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Sep 30, 2020
Revance Q3 2020 Earnings Report
Revance transitioned to a fully integrated commercial enterprise and reported positive Phase 3 results from ASPEN-1 study in cervical dystonia.
Key Takeaways
Revance Therapeutics reported financial results for Q3 2020. The company's first commercial quarter, marked by the launch of the Prestige Aesthetics Portfolio, generated $3.0 million in revenues. Positive Phase 3 results were announced from the ASPEN-1 study in cervical dystonia.
Successfully launched Prestige Aesthetics Portfolio with the RHA® Collection of Dermal Fillers and HintMD Platform, generating $3.0 million in revenues.
FDA has not scheduled a manufacturing site inspection related to the company’s Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection.
Announced Positive Results from ASPEN-1 Phase 3 Trial of DaxibotulinumtoxinA for Injection in Cervical Dystonia.
Reported Topline Results from Phase 2 Plantar Fasciitis Trial, which did not achieve statistical significance.
Revance
Revance
Forward Guidance
Revance provided near-term milestone expectations for Aesthetics and Therapeutics, along with a 2020 financial outlook.
Positive Outlook
- PDUFA date of November 25, 2020, for potential FDA approval of DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines.
- Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in upper facial lines expected in December 2020.
- Topline results from JUNIPER Phase 2 placebo-controlled, dose-ranging study of DaxibotulinumtoxinA for Injection in upper limb spasticity expected first quarter 2021.
- Topline results from the companion ASPEN-OLS Phase 3 open-label, long-term safety trial, expected in 2021.
- Management projects that the company is funded into 2023.
Challenges Ahead
- The FDA has not yet scheduled a site inspection at our Newark, CA manufacturing facility as part of our BLA submission, which may delay approval.
- Revance expects GAAP operating expense to be $285 to $295 million.
- Revance anticipates 2020 non-GAAP, non-HintMD related research and development expense to be $95 to $100 million.
- Results from Phase 2 Plantar Fasciitis Trial were disappointing.
- COVID-19-related travel restrictions at the Agency.