Welcome to the Revance Therapeutics Fourth Quarter and Full Year 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 at that time, please press star followed by one on your touch tone phone. If anyone has any difficulty hearing the conference call, please press star zero for operator assistance. As a reminder, this call is being recorded today, Tuesday, February 28th, 2023. I would now like to turn the conference over to Jessica Serra, head of investor relations at ESG for Revance. Please go ahead. Thank you, Jack. Joining us on the call today from Revance are Chief Executive Officer, Mark Foley, President, Dustin Sjuts, and Chief Financial Officer, Tobin Schilke. During this conference call, management will make forward-looking statements, including statements related to 2023 guidance, cash flow break even and future revenue and expenses, our value creation and growth potential, the efficacy and duration of DAXXIFY, our ability to draw on our debt, our regulatory submissions and approvals, our entry into the therapeutics market, our commercial success, consumer preferences and behavior, the benefits to us, practices and consumers of our products and services, consumer outcomes, the supply and manufacturing of DAXXIFY, sales team growth and our strategy, planned operations, services strategy, 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 annual report on Form 10-K filed with the SEC today, February 28th, 2023. 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 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 DAXXIFY. The approval makes DAXXIFY 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. DAXXIFY'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 DAXXIFY 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 OPUL platform can support meaningful features and functionalities. Practices are currently using OPUL 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 DAXXIFY 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 sBLA for DAXXIFY for the treatment of cervical dystonia, and we were provided with the PDUFA date of August 19, 2023. This new indication, if approved, would be our first step towards unlocking DAXXIFY's potential in therapeutics. On approval, we look forward to launching an early experience program similar to the DAXXIFY and RHA Preview programs, followed by full commercial launch in 2024. We expect to leverage these learnings to inform our launch plans and DAXXIFY 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 Coric, Chairman and CEO of Biohaven, as an independent director with an effective date of March first. 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 Philip 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 Amie Krause as our Chief People Officer, effective March thirteenth. Amie 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. Amie will build on the great work and progress that Justin and his team have made over the past 6 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 DAXXIFY 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 DAXXIFY'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 DAXXIFY 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 Ajinomoto Bio-Pharma 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 DAXXIFY. Turning to DAXXIFY, 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 DAXXIFY. 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 DAXXIFY from both the preview group and our broader Revance partners. 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 DAXXIFY. Since DAXXIFY 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 DAXXIFY. Number two, enhance the injector's ability to switch patients to DAXXIFY by ensuring seamless integration into their current practice routine. Each are core to ensuring we understand how to best meet the needs of our practice partners and to unlock the true potential for DAXXIFY. 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 monetization 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 U.S. aesthetics marketplace. With our deep versus wide strategy, we've leveraged our preview program, first with the RHA Collection and now with DAXXIFY. Following the completion of DAXXIFY 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 National 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. 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 are 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 DAXXIFY, 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 U.S. and no shortage of new entrants. 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 DAXXIFY and the continued growth of our comprehensive Revance Aesthetics portfolio. With that, I'll turn the call over to Tobin 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 DAXXIFY 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 DAXXIFY 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 DAXXIFY 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 DAXXIFY to increase. 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 DAXXIFY. 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 million-$400 million, primarily due to two non-cash 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 assets. This expense was associated with the sunsetting of the platform following the migration of customers to OPUL. 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 million-$280 million. While we recognized an impairment charge to our services segment, we continue to believe that services offerings such as OPUL will further enhance our competitive positioning and align with our prestige market strategy. Looking ahead, we expect our 2023 GAAP OpEx to be $460 million-$480 million and non-GAAP OpEx, which excludes costs of revenue, depreciation, amortization, and stock-based compensation to be $320 million-$340 million. Our 2023 non-GAAP research and development expense is expected to be $80 million-$90 million. Our guidance for non-GAAP OpEx primarily reflects increased investments in our aesthetics commercial infrastructure, including sales team expansion, DAXXIFY 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 equivalents, and short-term investments. As we previously indicated, with our current cash position, the committed $100 million tranche, dollar tranche two of the note purchasing agreement and our anticipated revenues and expenditures, we believe our U.S. aesthetics portfolio will be funded to breakeven. 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. With that, I'll turn the call back over to Mark. Thank you, Tobin. In closing, I'd like to take this opportunity to express my deep appreciation to the entire Revance organization for all their hard work and dedication in getting us to this important point in the company's history. We continue to believe that we have the potential to annually deliver at least $1 billion of revenue over time in the U.S. aesthetic market with the assets we've assembled, and that DAXXIFY will be the cornerstone for our revenue growth. We look forward to another eventful year as we launch DAXXIFY into the U.S. aesthetics market and begin our journey into therapeutics. With that, I will now open the call up for questions. Operator? Certainly. Again, as a reminder, if you'd like to ask a question, please press star one on your telephone keypad. David Amsellem with Piper Sandler, your line is open. [Audio distortion] Thanks. Can you guys hear me? Hey, can you hear me? Sorry about that. Okay, perfect. Thank you. Yeah, just a couple. First, as you're thinking about the landscape for DAXXIFY, can you just talk about how you're thinking about the evolution of pricing, particularly to the extent that we see another entrant that's the Juvéderm product, how you're thinking about that? I know you're thinking about DAXXIFY more in the prestige practice arena. Maybe Juvéderm is looking at it differently. How are you thinking about, you know, competitive dynamics and particularly pricing? That's number one. Secondly, it might be an obvious question, but to the extent that we see sort of a bounce back at some point, in the filler space, what does that mean for RHA in terms of its trajectory, considering you've been, at least so far, fairly insulated from the headwinds? Can you talk about that? Thank you. First on your question about evolution of pricing and, you know, as other competitors come into the market, how do we think about that interplay? You know, we've taken a little bit of a differentiated approach from the standpoint that we've got, you know, transparent pricing. We don't bind anybody to contracts. They, at the time of their purchase, can decide which of the tiers they wanna purchase. We heard this from practices when we were talking to them about, you know, what would they like to see from a partnership perspective. We've done that with our RHA product line. We've also launched DAXXIFY with that same sort of pricing tier. As a reminder, we have a no advertise pricing policy. We're trying to find ways that we can break the commoditization of the facial injectable market and put the injector back at the center and let them have a discussion with their patient about what's the best outcome for their patient, less driven by necessarily price and more about the outcome. David, as you pointed out, we're very focused on this prestige strategy, which doesn't have to be everything to everybody. We're going after those accounts that, again, don't necessarily depend on driving patient volume solely on price and that appreciate the ability to offer premium products and differentiation. We don't necessarily see the introduction of new competitors into the market in terms of changing our philosophy. There's already a, you know, a price segment in the market that exists. Thus far, we feel like the strategy that we've taken and the ability to offer consumers with a differentiated product offering and practices an opportunity to recapture some additional margin is the right strategy. Of course, we'll be continuing to be mindful of the market dynamics. Now that we also have DAXXIFY in the market, we have the ability to create some additional programs tied to our broader product portfolio. We'll continue to evaluate that. Our strategy at launch is very similar to what we've done with the RHA product lines. In terms of the bounce back in the filler space, you know, we continue to get asked on each call whether or not we're seeing any macroeconomic impacts in our business. Thus far, we haven't. Again, we are targeted or very focused on a much smaller group of providers. Thus far, we have not seen an impact of the economy on the facial injectable usage in the accounts that we're calling on. We continue to monitor that. Certainly, it's possible we could face that sometime in the future. You know, a bounce back to us, given that we're not seeing really an impact in terms of volumes in the accounts, I'm not sure would have a meaningful impact on us at this point. Okay. Thank you. Great. Thanks, David. Chris Shibutani with Goldman Sachs, your line is open. Hi, this is Roger on for Chris. Our question kind of pertains to the patient volume mix that you're seeing and anticipate in the future. You mentioned earlier that the greatest amount of value you guys are deriving, is coming from, you know, practices that are willing to switch quickly as opposed to those with, more, you know, capturing deal of the day type events. As you think about the future, do you think the dynamics, are going to influence that in terms of you'll be focusing more on patients who are switching from Botox? Or how do you think about, you know, capturing the patients who are new starters? I think that, you know, Roger, our strategy, as we've articulated before, is really targeted that prestige segment. We've said of the 40,000 accounts that we estimate in the US that do facial injectables, that, you know, about 1/3 of those really fit into our strategy. As of the end of Q4, we said that we're in roughly 5,000 accounts out of that, call it, you know, 12,000-15,000 account level. We are very focused on targeting those injector accounts that, you know, we believe are aligned with our strategy. Ours is less about going out and trying to capture consumers, but more about treating the consumers that reside in those prestige practices. We believe strongly that, you know, these leading injectors and practices heavily influence the choice that these consumers make when they come into the practices. The profile of consumer that we're going to end up switching over to DAXXIFY is gonna be reflected in who the existing consumers are that are already within those practices. There's no doubt that any time new innovation comes into the market, it sparks and it stirs consumer interest. We would think that the practices that provide DAXXIFY are going to end up getting a number of new patients that come in because they've heard about it. Again, our strategy is much more focused on arming these practices with all the information they need to provide a really good experience and outcome with DAXXIFY and to let consumers know that that's an option that they provide. Seamus Fernandez with Guggenheim Securities, your line is open. Seamus, can you hear us? Seamus Fernandez with Guggenheim Securities, your line is open. We might need to go to the next person and come back to Seamus. Annabel Samimy with Stifel, your line is open. Hi. Thanks for taking my question. I guess going back to I guess the strategy of going deeper as opposed to wider. I guess we've spoken in the past, and you mentioned that could be a potential headwind. Do you really see that as a headwind if you're gonna be going deeper in these accounts first of all? Second, you mentioned also that you got orders from the 400 participants in the preview. Have you started seeing reorders from them? You also mentioned maybe some other partners. Have people started ordering outside of this preview yet because of some level of desire to get ahead of the whole DAXXIFY trend? Maybe you can just start with that. Sure. The, the deeper versus wider strategy is something that we've been very consistent with going back to the RHA. If you look at it, you know, the onboarding pace of new customers on the RHA fillers has been you know, pretty consistent over time where we've added roughly 500 new accounts per quarter, all with the goal of let's make sure that when we introduce somebody to our products that they get trained the right way, they get the right information to be successful, and that again, we can drive stickiness. That's been a long-term part of our prestige strategy. That's very consistent with what we plan to do with DAXXIFY. As we've stated previously, we plan to target those accounts that we have an existing RHA relationship with first because we have a relationship with them. We think anytime you're introducing a new product, making sure that that onboarding process is robust, engaged, and that we are working to get it integrated into the practice versus just a sampling thing is the right strategy. If you look at our preview program, it was really designed to give us additional insights into practice integration, clinical outcome, real world usage, so that when we did go to full commercial launch, which we will kick off later this quarter towards the end of March, that we can take some of those learnings and make tweaks or modifications to the information that we share. We're very pleased with how preview is going, the learnings that we have, and we continue to be very much on target for our overall launch plan and strategy. With regards to the... I don't know that we've ever said that that's a headwind. I just think that, you know, that's always been the strategy and fits very well in that prestige of targeting those accounts. With regards to the preview, as you're aware, we rolled out the preview program to approximately 400 accounts in December. These accounts are accounts that were very anxious and eager to get DAXXIFY, had a lot of patients ready to use the product when they brought it in. We've certainly had a fair bit of reorders on those accounts. It's really provided that platform for learning and education to inform the broader market launch, which we plan to roll out again in late March. Okay. right. will you be giving us reorder metrics going forward? We haven't historically done that with RHA. We've talked more about account side of it. We're very early in that side of it. We'll continue to assess what we think makes sense as we have more data to inform that process. You know, if we look at what we've historically done, we've given the number of accounts that we have from an aesthetics portfolio standpoint, so I think that's a good baseline. Then as we get more information, but we're super early. We really like what we're seeing, and it's very consistent with the strategy that we've mapped out. As we have information that we think is informative going forward, we'll look to share that. Okay. One last question, if I can switch to therapeutics. Obviously, you're gonna be approaching a potential approval this year. Can you talk about some of the commercial and specifically payer efforts that you have underway, on how you'll be, I guess, pitching a premium product to a market that doesn't always use logic and pharmacoeconomics when they're making their access decisions? If you could just help us understand. Sure. how that would play out. Absolutely. Yeah, we tried to cover some of that in our prepared comments. You know, with our PDUFA date in August this year, our, you know, hope is that we'll get approved on our PDUFA date, and we will launch something very similar to the preview program that we've done with RHA and with DAXXIFY, all with this goal of trying to really figure out what's going to be the best way to drive depth and penetration. This will give us an opportunity to engage with payers. It'll give us an opportunity to get a lot of real-world clinical use. Obviously, there's a compelling value proposition to be made with a longer lasting toxin in these debilitating conditions. We think this collective body of information will help inform our, you know, the details of our go-to-market strategy and probably more importantly, even our pipeline strategy in terms of what other, you know, trials do we invest in from an indication expansion. We'll learn a lot through our preview phase later this year, assuming approval, and then we'll use that to inform our 2024 commercial launch strategy. Got it. Thank you. Seamus Fernandez with Guggenheim Securities, your line is open. Great. Thanks so much. Sorry for the miss earlier. Just, you know, a couple of quick questions. I was just hoping that if you might, obviously the consensus after the, you know, impressive fourth quarter uptake, you know, that I think really surprised relative to expectations, maybe it surprised you guys as well. You know, wanted to just get a sense, obviously, consensus numbers have risen. You know, what is your comfort with, you know, sort of the revenue range that sits out there today? I think given the initial uptake, there definitely is a bias to get quite excited about that early launch trajectory. Just wanted to get a better sense of how to think about, you know, I guess, as some would say, the rhythm of the numbers, as we move through the balance of the year. Maybe if you could just provide a little context on the importance of OPUL, really coming online and the timing of OPUL coming online to the contribution to, you know, the revenue potential for DAXXI this year. Yeah. Thanks, Seamus. You know, it's hard obviously to give guidance at this point. We're, what, two months into our preview launch. It's very early. You know, there's nothing that we've seen in the preview launch strategy that, you know, changes our optimism for the opportunity going forward or our strategy. You know, if we kind of take a step back when we look at it, we've talked about, you know, the fact that we think with the collection of assets that we have in the aesthetics franchise that, you know, between our RHA, DAXXIFY, and service segment, that, you know, we can get to $1 billion of revenue in the U.S. aesthetics market. We feel very good about where we are in that journey. It's just, it's hard to give any guidance right now given that we are so early in this journey. What I will tell you is that we have, you know, a significant number of accounts who are very interested in getting trained and getting onboarded with DAXXIFY. We know that they have, within those practices, a number of consumers who are very interested in getting DAXXIFY treatment. That's before, you know, we've really amplified the awareness that's out there. We feel like we're very well positioned in the preview program. We've been encouraged by the learnings that we've had and the experience that we've seen from both the injectors and from the consumers. I just think it's a little early for us to give any commentary about how we feel about guidance given where we are in that phase. On the AJI side, you know, we've long talked about what our supply chain strategy is. Newark, California, where we make both our drug substance and limited drug product, we said is not configured to meet the expected demand of DAXXIFY. We early on signed a partnership with Ajinomoto down in San Diego as a fill-finish contract manufacturer. The post-approval supplement was filed in 2022. We feel very good about where we are in that process and approval in 2023. They have been making product all along the journey prior to their approval. We do need them to come online in 2023, but we feel very good about where they are in that process to date. We've also signed an agreement with Lyophilization Services of New England because we believe that in order to meet the longer-term demand, that we're gonna need them to come online as well. We need them to come online in 2025, and we continue to be encouraged by the progress that they're making. We feel very good about where we're positioned right now. We've got, you know, a fair bit of inventory that we built in advance of our approval in the Newark site. We also feel good about where AJI is in terms of their process as well. Great. If I could just ask, a follow-up question. If you don't mind, could you just provide maybe a little bit of color on where the ASP is and, you know, sort of the unit-to-unit match-up relative to Botox and, you know, or at least where it was in the fourth quarter? If you can continue to provide updates with regard to where the ASP, you know, sits on a relative basis going forward? Sure. Maybe I'll start with the second part, the unit-to-unit. On the unit-to-unit side, if you look at our labeled indication for glabellar lines treatment, it's 40 units of DAXI in the glabella, which is the indicated dose. That has a core amount of active neurotoxin of 0.18 nanograms. If you compare that, to example, for Botox, their labeled indication for glabellar lines is 20 units, which also has 0.18 nanograms. What we have seen in practices is that they are looking to deliver basically the same amount of core neurotoxin that they're used to with other neuromodulators. If you compare it again to the market leader, we're about a two to one. If you look at our pricing of, you know, two vials to every one vial of the market leader, we believe our pricing probably to the practice comes in at anywhere from maybe a 10% premium to a 40% premium depending on where they are, our 2 vials to their 1 vial. That, you know, depends on what they buy for and what level they buy. We've got 4 different levels that practices can buy at with our product, and it has to do with the volume that they purchase at any given point in time. Our internal ASP will fluctuate based on the mix of how these practices buy. It's the same pricing for everybody based on how they choose to buy. again, that volume purchase is gonna vary probably on a quarterly basis. Okay, great. Maybe if I could just ask one final question. Sure. As we think about the, you know, sort of opportunity in therapeutics, how do you expect sort of the launch in therapeutics to compare to the launch in aesthetics? I presume it'll be, you know, quite a bit slower, a little bit more paced, than aesthetics, but just wanted to get maybe a little bit of color on how you're thinking about the uptake in the therapeutics market, I'll jump back in the queue. Thanks. Sure. I've got Dustin here with me. Maybe I'll throw that one over to him. Yeah. I think there'll be a lot of similarities in terms of how we look at learning from our providers in that space and ensuring that we have the key opinion leaders aligned with key clinical insights. Like with cervical dystonia, we will have a preview launch period, which will allow KOLs to kinda hone in on what is that retreatment interval that they'd like to bring back that cervical dystonia patient. As you know, with that disease state, there's a variety of disease progressions that also participate in different units, different dosages, different treatment intervals. I think we'll use our preview strategy similarly in cervical dystonia to kinda leverage those. I think what's unique about obviously therapeutics, but specifically cervical dystonia is obviously the use is fairly concentrated, right? We'll be able to get it in the hands of the KOLs early in preview, build that data set that's required to continue to and kind of increase the confidence in the larger population. With cervical dystonia, 1,000 CD injectors really make up nearly 70% of the overall volume. It's highly concentrated, and we'll focus in those areas first, with our deep strategy as well. Stacy Ku with Cowen, your line is open. Hi. Thanks for taking our questions, congratulations on the progress. Our first question is around the very early, any anecdotal feedback. We understand it's very early, but we appreciate any commentary from the preview program clinicians. We know it's still early for longevity, but any specific commentary on the onset of efficacy or aesthetic feel, appreciate some details. For the second question, we're wondering if you could add any additional details regarding the pacing on how you'll get to each level of aesthetic accounts. Maybe provide some timing or metrics around how you'll expand focus from the 5,000 accounts to the target 10,000-15,000 potential aesthetic accounts. What are the logistics as you move through the initial goals of demand? Thank you. Sure. Stacy, on the anecdotal feedback, we've been very encouraged by what we're hearing from the injectors and from the patients. You know, as you pointed out, we are early. We're, what? 2 months into the preview program, and so it's probably early to get any duration feedback, per se. You know, thus far, the patient response has been very consistent with what we would expect and what we've seen in the clinical trials. Given the size and the scope of our clinical trial program and some of the phase two work that we've done in the area, we would expect that to be very representative of what we're seeing. Again, it's early, but we're encouraged, and it's continued to reinforce that the strategy we've put in place is the right strategy. In terms of the pacing and the timing and the metrics, we're gonna be a little bit more, you know, cautious in terms of what we share for competitive purposes. As you can imagine, it's a very competitive market that is out there. What we did say is we would, you know, go into this preview program for a quarter, and then we would initiate our full commercial launch. We do expect to kick that off in late March. You know, as we've talked previously, we do think that there's a better experience or onboarding process that we can deliver here in our Nashville headquarters. We're gonna have a bias and an affinity to drive people into Nashville as we think that that's gonna yield more stickiness over time. And so that process will start this quarter. Then I think as we get into, you know, kind of our Q1 earnings, we'll be able to give a little bit more information as we'll have a bigger body of evidence. At this time, we're not gonna get into any more specifics around the timing and the metrics other than to say that, you know, we're tracking as planned and as we previously communicated, and that we're gonna kick off our full commercial launch with a bias towards those RHA customers, starting in late March with the training here in Nashville. Thank you. Sure. Thanks. Balaji Prasad with Barclays, your line is open. Hi. Good evening, and thanks for the questions. A couple from me. firstly, with regard to the guidance. Can you help me understand if you still have limited visibility to provide guidance, at least on the filler side? Thought we would see some color around there and maybe your account penetration, expectations for DAXI for the year, one. Two, with regard to the sales force hire, I mean, we know last year that there was widespread challenges across industries to hire labor. Do you still see those challenges? If so, does it mean that you're paying more than the current market prices for these hires? If so, that could help explain some of the OpEx for this year, which seems to be higher than what we had expected earlier. Thanks. Sure. I'll take the first one, and then maybe I'll kick the second one over to Dustin to talk about the sales force hire and then maybe even Tobin on some of the OpEx and what's underpinning that. On the guidance for the fillers, hey, listen, we hear you that we're what? 2 years into our filler launch, and that, you know, we certainly have a lot more visibility. We've been onboarding about 500 accounts a quarter, we've been very pleased with the traction and the growth that we've seen in that market, taking into account seasonality. I think the challenge that we have is we know that DAXXIFY is gonna introduce yet another new dynamic. When the reps were only selling RHA, it was much easier to, you know, estimate and forecast what we thought additional growth might look like. Now those same reps are gonna circle back, and they're gonna be the ones that will be introducing DAXXIFY into those accounts. In the near term, we may, although we're not sure, we may see a slowdown in new account adds, for example. However, there's certainly also some accounts that we've not been successful in getting a foothold in, but DAXXIFY might open that door, so we might see some of that as well. We have, you know, roughly 50 new salespeople that we're gonna be adding in Q2 that we expect to be fully up and running by Q3. We have a couple of crosscurrents this year that's just really hard for us to know exactly what we think that RHA profile is gonna look like. But again, if you up level it, we feel very good about our ability to grow RHA this year. We feel very good about our ability to launch DAXXIFY into the market. We believe we've got the right strategy. As I mentioned earlier, we believe that we can drive our U.S. aesthetics franchise with the products and services that we have to, you know, over $1 billion in revenue over time on an annual basis. Dustin, why don't you comment on the hiring process? Thanks, Mark. I mean, if we look back at kind of the hiring we've had to do in the past, right? Two years ago, we were hiring a large sales force for a new product, a dermal filler, in the middle of COVID, without kind of a track record for success, commercial execution, so a new entrant into the market. We were successfully able to hire that and recruit the individuals that were able to deliver outstanding results the past two years. Now we're in a very different situation with the approval of DAXXIFY, the progression of our services strategy alongside the success of RHA. We have been very, very pleased with the talent that is coming in for the kind of the hiring, both for the managers as well as the hiring events for the sales force. We've been excited about those that have had experience in the space as well as those outside that are encouraged about the opportunity we have in front of us. From a compensation perspective, we are at market rates. We haven't had to, as you mentioned, significantly increase the package based off of the environment. We obviously have competitive rates with the market. I don't know, Mark, do you wanna turn it over to Tobin on the OpEx side? Yep. Tobin? Sure, sure thing. You know, you know, as we talked about during the prepared remarks, you know, our non-GAAP OpEx was $267 million for 2022, and that was in line with the midpoint of our guidance range of $260 million-$280 million for 2022. If, you know, if there is any, you know, additional compensation for the sales reps, it's earned compensation for over-delivery on their commissions. We, you know, we feel pretty good about the guidance we gave and the delivery. You know, when we exceeded our GAAP OpEx, that was related to the non-cash charges that we talked about in the prepared remarks. I mean, as Balaji, as it relates to this year versus last year, you know, we've got obviously therapeutic that we're starting to ramp up for. We've got some supply chain investments that we're making. We've got the biosimilar to Botox. We have a number of initiatives that are, you know, outside of the standard normal aesthetics operating model. We think those are the right investments to be making at this point. We feel we're in a very good cash position to launch DAXXIFY and have the right priorities. Those are some of the things that are driving... Certainly, sales force expansion is adding to that, but it's some of those other factors that are driving the increased spend. Thank you. Sure. Tim Lugo with William Blair, your line is open. Hey, guys. This is Lachlan on for Tim. Thanks for taking the question. I guess I was wondering if you could just elaborate on the Q4 numbers and, you know, was that purely just the sales to the 400 accounts in Q4, or were there any, you know, one-time events that added to that? Just trying to think about, you know, setting my expectation for a sort of a run rate, heading into early 2023. May have missed this in the prepared remarks, but can you just talk about the plans for hiring the therapeutic sort of field team and, you know, when you would expect to be doing that and how big it is? Sure. I'll take the first one, maybe kick the second one over to Dustin Sjuts. On the Q4 numbers, you know, most of the DAXXIFY revenue that we generated, I think that's what you're referring to, came as a result of the 400 preview accounts that we onboarded in December. You know, that group bought the product to take advantage of what was one of the, you know, the busiest times of the year and the fact that they were gonna be some of the early ones to actually get the product, and therefore had a sort of a window of time to be one of the few people in their area that had it. You know, it's hard to know, given that we're only two months into the launch with that group, to know how that's going to settle out in terms of overall usage going forward. I know we got a lot of questions when we did our pre-announcement in early January around, is it stocking? You know, is this usage? It's not stocking in the traditional sense that there was no middleman or third party. It, you know, reflects what those accounts thought that they were gonna be able to use in whatever timeframe they thought. There are incentives in our purchasing program where if you buy more volume at the time of purchase, you do get better pricing. There might have been some folks that were trying to get better pricing, but it's still early. I come back to we're very encouraged by what we're seeing in the market, but it's hard to really know with that, you know, initial 400 group how that's gonna inform the behavior of the future accounts going forward. I'll take the therapeutic side. We currently have the GM of therapeutics, the market access head, and the head of marketing in place. If you look at kinda as we progress towards that PDUFA date and anticipated approval, we'll continue to expand kind of the market access efforts as well as our medical affairs efforts, aligned with our preview strategy and look forward to kinda updating you more on the field sales sizing and others, as we get closer to that date. Terence Flynn with Morgan Stanley, your line is open. Great. Thanks so much for taking the questions. I guess, you know, the first one is, I'm just trying to understand the comments around the Nashville training center in terms of the second phase of the rollout here. Are you implying that there's gonna be a bottleneck in terms of the number of people that you can actually bring to Nashville and flow through that site? The second question was, I know in the past you've talked a lot about the, you know, having a differentiated strategy because you have both RHA filler and that and then now DAXXIFY. Latest thoughts or color on a potential bundling strategy, and how that might be rolled out over the course, back half course of the year? Thank you. Sure. Terence, on your first question around Nashville and bottleneck, we think there's a proper way to onboard accounts, which is to engage them at a deep level to make sure that we've shared all the learnings that we have from some of the folks around how they message this to patients and we think Nashville is the right way to do that. There's no doubt that we have a limit to how many people that we can ultimately run through Nashville in any given training standpoint, but we are investing in building out more capacity here in Nashville. We are also going to explore virtual training options as well with a bias towards Nashville. I would look at this more of a, you know, thoughtful, measured rollout, versus necessarily having any bottlenecks that we don't think we can work our way through. I think that the first phase, given that we're just kicking off the commercial launch with a, you know, focus on Nashville is the right way to go and is the right long-term strategy. Again, we'll continue to look at ways that we can build out more capacity, here in Nashville. Then, you know, like I said, also with the virtual training options. As we get deeper into the launch, I think the collective learnings, will allow hopefully for, you know, more of a rapid onboarding. Realize too that, you know, exposing somebody to DAXXIFY is step one. The step two is the field salespeople need to schedule time to go into that practice, bring samples, set up a DAXXIFY day. There's some logistics as well that will play into this on the back end with our sales reps and why we think it's important to add to that group. We look at this less of a bottleneck and more as what we think is a very thoughtful and responsible way to onboard accounts with the goal of driving longer term stickiness. In terms of now that we've got, you know, both a toxin and a filler and bundling and different things, we will of course look at ways over time to reward customers that lean in more with us. Right now, our strategy is very much, you know, giving accounts sort of a democratic way to buy and get best pricing, whenever they purchase our product. Certainly over time, we will look at ways to, you know, find partnerships that make sense because we do have both a toxin and a filler. We think in the near term, having both of those will open doors for us and give us an opportunity to ask for more business, either on the toxin side or on the filler side, if, for example, we have strength in one of those areas but not the other. Douglas Tsao with H.C. Wainwright, your line is open. Hi, good afternoon and thanks for taking the question and congrats on the progress. Sure. Maybe as a starting point, on therapeutics, Mark, should we think that the addition of Vlad Coric to the board is a signal of renewed interest in starting a migraine program? Yes, I wouldn't overly read into it. I mean, we're looking at continuing to add expertise to the board that we think is gonna be really good for our overall business. If you look at Vlad's background and the experience that he has in, you know, he's an MD, so adding an MD to the board makes a lot of sense. He comes out of clinical practice, and then he's got, you know, extensive experience in the overall pharma space with a focus on neurology. I think he can help us think through a lot of our strategy around indication expansion, go-to-market strategy in those markets and a variety. I wouldn't overly read into it. I just think, you know, we're fortunate to have Vlad join the board. Of note too is wife's a dermatologist, so he also will get the aesthetic side of the business. Obviously somebody with his experience and the success that he's had in the market is gonna be another important voice around the board table, and we're excited to have him as part of the team. Yeah, no, I mean, I have to say, I think his experience speaks for itself, and he's a great addition. Also on therapeutics, maybe just talk about the planned sort of rollout of NCD. Obviously, it's a much more concentrated market, but it sounds like you're still sort of gonna go through a preview process. I guess maybe talk a little bit about how it will sort of differ from or similar as well as differ from what you've done in aesthetics. Thank you. This is Dustin. I'll kind of handle that a little bit. I think it's a little early to go into too many specifics on it. I think the similarities are it'll be the key KOLs that are gonna drive kind of that, our ability to build that faculty base to educate the broader market. In terms of the setup, in terms of what we'll be looking for in that disease state, you're gonna be looking at retreatment intervals, right? When would they like to bring those patient back? How are they handling different patient disease states just like they did in the clinical trial with a real world setting, which allows us to have a little bit more freedom for the provider to do what they currently do, right? As you'll remember in our clinical trials, you had specific doses that they were using. Where in clinical practice they may assess the patient, they may know that they've been on a certain toxin, and now they're gonna move them to DAXI, so they have more freedom. We'll leverage that opportunity for real world insights to inform our broader rollout and to educate the faculty. Okay, great. Thank you so much. Thanks. We have time for one final question. Serge Belanger with Needham & Company, your line is open. Hi, good afternoon. Thanks for squeezing me in here. I guess the first question on the DAXXIFY preview program. You had a great start with the initial training of 400 providers in December. Just curious if you kept that pace up through January and February, and I guess how many providers you expect to will have been trained by the time you launch late in the first quarter? Secondly, in terms of therapeutic indications, are there still plans to run a phase III program in upper limb spasticity, and when could that get underway? Thanks. Great, Serge. On the DAXXIFY preview program, hopefully we didn't miscommunicate on this, but the plan all along was to run the preview program for a quarter with a select small group of injectors, and that's 400. We've not added any additional accounts since we did the program in December, where we onboarded, you know, roughly 400 accounts as part of preview. The whole goal there was to get experience in a very controlled setting to figure out, you know, what insights we can glean from, again, how they're positioning this with patients, how they're pricing it, you know, how they're using the product, all those things. There have not been any additional, you know, adds as part of the preview program. The full commercial launch will now commence in late March, again, with a focus on in-person Nashvi lle training. That will kick off now the full commercial launch. You know, we look forward to getting that underway in late March with a focus on our existing RHA accounts. On the therapeutic indication side, you know, we've mentioned in our prepared remarks that our goal is to use the cervical dystonia approval to build clinical experience that will help inform our, you know, future therapeutic strategy. We think we'll learn a lot in this small number of concentrated accounts that are used to dealing with, you know, a number of these muscle movement diseases. You know, cervical dystonia will inform a lot around, again, what Dustin was mentioning previously, you know, what is the patient response? How often do they bring them back? Are they seeing greater symptom relief during that timeframe between when they bring them back? How we think that plays. Based on that information, I think that will give us a lot more clarity about what other indications we wanna prioritize, how aggressively will we wanna go after them. What also the payer engagement and experience is gonna influence that as well. Okay, one last one. I know the focus is on the U.S. launch, but have you given any more thoughts to European plans for DAXXIFY? Thanks. Thanks. Yeah, right now, we feel like we've got more than we can bite off with the U.S. launch. It's the biggest market. We've got an established field force. We've got over 5,000 accounts we've got relationships with. The pricing is the best in this market. That's gonna be our focus for now. There's no doubt that the international market opportunity provides us with additional growth opportunities as we go forward. We'll be very thoughtful about how we move into some of those markets as we move our way through. Stay tuned. But for now, and certainly for, you know, 2023, our primary focus is gonna be on the U.S. Great. Thank you. Great. I think that's the close. Yep. Go ahead, operator. This concludes Revance Therapeutics' fourth quarter and full year 2022 financial results and corporate update conference call. We thank you for your participation. You may now.
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