Roivant Sciences Ltd. (ROIV)
SIC breadcrumb: Manufacturing > Chemicals And Allied Products > SIC 2834 Pharmaceutical Preparations
SEC company page: https://www.sec.gov/edgar/browse/?CIK=1635088. Latest filing source: 0001635088-26-000061.
Informational only - descriptive public-record data, not investment advice.
Business
Read ROIV's verbatim Item 1 Business section from its latest 10-K: Business.
Risk Factors
Read ROIV's verbatim Item 1A Risk Factors from its latest 10-K: Risk Factors.
Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
|---|---|---|---|---|
| Revenue | 8,260,000 | USD | 2026 | 2026-05-20 |
| Net income | -299,771,000 | USD | 2026 | 2026-05-20 |
| Assets | 5,708,687,000 | USD | 2026 | 2026-05-20 |
Financials
Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-20. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001635088.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.
| Metric | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|
| Revenue | 23,795,000 | 55,286,000 | 31,530,000 | 29,053,000 | 8,260,000 | |
| Net income | -809,234,000 | -845,262,000 | -1,009,030,000 | 4,348,926,000 | -171,981,000 | -299,771,000 |
| Operating income | -1,070,898,000 | -1,351,642,000 | -906,763,000 | 4,497,032,000 | -1,003,294,000 | -515,068,000 |
| Diluted EPS | -1.26 | -1.42 | 5.23 | -0.24 | -0.54 | |
| Operating cash flow | -552,138,000 | -677,729,000 | -843,393,000 | -765,268,000 | -839,451,000 | -750,349,000 |
| Capital expenditures | 5,806,000 | 17,436,000 | 12,690,000 | 1,382,000 | 4,599,000 | 8,209,000 |
| Share buybacks | 0.00 | 0.00 | 1,293,232,000 | |||
| Assets | 2,589,692,000 | 2,585,129,000 | 2,389,604,000 | 7,222,482,000 | 5,436,940,000 | 5,708,687,000 |
| Liabilities | 527,687,000 | 523,695,000 | 782,017,000 | 773,953,000 | 249,742,000 | 416,275,000 |
| Stockholders' equity | 1,797,788,000 | 1,656,944,000 | 1,157,766,000 | 5,968,581,000 | 4,687,605,000 | 4,527,370,000 |
| Cash and cash equivalents | 2,055,044,000 | 2,060,400,000 | 1,676,813,000 | 6,494,953,000 | 2,715,411,000 | 1,419,232,000 |
| Free cash flow | -557,944,000 | -695,165,000 | -856,083,000 | -766,650,000 | -844,050,000 | -758,558,000 |
Ratios
| Metric | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|
| Return on equity | -45.01% | -51.01% | -87.15% | 72.86% | -3.67% | -6.62% |
| Return on assets | -31.25% | -32.70% | -42.23% | 60.21% | -3.16% | -5.25% |
| Liabilities / equity | 0.29 | 0.32 | 0.68 | 0.13 | 0.05 | 0.09 |
| Current ratio | 9.99 | 11.64 | 6.60 | 25.24 | 33.47 | 18.37 |
Industry Peer Context
ROE peer context
ROA peer context
Financial Bridges
Free cash flow = operating cash flow - capital expenditures
Figure provenance: SEC companyfacts FY 2026. Operating cash flow: accession 0001635088-26-000061; concept NetCashProvidedByUsedInOperatingActivities; source concepts us-gaap:NetCashProvidedByUsedInOperatingActivities | Capital expenditures: accession 0001635088-26-000061; concept PaymentsToAcquirePropertyPlantAndEquipment; source concepts us-gaap:PaymentsToAcquirePropertyPlantAndEquipment | Free cash flow: accession 0001635088-26-000061; concept NetCashProvidedByUsedInOperatingActivities - PaymentsToAcquirePropertyPlantAndEquipment; source concepts us-gaap:NetCashProvidedByUsedInOperatingActivities; us-gaap:PaymentsToAcquirePropertyPlantAndEquipment
Financial Charts
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: RevenueFromContractWithCustomerExcludingAssessedTax. Source concepts: us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: NetIncomeLoss. Source concepts: us-gaap:NetIncomeLoss.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: OperatingIncomeLoss. Source concepts: us-gaap:OperatingIncomeLoss.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: EarningsPerShareDiluted. Source concepts: us-gaap:EarningsPerShareDiluted.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: NetCashProvidedByUsedInOperatingActivities. Source concepts: us-gaap:NetCashProvidedByUsedInOperatingActivities.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: PaymentsToAcquirePropertyPlantAndEquipment. Source concepts: us-gaap:PaymentsToAcquirePropertyPlantAndEquipment.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-03-31; accession 0001140361-25-020715; filed 2025-05-29. Concept: PaymentsForRepurchaseOfCommonStock. Source concepts: us-gaap:PaymentsForRepurchaseOfCommonStock.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: Assets. Source concepts: us-gaap:Assets.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: Liabilities. Source concepts: us-gaap:Liabilities.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: StockholdersEquity. Source concepts: us-gaap:StockholdersEquity.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: CashAndCashEquivalentsAtCarryingValue. Source concepts: us-gaap:CashAndCashEquivalentsAtCarryingValue.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: NetCashProvidedByUsedInOperatingActivities - PaymentsToAcquirePropertyPlantAndEquipment. Source concepts: us-gaap:NetCashProvidedByUsedInOperatingActivities; us-gaap:PaymentsToAcquirePropertyPlantAndEquipment.
Quarterly
Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-20. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001635088.json.
| Quarter | End Date | Revenue | Net Income | Diluted EPS | Method |
|---|---|---|---|---|---|
| 2022-Q1 | 2022-06-30 | -0.48 | reported discrete quarter | ||
| 2022-Q2 | 2022-09-30 | -0.42 | reported discrete quarter | ||
| 2022-Q3 | 2022-12-31 | -0.49 | reported discrete quarter | ||
| 2023-Q1 | 2023-06-30 | 21,624,000 | -291,816,000 | -0.38 | reported discrete quarter |
| 2023-Q2 | 2023-09-30 | 37,101,000 | -304,327,000 | -0.40 | reported discrete quarter |
| 2023-Q3 | 2023-12-31 | 37,140,000 | 5,096,184,000 | 6.03 | reported discrete quarter |
| 2023-Q4 | 2024-03-31 | 28,930,000 | -151,115,000 | derived Q4 = FY annual - nine-month YTD | |
| 2024-Q1 | 2024-06-30 | 55,132,000 | 95,297,000 | 0.12 | reported discrete quarter |
| 2024-Q2 | 2024-09-30 | 4,475,000 | -230,184,000 | -0.31 | reported discrete quarter |
| 2024-Q3 | 2024-12-31 | 9,018,000 | 169,381,000 | 0.23 | reported discrete quarter |
| 2024-Q4 | 2025-03-31 | 7,570,000 | -206,475,000 | derived Q4 = FY annual - nine-month YTD | |
| 2025-Q1 | 2025-06-30 | 2,170,000 | -223,355,000 | -0.33 | reported discrete quarter |
| 2025-Q2 | 2025-09-30 | 1,571,000 | -113,519,000 | -0.17 | reported discrete quarter |
| 2025-Q3 | 2025-12-31 | 1,999,000 | -265,891,000 | -0.38 | reported discrete quarter |
| 2025-Q4 | 2026-03-31 | 2,520,000 | 302,994,000 | derived Q4 = FY annual - nine-month YTD |
Quarterly Charts
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: RevenueFromContractWithCustomerExcludingAssessedTax. Source concepts: us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2026-03-31; accession 0001635088-26-000061; filed 2026-05-20. Concept: NetIncomeLoss. Source concepts: us-gaap:NetIncomeLoss.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001635088-26-000011; filed 2026-02-06. Concept: EarningsPerShareDiluted. Source concepts: us-gaap:EarningsPerShareDiluted.
Macro Cross-References
- CPIAUCSL - Consumer Price Index for All Urban Consumers: All Items in U.S. City Average
- UNRATE - Unemployment Rate
- FEDFUNDS - Federal Funds Effective Rate
- CES0500000003 - Average Hourly Earnings of All Employees, Total Private
- DFEDTARU - Federal Funds Target Range - Upper Limit
- DFEDTARL - Federal Funds Target Range - Lower Limit
- DGS3MO - Market Yield on U.S. Treasury Securities at 3-Month Constant Maturity
- DGS2 - Market Yield on U.S. Treasury Securities at 2-Year Constant Maturity
- DGS10 - Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- DGS30 - Market Yield on U.S. Treasury Securities at 30-Year Constant Maturity
- T10Y2Y - 10-Year Treasury Constant Maturity Minus 2-Year Treasury Constant Maturity
- CPILFESL - Consumer Price Index for All Urban Consumers: All Items Less Food and Energy
- CPIUFDSL - Consumer Price Index for All Urban Consumers: Food
- CPIENGSL - Consumer Price Index for All Urban Consumers: Energy
- CUSR0000SAH1 - Consumer Price Index for All Urban Consumers: Shelter
- PCEPI - Personal Consumption Expenditures: Chain-type Price Index
- PCEPILFE - Personal Consumption Expenditures Excluding Food and Energy: Chain-type Price Index
- PPIACO - Producer Price Index by Commodity: All Commodities
- T10YIE - 10-Year Breakeven Inflation Rate
- U6RATE - Total Unemployed, Plus All Marginally Attached Workers Plus Total Employed Part Time for Economic Reasons
- PAYEMS - All Employees, Total Nonfarm
- CIVPART - Labor Force Participation Rate
- EMRATIO - Employment-Population Ratio
- UNEMPLOY - Unemployed
- CE16OV - Employment Level
- ICSA - Initial Claims
- JTSJOL - Job Openings: Total Nonfarm
- JTSQUR - Quits: Total Nonfarm
- GDPC1 - Real Gross Domestic Product
- A191RL1Q225SBEA - Real Gross Domestic Product: Percent Change from Preceding Period
- INDPRO - Industrial Production: Total Index
- TCU - Capacity Utilization: Total Index
- HOUST - New Privately-Owned Housing Units Started: Total Units
- PERMIT - New Privately-Owned Housing Units Authorized in Permit-Issuing Places: Total Units
- RSAFS - Advance Retail Sales: Retail Trade
- PCE - Personal Consumption Expenditures
- DSPIC96 - Real Disposable Personal Income
- PSAVERT - Personal Saving Rate
- M2SL - M2
- BOPGSTB - U.S. International Trade in Goods and Services: Balance
- MSPUS - Median Sales Price of Houses Sold for the United States
- HSN1F - New One Family Houses Sold: United States
- RHORUSQ156N - Homeownership Rate in the United States
- TTLCONS - Total Construction Spending: Total Construction in the United States
- RRVRUSQ156N - Rental Vacancy Rate in the United States
- TOTALSL - Total Consumer Credit Owned and Securitized
- REVOLSL - Revolving Consumer Credit Owned and Securitized
- DRCCLACBS - Delinquency Rate on Credit Card Loans, All Commercial Banks
- GDP - Gross Domestic Product
- GPDI - Gross Private Domestic Investment
- GCE - Government Consumption Expenditures and Gross Investment
- PCEC - Personal Consumption Expenditures
- NETEXP - Net Exports of Goods and Services
- GFDEBTN - Federal Debt: Total Public Debt
- GFDEGDQ188S - Federal Debt: Total Public Debt as Percent of Gross Domestic Product
- FYFSD - Federal Surplus or Deficit
- FGRECPT - Federal Government Current Receipts
- FGEXPND - Federal Government: Current Expenditures
- MANEMP - All Employees, Manufacturing
- USCONS - All Employees, Construction
- USTRADE - All Employees, Retail Trade
- USFIRE - All Employees, Financial Activities
- USGOVT - All Employees, Government
- AWHAETP - Average Weekly Hours of All Employees, Total Private
- DGORDER - Manufacturers' New Orders: Durable Goods
- NEWORDER - Manufacturers' New Orders: Nondefense Capital Goods Excluding Aircraft
- BUSINV - Total Business Inventories
- EXPGS - Exports of Goods and Services
- IMPGS - Imports of Goods and Services
- IR - Import Price Index (End Use): All Commodities
- PPIFIS - Producer Price Index by Commodity: Final Demand
Latest quarter (10-Q)
Latest 10-Q source: 0001635088-26-000011.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our (1) unaudited condensed consolidated financial statements and notes to those statements included in this Quarterly Report on Form 10-Q (“Quarterly Report”) and (2) audited consolidated financial statements and notes to those statements and management’s discussion and analysis of financial condition and results of operations for the fiscal year ended March 31, 2025, included in our Annual Report on Form 10-K, filed with the SEC on May 29, 2025 (the “Form 10-K”). Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Roivant’s actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see “Forward-Looking Statements” and “Risk Factors” in this Quarterly Report. Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31.
Overview
Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.
Pipeline
The following table summarizes selected product candidates from our pipeline:
| Product Candidate | Indication | Vant | Modality | Phase | ||||
|---|---|---|---|---|---|---|---|---|
| Brepocitinib | Dermatomyositis | Priovant | Small Molecule | NDA Filed | ||||
| Brepocitinib | Non-Infectious Uveitis | Priovant | Small Molecule | Phase 3* | ||||
| Brepocitinib | Cutaneous Sarcoidosis | Priovant | Small Molecule | Phase 3* | ||||
| IMVT-1402 | Graves’ Disease | Immunovant | Biologic | Phase 2/3* | ||||
| IMVT-1402 | Difficult-to-Treat Rheumatoid Arthritis | Immunovant | Biologic | Phase 2/3* | ||||
| IMVT-1402 | Myasthenia Gravis | Immunovant | Biologic | Phase 2/3* | ||||
| IMVT-1402 | Sjögren’s Disease | Immunovant | Biologic | Phase 2/3* | ||||
| IMVT-1402 | Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant | Biologic | Phase 2/3* | ||||
| IMVT-1402 | Cutaneous Lupus Erythematosus | Immunovant | Biologic | Phase 2 | ||||
| Batoclimab | Thyroid Eye Disease | Immunovant | Biologic | Phase 3* | ||||
| Mosliciguat | Pulmonary Hypertension associated with Interstitial Lung Disease | Pulmovant | Inhaled | Phase 2 |
Note: All product candidates in our current pipeline are investigational and subject to health authority approval. The “Phase” for a specific product candidate referenced above reflects both ongoing clinical trials and expected upcoming trials.
*Indicates registrational or potentially registrational trials.
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Vant Ownership
The following table summarizes our ownership of certain of our subsidiary companies and affiliates as of December 31, 2025.
| Roivant Ownership | ||||||||
|---|---|---|---|---|---|---|---|---|
| Vant | Basic1 | Fully Diluted2 | ||||||
| Priovant | 73 | % | 66 | % | ||||
| Immunovant | 56 | % | 3 | 52 | % | 3 | ||
| Pulmovant | 98 | % | 91 | % | ||||
| Genevant | 83 | % | 64 | % | ||||
| Covant | 95 | % | 91 | % | ||||
| Arbutus | 20 | % | 3 | 19 | % | 3 |
Note: In addition to the subsidiary companies and affiliates listed in the table above, Roivant continues to maintain ownership interests in certain other entities as previously disclosed, including Proxima (formerly VantAI), PsiThera (formerly Psivant) and Datavant, as well as the right to receive future milestones and royalties related to the sale of our subsidiary Dermavant in 2024.
1.Basic ownership refers to Roivant’s percentage ownership of the issued and outstanding common and preferred shares (if applicable) of the entity.
2.Fully diluted ownership refers to Roivant’s percentage ownership of all outstanding equity interests of the entity, including unvested RSUs, options and warrants, in each case whether vested or unvested.
3.Denotes entities that are publicly traded.
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Upcoming Catalysts
In the upcoming year, we have a robust set of expected near-term catalysts, including the items set forth in the table below. In addition, we plan to in-license multiple potentially category-leading drugs per year.
| Program | Vant | Catalyst | Expected Timing |
|---|---|---|---|
| Roivant pipeline growth | Roivant | New mid/late-stage in-licensing announcements | Ongoing |
| LNP platform | Genevant | Summary judgment phase in U.S. Moderna case | Ongoing |
| LNP platform | Genevant | Jury trial in U.S. Moderna case | March 2026 |
| Batoclimab | Immunovant | Topline data from both Phase 3 trials in thyroid eye disease | 1H 2026 |
| LNP platform | Genevant | First major hearings in ex-U.S. Moderna cases | 1H 2026 |
| Mosliciguat | Pulmovant | Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease | 2H 2026 |
| Brepocitinib | Priovant | Topline data from Phase 3 trials in non-infectious uveitis | 2H 2026 |
| IMVT-1402 | Immunovant | Topline data from Phase 2 trial in cutaneous lupus erythematosus | 2H 2026 |
| IMVT-1402 | Immunovant | Topline data from potentially registrational trial in ACPA+ difficult-to-treat rheumatoid arthritis | 2H 2026 |
| IMVT-1402 | Immunovant | Topline data from potentially registrational trials in Graves’ disease | 2027 |
| IMVT-1402 | Immunovant | Topline data from potentially registrational trial in myasthenia gravis | 2027 |
| IMVT-1402 | Immunovant | Topline data from potentially registrational trial in chronic inflammatory demyelinating polyneuropathy | 2028 |
| IMVT-1402 | Immunovant | Topline data from potentially registrational trial in Sjögren’s disease | 2028 |
Note: References under “Expected Timing” are to calendar years. All catalyst timings are based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. The timing of the litigation-related events noted above is subject to change, including at the discretion of the court.
Recent Developments
•Priovant: In February 2026, Priovant announced positive Phase 2 results for brepocitinib in cutaneous sarcoidosis ("CS"). Brepocitinib 45 mg significantly improved CS disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 p0.0001). Brepocitinib demonstrated rapid, deep and sustained improvements across all other efficacy endpoints measured with consistent safety profile. New Drug Application was submitted to the FDA for brepocitinib in dermatomyositis (DM). Topline data from Phase 3 studies in non-infectious uveitis are expected in the second half of calendar year 2026.
•Immunovant: Potentially registrational trial for IMVT-1402 in difficult-to-treat rheumatoid arthritis fully enrolled, with topline data expected in the second half of calendar year 2026. All other clinical development timelines remain on track for IMVT-1402 across announced indications, including potentially registrational trials in Graves’ disease ("GD"), myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease, and a proof-of-concept trial in cutaneous lupus erythematosus. Roivant-led Immunovant financing alongside key institutional investors generated gross proceeds to Immunovant of approximately $550 million, extending Immunovant’s cash runway to the launch of IMVT-1402 in GD.
•Pulmovant: Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease fully enrolled, with topline data expected in the second half of calendar year 2026.
•Genevant: Favorable summary judgment decision in U.S. Moderna case affirms Genevant's view of section 1498: the significant majority of liability belongs in the current case against Moderna. Jury trial in U.S. Moderna case
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scheduled for March 2026 and international proceedings continue with first major hearings expected in the first half of calendar year 2026.
•Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.5 billion as of December 31, 2025, supporting cash runway into profitability.
Components of Results of Operations
Revenue
Revenue primarily relates to amounts earned in connection with license agreements, as well as revenue generated by subscription and service-based fees.
Cost of revenues
Our cost of revenues primarily relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting and third-party data costs.
Research and development expenses
Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates. Research and development expenses primarily include the following:
•Program-specific costs, including direct third-party costs, which include expenses incurred under agreements with contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research and any other third-party expenses directly attributable to the development of our product candidates.
•Unallocated internal costs, including:
•employee-related expenses, such as salaries, share-based compensation and benefits, for research and development personnel; and
•other research and development related expenses that are not allocated to a specific program.
Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we advance our product candidates and our in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates.
The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following:
•the scope, rate of progress, expense and results of our preclinical development activities, any future clinical trials of our product candidates and other research and development activities that we may conduct;
•the number and scope of preclinical and clinical programs we decide to pursue;
•the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates;
•the number of doses that patients receive;
•the countries in which the trials are conducted;
•our ability to secure and leverage adequate CRO support for the conduct of clinical trials;
• our ability to establish an appropriate safety and efficacy profile for our product candidates;
• the timing, receipt and terms
[Excerpt truncated for page length; source filing is linked above.]
Latest 10-K MD&A
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of Roivant’s financial condition and results of operations should be read in conjunction with Roivant’s consolidated financial statements and notes to those statements included elsewhere in this Annual Report on Form 10-K. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Roivant’s actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see “Forward-Looking Statements” and “Risk Factors” in this Annual Report on Form 10-K. Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31.
Overview
Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of JAK1 and TYK2 currently under review at the FDA for the treatment of dermatomyositis and also in late stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.
Components of Results of Operations
Revenue
Revenue primarily relates to amounts earned in connection with license agreements, as well as revenue generated by subscription and service-based fees.
Cost of revenues
Our cost of revenues primarily relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting and third-party data costs.
Research and development expenses
Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates. Research and development expenses primarily include the following:
•Program-specific costs, including direct third-party costs, which include expenses incurred under agreements with contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research and any other third-party expenses directly attributable to the development of our product candidates.
•Unallocated internal costs, including:
•employee-related expenses, such as salaries, share-based compensation and benefits, for research and development personnel; and
•other research and development related expenses that are not allocated to a specific program.
Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we advance our product candidates with additional studies and our in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates.
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The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following:
•the scope, rate of progress, expense and results of our preclinical development activities, any future clinical trials of our product candidates and other research and development activities that we may conduct;
•the number and scope of preclinical and clinical programs we decide to pursue;
•the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates;
•the number of doses that patients receive;
•the countries in which the trials are conducted;
•our ability to secure and leverage adequate CRO support for the conduct of clinical trials;
•our ability to establish an appropriate safety and efficacy profile for our product candidates;
•the timing, receipt and terms of any approvals from applicable regulatory authorities;
•the potential additional safety monitoring or other studies requested by regulatory agencies;
•the significant and changing government regulation and regulatory guidance;
•our ability to establish clinical and commercial manufacturing capabilities, or make arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make product successfully; and
•our ability to maintain a continued acceptable safety profile of our product candidates following regulatory approval of our product candidates.
The successful development of our product candidates is highly uncertain, and we cannot reasonably estimate the costs that will be necessary to complete the remainder of the development of our product candidates. In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability.
Acquired in-process research and development expenses
Acquired in-process research and development (“IPR&D”) expenses include consideration for the purchase of IPR&D through asset acquisitions and license agreements, as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones.
Consideration for the purchase of IPR&D through asset acquisitions and license agreements may include cash upfront payments, shares and other liability instruments issued and the fair value of future contingent consideration payments.
General and administrative expenses
General and administrative (“G&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation and benefits, for employees engaged in G&A activities. G&A employees include those responsible for the identification and acquisition or in-license of new drug candidates, as well as for managing Vant operations and facilitating the use of our platform and technologies at the Vants. G&A expenses also consist of legal and accounting fees, consulting services and other operating costs relating to corporate matters and daily operations.
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We expect G&A expenses to increase in future periods to support our potential commercialization efforts. These increases will likely include additional costs related to the hiring of new personnel and fees to outside consultants, as well as other expenses. If any of our current or future product candidates receives regulatory approval in the U.S. or another jurisdiction, we expect that we would incur significantly increased expenses associated with building a sales and marketing team. Additionally, in July 2024, the Compensation Committee of the board of directors approved a multi-year incentive compensation program for each of Matthew Gline, Chief Executive Officer; Mayukh Sukhatme, President and Chief Investment Officer; and Eric Venker, President and Immunovant CEO. In July 2025, the Compensation Committee also approved a multi-year incentive compensation program for Frank Torti in connection with his appointment as an executive officer of the Company. Collectively, these compensation arrangements are referred to herein as the “Senior Executive Compensation Program.” The long-term equity incentive awards granted pursuant to this program will continue to result in significant share-based compensation expense over the vesting period of the awards. Refer to Note 9, “Share-Based Compensation and Other Compensation Plans” of our audited financial statements for further details.
Gain on sale of Telavant net assets
Gain on sale of Telavant net assets reflects a gain resulting from the sale of our entire equity interest in our majority-owned subsidiary, Telavant Holdings, Inc. (“Telavant”), to Roche Holdings, Inc. (“Roche”) in December 2023 (the “Roche Transaction”) as well as a gain resulting from the achievement of a one-time milestone in June 2024. In December 2023, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of the Roche Transaction and a one-time milestone payment of $150 million in cash, paid in August 2024 following the initiation of a Phase 3 trial in UC. Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer Inc. (“Pfizer”) owned the remaining 25%, in each case on an as-converted basis. The $7.1 billion in closing consideration and $150 million one-time milestone payment were paid to all of Telavant’s equity holders, including holders of Telavant restricted stock units, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction. We recognized a gain on sale of Telavant net assets of $110.4 million for our pro rata portion of the one-time milestone consideration during the year ended March 31, 2025 and approximately $5.3 billion for the sale of our entire equity interest in Telavant during the year ended March 31, 2024. Refer to Note 5, “Recent Transactions and Developments” of our audited financial statements for further information regarding the Roche Transaction.
Gain on litigation settlement
Gain on litigation settlement reflects a gain resulting from the settlement agreement (the “Settlement Agreement”) entered between our subsidiary, Genevant Sciences GmbH (“Genevant”), Arbutus Biopharma Corporation (together with Genevant, “Genevant/Arbutus”), and, solely for certain purposes, Genevant’s parent Genevant Sciences Ltd., and Moderna, Inc. and ModernaTx, Inc. (together, “Moderna”) in March 2026 to resolve all patent infringement litigation between Genevant/Arbutus and Moderna pending in the U.S. and internationally relating to Moderna’s unauthorized use of Genevant/Arbutus’ lipid nanoparticle (“LNP”) delivery technology in its vaccines, including SPIKEVAX. We recognized a gain on litigation settlement of $770.2 million during the year ended March 31, 2026 in the accompanying consolidated statements of operations for Genevant’s expected portion of the $950 million non-contingent, non-creditable, and non-refundable payment to be made by Moderna to Genevant and Arbutus on or before July 8, 2026 (the “Fixed Payment”). The allocation of this Fixed Payment is subject to adjustment upon final determination of actual litigation costs and expenses incurred. Refer to Note 5, “Recent Transactions and Developments” of our audited financial statements for further information regarding the Settlement Agreement.
Change in fair value of investments
Change in fair value of investments includes the unrealized (gain) loss on equity investments, including Arbutus Biopharma Corporation (“Arbutus”) and Heracles Parent, L.L.C. (“Datavant”). We have elected the fair value option to account for these investments.
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Change in fair value of liability instruments
Change in fair value of liability instruments primarily includes the loss (gain) relating to the measurement and recognition of fair value on a recurring basis of certain liabilities, including the earn-out share liabilities (prior to vesting) (the “Earn-Out Shares”) and warrant liabilities (prior to their redemption) issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”), a special purpose acquisition company. Refer to Note 13, “Earn-Out Shares, Public Warrants and Private Placement Warrants” of our audited financial statements for further information regarding the redemption of our warrants.
Gain on deconsolidation of subsidiaries
Gain on deconsolidation of subsidiaries resulted from the determination that we no longer had a controlling financial interest in certain subsidiaries.
Interest income
Interest income consists of interest earned on our cash equivalents and marketable securities.
Income tax expense
Income tax expense is recorded for the jurisdictions in which we do business. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded when, after consideration of all positive and negative evidence, it is not more likely than not that our deferred tax assets will be realizable. When uncertain tax positions exist, we recognize the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position and consideration of the available facts and circumstances.
Income (loss) from discontinued operations, net of tax
Income (loss) from discontinued operations, net of tax consists of the gain on sale of subsidiary interests for the year ended March 31, 2025 resulting from the sale of our entire equity interest in our majority-owned subsidiary, Dermavant Sciences Ltd. (“Dermavant”), to Organon & Co. (“Organon”) in October 2024 (the “Dermavant Transaction”) and the financial results of Dermavant through the closing of the Dermavant Transaction. Refer to Note 6, “Discontinued Operations” of our audited financial statements for further information.
Net loss attributable to noncontrolling interests
Net loss attributable to noncontrolling interests consists of the portion of net loss of those consolidated entities that is not allocated to us. We record net loss attributable to noncontrolling interests equal to the noncontrolling interest’s proportionate share of the respective operations.
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Results of Operations
Comparison of the years ended March 31, 2026, 2025 and 2024
The following table sets forth our results of operations for the years ended March 31, 2026, 2025 and 2024:
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Revenue | $ | 8,260 | $ | 29,053 | $ | 32,713 | $ | (20,793) | $ | (3,660) | ||||||||
| Operating expenses: | ||||||||||||||||||
| Cost of revenues | 1,285 | 911 | 1,599 | 374 | (688) | |||||||||||||
| Research and development | 681,812 | 550,413 | 439,909 | 131,399 | 110,504 | |||||||||||||
| Acquired in-process research and development | — | — | 26,450 | — | (26,450) | |||||||||||||
| General and administrative | 610,466 | 591,410 | 416,133 | 19,056 | 175,277 | |||||||||||||
| Total operating expenses | 1,293,563 | 1,142,734 | 884,091 | 150,829 | 258,643 | |||||||||||||
| Gain on sale of Telavant net assets | — | 110,387 | 5,348,410 | (110,387) | (5,238,023) | |||||||||||||
| Gain on litigation settlement | 770,235 | — | — | 770,235 | — | |||||||||||||
| (Loss) income from operations | (515,068) | (1,003,294) | 4,497,032 | 488,226 | (5,500,326) | |||||||||||||
| Change in fair value of investments | (105,046) | (55,186) | 47,973 | (49,860) | (103,159) | |||||||||||||
| Change in fair value of liability instruments | 47,704 | (15,756) | 46,838 | 63,460 | (62,594) | |||||||||||||
| Gain on deconsolidation of subsidiaries | (11,027) | (3,108) | (32,772) | (7,919) | 29,664 | |||||||||||||
| Interest income | (178,109) | (258,375) | (146,425) | 80,266 | (111,950) | |||||||||||||
| Other (income) expense, net | (4,012) | 10,721 | 13,562 | (14,733) | (2,841) | |||||||||||||
| (Loss) income from continuing operations before income taxes | (264,578) | (681,590) | 4,567,856 | 417,012 | (5,249,446) | |||||||||||||
| Income tax expense | 133,329 | 48,174 | 21,503 | 85,155 | 26,671 | |||||||||||||
| (Loss) income from continuing operations, net of tax | (397,907) | (729,764) | 4,546,353 | 331,857 | (5,276,117) | |||||||||||||
| Income (loss) from discontinued operations, net of tax | — | 373,030 | (315,147) | (373,030) | 688,177 | |||||||||||||
| Net (loss) income | (397,907) | (356,734) | 4,231,206 | (41,173) | (4,587,940) | |||||||||||||
| Net loss attributable to noncontrolling interests | (98,136) | (184,753) | (117,720) | 86,617 | (67,033) | |||||||||||||
| Net (loss) income attributable to Roivant Sciences Ltd. | $ | (299,771) | $ | (171,981) | $ | 4,348,926 | $ | (127,790) | $ | (4,520,907) |
Variance analysis for years ended March 31, 2026, 2025 and 2024
Revenue
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Revenue | $ | 8,260 | $ | 29,053 | $ | 32,713 | $ | (20,793) | $ | (3,660) |
Revenue decreased by $20.8 million to $8.3 million for the year ended March 31, 2026, compared to $29.1 million for the year ended March 31, 2025. Revenue decreased by $3.7 million to $29.1 million for the year ended March 31, 2025, compared to $32.7 million for the year ended March 31, 2024. During the years ended March 31, 2026, 2025 and 2024, revenue was primarily driven by amounts earned in connection with license agreements at Genevant.
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Research and development expenses
For the years ended March 31, 2026, 2025 and 2024, our research and development expenses consisted of the following:
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024(1) | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Program-specific costs: | ||||||||||||||||||
| Anti-FcRn franchise—endocrine diseases | $ | 90,359 | $ | 63,073 | $ | 33,205 | $ | 27,286 | $ | 29,868 | ||||||||
| Anti-FcRn franchise—neurological diseases | 82,515 | 93,224 | 41,060 | (10,709) | 52,164 | |||||||||||||
| Anti-FcRn franchise—rheumatology diseases | 48,813 | 23,897 | — | 24,916 | 23,897 | |||||||||||||
| Anti-FcRn franchise—dermatology diseases | 20,264 | 15,633 | — | 4,631 | 15,633 | |||||||||||||
| Anti-FcRn franchise—other clinical and nonclinical | 3,367 | 9,327 | 39,811 | (5,960) | (30,484) | |||||||||||||
| Anti-FcRn franchise—contractual costs related to batoclimab program discontinuation | 38,952 | — | — | 38,952 | — | |||||||||||||
| Brepocitinib | 60,272 | 45,125 | 38,563 | 15,147 | 6,562 | |||||||||||||
| Mosliciguat | 36,077 | 19,746 | 4,307 | 16,331 | 15,439 | |||||||||||||
| RVT-3101 | — | — | 35,129 | — | (35,129) | |||||||||||||
| Other development and discovery programs(2) | 48,251 | 57,729 | 57,141 | (9,478) | 588 | |||||||||||||
| Total program-specific costs | 428,870 | 327,754 | 249,216 | 101,116 | 78,538 | |||||||||||||
| Unallocated internal costs: | ||||||||||||||||||
| Share-based compensation | 47,867 | 39,780 | 32,400 | 8,087 | 7,380 | |||||||||||||
| Personnel-related expenses | 167,790 | 146,162 | 123,283 | 21,628 | 22,879 | |||||||||||||
| Other expenses | 37,285 | 36,717 | 35,010 | 568 | 1,707 | |||||||||||||
| Total research and development expenses | $ | 681,812 | $ | 550,413 | $ | 439,909 | $ | 131,399 | $ | 110,504 |
(1) Certain prior period amounts have been reclassified to conform to current period presentation.
(2) For the year ended March 31, 2026, included terminated program expenses of $1.9 million for namilumab. For the year ended March 31, 2025, included terminated program expenses of $12.7 million for namilumab and $1.9 million for RVT-2001. For the year ended March 31, 2024, included terminated program expenses of $13.2 million for namilumab and $10.1 million for RVT-2001.
Research and development expenses increased by $131.4 million to $681.8 million for the year ended March 31, 2026, compared to $550.4 million for the year ended March 31, 2025. This increase was primarily driven by an increase in program-specific costs of $101.1 million, personnel-related expenses of $21.6 million and share-based compensation of $8.1 million.
The increase of $101.1 million in program-specific costs was primarily driven by increases of $79.1 million related to the anti-FcRn franchise (of which $39.0 million related to contractual costs recognized in connection with the discontinuation of batoclimab), $16.3 million related to mosliciguat and $15.1 million related to brepocitinib.
The increase of $21.6 million in personnel-related expenses, which is an unallocated internal cost, was primarily driven by higher headcount to support additional clinical studies for the anti-FcRn franchise activities at Immunovant and brepocitinib at Priovant. The $8.1 million increase in share-based compensation expense was primarily driven by the Priovant Exchange Offer. Refer to Note 9, “Share-Based Compensation and Other Compensation Plans” of our financial statements for further details.
Research and development expenses increased by $110.5 million to $550.4 million for the year ended March 31, 2025, compared to $439.9 million for the year ended March 31, 2024. This increase was primarily driven by increases in program-specific costs of $78.5 million, personnel-related expenses of $22.9 million, share-based compensation of $7.4 million and other expenses of $1.7 million.
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The increase of $78.5 million in program-specific costs was primarily driven by increases of $91.1 million related to the anti-FcRn franchise, reflecting the progression of our programs, and $15.4 million related to mosliciguat, which was acquired during the year ended March 31, 2024. These increases were partially offset by a decrease in expense of $35.1 million related to RVT-3101, which was sold to Roche in December 2023.
The increase of $22.9 million in personnel-related expenses was primarily driven by higher personnel-related expenses at Immunovant as a result of higher headcount and enhancement of capabilities to support Immunovant’s strategic objectives as clinical activities progress. Included in personnel-related expenses is a special one-time cash retention bonus award granted to employees in December 2023 (the “Cash Bonus Program”). During the years ended March 31, 2025 and 2024, we recognized additional research and development expense of $5.8 million and $9.9 million, respectively, relating to the Cash Bonus Program.
Acquired in-process research and development expenses
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Acquired in-process research and development expenses | $ | — | $ | — | $ | 26,450 | $ | — | $ | (26,450) |
There were no acquired in-process research and development expenses for the years ended March 31, 2026 and 2025. Acquired in-process research and development expenses of $26.5 million for the year ended March 31, 2024 was driven by $14.0 million of consideration for the purchase of IPR&D relating to the asset acquisition of mosliciguat completed by our subsidiary, Pulmovant, Inc. (“Pulmovant”) and $12.5 million relating to the achievement of development and regulatory milestones for batoclimab.
General and administrative expenses
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| General and administrative expenses | $ | 610,466 | $ | 591,410 | $ | 416,133 | $ | 19,056 | $ | 175,277 |
General and administrative expenses increased by $19.1 million to $610.5 million for the year ended March 31, 2026, compared to $591.4 million for the year ended March 31, 2025. This increase was primarily due to an increase in share-based compensation expense of $58.8 million, primarily due to the long-term equity incentive awards from the Senior Executive Compensation Program and incremental share-based compensation expense resulting from the Priovant Exchange Offer, an impairment loss of $17.1 million related to the relocation of the U.S. corporate headquarters of Roivant Sciences, Inc. and an increase of $9.1 million in professional fees, reflecting higher litigation-related costs incurred. These increases were partially offset by a decrease of $69.9 million in personnel-related expense, which largely resulted from higher expense for the year ended March 31, 2025 related to the one-time cash retention awards from the Senior Executive Compensation Program and the Cash Bonus Program (as defined below).
General and administrative expenses increased by $175.3 million to $591.4 million for the year ended March 31, 2025, compared to $416.1 million for the year ended March 31, 2024. This increase was primarily due to increases in share-based compensation expense of $84.6 million and personnel-related expenses of $79.6 million, largely as a result of long-term equity and one-time cash retention awards from the Senior Executive Compensation Program. Refer to Note 9, “Share-Based Compensation and Other Compensation Plans” of our audited financial statements for further information.
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A summary of general and administrative expense relating to the one-time cash retention bonus award to its employees awarded during the year ended March 31, 2024 (the “Cash Bonus Program”) and Senior Executive Compensation Program is as follows (in thousands):
| Years Ended March 31, | Remaining Expense as of March 31, 2026 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | ||||||||||||
| (in thousands) | ||||||||||||||
| Cash Bonus Program | $ | 4,510 | $ | 21,209 | $ | 35,628 | $ | — | ||||||
| Senior Executive Compensation Program: | ||||||||||||||
| Cash awards | 14,819 | 86,421 | — | — | ||||||||||
| Performance restricted stock units | 139,374 | 82,186 | — | 141,773 | ||||||||||
| Restricted stock units | 13,457 | 6,410 | — | 52,859 | ||||||||||
| Stock options | 725 | 640 | — | 1,567 | ||||||||||
| Total | $ | 172,885 | $ | 196,866 | $ | 35,628 | $ | 196,199 |
Gain on sale of Telavant net assets
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Gain on sale of Telavant net assets | $ | — | $ | 110,387 | $ | 5,348,410 | $ | (110,387) | $ | (5,238,023) |
Gain on sale of Telavant net assets was $110.4 million for the year ended March 31, 2025 and $5.3 billion for the year ended March 31, 2024. The gain for the year ended March 31, 2025 resulted from the achievement of a one-time milestone in June 2024. The gain for the year ended March 31, 2024 resulted from the sale of our entire equity interest in Telavant to Roche in December 2023. Refer to Note 5, “Recent Transactions and Developments” of our audited financial statements for further information.
Gain on litigation settlement
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Gain on litigation settlement | $ | 770,235 | $ | — | $ | — | $ | 770,235 | $ | — |
Gain on litigation settlement was $770.2 million for the year ended March 31, 2026 and reflects Genevant’s expected portion of the Fixed Payment to be made by Moderna to Genevant and Arbutus as a result of the Settlement Agreement entered in March 2026. The allocation of this Fixed Payment is subject to adjustment upon final determination of actual litigation costs and expenses incurred. Refer to Note 5, “Recent Transactions and Developments” of our audited financial statements for further information.
Change in fair value of investments
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Change in fair value of investments | $ | (105,046) | $ | (55,186) | $ | 47,973 | $ | (49,860) | $ | (103,159) |
Change in fair value of investments were unrealized gains of $105.0 million and $55.2 million for the years ended March 31, 2026 and 2025, respectively. The change of $49.9 million was primarily driven by changes in the public share price of Arbutus, as well as the change in fair value of our investment in Datavant, which was driven by growth in forecasted financial performance.
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Change in fair value of investments was an unrealized gain of $55.2 million and an unrealized loss of $48.0 million for the years ended March 31, 2025 and 2024, respectively. The change of $103.2 million was primarily driven by changes in the public share price of Arbutus, as well as the change in the fair value of our investment in Datavant. Refer to Note 4, “Equity Method Investments” of our audited financial statements for further information.
Change in fair value of liability instruments
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Change in fair value of liability instruments | $ | 47,704 | $ | (15,756) | $ | 46,838 | $ | 63,460 | $ | (62,594) |
Change in fair value of liability instruments was a loss of $47.7 million, a gain of $15.8 million and a loss of $46.8 million for the years ended March 31, 2026, 2025 and 2024, respectively. The change in fair value of liability instruments for the year ended March 31, 2026 consisted of a loss relating to the Earn-Out Shares issued as part of the Business Combination. The Earn-Out Shares vested during the year ended March 31, 2026. Accordingly, the Earn-Out Shares were remeasured upon their vesting, and these final remeasurements were recognized in the change in fair value of liability instruments. No further liability remains related to the Earn-Out shares.
Change in fair value of liability instruments for the year ended March 31, 2025 primarily consisted of a gain relating to the Earn-Out Shares issued as part of the Business Combination. Change in fair value of liability instruments for the year ended March 31, 2024 primarily consisted of losses relating to the warrants and Earn-Out Shares issued as part of the Business Combination. Refer to Note 13, “Earn-Out Shares, Public Warrants and Private Placement Warrants” of our audited financial statements for further information.
Interest income
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Interest income | $ | (178,109) | $ | (258,375) | $ | (146,425) | $ | 80,266 | $ | (111,950) |
Interest income decreased by $80.3 million to $178.1 million for the year ended March 31, 2026, compared to $258.4 million for the year ended March 31, 2025. This decrease is primarily due to lower cash equivalents and marketable securities balances in our interest-bearing accounts as well as lower interest rates.
Interest income increased by $112.0 million to $258.4 million for the year ended March 31, 2025, compared to $146.4 million for the year ended March 31, 2024. This increase is primarily due to higher cash balances in our interest-bearing cash accounts.
Income tax expense
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Income tax expense | $ | 133,329 | $ | 48,174 | $ | 21,503 | $ | 85,155 | $ | 26,671 |
Income tax expense increased by $85.2 million to $133.3 million for the year ended March 31, 2026, compared to $48.2 million for the year ended March 31, 2025. The increase was primarily due to income associated with the gain on litigation settlement. Refer to Note 5, “Recent Transactions and Developments” of our audited financial statements for additional information.
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Income tax expense increased by $26.7 million to $48.2 million for the year ended March 31, 2025, compared to $21.5 million for the year ended March 31, 2024. The increase was primarily due to our fluctuating earnings by legal entity in various jurisdictions over the periods. As disclosed, the tax expense for the year ended March 31, 2024 was impacted by the gain on sale of Telavant’s net assets, which qualifies for the substantial shareholding exemption in the U.K. and consequently is not subject to the corporation income tax.
Income (loss) from discontinued operations, net of tax
| Years Ended March 31, | Change | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | 2026 vs. 2025 | 2025 vs. 2024 | ||||||||||||||
| (in thousands) | ||||||||||||||||||
| Income (loss) from discontinued operations, net of tax | $ | — | $ | 373,030 | $ | (315,147) | $ | (373,030) | $ | 688,177 |
Income from discontinued operations, net of tax was $373.0 million for the year ended March 31, 2025 and reflects the gain on sale of subsidiary interests resulting from the sale of our entire equity interest in our majority-owned subsidiary, Dermavant, to Organon in October 2024, partially offset by Dermavant’s net losses. Loss from discontinued operations, net of tax was $315.1 million for the year ended March 31, 2024 and represents the financial results of Dermavant. Refer to Note 6, “Discontinued Operations” of our audited financial statements for additional information.
Liquidity and Capital Resources
For the years ended March 31, 2026, 2025 and 2024, we had net losses from continuing operations of $397.9 million and $729.8 million and had net income from continuing operations of approximately $4.5 billion, respectively. As of March 31, 2026, we had cash, cash equivalents and marketable securities of approximately $4.3 billion and our accumulated deficit was $501.8 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditures for the foreseeable future. However, projections of future cash flows and operating expenses are inherently uncertain and subject to changes, as described under “Risk Factors” in Part I, Item 1A. of this Annual Report on Form 10-K. As a result, our existing cash, cash equivalents and marketable securities may not be sufficient to fund our operating expenses as anticipated, and we may need to raise additional capital to fund our operations.
Our short-term and long-term liquidity requirements as of March 31, 2026 included obligations under our leases (see Note 11, “Leases” of our audited financial statements). As of March 31, 2026, our subsidiary, Immunovant, had an accumulated accrual of $42.5 million of non-cancelable contractual costs as a result of the discontinuation of batoclimab, of which $39.0 million was recognized as research and development expense during the year ended March 31, 2026. Beyond this, we do not currently have any other material contractually obligated minimum purchases or firm non-cancelable purchase commitments. We anticipate other purchases in the ordinary course of business and have other payment obligations as discussed below.
Additionally, we have certain payment obligations under various asset acquisition and license agreements. Under these agreements we are required to make milestone payments upon successful completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events, such as the achievement of specified development, regulatory and commercial milestones, and the amount, timing and likelihood of such payments are not known. We will also be required to make milestone payments and royalty payments in connection with the sale of products developed under these agreements.
Potential material future milestone and royalty payments as of March 31, 2026 pursuant to certain key asset acquisition and license agreements are as follows:
•Anti-FcRn franchise (Immunovant): up to a maximum of $420.0 million to HanAll upon the achievement of certain regulatory and sales milestone events and tiered mid-single-digits to mid-teens royalty on net sales.
•Brepocitinib (Priovant): mid tens-of-millions sales milestone payment to Pfizer if aggregate net sales in a given year exceed a mid-hundreds-of-millions amount and tiered sub-teens royalty on net sales.
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•Mosliciguat (Pulmovant): up to a maximum of $280.0 million to Bayer upon the achievement of certain development, regulatory and commercial milestone events and tiered high-single-digits royalty on net sales.
•LNP Technology (Genevant): up to 20% of Royalty-Related Receipts (as defined in the Cross-License Agreement).
We have further commitments not reflected above relating to other asset acquisition and license agreements entered and expect to enter into additional asset acquisition and license agreements in the future, which may require upfront payments and long-term commitments of capital resources.
Additionally, we enter into agreements with contract service providers to assist in the performance of our research and development activities. Expenditures to contract research organizations and contract manufacturing organizations represent significant costs in the clinical development of our product candidates. Subject to required notice periods and certain obligations under binding purchase orders, we can elect to discontinue the work under these agreements at any time. We expect to enter into additional collaborative research, contract research, manufacturing and supplier agreements in the future, which may require upfront payments and long-term commitments of capital resources.
Our board of directors has authorized various share repurchase programs, including a $1.5 billion (excluding fees and expenses) program that was completed in June 2025 and a subsequent program authorized in June 2025 and subsequently increased in March 2026, allowing for aggregate repurchases up to $1.0 billion (excluding fees and expenses). As of March 31, 2026, approximately $890.3 million remains available for share repurchases. During the year ended March 31, 2026, we repurchased 24,225,812 shares (including 270,000 common shares with a trade date of March 31, 2025 that settled on April 1, 2025) for an aggregate purchase price of approximately $318.1 million (including fees and expenses). During the year ended March 31, 2025, we repurchased 128,361,786 shares for an aggregate purchase price of approximately $1.3 billion (including fees and expenses), including 71,251,083 shares repurchased from Sumitomo Pharma Co., Ltd. at $9.10 per share for approximately $648.4 million.
Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements, including the following completed during the years ended March 31, 2026, 2025 and 2024:
RSL Equity Financing Transaction
In September 2023, we entered into common share purchase and sale agreements with certain institutional investors, pursuant to which we sold an aggregate of 19,600,685 of our common shares at a purchase price of $10.21 per share. Net proceeds to us were approximately $199.8 million after deducting offering expenses.
Consolidated Vant Equity Financing Transactions
Immunovant
In October 2023, Immunovant completed an underwritten public offering of 8,475,500 shares of its common stock (including 1,526,316 shares of common stock purchased by us on the same terms as other investors in the offering and the full exercise of the underwriters’ option to purchase 1,105,500 additional shares of common stock) at a price to the public of $38.00 per share. Concurrent with the public offering, we purchased 4,473,684 shares of Immunovant’s common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at the same price per share as investors in the public offering of $38.00 per share. The net proceeds to Immunovant were approximately $466.7 million after deducting underwriting discounts and commissions, placement agent fees and offering expenses.
In January 2025, Immunovant entered into a share purchase agreement pursuant to which Immunovant issued 22,500,000 shares of its common stock (including 16,845,010 shares of common stock purchased by us) at a price of $20.00 per share in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the “IMVT PIPE”). The gross proceeds to Immunovant in the IMVT PIPE were approximately $450.0 million, of which $336.9 million related to our participation.
In December 2025, Immunovant completed an underwritten offering of 26,200,000 shares of its common stock (including 16,666,666 shares of common stock purchased by us) at a price of $21.00 per share, for net proceeds to Immunovant of approximately $543.6 million after deducting underwriting discounts and offering expenses.
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Sale of Subsidiary Interests
Dermavant
On October 28, 2024, we completed the sale of our entire equity interest in our majority-owned subsidiary, Dermavant, to Organon.
Pursuant to the Merger Agreement, Organon agreed to acquire Dermavant for aggregate cash consideration comprising (i) a payment of $175.0 million payable at the closing of the Dermavant Transaction, subject to certain adjustments, (ii) a $75.0 million milestone payment payable upon FDA approval of VTAMA (the “Product”) for the treatment of atopic dermatitis (the “AD Approval Milestone”) and (iii) up to $950.0 million in additional milestone payments payable upon achievement of certain tiered net sales amounts (each less than or equal to $1.0 billion) with respect to the Product. Additionally, Organon agreed to make tiered royalty payments of (x) low-to-mid single digit percentages with respect to annual net sales of the Product up to $1.0 billion and (y) 30% with respect to annual net sales of the Product above $1.0 billion. Such consideration and royalty payments are subject to certain post-closing adjustments and are payable to all of Dermavant’s equity holders, including holders of Dermavant restricted stock units, options and warrants, on a pro rata basis relative to their ownership of Dermavant prior to the closing of the Dermavant Transaction (in each case, after giving effect to the liquidation preference of Dermavant’s preference shares, all of which are held by us, and otherwise in accordance with the applicable terms of such securities). Under the liquidation preference of Dermavant’s preference shares, we are entitled to receive 100% of the first $270.0 million of consideration paid pursuant to the Merger Agreement. We received $183.6 million in cash in October 2024 upon the closing of the Dermavant Transaction, subject to certain post-closing adjustments that are not expected to be significant. The AD Approval Milestone was achieved in December 2024, and the Company received payment of the $75.0 million AD Approval Milestone in January 2025, pursuant to the terms of the Merger Agreement.
As contemplated by the Merger Agreement, in connection with the closing of the Dermavant Transaction, Dermavant repaid all amounts outstanding or otherwise payable (including accrued interest and all premiums and exit fees) pursuant to a senior secured credit facility (the “Credit Facility”), dated as of May 14, 2021 and amended as of May 24, 2024, by and among Dermavant, certain subsidiaries of Dermavant, XYQ Luxco S.A.R.L. and U.S. Bank Trust Company, National Association, and terminated the Credit Facility in accordance with its terms.
Following the closing of the Dermavant Transaction, all rights and obligations under each of (A) the Revenue Interest Purchase and Sale Agreement, dated as of May 14, 2021 and amended as of May 24, 2024, by and among Dermavant, Dermavant Sciences GmbH, XYQ Luxco S.A.R.L., NovaQuest Co-Investment Funds XVII, L.P., MAM Tapir Lender, LLC and U.S. Bank Trust Company, National Association and (B) the Funding Agreement, dated as of July 10, 2018 and amended as of May 24, 2024, by and among Dermavant, Dermavant Sciences GmbH and NovaQuest Co-Investment Fund VIII, L.P., were retained by Dermavant and its subsidiaries, which became indirect wholly owned subsidiaries of Organon. Refer to Note 6, “Discontinued Operations” of our audited financial statements for further information.
Proteovant
In August 2023, we completed a transaction with SK Biopharmaceuticals Co., Ltd. (“SK Bio”), a subsidiary of SK, Inc., pursuant to which SK Bio purchased all of our shares in Proteovant in exchange for $47.5 million.
Telavant
In December 2023, we completed the sale of our entire equity interest in our majority-owned subsidiary, Telavant, to Roche. The Roche Transaction was made pursuant to a Stock Purchase Agreement dated October 22, 2023 among us, Telavant, Pfizer and Roche. Telavant was jointly formed by us and Pfizer in November 2022 to develop and commercialize RVT-3101, an anti-TL1A antibody in development for ulcerative colitis (“UC”) and Crohn’s disease, in the U.S. and Japan. Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer owned the remaining 25%, in each case on an as-converted basis.
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Pursuant to the Stock Purchase Agreement, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of the Roche Transaction in December 2023, as well as a one-time milestone payment of $150 million in cash, paid in August 2024 following the initiation of a Phase 3 trial in UC. The $7.1 billion in closing consideration and $150 million one-time milestone payment were paid to all of Telavant’s equity holders, including holders of Telavant restricted stock units, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction. We received an upfront payment of approximately $5.2 billion in cash as our pro rata portion of the consideration upon closing of the Roche Transaction and a one-time milestone payment of approximately $110.4 million as our pro rata portion of the milestone payment following initiation of a Phase 3 trial in UC.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the discovery efforts, preclinical activities, clinical trials and potential commercialization of our product candidates. Our operating results, including our net losses, may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials, our expenditures on other research and development activities and our commercialization efforts. We anticipate our expenses will increase substantially as we:
•fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future;
•fund the manufacturing of drug substance and drug product of our product candidates in development;
•seek to identify, acquire, develop and commercialize additional product candidates;
•invest in activities related to the discovery of novel drugs and advancement of our internal programs;
•integrate acquired product candidates or technologies into a comprehensive regulatory and product development strategy;
•maintain, expand and protect our intellectual property portfolio;
•hire scientific, clinical, quality control and administrative personnel;
•add operational, financial and management information systems and personnel, including personnel to support our drug development efforts;
•achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties;
•seek regulatory approvals for any product candidates that successfully complete clinical trials;
•build out our sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain regulatory approval; and
•operate as a public company.
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While we do not have a need for additional capital to continue our current operations as a result of our current liquidity position, we may in the future require additional capital to fund our operations, pursue business opportunities or strategic transactions or respond to challenges, competition or unforeseen circumstances. In that case, until such time, if ever, that we can generate substantial revenues, we may finance future cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements or other collaborations at Roivant and the Vants. To the extent that we raise additional capital by issuing equity securities at Roivant or the Vants, our existing shareholders’ ownership, or our ownership in the Vants, may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that could harm the rights of our shareholders. Additionally, any agreements for future debt or preferred equity financings, if available, may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations or strategic alliances or through marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or technologies or grant licenses on terms that may not be favorable to us. The foregoing restrictions associated with potential sources of additional capital may make it more difficult for us to raise additional capital, if needed, or to pursue business opportunities, including potential acquisitions.
While we do not have a near-term need for additional capital as a result of our current liquidity position, we may in the future require additional capital, and if adequate funds are not available to us, in that case, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery programs, or be unable to expand operations or otherwise capitalize on business opportunities, which could materially affect our business, prospects, financial condition and results of operations.
Finally, as part of our ongoing business strategy we regularly evaluate new acquisition and in-licensing opportunities, as well as our capital structure. We may from time to time use our existing cash to fund such opportunities or to return capital to shareholders through share repurchases or the issuance of cash dividends on our common shares to optimize our capital structure. See “Risk Factors—Risks Related to Our Business and Industry—We face risks associated with acquisitions, divestitures and other strategic transactions.” in Part I, Item 1A. of this Annual Report for more information.
Cash Flows
The following table sets forth a summary of our cash flows for the years ended March 31, 2026, 2025 and 2024:
| Years Ended March 31, | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2026 | 2025 | 2024 | ||||||||
| (in thousands) | ||||||||||
| Net cash used in operating activities | $ | (750,349) | $ | (839,451) | $ | (765,268) | ||||
| Net cash (used in) provided by investing activities | $ | (682,333) | $ | (1,766,291) | $ | 5,203,623 | ||||
| Net cash provided by (used in) financing activities | $ | 134,236 | $ | (1,219,794) | $ | 419,364 |
Operating Activities
Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash flow from operating activities is derived from adjusting our net loss for non-cash items and changes in working capital.
For the year ended March 31, 2026, cash used in operating activities decreased by $89.1 million to $750.3 million compared to $839.5 million for the year ended March 31, 2025. This decrease was primarily due to certain cost savings during the year ended March 31, 2026 as a result of the sale of Dermavant along with lower cash compensation during the year ended March 31, 2026 as a result of higher one-time cash awards made pursuant to the Senior Executive Compensation Program during the year ended March 31, 2025. These decreases were partially offset by lower cash receipts from revenues in part as a result of the sale of Dermavant, less interest income received and greater cash requirements to advance our existing research and development programs, including the anti-FcRn franchise and brepocitinib, during the year ended March 31, 2026.
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For the year ended March 31, 2025, cash used in operating activities increased by $74.2 million to $839.5 million compared to $765.3 million for the year ended March 31, 2024, largely reflecting greater cash requirements to advance our research and development programs during the year ended March 31, 2025.
Investing Activities
For the year ended March 31, 2026, cash used in investing activities decreased by approximately $1.1 billion to $682.3 million compared to $1.8 billion for the year ended March 31, 2025. The decrease was primarily driven by increased proceeds from sales and maturities of marketable securities, partially offset by increased purchases of marketable securities during the year ended March 31, 2026.
For the year ended March 31, 2025, cash flow from investing activities changed by approximately $7.0 billion to net cash used in investing activities of approximately $1.8 billion for the year ended March 31, 2025 from net cash provided by investing activities of $5.2 billion for the year ended March 31, 2024. This change in cash flow was primarily due to purchases of marketable securities, partially offset by maturities, during the year ended March 31, 2025 and the proceeds received upon closing of the Roche Transaction during the year ended March 31, 2024.
Financing Activities
For the year ended March 31, 2026, cash flow from financing activities changed by approximately $1.4 billion to net cash provided by financing activities of $134.2 million for the year ended March 31, 2026 compared to net cash used in financing activities of $1.2 billion for the year ended March 31, 2025. This change was primarily due to a decrease in cash used for the repurchase of our common shares, an increase in cash proceeds from exercise of stock options and an increase in cash proceeds from the issuance of subsidiary common shares, net of issuance costs paid, during the year ended March 31, 2026.
For the year ended March 31, 2025, cash flow from financing activities changed by approximately $1.6 billion to net cash used in financing activities of $1.2 billion for the year ended March 31, 2025 from net cash provided by financing activities of $419.4 million for the year ended March 31, 2024. During the year ended March 31, 2025, net cash used in financing activities was primarily driven by the repurchase of approximately $1.3 billion of our common shares, partially offset by the issuance of common shares of our majority-owned subsidiary Immunovant. During the year ended March 31, 2024, net proceeds were primarily generated by the issuance of common shares of our majority-owned subsidiary Immunovant as well as the issuance of our common shares pursuant to purchase and sale agreements entered into with certain institutional investors.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingencies as of the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts or experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known.
We define our critical accounting policies as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles.
While our significant accounting policies are described in more detail in Note 2, “Summary of Significant Accounting Policies” in our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
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Accrued Research and Development Expenses, Including Clinical Trial Accruals
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. We record accruals for estimated costs of research and development activities, including preclinical studies, clinical trials and contract manufacturing, conducted by third-party service providers. Our process for determining such estimates includes reviewing open contracts, vendor agreements and purchase orders; communicating with our internal personnel and external service providers to understand the progress or stage of completion of services performed on our behalf; and estimating the associated costs for these services when we have not yet been invoiced. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time.
We recognize expenses related to clinical trials based on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical trials on our behalf. The financial terms of these agreements are subject to negotiation and vary from contract to contract. This may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on various factors, including the successful enrollment of patients and the completion of clinical trial milestones. The majority of our service providers invoice us in arrears based on a pre-determined schedule or when contractual milestones are met. In making these estimates, we consider various factors, including status and timing of services performed, the number of patients enrolled and the rate of patient enrollment. If the actual timing of the performance of services or the level of effort varies from our estimate, the accrual or prepaid expense is adjusted accordingly.
Other examples of estimated accrued research and development expenses include fees paid to:
a.investigative sites in connection with clinical trials;
b.vendors in connection with preclinical and clinical development activities; and
c.CMOs in connection with the production of product and clinical trial materials.
Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, we have not experienced significant changes in our estimates of accrued research and development expenses after a reporting period.
Valuation of Investment in Datavant
We hold an equity method investment in Datavant, which is a privately-held company. We do not consolidate Datavant as we do not have a controlling financial interest. Our investment in Datavant is subject to the equity method of accounting, and we have elected the fair value option to continuously remeasure the investment to fair value each reporting period with changes in fair value reflected in earnings. We have engaged an independent valuation specialist to determine the fair value as of each reporting date.
The fair value of our investment in Datavant uses significant unobservable inputs and is therefore classified as a Level 3 financial instrument. The estimate of fair value for this investment was determined using the income approach, market approach and implementation of the option pricing method (“OPM”). The income approach is based on the future expected cash flows, which are derived from certain assumptions attributable to Datavant including estimates of revenue growth rate, earnings before interest, taxes, depreciation and amortization and terminal growth rate. These expected cash flows are then discounted to their present value using a discount rate that reflects the risk and time value of money. The market approach estimates value by using valuation multiples derived from the stock prices of comparable publicly traded companies to determine the company’s equity value. The OPM allows for the allocation of a company’s equity value among the various equity capital owners (preferred and common shareholders). The OPM uses the preferred shareholders’ liquidation preferences, participation rights, dividend policy and conversion rights to determine how proceeds from a liquidity event shall be distributed among the various ownership classes at a future date.
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Recently Adopted Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Updates (“ASU”) 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which requires updates to the income tax disclosures related to the rate reconciliation and disaggregation of income taxes paid by jurisdiction. The amendments are effective for fiscal years beginning after December 15, 2024 and are applicable to our fiscal year beginning April 1, 2025, with early adoption permitted. The amendments should be applied prospectively, however retrospective application is permitted. We adopted this ASU prospectively for the fiscal year ended March 31, 2026. This resulted in expanded disclosures in line with the requirements of the ASU.
In September 2025, the FASB issued ASU 2025-07, “Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract”, which refines the scope of the guidance on derivatives in ASC 815 and clarifies the guidance on share-based payments from a customer in ASC 606. This guidance is effective for fiscal years and interim periods beginning after December 15, 2026, with early adoption permitted. These requirements may be applied prospectively or on a modified retrospective basis through a cumulative-effect adjustment to the opening balance of retained earnings. We early adopted this guidance during the quarter ended March 31, 2026. We applied the derivative scope refinements guidance on a modified retrospective basis and applied the share-based payments guidance on a prospective basis. The adoption of this guidance had no impact on our consolidated financial statements.
MD&A history
Prior-year 10-K MD&A spans are extracted from SEC filings with the same bounded parser used for the latest filing. The latest 10-K appears above; prior years are below.
FY 2025 10-K MD&A
SEC filing source: 0001140361-25-020715.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of Roivant’s financial condition and results of operations should be read in conjunction with Roivant’s consolidated financial
statements and notes to those statements included elsewhere in this Annual Report on Form 10-K. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and
uncertainties. Roivant’s actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see “Forward-Looking Statements” and “Risk Factors” in this Annual Report on Form
10-K. Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31.
Overview
Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes
brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn
in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble
subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.
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Components of Results of Operations
Revenue
Revenue primarily relates to amounts earned in connection with license agreements, as well as revenue generated by subscription and service-based fees.
Cost of revenues
Our cost of revenues primarily relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting and third-party
data costs.
Research and development expenses
Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates. Research and development expenses primarily
include the following:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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. |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Unallocated internal costs, including: |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | employee-related expenses, such as salaries, share-based compensation and benefits, for research and development personnel; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | other research and development related expenses that are not allocated to a specific program. |
Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we
advance our product candidates and our in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates.
The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the number and scope of preclinical and clinical programs we decide to pursue; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the number of doses that patients receive; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the countries in which the trials are conducted; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to secure and leverage adequate CRO support for the conduct of clinical trials; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to establish an appropriate safety and efficacy profile for our product candidates; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the timing, receipt and terms of any approvals from applicable regulatory authorities; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the potential additional safety monitoring or other studies requested by regulatory agencies; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the significant and changing government regulation and regulatory guidance; |
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| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to establish clinical and commercial manufacturing capabilities, or make arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make product candidates successfully; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to maintain a continued acceptable safety profile of our product candidates following regulatory approval of our product candidates. |
The successful development of our product candidates is highly uncertain, and we cannot reasonably estimate the costs that will be necessary to complete the remainder of the development of
our product candidates. In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability.
Acquired in-process research and development expenses
Acquired in-process research and development (“IPR&D”) expenses include consideration for the purchase of IPR&D through asset acquisitions and license agreements, as well as payments
made in connection with asset acquisitions and license agreements upon the achievement of development milestones.
Consideration for the purchase of IPR&D through asset acquisitions and license agreements may include cash upfront payments, shares and other liability instruments issued and the fair
value of future contingent consideration payments.
General and administrative expenses
General and administrative (“G&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation and benefits, for employees engaged in G&A
activities. G&A employees include those responsible for the identification and acquisition or in-license of new drug candidates, as well as for managing Vant operations and facilitating the use of our platform and technologies at the
Vants. G&A expenses also consist of legal and accounting fees, consulting services and other operating costs relating to corporate matters and daily operations.
We expect G&A expenses to increase in future periods to support our potential commercialization efforts. These increases will likely include additional costs related to the hiring of new
personnel and fees to outside consultants, as well as other expenses. If any of our current or future product candidates receives regulatory approval in the U.S. or another jurisdiction, we expect that we would incur significantly increased
expenses associated with building a sales and marketing team. Additionally, in July 2024, the Compensation Committee of the board of directors approved a multi-year incentive compensation program for each of Matthew Gline, Chief Executive
Officer; Mayukh Sukhatme, President and Chief Investment Officer; and Eric Venker, President and Chief Operating Officer (the “2024 Senior Executive Compensation Program”). The long-term equity incentive awards granted pursuant to this
program will result in significant share-based compensation expense over the vesting period of the awards. Refer to Note 9, “Share-Based Compensation and Other Compensation Plans” of our audited financial statements for further details.
Gain on sale of Telavant net assets
Gain on sale of Telavant net assets reflects a gain resulting from the sale of our entire equity interest in our
majority-owned subsidiary, Telavant Holdings, Inc. (“Telavant”), to Roche Holdings, Inc. (“Roche”) in December 2023 (the “Roche Transaction”) as well as a gain resulting from the achievement of a one-time milestone in June 2024. In December
2023, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of the Roche Transaction and a one-time milestone payment of $150 million in cash,
paid in August 2024 following the initiation of a Phase 3 trial in UC. Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer Inc. (“Pfizer”) owned the
remaining 25%, in each case on an as-converted basis. The $7.1 billion in closing consideration and $150 million one-time milestone payment were paid to all of Telavant’s equity holders, including holders of Telavant restricted stock units,
on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction. We recognized a gain on sale of Telavant net assets of $110.4 million for our pro rata portion of the one-time milestone
consideration during the year ended March 31, 2025 and approximately $5.3 billion for the sale of our entire equity interest in Telavant during the year ended March 31, 2024. Refer to Note 5, “Recent Transactions and Developments” of our
audited financial statements for further information regarding the Roche Transaction.
Change in fair value of investments
Change in fair value of investments includes the unrealized (gain) loss on equity investments, including Arbutus Biopharma Corporation (“Arbutus”) and Heracles Parent, L.L.C. (“Datavant”). We
have elected the fair value option to account for these investments.
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Change in fair value of liability instruments
Change in fair value of liability instruments primarily includes the (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities,
including the earn-out share liabilities and warrant liabilities, prior to their redemption, issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”), a special purpose
acquisition company. Refer to Note 13, “Earn-Out Shares, Public Warrants and Private Placement Warrants” of our audited financial statements for further information regarding the redemption of our warrants.
Gain on deconsolidation of subsidiaries
Gain on deconsolidation of subsidiaries resulted from the determination that we no longer had a controlling financial interest in certain subsidiaries.
Interest income
Interest income consists of interest earned on our cash equivalents and marketable securities.
Income tax expense
Income tax expense is recorded for the jurisdictions in which we do business. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences
between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in
which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation
allowance is recorded when, after consideration of all positive and negative evidence, it is not more likely than not that our deferred tax assets will be realizable. When uncertain tax positions exist, we recognize the tax benefit of tax
positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position and consideration of
the available facts and circumstances.
Income (loss) from discontinued operations, net of tax
Income (loss) from discontinued operations, net of tax consists of the gain on sale of subsidiary interests for the year ended March 31, 2025 resulting from the sale of our entire equity
interest in our majority-owned subsidiary, Dermavant Sciences Ltd. (“Dermavant”), to Organon & Co. (“Organon”) in October 2024 and the financial results of Dermavant through closing of the Dermavant Transaction (as defined below). In
September 2024, Dermavant entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Organon, Organon Bermuda Ltd., an indirect wholly owned subsidiary of Organon (“Merger Sub”), and us, solely in our capacity as the
representative of the securityholders of Dermavant, pursuant to which Organon agreed to acquire Dermavant (the “Dermavant Transaction”). The Dermavant Transaction was completed in October 2024.
For the year ended March 31, 2023, loss from discontinued operations, net of tax also includes the gain on sale of common shares of Myovant Sciences Ltd. (“Myovant”) as a result of Sumitovant
Biopharma Ltd.’s (“Sumitovant”) acquisition of the remaining noncontrolling interest in Myovant in March 2023. We were entitled to these shares of Myovant pursuant to the December 2019 transaction with Sumitomo Pharma Co., Ltd. (the “Sumitomo
Transaction”) that included, among other things, the transfer of our ownership interest in five Vants to Sumitovant. The Sumitomo Transaction was presented as discontinued operations during the year ending March 31, 2020, and the right to
receive certain common shares of Myovant was treated as a contingent consideration upon a sale of the business and accounted for as a gain contingency.
Refer to Note 6, “Discontinued Operations” of our audited financial statements for further information.
Net loss attributable to noncontrolling interests
Net loss attributable to noncontrolling interests consists of the portion of net loss of those consolidated entities that is not allocated to us. We record net loss attributable to
noncontrolling interests equal to the noncontrolling interest’s proportionate share of the respective operations.
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Results of Operations
Comparison of the years ended March 31, 2025, 2024 and 2023
The following table sets forth our results of operations for the years ended March 31, 2025, 2024 and 2023:
| Years Ended March 31, | Change | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | ||||||||||||||||
| (in thousands) | ||||||||||||||||||||
| Revenue | $ | 29,053 | $ | 32,713 | $ | 31,530 | $ | (3,660 | ) | $ | 1,183 | |||||||||
| Operating expenses: | ||||||||||||||||||||
| Cost of revenues | 911 | 1,599 | 3,034 | (688 | ) | (1,435 | ) | |||||||||||||
| Research and development | 550,413 | 439,909 | 454,062 | 110,504 | (14,153 | ) | ||||||||||||||
| Acquired in-process research and development | — | 26,450 | 97,749 | (26,450 | ) | (71,299 | ) | |||||||||||||
| General and administrative | 591,410 | 416,133 | 383,448 | 175,277 | 32,685 | |||||||||||||||
| Total operating expenses | 1,142,734 | 884,091 | 938,293 | 258,643 | (54,202 | ) | ||||||||||||||
| Gain on sale of Telavant net assets | 110,387 | 5,348,410 | — | (5,238,023 | ) | 5,348,410 | ||||||||||||||
| (Loss) income from operations | (1,003,294 | ) | 4,497,032 | (906,763 | ) | (5,500,326 | ) | 5,403,795 | ||||||||||||
| Change in fair value of investments | (55,186 | ) | 47,973 | 20,815 | (103,159 | ) | 27,158 | |||||||||||||
| Change in fair value of liability instruments | (15,756 | ) | 46,838 | 18,386 | (62,594 | ) | 28,452 | |||||||||||||
| Gain on deconsolidation of subsidiaries | (3,108 | ) | (32,772 | ) | (29,276 | ) | 29,664 | (3,496 | ) | |||||||||||
| Interest income | (258,375 | ) | (146,425 | ) | (32,184 | ) | (111,950 | ) | (114,241 | ) | ||||||||||
| Other expense, net | 10,721 | 13,562 | 486 | (2,841 | ) | 13,076 | ||||||||||||||
| (Loss) income from continuing operations before income taxes | (681,590 | ) | 4,567,856 | (884,990 | ) | (5,249,446 | ) | 5,452,846 | ||||||||||||
| Income tax expense | 48,174 | 21,503 | 4,082 | 26,671 | 17,421 | |||||||||||||||
| (Loss) income from continuing operations, net of tax | (729,764 | ) | 4,546,353 | (889,072 | ) | (5,276,117 | ) | 5,435,425 | ||||||||||||
| Income (loss) from discontinued operations, net of tax | 373,030 | (315,147 | ) | (226,391 | ) | 688,177 | (88,756 | ) | ||||||||||||
| Net (loss) income | (356,734 | ) | 4,231,206 | (1,115,463 | ) | (4,587,940 | ) | 5,346,669 | ||||||||||||
| Net loss attributable to noncontrolling interests | (184,753 | ) | (117,720 | ) | (106,433 | ) | (67,033 | ) | (11,287 | ) | ||||||||||
| Net (loss) income attributable to Roivant Sciences Ltd. | $ | (171,981 | ) | $ | 4,348,926 | $ | (1,009,030 | ) | $ | (4,520,907 | ) | $ | 5,357,956 |
Variance analysis for years ended March 31, 2025, 2024 and 2023
Revenue
| Years Ended March 31, | Change | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | |||||||||||||||
| (in thousands) | |||||||||||||||||||
| Revenue | $ | 29,053 | $ | 32,713 | $ | 31,530 | $ | (3,660 | ) | $ | 1,183 |
Revenue decreased by $3.7 million to $29.1 million for the year ended March 31, 2025, compared to $32.7 million for the year ended March 31, 2024. Revenue increased by $1.2 million to $32.7
million for the year ended March 31, 2024, compared to $31.5 million for the year ended March 31, 2023. During the years ended March 31, 2025, 2024, and 2023, revenue was primarily driven by amounts earned in connection with license
agreements at Genevant.
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Research and development expenses
For the years ended March 31, 2025, 2024 and 2023, our research
and development expenses consisted of the following:
| Years Ended March 31, | Change | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024(1) | 2023(1) | 2025 vs. 2024 | 2024 vs. 2023 | ||||||||||||||||
| (in thousands) | ||||||||||||||||||||
| Program-specific costs: | ||||||||||||||||||||
| Anti-FcRn franchise—neurological diseases | $ | 93,224 | $ | 41,060 | $ | 52,100 | $ | 52,164 | $ | (11,040 | ) | |||||||||
| Anti-FcRn franchise—endocrine diseases | 63,073 | 33,205 | 26,377 | 29,868 | 6,828 | |||||||||||||||
| Anti-FcRn franchise—rheumatology diseases | 23,897 | — | — | 23,897 | — | |||||||||||||||
| Anti-FcRn franchise—dermatology diseases | 15,633 | — | — | 15,633 | — | |||||||||||||||
| Anti-FcRn franchise—other clinical and nonclinical | 9,327 | 39,811 | 5,553 | (30,484 | ) | 34,258 | ||||||||||||||
| Brepocitinib | 45,125 | 38,563 | 38,627 | 6,562 | (64 | ) | ||||||||||||||
| Mosliciguat | 19,746 | 4,307 | — | 15,439 | 4,307 | |||||||||||||||
| Namilumab(2) | 12,744 | 13,236 | 11,757 | (492 | ) | 1,479 | ||||||||||||||
| RVT-2001(2) | 1,916 | 10,132 | 16,075 | (8,216 | ) | (5,943 | ) | |||||||||||||
| RVT-3101 | — | 35,129 | 7,559 | (35,129 | ) | 27,570 | ||||||||||||||
| Other development and discovery programs | 43,069 | 33,773 | 124,502 | 9,296 | (90,729 | ) | ||||||||||||||
| Total program-specific costs | 327,754 | 249,216 | 282,550 | 78,538 | (33,334 | ) | ||||||||||||||
| Unallocated internal costs: | ||||||||||||||||||||
| Share-based compensation | 39,780 | 32,400 | 28,669 | 7,380 | 3,731 | |||||||||||||||
| Personnel-related expenses | 146,162 | 123,283 | 118,523 | 22,879 | 4,760 | |||||||||||||||
| Other expenses | 36,717 | 35,010 | 24,320 | 1,707 | 10,690 | |||||||||||||||
| Total research and development expenses | $ | 550,413 | $ | 439,909 | $ | 454,062 | $ | 110,504 | $ | (14,153 | ) |
(1) Certain prior period amounts have been reclassified to conform to current period presentation.
(2) Reflects a discontinued program.
Research and development expenses increased by $110.5 million to $550.4 million for the year ended March 31, 2025, compared to $439.9 million for the year ended March 31, 2024, primarily due
to increases in program-specific costs of $78.5 million, personnel-related expenses of $22.9 million, share-based compensation of $7.4 million and other expenses of $1.7 million.
The increase of $78.5 million in program-specific costs was primarily driven by increases of $91.1 million related to the anti-FcRn franchise, reflecting the progression of our programs, and
$15.4 million related to mosliciguat, which was acquired during the year ended March 31, 2024. These increases were partially offset by a decrease in expense of $35.1 million related to RVT-3101, which was sold to Roche in December 2023.
The increase of $22.9 million in personnel-related expenses was primarily driven by higher personnel-related expenses at Immunovant as a result of higher headcount and enhancement of
capabilities to support Immunovant’s strategic objectives as clinical activities progress. Included in personnel-related expenses is a special one-time cash retention bonus award granted to employees in December 2023 (the “Cash Bonus
Program”). During the years ended March 31, 2025 and 2024, we recognized additional research and development expense of $5.8 million and $9.9 million, respectively, relating to the Cash Bonus Program. The remaining research and development
expense of $0.9 million as of March 31, 2025 will be recognized over the applicable service period of the award.
Research and development expenses decreased by $14.2 million to $439.9 million for the year ended March 31, 2024, compared to $454.1 million for the year ended March 31, 2023, primarily due
to a decrease in program-specific costs of $33.3 million, partially offset by increases in other expenses of $10.7 million, personnel-related expenses of $4.8 million, and share-based compensation of $3.7 million.
The decrease of $33.3 million in program-specific costs was primarily driven by a decrease of $90.7 million in other development and discovery program expense, which in part resulted from the
deconsolidation of Proteovant Sciences, Inc. (“Proteovant”) in August 2023 along with the reprioritization of certain programs and drug discovery efforts. This decrease was partially offset by increases of $27.6 million relating to RVT-3101
and $30.0 million relating to the anti-FcRn franchise. RVT-3101 was acquired in November 2022, and the rights to further develop and manufacture RVT-3101 were sold to Roche in December 2023.
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Acquired in-process research and development expenses
| Years Ended March 31, | Change | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | ||||||||||||||||
| (in thousands) | ||||||||||||||||||||
| Acquired in-process research and development expenses | $ | — | $ | 26,450 | $ | 97,749 | $ | (26,450 | ) | $ | (71,299 | ) |
There were no acquired in-process research and development expenses for the year ended March 31, 2025.
Acquired in-process research and development expenses decreased by $71.3 million to $26.5 million for the year ended March 31, 2024, compared to $97.7 million for the year ended March 31,
2023. The decrease was primarily due to higher consideration for the purchase of IPR&D during the year ended March 31, 2023 as a result of consideration for the purchase of IPR&D of $87.7 million relating to the acquisition of
RVT-3101 in November 2022 and the achievement of a development milestone relating to batoclimab, which resulted in a one-time milestone expense of $10.0 million. Acquired in-process research and development expenses for the year ended March
31, 2024 was driven by $14.0 million of consideration for the purchase of IPR&D relating to the asset acquisition of mosliciguat completed by our subsidiary, Pulmovant, Inc. (“Pulmovant”) and $12.5 million relating to the achievement of
development and regulatory milestones for batoclimab.
General and administrative expenses
| Years Ended March 31, | Change | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | |||||||||||||||
| (in thousands) | |||||||||||||||||||
| General and administrative expenses | $ | 591,410 | $ | 416,133 | $ | 383,448 | $ | 175,277 | $ | 32,685 |
General and administrative expenses increased by $175.3 million to $591.4 million for the year ended March 31, 2025, compared to $416.1
million for the year ended March 31, 2024. This increase was primarily due to increases in share-based compensation expense of $84.6 million and personnel-related expenses of $79.6 million, largely as a result of long-term equity and
one-time cash retention awards from the 2024 Senior Executive Compensation Program. Refer to Note 9, “Share-Based Compensation and Other Compensation Plans” of our audited financial statements for further information.
General and administrative expenses increased by $32.7 million to $416.1 million for the year ended March 31, 2024, compared to $383.4 million for the year ended March 31, 2023. This increase
was primarily due to an increase in personnel-related expenses of $27.0 million, which largely resulted from the Cash Bonus Program, and an increase in professional fees of $19.6 million. These increases were partially offset by a decrease in
share-based compensation expense of $20.1 million.
A summary of general and administrative expense relating to the Cash Bonus Program and 2024 Senior Executive Compensation Program is as follows (in thousands):
| Years Ended March 31, | Remaining Expense as of March 31, 2025 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | ||||||||||
| Cash Bonus Program | $ | 21,209 | $ | 35,628 | $ | 4,913 | |||||
| 2024 Senior Executive Compensation Program: | |||||||||||
| Cash awards | 86,421 | — | 7,319 | ||||||||
| Performance restricted stock units | 82,186 | — | 196,023 | ||||||||
| Restricted stock units | 6,410 | — | 45,380 | ||||||||
| Stock options | 640 | — | 2,293 | ||||||||
| Total | $ | 196,866 | $ | 35,628 | $ | 255,928 |
Gain on sale of Telavant net assets
| Years Ended March 31, | Change | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | |||||||||||||||
| (in thousands) | |||||||||||||||||||
| Gain on sale of Telavant net assets | $ | 110,387 | $ | 5,348,410 | $ | — | $ | (5,238,023 | ) | $ | 5,348,410 |
Gain on sale of Telavant net assets decreased by $5.2 billion to $110.4 million for the year ended March 31, 2025, compared
to $5.3 billion for the year ended March 31, 2024. The gain for the year ended March 31, 2025 resulted from the achievement of a one-time milestone in June 2024. The gain for the year ended March 31, 2024 resulted from the sale of our
entire equity interest in Telavant to Roche in December 2023. Refer to Note 5, “Recent Transactions and Developments” of our audited financial statements for further information.
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Change in fair value of investments
| Years Ended March 31, | Change | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | |||||||||||||||
| (in thousands) | |||||||||||||||||||
| Change in fair value of investments | $ | (55,186 | ) | $ | 47,973 | $ | 20,815 | $ | (103,159 | ) | $ | 27,158 |
Change in fair value of investments was an unrealized gain of $55.2 million and an unrealized loss of $48.0 million for the years ended March 31, 2025 and 2024, respectively. The change of
$103.2 million was primarily driven by changes in the public share prices of Arbutus and in the fair value of our investment in Datavant. Refer to Note 4, “Equity Method Investments” of our audited financial statements for further
information.
Change in fair value of investments were unrealized losses of $48.0 million and $20.8 million for the years ended March 31, 2024 and 2023, respectively. The change of $27.2 million was
primarily driven by changes in the public share prices of our equity investments, including Arbutus, as well as the change in fair value of our investment in Datavant.
Change in fair value of liability instruments
| Years Ended March 31, | Change | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | |||||||||||||||
| (in thousands) | |||||||||||||||||||
| Change in fair value of liability instruments | $ | (15,756 | ) | $ | 46,838 | $ | 18,386 | $ | (62,594 | ) | $ | 28,452 |
Change in fair value of liability instruments was a gain of $15.8 million, a loss of $46.8 million, and a loss of $18.4 million for the years ended March 31, 2025, 2024 and 2023,
respectively. Change in fair value of liability instruments for the year ended March 31, 2025 primarily consisted of a gain relating to the earn-out share liabilities issued as part of the Business Combination. Change in fair value of
liability instruments for the years ended March 31, 2024 and 2023 primarily consisted of losses relating to the warrant and earn-out share liabilities issued as part of the Business Combination. Refer to Note 13, “Earn-Out Shares, Public
Warrants and Private Placement Warrants” of our audited financial statements for further information.
Gain on deconsolidation of subsidiaries
| Years Ended March 31, | Change | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | ||||||||||||||||
| (in thousands) | ||||||||||||||||||||
| Gain on deconsolidation of subsidiaries | $ | (3,108 | ) | $ | (32,772 | ) | $ | (29,276 | ) | $ | 29,664 | $ | (3,496 | ) |
Gain on deconsolidation of subsidiaries was $3.1 million, $32.8 million, and $29.3 million for the years ended March 31, 2025, 2024 and 2023, respectively. The gain for the year ended March
31, 2025 resulted from the deconsolidation of a subsidiary in March 2025. The gain for the year ended March 31, 2024 resulted from the deconsolidation of certain subsidiaries, including VantAI Holdings, Inc. in July 2023 and Proteovant in
August 2023. The gain for the year ended March 31, 2023 resulted from the deconsolidation of certain subsidiaries in November 2022 and July 2022.
Interest income
| Years Ended March 31, | Change | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | ||||||||||||||||
| (in thousands) | ||||||||||||||||||||
| Interest income | $ | (258,375 | ) | $ | (146,425 | ) | $ | (32,184 | ) | $ | (111,950 | ) | $ | (114,241 | ) |
Interest income increased by $112.0 million to $258.4 million for the year ended March 31, 2025, compared to $146.4 million for the year ended March 31, 2024. This increase is primarily due
to higher cash balances in our interest-bearing cash accounts.
Interest income increased by $114.2 million to $146.4 million for the year ended March 31, 2024, compared to $32.2 million for the year ended March 31, 2023. This increase is primarily due to
higher cash balances in our interest-bearing cash accounts as well as higher interest rates.
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Income tax expense
| Years Ended March 31, | Change | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | |||||||||||||||
| (in thousands) | |||||||||||||||||||
| Income tax expense | $ | 48,174 | $ | 21,503 | $ | 4,082 | $ | 26,671 | $ | 17,421 |
Income tax expense increased by $26.7 million to $48.2 million for the year ended March 31, 2025, compared to $21.5 million for the year ended March 31, 2024. Income tax expense increased by
$17.4 million to $21.5 million for the year ended March 31, 2024, compared to $4.1 million for the year ended March 31, 2023. The increases were primarily due to our fluctuating earnings by legal entity in various jurisdictions over the
periods. As disclosed, the tax expense for the year ended March 31, 2024 was impacted by the gain on sale of Telavant’s net assets, which qualifies for the substantial shareholding exemption in the U.K. and consequently is not subject to the
corporation income tax.
Income (loss) from discontinued operations, net of tax
| Years Ended March 31, | Change | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | 2025 vs. 2024 | 2024 vs. 2023 | ||||||||||||||||
| (in thousands) | ||||||||||||||||||||
| Income (loss) from discontinued operations, net of tax | $ | 373,030 | $ | (315,147 | ) | $ | (226,391 | ) | $ | 688,177 | $ | (88,756 | ) |
Income from discontinued operations, net of tax was $373.0 million for the year ended March 31, 2025 and reflects the gain on sale of subsidiary interests resulting from the sale of our
entire equity interest in our majority-owned subsidiary, Dermavant, to Organon in October 2024, partially offset by Dermavant’s net losses. Loss from discontinued operations, net of tax was $315.1 million for the year ended March 31, 2024 and
represents the financial results of Dermavant. Loss from discontinued operations, net of tax was $226.4 million for the year ended March 31, 2023 and represents the financial results of Dermavant, partially offset by the gain on sale of
common shares of Myovant after Sumitovant’s acquisition of the remaining noncontrolling interest in Myovant in March 2023. Refer to Note 6, “Discontinued Operations” of our audited financial statements for additional information.
Liquidity and Capital Resources
For the years ended March 31, 2025, 2024 and 2023, we had a net loss from continuing operations of $729.8 million, net income from continuing operations of approximately $4.5 billion and a
net loss from continuing operations of $889.1 million, respectively. As of March 31, 2025, we had cash, cash equivalents and marketable securities of approximately $4.9 billion and retained earnings of $116.1 million. We believe that our
existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditures for the foreseeable future. However, projections of future cash flows and operating expenses are inherently
uncertain and subject to changes, as described under “Risk Factors” in Part I, Item 1A. of this Annual Report on Form 10-K. As a result, our existing cash, cash equivalents and marketable securities may not be sufficient to fund our operating
expenses as anticipated, and we may need to raise additional capital to fund our operations.
Our short-term and long-term liquidity requirements as of March 31, 2025 included:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | obligations under our leases (see Note 11, “Leases” of our audited financial statements); and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | certain commitments to Samsung Biologics Co., Ltd. (“Samsung”) pursuant to a Product Service Agreement (“PSA”) entered into between Immunovant and Samsung pursuant to which Samsung will manufacture and supply Immunovant with batoclimab drug substance for commercial sale, if approved, and perform other manufacturing-related services with respect to batoclimab. Upon execution of the PSA, Immunovant committed to purchase process performance qualification batches of batoclimab and pre-approval inspection batches of batoclimab which may be used for regulatory submissions and, pending regulatory approval, commercial sale. In addition, Immunovant has a minimum obligation to purchase additional batches of batoclimab in the four-year period of 2026 through 2029. As of March 31, 2025, the remaining minimum purchase commitment related to this agreement was estimated to be approximately $43.6 million, of which $5.5 million, $10.1 million, $14.0 million and $14.0 million is expected to be paid during the fiscal years ending March 31, 2026, 2028, 2029 and 2030, respectively. |
The above purchase commitments do not represent all of our anticipated purchases, but instead represent only the contractually obligated minimum purchases or firm commitments of
non-cancelable minimum amounts.
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Additionally, we have certain payment obligations under various asset acquisition and license agreements. Under these agreements we are required to make milestone payments upon successful
completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events, such as our achievement of specified
development, regulatory and commercial milestones, and the amount, timing and likelihood of such payments are not known. We will also be required to make milestone payments and royalty payments in connection with the sale of products
developed under these agreements.
Potential material future milestone payments as of March 31, 2025 pursuant to certain key asset acquisition and license agreements are as follows:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Anti-FcRn franchise (Immunovant): up to a maximum of $420.0 million to HanAll upon the achievement of certain regulatory and sales milestone events. |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Brepocitinib (Priovant Therapeutics, Inc.): mid tens-of-millions sales milestone payment to Pfizer if aggregate net sales in a given year exceed a mid-hundreds-of-millions amount. |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Mosliciguat (Pulmovant): up to a maximum of $280.0 million to Bayer upon the achievement of certain development, regulatory and commercial milestone events. |
Royalties are also due on net sales pursuant to these agreements. We have further commitments not reflected above relating to other asset acquisition and license agreements entered and expect
to enter into additional asset acquisition and license agreements in the future, which may require upfront payments and long-term commitments of capital resources.
Additionally, we enter into agreements with contract service providers to assist in the performance of our research and development activities. Expenditures to contract research organizations
and contract manufacturing organizations represent significant costs in the clinical development of our product candidates. Subject to required notice periods and certain obligations under binding purchase orders, we can elect to discontinue
the work under these agreements at any time. We expect to enter into additional collaborative research, contract research, manufacturing and supplier agreements in the future, which may require upfront payments and long-term commitments of
capital resources.
Our board of directors has authorized a common share repurchase program, allowing for repurchases of common shares in an
aggregate amount of up to $1.5 billion (excluding fees and expenses). The repurchase program is funded by available cash and cash equivalents on hand and does not have an expiration date. In April 2024, pursuant to the share repurchase
program, we entered into a share repurchase agreement with Sumitomo and repurchased all 71,251,083 common shares held by Sumitomo at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million.
Subsequent to the repurchase of the common shares held by Sumitomo, additional repurchases of 57,110,703 shares were made in open market transactions under the share repurchase program during the year ended March 31, 2025 for an aggregate
purchase price of approximately $644.8 million and together with the Sumitomo repurchase, approximately $1.3 billion of the $1.5 billion approved by our board of directors.
Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration
arrangements, including the following completed during the years ended March 31, 2025, 2024 and 2023:
RSL Equity Financing Transactions
In November 2022, we completed an underwritten primary and secondary public offering of 30,000,000 of our common shares at a price to the public of $5.00 per share. Of these common shares,
20,000,000 were sold by us and 10,000,000 were sold by certain selling shareholders. Net proceeds to us were approximately $94.7 million after deducting underwriting discounts and commissions and offering expenses. We did not receive any
proceeds from the sale of common shares by the selling shareholders in the offering.
In February 2023, we completed an underwritten public offering of 30,666,665 of our common shares (including 3,999,999 common shares issued and sold upon the full exercise of the
underwriters’ option to purchase additional shares) at a price to the public of $7.50 per share. Net proceeds to us were approximately $216.9 million after deducting underwriting discounts and commissions and offering expenses.
In September 2023, we entered into common share purchase and sale agreements with certain institutional investors, pursuant to which we sold an aggregate of 19,600,685 of our common shares at
a purchase price of $10.21 per share. Net proceeds to us were approximately $199.8 million after deducting offering expenses.
Consolidated Vant Equity Financing Transactions
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Immunovant
In October 2022, Immunovant completed an underwritten public offering of 12,500,000 shares of its common stock (including 416,667 shares of common stock purchased by us) at a price to the
public of $6.00 per share, for net proceeds to Immunovant of approximately $70.2 million after deducting underwriting discounts and commissions and offering expenses.
In October 2023, Immunovant completed an underwritten public offering of 8,475,500 shares of its common stock (including 1,526,316 shares of common stock purchased by us on the same terms as
other investors in the offering and the full exercise of the underwriters’ option to purchase 1,105,500 additional shares of common stock) at a price to the public of $38.00 per share. Concurrent with the public offering, we purchased
4,473,684 shares of Immunovant’s common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at the same price per share as investors in the public offering of $38.00 per share. The
net proceeds to Immunovant were approximately $466.7 million after deducting underwriting discounts and commissions, placement agent fees and offering expenses.
In January 2025, Immunovant entered into a share purchase agreement pursuant to which Immunovant issued 22,500,000 shares of its common stock (including 16,845,010 shares of common stock
purchased by us) at a price of $20.00 per share in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the “IMVT PIPE”). The gross proceeds to Immunovant in the IMVT PIPE were approximately
$450.0 million, of which $336.9 million related to our participation.
Sale of Subsidiary Interests
Dermavant
On October 28, 2024, we completed the sale of our entire equity interest in our majority-owned subsidiary, Dermavant, to Organon.
Pursuant to the Merger Agreement, Organon agreed to acquire Dermavant for aggregate cash consideration comprising (i) a payment of $175.0 million payable at the closing of the Dermavant
Transaction, subject to certain adjustments, (ii) a $75.0 million milestone payment payable upon FDA approval of VTAMA (the “Product”) for the treatment of atopic dermatitis (the “AD Approval Milestone”) and (iii) up to $950.0 million in
additional milestone payments payable upon achievement of certain tiered net sales amounts (each less than or equal to $1.0 billion) with respect to the Product. Additionally, Organon agreed to make tiered royalty payments of (x) low-to-mid
single digit percentages with respect to annual net sales of the Product up to $1.0 billion and (y) 30% with respect to annual net sales of the Product above $1.0 billion. Such consideration and royalty payments are subject to certain
post-closing adjustments and are payable to all of Dermavant’s equity holders, including holders of Dermavant restricted stock units, options and warrants, on a pro rata basis relative to their ownership of Dermavant prior to the closing of
the Dermavant Transaction (in each case, after giving effect to the liquidation preference of Dermavant’s preference shares, all of which are held by us, and otherwise in accordance with the applicable terms of such securities). Under the
liquidation preference of Dermavant’s preference shares, we are entitled to receive 100% of the first $270.0 million of consideration paid pursuant to the Merger Agreement. We received $183.6 million in cash in October 2024 upon the closing
of the Dermavant Transaction, subject to certain post-closing adjustments that are not expected to be significant. The AD Approval Milestone was achieved in December 2024, and the Company received payment of the $75.0 million AD Approval
Milestone in January 2025, pursuant to the terms of the Merger Agreement.
As contemplated by the Merger Agreement, in connection with the closing of the Dermavant Transaction, Dermavant repaid all amounts outstanding or otherwise payable (including accrued interest
and all premiums and exit fees) pursuant to a senior secured credit facility (the “Credit Facility”), dated as of May 14, 2021 and amended as of May 24, 2024, by and among Dermavant, certain subsidiaries of Dermavant, XYQ Luxco S.A.R.L. and
U.S. Bank Trust Company, National Association, and terminated the Credit Facility in accordance with its terms.
Following the closing of the Dermavant Transaction, all rights and obligations under each of (A) the Revenue Interest
Purchase and Sale Agreement, dated as of May 14, 2021 and amended as of May 24, 2024, by and among Dermavant, Dermavant Sciences GmbH, XYQ Luxco S.A.R.L., NovaQuest Co-Investment Funds XVII, L.P., MAM Tapir Lender, LLC and U.S. Bank Trust
Company, National Association and (B) the Funding Agreement, dated as of July 10, 2018 and amended as of May 24, 2024, by and among Dermavant, Dermavant Sciences GmbH and NovaQuest Co-Investment Fund VIII, L.P., were retained by Dermavant
and its subsidiaries, which became indirect wholly owned subsidiaries of Organon. Refer to Note 6, “Discontinued Operations” of our audited financial statements for further information.
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Proteovant
In August 2023, we completed a transaction with SK Biopharmaceuticals Co., Ltd. (“SK Bio”), a subsidiary of SK, Inc., pursuant to which SK Bio purchased all of our shares in Proteovant in
exchange for $47.5 million.
Telavant
In December 2023, we completed the sale of our entire equity interest in our majority-owned subsidiary, Telavant, to Roche. The Roche Transaction was made pursuant to a Stock Purchase
Agreement dated October 22, 2023 among us, Telavant, Pfizer and Roche. Telavant was jointly formed by us and Pfizer in November 2022 to develop and commercialize RVT-3101, an anti-TL1A antibody in development for ulcerative colitis (“UC”) and
Crohn’s disease, in the U.S. and Japan. Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer owned the remaining 25%, in each case on an as-converted
basis.
Pursuant to the Stock Purchase Agreement, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the
closing of the Roche Transaction in December 2023, as well as a one-time milestone payment of $150 million in cash, paid in August 2024 following the initiation of a Phase 3 trial in UC. The $7.1 billion in closing consideration and $150
million one-time milestone payment were paid to all of Telavant’s equity holders, including holders of Telavant restricted stock units, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction.
We received an upfront payment of approximately $5.2 billion in cash as our pro rata portion of the consideration upon closing of the Roche Transaction and a one-time milestone payment of approximately $110.4 million as our pro rata portion
of the milestone payment following initiation of a Phase 3 trial in UC.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the discovery efforts, preclinical activities, clinical trials and potential
commercialization of our product candidates. Our operating results, including our net losses, may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials, our expenditures on
other research and development activities and our commercialization efforts. We anticipate that our expenses will increase substantially as we:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | fund the manufacturing of drug substance and drug product of our product candidates in development; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | seek to identify, acquire, develop and commercialize additional product candidates; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | invest in activities related to the discovery of novel drugs and advancement of our internal programs; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | integrate acquired technologies into a comprehensive regulatory and product development strategy; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | maintain, expand and protect our intellectual property portfolio; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | hire scientific, clinical, quality control and administrative personnel; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | add operational, financial and management information systems and personnel, including personnel to support our drug development efforts; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | build out our sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any drug candidates for which we may obtain regulatory approval; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | operate as a public company. |
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While we do not have a need for additional capital to continue our operations as a result of our current cash position, we may in the future require additional capital to fund our operations,
pursue business opportunities or strategic transactions or to respond to challenges, competition or unforeseen circumstances. In that case, until such time, if ever, that we can generate substantial revenues, we may finance future cash needs
through a combination of equity offerings, debt financings, strategic alliances and license and development agreements or other collaborations at Roivant and the Vants. To the extent that we raise additional capital by issuing equity
securities at Roivant or the Vants, our existing shareholders’ ownership, or our ownership in the Vants, may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that could harm the
rights of our shareholders. Additionally, any agreements for future debt or preferred equity financings, if available, may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt,
making capital expenditures or declaring dividends. If we raise additional funds through collaborations or strategic alliances or through marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable
rights to our product candidates, future revenue streams, research programs or technologies or grant licenses on terms that may not be favorable to us. The foregoing restrictions associated with potential sources of additional capital may
make it more difficult for us to raise additional capital, if needed, or to pursue business opportunities, including potential acquisitions.
While we do not have a near-term need for additional capital as a result of our current cash position, we may in the future require additional capital, and if adequate funds are not available
to us in that case, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery programs, scale back marketing efforts for our product candidates or be
unable to expand operations or otherwise capitalize on business opportunities, which could materially affect our business, prospects, financial condition and results of operations.
Finally, as part of our ongoing business strategy we regularly evaluate new acquisition and in-licensing opportunities, as well as our capital structure. We may from time to time use our
existing cash to fund such opportunities or to retire outstanding debt obligations or to return capital to shareholders though share repurchases or the issuance of cash dividends on our common shares to optimize our capital structure. See
“Risk Factors—Risks Related to Our Business and Industry—We face risks associated with acquisitions, divestitures and other strategic transactions.” for more information.
Cash Flows
The following table sets forth a summary of our cash flows for the years ended March 31, 2025, 2024 and 2023:
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | ||||||||||
| (in thousands) | ||||||||||||
| Net cash used in operating activities | $ | (839,451 | ) | $ | (765,268 | ) | $ | (843,393 | ) | |||
| Net cash (used in) provided by investing activities | $ | (1,766,291 | ) | $ | 5,203,623 | $ | (44,269 | ) | ||||
| Net cash (used in) provided by financing activities | $ | (1,219,794 | ) | $ | 419,364 | $ | 499,462 |
Operating Activities
Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash flow from operating
activities is derived from adjusting our net loss for non-cash items and changes in working capital.
For the year ended March 31, 2025, cash used in operating activities increased by $74.2 million to $839.5 million compared to $765.3 million for the year ended March 31, 2024, largely
reflecting greater cash requirements to advance our research and development programs during the year ended March 31, 2025.
For the year ended March 31, 2024, cash used in operating activities decreased by $78.1 million to $765.3 million compared to $843.4 million for the year ended March 31, 2023 due to greater
cash requirements to fund operations during the year ended March 31, 2023.
Investing Activities
For the year ended March 31, 2025, cash flow from investing activities changed by approximately $7.0 billion to net cash used in investing activities of approximately $1.8 billion for the
year ended March 31, 2025 from net cash provided by investing activities of $5.2 billion for the year ended March 31, 2024. This change in cash flow is primarily due to purchases of marketable securities, partially offset by maturities,
during the year ended March 31, 2025 and the proceeds received upon closing of the Roche Transaction during the year ended March 31, 2024.
For the year ended March 31, 2024, cash flow from investing activities changed by $5.2 billion to net cash provided by investing activities of $5.2 billion from net cash used in investing
activities of $44.3 million for the year ended March 31, 2023. This change in cash flow from investing activities is primarily due to proceeds received upon closing of the Roche Transaction during the year ended March 31, 2024.
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Financing Activities
For the year ended March 31, 2025, cash flow from financing activities changed by approximately $1.6 billion to net cash used in financing activities of $1.2 billion for the year ended March
31, 2025 from net cash provided by financing activities of $419.4 million for the year ended March 31, 2024. During the year ended March 31, 2025, net cash used in financing activities was primarily driven by the repurchase of approximately
$1.3 billion of our common shares, partially offset by the issuance of common shares of our majority-owned subsidiary Immunovant. During the year ended March 31, 2024, net proceeds were primarily generated by the issuance of common shares of
our majority-owned subsidiary Immunovant as well as the issuance of our common shares pursuant to purchase and sale agreements entered into with certain institutional investors.
For the year ended March 31, 2024, cash provided by financing activities decreased by $80.1 million to $419.4 million compared to $499.5 million for the year ended March 31, 2023. During the
year ended March 31, 2024, net proceeds were primarily generated by the issuance of common shares of our majority-owned subsidiary Immunovant as well as the issuance of our common shares pursuant to purchase and sale agreements entered with
certain institutional investors. During the year ended March 31, 2023, proceeds were generated by funding pursuant to the terms of the RIPSA following the approval of VTAMA by the FDA in May 2022 as well as net proceeds from the issuance of
our common shares and the common shares of our majority-owned subsidiary Immunovant.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally
accepted accounting principles (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingencies
as of the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our estimates on
historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily
apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts or experience.
Changes in estimates and assumptions are reflected in reported results in the period in which they become known.
We define our critical accounting policies as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a
material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles.
While our significant accounting policies are described in more detail in Note 2, “Summary of Significant Accounting Policies” in our consolidated financial statements included elsewhere in
this Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Accrued Research and Development Expenses, Including Clinical Trial Accruals
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. We record accruals for estimated costs of
research and development activities, including preclinical studies, clinical trials and contract manufacturing, conducted by third-party service providers. Our process for determining such estimates includes reviewing open contracts, vendor
agreements and purchase orders; communicating with our internal personnel and external service providers to understand the progress or stage of completion of services performed on our behalf; and estimating the associated costs for these
services when we have not yet been invoiced. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time.
We recognize expenses related to clinical trials based on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical
trials on our behalf. The financial terms of these agreements are subject to negotiation and vary from contract to contract. This may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the
level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on various factors, including the successful enrollment of patients and the completion of clinical trial milestones.
The majority of our service providers invoice us in arrears based on a pre-determined schedule or when contractual milestones are met. In making these estimates, we consider various factors, including status and timing of services performed,
the number of patients enrolled and the rate of patient enrollment. If the actual timing of the performance of services or the level of effort varies from our estimate, the accrual or prepaid expense is adjusted accordingly.
Other examples of estimated accrued research and development expenses include fees paid to:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| a. | investigative sites in connection with clinical trials; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| b. | vendors in connection with preclinical and clinical development activities; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| c. | CMOs in connection with the production of product and clinical trial materials. |
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Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of
services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, we have not experienced significant changes in our estimates of accrued research and development expenses after a
reporting period.
Valuation of Investment in Datavant
We hold an equity method investment in Datavant, which is a privately-held company. We do not consolidate Datavant as we do not have a controlling financial interest. Our investment in
Datavant is subject to the equity method of accounting, and we have elected the fair value option to continuously remeasure the investment to fair value each reporting period with changes in fair value reflected in earnings. We have engaged
an independent valuation specialist to determine the fair value as of each reporting date.
The fair value of our investment in Datavant uses significant unobservable inputs and is therefore classified as a Level 3 financial
instrument. The estimate of fair value for this investment was determined using the income approach, market approach and implementation of the option pricing method (“OPM”). The income approach is based on the future expected cash flows,
which are derived from certain assumptions attributable to Datavant including estimates of revenue growth rate, earnings before interest, taxes, depreciation and amortization and terminal growth rate. These expected cash flows are then
discounted to their present value using a discount rate that reflects the risk and time value of money. The market approach estimates value by using valuation multiples derived from the stock prices of comparable publicly traded companies
to determine the company’s equity value. The OPM allows for the allocation of a company’s equity value among the various equity capital owners (preferred and common shareholders). The OPM uses the preferred shareholders’ liquidation
preferences, participation rights, dividend policy and conversion rights to determine how proceeds from a liquidity event shall be distributed among the various ownership classes at a future date.
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,” which updates reportable segment disclosure requirements
primarily through enhanced disclosures about significant segment expenses. The amendments are effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024. These
amendments should be applied retrospectively to all prior periods presented in the financial statements. Beginning with this Annual Report on Form 10-K, we adopted this standard which resulted in incremental segment disclosures. Refer to Note
16, “Segment Information” for disclosure of the information required under ASU 2023-07.
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FY 2024 10-K MD&A
SEC filing source: 0001140361-24-028145.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of Roivant’s financial condition and results of operations should be read in conjunction with Roivant’s consolidated
financial statements and notes to those statements included elsewhere in this Annual Report on Form 10-K. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and
uncertainties. Roivant’s actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see “Forward-Looking Statements” and “Risk Factors” in this Annual Report on Form 10-K.
Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31.
Overview
Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s
pipeline is concentrated in inflammation and immunology and includes VTAMA, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; IMVT-1402 and batoclimab, fully human monoclonal
antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; and brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 for the treatment of dermatomyositis and non-infectious
uveitis, in addition to several other therapies in various stages of clinical development. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics,
Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.
Components of Results of Operations
Product revenue, net
With the FDA approval of VTAMA for the treatment of plaque psoriasis in adult patients and our initial product launch in May 2022, we began to recognize product revenues. We record product
revenue net of estimated chargebacks, discounts, rebates, returns, and other allowances associated with the respective sales.
License, milestone and other revenue
License, milestone and other revenue includes the recognition of payments received in connection with license agreements as well as revenue generated by subscription
and service-based fees.
Cost of revenues
We began to recognize cost of product revenues after the initial product launch of VTAMA in May 2022. Cost of product revenues includes the cost of producing and distributing inventories related
to product revenue during the respective period, including manufacturing, freight, and indirect overhead costs. Additionally, milestone payments made in connection with regulatory approvals and sales-based milestones are capitalized and amortized
to cost of revenue over the remaining useful life of the asset. Our cost of revenues also relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting, and
third-party data costs.
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Research and development expenses
Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates. Research and development expenses primarily include
the following:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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. |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Unallocated internal costs, including: |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| ◦ | employee-related expenses, such as salaries, share-based compensation, and benefits, for research and development personnel; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| ◦ | other expenses that are not allocated to a specific program. |
Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we
advance our product candidates and our recently in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates. We expect higher employee-related expenses, including share-based
compensation expenses, as well as higher consulting costs as we hire additional resources to support increasing development activity.
The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the number and scope of preclinical and clinical programs we decide to pursue; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the number of doses that patients receive; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the countries in which the trials are conducted; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to secure and leverage adequate CRO support for the conduct of clinical trials; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to establish an appropriate safety and efficacy profile for our product candidates; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the timing, receipt and terms of any approvals from applicable regulatory authorities; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the potential additional safety monitoring or other studies requested by regulatory agencies; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the significant and changing government regulation and regulatory guidance; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the impact of any business interruptions to our operations due to the COVID-19 pandemic or other epidemics; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to maintain a continued acceptable safety profile of our product candidates following approval of our product candidates. |
The successful development of our product candidates is highly uncertain, and we cannot reasonably estimate the costs that will be necessary to complete the remainder of the development of our
product candidates. In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability.
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Acquired in-process research and development expenses
Acquired in-process research and development (“IPR&D”) expenses include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made
in connection with asset acquisitions and license agreements upon the achievement of development milestones.
Consideration for the purchase of IPR&D through asset acquisitions and license agreements may include cash upfront payments, shares and other liability instruments issued, and the fair value
of future contingent consideration payments.
Selling, general and administrative expenses
Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation, sales incentive compensation, and benefits,
for employees engaged in SG&A activities. SG&A employees include those responsible for the identification and acquisition or in-license of new drug candidates as well as for managing Vant operations and facilitating the use of our
platform and technologies at the Vants. SG&A expenses also consist of marketing programs, advertising, legal and accounting fees, consulting services, and other operating costs relating to corporate matters and daily operations.
We expect SG&A expenses to increase in future periods as we continue to expand our sales and marketing infrastructure and general administrative functions. These increases will likely include
salaries, sales incentive compensation, share-based compensation and travel expenses associated with our sales force, which began promoting VTAMA in the U.S. following approval by the FDA in May 2022, as well as expected costs associated with the
further build out of our commercial operations functions. We anticipate these expenses to further increase if any of our other current or future product candidates receives regulatory approval in the U.S. or another jurisdiction.
Gain on sale of Telavant net assets
Gain on sale of Telavant net assets represents the gain resulting from the sale of our entire equity interest in our majority-owned subsidiary, Telavant Holdings, Inc. (“Telavant”), to Roche
Holdings, Inc. (“Roche”) in December 2023 (the “Roche Transaction”). Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer Inc. owned the remaining 25%, in
each case on an as-converted basis. At closing, we received approximately $5.2 billion in cash. We are also eligible to receive an additional one-time milestone payment of approximately $110 million if the milestone payment condition is
satisfied. Refer to Note 6, “Recent Transactions” of our financial statements for further information regarding the Roche Transaction.
Change in fair value of investments
Change in fair value of investments primarily includes the unrealized loss on equity investments in publicly-traded companies, including Arbutus Biopharma Corporation (“Arbutus”), as well as our
equity investment in Heracles Parent, L.L.C. (“Datavant”). We have elected the fair value option to account for these investments.
Change in fair value of debt and liability instruments
Change in fair value of debt and liability instruments primarily includes the loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities, including
debt issued by a wholly-owned subsidiary of Dermavant Sciences Ltd. (“Dermavant”) to NovaQuest Co-Investment Fund VIII, L.P. (the “NovaQuest Facility”), and other liability instruments, including warrant liabilities, prior to their redemption,
and earn-out share liabilities issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”), a special purpose acquisition company. Refer to Note 15, “Earn-Out Shares, Public
Warrants and Private Placement Warrants” of our financial statements for further information regarding the redemption of our warrants.
Gain on deconsolidation of subsidiaries
Gain on deconsolidation of subsidiaries resulted from the determination that we no longer had a controlling financial interest in certain subsidiaries.
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Interest income
Interest income consists of interest earned on our cash equivalents.
Interest expense
Interest expense results from interest accrued on long-term debt and the amortization of debt discount and issuance costs.
Income tax expense
Income tax expense is recorded for the jurisdictions in which we do business. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences
between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which
those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is
recorded when, after consideration of all positive and negative evidence, it is not more likely than not that our deferred tax assets will be realizable. When uncertain tax positions exist, we recognize the tax benefit of tax positions to the
extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available
facts and circumstances.
Net loss attributable to noncontrolling interests
Net loss attributable to noncontrolling interests consists of the portion of net loss of those consolidated entities that is not allocated to us. Changes in the amount of net loss attributable to
noncontrolling interests are directly impacted by the net loss of our consolidated entities and changes in ownership percentages.
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Results of Operations
Comparison of the years ended March 31, 2024 and 2023
The following table sets forth our results of operations for the years ended March 31, 2024 and 2023:
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Revenues: | ||||||||||||
| Product revenue, net | $ | 75,057 | $ | 28,011 | $ | 47,046 | ||||||
| License, milestone and other revenue | 49,738 | 33,269 | 16,469 | |||||||||
| Revenue, net | 124,795 | 61,280 | $ | 63,515 | ||||||||
| Operating expenses: | ||||||||||||
| Cost of revenues | 15,560 | 13,128 | 2,432 | |||||||||
| Research and development | 501,736 | 525,215 | (23,479 | ) | ||||||||
| Acquired in-process research and development | 26,450 | 97,749 | (71,299 | ) | ||||||||
| Selling, general and administrative | 687,443 | 600,506 | 86,937 | |||||||||
| Total operating expenses | 1,231,189 | 1,236,598 | (5,409 | ) | ||||||||
| Gain on sale of Telavant net assets | 5,348,410 | — | 5,348,410 | |||||||||
| Income (loss) from operations | 4,242,016 | (1,175,318 | ) | 5,417,334 | ||||||||
| Change in fair value of investments | 47,973 | 20,815 | 27,158 | |||||||||
| Change in fair value of debt and liability instruments | 78,943 | 78,001 | 942 | |||||||||
| Gain on deconsolidation of subsidiaries | (32,772 | ) | (29,276 | ) | (3,496 | ) | ||||||
| Interest income | (146,425 | ) | (32,184 | ) | (114,241 | ) | ||||||
| Interest expense | 34,778 | 27,968 | 6,810 | |||||||||
| Other expense (income), net | 6,089 | (15,808 | ) | 21,897 | ||||||||
| Income (loss) from continuing operations before income taxes | 4,253,430 | (1,224,834 | ) | 5,478,264 | ||||||||
| Income tax expense | 22,224 | 5,190 | 17,034 | |||||||||
| Income (loss) from continuing operations, net of tax | 4,231,206 | (1,230,024 | ) | 5,461,230 | ||||||||
| Income from discontinued operations, net of tax | — | 114,561 | (114,561 | ) | ||||||||
| Net income (loss) | 4,231,206 | (1,115,463 | ) | 5,346,669 | ||||||||
| Net loss attributable to noncontrolling interests | (117,720 | ) | (106,433 | ) | (11,287 | ) | ||||||
| Net income (loss) attributable to Roivant Sciences Ltd. | $ | 4,348,926 | $ | (1,009,030 | ) | $ | 5,357,956 |
Variance analysis for years ended March 31, 2024 and 2023
Product revenue, net
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | |||||||||
| (in thousands) | |||||||||||
| Product revenue, net | $ | 75,057 | $ | 28,011 | $ | 47,046 |
Product revenue, net increased by $47.0 million to $75.1 million for the year ended March 31, 2024, compared to $28.0 million for the year ended March 31, 2023, primarily due to
higher units sold. Product revenue, net consists of net product revenues from VTAMA sales, following the approval of VTAMA for the treatment of plaque psoriasis in adult patients by the FDA in May 2022.
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License, milestone and other revenue
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | |||||||||
| (in thousands) | |||||||||||
| License, milestone and other revenue | $ | 49,738 | $ | 33,269 | $ | 16,469 |
License, milestone and other revenue increased by $16.5 million to $49.7 million for the year ended March 31, 2024, compared to $33.3 million for the year ended March 31, 2023.
The increase was primarily driven by $15.0 million of revenue relating to milestone income at Dermavant pursuant to a collaboration and license agreement with Japan Tobacco Inc. during the year ended March 31,
2024.
Cost of revenues
For the years ended March 31, 2024 and 2023, our cost of revenues consisted of the following:
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | |||||||||
| (in thousands) | |||||||||||
| Cost of product and other revenues | $ | 5,928 | $ | 5,660 | $ | 268 | |||||
| Amortization of intangible assets | 9,632 | 7,468 | 2,164 | ||||||||
| Cost of revenues | $ | 15,560 | $ | 13,128 | $ | 2,432 |
Cost of revenues increased by $2.4 million to $15.6 million for the year ended March 31, 2024, compared to $13.1 million for the year ended March 31, 2023. During the year ended March 31,
2024 and 2023, cost of revenues included $3.4 million and $1.8 million, respectively, of costs relating to VTAMA sales. Cost of revenues additionally included amortization expense recognized in
connection with milestones capitalized following the FDA approval of VTAMA in May 2022.
Research and development expenses
For the years ended March 31, 2024 and 2023, our research and development expenses consisted of the
following:
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023(1) | Change | ||||||||||
| (in thousands) | ||||||||||||
| Program-specific costs: | ||||||||||||
| Batoclimab(1) | $ | 74,265 | $ | 78,477 | $ | (4,212 | ) | |||||
| IMVT-1402(1) | 43,102 | 10,270 | 32,832 | |||||||||
| Brepocitinib | 38,563 | 38,627 | (64 | ) | ||||||||
| RVT-3101 | 35,129 | 7,559 | 27,570 | |||||||||
| Tapinarof | 34,256 | 45,201 | (10,945 | ) | ||||||||
| Namilumab | 13,236 | 11,757 | 1,479 | |||||||||
| RVT-2001 | 10,132 | 16,075 | (5,943 | ) | ||||||||
| Other development and discovery programs | 39,767 | 122,877 | (83,110 | ) | ||||||||
| Total program-specific costs | 288,450 | 330,843 | (42,393 | ) | ||||||||
| Unallocated internal costs: | ||||||||||||
| Share-based compensation | 34,595 | 30,914 | 3,681 | |||||||||
| Personnel-related expenses | 136,425 | 131,908 | 4,517 | |||||||||
| Other expenses | 42,266 | 31,550 | 10,716 | |||||||||
| Total research and development expenses | $ | 501,736 | $ | 525,215 | $ | (23,479 | ) |
| Column 1 | Column 2 |
|---|---|
| (1) | Certain prior period amounts have been reclassified to conform to current period presentation. |
Research and development expenses decreased by $23.5 million to $501.7 million for the year ended March 31, 2024, compared to $525.2 million for the year ended March 31, 2023, primarily due to a decrease in
program-specific costs of $42.4 million, partially offset by increases in other expenses of $10.7 million, personnel-related expenses of $4.5 million, and share-based compensation of $3.7 million.
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The decrease of $42.4 million in program-specific costs was primarily driven by a decrease of $83.1 million
in other development and discovery program expense, which in part resulted from the deconsolidation of Proteovant Sciences, Inc. (“Proteovant”) in August 2023 along with the reprioritization of certain programs and drug discovery efforts. This
decrease was partially offset by increases of $32.8 million relating to IMVT-1402 and $27.6 million relating to RVT-3101, which was acquired in November 2022.
The rights to further develop and manufacture RVT-3101 were sold to Roche in December 2023.
Acquired in-process research and development expenses
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Consideration for the purchase of IPR&D | $ | 13,950 | $ | 87,749 | $ | (73,799 | ) | |||||
| Development milestone payments | 12,500 | 10,000 | 2,500 | |||||||||
| Total acquired in-process research and development expenses | $ | 26,450 | $ | 97,749 | $ | (71,299 | ) |
Acquired in-process research and development expenses decreased by $71.3 million to $26.5 million for the
year ended March 31, 2024, compared to $97.7 million for the year ended March 31, 2023. The decrease was primarily
due to higher consideration for the purchase of IPR&D during the year ended March 31, 2023 as a result of consideration for the purchase of IPR&D of $87.7 million relating to the acquisition of
RVT-3101 in November 2022 and the achievement of a development milestone relating to batoclimab, which resulted in a one-time milestone expense of $10.0 million. Acquired in-process research and development expenses for the year ended March 31, 2024 was driven by $14.0 million of consideration for the purchase of IPR&D relating to an asset acquisition completed by a newly-formed subsidiary and $12.5 million relating to the achievement
of development and regulatory milestones for batoclimab.
Selling, general and administrative expenses
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | |||||||||
| (in thousands) | |||||||||||
| Selling, general and administrative | $ | 687,443 | $ | 600,506 | $ | 86,937 |
Selling, general and administrative expenses increased by $86.9 million to $687.4 million for the year ended
March 31, 2024, compared to $600.5 million for the year ended March 31, 2023. The increase was primarily due to an
increase in selling, general and administrative expenses of $55.7 million at Dermavant as a result of the progression of the commercial launch of VTAMA and an increase in personnel-related expenses of $25.1 million, primarily as a result of a
special one-time cash retention bonus award granted to employees.
Gain on sale of Telavant net assets
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | |||||||||
| (in thousands) | |||||||||||
| Gain on sale of Telavant net assets | $ | 5,348,410 | $ | — | $ | 5,348,410 |
Gain on sale of Telavant net assets was approximately $5.3 billion for the year ended March 31, 2024 and
resulted from the sale of our entire equity interest in Telavant to Roche in December 2023. At closing, we received approximately $5.2 billion in cash for our pro rata portion of the consideration. Additionally, we derecognized the carrying
amount of noncontrolling interest in Telavant of $87.5 million and transferred net liabilities of $26.5 million. This resulted in a gain of approximately $5.3 billion. Refer to Note 6, “Recent
Transactions” of our audited financial statements for further information regarding the Roche Transaction.
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Change in fair value of investments
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | |||||||||
| (in thousands) | |||||||||||
| Change in fair value of investments | $ | 47,973 | $ | 20,815 | $ | 27,158 |
Change in fair value of investments were unrealized losses of $48.0 million and $20.8 million for the years
ended March 31, 2024 and 2023, respectively. The change of $27.2 million was primarily driven by changes in the public share prices of our equity investments,
including Arbutus, as well as the change in fair value of our investment in Datavant.
Change in fair value of debt and liability instruments
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | |||||||||
| (in thousands) | |||||||||||
| Change in fair value of debt and liability instruments | $ | 78,943 | $ | 78,001 | $ | 942 |
Change in fair value of debt and liability instruments were losses of $78.9 million and $78.0 million for the
years ended March 31, 2024 and 2023, respectively. Change in fair value of debt and liability instruments for the year ended March
31, 2024 primarily consisted of a loss of $46.1 million relating to the warrant and earn-out share liabilities issued as part of the Business Combination and a loss of $32.1 million relating to the NovaQuest Facility, which was largely
due to the passage of time and increased probabilities of success as a result of advancement in the stage of development of the product candidate. Change in fair value of debt and liability instruments for the year ended March 31, 2023 primarily consisted of a loss of $59.6 million relating to the NovaQuest facility, which was primarily due to the impact of VTAMA approval in psoriasis, and a loss of $24.1 million relating to the warrant
and earn-out share liabilities issued as part of the Business Combination.
Gain on deconsolidation of subsidiaries
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Gain on deconsolidation of subsidiaries | $ | (32,772 | ) | $ | (29,276 | ) | $ | (3,496 | ) |
Gain on deconsolidation of subsidiaries was $32.8 million for the year ended March 31, 2024 and resulted from
the deconsolidation of certain subsidiaries, including VantAI Holdings, Inc. (“VantAI”) in July 2023 and Proteovant in August 2023.
Gain on deconsolidation of subsidiaries was $29.3 million for the year ended March 31, 2023 and resulted from
the deconsolidation of certain subsidiaries in November 2022 and July 2022.
Interest income
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Interest income | $ | (146,425 | ) | $ | (32,184 | ) | $ | (114,241 | ) |
Interest income increased by $114.2 million to $146.4 million for the year ended March 31, 2024, compared to $32.2 million for the year ended March 31, 2023. This increase is primarily due to higher cash balances in our
interest-bearing cash accounts as well as higher interest rates.
Interest expense
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | |||||||||
| (in thousands) | |||||||||||
| Interest expense | $ | 34,778 | $ | 27,968 | $ | 6,810 |
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Interest expense increased by $6.8 million to $34.8 million for the year ended March 31, 2024, compared to $28.0 million for the year ended March 31, 2023. The increase primarily resulted from Dermavant’s revenue interest
purchase and sale agreement (the “RIPSA”), pursuant to which funding of $160.0 million was received in June 2022 following the approval of VTAMA by the FDA in May 2022.
Income from discontinued operations, net of tax
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Income from discontinued operations, net of tax | $ | — | $ | 114,561 | $ | (114,561 | ) |
Income from discontinued operations, net of tax was $114.6 million for the year ended March 31, 2023 and
resulted from the gain on sale of common shares of Myovant Sciences Ltd. (the “Myovant Top-Up Shares”) after Sumitovant Biopharma Ltd.’s (“Sumitovant”) acquisition of Myovant Sciences Ltd. (“Myovant”) in March 2023. We were entitled to the
Myovant Top-Up Shares pursuant to the December 2019 transaction with Sumitomo Pharma Co., Ltd. (the “Sumitomo Transaction”) that included, among other things, the transfer of our ownership interest in five Vants to Sumitovant. The Sumitomo
Transaction was presented as discontinued operations during the year ending March 31, 2020, and the right to receive the Myovant Top-Up Shares was treated as a contingent consideration upon a sale of the business and accounted for as a gain
contingency. Refer to Note 9, “Discontinued Operations” of our audited financial statements for additional information.
Liquidity and Capital Resources
For the years ended March 31, 2024 and 2023, we had income from continuing operations of approximately $4.2 billion and incurred a loss from continuing operations of approximately $1.2 billion, respectively. As of March 31, 2024,
we had cash and cash equivalents of approximately $6.5 billion and our retained earnings was approximately $576.2 million. Through our subsidiary Dermavant, we launched our first commercial product, VTAMA, following approval by the FDA in May
2022. We began generating product revenue, net from sales of VTAMA in the U.S. in May 2022. We also have generated revenue through license agreements as well as from subscription and service-based fees.
Our short-term and long-term liquidity requirements as of March 31, 2024 included:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | contractual payments related to our long-term debt (see Note 8, “Long-Term Debt” and Note 18, “Subsequent Events” of our audited financial statements); |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | obligations under our leases (see Note 13, “Leases” of our audited financial statements); |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | certain commitments to Samsung Biologics Co., Ltd. (“Samsung”) pursuant to a Product Service Agreement entered between Immunovant and Samsung by which Samsung will manufacture and supply Immunovant with batoclimab drug substance for commercial sale and perform other manufacturing-related services with respect to batoclimab. Immunovant had the right to terminate the PSA with 30 days’ written notice to Samsung, exercisable no later than January 2024, in the event Immunovant decided to stop all development of, and all attempts to obtain regulatory approval for, batoclimab; subject to payment to Samsung of non-cancelable service fees and costs incurred by Samsung for all batches of batoclimab scheduled to be manufactured during the two-year period following such termination. Because efforts to develop and obtain regulatory approval for batoclimab remain ongoing, Immunovant did not exercise that early termination right and it has lapsed. As a result, Immunovant has an additional minimum obligation to purchase additional batches of batoclimab in the four-year period of 2026 through 2029. As of March 31, 2024, the remaining minimum purchase commitment related to this agreement was estimated to be approximately $46.2 million; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | certain commitments to GSK pursuant to a commercial supply agreement entered between Dermavant and GSK. In conjunction with Dermavant’s entry into the GSK Agreement in 2018, Dermavant entered into a clinical supply agreement pursuant to which GSK would provide a supply of tapinarof and clinical product at an agreed upon price during our clinical trials. In April 2019, Dermavant entered into a commercial supply agreement with GSK to continue to provide certain quantities of tapinarof and commercial product at agreed upon minimum quantities and prices. The commercial supply agreement commenced in April 2022 upon completion of certain quality and regulatory conditions. In July 2022, Dermavant and GSK amended the terms of the clinical supply and commercial supply agreements which released GSK of certain commitments to supply tapinarof and released Dermavant of certain commitments to purchase tapinarof in exchange for a supplementary fee. Other supply and purchase commitments under the agreements remain in effect. In addition, Dermavant and Thermo Fisher Scientific (“TFS”) entered into a Commercial Manufacturing and Supply Agreement for which TFS agreed to provide a supply of tapinarof to Dermavant at an agreed upon price. The agreements discussed above require Dermavant to purchase certain quantities of inventory over a period of five years. The minimum purchase commitment related to these agreements was estimated to be approximately $33.3 million. |
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The above purchase commitments do not represent all of our anticipated purchases, but instead represent only the contractually obligated minimum purchases or firm commitments of non-cancelable
minimum amounts.
Additionally, we have certain payment obligations under various asset acquisition and license agreements. Under these agreements we are required to make milestone payments upon successful
completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events, such as our achievement of specified
development, regulatory and commercial milestones, and the amount, timing, and likelihood of such payments are not known. We will also be required to make milestone payments and royalty payments in connection with the sale of products developed
under these agreements.
Potential material future milestone payments as of March 31, 2024 pursuant to certain key asset acquisition and license
agreements are as follows:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | VTAMA/tapinarof (Dermavant): up to CAD$75.0 million in remaining commercial milestones to Welichem Biotech Inc., with CAD$35.0 million payable upon VTAMA first U.S. commercial sale for atopic dermatitis and the remainder payable as first commercial sales are achieved in various countries outside of the U.S. Additional milestones are owed to NovaQuest pursuant to the NovaQuest Agreement. Refer to Note 8, “Long-Term Debt” and Note 18, "Subsequent Events" of our audited financials for further information. |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Anti-FcRn franchise (Immunovant): up to a maximum of $420.0 million to HanAll Biopharma Co., Ltd. upon the achievement of certain development, regulatory and sales milestone events. |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Brepocitinib (Priovant Therapeutics, Inc.): mid tens-of-millions sales milestone payment to Pfizer if aggregate net sales in a given year exceed a mid-hundred-of-millions amount. |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Namilumab (Kinevant Ltd.): up to approximately $40 million to the prior shareholders of Izana Biosciences Limited upon the achievement of certain milestones. |
Royalties are also due on net sales pursuant to these agreements. The Company has further commitments not reflected above
relating to other asset acquisition and license agreements entered and expects to enter into additional asset acquisition and license agreements in the future, which may require upfront payments and long-term commitments of capital resources.
We enter into agreements in the normal course of business with CROs and other vendors for clinical trials and with vendors for preclinical studies and other services and products for operating
purposes, which are generally cancelable upon written notice.
Our board of directors has authorized a common share repurchase program, allowing for repurchases of common shares in an aggregate amount of up to $1.5 billion (excluding fees and expenses). The
repurchase program is funded by available cash and cash equivalents on hand and does not have an expiration date. Pursuant to the share repurchase program, on April 2, 2024, we entered into a share repurchase agreement with Sumitomo to repurchase
all 71,251,083 common shares held by Sumitomo at a purchase price per share of $9.10, for an aggregate purchase price of approximately $648.4 million. The repurchase transaction with Sumitomo was completed on April 2, 2024.
Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration
arrangements.
RSL Equity Financing Transactions
Since inception, we have completed multiple equity financing transactions, including the following:
In December 2019, together with Sumitomo Pharma Co., Ltd. (“Sumitomo”), we completed the transactions contemplated by the transaction agreement by and between us and Sumitomo, dated as of October
31, 2019. In connection with the Sumitomo Transaction, we raised net proceeds of approximately $999.2 million due to the sale of our common shares to Sumitomo.
In September 2021, we completed our Business Combination with MAAC, a special purpose acquisition company, as well as entered into subscription agreements with certain investors, whereby we
issued 22,000,000 of our common shares at $10.00 per share for an aggregate purchase price of $220.0 million (the “PIPE Financing”). In connection with the Business Combination and PIPE Financing, we received approximately $213.4 million in cash
at closing.
In September 2022, we entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”) to sell our common shares having an aggregate offering price of up to $400.0
million from time to time through an “at-the-market” equity offering program under which Cowen acts as our agent (the “ATM Facility”). As of March 31, 2024, we had $400.0 million of remaining capacity available under the ATM Facility.
In November 2022, we completed an underwritten primary and secondary public offering of 30,000,000 of our common shares at a price to the public of $5.00 per share. Of these common shares,
20,000,000 were sold by us and 10,000,000 were sold by certain selling shareholders. Net proceeds to us were approximately $94.7 million after deducting underwriting discounts and commissions and offering expenses. We did not receive any proceeds
from the sale of common shares by the selling shareholders in the offering.
In February 2023, we completed an underwritten public offering of 30,666,665 of our common shares (including 3,999,999 common shares issued and sold upon the full exercise of the underwriters’
option to purchase additional shares) at a price to the public of $7.50 per share. Net proceeds to us were approximately $216.9 million after deducting underwriting discounts and commissions and offering expenses.
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In September 2023, we entered into common share purchase and sale agreements with certain institutional investors, pursuant to which we sold an aggregate
of 19,600,685 of our common shares at a purchase price of $10.21 per share. Net proceeds to us were approximately $199.8 million after deducting offering expenses.
Sumitomo Transaction
In December 2019, we closed the Sumitomo Transaction, including the transfer of our ownership interest in five Vants – Myovant, Urovant Sciences Ltd., Enzyvant Therapeutics Ltd., Altavant
Sciences Ltd., and Spirovant Sciences Ltd. – to Sumitovant, a wholly-owned subsidiary of Sumitomo. In addition, in connection with the Sumitomo Transaction, we (i) granted Sumitomo options to purchase all, or in the case of Dermavant, 75%, of our
ownership interests in six other subsidiaries and (ii) provided Sumitomo and Sumitovant with certain rights over and access to our proprietary technology platforms, DrugOme and Digital Innovation. In exchange for these components of the Sumitomo
Transaction, we received approximately $1.9 billion in cash, which was in addition to the approximately $999.2 million from the sale of our common shares to Sumitomo as discussed above.
In June 2021, we completed a transaction with Sumitomo pursuant to which Sumitomo terminated its existing options to acquire our equity interests in certain of our subsidiaries.
In October 2022, Myovant entered into an agreement with Sumitovant, its majority shareholder, under which Sumitovant would acquire the remaining shares of Myovant not already owned by Sumitovant
at a price of $27.00 per share in a cash transaction (the “Myovant Transaction”). The acquisition of Myovant by Sumitovant was completed in March 2023. In connection with the closing of the Myovant Transaction, we received approximately $114.6
million in March 2023 for the sale of the Myovant Top-Up Shares. Refer to Note 9, “Discontinued Operations” of our audited financial statements for additional information.
Consolidated Vant Equity Financing Transactions
Since inception, we have completed multiple Vant equity financing transactions, including the following:
Immunovant
In December 2019, Immunovant raised $111.0 million (including $5.1 million related to common shares purchased by us) through a business combination with Health Sciences Acquisition Corporation, a
special purpose acquisition company.
During the years ended March 31, 2021 and 2020, Immunovant issued shares of common stock for an aggregate net proceeds of $384.9 million (including an aggregate of $27.5 million of shares of
common stock purchased by us) in private financings, underwritten public offerings, and warrant exercises.
In October 2022, Immunovant completed an underwritten public offering of 12,500,000 shares of its common stock (including 416,667 shares of common stock purchased by us) at a price to the public
of $6.00 per share, for net proceeds to Immunovant of approximately $70.2 million after deducting underwriting discounts and commissions and offering expenses.
In October 2023, Immunovant completed an underwritten public offering of 8,475,500 shares of its common stock (including 1,526,316 shares of common stock purchased by us on the same terms as
other investors in the offering and the full exercise of the underwriters’ option to purchase 1,105,500 additional shares of common stock) at a price to the public of $38.00 per share. Concurrent with the public offering, we purchased 4,473,684
shares of Immunovant’s common stock in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, at the same price per share as investors in the public offering of $38.00 per share. The net proceeds
to Immunovant were approximately $466.7 million after deducting underwriting discounts and commissions, placement agent fees and offering expenses.
Consolidated Vant Debt Financings
Since inception, we have completed multiple Vant debt financings, including the following:
Dermavant
In May 2019, Dermavant entered into a loan and security agreement (the “Hercules Loan Agreement”) with Hercules, pursuant to which Dermavant borrowed an aggregate of $20.0 million. In May 2021,
all amounts outstanding under the Hercules Loan Agreement were repaid using the proceeds from the $40.0 million senior secured credit facility (the "Credit Facility") entered into by Dermavant with XYQ Luxco S.A.R.L (“XYQ Luxco”), as lender, and
U.S. Bank National Association, as collateral agent, in May 2021, and Dermavant terminated the Hercules Loan Agreement.
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Following the approval of VTAMA by the FDA in May 2022, Dermavant received $160.0 million in June 2022 pursuant to the terms of the RIPSA entered with XYQ Luxco, NovaQuest Co-Investment Fund
XVII, L.P., an affiliate of NovaQuest Capital Management, LLC, and MAM Tapir Lender, LLC, an affiliate of Marathon Asset Management, L.P., together with U.S. Bank National Association, as collateral agent. Under the terms of the RIPSA, Dermavant
is obligated to pay royalties based on a capped single-digit revenue interest in net sales of tapinarof for all dermatological indications in the U.S., up to a cap of $344.0 million, in exchange for the $160.0 million in committed funding to be
paid to Dermavant, conditioned on the approval of tapinarof by the FDA, which was achieved in May 2022. Dermavant used the RIPSA proceeds primarily for the milestone obligations to GSK, which was achieved upon FDA approval, and Welichem Biotech
Inc., which was achieved upon the first sale of VTAMA.
On May 24, 2024, Dermavant entered into amendments to (i) the NovaQuest Agreement, (ii) the Credit Facility, and (iii)
the RIPSA. Refer to Note 18, “Subsequent Events” of our audited consolidated financial statements for details regarding the amendments.
Other
Datavant
In July 2021, we received approximately $320 million in cash as a result of the Datavant Merger.
Proteovant
In August 2023, we completed a transaction with SK Biopharmaceuticals Co., Ltd. (“SK Bio”), a subsidiary of SK, Inc., pursuant to which SK Bio purchased all of our shares in Proteovant in
exchange for $47.5 million.
Telavant
In December 2023, we completed the sale of our entire equity interest in our majority-owned subsidiary, Telavant, to Roche. The Roche Transaction was made pursuant to a Stock Purchase Agreement
dated October 22, 2023 among us, Telavant, Pfizer Inc. (“Pfizer”), and Roche. Telavant was jointly formed by us and Pfizer in November 2022 to develop and commercialize RVT-3101, an anti-TL1A antibody in development for ulcerative colitis (“UC”)
and Crohn’s disease, in the U.S. and Japan. Prior to the Roche Transaction, we held 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, and Pfizer owned the remaining 25%, in each case on an as-converted
basis.
Pursuant to the Stock Purchase Agreement, Roche acquired all of the issued and outstanding shares of capital stock of Telavant in exchange for approximately $7.1 billion in cash at the closing of
the Roche Transaction and a one-time milestone payment of $150 million in cash payable upon the initiation of a Phase 3 trial in UC. The $7.1 billion in closing consideration was paid to all of Telavant’s equity holders, including holders of
restricted stock units, on a pro rata basis relative to their ownership of Telavant prior to the closing of the Roche Transaction, and this same treatment will be applied to the one-time milestone payment. We received an upfront payment of
approximately $5.2 billion in cash as our pro rata portion of the consideration upon closing of the Roche Transaction. Additionally, we are eligible to receive approximately $110 million for our pro rata portion of the one-time milestone payment
if the milestone payment condition is satisfied.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the discovery efforts, preclinical activities, clinical trials and potential
commercialization of our product candidates. Additionally, we expect to incur significant commercialization expenses with respect to VTAMA. Our operating results, including our net losses, may fluctuate significantly from quarter-to-quarter and
year-to-year, depending on the timing of our planned clinical trials, our expenditures on other research and development activities and our commercialization efforts. We anticipate that our expenses will increase substantially as we:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | fund the manufacturing of drug substance and drug product of our product candidates in development; |
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| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | seek to identify, acquire, develop and commercialize additional product candidates; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | invest in activities related to the discovery of novel drugs and advancement of our internal programs; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | integrate acquired technologies into a comprehensive regulatory and product development strategy; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | maintain, expand and protect our intellectual property portfolio; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | hire scientific, clinical, quality control and administrative personnel; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | add operational, financial and management information systems and personnel, including personnel to support our drug development efforts; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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 |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | operate as a public company. |
In the future, we may require significant additional capital to continue our operations, pursue business opportunities or strategic transactions, or respond to challenges, competition or
unforeseen circumstances. Until such time, if ever, that we can generate substantial revenues, we may finance future cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements
or other collaborations at Roivant and the Vants. To the extent that we raise additional capital by issuing equity securities at Roivant or the Vants, our existing shareholders’ ownership, or our ownership in the Vants, may experience substantial
dilution, and the terms of these securities may include liquidation or other preferences that could harm the rights of our shareholders. Additionally, any agreements for future debt or preferred equity financings, if available, may involve
covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing,
distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our products and product candidates, future revenue streams, research programs or technologies or grant licenses on terms that may not be
favorable to us. The foregoing restrictions associated with potential sources of additional capital may make it more difficult for us to raise additional capital or to pursue business opportunities, including potential acquisitions.
If adequate funds are not available to us, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery
programs, scale back marketing efforts for our current and future products or be unable to expand operations or otherwise capitalize on business opportunities, which could materially affect our business, prospects, financial condition and results
of operations.
Finally, as part of our ongoing business strategy we regularly evaluate new acquisition and in-licensing opportunities as well as our capital structure. We may from time to time use our existing
cash to fund such opportunities or to retire outstanding debt obligations or to return capital to shareholders though share repurchases or the issuance of cash dividends on our common shares to optimize our capital structure. See “Risk Factors—Risks Related to Our Business and Industry—We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management” for more
information.
Cash Flows
The following table sets forth a summary of our cash flows for the years ended March 31, 2024 and 2023:
| Years Ended March 31, | ||||||||
|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | |||||||
| (in thousands) | ||||||||
| Net cash used in operating activities | $ | (765,268 | ) | $ | (843,393 | ) | ||
| Net cash provided by (used in) investing activities | $ | 5,203,623 | $ | (44,269 | ) | |||
| Net cash provided by financing activities | $ | 419,364 | $ | 499,462 |
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Operating Activities
Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash flow from operating
activities is derived from adjusting our net loss for non-cash items and changes in working capital.
For the year ended March 31, 2024, cash used in operating activities decreased by $78.1 million to $765.3 million compared to the year ended March 31, 2023 due
to greater cash requirements to fund operations during the year ended March 31, 2023.
Investing Activities
Cash flow from investing activities includes proceeds from sale of Telavant net assets, milestone payments, cash decreases upon deconsolidation of subsidiaries, proceeds from sale of subsidiary
interests and other equity interests, and purchase of property and equipment.
For the year ended March 31, 2024, cash flow from investing activities changed by $5.2 billion to net cash
provided by investing activities of $5.2 billion from net cash used in investing activities of $44.3 million for the year ended March 31, 2023. This change in cash flow from investing activities is primarily due to proceeds received upon closing of the Roche Transaction during the year ended March 31, 2024.
Financing Activities
For the year ended March 31, 2024, cash provided by financing activities decreased by $80.1 million to $419.4 million compared to the year ended March 31, 2023. During the year ended March 31, 2024, net proceeds were
primarily generated by the issuance of common shares of our majority-owned subsidiary Immunovant as well as the issuance of our common shares pursuant to purchase and sale agreements entered with certain institutional investors. During the year
ended March 31, 2023, proceeds were generated by funding pursuant to the terms of the RIPSA following the approval of VTAMA by the FDA in May 2022 as well as net proceeds from the issuance of our common
shares and the common shares of our majority-owned subsidiary Immunovant.
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Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally
accepted accounting principles (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingencies as
of the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our estimates on
historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent
from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, or experience. Changes in
estimates and assumptions are reflected in reported results in the period in which they become known.
We define our critical accounting policies as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material
impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles.
While our significant accounting policies are described in more detail in Note 2, “Summary of Significant Accounting Policies” in our consolidated financial statements included elsewhere in this
Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Product Revenue Reserves
We recognize revenue when the customer obtains control of the product, which occurs at a point in time, either upon shipment or delivery to the customer. Revenues from product sales are recorded
at the net sales price, which includes estimates of variable consideration for which reserves are established that result from (a) invoice discounts for prompt payment and specialty distributor and specialty pharmacy service fees, (b) government
and private payer rebates, chargebacks, discounts and fees, (c) performance rebates and administrative fees, (d) product returns and (e) costs of co-pay assistance programs for patients. We establish reserves based on these gross-to-net
adjustments, which are based on amounts earned or to be claimed on the related sale and are classified as reductions of accounts receivable (if the amount is payable to the customer) or accrued expenses and other current liabilities (if the
amount is payable to a party other than a customer). Where appropriate, we utilize the expected value method to determine the appropriate amount for estimates of variable consideration. The estimates of reserves established for variable
consideration reflect current contractual and statutory requirements, our historical experience, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount of variable consideration that
is included in the transaction price may be constrained and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future
period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results vary from our estimates, we adjust these estimates in the period such change in estimate becomes known, which could affect net product
revenue and earnings in the period of the adjustment.
We make significant estimates and judgments that materially affect our recognition of net product revenue. Claims by third-party payors for rebates, chargebacks and discounts may be submitted to
us significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known. We will adjust our estimates based on new information, including information regarding actual rebates,
chargebacks and discounts for our products, as it becomes available.
The following table provides a summary of activity with respect to our sales allowances and accruals (in thousands):
| March 31, 2024 | March 31, 2023 | |||||||
|---|---|---|---|---|---|---|---|---|
| Sales return, rebate, and discounts balances, beginning of year | $ | (20,794 | ) | $ | — | |||
| Reduction of gross sales | (207,372 | ) | (129,717 | ) | ||||
| Cash payments | 199,151 | 108,923 | ||||||
| Sales return, rebate and discounts balances, end of year | $ | (29,015 | ) | $ | (20,794 | ) |
Accrued Research and Development Expenses, Including Clinical Trial Accruals
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. We record accruals for estimated costs of
research and development activities, including preclinical studies, clinical trials, and contract manufacturing, conducted by third-party service providers. Our process for determining such estimates includes reviewing open contracts, vendor
agreements, and purchase orders; communicating with our internal personnel and external service providers to understand the progress or stage of completion of services performed on our behalf; and estimating the associated costs for these
services when we have not yet been invoiced. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time.
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We recognize expenses related to clinical trials based on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical
trials on our behalf. The financial terms of these agreements are subject to negotiation and vary from contract to contract. This may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the
level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on various factors, including the successful enrollment of patients and the completion of clinical trial milestones. The
majority of our service providers invoice us in arrears based on a pre-determined schedule or when contractual milestones are met. In making these estimates, we consider various factors, including status and timing of services performed, the
number of patients enrolled, and the rate of patient enrollment. If the actual timing of the performance of services or the level of effort varies from our estimate, the accrual or prepaid expense is adjusted accordingly.
Other examples of estimated accrued research and development expenses include fees paid to:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| a. | investigative sites in connection with clinical trials; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| b. | vendors in connection with preclinical and clinical development activities; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| c. | CMOs in connection with the production of product and clinical trial materials. |
Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status
and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, we have not experienced significant changes in our estimates of accrued research and development
expenses after a reporting period.
Valuation of Investment in Datavant
We hold an equity method investment in Datavant, which is a privately-held company. We do not consolidate Datavant as we do not have a controlling financial interest. Our investment in Datavant
is subject to the equity method of accounting, and we have elected the fair value option to continuously remeasure the investment to fair value each reporting period with changes in fair value reflected
in earnings. We have engaged an independent valuation specialist to determine the fair value as of each reporting date.
The fair value of our investment in Datavant uses significant unobservable inputs and is therefore classified as a Level 3 financial instrument. The estimate of fair value for this investment was
determined using the income approach and implementation of the option pricing method (“OPM”). The OPM allows for the allocation of a company’s equity value among the various equity capital owners (preferred and common
shareholders). The OPM uses the preferred shareholders’ liquidation preferences, participation rights, dividend policy, and conversion rights to determine how proceeds from a liquidity event shall be distributed among the various ownership
classes at a future date.
Recently Adopted Accounting Pronouncements
We did not adopt any material accounting pronouncements during the year ended March 31, 2024.
FY 2023 10-K MD&A
SEC filing source: 0001140361-23-031798.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of Roivant’s financial condition and results of operations should be read in conjunction with Roivant’s consolidated financial
statements and notes to those statements included elsewhere in this Annual Report on Form 10-K. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and
uncertainties. Roivant’s actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see “Forward-Looking Statements” and “Risk Factors” in this Annual Report on Form
10-K. Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31.
Overview
Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the
development and commercialization of medicines that matter. Today, Roivant’s pipeline is concentrated in inflammation and immunology and includes VTAMA, a novel topical approved for the treatment of psoriasis and in development for the
treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; and RVT-3101, an anti-TL1A antibody
in development for ulcerative colitis and Crohn’s disease, in addition to several other therapies in various stages of clinical development. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our
medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.
Components of Results of Operations
Product revenue, net
With the FDA approval of VTAMA for the treatment of plaque psoriasis in adult patients and our initial product launch in May 2022, we began to recognize product revenues. We record product
revenue net of estimated chargebacks, discounts, rebates, returns, and other allowances associated with the respective sales.
License, milestone and other revenue
License, milestone and other revenue includes the recognition of upfront payments received in connection with license agreements as well as revenue generated by subscription and service-based fees.
Cost of revenues
We began to recognize cost of product revenues after the initial product launch of VTAMA in May 2022. Cost of product revenues includes the cost of producing and distributing inventories
related to product revenue during the respective period, including manufacturing, freight, and indirect overhead costs. Additionally, milestone payments made in connection with regulatory approvals and sales-based milestones are capitalized
and amortized to cost of revenue over the remaining useful life of the asset. Our cost of revenues also relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee,
hosting, and third-party data costs.
Research and development expenses
Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates. Research and development expenses primarily include the following:
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| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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. |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Unallocated internal costs, including: |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| ◦ | employee-related expenses, such as salaries, share-based compensation, and benefits, for research and development personnel; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| ◦ | other expenses that are not allocated to a specific program. |
Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we
advance our product candidates and our recently in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates. We expect higher employee-related expenses, including share-based
compensation expenses, as well as higher consulting costs as we hire additional resources to support increasing development activity.
The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the number and scope of preclinical and clinical programs we decide to pursue; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the number of doses that patients receive; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the countries in which the trials are conducted; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to secure and leverage adequate CRO support for the conduct of clinical trials; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to establish an appropriate safety and efficacy profile for our product candidates; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the timing, receipt and terms of any approvals from applicable regulatory authorities; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the potential additional safety monitoring or other studies requested by regulatory agencies; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the significant and changing government regulation and regulatory guidance; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the impact of any business interruptions to our operations due to the COVID-19 pandemic or other epidemics; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our ability to maintain a continued acceptable safety profile of our product candidates following approval of our product candidates. |
The successful development of our product candidates is highly uncertain, and we cannot reasonably estimate the costs that will be necessary to complete the remainder of the development of
our product candidates. In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability.
Acquired in-process research and development expenses
Acquired in-process research and development (“IPR&D”) expenses include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments
made in connection with asset acquisitions and license agreements upon the achievement of development milestones.
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Consideration for the purchase of IPR&D through asset acquisitions and license agreements includes cash upfront payments, shares and other liability instruments issued, and fair value of future contingent
consideration payments.
Selling, general and administrative expenses
Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses, such as salaries, share-based compensation, sales incentive compensation, and
benefits, for employees engaged in SG&A activities. SG&A employees include those responsible for the identification and acquisition or in-license of new drug candidates as well as for managing Vant operations and facilitating the use
of our platform and technologies at the Vants. SG&A expenses also consist of marketing programs, advertising, legal and accounting fees, consulting services, and other operating costs relating to corporate matters and daily operations.
Additionally, SG&A expenses include costs incurred relating to the identification, acquisition or in-license and technology transfer of promising drug candidates along with costs incurred relating to the integration of new technologies.
We expect SG&A expenses to increase in future periods as we continue to expand our sales and marketing infrastructure and general administrative functions. These increases will likely
include salaries, sales incentive compensation, share-based compensation and travel expenses associated with our sales force, which began promoting VTAMA in the United States following approval by the FDA in May 2022, as well as expected
costs associated with the further build out of our commercial operations functions. We anticipate these expenses to further increase if any of our other current or future product candidates receives regulatory approval in the United States or
another jurisdiction.
Change in fair value of investments
Change in fair value of investments primarily includes the unrealized loss on equity investments in publicly-traded companies, including Arbutus Biopharma Corporation (“Arbutus”), as well as our equity investment
in Heracles Parent, L.L.C., the parent entity of the Datavant business (“Datavant”). We have elected the fair value option to account for these investments.
Change in fair value of debt and liability instruments
Change in fair value of debt and liability instruments primarily includes the unrealized loss (gain) relating to the measurement and recognition of fair value on a recurring basis of certain
liabilities, including debt issued by a wholly-owned subsidiary of Dermavant Sciences Ltd. to NovaQuest Co-Investment Fund VIII, L.P. (the “NovaQuest Facility”), and other liability instruments, including warrant and earn-out share
liabilities issued in connection with our business combination (the “Business Combination”) with Montes Archimedes Acquisition Corp. (“MAAC”), a special purpose acquisition company.
Gain on deconsolidation of subsidiaries
Gain on deconsolidation of subsidiaries resulted from the determination that we no longer had a controlling financial interest in certain subsidiaries.
Interest income
Interest income consists of interest earned on our cash equivalents.
Interest expense
Interest expense results from interest accrued on long-term debt and the amortization of debt discount and issuance costs.
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Income tax expense
Income tax expense is recorded for the jurisdictions in which we do business. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences
between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in
which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation
allowance is recorded when, after consideration of all positive and negative evidence, it is not more likely than not that our deferred tax assets will be realizable. When uncertain tax positions exist, we recognize the tax benefit of tax
positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as
consideration of the available facts and circumstances.
Income from discontinued operations, net of tax
Income from discontinued operations, net of tax represents the gain on sale of common shares of Myovant Sciences Ltd. (“Myovant”) as a result of Sumitovant Biopharma Ltd.’s (“Sumitovant”)
acquisition of Myovant in March 2023. We were entitled to these shares of Myovant pursuant to the December 2019 transaction with Sumitomo Pharma Co., Ltd. (the “Sumitomo Transaction”) that included, among other things, the transfer of our
ownership interest in five Vants to Sumitovant. The Sumitomo Transaction was presented as discontinued operations during the year ending March 31, 2020, and the right to receive certain common shares of Myovant was treated as a contingent
consideration upon a sale of the business and accounted for as a gain contingency.
Net loss attributable to noncontrolling interests
Net loss attributable to noncontrolling interests consists of the portion of net loss of those consolidated entities that is not allocated to us. Changes in the amount of net loss
attributable to noncontrolling interests are directly impacted by the net loss of our consolidated entities and changes in ownership percentages.
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Results of Operations
Comparison of the years ended March 31, 2023 and 2022
The following table sets forth our results of operations for the years ended March 31, 2023 and 2022:
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Revenues: | ||||||||||||
| Product revenue, net | $ | 28,011 | $ | — | $ | 28,011 | ||||||
| License, milestone and other revenue | 33,269 | 55,286 | (22,017 | ) | ||||||||
| Revenue, net | 61,280 | 55,286 | $ | 5,994 | ||||||||
| Operating expenses: | ||||||||||||
| Cost of revenues | 13,128 | 8,966 | 4,162 | |||||||||
| Research and development | 525,215 | 483,035 | 42,180 | |||||||||
| Acquired in-process research and development | 97,749 | 139,894 | (42,145 | ) | ||||||||
| Selling, general and administrative | 600,506 | 775,033 | (174,527 | ) | ||||||||
| Total operating expenses | 1,236,598 | 1,406,928 | (170,330 | ) | ||||||||
| Loss from operations | (1,175,318 | ) | (1,351,642 | ) | 176,324 | |||||||
| Change in fair value of investments | 20,815 | 87,291 | (66,476 | ) | ||||||||
| Gain on sale of investment | — | (443,754 | ) | 443,754 | ||||||||
| Change in fair value of debt and liability instruments | 78,001 | (3,354 | ) | 81,355 | ||||||||
| Gain on termination of Sumitomo Options | — | (66,472 | ) | 66,472 | ||||||||
| Gain on deconsolidation of subsidiaries | (29,276 | ) | (5,041 | ) | (24,235 | ) | ||||||
| Interest income | (32,184 | ) | (369 | ) | (31,815 | ) | ||||||
| Interest expense | 27,968 | 7,041 | 20,927 | |||||||||
| Other income, net | (15,808 | ) | (3,237 | ) | (12,571 | ) | ||||||
| Loss from continuing operations before income taxes | (1,224,834 | ) | (923,747 | ) | (301,087 | ) | ||||||
| Income tax expense | 5,190 | 369 | 4,821 | |||||||||
| Loss from continuing operations, net of tax | (1,230,024 | ) | (924,116 | ) | (305,908 | ) | ||||||
| Income from discontinued operations, net of tax | 114,561 | — | 114,561 | |||||||||
| Net loss | (1,115,463 | ) | (924,116 | ) | (191,347 | ) | ||||||
| Net loss attributable to noncontrolling interests | (106,433 | ) | (78,854 | ) | (27,579 | ) | ||||||
| Net loss attributable to Roivant Sciences Ltd. | $ | (1,009,030 | ) | $ | (845,262 | ) | $ | (163,768 | ) |
Variance analysis for years ended March 31, 2023 and 2022
Product revenue, net
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | |||||||||
| (in thousands) | |||||||||||
| Product revenue, net | $ | 28,011 | $ | — | $ | 28,011 |
Product revenue, net was $28.0 million for the year ended March 31, 2023, consisting of net product
revenues from the sale of VTAMA, following the approval of VTAMA for the treatment of plaque psoriasis in adult patients by the FDA in May 2022. We did not generate any product revenues, net for the year ended March 31, 2022.
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License, milestone and other revenue
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | ||||||||||
| (in thousands) | ||||||||||||
| License, milestone and other revenue | $ | 33,269 | $ | 55,286 | $ | (22,017 | ) |
License, milestone and other revenue decreased by $22.0 million to $33.3 million for the year ended March 31, 2023, compared to $55.3 million for the year ended March 31, 2022. During the year ended March 31, 2023, license, milestone and other revenue primarily related to payments received in connection with licensing arrangements, including the collaboration and license agreement entered between
Covant Therapeutics Operating, Inc. and Boehringer Ingelheim International, GmbH in March 2023. During the year ended March 31, 2022, license, milestone and other revenue primarily related to
payments received in connection with license agreements and the licensing of technology as well as revenue relating to the sales of clinical product and milestone income at Dermavant pursuant to a collaboration and license agreement with
Japan Tobacco Inc.
Cost of revenues
For the years ended March 31, 2023 and 2022, our cost of revenues consisted of the following:
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Cost of product and other revenues | $ | 5,660 | $ | 8,966 | $ | (3,306 | ) | |||||
| Amortization of intangible assets | 7,468 | — | 7,468 | |||||||||
| Cost of revenues | $ | 13,128 | $ | 8,966 | $ | 4,162 |
Cost of revenues increased by $4.2 million to $13.1 million for the year ended March 31, 2023, compared to $9.0 million for the year ended March 31, 2022. During the year ended March 31, 2023, cost of revenues included $1.8 million of costs relating to the sale of VTAMA as well as $7.5 million of amortization expense recognized in connection with milestones capitalized following the FDA approval of
VTAMA in May 2022. During the year ended March 31, 2022, cost of revenues was primarily related to cost associated with the sales of clinical product of tapinarof by Dermavant to Japan Tobacco Inc.
Research and development expenses
For the years ended March 31, 2023 and 2022, our research and development expenses consisted of the following:
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| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022(1) | Change | ||||||||||
| (in thousands) | ||||||||||||
| Program-specific costs: | ||||||||||||
| Anti-FcRn franchise(2) | $ | 88,747 | $ | 52,009 | $ | 36,738 | ||||||
| Tapinarof | 45,201 | 64,496 | (19,295 | ) | ||||||||
| Brepocitinib | 38,627 | 24,890 | 13,737 | |||||||||
| RVT-2001 | 16,075 | 1,132 | 14,943 | |||||||||
| AFVT-2101 | 15,628 | 12,657 | 2,971 | |||||||||
| ARU-1801 | 12,940 | 23,312 | (10,372 | ) | ||||||||
| Namilumab | 11,757 | 8,745 | 3,012 | |||||||||
| RVT-3101 | 7,559 | — | 7,559 | |||||||||
| LSVT-1701 | 7,173 | 11,067 | (3,894 | ) | ||||||||
| ARU-2801 | 3,456 | 12,031 | (8,575 | ) | ||||||||
| Other development and discovery programs | 83,680 | 74,700 | 8,980 | |||||||||
| Total program-specific costs | 330,843 | 285,039 | 45,804 | |||||||||
| — | ||||||||||||
| Unallocated internal costs: | ||||||||||||
| Share-based compensation | 30,914 | 63,735 | (32,821 | ) | ||||||||
| Personnel-related expenses | 131,908 | 103,827 | 28,081 | |||||||||
| Other expenses | 31,550 | 30,434 | 1,116 | |||||||||
| Total research and development expenses | $ | 525,215 | $ | 483,035 | $ | 42,180 |
(1) Certain prior year amounts have been reclassified to conform to current year presentation.
(2) Reflects program-specific costs relating to Immunovant’s batoclimab program for the treatment of
neurology, endocrine, and hematology diseases and Immunovant’s IMVT-1402 program.
Research and development expenses increased by $42.2 million to $525.2 million for the year ended March 31, 2023, compared to $483.0 million for the year ended March 31, 2022, primarily due to increases in program-specific costs of $45.8 million and
personnel-related expenses of $28.1 million, partially offset by a decrease in share-based compensation of $32.8 million.
The increase of $45.8 million in program-specific costs largely reflects the progression of our programs and drug discovery, including the anti-FcRn franchise, RVT-2001, brepocitinib, and
RVT-3101. The asset acquisitions of brepocitinib, RVT-2001, and RVT-3101 were completed in September 2021, November 2021, and November 2022, respectively. Increases in program-specific costs were partially offset by certain decreases,
including $19.3 million for tapinarof, which was primarily due to the completion of ADORING 1 and ADORING 2 phase 3 atopic dermatitis clinical trials during the year ended March 31, 2023.
The increase of $28.1 million in personnel-related expenses largely reflects the progression of our programs, particularly the anti-FcRn franchise. Personnel-related expenses increased at
Immunovant primarily as a result of higher headcount and enhancement of capabilities to support Immunovant’s strategic objectives as clinical activities were resumed and potential new indications were evaluated.
The decrease of $32.8 million in share-based compensation expense was primarily due to the achievement of the liquidity event vesting condition for certain equity instruments upon the closing
of the Business Combination in September 2021, resulting in the recognition of a one-time catch-up expense of $22.9 million relating to cumulative service rendered between the grant date of the respective awards and completion of the Business
Combination and continued recognition of expense over the requisite service periods.
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Acquired in-process research and development expenses
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Consideration for the purchase of IPR&D | $ | 87,749 | $ | 97,412 | $ | (9,663 | ) | |||||
| Development milestone payments | 10,000 | 42,482 | (32,482 | ) | ||||||||
| Total acquired in-process research and development expenses | $ | 97,749 | $ | 139,894 | $ | (42,145 | ) |
Acquired in-process research and development expenses decreased by $42.1 million to $97.7 million for the
year ended March 31, 2023, compared to $139.9 million for the year ended March 31, 2022. The decrease was
primarily due to higher consideration for the purchase of IPR&D during the year ended March 31, 2022 as a result of consideration for the purchase of IPR&D of $82.1 million relating to the
acquisition of brepocitinib, a one-time milestone expense of approximately $39 million due to the achievement of a development milestone related to tapinarof, and consideration for the purchase of IPR&D of $14.1 million relating to the
acquisition of RVT-2001. Acquired in-process research and development expenses for the year ended March 31, 2023 was driven by consideration for the purchase of IPR&D of $87.7 million relating to
the acquisition of RVT-3101 and the achievement of a development milestone relating to batoclimab, which resulted in a one-time milestone expense of $10.0 million.
Selling, general and administrative expenses
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Selling, general and administrative | $ | 600,506 | $ | 775,033 | $ | (174,527 | ) |
Selling, general and administrative expenses decreased by $174.5 million to $600.5 million for the year
ended March 31, 2023, compared to $775.0 million for the year ended March 31, 2022. The decrease was primarily
due to a decrease in share-based compensation expense of $314.6 million, partially offset by higher selling, general and administrative expenses at Dermavant as a result of the commercial launch of VTAMA. The decrease in share-based
compensation resulted from the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination in September 2021, resulting in the recognition of a one-time catch-up expense of
$350.0 million for the year ended March 31, 2022 for cumulative service rendered between the grant date of the respective awards and completion of the Business Combination.
Change in fair value of investments
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Change in fair value of investments | $ | 20,815 | $ | 87,291 | $ | (66,476 | ) |
Change in fair value of investments was an unrealized loss of $20.8 million and unrealized loss of $87.3 million
for the years ended March 31, 2023 and 2022, respectively. The change of $66.5 million was primarily driven by
changes in the public share prices of our equity investments, including Arbutus, as well as the change in fair value of our investment in Datavant following the completion of the Datavant Merger (as defined below) in July 2021.
Gain on sale of investment
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | |||||||||
| (in thousands) | |||||||||||
| Gain on sale of investment | $ | — | $ | (443,754 | ) | $ | 443,754 |
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Gain on sale of investment was $443.8 million for the year ended March 31, 2022 and resulted from
Datavant’s merger with a wholly-owned subsidiary of Heracles Parent, L.L.C., the parent company of CIOX Health, (the “Datavant Merger”) in July 2021 at which point we received approximately $320 million in cash and a minority equity stake in
the combined company.
Change in fair value of debt and liability instruments
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | |||||||||
| (in thousands) | |||||||||||
| Change in fair value of debt and liability instruments | $ | 78,001 | $ | (3,354 | ) | $ | 81,355 |
Change in fair value of debt and liability instruments was an unrealized loss of $78.0 million and unrealized gain of $3.4 million for the years ended March 31, 2023 and 2022, respectively. Change in fair value of debt and liability instruments for the year
ended March 31, 2023 primarily consisted of an unrealized loss of $59.6 million relating to the NovaQuest facility, which was primarily due to the impact of VTAMA approval in psoriasis, and an
unrealized loss of $24.1 million relating to the warrant and earn-out share liabilities issued as part of the Business Combination. Change in fair value of debt and liability instruments for the year ended March 31, 2022 primarily consisted
of an unrealized gain of $30.8 million relating to the warrant and earn-out share liabilities issued as part of the Business Combination, partially offset by an unrealized loss of $27.3 million relating to the NovaQuest facility, which was
largely due to the passage of time and increased probabilities of success as a result of advancement in the stage of development of the product candidate.
Gain on termination of Sumitomo Options
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | |||||||||
| (in thousands) | |||||||||||
| Gain on termination of Sumitomo Options | $ | — | $ | (66,472 | ) | $ | 66,472 |
Gain on termination of Sumitomo Options was $66.5 million for the year ended March 31, 2022 due to the
completion of transactions contemplated by an Asset Purchase Agreement entered into with Sumitomo Pharma Co., Ltd. and its subsidiary Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.
Gain on deconsolidation of subsidiaries
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Gain on deconsolidation of subsidiaries | $ | (29,276 | ) | $ | (5,041 | ) | $ | (24,235 | ) |
Gain on deconsolidation of subsidiaries was $29.3 million for the year ended March 31, 2023 and resulted from the
deconsolidation of certain subsidiaries in November 2022 and July 2022.
Gain on deconsolidation of subsidiaries was $5.0 million for the year ended March 31, 2022 and resulted from the
deconsolidation of a subsidiary in January 2022.
Interest income
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Interest income | $ | (32,184 | ) | $ | (369 | ) | $ | (31,815 | ) |
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Interest income increased by $31.8 million to $32.2 million for the year ended March 31,
2023, compared to $0.4 million for the year ended March 31, 2022. The increase is primarily the result of higher interest rates on our invested
cash.
Interest expense
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | |||||||||
| (in thousands) | |||||||||||
| Interest expense | $ | 27,968 | $ | 7,041 | $ | 20,927 |
Interest expense increased by $20.9 million to $28.0 million for the year ended March 31, 2023, compared to $7.0 million for the year ended March 31, 2022. The increase primarily resulted from Dermavant’s revenue
interest purchase and sale agreement (the “RIPSA”), pursuant to which funding of $160.0 million was received in June 2022 following the approval of VTAMA by the FDA in May 2022.
Income from discontinued operations, net of tax
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | |||||||||
| (in thousands) | |||||||||||
| Income from discontinued operations, net of tax | $ | 114,561 | $ | — | $ | 114,561 |
Income from discontinued operations, net of tax was $114.6 million for the year ended March 31, 2023
and resulted from the gain on sale of common shares of Myovant (the “Myovant Top-Up Shares”) after Sumitovant’s acquisition of Myovant in March 2023. We were entitled to the Myovant Top-Up Shares pursuant to the Sumitomo Transaction, and
this right to receive the Myovant Top-Up Shares was treated as contingent consideration upon sale of business and accounted for as a gain contingency. Refer to Note 11, “Discontinued Operations” of our audited financial statements for
additional information.
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Liquidity and Capital Resources
For the years ended March 31, 2023 and 2022, we incurred losses from continuing operations of
approximately $1.2 billion and $924.1 million, respectively. As of March 31, 2023, we had cash and cash
equivalents of approximately $1.7 billion and our accumulated deficit was approximately $3.8 billion. Through our subsidiary Dermavant, we launched our
first commercial product, VTAMA, following approval by the FDA in May 2022. We began generating product revenue, net from sales of VTAMA in the United States in May 2022. We also have generated revenue through license agreements as well as
from subscription and service-based fees.
Our short-term and long-term liquidity requirements as of March 31, 2023 included:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | Contractual payments related to our long-term debt (see Note 9, “Long-Term Debt” of our audited financial statements); |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | obligations under our leases (see Note 15, “Leases” of our audited financial statements); |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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 $33.3 million; and |
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| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | certain commitments to GSK pursuant to a commercial supply agreement entered between Dermavant and GSK. In conjunction with Dermavant’s entry into the GSK Agreement in 2018, Dermavant entered into a clinical supply agreement pursuant to which GSK would provide a supply of tapinarof and clinical product at an agreed upon price during our clinical trials. In April 2019, Dermavant entered into a commercial supply agreement with GSK to continue to provide certain quantities of tapinarof and commercial product at agreed upon minimum quantities and price. The commercial supply agreement commenced in April 2022 upon completion of certain quality and regulatory conditions. In July 2022, Dermavant and GSK amended the terms of the clinical supply and commercial supply agreements which released GSK of certain commitments to supply tapinarof and released Dermavant of certain commitments to purchase tapinarof in exchange for a supplementary fee. Other supply and purchase commitments under the agreements remain in effect. In addition, Dermavant and Thermo Fisher Scientific (“TFS”) entered into a Commercial Manufacturing and Supply Agreement for which TFS agreed to provide a supply of tapinarof to Dermavant at an agreed upon price. The agreements discussed above require Dermavant to purchase certain quantities of inventory over a period of five years. The minimum purchase commitment related to these agreements is estimated to be approximately $38.0 million. |
The above purchase commitments do not represent all of our anticipated purchases, but instead represent only the contractually obligated minimum purchases or firm commitments of non-cancelable minimum amounts.
Additionally, we have certain payment obligations under various asset acquisition and license agreements. Under these agreements we are required to make milestone payments upon successful
completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events, such as our achievement of specified
development, regulatory and commercial milestones, and the amount, timing, and likelihood of such payments are not known. We will also be required to make milestone payments and royalty payments in connection with the sale of products
developed under these agreements.
We enter into agreements in the normal course of business with CROs and other vendors for clinical trials and with vendors for preclinical studies and other services and products for
operating purposes, which are generally cancelable upon written notice.
We had cash, cash equivalents and restricted cash of approximately $1.7 billion at March 31, 2023, which we expect to support cash runway into the second half of calendar year 2025.
However, we have based this estimate on assumptions that may prove to be wrong, which may require us to use our capital resources sooner than expected. See “Forward-Looking Statements” and “Risk Factors” in this Annual Report on Form 10-K.
Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and
collaboration arrangements.
RSL Equity Financing Transactions
Since inception, we have completed multiple equity financing transactions, including the following:
In December 2019, together with Sumitomo, we completed the transactions contemplated by the transaction agreement by and between us and Sumitomo, dated as of October 31, 2019. In connection
with the Sumitomo Transaction, we raised net proceeds of approximately $999.2 million due to the sale of our common shares to Sumitomo.
In September 2021, we completed our Business Combination with MAAC, a special purpose acquisition company, as well as concurrent PIPE Financing. In connection with the Business Combination
and PIPE Financing, we received approximately $213.4 million in cash at closing.
In September 2022, we entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”) to sell our common shares having an aggregate offering price of up to
$400.0 million from time to time through an “at-the-market” equity offering program under which Cowen acts as our agent (the “ATM Facility”). As of March 31, 2023, we had $400.0 million of remaining capacity available under the ATM Facility.
In November 2022, we completed an underwritten primary and secondary public offering of 30,000,000 of our common shares at a price to the public of $5.00 per share. Of these common shares,
20,000,000 were sold by us and 10,000,000 were sold by certain selling shareholders. Net proceeds to us were approximately $94.7 million after deducting underwriting discounts and commissions and offering expenses. We did not receive any
proceeds from the sale of common shares by the selling shareholders in the offering.
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In February 2023, we completed an underwritten public offering of 30,666,665 of our common shares (including 3,999,999 common shares issued and sold upon the full exercise of the
underwriters' option to purchase additional shares) at a price to the public of $7.50 per share. Net proceeds to us were approximately $216.9 million after deducting underwriting discounts and commissions and offering expenses.
Sumitomo Transaction
In December 2019, we closed the Sumitomo Transaction, including the transfer of our ownership interest in five Vants – Myovant, Urovant Sciences Ltd., Enzyvant Therapeutics Ltd., Altavant
Sciences Ltd., and Spirovant Sciences Ltd. – to Sumitovant, a wholly-owned subsidiary of Sumitomo. In addition, in connection with the Sumitomo Transaction, we (i) granted Sumitomo options to purchase all, or in the case of Dermavant, 75%, of
our ownership interests in six other subsidiaries and (ii) provided Sumitomo and Sumitovant with certain rights over and access to our proprietary technology platforms, DrugOme and Digital Innovation. In exchange for these components of the
Sumitomo Transaction, we received approximately $1.9 billion in cash, which was in addition to the approximately $999.2 million from the sale of our common shares to Sumitomo as discussed above.
In June 2021, we completed a transaction with Sumitomo pursuant to which Sumitomo terminated its existing options to acquire our equity interests in certain of our subsidiaries.
In October 2022, Myovant entered into an agreement with Sumitovant, its majority shareholder, under which Sumitovant would acquire the remaining shares of Myovant not already owned by
Sumitovant at a price of $27.00 per share in a cash transaction (the “Myovant Transaction”). The acquisition of Myovant by Sumitovant was completed in March 2023. In connection with the closing of the Myovant Transaction, we received
approximately $114.6 million in March 2023 for the sale of the Myovant Top-Up Shares. Refer to Note 11, “Discontinued Operations” of our audited financial statements for additional information.
Consolidated Vant Equity Financing Transactions
Since inception, we have completed multiple Vant equity financing transactions, including the following:
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Immunovant
In December 2019, Immunovant raised $111.0 million (including $5.1 million related to common shares purchased by us) through a business combination with Health Sciences Acquisition
Corporation, a special purpose acquisition company.
During the years ended March 31, 2021 and 2020, Immunovant issued shares of common stock for an aggregate net proceeds of $384.9 million (including an aggregate of $27.5 million of shares
of common stock purchased by us) in private financings, underwritten public offerings, and warrant exercises.
In October 2022, Immunovant completed an underwritten public offering of 12,500,000 shares of its common stock (including 416,667 shares of common stock purchased by us) at a price to the
public of $6.00 per share, for net proceeds to Immunovant of approximately $70.2 million after deducting underwriting discounts and commissions and offering expenses.
Proteovant
In December 2020, following Proteovant Sciences, Inc’s (“Proteovant”) acquisition of Oncopia in November 2020, SK, Inc. (formerly known as SK Holdings Co., Ltd.) (“SK”) entered into a
subscription agreement (the “Subscription Agreement”) pursuant to which SK agreed to make a $200.0 million equity investment in Proteovant, representing an ownership interest of 40.0% on the closing date. In January 2021, in accordance with
the terms of the Subscription Agreement, SK made the first payment of $100.0 million to Proteovant. In July 2021, Proteovant collected the subscription receivable relating to the second $100.0 million payment due under the SK Subscription
Agreement.
Consolidated Vant Debt Financings
Since inception, we have completed multiple Vant debt financings, including the following:
Dermavant
In May 2019, Dermavant entered into a loan and security agreement (the “Hercules Loan Agreement”) with Hercules, pursuant to which Dermavant borrowed an aggregate of $20.0 million. In May
2021, all amounts outstanding under the Hercules Loan Agreement were repaid using the proceeds from the $40.0 million senior secured credit facility entered into by Dermavant with XYQ Luxco S.A.R.L (“XYQ Luxco”), as lender, and U.S. Bank
National Association, as collateral agent, in May 2021, and Dermavant terminated the Hercules Loan Agreement.
Following the approval of VTAMA by the FDA in May 2022, Dermavant received $160.0 million in June 2022 pursuant to the terms of the RIPSA entered with XYQ Luxco, NovaQuest Co-Investment
Fund XVII, L.P., an affiliate of NovaQuest Capital Management, LLC, and MAM Tapir Lender, LLC, an affiliate of Marathon Asset Management, L.P., together with U.S. Bank National Association, as collateral agent. Under the terms of the RIPSA,
Dermavant is obligated to pay royalties based on a capped single-digit revenue interest in net sales of tapinarof for all dermatological indications in the United States, up to a cap of $344.0 million, in exchange for the $160.0 million in
committed funding to be paid to Dermavant, conditioned on the approval of tapinarof by the FDA, which was achieved in May 2022. Dermavant used the RIPSA proceeds primarily for the milestone obligations to GSK, which was achieved upon FDA
approval, and Welichem Biotech Inc., which was achieved upon the first sale of VTAMA.
Other
Datavant
In July 2021, we received approximately $320 million in cash as a result of the Datavant Merger.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the discovery efforts, preclinical activities, clinical trials and potential
commercialization of our product candidates. Additionally, we expect to incur significant commercialization expenses with respect to VTAMA. Our operating results, including our net losses, may fluctuate significantly from quarter-to-quarter
and year-to-year, depending on the timing of our planned clinical trials, our expenditures on other research and development activities and our commercialization efforts. We anticipate that our expenses will increase substantially as we:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | fund the manufacturing of drug substance and drug product of our product candidates in development; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | seek to identify, acquire, develop and commercialize additional product candidates; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | invest in activities related to the discovery of novel drugs and advancement of our internal programs; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | integrate acquired technologies into a comprehensive regulatory and product development strategy; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | maintain, expand and protect our intellectual property portfolio; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | hire scientific, clinical, quality control and administrative personnel; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | add operational, financial and management information systems and personnel, including personnel to support our drug development efforts; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
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| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | 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 |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | operate as a public company. |
We expect to continue to finance our cash needs through a combination of our cash on hand and future equity offerings, debt financings, sales of subsidiaries, and proceeds received from
collaborations, strategic alliances or marketing, distribution, licensing or similar arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership
interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common shareholder. Any agreements for future debt or preferred equity financings, if available,
may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Our ability to raise additional capital may be adversely impacted by
potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution, licensing or similar arrangements with third parties, we may be required to relinquish
valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. Adequate additional funding may not be available to us on acceptable terms, or
at all. If we are unable to raise capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates, grant rights to
develop and market product candidates that we would otherwise prefer to develop and market ourselves or potentially discontinue operations.
Cash Flows
The following table sets forth a summary of our cash flows for the years ended March 31, 2023 and 2022:
| Years Ended March 31, | ||||||||
|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | |||||||
| (in thousands) | ||||||||
| Net cash used in operating activities | $ | (843,393 | ) | $ | (677,729 | ) | ||
| Net cash (used in) provided by investing activities | $ | (44,269 | ) | $ | 303,295 | |||
| Net cash provided by financing activities | $ | 499,462 | $ | 306,792 |
Operating Activities
Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash flow from operating
activities is derived from adjusting our net loss for non-cash items and changes in working capital.
For the year ended March 31, 2023, cash used in operating activities increased by $165.7 million to $843.4 million compared to the year ended March 31, 2022. This increase was primarily driven by an increase in cash required to fund operations, particularly as
a result of the progression of clinical programs, and to support the commercial launch of VTAMA.
Investing Activities
Cash flow from investing activities includes cash used for milestone payments; purchase of property and equipment; and proceeds from sale of investment and other equity securities.
For the year ended March 31, 2023, cash flow from investing activities changed by $347.6 million to net
cash used in investing activities of $44.3 million from net cash provided by investing activities of $303.3 million for the year ended March 31, 2022. This change in cash flow from investing activities is primarily related to $320 million in cash we received as a result of the Datavant Merger during the year ended March
31, 2022. During the year ended March 31, 2023, cash used in investing activities was primarily driven by milestone payments made relating to VTAMA, which were partially offset by proceeds
from the sale of the Myovant Top-Up Shares.
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Financing Activities
For the year ended March 31, 2023, cash provided by financing activities increased by $192.7 million to
$499.5 million compared to the year ended March 31, 2022. During the year ended March 31, 2023, proceeds were
generated by funding pursuant to the terms of the RIPSA following the approval of VTAMA by the FDA in May 2022 as well as net proceeds from the issuance of our common shares and common shares of our majority-owned subsidiary Immunovant.
During the year ended March 31, 2022, proceeds were generated by the completion of our Business Combination and PIPE financing in September 2021, payment of the subscription receivable due to
Proteovant by SK in July 2021, and the senior secured credit facility entered into by Dermavant and certain of its subsidiaries with XYQ Luxco, as lender, and U.S. Bank National Association, as collateral agent, partially offset by cash used
to repay all amounts outstanding under a previously existing loan and security agreement with Hercules Capital, Inc.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S.
generally accepted accounting principles (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, and disclosures of
contingencies as of the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our
estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, or
experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known.
We define our critical accounting policies as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a
material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles.
While our significant accounting policies are described in more detail in Note 2, “Summary of Significant Accounting Policies” in our consolidated financial statements included elsewhere in
this Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Product Revenue Reserves
We recognize revenue when the customer obtains control of the product, which occurs at a point in time, either upon shipment or delivery to the customer. Revenues from product sales are
recorded at the net sales price, which includes estimates of variable consideration for which reserves are established that result from (a) invoice discounts for prompt payment and specialty distributor and specialty pharmacy service fees,
(b) government and private payer rebates, chargebacks, discounts and fees, (c) performance rebates and administrative fees, (d) product returns and (e) costs of co-pay assistance programs for patients. We establish reserves based on these
gross-to-net adjustments, which are based on amounts earned or to be claimed on the related sale and are classified as reductions of accounts receivable (if the amount is payable to the customer) or accrued expenses and other current
liabilities (if the amount is payable to a party other than a customer). Where appropriate, we utilize the expected value method to determine the appropriate amount for estimates of variable consideration. The estimates of reserves
established for variable consideration reflect current contractual and statutory requirements, our historical experience, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount
of variable consideration that is included in the transaction price may be constrained and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue
recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results vary from our estimates, we adjust these estimates in the period such change in estimate
becomes known, which could affect net product revenue and earnings in the period of the adjustment.
We make significant estimates and judgments that materially affect our recognition of net product revenue. Claims by third-party payors for rebates, chargebacks and discounts may be
submitted to us significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known. We will adjust our estimates based on new information, including information regarding
actual rebates, chargebacks and discounts for our products, as it becomes available.
The following table provides a summary of activity with respect to our sales allowances and accruals (in thousands):
| March 31, 2023 | March 31, 2022 | ||||||
|---|---|---|---|---|---|---|---|
| Sales return, rebate, and discounts balances, beginning of year | $ | — | $ | — | |||
| Reduction of gross sales | (129,717 | ) | — | ||||
| Cash payments | 108,923 | — | |||||
| Sales return, rebate, and discounts balances, end of year | $ | (20,794 | ) | $ | — |
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Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates. We expense research and development costs as incurred.
We accrue expense for preclinical studies and clinical trial activities performed by vendors based upon estimates of the proportion of work completed. We determine such estimates by
reviewing contracts, vendor agreements and purchase orders, and through discussions with our internal personnel and external service providers as to the progress or stage of completion and the agreed-upon fee to be paid for such services.
However, actual costs and timing of preclinical studies and clinical trials are highly uncertain, subject to risks, and may change depending upon a number of factors, including our clinical development plan.
We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known at that time. If the actual timing of the
performance of services or the level of effort varies from the estimate, the accrual is adjusted accordingly. Nonrefundable advance payments for goods and services are deferred and recognized as expense in the period that the related goods
are consumed or services are performed.
Share-Based Compensation
We recognize compensation costs related to share-based awards granted to employees, directors, and consultants based on the estimated fair value of the awards on the date of grant. The
grant date fair value of the stock-based awards is recognized over the requisite service period, which is generally the vesting period of the respective awards. We may grant awards with graded-vesting features. When such awards have only
service vesting requirements, we elected to record share-based compensation expense on a straight-line basis. If awards with graded-vesting features contain performance or market conditions, then we record share-based compensation expense
using the accelerated attribution method.
We estimate the fair value of stock options using the Black-Scholes option-pricing model, which requires assumptions, including the fair value of our common shares prior to our initial
public offering, volatility, the expected term of our stock options, the risk-free interest rate for a period that approximates the expected term of our stock options, and our expected dividend yield. Certain assumptions used in our
Black-Scholes option-pricing model represent management’s best estimates and involve a number of variables, uncertainties and assumptions and the application of management’s judgment, as they are inherently subjective. If any assumptions
change, our stock-based compensation expense could be materially different in the future.
These subjective assumptions are estimated as follows:
Fair value of common share—Prior to the closing of the Business Combination, as a privately held company, we estimated the fair value of the shares
of common stock underlying our share-based awards on each grant date. To determine the fair value of our common shares underlying option grants, we considered, among other things, valuations of our common share prepared by an unrelated
third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The estimation of the
fair value of the common shares considered factors including the following:
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the prices of our common shares sold to investors in arm’s length transactions; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the estimated present value of our future cash flows; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our business, financial condition and results of operations; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | our forecasted operating performance; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | the illiquid nature of our common shares; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | industry information such as market size and growth; |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | market capitalization of comparable companies and the estimated value of transactions such companies have engaged in; and |
| Column 1 | Column 2 | Column 3 |
|---|---|---|
| • | macroeconomic conditions. |
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We apply a similar methodology to estimate the fair value of the shares of common stock underlying share-based awards issued by our privately held Vants. Following the closing of the
Company’s business combination with MAAC, our common shares became publicly traded and we began determining the fair value of each common share underlying share-based awards based on the closing price of our common shares as reported by
Nasdaq on the date of grant. Therefore, it will not be necessary to determine the fair value of the new stock-based award pursuant to the methodology described above.
Expected term—We have generally elected to use the “simplified method” for estimating the expected term of options, whereby the expected term equals
the arithmetic average of the vesting term and the original contractual term of the option (generally 10 years).
Expected volatility—Prior to the closing of the Business Combination, we were a privately held company and did not have any trading history for our
common shares; accordingly, the expected volatility was estimated based on the average volatility for comparable publicly traded biotechnology companies over a period equal to the expected term of the stock option grants. The comparable
companies were chosen based on their similar size, stage in the life cycle or area of specialty. We apply similar methodology to estimate the expected volatility at our privately held Vants. Because we do not have an extended trading history
for our shares of common stock since the closing of the Business Combination, the method used to estimate the expected volatility remained unchanged.
Risk-free interest rate—The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of our stock options at the
time of the grant.
Expected dividend yield—We have not issued any dividends in our history and do not expect to issue dividends over the life of the options; therefore, we have estimated
the dividend yield to be zero.
Recently Adopted Accounting Pronouncements
We did not adopt any material accounting pronouncements during the year ended March 31, 2023.
Implications of Being an Emerging Growth Company and Smaller Reporting Company
We are an “emerging growth company” within the meaning of the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As an emerging growth company, we may take advantage of certain
exemptions from various public company reporting requirements, including the requirement that our internal control over financial reporting be audited by our independent registered public accounting firm pursuant to Section 404 of the
Sarbanes-Oxley Act, certain requirements related to the disclosure of executive compensation in this Annual Report on Form 10-K and in our periodic reports and proxy statements, and the requirement that we hold a nonbinding advisory vote on
executive compensation and any golden parachute payments. We have also taken advantage of the ability to provide reduced disclosure of financial information in this Annual Report on Form 10-K, such as being permitted to include only two years
of audited financial information and two years of selected financial information in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” disclosure. We may take advantage of these exemptions until we are no longer an emerging growth company. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended
transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those
standards would otherwise apply to private companies. We have elected not to avail ourselves of this extended transition period, and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of
such standards is required for other public companies. However, because we have taken advantage of certain reduced reporting requirements, the information contained herein may be different from the information you receive from other public
companies in which you hold shares.
We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the date of the first sale of Roivant common shares
pursuant to an effective registration statement or (b) in which we have total annual gross revenue of at least $1.235 billion (as adjusted for inflation pursuant to SEC rules from time to time), and (2) the date on which (x) we are deemed to
be a large accelerated filer, which means the market value of Roivant common shares that are held by non-affiliates exceeds $700 million as of the prior September 30th, or (y) the date on which we have issued more than $1.0 billion in
nonconvertible debt during the prior three-year period.
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Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations,
including, among other things, providing only two years of audited financial statements. We may continue to be a smaller reporting company as long as either (i) the market value of our common shares held by non-affiliates is less than $250
million as of the end of that year's second fiscal quarter, or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our common shares held by non-affiliates is less than $700
million as of the end of that year’s second fiscal quarter. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies more difficult.
FY 2022 10-K MD&A
SEC filing source: 0001193125-22-183362.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of Roivant’s financial condition and results of operations should be read in conjunction with Roivant’s consolidated financial statements and notes to those statements included elsewhere in this Annual Report on Form
10-K.
Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Roivant’s actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see “Forward-Looking Statements” and “Risk Factors” in this Annual Report on Form
10-K.
Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31.
Overview
We are building the next-generation “big pharma” company, organized to harness modern technologies and computational tools as well as the entrepreneurial spirit of nimble biotechnology companies at scale. Our mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity.
We are a diverse team of experienced drug developers, scientists, physicians, company builders, data scientists and engineers, biopharma investors, physicists and business development professionals dedicated to improving the lives of patients. At Roivant, we combine our team’s extensive experience and multi-disciplinary expertise with innovative technologies to identify and advance potentially transformative medicines.
We deploy a hypothesis-driven approach to identify novel or clinically-validated targets and biological pathways in areas of high unmet medical need. We then seek to acquire,
in-license
or discover promising drug candidates against those targets or pathways. Our small molecule discovery engine is powered by leading computational physics and machine learning (“ML”) capabilities for in silico drug design.
We develop drugs and drug candidates in subsidiary companies we call “Vants” with a distinct approach to sourcing talent, aligning incentives and deploying technology. Each of our Vant teams is built with deep relevant expertise to promote successful execution of our development strategy. Our Vants continue to benefit from the support of the Roivant platform and technologies that are built to address inefficiencies in the drug discovery, development and commercialization process.
Our agile Vant model has allowed us to rapidly add capabilities in diverse therapeutic areas, including immunology, dermatology and oncology, and modalities, including biologics, topicals and bifunctional small molecules. The Vant model also enables a modular approach to the monetization of therapies we advance through development, allowing us to pursue commercialization of some products independently, while selectively establishing partnerships for other Vants or divesting of the Vants entirely.
Since our inception in 2014, we have focused substantially all of our efforts and financial resources on acquiring and developing our product candidates and expanding our platform and technologies. For the years ended March 31, 2022 and 2021, we incurred net losses of $924.1 million and $900.2 million, respectively. As of March 31, 2022, we had cash and cash equivalents of approximately $2.1 billion and an accumulated deficit of approximately $2.8 billion. Through March 31, 2022, we had not generated any revenue from the sale of our product candidates. Through our subsidiary Dermavant Sciences Ltd., we have launched our first commercial product, VTAMA
®
(tapinarof) cream, following approval by the FDA in May 2022. Through March 31, 2022, our revenue, primarily generated through license agreements as well as from subscription and service-based fees, has not been significant. Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements.
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Recent Developments
Dermavant
In May 2022, VTAMA cream was approved by the FDA as the first and only
FDA-approved
steroid-free topical medication in its class for the treatment of plaque psoriasis in adult patients.
Following the approval of VTAMA cream by the FDA in May 2022, Dermavant Sciences Ltd. (together with its wholly owned subsidiaries, “Dermavant”) received $160.0 million in June 2022 pursuant to the terms of the revenue interest purchase and sale agreement (the “RIPSA”) as described in Note 7, “Long-Term Debt and Loan Commitment” of our audited financial statements.
Also, as a result of FDA approval, Dermavant achieved a regulatory milestone to GSK of £100.0 million (approximately $126 million on the date of achievement), which will be paid within 70 calendar days of FDA approval. Additionally, the first sale of VTAMA cream in May 2022 resulted in the achievement of a milestone to Welichem Biotech Inc. of CAD$25.0 million (approximately $20 million on the date of achievement), which will be paid within 60 calendar days of the invoice date. Dermavant intends to primarily use the RIPSA proceeds for the payment of these obligations.
Roivant
We have implemented a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and preserve our capital resources. As part of this initiative, we have discontinued the development of several programs, including ARU-1801, LSVT-1701, DMVT-502,
DMVT-503,
DMVT-504
and
CVT-TCR-01,
to focus our capital on the potentially most valuable and meaningful opportunities for patients in our pipeline, including our programs at newly launched Priovant. We elected to wind down the development of ARU-1801 after considering the future development costs of the program, the current market environment, and the clinical and commercial profile of the product candidate.
Impact of
COVID-19
The
COVID-19
pandemic continues to present global public health and economic challenges. Although some of our clinical development timelines have been impacted by delays related to the
COVID-19
pandemic, we have not experienced material financial impact on our business and operations as a result of the
COVID-19
pandemic. However, the impact on our future results will largely depend on future developments related to
COVID-19,
which are highly uncertain and cannot be predicted with confidence, such as the emergence of new variants, the ultimate duration and spread of the outbreak, the continuing impact of the
COVID-19
pandemic on financial markets and the global economy, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain, treat, and prevent the disease, including the availability and effectiveness of vaccines.
For additional information about risks and uncertainties related to the
COVID-19
pandemic that may impact our business, financial condition and results of operations, see the section titled “Risk Factors” included elsewhere in this Annual Report on Form
10-K.
Components of Results of Operations
Revenue, net
Through March 31, 2022, we have not generated any revenues from the sale of our product candidates. Our revenue through March 31, 2022 primarily includes the recognition of upfront payments received in connection with license agreements. Revenue is also generated by subscription and service-based fees. Our revenue recognized from inception through March 31, 2022 has not been significant.
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With the approval of VTAMA cream for the treatment of plaque psoriasis in adult patients by the FDA in May 2022, we began to recognize product revenues after our initial product launch.
Cost of revenues
Through March 31, 2022, our cost of revenues primarily relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting, and third-party data costs. Our cost of revenues through March 31, 2022 has not been significant.
With the approval of VTAMA cream for the treatment of plaque psoriasis in adult patients by the FDA in May 2022, we began to recognize cost of product revenues after our initial product launch.
Research and development expenses
Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates. Research and development expenses primarily include the following:
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | 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. |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | Unallocated internal costs, including: |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | employee-related expenses, such as salaries, share-based compensation, and benefits, for research and development personnel; and |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | other expenses that are not allocated to a specific program. |
Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we advance our product candidates through preclinical studies and clinical trials, as well as acquire new product candidates. In addition, we expect our research and development expenses to increase in the future, including as a result of our small molecule discovery engine (“Roivant Discovery”), comprising advanced computational physics and machine learning capabilities, integrated with an
in-house
wet lab facility. Research and development expenses will also be driven by the number of drug candidates from Roivant Discovery that we advance through preclinical studies and clinical trials. We expect higher employee-related expenses, including higher share-based compensation expenses, as well as higher consulting costs as we hire additional resources to support increasing development activity.
The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following:
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | 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; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the number and scope of preclinical and clinical programs we decide to pursue; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the number of doses that patients receive; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the countries in which the trials are conducted; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | our ability to secure and leverage adequate CRO support for the conduct of clinical trials; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | our ability to establish an appropriate safety and efficacy profile for our product candidates; |
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| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the timing, receipt and terms of any approvals from applicable regulatory authorities; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the potential additional safety monitoring or other studies requested by regulatory agencies; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the significant and changing government regulation and regulatory guidance; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | 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; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the impact of any business interruptions to our operations due to the COVID-19 pandemic; and |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | our ability to maintain a continued acceptable safety profile of our product candidates following approval of our product candidates. |
The successful development of our product candidates is highly uncertain, and we cannot reasonably estimate the costs that will be necessary to complete the remainder of the development of our product candidates. In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability.
Acquired
in-process
research and development expenses
For the year ended March 31, 2022, we began reporting acquired
in-process
research and development (“IPR&D”) expense as a separate line item in our consolidated statements of operations. Acquired IPR&D expenses include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones. These expenses were previously recorded in “Research and development” on the consolidated statements of operations. Prior periods have been revised to conform to the current period presentation.
Consideration for the purchase of IPR&D through asset acquisitions and license agreements includes cash upfront payments, shares and other liability instruments issued, and fair value of future contingent consideration payments.
General and administrative expenses
General and administrative expenses consist primarily of employee-related expenses, such as salaries, share-based compensation, and benefits, for general and administrative personnel, including those responsible for the identification and acquisition or
in-license
of new drug candidates as well as for overseeing Vant operations and facilitating the use of our platform and technologies at Vants. General and administrative expenses also consist of legal and accounting fees, consulting services and other operating costs relating to corporate matters and daily operations. Additionally, general and administrative expenses include costs incurred relating to the identification, acquisition or
in-license
and technology transfer of promising drug candidates along with costs incurred relating to the integration of new technologies.
We expect expenses to increase in future periods as we continue to expand our sales and marketing infrastructure and general administrative functions. These increases will likely include salaries, sales incentive compensation, share-based compensation and travel expenses associated with our sales force, which began promoting VTAMA cream in the United States following approval by the FDA in May 2022, as well as expected costs associated with the further build out of our commercial operations functions. We anticipate these expenses to further increase if any of our other current or future product candidates receives regulatory approval in the United States or another jurisdiction.
Change in fair value of investments
Change in fair value of investments includes the unrealized loss (gain) on equity investments in publicly-traded companies, including Sio Gene Therapies Inc. (“Sio”) and Arbutus Biopharma Corporation (“Arbutus”) as
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well as our equity investment in Heracles Parent, L.L.C., the parent entity of the Datavant business (“Datavant”), following Datavant’s merger with a wholly-owned subsidiary of Heracles Parent, L.L.C., the parent company of CIOX Health, (the “Datavant Merger”) in July 2021 at which point our minority equity interest in Datavant became subject to the equity method of accounting. We have elected the fair value option to account for these investments.
Gain on sale of investment
Gain on sale of investment resulted from the Datavant Merger in July 2021. Prior to the Datavant Merger, our investment in Datavant was accounted for using the measurement alternative to fair value. At closing of the Datavant Merger, we received approximately $320 million in cash and a minority equity interest in the combined company, which became subject to the equity method of accounting. We recognized a gain as a result of this transaction.
Change in fair value of debt and liability instruments
Change in fair value of debt and liability instruments primarily includes the unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities, including debt issued by a wholly-owned subsidiary of Dermavant Sciences Ltd. to NovaQuest
Co-Investment
Fund VIII, L.P. (the “NovaQuest Facility”), and other liability instruments, including warrant and
earn-out
share liabilities issued in connection with our business combination with Montes Archimedes Acquisition Corp. (“MAAC”) as well as options granted to Sumitomo Dainippon Pharma Co., Ltd. (“Sumitomo”) to purchase our ownership interests in certain subsidiaries (the “Sumitomo Options”) before the termination of those options in June 2021.
Gain on termination of Sumitomo Options
Gain on termination of Sumitomo Options resulted from the completion of transactions contemplated by an Asset Purchase Agreement entered into with Sumitomo and its subsidiary Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. (“SPC”) in May 2021. The transactions contemplated by the Asset Purchase Agreement closed in June 2021. Pursuant to the Asset Purchase Agreement: (i) Sumitomo terminated all of its existing options to acquire our ownership interest in certain subsidiaries; (ii) we transferred and assigned to SPC all of our intellectual property, development and commercialization rights for (a) lefamulin in Mainland China, Taiwan, Hong Kong, and Macau (collectively “Greater China”), (b) vibegron in Mainland China, (c) rodatristat ethyl in Greater China and South Korea and
(d) RVT-802
in Greater China and South Korea; (iii) Sumitomo agreed to pay us $5.0 million in cash; and (iv) Sumitomo entered into an agreement with us to pursue future collaborations with Genevant Sciences Ltd. (“Genevant”). We received the cash payment, net of certain withholding taxes, in August 2021.
Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity
Gain on deconsolidation of subsidiary resulted from the determination that we no longer had a controlling financial interest in certain subsidiaries. Gain on consolidation of unconsolidated entity resulted from the remeasurement of our previously held interest in Genevant following the consolidation of Genevant as of July 2020.
Other expense, net
Other expense, net consists of interest expense resulting from interest accrued on long-term debt and the amortization of debt discount and issuance costs, losses from our equity method investment prior to consolidation in July 2020, interest income on our cash and cash equivalents, and other miscellaneous (income) expense.
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Income tax expense
Income tax expense is recorded for the jurisdictions in which we do business. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded when, after consideration of all positive and negative evidence, it is not more likely than not that our deferred tax assets will be realizable. When uncertain tax positions exist, we recognize the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances.
Net loss attributable to noncontrolling interests
Net loss attributable to noncontrolling interests consists of the portion of net loss of those consolidated entities that is not allocated to us. Changes in the amount of net loss attributable to noncontrolling interests are directly impacted by the net loss of our consolidated entities and changes in ownership percentages.
Results of Operations
Comparison of the years ended March 31, 2022 and 2021
The following table sets forth our results of operations for the years ended March 31, 2022 and 2021:
| 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 | ) |
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Variance analysis for years ended March 31, 2022 and 2021
Revenue, net
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | |||||||||
| (in thousands) | |||||||||||
| Revenue, net | $ | 55,286 | $ | 23,795 | $ | 31,491 |
Revenue, net increased by $31.5 million to $55.3 million for the year ended March 31, 2022 compared to $23.8 million for the year ended March 31, 2021. The increase was primarily related to payments received in connection with license agreements and the license of technology. Additionally, we recognized revenue relating to the sales of clinical product as well as milestone income at Dermavant. Revenue generated was not significant in either period presented.
Cost of revenues
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | |||||||||
| (in thousands) | |||||||||||
| Cost of revenues | $ | 8,966 | $ | 2,057 | $ | 6,909 |
Cost of revenues increased by $6.9 million to $9.0 million for the year ended March 31, 2022 compared to $2.1 million for the year ended March 31, 2021, consistent with increased revenue. Cost of revenues was not significant in either period presented.
Research and development expenses
For the years ended March 31, 2022 and 2021, our research and development expenses consisted of the following:
| 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 |
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Research and development expenses increased by $246.4 million to $483.0 million for the year ended March 31, 2022 compared to $236.6 million for the year ended March 31, 2021, primarily due to increases in program-specific costs of $123.1 million, personnel-related expenses of $58.2 million, and share-based compensation of $41.1 million.
The increase of $123.1 million in program-specific costs largely reflects the progression of our programs and drug discovery. Program-specific costs for Dermavant’s tapinarof program increased by $30.5 million, largely resulting from purchases of clinical product as we prepared for commercial launch and incurred costs associated with our Phase 3 clinical program in atopic dermatitis. Program specific costs for Priovant Therapeutics, Inc.’s (“Priovant”) brepocitinib program were $24.9 million for the year ended March 31, 2022, reflecting costs incurred since the acquisition of brepocitinib in September 2021. Program-specific costs for Immunovant’s batoclimab program increased by $17.9 million, primarily reflecting activities to advance the clinical development of batoclimab in current and potentially new indications.
The increase of $58.2 million in personnel-related expenses was primarily driven by an increase in headcount to support the progression of our programs and drug discovery.
The increase of $41.1 million in share-based compensation expense was primarily due to the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination in September 2021, resulting in the recognition of a
one-time
catch-up
expense of $22.9 million relating to cumulative service rendered between the grant date of the respective awards and completion of the Business Combination and continued recognition of expense over the requisite service periods. Historically, we did not recognize share-based compensation expense related to these equity instruments as the liquidity event requirement had not been met and was not deemed probable of being met.
Acquired
in-process
research and development expenses
| 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 | ) |
Acquired
in-process
research and development expenses decreased by $456.2 million to $139.9 million for the year ended March 31, 2022 compared to $596.1 million for the year ended March 31, 2021. The decrease was primarily due to higher consideration for the purchase of IPR&D during the year ended March 31, 2021 as a result of the following: consideration of $399.6 million attributed to IPR&D relating to the acquisition of the business of Silicon Therapeutics; consideration of $116.5 million relating to the stock purchase agreement to acquire Oncopia; $41.4 million attributed to IPR&D as part of the consolidation of Genevant, which was previously accounted for as an equity method investment; and consideration relating to the licensing and strategic collaboration agreement with Affimed N.V. During the year ended March 31, 2022, acquired
in-process
research and development expenses included consideration for the purchase of IPR&D of $82.1 million relating to the acquisition of brepocitinib by Priovant and $14.1 million relating to a license agreement entered by Hemavant Sciences GmbH with Eisai Co., Ltd. Additionally, acquired
in-process
research and development expenses for year ended March 31, 2022 included a
one-time
milestone expense of CAD$50.0 million ($39.3 million) due to the achievement of a development milestone relating to Dermavant’s tapinarof program.
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General and administrative expenses
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | |||||||||
| (in thousands) | |||||||||||
| General and administrative | $ | 775,033 | $ | 259,878 | $ | 515,155 |
General and administrative expenses increased by $515.2 million to $775.0 million for the year ended March 31, 2022 compared to $259.9 million for the year ended March 31, 2021. The increase was primarily due to increases in share-based compensation expense of $438.9 million primarily as a result of the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination in September 2021, resulting in the recognition of a
one-time
catch-up
expense of $350.0 million relating to cumulative service rendered between the grant date of the respective awards and completion of the Business Combination and continued recognition of expense over the requisite service periods. Historically, we did not recognize share-based compensation expense related to these equity instruments as the liquidity event requirement had not been met and was not deemed probable of being met. Additionally, general and administrative expenses for Dermavant have increased as we prepared for commercial launch.
Change in fair value of investments
| Years Ended March 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | |||||||||
| (in thousands) | |||||||||||
| Change in fair value of investments | $ | 87,291 | $ | (95,533 | ) | $ | 182,824 |
Change in fair value of investments was an unrealized loss of $87.3 million and unrealized gain of $95.5 million for the years ended March 31, 2022 and 2021, respectively. The change of $182.8 million was primarily driven by changes in the public share prices of Arbutus and Sio as well as the change in fair value of our investment in Datavant following the completion of the Datavant Merger in July 2021.
Gain on sale of investment
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Gain on sale of investment | $ | (443,754 | ) | $ | — | $ | (443,754 | ) |
Gain on sale of investment was $443.8 million for the year ended March 31, 2022 due to the Datavant Merger in July 2021 at which point we received approximately $320 million in cash and a minority equity stake in the combined company. See “Components of Results of Operations—Gain on sale of investment” above for additional information.
Change in fair value of debt and liability instruments
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Change in fair value of debt and liability instruments | $ | (3,354 | ) | $ | 29,845 | $ | (33,199 | ) |
Change in fair value of debt and liability instruments was an unrealized gain of $3.4 million and unrealized loss of $29.8 million for the years ended March 31, 2022 and 2021, respectively. Change in fair value of debt and liability instruments for the year ended March 31, 2022 primarily consisted of an unrealized gain of $30.8 million
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relating to the warrant and
earn-out
share liabilities issued as part of the Business Combination, partially offset by an unrealized loss of $27.3 million relating to the NovaQuest facility, which was largely due to the passage of time and increased probabilities of success as a result of advancement in the stage of development of the product candidate. Change in fair value of debt and liability instruments for the year ended March 31, 2021 primarily consisted of an unrealized loss of $61.0 million relating to the NovaQuest Facility, partially offset by an unrealized gain of $33.5 million relating to the Sumitomo Options.
Gain on termination of Sumitomo Options
| Years Ended March 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | ||||||||||
| (in thousands) | ||||||||||||
| Gain on termination of Sumitomo Options | $ | (66,472 | ) | $ | — | $ | (66,472 | ) |
Gain on termination of Sumitomo Options was $66.5 million for the year ended March 31, 2022 due to the completion of transactions contemplated by the Asset Purchase Agreement entered into with Sumitomo and SPC. See “Components of Results of Operations—Gain on termination of Sumitomo Options” above for additional information.
Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity
| 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 |
Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity was $5.0 million and $115.4 million for the years ended March 31, 2022 and 2021, respectively. The gain of $5.0 million for the year ended March 31, 2021 resulted from the deconsolidation of a subsidiary. Gain on deconsolidation of subsidiary and consolidation of unconsolidated entity for the year ended March 31, 2021 primarily related to a gain of $86.5 million on the deconsolidation of Datavant in April 2020 and a gain of $28.8 million resulting from the remeasurement of our previously held interest in Genevant upon its consolidation in July 2020.
Liquidity and Capital Resources
For the years ended March 31, 2022 and 2021, we incurred net losses of $924.1 million and $900.2 million, respectively. As of March 31, 2022, we had cash and cash equivalents of approximately $2.1 billion and our accumulated deficit was approximately $2.8 billion. Through March 31, 2022, we have not generated any revenues from the sale of our product candidates. Through our subsidiary Dermavant, we have launched our first commercial product, VTAMA cream, following approval by the FDA in May 2022. Our revenue through March 31, 2022, primarily generated through license agreements as well as from subscription and service-based fees, has not been significant.
Our short-term and long-term liquidity requirements as of March 31, 2022 included:
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | Contractual payments related to our long-term debt (see Note 7, “Long-Term Debt and Loan Commitment” of our audited financial statements); |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | obligations under our operating leases (see Note 12, “Leases” of our audited financial statements); |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | 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 |
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| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | 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. |
Additionally, we have certain payment obligations under various asset acquisition and license agreements. Under these agreements we are required to make milestone payments upon successful completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones, and we will be required to make milestone payments and royalty payments in connection with the sale of products developed under these agreements.
In May 2022, VTAMA (tapinarof) cream was approved by the FDA as the first and only
FDA-approved
steroid-free topical medication in its class for the treatment of plaque psoriasis in adult patients. As a result of FDA approval, Dermavant achieved a regulatory milestone to GSK of £100.0 million (approximately $126 million on the date of achievement), which will be paid within 70 calendar days of FDA approval. Additionally, the first sale of VTAMA cream in May 2022 resulted in the achievement of a milestone to Welichem Biotech Inc. of CAD$25.0 million (approximately $20 million on the date of achievement), which will be paid within 60 calendar days of the invoice date. Dermavant intends to primarily use the RIPSA proceeds for the payment of these obligations.
Apart from the above mentioned regulatory milestones related to VTAMA (tapinarof) cream, the payment obligations under our asset acquisition and license agreements are contingent upon future events and the amount, timing, and likelihood of such payments are not know.
We enter into agreements in the normal course of business with CROs and other vendors for clinical trials and with vendors for preclinical studies and other services and products for operating purposes, which are generally cancelable upon written notice.
We expect our existing cash and cash equivalents will be sufficient to fund our committed operating expenses and capital expenditure requirements for at least the next twelve months based on current operating plans and financial forecasts. However, we have based this estimate on assumptions that may prove to be wrong, which may require us to use our capital resources sooner than expected. See “Forward-Looking Statements” and “Risk Factors” in this Annual Report on Form
10-K.
Our operations to date have been financed primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements.
RSL Equity Financing Transactions
Since inception, we have completed multiple equity financing transactions, including the following:
In December 2019, in connection with the Sumitomo Transaction, we raised net proceeds of approximately $999.2 million in connection with the sale of our common shares to Sumitomo.
In September 2021, we completed our Business Combination with MAAC, a special purpose acquisition company, as well as concurrent PIPE Financing. In connection with the Business Combination and PIPE Financing, we received approximately $213.4 million in cash at closing.
On February 14, 2022, we entered into a committed equity facility (the “Facility”) with an affiliate of Cantor Fitzgerald & Co. (“Cantor”). Under the terms of the Facility, Cantor has committed to purchase up to an aggregate of $250.0 million in our common shares from time to time at our request, subject to certain limitations and the satisfaction of certain conditions. Any sales of our common shares to Cantor under the Facility will be made at 99% of the volume-weighted average price of our common shares on Nasdaq on a given trading day. In
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consideration for entry into the Facility, we paid Cantor an upfront commitment fee in the form of 145,986 common shares. As of March 31, 2022, $250.0 million of our common shares remained available for sale under the Facility.
Sumitomo Transaction
In December 2019, we closed the Sumitomo Transaction, including the transfer of our ownership interest in five Vants—Myovant Sciences Ltd., Urovant Sciences Ltd., Enzyvant Therapeutics Ltd., Altavant Sciences Ltd., and Spirovant Sciences Ltd.—to Sumitovant Biopharma Ltd. (“Sumitovant”), a wholly-owned subsidiary of Sumitomo. In addition, in connection with the Sumitomo Transaction, we (i) granted Sumitomo options to purchase all, or in the case of Dermavant, 75%, of our ownership interests in six other subsidiaries and (ii) provided Sumitomo and Sumitovant with certain rights over and access to our proprietary technology platforms, DrugOme and Digital Innovation. In exchange for these components of the Sumitomo Transaction, we received approximately $1.9 billion in cash, which was in addition to the approximately $999.2 million from the sale of our common shares to Sumitomo as discussed above.
In June 2021, we completed a transaction with Sumitomo pursuant to which Sumitomo terminated its existing options to acquire our equity interests in certain of our subsidiaries. See “Components of Results of Operations—Gain on termination of Sumitomo Options” above for additional information.
Consolidated Vant Equity Financing Transactions
Since inception, we have completed multiple Vant equity financing transactions, including the following:
Immunovant
In December 2019, Immunovant raised $111.0 million (including $5.1 million related to common shares purchased by us) through a business combination with Health Sciences Acquisition Corporation, a special purpose acquisition company.
Additionally, during the years ended March 31, 2021 and 2020, Immunovant issued shares of common stock for an aggregate net proceeds of $384.9 million (including an aggregate of $27.5 million of shares of common stock purchased by us) in private financings, underwritten public offerings, and warrant exercises.
Proteovant
In December 2020, following Proteovant Sciences, Inc’s (“Proteovant”) acquisition of Oncopia in November 2020, SK, Inc. (formerly known as SK Holdings Co., Ltd.) (“SK”) entered into a subscription agreement (the “Subscription Agreement”) pursuant to which SK agreed to make a $200.0 million equity investment in Proteovant, representing an ownership interest of 40.0% on the closing date. In January 2021, in accordance with the terms of the Subscription Agreement, SK made the first payment of $100.0 million to Proteovant. In July 2021, Proteovant collected the subscription receivable relating to the second $100.0 million payment due under the SK Subscription Agreement.
Consolidated Vant Debt Financings
Since inception, we have completed multiple Vant debt financings, including the following:
Dermavant
In May 2019, Dermavant entered into a loan and security agreement (the “Hercules Loan Agreement”) with Hercules, pursuant to which Dermavant borrowed an aggregate of $20.0 million. In May 2021, all amounts outstanding under the Hercules Loan Agreement were repaid using the proceeds from the $40.0 million senior secured credit facility entered into by Dermavant in May 2021, and Dermavant terminated the Hercules Loan Agreement.
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Following the approval of VTAMA cream by the FDA in May 2022, Dermavant received $160.0 million in June 2022 pursuant to the terms of the revenue interest purchase and sale agreement entered with XYQ Luxco, NovaQuest
Co-Investment
Fund XVII, L.P., an affiliate of NovaQuest Capital Management, LLC, and MAM Tapir Lender, LLC, an affiliate of Marathon Asset Management, L.P., together with U.S. Bank National Association, as collateral agent. Under the terms of the RIPSA, the Purchasers procured a capped single-digit revenue interest in net sales of tapinarof for all dermatological indications in the United States, up to a cap of $344.0 million, in exchange for $160.0 million in committed funding to be paid to Dermavant, conditional based on the approval of tapinarof by the FDA. As described above, Dermavant intends to primarily use the RIPSA proceeds for the payment of certain
one-time
milestone obligations that became payable upon the approval and commercialization of VTAMA (tapinarof) cream for the treatment of plaque psoriasis in adult patients in the United States.
Other
Datavant
In July 2021, we received approximately $320 million in cash as a result of the Datavant Merger.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the discovery efforts, preclinical activities, clinical trials and potential commercialization of our product candidates. Additionally, we expect to incur significant commercialization expenses with respect to VTAMA cream. Our operating results, including our net losses, may fluctuate significantly from
quarter-to-quarter
and
year-to-year,
depending on the timing of our planned clinical trials, our expenditures on other research and development activities and our commercialization efforts. We anticipate that our expenses will increase substantially as we:
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | fund the manufacturing of drug substance and drug product of our product candidates in development; |
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|---|---|---|---|
| • | seek to identify, acquire, develop and commercialize additional product candidates; |
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|---|---|---|---|
| • | invest in activities related to the discovery of novel drugs and advancement of our internal programs; |
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|---|---|---|---|
| • | integrate acquired technologies into a comprehensive regulatory and product development strategy; |
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|---|---|---|---|
| • | maintain, expand and protect our intellectual property portfolio; |
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|---|---|---|---|
| • | hire scientific, clinical, quality control and administrative personnel; |
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|---|---|---|---|
| • | add operational, financial and management information systems and personnel, including personnel to support our drug development efforts; |
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|---|---|---|---|
| • | achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties; |
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|---|---|---|---|
| • | seek regulatory approvals for any product candidates that successfully complete clinical trials; |
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|---|---|---|---|
| • | 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 |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | operate as a public company. |
We expect to continue to finance our cash needs through a combination of our cash on hand and future equity offerings, debt financings, sales of subsidiaries, and collaborations, strategic alliances or marketing, distribution, licensing or similar arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of
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these securities may include liquidation or other preferences that adversely affect your rights as a common shareholder. Any agreements for future debt or preferred equity financings, if available, may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution, licensing or similar arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. Adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates, grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves or potentially discontinue operations.
Cash Flows
The following table sets forth a summary of our cash flows for the years ended March 31, 2022 and 2021:
| 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 |
Operating Activities
Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash flow from operating activities is derived from adjusting our net loss for
non-cash
items and changes in working capital.
For the year ended March 31, 2022, cash used in operating activities increased by $125.6 million to $677.7 million compared to the year ended March 31, 2021. This increase was primarily driven by an increase in cash required to fund operations, particularly as a result of the progression of Vant programs and payments made for a
one-time
milestone expense and purchases of clinical product as we prepared for a commercial launch of VTAMA cream and incurred costs associated with our Phase 3 clinical program in atopic dermatitis at Dermavant. Additionally, in November 2021, we made a $50.0 million cash payment related to the previously-disclosed $100.0 million second tranche of consideration due in connection with the acquisition of Silicon Therapeutics, LLC. The remaining consideration was settled by the issuance of 6,348,057 of our common shares.
Investing Activities
Cash flow from investing activities includes cash used for acquisitions, net of cash acquired; proceeds from investments; dispositions, net of cash disposed; capital expenditures; and purchases of equity securities and other investments.
For the year ended March 31, 2022, cash flow from investing activities changed by $335.0 million to net cash provided by investing activities of $303.3 million from net cash used in investing activities of $31.7 million for the year ended March 31, 2021. This change in cash flow from investing activities is primarily due to approximately $320 million in cash we received as a result of the Datavant Merger.
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Financing Activities
For the year ended March 31, 2022, cash provided by financing activities decreased by $149.5 million to $306.8 million compared to the year ended March 31, 2021. During the year ended March 31, 2022, proceeds were generated by the completion of our Business Combination and PIPE financing in September 2021, payment of the subscription receivable due to Proteovant by SK in July 2021, and the senior secured credit facility entered into by Dermavant and certain of its subsidiaries with XYQ Luxco, as lender, and U.S. Bank National Association, as collateral agent, partially offset by cash used to repay all amounts outstanding under a previously existing loan and security agreement with Hercules Capital, Inc. During the year ended March 31, 2021, cash provided by financing activities was primarily driven by the issuance of equity by our majority-owned subsidiaries, Immunovant and Proteovant.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingencies as of the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, or experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known.
We define our critical accounting policies as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles.
While our significant accounting policies are described in more detail in Note 2, “Summary of Significant Accounting Policies” in our consolidated financial statements included elsewhere in this Annual Report on Form
10-K,
we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates. We expense research and development costs as incurred.
We accrue expense for preclinical studies and clinical trial activities performed by vendors based upon estimates of the proportion of work completed. We determine such estimates by reviewing contracts, vendor agreements and purchase orders, and through discussions with our internal personnel and external service providers as to the progress or stage of completion and the agreed-upon fee to be paid for such services. However, actual costs and timing of preclinical studies and clinical trials are highly uncertain, subject to risks, and may change depending upon a number of factors, including our clinical development plan.
We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known at that time. If the actual timing of the performance of services or the level of effort varies from the estimate, the accrual is adjusted accordingly. Nonrefundable advance payments for goods and services are deferred and recognized as expense in the period that the related goods are consumed or services are performed.
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Share-Based Compensation
We recognize compensation costs related to share-based awards granted to employees, directors, and consultants based on the estimated fair value of the awards on the date of grant. The grant date fair value of the stock-based awards is recognized over the requisite service period, which is generally the vesting period of the respective awards. We may grant awards with graded-vesting features. When such awards have only service vesting requirements, we elected to record share-based compensation expense on a straight-line basis. If awards with graded-vesting features contain performance or market conditions, then we record share-based compensation expense using the accelerated attribution method.
We estimate the fair value of stock options using the Black-Scholes option-pricing model, which requires assumptions, including the fair value of our common shares prior to our initial public offering, volatility, the expected term of our stock options, the risk-free interest rate for a period that approximates the expected term of our stock options, and our expected dividend yield. Certain assumptions used in our Black-Scholes option-pricing model represent management’s best estimates and involve a number of variables, uncertainties and assumptions and the application of management’s judgment, as they are inherently subjective. If any assumptions change, our stock-based compensation expense could be materially different in the future.
These subjective assumptions are estimated as follows:
Fair value of common share
—Prior to the closing of the Business Combination, as a privately held company, we estimated the fair value of the shares of common stock underlying our share-based awards on each grant date. To determine the fair value of our common shares underlying option grants, we considered, among other things, valuations of our common share prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The estimation of the fair value of the common shares considered factors including the following:
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the prices of our common shares sold to investors in arm’s length transactions; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the estimated present value of our future cash flows; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | our business, financial condition and results of operations; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | our forecasted operating performance; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | the illiquid nature of our common shares; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | industry information such as market size and growth; |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | market capitalization of comparable companies and the estimated value of transactions such companies have engaged in; and |
| Column 1 | Column 2 | Column 3 | Column 4 |
|---|---|---|---|
| • | macroeconomic conditions. |
We apply a similar methodology to estimate the fair value of the shares of common stock underlying share-based awards issued by our privately held Vants. Following the closing of the Company’s business combination with MAAC, our common shares became publicly traded and we began determining the fair value of each common share underlying share-based awards based on the closing price of our common shares as reported by Nasdaq on the date of grant. Therefore, it will not be necessary to determine the fair value of the new stock-based award pursuant to the methodology described above.
Expected term
—We have generally elected to use the “simplified method” for estimating the expected term of options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option (generally 10 years).
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Expected volatility
—Prior to the closing of the Business Combination, we were a privately held company and did not have any trading history for our common shares; accordingly, the expected volatility was estimated based on the average volatility for comparable publicly traded biotechnology companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based on their similar size, stage in the life cycle or area of specialty. We apply similar methodology to estimate the expected volatility at our privately held Vants. Because we do not have an extended trading history for our shares of common stock since the closing of the Business Combination, the method used to estimate the expected volatility remained unchanged.
Risk-free interest rate
—The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of our stock options at the time of the grant.
Expected dividend yield
—We have not issued any dividends in our history and do not expect to issue dividends over the life of the options; therefore, we have estimated the dividend yield to be zero.
Recently Adopted Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, “Summary of Significant Accounting Policies” in our consolidated financial statements included elsewhere in this Annual Report on Form
10-K.
Implications of Being an Emerging Growth Company and Smaller Reporting Company
We are an “emerging growth company” within the meaning of the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As an emerging growth company, we may take advantage of certain exemptions from various public company reporting requirements, including the requirement that our internal control over financial reporting be audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act, certain requirements related to the disclosure of executive compensation in this Annual Report on Form
10-K
and in our periodic reports and proxy statements, and the requirement that we hold a nonbinding advisory vote on executive compensation and any golden parachute payments. We have also taken advantage of the ability to provide reduced disclosure of financial information in this Annual Report on Form
10-K,
such as being permitted to include only two years of audited financial information and two years of selected financial information in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure. We may take advantage of these exemptions until we are no longer an emerging growth company. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to avail ourselves of this extended transition period, and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies. However, because we have taken advantage of certain reduced reporting requirements, the information contained herein may be different from the information you receive from other public companies in which you hold shares.
We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the date of the first sale of Roivant common shares pursuant to an effective registration statement or (b) in which we have total annual gross revenue of at least $1.07 billion (as adjusted for inflation pursuant to SEC rules from time to time), and (2) the date on which (x) we are deemed to be a large accelerated filer, which means the market value of Roivant common shares that are held by
non-affiliates
exceeds $700 million as of the prior September 30th, or (y) the date on which we have issued more than $1.0 billion in nonconvertible debt during the prior three-year period.
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Additionally, we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation
S-K.
Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common shares held by
non-affiliates
exceeds $250 million as of the end of that year’s second fiscal quarter, or (ii) our annual revenues exceeded $100 million during such completed fiscal year and the market value of our common shares held by
non-affiliates
exceeds $700 million as of the end of that year’s second fiscal quarter. To the extent we take advantage of such reduced disclosure obligations, it may also make comparison of our financial statements with other public companies more difficult.