Revance Therapeutics, Inc.

Welcome to the Revance Therapeutics First Quarter 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in the 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 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 touch-turned 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, May 10, 2021. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG for Advance. Please go ahead, ma'am.

Thank you, Donna. Joining us on the call today from ReVance is President and Chief Executive Officer Mark Foley, Chief Financial Officer Toby Schilke, Chief Operating Officer and President of R&D and Product Operations, Dr. Abhay Joshi, Chief Commercial Officer, Aesthetics and Therapeutics, Dustin Suits, and President of Innovation and Technology, Aubrey Rankin. During this conference call, management will make forward-looking statements, including statements related to Revance's 2021 guidance, the clinical development of our product candidates, business strategy and planned operations, commercialization plans, the timing and outcome of the FDA's inspection of our Northern California manufacturing facility, the potential benefits of our drug product candidates and technologies, the launch of the next-generation Henton D-Fintech platform, the timing of any potential approval of daxibotulinum toxin A for injection and RHA1 by the FDA, the timing related to regulatory approval, submissions, and meetings, the market opportunity of our aesthetics and therapeutics franchises, the aesthetics industry, milestone expectations, and expected cash runway and financial performance. 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. Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our current report on Form 10-Q to be filed with the SEC this afternoon on May 10, 2021. REVANCE undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. 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 the earnings release. With that, I will turn over the call to Mark Foley. Mark?

Thank you, Jessica. Good afternoon, everyone, and thank you for joining our first quarter 2021 financial results conference call. Before I cover the results and provide commentary for the first quarter, I'd like to provide an update on the BLA for our lead product, doxybotulinum toxin A for injection for globular lines. Our standard operating procedure is to not comment on the status of our ongoing FDA review process or interactions with the agencies. However, given the unique environment that the COVID-19 pandemic has created and the length of time that has lasted since our PDUFA date, we felt that it was important to provide the investment community with an update. As of today, the FDA has not scheduled or conducted the pre-approval inspection of our Northern California manufacturing facility due to COVID-19 related travel restrictions. While we had expected to have an inspection date by now, we continue to engage with the FDA and leverage all available resources to facilitate an inspection as soon as possible. We're also encouraged to see the FDA recently issue its most comprehensive guidance to date, which outlined the agency's planned inspection approach going forward. Combined with the ramp up in vaccinations across the country, the decline in COVID cases, particularly in the geographic area of our manufacturing site, We anticipate that we will be provided an inspection date in the near term. Furthermore, we will now make an announcement once we receive the official communication from the FDA regarding our inspection timing. As a reminder, the approval of our BLA by the PDUFA date of November 25, 2020, was deferred due to FDA's inability to conduct an inspection of our facility due to COVID-related travel restrictions. Importantly, the FDA did not indicate any other outstanding review issues beyond the pending inspection, and we did not receive a complete response letter. We remain ready to support an on-site inspection as soon as the agency is able to visit our facility. And we continue to build drug product inventory in anticipation of approval and are eager to introduce this unique product into the aesthetics market. Now let me turn to our first quarter performance. Following our successful transition into a commercial entity in late 2020, we're very pleased to see the momentum in our aesthetics franchise continue in the first quarter of 2021. We delivered strong revenue from our RHA collection of thermal fillers and saw robust increase in processing volumes from the NMD FinTech platform, despite the COVID-19, despite the impact of COVID-19 and Q1 historically being a seasonally slower quarter for facial injectables. These results confirmed the market demand for innovative and premium products and services and further validated our targeted launch strategy. 2021 will undoubtedly be another exciting year for the company with a focus on ongoing successful commercial execution. That said, our playbook for the year is anchored by five strategic priorities. First and foremost is obtaining FDA approval on our lead neuromodulator product, doxybotulinum toxin A for injection, and launching the product with the same targeted approach that we used for the RHA collection and HintMD platform. Our second strategic priority is to deliver on our commercial strategy and aesthetics. We're driving market segmentation with our premium products and prestige launch strategy, targeting elite practices and partners. Looking ahead, we are excited about broadening our aesthetics portfolio with the introduction of RHA1 once approved and the next version of the HintMD platform. We are excited about our progress in aesthetics, and Dustin will cover more on that later in the call. Our third strategic priority relates to our therapeutics franchise, where we plan to bring the clinically proven benefits of daxibotulinum toxin A to muscle movement disorders and set a new standard of care for patients. With the expected completion of our Phase III open-label safety study in cervical dystonia, and submission of our end of phase two meeting request in adult upper limb spasticity, or AULS, this year, we've begun building the commercial foundation for our therapeutics franchise, and I'll expand on that later in the call. Our fourth strategic priority is the continued focus on discipline and capital allocation. We entered 2021 with a strong balance sheet and cashed into 2024. We continue to execute on our strategy from a position of strength, and are focused on ensuring that the investments we make today will allow us to realize our near-term growth objectives while also supporting our long-term strategic initiatives. Our fifth and final strategic priority for 2021 relates to our people initiatives, which are critical to our ability to drive sustainable growth in the years ahead. Revance more than doubled in size last year, opened offices in three additional cities, and established a national sales organization. Our ability to build a strong culture in a working environment where all employees feel welcome, supported, and empowered is critical. This is important not only for attracting and retaining talent, but also for fostering greater innovation in business outcomes. Throughout it all, we continue to lean in on our commitment to diversity and inclusion. In summary, we feel very good about where we are positioned and where we are headed. We have delivered two consecutive quarters of solid commercial results through our targeted launch strategy amassed a growing body of clinical data supporting the consistent and differentiated performance profile of daxibotulinum toxin A, maintained a strong financial profile, and lastly, built an incredibly talented and dedicated team. Coupled with the key catalysts for this year, most notably the anticipated FDA approval of our lead neuromodulator product, we look forward to delivering another year of significant growth. With that, I'll turn the call over to Dustin, who will cover the performance of our aesthetics business in the first quarter.