Roivant Sciences Q3 2022 Earnings Report
Key Takeaways
Roivant Sciences reported its financial results for the third fiscal quarter ended December 31, 2021. The company had cash and cash equivalents of approximately $2.2 billion as of December 31, 2021. R&D expenses were $153.5 million, and G&A expenses were $115.5 million. Net loss for the quarter was $306.1 million.
Hemavant entered into a licensing agreement with Eisai Co., Ltd. for exclusive global rights to RVT-2001.
Dermavant hired key commercial leadership positions in preparation for launch of tapinarof for psoriasis.
Immunovant achieved alignment with the FDA for a pivotal Phase 3 study of batoclimab in myasthenia gravis.
The FDA cleared the IND submitted by Kinevant for a Phase 2 trial evaluating namilumab for the treatment of sarcoidosis.
Roivant Sciences
Roivant Sciences
Forward Guidance
Roivant anticipates several major milestones.
Positive Outlook
- Dermavant expects a decision from the FDA on the approval of tapinarof for the treatment of adults with plaque psoriasis in the second quarter of calendar year 2022.
- Dermavant expects to report topline data from the Phase 3 clinical trial of tapinarof for the treatment of atopic dermatitis in the first half of calendar year 2023.
- Immunovant plans to initiate a pivotal trial evaluating batoclimab for the treatment of myasthenia gravis in 1H 2022, with topline results expected in 2024.
- Immunovant also plans to re-initiate its programs in thyroid eye disease and warm autoimmune hemolytic anemia in 2022, and to announce at least two new indications by August 2022.
- Aruvant expects to announce ongoing new patient and follow up data through 2022 and to initiate its Phase 3 trial for ARU-1801 for the treatment of sickle cell disease in 2023.
Challenges Ahead
- The company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time.
- Actual results may differ materially from those described in the forward-looking statements.
- All product candidates referenced in this press release are investigational and subject to health authority approval.
- The company's future performance is subject to risks, uncertainties and assumptions.
- The company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.