Roivant Sciences Ltd. (ROIV) Earnings

Management highlights

**Portfolio & Pipeline Milestones** - Brepocitinib was awarded Breakthrough Therapy Designation for cutaneous sarcoidosis; a Phase III study in this indication is expected to begin in 2026, and a Phase IIb/III trial for lichen planopilaris (LPP, an additional new indication with no approved therapies) is already enrolling. Commercial preparation for a brepocitinib launch in dermatomyositis (DM) is on track for launch by the end of September 2026, with payer engagement, commercial team buildout, and physician outreach completed. - Open-label 16-week preliminary data from the IMVT-1402 Phase II study in refractory double antibody-positive rheumatoid arthritis (DTRA) was released: 165 evaluable heavily refractory patients (all failing steroids/DMARDs, 65% failing JAK inhibitors + TNF inhibitors) achieved 73% ACR20, 50%+ ACR50, and 33%+ ACR70 response rates, with fully preserved response rates in the JAK/TNF refractory subset. The drug was well-tolerated with no new safety signals identified. The 12-week randomized withdrawal Period 2 of the study remains ongoing. - The Phase II FOCUS study of mosliciguat (inhaled sGC activator) for pulmonary hypertension with interstitial lung disease (PH-ILD) completed enrollment of 135 patients (target 120) within 12 months of first patient dosing; 95% of patients reached the maximum 4mg dose, with no emerging safety concerns. Top line data is expected in H2 2026. - The CLE study for IMVT-1402 is fully enrolled, with top line data expected in H2 2026. The Phase III Graves' disease trial of IMVT-1402 is enrolling ahead of expectations, with data expected in 2027. - Roivant reached a $2.25 billion legal settlement with Moderna, with the first $950 million upfront payment expected in July 2026. **Financial Position** - The company maintains a strong cash position with $4.3 billion in cash/cash equivalents (pre-Moderna settlement) and no debt. Roivant continues to execute an active share repurchase program, with R&D spending increasing modestly in line with expanded pipeline scope.

Guidance

- Brepocitinib launch in dermatomyositis remains on track for the end of September 2026. Phase III cutaneous sarcoidosis study initiation and NIU Phase III top line data are both expected in 2026. - Top line data for the IMVT-1402 DTRA study (including full patient-level analysis and FDA feedback) and for the fully enrolled CLE study are both expected in H2 2026. IMVT-1402 Phase III data in Graves' disease and myasthenia gravis is expected in 2027. - Top line Phase IIb data for mosliciguat in PH-ILD is expected in H2 2026. Full detailed analysis and regulatory discussions for IMVT-1402 in DTRA will be shared in H2 2026.

Segment performance

The transcript does not break out reported financial performance for individual product segments. It only provides overall company cash position: Roivant held $4.3 billion in cash and cash equivalents as of March 31, 2026, prior to receipt of the Moderna settlement, with no debt outstanding. No segment-specific revenue or contribution percentage data was disclosed in this call.

Risks & headwinds

- The randomized withdrawal Period 2 of the IMVT-1402 DTRA study may not meet its primary endpoint (loss of ACR20 response at 12 weeks), because high baseline ACR50/ACR70 responses mean patients will take longer than 12 weeks to lose sufficient response to meet the endpoint. The outcome of Period 2 may not change the overall development path if the quality of Period 1 data is confirmed. - Open-label study data may overestimate efficacy relative to future placebo-controlled registrational trials, though deep ACR50/ACR70 responses are less susceptible to placebo bias than ACR20 responses. - The mosliciguat Phase II FOCUS study is not powered to achieve a statistically significant p-value for the 6-minute walk endpoint, which is secondary to the primary PVR endpoint. - The commercial bar for IMVT-1402 in CLE is relatively high due to a more competitive existing landscape compared to the DTRA indication. - Development and regulatory timelines and path depend on FDA feedback after review of the new IMVT-1402 DTRA data, which is not yet finalized.

Analyst Q&A

• Q: Corinne Johnson (Goldman Sachs) asks how the 16-week ACR response rates for IMVT-1402 compare to the typical 24-week reporting timeline for RA, and how responses may trend over time with implications for the randomized withdrawal phase. /

  A: Gline states that it is unknown how responses will trend, as this is the first study of IMVT-1402 in RA. He notes that sicker patients generally require more time to improve, and that the data does not suggest responses have plateaued at 16 weeks, so continued improvement is possible. The full trend will only be known as additional patient data is collected.

• Q: David Risinger (Leerink Partners) asks if a statistically significant 6-minute walk benefit for mosliciguat in the current Phase II could support a single pivotal NDA submission, and if the company is exploring additional indications for mosliciguat. /

  A: Gline says the base case does not expect the underpowered 6-minute walk endpoint to reach significance, but any sufficiently positive data would prompt a regulatory discussion with FDA, which has recently been open to single pivotal designs in high unmet need indications. He confirms there are multiple opportunities for mosliciguat indication expansion, but even development focused solely on PH-ILD represents a large, high-value commercial opportunity.

• Q: Derek Archila (Wells Fargo) asks for clarification on IMVT-1402 safety (specifically LDL changes) and how the strong Period 1 data changes future trial design strategy. /

  A: Gline confirms no LDL changes or other new safety signals have been observed across hundreds of patients dosed with IMVT-1402, including the DTRA study. He says future trial design will be determined based on full data analysis and discussions with FDA, and the strong Period 1 data supports the potential for a leaner registrational program given the high unmet need in this refractory patient population.

• Q: Samantha Semenkow (Citi) asks what data will be included in the upcoming H2 2026 CLE readout for IMVT-1402, and what magnitude of effect is considered meaningful. /

  A: Gline clarifies the upcoming readout will only cover the 12-week randomized portion of the study. He notes that CLE has a more competitive commercial landscape than DTRA, so the bar for advancing the program is high: the data will need to be strong enough to support a viable program in the current market, and a go/no-go decision will be made based on the totality of the readout.

• Q: Prakhar Agrawal (Cantor Fitzgerald) asks about potential efficacy bias from the open-label IMVT-1402 DTRA study design, and whether there is less bias-prone secondary endpoint data available to contextualize the results. /

  A: Gline acknowledges the question is valid, but notes that deep ACR50/ACR70 responses are far less susceptible to placebo bias than ACR20, and that all joint assessments in the study were conducted by blinded evaluators unaware of treatment assignment, adding objectivity to the reported results. No additional secondary endpoint data is ready to share at this time, as analysis is still ongoing.