Revance Therapeutics, Inc.

Welcome to Revan's Therapeutics Third Quarter 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ensure that we have ample time to address everyone's question during the Q&A session, we would ask for a limit of one question and one follow-up question per person. To ask a question at that time, please press star followed by one on your touchtone phone. If anyone has difficulty hearing the conference call, please press star zero for operator assistance. As a reminder, this call is being recorded today, 9th of November 2021. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG of Revance. Please go ahead.

Thank you, Lori. Joining us on the call today from Revance are Chief Executive Officer Mark Foley, President Dustin Su, Chief Financial Officer Toby Schilke, and Senior Vice President of Clinical Development Roman Mudeo. During this conference call, management will make forward-looking statements, including statements related to the potential approval and timing of approval of doxybotulinum toxin A for injection and roller blinds, and therapeutic indications, our ability to remediate deficiencies identified by the FDA regarding our BLA, a type A meeting with an FDA, financial performance, revenue, and processing volume runway, financial performance and guidance, expected cash runway, our strategic priorities and cash preservation plans, our market and revenue opportunity and the market demand for our products and services, the safety, efficacy, and duration of daxibotulinum toxinase for injection, the potential commercial success and growth of our products and services, the potential benefits of our drug product candidates and technologies, the clinical development of our product candidates, our business strategy, planned operations, commercialization plans, and the aesthetics of therapeutics industry. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Also on today's call, we will present both GAAP and non-GAAP financial measures. A reconciliation of non-GAAP to GAAP measures is included in our earnings release. With that, I will turn the call over to Mark Foley. Mark?

Thank you, Jessica. Good afternoon, everyone, and thanks for joining our third quarter 2021 financial results conference call. Before we cover our performance for the third quarter and review the positive results from our Phase III Aspen OLS study for cervical dystonia, I'd like to provide an update on our VLA for Daxibotulinum Toxin A for injection in glabellar lines. As most of you are aware, we received a CRL from the FDA on October 15, citing their inability to approve our application in its present form due to deficiencies related to the on-site inspection or manufacturing facility. We're obviously very disappointed by the FDA's response and also understand that the continued delay of our BLA has been frustrating for all of our stakeholders. However, I can assure you that the entire revamped team is as determined as ever to get our neuromodulator product approved as soon as possible. We are currently working on preparing a briefing book for a Type A meeting request to gain clarity and alignment on the requirements needed for approval and are incorporating the additional information that was provided by the FDA following our CRL, including our establishment spectrum report, to inform our submission. Given where we are in this process and our pending engagement with the agency, it is inappropriate for us to comment beyond what we've already communicated until we have our Type A meeting. We look forward to providing an update once we have confirmation on our pathway to approval. This is not the first time we've experienced a launch delay. Recall that last year, the commercial rollout of RHA was pushed back five months due to COVID-induced supply chain constraints from our partner, Pioxane SA. Despite the delay in working under the limited parameters of the pandemic, we safely onboarded over 100 sales reps, trained injectors, and delivered a very successful launch that months, and a revenue run rate of over $70 million as of Q3 2021. Looking back, I'm proud of the tremendous progress we've made as an organization over the past two years. First and foremost, in aesthetics, we submitted our BLA for our lead product, Baxibotulinum Toxin A for injection for glabellar lines. We also successfully completed a phase two program for our drug product and upper facial lines. secured the exclusive distribution rights for Teoctane's RHA line of fillers in the U.S., acquired HIN-MD and launched Opal, and built out the strong commercial infrastructure. In therapeutics, we validated the opportunity for our long-acting neuromodulator to treat muscle movement disorders with the successful completion of our Phase III program in the treatment of cervical dystonia and our Phase II clinical trial for upper limb spasticity. Collectively, the muscle movement disorder market opportunity currently stands at $1.2 billion worldwide, and about 70% of that opportunity is in the U.S. The completion of our Aspen program for Daxibotulin toxin apron injection in cervical dystonia marks the company's second successfully executed Phase III program, supporting the differentiated performance profile of our neuromodulator across our clinical trials in aesthetics and therapeutics. All of these milestones position us to create meaningful value within our aesthetics and therapeutics franchises. To put it simply, the opportunity for a long-acting neuromodulator remains strong and continues to be an unmet need for patients and consumers. We continue to believe in the approvability of our product, and based on the CRL, the deficiencies cited were limited to observations made during the age In other words, the CRL is not related to our clinical data package or our product's anticipated label. That said, I'd like to outline our strategic priorities going forward while also announcing some related organizational changes. Our number one strategic priority is to obtain FDA approval for Daxibotulin and Toxin A for injection for gallbladder lines as soon as possible. Number two is to continue to increase our revenue in the $1.2 billion U.S. dermal filler market with our RHA collection. And number three is to expand and cultivate deep and lasting customer relationships through Opal, our fintech platform. In addition to aligning our capital allocation strategy with these priorities, we will also be preserving cash to enhance our financial flexibility. Justin and Toby will cover more on the specifics of our priorities later in the call. In line with our strategic initiatives and in order to optimize their structure for performance, I'm pleased to announce the promotion of Dustin Suess from Chief Commercial Officer to President of Revance. This change allows me to streamline my reports as I assume direct and personal oversight for all aspects of our BLA for Daxibotulinum Toxin A for injection. Further, this change positions the organization to better align resources, facilitate capital allocation efforts, and enhance performance. we have in his leadership he was instrumental in developing revance's commercial strategy integrating pin md building an exceptional team and successfully commercializing our aesthetics portfolio his experience and background will continue to be invaluable to our organization with that let me turn the call over to dustin who will cover our performance for the quarter dustin