Revance Q4 2019 Earnings Report
Key Takeaways
Revance Therapeutics reported fourth-quarter financial results, with key highlights including the FDA's acceptance of the BLA for DAXI in glabellar lines and an exclusive U.S. distribution agreement for TEOXANE dermal fillers. The company's cash, cash equivalents, and short-term investments totaled $290.1 million as of December 31, 2019.
FDA accepted the BLA for DAXI in glabellar lines with a PDUFA date of November 25, 2020.
An exclusive U.S. distribution agreement for TEOXANE dermal fillers was signed.
Enrollment was completed in Phase 3 Cervical Dystonia Trial and Phase 2 Plantar Fasciitis Trial.
A new Phase 2 trial was initiated for the treatment of upper facial lines.
Revance
Revance
Revance Revenue by Segment
Forward Guidance
Revance anticipates GAAP operating expense to be in the range of $270 to $280 million and non-GAAP operating expense to be in the range of $220 to $230 million in 2020. Revance expects 2020 non-GAAP research and development expense to be $95 to $100 million. Management projects that the company is funded into 2023.
Positive Outlook
- Commercial launch of RHA® range of dermal fillers expected in 2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DAXI in forehead lines expected in 2Q 2020.
- Topline results from Phase 2 open-label, dose-escalation study of DAXI in lateral canthal lines (crow’s feet) expected in 2Q 2020.
- PDUFA date of November 25, 2020, for potential BLA approval of DAXI in glabellar lines.
- Decision by Mylan on continuation of biosimilar to BOTOX® program expected by April 30, 2020.