Roivant Sciences Ltd. Q2 FY2026 earnings call

• Lysriah (BREPO) Commercial Launch: Approved in August, the drug generated $31 million in net revenue in its first five weeks. There is high physician and patient enthusiasm, with a broad prescriber base and strong initial uptake. Inventory dynamics showed a tailwind in Q2 due to pharmacy stocking ahead of demand, which may create a modest headwind in Q4, but inventory issues are expected to normalize next year.
• 1402 Rheumatoid Arthritis (RA) Data: Period 2 data from the randomized withdrawal trial was highly positive. Approximately 92.5% of patients maintained an ACR20 response at week 28 on the 600 mg dose, compared to ~75% on placebo. The 300 mg dose did not preserve responses effectively, reinforcing that deep IgG suppression is critical for efficacy. Safety profile remains consistent with previous reports.
• NIU (Non-Infectious Uveitis): Data from the Clarity studies demonstrated that BREPO achieved steroid-free quiescence in nearly two-thirds of patients over 48 weeks, meeting all primary and secondary endpoints. This represents a new standard of care for this poorly served indication.
• Moseley-Sigawatt (PHILD): Phase 2 data showed a 56% placebo-adjusted reduction in pulmonary vascular resistance (PVR) and significant improvements in six-minute walk distance. The drug was well-tolerated, with lower cough rates than placebo. Phase 3 enrollment is underway.
• Strategic Updates: The company will not likely progress 1402 into Sjogren's syndrome due to competitive landscape updates and futility signals. However, they will complete the current study to learn from the data. FDA discussions for 1402 in RA are ongoing.

The company reported $31 million in net revenue for the second quarter of 2026, driven by the commercial launch of Lysriah (BREPO) for dermatomyositis. This revenue reflects five weeks on the market and strong initial demand, with hundreds of patients on paid drug by quarter-end. The remainder of the business consists of clinical-stage assets (1402, NIU, Moseley/Sigawatt) which contributed no revenue but represent significant future growth pillars. Specific revenue contribution percentages for non-commercial segments were not disclosed as they are pre-revenue.

• Financial Guidance: No specific full-year financial guidance was provided during the call. The company noted a net loss of continuing operations of $153 million ($133 million non-GAAP) for the quarter.
• Operational Outlook: Management highlighted that 2027 will be a very busy year, expecting multiple important top-line data releases, including for 1402 in Graves’ disease and Myasthenia Gravis (MG). They anticipate filing the sNDA for NIU and potentially adding another indication for BREPO.
• Inventory Expectations: Management indicated that while Q2 benefited from pharmacy stocking, there may be a modest headwind in the December quarter, but inventory impacts should become irrelevant heading into 2027.

• Competitive Landscape in Sjogren’s: Progression into Sjogren’s is unlikely due to negative competitor data (e.g., J&J, Novartis, Amgen), suggesting limited opportunity in that specific indication despite completing the current study.
• Regulatory Uncertainty for 1402: Final approval strategy, including whether one Phase 3 trial is sufficient and the choice of endpoints, depends on ongoing FDA discussions, creating uncertainty around the timeline and design for RA development.
• Commercial Execution Risks: Early payer restrictions vary significantly, ranging from simple prior authorizations to more complex step therapies. While access has been straightforward so far, future plan designs could impact uptake speed.
• Clinical Development Failures: Past failures in other FCRN-targeting programs (e.g., Arteva) highlight the risk associated with late-stage RA trials, although Roivant believes their deeper IgG suppression provides a competitive safety and efficacy advantage.

Q: Dave Risinger asked about the evolution of paid Rx for Lysriah, specifically the percentage of scripts that are paid versus covered by bridge programs, and the mix of patients switching from off-label JAK inhibitors vs. IVIG. / A: Matt Gline clarified that all reported revenue is 'paid' as bridge programs are not counted as sales. He noted that early payer dynamics have been favorable with relatively straightforward access, though some plans are implementing restrictions. Patient uptake is broad, coming from various backgrounds including those switching from off-label DACs, IVIG, steroids, and even newly diagnosed patients, with no single dominant source yet identified.

Q: Sam Slusky and others asked about the IgG reduction differences between the 600 mg and 300 mg doses in the RA study and any sensitivity analyses regarding depth of suppression. / A: Matt Gline declined to share specific IgG or O-anybody data to maintain competitive advantage, but confirmed that the 600 mg dose outperformed the 300 mg dose, consistent with the thesis that deeper IgG suppression drives better outcomes. Sensitivity analyses support this, showing that higher levels of suppression correlate with sustained clinical benefit, particularly in maintaining ACR20/ACR50 responses.

Q: Yaron Werber and Dennis Ding asked if there was significant inventory buildup for Lysriah in Q2 and what the FDA discussion status is for 1402 in RA, specifically if one Phase 3 might suffice. / A: Gline confirmed there was meaningful undispensed inventory held by specialty pharmacies at quarter-end, which has since been dispensed, providing a Q2 tailwind but potential Q4 headwind. Regarding FDA, he stated it is too early to confirm if one Phase 3 is sufficient; they are proposing an aggressive plan given the unmet need and strong data, but endpoint and design details remain under discussion.

Q: Dennis Ding asked if the majority of the $31 million revenue came from inventory builds and how many Phase 3 patients converted to commercial use. / A: Gline emphasized that drawing lines on revenue composition is difficult due to the short launch window, but confirmed tens of US Phase 3 patients were on the drug. He noted there was no defined EAP transition path, so the conversion rate was organic. The number of patients on commercial drug vastly exceeds the total US Phase 3 population, indicating strong real-world demand rather than just trial carryover.

Q: Ash Verma asked about the anticipated trial design for 1402 in RA, specifically if it would be monotherapy/combo and parallel/randomized withdrawal. / A: Gline indicated that the goal is approval, and while they expect collaboration with the FDA, it is unlikely the Phase 3 will be a randomized withdrawal study. He anticipates a straightforward RCT similar to the Phase 2b population, possibly with combination therapy options, but specifics depend on final FDA alignment.