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Mar 31, 2023
Roivant Sciences Q4 2023 Earnings Report
Roivant Sciences reported its Q4 2023 financial results and provided a business update.
Key Takeaways
Roivant Sciences reported VTAMA net product revenue of $13.7 million for the quarter ended March 31, 2023, with a 25% gross-to-net yield. The company's cash, cash equivalents, and restricted cash stood at $1.7 billion as of March 31, 2023.
RVT-3101 demonstrated improved efficacy in the TUSCANY-2 Phase 2b study for ulcerative colitis.
A Phase 2 study of RVT-3101 in Crohn's disease has been initiated, with topline data expected in Q4 of calendar year 2024.
VTAMA net product revenue was $13.7M for the quarter and $28.0M for the fiscal year ended March 31, 2023.
A Phase 1 trial was initiated for IMVT-1402, with initial data expected in August/September 2023.
Roivant Sciences
Roivant Sciences
Forward Guidance
Roivant anticipates several milestones in the coming quarters, including Dermavant's sNDA submission for VTAMA in atopic dermatitis, Immunovant's data readouts for IMVT-1402 and batoclimab trials, Telavant's Phase 2 study of RVT-3101 in Crohn's disease, Priovant's topline results from trials evaluating brepocitinib, Hemavant's data from the RVT-2001 trial, and Kinevant's topline data from the namilumab trial.
Positive Outlook
- Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in Q1 2024.
- Immunovant expects IMVT-1402 Phase 1 initial data in August/September 2023 and multiple-ascending dose data in October/November 2023.
- Telavant initiated a Phase 2 dose-ranging study of RVT-3101 in Crohn’s disease with data expected in Q4 2024.
- Priovant plans to announce topline results from the trial evaluating brepocitinib for SLE in Q4 2023.
- Hemavant plans to announce data from the ongoing trial evaluating RVT-2001 for transfusion-dependent anemia in MDS patients in the second half of 2023.
Challenges Ahead
- Top-line results from the Phase 3 thyroid eye disease (TED) program are expected in the second half of calendar year 2025.
- Initial data from period 1 of the Phase 2B trial in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected in the first half of calendar year 2024.
- Initial results from the Phase 2 proof-of-concept trial in GD are expected in the fourth quarter of calendar year 2023.
- Priovant also expects to announce topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.
- Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the second half of calendar year 2024.