Immunovant, Inc. Q4 FY2022 earnings call

• Immunovant achieved alignment with the FDA Division of Ophthalmology to move forward with a pivotal program in thyroid eye disease (TED), planning to initiate two placebo-controlled Phase 3 trials for TED in the second half of 2022 with topline data expected in the first half of 2025. • Discussed the market opportunity for TED, estimating the total addressable population in the U.S. to be between 8,000 and 18,000 patients annually, with potential complementarity to Tepezza's growth. • Reviewed clinical development with TED, including data from a cell-based assay showing dose-dependent decreases in stimulatory auto-antibodies and exploratory proptosis data from a Phase 2b trial. • Plan to initiate the Phase 3 myasthenia gravis (MG) trial by the end of June 2022 with topline data expected in the second half of 2024. • Intend to engage with the FDA hematology division to discuss development for warm autoimmune hemolytic anemia (wAIHA) and plan to announce two new indications by August 2022.

• Plan to initiate two Phase 3 trials for TED in the second half of 2022 with topline data in the first half of 2025. • Phase 3 MG trial to be initiated by the end of June 2022 with topline data in the second half of 2024. • Engage with FDA hematology division for wAIHA development. • Announce two new indications by August 2022.

• Uncertainties in clinical trial results due to inherent uncertainties in estimates and assumptions. • Potential impact of concomitant medications on placebo response in clinical trials, as seen in wAIHA trials. • Risks associated with forward-looking statements, where actual results may differ materially from expectations.

Q: Can you talk about market research regarding moderate patients and why a patient or doctor would choose batoclimab over Tepezza?

A: Market research showed patients with active TED on systemic therapy still made lifestyle modifications. When comparing product profiles, more moderate patients tended towards batoclimab's profile with subcutaneous administration, less proptosis efficacy than Tepezza, and no hearing loss. For severely impacted patients, Tepezza's outstanding efficacy was preferred.

Q: Will patients who have previously been on Tepezza be allowed in the pivotal TED trial?

A: No, the pivotal trial will include naïve patients to biologic therapy to maintain apples-to-apples comparison with Tepezza's trials.

Q: Thoughts on wAIHA given fostamatinib's recent failure?

A: Placebo response rate variation by geography may be due to concomitant medications. Batoclimab's potential in wAIHA is exciting as there's been little innovation in the space.

Q: Regulatory dialogue and lipid management in TED?

A: Will apply same safety monitoring as MG trial, with no statin use initiated during trial and no unblinding due to LDL excursion.

Q: Enrolment in TED trials and regional breakdown?

A: Expect all regions to be important, aiming for expansive enrolment across regions despite competing trials.

Q: Tolerability of batoclimab and its role in market research?

A: Anti-FcRn class generally well tolerated. Blood monitoring for LDL in batoclimab profile didn't negatively impact decision making compared to Tepezza.

Q: MG Phase 3 completion and safety expansion for TED?

A: Safety exposures can be pooled across indications, helping meet safety database requirements for filings.

Q: Risk-reward in initiating pivotal trials for undisclosed indications?

A: Consider unmet need, patient population size, and technical success probability, using anti-FcRn data as a biomarker.

Q: Bar for efficacy in TED and confidence despite prior mixed results?

A: Efficacy bar is equal to or greater than steroids (around 50% proptosis response). Confidence comes from triangulating data across biomarkers, radiologic markers, and clinical parameters showing dose response.