Revance Therapeutics, Inc.

Welcome to the Re-Advanced Therapeutics fourth quarter and full year 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 questions during the Q&A session, we will 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, Monday, February 28, 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, Victor. Joining us today on the call from Revance are Chief Executive Officer Mark Foley, President Dustin Suess, 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 doxyglodulone toxicity for injection and glabella lines, as well as in therapeutic indications, plans related to the RJ collection and opal platform, our financial performance, processing volume runway, 2022 guidance, expected cash runway, strategic priorities and capital allocation plans, our market and revenue opportunity, and the market demand for our products and services, and our business strategy, planned operations, and commercialization plans. 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 could 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, Chief Executive Officer of Advance. Mark?

Thank you, Jessica. Good afternoon, everyone. Thank you for joining our fourth quarter and full year 2021 financial results conference call. 2021 marked Revance's first full commercial year, and we could not be more pleased with our execution, ending the year with over $72 million across our products and services. These results were led by our RHA collection, the latest advancement in hyaluronic acid thermal filler technology that continues to gain share in the large and growing U.S. filler market. We now have over 3,000 accounts in the U.S. across our Dermal Filler and FinTech platform, which generated over half a billion dollars in gross payment volume for the year. Our focus on innovation and our customers will continue to be core to our ability to scale in the years ahead. Coming into 2021, we have five key strategic priorities. Obtaining FDA approval for daxibotulinum toxin A for injection for the treatment of glabellar lines following the deferred action of our PDUCA date in November of 2020. Strong commercial execution. Advancement of our therapeutics franchise. Discipline capital allocation. And a focus on our people, culture, and diversity and inclusion. I would like to take a moment to review how we track on these priorities as well as provide some recent updates. First, while we did not receive FDA approval for our neuromodulator product as we had anticipated, we made meaningful progress in advancing our regulatory path. Earlier today, we announced that we have successfully manufactured three consecutive drug substance lots and one drug product lot as required by the FDA for the qualification of our new working cell bank. The completion of the manufacturing activities paves the way for the resubmission of our BLA for daxibotulinum toxin A for injection for glabellar lines as soon as possible. You'll recall that based on our Type A meeting with the agency in December, a complete response to address the outstanding observations related to, one, the qualification of our new working cell bank, and two, our drug substance manufacturing process required us to qualify our new working cell bank by producing three consecutive drug substance lots and one drug product lot. This qualification process was already underway at the time we announced our Type A meeting results, and we are very pleased to have completed the qualification activities in a timely manner. We are now working on our resubmission package and will provide an update once we have resubmitted our BLA. As we have indicated previously, and based on our Type A meeting, a reinspection of our manufacturing facility will be necessary once our resubmission is accepted by the agency. Further, based on FDA regulations, Once the resubmission is accepted, the agency has up to six months to complete its reinspection of our facility along with the review of our resubmitted VLA. We remain focused on getting our neuromodulator product approved as soon as possible and look forward to engaging with the agency to facilitate this process. As I already addressed our commercial execution in my opening remarks, I will now turn to our third strategic priority for 2021, the advancement of our therapeutics franchise. In 2021, we successfully completed both our Aspen Phase III clinical program for cervical dystonia and our Phase II clinical program for adult upper limb spasticity. The completion of our cervical dystonia clinical program marked the second successfully completed Phase III program for doxibotulinum toxin A for injection, demonstrating that the drug was generally safe and well tolerated with an extended duration profile across both therapeutic and aesthetic indications. For our adult upper limb spasticity indication, we completed the Phase II clinical program and also held a productive end of Phase II meeting with the FDA, which informed the requirements for a Phase III program for this indication. Given our progress, we are poised to file a supplemental BLA in cervical dystonia following the approval of daxibotulinum toxinate for injection in glabellar lines. For our adult upper limb spasticity program, given some of the cash conservation measures that we had implemented late last year due to the delayed approval of our neuromodulator, we have paused the commencement of that phase three program and will continue to evaluate the proper timing for its initiation. Turning to capital allocation, we have been disciplined in evaluating and pursuing opportunities that will generate the highest return for our stockholders. To that end, we have been prudent in our efforts to balance growth and costs throughout the year, particularly following our CRL to maximize our financial flexibility. These ongoing efforts have allowed us to end the year with cash into 2023. Finally, in spite of the challenges presented by our remote and hybrid work policies due to the COVID-19 pandemic, we have worked hard to foster employee engagement while also creating a strong culture that embraces diversity and inclusion. These priorities involve programs and initiatives across all levels of the organization. Of note, we successfully met our corporate diversity and inclusion goal for the year, spanning across talent acquisition and internal educational and leadership forums. Before I turn the call over to Dustin to walk us through our fourth quarter operational achievements, I would like to review our strategic priorities for 2022. First, our primary goal remains gaining FDA approval for Daxibotulinum Toxin A for injection in globular lines as soon as possible. We're actively working on a resubmission, which will bring us one step closer to that goal. Our second priority is to continue to drive top-line growth for our products and services which will continue to be anchored by the RHA collection of thermal fillers in 2022. Third, we plan to drive deeper penetration of our Opal relational commerce platform now that we have completed the payback migration and are able to expand the platform's functionality. Fourth, we will continue to focus on disciplined capital allocation to drive long-term value for our stockholders. Fifth and finally, we will continue to invest in our people and our culture upon which our success is built. I'm thankful for all the efforts and dedication of the Revance organization in 2021, and I look forward to our shared success in 2022. With that, let me turn the call over to Dustin, who will cover our performance in the fourth quarter.