Financial Update and Key Launch Metrics:
Preliminary Unaudited Full Year 2020 RHA® Collection Revenue of Between
$12.5 Millionand $13.0 Million. The company expects its first full quarter of unaudited RHA® Collection revenue to be between $9.5 millionand $10.0 millionfor the fourth quarter 2020, bringing full year RHA® Collection revenue to be between $12.5 millionand $13.0 million. The company launched the RHA® Collection in September 2020.
HintMD Processing Volume. The company expects to exit 2020 with an annualized run rate over
$200.0 millionin processing volume.
- Aesthetic Accounts. The company’s sales team activated approximately 1,000 Aesthetic accounts across products and services in 2020.
Preliminary Unaudited Full Year 2020 Operating Expenses In-Line with
Guidance Range. The company expects its full year 2020 unaudited total operating expenses and adjusted total operating expenses to be in-line with previously announced guidance.
- Cash Runway Into 2023. The company maintains a strong balance sheet and reaffirms its previously announced expectations to be funded into 2023.
“Given the challenging environment resulting from the COVID-19 pandemic, I’m incredibly proud of how the Revance organization responded and came together to deliver on a transformational year for the company. In the fourth quarter, our first full quarter of commercialization, we generated strong interest in our RHA® Collection of dermal fillers, validated our targeted launch strategy, and ended the year with an annualized run rate of over
Aesthetics Franchise Update:
Biologics License Application (BLA) Approval for DaxibotulinumtoxinA for Injection in the Treatment of Glabellar Lines Anticipated in 2021. On
November 25, 2020, the company announced that the United States (U.S.) Food and Drug Administration(FDA) has deferred a decision on the BLA for DaxibotulinumtoxinA for Injection due to the FDA’s inability to conduct a required inspection of the company’s Northern Californiamanufacturing facility as a result of COVID-19 pandemic travel restrictions. The inspection of the company’s manufacturing facility is required by the FDA as part of the BLA approval process. Though the company’s BLA is still under review, the FDA did not indicate any further outstanding review issues beyond the pending on-site inspection. The company remains confident in its BLA submission and continues to work proactively with the FDA on a pre-approval inspection as soon as possible in 2021.
- Positive Upper Facial Lines Phase 2 Open-Label Study (OLS) Results Reported. In December, Revance announced positive topline efficacy, safety and duration of effect results for the combined treatment of DaxibotulinumtoxinA for Injection in glabellar, forehead and lateral canthal lines, showing a median time to return to baseline wrinkle severity of at least 33 weeks (7.6 months) in responders. The company plans to submit the study’s results for presentation at the 2021 medical conferences and in peer-reviewed publications.
FDA Approval for RHA® 1. Our partner,
Teoxane, remains focused on an FDA approval for RHA® 1 for perioral (lip) lines in the second half 2021.
HintMD Development. The release of the next-generation HintMD fintech platform, including the vertical integration of payment facilitation (PayFac), is planned for mid-2021.
Therapeutics Franchise Update:
Upcoming Readouts for DaxibotulinumtoxinA for Injection in Muscle Movement Disorders. Topline results from Revance’s JUNIPER Phase 2 upper limb spasticity trial are expected in first quarter 2021, while the results from the
ASPEN-OLS Phase 3, long-term safety study for cervical dystonia are expected in the second half 2021. Revance expects these results to help inform the direction of its therapeutics franchise, anchored by a potential Supplemental Biologics License Application (sBLA) submission for DaxibotulinumtoxinA for Injection in cervical dystonia in 2022.
- In 2020, Revance expanded its team to over 470 full time employees to support the buildout of its commercial and manufacturing infrastructure, including the integration of HintMD.
In December, in conjunction with the State of Tennessee’s
Department of Economic and Community Development, Revance announced the company will move its global headquarters to Nashville, effective January 1, 2021. The new headquarters will include a multi-functional training and education center where healthcare providers, employees and other stakeholders can learn about the latest innovations in the company’s products and services.
In December, Revance also entered into an amended supply agreement with Ajinomoto Bio-Pharma Services for the supply of DaxibotulinumtoxinA for Injection, which will complement its
Northern California-based manufacturing location with a second Southern California-based location.
“Revance Therapeutics” and the Revance logo are registered trademarks of
RHA resilient hyaluronic acid® and RHA® are trademarks of
BOTOX® is a registered trademark of
Any statements in this press release that are not statements of historical fact, including statements related to the company’s financial outlook, run rate, milestone expectations, expected cash runway and financial performance; statements about our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and RHA® 1; the timing of the release of the next generation HintMD payments platform; the process and timing of, and ability to complete, the current and anticipated future clinical development of our product candidates including the timing and outcome of such clinical studies and trials; development of a biosimilar to BOTOX®; our ability to effectively and reliably manufacture supplies of DaxibotulinumtoxinA for Injection; the timing of, and benefits related to, moving our global headquarters to
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of COVID-19-related policies and travel restrictions currently in place at the FDA; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to obtain regulatory approval of our drug product candidates; disruption to our business caused by and unanticipated costs of moving our headquarters to
View source version on businesswire.com: https://www.businesswire.com/news/home/20210107005304/en/
Jenifer Slaw, 347-971-0906
Nadine Tosk, 504-453-8344