Revance Therapeutics, Inc.

Welcome to the Reven's Therapeutics Second 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 questions at that time, please press star followed by 1-1 on your touchtone phone. As a reminder, this call is being recorded today, Tuesday, August 9, 2022. I would now like to send a conference call to Sarah, Head of Investor Relations and ESG for REV. Please go ahead. Thank you, Bella.

Joining us on the call today from REVAN are Chief Executive Officer Mark Foley, President Dustin Stoops, and Chief Financial Officer Toby Schilke. During this conference call, management will make forward-looking statements including statements related to the regularity of the process and potential approval for daxibotulinum toxin A for injection. In globato lines and in therapeutic indications, potential indications for RO2 redensity, the effects of RO2 collection on the opal platform, consumer preferences, 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, our markets and revenue opportunity, our potential growth and our business strategy, planned operations, and commercialization plans, our actual results, and the time that 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 10Q filed with the SEC today, August 9, 2022. 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. 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 second quarter 2022 financial results conference call. We're very pleased with our performance in the second quarter, highlighted by our best RHA quarter to date and solid account growth across our pillars and overall relational commerce platform. These results reflect the continued success of our launch and also the strength and resilience of the facial injectables market. We're also excited to announce the launch of RHA Redensity, the first and only FDA-approved dermal filler for dynamic perioral or lip lines. Redensity is the latest innovation to our RHA collection, which now includes four distinct fillers that meet a broad range of consumer and practice needs. As a result of the progress we made in the first half of the year, including the resubmission and acceptance of our VLA for Daxibotulinum Toxinate for injection and our strong commercial traction, We look forward to our September 8th PDUFA date and the prospect of entering the new growth phase. As a reminder, the FDA designated our BLA as a Class 2 resubmission, which has a six-month review period and includes a required re-inspection of our manufacturing facility. As we previously communicated, we did not intend to provide details regarding our ongoing interactions with the agency. However, in light of the information we received this morning regarding the likelihood that the agency could satisfy the FOIA request on our manufacturing inspection prior to our Purdue today, we would like to provide everyone with a regulatory update so that all investors have access to the same information. First, I'm pleased to report that the FDA completed their inspection of our manufacturing facility from July 11th to July 15th. Next, the corrective and preventative actions completed in response to the five observations from the previous Form 483 that we received in July 2021 related to our pre-approval inspection have been reviewed by the FDA and are considered closed. Lastly, at the conclusion of the reinspection of our manufacturing facility in July, the agency provided us with a Form 483 that included three observations. For transparency and reference, we've included a summary of the observations in our earnings press release in Form 10-Q. A couple of points I would like to make about the three observations on Form 483 we received on July 15, 2022. First, it does not include any of the five observations that were outstanding from our previous Form 483 related to our pre-approval inspection. You will recall that these observations were the focus of our resubmission and, as previously stated, are considered closed. Second, we are confident in our responses, which we have already provided to the FDA, and I'm proud of our team for the timely turnaround. We continue to expect a decision from the agency by our reduced date of September 8th, which is just one month away. Obtaining approval remains our top corporate priority for 2022, and our team is prepared and eager to launch our flagship drug product once approved. As a reminder, upon approval, we will have the opportunity to expand our access to the $3.2 billion U.S. facial injectables market, which according to the latest Decision Resource Group report, includes neuromodulator sales of $1.7 billion and dermal filler sales of $1.5 billion. Further, according to the American Society of Lastic Surgeons, neuromodulators and dermal fillers remain the top two most performed minimally invasive aesthetic procedures. Historically, the market has grown in high single to low double digits and has held up well against macroeconomic headwinds, such as the economic recession in 2008 and 2009. Even with the COVID pandemic in 2020, we saw a V-shaped recovery in the following year when practices reopened. Over the mid to long term, the U.S. market is expected to grow at a compound annual growth rate of 8% to $4.7 billion by 2026. Given the current economic environment and questions surrounding its potential impact on the facial injectables market, I'd like to make a few comments. To date, based on the accounts that we are calling on, we haven't seen an impact on activity that would be beyond typical seasonality trends. You'll recall that the second and fourth quarters are usually the busiest times of the year for procedures compared to the first and third quarters. However, should macroeconomic factors begin to impact consumer spending in our target accounts, we take comfort in the resilience of the facial injectables market prior to downturns, and more importantly, are uniquely positioned in the market versus other manufacturers. First, we are still in our launch phase with the RHA collection. Second, we are bringing new innovations to the market, including today's launch of RHA Redensity and the launch of our next-generation neuromodulator for PRUDE. And third, we have a differentiated go-to-market strategy that is focused on the Prestige segment. Now let me turn to therapeutics. The approval of daxibotulinum toxin A for injection for glabellar lines would allow us to unlock our opportunity in multiple movement disorders. We have a strong pipeline in this category with our completed Phase III program for cervical dystonia and our completed Phase II program for upper limb spasticity. The clinical data in both of these programs demonstrated dacribotulinum toxin A for injection efficacy and median duration of effect of up to 24 weeks. We will be ready to file supplemental BLA for cervical dystonia shortly after the FDA's approval of our long-acting neuromodulator in glabellar lines. As a reminder, cervical dystonia would be our entry point into the over $900 million U.S. muscle movement disorder category that is expected to grow to $1.4 billion in the U.S. by 2026. In summary, we feel very good about the growth of our base business, our expanding RHA collection, and our pipeline in aesthetics and therapeutics pending approval of daxibotulinum toxin A for injection for glabellar lines. With that, I'll turn the call over to Dustin, who will cover our performance in the second quarter. Dustin?