Immunovant, Inc. Q1 FY2022 earnings call

• Roivant made a $200 million direct investment in Immunovant, with Frank Torti emphasizing confidence in 1401's unique asset and potential. - Progress in Myasthenia Gravis: On track to align pivotal MG design with FDA in Q4 2021, plan to initiate study early 2022. - Thyroid Eye Disease: Phase IIb study prematurely terminated due to lipid review, but observed dose-dependent IgG reduction is promising. - Warm Autoimmune Hemolytic Anemia program restarted, with compelling data from small patient set. - Indication selection criteria include probability of technical success and degree of unmet need, with focus on best-in-class or first-in-class opportunities.

For the fiscal first quarter ended June 30, 2021: R&D expenses were $18.7 million, up from $16.9 million in Q1 2020, driven by higher personnel and clinical activities. G&A expenses were $11.2 million, up from $9.7 million in Q1 2020, due to higher personnel-related expenses. Net loss was $30.5 million or $0.31 per common share, compared to $26.7 million or $0.38 per common share in Q1 2020.

• Expect meaningful update on MG program by end of 2021. - Expect updates on TED and WAIHA programs in early 2022. - Plan to hold R&D Day in Q1 2022. - Aim to pursue ambitious parallel development across multiple indications, with at least one pivotal trial in 2022 beyond MG, TED, and WAIHA.

• Lipid issues observed in Thyroid Eye Disease trial, with potential impact on product labeling. - Competition from other anti-FcRn companies aggressively pursuing multiple indications, requiring rapid execution of clinical development.

Q: Talk about rationale behind selection of indications, if at least one trial beyond MG, TED, WAIHA is a pivotal trial, and market evolution in TED.

A: Selection criteria include technical success probability and unmet need. One of the indications beyond MG could be a pivotal trial. In TED, market may evolve to sequential therapy with different mechanisms of action as patients may need multiple therapies.

Q: Any additional analyses on 1401 dosing and when to expect communication?

A: Yes, conducting PK/PD modeling on collected data, with details likely shared at R&D Day in Q1 2022.

Q: Details on pivotal MG study and gating factors?

A: Protocol has induction-maintenance flavor. Gating factors are FDA alignment logistics.

Q: Resuming WAIHA and TED studies, design size, and TED data release?

A: $200M investment provides flexibility; specifics not yet detailed. Won't release TED data granularity prior to FDA alignment on next trial.

Q: Mitigating LDL issue in TED trial and subsets of indications with less lipid issues?

A: TED may have shorter therapy duration, so short-term LDL excursions may not be an issue. Subsets of indications vary, but short-term LDL changes are not a concern for most patients.