UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 10-K

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(Mark One)

For the fiscal year ended March 31, 2024

OR

For the transition period from                      to                   

Commission File Number: 001-40782

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ROIVANT SCIENCES LTD.

(Exact name of Registrant as specified in its Charter)

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+44 207 400 3347

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Securities registered pursuant to Section 12(g) of the Act: None

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Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes ☐    No  ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes ☐    No  ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes ☒    No  ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes ☒    No ☐

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.  ☒

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes  ☐    No  ☒

DOCUMENTS INCORPORATED BY REFERENCE

Specified portions of the registrant’s proxy statement to be issued in conjunction with the registrant’s 2024 Annual Meeting of Shareholders, which is expected to be filed not later than 120 days after the registrant’s fiscal year ended March 31, 2024, are incorporated by reference into Part III of this Annual Report on Form 10-K. Except as expressly incorporated by reference, the registrant’s proxy statement shall not be deemed to be a part of this Annual Report on Form 10-K.

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		Page
PART I.
Item 1.	Business	6
Item 1A.	Risk Factors	52
Item 1B.	Unresolved Staff Comments	116
Item 1C.	Cybersecurity	116
Item 2.	Properties	116
Item 3.	Legal Proceedings	117
Item 4.	Mine Safety Disclosures	117
PART II.
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	118
Item 6.	[Reserved]	119
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	119
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	134
Item 8.	Financial Statements and Supplementary Data	135
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	173
Item 9A.	Controls and Procedures	173
Item 9B.	Other Information	174
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	175
Part III.
Item 10.	Directors, Executive Officers and Corporate Governance	176
Item 11.	Executive Compensation	176
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	176
Item 13.	Certain Relationships and Related Transactions, and Director Independence	176
Item 14.	Principal Accountant Fees and Services	176
Part IV.
Item 15.	Exhibits, Financial Statement Schedules	177
Item 16.	Form 10-K Summary	182
	Signatures	183

Summary Risk Factors

 

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

 

Risks Related to Our Business and Industry

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

Forward-Looking Statements

 

This Annual Report on Form 10-K contains statements, including matters discussed under Part I, Item 1A. “Risk Factors,” Part I, Item 3. “Legal Proceedings” and Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in other sections of this report, that are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

Investors and others should note that we may announce material business and financial information to our investors using our investor relations website (https://investor.roivant.com/), SEC filings, webcasts, press releases, and conference calls. We use these mediums, including our website, to communicate with our shareholders and the public about our company, our products and product candidates and other matters. It is possible that the information that we make available may be deemed to be material information. We therefore encourage investors and others interested in our company to review the information that we make available on our website. Information contained on, or that can be accessed through, our website is not incorporated by reference into this Annual Report on Form 10-K, and you should not consider information on our website to be part of this Annual Report on Form 10-K.

 

Industry and Market Data

 

We obtained the industry and market data in this Annual Report on Form 10-K from our own research as well as from industry and general publications, surveys and studies conducted by third parties. Industry and general publications, studies and surveys generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. These third parties may, in the future, alter the manner in which they conduct surveys and studies regarding the markets in which we operate our business. As a result, you should carefully consider the inherent risks and uncertainties associated with the industry and market data contained in this Annual Report on Form 10-K, including those discussed in Part I, Item 1A. “Risk Factors.”

 

PART I

 

 

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. 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. 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.

 

Note: All clinical stage drugs in our current pipeline are investigational and subject to health authority approval. Pipeline reflects both ongoing clinical trials and expected upcoming trials.

 

* Indicates registrational or potentially registrational trials.

 

The Vant model unlocks key strategic advantages for Roivant and, we believe, ultimately enables us to develop transformative medicines for diseases for which there are no approved therapies or where the current standard of care treatment has significant limitations faster than our competitors. We believe we are uniquely positioned to accomplish this by:

 

 

 

 

 

 

 

 

The structural advantages of the Vant model combined with our “force of will” culture and investor mindset have enabled us to achieve an impressive track record: Since Roivant’s founding in 2014, we have commercialized VTAMA, the leading branded topical in psoriasis, developed six FDA-approved medicines and completed 11 large registrational Phase 3 studies – the last 10 of which have yielded positive data (inclusive of approvals and Phase 3 studies from Vants transferred to Sumitomo Pharma).

 

Recent Developments

 

Key Business Highlights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary of Vant Milestone & Royalty Payments

 

The table below summarizes select potential future payment obligations from acquisitions, in-licensings and subsequent financings for select products and product candidates:

 

 

Note: The summaries above do not purport to be complete. 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.

		Roivant Ownership
Vant		Basic1					Fully Diluted2
Dermavant			100	%	*			86	%	*
Immunovant			55	%	3			49	%	3
Priovant			75	%				68	%
Genevant			83	%				65	%
Kinevant			96	%				90	%
Covant			100	%				87	%
Psivant			48	%				47	%
Arbutus			22	%	3			19	%	3
Lokavant			57	%				50	%
VantAI			60	%				49	%
Datavant			*	*				*	*

 

 

 

 

 

Upcoming Catalysts

 

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

 

 

Note: References are to calendar years, unless otherwise specified. As used above, “FY” refers to Roivant's fiscal year. All catalyst timings are based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change.

 Dermavant Overview

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       Endocrine Diseases

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The below schematics show the trial designs for the ongoing batoclimab trials:

 

MG Phase 3 Trial Design (N ~ 210)

CIDP Phase 2b Trial Design

GD Phase 2 Trial Design

A: Additional inclusion and exclusion criteria not listed

•	Roivant ownership:

•

As of March 31, 2024 we own 55% of the issued and outstanding shares of Immunovant common stock and 49% on a fully diluted basis.

•

Priovant is developing brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1, for the treatment of dermatomyositis (“DM”), non-infectious uveitis (“NIU”), and other immune-mediated diseases.

•	Lead program:

•

Brepocitinib is a potentially first-in-class, orally administered, small molecule inhibitor of TYK2 and JAK1 that suppresses signaling of TYK2- and JAK1-dependent cytokines linked to autoimmune disease, including type I and type II interferon, IL-6, IL-12, and IL-23.

•	Disease overview:

•

DM is a chronic, immune-mediated disease of the skin and muscles. Patients with DM usually present with a characteristic skin rash and proximal muscle weakness, which may lead to significant functional impairment or disfigurement. Patients with DM are at a substantially increased risk of interstitial lung disease, malignancy, and heart failure, contributing to an estimated 5-year mortality rate of 10-40%.

•

NIU is an immune-mediated disease of the eye. Patients with NIU usually present with eye inflammation, which can manifest as eye pain, eye redness, light sensitivity, blurred vision, reduced vision, and/or floaters. Patients with NIU are at a substantially increased risk of blindness, contributing to approximately 10% of cases of blindness in the U.S.

•

We estimate that there are approximately 37,000 adult DM patients and approximately 400,000 adult NIU patients in the US, including 70-100,000 adult non-anterior NIU patients.

•	Limitations of current treatments:

•

Corticosteroids, disease-modifying antirheumatic drugs (“DMARDs”), and immunosuppressants, administered alone or in combination, are traditional therapies for patients with DM and NIU. Many of these therapies are associated with significant toxicities and limited efficacy.

•

For patients with DM who do not respond adequately to traditional therapies, IVIg (OCTAGAM 10%) is an important FDA-approved treatment. However, clinical trial data from the Phase 3 ProDERM study of IVIg in patients with DM and case reports from years of prior off-label use confirm that even with IVIg, many patients with DM continue to suffer from residual disease activity. Moreover, IVIg administration is burdensome, typically requiring several hours of infusion therapy for multiple days each month. IVIg also has a black box warning for serious risks, including thrombosis and kidney failure.

•

For patients with NIU who do not respond adequately to traditional therapies, adalimumab (HUMIRA) administered subcutaneously, is the only FDA-approved modern treatment. NIU patients treated with HUMIRA have failure/relapse rates of approximately 50%, indicating a large unmet need for more efficacious treatment options.

•	Clinical data:

•

Brepocitinib has been evaluated in seven positive completed Phase 2 studies in immune-mediated diseases (alopecia areata, psoriatic arthritis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, Crohn’s disease and non-infectious uveitis). In the six placebo-controlled studies, treatment with brepocitinib was associated with statistically significant and clinically meaningful efficacy. 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.

Study Population		N1		Brepocitinib Dose		Primary Endpoint Result		Statistical Significance
Alopecia Areata		942		30 mg once daily3		49.18 placebo-adjusted CFB in SALT Score at week 24		P < 0.00014
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 < 0.0001
Hidradenitis Suppurativa Crohn’s Disease   Non-infectious Uveitis		100   151   26		45 mg once daily5   60 mg once daily6   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 = 0.02984   P = 0.00124

1.

Overall study N represents patients randomized to all brepocitinib dose levels or placebo and excludes patients randomized to other agents.

2.

Includes patients from initial 24-week study period only.

3.

60 mg once daily for 4 weeks followed by 30 mg once daily for 20 weeks.

4.

One-sided p-value (pre-specified statistical analysis).

5.

Brepocitinib 45 mg once daily was the only brepocitinib dose evaluated in this study.

6.

Brepocitinib 60 mg once daily was the only brepocitinib dose evaluated in the induction period of this study.

•

Brepocitinib’s safety database includes over 1,400 exposed participants evaluated in completed and ongoing clinical studies. In these studies, brepocitinib was generally safe and well-tolerated, and rates of JAK class treatment-emergent adverse events (“TEAEs”) of interest were comparable to those observed in the development programs of approved JAK inhibitors. 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. On the pre-specified primary efficacy endpoint of Treatment Failure at week 24, 29% of subjects receiving brepocitinib 45 mg and 44% of subjects receiving brepocitinib 15 mg met Treatment Failure criteria (lower failure rates reflect greater treatment benefit). The Treatment Failure rate from disease activity (discontinuations censored) was 18% in the brepocitinib 45 mg arm. All secondary efficacy endpoints were also positive and dose responsive, including measurements of potential benefit on prevention and treatment of uveitic macular edema. Brepocitinib was generally safe and well-tolerated in the study, with no new safety and tolerability signals identified.

•

Brepocitinib has not been evaluated in DM to date. However, several FDA-approved JAK inhibitors have been clinically validated in DM patients refractory to standard-of-care therapies, as reported in more than 100 off-label case reports and in an open-label clinical trial. In addition, since DM pathobiology is driven by dysregulations in cytokines whose signaling is mediated by both TYK2 and JAK1, we believe that, with its unique dual inhibition of both TYK2 and JAK1, brepocitinib, as compared to inhibitors selective to either TYK2 or JAK1, has the potential to demonstrate superior clinical efficacy in DM.

•	Development plan and upcoming milestones:

•

Priovant is currently conducting a large randomized, controlled Phase 3 study of brepocitinib in patients with refractory dermatomyositis. This study will enroll approximately 225 subjects in total and will evaluate 15 mg and 30 mg of brepocitinib once-daily compared to placebo. The primary endpoint of this study is the mean Total Improvement Score (“TIS”), a validated myositis improvement index, at Week 52. Topline data is expected in calendar year 2025.

•

Priovant is currently planning a Phase 3 study in non-infectious uveitis that is expected to initiate in the second half of calendar year 2024.

•

Priovant is also evaluating brepocitinib for development in other orphan and specialty immune-mediated diseases.

•

As of March 31, 2024, we own 75% of the issued and outstanding shares of Priovant and 68% on a fully diluted basis.

•

Overview:

•

Kinevant is focused on developing namilumab for sarcoidosis and potentially other diseases.

•	Lead program:

•

Namilumab is a fully human anti-GM-CSF monoclonal antibody with broad potential in inflammatory and autoimmune diseases being developed with potentially the least frequent dosing schedule among subcutaneous anti-GM-CSFs in Phase 2 clinical trial, with a single dose every four weeks after an initial loading period.

•	Disease overview:

•

Sarcoidosis is a multi-system inflammatory disease characterized by the presence of non-necrotizing granulomas believed to be formed by an exaggerated immune response to unidentified antigens. Sarcoidosis primarily affects the lungs and lymphatic system, though sarcoidosis may damage any organ. GM-CSF, a key pathogenic cytokine, has been implicated in multiple parts of the granulomatous response.

•

Sarcoidosis affects approximately 200,000 people in the U.S., with over 90% of cases presenting with pulmonary involvement.

•

An estimated 54% of pulmonary sarcoidosis patients are diagnosed, and approximately 90% of these patients receive some form of treatment. Market research with HCPs and third-party analysis of claims data suggest that approximately 25% of diagnosed and treated pulmonary sarcoidosis would be eligible for treatment with second-line or later therapy.

•	Limitations of current treatments:

•

Corticosteroids are the most widely used treatment for sarcoidosis, but they carry significant side effects when used longer-term. Second- and third-line treatment options, including immunosuppressive therapies and biologics, are limited by slow onset, safety risk, inconsistent effectiveness, and reimbursement challenges, leaving significant unmet medical need that could be met by a novel biologic.

•	Clinical data:

•

Early clinical data in pharmacokinetic/pharmacodynamic (PK/PD) and subsequent Phase 2 studies showed namilumab to be well-tolerated with a single subcutaneous injection given up to every four weeks.

•

In a Phase 1 study of healthy volunteers with a single subcutaneous injection, namilumab was observed to be generally well-tolerated.

•

In a Phase 2 trial in patients with moderate to severe rheumatoid arthritis conducted by Takeda, namilumab demonstrated decreased disease activity compared to placebo. In this trial, patients were given a subcutaneous injection of either 20, 80, or 150 mg of namilumab four times over a ten-week period. Over the 12-week study period, 14 of 27 (52%) subjects receiving placebo and 45 of 81 (56%) receiving namilumab experienced a treatment-emergent adverse event (TEAE). The 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.

•	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.

•

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. Our formulation showed superior potency and avoidance of immune stimulation relative to others.

•

Genevant LNP technology is included in the first RNA-LNP product to receive FDA-approval, Alnylam’s Onpattro (patisiran).

•	IP litigation:

•

In February 2022, Genevant and Arbutus jointly filed a complaint against Moderna in the U.S. District Court for the District of Delaware asserting infringement of six patents. In April 2024, the court in the Moderna case issued its claim construction (Markman) ruling, in which it agreed with Genevant and Arbutus’ proposed constructions for three of the four disputed terms. The court is expected to entertain requests to file summary judgment motions in late calendar year 2024 and a trial date has been set for April 2025.

•

In April 2023, Genevant and Arbutus jointly filed a complaint against Pfizer and BioNTech in the U.S. District Court for the District of New Jersey asserting infringement of five patents. The case is ongoing and a date for a claim construction (Markman) hearing has not been set.

•	Roivant ownership:

•

As of March 31, 2024, we own 83% of the issued and outstanding common shares of Genevant and 65% on a fully diluted basis.

•

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;

•

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.

•

Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. 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/or determine the dose required to produce the desired benefits. 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.

•

restrictions on the marketing or manufacturing of the drug or biologic, suspension of the approval, complete withdrawal of the drug from the market or product recalls;

•

fines, warning letters or holds on post-approval clinical trials;

•

refusal of the FDA to approve applications or supplements to approved applications, or suspension or revocation of drug or biologic approvals;

•

drug or biologic seizure or detention, or refusal to permit the import or export of drugs;

•

injunctions or the imposition of civil or criminal penalties; or

•

debarment from producing or marketing drug products or biologics.

•

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.

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expanded the entities eligible for discounts under the 340B Drug Discount Program.

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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.

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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. The research conducted by the Patient-Centered Outcomes Research Institute may affect the market for certain pharmaceutical products. The ACA established the Center for Medicare and Medicaid Innovation within CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

•

The centralized MA is issued by the European Commission through the centralized procedure, based on the opinion of the Committee for Medicinal Products for Human Use (the “CHMP”), of the EMA, and is valid throughout the entire territory of the EEA. The centralized procedure is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced-therapy medicinal products (gene-therapy, somatic cell-therapy or tissue-engineered medicines) and medicinal products containing a new active substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions and viral diseases. The centralized procedure is optional for products containing a new active substance not yet authorized in the EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of public health in the EEA.

•

National MAs, which are issued by the competent authorities of the Member States of the EEA and only cover their respective territory, are available for products not falling within the mandatory scope of the centralized procedure. 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 the product has not received a national MA in any Member State at the time of application, it can be approved simultaneously in various Member States through the decentralized procedure. Under the decentralized procedure an identical dossier is submitted to the competent authorities of each of the Member States in which the MA is sought, one of which is selected by the applicant as the Reference Member State (the “RMS”). The competent authority of the RMS coordinates the preparation of a draft assessment report, a draft summary of the product characteristics (the “SmPC”), and a draft of the labeling and package leaflet, which are sent to the other Member States (referred to as the Concerned Member States) for their final approval. 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).

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Hire high-caliber talent across all levels using both a dedicated in-house talent acquisition team and top-tier executive search firms

•

Recruit diverse, multidisciplinary talent from a broad range of industries, including biopharmaceuticals, financial services, technology, and consulting

•

Invest in early career diversity through a robust Rotational Analyst (RA) program, hiring recent college graduates from top private and public institutions

•

Support Roivant/Roivant Social Ventures’ Diversity in Pharma summer internship program for current PharmD candidates

•

Offer highly competitive short- and long-term incentives through both Roivant and Vant equity programs and meaningful performance-based cash bonuses

•

Undertake rigorous benchmarking analyses in partnership with third parties to ensure competitive compensation practices and conduct annual pay equity analyses to detect, analyze, and remediate any compensation disparities where appropriate

•

Provide company-wide training and speaker programs on topics such as unconscious bias and professional development

•

Partner with external organizations to support biopharma-related initiatives in the community

•

Offer a professional development stipend to each employee for use towards individual growth and development

•

Unlock unique career progression across Roivant and Vants through “Vant mobility” and offer unparalleled leadership opportunities for employees through the Vant model

•

Cultivate diversity and inclusion among our employee base through Employee Resource Groups (ERGs), including Women@Roivant (Roivant’s women’s employee resource group), ROI-GBIV (Roivant’s LGBTQ+ employee resource group), and BIPOC (Roivant’s black, indigenous and people of color employee resource group)

ITEM 1A.

RISK FACTORS

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successfully continue to commercialize VTAMA;

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successfully complete ongoing preclinical studies and clinical trials and obtain regulatory approvals for our current and future product candidates;

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identify new acquisition or in-licensing opportunities;

•

launch commercial sales of future product candidates, whether alone or in collaboration with others, including establishing sales, marketing and distribution systems;

•

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

•

attract and retain experienced management and advisory teams;

•

add operational, financial and management information systems and personnel, including personnel to support clinical, preclinical manufacturing and commercialization efforts and operations;

•

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

•

set acceptable prices for products and product candidates and obtain coverage and adequate reimbursement from third-party payors;

•

achieve market acceptance of products and product candidates in the medical community and with third-party payors and consumers;

•

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

•

successfully identify new product candidates through our discovery efforts and advance those product candidates into preclinical studies and clinical trials; and

•

maintain, expand and protect our intellectual property portfolio.

•

our ability to recruit and retain effective sales, marketing and customer service personnel;

•

our ability to obtain and retain access to physicians or persuade adequate numbers of physicians to prescribe VTAMA and any future products;

•

the inability to manufacture and to price VTAMA and any future products at a price point sufficient to ensure an adequate and attractive level of profitability;

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the extent to which coverage and adequate reimbursement for VTAMA and any future products will be available from government health administration authorities, private health insurers and other organizations;

•

the risks associated with potential co-promotion or partnership agreements, including the failure to realize the expected benefits of such arrangements;

•

the costs and other risks associated with expansion of a commercial product into multiple indications, including increased sales and marketing costs; and

•

other unforeseen costs, expenses and risks associated with the commercialization of biopharmaceutical products, including compliance costs.

•

our ability to successfully implement and execute on a marketing strategy for VTAMA and to commercialize any of our current or future products in the U.S. and internationally, whether alone or in collaboration with others;

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acceptance by physicians, payers and patients of the benefits, safety and efficacy of VTAMA or any of our current or future products, including relative to alternative and competing treatments;

•

timely completion of our nonclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors;

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whether we are required by the FDA or foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our current or future products or product candidates;

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acceptance of our proposed indications and primary and secondary endpoint assessments relating to the proposed indications of our current or future products or product candidates by the FDA and foreign regulatory authorities;

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the prevalence, duration and severity of potential side effects or other safety issues experienced with VTAMA or our current or future products or product candidates;

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the timely receipt of necessary marketing approvals from the FDA and foreign regulatory authorities for our current or future products or product candidates;

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achieving, maintaining and, where applicable, ensuring that our third-party contractors achieve and maintain compliance with our contractual obligations and with all regulatory requirements applicable to VTAMA or any of our current or future products or product candidates;

•

the willingness of physicians and patients to utilize or adopt VTAMA and any of our current or future products or product candidates, if approved;

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the ability of third parties upon which we rely to manufacture clinical trial and commercial supplies of VTAMA or any of our current or future products or product candidates to remain in good standing with relevant regulatory authorities and to develop, validate and maintain commercially viable manufacturing processes that are compliant with Current Good Manufacturing Practice (“cGMP”);

•

the availability of coverage and adequate reimbursement from private third-party payers and governmental healthcare programs for VTAMA and any of our current or future products or product candidates, such as Medicare and Medicaid;

•

patient demand for VTAMA and any of our current or future products or product candidates;

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our ability to establish and enforce intellectual property rights in and to any of our current or future products or product candidates;

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our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims; and

•

the ability to raise any additional required capital on acceptable terms, or at all.

•

the time and costs necessary to complete our ongoing, planned and future clinical trials for our current and future products and product candidates;

•

the time and costs necessary to pursue regulatory approvals for our current and future product candidates;

•

the costs associated with future acquisitions or in-licensing transactions;

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the approval, progress, timing, scope and costs of our preclinical studies, clinical trials and other related activities, including the ability to enroll patients in a timely manner for our ongoing and planned clinical trials and potential future clinical trials for our current and future product candidates;

•

the costs associated with our ongoing, planned and future preclinical studies and other drug discovery activities;

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our ability to successfully identify and negotiate acceptable terms for third-party supply and contract manufacturing agreements with contract manufacturing organizations (“CMOs”);

•

the costs of obtaining adequate clinical and commercial supplies of raw materials and drug products for our current and future products and product candidates;

•

our ability to successfully commercialize VTAMA, including:

o

the manufacturing, selling and marketing costs associated with VTAMA, including the cost and timing of expanding sales and marketing capabilities or entering into strategic collaborations with third parties; and

o

the amount and timing of sales and other revenues from VTAMA, including the sales price and the availability of adequate third-party reimbursement;

•

the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights, including current and future patent infringement actions brought against third parties, for our current and future product candidates;

•

the cost of pursuing and defending potential intellectual property disputes, including patent infringement actions with third parties, relating to our current or future products or product candidates; and

•

our ability to hire, attract and retain qualified personnel.

•

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.

•

inability to meet our product specifications and quality requirements consistently;

•

delay or inability to procure or expand sufficient manufacturing capacity;

•

manufacturing and product quality issues related to scale-up of manufacturing;

•

costs and validation of new equipment and facilities required for scale-up;

•

failure to comply with applicable laws, regulations and standards, including cGMP and similar standards;

•

deficient or improper record-keeping;

•

inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;

•

termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;

•

reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our products or product candidates in a timely fashion, in sufficient quantities or under acceptable terms;

•

lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;

•

operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier or other regulatory sanctions related to the manufacturer of another company’s product candidates;

•

carrier disruptions or increased costs that are beyond our control; and

•

failure to deliver our products or product candidates under specified storage conditions and in a timely manner.

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

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physicians may stop prescribing a product;

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reimbursement may not be available for a product;

•

we may elect to discontinue the sale of our products;

•

our products may become less competitive; and

•

our reputation may suffer.

•

restrictions on the manufacture of such products or product candidates;

•

restrictions on the labelling or marketing of such products or product candidates, including a “black box” warning or contraindication on the product label or communications containing warnings or other safety information about the product;

•

restrictions on product distribution or use;

•

requirements to conduct post-marketing studies or clinical trials, or any regulatory holds on our clinical trials;

•

requirement of a REMS (or equivalent outside the U.S.);

•

Warning or Untitled Letters or similar communications from other relevant regulatory authorities;

•

withdrawal of the product or product candidates from the market;

•

refusal to approve pending applications or supplements to approved applications that we submit;

•

recall of products or product candidates;

•

fines, restitution or disgorgement of profits or revenues;

•

suspension, variation, revocation or withdrawal of marketing approvals;

•

refusal to permit the import or export of our products or product candidates;

•

seizure of our products or product candidates; or

•

lawsuits, injunctions or the imposition of civil or criminal penalties.

•

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

•

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

•

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

•

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

•

the efficacy and safety of such products and product candidates as demonstrated in pivotal clinical trials and published in peer-reviewed journals;

•

the potential and perceived advantages compared to alternative treatments, including any similar generic treatments;

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

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

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

•

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

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

•

restrictions on how the product is dispensed or distributed;

•

the timing of market introduction of competitive products;

•

publicity concerning these products or competing products and treatments;

•

the strength of marketing and distribution support;

•

favorable third-party coverage and sufficient reimbursement; and

•

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

•

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.

•

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

•

the federal false claims laws, including the False Claims Act, which imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent; knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim; or knowingly making or causing to be made, a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties currently ranging from $13,508 to $27,018 for each false claim or statement for penalties assessed after January 30, 2023, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

•

the federal health care fraud statute (established by Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false or fraudulent statements relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

•

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

•

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

•

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

•

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

•

analogous state and EU and foreign national laws and regulations, such as state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales, and marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, and state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and several recently passed state laws that require disclosures related to state agencies and/or commercial purchasers with respect to certain price increases that exceed a certain level as identified in the relevant statutes, some of which contain ambiguous requirements that government officials have not yet clarified; and EU and foreign national laws prohibiting promotion of prescription-only medicinal products to individuals other than healthcare professionals, governing strictly all aspects of interactions with healthcare professionals and healthcare organizations, including prior notification, review and/or approval of agreements with healthcare professionals, and requiring public disclosure of transfers of value made to a broad range of stakeholders, including healthcare professionals, healthcare organizations, medical students, physicians associations, patient organizations and editors of specialized press.

•

the demand for our products and, if approved, product candidates;

•

our ability to receive or set a price that we believe is fair for our products;

•

our ability to generate revenue and achieve sustained profitability;

•

the amount of taxes that we are required to pay; and

•

the availability of capital.

•

multiple conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, anti-bribery and anti-corruption laws, regulatory requirements and other governmental approvals, permits and licenses;

•

failure by us or our collaborators to obtain appropriate licenses or regulatory approvals for the sale or use of our products or, if approved, product candidates, in various countries;

•

difficulties in managing operations in different jurisdictions;

•

complexities associated with managing multiple payor-reimbursement regimes or self-pay systems;

•

financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to currency exchange rate fluctuations;

•

varying protection for intellectual property rights;

•

natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; and

•

failure to comply with the U.S. Foreign Corrupt Practices Act (the “FCPA”), including its books and records provisions and its anti-bribery provisions, the United Kingdom Bribery Act 2010 (the “U.K. Bribery Act”), and similar anti-bribery and anti-corruption laws in other jurisdictions, for example by failing to maintain accurate information and control over sales or distributors’ activities.

•

ZORYVE (roflumilast), a topical PDE4 inhibitor, a potential competitor to VTAMA;

•

OPZELURA (ruxolitinib), a topical Janus kinase inhibitor, a potential competitor to VTAMA;

•

VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), neonatal Fc receptor blockers, potential competitors to IMVT-1402 and batoclimab;

•

Nipocalimab and RYSTIGGO (rozanolixizumab-noli), anti-FcRn antibodies, potential competitors to IMVT-1402 and batoclimab;

•

TEPEZZA (teprotumumab-trbw), an insulin-like growth factor-1 receptor inhibitor, a potential competitor to batoclimab; and

•

Dazukibart, an interferon beta (IFN-beta) inhibitor, a potential competitor to brepocitinib.

•

delays in or an inability to commercialize VTAMA, and any future products for which we obtain marketing approval;

•

impairment of our business reputation and significant negative media attention;

•

delay or termination of clinical trials, or withdrawal of participants from our clinical trials;

•

significant costs to defend the related litigation;

•

distraction of management’s attention from our primary business;

•

substantial monetary awards to patients or other claimants;

•

product recalls, withdrawals or labelling, marketing or promotional restrictions;

•

decreased demand for our VTAMA, and current or future product candidates, if approved; and

•

loss of revenue.

•

the scope of rights granted under the license agreement and other interpretation-related issues;

•

our financial or other obligations under the license agreement;

•

the extent to which our technology, products or product candidates infringe on intellectual property of the licensor that is not subject to the licensing agreement;

•

the sublicensing of patent and other rights;

•

our diligence obligations under the license agreements and what activities satisfy those diligence obligations;

•

the inventorship or ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and

•

the priority of invention of patented technology.

•

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;

•

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.

•

actual or anticipated fluctuations in our quarterly and annual financial results or the quarterly and annual financial results of companies perceived to be similar to it;

•

changes in the market’s expectations about operating results;

•

our operating results failing to meet market expectations in a particular period;

•

a Vant’s operating results failing to meet market expectations in a particular period, which could impact the market prices of shares of a public Vant or the valuation of a private Vant, and in turn adversely impact the trading price of our common shares;

•

receipt of marketing approval for a product or product candidate in one or more jurisdictions, or the failure to receive such marketing approval;

•

the results of clinical trials or preclinical studies conducted by us and the Vants;

•

changes in financial estimates and recommendations by securities analysts concerning us, the Vants or the biopharmaceutical industry and market in general;

•

operating and stock price performance of other companies that investors deem comparable to us;

•

changes in laws and regulations affecting our and the Vants’ businesses;

•

the outcome of litigation or other claims or proceedings, including governmental and regulatory proceedings, against us or the Vants;

•

changes in our capital structure, such as future issuances of securities or the incurrence of debt;

•

the volume of our common shares available for public sale and the relatively limited free float of our common shares;

•

any significant change in our board of directors or management;

•

sales of substantial amounts of our common shares by directors, executive officers or significant shareholders or the perception that such sales could occur; and

•

general economic and political conditions such as recessions, interest rates, fuel prices, international currency fluctuations and acts of war or terrorism.

•

a classified board of directors with staggered three-year terms;

•

the ability of our board of directors to determine the powers, preferences and rights of preference shares and to cause us to issue the preference shares without shareholder approval; and

•

requiring advance notice for shareholder proposals and nominations and placing limitations on convening shareholder meetings.

ITEM 1B.

UNRESOLVED STAFF COMMENTS

ITEM 1C.

CYBERSECURITY

ITEM 2.

PROPERTIES

ITEM 3.

LEGAL PROCEEDINGS

ITEM 4.

MINE SAFETY DISCLOSURES

ITEM 5.

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

ITEM 6.

[RESERVED]

ITEM 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

•

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.

•

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;

		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

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Product revenue, net		$	75,057			$	28,011			$	47,046

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
License, milestone and other revenue		$	49,738			$	33,269			$	16,469

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Cost of product and other revenues		$	5,928			$	5,660			$	268
Amortization of intangible assets			9,632				7,468				2,164
Cost of revenues		$	15,560			$	13,128			$	2,432

		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	)

		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	)

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Selling, general and administrative		$	687,443			$	600,506			$	86,937

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Gain on sale of Telavant net assets		$	5,348,410			$	—			$	5,348,410

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Change in fair value of investments		$	47,973			$	20,815			$	27,158

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Change in fair value of debt and liability instruments		$	78,943			$	78,001			$	942

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Gain on deconsolidation of subsidiaries		$	(32,772	)		$	(29,276	)		$	(3,496	)

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Interest income		$	(146,425	)		$	(32,184	)		$	(114,241	)

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Interest expense		$	34,778			$	27,968			$	6,810

		Years Ended March 31,
		2024				2023				Change
		(in thousands)
Income from discontinued operations, net of tax		$	—			$	114,561			$	(114,561	)

•

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. (“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. Immunovant had the right to terminate the PSA with 30 days’ written notice to Samsung, exercisable no later than January 2024, in the event Immunovant decided to stop all development of, and all attempts to obtain regulatory approval for, batoclimab; subject to payment to Samsung of non-cancelable service fees and costs incurred by Samsung for all batches of batoclimab scheduled to be manufactured during the two-year period following such termination. 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. 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. In conjunction with Dermavant’s entry into the GSK Agreement in 2018, Dermavant entered into a clinical supply agreement pursuant to which GSK would provide a supply of tapinarof and clinical product at an agreed upon price during our clinical trials. In April 2019, Dermavant entered into a commercial supply agreement with GSK to continue to provide certain quantities of tapinarof and commercial product at agreed upon minimum quantities and prices. The commercial supply agreement commenced in April 2022 upon completion of certain quality and regulatory conditions. In July 2022, Dermavant and GSK amended the terms of the clinical supply and commercial supply agreements which released GSK of certain commitments to supply tapinarof and released Dermavant of certain commitments to purchase tapinarof in exchange for a supplementary fee. Other supply and purchase commitments under the agreements remain in effect. In addition, Dermavant and Thermo Fisher Scientific (“TFS”) entered into a Commercial Manufacturing and Supply Agreement for which TFS agreed to provide a supply of tapinarof to Dermavant at an agreed upon price. The agreements discussed above require Dermavant to purchase certain quantities of inventory over a period of five years. The minimum purchase commitment related to these agreements was estimated to be approximately $33.3 million.

•

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 VTAMA and any drug candidates for which we may obtain regulatory approval; and

•

operate as a public company.

		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

		March 31, 2024				March 31, 2023
Sales return, rebate, and discounts balances, beginning of year		$	(20,794	)		$	—
Reduction of gross sales			(207,372	)			(129,717	)
Cash payments			199,151				108,923
Sales return, rebate and discounts balances, end of year		$	(29,015	)		$	(20,794	)

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.

ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK