Immunovant, Inc. Q1 FY2026 earnings call

Pipeline Progress

• Brevacitinib (Brepo) is on track for potential launch in dermatomyositis (DM) by the end of September 2026, with a PDUFA date in Q1 2026 Q3, complete commercial teams built and trained, and all launch preparations finalized
• Patient enrollment has begun in the Phase III cutaneous sarcoidosis (CS) study for brevacitinib, ahead of schedule. The trial is a 140-patient, 3:2 randomized (45mg brevacitinib vs placebo) study with a mandatory steroid taper, expecting top-line data in 2028
• The Phase III registrational study for brevacitinib in lichen planopilaris (LPP) is enrolling extremely well, with strong enthusiasm from physicians and patients
• Multiple upcoming top-line data readouts are scheduled for H2 2026: brevacitinib in non-infectious uveitis (NIU), Moseley in pulmonary hypertension with lung disease (PHLD), the D2GRA program in difficult-to-treat rheumatoid arthritis (Difficult-to-Treat RA), and a proof-of-concept (POC) study in cutaneous lupus erythematosus (CLE)

Commercial Launch Strategy

• Management plans for a "slow and steady" launch approach for brevacitinib in DM, prioritizing building long-term foundational infrastructure (access, patient support, scientific/physician engagement) that will support future indication launches beyond DM, rather than chasing strong near-term quarterly metrics
• Approximately half of all U.S. DM patients are treated at ~200 specialized myositis referral centers, which are a core focus of the launch engagement strategy

Legal and Intellectual Property Updates

• The company has received the $950 million upfront settlement payment from Moderna, with ~$770 million allocated to Roy Gant
• The 1498 patent appellate case is ongoing at the Federal Circuit, with a potential $1.3 billion additional payout for a favorable ruling
• Roy Gant has filed three international patent infringement lawsuits against Pfizer and BioNTech in July 2026, including cases in Canada and the Unified Patent Court, and is progressing the litigation as quickly as possible

No detailed product segment revenue breakdown was provided in this call. The only financial results shared are aggregate quarterly figures: R&D expense of $200 million, non-GAAP adjusted G&A expense of ~$100 million ($166 million GAAP G&A), cash on hand of under $4 billion prior to receipt of the $772 million settlement payment from Moderna, and approximately $200 million in share repurchase activity during the quarter.

• The upcoming brevacitinib launch in DM remains on track for the end of September 2026, with no change to the expected timeline
• Full top-line data readouts for multiple programs (brevacitinib NIU, Moseley PHLD, D2GRA, POC CLE) are still expected in H2 2026, with no change to the scheduled timeline
• Top-line data for the cutaneous sarcoidosis Phase III study is expected in 2028, with pivotal readout for brevacitinib in Graves' disease expected in 2027
• Management reaffirmed its commitment to a slow and steady launch cadence for brevacitinib in DM, with no plans to provide detailed early launch metrics beyond standard quarterly financial disclosure
• A full update on the Difficult-to-Treat RA 1402 program, including randomized withdrawal data and regulatory strategy, is expected in H2 2026, alongside a planned FDA meeting in fall 2026

• Variability in placebo response rates is the primary identified risk for Phase III immunology trials, including the brevacitinib NIU study, as placebo response can significantly impact trial outcome success
• Translation of positive PBR reduction efficacy from pulmonary arterial hypertension (PAH) to the PHLD patient population is a core risk for the Moseley program, as PHLD patient lung biology differs from PAH patients, and study success is not guaranteed
• Geographic variation in patient baseline characteristics and physician practice patterns adds noise to immunology trial results, though management notes this is an expected feature of large multi-site trials, not an unanticipated risk
• JAK inhibitor class-level black box safety warnings for malignancy and other adverse events could theoretically prescriber adoption of brevacitinib in DM, though management does not expect this to be a meaningful barrier
• Litigation outcomes for ongoing patent cases against Pfizer/BioNTech and the ongoing 1498 appellate case are not fully within the company's control, and favorable outcomes cannot be guaranteed

Q: What initial launch metrics will be provided for the DM launch, and what are the key considerations for the PHLD study patient population? / A: Management will not provide detailed early launch metrics beyond standard quarterly top-line financial results, preferring to focus internal resources on launch execution rather than external near-term guidance. For the PHLD study, emphysema inclusion was carefully designed into the trial from the start. The study is powered to detect a clear signal on pulmonary blood flow resistance (PBR), and a clear signal there is sufficient for a go decision; six-minute walk is not a primary endpoint and failure to see separation there would not derail the program.

Q: What is physician reception to brevacitinib in DM given JAK class safety concerns, and what is the current rate of off-label JAK use in DM? / A: Only low-to-mid single-digit percentage of DM patients currently use off-label JAK inhibitors, with wide variation across physician practice patterns. Physicians are not overly concerned about JAK class safety in DM: DM patients are already at higher underlying risk of adverse events including malignancy, current standard of care (high-dose steroids) carries worse safety risks than JAK inhibitors, and there are very few other effective treatment options available for the patient population.

Q: What is the biggest risk for the brevacitinib Phase III NIU trial, and would you expect similar Humira exposure rates as seen in Phase II? / A: The biggest risk is unpredictable, variable placebo response rates common in immunology trials, which can impact outcome detection even if the drug is active. Geographic variation in patient baseline characteristics is an expected source of noise, not an unanticipated major risk. There is no reason to expect meaningful differences in patient population characteristics including Humira exposure rates between the Phase II and Phase III NIU studies.

Q: How will you manage placebo response in the pivotal Graves' disease trial, and what is the opportunity for 1402 in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP)? / A: Placebo response is well-managed in the Graves trial, as treated patients need to achieve sustained normal thyroid hormone levels off anti-thyroid drugs, an outcome that does not occur spontaneously in placebo. For MG, the market is large enough to support multiple FCRN therapies, and 1402 has shown stronger clinical benefit signals than existing agents, creating a meaningful market opportunity. For CIDP, the market is less established, creating more room for 1402 to capture share if trial data is positive.