Immunovant, Inc. Q3 FY2026 earnings call

Matt Gline started by highlighting the positive Phase II results for brepocitinib in cutaneous sarcoidosis and Roivant's financial results. Notable updates include the NDA for brepo in dermatomyositis, fully enrolled Phase IIb study for 1402 in D2T RA, fully enrolled Phase II study for mosliciguat in PH-ILD. Ben Zimmer then detailed the Phase II data for brepocitinib in cutaneous sarcoidosis, noting statistically significant improvements in CSAMI activity scores, high response rates, and favorable safety profile. Financials were also mentioned with R&D expense of $165 million, adjusted non-GAAP of $147 million, G&A of $175 million, adjusted non-GAAP of $71 million, and cash remaining strong at $4.5 billion.

2026 is a busy year with major events like brepo NIU Phase III pivotal readout in second half, starting Phase III study in cutaneous sarcoidosis, top-line data for mosli in second half, D2T RA data in second half, proof-of-concept data in 1402 in CLE, and jury trial against Moderna starting March 9. Also, multiple commercial launches potential in coming years with brepo and DM as first, and multiple NDA/BLA filings.

Uncertainties in clinical trial outcomes, competition in drug development, and litigation risks related to the jury trial against Moderna.

Q: Corinne Johnson with Goldman Sachs asked about further development expansion opportunities for brepocitinib and sizing the opportunity set.

A: Matthew Gline said they are enthusiastic about further development, emphasizing the strong agent in patient populations with high unmet need. Ben Zimmer added on mechanistic alignment of TYK2/JAK1 inhibition to T cell polarization.

Q: Dave Risinger with Leerink Partners asked about CSAMI numbers and FDA timeline for DM.

A: Matthew Gline discussed baseline characteristic differences and noted DM is a severe disease with few options, leaving FDA priority review to FDA.

Q: Yaron Werber with TD Cowen asked about pricing of brepo and handling Pfizer's 25% ownership.

A: Matthew Gline said price not decided yet, and Pfizer's 25% ownership is accounted for as minority interest below net income line.

Q: Brian Cheng with JPMorgan asked about Phase III design and stability of efficacy.

A: Benjamin Zimmer discussed cushion in effect size, Phase III design considerations, and safety data support for 45mg dose.

Q: Yasmeen Rahimi with Piper Sandler asked about 1402 near-term RA readout.

A: Matthew Gline said expectations for RA are cautious, with need to engage FDA and share guidance on study continuation.

Q: Other questions on market opportunity, Phase III design, organ involvement, and commercial synergy were addressed with various responses on study design, market potential, and commercial strategy.