-1402 600 mg (n=40), IMVT-1402 300 mg (n=36), or placebo (n=41). IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28 (92.5% vs. 75.6% placebo, p=0.0139). Participants randomized to IMVT-1402 300 mg did not show a difference from placebo, with 75.0% maintaining an ACR20 response at Week 28 (p=0.9426). The secondary endpoints, change in Clinical Disease Activity Index (“CDAI”) and Simplified Disease Activity Index (“SDAI”) from Period 2 baseline to Week 28, numerically favored IMVT-1402 600 mg over placebo (p=0.1096 and p=0.1299, respectively). In exploratory analyses, ACR50 response rates at Week 28 were 80.0% for IMVT-1402 600 mg vs. 56.1% for placebo (nominal p=0.0117), and ACR70 response rates were 52.5% vs. 36.6% (nominal p=0.1674); the trial was not powered to detect differences in these measures. IMVT-1402 was generally well tolerated in Period 2, with no serious adverse events, Grade 3 or higher treatment-emergent adverse events, or adverse events leading to treatment discontinuation reported in any arm. FDA discussions are planned for later this year to determine the path forward for the registrational program of IMVT-1402 in D2T RA.
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In light of the evolving Sjögren’s disease (“SjD”) landscape and recent data in the field, we expect it is unlikely that we will advance IMVT-1402 further in SjD beyond the ongoing, fully enrolled Phase 2 trial.
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• Pulmovant: Mosliciguat demonstrated positive topline data in the Phase 2 PHocus study in pulmonary hypertension associated with interstitial lung disease (“PH-ILD”); the study met its primary endpoint, demonstrating a clinically meaningful and statistically significant placebo-adjusted reduction in pulmonary vascular resistance (“PVR”) of -56.3% (p<0.0001) at Week 16, the highest ever reported PVR reduction in any randomized controlled PH trial. The study also met its secondary endpoints at Week 16 with a +35.2-meter placebo-adjusted improvement in six-minute walk distance (6MWD, p=0.0027) and a -53.2% (-357.7 pg/mL) placebo-adjusted reduction in N-terminal pro - B-type natriuretic peptide (NT-proBNP, p=0.0002), both clinically meaningful and statistically significant. Pre-specified exploratory Week 24 results showed continued placebo-adjusted improvements in 6MWD to +52.7m (nominal p<0.0001) and NT-proBNP to -75.9% (-487.1 pg/mL, nominal p<0.0001). Mosliciguat was observed to be well tolerated with a favorable safety profile, and compared with placebo, a lower proportion of patients experienced cough (12.1% mosliciguat vs. 18.2% placebo), a common tolerability challenge with inhaled prostacyclins.
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The Phase 3 PHrontier study of mosliciguat in patients with PH-ILD has been initiated, with enrollment underway.
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Following the approval by the FDA in August 2026 of LISRAYA for the treatment of adults with dermatomyositis, we began to recognize product revenue. We record product revenue net of variable consideration, which includes prompt payment discounts, government rebates, chargebacks, product returns and co-pay assistance for patients.
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Following the approval by the FDA in August 2026 of LISRAYA for the treatment of adults with dermatomyositis, we began to recognize cost of product revenue associated with sales of LISRAYA, which includes royalties payable on net product revenue. Cost of product revenue will include the cost of inventory sold once zero-cost basis inventory manufactured prior to FDA approval is exhausted.
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We expect SG&A expenses to increase in future periods as we continue to expand our sales and marketing infrastructure and general administrative functions. These increases will likely include salaries, sales incentive compensation, share-based compensation and travel expenses associated with our sales force, which began promoting LISRAYA in the U.S. following approval by the FDA in August 2026, as well as expected costs associated with the further build out of our commercial operations functions. We anticipate these expenses to further increase if any of our current or future product candidates receives regulatory approval in the U.S. or another jurisdiction.
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Income from discontinued operations, net of tax includes a gain resulting from the resolution of post-closing adjustments in July 2026 related to the sale of our entire equity interest in our majority-owned subsidiary, Dermavant Sciences Ltd., to Organon & Co. (“Organon”) in October 2024.
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Product revenue, net was $31.0 million for the three and six months ended September 30, 2026, consisting of net product revenue from sales of LISRAYA in its first 5 weeks of launch following FDA approval in August 2026. We did not have product revenue for the three and six months ended September 30, 2025.
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The decrease of $6.4 million in program-specific costs was primarily driven by a decrease of $18.3 million related to the anti-FcRn franchise. This decrease reflected lower costs for the IMVT-1402 study in cutaneous lupus erythematosus, which was discontinued in September 2026, the wind-down of batoclimab clinical trials and the timing of contract manufacturing costs. These decreases were partially offset by higher costs for ongoing clinical trials of IMVT-1402 in Graves’ disease, and further offset by an increase of $11.6 million related to mosliciguat, reflecting the progression of the program.
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We recognized an income tax benefit of $13.4 million for the three months ended September 30, 2026, compared to income tax expense of $7.0 million for the three months ended September 30, 2025. The favorable change of $20.4 million was primarily due to the discrete tax consequences of the Fixed Payment Distribution (as defined below), as well as our fluctuating earnings by legal entity in various jurisdictions over the periods.
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We recognized an income tax benefit of $17.3 million for the six months ended September 30, 2026, compared to income tax expense of $11.6 million for the six months ended September 30, 2025. The favorable change of $29.0 million was primarily due to the discrete tax consequences of the Fixed Payment Distribution (as defined below), as well as our fluctuating earnings by legal entity in various jurisdictions over the periods.
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Following the approval of LISRAYA by the FDA in August 2026, we began incurring a tiered, sub-teens royalty payable to Pfizer on net sales of LISRAYA pursuant to the terms of the license and collaboration agreement entered into between Priovant and Pfizer in September 2021. We are also obligated to pay Pfizer a one-time mid-tens-of-million dollars sales milestone payment if net sales of LISRAYA in a given year exceed a mid-hundreds-of-millions dollars amount. 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.
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Our accounting policy over revenue recognition for product revenue, net involves judgment and estimation. The amount of net product revenue we recognize is impacted by variable consideration, as described in Note 2, “Summary of Significant Accounting Policies” of our financial statements, including prompt payment discounts, government rebates, chargebacks, product returns and co-pay assistance for patients. Our gross-to-net estimates are based on contracts with our customers, contractual and statutory requirements under Medicaid, Medicare and other government programs, available industry data and, as our commercial experience with LISRAYA develops, our own sales information, including dispense data from our customers. The judgments and estimates involved in determining these variable consideration reserves are reviewed each reporting period, as all are subject to adjustment as new information becomes available.
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Other information
The Company’s board of directors (the “Board”) appointed Jeffrey Hammerbacher to serve as a Class II director of the Company, effective November 9, 2026, increasing the size of the Board from eight to nine directors. Mr. Hammerbacher will serve, along with the other Class II directors, until the Company’s annual general meeting of shareholders in 2029 and until his successor is duly elected and qualified, or until his earlier death, resignation or removal. There are no arrangements or understandings between Mr. Hammerbacher and any other persons pursuant to which he was selected as a director of the Company and there are no transactions involving Mr. Hammerbacher that would require disclosure by the Company under Item 404(a) of Regulation S-K. The Board has determined that Mr. Hammerbacher qualifies as an “independent director” under the applicable listing standards of The Nasdaq Stock Market LLC.
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Mr. Hammerbacher is the Founder and Chief Executive Officer of Open Athena, a non-profit that partners with academic laboratories to build open source artificial intelligence models. He is also the Founder and Board Chair of Ortet, an artificial intelligence healthcare company, and a Strategic Partner at Thoreau, a healthcare investment firm. Mr. Hammerbacher previously served as a Senior Advisor to New Mountain Capital, from July 2024 to June 2026, as an Operating Advisor to Blackstone, from July 2023 to July 2024, and as a Senior Advisor to Sixth Street Partners, from April 2022 to April 2024. From 2019 to 2022, he was the Founder and Managing Partner of Related Sciences, a venture creation firm that starts preclinical drug development companies. Mr. Hammerbacher was previously a Research Assistant Professor at the Medical University of South Carolina, from 2017 to 2019, and at the Icahn School of Medicine at Mount Sinai, from 2012 to 2017. He was a founder of Cloudera, Inc., an enterprise data software company, where he served as Chief Scientist, from 2008 to 2017, and as Vice President, Product, from 2008 to 2010. Prior to that, he led the data team at Facebook (now Meta Platforms) and was a quantitative modeler at Bear Stearns. Mr. Hammerbacher previously served on the boards of directors of Datavant, Inc., Emids, PerkinElmer, The Emmes Company, LLC, Grant Thornton Advisors LLC, Cytel, Inc. and Sage Bionetworks. He holds an A.B. in Mathematics from Harvard College. The Board believes that Mr. Hammerbacher’s extensive experience as a founder and investor in the life sciences, health data and technology industries qualifies him to serve as a member of the Board.
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As a non-employee director, Mr. Hammerbacher will receive cash and equity compensation (including an initial equity retainer) in accordance with the terms of the Company’s Non-Employee Directors Compensation Policy as described in the Company’s proxy statement for the 2026 annual general meeting of shareholders filed with the SEC on July 29, 2026. Mr. Hammerbacher’s initial equity grant is expected to be made in November 2026.
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In connection with his appointment, Mr. Hammerbacher will enter into the Company’s standard form of indemnity agreement for directors, the form of which was previously filed as Exhibit 10.7 to the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2026, filed with the SEC on May 20, 2026.
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As previously disclosed, in July 2024, the Company granted its Chief Executive Officer, Matthew Gline, performance restricted stock units (“PSUs”). The PSUs have both a performance-based vesting condition, tied to six share price hurdles across six tranches (the “Performance Condition”), and a service-based vesting condition (the “Service Condition”). From October 2025 to June 2026, the PSUs satisfied the Performance Condition across each of the six tranches. The Service Condition runs for a one-year period, tranche by tranche, measured from the date the Performance Condition of a tranche of PSUs is satisfied. Following the date on which a tranche of PSUs satisfies both the Performance Condition and the Service Condition (the “Vesting Date”), it is settled into common shares on one or more settlement dates following the Vesting Date (each a “Settlement Date”). Under the terms of the PSUs, the common shares received at settlement are subject to a further two-year holding period, measured from the Vesting Date, before they may be sold or otherwise transferred (subject to an exception for shares that may be withheld or sold to satisfy applicable withholding tax obligations) (the “Two-Year Holding Period”). As used in this section, the term “PSU Shares” refers to the net shares (taking into account tax withholding) received upon settlement of PSUs on or prior to December 31, 2026. For more information on the terms of the PSUs, please refer to the Company’s Proxy Statement filed with the SEC on July 29, 2026.
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On November 6, 2026, the Compensation Committee of the Board approved, and the Company entered into, a letter agreement with Mr. Gline (the “Gline Letter Agreement”) permitting him to charitably donate to a donor advised fund (a “DAF”), in one or more transfers following each Settlement Date and on or before December 31, 2026, up to 100% of the PSU Shares (the “DAF Contribution”).
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In conjunction with the DAF Contribution, the Two-Year Holding Period that would otherwise be applicable to the DAF Contribution shares is transferred to a number of common shares underlying certain of Mr. Gline’s vested stock options previously granted to Mr. Gline on April 20, 2022, in an amount equal to 109% of the gross number of PSUs with respect to which net PSU Shares are transferred. This percentage is intended to ensure that the value of PSUs subject to DAF Contributions is generally equivalent to the value of the options whose underlying shares are being locked up, calculated based on the ratio of the value of a common share to the estimated Black-Scholes value of an option as of the date of the Gline Letter Agreement.
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For example, if Mr. Gline received 50 net PSU Shares (after satisfaction of applicable tax withholding and broker fee obligations) upon settlement of 100 gross PSUs with a Vesting Date of October 16, 2026, and then transferred those 50 PSU Shares to a DAF pursuant to the terms of the Gline Letter Agreement, then those 50 PSU Shares would no longer be subject to the Two-Year Holding Period, and instead 109 common shares underlying Mr. Gline’s vested stock options would become subject to the Two-Year Holding Period through October 16, 2028.
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The foregoing description of the Gline Letter Agreement is qualified in its entirety by the agreement filed as Exhibit 10.1 to this Quarterly Report on Form 10-Q and incorporated herein by reference.
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The 10-Q's risk factors against the 10-K
Item 1A of the 10-Q filed Nov 9, 2026 against Item 1A of the 10-K filed May 20, 2026.
A 10-Q repeats only the risks that changed, so a 10-K paragraph that is missing from it is not counted as removed.
Added is a paragraph with nothing like it in the 10-K, Reworded a sentence that is in both with several words changed,
Quiet changes a sentence in both where one to four words changed and one is a hedge or a modal
(cut words struck through, new words highlighted).
Text on the page, not a score; each links to the filing at sec.gov.
Phrases used for the first time
Two-word phrases in Risk Factors of the 10-K filed May 20, 2026 that are in none of the 1 earlier 10-Ks stored, back to May 29, 2025
hanall agreement ×19contingent payment ×10settlement agreement ×8topline data ×7biosecure act ×5mfn pricing ×5biotechnology equipment ×4national security ×4electronic records ×4moderna’s appeal ×4commercial stage ×3stage products ×3imposed pursuant ×3federal contracts ×3drug substance ×3one big ×3
Where each one is used
- hanall agreement: 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 could adversely affect Immunovant’s development or commercialization of IMVT-1402.
- contingent payment: In February 2022, Roivant’s subsidiary GSG and Roivant’s affiliate Arbutus filed a lawsuit in the U.S. District Court for the District of Delaware against Moderna and an affiliate seeking damages for infringement of certain patents, including U.S. Patent Nos. 8,492,359, 9,364,435, 9,504,651 and 11,141,378, in the...
- settlement agreement: In February 2022, Roivant’s subsidiary GSG and Roivant’s affiliate Arbutus filed a lawsuit in the U.S. District Court for the District of Delaware against Moderna and an affiliate seeking damages for infringement of certain patents, including U.S. Patent Nos. 8,492,359, 9,364,435, 9,504,651 and 11,141,378, in the...
- topline data: 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.
- biosecure act: Legislation targeting biotechnology companies with ties to certain foreign adversaries, including the BIOSECURE Act, could materially adversely affect our business, supply chain and results of operations.
- mfn pricing: Additionally, the Trump Administration is pursuing various 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,...
- biotechnology equipment: In particular, 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...
- national security: In addition, the pharmaceutical industry faces specific and evolving tariff-related risks. On April 2, 2026, the United States announced significant tariffs on certain pharmaceutical products, active pharmaceutical ingredients and key starting materials. These tariffs, which were imposed pursuant to a national...
Used at least twice, small words left out. Counted, not picked: a phrase can be new because the company renamed something.
What was taken out
21 paragraphs of last year's Risk Factors with nothing like them now. The longest are quoted.
Sources
Item 1A of each 10-K and 10-Q on EDGAR, quoted exactly. Each paragraph links to the filing at sec.gov.
Also
10-K change: what was reworded or cut, section by section.
Work with it
Excel workbook · CSV. Google Sheet that stays up to date: paste =IMPORTDATA("https://tickdelta.com/company/ROIV/export.csv") into a cell.