ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
11-12 St. James’s Square |
Not Applicable | |
(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
|
|
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
☒ | Smaller reporting company | |||||
Emerging growth company |
• | Our limited operating history and the inherent uncertainties and risks involved in biopharmaceutical product development may make it difficult for us to execute on our business model and for you to assess our future viability. |
• | We may never achieve or maintain profitability. |
• | We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to successfully market our products, acquire or in-license new products or product candidates, complete the development and commercialization of our products and product candidates and continue to pursue our drug discovery efforts. |
• | We have limited experience as a commercial company and the marketing and sale of VTAMA ® (tapinarof) or any future products may be unsuccessful or less successful than anticipated. |
• | We may not be successful in our efforts to acquire, in-license or discover new product candidates. |
• | We face risks associated with the allocation of capital and personnel across our businesses. |
• | We face risks associated with the Vant structure. |
• | The global pandemic resulting from the outbreak of the novel strain of coronavirus, SARS-CoV-2, COVID-19, could adversely impact our business, including the marketing of our products and our ongoing clinical trials and preclinical studies. |
• | Clinical trials and preclinical studies are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials or preclinical studies on the expected timelines, if at all. |
• | Our approach to the discovery and development of product candidates from our small molecule discovery engine is unproven, which makes it difficult to predict the time, cost of development and likelihood of successfully developing any product candidates from these platforms. |
• | Certain of our product candidates are novel, complex and difficult to manufacture. |
• | Obtaining approval of a new drug is an extensive, lengthy, expensive and inherently uncertain process, and the FDA or another regulator may delay, limit or deny approval. |
• | Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of product candidates that we may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization. |
• | Our products and product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval, cause us to suspend or discontinue clinical trials, abandon further development or limit the scope of any approved label or market acceptance. |
• | We depend on the knowledge and skills of our senior leaders and may not be able to manage our business effectively if we are unable to attract and retain key personnel. |
• | We will need to expand our organization and may experience difficulties in managing this growth, which could disrupt operations. |
• | 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. |
• | If the patent applications we hold or have in-licensed with respect to our products or product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for our current and future products or product candidates, it could dissuade companies from collaborating with us to develop product candidates, and threaten our ability to commercialize our products. |
• | Patent terms and their scope may be inadequate to protect our competitive position on current and future products and product candidates for an adequate amount of time. |
• | If our performance does not meet market expectations, the price of our securities may decline. |
• | We have incurred and will continue to incur increased costs as a result of operating as a public company and our management has devoted and will continue to devote a substantial amount of time to new compliance initiatives. |
• | Our failure to timely and effectively implement controls and procedures required by Section 404(a) of the Sarbanes-Oxley Act could have a material adverse effect on our business. |
• | Anti-takeover provisions in our memorandum of association, bye-laws and Bermuda law could delay or prevent a change in control, limit the price investors may be willing to pay in the future for our Common Shares and could entrench management. |
• | Our largest shareholders and certain members of our management own a significant percentage of our Common Shares and will be able to exert significant control over matters subject to shareholder approval. |
• | our limited operating history and risks involved in biopharmaceutical product development; |
• | our limited experience as a commercial-stage company and ability to successfully commercialize VTAMA ® (tapinarof); |
• | our ability to raise additional capital to fund our business on acceptable terms or at all; |
• | the fact that we will likely incur significant operating losses for the foreseeable future; |
• | the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic) on our business (including our clinical trials and preclinical studies), operations and financial condition and results; |
• | our ability to acquire, in-license or discover new product candidates; |
• | our Vant structure and the potential that we may fail to capitalize on certain development opportunities; |
• | clinical trials and preclinical studies, which are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes; |
• | the unproven nature of our approach to the discovery and development of product candidates from our small molecule discovery engine; |
• | the novelty, complexity and difficulty of manufacturing certain of our products and product candidates, including any manufacturing problems that result in delays in development or commercialization of our products and product candidates; |
• | difficulties we may face in enrolling and retaining patients in clinical trials and/or clinical development activities; |
• | the results of our clinical trials not supporting our proposed claims for a product candidate; |
• | changes in interim, top-line and/or preliminary data from our clinical trials changing as more data becoming available or being delayed due to audit and verification process; |
• | changes in product manufacturing or formulation that could lead to the incurrence of costs or delays; |
• | the failure of any third-party we contract with to conduct, supervise and monitor our clinical trials to perform in a satisfactory manner or to comply with applicable requirements; |
• | the fact that obtaining approvals for new drugs is a lengthy, extensive, expensive and unpredictable process that may end with our inability to obtain regulatory approval by the FDA or other regulatory agencies in other jurisdictions; |
• | the failure of our clinical trials to demonstrate substantial evidence of the safety and efficacy of our products and product candidates, including, but not limited to, scenarios in which our products and product candidates may cause adverse effects that could delay regulatory approval, discontinue clinical trials, limit the scope of approval or generally result in negative media coverage of us; |
• | our inability to obtain regulatory approval for a product or product candidate in certain jurisdictions, even if we are able to obtain approval in certain other jurisdictions; |
• | our ability to effectively manage growth and to attract and retain key personnel; |
• | any business, legal, regulatory, political, operational, financial and economic risks associated with conducting business globally; |
• | our ability to obtain and maintain patent and other intellectual property protection for our technology, products and product candidates; |
• | the inadequacy of patent terms and their scope to protect our competitive position; |
• | the failure to issue (or the threatening of their breadth or strength of protection) or provide meaningful exclusivity for our current and future products and product candidates of our patent applications that we hold or have in-licensed; |
• | the fact that we do not currently and may not in the future own or license any issued composition of matter patents covering certain of our products and product candidates and our inability to be certain that any of our other issued patents will provide adequate protection for such products and product candidates; |
• | the fact that our largest shareholders (and certain members of our management team) own a significant percentage of our stock and will be able to exert significant control over matters subject to shareholder approval; |
• | the outcome of any pending or potential litigation, including but not limited to our expectations regarding the outcome of any such litigation and costs and expenses associated with such litigation; |
• | changes in applicable laws or regulations; |
• | the possibility that we may be adversely affected by other economic, business and/or competitive factors; and |
• | any other risks and uncertainties, including those described under Part I, Item 1A. “Risk Factors.” |
ITEM 1. |
BUSINESS |
• | commercially launched VTAMA ® (tapinarof) cream 1% for the treatment of plaque psoriasis in adults; |
• | conducted nine international Phase 3 trials, the last eight of which have been successful; |
• | consummated a $3 billion upfront partnership with Sumitomo Pharma (“Sumitomo”); |
• | received five FDA approvals for drugs developed by Vants launched by Roivant, including VTAMA and four drugs that received FDA approval after their transfer to Sumitomo; |
• | built a broad and differentiated pipeline of drugs and drug candidates ranging from early discovery to commercial stage; and |
• | launched Roivant Discovery, our small molecule discovery engine, consisting of a collection of advanced computational physics capabilities, integrated with an in-house wet lab facility. |
Product/Product Candidate |
Indication |
Vant |
Modality |
Phase | ||||
VTAMA ® (tapinarof) |
Psoriasis | Dermavant | Topical | Commercial | ||||
VTAMA ® (tapinarof) |
Atopic Dermatitis | Dermavant | Topical | Phase 3 | ||||
Batoclimab |
Myasthenia Gravis | Immunovant | Biologic | Phase 3 | ||||
Batoclimab |
Thyroid Eye Disease | Immunovant | Biologic | Phase 3 | ||||
Batoclimab |
Warm Autoimmune Hemolytic Anemia | Immunovant | Biologic | Phase 2 or 3 | ||||
Batoclimab |
Other Indications | Immunovant | Biologic | Phase 2 or 3 | ||||
Brepocitinib |
Dermatomyositis | Priovant | Small Molecule | Phase 3 | ||||
Brepocitinib |
Systemic Lupus Erythematosus | Priovant | Small Molecule | Phase 2* | ||||
Brepocitinib |
Other Indications | Priovant | Small Molecule | Phase 2 | ||||
Namilumab |
Sarcoidosis | Kinevant | Biologic | Phase 2 | ||||
RVT-2001 |
Transfusion-Dependent Anemia in Patients with Lower-Risk MDS |
Hemavant | Small Molecule | Phase 1/2 | ||||
AFVT-2101 |
Solid Tumors | Affivant | Biologic | Preclinical |
• | Leveraging complementary approaches to identify or discover promising drug candidates: in-license or acquire programs where we believe we can deliver successful outcomes on accelerated timelines. In addition, our small molecule discovery engine allows us to design, optimize and validate our own novel product candidates, providing us with another avenue to pursue compelling targets or pathways and further expand our pipeline. |
• | Creating nimble, entrepreneurial Vants : |
• | Developing and deploying proprietary technologies: |
• | Allocating capital to maximize R&D efficiency: |
• | Maintaining a diversified pipeline with various risk profiles: |
• | Designing creative “win-win” deal structures: |
• | Providing operating leverage through centralized support functions: |
• | Heterobifunctionals and molecular glues: end-to-end |
• | Covalency: |
• | Deficiency to best-in-class: off-target effects or binding limitations, which we believe may enable us to rapidly optimize these small molecules and bring them into the clinic as potentially best-in-class |
• | A quantum mechanics-based molecular dynamics software platform to predict the interactions, energies and conformational behavior of targets and generate novel drug candidates. |
• | A supercomputing cluster composed of over 800 graphics processing units . |
• | A suite of degrader-specific ML tools. target-E3 interfaces; a degron knowledge graph, which we believe to be industry-leading, to map the ubiquitin proteasome system; and a unique model, based on millions of carefully curated protein stability datapoints, to predict degradation. |
• | A wet lab fully equipped for synthetic chemistry, crystallography, biophysics, biochemistry and biology . in-house laboratories are tightly integrated with our computational physics platform to directly augment simulations with biophysical data as well as validate simulation predictions. Certain experimental techniques enable more accurate and efficient simulations on targets where we lack crystal structures. Combined with homology modeling and X-ray crystallography, this allows for the simultaneous design of chemical matter against a target while refining atomistic structural models and solving high-resolution crystal structures. |
Vant |
Catalyst |
Expected Timing | ||
Dermavant | Updates on commercial launch of VTAMA | Ongoing | ||
Topline data from VTAMA Phase 3 trials in atopic dermatitis | 1H 2023 | |||
Immunovant | Topline data from batoclimab Phase 3 trial in MG | 2H 2024 | ||
Initiate two additional pivotal programs, including TED | 2H 2022 | |||
Announce two new indications | August 2022 | |||
Priovant | Topline data from potentially registrational brepocitinib Phase 2 trial in systemic lupus erythematosus |
2H 2023 | ||
Kinevant | Topline data from namilumab Phase 2 trial in sarcoidosis | 1H 2024 | ||
Hemavant | Data from RVT-2001 Phase 1/2 trial in lower-risk MDS |
2H 2023 |
Vant |
Product or Product Candidate |
Estimated U.S. Exclusivity / IP Coverage | ||
Dermavant | VTAMA ® (tapinarof) |
2038 | ||
Immunovant | IMVT-1401 | Later of (i) 2035 or (ii) 12 years post U.S. approval | ||
Priovant | Brepocitinib | 2039 | ||
Kinevant | Namilumab | 12 years post U.S. approval | ||
Hemavant | RVT-2001 |
2036 |
Vant |
Product or Product Candidate |
Milestones |
Royalty | |||
Dermavant |
VTAMA ® |
• £100M (~$126M on the date of achievement) milestone to GSK following VTAMA U.S. approval and CAD$25M (approximately $20M on the date of achievement) milestone to Welichem upon the first U.S. VTAMA commercial sale; to be paid using $160M RIPSA funding received in June 2022 • Up to CAD$75M in remaining commercial milestones to Welichem, with CAD$35M payable upon VTAMA first U.S. commercial sale for atopic dermatitis and the remainder payable as first commercial sales are achieved in various ex-U.S. countries • Additional milestones owed to NovaQuest in connection with two 2018 financings that are accounted for as debt |
• Low single-digit to high single-digit tiered percentage of quarterly revenues based on achievement of specified net sales thresholds, up to a $344M cap, to be paid to an investor group in exchange for $160M RIPSA funding received in June 2022, following VTAMA approval | |||
Immunovant |
IMVT-1401 | • Up to a maximum of $442.5M upon the achievement of certain development, regulatory and sales milestone events |
• Tiered royalties on net sales ranging from mid-single mid-teens | |||
Priovant |
Brepocitinib | • Mid tens-of-millions sales milestone payment if aggregate net sales in a given year exceed a mid hundred-of-millions amount |
• Tiered sub-teens royalty on net sales | |||
Kinevant |
Namilumab | • Up to $40M upon the achievement of certain milestones |
• Tiered royalties on net sales ranging from sub-teens mid-teens | |||
Hemavant |
RVT-2001 |
• Up to $65M in development and regulatory milestones for the first indication; up to $18M in payments for each additional indication; up to $295M in commercial milestone payments |
• Tiered high single-digit to sub-teens |
Roivant Ownership |
||||||||
Vant |
Basic 1 |
Fully Diluted 2 |
||||||
Dermavant |
100 | % | 83 | % | ||||
Immunovant |
63 | % 3 |
58 | % 3 | ||||
Priovant |
75 | % | 70 | % | ||||
Proteovant |
60 | % | 54 | % | ||||
Genevant |
83 | % | 67 | % | ||||
Kinevant |
88 | % | 83 | % | ||||
Hemavant |
100 | % | 100 | % | ||||
Affivant |
100 | % | 99 | % | ||||
Arbutus |
26 | % 3 |
24 | % 3 | ||||
Lokavant |
90 | % | 84 | % | ||||
Datavant |
* | * |
• |
Overview : |
• | Dermavant is marketing VTAMA ® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. |
• | Dermavant is also developing VTAMA for the treatment of atopic dermatitis in adults and children and expects to release topline results from its Phase 3 clinical trials in the first half of calendar year 2023. |
• | Dermavant’s earlier stage development pipeline includes an additional novel aryl hydrocarbon receptor (“AhR”) agonist, DMVT-506, with a similar profile to VTAMA. Dermavant is developing DMVT-506 for the treatment of immunological and inflammatory diseases. |
• |
Lead program : |
• | VTAMA is a novel, once daily, steroid-free topical cream approved in the US for the treatment of plaque psoriasis in adults. Dermavant is developing VTAMA for the treatment of atopic dermatitis in adults and children as young as age two. |
• | VTAMA directly targets the AhR, a key regulator of skin homeostasis and inflammation. |
• |
Disease overview : |
• | Plaque psoriasis is a chronic, inflammatory disease of the skin characterized by lesions consisting of red patches and plaques with silvery scales. |
• | Atopic dermatitis, the most common type of eczema, is a chronic condition characterized by dry, itchy skin. |
• | Psoriasis and atopic dermatitis affect approximately 8 million and 26 million people in the United States, respectively. |
• |
Limitations of current treatment : |
• | Topical corticosteroids (“TCS”) are the most common first-line therapies but they typically cannot be used for longer than four weeks due to the risk of significant side effects. |
• | While oral and biologic therapies have become increasingly available, they are often limited to moderate-to-severe |
• |
Clinical data : |
• | We completed two pivotal Phase 3 clinical trials, PSOARING 1 and PSOARING 2, for the use of VTAMA in treating mild, moderate, and severe plaque psoriasis in adults. |
• | In both pivotal Phase 3 trials, which enrolled over 500 patients each, VTAMA met its primary endpoint and secondary endpoints with clinically meaningful and statistically significant results. |
• | Our long-term open-label PSOARING 3 study provides supportive evidence of VTAMA’s increased therapeutic effect beyond the 12-week double-blind treatment periods, suggesting treatment durability over time, as well as supportive evidence of a remittive effect, measured by time until disease worsening following treatment discontinuation. |
• |
Development plan and upcoming milestones : |
• | The FDA approved VTAMA for the once daily topical treatment of adults with plaque psoriasis in May 2022. |
• | VTAMA is the first topical novel chemical entity launched for plaque psoriasis in the U.S. in 25 years, offering a favorable mix of treatment effect, safety, tolerability, durability on therapy, and remittive effect. |
• | In September 2021, we dosed the first patient in our Phase 3 clinical trials of VTAMA for the treatment of atopic dermatitis, ADORING 1 and ADORING 2. We expect to report topline data from ADORING 1 and ADORING 2 in the first half of calendar year 2023. |
• |
Roivant ownership: |
• | As of March 31, 2022, we own 100% of the issued and outstanding common shares of Dermavant and 83% on a fully-diluted basis. |
TCS |
Vitamin D / Combos / Retinoids |
Biologics |
Otezla |
Other Oral |
||||||||||||||||
Annual Scripts for PsO (2020) |
~2.35M | ~508K | ~1.05M | ~258K | ~241K |
TCS |
TCI |
Eucrisa |
Dupixent |
|||||||||||||
Annual Scripts for AD (2020) |
~16.4M | ~996K | ~352K | ~344K |
* | Patients with PGA of 2 (mild) and PGA of 4 (severe) limited to ~10% each of the total randomized population; ~80% of the total randomized population with PGA of 3 (moderate); †Patients electing not to participate in LTE had follow-up visit 4 weeks after completion of treatment period. BSA, body surface area; LTE, long-term extension; PASI75, ≥ 75% improvement in Psoriasis Area and Severity Index; PASI90, ≥ 90% improvement in Psoriasis Area and Severity Index; PGA, Physician Global Assessment; QD, once daily. 1. Clinicaltrials.gov; NCT03956355. 2. Clinicaltrials.gov; NCT03983980. 3. Clinicaltrials.gov; NCT04053387. |
* |
Difference versus vehicle cream is statistically significant at p=0.05 level (the 95% confidence interval excludes 0). |
• |
Overview: |
• | Immunovant is developing batoclimab for the treatment of Myasthenia Gravis (“MG”), Thyroid Eye Disease (“TED”) and Warm Autoimmune Hemolytic Anemia (“WAIHA”). |
• |
Lead program: |
• | Batoclimab is a novel, fully human monoclonal antibody targeting the neonatal fragment crystallizable receptor (“FcRn”). |
• | Designed to be optimized as a simple, self-administered subcutaneous (“SC”) injection with dosing that we believe can be tailored based on disease severity and stage. |
• | In nonclinical studies and in clinical trials conducted to date, batoclimab has been observed to reduce immunoglobulin G (“IgG”) antibody levels. High levels of pathogenic IgG antibodies drive a variety of autoimmune diseases and, as a result, we believe batoclimab has the potential for broad application in related disease areas. |
• |
Disease overview: |
• | MG is an autoimmune disorder associated with muscle weakness and fatigue. The estimated prevalence of MG is 17.8 per 100,000, with up to 59,000 people in the U.S., and 24.2 per 100,000, or approximately 126,000 cases in Europe. |
• | TED is an autoimmune inflammatory disorder that affects the muscles and tissues surrounding the eyes, and in severe cases can be sight-threatening. TED has an estimated annual incidence of 9.7 in 100,000 in the U.S. and 4.8 in 100,000 Europe. |
• | WAIHA is a rare hematologic disease in which autoantibodies mediate hemolysis, or the destruction of red blood cells (“RBCs”), affecting approximately 40,000 patients in the U.S. and 71,000 patients in Europe. |
• |
Limitations of current treatments: |
• | Early-stage disease: corticosteroids and immunosuppressants. |
• | Later-stage disease: intravenous immunoglobulin (“IVIg”), or plasma exchange. |
• | Approaches are limited by delayed onset of action, waning therapeutic benefit over time and unfavorable safety profiles. |
• |
Clinical data: |
• | In the highest dose cohorts in the Phase 1 clinical trial, four weekly SC administrations of 680 mg resulted in a mean maximum reduction of serum IgG levels of 78%, with a standard deviation of 2%. Injection site reactions were similar between batoclimab and placebo arms. |
• | As previously disclosed, we voluntarily paused dosing in our early phase clinical studies to evaluate batoclimab-induced elevations in total cholesterol and low density lipoprotein (“LDL”) levels observed in some trial subjects. After evaluation of the available safety data and following discussions with multiple regulatory agencies, we are continuing the clinical development of batoclimab. |
• | In 2019, we initiated an open-label, single-arm Phase 2a clinical trial of batoclimab for the treatment of TED. The majority of subjects (four of seven) evaluated at the end of treatment experienced a greater than or equal to 2-point improvement in clinical activity score (CAS) and three of seven subjects were proptosis responders, defined as a greater than or equal to 2mm reduction in proptosis in the study eye. In 2019, we initiated a randomized, masked, placebo-controlled Phase 2b clinical trial of batoclimab in TED. Our voluntary pause in dosing in February 2021 resulted in unblinding this trial and the primary |
endpoint was not significant. However, our analysis of exploratory endpoints from this trial increased our confidence in the anti-FcRn mechanism of action for patients with TED, and they provide part of the basis for our interest in moving forward with further development of in this indication. |
• | In 2019, we initiated a multi-center, randomized, blinded, placebo-controlled Phase 2a clinical trial of batoclimab for the treatment of MG. As evaluated in a pre-specified, pooled analysis of 15 subjects who completed Day 42 of the trial, batoclimab-treated subjects (N=10) showed a clinical improvement in both the MG-ADL scale and the MGC scale. |
• |
Development plan and upcoming milestones: |
• | As previously disclosed in December 2021, we achieved alignment with the FDA Division of Neurology 1 to move forward with our pivotal trial of batoclimab as a treatment for MG. We have initiated our Phase 3 study in MG which is now open for enrollment. We expect top-line data from this Phase 3 trial to be available in the second half of calendar year 2024. |
• | We plan to initiate two Phase 3 clinical trials to evaluate batoclimab for the treatment of TED in the second half of calendar year 2022, and we expect top-line results from both Phase 3 trials to be available in the first half of calendar year 2025. |
• | We plan to announce two new indications by August 2022, and we expect one of the three indications, including WAIHA, to be initiated as a pivotal trial in calendar year 2022. |
• |
Roivant ownership: |
• | As of March 31, 2022 we own 63% of the issued and outstanding shares of Immunovant common stock and 58% on a fully diluted basis. |
• | 12-week Induction Period: Includes doses of 680 mg SC injection weekly (“SC QW”) or anchor dose of 340 mg SC QW compared to placebo. The objective is to achieve maximum efficacy at the beginning of treatment and determine the potential benefit of 680 mg SC QW (i.e., speed and depth of clinical response). |
• | 12-week Maintenance Period: Includes anchor doses of 340 mg SC QW and 340 mg SC injection once every two weeks compared to placebo to assess lower effective maintenance doses with potentially fewer side effects related to long term IgG suppression or serum analyte changes. |
• | 52-week Long Term Extension: Includes long term safety assessment of the 2 maintenance doses; also includes tailored dosing allowing for treatment of disease exacerbations with short-term, re-induction dosing of batoclimab (680 mg SC QW x 4 weeks) followed by resumption of 340 mg SC QW. |
• |
Overview: |
• | Proteovant is focused on the discovery and development of a robust pipeline of protein degraders targeting indications in oncology and immunology. |
• |
Protein degradation: |
• | Protein degraders are a novel class of small molecules that target and destroy cellular proteins, rather than inhibiting them. Degraders are engineered to induce the degradation of specific disease-causing proteins through the ubiquitin-proteasome system, which ordinarily tags and degrades proteins that have been misfolded or have already fulfilled their biological function. |
• | In heterobifunctional degraders, the protein ligand domain, commonly referred to as a “warhead,” targets the specific protein of interest. At the other end of the complex, the ligase ligand recruits a specific E3 ubiquitin ligase. Both ends of the complex are connected by a linker that orients the target protein and E3 ligase in a cooperative ternary complex, driving ubiquitination. Similar to heterobifunctional degraders, molecular-glue-type degraders are small molecules that induce a novel interaction between a ligand of an E3 ubiquitin ligase and a target protein, leading to proteolysis of the target via the ubiquitin-proteasome system. |
• | We believe degraders represent a promising new approach to drug previously “undruggable” targets and transform the treatment of diseases with significant unmet medical need. Degraders open a new set of opportunities for small molecule drug development and have multiple distinct potential advantages over inhibitors, including that they: |
• | are not bound by “inhibitory” requirements, meaning they can target historically “undruggable” proteins, including transcription factors and scaffolding proteins that lack a catalytic pocket; |
• | may achieve efficacy at lower doses to decrease off-target dose-limiting toxicities; and |
• | have demonstrated protein depletion in tumors that have shown resistance to specific inhibitors. |
• |
Proteovant’s degrader strategy: |
• | Proteovant is leveraging leading protein degrader capabilities via its SRA with the lab of Dr. Shaomeng Wang, a world-renowned scientist focused on the discovery of protein degraders, at the University of Michigan. |
• | Proteovant has assembled a world-class team of scientists and drug developers with deep drug hunting capabilities in the field of small molecule degrader development to support its internal degrader discovery and development efforts. The core skill sets of the Proteovant team span all aspects of drug discovery and development, including medicinal chemistry, biology and structural biology, which is also supported by access to next generation wet labs. |
• | Proteovant has an exclusive partnership with VantAI, which, through its focus on in silico |
• | A novel protein contact-first workflow that utilizes information about known protein-protein interactions to design new degraders that can effectively stabilize target-E3 interfaces; |
• | A degron knowledge graph, which we believe to be industry-leading, that maps the ubiquitin proteasome system and enables the analysis of interactions between E3 ligases and degrons as well as the protein components that bind to E3 ligases and regulate degradation; and |
• | A unique model for predicting degradation based on millions of carefully curated protein stability datapoints. |
• |
Pipeline: |
• | Proteovant has a broad pipeline of programs across oncology and immunology indications, and its protein degrader structures include hererobifunctionals and molecular glues. The protein degraders in Proteovant’s pipeline range from early target validation through later stages of preclinical development. Select targets include STAT3, CBP/p300, and SMARCA2/4. |
• | In addition to Proteovant’s wholly owned pipeline, Proteovant has an ongoing strategic collaboration with Blueprint Medicines, pursuant to which the two companies intend to advance up to two novel protein degrader compounds into development candidates. In addition, the collaboration includes an option to expand to up to two additional novel protein degrader target programs. As a part of the collaboration, VantAI will deploy its technology for degrader generation and optimization. |
• |
Development plan and upcoming milestones: |
• | Proteovant aims to generate 1-2 INDs per year beginning in 2024. |
• |
Roivant ownership: |
• | As of March 31, 2022, we own 60% of the issued and outstanding common shares of Proteovant and 54% 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: |
• | Genevant has two delivery platforms: LNP and ligand conjugate. |
• | LNP platform: |
• | Proven technology as demonstrated by head-to-head in vivo |
• | Clinically validated for hepatocyte and vaccine applications and in various stages of development for other traditionally hard-to-reach |
• | Approximately 750 issued patents and pending patent applications as of June 15, 2022 |
• | Ligand conjugate platform: |
• | Novel GalNAc ligands with demonstrated ability to deliver to the liver in preclinical studies |
• | In preclinical head-to-head |
• | Applying delivery expertise to design novel extrahepatic ligands to expand therapeutic reach |
• |
Collaboration-based business model: |
• | 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 collaboration-based business model is to seek some or all of upfront payments, R&D reimbursements, and milestones and royalties (or profit share) 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-license. |
• | Some current collaboration partners include BioNTech, Takeda, Sarepta, Gritstone, ST Pharm, 2seventy bio, Chulalongkorn University (through its Vaccine Research Center), and Providence Therapeutics. |
• |
Clinical data: |
• | Genevant LNP technology has been in clinical testing in over a dozen distinct product candidates, representing hundreds of subjects of clinical experience. |
• | Genevant LNP technology is included in the first RNA-LNP product to receive FDA-approval, Alnylam’s Onpattro (patisiran). |
• |
Roivant ownership: |
• | As of March 31, 2022, we own 83% of the issued and outstanding common shares of Genevant and 67% on a fully diluted basis. |
1. | Multi-component formulations that contain specialized lipids optimized for potency and tolerability, are capable of encapsulating a broad range of nucleic acid payloads, and have limited constraints on nucleic acid composition, structure or size |
2. | A manufacturing process developed and scaled to produce stable uniform dispersion of colloidal nanoparticles with particle size appropriate for parenteral or intramuscular administration |
3. | Efficient intracellular delivery of nucleic acids to cell cytoplasm via engineered active endosomal escape mechanism |
• | Contains intrinsic endosomolytic properties |
• | Has demonstrated marked in vivo |
• | Has maintained a subcutaneous dosing regimen and is expected to be dosed subcutaneously in clinical trials |
• | Remains compatible with other ligand types |
• | Access to validated technology to deliver nucleic acid therapeutics for hepatocyte or vaccine applications |
• | Potential to deliver RNA payloads to historically challenging-to-reach |
• | No need to build internal delivery expertise or build intellectual property estate from scratch in an increasingly complex field |
• | Opportunity to expand core delivery technology and capabilities, maintaining leadership position in nucleic acid delivery |
• | Typically, the ability to exploit certain rights to delivery-related intellectual property developed in the context of collaboration ourselves or with other collaborators |
• | Opportunity to generate revenue through deal structures including some combination of upfront payments, R&D reimbursements and additional milestones and royalties upon successful outcomes |
• | Gritstone COVID-19 vaccine program |
• | Gritstone |
• | Sarepta LNP-gene editing therapeutics for specified neuromuscular diseases; Genevant will design and collaborate with Sarepta in the development of muscle targeted LNPs to be applied to gene editing targets in multiple indications, including Duchenne muscular dystrophy |
• | BioNTech —Co-development in up to five rare diseases with high unmet medical need, and access to LNP technology for use with BioNTech’s mRNA for a specified number of oncology targets |
• | Takeda |
• | Takeda |
• | ST Pharm COVID-19 vaccine program |
• | Providence COVID-19 vaccine program |
• | 2seventy |
• | Chulalongkorn University COVID-19 vaccine program |
• | Robust and expansive patent portfolio. |
• | Experienced leadership team. |
• | Manufacturing know-how. know-how. Our manufacturing process is rapid and reproducible, has intellectual property protection and is capable of commercial scale. |
• | 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; and |
• | Various aspects of our manufacturing process. |
• |
Overview : |
• | Priovant is developing brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1, for the treatment of dermatomyositis (“DM”), systemic lupus erythematosus (“SLE”) and other immune-mediated diseases. |
• |
Lead program : |
• | Brepocitinib is a potentially first-in-class, 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%. |
• | SLE is a chronic, immune-mediated connective tissue disease that can impact nearly all major organ systems. The most common manifestations of SLE are cutaneous and musculoskeletal symptoms, although neurological, gastrointestinal, hematological, and renal symptoms are regularly observed as well. Patients with SLE are at a substantially increased risk of infection and cardiovascular disease, contributing to estimated 10- and 15-year mortality rates of 9% and 15%, respectively. |
• | We estimate that there are approximately 37,000 adult DM patients and up to 300,000 adult SLE patients in the US. |
• |
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 SLE. 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 SLE who do not respond adequately to traditional therapies, belimumab (BENLYSTA) and anifrolumab (SAPHNELO) are FDA-approved biologic treatments. However, in each of belimumab’s BLISS Phase 3 program and anifrolumab’s TULIP Phase 3 program, the clinical trial data demonstrates that many patients failed to respond to these therapies, and both therapies are administered intravenously or subcutaneously. |
• |
Clinical data : |
• | Brepocitinib has been evaluated in five completed placebo-controlled Phase 2 studies in immune-mediated diseases (psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata, and hidradenitis suppurativa). In all five of these studies, treatment with brepocitinib was associated with statistically significant and clinically meaningful efficacy. |
Study Population |
N 1 |
Brepocitinib Dose |
Primary Endpoint Result |
Statistical Significance | ||||
Psoriatic Arthritis |
218 | 30 mg once daily | 23.4% placebo-adjusted ACR20 RR at week 16 | P = 0.0197 | ||||
Plaque Psoriasis |
212 | 30 mg once daily | -10.1 placebo-adjusted CFB in PASI score at week 12 | P < 0.0001 | ||||
Ulcerative Colitis |
167 | 30 mg once daily | -2.28 placebo-adjusted CFB in Mayo Score at week 8 | P = 0.0005 | ||||
Alopecia Areata |
94 2 |
30 mg once daily 3 |
49.18 placebo-adjusted CFB in SALT Score at week 24 | P < 0.0001 4 | ||||
Hidradenitis Suppurativa |
100 | 45 mg once daily 5 |
18.7% placebo-adjusted HiSCR rate at week 16 | P = 0.0298 4 |
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 QD for 4 weeks followed by 30 mg QD for 20 weeks. |
4. | One-sided p-value (pre-specified statistical analysis). |
5. | Brepocitinib 45 mg once daily was the only dose evaluated in this study. |
• | Brepocitinib’s safety database includes over 1,000 exposed participants evaluated in 14 completed Phase 1 and Phase 2 studies and three ongoing Phase 1 and Phase 2 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. |
• | 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 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. |
• | Brepocitinib has not been evaluated in SLE to-date. However, FDA-approved and investigational JAK inhibitors have completed successful proof-of-concept |
• |
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. |
• | Brepocitinib is currently being evaluated in a large, randomized controlled Phase 2B study in patients with moderate to severe active SLE. This study will enroll approximately 350 subjects in total and will evaluate 15 mg, 30 mg, and 45 mg of brepocitinib once-daily compared to placebo. The primary |
endpoint of this study is the Systemic Lupus Erythematosus Responder Index (“SRI-4”), a validated SLE improvement index, at Week 52. Priovant anticipates receiving topline results from this study in the second half of 2023. |
• | Priovant is also evaluating brepocitinib for the development of hidradenitis suppurativa and non-infectious uveitis. |
• |
Roivant ownership : |
• | As of March 31, 2022, we own 75% of the issued and outstanding shares of Priovant and 70% 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 anti-GM-CSFs |
• |
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 United States, 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 initiated a Phase 2 trial to evaluate the safety and efficacy of namilumab in pulmonary sarcoidosis, with a readout expected in the first half of 2024. |
• |
Roivant ownership: |
• | As of March 31, 2022, we own 88% of the issued and outstanding common shares of Kinevant, and 83% on a fully diluted basis. |
• |
Overview : |
• | Hemavant is developing RVT-2001, a small molecule SF3B1 modulator, for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (“MDS”). |
• |
Lead program : |
• | RVT-2001 is a potentially first-in-class, |
• |
Disease overview : |
• | Myelodysplastic syndromes are a group of hematologic malignancies in which immature blood cells in the bone marrow do not mature and become healthy blood cells. MDS patients are at risk for symptoms related to anemia, infection and bleeding, and they have variable survival expectations and rates of progression to acute myeloid leukemia. Assessment of prognosis is a key aspect in selecting therapy for the patient with MDS, and prognostic models broadly differentiate patients into either lower-risk MDS or higher-risk MDS. |
• | We believe that there are approximately 115,000 MDS patients in the US, with approximately 17,000 new MDS cases per year, two thirds of which are lower-risk MDS. |
• |
Limitations of current treatments : |
• | Chronic anemia in patients with MDS requires regular and repeated red blood cell (“RBC”) transfusions, creating a significant burden for patients and an increased risk of organ toxicity from iron overload. |
• | One of the primary goals of treatment is to reduce or eliminate RBC transfusion dependence while minimizing treatment-related toxicity. The first line of treatment for most lower-risk MDS patients consists of erythropoiesis-stimulating agents (“ESAs”), which are ineffective in over 50% of patients. |
• | For patients who fail ESAs, the available treatment options depend on mutational status and disease phenotypes. In 2020, Reblozyl (luspatercept) became the only FDA-approved therapy for lower-risk MDS patients who are ring sideroblast positive and who have failed an ESA. Although Reblozyl can lead to transfusion independence, it is ineffective in over 50% of patients and is most effective in patients with a low transfusion burden. Reblozyl is delivered as an injection and is associated with numerous adverse events, including fatigue, a significant concern for patients already experiencing fatigue from anemia. |
• |
Clinical data : |
• | In the dose-escalation portion of an ongoing Phase 1/2 study, over 30% (6/19) of patients with lower-risk, transfusion-dependent MDS treated with RVT-2001 became RBC-transfusion independent (“RBC-TI”), with a median duration of treatment of approximately two years for responders. The dose-escalation portion of the study was conducted in a highly refractory patient population, which we believe may have decreased the observed treatment response relative to what would be expected in a less refractory target population. |
• | In the dose-escalation portion of this ongoing Phase 1/2 study, which had a total of 84 patients with acute myeloid leukemia (“AML”), chronic myelomonocytic leukemia or MDS, RVT-2001 was observed to be generally well-tolerated, with the majority of events being classified as Grade 1. |
• |
Development plan and upcoming milestones : |
• | We have amended the IND for the ongoing open-label Phase 1/2 trial to add a dose-optimization cohort. We are enrolling a less refractory patient population in the dose-optimization cohort than the |
population from which the first 19 lower-risk, transfusion-dependent MDS patients were drawn during the dose-escalation portion by excluding patients with prior exposure to lenalidomide or hypomethylating agents. We are targeting a genetically defined subpopulations by enrolling only lower-risk MDS patients with SF3B1 mutations. In addition, we are evaluating baseline expression of TMEM14C transcripts as a potential biomarker predictive of response to RVT-2001, since among the 7 MDS patients with the highest levels of aberrant TMEM14C transcripts in the dose-escalation portion of this Phase 1/2 trial, 71% (5/7) became RBC-TI. We also aim to strengthen the phamacodynamic effect by optimizing the dosage of RVT-2001. We expect data from the dose-optimization cohort of the Phase 1/2 trial to be available in 2023. |
• | Our initial plan is to position RVT-3002 as second line therapy in SF3B1-mutated patients, with the potential to expand to other spliceosome mutations and ultimately first line treatment. |
• |
Roivant ownership: |
• | As of March 31, 2022, we own 100% of the issued and outstanding common shares of Hemavant and 100% on a fully diluted basis. |
• |
Overview: |
• | Affivant is focused on the future development and commercialization of AFVT-2101 and other bispecific antibodies through its licensing and strategic collaboration agreement with Affimed to develop and commercialize novel innate cell engagers for multiple cancer targets. |
• |
Lead program: |
• | AFVT-2101 is a preclinical immune-engaging bispecific antibody licensed from Affimed with potential applicability to several solid tumor indications. |
• | Bispecific innate cell engagers (“ICE”), which are generated by Affimed’s Redirected Optimized Cell Killing (“ROCK”) platform technology, are a novel class of drugs that activate the innate immune system and trigger a concerted anti-tumoral immune response. These bispecific antibodies consist of tumor-associated antigen binding domains, which cause high affinity and high specificity binding to the tumor surface, and immune cell binding domains, which bind and activate specific immune cell subsets able to kill the tumor cell. |
• | AFVT-2101 is an ICE program whose Fc region is fused to two high affinity CD16A binding single chain variable regions to maximize NK cell and macrophage engagement. The biological target of AFVT-2101’s tumor-associated antigen binding domain has been clinically validated via other targeted agents (mAb and ADC), including both evidence of single agent activity and a generally well-tolerated safety profile of the corresponding mAb in published studies. |
• | We believe AFVT-2101 has potential applicability across several highly prevalent solid tumor types, providing the optionality to pursue multiple large-market indications. |
• |
Preclinical data: |
• | In a head-to-head |
• | AFVT-2101’s potency also exceeded the potency of antibody-drug conjugate (“ADC”) agents that have been clinically validated against the same tumor target, as reported in published preclinical studies. |
• | Based on preclinical and clinical experiences with other ICE antibodies in separate studies, we believe that the tolerability of AFVT-2101 has the potential to be superior to that observed to date with ADCs in published literature. |
• |
Development plan and upcoming milestones: |
• | We expect to file an IND for AFVT-2101 in the first half of calendar year 2023. |
• | Pursuant to a collaboration and licensing agreement between Affivant and Affimed, Affimed is conducting a significant portion of the AFVT-2101 preclinical work for the collaboration under the governance of a Joint Steering Committee controlled by Affivant. |
• | Pursuant to the agreement Affivant will be responsible for submitting any IND or equivalent for AFVT-2101, and will be responsible for all future clinical development and commercialization worldwide, with Affimed retaining an option for co-promotion. |
• | We also have the option to license from Affimed additional ICE molecules directed against targets that are not (a) currently licensed or optioned to third parties or (b) directed against targets included in Affimed’s current pipeline. |
• |
Roivant ownership: |
• | As of March 31, 2022, we own 100% of the issued and outstanding common shares of Affivant and 99% 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 United States. |
• | 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; or |
• | 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 |
• | 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. 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). |
ITEM 1A. |
RISK FACTORS |
• | successfully commercialize VTAMA; |
• | identify new acquisition or in-licensing opportunities; |
• | successfully complete ongoing preclinical studies and clinical trials and obtain regulatory approvals for our current and future products and product candidates; |
• | successfully identify new product candidates through our small molecule discovery engine and advance those product candidates into preclinical studies and clinical trials; |
• | successfully market our healthcare technology products and services; |
• | raise additional funds when needed and on terms acceptable to us; |
• | 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; |
• | launch commercial sales of future product candidates, whether alone or in collaboration with others, including establishing sales, marketing and distribution systems; |
• | initiate and continue 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 the U.S. Food and Drug Administration (the “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; and |
• | maintain, expand and protect our intellectual property portfolio. |
• | the time and costs necessary to complete our ongoing, planned and future clinical trials; |
• | 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; |
• | the 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; |
• | the costs associated with our ongoing, planned and future preclinical studies and other drug discovery activities; |
• | 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 products and product candidates; |
• | our ability to successfully commercialize VTAMA, including: |
• | 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 |
• | 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; |
• | the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us or any of our current or future products or product candidates; and |
• | our ability to hire, attract and retain qualified personnel. |
• | our ability to recruit and retain effective sales, marketing and customer service personnel; |
• | our ability to obtain 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; |
• | the extent to which coverage and adequate reimbursement for these 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; and |
• | other unforeseen costs, expenses and risks associated with the commercialization of biopharmaceutical products, including compliance costs. |
• | our ability to sell and market our current and future products and, if approved, product candidates, including as a result of government- or employer-imposed remote work orders and travel and workplace visitor restrictions; |
• | a decrease in patient health care utilization due to quarantines, travel restrictions, work from home orders or other public health measures; |
• | delays or disruptions in our commercial supply chain including as a result of quarantines, travel restrictions, work from home orders or other public health measures; |
• | delays or difficulties in enrolling patients in our clinical trials, and the consequences of such delays or difficulties, including terminating clinical trials prematurely; |
• | delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
• | delays or disruptions in nonclinical experiments due to unforeseen circumstances at contract research organizations (“CROs”), and vendors along their supply chain; |
• | increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19, being forced to quarantine or not accepting home health visits; |
• | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; |
• | interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures (particularly any procedures that may be deemed non-essential), which may impact the integrity of subject data and clinical study endpoints; |
• | interruption or delays in the operations of the FDA and comparable non-U.S. regulatory agencies, which may impact review and approval timelines; |
• | interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems; |
• | limitations on employee resources that would otherwise be focused on the conduct of our clinical trials and preclinical studies, including because of sickness of employees or their families, the desire of employees to avoid contact with large groups of people and increased reliance on working from home or mass transit disruptions; |
• | other disruptions to our business generally, including remote working activities and the implementation of new health and safety requirements for our employees; and |
• | waiver or suspension of patent or other intellectual property rights. |
• | increased operating expenses and cash requirements; |
• | the assumption of indebtedness or contingent liabilities; |
• | the issuance of our or our subsidiaries’ equity securities which would result in dilution to existing shareholders; |
• | assimilation of operations, intellectual property and products, including difficulties associated with integrating new personnel; |
• | diversion of management time and focus away from operating our business; |
• | the loss of key personnel and uncertainties in our ability to maintain key business relationships; |
• | risks and uncertainties associated with the counterparty to any such transaction; |
• | our inability to eventually generate revenue from acquired technology or products or product candidates sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs; |
• | litigation or other claims, including claims from terminated employees, customers, former shareholders or other third parties. |
• | conducting research and development activities in new therapeutic areas or treatment approaches in which we have little to no experience; |
• | diversion of financial and managerial resources from existing operations; |
• | actual or potential conflicts among new and existing Vants to the extent they have overlapping or competing areas of focus or pipeline products; |
• | successfully negotiating a proposed acquisition, in-license or investment in a timely manner and at a price or on terms and conditions favorable to us; |
• | successfully combining and integrating a potential acquisition into our existing business to fully realize the benefits of such acquisition; |
• | the impact of regulatory reviews on a proposed acquisition, in-license or investment; and |
• | the outcome of any legal proceedings that may be instituted with respect to the proposed acquisition, in-license or investment. |
• | 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; |
• | if an NDA, BLA or a similar application is reviewed by an advisory committee, the FDA or other relevant regulatory authority, as the case may be, may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the FDA or other relevant regulatory authorities, as the case may be, require, as a condition of approval, additional nonclinical, preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; |
• | the FDA or other relevant regulatory authorities may require development of a risk evaluation and mitigation strategy (“REMS”) 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, suspend, vary, or limit their approval of the product or require a REMS (or equivalent outside the United States) to impose restrictions on its distribution or other risk management measures; |
• | regulatory authorities may 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 labeling statements, such as warnings or contraindications, require other labeling 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 labeling 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; |
• | physicians may stop prescribing a product; |
• | 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 labeling 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 United States); |
• | 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 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; |
• | the ability to offer these products for sale at competitive prices; |
• | the ability to offer appropriate patient financial assistance programs, such as commercial insurance co-pay assistance; |
• | convenience and ease of dosing and administration compared to alternative treatments; |
• | the clinical indications for which the product or product candidate is approved by FDA or comparable non-U.S. regulatory agencies; |
• | product labeling or product insert requirements of the FDA or other comparable non-U.S. regulatory authorities, including any limitations, contraindications or warnings contained in a product’s approved labeling; |
• | restrictions on how the product 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 $11,803 to $23,607 for each false claim or statement for penalties assessed after December 13, 2021, 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 impose obligations with respect to safeguarding the privacy, security, and cross-border transmission of personal data and 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 or maintain 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 United States 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. |
• | Roflumilast, a PDE4 inhibitor, a potential competitor to VTAMA, which in May 2022 was approved by the FDA for the treatment of plaque psoriasis in adults in the U.S. under the brand name VTAMA cream and which is also in development by Dermavant for the topical treatment of atopic dermatitis; |
• | Ruxolitinib, a topical Janus kinase inhibitor, a potential competitor to VTAMA, in development by Dermavant for the topical treatment of atopic dermatitis; |
• | Teprotumumab, an insulin-like growth factor-1 receptor inhibitor, which in January 2020 was approved by the FDA for the treatment of TED, a potential competitor to batoclimab, in development by Immunovant for the treatment of TED and other autoimmune diseases; |
• | VYVGART ™ (efgartigimod alfa-fcab), a neonatal Fc receptor blocker, which in December 2021 was approved by the FDA for the treatment of MG in adults who test positive for the anti-acetylcholine |
receptor antibody, a potential competitor to batoclimab, in development by Immunovant for the treatment of MG and other autoimmune diseases; |
• | Efgartigimod, an anti-FcRn antibody fragment, nipocalimab, an anti-FcRn antibody, Zilucoplan, a peptide inhibitor of C5, and inebilizumab, a CD19-targeted humanized monoclonal antibody, all potential competitors to batoclimab, in development by Immunovant for the treatment of MG and other autoimmune diseases; |
• | Ultomiris (Ravulizumab-cwvz), a complement inhibitor, which in April 2022 was approved by the FDA for the treatment of generalized MG in adults who are anti-acetylcholine receptor antibody-positive, a potential competitor to batoclimab, in development by Immunovant for the treatment of MG and other autoimmune diseases; |
• | Rituximab, a monoclonal antibody, a potential competitor to batoclimab, in development by Immunovant for the treatment of TED, WAIHA and other autoimmune diseases; |
• | Fostamatinib, a syk inhibitor, ibrutinib, a BTK inhibitor, and ANX005, an antibody inhibitor, all potential competitors to batoclimab, in development by Immunovant for the treatment of WAIHA and other autoimmune diseases; and |
• | 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 labeling, marketing or promotional restrictions; |
• | decreased demand for our products, existing product candidates or any future product candidate, 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 United States 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; |
• | the ability of our board of directors to prevent the transfer of capital stock, or the exercise of rights with respect to our capital stock, if the effect of such transfer or exercise of rights would result in a shareholder holding more than 9.9% of the total issued and outstanding shares of our capital stock on a fully diluted basis; and |
• | requiring advance notice for shareholder proposals and nominations and placing limitations on convening shareholder meetings. |
• | 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; |
• | 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; and |
• | our ability to maintain a continued acceptable safety profile of our product candidates following approval of our product candidates. |
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Revenue, net |
$ | 55,286 | $ | 23,795 | $ | 31,491 | ||||||
Operating expenses: |
||||||||||||
Cost of revenues |
8,966 | 2,057 | 6,909 | |||||||||
Research and development |
483,035 | 236,626 | 246,409 | |||||||||
Acquired in-process research and development |
139,894 | 596,132 | (456,238 | ) | ||||||||
General and administrative |
775,033 | 259,878 | 515,155 | |||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
1,406,928 | 1,094,693 | 312,235 | |||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
(1,351,642 | ) | (1,070,898 | ) | (280,744 | ) | ||||||
|
|
|
|
|
|
|||||||
Change in fair value of investments |
87,291 | (95,533 | ) | 182,824 | ||||||||
Gain on sale of investment |
(443,754 | ) | — | (443,754 | ) | |||||||
Change in fair value of debt and liability instruments |
(3,354 | ) | 29,845 | (33,199 | ) | |||||||
Gain on termination of Sumitomo Options |
(66,472 | ) | — | (66,472 | ) | |||||||
Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity |
(5,041 | ) | (115,364 | ) | 110,323 | |||||||
Other expense, net |
3,435 | 8,701 | (5,266 | ) | ||||||||
|
|
|
|
|
|
|||||||
Loss before income taxes |
(923,747 | ) | (898,547 | ) | (25,200 | ) | ||||||
Income tax expense |
369 | 1,686 | (1,317 | ) | ||||||||
|
|
|
|
|
|
|||||||
Net loss |
(924,116 | ) | (900,233 | ) | (23,883 | ) | ||||||
Net loss attributable to noncontrolling interests |
(78,854 | ) | (90,999 | ) | 12,145 | |||||||
|
|
|
|
|
|
|||||||
Net loss attributable to Roivant Sciences Ltd. |
$ | (845,262 | ) | $ | (809,234 | ) | $ | (36,028 | ) | |||
|
|
|
|
|
|
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Revenue, net |
$ | 55,286 | $ | 23,795 | $ | 31,491 |
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Cost of revenues |
$ | 8,966 | $ | 2,057 | $ | 6,909 |
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Program-specific costs: |
||||||||||||
Batoclimab |
$ | 67,181 | $ | 49,236 | $ | 17,945 | ||||||
Tapinarof |
64,496 | 34,002 | 30,494 | |||||||||
Brepocitinib |
24,890 | — | 24,890 | |||||||||
ARU-1801 |
23,312 | 24,347 | (1,035 | ) | ||||||||
AFVT-2101 |
12,657 | 3,782 | 8,875 | |||||||||
ARU-2801 |
12,031 | 784 | 11,247 | |||||||||
LSVT-1701 |
11,067 | 3,383 | 7,684 | |||||||||
Namilumab |
8,745 | 820 | 7,925 | |||||||||
Other program-specific costs |
60,660 | 45,558 | 15,102 | |||||||||
|
|
|
|
|
|
|||||||
Total program-specific costs |
285,039 | 161,912 | 123,127 | |||||||||
|
|
|
|
|
|
|||||||
Unallocated internal costs: |
||||||||||||
Share-based compensation |
63,735 | 22,637 | 41,098 | |||||||||
Personnel-related expenses |
103,827 | 45,646 | 58,181 | |||||||||
Other expenses |
30,434 | 6,431 | 24,003 | |||||||||
|
|
|
|
|
|
|||||||
Total research and development expenses |
$ | 483,035 | $ | 236,626 | $ | 246,409 | ||||||
|
|
|
|
|
|
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Consideration for the purchase of IPR&D |
$ | 97,412 | $ | 591,916 | $ | (494,504 | ) | |||||
Development milestone payments |
42,482 | 4,216 | 38,266 | |||||||||
|
|
|
|
|
|
|||||||
Total acquired in-process research and development expenses |
$ | 139,894 | $ | 596,132 | $ | (456,238 | ) | |||||
|
|
|
|
|
|
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
General and administrative |
$ | 775,033 | $ | 259,878 | $ | 515,155 |
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Change in fair value of investments |
$ | 87,291 | $ | (95,533 | ) | $ | 182,824 |
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Gain on sale of investment |
$ | (443,754 | ) | $ | — | $ | (443,754 | ) |
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Change in fair value of debt and liability instruments |
$ | (3,354 | ) | $ | 29,845 | $ | (33,199 | ) |
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Gain on termination of Sumitomo Options |
$ | (66,472 | ) | $ | — | $ | (66,472 | ) |
Years Ended March 31, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(in thousands) |
||||||||||||
Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity |
$ | (5,041 | ) | $ | (115,364 | ) | $ | 110,323 |
• | Contractual payments related to our long-term debt (see Note 7, “Long-Term Debt and Loan Commitment” of our audited financial statements); |
• | obligations under our operating leases (see Note 12, “Leases” of our audited financial statements); |
• | certain commitments to Palantir Technologies Inc. (“Palantir”) totaling $30.0 million related to a master subscription agreement entered in May 2021 for access to Palantir’s proprietary software for a five-year period; and |
• | 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. The minimum purchase commitment related to this agreement is estimated to be approximately $36.0 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, |
||||||||
2022 |
2021 |
|||||||
(in thousands) |
||||||||
Net cash used in operating activities |
$ | (677,729 | ) | $ | (552,138 | ) | ||
Net cash provided by (used in) investing activities |
$ | 303,295 | $ | (31,702 | ) | |||
Net cash provided by financing activities |
$ | 306,792 | $ | 456,264 |
• | the prices of our common shares sold to investors in arm’s length transactions; |
• | the estimated present value of our future cash flows; |
• | our business, financial condition and results of operations; |
• | our forecasted operating performance; |
• | the illiquid nature of our common shares; |
• | industry information such as market size and growth; |
• | market capitalization of comparable companies and the estimated value of transactions such companies have engaged in; and |
• | macroeconomic conditions. |
Page |
||||
18 6 |
||||
Consolidated Financial Statements |
||||
1 87 |
||||
1 88 |
||||
1 89 |
||||
19 0 |
||||
19 1 |
||||
19 2 |
March 31, 2022 |
March 31, 2021 |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
||||||||
Other current assets |
||||||||
|
|
|
|
|||||
Total current assets |
||||||||
Property and equipment, net |
||||||||
Operating lease right-of-use |
||||||||
Restricted cash, net of current portion |
||||||||
Investments measured at fair value |
||||||||
Long-term investment |
||||||||
Other assets |
||||||||
|
|
|
|
|||||
Total assets |
$ | $ | ||||||
|
|
|
|
|||||
Liabilities, Redeemable Noncontrolling Interest and Shareholders’ Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued expenses |
||||||||
Operating lease liabilities |
||||||||
Deferred consideration liability |
||||||||
Deferred revenue |
||||||||
Other current liabilities |
||||||||
|
|
|
|
|||||
Total current liabilities |
||||||||
Liability instruments measured at fair value |
||||||||
Operating lease liabilities, noncurrent |
||||||||
Long-term debt (includes $ |
||||||||
Deferred revenue, noncurrent |
||||||||
Other liabilities |
||||||||
|
|
|
|
|||||
Total liabilities |
||||||||
|
|
|
|
|||||
Commitments and contingencies (Note 13) |
||||||||
Redeemable noncontrolling interest |
||||||||
Shareholders’ equity: (1) |
||||||||
Common shares, par value $ per share, |
||||||||
Additional paid-in capital |
||||||||
Subscription receivable |
( |
) | ||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Accumulated other comprehensive (loss) income |
( |
) | ||||||
|
|
|
|
|||||
Shareholders’ equity attributable to Roivant Sciences Ltd. |
||||||||
Noncontrolling interests |
||||||||
|
|
|
|
|||||
Total shareholders’ equity |
||||||||
|
|
|
|
|||||
Total liabilities, redeemable noncontrolling interest and shareholders’ |
$ | $ | ||||||
|
|
|
|
(1) |
Retroactively restated for the stock subdivision as described in Note 3. |
Years Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Revenue, net |
$ | $ | ||||||
Operating expenses: |
||||||||
Cost of revenues |
||||||||
Research and development (includes $ |
||||||||
Acquired in-process research and development |
||||||||
General and administrative (includes $ |
||||||||
|
|
|
|
|||||
Total operating expenses |
||||||||
|
|
|
|
|||||
Loss from operations |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Change in fair value of investments |
( |
) | ||||||
Gain on sale of investment |
( |
) | ||||||
Change in fair value of debt and liability instruments |
( |
) | ||||||
Gain on termination of Sumitomo Options |
( |
) | ||||||
Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity |
( |
) | ( |
) | ||||
Other expense, net |
||||||||
|
|
|
|
|||||
Loss before income taxes |
( |
) | ( |
) | ||||
Income tax expense |
||||||||
|
|
|
|
|||||
Net loss |
( |
) | ( |
) | ||||
Net loss attributable to noncontrolling interests |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net loss attributable to Roivant Sciences Ltd. |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
|||||
Net loss per common share—basic and diluted(1) |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
|||||
Weighted average shares outstanding—basic and diluted (1) |
||||||||
|
|
|
|
(1) |
Retroactively restated for the stock subdivision as described in Note 3. |
Years Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Other comprehensive loss: |
||||||||
Foreign currency translation adjustment |
( |
) | ||||||
|
|
|
|
|||||
Total other comprehensive (loss) income |
( |
) | ||||||
|
|
|
|
|||||
Comprehensive loss |
( |
) | ( |
) | ||||
Comprehensive loss attributable to noncontrolling interests |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Comprehensive loss attributable to Roivant Sciences Ltd. |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
Shareholders’ Equity (1) |
||||||||||||||||||||||||||||||||||||
Redeemable Noncontrolling Interest |
Common Stock |
Additional Paid-in Capital |
Subscription Receivable |
Accumulated Other Comprehensive Income (Loss) |
Accumulated Deficit |
Noncontrolling Interests |
Total Shareholders’ Equity |
|||||||||||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||||||||||||||
Balance at March 31, 2020 |
$ | $ | $ | $ | $ | ( |
) | $ | ( |
) | $ | $ | ||||||||||||||||||||||||
Issuance of the Company’s common shares |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||
Issuance of subsidiary common shares, net |
— | — | — | ( |
) | — | — | |||||||||||||||||||||||||||||
Issuance of subsidiary common shares to the Company |
— | — | — | ( |
) | — | — | — | — | |||||||||||||||||||||||||||
Exercise of subsidiary stock options and vesting of subsidiary restricted stock units |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||
Deconsolidation of subsidiary |
— | — | — | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||
Consolidation of unconsolidated entity |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||
Repurchase of equity awards |
— | — | — | ( |
) | — | — | — | — | ( |
) | |||||||||||||||||||||||||
Cash contribution to majority-owned subsidiaries |
— | — | — | ( |
) | — | — | — | — | |||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | |||||||||||||||||||||||||||||||
Foreign currency translation adjustment |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||
Balance at March 31, 2021 |
$ | $ | $ | $ | ( |
) | $ | $ | ( |
) | $ | $ | ||||||||||||||||||||||||
Issuance of subsidiary warrants |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||
Issuance of the Company’s common shares upon closing of Business Combination and PIPE Financing, net of issuance costs |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||
Issuance of the Company’s c ommon s haresrelated to settlement of transaction consideration |
— | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||
Issuance of subsidiary preferred shares |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||
Issuance of subsidiary common and preferred shares to the Company |
— | — | — | ( |
) | — | — | — | — | |||||||||||||||||||||||||||
Payment of subscription receivable |
— | — | — | ( |
) | — | — | |||||||||||||||||||||||||||||
Repurchase of equity awards |
— | — | — | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||||||||
Issuance of the Company’s c ommon s hares |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||
Issuance of common stock upon warrants exercise |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||
Stock options exercised and restricted stock units vested and settled |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||
Deconsolidation of subsidiary |
— | — | — | — | — | — | — | |||||||||||||||||||||||||||||
Cash contributions to majority-owned subsidiaries |
— | — | — | ( |
) | — | — | — | — | |||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | ||||||||||||||||||||||||||||||
Foreign currency translation adjustment |
— | — | — | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||||||||
Net loss |
— | — | — | — | — | — | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||
Balance at March 31, 2022 |
$ | $ | $ | $ | $ | ( |
) | $ | ( |
) | $ | $ | ||||||||||||||||||||||||
(1) |
Retroactively restated for the stock subdivision as described in Note 3. |
Years Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Non-cash acquired in-process research and development |
||||||||
Share-based compensation |
||||||||
Change in fair value of investments |
( |
) | ||||||
Gain on sale of investment |
( |
) | ||||||
Change in fair value of debt and liability instruments |
( |
) | ||||||
Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity |
( |
) | ( |
) | ||||
Gain on termination of Sumitomo Options |
( |
) | ||||||
Loss from equity method investment |
||||||||
Other |
||||||||
Changes in assets and liabilities, net of effects from acquisition and divestiture: |
||||||||
Accounts payable |
||||||||
Accrued expenses |
||||||||
Deferred consideration liability |
( |
) | ||||||
Operating lease liabilities |
( |
) | ( |
) | ||||
Deferred revenue |
||||||||
Other |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net cash used in operating activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Cash flows from investing activities: |
||||||||
Proceeds from sale of investment |
||||||||
Purchase of property and equipment |
( |
) | ( |
) | ||||
Other |
( |
) | ||||||
|
|
|
|
|||||
Net cash provided by (used in) investing activities |
( |
) | ||||||
|
|
|
|
|||||
Cash flows from financing activities: |
||||||||
Proceeds from Business Combination and PIPE Financing |
||||||||
Proceeds from issuance of subsidiary common shares, net of issuance costs paid |
||||||||
Proceeds from payment of subscription receivable |
||||||||
Proceeds from subsidiary debt financings, net of financing costs paid |
||||||||
Repayment of long-term debt by subsidiary |
( |
) | ||||||
Payment of offering costs and loan origination costs |
( |
) | ( |
) | ||||
Other |
( |
) | ||||||
|
|
|
|
|||||
Net cash provided by financing activities |
||||||||
|
|
|
|
|||||
Net change in cash, cash equivalents and restricted cash |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash at beginning of period |
||||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash at end of period |
$ | $ | ||||||
|
|
|
|
|||||
Non-cash investing and financing activities: |
||||||||
Subscription receivable related to issuance of subsidiary common shares |
$ | $ | ||||||
Other |
$ | $ | ||||||
Supplemental disclosure of cash paid: |
||||||||
Income taxes paid |
$ | $ | ||||||
Interest paid |
$ | $ |
March 31, 2022 |
March 31, 2021 |
|||||||
Cash and cash equivalents |
$ | $ | ||||||
Restricted cash |
||||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash |
$ | $ | ||||||
|
|
|
|
Property and Equipment |
Estimated Useful Life | |
Computers |
||
Laboratory and other equipment |
||
Furniture and fixtures |
||
Software |
||
Leasehold improvements |
• | 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. |
• | Licenses of intellectual property: 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. For licenses that are not distinct from other promises, the Company applies judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the related revenue recognition accordingly. |
• | Milestone payments: 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: pre-specified level of sales, the Company |
recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Achievement of these royalties and commercial milestones may solely depend upon performance of the licensee. |
a. | each share of MAAC Class A common stock (the “MAAC Class A Shares”) and each share of MAAC Class B common stock (the “MAAC Class B Shares”) that were outstanding immediately before the Effective Time (other than treasury shares and any shares held by Patient Square Capital LLC (the “MAAC Sponsor”), any affiliate of the MAAC Sponsor or any of MAAC’s independent directors (the “MAAC Independent Directors”) or its transferee) were automatically canceled and extinguished and converted into one c s |
b. | each MAAC Class B Share that was outstanding immediately before the Effective Time and held by the MAAC Sponsor, any affiliate of the MAAC Sponsor or any of the MAAC Independent Directors or its transferee were automatically canceled and extinguished and converted into a number of Roivant C S C S |
c. | each warrant to purchase MAAC Class A Shares that was outstanding immediately before the Effective Time was converted automatically into a right to acquire a Roivant Common Share (a “Roivant Warrant”) at an exercise price of $ |
a. | C S C S Earn-Out Shares”), each in respect |
of its MAAC Class B Shares, will vest if the closing price of Roivant C S |
b . |
C S C S Earn-Out Shares” and, together with the Earn-Out Shares, the “Earn-Out Shares”), each in respect of its MAAC Class B Shares, will vest if the closing price of Roivant C S |
c . |
The remaining number of Roivant C S |
• | in whole and not in part; |
• | at a price of $ |
• | upon a minimum of |
• | if, and only if, the last reported sale price of c stock 30 -trading day period ending on the third trading day prior to the date on which the Company sends the notice of redemption to the warrantholders (the “Reference Value”) equals or exceeds $ |
• | in whole and not in part; |
• | at $ C S C S |
• | if, and only if, the Reference Value equals or exceeds $ |
• | if the Reference Value is less than $ |
• | Genevant issued |
• | $ |
• | Genevant issued |
March 31, 2022 |
March 31, 2021 |
|||||||
Research and development expenses |
$ | $ | ||||||
Compensation-related expenses |
||||||||
Other general and administrative expenses |
||||||||
Total accrued expenses |
$ | $ | ||||||
March 31, 2022 |
March 31, 2021 |
|||||||
Principal amount |
$ | $ | ||||||
Exit fee / end of term charge |
||||||||
Less: unamortized debt discount and issuance costs |
( |
) | ( |
) | ||||
Total debt, net |
||||||||
Less: current portion |
||||||||
Total long-term debt, net |
$ | $ | ||||||
Years Ending March 31, |
||||
2023 |
$ | |||
2024 |
||||
2025 |
||||
2026 |
||||
2027 |
||||
Thereafter |
||||
Total |
$ | |||
Years Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Share-based compensation expense recognized as: |
||||||||
R&D expenses |
$ | $ | ||||||
G&A expenses |
||||||||
|
|
|
|
|||||
Total |
$ | $ | ||||||
|
|
|
|
Number of Options |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Life (in years) |
Aggregate Intrinsic Value (in thousands) |
|||||||||||||
Options outstanding at March 31, 2021 |
$ | |||||||||||||||
Granted |
$ | |||||||||||||||
Exercised |
( |
) | $ | |||||||||||||
Forfeited/Canceled |
( |
) | $ | |||||||||||||
|
|
|||||||||||||||
Options outstanding at March 31, 2022 |
$ | $ | ||||||||||||||
|
|
|||||||||||||||
Options exercisable at March 31, 2022 |
$ | $ | ||||||||||||||
|
|
Years Ended March 31, |
||||||||
Assumptions |
2022 |
2021 |
||||||
Expected stock price volatility |
% | % | ||||||
Expected risk free interest rate |
% | % | ||||||
Expected term, in years |
||||||||
Expected dividend yield |
% | % |
Years Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Intrinsic value of options exercised |
$ | $ | ||||||
Grant date fair value of options vested |
$ | $ | ||||||
Weighted-average grant date fair value per share of stock options granted |
$ | $ |
Number of Restricted Stock Units |
Weighted Average Grant Date Fair Value |
|||||||
Non-vested balance at March 31, 2021 |
$ | |||||||
Granted |
$ | |||||||
Vested |
( |
) | $ | |||||
Forfeited |
( |
) | $ | |||||
|
|
|||||||
Non-vested balance at March 31, 2022 |
$ | |||||||
|
|
Number of CVARs |
Weighted Average Grant Date Fair Value |
|||||||
Non-service-vested CVARs balance at March 31, 2021 |
$ | |||||||
Granted |
$ | |||||||
Service-vested |
( |
) | $ | |||||
Forfeited |
( |
) | $ | |||||
Non-service-vested CVARs balance at March 31, 2022 |
$ | |||||||
Number of CVARs |
Weighted Average Grant Date Fair Value |
|||||||
Non-vested balance at March 31, 2021 |
$ | |||||||
Granted |
$ | |||||||
Forfeited |
( |
) | $ | |||||
Non-vested balance at March 31, 2022 |
$ | |||||||
Years Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Loss before income taxes: |
||||||||
Bermuda (1) |
$ | $ | ( |
) | ||||
United States |
( |
) | ( |
) | ||||
Switzerland |
( |
) | ( |
) | ||||
Other (2) |
( |
) | ( |
) | ||||
Total loss before income taxes |
$ | ( |
) | $ | ( |
) | ||
(1) |
Primarily entities which are centrally managed and controlled in the United Kingdom |
(2) |
Primarily Greater China and United Kingdom activity |
Years Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Current taxes: |
||||||||
Bermuda |
$ | $ | ||||||
United States |
( |
) | ||||||
Switzerland |
||||||||
Other (1) |
||||||||
Total current tax expense |
$ | $ | ||||||
Deferred taxes: |
||||||||
Bermuda |
$ | $ | ||||||
United States |
||||||||
Switzerland |
||||||||
Other |
||||||||
Total deferred tax benefit |
$ | $ | ||||||
Total income tax expense |
$ | $ | ||||||
(1) |
Primarily Greater China and United Kingdom activity |
Year Ended March 31, 2022 |
Year Ended March 31, 2021 |
|||||||||||||||
Income tax benefit at Bermuda statutory rate |
$ | % | $ | % | ||||||||||||
Foreign rate differential (1) |
( |
) | % | ( |
) | % | ||||||||||
Permanent disallowed IPR&D |
( |
)% | ( |
)% | ||||||||||||
Tax-effect of changes in the fair value of investments and loss from equity method investment |
( |
)% | ( |
) | % | |||||||||||
Nontaxable gain on sale of investment |
( |
) | % | % | ||||||||||||
Nontaxable gain on deconsolidation of business |
( |
) | % | ( |
) | % | ||||||||||
Nondeductible executive compensation |
( |
)% | ( |
)% | ||||||||||||
Tax deficiencies (excess tax benefits) from share-based compensation |
( |
)% | ( |
) | % | |||||||||||
Other permanent adjustments |
( |
)% | ( |
)% | ||||||||||||
Research tax credits |
( |
) | % | ( |
) | % | ||||||||||
Valuation allowance |
( |
)% | ( |
)% | ||||||||||||
Tax rate changes |
( |
) | % | ( |
)% | |||||||||||
Other |
( |
) | % | ( |
)% | |||||||||||
Total income tax expense |
$ | ( |
)% | $ | ( |
)% | ||||||||||
(1) |
Primarily related to operations in the United States, Switzerland, the United Kingdom, and other jurisdictions with statutory tax rates different than the Bermuda rate. |
March 31, 2022 |
March 31, 2021 |
|||||||
Deferred tax assets |
||||||||
Research tax credits |
$ | $ | ||||||
Intangible assets |
||||||||
Net operating loss |
||||||||
Share-based compensation |
||||||||
Lease liabilities |
||||||||
Other assets |
||||||||
Subtotal |
||||||||
Valuation allowance |
( |
) | ( |
) | ||||
Deferred tax liabilities |
||||||||
Depreciation |
( |
) | ( |
) | ||||
Right-of-use |
( |
) | ( |
) | ||||
Other liabilities |
( |
) | ( |
) | ||||
Total deferred tax assets/(liabilities) |
$ | $ | ||||||
Years Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Operating lease cost |
$ | $ | ||||||
Short-term lease cost |
||||||||
Variable lease cost |
||||||||
Total operating lease cost |
$ | $ | ||||||
During the Year Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Cash paid for operating lease liabilities |
$ | $ | ||||||
Operating lease right-of-use assets obtained in exchange for operating lease liabilities |
$ | $ |
March 31, 2022 |
March 31, 202 1 |
|||||||
Weighted average remaining lease term (in years) |
||||||||
Weighted average discount rate |
% | % |
Years Ending March 31, |
||||
2023 |
$ | |||
2024 |
||||
2025 |
||||
2026 |
||||
2027 |
||||
Thereafter |
||||
Total lease payments |
||||
Less: present value adjustment |
( |
) | ||
Less: tenant improvement allowance |
( |
) | ||
Total |
$ | |||
As of March 31, 2022 |
As of March 31, 2021 |
|||||||||||||||||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Balance as of March 31, 2022 |
Level 1 |
Level 2 |
Level 3 |
Balance as of March 31, 2021 |
|||||||||||||||||||||||||
Assets: |
||||||||||||||||||||||||||||||||
Money market funds |
$ | $ | — | $ | — | $ | $ | $ | — | $ | — | $ | ||||||||||||||||||||
Investment in Datavant Class A units |
— | — | — | — | ||||||||||||||||||||||||||||
Investment in Sio common shares |
— | — | — | — | ||||||||||||||||||||||||||||
Investment in Arbutus common shares |
— | — | — | — | ||||||||||||||||||||||||||||
Investment in Arbutus convertible preferred shares |
— | — | — | — | ||||||||||||||||||||||||||||
Other investments |
— | — | — | — | ||||||||||||||||||||||||||||
Total assets at fair value |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
Liabilities: |
||||||||||||||||||||||||||||||||
Debt issued by Dermavant to NovaQuest |
$ | — | $ | — | $ | $ | $ | — | $ | — | $ | $ | ||||||||||||||||||||
Liability instruments measured at fair value (1) |
— | — | ||||||||||||||||||||||||||||||
Total liabilities at fair value |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
(1) |
At March 31, 2022, Level 1 includes the fair value of the Public Warrants of $ Earn-Out Shares of $ |
Balance at March 31, 2021 |
$ | |||
Fair value of investment in Datavant at recognition date |
||||
Changes in fair value of investment in Datavant, included in net loss |
( |
) | ||
Balance at March 31, 2022 |
$ | |||
Balance at March 31, 2020 |
$ | |||
Changes in fair value of debt and liability instruments, included in net loss |
||||
Liability instruments disposed due to deconsolidation of subsidiary |
( |
) | ||
Balance at March 31, 2021 |
||||
Fair value of liability instrument issued |
||||
Changes in fair value of debt and liability instruments, included in net loss |
||||
Settlements |
( |
) | ||
Termination of DSP Options |
( |
) | ||
Balance at March 31, 2022 |
$ | |||
Point Estimate Used |
||||
Input |
As of March 31, 2022 |
|||
Volatility |
% | |||
Risk-free rate |
% |
Point Estimate Used | ||
Input |
As of March 31, 2022 | |
Volatility |
||
Risk-free rate |
Point Estimate Used | ||
Input |
As of March 31, 2022 | |
Volatility |
||
Risk-free rate |
||
Term (in years) |
Range or Point Estimate Used |
||||
Input |
As of March 31, 2021 |
|||
Time to expiration (in years) |
||||
Risk-free rate |
||||
Volatility |
% |
Years Ended March 31, |
||||||||
2022 |
2021 |
|||||||
Loss from equity method investment |
$ | — | $ | |||||
Interest income |
( |
) | ( |
) | ||||
Interest expense |
||||||||
Other (income) expense |
( |
) | ||||||
|
|
|
|
|||||
Total |
$ | $ | ||||||
|
|
|
|
March 31, 2022 |
March 31, 2021 |
|||||||
Stock options and performance stock options |
||||||||
Restricted stock units and performance stock units (non-vested) |
||||||||
March 2020 CVARs (1) |
||||||||
November 2021 CVARs |
— | |||||||
Restricted c ommon stock (non-vested) |
||||||||
Earn-Out Shares (non-vested) |
— | |||||||
Private Placement Warrants |
— | |||||||
Public Warrants |
— | |||||||
Other instruments issued |
(1) |
Refer to Note 10, “Share-Based Compensation” for details regarding settlement of CVARs. |
ITEM 16. |
FORM 10-K SUMMARY |
Exhibit Number |
Description |
Incorporated by Reference |
Filing Date | |||||||
Form |
File No. |
Exhibit | ||||||||
2.1+ | Business Combination Agreement, dated as of May 1, 2021, by and among Montes Archimedes Acquisition Corp., Roivant Sciences Ltd. and Rhine Merger Sub, Inc. | — | — | — | Filed herewith | |||||
2.2#* | Agreement and Plan of Merger, dated as of February 2, 2021, by and among Roivant Sciences Ltd., Silicon Insite, Inc., Silicon TX China, Silicon Therapeutics, LLC and Silicon SWAT, Inc. | S-4/A |
333-256165 |
2.2 | July 1, 2021 | |||||
2.3#* | Stock Purchase Agreement, dated as of November 6, 2020, by and among Oncopia Therapeutics, Inc., Pharmavant 5, Inc., certain selling securityholders and certain seller representatives | S-4/A |
333-256165 |
2.3 | July 1, 2021 | |||||
2.4#* | Amendment No. 1 to the Stock Purchase Agreement, dated as of November 17, 2020, by and among Oncopia Therapeutics, Inc., Pharmavant 5, Inc., certain selling securityholders and WRYP Stockholders Services, LLC | S-4/A |
333-256165 |
2.4 | July 1, 2021 |
Exhibit Number |
Description |
Incorporated by Reference |
Filing Date | |||||||
Form |
File No. |
Exhibit | ||||||||
23.1 | Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm of Roivant Sciences Ltd. | — | — | — | Filed herewith | |||||
24.1 | Power of Attorney (included on signature page) | — | — | — | Filed herewith | |||||
31.1 | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | — | — | — | Filed herewith | |||||
31.2 | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | — | — | — | Filed herewith | |||||
32.1 | Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | — | — | — | Filed herewith | |||||
32.2 | Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | — | — | — | Filed herewith | |||||
101.INS | Inline XBRL Instance Document | — | — | — | Filed herewith | |||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | — | — | — | Filed herewith | |||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | — | — | — | Filed herewith | |||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | — | — | — | Filed herewith | |||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | — | — | — | Filed herewith | |||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | — | — | — | Filed herewith | |||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | — | — | — | Filed herewith |
# | Portions of this exhibit have been omitted because they are both (i) not material and (ii) would likely cause competitive harm to Roivant Sciences Ltd. if publicly disclosed. |
+ | This exhibit was previously filed with the Company’s Form S-4 (File No. 333-256165). For administrative convenience, the Company has re-filed this exhibit with this Form 10-K. |
† |
Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the Securities and Exchange Commission. |
* | Previously filed |
** | In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release Nos. 33-8238 and 34-47986, Final Rule: Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Annual Report on Form 10-K and will not be deemed “filed” for purpose of Section 18 of the Exchange Act. Such certifications will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference. |
^ | Management contract or compensatory plan or arrangement required to be filed as an exhibit to this Form 10-K pursuant to Item 15(b). |
Roivant Sciences Ltd. | ||||||
Date: June 28, 2022 | By: | /s/ Matt Maisak | ||||
Name: Matt Maisak | ||||||
Title: Authorized Signatory |
Signature |
Title |
Date | ||
/s/ Matthew Gline Matthew Gline |
Chief Executive Officer and Director (Principal Executive Officer) |
June 28, 2022 | ||
/s/ Richard Pulik Richard Pulik |
Chief Financial Officer (Principal Financial Officer) |
June 28, 2022 | ||
/s/ Rakhi Kumar Rakhi Kumar |
Chief Accounting Officer (Principal Accounting Officer) |
June 28, 2022 | ||
/s/ Vivek Ramaswamy Vivek Ramaswamy |
Director | June 28, 2022 | ||
/s/ Andrew Lo Andrew Lo |
Director | June 28, 2022 | ||
/s/ Keith Manchester Keith Manchester |
Director | June 28, 2022 | ||
/s/ Ilan Oren Ilan Oren |
Director | June 28, 2022 |
Signature |
Title |
Date | ||
/s/ Daniel Gold Daniel Gold |
Director | June 28, 2022 | ||
/s/ Masayo Tada Masayo Tada |
Director | June 28, 2022 | ||
/s/ Patrick Machado Patrick Machado |
Director | June 28, 2022 | ||
/s/ James C. Momtazee James C. Momtazee |
Director | June 28, 2022 |