Slide 1: LISRAYA (brepocitinib) Approved for Treatment of Patients with Dermatomyositis
LISRAYA (brepocitinib) Approved for Treatment of Patients with Dermatomyositis August 28, 2026 For investor audiences only
Slide 2: Forward-Looking Statements
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 c
Slide 3: LISRAYA is a TYK2 and JAK inhibitor indicated for dermatomyositis in adults
3 LISRAYA is a tyrosine kinase 2 (TYK2) and Janus kinase (JAK) inhibitor indicated for the treatment of dermatomyositis in adult patients NOW APPROVED See important LISRAYA safety information, including boxed warning, at lisrayahcp.com/pi For investor audiences only
Slide 4: FDA Office of Immunology and Inflammation Director comment on approval
4 Nikolay Nikolov, M.D. Director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research “For too long, patients with dermatomyositis have faced a significant unmet need for effective treatments, often relying on therapies meant for other diseases. Today’s a
Slide 5: Approval: A Litany of Firsts for Dermatomyositis
5 Approval: A Litany of Firsts for Dermatomyositis… See important LISRAYA safety information, including boxed warning, at lisrayahcp.com/pi First targeted therapy ever approved for DM First once daily oral therapy ever approved for DM First therapy ever approved for steroid-sparing benefit in DM, al
Slide 6: After a Graveyard of Failed Attempts and Decades of Poor Standard of Care
Failed in DM and PM Failed in DM and PM Failed in DM and PM Failed in DM and PM Failed in DM Failed in DM and PM Failed in DM and PM Failed in DM, PM, and IMNM PM: Polymyositis IMNM: Immune-mediated necrotizing myopathy All trademarks are the property of their respective owners …After a Graveyard of
Slide 7: LISRAYA is Commercially Available Today, Ahead of Schedule
7 We are bringing LISRAYA to patients immediately – commercial launch coincides with FDA approval, ahead of prior guidance – reflecting the urgency of unmet need in DM LISRAYA is Commercially Available Today, Ahead of Schedule Note: My Compass Support program eligibility, terms and conditions apply
Slide 8: LISRAYA Label Highlights
8 LISRAYA Label Highlights Note: FDA applied its own data handling rules for endpoints. In some cases, this deviated in immaterial ways from the pre-specified data handling rules in the VALOR Statistical Analysis Plan; therefore, data in label does precisely match data as reported in scientific conf
Slide 9: Higher Likelihood of Moderate and Major Symptom Improvement With Minimal or No Steroids
9 With LISRAYA, DM Patients Saw Higher Likelihood of Both Moderate and Major Symptom Improvement – With Minimal or No Steroids CI: confidence interval Notes: LS mean TIS, difference and 95% CI based on an analysis of covariance model adjusted for stratification factors Response rate (risk) differenc
Slide 10: VALOR: Largest Phase 3 Placebo-Controlled Study Ever in Dermatomyositis
10 Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide DM: dermatomyositis; QD: daily; OCS: oral corticosteroids; CDASI: Cutaneous Dermatomyositis Disease Area and Severity Index; DMOMS: Dermatomyositis Out
Slide 11: VALOR Baseline Disease and Treatment Characteristics
11 VALOR Baseline Disease and Treatment Characteristics Reflect Real-World Patient Population Brepocitinib 30 mg (N = 81) Brepocitinib 15 mg (N = 81) Placebo (N = 79) Characteristic Mean age (range) – yr 50 (21-77) 51 (23-72) 51 (20-74) Female sex – no. (%) 65 (80%) 67 (83%) 55 (70%) Race or ethnic
Slide 12: Strong Efficacy Data Across All Phase 3 Ranked Endpoints
12 Brepocitinib Demonstrated Strong Efficacy Data Across All Phase 3 Ranked Endpoints Measurements of skin disease, muscle disease, rapidity of onset and steroid sparing; consistent dose response was also seen across endpoints Key Endpoint Important Features Brepocitinib 30mg (N = 81) Placebo (N = 7
Slide 13: Overview of Safety Events in the Phase 3 VALOR Study
13 Overview of Safety Events in the Phase 3 VALOR Study AE: adverse event, ALT: alanine aminotransferase; AST: aspartate aminotransferase Notes: Percentages are based on the number of unique participants with an event out of the column total. Treatment-emergent AEs are reported Minor numerical diffe
Slide 14: LISRAYA Can Now Benefit Tens of Thousands of Patients Across the US
LISRAYA Can Now Benefit Tens of Thousands of Patients Across the US Literature-Based Estimates Priovant Claims Analysis Other Companies Developing DM Therapies 23K1 70K 40K 52K2 51K US ADULT PREVALENCE 37K INCIDENCE Literature-Based Estimates 1.1/100,0003 3.0/100,0004 1. Smoyer-Tomic et al, BMC Musc
Slide 15: DM Patients Struggle With Everyday Function, and Standard of Care Is Suboptimal
15 DM Patients Struggle With Everyday Function, and Standard of Care Therapies Are Suboptimal 1. Priovant/TMA Patient Survey. 2. Myositis Journey and Burden of Disease Survey, MSU (2022). 3. Analysis by Roivant/Priovant using closed claims data from Inovalon from 2019-2024 4. Christopher-Stine et al
Slide 16: Patients Are At The Center Of Our Launch
16 Patients Are At The Center Of Our Launch Note: My Compass Support program eligibility, terms and conditions apply Eligible patients may pay as little as $0 per month for LISRAYA through My Compass Support Patients can enroll in LISRAYA My Compass Support, which offers personalized assistance from
Slide 17: LISRAYA Is Ready for Launch in DM
Given limited historical innovation and long-established prescribing patterns in DM, LISRAYA adoption is expected to build gradually Limited Distribution Network of Specialty Pharmacies Priovant Hub and Patient Services Program Distribution and dispensing workflows validated pre-launch Hub team and
Slide 18: Approval in DM is Only the Beginning of a Multi-Indication Journey
Lichen Planopilaris Ph2b/3 Initiated Approval in DM is Only the Beginning of a Potential Multi-Indication Journey for LISRAYA, with 3 Other Pivotal Datasets Expected Over the Next 36 Months Dermatomyositis NDA Filed Cutaneous Sarcoidosis Positive Ph2 Topline Data Non-Infectious Uveitis Ph3 Topline D
Slide 19: High-Value Pipeline, Delivering Series of Near-Term Catalysts
19 Phase 1 Phase 2 Registrational Approved Brepocitinib DM NIU CS LPP IMVT-1402 D2T RA GD MG CIDP SjD CLE Mosliciguat PH-ILD High-Value Pipeline, Delivering Series of Near-Term Catalysts Note: LISRAYA (brepocitinib) is FDA-approved only for treatment of dermatomyositis in adult patients. All other d
Slide 20: Thank you.
Thank you.
Slide 21: Appendix
Appendix roivant
Slide 22: LISRAYA Important Safety Information and Indication and Usage
LISRAYA IMPORTANT SAFETY INFORMATION and INDICATION AND USAGE WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS INDICATIONS AND USAGE LISRAYA (brepocitinib) is indicated for the treatment of adults with dermatomyositis (DM). Limitations of
Slide 23: LISRAYA Important Safety Information (continued)
LISRAYA IMPORTANT SAFETY INFORMATION and INDICATION AND USAGE WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNINGS and PRECAUTIONS (continued): Hypersensitivity. LISRAYA is contraindicated in patients with known hypersensitivity to b
Slide 24: Priovant: Other Details
24 Priovant: Other Details ROIV owns 71%1 of Priovant, with Pfizer owning 24%. Ownership Geographic Rights Intellectual Property Milestones Royalties 1. As of June 30, 2026. 65% on a fully diluted basis. 2. Includes potential patent term extension We expect brepocitinib to have US exclusivity at lea
Slide 25: Illustrative Accounting Treatment
Illustrative Accounting TreatmentThe information contained in these slides is provided for illustrative and educational purposes only. It is not intended to be comprehensive and is not a substitute for reviewing Roivant’s consolidated financial statements, including the notes thereto. This should no
Slide 26: Reflecting Consolidated Vants on Roivant Financial Statements
Reflecting Consolidated Vants on Roivant Financial StatementsIllustrative Consolidation Accounting Treatment 100% CONSOLIDATED TO ROIV Vant Product Revenue, net ROIV books 100% of Vant net product revenue, not just ROIV's ownership % Vant License, Milestone & Other Revenue ROIV books 100% of Vant mi
Slide 27: Impact of NCI on Roivant EPS
27 Impact of NCI on Roivant EPS 1. Basic ownership refers to percentage ownership of the issued and outstanding Vant shares, including preferred shares in certain instances. Additional allocation to NCI may be required if participating securities exist. 2. Includes allocation to securities issued by