Roivant Sciences Ltd. Q4 FY2026 earnings call

- Clinical Pipeline & Data Updates * IMD-1402 (for refractory ACPA-positive rheumatoid arthritis, DGTRA): Preliminary open-label 16-week data from the 1402 study showed clinically meaningful high response rates: 73% ACR20, over 50% ACR50, and over 33% ACR70 across a heavily refractory patient population (all patients failed steroids, DMARDs, and at least two advanced lines of therapy; ~65% failed JAK inhibitors, almost all also failed TNF inhibitors). The drug was safe and well-tolerated, with no new safety signals identified. The randomized withdrawal Period 2 of the study is ongoing, with more than half of patients still receiving treatment. Management notes that the depth of responses makes Period 2's primary endpoint (loss of ACR20 response after withdrawal) less meaningful than the quality of the open-label data, and the company plans to discuss a path forward with the FDA regardless of the Period 2 result. The target patient population for this indication is estimated at 85,000 or higher. * Moseley (mosaciguat, inhaled SGC activator for pulmonary hypertension with interstitial lung disease, PHLD): Enrollment completed for the 135-patient Phase 2b placebo-controlled randomized study, with over 95% of patients achieving the maximum 4mg dose and low early discontinuation rates. Top-line data is expected in the second half of 2026. PHLD is a large underserved market with ~200,000 patients across the US and Europe, less than 5-year median survival, and only two approved prostacyclin therapies with significant tolerability and efficacy limitations. Moseley has a differentiated first-in-class inhaled mechanism, with Phase 1 data showing deep PVR reductions (mean peak reduction of ~38%) and good tolerability with minimal systemic side effects or cough. The Phase 2 study primary endpoint is change from baseline in PVR at 16 weeks, and is not powered for statistical significance on six-minute walk. * Brepocitinib (BREPO): Breakthrough Therapy Designation was granted for brepocitinib. A new indication (Lichen Planopilaris, LPP) was announced, and the study is currently enrolling. Brepocitinib is on track for a potential US launch in dermatomyositis by the end of September 2026, assuming FDA approval. The Phase 3 study in lupus nephritis (NIU) is expected to read out top-line data in the second half of 2026, and a Phase 3 study in kenya sarcoidosis is expected to begin in 2026. Commercial preparation is well underway, including payer engagement, commercial team buildout, distribution planning, and patient engagement; Phase 3 data was recently published in the New England Journal of Medicine. LPP is a high-unmet-need indication with ~100,000 patients in the US and no approved therapies. * Other pipeline updates: The betocumab study in TED failed, but observed thyroid normalization in hyperthyroid patients, which supports the ongoing GRADE studies that continue to enroll well. CLE is fully enrolled, with top-line data expected in the second half of 2026. 1402 Phase 3 data in Graves' disease and myasthenia gravis is expected in 2027. Enrollment for the Graves' disease pivotal program is progressing ahead of expectations, and the study is on track to read out in 2027 as previously planned. - Corporate / Financial Updates * Roivant reached a $2.25 billion settlement with Moderna, with the $950 million upfront payment expected to be received in July 2026. The company maintains a strong cash position with no debt and an active share repurchase program.

As of March 31, 2026, Roivant held $4.3 billion in cash and cash equivalents prior to the receipt of the Moderna settlement, with zero outstanding debt. The company continued its active share repurchase program, purchasing a significant number of shares during the quarter. R&D spending increased modestly year-over-year, aligned with the expanded scope of the company's clinical development portfolio. No additional segment-level revenue or absolute financial performance data was provided in this call.

- No changes to prior top-line financial or revenue guidance were provided in the call. - Top-line data for Moseley Phase 2b in PHLD, additional patient-level analysis of the IMD-1402 DGTRA study, and results of FDA discussions for 1402 are all expected to be shared in the second half of 2026. - A brepocitinib launch in dermatomyositis is still targeted for the end of September 2026, pending FDA approval; NIU Phase 3 top-line data and the start of the kenya sarcoidosis Phase 3 study are expected in 2026. - CLE top-line data (12-week randomized portion only) is expected in the second half of 2026. - Pivotal 1402 data in Graves' disease and myasthenia gravis remains on track for 2027, with enrollment progressing better than initial expectations.

- The open-label design of the first period of the 1402 DGTRA study introduces potential bias, even though the depth of ACR50/ACR70 responses makes large placebo effects unlikely, and joint assessments are conducted by blinded evaluators. - The primary endpoint of the 1402 study's randomized withdrawal Period 2 may be less meaningful given the high depth of responses observed in Period 1, as it can take longer than 12 weeks for patients who achieved deep responses to lose sufficient response to meet the endpoint. - The Moseley Phase 2b study is not powered to achieve statistical significance for the six-minute walk endpoint, which means a statistically significant result on this endpoint is not expected as a base case. - The development path and registration strategy for 1402 will depend on FDA feedback, which is still pending, so the ultimate trial design and approval path remain uncertain. - The PHLD market has limited existing drug development, and the path for commercial adoption and reimbursement for combination therapy with existing prostacyclin treatments is still being established.

Q: How should the 16-week ACR responses for IMD-1402 be contextualized, and how would you expect responses to trend over more time on therapy for the randomized withdrawal phase? / A: Management notes that there is no prior data for this drug in this patient population, so it is unknown how responses will trend over time. There is no indication that response is already maximized at 16 weeks, and continued improvement with longer treatment is possible. This uncertainty aligns with management's prior comment that the Period 2 endpoint may be less meaningful given the current data.

Q: Could a statistically significant six-minute walk result in the Moseley Phase 2b study qualify as a pivotal study for NDA filing, and is the company planning additional indications for Moseley? / A: It is impossible to say what regulatory path would be pursued before seeing the data, and a single pivotal trial may be possible if the data is strong enough, though this is not the base case expectation (the study is not powered for six-minute walk significance). While PHLD is the current focus, and is already a large high-value opportunity, the company is actively evaluating additional indications for Moseley given its strong early profile.

Q: Given the open-label design of 1402 Period 1, how much efficacy degradation should be expected when moving to a placebo-controlled registration trial, and are there any less bias-prone secondary endpoint data available? / A: Management notes that deep responses (ACR50/ACR70) are far less likely to be driven by open-label bias than mild ACR20 responses, and all joint assessments in the study were conducted by blinded evaluators, adding objectivity to the current data. No secondary endpoint data is available to share at this time, but the full data set is still being analyzed.

Q: Given the strong 1402 Period 1 data, how will this change future trial design for the program, and were there any safety signals like LDL changes observed? / A: Across hundreds of patients dosed with 1402 across all studies, no changes in albumin or LDL have been observed, and no new safety signals were seen in the DGTRA study. The development path and trial design will be determined following detailed analysis of the full data set and discussions with the FDA; stronger early data supports the potential for a more streamlined lean registration program going forward, though this remains to be finalized with regulators.