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Sep 30, 2022
Roivant Sciences Q2 2023 Earnings Report
Roivant Sciences reported financial results and provided a business update.
Key Takeaways
Roivant Sciences reported a net loss of $315.9 million for the quarter ended September 30, 2022. VTAMA net product revenue was $5.0 million. The company's cash runway is expected to extend into the second half of calendar year 2025.
Cash runway extended into the second half of calendar year 2025.
First major PBM/payer contract signed for VTAMA, effective October 1.
Over 54,000 VTAMA prescriptions written by approximately 6,400 prescribers since launch show strong demand, with fiscal Q2 2022 net product revenue of $5.0 million.
Completed enrollment for potentially registrational trial for brepocitinib in systemic lupus erythematosus (SLE), with topline data on track to be announced in the second half of calendar year 2023.
Roivant Sciences
Roivant Sciences
Forward Guidance
Roivant expects to provide updates on VTAMA commercial launch, report topline data for brepocitinib, and progress Phase 3 trials of batoclimab.
Positive Outlook
- Updates on the commercial launch of VTAMA for psoriasis will be provided on a periodic basis.
- Topline data from the Phase 3 trials of VTAMA for the treatment of atopic dermatitis is expected in the first half of calendar year 2023.
- Topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with SLE are planned to be announced in the second half of calendar year 2023.
- Phase 3 trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) are progressing.
- Initial results from the open label period of pivotal Phase 2b trial in CIDP are expected in the first half of calendar year 2024.
Challenges Ahead
- No specific negative forward-looking statements were identified in the provided text.
- The Myovant transaction is expected to close in the first calendar quarter of 2023, subject to customary closing conditions.
- Phase 3 trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) progressing and expects to have top-line results from the MG trial in the second half of calendar year 2024 and from the two TED trials in the first half of calendar year 2025.
- A pivotal Phase 2b trial in CIDP is planned to be initiated by the end of calendar year 2022, with initial results from the open label period expected in the first half of calendar year 2024.
- In Graves’ disease, a Phase 2 trial is planned to be initiated in early calendar year 2023 with initial results expected in the second half of calendar year 2023.