Revance Therapeutics, Inc.

Welcome to the Revance Therapeutics third quarter 2022 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 ask a question during the session, you will need to press star 1-1 on your telephone. As a reminder, this call is being recorded today, Tuesday, November 8, 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, Daniel. 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 our regulatory submissions and approvals, consumer preferences and behavior, the benefits to us, practices and consumers of a product, 2022 guidance, cash flow breakeven, future capital expenditures and capital allocation plans, our ability to draw on our debt, our ability to effectively compete, our blockbuster and growth potential, the supply and manufacturing of Daxify, the impact of economic headwinds on our business and consumers, and our strategy, planned operations, and commercialization plans and timing. 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 quarterly report on Form 10-Q filed with the SEC today, November 8, 2022. Remance undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. With that, I will turn the call over to Mark Foley, Chief Executive Officer of Remance. Mark?

Thank you, Jessica. Good afternoon, everyone, and thank you for joining our third quarter 2022 financial results conference call. The third quarter of this year marked an inflection point for the company, given the FDA's approval of Daxify, the first and only long-acting peptide-formulated neuromodulator for glabellar lines. This significant milestone positions Revans as the innovation leader in facial injectables and will enable us to realize our blockbuster potential in the U.S. aesthetics market. We're also providing the foundation for our SPLA submission for cervical dystonia, our first therapeutic indication. Further, upon Daxify's approval, we closed the $230 million follow-on offering which bolstered our balance sheet and positions us to launch Daxify from a position of strength. The third quarter was also strong from a commercial standpoint, as we delivered record RHA revenue of $26.1 million, representing a 43% year-over-year increase despite broader economic factors. Our solid performance in the quarter reflected our continued market share growth and the successful launch of RHA Redensity, which Dustin will cover later in the call. Enthusiasm for Daxify continues to be very strong, as evidenced by the over 1.1 billion impressions from earned media post-approval, along with the countless inquiries we continue to receive from injectors and consumers. Daxify's 24-week media duration, unique peptide formulation, and strong value proposition have all been highlighted as key drivers of interest. we are very encouraged by this high level of engagement and support, which we believe will bode well for the product's uptake and adoption upon launch. Progress is also made on our supply chain as we prepare to bring Daxify to market. We recently filed and received the FDA's acceptance of our prior approval supplement, or PAS, for our dual-source, fill-finish contract manufacturer, Ajinomoto Biopharma, or AGI, based in San Diego, California. AGI is already in the process of building inventory, and we anticipate the FDA's approval of that site in 2023. Recall that we have a wholly owned, FDA-approved manufacturing facility in Newark, California that produces both drug substance and drug product, and we've been building inventory at that site in advance of approval. So, between Newark's existing inventory, production capacity, and AGI's anticipated approval, we believe we are well-positioned to execute on our launch strategy. Additionally, to support our longer-term production needs, we have an agreement in place with an additional contract manufacturer, Lyophilization Services of New England, or LS&E, which will meaningfully enhance our capacity. And as our CMOs come online and as our volume increases, we expect DACtify's cost of goods to decrease over time. Beyond aesthetics, we have long talked about Daxify's compelling opportunity in therapeutics, beginning with cervical dystonia. Cervical dystonia is a painful and disabling condition that affects the muscles in the neck. In our phase three clinical trial, Daxify demonstrated that it was effective and generally safe and well tolerated in reducing the signs and symptoms of cervical dystonia while providing a median duration of effect of 20 to 24 weeks. Neuromodulators are the standard of care for treating cervical dystonia patients, Yet, re-treatment is not allowed by payers prior to week 12. In fact, a published peer-reviewed article in the Journal of Neurology titled, An International Survey of Patients with Cervical Dystonia, reported results from a survey of over 1,000 patients in 38 countries, which revealed that 88% of patients experienced symptom re-emergence between treatment sessions. And notably, the mean time to the re-emergence of symptoms was about 10 and a half weeks. As a result, patients who have symptom recurrence prior to week 12 have to manage without treatment effect. Based on the current treatment landscape, Daxify's differentiated clinical profile and potential to provide significant pharmacoeconomic benefits could represent an important advance in care for patients, providers, and payers. We look forward to bringing Daxify to the CD market and to providing patients with a compelling option. Following the approval of Daxify for 12-dollar lines, we worked hard to finalize and submit our SPLA for cervical dystonia. Our submission is supported by data from our Aspen Phase III Clinical Development Program, which included the Aspen 1 and Aspen OLS studies. We are anticipating a PDUFA date in 2023 and, if approved, Look forward to launching Dactify into the nearly $1 billion U.S. muscle movement disorder market, which includes both cervical dystonia and spasticity. This category also represents the largest single opportunity within the therapeutic neuromodulator market, followed by migraine. The total U.S. market size for therapeutic neuromodulators sits at about $2.3 billion. In short, Dactify is our innovation foundation across aesthetics and therapeutics, allowing for tremendous value to be unlocked over time. Before I turn the call over to Dustin, I'd like to welcome David Hollander as Chief Medical Officer, overseeing clinical development, data science, medical affairs, scientific innovation, pharmacovigilance, and regulatory affairs. David is a proven executive with broad operational experience and someone who has familiarity with both toxins and aesthetics. David will be a strong contributor as we set our eyes on Daxify's commercial launch, our international regulatory strategy and timing, and our therapeutics program following our SBLA filing for cervical dystonia. He will also play an important role in guiding our biosimilar to Botox program. With that, I'll turn the call over to Dustin, who will cover our performance in the third quarter.