The company also announced progress on its DaxibotulinumtoxinA for Injection for glabellar lines and intent to launch the RHA Redensity dermal filler in the second half of 2022.
Revance Therapeutics, a biotechnology company focused on aesthetic and therapeutic offerings, reported its fourth quarter and full year 2021 financial results. Q4 2021 revenue was $26 million compared to $11.1 million in Q4 2020. Full year 2021 revenue was $77.8 million compared to $15.3 million for full year 2020. The company credits its revenue growth to increased sales of the RHA Collection of dermal fillers. The company reported Q4 product revenue from the RHA Collection of dermal fillers of $23.8 million—a 138.2% increase from the same period last year.
In reporting the company’s financial results, Revance CEO Mark J. Foley also provided an update on the companies products. “I am pleased to announce that we have completed the manufacturing of three consecutive drug substance lots and one drug product lot as part of the qualification of our new working cell bank, as required by the FDA, and are actively working on completing the resubmission package for our BLA for DaxibotulinumtoxinA for Injection for glabellar lines. We remain focused on getting our neuromodulator approved as soon as possible and look forward to engaging with the agency to facilitate this process.”
Foley added, “In 2022 and beyond, we plan to leverage our differentiated products and services along with our customer-centric marketing strategy to build upon our very successful year of commercial results, which totaled over $70 million for the RHA Collection. With over 3,000 active accounts to date, we believe that we are able to provide accounts and their consumers with a compelling value proposition that can further be enhanced once our neuromodulator is approved. In addition, we believe our long-acting neuromodulator, once approved, should not only accelerate our growth in aesthetics, but will also pave the way for us to file a supplemental BLA for cervical dystonia. We look forward to our growth catalysts ahead and remain very focused on executing on our strategic priorities for the year.”
In 2022, the company has laid out a number of strategic priorities, including 1) obtaining FDA approval for DaxibotulinumToxinA for Injection for the treatment of moderate to severe glabellar lines as soon as possible; 2) continuing to drive revenue growth by increasing adoption of the RHA Collection of dermal fillers; 3) expanding and deepening customer relationships through OPUL—the company’s end-to-end, cloud-based payment platform designed to cultivate long-term customer relationships and optimize business operations for aesthetic practices that was launched in October.
In December 2021, Revance held a Type A meeting with the FDA regarding the Complete Response Letter (CRL) received for DaxibotulinumtoxinA for Injection for glabellar lines. According to the Type A meeting minutes, a complete response to address the outstanding observations related to the new working cell bank (WCB) and the drug substance manufacturing process required Revance to qualify its new WCB by producing three consecutive drug substance lots and one drug product lot. Revance announced that it has completed these manufacturing activities and is working on resubmitting its BLA for DaxibotulinumToxinA for Injection for the treatment of glabellar lines as soon as possible. Based on the Type A meeting minutes, a reinspection of the manufacturing facility will be necessary once the resubmission is accepted by the FDA.
The company also provided an update on its RHA Redensity dermal filler. In December, Revance’s partner, Teoxane SA, received FDA approval for RHA Redensity’s first indication, which is for the treatment of moderate to severe dynamic perioral rhytids (lip lines) in adults aged 22 or older. RHA Redensity is expected to be launched in the second half of 2022.
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