Immunovant, Inc. (IMVT) Earnings

Management highlights

### Pipeline Progress & Clinical Updates - Brexpiprazole for dermatomyositis (DM) is on track for potential launch by the end of September 2026, with a PDUFA date in Q3 2026, priority review from the FDA, and a fully built, trained commercial and patient support team ready for on-time deployment - Patient enrollment has begun in the Phase III trial of brexpiprazole for cutaneous sarcoidosis (CS), running ahead of schedule. The 140-patient, 3:1 randomized placebo-controlled study includes a mandatory steroid taper, with top line data expected in 2028. Phase II data showed a >20-point benefit on the CSAMI scale vs. placebo, for an indication with ~40,000 patients in the U.S. and high unmet need - The Phase III brexpiprazole study for lichen planopilaris (LPP), initiated earlier in 2026, is enrolling patients faster than expected, driven by high unmet need and physician/patient enthusiasm - Top line data from multiple additional studies is expected in H2 2026: the Phase III monotherapy study of Mosley (sotatercept) for pulmonary hypertension associated with interstitial lung disease (PH-ILD), the brexpiprazole Phase III for non-infectious uveitis (NIU), and a proof-of-concept (POC) study for cutaneous lupus erythematosus (CLE) - Further updates on the DroTRA program at Immunovant, including outcomes of an expected conversation with the FDA, are expected in H2 2026 ### Legal & Financial Updates - Roivant has received the $950 million upfront payment from the Moderna settlement, with $772 million allocated to Genevant and the remainder to Arbutus - The appellate process for the '1498 patent case, which could deliver an additional $1.3 billion in proceeds for a favorable ruling, is ongoing at the Federal Circuit - Roivant has filed three international patent infringement lawsuits against Pfizer and BioNTech (in Canada and the Unified Patent Court) in July 2026, and is advancing the case as quickly as possible ### Commercial Launch Strategy - Management is taking a "slow and steady" approach to the brexpiprazole DM launch, focused on building long-term infrastructure for the full multi-indication opportunity for the drug rather than maximizing near-term sales velocity. The company is prioritizing building out foundational access, patient support, and scientific/medical engagement to support future indications beyond DM.

Guidance

- Maintains expectation of a potential brexpiprazole DM launch by the end of September 2026, assuming FDA approval as currently expected under the priority review timeline - Confirms that multiple top line data readouts are still on track for H2 2026, including: brexpiprazole NIU Phase III, Mosley PH-ILD Phase III monotherapy, and brexpiprazole CLE proof-of-concept - Expects at least 3 commercial launches, 9 study readouts, and 4+ NDA/BLA filings by the end of 2028 - A full update on the 1402 difficult-to-treat rheumatoid arthritis (D2GRA) program, including randomized withdrawal Phase II data and regulatory strategy from an upcoming FDA meeting, is expected in H2 2026, with the company planning to release all relevant updates at the same time - The company will continue its authorized share repurchase program following the receipt of the Moderna settlement proceeds

Segment performance

Roivant did not break out revenue by individual product segments in this call. Aggregate quarterly financials are as follows: R&D expense totaled $200 million, non-GAAP adjusted G&A expense was just under $100 million, GAAP G&A expense was $166 million, and cash on hand was just under $4 billion before receiving the $772 million upfront payment from the Moderna settlement. The company repurchased approximately $200 million of its own shares in the first quarter, with a total of $1.5 billion in share repurchases completed through mid-last year at an average purchase price of ~$10 per share, and the most recent round of repurchases starting in March completed at an average price in the high $20s per share.

Risks & headwinds

- Clinical trial success is not guaranteed, and the primary risk cited for the Phase III brexpiprazole NIU trial is historically high and unpredictable variability in placebo response rates in immunology studies - Translation of positive pulmonary vascular resistance (PVR) reduction results from Mosley in PAH to the PH-ILD population carries inherent uncertainty, as PH-ILD patient lung physiology differs from PAH, creating risk of an unexpected outcome - Geographic variation in patient baseline characteristics and physician practice patterns may add variability to immunology study outcomes, though management notes this is an expected feature of multi-site trials, not an unanticipated risk - JAK inhibitors carry class-wide black box safety warnings for malignancy and cardiometabolic events, which may impact physician adoption of brexpiprazole, though management notes this risk is mitigated by the high unmet need in DM and the worse safety profile of current standard-of-care high-dose steroids - Patent litigation timelines and outcomes are not fully within Roivant's control, so there is uncertainty around the timing and final outcome of ongoing cases against Pfizer/BioNTech and the pending '1498 appellate ruling

Analyst Q&A

• Q: What initial launch metrics will be provided for brexpiprazole in DM, and what are the implications of higher sotatercept use in the PH-ILD study population for trial success? /

  A: Roivant will not provide extensive detailed launch metrics in the early days of the launch, and will only add more color after potential approval, with quarterly top-line financials being the primary source of initial visibility. For PH-ILD, the study was designed from the outset to carefully control for levels of emphysema in the enrolled population. The study is powered to detect a clear PVR signal, which is the primary endpoint of interest, and is not powered for 6-minute walk distance; a clear 6-minute walk separation is not required for a go-forward decision.

• Q: Given JAK class-wide safety concerns, how are physicians responding to brexpiprazole for DM, which has a favorable trial safety profile but treats a patient population already at higher baseline cancer risk? /

  A: Roivant specifically selected indications with high unmet need where JAK safety concerns are much less relevant to clinical decision-making. DM patients currently rely on high-dose steroids, which carry far worse safety risks for malignancy and cardiometabolic events than JAK inhibitors, and effective treatment of DM itself reduces patients' underlying risk. Physicians are already comfortable using JAK inhibitors for much less severe diseases, and do not view the class warnings as a major barrier to adoption for brexpiprazole in this setting.

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

  A: There has been no novel therapy developed for Graves' disease since the 1950s-1960s, and there is enormous unmet need large enough to support multiple successful therapies. Roivant will be the first to market with an advanced therapy, giving it the opportunity to shape treatment paradigms long before competitors. Competitor approaches often have distinct safety profiles or target smaller subsets of later-line patients, and Roivant will use its first-mover position and early clinical learnings to inform future study and commercial planning.

• Q: What is the outlook for 1402 in myasthenia gravis (MG) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) as the competitive landscape evolves? /

  A: FcRn inhibitors have already established clinical benefit in MG, and 1402's early data shows promising treatment benefit on key clinical endpoints that other FcRn inhibitors have not matched. The MG market is large enough to support multiple therapies, even a modest share is a meaningful opportunity, and there is room for additional options with different dosing and administration profiles. In CIDP, class leadership is not yet established, so there is more room for new entrants, and 1402's early data is encouraging, giving it a strong opportunity to capture meaningful market share.