Roivant Sciences Ltd. (NASDAQ: ROIV) Q1 2025 Earnings | 08/11/2025

10 days ago

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Inside Ticker

Earnings Calls

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Summary of Roivant Sciences Ltd. Q1 2025 Earnings Call (August 11, 2025)

Key Highlights:

Upcoming Catalysts:
- Brepocitinib (BREPO) in Dermatomyositis (DM):
  - Registrational data expected in H2 2025 (VALOR study completed last patient visit).
  - Potential NDA filing in early 2026, with commercial launch preparations underway.
  - BREPO is the only oral therapy in late-stage development for DM, a debilitating disease with high unmet need.
- IMVT-1402 (anti-FcRn antibody):
  - Multiple registrational trials ongoing (Graves’ disease, Sjögren’s, CIDP, MG).
  - Graves’ disease Phase 2 six-month remission data to be presented at ATA next month.
- LNP Litigation (Moderna & Pfizer/BioNTech):
  - Moderna trial set for March 2026; summary judgment motions pending (rulings expected fall 2025).
  - Pfizer/BioNTech case in discovery; Markman ruling possible in 2025.
Financial & Share Repurchase Update:
- $1.5B share buyback completed (reduced share count by ~15%).
- New $500M repurchase program authorized.
- Strong balance sheet: $4.5B cash, no debt.
Pipeline Progress:
- Immunovant (IMVT-1402):
  - Graves’ disease enrollment strong; second registrational trial initiated.
  - CIDP and MG studies advancing.
- Brepocitinib (Priovant):
  - Non-infectious uveitis (NIU) Phase 3 data expected H1 2027.
  - Cutaneous sarcoidosis proof-of-concept data in 2026.
- Other Programs:
  - Cilagavaptan (hypertension) update in H2 2026.
Business Development (BD):
- Active in evaluating late-stage assets, including opportunities in China.
- Focus on autoimmune & immunology mechanisms (e.g., FcRn, JAK/TYK2).

Q&A Highlights:

DM Trial Design: Steroid taper success (98% compliance, 40% fully off steroids) may help differentiate BREPO.
Graves’ Disease: Even modest remission rates could be practice-changing for severe patients.
Competition in DM: Roivant aims to be first to market with an oral therapy.
LNP Litigation: Key updates expected fall 2025 on summary judgment motions.

About this video

Roivant Sciences Ltd. reported its financial results for the first quarter ended June 30, 2025, marked by execution on clinical progress and strategic capital management. The company reported earnings per share (EPS) of $0.33, beating consensus estimates of $0.23, representing an earnings surprise of approximately 44%. However, revenue was $2.17 million, significantly below the consensus estimate of $6.92 million, and down sharply from $55.13 million a year ago. Roivant completed a $1.5 billion authorized stock repurchase program, reducing its share count by over 15% from March 31, 2024. In June 2025, the board approved an additional $500 million share repurchase program, reflecting the company’s commitment to capital return and shareholder value. The company holds a strong cash position with consolidated cash, cash equivalents, restricted cash, and marketable securities totaling approximately $4.5 billion as of June 30, 2025, supporting a cash runway into profitability. Research and development (R&D) expenses increased by $32.4 million year-over-year to $152.9 million, primarily driven by program-specific costs related to its anti-FcRn franchise, mosliciguat, and brepocitinib development. Personnel-related expenses rose due to increased headcount supporting clinical studies. Key clinical updates include the ongoing Phase 3 VALOR study of brepocitinib for dermatomyositis (DM), with topline data expected in the second half of 2025, and accelerated enrollment in additional registrational trials. The company also provided updates on its litigation with Moderna over lipid nanoparticle (LNP) patents, with trials scheduled for 2026 and 2027. Management expressed pride in continued execution, clinical progress, and strategic financial actions, with a focus on upcoming catalysts, pipeline expansion, and potential business development opportunities. Risks cited include clinical trial uncertainties, competitive and regulatory challenges, and the ongoing need to optimize cost management amid elevated expenses. About Inside Ticker: Inside Ticker delivers timely, in-depth financial news and earnings analysis to empower investors with actionable insights on global companies across sectors. For comprehensive video analysis and real-time updates, visit https://www.insideticker.com/. #RoivantSciences #ROIV #Q12025 #Earnings #FinancialResults #EPS #StockRepurchase #ClinicalTrials #Brepocitinib #Dermatomyositis #Mosliciguat #AntiFcRn #LipidNanoparticleLitigation #CashPosition #R&D #PipelineExpansion #InvestorUpdates #Biopharma #DrugDevelopment #NASDAQ #InsideTicker

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