Q4 2025 Roivant Sciences Ltd Earnings Call Transcript
Key Points
- Roivant Sciences Ltd (ROIV) reported strong clinical data from its 1,402 study, showing high ACR response rates, with 73% of patients achieving ACR20, over half achieving ACR50, and over a third achieving ACR70.
- The company received breakthrough therapy designation for PrEP/Sitnib for retinue sarcoidosis, highlighting its potential impact on patient treatment.
- Roivant Sciences Ltd (ROIV) announced a $2.25 billion settlement with Moderna, with $950 million expected upfront in July, strengthening its financial position.
- The company is on track to launch brevacitinib for dermatomyositis by the end of September, pending FDA approval, indicating strong commercial preparation.
- Roivant Sciences Ltd (ROIV) has a robust pipeline with multiple upcoming data readouts, including Phase 3 NIU data and Moseley PNHLD Phase 2B top-line data, suggesting continued growth and innovation.
- The failure of the betokumab studies in TED was announced, although hyperthyroid patients showed normalization, indicating mixed results in ongoing studies.
- The Phase 2 study for Mosley is not powered to achieve a p-value on the six-minute walk test, which may limit the immediate impact of the results.
- There is uncertainty regarding the period two data of the 1,402 study, as the primary endpoint is losing an ACR-20 response, which may not fully capture the drug's efficacy.
- Roivant Sciences Ltd (ROIV) faces a competitive landscape in the CLE market, requiring strong data to support its program amidst emerging mechanisms.
- The company is still analyzing detailed patient-level data and has not yet finalized its path forward with the FDA, indicating potential regulatory hurdles.
Ladies and gentlemen, thank you for standing by. Welcome to the Braven fourth quarter 2025 earnings call. (Operator Instructions) Please be advised that today's conference is being recorded. I would like now to turn the conference over to Stephanie Lee. Please go ahead.
Good morning, and thanks for joining today's call to review business updates from Roivant's fourth quarter and fiscal year ended March 31, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Glein, CEO of Roivant, and Drew Prompkin, CEO of Pomovance. For those dialing in via conference call, you can find the slides being presented today, as well as a press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making. Certain forward-looking statements during today's presentation. We strongly
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