Roivant Sciences Ltd. · NASDAQ:ROIV
Roivant Sciences — Investor Day (December 2025)
192 slides from Roivant Sciences's investor day presentation, Dec 11, 2025
Slide 1: Investor Day, December 11, 2025, New York City
December 11, 2025 New York City
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: Today's Agenda
Today’s Agenda 8:00 – 8:15 Introduction 8:15 – 9:00 Brepocitinib 9:00 – 9:15 Q&A 9:15 – 9:25 Break 9:25 – 10:20 IMVT-1402 10:20 – 10:30 Q&A 10:30 – 10:50 Mosliciguat 10:50 - 11:00 Q&A 11:00 – 11:10 Break 11:10 – 11:25 LNP Litigation 11:25 – 11:30 Financial Outlook 11:30 – 11:40 Closing Remarks 11:40
Slide 4: Today's Speakers
Today’s Speakers Matt Gline CEO, Roivant Ben Zimmer CEO, Priovant Drew Fromkin CEO, Pulmovant Richard Pulik CFO, Roivant Frank Torti President & Vant Chair, Roivant 4 CEO, Immunovant President, Roivant Eric Venker Lindsay Androski Special Counsel, Genevant CEO, Arbutus
Slide 5: Introduction
Matt Gline CEO, Roivant 5 Introduction
Slide 6: Key Takeaways From Today
6 Key Takeaways From Today Roivant’s next decade will look materially different from its last: now simplified to a “traditional development and commercialization” company with a near-term commercial launch Executing on our existing portfolio is the highest priority for us Multiple “pipeline-in-a-pro
Slide 7: Combination of Capital, Expertise and Track Record Maximizes Value
7 Combination of Capital, Expertise and Track Record Maximizes Value for Patients, Partners and Shareholders 1. Consolidated cash, cash equivalents, marketable securities, and other current assets as of September 30, 2025. Does not include $200M in non-ROIV gross proceeds from Immunovant’s December
Slide 8: What Makes Roivant Unique
8 What Makes Roivant Unique Entrepreneurial mindset with aligned incentives Lean, dynamic and agile organization Homegrown leadership – unique mix of expertise Talent, Organization & Culture Creative Product Development Brepocitinib Identifying rare I&I as our opportunity IMVT-1402 Identifying and p
Slide 9: Strong Execution With Multiple Positive Updates to Timing Guidance
9 Strong Execution With Multiple Positive Updates to Timing Guidance Note: All drugs are investigational and subject to regulatory approvals. All catalyst timings are approximate, based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. All refer
Slide 10: Over the Next Months, Roivant Will Execute on...
10 Over the Next 36 Months (by End of CY 2028), Roivant Will Execute on… Note: All drugs are investigational and subject to regulatory approvals. All catalyst timings are approximate, based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. All r
Slide 11: Roivant's Commercial Opportunity Is Rooted in High-Value, Tractable Indications
11 Roivant’s Commercial Opportunity Is Rooted in High-Value, Tractable Indications Note: All drugs are investigational and subject to regulatory approvals. DM: dermatomyositis; NIU: non-infectious uveitis; CS: cutaneous sarcoidosis; GD: Graves’ disease; CIDP: chronic inflammatory demyelinating polyn
Slide 12: Capital Efficiency & Value Creation With Minimal Dilution
12 Capital Efficiency & Value Creation With Minimal Dilution 1. 2021 ROIV IPO includes cumulative capital raised by ROIV as private company and via IPO 2. Today’s equity capital raised reflects gross proceeds from parent company equity issuances, net of share repurchases 3. Consolidated cash, cash e
Slide 13: We Are at a Unique Time in the Evolution of the Biotech Industry
Select success stories from each era 13 We Are at a Unique Time in the Evolution of the Biotech Industry Note: All trademarks are property of their respective owners Genesis: <2000 Strategic Partnering: Licensing replaces pure acquisition Launch Success: ~40% of launch stocks outperformed by 25% ("O
Slide 14: Confluence of Factors Creates Opportunity for Roivant
14 M&A for $10BN+ Biotechs Remains Limited Rapid Rise & Influence of China Biopharma Sector Themes Capital Markets Remain Fickle Roivant’s portfolio of unique, differentiated products provides insulation against regulatory & reimbursement dynamics Roivant’s cash balance supports runway into profitab
Slide 15: Significant Upside and Value Creation Across Recent Launches
15 Significant Upside and Value Creation Across Recent Launches 1. Table represents change from post readout/pre-approval relative to today, as of December 9, 2025 2. Historical and current consensus revenue estimates sourced from Bloomberg Selected Paradigm-Shifting Pivotal Readouts Efgartigimod in
Slide 16: Common Themes Among the Recent Biotech Graduating Class
16 Common Themes Among the Recent Biotech Graduating Class Key Takeaways from Selected Success Stories High unmet medical need Limited competition at launch Dedicated patient access support and organizations Specialty centers / doctors Prevalence in thousands, not millions Tractable commercial execu
Slide 17: Common Themes Among the Recent Biotech Graduating Class
17 Common Themes Among the Recent Biotech Graduating Class Key Takeaways from Selected Success Stories High unmet medical need Limited competition at launch Dedicated patient access support and organizations Specialty centers / doctors Prevalence in thousands, not millions Tractable commercial execu
Slide 18: High-Value Pipeline, Delivering Series of Near-Term Catalysts
18 Phase 1 Phase 2 Registrational Approved DM NIU CS TED D2T RA GD MG CIDP SjD CLE PH-ILD High-Value Pipeline, Delivering Series of Near-Term Catalysts Note: All drugs are investigational and subject to regulatory approvals. All catalyst timings are approximate, based on current expectations and, wh
Slide 19: Brepocitinib
19 Brepocitinib Ben Zimmer CEO, Priovant Matt Gline CEO, Roivant
Slide 20: Brepocitinib program overview
20 Brepocitinib program is focused on indications with biology suited for dual JAK1/TYK2 inhibition and significant unmet need NDA filing for brepocitinib in DM expected in early 2026; preparations underway for potential commercial launch in DM in early 2027 No approved therapies and risk of permane
Slide 21: JAK-STAT Signaling Pathway Reminder
JAK-STAT Signaling Pathway Reminder Figure adapted from Morris et al., 2018 21 There are 4 human JAK isoforms (JAK1, JAK2, JAK3, and TYK2) and distinct combinations of each are required for specific cytokine signaling pathways Inhibiting different JAK isoforms has a distinct pharmacologic effect in
Slide 22: Dual JAK1/TYK2 Inhibition Is a Novel Mechanism of Action
Dual JAK1/TYK2 Inhibition Is a Novel Mechanism of Action, With Potential for Greater Efficacy Than Earlier Generation JAK Inhibitors IFN-γ IL-31 IL-2 IL-21 IL-6 IFN-α/βIL-10 IL-22 IL-12IL-23 JAK1 and TYK2Brepocitinib JAK1 TYK2 22
Slide 23: Brepocitinib: Pursuing Indications at the Intersection of Biology and Unmet Need
23 Brepocitinib: Pursuing Indications at the Intersection of Dual JAK1/TYK2 Biology and High Unmet Medical Need Non-Infectious Uveitis, Dermatomyositis, Cutaneous Sarcoidosis Mid-high tens-of-thousands prevalence JAK1 and/or TYK2 clinical proof-of-concept Few to no therapies approved Large unmet med
Slide 24: Catalyst-Rich 2026 for the Brepocitinib Program
24 Successful Clinical Execution Has Set Up the Brepocitinib Program for a Catalyst-Rich 2026 Note: All drugs are investigational and subject to regulatory approvals. All catalyst timings are approximate, based on current expectations and, where applicable, contingent on FDA feedback, and may be sub
Slide 25: Non-Infectious Uveitis
Non-Infectious Uveitis roivant Investor day 2028
Slide 26: Non-Infectious Uveitis: Highly Morbid, Poorly Served Indication
26 Non-Infectious Uveitis (NIU): Highly Morbid, Poorly Served Indication With Large Unmet Need 1. Dayani, Modern Retina (2020) 2. Jaffe et al., NEJM (2016) 3. Tallouzi et al., BMJ Open Ophth (2020) 4. Thorne et al., JAMA Opthalmol (2016) 5. Analysis by Roivant/Priovant using closed claims data from
Slide 27: Inadequate Control of Uveitic Inflammation Leads to Vision Loss
27 Inadequate Control of Uveitic Inflammation Leads to Vision Loss The results of the SITE study1 – covering nearly 9,000 eyes – demonstrated that any ocular inflammation contributes to worsened visual outcomes, with greater inflammation resulting in greater expected vision loss 1. PIstilli et al.,
Slide 28: Two Distinct Prescriber Bases for Novel Systemic Therapy for NIU
28 Two Distinct Prescriber Bases for Novel Systemic Therapy for NIU Uveitis Specialists Community Retina Doctors / Partnered Rheumatologists Approach To Systemic Medication Quickly move to systemic medications; uveitis specialist leads medication selection Start with short-term local intervention; p
Slide 29: IQVIA Analysis Confirms >40,000 Patients Receiving TNFi for NIU
29 2023 IQVIA Analysis of the NIU Market Confirms >40,000 Patients Receiving TNFi for NIU, with >10% CAGR for Advanced Therapies Analysis includes patients with at least 2 NIU Dx claims at least 30 days in or before 2022 (patients had to have continuous pharmacy and medical benefit enrollment in 202
Slide 30: Humira Successfully Treats Only Half of Patients With Active Uveitis
30 In Both Placebo-Controlled and Open-Label Settings, Humira Successfully Treats Only Half of Patients With Active Uveitis 1. Jaffe et al., NEJM (2016) 2. Data as reported on HumiraPro.com/Uveitis; DCs are censored. Analysis population for Humira unknown 3. Suhler et al., Ophthalmology (2018) VISUA
Slide 31: Dual Inhibition of TYK2 and JAK1 Addresses Th1 and Th17 Autoimmunity in NIU
31 Brepocitinib’s Dual Inhibition of TYK2 and JAK1 Distinctively Addresses Th1-Mediated and Th17-Mediated Autoimmunity in NIU Only mechanism that can simultaneously suppress IL-6, IFNγ, IL-12, and IL-23 with single targeted agent Figure adapted from Sen et al., Nat. Rev. Rheumatol. 2015 JAK1 IL-6 Th
Slide 32: NEPTUNE: Phase 2 Study of Brepocitinib in NIU
32 NEPTUNE: Phase 2 Study of Brepocitinib in NIU Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide QD: daily; OCS: oral corticosteroids; ACC: anterior chamber cell; VH: vitreous haze; BCVA: Best Corrected
Slide 33: NEPTUNE Median Time to Treatment Failure Data
Phase 2 NEPTUNE Median Time to Treatment Failure Data Suggests Potential For Best-In-Indication Efficacy Profile 6-week taper in NEPTUNE trial following two-week steroid burst, compared to 13-week taper in VISUAL 1 45 mg N = 17 Brepocitinib (NEPTUNE) 15 mg N = 9 Active N = 110 Humira (VISUAL I1) Pla
Slide 34: Dose Dependent Benefit on Posterior Segment Inflammation
Last observation carried forward used for participants with treatment failure or intercurrent event. 1. Tugal-Tutkun et al., Int Ophthalmol (2010) Dose Dependent Benefit on Posterior Segment Inflammation Seen, With Sustained Improvement at 52 Weeks Measurement of retinal vascular leakage by wide-fie
Slide 35: Sustained Improvement in Central Subfield Thickness Through Week 52
Brepocitinib 45 mg Associated With Sustained Improvement in Central Subfield Thickness Through Week 52 35 Threshold for macular edema Mean change from baseline = - 0.04% Mean change from baseline = - 8.3% Phase 3 CLARITY Study Evaluates Brepocitinib 45 mg Against Placebo
Slide 36: CLARITY: Phase 3 Study of Brepocitinib in NIU
36 CLARITY: Phase 3 Study of Brepocitinib in NIU Two identical sub-studies, CLARITY-1 and CLARITY-2, under a single protocol; study is now fully enrolled and topline results are expected 2H 2026 Note: Additional inclusion and exclusion criteria not listed on slide. Note: Additional primary and secon
Slide 37: Cutaneous Sarcoidosis
Cutaneous Sarcoidosis roivant Investor day 2028
Slide 38: High Urgency to Treat Given Poor Cosmesis and Potential Irreversible Damage
38 High Urgency to Treat Given Poor Cosmesis and Potential to Cause Irreversible Damage Unlike many inflammatory skin diseases (e.g., plaque psoriasis, eczema, alopecia areata), inadequately treated cutaneous sarcoidosis can rapidly cause permanent scarring or even cartilage destruction Images adapt
Slide 39: Ocular and Cutaneous Sarcoidosis Programs Address Large Segment of Population
39 Ongoing Programs in Ocular (Uveitis) and Cutaneous Sarcoidosis Could Collectively Address Large Segment of Overall Sarcoidosis Population After the lungs, skin and eyes are the organs most commonly affected by sarcoidosis 1. Grunewald et al., Nat Rev Primers (2019) 2. Assumes 200,000 overall prev
Slide 40: Cutaneous Sarcoidosis Includes Eligible Population of ~40,000 Patients
40 Cutaneous Sarcoidosis Alone Includes Eligible Population of ~40,000 Patients 1. Foundation for Sarcoidosis Research 2. Haimovic, et al., J Am Acad Dermatol (2012) 3. Altmeyer et al., Altmeyers Encycl (2025) ~40K CS patients in the US1,2 ~16K have minimal to no activity in other organs ~24K have o
Slide 41: BEACON: Phase 2 Study of Brepocitinib in Cutaneous Sarcoidosis
41 BEACON: Phase 2 Study of Brepocitinib in Cutaneous Sarcoidosis Study is now fully enrolled and topline results are expected 1H 2026 Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide CS: cutaneous sarco
Slide 42: BEACON's Primary Efficacy Endpoint: CSAMI
42 1. Noe et al., JAMA Dermatol (2020) BEACON’s Primary Efficacy Endpoint: Change from Baseline in Cutaneous Sarcoidosis Activity & Morphology Index (CSAMI) CSAMI is analogous to other area-and-severity instruments CSAMI Activity (CSAMI-A) scores range from 0 – 165 Minimal clinically important diffe
Slide 43: Dermatomyositis
Dermatomyositis roivant Investor day 2028
Slide 44: Dermatomyositis Patient Video
Dermatomyositis Patient Video
Slide 45: High Steroid Burden Within First Year of Diagnosis
45 Within the First Year of Diagnosis, DM Patients Experience a High Steroid Burden Note: Analysis by Roivant/Priovant using closed claims data from Inovalon. Analysis includes patients with DM, continuous enrollment from 2019-2024, and steroids use in first year post index 128 Average number of day
Slide 46: High Rates of Polypharmacy Reflect Limited Efficacy
46 High Rates of Polypharmacy Treatment Reflect Limited Efficacy of Existing DM Treatment Options Note: Analysis by Roivant/Priovant using closed claims data from Inovalon. Analysis includes patients with DM with continuous enrollment from 2019-2024. Note: all glucocorticoids considered as 1 therapy
Slide 47: Steroid Use Is High Even With Steroid Sparing Therapy
47 Steroid Use is High Among DM Patients, Even for Those Who Receive Concomitant Steroid Sparing Therapy Note: Analysis by Roivant/Priovant using closed claims data from Inovalon from 2019-2024. IST: immunosuppressive therapy; DMARD: disease-modifying antirheumatic drug; IVIG: intravenous immunoglob
Slide 48: DM Patients Report Persistent Dissatisfaction With Standard-of-Care
48 DM Patients Report Persistent Dissatisfaction with Current Standard-of-Care 1. Christopher-Stine et al., BMC Rheumatology (2025) 2. TMA/MSU EL-PFDD Meeting (2025) 62% (N=195) Dissatisfied with Current Treatment Options1 65% (N=34) Only Partially Controlled with Current Regimens2 60% (N=195) Disco
Slide 49: High Rates of Flare, Hospitalizations, and Pain
73% (N=524) Experienced ≥ 1 Disease Flare in the Past Year1 72% (N=378) Hospitalization Rate Among Patients Who Experienced ≥ 1 Disease Flare1 97% (N=183) Experienced Pain Attributed to Their Myositis2 57% (N=195) Used Opioids to Manage DM-Associated Pain2 49 Despite Widespread Use of Standard Thera
Slide 50: Significant Muscle Disease Burden and Impact on ADLs
50 Patient Advocacy Group Surveys (TMA, MSU) Report Significant Muscle Disease Burden and Impact on Patients’ ADLs 1. Priovant/TMA Patient Survey 2. Myositis Journey and Burden of Disease Survey, MSU (2022) 53%2 Unable to walk more than 1 mile Unable to lift or carry groceries 36%2 63%1 Unable to cl
Slide 51: DM Skin Disease Disrupts Quality of Life
51 DM Skin Disease Activity Contributes to Major Quality of Life Disruption and Is Associated With Poor Emotional and Social Health ADL: Activities of Daily Living Survey data adapted from Kleitsch et al, Arch Dermatol Res (2023) 1. Goreshi et al., J AM Acad Dermatol (2011) Reported that their cutan
Slide 52: Durable Skin Remission Remains Rare
52 Even in Specialized Myositis Centers, Durable Skin Remission Remains Rare, Underscoring the Limitations of Standard Therapies 1. Wolstencroft and Fiorentino et al., JAMA Derm 2018 2. Ahmed et al., Semin Arthritis Rheum (2020) Treatment Study Cohort (n = 74) Mycophenolate mofetil 27 (36%) Antimala
Slide 53: Systemic Steroid Use Drives Adverse Event Burden in DM
53 Systemic Steroid Use Drives Much of the Adverse Event Burden in DM 1. Aggarwal et al., Clin Rheumatol (2025) 2. Loarce-Martos et al., Clin Rheumatol (2021) 3. Mirza et al., Clin Rheumatol (2021) 4. Choy et al., Rheumatol (2002) 5. Pujades-Rodriguez et al., PLoS Med (2020) Systemic Corticosteroid
Slide 54: Higher Risk From Corticosteroids Versus Other Medications
54 Pooled Safety Data From Multiple Sources Suggest Significantly Higher Risk From Corticosteroids Versus Other Medication Categories for Most AESIs 1. Khan et al., Adv Ther (2021) 2. Lane et al., Ophthalmology (1995) 3. Wei et al., Ann Intern Med (2004) 4. George et al., Ann Intern Med (2020) 5. Ge
Slide 55: High Unmet Need for Novel, Targeted Therapy in DM
Patients are heavily treated with polypharmacy, including high dose OCS administered chronically1 Patient are unhappy with the current treatment options and are frequently switching their treatment2 Patients report continued symptoms, flares, and pain despite treatment3,4 Continued symptoms are lead
Slide 56: VALOR: Phase 3 Study Design
56 VALOR: Phase 3 Study Design Positive topline results announced in September 2025 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 N = 241 Adul
Slide 57: VALOR Baseline Disease and Treatment Characteristics
57 VALOR Baseline Disease and Treatment Characteristics Reflect Real-World Patient Population: Active, Multisystem Disease Requiring Multiple Therapies Brepocitinib 30 mg(n = 81) Brepocitinib 15 mg(n = 81) Placebo(n = 79) Disease Activity (PhGA) – no. (%) Mild (0 to < 4 cm) 13 (16%) 19 (24%) 13 (16%
Slide 58: Statistically Significant Benefit on All Ten Ranked Endpoints
Brepocitinib 30 mg Achieved Statistically Significant Benefit On All Ten Ranked Endpoints in the VALOR Study 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
Slide 59: Significant Improvement on Primary Endpoint of TIS
Brepocitinib Showed Significant and Clinically Meaningful Improvement on Primary Endpoint of TIS Separation between brepocitinib 30 mg and placebo at all time points, starting as early as week 4, achieved together with substantially greater steroid reduction in brepocitinib 30 mg arm *Nominal P < 0.
Slide 60: TIS Moderate and Major Responses at Week 52
60 TIS 40 (Moderate) and TIS 60 (Major) Responses at Week 52 Greater achievement of TIS 40 and TIS 60 responses including with minimal or no steroids Adjusted response rate (risk) differences calculated using the Mantel-Haenszel method. OCS dose assessed at weeks 48 and 52. Percentages are calculate
Slide 61: Overview of Safety Events
61 Overview of Safety Events Abbreviations: AE=adverse event, ALT=alanine aminotransferase, AST=aspartate aminotransferase, SAE=serious adverse event. Note: Percentages are based on the number of unique participants with an event out of the column total. Treatment-emergent AEs are reported. Brepocit
Slide 62: Key Regulatory and Launch Planning Activities
Key Regulatory and Launch Planning Activities Strong engagement with patient community Patient advocacy group collaborations and events Dermatomyositis.com disease website and associated social media ecosystem Limited distribution network and in-house Priovant Hub Strategy consistent with prior succ
Slide 63: Upcoming Brepocitinib Catalysts
Upcoming Brepocitinib Catalysts Over the Next 18 Months Pivotal / Potentially Registrational Proof of Concept / Other Early 2026 Expected NDA filing in DM 2026 2H 2026 Topline data in NIU 1H 2027 Potential sNDA filing in NIU 1H 2026 Topline data in CS 63 2027 Early 2027 Potential commercial launch i
Slide 64: In Summary: Brepocitinib
64 In Summary: Brepocitinib Phase 2 BEACON study for brepocitinib in CS expected to read out 1H 2026; CS has high unmet medical need Following positive VALOR readout, planning for commercial launch of brepocitinib in DM is underway, with launch expected early 2027 Note: All drugs are investigational
Slide 65: Q&A
Q&A roivant Investor day 2025
Slide 66: IMVT-1402
66 IMVT-1402 Eric Venker CEO, Immunovant Matt Gline CEO, Roivant
Slide 67: IMVT-1402 Overview
67 IMVT-1402 drives deep dose-dependent reductions of pathogenic IgG autoantibodies; expected to reach best-in-class IgG reductions of ~80%, unmatched by current anti-FcRn competitors Pipeline-in-a-product potential; approved anti-FcRns antibodies have generated ~$7BN in cumulative revenue in MG and
Slide 68: IMVT-1402 Potential First- and Best-in-Class Therapy
68 IMVT-1402 Has the Potential to Be a First- and Best-in-Class Therapy in Autoantibody-Driven Disease Favorable Safety Profile Convenient Administration Simple subcutaneous autoinjector with 5-10 second self-administration; currently being tested in all IMVT-1402 trials Potential Best-in-Class Effi
Slide 69: Settling the Deeper Is Better Debate With Batoclimab
Settling the “Deeper Is Better” Debate With Batoclimab Proof-of-Concept Trials Our clinical data generated across multiple indications consistently shows that deeper IgG reduction leads to improved clinical outcomes for patients Graves’ Phase 2a1 MG Phase 31 CIDP Phase 2b1,3 ATD-Free Response: % of
Slide 70: IMVT-1402 Development With Registrational Datasets in Next 36 Months
70 IMVT-1402 Development Well Underway With 5 Potentially Registrational Datasets Expected in Next 36 Months Note: GD: Graves’ disease; SjD: Sjogren’s disease; ACPA+ D2T RA: anti-citrullinated protein antibody positive (ACPA+), difficult-to-treat rheumatoid arthritis; CIDP: chronic inflammatory demy
Slide 71: IMVT-1402 Indication Selection
71 IMVT-1402 Indication Selection Optimizes Across Both Clinical Validation and Commercial Potential Note: Bubble placement is illustrative and not representative of expected clinical risk and commercial opportunity. Size of bubbles is not indicative of market size Commercial Opportunity Low Clinica
Slide 72: Anti-FcRns Have Pipeline-in-a-Product Potential
72 Anti-FcRns Have Pipeline-in-a-Product Potential Across Autoimmune Diseases Driven by Harmful IgG Autoantibodies With Continued Room for Growth Current IMVT-1402 indications Note: Indications listed include possible indications where anti-FcRn may have mechanistic rationale to pursue gMG CIDP wAIH
Slide 73: Anti-FcRn Antibody Development Has Seen Explosive Growth Since 2020
73 Note: Indications in development cover anti-FcRn antibodies in development by Immunovant, argenx, JNJ and UCB 1. Includes disclosed sales from argenx and UCB ENDOCRINOLOGY RHEUMATOLOGY NEUROLOGY DERMATOLOGY RENAL HEMATOLOGY 8 Total Indications in Development ~700K Total Addressable Patient Popula
Slide 74: Later Product Launches With Better Profile Captured Market Share
In Both TNF-α and JAKi Classes, a Later Product Launch With a Better Profile Rapidly Captured Dominant Market Share in Autoimmune Disease 1. Data from Evaluate. 4Q2025 net sales for Vyvgart held constant based on sales in 3Q2025. Remicade and Enbrel launch in 1998, Humira in 2003. Vyvgart launch in
Slide 75: IMVT-1402 Expected to Address >600K US Patients
75 IMVT-1402 Is Expected to Potentially Address >600K US Patients Note: Addressable populations as listed in IMVT Pipeline in IMVT Corporate Overview deck ~$7BN global anti-FcRn sales across two indications in 4 years Opportunity for IMVT-1402 to be first-/best-in-class for hundreds of thousands add
Slide 76: Near-Term Upside Catalysts for IMVT-1402
Near-Term Upside Catalysts for IMVT-1402
Slide 77: Key Catalysts Expected in D2T RA and CLE in 2026
77 IMVT-1402 Is Leading in 3 First-/Best-in-Class Indications With Key Catalysts Expected in D2T RA and CLE in 2026 Note: All drugs are investigational and subject to regulatory approvals. All catalyst timings are approximate, based on current expectations and, where applicable, contingent on FDA fe
Slide 78: Difficult-to-Treat Rheumatoid Arthritis Unmet Medical Need
78 Difficult-to-Treat Rheumatoid Arthritis (D2T RA) Represents an Unmet Medical Need With Few Current Treatment Options ACPA: anticitrullinated protein autoantibodies 1. Takanashi et al., Rheumatology (2021) 2. Aletaha and Smolen, JAMA (2018) 3. Taylor et al., ACR (2023) Deeper Is Better Phase 2 ant
Slide 79: Subset of US RA Patients Progresses to D2T Status
79 Of the 1.5M US RA Patients, a Subset Progresses to D2T Status ina Relatively Short Period of Time and Requires New Therapeutic Options1 Market Opportunity Patient Journey Learnings ~50% of patients fail their first b/tsDMARD therapy within the first year of treatment 4,5 Fewer than 50% of RA pati
Slide 80: Cutaneous Lupus Erythematosus Is a Debilitating Skin Condition
80 Cutaneous Lupus Erythematosus (CLE) Is a Debilitating Skin Condition With Minimal Current Treatment Options 1. Presto and Werth, Curr Treat Opt Rheum (2016) Early Proof of Concept Data Disruption of CLE pathology by upstream targeted approach supported by IMVT-1402 patient case studies 12-week tr
Slide 81: Dermatologists Desire a Targeted Biologic for CLE
1. Internal Market Research CLE Dermatologist Unmet Need (2023), Internal Market Research CLE Patient Journey (2024) 2. Presto and Werth, Curr Treat Opt Rheum (2016) 3. Jarukitsopa et al., Arthritis Care Res (2015) 4. IMVT Spherix Internal Market Research 5. Wahie and Meggitt, Br J Dermatol (2013) D
Slide 82: Introducing Dr. Mark Lupo, Graves' Disease Thought Leader
Introducing Dr. Mark LupoGraves’ Disease Thought Leader Mark A. Lupo, MD, FACE, ECNUThyroid & Endocrine Center of FloridaAssistant Clinical Professor of MedicineFlorida State University, College of MedicineSarasota, Florida
Slide 83: Why Are We Still Treating Graves' Disease Like It's 1950?
Why Are We Still Treating Graves’ Disease Like It’s 1950? Mark A. Lupo, MD, FACE, ECNU Thyroid & Endocrine Center of Florida Assistant Clinical Professor of Medicine Florida State University, College of Medicine Sarasota, Florida 83 For investor audiences only
Slide 84: Disclosures
Disclosures Mark A. Lupo, MD Speaking, research, and/or consulting: AbbVie, Amgen, argenx, Eisai, Immunovant, Interpace Diagnostics, Lycia Therapeutics, QuidelOrtho, Takeda, Viridian 84 For investor audiences only
Slide 85: My Practice
My Practice Established in 2002 Independent center focused on thyroid and parathyroid disease 3 Endocrinologists We see/follow hundreds of Graves’ disease patients About half still on long-term antithyroid drug treatment 85 For investor audiences only
Slide 86: Patient Phenotypes
Patient Phenotypes MILD (~50%) Small goiter +/- Slightly high T4/T3 No TED/mild TED Modest TRAb elevation Predictable ATD response MODERATE (~35-40%) +/- Goiter Overt hyper (T4/T3 elevation) +/- TED mild-moderate TRAb elevation >3-5x normal Multiple ATD dose changes SEVERE (~10-15%) Large Goiter T4/
Slide 87: For investor audiences only
87 For investor audiences only
Slide 88: Consequences of Uncontrolled Graves'
Consequences of Uncontrolled Graves’ Cardiovascular Atrial Fibrillation Stroke/Death High Output Heart Failure Morbidity/Death Increased Clotting Risks Stroke/Blood Clots Bone Loss Osteoporosis/Fracture Thyroid Eye Disease Vision Threatening Quality of Life Impact Anxiety, Insomnia, Muscle
Slide 89: Atrial Fibrillation Risk with Hyperthyroidism
Atrial Fibrillation Risk with Hyperthyroidism Registry Data of 586,460 Adults No Prior Atrial Fibrillation or Recorded Thyroid Disease 16,170 Atrial Fibrillation Events Selmer C et al. BMJ 2012. 89 For investor audiences only
Slide 90: Fracture Risk by TSH
Fracture Risk by TSH Blum M et al. JAMA 2015 90 For investor audiences only
Slide 91: Graves' disease treatment mechanisms and survey
aAll respondents were residing in the US. GD, Graves’ disease; MOA, mechanism of action. References: 1. Kahaly GJ. J Clin Endocrinol Metab. 2020;105(12):3704-20. 2. PrPROPYL-THYRACIL (propylthiouracil tablets USP) [prescribing information]. Paladin Labs Inc.; 2020. 3. Methimazole tablet [prescribing
Slide 92: Definitive Treatment Discussion
Definitive Treatment Discussion Radioactive Iodine Increased risk TED TRAb elevation Radiation exposure Permanent hypothyroidism Thyroidectomy Indicated if concern for cancer or large obstructive goiter Higher risk* Hypoparathyroidism Post-operative bleeding Tracheostomy Scar Permanent Hypothyroidis
Slide 93: Quality of Life after Definitive Treatment
Quality of Life after Definitive Treatment Hypothyroid patients consistently report lower scores on QOL scales compared to general population Treatment specific complications 1 in 4 patients still feel “unwell” but often told they are fine due to normal thyroid labs 93 For investor audiences only
Slide 94: Long-term Outcomes
Long-term Outcomes 2430 GD patients diagnosed 2003-2005 60% had follow-up data mean 8 years Remission rates: ATD-45%, RAI-82%, Surgery-96% ATD, second course 29% remission rate Patients receiving ATD had 50% chance of avoiding definitive treatment and 40% chance of achieving euthyroid state Overall,
Slide 95: TED, thyroid eye disease. Reference: Villagelin D, et al. J Clin Endocrinol Metab. 2024;109(11):2956-2966.
TED, thyroid eye disease. Reference: Villagelin D, et al. J Clin Endocrinol Metab. 2024;109(11):2956-2966. 95 For investor audiences only
Slide 96: For investor audiences only
96 For investor audiences only
Slide 97: Real-World Treatment Patterns of Methimazole Use
Real-World Treatment Patterns of Methimazole (MMI) Use in the United States Study Methods Data Source IQVIA Open Claims and PharMetrics Plus databases Time Period Analyzed November 2017 to October 2023 Inclusion Criteria Patients with a GD diagnosis within 3 years prior to or 2 years after an MMI pr
Slide 98: Longitudinal Patient Dose Journey After First MMI Dose
10% 15% 34% 41% 9% 14% 28% 34% 7% 8% 8% 12% 27% 32% 9% 11% 7% 10% 25% 33% 7% 18% 5% 8% 21% 30% 8% 27% 4% 6% 19% 31% 6% 35% Week 4 Week 8 Week 12 Week 24 Week 36 Week 56 Proportion of patients, % MMI dosage: High (>25 mg/d) Moderate-High (>15–≤25 mg/d) Moderate (>5–≤15 mg/d) Low (≤5 mg/d) Break (fail
Slide 99: ATD, antithyroid drug; GD, Graves’ disease; RAI, radioactive iodine; TRAb, thyroid-stimulating hormone receptor antib…
ATD, antithyroid drug; GD, Graves’ disease; RAI, radioactive iodine; TRAb, thyroid-stimulating hormone receptor antibodies. References: 1. Kahaly GJ, et al. Eur Thyroid J. 2018;7:167-86. 2. Ross DS, et al. Thyroid. 2016;26(10):1343-421. 3. Cooper DS. Curr Opin Endocrinol Diabetes Obes. 2021;28:510-6
Slide 100: Unmet Needs in Graves' Disease Standard of Care
Current therapies do not target the underlying autoimmune response1 While a significant proportion of patients respond to ATD therapy, up to ~25% are unable to complete their initial course2 ~50% remission rate after stopping ATD therapy3,4 Positive TRAb levels are associated with markedly increased
Slide 101: Rationale for Treatment of GD With an FcRn Blocker
Rationale for Treatment of GD With an FcRn Blocker FcRn blocker blocks FcRn-mediated IgG recycling in circulation In the presence of FcRn blocker, FcRn is blocked from binding to anti-TSHR Ab, which are then transported to the lysosome for degradation, decreasing their levels in the circulation Lyso
Slide 102: Dr. Mark Lupo, Graves' Disease Thought Leader
Dr. Mark LupoGraves’ Disease Thought Leader Mark A. Lupo, MD, FACE, ECNUThyroid & Endocrine Center of FloridaAssistant Clinical Professor of MedicineFlorida State University, College of MedicineSarasota, Florida
Slide 103: Paving the Path Forward in Graves' Disease
Paving the Path Forward in Graves’ Disease
Slide 104: Graves' Patients Have Higher Risk of Severe Comorbidities
Graves’ Disease Patients Have Higher Risk of Sequelae of Severe Comorbidities 1. Okosieme et al., Lancet Diabetes Endocrinol (2019) 2. Aggarwal et al., Gynecol Obstet Invest (2014) 3. Chin et al., Clin Endocrinol (Oxf.) (2020) 4. Potvin et al., Ophthalmic Plast Reconstr Surg (2023) 5. Galindo et al.
Slide 105: 25-30% of Patients Relapsed, Uncontrolled, or Intolerant to ATDs
Shift Away From Ablation and Lack of New Medical Therapies Leaves 25-30% of Patients Who Are Relapsed, Uncontrolled, or Intolerant to ATDs Diagnosed With Graves’ Disease Anti-Thyroid Drug (ATD) ~90-95% Ablation ~5-10% 1st Line Treatment Continued Control with ATDs ~60-65% Ablation ~3-5% Relapse / Un
Slide 106: Patients Uncontrolled on ATDs Experience Significant Disease Burden
RAI and surgery are associated with significant complications including increased risk of death from solid cancers; patients are often hypothyroid and require lifelong thyroid hormone replacement1,2 106 Graves’ Patients Uncontrolled on ATDs Experience Significant Disease Burden and Risk of Adverse E
Slide 107: Methimazole Dosing Shows Many Patients Remaining on ATDs After 5 Years
107 Follow-Up of Graves’ Disease Patient Methimazole Dosing Shows Significant Percent of Patients Remaining on ATDs After 5-Years Source: Roivant claims analysis Patients continuously enrolled from 2016 - 2024, newly diagnosed in 2019, 5 years of follow up data from initial MMI script 5-Year Follow-
Slide 108: Graves' Disease Market Opportunity
Graves’ Disease Market Opportunity Includes Annual Incident Population and a Significant Untapped Prevalent Patient Pool Annual Market of 2nd Line Incident Uncontrolled Patients ~7K 1st Line Ablation ~34K Continued ATD Remission3,4 ~65K Annual Diagnosed & Treated U.S. Adult Population1 ~58K Receive
Slide 109: Durability of Response Through Six Months Off-Treatment
Potential for Disease Modification With Responders Demonstrating Strong Durability of Response Through Six Months Off-Treatment 25 Uncontrolled Graves’ disease patients Baseline Week 48 Patients off-drug for 24 weeks1,2 Week 12 Pts receive 12 weeks of 680 mg QW batoclimab1 Week 24 Pts receive 12 wee
Slide 110: ~50% of Responders Achieved ATD-Free Remission
~50% of Responders at Week 48 Achieved ATD-Free Remission, Demonstrating Strong Potential for Disease Modification by a High-Dose FcRn 8 of 17 Patients With Normal T3/T4 at Week 48 Were in ATD-Free Remission 17 T3/T4 ≤ULN Week 48 13/17 responders on ATD doses ≤2.5 mg / day after six months off-treat
Slide 111: Sustained TRAb Reductions Post-Batoclimab Treatment
Off-Treatment Follow-up Mean percent change from baseline Baseline Week 4 Week 8 Week 12 Week 24 Week 48 340 mg batoclimab QW SC 680 mg batoclimab QW SC Step-down Sustained TRAb Reductions Post-Batoclimab Treatment Further Demonstrate Potential for Disease Modification Notes: Data includes up to las
Slide 112: IMVT-1402 Could Be First Disease-Modifying Therapy in Graves' Disease
112 IMVT-1402 Could Potentially Be the First-in-Class Disease-Modifying Therapy in Graves’ Disease Remarkable effect seen in uncontrolled Graves’ disease patients: 18 of 25 patients treated with batoclimab are responders at Week 24 01 Durable off-drug response: of the 21 patients who entered the off
Slide 113: Opportunities for IMVT-1402 to Win on Efficacy
Opportunities for IMVT-1402 to Win on Efficacy
Slide 114: IMVT-1402 Best-in-Class Potential in MG, SjD and CIDP
114 IMVT-1402 Has the Potential to Be Best-in-Class in MG, SjD and CIDP, With Room to Penetrate Large, Well-Validated Markets Note: All drugs are investigational and subject to regulatory approvals. All catalyst timings are approximate, based on current expectations and, where applicable, contingent
Slide 115: Sjögren's Disease Is a Chronic Autoimmune Disease
115 Sjögren’s Disease (SjD) Is a Chronic Autoimmune Disease Characterized by Lymphocytic Infiltration of the Salivary and Lacrimal Glands 1. Mariette et al., N. Engl J Med (2018) 2. Brito-Zeron et al., Nat Rev Dis Primers (2016) 3. GlobalData Analysis and Forecast, January 2025 4. Gottenberg et al.,
Slide 116: Sizable SjD Patient Group With Unmet Need
Sizable SjD Patient Group With Unmet Need for an Approved Treatment Option Sizable Unmet Need Expansion Opportunities Potential to impact conditions with shared autoimmune pathology Secondary Sjögren’s Unmet need to improve glandular manifestations beyond symptom relief Glandular Disease Disease imp
Slide 117: IMVT-1402 Potential in Myasthenia Gravis
117 IMVT-1402 Has the Potential to Improve Myasthenia Gravis (MG) Treatment Outcomes as a Best-in-Class Therapy AChR: anti-acetylcholine receptor 1. IMVT Market Research HCP Unmet Need 2. Phillips et al., Neurology (1992) 3. Mina-Osorio et al., AANEM (2023) 4. Lazaridis and Tzartos, Front Immunol (2
Slide 118: IMVT-1402 Potential in CIDP
118 IMVT-1402 Has the Potential to Deliver Best-in-Class Efficacy in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 1. Internal Market Research Market Dynamics 2024 2. Broers et al., Neuroepidemiology (2019) 3. Querol et al., J Neurol (2021) 4. IMVT batoclimab initial Period 1 Data Investo
Slide 119: Rich Catalyst Calendar Over the Next Months
Rich Catalyst Calendar Over the Next 36 Months 2026 Pivotal / Potentially Registrational Proof of Concept 1H 2026 Topline data in TED* Note: All drugs are investigational and subject to regulatory approvals. All catalyst timings are approximate, based on current expectations and, where applicable, c
Slide 120: In Summary: IMVT-1402
120 In Summary: IMVT-1402 Focused clinical execution: topline data in D2T RA now expected in 2026; readouts in 3 potentially registrational trials and 1 PoC expected in next 24 months The anti-FcRn class is rapidly growing; precedent best-in-class products have won significant market share in I&I in
Slide 121: Q&A
Q&A roivant Investor day 2025
Slide 122: Mosliciguat
122 Mosliciguat Drew Fromkin CEO, Pulmovant Frank Torti President & Vant Chair, Roivant
Slide 123: PH-ILD Represents Intense Unmet Medical Need
123 PH-ILD represents an area of intense unmet medical need with only one approved mechanism (two therapies) and an estimated 200,000 patients across the US and Europe Topline data from ongoing Phase 2 study (PHocus) is expected in 2H 2026 – 120 patient study with the potential to define a new stand
Slide 124: Mosliciguat Mechanism: sGC Activation
124 1. Sandner et al., Respir Med (2017) 2. Thoonen et al., Nat Commun (2015) 3. Becker-Pelster et al., Respir Res (2022) 4. Saleh et al., Clin Pharmacokinet (2025) x x sGC is a key enzyme in the NO-cGMP pathway and its activity is essential for vascular homeostasis1 Oxidative stress in pulmonary di
Slide 125: Mosliciguat Offers Differentiated Profile for Pulmonary Diseases
125 Pulmonary Diseases Are Highly Comorbid and Create Complexities for Patient Treatment Blanco et al., Curr Opin Pulm Med (2024) Mosliciguat Offers a Differentiated Profile With Potential to Address Complex Nature of Pulmonary Diseases Narrowing, remodeling, or obstruction of pulmonary vessels Incr
Slide 126: Mosliciguat Mechanism Video
Mosliciguat Mechanism Video 126
Slide 127: Pulmovant mission
Pulmovant is committed to transforming the lives of patients with pulmonary diseases For investor audiences only
Slide 128: A Brief Reminder of How We Got Here and What's Next
128 A Brief Reminder of How We Got Here and What’s Next… 1. A separate, open-label Phase 2 study (PHactor), is planned to evaluate the tolerability and safety of inhaled mosliciguat in combination with inhaled treprostinil in participants with PH-ILD (n=20). Note: All drugs are investigational and s
Slide 129: Phase 1 Investigations in Healthy Volunteers and PH Patients
HSF 129 Mosliciguat’s MoA and Molecular Properties Prompted Phase 1 Investigations in Healthy Volunteers and PH Patients (N=170) HSF Group 1 Group 4 Group 2 Group 3 Group 5 Pulmonary Arterial Hypertension PH associated with left heart disease PH associated with lung diseases and/or hypoxia PH associ
Slide 130: Single Dose Led to Reductions in PVR of Up to ~38%
130 (Single Dose - Group 1 and Group 4 Patients) Single Dose of Inhaled Mosliciguat Led to Sustained, Clinically Meaningful Mean-Max Reductions in Pulmonary Vascular Resistance (PVR) of Up to ~38% 1. Based on data seen in open-label, single-dose escalation multicenter trial in patients with untreate
Slide 131: Among the Highest PVR Reductions Ever Seen
131 Mosliciguat Has Shown Among the Highest PVR Reductions Ever Seen in the Single or Repeat Dose Setting * -31.81 * indicates trough PVR observation. 1. Represents average PVR reduction for participants in 4 mg dose group at hour 3 in ATMOS study. 2. Represents average of largest reduction in PVR f
Slide 132: cGMP Increases With Limited Systemic Effects
132 (Single Dose - Group 1 and Group 4 Patients) cGMP Concentrations Increased With Limited Systemic Effects and Correlated With Reductions in Mean Pulmonary Arterial Pressure and Increases in Cardiac Output1 Increase in Cardiac Output (CO) Mean increase in CO of up to 1.1L/min from baseline, equiva
Slide 133: Mosliciguat Was Well Tolerated Across Doses
133 Mosliciguat Was Well Tolerated Across Doses and Study Participants Results from Phase 1 SAD, MAD and ATMOS studies. 1. Numbers do not include subjects randomized to placebo. Reported TEAEs were of mild/moderate intensity and consistent across healthy volunteers (HVs) and PH participants All inha
Slide 134: Mosliciguat Attributes for Complex Pulmonary Disorders Like PH-ILD
134 Phase 1 and ATMOS Demonstrated Mosliciguat Has the Attributes to Potentially Address Complex, Heterogeneous Pulmonary Disorders Like PH-ILD 1. Evidenced by data demonstrated in ATMOS and Phase 1 studies conducted in healthy volunteers 2. Becker-Peslster et al., Respir Res (2022) PH-ILD MOSLICIGU
Slide 135: PH-ILD Represents Unmet Medical Need With Few Treatment Options
135 PH-ILD Represents Unmet Medical Need With Few Current Treatment Options 1. Sathananthan et al., Chest (2023) 2. Kacprzak et al., Diagnostics (2023) 3. Hilberg et al., ERJ Open Res (2022) 4. Raghu et al., Eur Respir J (2015) 5. King et al., Chest (2020) 6. Collard et al., J Am Geriatr Soc (2012)
Slide 136: Mosliciguat Differentiated From Other Potential PH-ILD Therapies
136 Potential for Robust PVR Reductions, Favorable Tolerability, and Simple, Inhaled, Once-per-Day Dosing Regimen Differentiate Mosliciguat from Other, Potential PH-ILD Therapies Figure represents a cross-study comparison and not a head-to-head study. Differences exist between study designs and subj
Slide 137: Rapid Growth in Tyvaso Sales Since PH-ILD Approval
137 Rapid Growth in Tyvaso Sales Since PH-ILD Approval Illustrates Clear Unmet Need Yet PH-ILD Treatment Domain Remains in Its Infancy Blockbuster sales in PH-ILD achieved ~3 years into launch1 1. Company estimate for breakdown of Tyvaso sales in PAH / PH-ILD.2. Per UTHR management guidance. April ’
Slide 138: Evolution of PAH Treatment Paradigm
138 Evolution of Pulmonary Arterial Hypertension (PAH) Treatment Paradigm Represents a Likely Path for PH-ILD Market Development Key Treatment Pathway(s) | Median Survival Progression 1. Dalonzo et al., Ann Intern Med (1991) 2. Sitbon et al., JACC (2002) 3. Benza et al., Chest (2012) 4. Hendriks et
Slide 139: PAH Supports Multiple Modalities and Combination Therapy
139 PAH Disease Severity Supports Multiple Modalities With Increased Preference for Combination Therapy 1. Muller et al., Adv Ther (2024) Evolution of Total PAH Sales: 2002 – 2025 $9BN + $49BN + $44BN 6 drug approvals 5 drug approvals(5 drugs off patent in period) 4 drug approvals $ BN 15+ approved
Slide 140: Phase 2 Development Focuses on Needs of Patients With PH-ILD
140 Phase 2 Development of Mosliciguat Focuses on the Urgent and Complex Needs of Patients With PH-ILD Adapted from Humbert et al., Eur Heart J (2022) Group 3 PH associated with lung diseases and/or hypoxia Phase 2 PHocus Study of Mosliciguat in Adult Patients with PH-ILD PH associated with left hea
Slide 141: Phase 2 PHocus Study of Mosliciguat in PH-ILD
141 Phase 2 PHocus Study of Mosliciguat in Adult Patients With PH-ILD Double-blinded, multi-center, global trial in ~120 PH-ILD patients with topline readout expected in 2H 2026 Extension Period Treatment Period Screening Period Inclusion/Exclusion Confirmed ILD (IIP, CHP, ILD-CTD) Elevated baseline
Slide 142: Phase 2 PHactor Study With Inhaled Treprostinil
Phase 2 PHactor Study of Mosliciguat in Combination with Inhaled Trepostinil A separate, open-label Phase 2 study is planned to evaluate the tolerability and safety of inhaled mosliciguat in combination with inhaled treprostinil in participants with PH-ILD (n=20). This study is expected to initiate
Slide 143: In Summary: Mosliciguat
143 In Summary: Mosliciguat Among the best PVR reductions seen to date with differentiated MoA, convenient once-daily dosing and favorable safety profile PH-ILD is an area of unmet medical need – tractable market with only one approved mechanism Topline data from ongoing Phase 2 study (PHocus) expec
Slide 144: Q&A
Q&A roivant Investor day 2025
Slide 145: Genevant & Arbutus LNP Litigation
145 Genevant & Arbutus LNP Litigation Lindsay Androski Special Counsel, Genevant CEO, Arbutus Matt Gline CEO, Roivant
Slide 146: Genevant/Arbutus LNP Patent Infringement Claims Overview
146 We believe that both the Moderna COVID-19 vaccine (SPIKEVAX) and Pfizer/BioNTech’s COVID-19 vaccine (COMIRNATY) infringe multiple Genevant/Arbutus LNP patents In the ex-US Moderna litigation, initial court hearings and rulings are expected in 2026 Markman rulings (claim construction) have been i
Slide 147: Genevant and Arbutus Corporate History
Genevant and Arbutus Corporate History 2006 Protiva acquired Tekmira, another company working on LNP technology Roivant set out to assemble a leading global HBV company by merging OnCore Biopharma with Protiva/Tekmira to form Arbutus Biopharma Roivant and Arbutus launched Genevant as a joint venture
Slide 148: A Leading Nucleic Acid Delivery Company
148 A Leading Nucleic Acid Delivery Company Industry-leading LNP delivery capabilities and IP portfolio Selective collaboration business model, partnering with payload companies to develop innovative nucleic acid medicines The first LNP technology to be part of an FDA-approved RNA product, Alnylam’
Slide 149: Genevant/Arbutus IP Portfolio and Pending Litigation
Some of the US patents licensed by Genevant from Arbutus include: Moderna previously sought to invalidate two of the particle composition patents referenced above with IPR challenges but was largely unsuccessful Litigation is ongoing against Moderna in the US and certain other jurisdictions and agai
Slide 150: mRNA COVID-19 Vaccines Have Generated Over $145BN in Revenue
150 mRNA COVID-19 Vaccines from Moderna and Pfizer/BioNTech Have Generated Over $145BN in Revenue Revenue as of 9/30/2025 Data and sales calculated from Evaluate and company docs from MRNA, PFE, and BNTX Total SpikeVax Sales account for ~1/3 of mRNA vaccine sales to date; Comirnaty sales account for
Slide 151: Moderna Case
Moderna Case roivant Investor day 2028
Slide 152: February 2022 Complaint Against Moderna
152 In February 2022, Genevant and Arbutus Jointly Filed a Complaint Against Moderna Asserting Patent Infringement on Patents Related to LNP Technology Case filed in the US District Court for the District of Delaware asserting infringement of six patents Genevant and Arbutus did not seek an injuncti
Slide 153: Moderna Patent Litigation Timeline
153 Moderna Patent Litigation Timeline: Years in the Making 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 informatio
Slide 154: Summary Judgment Motions Filed in US Moderna Case
154 Summary Judgment Motions Filed in US Moderna Case 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 t
Slide 155: Daubert Motions: Expert Testimony
155 Moderna’s Motions to Exclude Genevant/Arbutus’ Expert Testimony Damages methodologies Opinions regarding willful infringement Fractionation testing Opinions regarding infringement Opinions regarding applicability of Section 1498 Genevant/Arbutus’ Motions to Exclude Moderna’s Expert Testimony Dam
Slide 156: Key Upcoming Milestones in US Litigation
Key Upcoming Milestones in US Litigation Judge to rule on summary judgment motions, including decision on § 1498, before the jury trial in March Judge will rule on Daubert motions, which could narrow the expert testimony allowed to be presented on both sides or impact presentations on damages, infri
Slide 157: Overview of International Infringement Litigation
157 Overview of International Infringement Litigation; Accounts for Significant Portion of Ex-US SpikeVax Revenue All ex-US jurisdictions with cases pending bifurcate liability from damages and, with success in liability phase, typically issue injunction preventing future sales; many award damages b
Slide 158: Pfizer Case
Pfizer Case LE LATS LL. LLLP LALLLL LLP LLL roivant Investor day 2028
Slide 159: Pfizer/BioNTech Litigation Timeline to Date
159 Pfizer/BioNTech Litigation Timeline to Date 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 f
Slide 160: Publicly Available Evidence Supports the Initial Filing of Our Case
Publicly Available Evidence Supports the Initial Filing of Our Case Publicly Available Evidence Supporting the Case1 BioNTech had license to Genevant LNP Technology for use for specific cancer and rare liver disease targets dating back to 2018; contract described Genevant’s platform as “the best lip
Slide 161: In Summary: LNP Litigation
161 In Summary: LNP Litigation We believe both Moderna’s and Pfizer/BioNTech’s COVID-19 vaccines infringe multiple Genevant/Arbutus patents Trial/hearings in both the US and the ex-US litigation against Moderna expected in 2026 Awaiting court scheduling in the Pfizer/BioNTech litigation Markman deci
Slide 162: Financial Outlook
Richard Pulik CFO, Roivant 162 Financial Outlook
Slide 163: Portfolio Supports $15BN+ Peak Revenue Potential
163 Our Portfolio Supports Wave of Approvals in Untapped High-Value Growth Markets With $15BN+ Peak Revenue Potential Represents non-probability adjusted peak sales across all announced indications. Graph is an approximate illustration of peak sales opportunity and is not drawn to scale time $ in bi
Slide 164: Capitalized to Profitability With $4.4BN Cash Balance
164 Roivant Capitalized to Profitability With $4.4BN Cash Balance to Advance Current Priorities and Fund Selective Capital Allocation Opportunities1 1. Cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2025 Invest in Current Pipeline & Launches 10+ disclosed indi
Slide 165: Selected Financial Metrics and Non-GAAP Modeling Assumptions
Modeling Assumptions2 in $ millions, unaudited GAAP1 Non-GAAP1 Roivant Consolidated Net Revenue $20 $20 R&D $604 $560 G&A $566 $278 Total OpEx $1,171 $839 Interest Income $210 $210 Immunovant R&D $404 $375 G&A $83 $56 Total OpEx $487 $431 Interest Income $23 $23 165 Selected Financial Metrics and No
Slide 166: Non-GAAP Disclosures
Non-GAAP Disclosures (1) Represents non-cash share-based compensation expense. (2) Represents non-cash depreciation and amortization expense. Notes to non-GAAP financial measures: Reconciliation of GAAP to Non-GAAP Financial Measures (unaudited, in millions) 166 Last 12 Months Actual Note September
Slide 167: Non-GAAP Disclosures
167 Non-GAAP Disclosures Reconciliation of GAAP to Non-GAAP Financial Measures (unaudited, in millions) Last 12 Months Actual Note September 30, 2025 Total Roivant Research and development expenses $ 604 Adjustments Share-based compensation (1) 41 Depreciation and amortization (2) 3 Adjusted researc
Slide 168: Closing Remarks
Matt Gline CEO, Roivant 168 Closing Remarks
Slide 169: Keys to Our Success in 2026 and Beyond
169 Keys to Our Success in 2026 and Beyond Well-capitalized Funded through profitability Unique and creative development programs for high quality molecules Purposeful indication selection across pipeline programs Ability to successfully commercialize drugs in non-mass-market indications Preparing f
Slide 170: 2026: Another Catalyst-Rich Year for Roivant
2026: Another Catalyst-Rich Year for Roivant For investor audiences only LNP litigation jury trial in US Moderna case in 1Q 2026 Mosliciguat PH-ILD Ph2b topline data in 2H 2026 Brepocitinib NIU Ph3 topline data in 2H 2026 Brepocitinib DM NDA filing planned for early 2026 Topline data in PoC studies
Slide 171: Roivant's Priorities for the Next Months
171 Roivant’s Priorities for the Next 12 Months… Prepare for brepocitinib launch Progress IMVT-1402 development across multiple pivotal studies Convert multiple PoC studies across 3 products into pivotal programs Execute on LNP litigation Add to existing pipeline For investor audiences only
Slide 172: To Fully Capitalize on an Exciting Next Decade
172 … To Fully Capitalize on an Exciting Next Decade Represents non-probability adjusted peak sales across all announced indications. Graph is an approximate illustration of peak sales opportunity and is not drawn to scale time $ in billions Potential for growth across all programs Mosliciguat 1 ann
Slide 173: Rich Catalyst Calendar Over the Next Months
Rich Catalyst Calendar Over the Next 36 Months Note: All drugs are investigational and subject to regulatory approvals. All catalyst timings are approximate, based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. All references are to calendar
Slide 174: Q&A
Q&A roivant Investor day 2025
Slide 175: Appendix
Appendix
Slide 176: Selected Study Designs
Selected Study Designs roivant Investor day 2028
Slide 177: Phase 3 Study for Brepocitinib in Dermatomyositis
177 Positive topline results announced in September 2025 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 Disea
Slide 178: Phase 3 Study for Brepocitinib in Non-Infectious Uveitis
178 : : Phase 3 Study for Brepocitinib in Non-Infectious Uveitis Two identical sub-studies, CLARITY-1 and CLARITY-2, under a single protocol Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide QD: daily; OC
Slide 179: BEACON: Phase 2 Study in Cutaneous Sarcoidosis
179 BEACON: Phase 2 Study for Brepocitinib in Cutaneous Sarcoidosis Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide CS: cutaneous sarcoidosis; QD: daily; CFB: change from baseline; CSAMI: Cutaneous Sarc
Slide 180: Potentially Registrational Study for IMVT-1402 in Graves' Disease
180 : Potentially Registrational Study for IMVT-1402 in Graves’ Disease Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide Note: Throughout the study, ATD titration occurs to lowest effective dose (includi
Slide 181: Potentially Registrational Study II for IMVT-1402 in Graves' Disease
181 II: Potentially Registrational Study for IMVT-1402 in Graves’ Disease Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide Note: Throughout the study, ATD titration occurs to lowest effective dose (inclu
Slide 182: Potentially Registrational Study for IMVT-1402 in Myasthenia Gravis
182 : Potentially Registrational Study for IMVT-1402 in Myasthenia Gravis Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide Note: Long-Term Extension (LTE) study starts at Week 26 AChR Ab+: acetylcholine
Slide 183: Potentially Registrational Study for IMVT-1402 in D2T RA
183 : Potentially Registrational Study for IMVT-1402 in Difficult-to-Treat Rheumatoid Arthritis Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide 1. 1:1:1 randomization of patients meeting ACR20 criteria
Slide 184: Study Design for IMVT-1402 in Sjögren's Disease
184 Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide *Only clinESSDAI responders (improvement of ≥ 4 points from baseline) continue through period 2 anti-SSA: anti-Sjögren’s-syndrome-related antigen A an
Slide 185: Study Design for IMVT-1402 in CIDP
185 Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide Note: Simplified study design without washout period and flare requirement prior to randomization based on experience in the batoclimab CIDP study in
Slide 186: Proof-of-Concept Study for IMVT-1402 in CLE
186 Proof-of-Concept Study for IMVT-1402 in Cutaneous Lupus Erythematosus Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide Note: Simplified study design without washout period and flare requirement prior
Slide 187: Phase 3 Studies for Batoclimab in Thyroid Eye Disease
187 GO and GO-2: Phase 3 Studies for Batoclimab in Thyroid Eye Disease Anticipate sharing topline data from both trials in 1H 2026* Note: Additional inclusion and exclusion criteria not listed on slide; additional primary and secondary endpoint details not listed on slide; participants that complete
Slide 188: Phase 2 Study of Mosliciguat in PH-ILD
188 : Phase 2 Study of Mosliciguat in Pulmonary Hypertension Associated With Interstitial Lung Disease Note: Additional inclusion and exclusion criteria not listed on slide Note: Additional primary and secondary endpoint details not listed on slide *Rapid uptitration to stable dose PH-ILD: pulmonary
Slide 189: Vant Financials Overview
Vant Financials Overview roivant Investor day 2028
Slide 190: Priovant: Other Details
190 Priovant: Other Details ROIV owns 73%1 of Priovant, with Pfizer owning 24%. Ownership Geographic Rights Intellectual Property Milestones Royalties 1. As of September 30, 2025. 65% on a fully diluted basis. 2. Includes potential patent term extension We expect brepocitinib to have US exclusivity
Slide 191: Immunovant: Other Details
191 Immunovant: Other Details Immunovant is publicly traded, with ROIV owning 55%1 Ownership Geographic Rights Intellectual Property Milestones Royalties 1. As of September 30, 2025, 50% on a diluted basis 2. Immunovant has commercialization rights in U.S., Canada, Mexico, the E.U., the U.K., Switze
Slide 192: Pulmovant: Other Details
192 Pulmovant: Other Details ROIV owns 98%1 of Pulmovant. Ownership Geographic Rights Intellectual Property Milestones Royalties 1. As of September 30, 2025. 91% on a fully diluted basis. 2. Includes potential patent term extension We expect mosliciguat to have US exclusivity until the mid-2040s2. P