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Mar 31, 2020
Revance Q1 2020 Earnings Report
Revance's financial results for Q1 2020 were reported, and a corporate update was provided.
Key Takeaways
Revance Therapeutics reported financial results for the quarter ended March 31, 2020. Key updates included the FDA acceptance of the BLA for DaxibotulinumtoxinA for Injection in Glabellar Lines, the signing of an exclusive U.S. distribution agreement for TEOXANE Dermal Fillers, and a corporate update in response to COVID-19.
BLA for DaxibotulinumtoxinA for Injection in Glabellar Lines was accepted by the FDA with a PDUFA date of November 25, 2020.
An exclusive U.S. distribution agreement for FDA-Approved TEOXANE Dermal Fillers was signed.
The company adjusted the launch of its RHA® dermal filler line by one quarter due to COVID-19 impacts.
Public offering of common stock and private offering of convertible senior notes were closed.
Revance
Revance
Forward Guidance
Revance expects 2020 GAAP operating expense to be at the lower end of the range of $270 to $280 million and non-GAAP operating expense to be at the lower end of the range of $220 to $230 million. They anticipate 2020 non-GAAP research and development expense to be $95 to $100 million and are funded into 2023.
Positive Outlook
- Commercial launch of RHA® range of dermal fillers expected in 3Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in forehead lines expected in 2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in lateral canthal lines (crow’s feet) expected in 2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in upper facial lines expected in 4Q 2020.
- PDUFA date of November 25, 2020, for potential FDA approval of DaxibotulinumtoxinA for Injection in glabellar lines.
Challenges Ahead
- Patient enrollment in JUNIPER Phase 2 study of DaxibotulinumtoxinA for Injection in upper limb spasticity has been paused.
- COVID-19 has caused Revance to adjust the launch of its RHA® dermal filler line.
- COVID-19 has caused the temporary closure of Teoxane’s Swiss manufacturing facility.
- There may be delays in sales force hires.
- Mylan's decision regarding the biosimilar to BOTOX program is pending and uncertain.