• Revance has multiple therapeutic clinical trials for DAXI underway, including the ASPEN-1 Phase 3 study and the ASPEN open-label safety study (OLS) in cervical dystonia, the JUNIPER Phase 2 trial in adult upper limb spasticity, and a Phase 2 trial for plantar fasciitis. The ASPEN-1 and plantar fasciitis trials are fully enrolled with all subjects dosed and past the primary endpoint visit; enrollment for ASPEN-OLS is ongoing. Enrollment in the JUNIPER Phase 2 adult upper limb spasticity trial is paused due to challenges in subject assessments during time of required social distancing. Revance plans to report topline results for the ASPEN-1 cervical dystonia and Phase 2 plantar fasciitis trials in 2H of 2020[as per prior guidance], and will provide additional updates as there is greater clarity.
• Revance has three aesthetic trials underway for DAXI, including Phase 2 open-label studies in forehead lines, crow’s feet and upper facial lines. The forehead lines and crow’s feet trials are fully enrolled with all subjects dosed and past the primary endpoint visit. The upper facial lines trial is fully enrolled, and all subjects have been dosed. Revance is on-track for 2Q 2020 readouts of the forehead and crow’s feet line Phase 2 studies, and will provide an update on the timing of the upper facial lines study results as it gets greater clarity.
• To ensure proper trial coordination and completion, in line with the FDA-issued guidance of March 18, 2020 on the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic, Revance is evaluating and implementing risk-based approaches for remote clinical trial monitoring and activities, including remote patient assessment, for those subjects who cannot physically visit clinic sites, to ensure the full completion of trials.
Product Supply
• As Revance is U.S. based and manufactures its drug substance and drug product in Newark, CA, the company does not anticipate any supply chain issues related to the production of DAXI and expects to have drug product on time for commercial launch, subject to product approval.
• Product supply of RHA dermal fillers has been delayed by distribution partner, Teoxane SA, as they temporarily suspended production in Geneva, Switzerland as a precaution surrounding the COVID-19 situation. Teoxane SA is committed to resuming manufacturing operations as soon as it is prudent to do so and has projected a supply delay of one quarter. As a result, Revance’s anticipated product launch of the RHA 2, 3 and 4 dermal fillers has moved from 2Q to 3Q of 2020.
Commercial Launches
• As of last week, the company completed the hiring of its commercial leadership team to support the launch of three FDA-approved Resilient Hyaluronic Acid® (RHA) dermal fillers, RHA 2, 3 and 4, and the anticipated approval and launch of DAXI in 4Q of 2020. The commercial team is currently focused on setting up key operations including commercial processes, systems, sales team training, and customer targeting.
• The hiring timeframe of an approximately 100-person sales force, to initially focus on RHA dermal fillers, has been adjusted to coincide with product availability. Revance is actively recruiting field representatives using a unique platform technology facilitating remote, live group interviews with potential candidates in the safety of their home. Revance plans to source the best candidates for each geography and will onboard the field representatives in a manner that is consistent with the revised RHA® product launch timeframe.
Financials
• Revance reiterates its 2020 GAAP and non-GAAP operating expense financial guidance of $270-$280 million and $220-$230 million respectively, but notes that with the delay in the RHA dermal fillers launch and associated hiring of field representatives, actual operating expense results could be at the lower end of these ranges.
• [As previously reported], as of February 14, 2020, Revance had $533.3M in cash, cash equivalents and short-term investments, with 56.9M shares outstanding as of February 13, 2020. [This share count excludes options and potential conversions from the convertible notes].
In short, this PR largely reiterates what RVNC’s IR department has stated (#msg-154432511); the main new news is: i) a one-quarter delay in the launch of the Teoxane dermal fillers; and ii) somewhat lower-than-expected operating expenses.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
AI
