Roivant Sciences Ltd. (ROIV) Earnings

Management highlights

### Pipeline Progress - The Phase III study for brevacitinib in cutaneous sarcoidosis has initiated enrollment ahead of schedule, with top-line data expected in 2028. The study enrolls 140 patients randomized 3:2 to 45mg brevacitinib or placebo, with a mandatory steroid taper over 8 weeks, and a primary endpoint of ≥50% CSAMI response rate. - The brevacitinib Phase III study for lichen planipolaris (LPP), added as a fourth registrational indication earlier in 2026, is enrolling extremely well, driven by high unmet need for the condition. - The D2DRA study for 1402 in difficult-to-treat rheumatoid arthritis (RA) has completed the open-label period, with randomized withdrawal data expected in H2 2026 ahead of a planned FDA meeting in fall 2026. Top-line data for 1402 in Graves disease is expected in 2027. - Multiple top-line data readouts are scheduled for H2 2026: brepo in the NIU study, Moseley Phase II in PHLD, a D2DRA program update including an FDA consultation, and proof-of-concept data for CLE. ### Upcoming Brevacitinib Launch in Dermatomyositis (DM) - Brevacitinib has a PDUFA date in Q3 2026, with launch expected by the end of September 2026 pending FDA approval. All commercial and patient support teams are fully hired, trained, and ready to deploy on schedule. - Management is pursuing a "slow and steady" launch strategy to build a long-term foundation for brevacitinib across multiple future indications (NIU, cutaneous sarcoidosis, LPP), rather than prioritizing near-term peak sales. The focus is on establishing access, patient support, and provider engagement that will benefit the full brevacitinib franchise. - DM is a high unmet need indication with no previously approved novel targeted therapies; most patients are dissatisfied with existing treatments, and provider and patient enthusiasm for the new therapy is high. ### Legal and Capital Update - Roybant has received the initial upfront payment from the Moderna settlement, and the 1498 appellate proceeding at the Federal Circuit is ongoing; a favorable ruling would deliver an additional $1.3 billion. International litigation against Pfizer and BioNTech for the 1498 patent is progressing, with lawsuits filed in Canada and the UPC in July 2026. - The company has accelerated its share repurchase program following the Moderna settlement, retiring $200 million of shares in the quarter at an average price in the high $20s, adding to prior repurchases completed at an average of ~$10 per share.

Guidance

- Brevacitinib launch in DM remains on track for the end of September 2026 pending FDA approval, and management maintains a "slow and steady" launch pace guidance, focused on long-term franchise foundation building rather than near-term quarterly sales peaks. - A full catalyst slate is confirmed for H2 2026, including top-line data for brepo NIU, Moseley PHLD Phase II, CLE proof-of-concept, and a full D2DRA program update including randomized withdrawal data and FDA feedback. Top-line data for the cutaneous sarcoidosis Phase III is expected in 2028, with 1402 Graves disease pivotal data expected in 2027. - No change to overall capital return guidance: the company will continue share repurchases under existing authorization following the Moderna settlement receipt. - Multiple new potential indications for existing pipeline molecules are in active preparation, with new program announcements possible within the next year.

Segment performance

No detailed product segment financial performance breakdown was provided in the call. Aggregate quarterly financials are as follows: R&D expense totaled $200 million; non-GAAP adjusted G&A expense was just under $100 million, with GAAP G&A expense at $166 million; cash on hand was just under $4 billion prior to receipt of the $772 million settlement payment from Moderna; approximately $200 million in share repurchases were completed during the quarter. The company received a $950 million upfront settlement payment from Moderna, with $770 million allocated to Roybant and the remainder to Arbutus.

Risks & headwinds

- Placebo response rate variability in immunology trials (including the NIU Phase III and D2DRA program) is the top near-term regulatory risk, as unpredictable placebo response can complicate trial outcome interpretation even with strong Phase II data. - Translational risk exists for the Moseley Phase II study in PHLD: while PVR reduction is well-established in PAH, it is uncertain if this effect will translate to the PH-ILD patient population, as PHLD patient lung physiology differs from idiopathic PAH. - As a first-in-class novel therapy launch in DM, there is no existing launch analog to predict adoption trajectory, and formulary coverage may take time to finalize, though the company has built out processes to facilitate patient access via medical exceptions in the interim. - JAK class black box safety warnings could potentially influence provider prescribing, though management notes that existing DM treatments (high-dose steroids) carry greater safety risks, and the severity of unmet need in DM reduces provider concern over class labeling.

Analyst Q&A

• Q: What launch metrics will be available early after the brevacitinib DM launch, and what is the bar for success for the Moseley PHLD study's key endpoints? /

  A: Management will not provide detailed early launch metrics in the immediate post-launch period, preferring to focus on commercial execution; limited quarterly top-line data will be available in standard financial reporting, with more color added after approval and in successive quarterly calls. For Moseley, patient baseline emphysema levels were controlled in study design to account for prior data in PHLD. The study is not powered for six-minute walk distance, so a clear signal is not required for a go-no-go decision; a clear PVR reduction signal is expected if the drug is active and is the key outcome for the trial.

• Q: How have physicians responded to brevacitinib in DM given JAK class safety concerns, given DM patients already have elevated underlying cancer risk? /

  A: Management notes that JAK inhibitors are already widely used for less severe diseases with more alternative treatment options. In DM, there are almost no effective approved options, and current standard of care (high-dose steroids) carries worse safety risks than JAK inhibitors. Effective treatment of DM improves patient overall health and reduces underlying risk, so physicians are not overly concerned about the required class black box labeling.

• Q: What is the biggest risk for the brevacitinib NIU Phase III trial, and is geographic variation a meaningful concern? /

  A: The biggest risk is unpredictable placebo response variability, which is common across immunology trials, even with strong Phase II data. Geographic variation in patient baseline characteristics or physician practice exists, but it is not an unanticipated risk and is just a normal feature of large multi-center immunology studies. Management remains optimistic about the trial outcome.

• Q: What is the competitive landscape for 1402 in Graves disease, and what is the strategy for future development? /

  A: There has been no novel therapy approved for Graves disease since the 1950-1960s, so there is enormous unmet need that can accommodate multiple new therapies. Roybant will be the first to market with a pivotal readout, giving the company first-mover advantage to shape treatment paradigms. Other competing approaches target different patient subsets or carry greater safety liabilities, and the company will leverage clinical data and early market access to build its position.