Revance Provides Corporate Update in Light of COVID-19
Key Changes to 2020 Plan:
- Launch of RHA® fillers, and associated hiring of 100 field representatives, pushed back one quarter due to COVID-19 situation and temporary closure of Teoxane’s Swiss manufacturing facility -
- JUNIPER Phase 2 trial for adult upper limb spasticity paused due to challenges in subject assessments during time of required social distancing -
Areas of No Change:
- FY 2020 GAAP, Non-GAAP Financial Guidance –
- Cash and equivalents sufficient to fund company into 2023; as of
- PDUFA target action date for DAXI in glabellar lines of
- The health and safety of the Revance team and their families remains the company’s top priority. As a result, the company has curtailed employee travel and implemented a corporate shut down and work from home policy. Management continues to monitor the situation and will resume normal operations once it is prudent to do so. In the meantime, the company has adopted remote working tools to ensure minimal disruption and enable achievement of existing goals and objectives.
On the regulatory front, the Biologics License Application (BLA) application for DAXI in the treatment of glabellar (frown) lines was accepted in February by the
U.S. Food and Drug Administration(FDA) with a Prescription Drug User Fee Act (PDUFA) date of November 25, 2020. At this time, the FDA has not informed the company of any changes to its PDUFA date and Revance continues to assist the Agency with its review.
Revance has multiple therapeutic clinical trials for DAXI underway, including the
ASPEN-1 Phase 3 study and the ASPENopen-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, 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, 2020on 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.
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, Switzerlandas a precaution surrounding the COVID-19 situation. Teoxane SAis 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.
- 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.
Revance reiterates its 2020 GAAP and non-GAAP operating expense financial guidance of
$270-$280 millionand $220-$230 millionrespectively, 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.
February 14, 2020, Revance had $533.3Min cash, cash equivalents and short-term investments, with 56.9M shares outstanding as of February 13, 2020.
“We are excited to bring the RHA® portfolio of FDA approved dermal filler products to the market as soon as the COVID-19 situation allows and, in the meantime, we continue to put the necessary infrastructure in place to ensure a successful launch,” said
“Revance Therapeutics” and the Revance logo are registered trademarks of
Resilient Hyaluronic Acid® and RHA® are trademarks of
BOTOX® is a registered trademark of
This press release contains forward-looking statements, including statements related to the anticipated impact of the COVID-19 (coronavirus) situation on our operations, cash reserves and financial results, clinical, development, regulatory and commercial milestones, including with respect to our anticipated product launches; the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects statements about the timing and our ability to obtain regulatory approval and launch products, including with respect to anticipated approval of DAXI and PDUFA date; and potential benefits of our drug product candidates and our technologies; and our ability to compete in the neuromodulator market. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the clinical and commercial success, and ability to obtain and maintain regulatory approval of, our drug product candidates, including ability to receive timely approval of DAXI; our ability to achieve clinical and commercial success, realize anticipated synergies and successfully commercialize Teoxane’s dermal fillers; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain funding for our operations and achieve our goals; risks relating to our existing convertible debt; our plans to research, develop, and commercialize our drug product candidates; our ability to successfully compete with treatments and therapies, our ability to achieve, and the rate and degree of market acceptance and adoption of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully manufacture and commercialize our drug product candidates and the timing of commercialization activities; our ability to attract, retain and motivate management, clinical, scientific and sales and marketing personnel and to develop related capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance’s periodic filings with the
Jenifer Slaw, 347-971-0906
Nadine Tosk, 504-453-8344