Slide 1: Brepocitinib in DM: VALOR Topline Results
Brepocitinib in DM: VALOR Topline Results September 17, 2025
Slide 2: Forward-Looking Statements
2 For investor audiences only 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 st
Slide 3: Roivant in 2025: Transformational Potential
Roivant in 2025: Transformational Potential 3 For investor audiences only 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 furt
Slide 4: Robust Late-Stage Pipeline with Registrational Trials in Indications with Blockbuster Potential
4 For investor audiences only 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 registrationa
Slide 5: Brepocitinib Data in DM Kicks Off Months Stacked with Potential Readouts and Launches
5 For investor audiences only 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
Slide 6: Brepocitinib VALOR Topline Results
CONFIDENTIAL Brepocitinib VALOR Topline Results
Slide 7: Brepocitinib – Highlights of Phase 3 VALOR Study Results in DM
CONFIDENTIAL Brepocitinib – Highlights of Phase 3 VALOR Study Results in DM VALOR succeeded, with highly significant, robust, and consistent data across primary and all key secondary endpoints Consistent dose response seen between 15 mg and 30 mg, establishing 30 mg dose as optimal in this setting R
Slide 8: DM Patients Have Significant Unmet Medical Needs
CONFIDENTIAL DM Patients Have Significant Unmet Medical Needs 75% 13% 11% Therapies Received by Treated DM Patients Steroids & ISTs Alone IVIG-Containing Regimens Off-Label Targeted Therapy-Containing Regimens (No IVIG) Standard-of-care in DM is largely unchanged since the 1980s: combinations of cor
Slide 9: VALOR Study Success Represents a Landmark Achievement in Dermatomyositis Field
CONFIDENTIAL VALOR Study Success Represents a Landmark Achievement in Dermatomyositis Field Extensive track record of failure for targeted therapies in dermatomyositis, even among approved drugs that are blockbusters in other I&I indications Failed in DM and PM Failed in DM Failed in DM and PM Faile
Slide 10: Brepocitinib Inhibits both TYK2 and JAK1, Well-Suited to Address Underlying DM Pathobiology
CONFIDENTIAL Brepocitinib Inhibits both TYK2 and JAK1, Making It Particularly Well-Suited to Address Underlying DM Pathobiology Pathogenic Cytokine Role in DM Pathogenesis Brepocitinib Selective JAK1 Inhibitor Selective Tyk2 Inhibitor Type I IFN Antibody Type I IFN (IFNα/β) Lymphocyte Activation Typ
Slide 11: Key Endpoints and P-Values
CONFIDENTIAL Key Endpoint Important Features P-Value Mean TIS (Primary) Composite endpoint, focus on muscle disease and global benefit 0.0006 CDASI-A change from baseline at Week 52 Improvement in skin disease activity 0.0006 DMOMS at Week 52 DM-specific muscle and skin composite measure of benefit
Slide 12: VALOR: Global Phase 3 Placebo-Controlled Study Evaluating Brepocitinib In Dermatomyositis
CONFIDENTIAL Eligible Patients Definite or probable dermatomyositis (2017 EULAR/ACR criteria) Skin activity: CDASI-A ≥6 Muscle activity: MMT-8 ≤142 Refractory or intolerant to SOC therapy Permitted Background Therapy Oral IST, antimalarial, and/or OCS Primary Endpoint 30 mg vs. placebo mean Total Im
Slide 13: Baseline Characteristics
CONFIDENTIAL Brepocitinib 30 mg (n = 81) Brepocitinib 15 mg (n = 81) Placebo (n = 79) Mean Age (years) (± SD) 50.4 (14.5) 50.7 (12.1) 50.7 (13.5) Sex (Female) – no. (%) 65 (80%) 67 (83%) 55 (70%) Region: US/Canada – no. (%) 32 (40%) 34 (42%) 30 (38%) Disease Activity – no. (%) Mild 13 (16%) 19 (24%)
Slide 14: Disposition: Higher Completion Rate and Lower Rescue Rate Than Placebo
CONFIDENTIAL 241 subjects randomized Brepocitinib 30 mg (n=81) Brepocitinib 15 mg (n=81) Placebo (n=79) 75 (93%) completed the blinded treatment period 70 (86%) completed the blinded treatment period 65 (82%) completed the blinded treatment period 6 (7%) discontinued early 11 (14%) discontinued earl
Slide 15: Brepocitinib Showed Significant and Clinically Meaningful Improvement on Primary Endpoint of TIS
CONFIDENTIAL Brepocitinib Showed Significant and Clinically Meaningful Improvement on Primary Endpoint of TIS 0 5 10 15 20 25 30 35 40 45 50 0 4 8 12 16 20 32 36 40 44 48 52 Mean TIS (± SE) Brepocitinib 30 mg (n = 81) Brepocitinib 15 mg (n = 81) Placebo (n = 79) 24 28 Study Week * * * * * * * * * **
Slide 16: Patients Achieving Moderate (TIS40) and Major (TIS60) TIS Response
CONFIDENTIAL 46% 29% 26% >2/3 of Patients on 30 mg Achieved Moderate TIS Response (TIS40) & Nearly Half Achieved Major TIS Response (TIS60) Patients Achieving Moderate TIS Response (TIS40) at Week 52 Patients Achieving Major TIS Response (TIS60) at Week 52 68% 54% 44% Brepocitinib 30 mg (n = 81) Bre
Slide 17: High Rates of Clinically Meaningful Improvement: Cross-Trial Comparison of TIS Responder Rates
CONFIDENTIAL Brepocitinib 30 mg Resulted in High Rates of Clinically Meaningful Improvement 68% 58% 46% 38% 0% 10% 20% 30% 40% 50% 60% 70% Cross-Trial Comparison of TIS Responder Rates At Similar Timepoints TIS40 Response Rate TIS60 Response Rate ProDERM – Week 40 Open-Label VALOR – Week 52 Placebo-
Slide 18: More Than A Third Achieved Major TIS Response And Minimal or No Steroid Burden
CONFIDENTIAL 36% 20% 9% 54% 41% 27% More Than A Third of Brepocitinib 30 mg Patients Achieved Both Major TIS Response And Minimal or No Steroid Burden At Week 52 *Nominal p-value calculated as part of post-hoc analysis Adjusted response rate (risk) differences calculated using the Mantel-Haenszel me
Slide 19: Time Course of CDASI-Activity Change from Baseline
CONFIDENTIAL Time Course of CDASI-Activity Change from Baseline Statistically significant, clinically meaningful separation between brepocitinib 30 mg and placebo at all time points, starting as early as week 4 Brepocitinib 30 mg (n = 81) Brepocitinib 15 mg (n = 81) Placebo (n = 79) -14 -12 -10 -8 -
Slide 20: Meaningful Cutaneous Improvement in Subjects with Moderate-to-Severe Skin Disease
CONFIDENTIAL Brepocitinib 30 mg Achieved Meaningful Cutaneous Improvement in Subjects with Moderate-to-Severe Skin Disease at Baseline Ns for subjects with moderate-to-severe skin disease at baseline: brepocitinib 30 mg n = 46; placebo n = 53 *Nominal p-value calculated as part of post-hoc analysis
Slide 21: Substantial Evidence of Improvement on Muscle Disease Across Multiple Endpoints
CONFIDENTIAL Brepocitinib 30 mg Demonstrated Substantial Evidence of Improvement on Muscle Disease Across Multiple Endpoints Motor Strength Confirmed Benefit on MMT-8 with Brepocitinib 30 mg vs. Placebo Global Benefit Substantial Improvement on TIS in Patients with Moderate-to-Severe Muscle Disease
Slide 22: Rapid Onset Of Action, With Confirmed Benefit As Early As Week 4
CONFIDENTIAL Brepocitinib 30 mg Achieved Rapid Onset Of Action, With Confirmed Benefit As Early As Week 4 Rapid onset of action consistent with TYK2/JAK1 mechanism of action Rapid Statistically Significant Separation From Placebo Rapid Achievement of Clinical Improvement Thresholds Week 4 Time to ac
Slide 23: Key Endpoints: Brepocitinib 30 mg vs. Placebo
CONFIDENTIAL Key Endpoint Important Features Brepocitinib 30mg (n=81) Placebo (n=79) P-Value Mean TIS (Primary) Composite endpoint, focus on muscle disease and global benefit 46.5 31.2 0.0006 CDASI-A change from baseline at Week 52 Improvement in skin disease activity -11.7 -7.0 0.0006 DMOMS at Week
Slide 24: Overview of Safety Events
CONFIDENTIAL Overview of Safety Events Brepocitinib 30 mg QD (N=81) Brepocitinib 15 mg QD (N=81) Placebo (N=79) Participants with: AEs 73 (90%) 70 (86%) 72 (91%) Death 0 0 0 SAEs 13 (16%) 7 (9%) 10 (13%) AEs leading to treatment discontinuation 5 (6%) 6 (7%) 9 (11%) AEs leading to study discontinuat
Slide 25: VALOR Results Confirm Brepocitinib's Potential to Meaningfully Improve the Lives of Patients with DM
CONFIDENTIAL Statistically and clinically significant improvement in skin disease Statistically and clinically significant improvement in muscle disease Breadth of Response High TIS response rates even while aggressively tapering steroids Functional remission of skin disease achieved in nearly half
Slide 26: Upcoming Roivant Investor Day
Upcoming Roivant Investor Day Thursday, December 11th, 2025 In-Person Details to follow
Slide 27: Q&A
Q&A roivant
Slide 28: Appendix
Appendix roivant
Slide 29: Dermatomyositis: Disease Overview
Dermatomyositis: Disease Overview Literature-Based Estimates Priovant Claims Analysis Other Companies Developing DM Therapies 23K1 70K 40K 52K2 51K Dermatomyositis is a chronic inflammatory disease of the skin and muscles that affects approximately 40-50K US adults US ADULT PREVALENCE 29 For investo
Slide 30: Brepocitinib: Other Details
30 For investor audiences only Brepocitinib: Other Details ROIV owns 74%1 of Priovant, with Pfizer owning 25%. Ownership Geographic Rights Intellectual Property Milestones Royalties As of June 30, 2025. 65% on a fully diluted basis. Includes potential patent term extension We expect Brepocitinib to
Slide 31: Speaker Biographies
31 For investor audiences only Speaker Biographies Matthew Gline Matt Gline serves as Chief Executive Officer of Roivant Sciences. Mr. Gline joined Roivant in March 2016 and previously served as Chief Financial Officer. From April 2014 to March 2016, he was a Vice President at Goldman Sachs, Fixed I
Slide 32: Thank you.
Thank you. roivant