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Dec 31, 2021
Roivant Sciences Q3 2022 Earnings Report
Roivant Sciences reported its financial results and provided a business update.
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.