Revance Therapeutics, Inc.

Thank you, Jessica. Good afternoon, everyone, and thank you for joining our fourth quarter and full year 2022 financial results conference call. 2022 was a landmark year for revance. With strong execution on our strategic priorities, we not only delivered outstanding financial results for the year, but also positioned ourselves for significant value creation going forward. Highlighting our many achievements was the approval of DAXify. The approval makes Daxify the first and only peptide-formulated neuromodulator with long-lasting results and the first true innovation in neuromodulator formulation in over 30 years. Moreover, the product's efficacy and median duration of six months has been achieved by using a similar amount of core active ingredient as that of the leading competitor. Daxify's approval not only enhances our competitive positioning in the facial aesthetics market, but also lays the foundation for our entry into therapeutics. As previously communicated, we initiated the introduction of Daxify to the aesthetics market through our planned early experience preview program in December. Thus far, we've been very pleased with the strong initial uptake and positive feedback from both injectors and consumers. Our second strategic priority for 2022 was to drive the top-line growth of our RHA collection of dermal fillers. Through our focused execution and with the introduction of new innovation, RHA Redensity, we increased adoption, enhanced account productivity, and are very pleased to report a 51% revenue increase from last year. Turning to our third strategic priority, we made meaningful progress in enhancing our customer relationships through our services segment. Our core belief is that by complementing our products with value-added services, we can develop deeper and lasting relationships with our practice partners. Over the past few years, we've taken important steps to become an authorized payment facilitator so that the Opal platform can support meaningful features and functionalities. Practices are currently using Opal to process payments at competitive rates, customize checkout options through a catalog of over 7,000 SKUs, and generate data insights. While it has taken us longer than expected to get to this stage of our platform's development, which led to an impairment charge that was recorded in Q4, we are making progress and will continue to develop our services offering as part of our long-term strategy to unlock additional value for our aesthetics portfolio. In Q4, we ended the year with over 5,000 accounts across our aesthetics portfolio, up from 3,000 accounts from one year ago. Prudent capital allocation was our fourth priority, And I'm pleased to report that the combination of effective cash management and strategic financings have allowed us to execute on our priorities and launch Daxify from a position of strength, despite the challenging financial market backdrop. Finally, investing in our people and culture is always a priority for revance. So much so that our initiatives in these areas continue to be reflected in our annual company goals for which a portion of our executive and corporate bonuses are based. To that end, we're very pleased to achieve over 100% of our diversity and inclusion and people goals, which covered talent attraction, culture assessment, D&I educational programs, and women in leadership. We're also looking forward to publishing our second ESG report shortly. In addition to all these important accomplishments and our strong financial results for the quarter and year, we continue to make progress across several areas of the business in the early months of 2023. The FDA recently accepted our SPLA for Daxify for the treatment of cervical dystonia, and we were provided with a PDUFA date of August 19th, 2023. This new indication, if approved, would be our first step towards unlocking Daxify's potential in therapeutics. Upon approval, we look forward to launching an early experience program similar to the Daxify and RHA preview programs, followed by full commercial launch in 2024. We expect to leverage these learnings to inform our launch plans and DAXify pipeline strategy in therapeutics. On the corporate side, I'll touch on a few board and management changes. Earlier today, we announced the appointment of Dr. Vlad Korek, Chairman and CEO of Biohaven, as an independent director with an effective date of March 1st. Vlad is a seasoned pharmaceutical executive who brings a 22-plus year track record in biotech value creation, particularly in the area of neurology. His appointment will further enhance the collective skill set of our strong and diverse board and will help support our innovation and market expansion efforts. Vlad's appointment also coincides with the retirement of Phil Vickers prior to the company's 2023 annual meeting. Phil has been instrumental in shaping our scientific progress over the past eight years, and on behalf of both management and the board, I would like to thank him for his service and wish him all the best in the future. I'd also like to welcome Amy Krause as our Chief People Officer effective March 13th. Amy brings over 25 years of experience in human capital management and will be stepping into this critical role as Justin Ford, our Senior Vice President, Human Resources, and Head of People retires. Amy will build on the great work and progress that Justin and his team have made over the past six years. I'd like to thank Justin for his invaluable leadership in supporting our rapid growth as a company attracting great talent, and in shaping our inclusive and diverse workplace culture. In summary, I'm proud of all that we were able to accomplish in 2022, setting the stage for another exciting and important year. We look forward to growing our U.S. Aesthetics franchise by successfully launching DAXify and driving deeper adoption of the RHA collection, while also continuing to enhance our services offerings. At the same time, we are eagerly awaiting our first anticipated therapeutics approval and are actively preparing for our market entry. With that, I'll turn the call over to Dustin. Dustin?

Thank you, Mark. I'm very pleased to see the progress our entire organization has made, specifically our strong sales results underscored by our commercial strategy and our consistent execution. Starting with the RHA collection, we saw strong demand in Q4 resulting from numerous training events in Nashville focused on the unique rheologic properties of the RHA collection, targeted consumer activation campaigns, and the benefit of RHA Redensity in further customer engagement and adoption. These efforts were also amplified by DAXify's approval and resulted in $34.8 million of revenue in Q4, up 46% from last year. For the year, total RHA sales were $107 million up 51%. The RHA collection is currently the fastest-growing HA filler brand in the competitive U.S. filler market. Our success is a function of both our targeted strategy and the uniqueness of the product. From the way it's manufactured to its performance profile, RHA offers injectors important versatility in treating a wide range of patient needs and, as a result, has become a product that can stand on its own independent of a neuromodulator. The approval and launch of Daxify will therefore introduce a new dynamic for the RHA collection. We're excited to begin seeing synergies from our differentiated suite of products and services. We ended the quarter with over 5,000 accounts across our aesthetics portfolio. Further, our FinTech platform generated $179 million of gross processing volume, or GPV, for the quarter and $665 million of GPV for the year. On the infrastructure side, our prior approval supplement for Genomoto Biopharma Services remains on track, and we continue to anticipate potential approval in 2023. Once approved, Aji will serve as a fill-finish contract manufacturer, an important part of our supply chain to meet the anticipated demand for DAXify. Turning to DAXify, we are very pleased with the progress of our preview program, our early experience program. which kicked off in December and included approximately 400 practices. These select partners were extremely engaged and excited about the exclusive opportunity to be one of the first to experience DAXify. After being selected to participate in Preview, many of them leveraged the busiest time of the year for aesthetic procedures to pre-schedule injection events to capitalize on the pent-up demand for this new innovation and to accelerate the opportunity to gain real-world clinical insights. We continue to be very encouraged by the high level of engagement surrounding Daxify from both the preview group and our broader revamped partners. And with thousands of patients treated thus far, we feel very good about the feedback we've received and are encouraged by the high interest among injectors and consumers to experience Daxify. Since Daxify is the first and only peptide-stabilized neuromodulator, In addition to being the only aesthetic neuromodulator to receive U.S. approval prior to any international or therapeutic approvals, Preview is essential in delivering on our pre-launch objectives. Number one, delivering optimized outcomes for consumers by generating real-world clinical experience with Daxify. Number two, enhance the injector's ability to switch patients to Daxify by ensuring seamless integration into their current practice routines. each our core to ensuring we understand how to best meet the needs of our practice partners and to unlock the true potential for DAXify. Unique to Revance, our commercial strategy is focused on the practice and provider first. We continue to believe that these providers have the power to drive consumer choice and ultimately the adoption of our portfolio. There's an increasing opportunity for Revance to shape provider behavior by pursuing a stronger and deeper partnership. To do this, our goal is to break the current product commoditization with our innovation, value proposition, and no advertising pricing policy, all designed to arm our partners with what they need to optimize aesthetic outcomes, and at the same time, enhance their profitability. Picking the right partner at the right time is critical to accelerating adoption of our portfolio within the highly competitive US aesthetics marketplace. With our deep versus wide strategy, we've leveraged our preview program, first with the RHA collection and now with Daxify. Following the completion of Daxify preview, we expect to kick off our elite partner launch phase in late March, which focuses on a thoughtful rollout to existing customers, leveraging live training and education programs to be held at our national headquarters. Over the past two years, we've learned that our Nashville Experience Center has been a valuable and differentiated asset for driving early product adoption, strong customer engagement, and continued partnership. For this reason, Nashville remains central to our commercial strategy, and we are continuing to invest in expanding our training and education facility to support our commercialization efforts. We plan to also augment our onboarding process by evaluating virtual training options, as well as a forum for sharing best practice insights. To further capitalize on our market opportunity across the aesthetics portfolio, we're on our way to adding approximately 50 additional sales roles in late Q1, early Q2, with the expectation that they will be productive by Q3. Throughout the rollout of DAXify, we expect to adhere to our strategy of building meaningful partnerships with our customers by going deep into accounts versus wide in order to optimize product adoption and penetration. As you may know, there are roughly over 40,000 aesthetic practices in the US and no shortage of new entrants. And not all accounts behave the same. Past aesthetic launch experience coupled with our learnings of the RHA collection prove our greatest return is from targeted accounts that are willing to quickly switch patients to our product portfolio and align with our broader prestige value proposition versus the large number of accounts that focus on sampling, dabbling, or primarily making decisions driven by deal-of-the-day pricing programs. This approach aligns with our prestige strategy, optimizes our leverage, and unlocks our ability to scale. We are looking forward to furthering our track record of success in commercial execution with our introduction of DAXify and the continued growth of our comprehensive Revance Aesthetics portfolio. With that, I'll turn the call over to Toby to cover our fourth quarter and full-year financials.

Thank you, Dustin. Total revenue for the fourth quarter 2022 was $49.9 million, representing a 92% increase from the same period last year due to increased sales of the RHA collection and sales of Daxify during the preview program. Total revenue for the full year 2022 was $132.6 million, representing a 70% increase from the same period last year primarily due to higher RHA collection sales. Revenue for the fourth quarter included $34.8 million of RHA collection revenue, $11 million of DAXify revenue, $2.9 million of service revenue, and $1.2 million of collaboration revenue. Before I cover our operating expenses, I'd like to take note of a few items on our cost of product revenue. Recall, in accordance with GAAP, that we have been expensing manufacturing costs related to DAXify as a period R&D item until the product was approved. When our prior approval inventory is used, we expect our cost of product revenue for DAXify to increase. In addition, our cost of product revenue for the fourth quarter reflected an increase in the purchase price of the RHA collection associated with a one-time charge for 2022 and other manufacturing, royalty, and distribution costs related to DAXify. Turning to OPEX, GAAP OPEX for the fourth quarter and full year 2022 were $194.3 million and $474.5 million, respectively, compared to $87.6 million and $352.5 million for the same period in 2021. GAAP OPEX for the year exceeded our previously announced guidance range of $375 to $400 million, primarily due to two non-cast charges that were recorded in the fourth quarter. The first charge was an impairment loss to our services segment of $69.8 million. The charge resulted from a reduction in the internal segment forecast and growth rates. driven by the performance of the service segment and the delay in the development of certain platform features and functionalities. The analysis also reflected the decrease in current valuation of the broader payment sector. The second charge was a one-time accelerated amortization expense of $11.7 million for our legacy HintMD developed technology asset. This expense was associated with the sunsetting of the platform following the migration of customers to Oval. Excluding the cost of revenue depreciation, amortization, stock-based compensation, and our impairment charge, non-GAAP OPEX were $72.8 million for the fourth quarter and $267 million for the year. which was in line with the midpoint of our previously announced guidance range of $260 to $280 million. While we recognize an impairment charge to our services segment, we continue to believe that services offerings such as Opal will further enhance our competitive positioning and align with our prestige market strategy. Looking ahead, we expect our 2023 GAAP OPEX to be $460 to $480 million, and non-GAAP OPEX, which excludes costs of revenue, depreciation, amortization, and stock-based compensation, to be $320 to $340 million. Our 2023 non-GAAP research and development expense is expected to be $80 to $90 million. Our guidance for non-GAAP OPEX primarily reflects increased investments in our aesthetics commercial infrastructure, including sales team expansion, DAXify and RHA commercial investments, and biosimilar partnership investments. Turning to our balance sheet, we took important steps to strengthen our financial position and our flexibility over the course of the year through strategic financings. We ended Q4 with $340.7 million in cash, cash equivalents, and short-term investments. As we previously indicated with our current cash position, the committed $100 million tranche two of purchasing agreement and our anticipated revenues and expenditures, we believe our U.S. aesthetics portfolio will be funded to break even. Finally, Revance's shares of common stock outstanding as of February 16th, 2023, were approximately 83 million with 92 million fully diluted shares, excluding the impact of convertible debt. And with that, I'll turn the call back over to Mark.