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Mar 31, 2024
Roivant Sciences Q4 2024 Earnings Report
Roivant reported financial results for Q4 2024 and provided a business update.
Key Takeaways
Roivant reported a productive fourth quarter, with positive data for brepocitinib in NIU and progress in Immunovant's IMVT-1402 development. VTAMA net product revenue was $19.3M for the quarter and $75.1M for the fiscal year. The company has $6.6B in cash, supporting cash runway into profitability.
Brepocitinib produced best Treatment Failure rates in active non-infectious uveitis (NIU), supporting initiation of a pivotal program in NIU in the second half of calendar year 2024.
Immunovant is on track to initiate 4-5 potentially registrational studies with IMVT-1402 over the fiscal year ending March 31, 2025.
VTAMA sNDA submission for atopic dermatitis was accepted by the FDA, with PDUFA action expected in the fourth quarter of calendar year 2024.
Roivant renegotiated Dermavant’s debt obligations, reducing potential cash payments due by over $300M in the aggregate.
Forward Guidance
Roivant anticipates several milestones in the coming periods. Dermavant expects PDUFA action for VTAMA in atopic dermatitis in Q4 2024. Kinevant plans to report topline data from the Phase 2 trial of namilumab for sarcoidosis in Q4 2024. Priovant expects topline results from the Phase 3 trial of brepocitinib in dermatomyositis in 2025 and to initiate a Phase 3 pivotal trial of brepocitinib in the second half of 2024. Immunovant plans to have initiated 4-5 potentially registrational programs by March 31, 2025.
Positive Outlook
- Dermavant expects PDUFA action for VTAMA in atopic dermatitis in the fourth quarter of calendar year 2024.
- Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the fourth quarter of calendar year 2024.
- Priovant expects topline results from the ongoing Phase 3 trial of brepocitinib in dermatomyositis (DM) in calendar year 2025
- Priovant expects to initiate a Phase 3 pivotal trial of brepocitinib in the second half of calendar year 2024.
- Immunovant plans to have initiated 4-5 potentially registrational programs by March 31, 2025
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