# Roivant Sciences Ltd.: Form 10-Q for the period ended Jun 30, 2026

- Company: [Roivant Sciences Ltd.](/companies/roiv.md) (CIK 1635088)
- Form: 10-Q
- Filed: 2026-08-06
- Accepted by EDGAR: Aug 6, 2026, 07:28 ET
- Period: 2026-06-30
- Accession: 0001635088-26-000090
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/1635088/000163508826000090/roiv-20260630.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1635088/000163508826000090/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2026-06-30.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Revenue | 3 months, 2026-04-01 to 2026-06-30 | $1.4m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Research and development | 3 months, 2026-04-01 to 2026-06-30 | $202.0m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months, 2026-04-01 to 2026-06-30 | −$366.0m | us-gaap:OperatingIncomeLoss |
| Income tax | 3 months, 2026-04-01 to 2026-06-30 | −$4.0m | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months, 2026-04-01 to 2026-06-30 | −$189.8m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2026-04-01 to 2026-06-30 | −$0.26 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2026-04-01 to 2026-06-30 | −$0.26 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2026-04-01 to 2026-06-30 | 720,776,739 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 3 months, 2026-04-01 to 2026-06-30 | −$270.5m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 3 months, 2026-04-01 to 2026-06-30 | $419.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Share repurchases | 3 months, 2026-04-01 to 2026-06-30 | $206.7m | us-gaap:PaymentsForRepurchaseOfCommonStock |
| Cash and equivalents | at 2026-06-30 | $1.25bn | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2026-06-30 | $4.74bn | us-gaap:AssetsCurrent |
| Total assets | at 2026-06-30 | $5.31bn | us-gaap:Assets |
| Current liabilities | at 2026-06-30 | $283.6m | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2026-06-30 | $384.6m | us-gaap:Liabilities |
| Shareholders' equity | at 2026-06-30 | $4.23bn | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 38,802 characters.

*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, 2026, included in our Annual Report on Form 10-K, filed with the SEC on May 20, 2026 (the “Annual Report”). 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 “Cautionary Note Regarding Forward-Looking Statements” 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 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.

### Pipeline

The following table summarizes selected product candidates from our pipeline:

| Product Candidate | Indication | Vant | Modality | Phase |
| --- | --- | --- | --- | --- |
| Brepocitinib | Dermatomyositis | Priovant | Small Molecule | PDUFA Date 3Q 2026 |
| Brepocitinib | Non-Infectious Uveitis | Priovant | Small Molecule | Phase 3\* |
| Brepocitinib | Cutaneous Sarcoidosis | Priovant | Small Molecule | Phase 3\* |
| Brepocitinib | Lichen Planopilaris | Priovant | Small Molecule | Phase 2b/3\* |
| IMVT-1402 | Difficult-to-Treat Rheumatoid Arthritis | Immunovant | Biologic | Phase 2/3\* |
| IMVT-1402 | Graves’ Disease | Immunovant | Biologic | Phase 2/3\* |
| IMVT-1402 | Myasthenia Gravis | Immunovant | Biologic | Phase 2/3\* |
| IMVT-1402 | Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant | Biologic | Phase 2/3\* |
| IMVT-1402 | Sjögren’s Disease | Immunovant | Biologic | Phase 2/3\* |
| IMVT-1402 | Cutaneous Lupus Erythematosus | Immunovant | Biologic | Phase 2 |
| 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. References to timing under "Phase" are to calendar years. The “Phase” for a specific product candidate referenced above reflects both ongoing clinical trials and expected upcoming trials.*

#### \* Indicates registrational or potentially registrational trials.

### Vant Ownership

The following table summarizes our ownership of certain of our subsidiary companies and affiliates as of June 30, 2026.

| Vant | Roivant Ownership Basic1 |  | Fully Diluted2 |  |
| --- | ---: | ---: | ---: | ---: |
| Priovant | 71% |  | 65% |  |
| Immunovant | 55% | 3 | 52% | 3 |
| Pulmovant | 97% |  | 90% |  |
| Genevant4 | 83% |  | 64% |  |
| Covant | 96% |  | 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.

*4. The reference to “Genevant” in the table above is to Genevant Sciences Ltd. Please see Note 14, “Subsequent Events” for additional detail on the expected distribution to Genevant’s non-Roivant equity holders, including Arbutus, of a portion of the $771.6 million Fixed Payment Genevant received from Moderna in July 2026.*

### 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 |
| Brepocitinib | Priovant | FDA decision on brepocitinib in dermatomyositis | 3Q 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 | Further updates from difficult-to-treat rheumatoid arthritis program | 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 Sjögren’s disease | 2028 |
| IMVT-1402 | Immunovant | Topline data from potentially registrational trial in chronic inflammatory demyelinating polyneuropathy | 2028 |
| Brepocitinib | Priovant | Topline data from Phase 3 trial in cutaneous sarcoidosis | 2028 |
| Brepocitinib | Priovant | Topline data from Phase 2b/3 trial in lichen planopilaris | TBC |

*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.*

### Recent Developments

- **Priovant**: Commercial preparations for brepocitinib in dermatomyositis (“DM”) are progressing well and on track for launch by the end of September 2026. The first patients have been enrolled in the Phase 3 study of brepocitinib in cutaneous sarcoidosis (“CS”). This follows brepocitinib’s Phase 2 study, the first positive placebo-controlled study in CS, which led to FDA Breakthrough Therapy Designation.

The Phase 3 study (BEACON+) will be conducted as a Part B to the positive Phase 2 BEACON trial. BEACON+ will enroll approximately 140 patients with CS across approximately 70 sites globally. Patients will be randomized 3:2 between brepocitinib 45mg once daily and placebo. The primary endpoint is the proportion of patients achieving a 50% or greater reduction in the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity Score (CSAMI-A) at Week 16. In Phase 2, 77% of brepocitinib 45mg patients achieved this endpoint compared to 0% of placebo patients.

CS is an inflammatory granulomatous skin disease affecting approximately 40,000 adults in the United States. The condition disproportionately impacts Black Americans. Unlike many inflammatory skin diseases, inadequately treated cutaneous sarcoidosis can rapidly cause permanent scarring and destruction of bone, cartilage and hair follicles. Despite this significant unmet therapeutic need, there are currently no FDA-approved therapies for CS.

Additionally, enrollment in Part 1 of the Phase 2b/3 study in lichen planopilaris (LPP) is progressing well.

- **Immunovant**: All clinical development timelines remain on track for IMVT-1402 across announced indications, including potentially registrational trials in Graves’ disease (“GD”), myasthenia gravis (“MG”), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (“D2T RA”) and Sjögren’s disease (“SjD”), and a proof-of-concept trial in cutaneous lupus erythematosus (“CLE”).
- **Pulmovant**: Phase 2 study of mosliciguat in pulmonary hypertension associated with interstitial lung disease (“PH-ILD”) remains on track.
- **Genevant**: In July 2026, Genevant Sciences GmbH (“Genevant”) and Arbutus received $950 million from Moderna, the initial payment under the global $2.25 billion patent infringement settlement, and filed new international lawsuits against Pfizer and BioNTech.
- **Roivant**: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $3.9 billion as of June 30, 2026, excluding the cash payment received from Moderna in July, supporting cash runway into profitability. For the three months ended June 30, 2026, Roivant repurchased 7.3 million common shares for an aggregate repurchase price of approximately $208.7 million.

### 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.

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.

### 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 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 8, “Share-Based Compensation” of our financial statements for further details.

### 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.

### Interest income

Interest income consists of interest earned on our cash equivalents and marketable securities.

### Income tax (benefit) expense

Income tax (benefit) 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.

### 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.

### Results of Operations

### Comparison of the three months ended June 30, 2026 and 2025

The following table sets forth our results of operations for the three months ended June 30, 2026 and 2025:

*(in thousands)*

|  | Three Months Ended June 30, 2026 | 2025 | Change |
| --- | ---: | ---: | ---: |
| Revenue | $1,442 | $2,170 | $(728) |
| Operating expenses: |  |  |  |
| Cost of revenues | 284 | 154 | 130 |
| Research and development | 202,016 | 152,919 | 49,097 |
| General and administrative | 165,527 | 134,019 | 31,508 |
| Total operating expenses | 367,827 | 287,092 | 80,735 |
| Gain on litigation settlement | 392 | — | 392 |
| Loss from operations | (365,993) | (284,922) | (81,071) |
| Change in fair value of investments | (36,637) | 19,125 | (55,762) |
| Change in fair value of liability instruments | — | 2,329 | (2,329) |
| Interest income | (36,922) | (48,322) | 11,400 |
| Other expense, net | 2,130 | 11,208 | (9,078) |
| Loss before income taxes | (294,564) | (269,262) | (25,302) |
| Income tax (benefit) expense | (3,958) | 4,649 | (8,607) |
| Net loss | (290,606) | (273,911) | (16,695) |
| Net loss attributable to noncontrolling interests | (100,769) | (50,556) | (50,213) |
| Net loss attributable to Roivant Sciences Ltd. | $(189,837) | $(223,355) | $33,518 |

### Variance analysis for three months ended June 30, 2026 and 2025

### Research and development expenses

For the three months ended June 30, 2026 and 2025, our research and development expenses consisted of the following:

*(in thousands)*

| Program-specific costs: | Three Months Ended June 30, 2026 | 2025 | Change |
| --- | ---: | ---: | ---: |
| Anti-FcRn franchise—endocrine diseases | $42,885 | $19,329 | $23,556 |
| Anti-FcRn franchise—neurological diseases | 25,455 | 20,937 | 4,518 |
| Anti-FcRn franchise—rheumatology diseases | 22,340 | 8,209 | 14,131 |
| Anti-FcRn franchise—dermatology diseases | 7,542 | 5,145 | 2,397 |
| Anti-FcRn franchise—other clinical and nonclinical | 2,609 | 2,392 | 217 |
| Brepocitinib | 14,092 | 15,020 | (928) |
| Mosliciguat | 13,041 | 8,385 | 4,656 |
| Other development and discovery programs | 11,118 | 10,236 | 882 |
| Total program-specific costs | 139,082 | 89,653 | 49,429 |
| Unallocated internal costs: |  |  |  |
| Share-based compensation | 8,721 | 11,099 | (2,378) |
| Personnel-related expenses | 46,354 | 42,530 | 3,824 |
| Other expenses | 7,859 | 9,637 | (1,778) |
| **Total research and development expenses** | $202,016 | $152,919 | $49,097 |

Research and development expenses increased by $49.1 million to $202.0 million for the three months ended June 30, 2026, compared to $152.9 million for the three months ended June 30, 2025. This increase was primarily driven by an increase in program-specific costs of $49.4 million and personnel-related expenses of $3.8 million.

The increase of $49.4 million in program-specific costs was primarily driven by increases of $44.8 million related to the anti-FcRn franchise and $4.7 million related to mosliciguat, reflecting the progression of our programs. The increase of $3.8 million in personnel-related expenses was primarily driven by $4.1 million in employee bonuses related to the global settlement reached with Moderna in March 2026.

The majority of share-based compensation and personnel-related expenses, which are unallocated internal costs, were related to the anti-FcRn franchise activities at Immunovant during the three months ended June 30, 2026 and 2025.

### General and administrative expenses

*(in thousands)*

|  | Three Months Ended June 30, 2026 | 2025 | Change |
| --- | ---: | ---: | ---: |
| General and administrative | $165,527 | $134,019 | $31,508 |

General and administrative expenses increased by $31.5 million to $165.5 million for the three months ended June 30, 2026, compared to $134.0 million for the three months ended June 30, 2025. This increase was primarily due to an increase in personnel-related expense of $26.1 million, largely resulting from $18.8 million in employee bonuses related to the global settlement reached with Moderna in March 2026 and $6.3 million of employer payroll taxes associated with equity award activity.

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):

*(in thousands)*

|  | Three Months Ended June 30, 2026 | 2025 | Remaining Expense as of June 30, 2026 |
| --- | ---: | ---: | ---: |
| Cash Bonus Program | $— | $2,111 | $— |
| Senior Executive Compensation Program: |  |  |  |
| Cash awards | — | 3,660 | — |
| Performance restricted stock units(1) | 38,277 | 30,157 | 103,496 |
| Restricted stock units | 3,361 | 2,307 | 49,498 |
| Stock options | 182 | 174 | 1,385 |
| **Total** | $41,820 | $38,409 | $154,379 |
| (1) As of June 30, 2026, all performance restricted stock units have satisfied the Performance Condition and remain subject to the Service Condition and an additional two-year holding period before such common shares may be sold by the executive (subject to certain customary exceptions). Refer to Note 8, “Share-Based Compensation” of our financial statements for further details. The remaining expense of $103.5 million as of June 30, 2026 will be recognized through June 2027. |  |  |  |

### Change in fair value of investments

*(in thousands)*

|  | Three Months Ended June 30, 2026 | 2025 | Change |
| --- | ---: | ---: | ---: |
| Change in fair value of investments | $(36,637) | $19,125 | $(55,762) |

Changes in fair value of investments were an unrealized gain of $36.6 million and an unrealized loss of $19.1 million for the three months ended June 30, 2026 and 2025, respectively. The change of $55.8 million was driven by changes in the public share price of Arbutus, as well as the change in the fair value of our investment in Datavant.

### Interest income

*(in thousands)*

|  | Three Months Ended June 30, 2026 | 2025 | Change |
| --- | ---: | ---: | ---: |
| Interest income | $(36,922) | $(48,322) | $11,400 |

Interest income decreased by $11.4 million to $36.9 million for the three months ended June 30, 2026, compared to $48.3 million for the three months ended June 30, 2025. The decrease was primarily due to lower cash equivalents and marketable securities balances in our interest-bearing accounts as well as lower interest rates.

### Liquidity and Capital Resources

For the three months ended June 30, 2026 and 2025, we had net losses of $290.6 million and $273.9 million, respectively. As of June 30, 2026, we had cash, cash equivalents and marketable securities of approximately $3.8 billion and our accumulated deficit was $900.4 million. We believe 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. in our Annual Report for the year ended March 31, 2026. 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 June 30, 2026 included:

- obligations under our leases (refer to Note 11, “Leases” in our Annual Report for the year ended March 31, 2026 for further information regarding our lease commitments);
- certain non-cancelable contractual costs accrued as a result of the discontinuation of batoclimab of $42.5 million, which were recognized as research and development expense in prior fiscal years.; and
- certain commitments pursuant to an agreement entered by Immunovant in April 2026 that includes provisions for minimum obligations for the contract manufacturing of IMVT-1402 drug substance. As of June 30, 2026, the minimum commitment was approximately $22.8 million, of which $4.2 million and $18.6 million are expected to be paid during the fiscal years ending March 31, 2027 and 2028, respectively. The agreement includes a variable component whereby service prices may be adjusted based on related commitments for raw materials and other costs, and annual inflationary changes in an applicable price index.

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. We expect to enter into additional asset acquisition and license agreements in the future, which may require upfront payments and long-term commitments of capital resources.

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). During the three months ended June 30, 2026, we repurchased 7,305,646 shares (including 413,183 common shares with trade dates in June 2026 that settled in July 2026) for an aggregate purchase price of approximately $208.7 million (including fees and expenses). Following these repurchases, approximately $681.7 million remains available for share repurchases. During the three months ended June 30, 2025, we repurchased 20,269,450 shares for an aggregate purchase price of approximately $208.3 million (including fees and expenses).

We have historically financed our operations primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements.

Pursuant to the Settlement Agreement with Moderna as described in Note 5, “Recent Transactions and Developments,” our subsidiary, Genevant Sciences GmbH (“Genevant”), received $771.6 million for its portion of the Fixed Payment on July 8, 2026. Genevant’s parent, Genevant Sciences Ltd. (“GSL”), expects to distribute up to $188 million of the Fixed Payment to non-RSL common shareholders of GSL, including Arbutus, and holders of equity awards granted under the GSL 2018 Equity Incentive Plan, through a combination of dividends and dividend equivalent rights payments. In addition, as described in Note 6, “Certain Balance Sheet Components” as of June 30, 2026, we accrued compensation-related expenses of $22.9 million for employee bonus arrangements expected to be paid in relation to the Settlement Agreement.

### 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.

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 our Annual Report for more information.

### Cash Flows

The following table sets forth a summary of our cash flows for the three months ended June 30, 2026 and 2025:

*(in thousands)*

|  | Three Months Ended June 30, 2026 | 2025 |
| --- | ---: | ---: |
| Net cash used in operating activities | $(270,504) | $(204,383) |
| Net cash provided by (used in) investing activities | $281,260 | $(1,085,716) |
| Net cash used in financing activities | $(181,510) | $(187,768) |

### 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 three months ended June 30, 2026, cash used in operating activities increased by $66.1 million to $270.5 million compared to $204.4 million for the three months ended June 30, 2025. This increase was primarily driven by increased spending to advance our research and development programs, including the anti-FcRn franchise and mosliciguat, and to support commercial-readiness activities for brepocitinib. The increase also reflected higher income tax payments during the three months ended June 30, 2026.

### Investing Activities

For the three months ended June 30, 2026, cash flow from investing activities changed by approximately $1.4 billion to net cash provided by investing activities of $281.3 million for the three months ended June 30, 2026 from net cash used in investing activities of $1.1 billion for the three months ended June 30, 2025. This change in cash flow was primarily due to a decrease in purchases of marketable securities, partially offset by a decrease in maturities of marketable securities during the three months ended June 30, 2026.

### Financing Activities

For the three months ended June 30, 2026, cash used in financing activities decreased by $6.3 million to $181.5 million compared to $187.8 million for the three months ended June 30, 2025. This is primarily due to a decrease in repurchases of the Company’s common shares and higher proceeds from stock option exercises, partially offset by higher taxes paid related to net settlement of equity awards during the three months ended June 30, 2026.

### 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 unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The preparation of these unaudited condensed consolidated 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 unaudited condensed consolidated 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.

There have been no significant changes to our critical accounting policies and use of estimates from those disclosed under Management’s Discussion and Analysis of Financial Condition and Results of Operations for the year ended March 31, 2026 in our Annual Report.

## Market risk

As filed, 2,729 characters.

We are exposed to market risks in the ordinary course of our business, primarily related to interest rate sensitivity, foreign currency sensitivity and equity price risk.

#### Interest Rate Sensitivity

As of June 30, 2026, we had cash, cash equivalents and marketable securities of approximately $3.8 billion (or approximately $3.9 billion including restricted cash). Our management team has broad discretion in respect of use of our cash, cash equivalents and marketable securities. The primary objective of our investment activities is to preserve capital to fund our operations. We may use all or a portion of such proceeds for one or more strategic transactions, including acquisitions of companies, asset purchases or sales or in-licensing of product candidates. We also seek to maximize income from our investments without assuming significant risk. To achieve our objectives, we maintain a portfolio of investments in a variety of securities of high credit quality and average short-term duration, according to our board-approved investment policy. Interest income is sensitive to changes in the general level of interest rates; however, due to the nature of our account portfolio, a hypothetical 10% change in interest rates would not have a material effect on our financial condition or unaudited condensed consolidated financial statements.

#### Foreign Currency Sensitivity

Our employees and our operations are currently primarily located in the U.S., and our expenses are generally denominated in U.S. dollars. We therefore are not currently exposed to significant market risk related to changes in foreign currency exchange rates. However, we are exposed to fluctuations in foreign currency exchange rate risk as a result of entering into transactions denominated in currencies other than U.S. dollars as we have contracted with and may continue to contract with foreign vendors and counterparties. A hypothetical 10% change in exchange rates during any of the periods presented would not have a material effect on our financial condition or unaudited condensed consolidated financial statements.

#### Equity Price Risk

As of June 30, 2026, we were exposed to price risk on equity securities included in our portfolio of investments, the most significant of which were our investments in Arbutus and Datavant. Our investments in Arbutus and Datavant are measured at fair value with any changes in fair value recognized in our statements of operations, which therefore may increase the volatility of our earnings. A hypothetical 10% increase or decrease in the fair value of our investments in Arbutus and Datavant would have increased or decreased their fair value as of June 30, 2026 by approximately $44.5 million.

## Controls and procedures

As filed, 2,632 characters.

### Evaluation of Disclosure Controls and Procedures.

We maintain “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), that are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

Disclosure controls and procedures include, without limitation, controls and procedures designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.

Our management, with the participation of our Principal Executive Officer and our Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026, the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2026 at the reasonable assurance level.

### Changes in Internal Control Over Financial Reporting.

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended June 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

### Inherent Limitation on the Effectiveness of Internal Control.

Our management, including our Principal Executive Officer and Principal Financial Officer, does not expect that our disclosure controls and procedures, or our internal controls, will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected.

## Risk factors

As filed, 31,699 characters.

*Our business involves a high degree of risk. You should carefully consider the risks described in “Part I, Item 1A. Risk Factors” of our Annual Report, together with the other information contained in this Quarterly Report, including the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report, as well as the risks, uncertainties and other information set forth in the reports and other materials filed or furnished by us and our majority-controlled subsidiary, Immunovant, Inc. (“Immunovant”), with the SEC. We cannot assure you that any of the events discussed in the risk factors below will not occur. These risks could have a material and adverse impact on our business, prospects, results of operations, financial condition and cash flows. If any such events were to happen, the trading price of our common shares could decline, and you could lose all or part of your investment. Unless the context otherwise requires, references in this section to “we,” “us,” “our,” “Roivant” and the “Company” refer to Roivant Sciences Ltd. and its subsidiaries and affiliates. References to our “product candidates” include our current product candidates and any future products or product candidates. Approval from the U.S. Food and Drug Administration (“FDA”) or other applicable international regulatory authority is required before a product or product candidate may be marketed and sold in the relevant jurisdiction. During the quarter ended June 30, 2026, our risk factors have not changed materially from those described in the Annual Report, except for the risk factors noted below.*

### Risks Related to the Development of Our Product Candidates

***Clinical trials and preclinical studies are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes. We may encounter substantial delays in clinical trials, or may not be able to conduct or complete clinical trials or preclinical studies on the expected timelines, if at all.***

Our biopharmaceutical product candidates that are in clinical development or preclinical studies will require, as applicable, extensive clinical testing before a New Drug Application (“NDA”) or other similar application for regulatory approval, such as a Biologics License Application (“BLA”) or an application for marketing authorization in the European Union (“E.U.”) or United Kingdom (“U.K.”), may be submitted, or extensive preclinical testing before an Investigational New Drug application (“IND”) or an application for authorization to conduct a clinical trial in the E.U. or U.K. may be submitted, a Clinical Trial Application (“CTA”). We cannot provide any assurance that we will submit an IND, NDA, CTA or other similar application for regulatory approval for our product candidates within projected timeframes or whether any such application will be accepted for review or ultimately approved by the relevant regulatory authorities.

We cannot provide any assurance that any clinical trials will be conducted as planned or completed on schedule, if at all. Clinical trials and preclinical studies are very expensive, time-consuming and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time-consuming and costly and is dependent upon collaboration with many contract research organizations (“CROs”) and clinical trial sites. For instance, the FDA, an institutional review board (“IRB”), an Ethics Committee (“EC”) or other regulatory authorities may not agree with the proposed analysis plans or trial design for the clinical trials of our product candidates, and during any such review, may identify unexpected efficacy or safety concerns, which may delay the effective date of an IND or approval of an NDA, BLA or similar application. The FDA, the European Medicines Agency (“EMA”), the European Commission, the Medicines and Healthcare products Regulatory Agency (“MHRA”) or other relevant regulatory authority may also find that the benefits of any product candidate in any applicable indication do not outweigh its risks in a manner sufficient to grant regulatory approval.

The FDA or other regulatory authorities may also not agree with the scope of our proposed investigational plan. For example, they may find that our proposed development program is not sufficient to support a marketing authorization application, or that the proposed indication is considered to be too broad. Moreover, the FDA or other regulatory authorities may also refuse or impose certain restrictions on our reliance on data supporting our clinical trial application or marketing authorization application should such data originate from studies outside of the relevant jurisdiction or be affected by regulatory non-compliance, including issues of data integrity. In the E.U., data derived from clinical trials that were conducted outside the E.U. cannot be used to support a CTA unless the clinical trial was registered on a relevant database. In each case, this could delay the clinical development and authorization timeline for a given product candidate.

Failures can occur at any stage of development, including clinical trials or preclinical studies, and we could encounter problems that cause us to abandon or repeat clinical trials or preclinical studies. In addition, results from clinical trials or preclinical studies may require further evaluation, delaying the next stage of development or submission of an IND or an NDA or similar application in the U.S. or another jurisdiction. Further, product candidates in later stages of clinical trials may fail to show the desired safety and efficacy results despite having successfully progressed through preclinical and earlier stage clinical trials. Such product candidates may exhibit safety signals in later stage clinical trials that they did not exhibit in earlier studies or trials. A number of companies in the biopharmaceutical industry have suffered significant setbacks in, or the discontinuation of, advanced clinical trials with a product candidate due to lack of efficacy or adverse safety findings, despite having promising results in earlier trials or studies. Likewise, the results of early clinical trials or preclinical studies of our product candidates may not be predictive of the results of current or future development programs. There can also be no assurance that the results of studies conducted by collaborators or other third parties with similar product candidates in similar indications will be viewed favorably or indicative of our own future trial results.

The commencement and completion of clinical trials and other studies may be delayed by several factors, including:

- the inability to generate sufficient data to support the initiation or continuation of clinical trials;
- difficulty identifying patients and enrolling them in clinical trials and other studies, including as a result of competing trials run by other pharmaceutical companies;
- the failure to add, or delays in activating, a sufficient number of clinical trial sites;
- the inability to reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
- the failure by our CROs or other third parties to adhere to clinical trial agreements;
- the failure to manufacture or release sufficient quantities of our product candidates or failure to obtain sufficient quantities of active comparator medications for our clinical trials, if applicable, that in each case meet our quality standards, for use in clinical trials;
- the inability or unwillingness of clinical investigators or study participants to follow our clinical and other applicable protocols or applicable regulatory requirements;
- unforeseen safety issues, or subjects experiencing severe or unexpected adverse events;
- a lack of clinical benefit or effectiveness being demonstrated during clinical trials;
- the occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors;
- premature discontinuation of study participants from clinical trials or missing data;
- the inability to monitor patients adequately during or after treatment;
- inappropriate unblinding of trial results;
- changes in the market that render continued development of a product candidate no longer reasonable or commercially attractive;
- the cost of clinical trials of our product candidates being greater than we anticipated;
- unanticipated impact from changes in or modifications to protocols or clinical trial design, including those that may be required by the FDA or other regulatory authorities;
- changes to our statistical analysis plans or the method of calculating primary or secondary endpoints, including changes required by, or subsequently rejected by, the FDA or other regulatory authorities;
- the failure to obtain regulatory authorization to commence a clinical trial or reach consensus with regulatory authorities regarding the design or implementation of our studies;
- resolving any dosing issues, including those raised by the FDA or other regulatory authorities;
- changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;
- changes in the approval policies or regulations of the FDA or other regulatory authorities;
- an IRB or EC refusing to approve, suspending, or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; or
- other regulatory issues, including the receipt of any inspectional observations on FDA’s Form-483, Warning or Untitled Letters, clinical holds or complete response letters or similar communications/objections by other regulatory authorities.

We, the FDA or other regulatory authorities may suspend our clinical trials in an entire country at any time, or an IRB/EC may suspend our clinical trial sites within any country, if it appears that we or our collaborators, or the principal investigator, are failing to conduct a trial in accordance with the protocol, applicable regulatory requirements, including Good Clinical Practice (“GCP”) regulations, that we are exposing participants to unacceptable health risks, or if the FDA or other regulatory authority finds deficiencies in our IND or equivalent applications for other countries or in the manner in which clinical trials are conducted. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, the competent authorities of the E.U. Member States and the U.K. or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a clinical benefit from using a product candidate, changes in governmental regulations or administrative actions, developments on trials conducted by us or our competitors for related technology that raises regulatory concerns about risk to patients of the technology broadly, or lack of adequate funding to continue the clinical trial. Therefore, we cannot predict with any certainty the schedule for commencement and completion of future clinical trials.

If we experience delays in the commencement or completion of our clinical trials, or if we terminate a clinical trial prior to completion, the commercial prospects of our product candidates could be harmed, and our ability to generate product revenue from any of our product candidates, if approved, may be delayed. In addition, any delays in our clinical trials could increase our costs, cause a decline in our share price, slow down the approval process, and jeopardize our ability to commence product sales and generate revenue. Any of these occurrences may harm our business, financial condition and results of operations. In addition, many of the factors that cause or lead to a termination or suspension of, or delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. We may make formulation or manufacturing changes to our product candidates, in which case we may need to conduct additional preclinical or clinical studies to bridge our modified product candidates to earlier versions. Any delays to our clinical trials that occur as a result could shorten any period during which we may have the exclusive right to commercialize our product candidates and our competitors may be able to bring product candidates to market before we do, and the commercial viability of our product candidates could be significantly reduced.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or other regulatory authorities. The FDA or other regulatory authorities may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected the integrity of the study. The FDA or other regulatory authorities may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing and authorization applications by the FDA or other regulatory authorities, as the case may be, and may ultimately lead to the denial of marketing approval of any of our product candidates.

In addition, for our product candidates that are in clinical development, prior to our acquisition of the rights to those product candidates we had no involvement with or control over the preclinical or clinical development of those product candidates. We are therefore dependent on our licensing and other transaction partners having conducted such research and development in accordance with the applicable protocols and legal, regulatory and scientific standards, having used appropriately regulated and compliant equipment and devices during the preclinical or clinical development, having accurately reported the results of all clinical trials and other research they conducted prior to our acquisition of the rights to those product candidates, having correctly collected and interpreted the data from these trials and other research and having supplied us with complete information, data sets and reports required to adequately demonstrate the results reported through the date of our acquisition of these product candidates. Problems associated with the pre-acquisition development of our product candidates could result in increased costs and delays in the commercialization or development of our product candidates, which could harm our ability to generate any future revenue from sales of our product candidates following regulatory approval.

***Interim, preliminary or topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.***

From time to time, we may publicly disclose interim, preliminary or topline data from our clinical trials, which are based on a preliminary analysis of then-available data. These results and related findings and conclusions are subject to change following a full analysis of all data related to the particular trial.

We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, preliminary and topline results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the topline data we previously reported. As a result, interim, preliminary and topline data should be viewed with caution until the final data are available. Interim data are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse differences between interim, preliminary or topline data and final data could significantly harm our business prospects. Further, disclosure of preliminary or interim data by us or by our competitors could result in increased volatility in the price of our shares.

Further, other parties, including our collaborators or regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of a particular product candidate and our business in general.

In addition, our analyses, interpretations, and presentation of clinical trial data may evolve over time, including through changes to primary or secondary endpoints, statistical methods, endpoint hierarchies, or the methodologies used to calculate or present them. We may make these changes to ongoing studies. We may also conduct post-hoc, retrospective, subgroup or other modified data or statistical analyses after database lock or unblinding of a clinical trial. Regulatory authorities may give less weight to, or decline to accept, results based on such changes or analyses conducted thereafter, including on the basis that such changes in endpoints or analytical methodology are not adequately justified, which could adversely affect our ability to obtain regulatory approval.

In addition, the information we choose or are required to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure. Any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate or our business. If the interim, preliminary or topline data that we report differ from later, final or actual results, or if others, including our collaborators or regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for and commercialize our product candidates and our business, operating results, prospects or financial condition may be harmed.

### Risks Related to Our Intellectual Property

***We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.***

Competitors may infringe, misappropriate or otherwise violate our patents, the patents of our licensors or our other intellectual property rights. To counter infringement or unauthorized use, we may be required to file and prosecute legal claims against one or more third parties, which can be expensive and time-consuming, even if ultimately successful.

In February 2022, Roivant’s subsidiary GSG and Roivant’s affiliate Arbutus filed a lawsuit in the U.S. District Court for the District of Delaware against Moderna and an affiliate seeking damages for infringement of certain patents, including U.S. Patent Nos. 8,492,359, 9,364,435, 9,504,651 and 11,141,378, in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19 (the “U.S. Moderna Action”). In 2025, GSG and Arbutus filed five international lawsuits against Moderna targeting alleged infringing activity with respect to Moderna’s vaccine for COVID-19 in 30 countries (the “Moderna International Actions” and, together with the U.S. Moderna Action, the “Moderna Actions”). On March 3, 2026, GSG and, solely for certain purposes, Genevant, and Arbutus entered into a settlement agreement with Moderna Inc. and Moderna TX, Inc. (the “Settlement Agreement”) to resolve the Moderna Actions. Under the Settlement Agreement, Moderna made a $950 million aggregate lump sum payment to GSG and Arbutus on July 8, 2026, including $771.6 million to GSG. In addition, as described in more detail below, Moderna agreed to make an additional aggregate lump sum payment of up to $1.3 billion (the “Contingent Payment”) to GSG and Arbutus, contingent on the outcome of Moderna’s appeal of the District Court’s rejection of Moderna’s affirmative defense under 28 U.S.C. § 1498. Briefing of Moderna’s appeal with the U.S. Court of Appeals for the Federal Circuit (the “Federal Circuit”) was completed in July 2026, with oral arguments before the Federal Circuit expected to take place in 2027.

Under the terms of the Settlement Agreement, Moderna will make the Contingent Payment to GSG and Arbutus (i) if the Federal Circuit affirms, or if there is a final non-appealable judgment that affirms, the rejection of Moderna’s affirmative defense pursuant to § 1498 by the District Court in its entirety or otherwise holds that § 1498 does not bar GSG’s and Arbutus’s claim against Moderna as to either or both of direct infringement and indirect infringement with respect to all of the doses subject to Moderna’s appeal, or (ii) upon a voluntary dismissal of Moderna’s appeal (any of the foregoing under (i) or (ii), a “GSG/Arbutus § 1498 Victory”).

The receipt of the Contingent Payment is subject to a number of risks and uncertainties that could impact the amount and timing of any proceeds received by GSG and Arbutus. If the Federal Circuit determines that § 1498 bars GSG’s and Arbutus’s direct and indirect infringement claims with respect to all doses subject to Moderna’s appeal, no Contingent Payment will be owed to GSG and Arbutus. If § 1498 is found to bar claims only with respect to some of such doses, the Contingent Payment will be prorated and the precise amount of the Contingent Payment could be subject to dispute if the Federal Circuit’s ruling does not clearly articulate the number of affected doses, potentially requiring binding arbitration to resolve. We cannot predict the timing or outcome of the § 1498 Appeal. Even if GSG and Arbutus receive the Contingent Payment following a favorable appellate outcome, as described above, GSG and Arbutus would be required to return the Contingent Payment to Moderna, plus interest, if the favorable outcome were to be subsequently overturned in Moderna’s favor in a final non-appealable decision. The obligation to potentially return the Contingent Payment, together with interest, could have a material adverse effect on our consolidated financial condition if such a repayment obligation were to arise after the proceeds are deployed or distributed.

More broadly, litigation settlement agreements involve inherent risks and uncertainties. For example, Moderna could default on, or otherwise fail to make, the Contingent Payment under certain circumstances. In addition, the terms of the Settlement Agreement represent a final resolution of the Moderna Actions. GSG and Arbutus will have no further ability to seek additional damages from Moderna in connection with the licensed products and activities covered by the Settlement Agreement, even if circumstances change or additional infringing activities are discovered that fall within the scope of the license. The mutual releases contained in the Settlement Agreement extinguish claims that might otherwise have been available to GSG and Arbutus. In addition, the Settlement Agreement resolves only the disputes between GSG and Arbutus, on the one hand, and Moderna and its affiliates, on the other, and does not affect other pending litigation, including the Pfizer Actions described below, which remain ongoing and subject to its own risks and uncertainties.

In April 2023, GSG and Arbutus filed a lawsuit in the U.S. District Court for the District of New Jersey against Pfizer and BioNTech seeking damages for infringement of U.S. Patent Nos. 9,504,651, 8,492,359, 11,141,378, 11,298,320 and 11,318,098 in the manufacture and sale of COMIRNATY (the “U.S. Pfizer Action”). In July 2023, Pfizer and BioNTech filed an answer. The court held a claim construction hearing in the U.S. Pfizer Action in December 2024. In

September 2025, the court issued its claim construction ruling, which construed the disputed claim terms in a manner that GSG generally considers to be favorable. In July 2026, Arbutus and GSG filed three international lawsuits against Pfizer and BioNTech — one in Canada and two before the Unified Patent Court (the “UPC”) — seeking monetary relief as well as injunctions against Pfizer and BioNTech’s mRNA-LNP COVID-19 vaccines and any other products that would infringe the asserted patents, which include Canadian Patent No. 2,721,333, EP 4 241 767 and EP 4 495 237 (the “International Pfizer Actions” and, together with the U.S. Pfizer Action, the “Pfizer Actions”). The UPC actions seek relief across 20 European countries which, together with the Canadian action, cover 21 jurisdictions in total. We cannot predict the timing or outcome of these matters, and there is no assurance that the resolution of the Moderna Actions will be predictive of the outcome of the litigation against Pfizer and BioNTech.

In an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. The standards that courts use to interpret patents are not always applied predictably or uniformly and can change, particularly as new technologies develop. As a result, we cannot predict with certainty how much protection, if any, will be given to our patents if we attempt to enforce them and they are challenged in court and if any such suits, including the Pfizer Actions, will ultimately be resolved successfully. In particular, there is no assurance that the resolution of the Moderna Actions will be predictive of the outcome of the Pfizer Actions. Further, even if we prevail against an infringer in U.S. district court, there is always the risk that the infringer will file an appeal and the district court judgment will be overturned at the appeals court and that an adverse decision will be issued by the appeals court relating to the validity or enforceability of our patents. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly in a manner insufficient to achieve our business objectives, or could put our patent applications at risk of not issuing. The initiation of a claim against a third party may also cause the third-party to bring counter claims against us such as claims asserting that our patents are unpatentable, invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of written description, or non-statutory subject matter as well as for double-patenting. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution or that inventorship of the patent was incorrectly named. Third parties may also raise similar validity or unpatentability claims before the USPTO in post-grant proceedings such as ex parte reexaminations, IPR or post-grant review, or oppositions or similar proceedings outside the U.S., in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of unpatentability, invalidity and unenforceability is unpredictable. We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For the patents and patent applications that we have in-licensed, we may have limited or no right to participate in the defense of any licensed patents against challenge by a third party. If a defendant were to prevail on a legal assertion of unpatentability, invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our product candidates. Such a loss of patent protection could harm our business. Additionally, any adverse outcome could allow third parties to commercialize our product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products, if approved, without infringing third-party patent rights.

Even if we establish infringement, we may not seek, or the court may decide not to grant, an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. We may not be able to detect or prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the U.S. Any litigation or other proceedings to enforce our intellectual property rights may fail and, even if successful, may result in substantial costs and distract our management and other employees.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our common shares.

We may not have sufficient financial or other resources to adequately conduct the Pfizer Actions or any other such litigation or proceedings. Some of our competitors or other third parties may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Because of the expense and uncertainty of litigation, we may conclude that even if a third party is infringing our issued patent, any patents that may be issued as a result of our pending or future patent applications or other intellectual property rights, the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best interest of our company or our shareholders. In such cases, we may decide that the more prudent course of action is to simply monitor the situation or initiate or seek some other non-litigious action or solution.

Filed Aug 6, 2026.
Source: SEC EDGAR, the filing index for accession 0001635088-26-000090. Last ingested by Listed: Nov 5, 2026, 14:01 ET. No prices; not investment advice.