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What changed in Roivant Sciences Ltd.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Roivant Sciences Ltd.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+1494 added−1449 removedSource: 10-K (2025-05-29) vs 10-K (2024-05-30)

Top changes in Roivant Sciences Ltd.'s 2025 10-K

1494 paragraphs added · 1449 removed · 972 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

216 edited+138 added−137 removed273 unchanged
Biggest changeThe most common TEAEs were nasopharyngitis, dyspnea, bronchitis, and headache. • Development plan and upcoming milestones : • We have completed enrollment for a Phase 2 trial to evaluate the safety and efficacy of namilumab in pulmonary sarcoidosis, with data expected in the fourth quarter of calendar year 2024. 20 Table of Contents The below schematic shows the trial design for the Phase 2 trial in pulmonary sarcoidosis: • Roivant ownership : o As of March 31, 2024, we own 96% of the issued and outstanding common shares of Kinevant, and 90% on a fully diluted basis. 21 Table of Contents Genevant Overview • Overview : • Genevant is a technology-focused nucleic acid delivery and development company with two delivery platforms—a lipid nanoparticle (“LNP”) platform and a ligand conjugate platform—an expansive intellectual property portfolio and deep scientific expertise, currently focused on partnering with other pharmaceutical or biotechnology companies to enable the development of nucleic acid therapeutics for unmet medical needs. • Delivery platforms and patent portfolio : • Genevant has two delivery platforms: LNP and ligand conjugate. • LNP platform: • Proven technology as demonstrated by head-to-head in vivo ionizable lipid study assessing LNP potency and immune stimulation. • Clinically validated for hepatocyte and vaccine applications and in various stages of development for other traditionally hard-to-reach tissues and cell types, including lung, eye, central nervous system, and hepatic stellate and immune cells. • Approximately 650 issued patents and pending patent applications as of March 31, 2024, including patents directed to: • lipid structures, including cationic and PEG-lipids • particle compositions, including commonly used ranges of lipid ratios for nucleic acid-containing particles • nucleic acid-containing particles with certain structural characteristics • mRNA-containing LNP formulations • various aspects of our manufacturing process • Ligand conjugate platform: • Novel GalNAc ligands with demonstrated ability to deliver to the liver in preclinical studies. • In preclinical head-to-head testing, demonstrated equal or better preclinical potency, assessed by duration and magnitude of knockdown, compared to a current industry benchmark. • Applying delivery expertise to design novel extrahepatic ligands to expand therapeutic reach. • Collaboration-based business model : • Genevant seeks to partner with other pharmaceutical or biotechnology companies in the development of RNA therapeutics, crafting mutually beneficial collaborations that allow collaboration partners to access innovative technologies while providing Genevant the opportunity to leverage our expertise to expand the technology and its therapeutic application. • Genevant uses its expertise in the delivery of nucleic acid therapeutics to develop optimal delivery systems for its collaborators’ identified payloads or target tissues. • Genevant’s collaboration-based business model is to seek upfront payments, R&D reimbursements, milestones and royalties payment or profit sharing upon success, while also retaining certain rights in the delivery-related intellectual property developed in the context of the collaboration for potential use or out-licensing. • Some current collaboration partners include Novo Nordisk, BioNTech, Takeda, Gritstone, Tome Biosciences, ST Pharm, Korro Bio, Chulalongkorn University (through its Vaccine Research Center) and Providence Therapeutics. • Clinical and preclinical data : • Genevant LNP technology has been in clinical testing in over a dozen distinct product candidates, representing hundreds of subjects of clinical experience. • In a head-to-head study comparing multiple LNP formulations varying only the key ionizable lipid, Genevant’s current lead formulation outperformed third-party formulations.
Biggest changeGenevant Overview • Overview : • Genevant is a technology-focused nucleic acid delivery and development company with two delivery platforms—a lipid nanoparticle (“LNP”) platform and a ligand conjugate platform—an expansive intellectual property portfolio and deep scientific expertise, currently focused on partnering with other pharmaceutical or biotechnology companies to enable the development of nucleic acid therapeutics for unmet medical needs. • Delivery platforms and patent portfolio : • Genevant has two delivery platforms: LNP and ligand conjugate. • LNP platform : • Technology used in the first systemic RNA-LNP product to receive FDA-approval, Alnylam’s Onpattro (patisiran) for the treatment of polyneuropathy caused by hereditary ATTR amyloidosis. • Outperformed all third-party formulations tested in a head-to-head in vivo ionizable lipid study assessing LNP potency and immune stimulation. • Clinically validated for hepatocyte and vaccine applications and in various stages of development for other traditionally hard-to-reach tissues and cell types, including T-cells, immune cells, stellate cells, lung, eye, and central nervous system. • More than 550 issued patents and pending patent applications worldwide as of March 31, 2025, including patents directed to: • lipid structures, including cationic and PEG-lipids • particle compositions, including ranges of lipid ratios for nucleic acid-containing particles • nucleic acid-containing particles with certain structural characteristics • mRNA-containing LNP formulations • various manufacturing process aspects • Ligand conjugate platform : • Novel GalNAc ligands with clinical validation from imdusiran, an siRNA currently in Phase 2 clinical development by Arbutus Biopharma for the treatment of chronic hepatitis B (cHBV). • In preclinical head-to-head testing, Genevant’s GalNAc ligands demonstrated equal or better preclinical potency, assessed by duration and magnitude of knockdown, compared to a current industry benchmark. • Applying delivery expertise to design novel extrahepatic ligands to expand therapeutic reach. • Collaboration-based business model : • Genevant seeks to partner with other pharmaceutical or biotechnology companies in the development of RNA therapeutics, crafting mutually beneficial collaborations that allow collaboration partners to access its innovative technologies while providing Genevant the opportunity to leverage its expertise to expand the technology and its therapeutic application. • Genevant uses its expertise in the delivery of nucleic acid therapeutics to develop optimal delivery systems for its collaborators’ identified payloads. 21 Table of Contents • Genevant’s collaboration-based business model is to seek upfront payments, R&D reimbursements, milestones and royalties or profit sharing upon success, while also retaining certain rights in the delivery-related intellectual property developed in the context of the collaboration for potential use or out-licensing. • Some current collaboration partners include Novo Nordisk, BioNTech, Takeda, Korro Bio, Repair Biotechnologies, Editas Medicine, Epitopea and Mammoth Biotechnologies. • Clinical and preclinical data : • Genevant LNP technology has been in clinical trials of over a dozen distinct product candidates, representing hundreds of subjects of clinical experience. • In a head-to-head study in mice comparing multiple LNP formulations which varied only the key ionizable lipid, Genevant’s formulation outperformed all third-party formulations tested.
These royalty obligations apply on a product-by-product and country-by-country basis and end upon the latest of: (A) the date on which the last valid claim of the licensed patents expire, (B) the date on which the data or market exclusivity expires or (C) 11 years after the first commercial sale of the licensed product, in each case, with respect to a given product in a given country.
These royalty obligations apply on a product-by-product and country-by-country basis and end upon the latest of: (A) the date on which the last valid claim of the licensed patents expire, (B) the date on which the data or market exclusivity expires and (C) 11 years after the first commercial sale of the licensed product, in each case, with respect to a given product in a given country.
In addition, under the HanAll Agreement, ISG has agreed to use commercially reasonable efforts to develop and commercialize licensed products in the HanAll Licensed Territory. Each party has agreed that neither it nor certain of its affiliates will clinically develop or commercialize certain competitive products in the Licensed Territory.
In addition, under the HanAll Agreement, ISG has agreed to use commercially reasonable efforts to develop and commercialize licensed products in the HanAll Licensed Territory. Each party to the HanAll Agreement has agreed that neither it nor certain of its affiliates will clinically develop or commercialize certain competitive products in the Licensed Territory.
Priovant also granted back to Pfizer (i) an exclusive, sublicensable, royalty-bearing license under certain patents and (ii) a non-exclusive, sublicensable, royalty-bearing license under certain know-how, in each case, to commercialize (x) brepocitinib and products incorporating such compound outside of the U.S. and Japan, and (y) TYK2 compounds and products incorporating such compound outside of the U.S., in each case for all human and animal uses.
Priovant also granted back to Pfizer (i) an exclusive, sublicensable, royalty-bearing license under certain patents and (ii) a non-exclusive, sublicensable, royalty-bearing license under certain know-how, in each case, to commercialize (x) brepocitinib and products incorporating such compound outside of the U.S. and Japan, and (y) TYK2 compounds and products incorporating such compounds outside of the U.S., in each case for all human and animal uses.
The Complete Response Letter may require the applicant to obtain additional clinical data, including the potential requirement to conduct additional pivotal Phase 3 clinical trial(s) and/or to complete other significant and time-consuming requirements related to clinical trials, or to conduct additional preclinical studies or manufacturing activities.
The Complete Response Letter may require the applicant to obtain additional clinical data, including the potential requirement to conduct additional pivotal Phase 3 clinical trial(s) and to complete other significant and time-consuming requirements related to clinical trials, or to conduct additional preclinical studies or manufacturing activities.
Additionally, Congress has introduced several pieces of legislation aimed at significantly revising or repealing the ACA, and the law may be subjected to various Executive Orders and/or regulatory action to expand or reduce the scope of the law, based on the administration controlling the White House. The law may continue to exert significant pressure on pharmaceutical pricing and our profitability.
Additionally, Congress has introduced several pieces of legislation aimed at significantly revising or repealing the ACA, and the law may be subjected to various executive orders and regulatory action to expand or reduce the scope of the law, based on the administration controlling the White House. The law may continue to exert significant pressure on pharmaceutical pricing and our profitability.
Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and/or the regulatory authorities of the individual country. These requirements are provided in the national laws, industry codes or professional codes of conduct, applicable in the relevant country.
Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and the regulatory authorities of the individual country. These requirements are provided in the national laws, industry codes or professional codes of conduct, applicable in the relevant country.
Market exclusivity may also be broken, so a similar product may be authorized for the same indication, in very select cases, such as if (i) it is established that a similar medicinal product is safer, more effective or otherwise clinically superior to the authorized product; (ii) the marketing authorization holder consents to the grant of the similar product; or (iii) the marketing authorization holder cannot supply enough orphan medicinal product.
Market exclusivity may also be broken, so a similar product may be authorized for the same indication, in very select cases, such as if (i) it is established that a similar medicinal product is safer, more effective or otherwise clinically superior to the authorized product; (ii) the marketing authorization holder consents to the grant of marketing authorization for the similar product; or (iii) the marketing authorization holder cannot supply enough orphan medicinal product.
Post-Marketing Requirements Following approval of a new product, the manufacturer and the approved product are subject to continuing regulation by the FDA, including, among other things, monitoring and record-keeping activities, reporting of adverse experiences and certain problems in the manufacturing process, complying with promotion and advertising requirements, which include restrictions on promoting products for unapproved uses or patient populations (known as “off-label use”) and limitations on industry-sponsored scientific and educational activities.
Post-Marketing Requirements Following regulatory approval of a new product, the manufacturer and the approved product are subject to continuing regulation by the FDA, including, among other things, monitoring and record-keeping activities, reporting of adverse experiences and certain problems in the manufacturing process, complying with promotion and advertising requirements, which include restrictions on promoting products for unapproved uses or patient populations (known as “off-label use”) and limitations on industry-sponsored scientific and educational activities.
Each of Priovant’s and Pfizer’s royalty obligations apply on a product-by-product and country-by-country basis and end upon the expiration of a customary royalty term, which is the latest of (a) a certain amount of years following the first commercial sale of the applicable products in the applicable country, (b) the date on which the regulatory exclusivity provided by the applicable government authority for the applicable products in that country expires and (c) the date upon which the use, sale, offer for sale or importation of such product in such country would no longer be covered by a valid claim of a licensed product right.
Each of Priovant’s and Pfizer’s royalty obligations apply on a product-by-product and country-by-country basis and end upon the expiration of a customary royalty term, which is the latest of (a) a certain amount of years following the first commercial sale of the applicable product in the applicable country, (b) the date on which the regulatory exclusivity provided by the applicable government authority for the applicable product in that country expires and (c) the date upon which the use, sale, offer for sale or importation of such product in such country would no longer be covered by a valid claim of a licensed product right.
At the same time, safety and further PK and PD information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted. • Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product labeling.
At the same time, safety and further PK and PD information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted. • Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in such use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product labeling.
We centralize capital allocation decisions at the Roivant level, while distributing operational decisions to the Vants, allowing us to strategically deploy capital in high growth areas, regardless of potentially competing operational priorities. • Maintaining a diversified pipeline with various risk profiles: We have built a broad and differentiated pipeline that includes a commercial drug and several drug candidates across different therapeutic areas, phases of development, modalities and geographies.
We centralize capital allocation decisions at the Roivant level, while distributing operational decisions to the Vants, allowing us to strategically deploy capital in high growth areas, regardless of potentially competing operational priorities. • Maintaining a diversified pipeline with various risk profiles: We have built a broad and differentiated pipeline that includes several drug candidates across different therapeutic areas, phases of development, modalities and geographies.
Among the changes made by the ACA to preexisting law of importance to the pharmaceutical industry are that the ACA: • made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers’ rebate liability by raising the minimum basic Medicaid rebate on most branded prescription drugs to 23.1% of average manufacturer price (“AMP”), and adding a new rebate calculation for “line extensions” (i.e., new formulations, such as extended release formulations) of solid oral dosage forms of branded products, as well as potentially impacting their rebate liability by modifying the statutory definition of AMP. • imposed a requirement on manufacturers of branded drugs to provide a 70% (increased pursuant to the Bipartisan Budget Act of 2018, effective as of 2019) point-of-sale discount off the negotiated price of branded drugs dispensed to Medicare Part D beneficiaries in the coverage gap (i.e., “donut hole”) as a condition for a manufacturer’s outpatient drugs being covered under Medicare Part D. • extended a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations. • expanded the entities eligible for discounts under the 340B Drug Discount Program. • established a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected. • imposed an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their market share in certain government healthcare programs. • established a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
Among the changes made by the ACA to preexisting law of importance to the pharmaceutical industry are that the ACA: • made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers’ rebate liability by raising the minimum basic Medicaid rebate on most branded prescription drugs to 23.1% of average manufacturer price (“AMP”), and adding a new rebate calculation for “line extensions” (i.e., new formulations, such as extended release formulations) of solid oral dosage forms of branded products, as well as potentially impacting their rebate liability by modifying the statutory definition of AMP. 37 Table of Contents • imposed a requirement on manufacturers of branded drugs to provide a 70% (increased pursuant to the Bipartisan Budget Act of 2018, effective as of 2019) point-of-sale discount off the negotiated price of branded drugs dispensed to Medicare Part D beneficiaries in the coverage gap (i.e., “donut hole”) as a condition for a manufacturer’s outpatient drugs being covered under Medicare Part D. • extended a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations. • expanded the entities eligible for discounts under the 340B Drug Discount Program. • established a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected. • imposed an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their market share in certain government healthcare programs. • established a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
To obtain 510(k) clearance for a medical device, or for certain modifications to devices that have received 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or to a preamendment device that was in commercial distribution before May 28, 1976, or other predicate devices, for which the FDA has not yet called for the submission of a premarket approval application (“PMA”).
To obtain 510(k) clearance for a medical device, or for certain modifications to devices that have received 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or to a preamendment device that was in commercial distribution before May 28, 1976, or other predicate devices, for which the FDA has not yet called for the submission of a premarket approval (“PMA”).
Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices.
Several states have enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices.
On January 1, 2024, the International Recognition Procedure (“IRP”) was introduced, whereby the Medicines and Healthcare products Regulatory Agency (the “MHRA”), the UK medicines regulator, may rely on a decision taken by other international regulators, including the European Commission and the U.S. FDA, in order to more quickly grant a new MA valid in Great Britain or the U.K.
On January 1, 2024, the International Recognition Procedure (“IRP”) was introduced, whereby the Medicines and Healthcare products Regulatory Agency (the “MHRA”), the U.K. medicines regulator, may rely on a decision taken by other international regulators, including the European Commission and the U.S. FDA, in order to more quickly grant a new MA valid in Great Britain or the U.K.
This approach limits our exposure to several concentrated scientific and biological risks and allows us to pursue multiple innovative hypotheses across our portfolio as we seek to develop therapies for patient populations with high unmet need. • Designing creative “win-win” deal structures: We structure our partnerships to balance risk and the potential for future value creation.
This approach limits our exposure to concentrated scientific and biological risks and allows us to pursue multiple innovative hypotheses across our portfolio as we seek to develop therapies for patient populations with high unmet need. • Designing creative “win-win” deal structures: We structure our partnerships to balance risk and the potential for future value creation.
We believe we are uniquely positioned to accomplish this by: • Leveraging our business development expertise to identify and in-license promising drug candidates: We assembled our development-stage product candidate pipeline by leveraging our business development expertise and vast network of industry relationships to relentlessly pursue opportunities to in-license or acquire programs where we believe we can deliver successful outcomes on accelerated timelines.
We believe we are uniquely positioned to accomplish this by: • Leveraging our business development expertise to identify and in-license promising drug candidates: We assembled our product candidate pipeline by leveraging our business development expertise and vast network of industry relationships to relentlessly pursue opportunities to in-license or acquire programs where we believe we can deliver successful outcomes on accelerated timelines.
European Union and United Kingdom Drug Marketing Much like the federal Anti-Kickback Statue prohibition in the U.S., the provision of benefits or advantages to physicians and/or healthcare organizations to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order, administration or use of medicinal products is also prohibited in the EEA and U.K.
European Union and United Kingdom Drug Marketing Much like the federal Anti-Kickback Statue prohibition in the U.S., the provision of benefits or advantages to physicians and healthcare organizations to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order, administration or use of medicinal products is also prohibited in the EEA and U.K. E.U.
Collectively, these data suggest a safety profile that is similar to those of approved JAK inhibitors. • In the Phase 2 NEPTUNE study of once-daily oral brepocitinib in NIU, the 45 mg results represented the best Treatment Failure rates observed to date among active NIU studies measuring this registrational endpoint.
Collectively, these data suggest a safety profile that is similar to those of approved JAK inhibitors. • In the Phase 2 NEPTUNE study of once-daily oral brepocitinib in NIU, the 45 mg results represented the best Treatment Failure rates observed to date among active NIU studies measuring this endpoint.
EU Directive 2001/83/EC further provides that, where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy.
Directive 2001/83/EC further provides that, where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy.
Any agency or judicial enforcement action could have a material adverse effect on our business, the market acceptance of our products and our reputation. Our product candidates must be approved by the FDA through either an NDA or a BLA process before they may be legally marketed in the U.S.
Any agency or judicial enforcement action could have a material adverse effect on our business, the market acceptance of our product candidates and our reputation. Our product candidates must be approved by the FDA through either an NDA or a BLA process before they may be legally marketed in the U.S.
The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials and/or other clinical development programs.
The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials and other clinical development programs.
For example, a rule enacted under the Trump Administration known as the “Most Favored Nations” rule would have set Medicare Part B reimbursement at an amount no higher than the lowest price that a drug manufacturer receives on a particular product in an index of foreign countries.
For example, a rule enacted under the first Trump Administration known as the “Most Favored Nations” rule would have set Medicare Part B reimbursement at an amount no higher than the lowest price that a drug manufacturer receives on a particular product in an index of foreign countries.
If we expand our presence outside of the U.S., it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside of the U.S., which could limit our growth potential and increase our development costs.
If we expand our presence outside of the U.S., it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain product candidates outside of the U.S., which could limit our growth potential and increase our development costs.
In general, the prices of drug products under such systems are substantially lower than in the U.S. Other countries allow companies to fix their own prices for drug products, but monitor and control company profits. Accordingly, in markets outside the U.S., the acquisition costs and reimbursement for drug products may lower than within the U.S.
In general, the prices of drug products under such systems are substantially lower than in the U.S. Other countries allow companies to fix their own prices for drug products, but monitor and control company profits. Accordingly, in markets outside the U.S., the acquisition costs and reimbursement for drug products may be lower than within the U.S.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug or biologic has been associated with unexpected serious harm to patients.
Similarly, an IRB can suspend or terminate approval of a clinical trial at an institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug or biologic has been associated with unexpected serious harm to patients.
The process generally involves the following: • completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements; • submission to the FDA of an IND, which must become effective before human clinical trials may begin; • approval by an IRB, or independent ethics committee at each clinical trial site before each human trial may be initiated; • performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations and requirements, GCP requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication; • submission to the FDA of an NDA or BLA; • a determination by the FDA within 60 days of its receipt of an NDA or BLA to accept the filing for review; • satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug or biologic will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug or biologic’s identity, strength, quality and purity; • potential FDA inspection of the clinical trial sites that generated the data in support of the NDA or BLA and/or us as the sponsor; 31 Table of Contents • payment of user fees for FDA review of the NDA or BLA (unless a fee waiver applies); • agreement with FDA on the final labeling for the product and the design and implementation of any required REMS; and • FDA review and approval of the NDA or BLA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug or biologic in the U.S.
The process generally involves the following: • completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements; • submission to the FDA of an IND, which must become effective before human clinical trials may begin; • approval by an IRB, or independent ethics committee for each clinical trial site before each human trial may be initiated; • performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations and requirements, GCP requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication; • submission to the FDA of an NDA or BLA; • a determination by the FDA within 60 days of its receipt of an NDA or BLA to accept the filing for review; • satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug or biologic will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug or biologic’s identity, strength, quality and purity; • potential FDA inspection of the clinical trial sites that generated the data in support of the NDA or BLA and us as the sponsor; • payment of user fees for FDA review of the NDA or BLA (unless a fee waiver applies); • agreement with FDA on the final labeling for the product and the design and implementation of any required REMS; and • FDA review and approval of the NDA or BLA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug or biologic in the U.S.
In the Phase 2 NEPTUNE proof-of-concept study, brepocitinib demonstrated the best Treatment Failure rates observed to date among active NIU studies measuring this registrational endpoint. 17 Table of Contents Study Population N 1 Brepocitinib Dose Primary Endpoint Result Statistical Significance Alopecia Areata 94 2 30 mg once daily 3 49.18 placebo-adjusted CFB in SALT Score at week 24 P 4 Psoriatic Arthritis Ulcerative Colitis Plaque Psoriasis 218 167 212 30 mg once daily 30 mg once daily 30 mg once daily 23.4% placebo-adjusted ACR20 RR at week 16 -2.28 placebo-adjusted CFB in Mayo Score at week 8 -10.1 placebo-adjusted CFB in PASI score at week 12 P = 0.0197 P = 0.0005 P Hidradenitis Suppurativa Crohn’s Disease Non-infectious Uveitis 100 151 26 45 mg once daily 5 60 mg once daily 6 45 mg once daily 18.7% placebo-adjusted HiSCR Rate at week 16 21.4% placebo-adjusted SES-CD 50 Rate at week 12 29.4% Treatment Failure Rate at week 24 P = 0.0298 4 P = 0.0012 4 1.
In the Phase 2 NEPTUNE proof-of-concept study, brepocitinib demonstrated the best time to treatment failure observed to date among active NIU studies measuring this registrational endpoint. 12 Table of Contents Study Population N 1 Brepocitinib Dose Primary Endpoint Result Statistical Significance Alopecia Areata 94 2 30 mg once daily 3 49.18 placebo-adjusted CFB in SALT Score at week 24 P 4 Psoriatic Arthritis 218 30 mg once daily 23.4% placebo-adjusted ACR20 RR at week 16 P = 0.0197 Ulcerative Colitis 167 30 mg once daily -2.28 placebo-adjusted CFB in Mayo Score at week 8 P = 0.0005 Plaque Psoriasis 212 30 mg once daily -10.1 placebo-adjusted CFB in PASI score at week 12 P Hidradenitis Suppurativa 100 45 mg once daily 5 18.7% placebo-adjusted HiSCR Rate at week 16 P = 0.0298 4 Crohn’s Disease 151 60 mg once daily 6 21.4% placebo-adjusted SES-CD 50 Rate at week 12 P = 0.0012 4 Non-infectious Uveitis 26 45 mg once daily 29.4% Treatment Failure Rate at week 24 1.
If the Concerned Member States raise no objections, based on a potential serious risk to public health, to the assessment, SmPC, labeling, or packaging circulated by the RMS, the coordinated procedures is closed, and the product is subsequently granted a national MA in all the Member States (i.e., in the RMS and the Concerned Member States). 45 Table of Contents Under the above-described procedures, during the assessment of the documents submitted in the MAA and before granting the MA, the EMA or the competent authorities of the Member States of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
If the Concerned Member States raise no objections, based on a potential serious risk to public health, to the assessment, SmPC, labeling, or packaging circulated by the RMS, the coordinated procedures is closed, and the product is subsequently granted a national MA in all the Member States (i.e., in the RMS and the Concerned Member States). 42 Table of Contents Under the above-described procedures, during the assessment of the documents submitted in the MAA and before granting the MA, the EMA or the competent authorities of the Member States of the EEA make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
We ensure that a significant proportion of near-term expenses go toward development, allowing us to stage our investment and align incentives as well as limit losses in the event of a setback.
We ensure a significant proportion of near-term expenses go toward development, allowing us to stage our investment and align incentives as well as limit losses in the event of a setback.
These laws, and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used. 50 Table of Contents Outside of the U.S., the pricing of pharmaceutical products and medical devices is subject to governmental control in many countries.
These laws and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used. 47 Table of Contents Outside of the U.S., the pricing of pharmaceutical products and medical devices is subject to governmental control in many countries.
Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or following approval may subject an applicant to administrative actions or judicial sanctions.
Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or following regulatory approval may subject an applicant to administrative actions or judicial sanctions.
ACR20: American College of Rheumatology 20% Improvement; RR: Response Rate; CFB: Change From Baseline; PASI: Psoriasis Area and Severity Index; SALT: Severity of Alopecia Tool; HiSCR: Hidradenitis Suppurativa Clinical Response; SES-CD: Simple Endoscopic Score for Crohn’s Disease • Brepocitinib’s safety database includes over 1,400 exposed participants evaluated in completed and ongoing clinical studies.
ACR20: American College of Rheumatology 20% Improvement; RR: Response Rate; CFB: Change From Baseline; PASI: Psoriasis Area and Severity Index; SALT: Severity of Alopecia Tool; HiSCR: Hidradenitis Suppurativa Clinical Response; SES-CD: Simple Endoscopic Score for Crohn’s Disease. • Brepocitinib’s safety database includes over 1,500 exposed participants evaluated in completed and ongoing clinical studies.
Even so, companies relying on SCCs must, subject to additional guidance from regulators in the EEA and the U.K., regularly evaluate and implement supplementary measures that provide privacy protections additional to those provided under SCCs. 47 Table of Contents The use of the new SCCs may increase the legal risks and liabilities under EEA privacy, data protection, and information security laws.
Even so, companies relying on SCCs must, subject to additional guidance from regulators in the EEA and the U.K., regularly evaluate and implement supplementary measures that provide privacy protections additional to those provided under SCCs. 44 Table of Contents The use of the new SCCs may increase the legal risks and liabilities under EEA privacy, data protection and information security laws.
ITEM 1. BUSINESS References to “Roivant,” the “Company,” “we,” “us” or “our” in the following section refer to Roivant Sciences Ltd. and its consolidated subsidiaries, unless the context otherwise requires. Overview Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter.
ITEM 1. BUSINESS References to “Roivant,” the “Company,” “we,” “us” or “our” in the following section refer to Roivant Sciences Ltd. and its consolidated subsidiaries, unless the context otherwise requires. Overview Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter.
Civil and criminal penalties may be imposed on entities subject to HIPAA, both by the HHS Office for Civil Rights and by state attorneys general, who have the authority to file civil actions for damages or injunctions in federal courts to enforce the HIPAA privacy and security regulations and to seek attorney’s fees and costs associated with pursuing such actions.
Civil and criminal penalties may be imposed on entities subject to HIPAA, both by the HHS Office for Civil Rights and by state attorneys general, who have the authority to file civil actions for damages or injunctions in federal courts to enforce the HIPAA privacy, security and security breach notification regulations and to seek attorney’s fees and costs associated with pursuing such actions.
Under the HanAll Agreement, RSG received (1) the non-exclusive right to manufacture and (2) the exclusive, royalty-bearing right to (a) develop, import and use (i) the antibody referred to as batoclimab, (ii) certain back-up and next-generation antibodies (including IMVT-1402), and (iii) products containing such antibodies, and (b) to commercialize such products, in the U.S., Canada, Mexico, the E.U., the U.K., Switzerland, the Middle East, North Africa and Latin America (the “HanAll Licensed Territory”), for all human and animal uses.
Under the HanAll Agreement, RSG received (1) the non-exclusive right to manufacture and (2) the exclusive, royalty-bearing right to (a) develop, import and use (i) the antibody referred to as batoclimab, (ii) certain back-up and next-generation antibodies (including IMVT-1402), and (iii) products containing such antibodies, and (b) to commercialize such products, in the U.S., Canada, Mexico, the E.U., the U.K., Switzerland, the Middle East, North Africa and Latin America (the “HanAll Licensed Territory”), for all human and animal uses during the term of the agreement.
Our current and future arrangements with healthcare providers and physicians and any future arrangements with third-party payers, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any drugs for which we obtain marketing approval.
Our current and future arrangements with healthcare providers and physicians and any future arrangements with third-party payors, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any drugs for which we obtain marketing approval.
The UK GDPR and the UK Data Protection Act 2018 set out the U.K.’s data protection regime, which is independent from but aligned to the European Union’s data protection regime. Non-compliance with the UK GDPR may result in monetary penalties of up to £17.5 million or 4% of worldwide revenue, whichever is higher.
Data Protection Act 2018 set out the U.K.’s data protection regime, which is independent from but aligned to the European Union’s data protection regime. Non-compliance with the U.K. GDPR may result in monetary penalties of up to £17.5 million or 4% of worldwide revenue, whichever is higher.
Our issued patents and those that may issue in the future may be challenged, narrowed, circumvented or invalidated, which could limit our ability to stop competitors from marketing related products or technologies or limit the length of the term of patent protection that we may have for our current and future products and product candidates and technologies.
Our issued patents and those that may be issued in the future may be challenged, narrowed, circumvented or invalidated, which could limit our ability to stop competitors from marketing related products or technologies or limit the length of the term of patent protection that we may have for our product candidates and technologies.
In October 2022, President Biden issued an executive order calling on the Secretary to consider whether to select for testing by the CMS innovation center new health care payment and delivery models that would lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid programs, including models that may lead to lower cost-sharing for commonly used drugs and support value-based payment that promotes high-quality care.
In October 2022, former President Biden issued executive order 14087 calling on the Secretary to consider whether to select for testing by the CMS innovation center new health care payment and delivery models that would lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid programs, including models that may lead to lower cost-sharing for commonly used drugs and support value-based payment that promotes high-quality care.
We may also rely on trade secrets, know-how, continuing technological innovation and potential in-licensing opportunities to develop and maintain our proprietary position. The patent positions of companies like us are generally uncertain and involve complex legal and factual questions.
We may also rely on trade secrets, know-how, continuing technological innovation and potential in-licensing opportunities to develop and maintain our proprietary position. The patent positions of companies like ours are generally uncertain and involve complex legal and factual questions.
Basic ownership refers to Roivant’s percentage ownership of the issued and outstanding common and preferred shares (if applicable) of the entity. 2. Fully diluted ownership refers to Roivant’s percentage ownership of all outstanding equity interests of the entity, including unvested RSUs as well as options and warrants, in each case whether vested or unvested. 3.
Basic ownership refers to Roivant’s percentage ownership of the issued and outstanding common and preferred shares (if applicable) of the entity. 2. Fully diluted ownership refers to Roivant’s percentage ownership of all outstanding equity interests of the entity, including unvested RSUs, options and warrants, in each case whether vested or unvested. 3.
However, as of January 1, 2021, the U.K.’s European Union (Withdrawal) Act 2018 incorporated the GDPR (as it existed on December 31, 2020 but subject to certain UK specific amendments) into UK law, referred to as the UK GDPR.
However, as of January 1, 2021, the U.K.’s European Union (Withdrawal) Act 2018 incorporated the GDPR (as it existed on December 31, 2020 but subject to certain U.K. specific amendments) into U.K. law, referred to as the U.K. GDPR. The U.K. GDPR and the U.K.
The patents of this patent family may expire in 2035, without taking into account any possible patent term adjustment or extension and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. 29 Table of Contents In addition, the in-licensed patent portfolio includes another patent family that discloses a pharmaceutical formulation for an anti-FcRn antibody.
The patents of this patent family may expire in 2035, without taking into account any possible patent term adjustment or extension and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. In addition, the in-licensed patent portfolio includes another patent family that discloses a pharmaceutical formulation for an anti-FcRn antibody.
RSG also received the right to grant a sublicense, with prior written notice to HanAll of such sublicense, to: (1) a third party in any country in the HanAll Licensed Territory outside of the U.S. and E.U.; (2) an affiliate of RSG in any country in the HanAll Licensed Territory; and (3) a third party in the U.S. and E.U. only after submission of a Biologics License Application (“BLA”) in the U.S. or a Marketing Authorization Application in the E.U.
With respect to these licenses, RSG also received the right to grant a sublicense, with prior written notice to HanAll of such sublicense, to: (1) a third party in any country in the HanAll Licensed Territory outside of the U.S. and E.U.; (2) an affiliate of RSG in any country in the HanAll Licensed Territory; and (3) a third party in the U.S. and E.U. only after submission of a biologics license application (“BLA”) in the U.S. or a Marketing Authorization Application in the E.U.
The U.K. formally left the European Union on January 31, 2020. A transition period began on February 1, 2020, during which EU pharmaceutical law remained applicable in the U.K. However, this ended on December 31, 2020.
The U.K. formally left the European Union on January 31, 2020. A transition period began on February 1, 2020, during which E.U. pharmaceutical law remained applicable in the U.K. However, this ended on December 31, 2020.
A drug or biologic product can also obtain pediatric market exclusivity in the U.S. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms.
A drug or biologic product can also obtain pediatric market exclusivity in the U.S. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and, for drug products, patent terms.
In addition, the proposal envisages changes to the concept of unmet medical need and considers introducing novel rewards for orphan medical products addressing high unmet medical need. The adoption of the new legislation is not expected before 2025 and it will start to apply 18 months after the entry in force.
In addition, the proposal envisages changes to the concept of unmet medical need and considers introducing novel rewards for orphan medical products addressing high unmet medical need. The adoption of the new legislation is not expected before the end of 2025 at the earliest and it will start to apply 18 months after the entry in force.
Any patent issued from this patent family may expire in 2044, without taking into account any possible patent term adjustment or extension and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. ISG also owns a U.S. provisional application directed to methods of improving anti-FcRn therapies, which describes specific dosing regimens for IMVT-1402.
Any patent issued from this patent family may expire in 2044, without taking into account any possible patent term adjustment or extension and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. ISG also owns a PCT application directed to methods of improving anti-FcRn therapies, which describes specific dosing regimens for IMVT-1402.
European Union and United Kingdom Data Protection and Market Exclusivity In the EEA and UK, innovative medicinal products, approved on the basis of a full dossier of preclinical and clinical data as part of the MAA, qualify for eight years of data protection upon marketing authorization and an additional two years of market exclusivity.
European Union and United Kingdom Data Protection and Market Exclusivity In the EEA and U.K., innovative medicinal products, approved on the basis of a full dossier of preclinical and clinical data as part of the MAA, qualify for eight years of data protection upon marketing authorization and an additional two years of market exclusivity.
If a product is to be authorized in more than one Member State, the assessment procedure is coordinated between the relevant EU Member States. Where a product has already been authorized for marketing in a Member State of the EEA, the national MA can be recognized in another Member States through the mutual recognition procedure.
If a product is to be authorized in more than one Member State, the assessment procedure is coordinated between the relevant E.U. Member States. Where a product has already been authorized for marketing in a Member State of the EEA, the national MA can be recognized in another Member State through the mutual recognition procedure.
European Union and United Kingdom Pediatric Investigation Plan In the EEA and UK, MAAs for new medicinal products have to include the results of studies conducted in the pediatric population, in compliance with a pediatric investigation plan (a “PIP”), agreed with the EMA’s Pediatric Committee (a “PDCO”) or MHRA as relevant.
European Union and United Kingdom Pediatric Investigation Plan In the EEA and U.K., MAAs for new medicinal products have to include the results of studies conducted in the pediatric population, in compliance with a pediatric investigation plan (a “PIP”), agreed with the EMA’s Pediatric Committee (a “PDCO”) or MHRA as relevant.
HanAll may terminate the HanAll Agreement if ISG or its affiliates challenge the validity or enforceability of any of the licensed patents. Product Service Agreement and Master Services Agreement On November 17, 2021, ISG entered into a Product Service Agreement (“PSA”) with Samsung Biologics Co., Ltd.
HanAll may terminate the HanAll Agreement if ISG or its affiliates challenge the validity or enforceability of any of the licensed patents. 23 Table of Contents Product Service Agreement and Master Services Agreement On November 17, 2021, ISG entered into a Product Service Agreement (“PSA”) with Samsung Biologics Co., Ltd.
Pfizer is obligated to pay Priovant a low tens-of-millions milestone payment if aggregate net sales of its licensed products outside of Priovant’s territory in a given year exceed a mid hundreds-of-millions amount. Priovant is obligated to pay Pfizer a tiered, sub-teens royalty on aggregate net sales of its licensed products in Priovant’s territory.
Pfizer is obligated to pay Priovant a low tens-of-millions milestone payment if aggregate net sales of its licensed products outside of Priovant’s territory in a given year exceed a mid hundreds-of-millions amount. 22 Table of Contents Priovant is obligated to pay Pfizer a tiered, sub-teens royalty on aggregate net sales of its licensed products in Priovant’s territory.
The data protection, if granted, prevents generic or biosimilar applicants from referencing the innovator’s preclinical and clinical trial data contained in the dossier of the reference innovative product when applying for a generic or biosimilar MA in the EEA/UK, for a period of eight years from the date of authorization of the reference product.
The data protection, if granted, prevents generic or biosimilar applicants from referencing the innovator’s preclinical and clinical trial data contained in the dossier of the reference innovative product when applying for a generic or biosimilar MA in the EEA/U.K., for a period of eight years from the date of authorization of the reference product.
In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions. 43 Table of Contents U.S.
In addition, failure to comply with these laws and regulations may result in substantial fines, penalties or other sanctions. 40 Table of Contents U.S.
Given that, at present, there are few, if any, viable alternatives to the SCCs and the DPF, any transfers by us or our vendors of personal information from the EEA to the US may not comply with the EEA data protection laws, which may increase our exposure to the GDPR’s heightened sanctions for violations of its cross-border data transfer restrictions and may prohibit our transfer of EEA personal information outside of the EEA (including clinical trial data), and may adversely impact our operations, product development and ability to provide our products.
Given that, at present, there are few, if any, viable alternatives to the SCCs and the DPF, any transfers by us or our vendors of personal information from the EEA to the U.S. may not comply with the EEA data protection laws, which may increase our exposure to the GDPR’s heightened sanctions for violations of its cross-border data transfer restrictions and may prohibit our transfer of EEA personal information outside of the EEA (including clinical trial data), and may adversely impact our operations and product development.
These patents and pending applications, if issued, are expected to expire as early as 2035, in each case without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees, and (2) exclusively licensed rights to three patent families for ropsacitinib containing at least 126 issued patents and 25 pending patent applications in the U.S. and other jurisdictions, including the European Union and Japan, with claims covering a composition of matter, a treatment of hidradenitis and a crystalline form.
These patents and pending applications, if issued, are expected to expire as early as 2035, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees, and (2) exclusively licensed rights to three patent families for ropsacitinib containing at least 138 issued patents and 31 pending patent applications in the U.S. and other jurisdictions, including the European Union and Japan, with claims covering a composition of matter, a treatment of hidradenitis and a crystalline form.
A PCT application is pending in this family. Notably, in this patent family, a U.S. patent was issued on March 12, 2024, with claims directed to IMVT-1402 as defined by its CDRs, a pharmaceutical composition comprising such antibody or antigen-binding fragment thereof, and methods of treating an autoimmune disease using such antibody or antigen-binding fragment thereof.
Notably, in this patent family, a U.S. patent was issued on March 12, 2024, with claims directed to IMVT-1402 as defined by its CDRs, a pharmaceutical composition comprising such antibody or antigen-binding fragment thereof, and methods of treating an autoimmune disease using such antibody or antigen-binding fragment thereof.
The area of patents and other intellectual property rights in biotechnology is an evolving one with many risks and uncertainties, which may prevent us from commercializing our current and future products and product candidates and practicing our proprietary technology.
The area of patents and other intellectual property rights in biotechnology is an evolving one with many risks and uncertainties, which may prevent us from commercializing our product candidates and practicing our proprietary technology.
Additionally, as of May 22, 2024, independent of the licensed patent portfolio, ISG owns patent families directed to methods of treating thyroid eye disease (Graves’ ophthalmopathy) and methods of treating warm autoimmune hemolytic anemia using anti-FcRn antibodies that include patent applications in the U.S. as well as foreign counterparts in certain jurisdictions.
Additionally, as of May 29, 2025, independent of the licensed patent portfolio, ISG owns patent families directed to methods of treating thyroid eye disease (Graves’ ophthalmopathy) and methods of treating warm autoimmune hemolytic anemia using anti-FcRn antibodies that include patent applications in the U.S. as well as foreign counterparts in certain jurisdictions.
For example, in the European Union and UK, pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement price has been agreed.
For example, in the European Union and U.K., pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after a reimbursement price has been agreed.
Please refer to “—Asset Acquisition and License Agreements; Other Vant Agreements” and the agreements themselves, filed as exhibits to this Annual Report on Form 10-K, for more information on the terms of these agreements. Vant Ownership The following table summarizes our ownership of certain of our subsidiary companies and affiliates as of March 31, 2024.
Please refer to “—Vant License Agreements & Other Vant Agreements” and the agreements themselves, filed as exhibits to this Annual Report on Form 10-K, for more information on the terms of these agreements. Vant Ownership The following table summarizes our ownership of certain of our subsidiary companies and affiliates as of March 31, 2025.
Generally, before a new drug, biologic or diagnostic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved, authorized, or cleared by the applicable regulatory authority. U.S.
Generally, before a new drug, biologic or diagnostic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved, authorized or cleared by the applicable regulatory authority. 27 Table of Contents U.S.
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. The following table summarizes selected commercial and development-stage pipeline products and product candidates.
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. The following table summarizes selected product candidates from our pipeline.
Packaging and Distribution in the United States If our products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act.
Packaging and Distribution in the United States If our product candidates are made available to authorized users of the Federal Supply Schedule of the General Services Administration once approved, additional laws and requirements apply. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act.
These patents and pending applications, if issued, are expected to expire between 2029 and 2044, in each case without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
These patents and pending applications, if issued, are expected to expire between 2029 and 2045, in each case without taking into account any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees.
The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the product candidate. 32 Table of Contents • Phase 2 clinical trials involve studies in disease-affected patients to evaluate proof of concept and/or determine the dose required to produce the desired benefits.
The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the product candidate. • Phase 2 clinical trials involve studies in disease-affected patients to evaluate proof of concept and determine the dose required to produce the desired benefits.
Acceptance into the RTOR pilot does not guarantee or influence approvability of the application, which is subject to the usual benefit-risk evaluation by FDA reviewers, but the program allows FDA to review data earlier, before an applicant formally submits a complete application. The RTOR pilot program does not affect FDA’s PDUFA timelines.
Acceptance into the RTOR pilot does not guarantee or influence approvability of the application, which is subject to the usual benefit-risk evaluation by FDA reviewers, but the program allows FDA to review data earlier, before an applicant formally submits a complete application.
EU Directive 2001/83/EC, which is the Directive governing medicinal products for human use, as implemented in the relevant Member State and the UK, the national anti-bribery laws of the European Union Member States, and the Bribery Act 2010 in the UK, as well as the industry Codes of Practice that are based on the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice, collectively govern the provision of benefits or advantages to induce or reward improper performance.
Directive 2001/83/EC, which is the Directive governing medicinal products for human use, as implemented in the relevant Member State and the U.K., the national anti-bribery laws of the European Union Member States, and the Bribery Act 2010 in the U.K., as well as the industry Codes of Practice that are based on the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice, collectively prohibit the provision of benefits or advantages to induce or reward improper performance.
Third-party payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity, and reviewing the cost-effectiveness of medical products and services and imposing controls to manage costs. 49 Table of Contents The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the “MMA”), established the Medicare Part D program to provide a voluntary prescription drug benefit to Medicare beneficiaries.
Third-party payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity and reviewing the cost-effectiveness of medical products and services and imposing controls to manage costs. 46 Table of Contents The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the “Medicare Modernization Act” or the “MMA”), established the Medicare Part D program to provide a voluntary prescription drug benefit to Medicare beneficiaries.
With respect to transfers of personal data from the EEA to the U.K., on June 28, 2021 the European Commission issued an adequacy decision in respect of the UK’s data protection framework, enabling data transfers from EU member states to the UK to continue without requiring organizations to put in place contractual or other measures in order to lawfully transfer personal data between the territories.
With respect to transfers of personal data from the EEA to the U.K., on June 28, 2021 the European Commission issued an adequacy decision in respect of the U.K.’s data protection framework, enabling data transfers from E.U. member states to the U.K. to continue without requiring organizations to put in place contractual or other measures in order to lawfully transfer personal data between the territories.
References to our website address do not constitute incorporation by reference of the information contained on the website, and the information contained on the website is not part of this document or any other document that we file with or furnish to the SEC. 51 Table of Contents
References to our website do not constitute incorporation by reference of the information contained on our website, and the information contained on our website is not part of this document nor any other document that we file with or furnish to the SEC. 48 Table of Contents
Absent further Congressional action, there is a possibility that an up to 4% Medicare sequester could be triggered in January 2025, pursuant to the Statutory Pay-As-You-Go Act of 2010 (“PAYGO”).
Absent Congressional action, there also was a possibility that an up to 4% Medicare sequester could be triggered in January 2025, pursuant to the Statutory Pay-As-You-Go Act of 2010 (“PAYGO”).
According to the ruling, the competent authorities of EU Member States may, under certain strict conditions, bring claims to their national courts against a company for breaches of the GDPR, including unlawful cross-border processing activities, even such company does not have an establishment in the EU member state in question and the competent authority bringing the claim is not the lead supervisory authority.
Member States may, under certain strict conditions, bring claims to their national courts against a company for breaches of the GDPR, including unlawful cross-border processing activities, even such company does not have an establishment in the E.U. member state in question and the competent authority bringing the claim is not the lead supervisory authority.
In December 2018, Immunovant Sciences GmbH, (“ISG”) obtained and assumed all rights, title, interest and obligations under the HanAll Agreement from RSG, including all rights to IMVT-1402 and batoclimab in the HanAll Licensed Territory, for an aggregate purchase price of $37.8 million.
In December 2018, Immunovant Sciences GmbH, (“ISG”) obtained and assumed all of the rights, title, interest and obligations under the HanAll Agreement from RSG, including all rights to IMVT-1402 and batoclimab in the HanAll Licensed Territory, pursuant to an assignment and assumption agreement between RSG and ISG, for an aggregate purchase price of $37.8 million.
The EU clinical trials legislation is undergoing a transition process due to the application of a new Clinical Trials Regulation (EU) No 536/2014 (the “Regulation”), which is mainly aimed at harmonizing and streamlining clinical trial authorization, simplifying adverse-event reporting procedures, improving the supervision of clinical trials and increasing their transparency.
The E.U. clinical trials legislation underwent a transition process due to the application of the new Clinical Trials Regulation (E.U.) No 536/2014 (the “Regulation”), which is mainly aimed at harmonizing and streamlining clinical trial authorization, simplifying adverse-event reporting procedures, improving the supervision of clinical trials and increasing their transparency.
For more information on Roivant’s ownership interest in Datavant, please refer to Note 4 to Roivant’s audited consolidated financial statements included in this Annual Report on Form 10-K. 9 Table of Contents Upcoming Catalysts In the upcoming year, we have a robust set of expected near-term catalysts, including the items set forth below.
For more information on Roivant’s ownership interest in Datavant, please refer to Note 4, “Equity Method Investments” to Roivant’s consolidated financial statements included in this Annual Report on Form 10-K. Upcoming Catalysts In the upcoming year, we have a robust set of expected near-term catalysts, including the items set forth in the table below.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThere 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. 61 Table of Contents The commencement and completion of preclinical studies and clinical trials may be delayed by several factors, including: • failure to obtain regulatory authorization to commence a clinical trial or reaching consensus with regulatory authorities regarding the design or implementation of our studies; • other regulatory issues, including the receipt of any inspectional observations on FDA’s Form-483, Warning or Untitled Letters, clinical holds, or complete response letters or similar communications/objections by other regulatory authorities; • unforeseen safety issues, or subjects experiencing severe or unexpected adverse events; • occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors; • lack of effectiveness during clinical trials; • resolving any dosing issues, including those raised by the FDA or other regulatory authorities; • inability to reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • slower than expected rates of patient recruitment or failure to recruit suitable patients to participate in a trial; • failure to add a sufficient number of clinical trial sites; • unanticipated impact from changes in or modifications to protocols or clinical trial design, including those that may be required by the FDA or other regulatory authorities; • inability or unwillingness of clinical investigators or study participants to follow our clinical and other applicable protocols or applicable regulatory requirements; • an IRB or EC refusing to approve, suspending, or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; • premature discontinuation of study participants from clinical trials or missing data; • failure to manufacture or release sufficient quantities of our product candidates or failure to obtain sufficient quantities of active comparator medications for our clinical trials, if applicable, that in each case meet our quality standards, for use in clinical trials; • inability to monitor patients adequately during or after treatment; or • inappropriate unblinding of trial results.
Biggest changeThe commencement and completion of clinical trials and other studies may be delayed by several factors, including: • the inability to generate sufficient data to support the initiation or continuation of clinical trials; • difficulty identifying patients and enrolling them in clinical trials and other studies, including as a result of competing trials run by other pharmaceutical companies; • the failure to add, or delays in activating, a sufficient number of clinical trial sites; • the inability to reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; • the failure by our CROs or other third parties to adhere to clinical trial agreements; • the failure to manufacture or release sufficient quantities of our product candidates or failure to obtain sufficient quantities of active comparator medications for our clinical trials, if applicable, that in each case meet our quality standards, for use in clinical trials; • the inability or unwillingness of clinical investigators or study participants to follow our clinical and other applicable protocols or applicable regulatory requirements; • unforeseen safety issues, or subjects experiencing severe or unexpected adverse events; • a lack of clinical benefit or effectiveness being demonstrated during clinical trials; • the occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors; • premature discontinuation of study participants from clinical trials or missing data; • the inability to monitor patients adequately during or after treatment; • inappropriate unblinding of trial results; • changes in the market that render continued development of a product candidate no longer reasonable or commercially attractive; • the cost of clinical trials of our product candidates being greater than we anticipated; 57 Table of Contents • unanticipated impact from changes in or modifications to protocols or clinical trial design, including those that may be required by the FDA or other regulatory authorities; • the failure to obtain regulatory authorization to commence a clinical trial or reach consensus with regulatory authorities regarding the design or implementation of our studies; • resolving any dosing issues, including those raised by the FDA or other regulatory authorities; • changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; • changes in the approval policies or regulations of the FDA or other regulatory authorities; • an IRB or EC refusing to approve, suspending, or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; or • other regulatory issues, including the receipt of any inspectional observations on FDA’s Form-483, Warning or Untitled Letters, clinical holds or complete response letters or similar communications/objections by other regulatory authorities.
Interim, top-line or preliminary 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.
Interim, preliminary or top-line 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.
Any significant delay in the supply of a product or product candidate, or the raw material components thereof, or of equipment and devices as necessary, for either commercialization or an ongoing clinical trial, due to the need to replace a third-party manufacturer or otherwise, could considerably delay marketing efforts for the product in question or the completion of clinical trials, product testing and potential regulatory approval of the product candidate in question.
Any significant delay in the supply of a product candidate, or the raw material components thereof, or of equipment and devices as necessary, for either commercialization or an ongoing clinical trial, due to the need to replace a third-party manufacturer or otherwise, could considerably delay marketing efforts for the product in question or the completion of clinical trials, product testing and potential regulatory approval of the product candidate in question.
These regulations govern manufacturing processes and procedures, including record-keeping, and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of our products and product candidates.
These regulations govern manufacturing processes and procedures, including record-keeping, and the implementation and operation of quality systems to control and assure the quality of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of our product candidates.
We and/or our CMOs must supply all necessary documentation in support of an NDA or similar regulatory application on a timely basis, and must adhere to regulations enforced by the FDA and other regulatory agencies through their facilities inspection program.
We and our CMOs must supply all necessary documentation in support of an NDA or similar regulatory application on a timely basis, and must adhere to regulations enforced by the FDA and other regulatory agencies through their facilities inspection program.
If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time consuming for us or a third party to implement, and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility.
If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and time consuming for us or a third party to implement, and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility.
Clinical trial delays could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize product candidates and may harm our business and results of operations.
Clinical trial delays could also shorten any periods during which our product candidates have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize product candidates and may harm our business and results of operations.
Factors that may inhibit our efforts to commercialize a product or, if approved, product candidate on our own include: • the inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs, and other support personnel; • the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future approved products; • the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement, and other acceptance by payors; • the inability to price products at a sufficient price point to ensure an adequate and attractive level of profitability; • restricted or closed distribution channels that make it difficult to distribute our products to segments of the patient population; • the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and • unforeseen costs and expenses associated with creating an independent commercialization organization.
Factors that may inhibit our efforts to commercialize a product candidate, if approved, on our own include: • the inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs and other support personnel; • the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future approved products; • the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement and other acceptance by payors; • the inability to price products at a sufficient price point to ensure an adequate and attractive level of profitability; • restricted or closed distribution channels that make it difficult to distribute our products to segments of the patient population; • the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and • unforeseen costs and expenses associated with creating an independent commercialization organization.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than our products and product candidates.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than our product candidates.
Furthermore, currently approved products could be discovered to have application for treatment of our targeted disease indications or similar indications, which could give such products significant regulatory and market timing advantages over our products and product candidates.
Furthermore, currently approved products could be discovered to have application for treatment of our targeted disease indications or similar indications, which could give such products significant regulatory and market timing advantages over our product candidates.
In addition, we could face litigation or other proceedings with respect to the scope, ownership, validity and/or enforceability of our patents relating to our competitors’ products and our competitors may allege that our products or product candidates infringe, misappropriate or otherwise violate their intellectual property.
In addition, we could face litigation or other proceedings with respect to the scope, ownership, validity and enforceability of our patents relating to our competitors’ products and our competitors may allege that our product candidates infringe, misappropriate or otherwise violate their intellectual property.
There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. Furthermore, our employees, affiliates and/or business partners may use social media for their personal use, and their activities on social media or in other forums could result in adverse publicity for us.
There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. Furthermore, our employees, affiliates and business partners may use social media for their personal use, and their activities on social media or in other forums could result in adverse publicity for us.
Furthermore, there is always a risk that our licensed or owned issued patents and any pending and future patent applications may not protect our products or product candidates, in whole or in part, and may not effectively prevent others from commercializing competitive products or product candidates, or that an alteration to our products or product candidates or processes may provide sufficient basis for a competitor to avoid infringing our patent claims.
Furthermore, there is always a risk that our licensed or owned issued patents and any pending and future patent applications may not protect our product candidates, in whole or in part, and may not effectively prevent others from commercializing competitive products, or that an alteration to our product candidates or processes may provide sufficient basis for a competitor to avoid infringing our patent claims.
Therefore, we cannot know with certainty whether we or our licensors were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions.
Therefore, we cannot know with certainty whether we or our licensors were the first to make the inventions claimed in our owned or in-licensed patents or pending patent applications, or that we or our licensors were the first to file for patent protection of such inventions.
However, the life of a patent, and the protection it affords, are limited. Even if patents covering products or product candidates are obtained, once the patent life has expired, we may be open to competition from other products or product candidates, including generics or biosimilars.
However, the life of a patent, and the protection it affords, are limited. Even if patents covering product candidates are obtained, once the patent life has expired, we may be open to competition from other products or product candidates, including generics or biosimilars.
Even if we are able to obtain an extension, the patent term may still expire before or shortly after we receive FDA marketing approval for a given product or product candidate.
Even if we are able to obtain an extension, the patent term may still expire before or shortly after we receive FDA marketing approval for a given product candidate.
Further, even if we prevail against an infringer in U.S. district court, there is always the risk that the infringer will file an appeal and the district court judgment will be overturned at the appeals court and/or that an adverse decision will be issued by the appeals court relating to the validity or enforceability of our patents.
Further, even if we prevail against an infringer in U.S. district court, there is always the risk that the infringer will file an appeal and the district court judgment will be overturned at the appeals court and that an adverse decision will be issued by the appeals court relating to the validity or enforceability of our patents.
We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For the patents and patent applications that we have licensed, we may have limited or no right to participate in the defense of any licensed patents against challenge by a third party.
We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For the patents and patent applications that we have in-licensed, we may have limited or no right to participate in the defense of any licensed patents against challenge by a third party.
Moreover, a third party may challenge the current patents, or patents that may issue in the future, within our portfolio, which could result in the invalidation of some or all of the patents that might otherwise be eligible for listing in the Orange Book for one of our products.
Moreover, a third party may challenge the current patents, or patents that may issue in the future, within our portfolio, which could result in the invalidation of some or all of the patents that might otherwise be eligible for listing in the Orange Book for one of our future products.
We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with our advisors, employees, third-party contractors and consultants prior to beginning research or disclosing proprietary information.
We seek to protect our proprietary technology and information in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with our advisors, employees, third-party contractors and consultants prior to beginning research or disclosing proprietary information.
Although we seek to protect our ownership of intellectual property rights by ensuring that our agreements with our employees, collaborators and other third parties with whom we do business include provisions requiring such parties to not use the confidential information of their former employer, we may be subject to claims that we or our employees, consultants, independent contractors or other third parties have inadvertently or otherwise used or disclosed confidential information of our employees’ former employers or other third parties.
Although we seek to protect our ownership of intellectual property rights by ensuring that our agreements with our employees, collaborators, consultants, independent contractors and other third parties with whom we do business include provisions requiring such parties to not use the confidential information of their former employer, we may be subject to claims that we or our employees, consultants, independent contractors or other third parties have inadvertently or otherwise used or disclosed confidential information of our employees’ former employers or other third parties.
We may also be subject to claims that former employers or other third parties have an ownership interest in our owned or licensed patents or patent applications. Litigation may be necessary to defend against these claims.
We may also be subject to claims that former employers or other third parties have an ownership interest in our owned or in-licensed patents or patent applications. Litigation may be necessary to defend against these claims.
These provisions may make more difficult the removal of management and may discourage transactions that otherwise could involve payment of a premium over prevailing market prices for our securities.
These provisions may make the removal of management more difficult and may discourage transactions that otherwise could involve payment of a premium over prevailing market prices for our securities.
If our operations are found to be in violation of any of these or any other applicable health regulatory laws that may apply to us, we may be subject to significant penalties, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
If our operations are found to be in violation of any of these or any other applicable health regulatory laws that may apply to us, we may be subject to significant penalties, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal or state healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
We are therefore dependent on our licensing and other transaction partners having conducted such research and development in accordance with the applicable protocols and legal, regulatory and scientific standards, having used appropriately regulated and compliant equipment and devices during the preclinical or clinical development, having accurately reported the results of all clinical trials and other research they conducted prior to our acquisition of the rights to those products or product candidates, having correctly collected and interpreted the data from these trials and other research and having supplied us with complete information, data sets and reports required to adequately demonstrate the results reported through the date of our acquisition of these products or product candidates.
We are therefore dependent on our licensing and other transaction partners having conducted such research and development in accordance with the applicable protocols and legal, regulatory and scientific standards, having used appropriately regulated and compliant equipment and devices during the preclinical or clinical development, having accurately reported the results of all clinical trials and other research they conducted prior to our acquisition of the rights to those product candidates, having correctly collected and interpreted the data from these trials and other research and having supplied us with complete information, data sets and reports required to adequately demonstrate the results reported through the date of our acquisition of these product candidates.
The Bayh-Dole Act also provides federal agencies with “march-in rights.” March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” For example, the research resulting in certain of our acquired or in-licensed patent rights and technology for certain products or product candidates was funded in part by the U.S. federal government.
The Bayh-Dole Act also provides federal agencies with “march-in rights.” March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” For example, the research resulting in certain of our acquired or in-licensed patent rights and technology for certain product candidates was funded in part by the U.S. federal government.
The following examples are illustrative: • others may be able to make formulations or compositions that are the same as or similar to our products or product candidates, but that are not covered by the claims of the patents that we own; • others may be able to make product candidates that are similar to our products or product candidates that we intend to commercialize that are not covered by the patents that we exclusively licensed and have the right to enforce; • we, our licensor or any collaborators might not have been the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own or have exclusively licensed; • we or our licensor or any collaborators might not have been the first to file patent applications covering certain of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • it is possible that our pending patent applications will not lead to issued patents; • issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges; • our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive product candidates for sale in our major commercial markets; and we may not develop additional proprietary technologies that are patentable; • third parties performing manufacturing or testing for us using our products, product candidates or technologies could use the intellectual property of others without obtaining a proper license; 108 Table of Contents • parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property; • we may not develop or in-license additional proprietary technologies that are patentable; • we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all; • the patents of others may harm our business; and • we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property.
The following examples are illustrative: • others may be able to make formulations or compositions that are the same as or similar to our product candidates, but that are not covered by the claims of the patents that we own; • others may be able to make products that are similar to our product candidates that we intend to commercialize that are not covered by the patents that we exclusively licensed and have the right to enforce; • we, our licensor or any collaborators might not have been the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own or have exclusively licensed; • we or our licensor or any collaborators might not have been the first to file patent applications covering certain of our inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; • it is possible that our pending patent applications will not lead to issued patents; • issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges; • our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive product candidates for sale in our major commercial markets; and we may not develop additional proprietary technologies that are patentable; • third parties performing manufacturing or testing for us using our product candidates or technologies could use the intellectual property of others without obtaining a proper license; • parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property; • we may not develop or in-license additional proprietary technologies that are patentable; • we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all; • the patents of others may harm our business; and • we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property.
We and our CROs are required to comply with Good Laboratory Practices (“GLPs”) and GCPs, which are regulations and guidelines enforced by the FDA and other comparable non-U.S. regulatory authorities, which also require compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) guidelines for any of our products and product candidates that are in preclinical and clinical development.
We and our CROs are required to comply with Good Laboratory Practices (“GLPs”) and GCPs, which are regulations and guidelines enforced by the FDA and other comparable non-U.S. regulatory authorities, which also require compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) guidelines for any of our product candidates that are in preclinical and clinical development.
We cannot guarantee that any of our or our licensors’ patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the U.S. and abroad that is or may be relevant to or necessary for the commercialization of products or product candidates in any jurisdiction.
We cannot guarantee that any of our or our licensors’ patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the U.S. and abroad that is or may be relevant to or necessary for the commercialization of our product candidates in any jurisdiction.
If our manufacturers or we are unable to purchase these raw materials after regulatory approval has been obtained for our products or product candidates, the commercial launch of our products or product candidates would be delayed or there would be a shortage in supply, which would impair our ability to generate revenue from the sale of our products or product candidates and may require notification to the FDA or other regulatory authorities.
If our manufacturers or we are unable to purchase these raw materials after regulatory approval has been obtained for our product candidates, the commercial launch of our product candidates would be delayed or there would be a shortage in supply, which would impair our ability to generate revenue from the sale of our product candidates and may require notification to the FDA or other regulatory authorities.
In addition, we may need to obtain additional licenses from our licensors and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensors, including by agreeing to terms that could enable third parties, including our competitors, to receive licenses to a portion of the intellectual property that is subject to our existing licenses and to compete with our products and product candidates.
In addition, we may need to obtain additional licenses from our licensors and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensors, including by agreeing to terms that could enable third parties, including our competitors, to receive licenses to a portion of the intellectual property that is subject to our existing licenses and to compete with our product candidates.
Furthermore, any such litigation or other proceedings to enforce or defend intellectual property rights are often very complex in nature, may be very expensive and time-consuming, may divert management’s attention from our core business, and may result in unfavorable results that could limit our ability to prevent third parties from competing with our products and product candidates.
Furthermore, any such litigation or other proceedings to enforce or defend intellectual property rights are often very complex in nature, may be very expensive and time-consuming, may divert management’s attention from our core business, and may result in unfavorable results that could limit our ability to prevent third parties from competing with product candidates.
If the FDA or comparable non-U.S. regulatory authorities do not approve these facilities for the manufacture of our products or product candidates or if they withdraw any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to market our products and develop, obtain regulatory approval for or market our product candidates, if approved.
If the FDA or comparable non-U.S. regulatory authorities do not approve these facilities for the manufacture of our product candidates or if they withdraw any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop and obtain regulatory approval for our product candidates and, if approved, market our product candidates.
Non-compliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent applications, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.
Non-compliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent applications, failure to respond to official actions within prescribed time limits, underpayment or non-payment of fees and failure to properly legalize and submit formal documents within prescribed time limits.
The aggregate number of shares initially reserved for issuance under the 2021 EIP increases annually on the first day of each fiscal year during the term of the plan in an amount equal to the lesser of (i) 5% of the number of our common shares outstanding as of the day of the immediately preceding fiscal year and (ii) such number of our common shares as determined by our board of directors in its discretion.
The aggregate number of shares reserved for issuance under the 2021 EIP increases annually on the first day of each fiscal year during the term of the plan in an amount equal to the lesser of (i) 5% of the number of our common shares outstanding as of the day of the immediately preceding fiscal year and (ii) such number of our common shares as determined by our board of directors in its discretion.
Under some circumstances, the FDA, the EMA, the MHRA or other comparable regulatory authorities may require that we not distribute a lot until the agency authorizes its release. Slight deviations in the manufacturing process, including those affecting quality attributes and stability, may result in unacceptable changes in the product that could result in lot failures or product recalls.
Under some circumstances, the FDA, the EMA, the MHRA or other comparable regulatory authorities may require that we not distribute a lot until the agency authorizes its release. Slight deviations in the manufacturing process, including those affecting quality attributes and stability, may result in unacceptable changes in the product candidate that could result in lot failures or product recalls.
If a third party successfully challenges all of the patents that might otherwise be eligible for listing in the Orange Book for one of our products before an ANDA or 505(b)(2) NDA is filed we will be unable to obtain a 30-month stay of FDA approval of a 505(b)(2) or ANDA.
If a third party successfully challenges all of the patents that might otherwise be eligible for listing in the Orange Book for one of our future products before an ANDA or 505(b)(2) NDA is filed we will be unable to obtain a 30-month stay of FDA approval of a 505(b)(2) or ANDA.
These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unobserved adverse events. The results of preclinical studies and early clinical trials of our products and product candidates may not be predictive of the results of later-stage clinical trials.
These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unobserved adverse events. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials.
If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. The patent applications that we own or in-license may fail to result in issued patents with claims that cover products or product candidates in the U.S. or in other countries.
If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. The patent applications that we own or in-license may fail to result in issued patents with claims that cover product candidates in the U.S. or in other countries.
Furthermore, if our licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors or other third parties would have the freedom to seek regulatory approval of, and to market, products identical or competitive to ours and we may be required to cease our development and commercialization of certain of our products and product candidates.
Furthermore, if our licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors or other third parties would have the freedom to seek regulatory approval of, and to market, products identical or competitive to ours and we may be required to cease our development and, following regulatory approval, commercialization of certain of our product candidates.
We cannot provide any assurances that third-party patents do not exist which might be enforced against our products or product candidates, resulting in either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties.
We cannot provide any assurances that third-party patents do not exist which might be enforced against our product candidates, resulting in either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and other forms of compensation to third parties.
Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, IPR or post-grant review, or oppositions or similar proceedings outside the U.S., in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
Third parties may also raise similar validity or unpatentability claims before the USPTO in post-grant proceedings such as ex parte reexaminations, IPR or post-grant review, or oppositions or similar proceedings outside the U.S., in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of unpatentability, invalidity and unenforceability is unpredictable.
Any adverse development at Dermavant or any other Vant, including the loss of key members of management, the termination of a key license agreement or other loss of the intellectual property underlying a product or 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.
Any adverse development at a key Vant, including the loss of key members of management, the termination of a key license agreement or other loss of the intellectual property underlying a product candidate or the failure of a clinical trial for a product candidate under development at the Vant, could have a material adverse effect on our consolidated business, financial condition, results of operations or prospects.
In addition, the July 2021 executive order pertaining to drug pricing directs the FDA to support and work with States and Indian Tribes to develop importation plans to import prescription drugs from Canada under the MMA and final rule. Several states have enacted laws intended to support importation processes and have submitted importation program proposals to FDA.
In addition, a July 2021 executive order pertaining to drug pricing directs the FDA to support and work with States and Indian Tribes to develop importation plans to import prescription drugs from Canada under the MMA and final rule. Several states have enacted laws intended to support importation processes and have submitted importation program proposals to FDA.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to our own and, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
As a result, our owned and in-licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to our own and, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us or the applicable licensor to expend substantial resources. In addition, our rights in such inventions may be subject to certain requirements to manufacture products or product candidates embodying such inventions in the U.S.
Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us or the applicable licensor to expend substantial resources. In addition, our rights in such inventions may be subject to certain requirements to manufacture product candidates embodying such inventions in the U.S.
Further, other parties, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of a particular product or product candidate and our business in general.
Further, other parties, including our collaborators or regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of a particular product candidate and our business in general.
In some cases, the technical skills required to manufacture our products and product candidates may be unique or proprietary to the original CMO and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.
In some cases, the technical skills required to manufacture our product candidates may be unique or proprietary to the original CMO and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.
Even after an orphan drug is approved, the FDA or the European Commission can subsequently approve the same drug for a different condition or the same condition if the FDA or the EMA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.
Even after an orphan drug is approved, the FDA or the European Commission or MHRA can subsequently approve the same drug for a different condition or the same condition if the FDA or the EMA or the MHRA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.
While we generally are not subject to the HIPAA privacy or security regulations, we do business with various entities (including clinical trial investigators) that are subject those regulations, and we have to expend resources to understand their obligations, adjust contractual terms in light of those obligations, or otherwise modify our business practices.
While we generally are not subject to the HIPAA privacy or security regulations, we do business with entities (including clinical trial investigators) that are subject to those regulations, and we have to expend resources to understand their obligations, adjust contractual terms in light of those obligations, or otherwise modify our business practices.
Additionally, we may not have sufficient ability to provide input into the patent prosecution, maintenance and defense process with respect to such patents, and our licensors may fail to take the steps that we believe are necessary or desirable in order to obtain, maintain, defend and enforce the licensed patents.
Additionally, we may not have sufficient ability to provide input into the patent prosecution, maintenance, enforcement and defense process with respect to such patents, and our licensors may fail to take the steps that we believe are necessary or desirable in order to obtain, maintain, enforce and defend the in-licensed patents.
If we are unable to protect the confidentiality of any trade secrets, our business and competitive position would be harmed. In addition to seeking patents for our products and product candidates, we may rely on trade secrets, including unpatented software, know-how, technology and other proprietary information, to maintain our competitive position.
If we are unable to protect the confidentiality of any trade secrets, our business and competitive position would be harmed. In addition to seeking patents for our product candidates, we may rely on trade secrets, including unpatented software, know-how, technology and other proprietary information, to maintain our competitive position.
Furthermore, any negative results or new safety signals we may report in clinical trials of our products or product candidates may make it difficult or impossible to recruit and retain patients in other clinical trials we are conducting or to resume enrolling patients once a paused clinical trial has been resumed.
Furthermore, any negative results or new safety signals we may report in clinical trials of our product candidates may make it difficult or impossible to recruit and retain patients in other clinical trials we are conducting or to resume enrolling patients once a paused clinical trial has been resumed.
Products and product candidates in later stage clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical and initial clinical trials. A future failure of a clinical trial to meet its pre-specified endpoints may cause us to abandon development of the product candidate in question.
Product candidates in later stage clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical and initial clinical trials. A future failure of a clinical trial to meet its pre-specified endpoints may cause us to abandon development of the product candidate in question.
We rely, and will continue to rely, upon a combination of patents, trademarks, trade secret protection and confidentiality agreements with employees, consultants, collaborators, advisors and other third parties to protect the intellectual property related to our brand, current and future drug development programs, products and product candidates.
We rely, and will continue to rely, upon a combination of patents, trademarks, trade secret protection and confidentiality agreements with employees, consultants, collaborators, advisors and other third parties to protect the intellectual property related to our brand, current and future drug development programs and product candidates.
The FDA, the European Medicines Agency (“EMA”), the European Commission, the Medicines and Healthcare product Regulatory Agency (“MHRA”) or other relevant regulatory authority may also find that the benefits of any product candidate in any applicable indication do not outweigh its risks in a manner sufficient to grant regulatory approval.
The FDA, the European Medicines Agency (“EMA”), the European Commission, the Medicines and Healthcare products Regulatory Agency (“MHRA”) or other relevant regulatory authority may also find that the benefits of any product candidate in any applicable indication do not outweigh its risks in a manner sufficient to grant regulatory approval.
Moreover, unlike small molecules, the physical and chemical properties of biologics generally cannot be fully characterized. As a result, assays of the finished product may not be sufficient to ensure that the product is consistent from lot-to-lot or will perform in the intended manner.
Moreover, unlike small molecules, the physical and chemical properties of biologics generally cannot be fully characterized. As a result, assays of the finished product candidate may not be sufficient to ensure that the product candidate is consistent from lot-to-lot or will perform in the intended manner.
FDA approval for a product candidate in the United States does not guarantee that we will be able to or that we will make efforts to obtain approval for or commercialize our product candidates in any other jurisdiction, which would limit our ability to realize the drug candidate’s full market potential.
FDA approval for a product candidate in the United States does not guarantee that we will be able to or that we will make efforts to obtain approval for or commercialize our product candidates in any other jurisdiction, which would limit our ability to realize the product candidate’s full market potential.
In addition, U.S. patent applications filed before November 29, 2000 and certain U.S. patent applications filed after that date that will not be filed outside the U.S. remain confidential until patents issue. Therefore, patent applications covering our products and product candidates could have been filed by others without our knowledge.
In addition, U.S. patent applications filed before November 29, 2000 and certain U.S. patent applications filed after that date that will not be filed outside the U.S. remain confidential until patents issue. Therefore, patent applications covering our product candidates could have been filed by others without our knowledge.
Fast Track Designation alone does not guarantee qualification for the FDA’s priority review procedures. Regulatory authorities in some jurisdictions, including the U.S. and the European Economic Area (the “EEA”), may designate drugs and biologics for relatively small patient populations as orphan drugs.
Fast Track Designation alone does not guarantee qualification for the FDA’s priority review procedures. Regulatory authorities in some jurisdictions, including the U.S., the U.K. and the European Economic Area (the “EEA”), may designate drugs and biologics for relatively small patient populations as orphan drugs.
In the U.S., the Medicare Modernization Act (“MMA”) contains provisions that may change U.S. importation laws and expand pharmacists’ and wholesalers’ ability to import cheaper versions of an approved drug and competing products from Canada, where there are government price controls.
In the U.S., the Medicare Modernization Act contains provisions that may change U.S. importation laws and expand pharmacists’ and wholesalers’ ability to import cheaper versions of an approved drug and competing products from Canada, where there are government price controls.
If we are unable to continue to attract and retain high-quality personnel and consultants, the rate and success at which we can discover and develop our products and product candidates will be harmed, which could negatively impact our financial condition, results of operations and cash flows.
If we are unable to continue to attract and retain high-quality personnel and consultants, the rate and success at which we can discover and develop our product candidates will be harmed, which could negatively impact our financial condition, results of operations and cash flows.
Among other things, the CMIA, with limited exceptions, requires that a pharmaceutical company obtain a signed, written authorization from a patient or company employee in order to disclose his or her personal health information and requires pharmaceutical companies to maintain reasonable security measures to protect such information.
Among other things, the CMIA, with limited exceptions, requires that a pharmaceutical company obtain a signed, written authorization from a patient or company employee in order to disclose his or her personal health information and requires the company to maintain reasonable security measures to protect such information.
As the biotechnology and pharmaceutical industries expand and more patents are issued, and as we gain greater visibility, the risk increases that our products, product candidates or other business activities may be subject to claims of infringement of the patent and other proprietary rights of third parties.
As the biotechnology and pharmaceutical industries expand and more patents are issued, and as we gain greater visibility, the risk increases that our product candidates or other business activities may be subject to claims of infringement of the patent and other proprietary rights of third parties.
Third parties may assert that we are infringing their patents or employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our products or product candidates.
Third parties may assert that we are infringing their patents or employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates.
The initiation of a claim against a third party may also cause the third-party to bring counter claims against us such as claims asserting that our patents are invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are commonplace.
The initiation of a claim against a third party may also cause the third-party to bring counter claims against us such as claims asserting that our patents are unpatentable, invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are commonplace.
We may not be able to protect our intellectual property rights throughout the world. Filing, prosecuting and defending patents on products and product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S. can be less extensive than those in the U.S.
We may not be able to protect our intellectual property rights throughout the world. Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S. can be less extensive than those in the U.S.
If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or comparable non-U.S. regulatory authorities, we will not be able to secure or maintain regulatory approval for our products or product candidates.
If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or comparable non-U.S. regulatory authorities, we will not be able to secure or maintain regulatory approval for our product candidates.
Risks Related to Our Intellectual Property If we are unable to obtain and maintain patent and other intellectual property protection for our technology, products and product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
Risks Related to Our Intellectual Property If we are unable to obtain and maintain patent and other intellectual property protection for our technology and product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
In certain instances, the patent term may be adjusted to add additional days to compensate for delays incurred by the USPTO in issuing the patent. Also, the patent term may be extended for a period of time to compensate for at least a portion of the time a product or product candidate was undergoing FDA regulatory review.
In certain instances, the patent term may be adjusted to add additional days to compensate for delays incurred by the USPTO in issuing the patent. Also, the patent term may be extended for a period of time to compensate for at least a portion of the time a product candidate was undergoing FDA regulatory review.
Such laws include, without limitation: 78 Table of Contents • the federal Anti-Kickback Statute, which is a criminal law that prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under a federal healthcare program (such as Medicare and Medicaid).
Such laws include, without limitation: 70 Table of Contents • the federal Anti-Kickback Statute, which is a criminal law that prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under a federal healthcare program (such as Medicare and Medicaid).
We may choose not to seek patent protection for certain innovations, products or product candidates and may choose not to pursue patent protection in certain jurisdictions, and under the laws of certain jurisdictions, patents or other intellectual property rights may be unavailable or limited in scope and, in any event, any patent protection we obtain may be limited.
We may choose not to seek patent protection for certain innovations or product candidates and may choose not to pursue patent protection in certain jurisdictions, and under the laws of certain jurisdictions, patents or other intellectual property rights may be unavailable or limited in scope and, in any event, any patent protection we obtain may be limited.
Moreover, if disputes over intellectual property that we license prevent or impair our ability to maintain other licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected products or product candidates.
Moreover, if disputes over intellectual property that we license prevent or impair our ability to maintain other licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.
Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and product candidates and may also export infringing products and product candidates to territories where we have patent protection, but enforcement is not as strong as that in the U.S.
Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own product candidates and may also export infringing product candidates to territories where we have patent protection, but enforcement is not as strong as that in the U.S.
As previously disclosed, our board of directors has authorized a common share repurchase program, allowing for repurchases of common shares in an aggregate amount of up to $1.5 billion (excluding fees and expenses) (the “2024 Repurchase Program”).
As previously disclosed, our board of directors authorized a common share repurchase program, allowing for repurchases of common shares in an aggregate amount of up to $1.5 billion (excluding fees and expenses) (the “2024 Repurchase Program”).
As a result, the preliminary and top-line results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated.
As a result, the interim, preliminary and top-line results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated.
A certification under 21 CFR § 314.94(a)(12)(i)(A)(4) that the new product will not infringe the Orange Book-listed patents for the applicable product or, if approved, product candidate, or that such patents are invalid, is called a paragraph IV certification.
A certification under 21 CFR § 314.94(a)(12)(i)(A)(4) that the new product will not infringe the Orange Book-listed patents for the applicable approved product candidate, or that such patents are invalid, is called a paragraph IV certification.
If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our products or product candidates.
If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our product candidates.
Problems with the manufacturing process, even minor deviations from the normal process, could result in product defects or manufacturing failures that result in lot failures, product recalls, product liability claims or insufficient inventory to conduct clinical trials or supply commercial markets.
Problems with the manufacturing process, even minor deviations from the normal process, could result in product candidate defects or manufacturing failures that result in lot failures, product recalls, product liability claims or insufficient inventory to conduct clinical trials or supply commercial markets.
We face risks associated with the Vant structure. Our products and product candidates are developed at our Vants, which operate similarly to independent biopharmaceutical companies with their own management teams and equity incentive structures.
We face risks associated with the Vant structure. Our product candidates are developed at our Vants, which operate similarly to independent biopharmaceutical companies with their own management teams and equity incentive structures.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeAt least annually, the Audit Committee discusses our risk management program, including any information security and technology risks and findings from any audits, with our internal audit staff, including our Chief Accounting Officer. At the management level, our CISO is primarily responsible for leading our cybersecurity strategy centrally at Roivant and the majority of our Vants.
Biggest changeAt least annually, the Audit Committee discusses our risk management program, including any information security and technology risks and findings from any audits, with our Chief Accounting Officer and other members of our management team. At the management level, our CISO is primarily responsible for leading our cybersecurity strategy centrally at Roivant and the majority of our Vants.
Certain of our Vants, including Immunovant, Dermavant and our healthcare technology Vants, have established and maintain separate cybersecurity functions which are similarly designed to protect their information and assets from cybersecurity threats or incidents.
Certain of our Vants, including Immunovant and our healthcare technology Vants, have established and maintain separate cybersecurity functions which are similarly designed to protect their information and assets from cybersecurity threats or incidents.
Roivant and the Vants’ cybersecurity programs are informed by industry standards and includes periodic risk assessments and security testing supported by cybersecurity technologies, including third-party security solutions, vulnerability management, and monitoring tools, designed to monitor, identify and manage risks from cybersecurity threats and incidents. In addition, we have implemented employee security and awareness training related to cybersecurity threats and incidents.
Roivant and the Vants’ cybersecurity programs are informed by industry standards and include periodic risk assessments and security testing supported by cybersecurity technologies, including third-party security solutions, vulnerability management and monitoring tools, designed to monitor, identify and manage risks from cybersecurity threats and incidents. In addition, we have implemented employee security and awareness training related to cybersecurity threats and incidents.
At Immunovant, Dermavant and the healthcare technology Vants that have established and maintain separate cybersecurity functions, governance is similarly overseen in the first instance by the boards of directors of those Vants as part of their overall risk management strategy, with ultimate oversight on a company-wide basis by the Roivant board of directors.
At Immunovant and the healthcare technology Vants that have established and maintain separate cybersecurity functions, governance is similarly overseen in the first instance by the boards of directors of those Vants as part of their overall risk management strategy, with ultimate oversight on a company-wide basis by the Roivant board of directors. 111 Table of Contents

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeOur subsidiary Roivant Sciences, Inc. subleases 83,340 square feet of office space located in New York, New York, pursuant to a sublease agreement that expires in October 2032. Certain of our subsidiaries and affiliates also lease office space in New York, New York and Basel, Switzerland.
Biggest change(“RSI”) subleases 83,340 square feet of office space located in New York, New York, pursuant to a sublease agreement that expires in October 2032.
We do not own any properties. 116 Table of Contents We believe that our and our subsidiaries’ leased facilities are in good condition and are well maintained and that our current arrangements will be sufficient to meet our needs for the foreseeable future and that any required additional space will be available on commercially reasonable terms to meet space requirements if they arise.
We believe that our and our subsidiaries’ leased facilities are in good condition and are well maintained and that our current arrangements will be sufficient to meet our needs for the foreseeable future and that any required additional space will be available on commercially reasonable terms to meet space requirements if they arise.
ITEM 2. PROPERTIES Our principal executive offices are located at 7th Floor, 50 Broadway, London SW1H 0DB, United Kingdom. Our registered office is located at Clarendon House, 2 Church Street, Hamilton HM 11, Bermuda. Certain of our subsidiaries and affiliates also have business operations in New York, New York and Basel, Switzerland.
ITEM 2. PROPERTIES Our principal executive offices are located at 7th Floor, 50 Broadway, London SW1H 0DB, United Kingdom. Our registered office is located at Clarendon House, 2 Church Street, Hamilton HM 11, Bermuda. Our subsidiary Roivant Sciences, Inc.
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In September 2024, RSI entered into a new lease agreement (the “RSI Lease Agreement”) with One Penn Plaza LLC for office space in New York, New York to serve as the future U.S. corporate headquarters of RSI. The RSI Lease Agreement commenced in December 2024 and will expire in August 2041.
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The lease contains an option to early terminate in August 2036 and an option to extend the term for one additional period of five years or 10 years at then-market rates in August 2041. Certain of our subsidiaries and affiliates also lease office space in New York, New York and Basel, Switzerland. We do not own any properties.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

3 edited+9 added−1 removed4 unchanged
Biggest changeThe comparisons in the graph are required by the SEC and are not intended to forecast or be indicative of possible future performance of our common shares. 118 Table of Contents The information included under the heading Performance Graph is “furnished” and not “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed to be “soliciting material” subject to Regulation 14A or incorporated by reference in any filing under the Securities Act or the Exchange Act.
Biggest changeThe information included under the heading Performance Graph is “furnished” and not “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed to be “soliciting material” subject to Regulation 14A or incorporated by reference in any filing under the Securities Act or the Exchange Act.
Performance Graph The following stock performance graph illustrates a comparison from October 1, 2021 (the date our common shares commenced trading on the Nasdaq Global Market) through March 31, 2024, of the total cumulative shareholder return on our common shares, the Nasdaq Composite Index and the Nasdaq Biotechnology Index.
Performance Graph The following stock performance graph illustrates a comparison from October 1, 2021 (the date our common shares commenced trading on The Nasdaq Global Market) through March 31, 2025, of the total cumulative shareholder return on our common shares, The Nasdaq Composite Index and The Nasdaq Biotechnology Index.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common shares are listed on the Nasdaq Global Select Market under the symbol “ROIV.” Holders As of May 28, 2024, there were approximately 70 holders of record of our common shares.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common shares are listed on The Nasdaq Global Select Market under the symbol “ROIV.” Holders As of May 21, 2025, there were approximately 64 holders of record of our common shares.
Removed
Sales of Unregistered Securities and Use of Proceeds None. Issuer Repurchases of Equity Securities None. ITEM 6. [RESERVED]
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The comparisons in the graph are required by the SEC and are not intended to forecast or be indicative of possible future performance of our common shares.
Added
Sales of Unregistered Securities and Use of Proceeds None. 113 Table of Contents Issuer Repurchases of Equity Securities During the three and twelve months ended March 31, 2025, we repurchased 27,126,867 and 128,631,786 common shares, respectively, for $292 million and $1.3 billion, respectively, including 270,000 common shares which were repurchased on March 31, 2025, with a settlement date of April 1, 2025.
Added
As of March 31, 2025, we were authorized to repurchase up to $205 million of our common shares.
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The following table summarizes our common share repurchase transactions for the three months ended March 31, 2025: Period Total Number of Common Shares Purchased (1) Average Price Paid per Common Share Total Number of Common Shares Purchased as Part of Publicly Announced Program (1)(2) Approximate Dollar Value of Common Shares that May Yet Be Purchased Under the Program (2) (in millions) January 1 – 31, 2025 5,623,652 $ 11.15 5,623,652 $ 434.5 February 1 – 28, 2025 8,065,457 $ 10.66 8,065,457 $ 348.5 March 1 – 31, 2025 13,437,758 $ 10.67 13,437,758 $ 205.2 Total 27,126,867 27,126,867 (1) The total number of common shares purchased set forth in this column is based on the trade date of the repurchase transaction (not the settlement date of the repurchase transaction), including 270,000 common shares which were repurchased on March 31, 2025, with a settlement date of April 1, 2025.
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(2) On April 2, 2024, we announced that our board of directors had authorized a common share repurchase program, allowing for repurchases of Roivant common shares in an aggregate amount of up to $1.5 billion (excluding fees and expenses).
Added
The timing and total amount of common shares repurchased depends on several factors, including the market price of our common shares, general business, macroeconomic and market conditions and other investment opportunities.
Added
Under the repurchase program, purchases may be conducted through open market transactions, tender offers or privately negotiated transactions, including the use of trading plans under Rule 10b5-1 of the Securities Exchange Act of 1934, as amended.
Added
Please refer to Note 8, “Shareholders’ Equity” to Roivant’s consolidated financial statements included in this Annual Report on Form 10-K for additional information related to share repurchases.
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The table excludes fees and commissions payable in connection with common share repurchases. * In addition to the repurchase transactions set forth above, during the fiscal year ended March 31, 2025, we withheld 3,790,584 common shares associated with net share settlements to cover (i) tax withholding obligations upon the vesting and settlement of equity incentive awards issued under our equity incentive plans, including RSUs and CVARs and (ii) the payment of the exercise price of certain stock options.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

75 edited+62 added−58 removed32 unchanged
Biggest changeChanges in the amount of net loss attributable to noncontrolling interests are directly impacted by the net loss of our consolidated entities and changes in ownership percentages. 122 Table of Contents Results of Operations Comparison of the years ended March 31, 2024 and 2023 The following table sets forth our results of operations for the years ended March 31, 2024 and 2023 : Years Ended March 31, 2024 2023 Change (in thousands) Revenues: Product revenue, net $ 75,057 $ 28,011 $ 47,046 License, milestone and other revenue 49,738 33,269 16,469 Revenue, net 124,795 61,280 $ 63,515 Operating expenses: Cost of revenues 15,560 13,128 2,432 Research and development 501,736 525,215 (23,479 ) Acquired in-process research and development 26,450 97,749 (71,299 ) Selling, general and administrative 687,443 600,506 86,937 Total operating expenses 1,231,189 1,236,598 (5,409 ) Gain on sale of Telavant net assets 5,348,410 — 5,348,410 Income (loss) from operations 4,242,016 (1,175,318 ) 5,417,334 Change in fair value of investments 47,973 20,815 27,158 Change in fair value of debt and liability instruments 78,943 78,001 942 Gain on deconsolidation of subsidiaries (32,772 ) (29,276 ) (3,496 ) Interest income (146,425 ) (32,184 ) (114,241 ) Interest expense 34,778 27,968 6,810 Other expense (income), net 6,089 (15,808 ) 21,897 Income (loss) from continuing operations before income taxes 4,253,430 (1,224,834 ) 5,478,264 Income tax expense 22,224 5,190 17,034 Income (loss) from continuing operations, net of tax 4,231,206 (1,230,024 ) 5,461,230 Income from discontinued operations, net of tax — 114,561 (114,561 ) Net income (loss) 4,231,206 (1,115,463 ) 5,346,669 Net loss attributable to noncontrolling interests (117,720 ) (106,433 ) (11,287 ) Net income (loss) attributable to Roivant Sciences Ltd. $ 4,348,926 $ (1,009,030 ) $ 5,357,956 Variance analysis for years ended March 31, 2024 and 2023 Product revenue, net Years Ended March 31, 2024 2023 Change (in thousands) Product revenue, net $ 75,057 $ 28,011 $ 47,046 Product revenue, net increased by $47.0 million to $75.1 million for the year ended March 31, 2024 , compared to $28.0 million for the year ended March 31 , 2023 , primarily due to higher units sold.
Biggest changeWe record net loss attributable to noncontrolling interests equal to the noncontrolling interest’s proportionate share of the respective operations. 117 Table of Contents Results of Operations Comparison of the years ended March 31, 2025, 2024 and 2023 The following table sets forth our results of operations for the years ended March 31, 2025 , 2024 and 2023 : Years Ended March 31, Change 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 (in thousands) Revenue $ 29,053 $ 32,713 $ 31,530 $ (3,660 ) $ 1,183 Operating expenses: Cost of revenues 911 1,599 3,034 (688 ) (1,435 ) Research and development 550,413 439,909 454,062 110,504 (14,153 ) Acquired in-process research and development — 26,450 97,749 (26,450 ) (71,299 ) General and administrative 591,410 416,133 383,448 175,277 32,685 Total operating expenses 1,142,734 884,091 938,293 258,643 (54,202 ) Gain on sale of Telavant net assets 110,387 5,348,410 — (5,238,023 ) 5,348,410 (Loss) income from operations (1,003,294 ) 4,497,032 (906,763 ) (5,500,326 ) 5,403,795 Change in fair value of investments (55,186 ) 47,973 20,815 (103,159 ) 27,158 Change in fair value of liability instruments (15,756 ) 46,838 18,386 (62,594 ) 28,452 Gain on deconsolidation of subsidiaries (3,108 ) (32,772 ) (29,276 ) 29,664 (3,496 ) Interest income (258,375 ) (146,425 ) (32,184 ) (111,950 ) (114,241 ) Other expense, net 10,721 13,562 486 (2,841 ) 13,076 (Loss) income from continuing operations before income taxes (681,590 ) 4,567,856 (884,990 ) (5,249,446 ) 5,452,846 Income tax expense 48,174 21,503 4,082 26,671 17,421 (Loss) income from continuing operations, net of tax (729,764 ) 4,546,353 (889,072 ) (5,276,117 ) 5,435,425 Income (loss) from discontinued operations, net of tax 373,030 (315,147 ) (226,391 ) 688,177 (88,756 ) Net (loss) income (356,734 ) 4,231,206 (1,115,463 ) (4,587,940 ) 5,346,669 Net loss attributable to noncontrolling interests (184,753 ) (117,720 ) (106,433 ) (67,033 ) (11,287 ) Net (loss) income attributable to Roivant Sciences Ltd. $ (171,981 ) $ 4,348,926 $ (1,009,030 ) $ (4,520,907 ) $ 5,357,956 Variance analysis for years ended March 31, 2025 , 2024 and 2023 Revenue Years Ended March 31, Change 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 (in thousands) Revenue $ 29,053 $ 32,713 $ 31,530 $ (3,660 ) $ 1,183 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.
Research and development expenses primarily include the following: • Program-specific costs, including direct third-party costs, which include expenses incurred under agreements with contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research, and any other third-party expenses directly attributable to the development of our product candidates. • Unallocated internal costs, including: ◦ employee-related expenses, such as salaries, share-based compensation, and benefits, for research and development personnel; and ◦ other expenses that are not allocated to a specific program.
Research and development expenses primarily include the following: • Program-specific costs, including direct third-party costs, which include expenses incurred under agreements with contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research and any other third-party expenses directly attributable to the development of our product candidates. • Unallocated internal costs, including: • employee-related expenses, such as salaries, share-based compensation and benefits, for research and development personnel; and • other research and development related expenses that are not allocated to a specific program.
Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we advance our product candidates and our recently in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates.
Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we advance our product candidates and our in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates.
The fair value of our investment in Datavant uses significant unobservable inputs and is therefore classified as a Level 3 financial instrument. The estimate of fair value for this investment was determined using the income approach and implementation of the option pricing method (“OPM”).
The fair value of our investment in Datavant uses significant unobservable inputs and is therefore classified as a Level 3 financial instrument. The estimate of fair value for this investment was determined using the income approach, market approach and implementation of the option pricing method (“OPM”).
GAAP”). The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingencies as of the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. In accordance with U.S.
The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingencies as of the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. In accordance with U.S.
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 as well as consideration of the available facts and circumstances.
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.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our products and product candidates, future revenue streams, research programs or technologies or grant licenses on terms that may not be favorable to us.
If we raise additional funds through collaborations or strategic alliances or through marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or technologies or grant licenses on terms that may not be favorable to us.
Until such time, if ever, that we can generate substantial revenues, we may finance future cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements or other collaborations at Roivant and the Vants.
In that case, until such time, if ever, that we can generate substantial revenues, we may finance future cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements or other collaborations at Roivant and the Vants.
Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31. Overview Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter.
Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31. Overview Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter.
Net proceeds to us were approximately $216.9 million after deducting underwriting discounts and commissions and offering expenses. 128 Table of Contents In September 2023, we entered into common share purchase and sale agreements with certain institutional investors, pursuant to which we sold an aggregate of 19,600,685 of our common shares at a purchase price of $10.21 per share.
Net proceeds to us were approximately $216.9 million after deducting underwriting discounts and commissions and offering expenses. In September 2023, we entered into common share purchase and sale agreements with certain institutional investors, pursuant to which we sold an aggregate of 19,600,685 of our common shares at a purchase price of $10.21 per share.
For the year ended March 31, 2024, cash used in operating activities decreased by $78.1 million to $765.3 million compared to the year ended March 31, 2023 due to greater cash requirements to fund operations during the year ended March 31, 2023.
For the year ended March 31, 2024, cash used in operating activities decreased by $78.1 million to $765.3 million compared to $843.4 million for the year ended March 31, 2023 due to greater cash requirements to fund operations during the year ended March 31, 2023.
The foregoing restrictions associated with potential sources of additional capital may make it more difficult for us to raise additional capital or to pursue business opportunities, including potential acquisitions.
The foregoing restrictions associated with potential sources of additional capital may make it more difficult for us to raise additional capital, if needed, or to pursue business opportunities, including potential acquisitions.
Our cost of revenues also relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting, and third-party data costs. 119 Table of Contents Research and development expenses Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates.
Cost of revenues Our cost of revenues primarily relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting and third-party data costs. Research and development expenses Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates.
The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following: • the scope, rate of progress, expense and results of our preclinical development activities, any future clinical trials of our product candidates, and other research and development activities that we may conduct; • the number and scope of preclinical and clinical programs we decide to pursue; • the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates; • the number of doses that patients receive; • the countries in which the trials are conducted; • our ability to secure and leverage adequate CRO support for the conduct of clinical trials; • our ability to establish an appropriate safety and efficacy profile for our product candidates; • the timing, receipt and terms of any approvals from applicable regulatory authorities; • the potential additional safety monitoring or other studies requested by regulatory agencies; • the significant and changing government regulation and regulatory guidance; • our ability to establish clinical and commercial manufacturing capabilities, or make arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make product successfully; • the impact of any business interruptions to our operations due to the COVID-19 pandemic or other epidemics; and • our ability to maintain a continued acceptable safety profile of our product candidates following approval of our product candidates.
The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following: • the scope, rate of progress, expense and results of our preclinical development activities, any future clinical trials of our product candidates and other research and development activities that we may conduct; • the number and scope of preclinical and clinical programs we decide to pursue; • the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates; • the number of doses that patients receive; • the countries in which the trials are conducted; • our ability to secure and leverage adequate CRO support for the conduct of clinical trials; • our ability to establish an appropriate safety and efficacy profile for our product candidates; • the timing, receipt and terms of any approvals from applicable regulatory authorities; • the potential additional safety monitoring or other studies requested by regulatory agencies; • the significant and changing government regulation and regulatory guidance; 115 Table of Contents • 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 candidates successfully; and • our ability to maintain a continued acceptable safety profile of our product candidates following regulatory approval of our product candidates.
SG&A employees include those responsible for the identification and acquisition or in-license of new drug candidates as well as for managing Vant operations and facilitating the use of our platform and technologies at the Vants. SG&A expenses also consist of marketing programs, advertising, legal and accounting fees, consulting services, and other operating costs relating to corporate matters and daily operations.
G&A employees include those responsible for the identification and acquisition or in-license of new drug candidates, as well as for managing Vant operations and facilitating the use of our platform and technologies at the Vants. G&A expenses also consist of legal and accounting fees, consulting services and other operating costs relating to corporate matters and daily operations.
Royalties are also due on net sales pursuant to these agreements. The Company has further commitments not reflected above relating to other asset acquisition and license agreements entered and expects to enter into additional asset acquisition and license agreements in the future, which may require upfront payments and long-term commitments of capital resources.
Royalties are also due on net sales pursuant to these agreements. We have further commitments not reflected above relating to other asset acquisition and license agreements entered and 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.
(“Samsung”) pursuant to a Product Service Agreement entered between Immunovant and Samsung by which Samsung will manufacture and supply Immunovant with batoclimab drug substance for commercial sale and perform other manufacturing-related services with respect to batoclimab.
(“Samsung”) pursuant to a Product Service Agreement (“PSA”) entered into between Immunovant and Samsung pursuant to which Samsung will manufacture and supply Immunovant with batoclimab drug substance for commercial sale, if approved, and perform other manufacturing-related services with respect to batoclimab.
In October 2022, Immunovant completed an underwritten public offering of 12,500,000 shares of its common stock (including 416,667 shares of common stock purchased by us) at a price to the public of $6.00 per share, for net proceeds to Immunovant of approximately $70.2 million after deducting underwriting discounts and commissions and offering expenses.
Consolidated Vant Equity Financing Transactions 123 Table of Contents Immunovant In October 2022, Immunovant completed an underwritten public offering of 12,500,000 shares of its common stock (including 416,667 shares of common stock purchased by us) at a price to the public of $6.00 per share, for net proceeds to Immunovant of approximately $70.2 million after deducting underwriting discounts and commissions and offering expenses.
Funding Requirements We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the discovery efforts, preclinical activities, clinical trials and potential commercialization of our product candidates. Additionally, we expect to incur significant commercialization expenses with respect to VTAMA.
Funding Requirements We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the discovery efforts, preclinical activities, clinical trials and potential commercialization of our product candidates.
Cash Flows The following table sets forth a summary of our cash flows for the years ended March 31, 2024 and 2023 : Years Ended March 31, 2024 2023 (in thousands) Net cash used in operating activities $ (765,268 ) $ (843,393 ) Net cash provided by (used in) investing activities $ 5,203,623 $ (44,269 ) Net cash provided by financing activities $ 419,364 $ 499,462 131 Table of Contents Operating Activities Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities.
Cash Flows The following table sets forth a summary of our cash flows for the years ended March 31, 2025, 2024 and 2023: Years Ended March 31, 2025 2024 2023 (in thousands) Net cash used in operating activities $ (839,451 ) $ (765,268 ) $ (843,393 ) Net cash (used in) provided by investing activities $ (1,766,291 ) $ 5,203,623 $ (44,269 ) Net cash (used in) provided by financing activities $ (1,219,794 ) $ 419,364 $ 499,462 Operating Activities Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities.
The Sumitomo Transaction was presented as discontinued operations during the year ending March 31, 2020, and the right to receive the Myovant Top-Up Shares was treated as a contingent consideration upon a sale of the business and accounted for as a gain contingency. Refer to Note 9, “Discontinued Operations” of our audited financial statements for additional information.
The Sumitomo Transaction was presented as discontinued operations during the year ending March 31, 2020, and the right to receive certain common shares of Myovant was treated as a contingent consideration upon a sale of the business and accounted for as a gain contingency. Refer to Note 6, “Discontinued Operations” of our audited financial statements for further information.
We anticipate that our expenses will increase substantially as we: • fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future; • fund the manufacturing of drug substance and drug product of our product candidates in development; 130 Table of Contents • seek to identify, acquire, develop and commercialize additional product candidates; • invest in activities related to the discovery of novel drugs and advancement of our internal programs; • integrate acquired technologies into a comprehensive regulatory and product development strategy; • maintain, expand and protect our intellectual property portfolio; • hire scientific, clinical, quality control and administrative personnel; • add operational, financial and management information systems and personnel, including personnel to support our drug development efforts; • achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties; • seek regulatory approvals for any product candidates that successfully complete clinical trials; • build out our sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize VTAMA and any drug candidates for which we may obtain regulatory approval; and • operate as a public company.
We anticipate that our expenses will increase substantially as we: • fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future; • fund the manufacturing of drug substance and drug product of our product candidates in development; • seek to identify, acquire, develop and commercialize additional product candidates; • invest in activities related to the discovery of novel drugs and advancement of our internal programs; • integrate acquired technologies into a comprehensive regulatory and product development strategy; • maintain, expand and protect our intellectual property portfolio; • hire scientific, clinical, quality control and administrative personnel; • add operational, financial and management information systems and personnel, including personnel to support our drug development efforts; • achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties; • seek regulatory approvals for any product candidates that successfully complete clinical trials; • build out our sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain regulatory approval; and • operate as a public company. 125 Table of Contents While we do not have a need for additional capital to continue our operations as a result of our current cash position, we may in the future require additional capital to fund our operations, pursue business opportunities or strategic transactions or to respond to challenges, competition or unforeseen circumstances.
Pursuant to the share repurchase program, on April 2, 2024, we entered into a share repurchase agreement with Sumitomo to repurchase all 71,251,083 common shares held by Sumitomo at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million. The repurchase transaction with Sumitomo was completed on April 2, 2024.
In April 2024, pursuant to the share repurchase program, we entered into a share repurchase agreement with Sumitomo and repurchased all 71,251,083 common shares held by Sumitomo at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million.
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 an asset acquisition completed by a newly-formed subsidiary and $12.5 million relating to the achievement of development and regulatory milestones for batoclimab.
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.
Pursuant to the Stock Purchase Agreement, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of the Roche Transaction and a one-time milestone payment of $150 million in cash payable upon the initiation of a Phase 3 trial in UC.
Pursuant to the Stock Purchase Agreement, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of the Roche Transaction in December 2023, as well as a one-time milestone payment of $150 million in cash, paid in August 2024 following the initiation of a Phase 3 trial in UC.
Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period.
CMOs in connection with the production of product and clinical trial materials. 127 Table of Contents Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period.
The $7.1 billion in closing consideration was paid to all of Telavant’s equity holders, including holders of restricted stock units, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction, and this same treatment will be applied to the one-time milestone payment.
The $7.1 billion in closing consideration and $150 million one-time milestone payment were paid to all of Telavant’s equity holders, including holders of Telavant restricted stock units, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction.
The minimum purchase commitment related to these agreements was estimated to be approximately $33.3 million. 127 Table of Contents The above purchase commitments do not represent all of our anticipated purchases, but instead represent only the contractually obligated minimum purchases or firm commitments of non-cancelable minimum amounts. Additionally, we have certain payment obligations under various asset acquisition and license agreements.
The above purchase commitments do not represent all of our anticipated purchases, but instead represent only the contractually obligated minimum purchases or firm commitments of non-cancelable minimum amounts. 122 Table of Contents Additionally, we have certain payment obligations under various asset acquisition and license agreements.
Interest income Years Ended March 31, 2024 2023 Change (in thousands) Interest income $ (146,425 ) $ (32,184 ) $ (114,241 ) Interest income increased by $114.2 million to $146.4 million for the year ended March 31, 2024 , compared to $32.2 million for the year ended March 31, 2023 .
Interest income Years Ended March 31, Change 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 (in thousands) Interest income $ (258,375 ) $ (146,425 ) $ (32,184 ) $ (111,950 ) $ (114,241 ) Interest income increased by $112.0 million to $258.4 million for the year ended March 31, 2025, compared to $146.4 million for the year ended March 31, 2024.
If adequate funds are not available to us, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery programs, scale back marketing efforts for our current and future products or be unable to expand operations or otherwise capitalize on business opportunities, which could materially affect our business, prospects, financial condition and results of operations.
While we do not have a near-term need for additional capital as a result of our current cash position, we may in the future require additional capital, and if adequate funds are not available to us in that case, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery programs, scale back marketing efforts for our product candidates or be unable to expand operations or otherwise capitalize on business opportunities, which could materially affect our business, prospects, financial condition and results of operations.
(“VantAI”) in July 2023 and Proteovant in August 2023. Gain on deconsolidation of subsidiaries was $29.3 million for the year ended March 31, 2023 and resulted from the deconsolidation of certain subsidiaries in November 2022 and July 2022.
The gain for the year ended March 31, 2023 resulted from the deconsolidation of certain subsidiaries in November 2022 and July 2022.
(the “Myovant Top-Up Shares”) after Sumitovant Biopharma Ltd.’s (“Sumitovant”) acquisition of Myovant Sciences Ltd. (“Myovant”) in March 2023. We were entitled to the Myovant Top-Up Shares pursuant to the December 2019 transaction with Sumitomo Pharma Co., Ltd. (the “Sumitomo Transaction”) that included, among other things, the transfer of our ownership interest in five Vants to Sumitovant.
We were entitled to these shares of Myovant pursuant to the December 2019 transaction with Sumitomo Pharma Co., Ltd. (the “Sumitomo Transaction”) that included, among other things, the transfer of our ownership interest in five Vants to Sumitovant.
This change in cash flow from investing activities is primarily due to proceeds received upon closing of the Roche Transaction during the year ended March 31, 2024 . Financing Activities For the year ended March 31, 2024 , cash provided by financing activities decreased by $80.1 million to $419.4 million compared to the year ended March 31, 2023 .
This change in cash flow from investing activities is primarily due to proceeds received upon closing of the Roche Transaction during the year ended March 31, 2024. 126 Table of Contents Financing Activities For the year ended March 31, 2025, cash flow from financing activities changed by approximately $1.6 billion to net cash used in financing activities of $1.2 billion for the year ended March 31, 2025 from net cash provided by financing activities of $419.4 million for the year ended March 31, 2024.
The Roche Transaction was made pursuant to a Stock Purchase Agreement dated October 22, 2023 among us, Telavant, Pfizer Inc. (“Pfizer”), and Roche. Telavant was jointly formed by us and Pfizer in November 2022 to develop and commercialize RVT-3101, an anti-TL1A antibody in development for ulcerative colitis (“UC”) and Crohn’s disease, in the U.S. and Japan.
Telavant was jointly formed by us and Pfizer in November 2022 to develop and commercialize RVT-3101, an anti-TL1A antibody in development for ulcerative colitis (“UC”) and Crohn’s disease, in the U.S. and Japan.
Our short-term and long-term liquidity requirements as of March 31, 2024 included: • contractual payments related to our long-term debt (see Note 8, “Long-Term Debt” and Note 18, “Subsequent Events” of our audited financial statements); • obligations under our leases (see Note 13, “Leases” of our audited financial statements); • certain commitments to Samsung Biologics Co., Ltd.
Our short-term and long-term liquidity requirements as of March 31, 2025 included: • obligations under our leases (see Note 11, “Leases” of our audited financial statements); and • certain commitments to Samsung Biologics Co., Ltd.
(“Telavant”), to Roche Holdings, Inc. (“Roche”) in December 2023 (the “Roche Transaction”). Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer Inc. owned the remaining 25%, in each case on an as-converted basis. At closing, we received approximately $5.2 billion in cash.
Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer Inc. (“Pfizer”) owned the remaining 25%, in each case on an as-converted basis.
Gain on deconsolidation of subsidiaries Years Ended March 31, 2024 2023 Change (in thousands) Gain on deconsolidation of subsidiaries $ (32,772 ) $ (29,276 ) $ (3,496 ) Gain on deconsolidation of subsidiaries was $32.8 million for the year ended March 31, 2024 and resulted from the deconsolidation of certain subsidiaries, including VantAI Holdings, Inc.
Gain on deconsolidation of subsidiaries Years Ended March 31, Change 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 (in thousands) Gain on deconsolidation of subsidiaries $ (3,108 ) $ (32,772 ) $ (29,276 ) $ 29,664 $ (3,496 ) Gain on deconsolidation of subsidiaries was $3.1 million, $32.8 million, and $29.3 million for the years ended March 31, 2025, 2024 and 2023, respectively.
Refer to Note 6, “Recent Transactions” of our audited financial statements for further information regarding the Roche Transaction. 125 Table of Contents Change in fair value of investments Years Ended March 31, 2024 2023 Change (in thousands) Change in fair value of investments $ 47,973 $ 20,815 $ 27,158 Change in fair value of investments were unrealized losses of $48.0 million and $20.8 million for the years ended March 31, 2024 and 2023, respectively.
Refer to Note 5, “Recent Transactions and Developments” of our audited financial statements for further information. 120 Table of Contents Change in fair value of investments Years Ended March 31, Change 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 (in thousands) Change in fair value of investments $ (55,186 ) $ 47,973 $ 20,815 $ (103,159 ) $ 27,158 Change in fair value of investments was an unrealized gain of $55.2 million and an unrealized loss of $48.0 million for the years ended March 31, 2025 and 2024, respectively.
The change of $27.2 million was primarily driven by changes in the public share prices of our equity investments, including Arbutus, as well as the change in fair value of our investment in Datavant.
Change in fair value of investments were unrealized losses of $48.0 million and $20.8 million for the years ended March 31, 2024 and 2023, respectively. The change of $27.2 million was primarily driven by changes in the public share prices of our equity investments, including Arbutus, as well as the change in fair value of our investment in Datavant.
In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability. 120 Table of Contents Acquired in-process research and development expenses Acquired in-process research and development (“IPR&D”) expenses include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones.
Acquired in-process research and development expenses Acquired in-process research and development (“IPR&D”) expenses include consideration for the purchase of IPR&D through asset acquisitions and license agreements, as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones.
The successful development of our product candidates is highly uncertain, and we cannot reasonably estimate the costs that will be necessary to complete the remainder of the development of our product candidates.
The successful development of our product candidates is highly uncertain, and we cannot reasonably estimate the costs that will be necessary to complete the remainder of the development of our product candidates. In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability.
Research and development expenses decreased by $23.5 million to $501.7 million for the year ended March 31, 2024 , compared to $525.2 million for the year ended March 31, 2023 , primarily due to a decrease in program-specific costs of $42.4 million , partially offset by increases in other expenses of $10.7 million , personnel-related expenses of $4.5 million , and share-based compensation of $3.7 million . 124 Table of Contents The decrease of $42.4 million in program-specific costs was primarily driven by a decrease of $83.1 million in other development and discovery program expense, which in part resulted from the deconsolidation of Proteovant Sciences, Inc.
Research and development expenses decreased by $14.2 million to $439.9 million for the year ended March 31, 2024, compared to $454.1 million for the year ended March 31, 2023, primarily due to a decrease in program-specific costs of $33.3 million, partially offset by increases in other expenses of $10.7 million, personnel-related expenses of $4.8 million, and share-based compensation of $3.7 million.
We record accruals for estimated costs of research and development activities, including preclinical studies, clinical trials, and contract manufacturing, conducted by third-party service providers.
Accrued Research and Development Expenses, Including Clinical Trial Accruals As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. We record accruals for estimated costs of research and development activities, including preclinical studies, clinical trials and contract manufacturing, conducted by third-party service providers.
We received an upfront payment of approximately $5.2 billion in cash as our pro rata portion of the consideration upon closing of the Roche Transaction. Additionally, we are eligible to receive approximately $110 million for our pro rata portion of the one-time milestone payment if the milestone payment condition is satisfied.
We received an upfront payment of approximately $5.2 billion in cash as our pro rata portion of the consideration upon closing of the Roche Transaction and a one-time milestone payment of approximately $110.4 million as our pro rata portion of the milestone payment following initiation of a Phase 3 trial in UC.
Payments under some of these contracts depend on various factors, including the successful enrollment of patients and the completion of clinical trial milestones. The majority of our service providers invoice us in arrears based on a pre-determined schedule or when contractual milestones are met.
The majority of our service providers invoice us in arrears based on a pre-determined schedule or when contractual milestones are met. In making these estimates, we consider various factors, including status and timing of services performed, the number of patients enrolled and the rate of patient enrollment.
We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. 133 Table of Contents We recognize expenses related to clinical trials based on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical trials on our behalf.
We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time.
Change in fair value of debt and liability instruments for the year ended March 31, 2023 primarily consisted of a loss of $59.6 million relating to the NovaQuest facility, which was primarily due to the impact of VTAMA approval in psoriasis, and a loss of $24.1 million relating to the warrant and earn-out share liabilities issued as part of the Business Combination.
Change in fair value of liability instruments for the year ended March 31, 2025 primarily consisted of a gain relating to the earn-out share liabilities issued as part of the Business Combination.
Liquidity and Capital Resources For the years ended March 31, 2024 and 2023 , we had income from continuing operations of approximately $4.2 billion and incurred a loss from continuing operations of approximately $1.2 billion , respectively.
Refer to Note 6, “Discontinued Operations” of our audited financial statements for additional information. Liquidity and Capital Resources For the years ended March 31, 2025, 2024 and 2023, we had a net loss from continuing operations of $729.8 million, net income from continuing operations of approximately $4.5 billion and a net loss from continuing operations of $889.1 million, respectively.
Consideration for the purchase of IPR&D through asset acquisitions and license agreements may include cash upfront payments, shares and other liability instruments issued, and the fair value of future contingent consideration payments.
Consideration for the purchase of IPR&D through asset acquisitions and license agreements may include cash upfront payments, shares and other liability instruments issued and the fair value of future contingent consideration payments. General and administrative expenses General and administrative (“G&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation and benefits, for employees engaged in G&A activities.
Other examples of estimated accrued research and development expenses include fees paid to: a. investigative sites in connection with clinical trials; b. vendors in connection with preclinical and clinical development activities; and c. CMOs in connection with the production of product and clinical trial materials.
If the actual timing of the performance of services or the level of effort varies from our estimate, the accrual or prepaid expense is adjusted accordingly. Other examples of estimated accrued research and development expenses include fees paid to: a. investigative sites in connection with clinical trials; b. vendors in connection with preclinical and clinical development activities; and c.
During the year ended March 31, 2023 , proceeds were generated by funding pursuant to the terms of the RIPSA following the approval of VTAMA by the FDA in May 2022 as well as net proceeds from the issuance of our common shares and the common shares of our majority-owned subsidiary Immunovant. 132 Table of Contents Critical Accounting Policies and Significant Judgments and Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S.
During the year ended March 31, 2023, proceeds were generated by funding pursuant to the terms of the RIPSA following the approval of VTAMA by the FDA in May 2022 as well as net proceeds from the issuance of our common shares and the common shares of our majority-owned subsidiary Immunovant.
Acquired in-process research and development expenses Years Ended March 31, 2024 2023 Change (in thousands) Consideration for the purchase of IPR&D $ 13,950 $ 87,749 $ (73,799 ) Development milestone payments 12,500 10,000 2,500 Total acquired in-process research and development expenses $ 26,450 $ 97,749 $ (71,299 ) Acquired in-process research and development expenses decreased by $71.3 million to $26.5 million for the year ended March 31, 2024 , compared to $97.7 million for the year ended March 31, 2023 .
Acquired in-process research and development expenses decreased by $71.3 million to $26.5 million for the year ended March 31, 2024, compared to $97.7 million for the year ended March 31, 2023.
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.
We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies.
Gain on sale of Telavant net assets Years Ended March 31, 2024 2023 Change (in thousands) Gain on sale of Telavant net assets $ 5,348,410 $ — $ 5,348,410 Gain on sale of Telavant net assets was approximately $5.3 billion for the year ended March 31, 2024 and resulted from the sale of our entire equity interest in Telavant to Roche in December 2023.
The gain for the year ended March 31, 2025 resulted from the achievement of a 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.
Interest expense Interest expense results from interest accrued on long-term debt and the amortization of debt discount and issuance costs. Income tax expense Income tax expense is recorded for the jurisdictions in which we do business.
Interest income Interest income consists of interest earned on our cash equivalents and marketable securities. Income tax expense Income tax expense is recorded for the jurisdictions in which we do business.
Selling, general and administrative expenses Years Ended March 31, 2024 2023 Change (in thousands) Selling, general and administrative $ 687,443 $ 600,506 $ 86,937 Selling, general and administrative expenses increased by $86.9 million to $687.4 million for the year ended March 31, 2024 , compared to $600.5 million for the year ended March 31, 2023 .
General and administrative expenses Years Ended March 31, Change 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 (in thousands) General and administrative expenses $ 591,410 $ 416,133 $ 383,448 $ 175,277 $ 32,685 General and administrative expenses increased by $175.3 million to $591.4 million for the year ended March 31, 2025, compared to $416.1 million for the year ended March 31, 2024.
Today, Roivant’s pipeline is concentrated in inflammation and immunology and includes VTAMA, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; and brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 for the treatment of dermatomyositis and non-infectious uveitis, in addition to several other therapies in various stages of clinical development.
Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease.
The financial terms of these agreements are subject to negotiation and vary from contract to contract. This may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense.
There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on various factors, including the successful enrollment of patients and the completion of clinical trial milestones.
Refer to Note 15, “Earn-Out Shares, Public Warrants and Private Placement Warrants” of our financial statements for further information regarding the redemption of our warrants.
(“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. Gain on deconsolidation of subsidiaries Gain on deconsolidation of subsidiaries resulted from the determination that we no longer had a controlling financial interest in certain subsidiaries.
Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements. RSL Equity Financing Transactions Since inception, we have completed multiple equity financing transactions, including the following: In December 2019, together with Sumitomo Pharma Co., Ltd.
Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements, including the following completed during the years ended March 31, 2025, 2024 and 2023: RSL Equity Financing Transactions In November 2022, we completed an underwritten primary and secondary public offering of 30,000,000 of our common shares at a price to the public of $5.00 per share.
Change in fair value of investments Change in fair value of investments primarily includes the unrealized loss on equity investments in publicly-traded companies, including Arbutus Biopharma Corporation (“Arbutus”), as well as our equity investment in Heracles Parent, L.L.C. (“Datavant”). We have elected the fair value option to account for these investments.
Refer to Note 5, “Recent Transactions and Developments” of our audited financial statements for further information regarding the Roche Transaction. Change in fair value of investments Change in fair value of investments includes the unrealized (gain) loss on equity investments, including Arbutus Biopharma Corporation (“Arbutus”) and Heracles Parent, L.L.C. (“Datavant”).
(“SK Bio”), a subsidiary of SK, Inc., pursuant to which SK Bio purchased all of our shares in Proteovant in exchange for $47.5 million. Telavant In December 2023, we completed the sale of our entire equity interest in our majority-owned subsidiary, Telavant, to Roche.
Refer to Note 6, “Discontinued Operations” of our audited financial statements for further information. 124 Table of Contents Proteovant In August 2023, we completed a transaction with SK Biopharmaceuticals Co., Ltd. (“SK Bio”), a subsidiary of SK, Inc., pursuant to which SK Bio purchased all of our shares in Proteovant in exchange for $47.5 million.
Income from discontinued operations, net of tax Years Ended March 31, 2024 2023 Change (in thousands) Income from discontinued operations, net of tax $ — $ 114,561 $ (114,561 ) Income from discontinued operations, net of tax was $114.6 million for the year ended March 31, 2023 and resulted from the gain on sale of common shares of Myovant Sciences Ltd.
Loss from discontinued operations, net of tax was $226.4 million for the year ended March 31, 2023 and represents the financial results of Dermavant, partially offset by the gain on sale of common shares of Myovant after Sumitovant’s acquisition of the remaining noncontrolling interest in Myovant in March 2023.
(the “NovaQuest Facility”), and other liability instruments, including warrant liabilities, prior to their redemption, and earn-out share liabilities issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”), a special purpose acquisition company.
We have elected the fair value option to account for these investments. 116 Table of Contents Change in fair value of liability instruments Change in fair value of liability instruments primarily includes the (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities, including the earn-out share liabilities and warrant liabilities, prior to their redemption, issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp.
We anticipate these expenses to further increase if any of our other current or future product candidates receives regulatory approval in the U.S. or another jurisdiction. Gain on sale of Telavant net assets Gain on sale of Telavant net assets represents the gain resulting from the sale of our entire equity interest in our majority-owned subsidiary, Telavant Holdings, Inc.
Gain on sale of Telavant net assets Gain on sale of Telavant net assets reflects a gain resulting from the sale of our entire equity interest in our majority-owned subsidiary, Telavant Holdings, Inc. (“Telavant”), to Roche Holdings, Inc.
Refer to Note 8, “Long-Term Debt” and Note 18, "Subsequent Events" of our audited financials for further information. • Anti-FcRn franchise (Immunovant): up to a maximum of $420.0 million to HanAll Biopharma Co., Ltd. upon the achievement of certain development, regulatory and sales milestone events. • Brepocitinib (Priovant Therapeutics, Inc.): mid tens-of-millions sales milestone payment to Pfizer if aggregate net sales in a given year exceed a mid-hundred-of-millions amount. • Namilumab (Kinevant Ltd.): up to approximately $40 million to the prior shareholders of Izana Biosciences Limited upon the achievement of certain milestones.
Potential material future milestone payments as of March 31, 2025 pursuant to certain key asset acquisition and license agreements are as follows: • Anti-FcRn franchise (Immunovant) : up to a maximum of $420.0 million to HanAll upon the achievement of certain regulatory and sales milestone events. • Brepocitinib (Priovant Therapeutics, Inc.) : mid tens-of-millions sales milestone payment to Pfizer if aggregate net sales in a given year exceed a mid-hundreds-of-millions amount. • Mosliciguat (Pulmovant): up to a maximum of $280.0 million to Bayer upon the achievement of certain development, regulatory and commercial milestone events.
See “Risk Factors—Risks Related to Our Business and Industry—We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management” for more information.
See “Risk Factors—Risks Related to Our Business and Industry—We face risks associated with acquisitions, divestitures and other strategic transactions.” for more information.
Change in fair value of debt and liability instruments Years Ended March 31, 2024 2023 Change (in thousands) Change in fair value of debt and liability instruments $ 78,943 $ 78,001 $ 942 Change in fair value of debt and liability instruments were losses of $78.9 million and $78.0 million for the years ended March 31, 2024 and 2023 , respectively.
Change in fair value of liability instruments Years Ended March 31, Change 2025 2024 2023 2025 vs. 2024 2024 vs. 2023 (in thousands) Change in fair value of liability instruments $ (15,756 ) $ 46,838 $ 18,386 $ (62,594 ) $ 28,452 Change in fair value of liability instruments was a gain of $15.8 million, a loss of $46.8 million, and a loss of $18.4 million for the years ended March 31, 2025, 2024 and 2023, respectively.
This increase is primarily due to higher cash balances in our interest-bearing cash accounts as well as higher interest rates.
This increase is primarily due to higher cash balances in our interest-bearing cash accounts. Interest income increased by $114.2 million to $146.4 million for the year ended March 31, 2024, compared to $32.2 million for the year ended March 31, 2023.
Because efforts to develop and obtain regulatory approval for batoclimab remain ongoing, Immunovant did not exercise that early termination right and it has lapsed. As a result, Immunovant has an additional minimum obligation to purchase additional batches of batoclimab in the four-year period of 2026 through 2029.
Upon execution of the PSA, Immunovant committed to purchase process performance qualification batches of batoclimab and pre-approval inspection batches of batoclimab which may be used for regulatory submissions and, pending regulatory approval, commercial sale. In addition, Immunovant has a minimum obligation to purchase additional batches of batoclimab in the four-year period of 2026 through 2029.
Change in fair value of debt and liability instruments for the year ended March 31, 2024 primarily consisted of a loss of $46.1 million relating to the warrant and earn-out share liabilities issued as part of the Business Combination and a loss of $32.1 million relating to the NovaQuest Facility, which was largely due to the passage of time and increased probabilities of success as a result of advancement in the stage of development of the product candidate.
Change in fair value of liability instruments for the years ended March 31, 2024 and 2023 primarily consisted of losses relating to the warrant and earn-out share liabilities issued as part of the Business Combination. Refer to Note 13, “Earn-Out Shares, Public Warrants and Private Placement Warrants” of our audited financial statements for further information.
At closing, we received approximately $5.2 billion in cash for our pro rata portion of the consideration. Additionally, we derecognized the carrying amount of noncontrolling interest in Telavant of $87.5 million and transferred net liabilities of $26.5 million. This resulted in a gain of approximately $5.3 billion .
We recognized a gain on sale of Telavant net assets of $110.4 million for our pro rata portion of the one-time milestone consideration during the year ended March 31, 2025 and approximately $5.3 billion for the sale of our entire equity interest in Telavant during the year ended March 31, 2024.
In May 2021, all amounts outstanding under the Hercules Loan Agreement were repaid using the proceeds from the $40.0 million senior secured credit facility (the "Credit Facility") entered into by Dermavant with XYQ Luxco S.A.R.L (“XYQ Luxco”), as lender, and U.S.
As contemplated by the Merger Agreement, in connection with the closing of the Dermavant Transaction, Dermavant repaid all amounts outstanding or otherwise payable (including accrued interest and all premiums and exit fees) pursuant to a senior secured credit facility (the “Credit Facility”), dated as of May 14, 2021 and amended as of May 24, 2024, by and among Dermavant, certain subsidiaries of Dermavant, XYQ Luxco S.A.R.L. and U.S.
Research and development expenses For the years ended March 31, 2024 and 2023 , our research and development expenses consisted of the following: Years Ended March 31, 2024 2023 (1) Change (in thousands) Program-specific costs: Batoclimab (1) $ 74,265 $ 78,477 $ (4,212 ) IMVT-1402 (1) 43,102 10,270 32,832 Brepocitinib 38,563 38,627 (64 ) RVT-3101 35,129 7,559 27,570 Tapinarof 34,256 45,201 (10,945 ) Namilumab 13,236 11,757 1,479 RVT-2001 10,132 16,075 (5,943 ) Other development and discovery programs 39,767 122,877 (83,110 ) Total program-specific costs 288,450 330,843 (42,393 ) Unallocated internal costs: Share-based compensation 34,595 30,914 3,681 Personnel-related expenses 136,425 131,908 4,517 Other expenses 42,266 31,550 10,716 Total research and development expenses $ 501,736 $ 525,215 $ (23,479 ) (1) Certain prior period amounts have been reclassified to conform to current period presentation.
During the years ended March 31, 2025, 2024, and 2023, revenue was primarily driven by amounts earned in connection with license agreements at Genevant. 118 Table of Contents Research and development expenses For the years ended March 31, 2025 , 2024 and 2023 , our research and development expenses consisted of the following: Years Ended March 31, Change 2025 2024 (1) 2023 (1) 2025 vs. 2024 2024 vs. 2023 (in thousands) Program-specific costs: Anti-FcRn franchise—neurological diseases $ 93,224 $ 41,060 $ 52,100 $ 52,164 $ (11,040 ) Anti-FcRn franchise—endocrine diseases 63,073 33,205 26,377 29,868 6,828 Anti-FcRn franchise—rheumatology diseases 23,897 — — 23,897 — Anti-FcRn franchise—dermatology diseases 15,633 — — 15,633 — Anti-FcRn franchise—other clinical and nonclinical 9,327 39,811 5,553 (30,484 ) 34,258 Brepocitinib 45,125 38,563 38,627 6,562 (64 ) Mosliciguat 19,746 4,307 — 15,439 4,307 Namilumab (2) 12,744 13,236 11,757 (492 ) 1,479 RVT-2001 (2) 1,916 10,132 16,075 (8,216 ) (5,943 ) RVT-3101 — 35,129 7,559 (35,129 ) 27,570 Other development and discovery programs 43,069 33,773 124,502 9,296 (90,729 ) Total program-specific costs 327,754 249,216 282,550 78,538 (33,334 ) Unallocated internal costs: Share-based compensation 39,780 32,400 28,669 7,380 3,731 Personnel-related expenses 146,162 123,283 118,523 22,879 4,760 Other expenses 36,717 35,010 24,320 1,707 10,690 Total research and development expenses $ 550,413 $ 439,909 $ 454,062 $ 110,504 $ (14,153 ) (1) Certain prior period amounts have been reclassified to conform to current period presentation.
As of March 31, 2024, the remaining minimum purchase commitment related to this agreement was estimated to be approximately $46.2 million; and • certain commitments to GSK pursuant to a commercial supply agreement entered between Dermavant and GSK.
As of March 31, 2025 , the remaining minimum purchase commitment related to this agreement was estimated to be approximately $43.6 million, of which $5.5 million, $10.1 million, $14.0 million and $14.0 million is expected to be paid during the fiscal years ending March 31, 2026, 2028, 2029 and 2030, respectively.
Removed
Components of Results of Operations Product revenue, net With the FDA approval of VTAMA for the treatment of plaque psoriasis in adult patients and our initial product launch in May 2022, we began to recognize product revenues. We record product revenue net of estimated chargebacks, discounts, rebates, returns, and other allowances associated with the respective sales.
Added
Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. 114 Table of Contents Components of Results of Operations Revenue Revenue primarily relates to amounts earned in connection with license agreements, as well as revenue generated by subscription and service-based fees.
Removed
License, milestone and other revenue License, milestone and other revenue includes the recognition of payments received in connection with license agreements as well as revenue generated by subscription and service-based fees. Cost of revenues We began to recognize cost of product revenues after the initial product launch of VTAMA in May 2022.
Added
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.
Removed
Cost of product revenues includes the cost of producing and distributing inventories related to product revenue during the respective period, including manufacturing, freight, and indirect overhead costs. Additionally, milestone payments made in connection with regulatory approvals and sales-based milestones are capitalized and amortized to cost of revenue over the remaining useful life of the asset.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

155 edited+94 added−117 removed107 unchanged
Biggest changeConsolidated Statements of Shareholders’ Equity and Redeemable Noncontrolling Interest (in thousands, except share data) Shareholders’ Equity Redeemable Noncontrolling Interest Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss (Accumulated Deficit) / Retained Earnings Noncontrolling Interests Total Shareholders’ Equity Shares Amount Balance at March 31, 2022 $ 22,491 694,975,965 $ — $ 4,421,614 $ (946 ) $ (2,763,724 ) $ 381,999 $ 2,038,943 Issuance of the Company’s common shares, net of issuance costs — 50,666,665 — 311,683 — — — 311,683 Issuance of common shares in connection with equity incentive plans and tax withholding payments — 10,903,648 — (8,737 ) — — — (8,737 ) Issuance of the Company’s common shares related to settlement of transaction consideration — 1,455,719 — — — — — — Issuance of the Company’s common shares and other consideration for an acquisition — 2,029,877 — 8,836 — — 112 8,948 Issuance of subsidiary common shares to the Company and cash contributions to majority-owned subsidiaries — — — (5,463 ) — — 5,463 — Issuance of subsidiary common shares, net of issuance costs — — — 19,599 — — 48,129 67,728 Subsidiary stock options exercised — — — 392 — — 278 670 Issuance of subsidiary preferred shares — — — — — — 87,500 87,500 Deconsolidation of subsidiaries (22,491 ) — — — — — (292 ) (292 ) Issuance of common shares under employee stock purchase plan — 111,519 — 316 — — — 316 Share-based compensation — — — 184,897 — — 32,884 217,781 Foreign currency translation adjustment — — — — (1,671 ) — 181 (1,490 ) Net loss — — — — — (1,009,030 ) (106,433 ) (1,115,463 ) Balance at March 31, 2023 $ — $ 760,143,393 $ — $ 4,933,137 $ (2,617 ) $ (3,772,754 ) $ 449,821 $ 1,607,587 Issuance of the Company’s common shares, net of issuance costs — 19,600,685 — 199,822 — — — 199,822 Issuance of the Company’s common shares in connection with equity incentive plans, net of forfeitures, and tax withholding payments — 18,926,077 — 10,857 — — — 10,857 Issuance of the Company’s common shares related to settlement of warrants — 7,554,549 — 83,264 — — — 83,264 Issuance of the Company’s common shares related to settlement of transaction consideration — 313,023 — — — — — — Issuance of the Company’s common shares under employee stock purchase plan — 140,227 — 951 — — — 951 Issuance of subsidiary common shares, net of issuance costs — — — 129,763 — — 108,970 238,733 Subsidiary stock options exercised — — — 3,192 — — 2,550 5,742 Issuance of subsidiary common shares to the Company and cash contributions to majority-owned subsidiaries — — — (106,531 ) — — 106,531 — Deconsolidation of subsidiaries — — — — — — (35,148 ) (35,148 ) Dividend declared by subsidiary — — — — — — (6,000 ) (6,000 ) Disposition of Telavant — — — — — — (87,500 ) (87,500 ) Share-based compensation — — — 142,037 — — 57,914 199,951 Foreign currency translation adjustment — — — — (1,466 ) — 530 (936 ) Net income (loss) — — — — — 4,348,926 (117,720 ) 4,231,206 Balance at March 31, 2024 $ — 806,677,954 $ — $ 5,396,492 $ (4,083 ) $ 576,172 $ 479,948 $ 6,448,529 The accompanying notes are an integral part of these consolidated financial statements. 142 Table of Contents ROIVANT SCIENCES LTD.
Biggest changeConsolidated Statements of Shareholders’ Equity and Redeemable Noncontrolling Interest (in thousands, except share data) Shareholders’ Equity Redeemable Noncontrolling Interest Common Stock Additional Paid-in Capital Accumulated Other Comprehensive (Loss) Income (Accumulated Deficit) / Retained Earnings Noncontrolling Interests Total Shareholders’ Equity Shares Amount Balance at March 31, 2022 $ 22,491 694,975,965 $ — $ 4,421,614 $ (946 ) $ (2,763,724 ) $ 381,999 $ 2,038,943 Issuance of the Company’s common shares, net of issuance costs — 50,666,665 — 311,683 — — — 311,683 Issuance of common shares in connection with equity incentive plans and tax withholding payments — 10,903,648 — (8,737 ) — — — (8,737 ) Issuance of the Company’s common shares related to settlement of transaction consideration — 1,455,719 — — — — — — Issuance of the Company’s common shares and other consideration for an acquisition — 2,029,877 — 8,836 — — 112 8,948 Issuance of subsidiary common shares to the Company and cash contributions to majority-owned subsidiaries — — — (5,463 ) — — 5,463 — Issuance of subsidiary common shares, net of issuance costs — — — 19,599 — — 48,129 67,728 Subsidiary stock options exercised — — — 392 — — 278 670 Issuance of subsidiary preferred shares — — — — — — 87,500 87,500 Deconsolidation of subsidiaries (22,491 ) — — — — — (292 ) (292 ) Issuance of common shares under employee stock purchase plan — 111,519 — 316 — — — 316 Share-based compensation — — — 184,897 — — 32,884 217,781 Foreign currency translation adjustment — — — — (1,671 ) — 181 (1,490 ) Net loss — — — — — (1,009,030 ) (106,433 ) (1,115,463 ) Balance at March 31, 2023 $ — 760,143,393 $ — $ 4,933,137 $ (2,617 ) $ (3,772,754 ) $ 449,821 $ 1,607,587 Issuance of the Company’s common shares, net of issuance costs — 19,600,685 — 199,822 — — — 199,822 Issuance of the Company’s common shares in connection with equity incentive plans, net of forfeitures, and tax withholding payments — 18,926,077 — 10,857 — — — 10,857 Issuance of the Company’s common shares related to settlement of warrants — 7,554,549 — 83,264 — — — 83,264 Issuance of the Company’s common shares related to settlement of transaction consideration — 313,023 — — — — — — Issuance of the Company’s common shares under employee stock purchase plan — 140,227 — 951 — — — 951 Issuance of subsidiary common shares, net of issuance costs — — — 129,763 — — 108,970 238,733 Subsidiary stock options exercised — — — 3,192 — — 2,550 5,742 Issuance of subsidiary common shares to the Company and cash contributions to majority-owned subsidiaries — — — (106,531 ) — — 106,531 — Deconsolidation of subsidiaries — — — — — — (35,148 ) (35,148 ) Dividend declared by subsidiary — — — — — — (6,000 ) (6,000 ) Disposition of Telavant — — — — — — (87,500 ) (87,500 ) Share-based compensation — — — 142,037 — — 57,914 199,951 Foreign currency translation adjustment — — — — (1,466 ) — 530 (936 ) Net income (loss) — — — — — 4,348,926 (117,720 ) 4,231,206 Balance at March 31, 2024 $ — 806,677,954 $ — $ 5,396,492 $ (4,083 ) $ 576,172 $ 479,948 $ 6,448,529 Issuance of the Company’s common shares in connection with equity incentive plans, net of forfeitures, and tax withholding payments — 17,503,515 — 7,354 — — — 7,354 Issuance of subsidiary common shares, net — — — 77,267 — — 47,162 124,429 Sale of interests in subsidiary — — — — — — (48,079 ) (48,079 ) Subsidiary stock options exercised — — — 2,852 — — 2,175 5,027 Issuance of the Company’s common shares under employee stock purchase plan — 118,640 — 1,028 — — — 1,028 Issuance of subsidiary common shares to the Company and cash contributions to majority-owned subsidiaries — — — (142,100 ) — — 142,100 — Deconsolidation of subsidiary — — — — — — (3,706 ) (3,706 ) Repurchase of the Company’s common shares — (128,361,786 ) — (1,005,101 ) — (288,131 ) — (1,293,232 ) Share-based compensation — — — 224,315 — — 64,808 289,123 Change in fair value of debt due to change in subsidiary credit risk — — — — (1,200 ) — — (1,200 ) Foreign currency translation adjustment — — — — (5,148 ) — (62 ) (5,210 ) Amounts reclassified from accumulated other comprehensive (loss) income — — — — 19,869 — — 19,869 Net loss — — — — — (171,981 ) (184,753 ) (356,734 ) Balance at March 31, 2025 $ — 695,938,323 $ — $ 4,562,107 $ 9,438 $ 116,060 $ 499,593 $ 5,187,198 The accompanying notes are an integral part of these consolidated financial statements. 137 Table of Contents ROIVANT SCIENCES LTD.
Certain transactions of the Company and its subsidiaries are denominated in currencies other than their functional currency. Adjustments resulting from the translation of the financial statements of the Company’s foreign functional currency subsidiaries into U.S. dollars are excluded from the determination of net loss and are accumulated in a separate component of shareholders’ equity.
Adjustments resulting from the translation of the financial statements of the Company’s foreign functional currency subsidiaries into U.S. dollars are excluded from the determination of net loss and are accumulated in a separate component of shareholders’ equity. Certain transactions of the Company and its subsidiaries are denominated in currencies other than their functional currency.
The amendments are effective for fiscal years beginning after December 15, 2024 and is applicable to the Company’s fiscal year beginning April 1, 2025, with early adoption permitted. The amendments should be applied prospectively, however retrospective application is permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements.
The amendments are effective for fiscal years beginning after December 15, 2024 and are applicable to the Company’s fiscal year beginning April 1, 2025, with early adoption permitted. The amendments should be applied prospectively, however retrospective application is permitted. The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements.
In the event any CVARs have satisfied the time-based service and liquidity event vesting requirements (“service-vested CVARs”) but have not satisfied the applicable hurdle price on an applicable measurement date, then such CVARs will be deemed to remain outstanding and the applicable award holder will be provided the right to earn such CVARs if the hurdle price is satisfied on subsequent annual “hurdle measurement dates” prior to the original expiration date of the CVARs, being March 31, 2026.
In the event any CVARs have satisfied the time-based service and liquidity event vesting requirements (“service-vested CVARs”) but have not satisfied the hurdle price on an applicable measurement date, then such CVARs will be deemed to remain outstanding and the applicable award holder will be provided the right to earn such CVARs if the hurdle price is satisfied on subsequent annual “hurdle measurement dates” prior to the original expiration date of the CVARs, being March 31, 2026.
The Company elected the practical expedient not to apply the recognition and measurement requirements to short-term leases, which is any lease with a term of one year or less as of the lease commencement date. Leases may require the Company to pay additional amounts for taxes, insurance, maintenance, and other expenses, which are generally referred to as non-lease components.
The Company elected the practical expedient not to apply the recognition and measurement requirements to short-term leases, which are any leases with a term of one year or less as of the lease commencement date. Leases may require the Company to pay additional amounts for taxes, insurance, maintenance and other expenses, which are generally referred to as non-lease components.
Foreign exchange transaction gains and losses are included in “Other expense (income), net” in the Company’s statements of operations. (R) Revenue Recognition 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.
Foreign exchange transaction gains and losses are included in “Other expense, net” in the Company’s statements of operations. (R) Revenue Recognition 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.
If any Earn-Out Shares have not vested on or prior to the end of such Vesting Period, then such Earn-Out Shares will be forfeited. The Earn-Out Shares require liability classification and are classified as “Liability instruments measured at fair value” on the consolidated balance sheets.
If any Earn-Out Shares have not vested on or prior to the end of such Vesting Period, then such Earn-Out Shares will be forfeited. The Earn-Out Shares require liability classification and are classified as “Liability instruments measured at fair value” on the accompanying consolidated balance sheets.
Achievement of these royalties and commercial milestones may solely depend upon performance of the licensee. Revenue is also generated by certain technology-focused contracts from subscription and service-based fees recognized for the use of certain technology internally developed. Subscription revenue is recognized ratably over the contract period.
Achievement of these royalties and commercial milestones may solely depend upon performance of the licensee. 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.
The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate. 136 Table of Contents Clinical Trial Accrual Description of the Matter As discussed in Note 2 to the consolidated financial statements, the Company accrues costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by contract research organizations.
The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate. 131 Table of Contents Clinical Trial Accrual Description of the Matter As discussed in Note 2 to the consolidated financial statements, the Company accrues costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by contract research organizations.
The election to use the measurement alternative is made for each eligible investment. The Company has elected the fair value option to account for certain investments over which the Company has significant influence. The Company believes the fair value option best reflects the underlying economics of the investment.
The election to use the measurement alternative is made for each eligible investment. The Company has elected the fair value option to account for certain investments over which the Company has significant influence. The Company believes the fair value option best reflects the underlying economics of these investments.
The Company’s unrecognized tax benefit activity during the years ended March 31, 2024 and March 31, 2023 were not material to the Company’s consolidated financial statements. No interest and penalties related to unrecognized tax benefits were recorded as of March 31, 2024 or March 31, 2023 .
The Company’s unrecognized tax benefit activity during the years ended March 31, 2025, 2024 and 2023 were not material to the Company’s consolidated financial statements. No interest and penalties related to unrecognized tax benefits were recorded as of March 31, 2025, 2024 or 2023 .
Auditing the Company’s accrual for clinical trial costs is especially complex due to the fact that information necessary to estimate the accruals is accumulated from clinical research organizations and the Company’s assessment of that information is subject to variability and uncertainty.
Auditing the Company’s accrual for clinical trial costs is complex due to the fact that information necessary to estimate the accruals is accumulated from clinical research organizations and the Company’s assessment of that information is subject to variability and uncertainty.
Under the terms of the Warrant Agreement, the Company was entitled to redeem the Public Warrants at a redemption price of $0.10 per Public Warrant because the last reported sales price (the “Reference Value”) of the Company’s common shares was at least $10.00 per share for any twenty (20) trading days within the thirty (30) trading-day period ending on the third trading day prior to the date on which RSL gave a Notice of Redemption.
Under the terms of the Warrant Agreement, the Company was entitled to redeem the Public Warrants at a redemption price of $0.10 per Public Warrant because the last reported sales price (the “Reference Value”) of the Company’s common shares was at least $10.00 per share for any 20 trading days within the 30 trading-day period ending on the third trading day prior to the date on which RSL gave a Notice of Redemption.
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. • 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).
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. 144 Table of Contents • 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).
(C) Common Share Purchase and Share Agreements In September 2023, the Company entered into common share purchase and sale agreements with certain institutional investors, pursuant to which the Company sold an aggregate of 19,600,685 of its common shares at a purchase price of $10.21 per share. Net proceeds to the Company were approximately $199.8 million after deducting offering expenses.
(D) Common Share Purchase and Share Agreements In September 2023, the Company entered into common share purchase and sale agreements with certain institutional investors, pursuant to which the Company sold an aggregate of 19,600,685 of its common shares at a purchase price of $10.21 per share. Net proceeds to the Company were approximately $199.8 million after deducting offering expenses.
As a result of this transaction, the Company deconsolidated Cytovant and recorded a gain on deconsolidation of $16.8 million, primarily as a result of relieving its redeemable noncontrolling interest, in the accompanying consolidated statements of operations for the year ended March 31, 2023 . (E) Consolidated Vant Equity Transactions Immunovant In October 2022, the Company’s subsidiary, Immunovant, Inc.
As a result of this transaction, the Company deconsolidated Cytovant and recorded a gain on deconsolidation of $16.8 million, primarily as a result of relieving its redeemable noncontrolling interest, in the accompanying consolidated statements of operations for the year ended March 31, 2023 . (F) Consolidated Vant Equity Transactions Immunovant In October 2022, the Company’s subsidiary, Immunovant, Inc.
We also evaluated management’s estimates of the vendor’s progress for a sample of clinical trials by making direct inquiries of the Company’s operations personnel overseeing the clinical trials and obtaining information directly from certain service providers about the service providers’ estimate of costs that had been incurred through March 31, 2024.
We also evaluated management’s estimates of the vendor’s progress for a sample of clinical trials by making direct inquiries of the Company’s operations personnel overseeing the clinical trials and obtaining information directly from certain service providers about the service providers’ estimate of costs that had been incurred through March 31, 2025.
(G) Property and Equipment Property and equipment, consisting primarily of computers, laboratory and other equipment, furniture and fixtures, software, and leasehold improvements, is recorded at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred.
(H) Property and Equipment Property and equipment, consisting primarily of computers, laboratory and other equipment, furniture and fixtures, software and leasehold improvements, is recorded at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred.
Share-based compensation expense included in SG&A expense for the year ended March 31, 2023 includes a reversal of expense of $20.8 million related to the modification of these awards. (B) Employee Stock Purchase Plan In September 2021, the Company adopted the Roivant Sciences Ltd.
Share-based compensation expense included in G&A expense for the year ended March 31, 2023 includes a reversal of expense of $20.8 million related to the modification of these awards. (B) Employee Stock Purchase Plan In September 2021, the Company adopted the Roivant Sciences Ltd.
A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s financial instruments include shares of common stock of Arbutus Biopharma Corporation (“Arbutus”); Class A units of Heracles Parent, L.L.C.
A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s financial instruments include shares of common stock of Arbutus Biopharma Corporation (“Arbutus”) and Class A units of Heracles Parent, L.L.C. (“Datavant”).
(D) Disposal of Cytovant In July 2022, the Company exited its operations in Cytovant Sciences HK Limited (“Cytovant”) by transferring all of its equity interest to certain investors holding Series A-1 preference shares of Cytovant in exchange for nominal consideration.
(E) Disposal of Cytovant In July 2022, the Company exited its operations in Cytovant Sciences HK Limited (“Cytovant”) by transferring all of its equity interest to certain investors holding Series A-1 preference shares of Cytovant in exchange for nominal consideration.
The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the related revenue recognition accordingly. 151 Table of Contents • 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.
The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the related revenue recognition accordingly. • 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.
In October 2023, the Company’s subsidiary, Immunovant, Inc., completed an underwritten public offering of 8,475,500 shares of its common stock (including 1,526,316 shares of common stock purchased by the Company on the same terms as other investors in the offering and the full exercise of the underwriters’ option to purchase 1,105,500 additional shares of common stock) at a price to the public of $38.00 per share.
In October 2023, Immunovant completed an underwritten public offering of 8,475,500 shares of its common stock (including 1,526,316 shares of common stock purchased by the Company on the same terms as other investors in the offering and the full exercise of the underwriters’ option to purchase 1,105,500 additional shares of common stock) at a price to the public of $38.00 per share.
The Earn-Out Shares liability is subject to remeasurement at each balance sheet date with changes in fair value recognized in the Company’s consolidated statements of operations. As of March 31, 2024, no Earn-Out Shares have vested.
The Earn-Out Shares liability is subject to remeasurement at each balance sheet date with changes in fair value recognized in the Company’s consolidated statements of operations. As of March 31, 2025, no Earn-Out Shares have vested.
(P) Share-Based Compensation Share-based awards to employees, directors, and consultants, including stock options, restricted stock units, performance options and capped value appreciation rights, are measured at fair value on the date of the grant and that fair value is recognized as share-based compensation expense in the Company’s consolidated statements of operations over the requisite service period of the respective award.
(P) Share-Based Compensation Share-based awards to employees, directors and consultants, including stock options, restricted stock units (“RSUs”), performance options, performance restricted stock units (“PSUs”) and capped value appreciation rights (“CVARs”), are measured at fair value on the date of the grant and that fair value is recognized as share-based compensation expense in the Company’s consolidated statements of operations over the requisite service period of the respective award.
In those cases, payments for milestones achieved and payments for a product license prior to regulatory approval of the product are expensed in the period incurred. Payments made in connection with regulatory and sales-based milestones are capitalized and amortized to cost of revenue.
In those cases, payments for milestones achieved and payments for a product license prior to regulatory approval of the product are expensed in the period incurred. Payments made in connection with regulatory and sales-based milestones are capitalized and amortized to cost of revenues.
Changes in the fair value related to updated assumptions and estimates are recorded within the consolidated statements of operations at the end of each reporting period. 170 Table of Contents The fair value of Level 3 assets and liabilities may change significantly as additional data are obtained, impacting the Company’s assumptions regarding probabilities of potential scenarios used to estimate fair value.
Changes in the fair value related to updated assumptions and estimates are recorded within the consolidated statements of operations at the end of each reporting period. The fair value of Level 3 assets and liabilities may change significantly as additional data are obtained, impacting the Company’s assumptions regarding probabilities of potential scenarios used to estimate fair value.
Trade Receivables, Net The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in customer credit profiles.
Trade Receivables, Net T he Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in customer credit profiles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of March 31, 2024, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework) and our report dated May 30, 2024 expressed an unqualified opinion thereon.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of March 31, 2025, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework) and our report dated May 29, 2025 expressed an unqualified opinion thereon.
To evaluate the completeness of the accruals, we also examined subsequent invoices from the service providers and cash disbursements to the service providers, to the extent such invoices were received, or payments were made prior to the date that the consolidated financial statements were issued. 137 Table of Contents Valuation of Investment in Datavant Description of the Matter At March 31, 2024, the fair value of the Company’s minority equity investment in Heracles Parent, L.L.C.
To evaluate the completeness of the accruals, we also examined subsequent invoices from the service providers and cash disbursements to the service providers, to the extent such invoices were received, or payments were made prior to the date that the consolidated financial statements were issued. 132 Table of Contents Valuation of Investment in Datavant Description of the Matter At March 31, 2025, the fair value of the Company’s minority equity investment in Heracles Parent, L.L.C.
The effective tax rate for the year ended March 31, 2023 is driven by the earnings by jurisdiction and a valuation allowance that eliminates the Company’s global net deferred tax assets.
The effective tax rate for the year ended March 31, 2025 is driven by earnings by jurisdiction and a valuation allowance that eliminates the Company’s global net deferred tax assets.
Diluted net income (loss) per common share is computed by dividing the net income (loss) attributable to Roivant Sciences Ltd. by the diluted weighted-average number of common stock outstanding during the period.
Diluted net (loss) income per common share is computed by dividing the net (loss) income attributable to Roivant Sciences Ltd. by the diluted weighted-average number of common shares outstanding during the period.
During the years ended March 31, 2024 and 2023, 140,227 and 111,519 common shares were purchased and issued under the RSL ESPP, respectively. Share-based compensation expense recorded was approximately $0.5 million and $0.3 million for the years ended March 31, 2024 and 2023, respectively .
During the years ended March 31, 2025, 2024 and 2023, 118,640, 140,227 and 111,519 common shares were purchased and issued under the RSL ESPP, respectively. Share-based compensation expense recorded was approximately $0.5 million, $0.5 million and $0.3 million for the years ended March 31, 2025, 2024 and 2023, respectively.
Years Ended March 31, Assumptions 2024 2023 Expected stock price volatility 72.22 % 85.95 % Expected risk free interest rate 3.72 % 2.89 % Expected term, in years 6.21 6.25 Expected dividend yield — % — % Additional information regarding stock options and performance stock options is set forth below (in thousands, except per share data).
Years Ended March 31, Assumptions 2025 2024 2023 Expected stock price volatility 70.52 % 72.22 % 85.95 % Expected risk free interest rate 4.52 % 3.72 % 2.89 % Expected term, in years 6.21 6.21 6.25 Expected dividend yield — % — % — % Additional information regarding stock options and performance stock options is set forth below (in thousands, except per share data).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at March 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended March 31, 2024, in conformity with U.S. generally accepted accounting principles.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at March 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended March 31, 2025, in conformity with U.S. generally accepted accounting principles.
The Company reserves against trade receivables for estimated losses that may arise from a customer’s inability to pay, and any amounts determined to be uncollectible are written off against the reserve when it is probable that the receivable will not be collected. The reserve amount for estimated losses was de minimis as of March 31, 2024 and 2023.
The Company reserves against trade receivables for estimated losses that may arise from a customer’s inability to pay, and any amounts determined to be uncollec tible are written off against the reserve when it is probable that the receivable will not be collected. The reserve amount for estimated losses was de minimis as of March 31, 2025 and 2024.
(the Company) as of March 31, 2024 and 2023, the related consolidated statements of operations, comprehensive income (loss), shareholders’ equity and redeemable noncontrolling interest and cash flows for each of the two years in the period ended March 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”).
(the Company) as of March 31, 2025 and 2024, the related consolidated statements of operations, comprehensive (loss) income, shareholders’ equity and redeemable noncontrolling interest and cash flows for each of the three years in the period ended March 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”).
The Company evaluates in-licensed agreements for IPR&D projects to determine if it meets the definition of a business and thus should be accounted for as a business combination.
The Company evaluates in-licensed agreements for IPR&D projects to determine if the acquired set meets the definition of a business and thus should be accounted for as a business combination.
The Roche Transaction was made pursuant to a Stock Purchase Agreement dated October 22, 2023 among the Company, Telavant, Pfizer Inc. (“Pfizer”), and Roche (the “Stock Purchase Agreement”).
(“Roche”) (the “Roche Transaction”). The Roche Transaction was made pursuant to a Stock Purchase Agreement dated October 22, 2023 among the Company, Telavant, Pfizer Inc. (“Pfizer”) and Roche (the “Stock Purchase Agreement”).
For the period April 1, 2023 through March 31, 2024, the valuation allowance increased by $92.3 million, primarily as a result of corresponding increases in our global net operating losses. The amount of the deferred tax asset considered realizable could be adjusted for future factors that would impact the assessment of the objective and subjective evidence of the Company.
For the period April 1, 2024 through March 31, 2025, the valuation allowance increased by $142.4 million, primarily as a result of corresponding increases in our global net operating losses. The amount of the deferred tax asset considered realizable could be adjusted for future factors that would impact the assessment of the objective and subjective evidence of the Company.
Note 11—Share-Based Compensation (A) RSL Equity Incentive Plans RSL has three equity incentive plans: the Roivant Sciences Ltd. 2021 Equity Incentive Plan (the “RSL 2021 EIP”), the Roivant Sciences Ltd. Amended and Restated 2015 Equity Incentive Plan (the “RSL 2015 EIP”), and the Roivant Sciences Ltd.
Note 9—Share-Based Compensation and Other Compensation Plans (A) RSL Equity Incentive Plans RSL has three equity incentive plans: the Roivant Sciences Ltd. 2021 Equity Incentive Plan (the “RSL 2021 EIP”), the Roivant Sciences Ltd. Amended and Restated 2015 Equity Incentive Plan (the “RSL 2015 EIP”) and the Roivant Sciences Ltd.
As a basis for considering market participant assumptions in fair value measurements, the guidance establishes a three-tier fair value hierarchy that distinguishes among the following: • Level 1-Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2-Valuations are based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. • Level 3-Valuations are based on inputs that are unobservable (supported by little or no market activity) and significant to the overall fair value measurement.
As a basis for considering market participant assumptions in fair value measurements, the guidance establishes a three-tier fair value hierarchy that distinguishes among the following: 141 Table of Contents • Level 1-Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2-Valuations are based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. • Level 3-Valuations are based on inputs that are unobservable (supported by little or no market activity) and significant to the overall fair value measurement.
Refer to Note 15, “Earn-Out Shares, Public Warrants and Private Placement Warrants” for additional details.
Refer to Note 13, “Earn-Out Shares, Public Warrants and Private Placement Warrants” for additional details.
All March 2020 CVARs have been fully expensed as of March 31, 2024 . November 2021 CVAR Grants In November 2021, the Company made one-time grants of 6,317,350 CVARs in the aggregate under the RSL 2021 EIP to eligible participants. The CVARs are eligible to vest based on the satisfaction of service-based and performance-based vesting requirements.
All March 2020 CVARs have been fully expensed since December 2023. November 2021 CVAR Grants In November 2021, the Company made one-time grants of 6,317,350 CVARs in the aggregate under the RSL 2021 EIP to eligible participants. The CVARs are eligible to vest based on the satisfaction of service-based and performance-based vesting requirements.
The valuation specialists’ procedures included independently developing fair value estimates and comparing them to the amounts recorded. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2016. Iselin, New Jersey May 30, 2024 138 Table of Contents ROIVANT SCIENCES LTD.
The valuation specialists’ procedures included independently developing fair value estimates and comparing them to the amounts recorded. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2016. Iselin, New Jersey May 29, 2025 133 Table of Contents ROIVANT SCIENCES LTD.
If the in-licensed agreement for IPR&D does not meet the definition of a business and the assets have not reached technological feasibility and have no alternative future use, the Company expenses payments made under such license agreements as acquired in-process research and development expense in its consolidated statements of operations.
If the acquired set does not meet the definition of a business and the assets have not reached technological feasibility and have no alternative future use, the Company expenses payments made under such license agreements as acquired in-process research and development expense in its consolidated statements of operations.
Due to the Company’s cumulative loss position which provides significant negative evidence difficult to overcome, the Company has recorded a valuation allowance of $766.8 million as of March 31, 2024, representing the portion of the deferred tax asset that is not more likely than not to be realized.
Due to the Company’s cumulative loss position which provides significant negative evidence difficult to overcome, the Company has recorded a valuation allowance of $701.2 million as of March 31, 2025, representing the portion of the deferred tax asset that is not more likely than not to be realized.
In particular, to value its investment in Datavant, the Company used significant unobservable inputs such as the weighted average cost of capital, revenue growth rate, earnings before interest, taxes, depreciation and amortization and terminal growth rate, which are affected by expectations about future market or economic conditions.
In particular, to value its investment in Datavant, the Company used significant unobservable inputs such as the discount rate, revenue growth rate, earnings before interest, taxes, depreciation and amortization and terminal growth rate, which are affected by expectations about future market or economic conditions.
(“Datavant”) was $147.5 million and was classified as Level 3 within the fair value hierarchy. As discussed in Notes 4 and 16 to the consolidated financial statements, the Company has elected the fair value option to account for its investment in Datavant.
(“Datavant”) was $167.4 million and was classified as Level 3 within the fair value hierarchy. As discussed in Notes 4 and 14 to the consolidated financial statements, the Company has elected the fair value option to account for its investment in Datavant.
(C) Concentrations Financial instruments that potentially subject the Company to concentration of credit risk include cash and cash equivalents. The Company maintains cash deposits and cash equivalents in highly-rated, federally-insured financial institutions in excess of federally insured limits. The Company has established guidelines relative to diversification and maturities to maintain safety and liquidity.
(C) Concentrations Financial instruments that potentially subject the Company to concentration of credit risk include cash, cash equivalents and marketable securities. The Company maintains cash deposits and cash equivalents in, and invests in marketable securities through, highly-rated, federally-insured financial institutions in excess of federally insured limits. The Company has established guidelines regarding diversification and maturities to maintain safety and liquidity.
See Note 5, “Intangible Assets.” (J) Fair Value Measurements The Company utilizes fair value measurement guidance prescribed by U.S. GAAP to value its financial instruments. The guidance establishes a fair value hierarchy for financial instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs).
See Note 4, “Equity Method Investments.” (J) Fair Value Measurements The Company utilizes fair value measurement guidance prescribed by U.S. GAAP to value its financial instruments. The guidance establishes a fair value hierarchy for financial instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs).
License, Milestone and Other Revenue The Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating transaction price to performance obligations within a contract, determining when performance obligations have been met, assessing the recognition and future reversal of variable consideration, and determining and applying appropriate methods of measuring progress for performance obligations satisfied over time.
The Company applies significant 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.
Auditing the fair value of the Company’s investment in Datavant was complex and required substantial auditor judgment due to the significant estimation required in determining the fair value of the investment in Datavant.
Auditing the fair value of the Company’s investment in Datavant is especially complex and requires substantial auditor judgment due to the significant estimation required in determining the fair value of the investment in Datavant.
Prior to April 1, 2024, the board of directors resolved not to increase the number of common shares reserved for issuance under the RSL 2021 EIP on April 1, 2024, but instead to defer until later this fiscal year the decision as to whether to increase the reserve by up to 5% of the common shares outstanding as of the March 31, 2024.
Prior to April 1, 2025, the Company’s board of directors resolved not to increase the number of common shares reserved for issuance under the RSL 2021 EIP on April 1, 2025, but instead to defer until later during the year ending March 31, 2026 the decision as to whether to increase the reserve by up to 5% of the common shares outstanding as of March 31, 2025.
Pursuant to the share repurchase program, on April 2, 2024, the Company entered into a share repurchase agreement with Sumitomo to repurchase all 71,251,083 common shares held by Sumitomo at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million. The repurchase transaction with Sumitomo was completed on April 2, 2024.
In April 2024, pursuant to the share repurchase program, the Company entered into a share repurchase agreement with Sumitomo and repurchased all 71,251,083 common shares held by Sumitomo at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million.
(H) Investments Investments in equity securities may be accounted for using (i) the fair value option if elected, (ii) fair value through earnings if fair value is readily determinable or (iii) for equity investments without readily determinable fair values, the measurement alternative to measure at cost adjusted for any impairment and observable price changes, as applicable.
(I) Investments in Equity Securities Investments in equity securities for which the Company does not have control or significant influence may be accounted for using (i) the fair value option, if elected, (ii) fair value through earnings, if fair value is readily determinable or (iii) for equity investments without readily determinable fair values, the measurement alternative to measure at cost adjusted for any impairment and observable price changes, as applicable.
Of these common shares, 20,000,000 were sold by RSL and 10,000,000 were sold by certain selling shareholders. Net proceeds to the Company were approximately $94.7 million after deducting underwriting discounts and commissions and offering expenses. The Company did not receive any proceeds from the sale of common shares by the selling shareholders in the offering.
Net proceeds to the Company were approximately $94.7 million after deducting underwriting discounts and commissions and offering expenses. The Company did not receive any proceeds from the sale of common shares by the selling shareholders in the offering.
All other CVARs granted in March 2020 that remain outstanding have met the service vesting condition as of March 31, 2024 but have not satisfied their applicable hurdle price on an applicable hurdle measurement date. The total fair value of CVARs that service-vested during the years ended March 31, 2024 and 2023 was $2.1 million and $16.7 million , respectively.
As of March 31, 2025, 17,548,368 CVARs granted in March 2020 remain outstanding. These CVARs have met the service vesting condition but have not satisfied the $11.50 hurdle price on an applicable hurdle measurement date. The total fair value of CVARs that service-vested during the years ended March 31, 2024 and 2023 was $2.1 million and $16.7 million, respectively.
This share price performance requirement was satisfied as of July 28, 2023. 169 Table of Contents Prior to the Redemption Date, Warrant holders were permitted to exercise the Warrants (i) for cash, at an exercise price of $11.50 per common share, or (ii) on a “cashless basis” whereby, in lieu of paying the Company the $11.50 exercise price per common share, the surrendering holder would receive approximately 0.2495 common shares per Warrant as determined in accordance with the terms of the Warrant Agreement.
Prior to the Redemption Date, Warrant holders were permitted to exercise the Warrants (i) for cash, at an exercise price of $11.50 per common share, or (ii) on a “cashless basis” whereby, in lieu of paying the Company the $11.50 exercise price per common share, the surrendering holder would receive approximately 0.2495 common shares per Warrant as determined in accordance with the terms of the Warrant Agreement.
Any references in these notes to applicable accounting guidance are meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (‘‘ASC’’) and Accounting Standards Updates (‘‘ASU’’) of the Financial Accounting Standards Board (‘‘FASB’’).
Any references in these notes to applicable accounting guidance are meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
Since the effective date of the RSL 2021 EIP, no further stock awards have been or will be made under the RSL 2015 EIP. Additionally, no further stock awards will be made under the 2015R Plan. As of March 31, 2024, 142,055,968 of the Company’s common shares were reserved for issuance under the RSL 2021 EIP.
Since the effective date of the RSL 2021 EIP, no further stock awards have been or will be made under the RSL 2015 EIP. Additionally, no further stock awards will be made under the 2015R Plan. As of March 31, 2025, 182,389,866 of the Company’s common shares were reserved for issuance under the RSL 2021 EIP.
Index to Consolidated Financial Statements Page Report of Independent Registered Public Accounting Firm (PCAOB ID No. 42 ) 136 Consolidated Financial Statements Consolidated Balance Sheets as of March 31, 2024 and 2023 140 Consolidated Statements of Operations for the Years Ended March 31, 2024 and 2023 141 Consolidated Statements of Comprehensive Income (Loss) for the Years Ended March 31, 2024 and 2023 142 Consolidated Statements of Shareholders’ Equity and Redeemable Noncontrolling Interest for the Years Ended March 31, 2024 and 2023 143 Consolidated Statements of Cash Flows for the Years Ended March 31, 2024 and 2023 144 Notes to Consolidated Financial Statements 145 135 Table of Contents Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors of Roivant Sciences Ltd.
Index Page Report of Independent Registered Public Accounting Firm (PCAOB ID No. 42 ) 131 Consolidated Financial Statements Consolidated Balance Sheets as of March 31, 2025 and 2024 134 Consolidated Statements of Operations for the Years Ended March 31, 2025, 2024 and 2023 135 Consolidated Statements of Comprehensive (Loss) Income for the Years Ended March 31, 2025, 2024 and 2023 136 Consolidated Statements of Shareholders’ Equity and Redeemable Noncontrolling Interest for the Years Ended March 31, 2025, 2024 and 2023 137 Consolidated Statements of Cash Flows for the Years Ended March 31, 2025, 2024 and 2023 138 Notes to Consolidated Financial Statements 139 130 Table of Contents Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors of Roivant Sciences Ltd.
Pursuant to the Stock Purchase Agreement, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of the Roche Transaction and a one-time milestone payment of $150 million in cash payable upon the initiation of a Phase 3 trial in UC.
Pursuant to the Stock Purchase Agreement, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of the Roche Transaction in December 2023, as well as a one-time milestone payment of $150 million in cash, paid in August 2024 following the initiation of a Phase 3 trial in UC.
(D) Cash, Cash Equivalents, and Restricted Cash Cash and cash equivalents include cash deposits in banks and all highly liquid investments that are readily convertible to cash. The Company considers all highly liquid investments purchased with original maturities of three months or less to be cash equivalents.
(E) Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents include cash deposits in banks and all highly liquid investments that are readily convertible to cash. The Company considers all highly liquid investments purchased with original maturities of three months or less to be cash equivalents. Cash equivalents consist of amounts invested in money market funds.
These judgments are discussed in more detail below. • Licenses of intellectual property: If the licenses to intellectual property are determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license.
These judgments are discussed in more detail below. • 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.
During the year ended March 31, 2024, 1,247,737 common shares were issued upon their settlement. At March 31, 2024, total unrecognized compensation expense related to non-vested CVARs was approximately $1.3 million and is expected to be recognized over a weighted-average period of approximately 1.12 years.
During the year ended March 31, 2025, 1,186,418 common shares were issued upon their settlement. At March 31, 2025, total unrecognized compensation expense related to non-vested CVARs was approximately $44 thousand and is expected to be recognized over a weighted-average period of approximately 0.12 years.
The Switzerland net operating losses will expire in varying amounts between March 31, 2025 and March 31, 2031.
The Switzerland net operating losses will expire in varying amounts between March 31, 2026 and March 31, 2032.
In addition, because the Reference Value was less than $18.00 per share, the outstanding Private Placement Warrants were also required to be concurrently called for redemption on the same terms as the outstanding Public Warrants.
In addition, because the Reference Value was less than $18.00 per share, the outstanding Private Placement Warrants were also required to be concurrently called for redemption on the same terms as the outstanding Public Warrants. This share price performance requirement was satisfied as of July 28, 2023.
(M) Selling, General and Administrative Expenses Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation, sales incentive compensation, and benefits, for employees engaged in SG&A activities.
(M) General and Administrative Expenses General and administrative (“G&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation and benefits for employees engaged in G&A activities.
For CVARs with the lower hurdle price of $6.40, in the event the fair market value of a common share is greater than $6.40 per share but less than $9.20 per share as of the relevant date of determination (the “Knock-In Condition”), this award of CVARs will remain outstanding unless and until the knock-in condition is satisfied as of any applicable monthly measurement date thereafter before the expiration date of the CVARs.
CVARs with the lower hurdle price of $6.40 were subject to a condition (the “Knock-In Condition”) pursuant to which in the event the fair market value of a common share was greater than $6.40 per share but less than $9.20 per share as of the relevant date of determination, the award of CVARs remained outstanding unless and until the Knock-In Condition was satisfied as of any applicable monthly measurement date before the expiration date of the CVARs.
(2) Primarily relates to deferred tax assets associated with entities no longer included in the consolidated financial statements (i.e., sold, deconsolidated or liquidated). The Company’s effective tax rate for the years ended March 31, 2024 and 2023 was 0.52% and (0.42)%, respectively.
(2) Primarily relates to deferred tax assets associated with entities no longer included in the consolidated financial statements (i.e., sold, deconsolidated or liquidated) and Switzerland expiring net operating losses. The Company’s effective tax rate for the years ended March 31, 2025, 2024 and 2023 was (7.07)%, 0.47% and (0.46)%, respectively.
Consolidated Statements of Cash Flows (in thousands) Years Ended March 31, 2024 2023 Cash flows from operating activities: Net income (loss) $ 4,231,206 $ (1,115,463 ) Adjustments to reconcile net income (loss) to net cash used in operating activities: Non-cash acquired in-process research and development — 87,749 Share-based compensation 199,627 217,781 Change in fair value of investments 47,973 20,815 Change in fair value of debt and liability instruments 78,943 78,001 Gain on deconsolidation of subsidiaries (32,772 ) (29,276 ) Gain on sale of Telavant net assets (5,348,410 ) — Gain on recovery of contingent consideration — (114,561 ) Depreciation and amortization 22,036 18,857 Non-cash lease expense 6,845 7,565 Other 10,249 (21,206 ) Changes in assets and liabilities, net of effects from acquisition and divestiture: Other current assets (81,478 ) (31,670 ) Other assets 16,488 (17,416 ) Accounts payable 22,684 4,359 Accrued expenses 40,150 38,956 Operating lease liabilities (8,326 ) (8,604 ) Accrued interest 21,977 18,571 Other liabilities 7,540 2,149 Net cash used in operating activities (765,268 ) (843,393 ) Cash flows from investing activities: Proceeds from sale of Telavant net assets, net 5,233,396 — Proceeds from sale of subsidiary interests 47,500 — Cash decrease upon deconsolidation of subsidiaries (84,483 ) (6,706 ) Proceeds from sale of Myovant Top-Up Shares — 114,561 Milestone payments — (140,136 ) Purchase of property and equipment (1,382 ) (12,690 ) Other 8,592 702 Net cash provided by (used in) investing activities 5,203,623 (44,269 ) Cash flows from financing activities: Proceeds from issuance of the Company’s common shares, net of issuance costs paid 199,822 311,981 Proceeds from issuance of subsidiary common shares, net of issuance costs paid 238,733 67,727 Proceeds from subsidiary debt financings, net of financing costs paid — 159,899 Payment of subsidiary dividend (6,000 ) — Repayment of debt by subsidiary (29,158 ) (29,452 ) Payment of offering costs and loan origination costs — (2,250 ) Taxes paid related to net settlement of equity awards (37,715 ) (10,881 ) Proceeds from exercise of the Company’s and subsidiary stock options 54,314 2,814 Payments on principal portion of finance lease obligations (1,547 ) (692 ) Proceeds from issuance of the Company’s common stock under employee stock purchase plan 951 316 Proceeds from exercise of the Company’s warrants 5 — Payment for redemptions of the Company’s warrants (41 ) — Net cash provided by financing activities 419,364 499,462 Effect of exchange rate changes on cash, cash equivalents, and restricted cash 616 6,281 Net change in cash, cash equivalents and restricted cash 4,858,335 (381,919 ) Cash, cash equivalents and restricted cash at beginning of period 1,692,115 2,074,034 Cash, cash equivalents and restricted cash at end of period $ 6,550,450 $ 1,692,115 Non-cash investing and financing activities: Cashless exercise of the Company’s warrants $ 83,258 $ — Issuance of the Company’s common shares and other consideration for an acquisition $ — $ 9,694 Other $ 2,231 $ 10,860 Supplemental disclosure of cash paid: Income taxes paid $ 12,354 $ 5,128 Interest paid $ 10,268 $ 5,303 The accompanying notes are an integral part of these consolidated financial statements. 143 Table of Contents ROIVANT SCIENCES LTD.
Consolidated Statements of Cash Flows (in thousands) Years Ended March 31, 2025 2024 2023 Cash flows from operating activities: Net (loss) income $ (356,734 ) $ 4,231,206 $ (1,115,463 ) Adjustments to reconcile net (loss) income to net cash used in operating activities: Non-cash acquired in-process research and development — — 87,749 Share-based compensation 289,029 199,627 217,781 Change in fair value of investments (55,186 ) 47,973 20,815 Change in fair value of debt and liability instruments (113,078 ) 78,943 78,001 Gain on sale of subsidiary interests (376,506 ) — — Gain on deconsolidation of subsidiaries (3,108 ) (32,772 ) (29,276 ) Gain on sale of Telavant net assets (110,387 ) (5,348,410 ) — Gain on recovery of contingent consideration — — (114,561 ) Accretion of discount and amortization of premium on marketable securities, net (69,959 ) — — Loss on extinguishment of debt 8,848 — — Depreciation and amortization 14,071 22,036 18,857 Non-cash lease expense 6,843 6,845 7,565 Other 3,762 10,249 (21,206 ) Changes in assets and liabilities, net of effects from acquisition and divestiture: Other current assets (25,070 ) (81,478 ) (31,670 ) Other assets (8,758 ) 16,488 (17,416 ) Accounts payable (18,168 ) 22,684 4,359 Accrued expenses (10,070 ) 40,150 38,956 Operating lease liabilities (5,700 ) (8,326 ) (8,604 ) Accrued interest — 21,977 18,571 Other liabilities (9,280 ) 7,540 2,149 Net cash used in operating activities (839,451 ) (765,268 ) (843,393 ) Cash flows from investing activities: Purchase of marketable securities (4,061,521 ) — — Maturities of marketable securities 1,960,000 — — Proceeds from sale of Telavant net assets, net 110,387 5,233,396 — Proceeds from sale of subsidiary interests 260,586 47,500 — Cash decrease upon deconsolidation of subsidiaries (31,223 ) (84,483 ) (6,706 ) Proceeds from sale of Myovant Top-Up Shares — — 114,561 Milestone payments — — (140,136 ) Purchase of property and equipment (4,599 ) (1,382 ) (12,690 ) Other 79 8,592 702 Net cash (used in) provided by investing activities (1,766,291 ) 5,203,623 (44,269 ) Cash flows from financing activities: Repurchase of the Company’s common shares (1,293,232 ) — — Proceeds from issuance of the Company’s common shares, net of issuance costs paid — 199,822 311,981 Proceeds from issuance of subsidiary common shares, net of issuance costs paid 112,782 238,733 67,727 Proceeds from subsidiary debt financings, net of financing costs paid — — 159,899 Repayment of debt by subsidiary (51,979 ) (29,158 ) (29,452 ) Payment of offering costs and loan origination costs — — (2,250 ) Proceeds from exercise of the Company’s and subsidiary stock options 49,597 54,314 2,814 Taxes paid related to net settlement of equity awards (37,216 ) (37,715 ) (10,881 ) Proceeds from issuance of the Company’s common shares under employee stock purchase plan 1,028 951 316 Payments on principal portion of finance lease obligations (774 ) (1,547 ) (692 ) Payment of subsidiary dividend — (6,000 ) — Proceeds from exercise of the Company’s warrants — 5 — Payment for redemptions of the Company’s warrants — (41 ) — Net cash (used in) provided by financing activities (1,219,794 ) 419,364 499,462 Effect of exchange rate changes on cash, cash equivalents and restricted cash 747 616 6,281 Net change in cash, cash equivalents and restricted cash (3,824,789 ) 4,858,335 (381,919 ) Cash, cash equivalents and restricted cash at beginning of period 6,550,450 1,692,115 2,074,034 Cash, cash equivalents and restricted cash at end of period $ 2,725,661 $ 6,550,450 $ 1,692,115 Non-cash investing and financing activities: Cashless exercise of the Company’s warrants $ — $ 83,258 $ — Issuance of subsidiary shares in connection with debt renegotiation $ 11,647 $ — $ — Operating lease right-of-use assets obtained and exchanged for operating lease liabilities $ 51,364 $ 1,790 $ 4,224 Issuance of the Company’s common shares and other consideration for an acquisition $ — $ — $ 9,694 Other $ 59 $ 441 $ 6,636 Supplemental disclosure of cash paid: Income taxes paid $ 61,910 $ 12,354 $ 5,128 Interest paid $ 5,963 $ 10,268 $ 5,303 The accompanying notes are an integral part of these consolidated financial statements. 138 Table of Contents ROIVANT SCIENCES LTD.
To date, the Company has not incurred any material costs related to these indemnification obligations and has not accrued any liabilities related to such obligations in the consolidated financial statements as of March 31, 2024 and 2023. 168 Table of Contents Note 15—Earn-Out Shares, Public Warrants and Private Placement Warrants Earn-Out Shares In connection with the Business Combination, the Company issued the following: a. 2,033,591 common shares to Patient Square Capital LLC (the “MAAC Sponsor”) and 10,000 common shares issued to each of MAAC’s independent directors (collectively, the “20% Earn-Out Shares”), which will vest if the closing price of the Company’s common shares is greater than or equal to $15.00 over any twenty out of thirty trading day period during the Vesting Period (defined below). b. 1,016,796 common shares issued to the MAAC Sponsor and 5,000 common shares issued to each of MAAC’s independent directors (collectively, the “10% Earn-Out Shares” and, together with the 20% Earn-Out Shares, the “Earn-Out Shares”), each in respect of its MAAC Class B Shares, will vest if the closing price of the Company’s common shares is greater than or equal to $20.00 over any twenty out of thirty trading day period during the Vesting Period (as defined below). c.
Note 13—Earn-Out Shares, Public Warrants and Private Placement Warrants Earn-Out Shares In connection with the Business Combination, the Company issued the following: 162 Table of Contents a. 2,033,591 common shares to Patient Square Capital LLC (the “MAAC Sponsor”) and 10,000 common shares issued to each of MAAC’s independent directors (collectively, the “20% Earn-Out Shares”), which will vest if the closing price of the Company’s common shares is greater than or equal to $15.00 over any 20 out of 30 trading day period during the Vesting Period (defined below). b. 1,016,796 common shares issued to the MAAC Sponsor and 5,000 common shares issued to each of MAAC’s independent directors (collectively, the “10% Earn-Out Shares” and, together with the 20% Earn-Out Shares, the “Earn-Out Shares”), each in respect of its MAAC Class B Shares, will vest if the closing price of the Company’s common shares is greater than or equal to $20.00 over any 20 out of 30 trading day period during the Vesting Period (as defined below). c.
The Company presents noncontrolling interests as a component of shareholders’ equity on its consolidated balance sheets. The Company accounts for changes in its ownership interest in its subsidiaries while control is retained as equity transactions. The carrying amount of the noncontrolling interest is adjusted to reflect the change in RSL’s ownership interest in the subsidiary.
The Company accounts for changes in its ownership interest in its subsidiaries while control is retained as equity transactions. The carrying amount of the noncontrolling interest is adjusted to reflect the change in RSL’s ownership interest in the subsidiary.
As of March 31, 2024 and 2023 , 31,972,222 and 30,196,555 CVARs, respectively, had met the service-vesting requirement. During the year ended March 31, 2024, 14,482,570 service-vested CVARs satisfied their applicable hurdle price and the knock-in condition, if relevant, on the applicable measurement date, and as a result, 5,366,815 common shares were issued upon their settlement.
During the year ended March 31, 2025, no service-vested CVARs satisfied their applicable hurdle price on the applicable measurement date. During the year ended March 31, 2024, 14,482,570 service-vested CVARs satisfied their applicable hurdle price and the Knock-In Condition, if relevant, on the applicable measurement date, and as a result, 5,366,815 common shares were issued upon their settlement.
As of March 31, 2024 and 2023, the following potentially dilutive common stock equivalents were excluded from the computation of diluted net income (loss) per common share because including them would have been anti-dilutive: March 31, 2024 March 31, 2023 Stock options and performance stock options 54,648,258 154,271,791 Restricted stock units and performance stock units (non-vested) 5,422,465 20,700,788 March 2020 CVARs (1) 17,548,368 32,011,996 November 2021 CVARs (non-vested) 249,120 3,222,645 Restricted common stock (non-vested) 255,911 689,026 Earn-Out Shares (non-vested) 3,080,387 3,080,387 Private Placement Warrants — 10,214,365 Public Warrants — 20,475,875 Other stock based awards and instruments issued 3,924,305 6,122,842 (1) Refer to Note 11, “Share-Based Compensation” for details regarding settlement of CVARs.
For the years ended March 31, 2025 and 2023, all outstanding common stock equivalents have been excluded from the computation of diluted loss per share because their effect was anti-dilutive due to the loss from continuing operations. 165 Table of Contents As of March 31, 2025, 2024 and 2023, the following potentially dilutive common stock equivalents were excluded from the computation of diluted net (loss) income per common share: March 31, 2025 March 31, 2024 March 31, 2023 Stock options and performance stock options 139,412,098 54,648,258 154,271,791 Restricted stock units and performance restricted stock units (non-vested) 50,992,414 5,422,465 20,700,788 March 2020 CVARs (1) 17,548,368 17,548,368 32,011,996 November 2021 CVARs (non-vested) 348,527 249,120 3,222,645 Restricted common stock (non-vested) — 255,911 689,026 Earn-Out Shares (non-vested) 3,080,387 3,080,387 3,080,387 Private Placement Warrants — — 10,214,265 Public Warrants — — 20,475,875 Other stock based awards and instruments issued 4,731,198 3,924,305 6,122,842 (1) Refer to Note 9, “Share-Based Compensation and Other Compensation Plans” for details regarding settlement of CVARs.
Management determines the fair value of the Company’s investment in Datavant using the income approach and implementation of the option pricing method, which uses significant unobservable inputs. Determining the fair value of the Company’s investment in Datavant requires management to make significant judgments about the valuation methodologies, including the unobservable inputs and other assumptions and estimates used in the measurements.
Determining the fair value of the Company’s investment in Datavant requires management to make significant judgments about the valuation methodologies, including the unobservable inputs and other assumptions and estimates used in the measurements.
The Company recorded share-based compensation expense of $67.0 million and $49.0 million for the years ended March 31, 2024 and 2023, respectively, related to subsidiary EIPs. At March 31, 2024, total unrecognized compensation expense related to subsidiary equity was approximately $119.9 million.
The Company recorded share-based compensation expense of $56.1 million, $54.9 million and $36.5 million for the years ended March 31, 2025, 2024 and 2023, respectively, related to subsidiary EIPs. At March 31, 2025, total unrecognized compensation expense related to subsidiary equity was approximately $109.1 million.
Due to the Company’s significant influence over operating and financial policies of these entities, the entities are considered related parties of the Company. The Company holds an investment in Arbutus in the form of 38,847,462 common shares of Arbutus. The Company additionally holds an investment in Class A units of Datavant.
The Company determined that it does not control these entities and as a result does not consolidate these entities. Due to the Company’s significant influence over operating and financial policies of these entities, the entities are considered related parties of the Company. The Company holds an investment in Arbutus in the form of 38,847,462 common shares of Arbutus.
The $7.1 billion in closing consideration was paid to all of Telavant’s equity holders, including holders of restricted stock units, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction, and this same treatment will be applied to the one-time milestone payment.
The $7.1 billion in closing consideration and $150 million one-time milestone payment were paid to all of Telavant’s equity holders, including holders of Telavant RSUs, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction.

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