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Mar 31, 2021
Revance Q1 2021 Earnings Report
Reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.
Key Takeaways
Revance Therapeutics reported strong commercial execution in Q1 2021, with revenue totaling $13.3 million, primarily driven by sales of the RHA® Collection of dermal fillers and increased revenue from the biosimilar program. The company is progressing with its therapeutics franchise and anticipates FDA approval for DaxibotulinumtoxinA for Injection this year.
Q1 revenue for the RHA® Collection of dermal fillers was $11.6 million.
HintMD's processing volume run-rate more than doubled to over $400 million from the prior quarter.
Over 1,500 aesthetic accounts were activated across products and services at quarter-end.
FDA approval for DaxibotulinumtoxinA for Injection for glabellar lines remains under review with a deferred action due to COVID-related travel restrictions.
Revance
Revance
Forward Guidance
Revance reiterated its financial guidance provided in February 2021 and expects to be funded into 2024.
Positive Outlook
- BLA approval for DaxibotulinumtoxinA for Injection in the treatment of glabellar lines is anticipated in 2021.
- The next-generation HintMD fintech platform, including the vertical integration of payment facilitation (PayFac), is planned for mid-2021.
- Teoxane SA has submitted the pre-market approval application for RHA® 1 for perioral (lip) lines and anticipates FDA approval in the second half 2021.
- Topline results from the ASPEN-OLS Phase 3 open-label, long-term safety study of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia are expected in the second half 2021.
- An end-of-Phase 2 meeting with the FDA is anticipated in the second half of 2021 for DaxibotulinumtoxinA for Injection for the treatment of adults with upper limb spasticity.
Challenges Ahead
- The FDA has not scheduled or conducted a pre-approval inspection of the company's Northern California manufacturing facility.
- The FDA approval for DaxibotulinumtoxinA for Injection for glabellar lines remains under review with a deferred action due to COVID-related travel restrictions.
- The company is still waiting for the FDA to schedule an inspection as soon as possible.
- COVID-19 and seasonality impacted the aesthetics market in the first quarter.
- There is no guarantee that the FDA will approve DaxibotulinumtoxinA for Injection