Roivant Sciences Ltd. · NASDAQ:ROIV
Roivant Sciences — FY2024 Earnings Presentation
33 slides from Roivant Sciences's earnings presentation, May 30, 2024
Slide 1: Financial Results and Business Update for the Year Ended March 31, 2024
Financial Results and Business Update for the Year Ended March 31, 2024 May 30, 2024
Slide 2: Speakers
Speakers Matthew Richard Frank Eric Venker, MD, Mayukh Gline Pulik Torti, MD PharmD Sukhatme, MD Chief Chief Vant Chair President and President and Executive Officer Financial Officer Chief Operating Chief Investment Officer Officer 2 For investor audiences only
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks This presentation includes data for brepocitinib as compared to certain other products and uncertainties that could cause actual results to differ materially from those expressed or
Slide 4: Agenda
Agenda ➢ Roivant in 2024 ➢ Immunovant Updates ➢ Recent Brepocitinib NIU Data ➢ VTAMA® Psoriasis Launch and Atopic Dermatitis Program ➢ Upcoming Catalysts and Other Business Updates ➢ Financial Update ➢ Q&A 4 For investor audiences only
Slide 5: 2024 Will Be a Year of Expansion for Roivant
2024 Will Be a Year of Expansion for Roivant Deliver Clinical Data Advance Clinical File VTAMA sNDA in Expand Pipeline Finalize Capital for Leading Anti-FcRn Development In a AD & Accelerate PsO Through Mid-Late- Allocation Strategy Franchise and Range of Revenue Growth Stage Business Across Best Va
Slide 6: Our Next Chapter is Anchored by Our Robust Late-Stage Pipeline
Our Next Chapter is Anchored by Our Robust Late-Stage Pipeline Exciting late-stage pipeline with 6 ongoing registrational trials in multi-billion dollar markets and 4-5 additional potentially registrational programs with IMVT-1402 expected by March 2025 Modality Preclinical Phase 1 Phase 2 Phase 3 A
Slide 7: Immunovant Updates
Immunovant Updates roivant
Slide 8: Ongoing Progress at Immunovant Building a Leading FcRn Franchise
Ongoing Progress at Immunovant Building a Leading FcRn Franchise IMVT-1402 Development Portfolio Optimization IMVT-1402 IP Progress • Held successful Type B meeting • IMVT-1402 designated as lead • Recently issued patent for IMVT- with the FDA on 1402 program 1402 covering composition of development
Slide 9: Updates Across Broad Spectrum of Indications Where Greater IgG Reduction May Drive Efficacy
Updates Across Broad Spectrum of Indications Where Greater IgG Reduction May Drive Best-In-Class Efficacy Detailed results from the study of batoclimab as well as an overview of the development plan of GD IMVT-1402 expected in the fall of 2024 Topline data from the batoclimab study is expected over
Slide 10: Consistent Evidence Across Programs that Greater IgG Reduction Leads to Greater Efficacy
Consistent Evidence Across Programs and Indications that Greater IgG Reduction Leads to Greater Efficacy1 Company Evidence of Greater IgG Reductions Translating to Clinical Benefit Patient-level scatter plot showed that greater IgG declines ➔ greater MG MG-ADL improvements2,3 Greater IgG reduction a
Slide 11: Positive Initial Phase 2 Proof-of-Concept Data Enhances First-in-Class Opportunity in GD
Positive Initial Phase 2 Proof-of-Concept Data Enhances First-in-Class Opportunity in GD Results from the initial cohort of patients in the ongoing 24-week clinical trial meaningfully exceeded 50% response rates Numerically higher responses for ATD dose tapering and ATD discontinuation observed in p
Slide 12: Recent Brepocitinib NIU Data
Recent Brepocitinib NIU Data
Slide 13: Significant Unmet Need & Commercial Opportunity in NIU
Significant Unmet Need & Commercial Opportunity in NIU Uveitis is the fourth-leading cause of blindness among working-age population in the developed world1 • Accounts for approximately 10% of cases of blindness in U.S.2,3 At an orphan price point with differentiated data, • Tens of thousands of new
Slide 14: NIU Opportunity Parallels Other Blockbuster Orphan Indications, With Less Competition
NIU Opportunity Parallels Other Blockbuster Orphan Indications, With Less Competition Non-Infectious Hidradenitis Thyroid Eye Myasthenia Uveitis Suppurativa Disease Gravis Overall 400,0001,2 300,000 100,000 65,000 Prevalence Prevalence in 15,000 - 20,000 Relevant Sub- 70,000 - 100,0002 100,000 - 150
Slide 15: NEPTUNE Study Design
NEPTUNE Study Design A Phase 2 Randomized, Double-Masked, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Active Non-Infectious Intermediate-, Posterior-, and Panuveitis 4 WEEK TREATMENT PERIOD 4 WEEK Key Efficacy Endpoints SCREENING FOLLOW-UP • Treatmen
Slide 16: Steroid Taper Sets Higher Bar for Brepocitinib Compared to Precedent Studies
Steroid Taper Sets Higher Bar for Brepocitinib Compared to Precedent Studies KEY IMPLICATIONS OF DIFFERENT TAPERS NEPTUNE (brepocitinib) study is modeled on VISUAL I (active uveitis registrational study for Humira) with one key exception – brepocitinib steroid taper was more than twice as fast Brepo
Slide 17: Treatment Failure Rate at Week 24 Including Cross-Study Comparison to VISUAL I
Treatment Failure Rate at Week 24 (lower rate = greater treatment benefit) Including Cross-Study Comparison to VISUAL I Treatment Failure Treatment Failure (ITT; ICEs Imputed as Treatment Failure; Pre-Specified) (DCs Censored) 100% 100% 82% 78% 80% 80% Patients (%) Patients (%) 62% 60% 60% 50% 44% 4
Slide 18: Brepocitinib Proof-of-Concept in Potentially Resolving and Preventing Macular Edema
Brepocitinib Proof-of-Concept in Potentially Resolving and Preventing Macular Edema Data suggests potential to resolve macular edema and potential to prevent or reverse swelling before threshold for macular edema is reached and patient is formally diagnosed with UME In the 45 mg arm, at Baseline: In
Slide 19: NEPTUNE Data Supports Potentially Differentiated Product Profile for Brepocitinib
NEPTUNE Data Supports Potentially Differentiated Product Profile for Brepocitinib: Potential Early Treatment Option for Physicians Looking to Intervene Aggressively to Prevent Vision Loss NIU treatment paradigm places premium on efficacy, given particularly high morbidity Try Multiple ISTs and Biolo
Slide 20: VTAMA Psoriasis Launch and Atopic Dermatitis Program
VTAMA® Psoriasis Launch and Atopic Dermatitis Program
Slide 21: VTAMA in Psoriasis Launch Progressing Steadily
VTAMA in Psoriasis Launch Progressing Steadily 7,000 PsO Branded Topical Market - Weekly TRx • $75.1M net product revenue for the fiscal year ended March 31, 6,000 2024 5,000 • $19.3M net product revenue for the quarter ended March 31, 4,000 2024 3,000 • 24% gross to net yield for the quarter ended
Slide 22: Strong Foundation for Rapid Launch in Atopic Dermatitis
Strong Foundation for Rapid Launch in Atopic Dermatitis Proven ability to drive switches from standard of care Exceptional clinical data including patients down to to VTAMA based on script patterns since launch1 age 2 supports approximately 4x expansion opportunity in AD; PDUFA date Q4 2024 VTAMA NB
Slide 23: Renegotiation of Dermavant Debt and Royalty Obligations Reduces Potential Cash Payments
Renegotiation of Dermavant Debt and Royalty Obligations Reduces Potential Cash Payments by ~$300M, Including ~$225M in Next Three Fiscal Years Debt and Royalty Pre-Restructuring Post-Restructuring Commentary Instruments NovaQuest PsO and AD $171M of total savings due to reduced total approval $294M
Slide 24: Upcoming Catalysts & Other Business Updates
Upcoming Catalysts & Other Business Updates
Slide 25: Clinical Trial Readouts and Milestones Will Drive Significant Potential Value Creation
Clinical Trial Readouts and Milestones Will Drive Significant Potential Value Creation Opportunities Brepocitinib VTAMA IMVT-1402/ Namilumab Batoclimab IMVT-1402 Batoclimab Fall 2024 4Q 2024 By FY End By FY End ✓ ✓ Detailed results Topline data from from batoclimab Initiate 4-5 sNDA filing for Topli
Slide 26: Roivant Announced $1.5BN Share Repurchase Program Including Sumitomo Stake
Roivant Announced $1.5BN Share Repurchase Program Including Purchase of Entire Sumitomo Stake for $648M, Reducing Share Count by ~9% Goal of repurchase program is to drive value creation for investors by taking advantage of price dislocation to reduce share count and shareholder concentration, while
Slide 27: Continued Progress at VantAI Underscores Unique Opportunity
Continued Progress at VantAI Underscores Unique Opportunity Select recent milestones Pre-clinical milestones hit on every major collaboration with $3.6B+ in total potential upside1 Proximity Modulators Entered into collaboration to accelerate molecular glue drug discovery with generative AI. Eligibl
Slide 28: Other Quarter Updates
Other Quarter Updates Moderna Patent Litigation • In April 2024, the court agreed with Genevant and Arbutus’ proposed constructions for three of the four disputed terms against Moderna in the claim construction (Markman) ruling • Fact and expert discovery are ongoing, and the court will entertain re
Slide 29: Financial Update
Financial Update roivant
Slide 30: Key Financial Items
Key Financial Items Income Statement Metrics and Income Statement Metrics and Select Non-GAAP Metrics Select Non-GAAP Metrics Balance Sheet Metrics for the Three Months for the Fiscal Year at March 31, 2024 Ended March 31, 2024 Ended March 31, 2024 • Net revenue of $29M, including net • Net revenue
Slide 31: Non-GAAP Disclosures
Non-GAAP Disclosures Reconciliation of GAAP to Non-GAAP Financial Measures (unaudited, in thousands) Notes to non-GAAP financial measures: (1) Represents non-cash amortization of intangible assets associated with milestone payments made in at fair value with changes in value reported in earnings. co
Slide 32: Rich Catalyst Calendar Through 2025
Rich Catalyst Calendar Through 2025 Expected Program Vant Catalyst 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 Additional
Slide 33: Thank you.
Thank you. roivan