Roivant Sciences Ltd. · NASDAQ:ROIV
Roivant Sciences — Investor Presentation (November 2023)
93 slides from Roivant Sciences's investor presentation, November 2023
Slide 1: Roivant Overview
Roivant Overview November 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks very competitive and rapidly changing environment in which new risks emerge from time to and uncertainties that could cause actual results to differ materially from those expressed
Slide 3: Roivant: Developing and Commercializing Transformative Medicines
Roivant: Developing and Commercializing Transformative Medicines Vant model aligns incentives to drive fast, high-quality execution and rigorous capital allocation Proven track record with 10 consecutive positive Phase 3 trials and 6 FDA approvals1 Cash, cash equivalents and restricted cash of $1.4B
Slide 4: 2023: Roivant's Biggest Year Yet
2023: Roivant’s Biggest Year Yet Expanded VTAMA ADORING 1 and 2 - RVT-3101 (Anti-TL1A) IMVT-1402 Brepocitinib Coverage and Reach VTAMA Phase 3 UC Phase 2b Data (Next-Gen Anti-FcRn) (TYK2/JAK1) Pivotal Readouts in AD Initial Human Data Trial Readout in SLE Pending sale to Roche ✓ ✓ to maximize patien
Slide 5: Robust Late-Stage Pipeline
Robust Late-Stage Pipeline Six ongoing registrational trials in multi-billion dollar markets Modality Preclinical Phase 1 Phase 2 Phase 3 Approved Psoriasis | Dermavant Topical ► Atopic Dermatitis | Dermavant Topical Completed BATOCLIMAB Myasthenia Gravis | Immunovant Biologic ► BATOCLIMAB Thyroid E
Slide 6: Rich Catalyst Calendar Through 2025
Rich Catalyst Calendar Through 2025 Program Vant Catalyst Expected Timing VTAMA (tapinarof) cream Updates on commercial launch of VTAMA in psoriasis Ongoing Roivant pipeline growth New mid/late-stage in-licensing announcements Ongoing LNP platform Updates to LNP patent litigation Ongoing Batoclimab
Slide 7: Pending Sale of Telavant
Pending Sale of Telavant roivant
Slide 8: Roche to Acquire Telavant
Roche to Acquire Telavant Roche to acquire Telavant for $7.1BN upfront and a $150M milestone, which includes: — Development and commercial rights to RVT-3101 in US and Japan — Option to collaborate with Pfizer on next-generation p40/TL1A directed bispecific antibody Expected cash proceeds to Roivant
Slide 9: Transaction Generates Significant Value for Patients and Shareholders
Transaction Generates Significant Value for Patients and Shareholders Near Term Value Capital Infusion Creates Maximize Patient Access Generation Opportunities for Growth ❖ Adds resources and expertise ❖ $7.25BN deal value reflects large ❖ We will be patient and from a large global scale of TL1A opp
Slide 10: Commercial Launch of VTAMA Cream
Commercial Launch of VTAMA® Cream
Slide 11: VTAMA is Charting a Path to Become a Potential Blockbuster Topical
VTAMA is Charting a Path to Become a Potential Blockbuster Topical in Both Psoriasis and Atopic Dermatitis 1 2 3 Powerful efficacy Favorable safety and Convenient, once- and rapid onset in tolerability profile daily product with plaque psoriasis with that enables long expected single tube remittive
Slide 12: VTAMA Leads the Other Branded Topicals in Weekly TRx
VTAMA Leads the Other Branded Topicals in Weekly TRx Over 250,000 VTAMA prescriptions written by approximately 12,800 unique prescribers since launch PsO Branded Topical Market – Weekly TRxs1 6,000 Weekly TRx 5,000 4,000 3,000 2,000 1,000 ENSTILAR SOTYKTU DUOBRII LEXETTE BRYHALI WYNZORA 0 SORILUX VT
Slide 13: Another Quarter of VTAMA Launch Execution & Strong Demand
Another Quarter of VTAMA Launch Execution & Strong Demand Net Product Revenue Since Launch $ 25 $ 20 $18.4 Net Revenue ($M) $16.7 $ 15 $13.7 $18.4M net product revenue for quarter ended Sept. 30, 2023 $9.2 $ 10 $5.0 $5 $0 FQ2 2022 FQ3 2022 FQ4 2022 FQ1 2023 FQ2 2023 28% net yield for quarter ended S
Slide 14: Commercial and Government Coverage Progressing Ahead of Plan
Commercial and Government Coverage Progressing Ahead of Plan Innovation and TRx performance driving VTAMA accelerated coverage ✓ 3 National PBM Formulary Additions 137M ✓ 4 National Health Plan Formulary Additions ✓ 1 Regional PBM Formulary Addition Commercial Lives Covered (83% of Total) ✓ 16 Regio
Slide 15: AD Data Supports Potential Market Expansion in Topical TRx
AD Data Supports Potential Market Expansion from ~90K Weekly Topical TRx in Psoriasis to >400K Combined Weekly Topical TRx Market Psoriasis and Atopic Dermatitis Total Market – Weekly TRx1 Psoriasis Atopic Dermatitis Total 600,000 VTAMA approved indication2 Positive Phase 3 Readouts 34,290 347,875 4
Slide 16: VTAMA: A Paradigm Shift In Everyday Psoriasis Care
VTAMA: A Paradigm Shift In Everyday Psoriasis Care Physician Quotes from Investor Day KOL Panel: “What has really struck me using this post approval in the real world is really the fast onset of action. I am seeing some of my patients come back into the office or message me through the portal tellin
Slide 17: VTAMA Cream Broad and Differentiated FDA-Approved Label
VTAMA Cream Broad and Differentiated FDA-Approved Label Mild, moderate & severe Broad Target plaque psoriasis Population and Use Cases May be applied to all affected skin areas Unlimited duration of treatment as demonstrated Differentiated in clinical studies over 52 weeks Clinical Efficacy Demonstr
Slide 18: VTAMA Cream's FDA Label is Differentiated Among Competitors
VTAMA Cream’s FDA Label is Differentiated Among Competitors Non-Steroidal Topicals Systemics Topical Steroids Steroid Combinations On Label DUOBRIITM ENSTILAR® OTEZLA® HUMIRA® SOTYKTUTM ZORYVETM Clobetasol Halobetasol Betamethasone (Corticosteroid/ (Corticosteroid/ (Oral) (Subcutaneous) (Oral) Vitam
Slide 19: 6x Treatment Success Rate vs. Vehicle at Week 12
6x Treatment Success Rate vs. Vehicle at Week 12, With Significant Efficacy Seen as Early as Week 41-3 1-3 PGA treatment success: PGA score of 0 or 1 & a >2-grade improvement from baseline to week 12 50 PSOARING 1 PSOARING 2 50 • VTAMA cream (n=340) • VTAMA cream (n=343) • Vehicle QD (n=170) • Vehic
Slide 20: Remittive Effect is Unprecedented, and The Hallmark of VTAMA
Remittive Effect is Unprecedented, and The Hallmark of VTAMA PSOARING 1 PSOARING 3 LTE 12 Weeks on treatment 12 Weeks on treatment 24 Weeks off treatment Month Month Month Month Month Month Month Month Month Month Month Month 1 2 3 4 5 6 7 8 9 10 11 12 Patient achieved PGA=0 on treatment and Patient
Slide 21: VTAMA Demonstrated Positive Results in Intertriginous Plaque Psoriasis
VTAMA Demonstrated Positive Results in Intertriginous Plaque Psoriasis Robust and rapid efficacy in Phase 4 open-label trial of VTAMA for the treatment of intertriginous areas after 12 weeks iPGA Score of Clear (0) or Almost Clear (1) iPGA Score of Clear (0) and ≥2-grade Improvement from Baseline at
Slide 22: VTAMA Cream Phase 3 ADORING Program – Trial Design
VTAMA Cream Phase 3 ADORING Program – Trial Design 813 patients down to two years of age with atopic dermatitis in two identical pivotal trials followed by long-term, open-label extension Double-blind Treatment Long-term, Open-label Extension‡ Follow-up (8 weeks) (48 weeks) (1 week) Patients with mo
Slide 23: ADORING 1 & 2: Baseline Demographics and Disease Characteristics
ADORING 1 & 2: Baseline Demographics and Disease Characteristics 80% pediatric patients and well balanced across pediatric age cohorts ADORING 1 ADORING 2 Patients, n (%) VTAMA 1% QD Vehicle QD Overall VTAMA 1% QD Vehicle QD Overall (n=270) (n=137) (n=407) (n=271) (n=135) (n=406) Age, mean (SD) 15.6
Slide 24: ADORING 1 and 2 Successful Across All Primary and Secondary Endpoints
ADORING 1 and 2 Successful Across All Primary and Secondary Endpoints EASI75 PP-NRS vIGA-AD ADORING 1 ADORING 2 ADORING 1 ADORING 2 ADORING 1 ADORING 2 vIGA-ADTM Score of 0 or 1 and vIGA-ADTM Score of 0 or 1 and Improvement in PP-NRS of ≥4 Improvement in PP-NRS of ≥4 at Least a ≥2-grade EASI75 from
Slide 25: ADORING 1 & 2: Summary of TEAEs – Safety Population
ADORING 1 & 2: Summary of TEAEs – Safety Population VTAMA 1% QD demonstrates highly favorable safety profile in AD patients down to age 2 years old ADORING 1 ADORING 2 VTAMA 1% QD Vehicle QD VTAMA 1% QD Vehicle QD Patients, n (%) (n=270) (n=137) (n=271) (n=133) Adverse events of special interest (tr
Slide 26: ADORING 2: Primary Efficacy Endpoint – VTAMA Cream Regulatory Success
ADORING 2: Primary Efficacy Endpoint – VTAMA Cream Regulatory Success Rapid response to treatment with VTAMA cream in pediatric patient achieving regulatory endpoint by Week 2 BASELINE WEEK 2 WEEK 4 WEEK 8 vIGA-ADTM 3 1 1 1 EASI 6.5 3.0 0.3 0.9 CDLQI 6 5 2 0 PP-NRS 9 4.6 3.7 0.3 Example of a represe
Slide 27: VTAMA Demonstrated Rapid and Significant Reduction of Pruritis in AD
VTAMA Demonstrated Rapid and Significant Reduction of Pruritis in AD in ADORING 1 & 2 Studies Rapid reduction in pruritis as early as 24 hours after first application Clinically meaningful difference (≥4-point reduction in mean baseline PP-NRS score) surpassed in tapinarof groups at week 8 PP-NRS, P
Slide 28: EASI-75 Responder Rate vs Existing Topical and Systemic Therapies
EASI-75 Responder Rate vs Existing Topical and Systemic Therapies Moderate to Severe Moderate to Severe Moderate to Severe Mild to Moderate Mild to Moderate Mild to Moderate (ADORING 1 & 2 Phase 3; (Phase 3; (Phase 3; (Phase 3; (Phase 3; (Phase 3; Topical QD) Injection Q2W) Injection EOW) Topical BI
Slide 29: Systemic-Like Efficacy Alongside Exceptional Product Profile
Systemic-Like Efficacy Alongside Exceptional Product Profile as a Non- Steroidal Once Daily Topical Topical JAK Topical PDE4 Biologics Opzelura® ZORYVE® Eucrisa® Dupixent® Adbry® Studied in Subjects with AD Down to 2 Years Old ✔ ✗ ✗ ✔ ✔ ✗ Studied in Moderate to Severe AD ✔ ✗ ✗ ✗ ✔ ✔ Once Daily Dosin
Slide 30: Anti-FcRn Franchise: Batoclimab and IMVT-1402
Anti-FcRn Franchise: Batoclimab and IMVT-1402
Slide 31: Differentiated Assets to Address a Range of Patient Needs
Differentiated Assets to Address a Range of Patient Needs Are the Goals of Our Development Batoclimab Tailored dosing to address varying symptom severity across + indications and stage of disease + • Short term maximal IgG suppression + • Lower chronic doses where less IgG suppression needed • Simpl
Slide 32: Our Opportunity: Autoimmune Diseases Driven by Harmful IgG Autoantibodies
Our Opportunity: Autoimmune Diseases Driven by Harmful IgG Autoantibodies 22 indications currently announced or in development across the anti-FcRn class1 NEUROLOGY RHEUMATOLOGY Myasthenia gravis (MG) Primary Sjogrens syndrome Chronic inflammatory demyelinating polyneuropathy Systemic lupus erythema
Slide 33: Greater IgG Reduction Leads to Greater Efficacy
Consistent Evidence Across Programs and Indications that Greater IgG Reduction Leads to Greater Efficacy* Company Evidence of Greater IgG Reductions Translating to Clinical Benefit Patient-level scatter plot showed that greater IgG declines ➔ greater MG MG-ADL improvements Greater IgG reduction acro
Slide 34: Best-in-Class Potential for IMVT-1402 – Why it Matters
Best-in-Class Potential for IMVT-1402 – Why it Matters FcRn inhibition is a proven mechanism with broad potential applicability based on targeted reduction of IgG as an improved and more targeted modality Evidence across broad range of auto-antibody conditions that deeper IgG reduction correlates wi
Slide 35: IMVT-1402 Phase 1 Trial: Multiple-Ascending Subcutaneous Doses
IMVT-1402 Phase 1 Trial: Multiple-Ascending Subcutaneous Doses (Once-weekly dosing x 4 weeks)
Slide 36: IMVT-1402 600mg MAD Data Consistent with 300mg MAD Data
IMVT-1402 600mg MAD Data Consistent with 300mg MAD Data IgG % change over time Albumin % change over time LDL % change over time IMVT-1402: Multiple-ascending SC Dose IMVT-1402: Multiple-ascending SC Dose IMVT-1402: Multiple-ascending SC Dose 40% 20% 50% 40% 20% 10% 30% 0% 20% 0% -20% 10% -10% 0% -4
Slide 37: IMVT-1402 MAD Data Suggests Potential Best-in-Class IgG Reduction
IMVT-1402 MAD Data Suggests Potential Best-in-Class IgG Reduction IgG % change over time IMVT-1402: Multiple-ascending 600mg SC Dose IMVT-1402: Multiple-ascending 300mg SC Dose 40% 40% 20% 20% 0% 0% -20% -20% -40% -40% -60% -60% -80% -80% -100% -100% Day Day IMVT-1402: MAD SC 600mg Group Mean IMVT-1
Slide 38: IMVT-1402 MAD Data: IgG Reduction Similar to Batoclimab
IMVT-1402 MAD Data Suggests Potential Best-in-Class IgG Reduction Similar to Batoclimab* IgG % change over time Multiple-ascending SC Dose 40% 20% 0% -20% -40% -60% -80% -100% 0 5 10 15 20 25 30 IMVT-1402: MAD SC 600mg Group Mean Day IMVT-1402: MAD SC 300mg Group Mean IMVT-1402: MAD SC Placebo (600m
Slide 39: IMVT-1402 MAD Data: Minimal to No Albumin Reduction
IMVT-1402 MAD Data: Minimal to No Albumin Reduction, Similar to Placebo, After Four Weeks of Dosing Albumin % change over time IMVT-1402: Multiple-ascending 600mg SC Dose IMVT-1402: Multiple-ascending 300mg SC Dose 20% 20% 10% 10% 0% 0% -10% -10% -20% -20% -30% -30% -40% -40% Day Day IMVT-1402: MAD
Slide 40: IMVT-1402 MAD Data: Minimal to No LDL Increase
IMVT-1402 MAD Data: Minimal to No LDL Increase, Similar to Placebo, After Four Weeks of Dosing LDL % change over time IMVT-1402: Multiple-ascending 600mg SC Dose IMVT-1402: Multiple-ascending 300mg SC Dose 50% 50% 40% 40% 30% 30% 20% 20% 10% 10% 0% 0% -10% -10% -20% -20% -30% -30% -40% -40% -50% -50
Slide 41: IMVT-1402 Showed a Favorable Safety Profile in Initial Phase 1 Data Set
IMVT-1402 Showed a Favorable Safety Profile in Initial Phase 1 Data Set SC SAD SC MAD Placebo 300mg 600mg Placebo 300mg 600mg N=4 N=6 N=6 N=4 N = 10 N = 10 n (%) n (%) n (%) n (%) n (%) n (%) Participants with at least one TEAE 3 (75) 4 (67) 5 (83) 4 (100) 7 (70) 6 (60) Participants with at least on
Slide 42: Portfolio Development for IMVT-1402
Portfolio Development for IMVT-1402
Slide 43: Creating the Best Portfolio of Indications for IMVT-1402
Creating the Best Portfolio of Indications for IMVT-1402 Guided by IgG biomarker in proven mechanism with well-characterized safety profile Addressable population Unmet patient need Potential to address Competitive differentiation multiple indications in an exciting class Technical success probabili
Slide 44: Potential Best-in-Class Product Profile Opens Broad Range of Indications
Potential Best-in-Class Product Profile Opens Broad Range of Indication Opportunities for IMVT-1402 • Assuming differentiated benefit/risk and simple SC delivery, High unmet opportunity to leverage potency of 1402 to further expand First-in-Class applicable patient types for anti-FcRn development ne
Slide 45: Examples of Potential First-in-Class and/or Best-in-Class Indications
Examples of Potential First-in-Class and/or Best-in-Class Indications* Graves’ Disease Rheumatoid Arthritis Large unmet need between oral anti-thyroid medications Large unmet need in refractory rheumatoid arthritis (RA) 1 (ATD) that work for many & definitive therapies that 1 for patients who fail t
Slide 46: IMVT-1402 Has Potentially Best-In-Class Attributes
IMVT-1402 Has Potentially Best-In-Class Attributes to Address Large Unmet Need in Autoimmune Disease IMVT-1402 + + Deep IgG Lowering Initial Phase 1 data suggests deep + dose-dependent IgG lowering similar to batoclimab Favorable Analyte Profile Initial Phase 1 data supports a favorable analyte prof
Slide 47: Indications
Indications roivan
Slide 48: Myasthenia Gravis (MG): IgG-Mediated Autoimmune Disease
Myasthenia Gravis (MG): IgG-Mediated Autoimmune Disease that Typically Requires Lifestyle Changes Key Takeaways1 Extent of Lifestyle Modifications2 • One of the larger IgG-mediated autoimmune diseases 22% Slight 38% o ~65,000 patients estimated in the US and changes Major ~100,000 in Europe changes
Slide 49: Encouraging Efficacy Signals in a Phase 2 Trial of Batoclimab in MG
Encouraging Efficacy Signals in a Phase 2 Trial of Batoclimab in MG Data at Week 7, End of Controlled Portion of Study 10% 2% 3% 0% -3% -10% % Change from baseline -20% -23% Placebo (N=6) -30% -40% Batoclimab -38% 340mg/week -50% (N=5) -54% -60% Batoclimab -59% 680 mg/week -70% (N=6) -80% -76% -90%
Slide 50: Batoclimab Phase 3 Trial Designed to Address Unmet Patient Needs
Batoclimab Phase 3 Trial Designed to Address Unmet Patient Needs Flexible Design First for a Myasthenia Gravis Trial but Common in Immunology INDUCTION MAINTENANCE LONG-TERM 1 PHASE 2 PHASE 3 EXTENSION Gain control Keep control Optimize control High doses included, designed to Lower dose designed to
Slide 51: Registrational Phase 3 Trial of Batoclimab in MG
Registrational Phase 3 Trial of Batoclimab Designed to Offer MG Patients Tailored Dosing Top-line data expected in the second half of 2024 Period 1: Period 2: Induction (12 weeks) Maintenance (12 weeks) Placebo-controlled, Placebo-controlled, two dose regimens: two dose regimens: Primary analysis po
Slide 52: TED: A Heterogeneous Condition with Variety of Clinical Symptoms
TED: A Heterogeneous Condition that Presents with a Variety of Clinical Symptoms TED is a rare autoantibody mediated inflammatory disease that affects between 15,000 and 20,0001 new patients each year in the United States Clinical Presentation and Unmet Need Clinical features include eye bulging (“p
Slide 53: Batoclimab TED Data Showed Higher Clinical Response with Deeper IgG Reduction
Batoclimab TED Data Showed Higher Clinical Response with Deeper IgG Reduction Deeper IgG reduction led to greater restoration of normal levels of pathogenic antibodies and greater proptosis response in Phase 2 trial in TED Batoclimab Batoclimab Batoclimab Placebo 255 mg 340 mg 680 mg Median Max % Ig
Slide 54: Two Phase 3 Clinical Trials of Batoclimab in TED Initiated
Two Phase 3 Clinical Trials of Batoclimab in TED Initiated Top-line data from both trials expected in the first half of 2025 Study 1 and 2: Inclusion Active Treatment Phase Primary endpoint: • Subjects with clinical Proptosis responders at diagnosis of TED Placebo-controlled, Week 24 vs placebo wher
Slide 55: CIDP: A Complex Chronic Neurological Disease
CIDP: A Complex Chronic Neurological Disease & Exciting Opportunity for Anti-FcRn Class CIDP is an autoimmune associated with pathogenic, complement-activating IgG and IgM autoantibodies that target myelin and other neuronal proteins that affects up to 16,0001,2 people in the United States Clinical
Slide 56: Key Learnings from Historical and Ongoing CIDP Trials
Key Learnings from Historical and Ongoing CIDP Trials Applied to Address Challenges Unique to CIDP Two-stage approach, to accommodate additional registration trial, if necessary, has the potential to deliver a differentiated product label with a larger effect size Mitigation Mitigation Trial risks M
Slide 57: Pivotal Phase 2b Trial in CIDP
Pivotal Phase 2b Trial Intended to Develop Potentially Best-in-Class Chronic Anti-FcRn Therapy in CIDP Study timeline Week -12 Week 0 Week 12 analysis Week 36 analysis Period 1C: Period 2D: ScreeningA WashoutB Randomize Treatment Responders Randomized Treatment Randomized Withdrawal ≤ 28 days ≤ 12 w
Slide 58: Graves' Disease: a Systemic Disease Impacting Multiple Organ Systems
Graves’ Disease: a Systemic Disease that Impacts Multiple Organ Systems Leaving Many Patients with Substantial Symptoms Graves’ Disease is an immune disorder characterized by hyperthyroidism and has an incidence of about 116,000 cases per year in the U.S.1,2 Clinical Presentation and Unmet Need Targ
Slide 59: The First and Only Anti-FcRn Program Targeting Graves' Disease
The First and Only Anti-FcRn Program Targeting Graves’ Disease1,2 Treatment Period: (24 weeks) InclusionA N = up to 40 • Subjects with active Screening (4 weeks) Follow-up Period GD as documented by Primary endpoint: Two doses tested presence of elevated Proportion of participants stimulatory TSH-R-
Slide 60: Brepocitinib
Brepocitinib roivant
Slide 61: Oral Brepocitinib Overview
Oral Brepocitinib Overview Potential multi-billion dollar specialty autoimmune franchise with upcoming catalysts in 2024 and 2025 • Clinically meaningful efficacy demonstrated in Psoriasis, Alopecia, Psoriatic Arthritis, Ulcerative Colitis, Six Positive Placebo-Controlled Hidradenitis Suppurativa, a
Slide 62: Dual TYK2/JAK1 Inhibition for Heterogeneous Autoimmune Diseases
Dual TYK2/JAK1 Inhibition is Optimized For Highly Inflammatory Heterogeneous Autoimmune Diseases With Multiple Pathogenic Cytokines JAK inhibitors have Rheumatology Immuno-Dermatology IBD been approved in… RA, PsA, AS, JIA, axSpA PsO, AD, Vitiligo, Alopecia Ulcerative Colitis, Crohn’s Disease states
Slide 63: In Vitro Data Support Mechanistic Benefits of Dual Inhibition
In Vitro Data Support Mechanistic Benefits of Dual Inhibition of TYK2 and JAK1 Dual Hit Greater Coverage Percent Cytokine Inhibition at Modeled Exposures* Percent Cytokine Inhibition at Modeled Exposures* Rinvoq 15 mg QD IFNγ Sotyktu 6 mg QD Brepocitinib 30 mg QD Rinvoq 15 mg QD (upadacitinib) JAK1
Slide 64: Clinical Experience Confirms Oral Brepocitinib is Highly Active
Clinical Experience Confirms Oral Brepocitinib is Highly Active and Able to Generate Consistent, Reproducible Clinical Benefit in TYK2- and JAK1-Driven Indications Statistically Significant and Clinically Meaningful Results in Six Placebo-Controlled Phase 2 Studies Study Population N1 Brepocitinib D
Slide 65: Priovant Strategy: Indications with High Unmet Need
Priovant Strategy: Indications with High Unmet Need and Tailored to Novel Mechanism of dual TYK2 / JAK1 Inhibition Focus on indications with high unmet need Opportunity for brepocitinib to and tailored to novel mechanism of dual become a leading treatment option TYK2 / JAK1 inhibition in large, uncr
Slide 66: Dermatomyositis: Large Orphan Indication With Blockbuster Opportunity
Dermatomyositis: Large Orphan Indication With Blockbuster Opportunity For An Efficacious Oral Therapy 37,000 Affected adult patients in the United States alone1 10-40% Mortality at five years2 Red, painful, itchy skin rash often disseminated across 100% substantial body surface area Proximal muscle
Slide 67: Clinical Proof-of-Concept with Tofacitinib Suggests High Probability of Success
Clinical Proof-of-Concept with Tofacitinib Suggests High Probability of Success For Brepocitinib in Ongoing Phase 3 Study Investigator-initiated open-label study of tofacitinib in refractory dermatomyositis demonstrated activity comparable to that of IVIg, the only approved non-corticosteroid/cortic
Slide 68: Single Phase 3 Study Ongoing; Expected To Generate Registrational Data
Single Phase 3 Study Ongoing; Expected To Generate Registrational Data Required for Approval Primary Endpoint: Total Improvement Score (TIS), a recognized myositis improvement index that served as basis of approval for IVIg in dermatomyositis 52-week treatment period Eligible Patients Adult subjects
Slide 69: Expansion Opportunities
Expansion Opportunities Non-Infectious Uveitis Hidradenitis Suppurativa 69
Slide 70: Non-Infectious Uveitis: A Sight-Threatening Ocular Disease
Non-Infectious Uveitis: A Sight-Threatening Ocular Disease Opportunity for brepocitinib to become the first approved oral therapy for the treatment of a leading cause of blindness New cases of legal blindness attributable to NIU 30,000 in the US each year1 Patients living with non-anterior NIU in th
Slide 71: Phase 2 POC Study Designed to Validate TYK2/JAK1 Approach in NIU
Phase 2 POC Study Designed to Provide Rapid Validation of TYK2/JAK1 Approach in NIU Enrollment complete; topline data expected in Q1 2024 24-week main treatment period 28-week extension period Eligible Patients Adult subjects with active intermediate, posterior, or panuveitis Brepocitinib 45 mg QD (
Slide 72: Hidradenitis Suppurativa: A Severe and Disfiguring Skin Disease
Hidradenitis Suppurativa: A Severe and Disfiguring Skin Disease Opportunity for brepocitinib to become leading oral therapy for treatment of exceptionally debilitating inflammatory skin disease 170,000 Patients living with HS in the United States1 Key Nodule, abscess, and tunnel formation in Symptom
Slide 73: Dual TYK2/JAK1 Inhibition May Generate Greater Efficacy than JAK1 Alone
Dual TYK2/JAK1 Inhibition May Generate Greater Efficacy than Inhibition of JAK1 Alone HiSCR50 Response Cross-Study Comparisons; No Head-to-Head Data Available ∆ 19% 60% 52% ∆ 17% 50% 45% ∆ 13% Absolute and placebo-adjusted results numerically better than 38% Patients (%) 40% other oral agents and 33
Slide 74: Clear Path To Multi-Billion Dollar Specialty Autoimmune Franchise
Clear Path To Multi-Billion Dollar Specialty Autoimmune Franchise Multiple Catalysts Over the Near and Long Term 2024 2025 Phase 3 Study Phase 3 Data Read Out DM Fully Enrolled (expected to be sufficient for registration) NIU POC Data Identify additional indications uniquely suited Read Out (Q1) to
Slide 75: RVT-2001
RVT-2001 roivant
Slide 76: RVT-2001: Potential First-in-Class Small Molecule SF3B1 Modulator
RVT-2001: Potential First-in-Class Small Molecule SF3B1 Modulator for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS Lower-Risk MDS is a Commercially Validated Market Multipronged Expect Fast, Lower-Risk MDS Encouraging Strategy to Well-Established Strong Intellectual
Slide 77: High Unmet Need for an Oral Therapy in Lower-Risk MDS
High Unmet Need for an Oral Therapy in Transfusion-Dependent Anemia in Lower-Risk MDS Current treatment options leave significant unmet need in multiple treatment segments ~17K new MDS cases/year, • Lower-risk MDS is a chronic condition; therapy is focused on ~115K MDS patients total in US1 manageme
Slide 78: SF3B1: A Target Uniquely Suited to Improving Anemia in MDS
SF3B1: A Target Uniquely Suited to Improving Anemia in MDS RVT-2001 is an oral therapy for the treatment of anemia associated with lower-risk MDS that utilizes a novel mechanism to correct aberrant splicing caused by SF3B1 mutations RVT-2001 Mutations in SF3B1 cause alterations in splicing of hundre
Slide 79: Encouraging Early Data Demonstrate RVT-2001's Clinical Potential
Encouraging Early Data Demonstrate RVT-2001’s Clinical Potential Meaningful Clinical Impact in Refractory Potential for Improved Therapeutic Patient Population to Date1 Effect in Earlier-Line Patients • RVT-2001: RBC-TI rate of >30% in Phase 1/2 study in • Hemavant enrolling earlier-line patients in
Slide 80: Trial Design Intended to Target Improved and Extended Responses
Trial Design Intended to Target Improved and Extended Responses Robust signal-enhancing design can provide multiple paths to demonstrate value through potential high response rates and/or long duration either in the overall population or in genetically defined subsets Target Genetically Defined Subp
Slide 81: Phase 1/2 Ongoing with Recently Added Dose-Optimization Cohort
Phase 1/2 Ongoing with Recently Added Dose-Optimization Cohort Key Exclusion/Inclusion Criteria: N = up to 64 Excluding lower-risk MDS patients with prior HMA or lenalidomide exposure Primary endpoint at 24 weeks Enrolling only lower-risk MDS patients with SF3B1 mutations Evaluating baseline express
Slide 82: Namilumab
Namilumab roivant
Slide 83: Namilumab: Potential First Novel Therapy for Pulmonary Sarcoidosis
Namilumab: Potential First Novel Therapy for Pulmonary Sarcoidosis, a Large, Untapped Orphan Market Pulmonary Sarcoidosis GM-CSF Inhibition Compelling Drug Robust RESOLVE-LUNG Is A Large, Untapped Uniquely Stops the “Bad Properties Study Underway Orphan Market Actor” Cell Type ~180,000 patients in t
Slide 84: Pulmonary Sarcoidosis is a Large, Untapped Orphan Market
Pulmonary Sarcoidosis is a Large, Untapped Orphan Market A well-tolerated and effective, steroid-sparing therapy for sarcoidosis has blockbuster commercial potential1 ~180,000 patients in the US alone2 Characterized by the accumulation of granulomas – compact, centrally organized collections of macr
Slide 85: GM-CSF Inhibition Uniquely Stops the Bad Actor Cell Type
GM-CSF Inhibition Uniquely Stops the “Bad Actor” Cell Type: Alveolar Macrophages Alveolar macrophages are Alveolar uniquely driven by macrophages then GM-CSF signaling form noncaseating Alveolar granulomas in the Pulmonary sarcoidosis macrophages lungs is an autoimmune contribute to a Granulomas and
Slide 86: RESOLVE-Lung: Phase 2 Pulmonary Sarcoidosis Study
RESOLVE-Lung: Phase 2 Pulmonary Sarcoidosis Study Could Serve as a Registrational Study if Successful Primary Endpoint Proportion of subjects requiring rescue1 for worsening of sarcoidosis Key Secondary Endpoints • Change from baseline in ppFVC • Time to rescue treatment • Proportion of subjects suc
Slide 87: LNP Patent Litigation
LNP Patent Litigation roivant
Slide 88: Genevant is a Leading Nucleic Acid Delivery Solutions Company
Genevant is a Leading Nucleic Acid Delivery Solutions Company • Genevant was formed in 2018 by Roivant and Arbutus and licensed Arbutus’s LNP technology and patent portfolio • Deep expertise in delivery systems for mRNA and other nucleic acids • Without adequate protection, nucleic acids degrade qui
Slide 89: Genevant Collaborates with Leading Companies for Access to its LNP Technology
Genevant Collaborates with Leading Companies for Access to its LNP Technology to Develop Medicines for a Variety of Diseases and Disorders, Including COVID-19 Collaboration LNP Collaborations Outside of COVID-19 Publicly Disclosed Financials* Partner Royalty rate: mid-single to low-double digits† Ge
Slide 90: Updates on Genevant IP Litigation
Updates on Genevant IP Litigation • In February 2022, Genevant and Arbutus jointly filed a complaint against Moderna in the US District Court for the District of Delaware asserting infringement of six patents • On November 2, the federal district court in Delaware issued an opinion and order denying
Slide 91: VantAI
VantAl roivant
Slide 92: VantAI Positioned to Unlock the Potential of Induced Proximity
VantAI Positioned to Unlock the Structural Proteomics Potential of Induced Proximity VantAI has positioned itself at the intersection of three Targeted protein degradation is just the transformative technologies… Generative AI beginning… Induced Proximity • Many more fields to come beyond degradatio
Slide 93: Thank you.
Thank you. roivan
Roivant Sciences — Investor Presentation (November 2023) on 6ix