Slides
Page 1
Financial Results and Business Update for the Quarter Ended June 30, 2025 August 11, 2025
Page 2
2 Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, potential uses of cash and capital allocation, research and development plans, the anticipated timing, costs, design, conduct and results of our ongoing and planned preclinical studies and clinical trials for our product candidates, and any commercial potential of our product candidates following applicable regulatory approvals, are forward-looking statements. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this presentation and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward -looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements. These forward-looking statements may be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the sections captioned “Risk Factors” and “Forward-Looking Statements” of our filings with the U.S. Securities and Exchange Commission, available at www.sec.gov and investor.roivant.com. We operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this presentation, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward -looking statements, whether as a result of new information, future events or otherwise. This presentation includes data for brepocitinib as compared to certain other potential competitor products generated from separate, independent studies and that do not come from head-to-head analyses. Differences exist between study or trial designs and subject characteristics and caution should be exercised when comparing data across studies. Data regarding other products is based on publicly available information. Non-GAAP Financial Information The discussions during this conference call will include certain financial measures that were not prepared in accordance with U.S. generally accepted accounting principles (GAAP). Additional information regarding non-GAAP financial measures can be found on slide 23 and in our earnings release furnished with our Current Report on Form 8 -K dated August 11, 2025. Any non-GAAP financial measures presented are not, and should not be viewed as, substitutes for financial measures required by U.S. GAAP, have no standardized meaning prescribed by U.S. GAAP and may not be comparable to the calculation of similar measures of other companies. Disclaimer This presentation is intended for the investor community only; it is not intended to promote the product candidates referenced herein or otherwise influence healthcare prescribing decisions. For investor audiences only
Page 3
3 Agenda Roivant in 2025 Brepocitinib Updates LNP Litigation Financial Update Q&A For investor audiences only
Page 4
Roivant in 2025
Page 5
Roivant in 2025: Transformational Potential 5Note: All references are to calendar years and are approximate and subject to change. The timing of the litigation-related events noted above is subject to change, including at the discretion of the court. See Slide 2 for further information on these forward- looking statements. The court in the Pfizer/BioNTech case has not provided guidance for the timing of its ruling for the Markman hearing, which could potentially be in 2025 Validate IMVT-1402 First- /Best-in-Class Potential Bato MG & CIDP data further validate “Deeper is Better”; TED data expected 2H ‘25 Focused execution on 6 announced IMVT-1402 indications Registrational Dermatomyositis (DM) Readout Sets Stage for Commercial Launch of Brepocitinib Pivotal study would enable brepocitinib to be first novel oral DM drug with multi-year lead over any other late-stage program Advance LNP Litigation with Moderna and Pfizer/BioNTech Summary judgment phase ongoing in US Moderna case; jury trial scheduled for March 2026 Ongoing progress expected in Pfizer/BioNTech case following Markman hearing For investor audiences only
Page 6
6 Robust Late-Stage Pipeline with 11 Registrational Trials in Indications with Blockbuster Potential Focusing on Clinical Trial Execution to Drive Significant Potential Value Note: Trials listed as registrational include those that we believe are potentially registrational For investor audiences only Modality Proof of Concept Registrational Status BREPOCITINIB Dermatomyositis | Priovant Small Molecule Topline expected 2H 2025 BREPOCITINIB Non-Infectious Uveitis | Priovant Small Molecule Actively Enrolling BREPOCITINIB Cutaneous Sarcoidosis | Priovant Small Molecule ► Actively Enrolling IMVT-1402 Graves’ Disease | Immunovant Biologic Actively Enrolling IMVT-1402 Difficult-to-Treat Rheumatoid Arthritis | Immunovant Biologic Actively Enrolling IMVT-1402 Myasthenia Gravis | Immunovant Biologic Actively Enrolling IMVT-1402 Sjögren’s Disease | Immunovant Biologic Actively Enrolling IMVT-1402 Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant Biologic Actively Enrolling IMVT-1402 Cutaneous Lupus Erythematosus | Immunovant Biologic ► Actively Enrolling BATOCLIMAB Thyroid Eye Disease | Immunovant Biologic Topline expected 2H 2025 MOSLICIGUAT Pulmonary Hypertension associated with Interstitial Lung Disease | Pulmovant Inhaled ► Actively Enrolling ONGOING BD Pipeline Expansion Opportunities | Roivant
Page 7
7 Upcoming Brepocitinib Data in DM Kicks Off 36 Months Stacked with Potential Readouts and Launches Note: Figure is illustrative of potential registrational data readouts and product launches and is not intended to be representative of timelines on the events noted. Trials listed as registrational include those that we believe are potentially registrational Launch of Brepocitinib in DM Launch of Brepocitinib in NIU Launch of IMVT-1402 in Multiple Potential Blockbuster Indications Brepocitinib Registrational Data Readouts IMVT-1402 Registrational Data Readouts DM NIU D2T RA GD MG SjD CIDP For investor audiences only
Page 8
8 Completed $1.5BN Share Repurchase Program in June 2025 1. Issued and outstanding share count on 6/30/2025 as compared to Issued and outstanding share count as of 3/31/2024 Reduced Share Count Repurchased ~149M shares at an average price of $10.09, reducing share count by >15%1 Executed on Organic Growth Opportunities In same period, expanded pipeline with the initiation of 6 potentially registrational studies and 3 POC studies Increased Exposure to ROIV Catalysts Increased shareholder exposure to clinical and litigation catalysts over the next 36 months Potential for Additional Return Board authorized an additional $500M share repurchase program; plan to continue evaluating for opportunistic use For investor audiences only
Page 9
9 Continued Development Progress Across Pipeline Note: All references are to calendar years and are approximate and subject to change. The timing of the litigation-related events noted above is subject to change, including at the discretion of the court. See Slide 2 for further information on these forward- looking statements 1. The court in the Pfizer/BioNTech case has not provided guidance for the timing of its ruling for the Markman hearing, which could potentially be in 2025 Advancing Brepocitinib Across Indications • Completed last patient last visit in July for VALOR, a global Phase 3 study of brepocitinib in dermatomyositis; topline data expected 2H 2025 • Rapidly enrolling potentially registrational trials in non-infectious uveitis and proof-of-concept in cutaneous sarcoidosis For investor audiences only Focusing on Clinical Execution of IMVT-1402 • Continued excitement around Graves’ disease; initiated 2nd potentially registrational trial • Additional data from batoclimab Phase 2 trial in Graves’ disease, including 6-month remission data to be presented at ATA in September • Initiated potentially registrational trial in Sjögren’s disease Continuing Progress in LNP Litigation • Summary judgement phase ongoing in US Moderna case; jury trial scheduled for March 2026 • Ongoing progress in 5 international cases against Moderna • Pfizer/BioNTech Markman decision expected in 2025 1
Page 10
Brepocitinib Updates
Page 11
1. Overall study N represents patients randomized to all brepocitinib dose levels or placebo and excludes patients randomized to other agents 2. Includes patients from initial 24-week study period only 3. 60 mg QD for 4 weeks followed by 30 mg QD for 20 weeks 4. Brepocitinib 45 mg once daily was the only brepocitinib dose evaluated in this study 5. Brepocitinib 60 mg once daily was the only brepocitinib dose evaluated in the induction period of this study Note: The failed SLE study was conducted by Pfizer. All other studies on the left-hand side timeline were conducted by Priovant. Out of the seven positive phase 2 studies on the right-hand side table, the non-infectious uveitis study was conducted by Priovant, and all others were conducted by Pfizer. 11 Rapid Expansion of Brepocitinib Program into Multiple Orphan Immunological Conditions with Well Established Safety Profile Across >1,500 Patients 4Q 2023 Pfizer SLE Ph2b trial failed to meet primary endpoint 3Q 2021 Priovant established by Roivant licensing brepo from Pfizer 3Q 2022 Initiated pivotal trial in DM and POC trial in NIU 1Q 2024 NIU Ph2 readout showing potential best- in-indication efficacy 3Q 2024 Initiated pivotal trial in NIU 2Q 2025 Initiated POC trial in CS Psoriatic Arthritis Patients with active PsA Study Population N1 Plaque Psoriasis Patients with moderate-to-severe PsO Ulcerative Colitis Patients with moderate-to-severe UC Alopecia Areata Patients with moderate-to-severe AA Hidradenitis Suppurativa Patients with moderate-to-severe HS 218 212 167 94 2 100 Brepocitinib Dose 30 mg once daily 30 mg once daily 30 mg once daily 30 mg once daily3 45 mg once daily4 Seven Positive Phase 2 Studies Crohn’s Disease Patients with moderate-to-severe CD 151 60 mg once daily 5 Non-infectious Uveitis Patients with active non-infectious intermediate-, posterior-, and panuveitis 26 45 mg once daily Roivant’s Rapid Expansion of Brepocitinib For investor audiences only
Page 12
12 Brepocitinib Could Redefine SoC for Patients with Dermatomyositis (DM) • Dermatomyositis is a chronic inflammatory disease of the skin and muscles that affects >40K US adults; DM skin and muscle disease is debilitating to patients’ quality of life • Patients are heavily treated with high-dose chronic steroids and immunosuppressive therapies, with limited efficacy • Brepo is only oral therapy in late-stage development and could be first advanced novel approved therapy of any modality for patients with DM DM is a debilitating disease with significant unmet medical need VALOR Study is designed to potentially establish brepocitinib as a new SoC in DM • Strong clinical and pharmacologic rationale for TYK2/JAK1 inhibition in DM • VALOR is largest interventional DM trial ever conducted, with clinically relevant endpoints and enrolled patient population representative of real-world DM population • Strong success seen with steroid taper during study (blinded/pooled) For investor audiences only SoC = Standard of Care
Page 13
13 VALOR: A Single Phase 3 Study of Brepocitinib in Adults with Dermatomyositis Pivotal study fully enrolled with topline data expected 2H 2025 Primary Endpoint • 30 mg vs placebo mean Total Improvement Score (TIS) at Week 52 Secondary Endpoints Include • TIS responder analyses • CDASI-A • DMOMS Brepocitinib 15 mg QD Double-blind treatment (52 weeks) Brepocitinib 30 mg QD Open-label extension (52 weeks) Baseline Adults with active DM N = 241 • US: 38% • EU: 32% • ROW: 30% Placebo Week 52: Primary Endpoint 1:1:1 Randomization For investor audiences only Endpoints Assessed Approximately 1x Per Month Note: Brepocitinib is investigational and subject to regulatory approvals. All catalyst timings are based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. All references are to calendar years. CDASI: Cutaneous Dermatomyositis Disease Area and Severity Index DMOMS: Dermatomyositis Outcomes for Muscle and Skin
Page 14
14 VALOR Pooled/Blinded Baseline Characteristics, Compared to ProDERM (IVIg Phase 3 Trial) Pooled VALOR enrolled similar patient population, with modestly higher proportion of patients having severe disease 1. Aggarwal et al, NEJM (2022) VALOR (N = 241) ProDERM1 (N = 95) Disease Activity (by Physician Global Activity) Mild 45 (19%) 26 (27%) Moderate 142 (59%) 56 (59%) Severe 54 (22%) 13 (14%) Median Time Since Diagnosis (years) 3.0 2.6 Mean MMT-8 (Max score = 150, lower scores indicate more weakness) 122.6 120.9 Mean CDASI-A (Max score = 100, higher scores indicate more severe disease) 19.8 18.9 CDASI-A > 14 146 (61%) 51 (54%) For investor audiences only All VALOR data are pooled and blinded to sponsor and investigators. Data extracted prior to final database lock are preliminary and subject to change. Data reflects cross-trial comparisons and not data from head-to-head studies. Differences exist between trial designs and participant characteristics and caution should be exercised when comparing data a cross trials.
Page 15
15 Steroid Tapering Was A Key Focus of VALOR Study ICE = Intercurrent Event 1. Observed patients to date Protocol Requirements • Mandatory taper to ≤5 mg/day for any subjects on >5 mg/day at baseline (N = 133) • Encouraged taper off steroids altogether for all subjects on background OCS (N = 181) Among Subjects Taking OCS at Baseline Without ICE Mean OCS Dose Baseline End of Study1 ~12 mg/day ~2.5 mg/day Proportion Achieving OCS Dose Reduction >50% from BL >85% Proportion Achieving OCS Dose Reduction >75% from BL >60% Proportion Eliminating OCS Entirely >40% Success Rate of Mandatory Taper >98% All clinical improvement demonstrated in VALOR results will be against the backdrop of significant reductions in harmful steroid exposure For investor audiences only All VALOR data are pooled and blinded to sponsor and investigators. Data extracted prior to final database lock are preliminary and subject to change.
Page 16
Brepocitinib Dazukibart Efgartigimod Anifrolumab Phase 3 Top Line Readout* 2H 2025 2H 2026 2H 2026 1H 2027 Route of Administration Oral IV SC SC Increasing Pharma Recognition of Commercial Opportunity in DM with Brepocitinib Well Ahead of the Pack and Only Oral Option in Phase 3 For investor audiences only 16 Phase 2 DM Clinical Program Initiations Since VALOR Study Start Note: All drugs are investigational and subject to regulatory approvals. All timings are based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. All references are to calendar years. Note: All trademarks are property of their respective owners *Phase 3 top line readouts per ClinicalTrials.gov
Page 17
17 Brepocitinib: Expected Upcoming Events For investor audiences only 2H 2026 Proof of Concept data from CS study 2H 2025 VALOR study readout for brepo in DM 1H 2027 Topline data readout from pivotal study in NIU 2H 2027 Potential regulatory filing of brepo for use in NIU Early 2027 Potential brepo approval and launch in DM Early 2026 Potential regulatory filing of brepo for use in DM Additional opportunities evaluation and pivotal study progression based on PoC data Note: Brepocitinib is investigational and subject to regulatory approvals. All catalyst timings are based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. All references are to calendar years.
Page 18
LNP Litigation
Page 19
19 Pivotal Period for LNP Litigation Note: All references are to calendar years and are approximate and subject to change. The timing of the litigation-related events noted above is subject to change, including at the discretion of the court. See Slide 2 for further information on these forward-looking statements Note: The court in the Pfizer/BioNTech case has not provided guidance for the timing of its ruling for the Markman hearing, which could potentially be in 2025 Moderna Cases Pfizer Case For investor audiences only Pre-trial process to narrow scope of claims and defenses Summary judgment phase ongoing First major international hearings expected in 1H 2026 US jury trial scheduled for March 2026 Ongoing progress in discovery phase Markman hearing held in December 2024; Markman ruling could come in 2025
Page 20
20 Summary Judgment Motions Filed in US Moderna Case Note: The timing of the litigation-related events noted above is subject to change, including at the discretion of the court. See Slide 2 for further information on these forward-looking statements Genevant and Arbutus Filed 3 Motions for Summary Judgment 1. Moderna cannot relitigate obviousness arguments against the Lipid Composition Patents (the ’359, ’435, and ’378 patents) already raised in its unsuccessful IPRs and appeals 2. Moderna cannot argue at trial that the Asserted Patents are invalid because they do not enable someone in the art to practice the inventions without undue experimentation 3. Arbutus and Genevant did not derive the invention disclosed in the ’651 patent from a much later Moderna invention Moderna Filed 3 Motions for Summary Judgment 1. 28 U.S.C. § 1498 requires Arbutus and Genevant to recover damages for infringement under one government contract from the U.S. government, not Moderna 2. Plaintiffs’ claims under the doctrine of equivalents are barred by amendments and arguments made to the PTO during patent prosecution, and Arbutus and Genevant should be able to recover for literal infringement only 3. The asserted claims of the ’651 patent are invalid for indefiniteness with respect to the Court’s construction of the term “fully encapsulated” Asserted Patents (Following Initial Claim Narrowing) Other Developments and Upcoming Dates • The case has been assigned to a new judge in the same court; jury trial continues to be scheduled in March 2026 8/22: Oppositions to summary judgment motions due 9/5: Replies in support of summary judgment motions due 9/19: Plaintiffs’ sur-replies to indefiniteness and § 1498 liability due Subject Matter US Patent No. Lipid Composition 8,492,359 9,364,435 11,141,378 mRNA-LNP Composition 9,504,651 For investor audiences only
Page 21
Financial Update
Page 22
22 Key Financial Items Note: For a reconciliation of each non-GAAP financial metric to the comparable GAAP financial metric, please see slide 23 For investor audiences only • R&D expense of $153M; adjusted R&D expense of $141M (non-GAAP) • Includes $0.5M of one-time cash bonus expense • G&A expense of $134M; adjusted G&A expense of $63M (non-GAAP) • Includes $5.8M of one-time cash bonus expense • Loss from continuing operations, net of tax of $274M; adjusted loss from continuing operations, net of tax of $170M (non-GAAP) Select Income Statement Metrics and Non-GAAP Metrics for the Three Months Ended June 30, 2025 • Cash, cash equivalents, restricted cash and marketable securities of $4.5BN as of June 30, 2025 • No debt on balance sheet as of June 30, 2025 • 682,881,743 common shares issued and outstanding as of August 6, 2025 • 20.3M common shares repurchased for $208.3M in the 3 months ended June 30, 2025 • 148.6M common shares repurchased for $1.5BN since March 31, 2024 Select Balance Sheet Metrics as of June 30, 2025
Page 23
23 Non-GAAP Disclosures For investor audiences only (1) Represents non-cash share-based compensation expense. (2) Represents non-cash depreciation and amortization expense. (3) Represents a gain on the sale of Telavant net assets to Roche due to the achievement of a one-time milestone in June 2024. (4) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings. (5) Represents the change in fair value of liability instruments, which is non-cash and primarily includes the unrealized losses relating to the measurement and recognition of fair value on a recurring basis of certain liabilities. (6) Represents the estimated tax effect of the adjustments. Notes to non-GAAP financial measures: Reconciliation of GAAP to Non-GAAP Financial Measures (unaudited, in thousands) Three Months Ended June 30, Note 2025 2024 Loss from continuing operations, net of tax $ (273,911) $ (31,603) Adjustments: Research and development: Share-based compensation (1) 11,099 10,532 Depreciation and amortization (2) 786 694 General and administrative: Share-based compensation (1) 71,079 36,841 Depreciation and amortization (2) 312 1,091 Gain on sale of Telavant net assets (3) — (110,387) Other: Change in fair value of investments (4) 19,125 (15,226) Change in fair value of liability instruments (5) 2,329 1,150 Estimated income tax impact from adjustments (6) (943) (204) Adjusted loss from continuing operations, net of tax (Non-GAAP) $ (170,124) $ (107,112) Three Months Ended June 30, Note 2025 2024 Research and development expenses $ 152,919 $ 120,507 Adjustments: Share-based compensation (1) 11,099 10,532 Depreciation and amortization (2) 786 694 Adjusted research and development expenses (Non- GAAP) $ 141,034 $ 109,281 Three Months Ended June 30, Note 2025 2024 General and administrative expenses $ 134,019 $ 99,892 Adjustments: Share-based compensation (1) 71,079 36,841 Depreciation and amortization (2) 312 1,091 Adjusted general and administrative expenses (Non- GAAP) $ 62,628 $ 61,960
Page 24
24 Rich Catalyst Calendar *The court has not provided guidance for the timing of its ruling, which could potentially be in 2025 Note: 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. All timelines reference calendar years unless otherwise noted Program Vant Catalyst Expected Timing Roivant pipeline growth New mid/late-stage in-licensing announcements Ongoing LNP platform Summary judgment phase in US Moderna case Ongoing Batoclimab Additional data in Graves’ disease including 6 -month remission data September 2025 Brepocitinib Topline data from Phase 3 trial in dermatomyositis 2H 2025 Batoclimab Topline data from Phase 3 trials in thyroid eye disease 2H 2025 LNP platform Markman hearing decision in Pfizer/BioNTech case 2025* LNP platform Jury trial in US Moderna case 1Q 2026 Mosliciguat Topline data from Phase 2 trial in pulmonary hypertension associated with interstitial lung disease 2H 2026 Brepocitinib Topline data from Phase 2 trial in cutaneous sarcoidosis 2H 2026 IMVT-1402 Initial results from open label period 1 of potentially registrational trial in ACPA+ difficult -to-treat rheumatoid arthritis 2026 IMVT-1402 Topline data from Phase 2 trial in cutaneous lupus erythematosus 2026 Brepocitinib Topline data from Phase 3 trials in non-infectious uveitis 1H 2027 IMVT-1402 Topline data from potentially registrational trial in ACPA+ difficult -to-treat rheumatoid arthritis 2027 IMVT-1402 Topline data from potentially registrational trials in Graves’ disease 2027 IMVT-1402 Topline data from potentially registrational trial in myasthenia gravis 2027 IMVT-1402 Topline data from potentially registrational trial in Sjögren’s disease 2028 IMVT-1402 Topline data from potentially registrational trial in chronic inflammatory demyelinating polyneuropathy 2028 For investor audiences only
Page 25
Thank you.