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Revance Provides Corporate Update and Anticipated Milestones for 2021
Thu, January 7, 2021, 8:00 AM EST
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today provided a corporate update, product pipeline timing and anticipated milestones for 2021.

Financial Update and Key Launch Metrics:

Preliminary Unaudited Full Year 2020 RHA® Collection Revenue of Between $12.5 Million and $13.0 Million. The company expects its first full quarter of unaudited RHA® Collection revenue to be between $9.5 million and $10.0 million for the fourth quarter 2020, bringing full year RHA® Collection revenue to be between $12.5 million and $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 million in 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 $200 million in credit card transaction processing volume on the HintMD platform. On the clinical development side, we also reported positive efficacy, duration and safety results across several different programs for DaxibotulinumtoxinA for Injection," said Mark Foley, President and Chief Executive Officer of Revance. "Our strong cash position, innovative aesthetics product portfolio, and the unique performance profile of our propriety neuromodulator product continue to provide us with a solid foundation to deliver meaningful progress on both our aesthetics and therapeutic franchises as we move forward. In 2021, we hope to receive our first FDA approval for our next-generation neuromodulator, DaxibotulinumtoxinA for Injection, for the treatment of glabellar lines, further refine our therapeutics strategy and continue to execute on our focused and disciplined launch in aesthetics. I want to thank the entire Revance team for their steadfast commitment to the achievement of our goals while prioritizing the health and safety of our entire organization. Even though the ongoing pandemic continues to introduce a level of uncertainty, our momentum is strong, and I look forward to another pivotal year for the company."

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 California manufacturing 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.

Corporate Update:

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.

https://finance.yahoo.com/news/revance-provides-corporate-anticipated-milestones-130000976.html