Immunovant, Inc. (NASDAQ: IMVT) Q2 2025 Earnings | 08/11/2025

Immunovant Q2 2025 Earnings Call Summary

Key Highlights:

• Upcoming Catalysts: Phase 3 VALOR trial data (dermatomyositis) expected H2 2025; potential regulatory filing in early 2026.

• Pipeline Progress:

  • Brepocitinib (TYK2/JAK1 inhibitor):

    • Dermatomyositis (DM): Largest-ever interventional trial (VALOR) with steroid taper success (98% compliance, 40% off steroids).

    • Non-infectious uveitis (NIU): Enrollment ongoing; data expected H1 2027.

    • Cutaneous sarcoidosis: Proof-of-concept data in 2026.

  • IMVT-1402 (anti-FcRn):

    • Graves’ disease: Phase 2 remission data at ATA (Sept 2025); Phase 3 GRAPES trial enrolling.

    • Sjogren’s syndrome: Registrational program initiated.

• Financial Strength: $4.5B cash, no debt; completed $1.5B share buyback (15% share count reduction).

• Litigation Update: LNP patent lawsuits (vs. Moderna/Pfizer) advancing; trial set for March 2026.

Brepocitinib (DM & Beyond)

VALOR Trial (Dermatomyositis)

• Design: 52-week study with steroid taper; primary endpoint = TIS (Total Improvement Score).

• Key Metrics:

  • 40% of patients fully off steroids, 60% with ≥50% reduction.

  • Baseline characteristics aligned with prior successful IVIG trials.

• Competitive Landscape: Only oral therapy in late-stage development; rivals include dezapibart (Pfizer), efgartigimod (Argenx).

• Commercial Potential: ~40K U.S. patients; launch targeted for 2026.

Future Milestones:

• NIU: Phase 3 data (H1 2027), potential filing (H2 2027).

• Cutaneous Sarcoidosis: PoC data (2026).

IMVT-1402 (Anti-FcRn)

• Graves’ Disease:

  • Phase 2 Remission Data (ATA 2025): Even 10% remission could be practice-changing.

  • Phase 3 GRAPES Trial: Enrolling; includes 300 µg dose for regulatory flexibility.

• Sjogren’s Syndrome: Registrational program underway.

• TED (Thyroid Eye Disease): Data may inform Graves’ strategy; partnership with HanAll.

Financial & Operational Updates

• Cash Position: $4.5B (no debt); R&D spend rising due to 5 registrational trials for IMVT-1402.

• Share Buybacks: $500M new program authorized after completing $1.5B repurchase.

• BD Strategy: Actively evaluating late-stage assets (autoimmune/oncology), including opportunities in China.

Litigation (LNP Patents)

• Moderna Case: Summary judgment rulings expected fall 2025; trial set for March 2026.

• Pfizer/BioNTech: Markman ruling likely 2025.

• Key Patents: Cover LNP composition (lipids) and mRNA encapsulation.

Key Takeaways

1. DM Data Imminent: VALOR results could position brepocitinib as first oral DM therapy.

2. FcRn Leadership: IMVT-1402 advancing in Graves’/Sjogren’s; remission data a near-term catalyst.

3. Financial Flexibility: Strong balance sheet supports BD, pipeline expansion, and buybacks.

4. Legal Upside: LNP patent cases could unlock additional revenue streams.