Revance Therapeutics, Inc.

Welcome to the Revents Therapeutics First Quarter 2022 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following management prepared remarks, we will hold a Q&A session. To ask a question at that time, please press star followed by 1 on your touchtone phone. If anyone has difficulty hearing the conference call, please press star 0 for operator assistance. As a reminder, this call is being recorded today, Tuesday, May 10, 2022. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead.

Thank you, Mika. Joining us on the call today from Revance are Chief Executive Officer Mark Foley, President Dustin Suits, and Chief Financial Officer Toby Schilke. During this conference call, management will make forward-looking statements, including statements related to the regulatory process and potential approval and timing of approval for Daxibotulinum Toxamate for injection in global over the line and a therapeutic indication. Plans related to RHA Redensity and OPAL platform, the benefits to us, practices and patients of our products and services, our financial performance, 2022 guidance, expected cash runway, strategic priorities and capital allocation plans, a market and revenue opportunity and the market demand for our products and services, portfolio growth and our business strategy, planned operations and commercialization plans. With that, I will turn the call over to Mark Foley, Chief Executive Officer of Revance. Mark?

Thank you, Jessica. Good afternoon, everyone, and thank you for joining our first quarter 2022 financial results conference call. We had a very productive start to the year, delivering on several important objectives. First and most importantly, the FDA accepted our VLA resubmission for daxobotulinum toxin A for injection for glabellar lines. With the acceptance, we received a new PDUPA date of September 8, 2022, which reflects a Class II resubmission and will include a reinspection of our manufacturing facility. This important regulatory milestone was made possible by the completion of our new working cell bank qualification package in Q1. And I would like to thank the technical operations, clinical, and regulatory teams for all of their hard work in achieving this objective. Having a PDUFA date is key. This will be the first time since our deferred action in November 2020 that we are working towards a specific date. We will continue to work with the FDA to facilitate their timely review while recognizing that we are now one step closer to a potential approval later this year. Another priority was to strengthen our balance sheet and extend our cash runway in order to support our strategic priorities of getting our lead asset approved, increasing sales of our RHA collection, and enhancing our customer relationships with Opal. To that end, we were pleased to achieve this key objective by completing a $300 million non-dilutive debt financing with Ethereum Capital and raising an additional $31.8 million in net proceeds from our ATM offering program. With our recent financing activities and the additional notes that we can issue with the FDA approval of Daxibotulinum Toxin A for injection, our cash runway can be extended into 2024. We believe we are well positioned for the significant opportunity ahead at Revance. In aesthetics, we believe our innovative portfolio of products and services will allow us to capitalize on the multi-billion dollar market opportunity that continues to grow at a healthy clip. Order Our Portfolio is our long-acting neuromodulator, and we are both ready and excited to bring our drug product to market. Our commercial infrastructure is strong, anchored by our proven 100-plus person sales team, our over 3,500 aesthetic accounts, which continue to grow, and our industry-leading Training and Experience Center at our Nashville corporate headquarters. Together with our differentiated commercial strategy and complementary portfolio offering, we believe Daxibotulinum Toxin A for Injection has a solid foundation for commercial success. Additionally, in advance of the anticipated approval of our neuromodulator, we've entered into partnerships with two experienced, full-finished contract manufacturing organizations to help support our production needs. This is in addition to the drug substance and drug product we will be manufacturing at our Northern California facility. Turning to therapeutics, we continue to be excited about the opportunity for our long-acting neuromodulator. Currently, we are ready to file a supplemental BLA for doxibotulinum toxin A for injection for the treatment of cervical dystonia following the FDA approval of our indication for glabellar lines. We successfully completed our Aspen Phase III clinical program in November of last year and have been actively preparing our supplemental filing. Given the encouraging data from our clinical programs, which showed that our drug product was generally safe, effective, and had a long duration profile, we look forward to our potential opportunity in therapeutics as well. Indication for cervical dystonia will be our entry point into the $1.2 billion global muscle movement disorder category, which has a compound annual growth rate in the high single digits. In summary, we have several important near-term catalysts across our business, and execution will continue to be key. We remain bullish on the long-term market opportunity for revance, and in particular, on our ability to lead the long-acting neuromodulator segment. I would like to thank all members of the organization for their continued dedication and support in advancing our corporate objectives and priorities. With that, let me turn the call over to Dustin, who will cover our performance in the first quarter. Dustin?