Good morning, and welcome to the Revance 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 one on your touchtone cell phone. As a reminder, this call is being recorded today, September 8th, 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, Olivia. Good morning, everyone, and thank you for joining our conference call to discuss the U.S. FDA approval of DAXXIFY, the brand name for DaxibotulinumtoxinA-lanm for injection. Joining us are Chief Executive Officer Mark Foley, President Dustin Sjuts, and Chief Financial Officer Tobin Schilke. The press release announcing the approval issued earlier today is available on our corporate website and contains the indication statement for DAXXIFY as well as important safety information. The product label and full U.S. prescribing information for DAXXIFY are also available on our website. During this conference call, management will make forward-looking statements, including statements related to our cash runway, financing plans, business strategy, planned operations, manufacturing plans, commercialization plans and prospects, the launch of DAXXIFY, the needs and behavior of consumers and practices, the potential benefits to consumers and practices of DAXXIFY, including the economics of DAXXIFY, the differentiation of DAXXIFY, the timing related to regulatory approval and submissions, the market opportunity for and market impact of DAXXIFY and our product candidates, our growth potential, and our plans in therapeutics. 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 this section titled Risk Factors in our current report on Form 10-Q filed with SEC on 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 expectations. With that, I will turn the call over to Mark Foley. Mark? Thank you, Jessica. Good morning, everyone, and thank you for joining us to discuss Revance's first drug product approval, DAXXIFY, the first and only long-lasting peptide-formulated neuromodulator for the treatment of moderate to severe glabellar lines or frown lines in adult patients. With a median duration of six months and up to nine months for some patients, as supported by its approved label, DAXXIFY is the first U.S. FDA-approved peptide-formulated neuromodulator positioned to disrupt the multibillion-dollar neuromodulator market. We are very proud and thrilled to have DAXXIFY anchor our innovative aesthetics portfolio, which also includes the RHA® Collection of dermal fillers and the OPUL Relational Commerce platform. With our compelling combination of neuromodulator, dermal filler, and aesthetic fintech services, we look forward to building on our commercial success and accelerating our growth in the years ahead. Today's approval marks the culmination of decades of pioneering research and development and unwavering perseverance from the entire organization. I would like to thank the entire Revance team, past and present, for supporting our journey, and importantly, for getting us to this critical milestone of approval. Our gratitude also extends to the patients, investigators, investors and partners who have made this moment possible. The FDA's approval of DAXXIFY is a seminal achievement for the company for several reasons. First, it positions Revance as the innovation leader in the facial injectables market and provides us with the opportunity to disrupt the large and established U.S. neuromodulator market. Second, it significantly enhances our ability to create a new prestige segment in the facial injectables market. Third, we believe it is the gateway to our therapeutics potential, which I will cover later in the call. As I mentioned earlier, DAXXIFY is setting the new standard for neuromodulator formulation with a median duration of effect of 24 weeks or six months and up to nine months for some patients. As many of you know, the neuromodulator market has remained largely unchanged for over 30 years and is ripe for innovation. While new products have entered the market, they all have similar formulations and performance profiles, delivering a median duration of effect of 12-16 weeks or three-four months. Therefore, in order to maintain year-long results, consumers frequently need to seek treatment 3-4 times a year. However, based on market data and our own research, we found that on average, consumers get injected less than two times a year, which can lead to gaps in treatment effectiveness. For these reasons, and based on our data, we believe that duration is the greatest unmet need for both consumers and physicians seeking a neuromodulator treatment. In fact, according to our market research, approximately 86% of physicians surveyed want a longer-lasting neuromodulator, and 88% of consumers surveyed considered duration to be essential. DAXXIFY therefore provides a compelling alternative to existing products with the ability to deliver year-long results with as few as treatments per year. Importantly, DAXXIFY does not rely on a higher amount of core active ingredient. It uses 0.18 nanograms of core active neurotoxin in the 40-unit labeled indication for glabellar lines, which is similar to the amount of core neurotoxin found in other neuromodulator products for the same indication based on published data. In addition to long duration, our clinical data demonstrated a median time to onset of just two days, with some patients seeing results as early as 1 day after treatment. Moreover, our clinical data demonstrated high rates of patient satisfaction of 95% and 96% in SAKURA 1 and SAKURA 2 respectively at week 4 of treatment. Now let's turn to our label. Given that DAXXIFY is the first and only peptide-formulated neuromodulator with long-lasting results, we worked closely with the agency to align on a label that reflects the duration profile of DAXXIFY by including the full clinical data set. We are very pleased with our efforts as we believe we have achieved a differentiated label compared to other neuromodulators. Specifically, DAXXIFY's label contains the full 36 weeks or nine months data from our SECURE clinical trials, representing the largest ever phase 3 clinical program conducted for glabellar lines. Having our full 36 week data in the label is key for three reasons. First, the label includes the two most clinically meaningful pre-specified secondary endpoints. The percentage of patients whose wrinkles were rated none or mild by the investigator and the patient. The inclusion of this secondary endpoint reflects the agency's acknowledgment that it provides meaningful, incremental, and relevant information for treatment success. In this case, the none or mild data reflected in the label provides important duration data that we believe is most reflective of clinical practice. Second, it differentiates our label from conventional neuromodulators as no other neuromodulator approved for glabellar lines in the U.S. has a label that includes 36 weeks of glabellar lines efficacy data. Lastly, we consider the inclusion of the full efficacy data to be more versatile than a descriptive statement of duration. With it, we will be able to make a range of claims supported by the data in the label. To put this in perspective, the last two neuromodulators approved for glabellar lines only contain clinical data in their labels that extended out to 30 and 120 days respectively. Altogether, we believe the full 36-week data set included in our label is the strongest representation of DAXXIFY's efficacy profile. The data in our label shows that we met both our primary and secondary endpoints in the SECURE program. The primary endpoint demonstrates that 74% of DAXXIFY-treated subjects achieved at least a two-point improvement from baseline on both the investigator and subject rating scale at week 4. This endpoint is required by the FDA to demonstrate treatment success at week 4. While the SECURE program was not a head-to-head study against other neuromodulators, these proportions were higher than those reported by any other aesthetic neuromodulator approved in the U.S. that uses this same endpoint. Our more clinically meaningful secondary endpoints were designed and included in the clinical program in order to capture the duration of effect of DAXXIFY. These endpoints measured the proportion of subjects rated as none or mild by the investigator and by the subject, and which demonstrated DAXXIFY's median duration of six months and up to nine months for some patients. As you can see on the investigator none or mild chart in the label, 24 weeks or six months is the first time point when more than 50% of patients lose their none or mild status. Notably, of the last three neuromodulators approved for glabellar lines in the U.S., including DAXXIFY is the only one with a label that includes the clinically meaningful endpoint of proportion of subjects rated as none or mild in wrinkle severity by the investigator and the subject. As I noted earlier, achieving and maintaining a rating of none or mild is most reflective of efficacy in clinical practice and is far and away the most frequently used endpoint in scientific publications regarding neuromodulators. Turning to safety, DAXXIFY has been shown to be generally safe and well-tolerated, with no serious treatment-related adverse events reported in the clinical trials. Further, its safety profile is consistent with other neuromodulator products on the market today. The most common treatment-related adverse events from our pivotal trials were headaches in approximately 6% of the subjects, followed by eyelid ptosis at approximately 2% and facial paresthesias, including facial asymmetry at approximately 1%. The majority of ptosis events were characterized as mild in severity and transient in nature. Moreover, the rate of treatment-related adverse events decreased over successive treatments. DAXXIFY's safety and efficacy data is backed by the largest phase 3 clinical trial ever conducted for glabellar lines, which included more than 2,700 patients and approximately 4,200 treatments. These results have been widely presented in major medical conferences and published in prestigious peer-reviewed literature, including the Journal of the American Academy of Dermatology and the Plastic and Reconstructive Surgery Journal. In summary, we are very pleased with our label as it reflects the rigor and quality of our clinical program, rewards the size and scale of our clinical investment, aligns with our previously communicated label expectations, and reflects DAXXIFY's unique performance profile. Most importantly, we believe that the approved label will provide the necessary foundation for our marketing claims. Taking all this into consideration, including DAXXIFY's innovative formulation, strong label, expected portfolio revenue synergies, and the tailwinds of the broader aesthetics market, we remain bullish on our long-term growth potential. We believe in the blockbuster potential of the U.S. Revance Aesthetics franchise of DAXXIFY, RHA, and OPUL combined, which will be further augmented by DAXXIFY's potential in therapeutics and international expansion. With that, I'll turn the call over to Dustin, who will touch on DAXXIFY's formulation and review the market opportunity and our commercial plans. Dustin? Thanks, Mark. We're thrilled to see Revance in its next chapter of growth with the approval of DAXXIFY. To echo Mark's comments, DAXXIFY is the first neuromodulator to market that addresses duration, which we believe is the greatest unmet need of both injectors and consumers today. DAXXIFY's median duration of six months has been demonstrated across not only our aesthetics clinical trial, also in our therapeutics program. For aesthetics, these include our phase III program for glabellar lines and our phase II studies for upper facial lines, forehead lines, and lateral canthal lines. Our therapeutics trials include our phase III program for cervical dystonia, as well as our phase II trial for upper limb spasticity. We believe the depth and breadth of our data supporting DAXXIFY's duration is compelling and an important differentiator to conventional neuromodulators. DAXXIFY's novel formulation is powered by Revance's peptide exchange technology or PXT. PXT is our proprietary synthetic 35 amino acid stabilizing peptide excipient. We're really excited about this technology and the key advantages that it delivers. First, the positively charged peptide may lead to increased affinity of the neurotoxin to the cell membrane. This could cause the neurotoxin to anchor to its target, which may in turn facilitate increased cellular uptake and may maximize the efficiency of the neurotoxin. Second, PXT reduces aggregation of the toxin molecule and helps prevent adherence of the core neurotoxin to the glass vial surface prior to administration. Finally, the peptide excipient helps to eliminate the need for human serum albumin, making DAXXIFY the only neuromodulator in the market today formulated without human or animal-derived components. Furthermore, DAXXIFY is the only approved aesthetic neuromodulator 100% sourced and manufactured here in the United States. Turning to our market opportunity, today's approval puts Revance at the forefront of a thriving and resilient $3.2 billion U.S. facial injectables market that includes neuromodulator sales of $1.7 billion and dermal filler sales of $1.5 billion. For more than a decade, this market has generally grown at high single- to low double-digit% and has demonstrated resilience both in macroeconomic factors and the COVID-19 pandemic. Growth in the U.S. injectables market is projected to continue at a compound annual growth rate of over 8% as the market remains significantly under-penetrated. Aided by increased awareness, broader acceptance of aesthetic procedures, and greater accessibility to injectors, we continue to see adoption grow at a healthy pace. Importantly, we believe that the new innovations such as DAXXIFY will contribute to increased adoption in the years to come. Looking ahead, U.S. aesthetic neuromodulator market is projected to grow to $2.5 billion by 2026, which represents a compound annual growth rate of 8.6%. Globally, this $3 billion market is expected to grow to $4.4 billion by 2026. DAXXIFY stands to benefit from the commercial foundation we have laid with our RHA® Collection of dermal fillers and the OPUL relational commerce platform. With our perceived strategy, our sales force has delivered well over $130 million of RHA revenue since launch without the benefit of a neuromodulator and despite us launching in the middle of a pandemic. At the same time, we drove increased adoption of our FinTech platform, and for the trailing twelve months into June 30, 2022, achieved gross processing volume of over $600 million. We have relationships with over 4,000 accounts, have a field force over 100, and an industry-leading training and experience center in Nashville, Tennessee. In terms of our manufacturing infrastructure for DAXXIFY, we have our Northern California facility that manufactures both drug substance and drug product. In addition, we have partnerships with two experienced fill-finish contract manufacturing organizations to support our current and future supply needs. To sum it up, we strongly believe that we have the right people, strategy, and commercial foundation to successfully launch DAXXIFY and continue to capture share in the growing facial injectables market. Turning to our commercial plan, our launch strategy will be laser-focused on two areas. First, driving exceptional outcomes, and second, ensuring seamless practice integration. 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 approval, thoughtful training and education will be essential to our launch success. For this reason, we intend to take a measured approach to our commercial rollout. Consistent with our preview program for the RHA® Collection, we plan to allow a select group of our elite partners to gain early hands-on experience with DAXXIFY. Our goal is to educate and familiarize them with the maximum benefits of our novel neuromodulator formulation. With practice in a real-world setting under the guidance of our medical affairs team, these injectors will be learning how to deliver the best consumer outcomes with DAXXIFY. Further, with the completion of preview, these injectors will become our core group of educators and trainers to assist us in our commercial launch. Preview will be initiated shortly at our world-class training and education center in Nashville and is expected to continue through Q1 of 2023, followed by a broader commercial launch, starting with our more than 4,000 current elite practice partners. Practice integration is another strategic focus of ours. Injectors have long relied on their established routines for treating consumers, including their injection techniques, reconstitution methods, treatment pricing, and product selection mix. As a result, coupled with their busy schedules, injectors can have a natural tendency to resist new product adoption, particularly if there's no real incentives for them to switch. With DAXXIFY, the reason to switch is compelling. We plan to leverage not only our unique product attributes, but also lessons learned from prior neuromodulator launches to help practices overcome their barriers to adoption. To that end, we have a holistic approach to practice integration, arming injectors and practices with all the necessary tools and training to make it seamless to learn, use, and market this next-generation neuromodulator to consumers. We believe this approach will help ensure DAXXIFY's long-term commercial success. We've conducted extensive research to understand the evolving pricing dynamics of the neuromodulator market for both practices and consumers. Our research found that the combination of new injectors entering the space, the lack of product differentiation, and wide-scale me-too brand couponing has led to market commoditization that's failed to align consumer loyalty with practices. The end result is status quo for consumers and eroding profits for practices. However, innovation has proven time and time again to be the answer to market commoditization. For this reason, we believe that Revance's exclusive commercial strategy with no advertised pricing, coupled with DAXXIFY's value proposition, will help put the power back in the hands of the provider. In terms of pricing, it's important to note that we have a business-to-business consumer model and do not control DAXXIFY's end price to the consumer. Consumer pricing is determined by a provider's practice and the treatment goals for each patient, and therefore can vary. That said, based on our pricing research, we expect injectors to capture and realize the majority of the incremental value that consumers have indicated they are willing to pay for long-acting neuromodulator. While we do not plan on disclosing DAXXIFY's list price to practices at this point in time, in part due to competitive reasons, we do believe our pricing strategy will be a win-win for all players. Injectors have the potential to enhance their profitability per treatment. Consumers can realize the value proposition of DAXXIFY's long-duration profile, and Revance can leverage a differentiated pricing model to drive adoption that is not dependent on couponing. We are excited and ready to execute our commercial strategy and realize our vision to bring our next-generation neuromodulator to market. Over the course of this past year, the team has refined our launch plan and continued to build strong relationships with key accounts across the country. We believe that we are better positioned than ever to capitalize on the significant opportunity in front of us and build a blockbuster aesthetics portfolio over time. I'd like to thank our entire organization for their unwavering commitment and diligence in preparing for DAXXIFY's launch. With that, I'll now turn the call over to Mark for closing comments. Mark? Thank you, Dustin. As I mentioned earlier, today's approval lays the critical groundwork for us to pursue additional therapeutic indications for our neuromodulator, including cervical dystonia and upper limb spasticity. Cervical dystonia and spasticity represent a combined $1.2 billion global opportunity, 78% of which is in the United States. We have already completed our phase III clinical program evaluating DAXXIFY for the treatment of cervical dystonia, as well as a phase II clinical trial in upper limb spasticity. Given today's approval in glabellar lines, we plan to file the supplemental BLA for cervical dystonia in the coming months with an anticipated PDUFA target action date in 2023, bringing us one step closer to helping patients with debilitating and painful conditions achieve long-lasting symptom relief. In the coming months, we will also be preparing for a supplemental BLA for our contract manufacturing partner, Ajinomoto Bio-Pharma Services or AJI. If approved, AJI would have a dedicated fill and finish line for the manufacturing of DAXXIFY and would serve as our dual source manufacturing partner. We look forward to our partnership as we build out our supply chain to support our anticipated growth. Finally, as a reminder, we ended the second quarter of 2022 with $233.8 million in cash equivalents, and short-term investments. With DAXXIFY's approval, we have cash into 2024, assuming that we elect to draw down the second $100 million debt tranche from Athyrium Capital Management that is now available to us until September 2023. The note carries with it a fixed interest rate of 8.5%. In closing, today's approval creates strong momentum across our business. DAXXIFY is just the beginning for Revance as we look to leverage our novel neuromodulator formulation to continue our growth in aesthetics and therapeutics. We remain committed to driving innovation, meeting the evolving treatment needs of our consumers and healthcare providers, and to creating long-term value for all of our stakeholders along the way. With that, I will now open the call up for questions. Operator? Thank you. Ladies and gentlemen, if you'd like to ask a question at this time, you will need to press star one one on your touch-tone telephone. Please stand by while we compile the Q&A roster. Now first question coming from the line of Ken Cacciatore from Cowen. Your line is open. Hey, congratulations team, a wonderful label, and the name is spectacular. Totally worth the wait, so congratulations on that as well. Just a couple questions on pricing. I was wondering, Mark, if you could get a little bit more nuance. Is this gonna be by level, meaning by kind of volume level, you'll try to segment, maybe any more nuance you can give there. You talk about the launch and a little bit of a control on the launch. Does every early prescriber need to actually come to get trained, or are you gonna go train them, and then talk about how that rolls out to the broader group of the 4,000 accounts that you currently have? Do they need to actually have hands-on training? Just lastly, just a lot of discussion you gave us on the glabellar label. Can you talk about the direct-to-consumer, to what degree all of that can be included and maybe when you are going to turn that on. Thanks so much. Sure Ken. Well, thanks. Obviously, we're equally as excited and are thrilled with the name that we got as well. I'll hit a few of these and then hand some of this over to Dustin to add a little bit of color. On the pricing side of it, I don't know that we're in a position right now to give additional color for, you know, what we indicated were competitive reasons. If you look at the market dynamics, pricing varies across practices based on bundling, volume discounts and a variety of things. We'll provide more insight as we get closer to full launch, but at this point, we're just not gonna give more detail on that. In terms of the launch strategy, why don't I hand that over to Dustin in terms of the phasing and what we sort of see the requirement being in onboarding of new customers. Yeah. Thanks, Mark. Again, Ken, appreciate you recognizing the name. I don't have to say DaxibotulinumtoxinA for Injection over and over again now. We're excited for DAXXIFY. From a re-training requirement perspective, we laid out two priorities. It's not only the outcomes, obviously the needle to skin training and the clinical education, but it's also this idea of how do you integrate a new product like this into your practice across everyone from the front desk to the injector and all the way back to the practice. Our initial phase of that will be live hands-on here in Nashville. We'll have large groups. We'll leverage this unique space to deliver an education program that crosses both of those. After you hit a critical mass into kind of 2023, we'll likely have different options for both live training done via our sales force and medical affairs in the practice, also some virtual options as well as then options here in Nashville. It'll be kind of a component as we kind of phase through this and grab kind of more understanding and kind of involvement with the practices. Yeah. On your third question, Ken, around the label and DTC, you know, as we've noted, we're thrilled with the label that we were able to work out with the agency that includes the full 36 weeks of data, and that provides the foundation for us to market to the duration profile of DAXXIFY, the median duration of six months with some patients seeing results up to nine months. That will obviously help us in our consumer advertising. We certainly do plan to supplement the launch with consumer investment, but certainly in the early phase, it's not going to be dependent on huge DTC spend. Our focus is really gonna be more at the practice level and educating the practices and the injectors, as we believe they're best positioned to offer consumers choice, and to be able to describe the different duration profile of our product. We will absolutely over time raise consumer visibility, but again, our launch strategy doesn't depend on a huge DTC spend, certainly not at this point. Can I add a little color to that on the DTC side? I think what's interesting is that if you look at all the neuromodulators in the U.S. market today, what they're able to say to the consumer is exactly the same. If you change the models and change the logos, you'd have a hard time understanding which product was being marketed to the consumer. That's been over the past 30 years, the same message. For the first time, the consumer now gets a message around a different duration profile as well as a different formulation, and DTC has evolved so much from the days of television advertising to digital and social media. I do think that we are really going to leverage the new environment of DTC around digital information gathering and the uniqueness of an entirely new message to both consumers that are in the clinics today getting these treatments and those that have been sitting on the sidelines. We're excited about that, over the next coming months. Great. Congratulations again. Thanks, Ken. Thank you. Our next question coming from the line of Seamus Fernandez from Guggenheim. Your line is open. Oh, great. Let me echo my congratulations, also getting a lot of good feedback on the name as well. Congrats again. You know, can you guys talk a little bit about how you see, you know, the patients coming into the office, kind of who you see as the first adopters, from a patient perspective, and then the physician practices, you know, it seems like this is gonna be something that practice or practices are actually going to have to have, because it's the first differentiated product. Just from a demand perspective, you guys mentioned AJI, just in terms of the launch volumes, is AJI just kind of back up for the next couple of years, you know, and then, you know, no real worries on supply, you're fully supplied and ready to go all the way through the full portion of 2023? Just wanna kinda make sure that now I'm sure you guys are dialed up and ready to go, but that you also have capacity should the launch go better than expected. Then just the last question. You guys mentioned the, you know, 40,000 potential practices. Just wanted to get a sense of, you know, what percentage of that, you know, over the next two years you actually think you can, you know, sort of market to, from an injector or aesthetic adoption perspective. I believe, you know, just the dermatologists represent a relatively smaller portion of that. What can you guys kind of promote to, and what percentage of sort of BOTOX volume do you think you could potentially access, you know, in those practices by the, you know, let's say over the next couple of years? Thanks, Seamus. Maybe I'll work backwards and hand some of this over to Dustin too. First, on the practice sizing, the 40,000. You know, we've consistently said that we're targeting the top third of accounts, so 12,000-13,000 accounts. As of the end of Q2, we were in 4,000 accounts, and we've been adding roughly 500 new accounts per quarter across products and services. I'm not sure if that's still going to be the right new adoption going forward, given that now that we've got DAXXIFY in the market, we'll obviously be spending time circling back to those accounts. I don't know that we're in a position yet to talk about sort of that trajectory of how do we get from 4,000 to those 12,000-13,000. Obviously, we feel good about the accounts that we're in, and we feel good about our ability to continue to drive both deeper into those accounts and open up new accounts. We've also said that we believe that 1/3 of accounts represents, you know, more than 50% of the facial injectable business. We believe that we'll get access to more than 50% of that market. I think now that we'll be in the market with both toxins and fillers, we'll have to reevaluate sort of our, you know, number of reps that we have out there, number of accounts that they can manage and what that looks like, but these are all, you know, great problems to have. On the product supply and as it relates to Aji, you know, we've long said that our manufacturing facility is not capable of supporting the production volumes that we need to reach the levels that we want, which is why we signed an agreement not only with Aji, but also with LSNE. Both of those partners will be important and critical to supplying the necessary volumes as we move forward. Aji's already been making product, and we're looking forward to getting them online. We will be filing a supplemental BLA to bring that facility online, and that will be important for us to meet demand. Certainly out of the gates, we've got adequate supply based on what we have made, but we will need them to come online over time to make sure that we can service the expected demand. In terms of the practices and to your point, you know, what is likely gonna be significant interest on the practice side of it so that they at least have long-acting as an option to provide patients as buzz starts to build in the community, we do think that that's going to be an important driver of trial and adoption as these injectors do not wanna be left out. They don't wanna have their patients go elsewhere to get treatment, and we do think that that will help drive certainly, interest and adoption over time. In terms of the patient profile, why don't I hand it over to Dustin, on kind of who we see those patients as being in this early phase and going forward. Sure. Thanks, Mark. I'll add just a little bit of color on the practices side. From a consumer patient, as you saw, the unmet need is more than 80% of patients saying that they would want a longer-lasting neuromodulator. We feel like as the provider is confident in how to talk about the product, confident in how to price it, and confident in how to inject it to give that outcome that they're used to, we believe that there'll be compelling reasons that they offer it to all of their patients. Those patients that come in 3-4 times a year, which are not very likely, majority come in two times or even less, both of those consumer segments can benefit from a new neuromodulator that has efficacy such as DAXXIFY in the early time periods as well as the duration profile. I think it's gonna be more about making sure that the practices are confident in delivering that outcome that they're used to, as well as the enhanced outcome with DAXI and how to integrate it. We've seen that's where practices, excuse me, competitors have tripped up in the past, is in this space you get a lot of hand raisers to try products and to dabble, and they soak up a lot of resources and aren't fully versed in the product and sometimes can get a different outcome than what they're used to. Of course, they blame that product, right, instead of their commitment to kind of understanding this new tool in their practice. Our focus is to avoid that dabble, really focus on those that wanna partner with us, align all of our resources as it relates to both marketing, and sales organization around those practices and be a true partner versus having a significant number of folks out there and kind of being agnostic to who has it, that everybody has access to our product. We look forward to kind of rolling that out. We do believe that there's gonna be high consumer demand within the practices at any given point. Great. Maybe just one last question. You know, just in terms of timing of being able to move towards closer to a full rollout, at least in the, you know, let's say the 4,000 practices that you guys have today, is it reasonable to expect that you'll have, you know, sort of the full resources and capabilities to do something like that, you know, let's say by the second quarter of next year, or is it likely to be a little bit later in 2023? I think, Seamus, consistent with what we said previously, we expect to be in this preview phase through Q1 of 2023, and that full launch where we would expand to the broader base would start in Q2. That's the current expected plan that we have in place. Again, similar to what we did with the RHA filler line with a preview program, we think that's the right strategy to ensure, you know, good clinical outcomes and the right practice integration as we move into full-scale launch in Q2. Excellent. Congrats on sneaking in a Wall Street Journal article as well. Thanks, guys. Great. Our next question coming from the line of Annabel Samimy from Stifel. Your line is open. Hi, again, congratulations on this milestone. I just wanna go back to the practice integration a bit. I mean, obviously you've been in the marketplace with RHA for some time, so I imagine you would have gotten a chance to speak to some of your Prestige client base and how physicians might incorporate it from their practice perspective. Do you have any sense how they might do that? Will they be holding both long-acting, short-acting, and then over time offer just the long-acting? Do you have any early feedback from them as to how they might integrate that? When you think about DTC and marketing, will you be helping them market to patients as well? Separately, do you have any sense of how physicians are gonna be incorporating DAXXIFY into the practice from a market perspective, and what the pricing sensitivity of their customer base might be within the prestige client base? Those are a couple questions on cosmetic side. Just really quickly, the prospects for restarting the upper limb spasticity trial and any other therapeutic indications other than CD. Thanks. Great. Thanks, Annabel. Why don't I hand it over to Dustin to handle your first ones around kind of practice integration and how, you know, feedback we've heard from docs in terms of how they'll incorporate it, and DTC and marketing, what we do to help, and then, you know, how we'll just get incorporated from a pricing and positioning. Then I'll hit the therapeutics at the end. On the practice integration side, I think we've long talked about there really being two markets, right? There's a short-acting market, for those that want kinda, that quick Groupon, a la carte kinda toxin model. There'll be practices that wanna offer that, and that's that patient base that they're going after. There'll be others that want to, market to a different patient around kind of, treatment outcomes, not advertising price to try to drive demand. We believe those will go heavier with the long-acting neuromodulator. I don't think there's an expectation where a practice, you know, obviously in the short term is gonna be 100%, you know, long-acting neuromodulator. I think they'll evaluate different patient types and understand kind of where that best value is. I think that will kind of progress over time, as we get into the market and then practices kinda decide how they wanna meet the needs of the consumer. There's certainly going to be likely practices that do both, offer both, and there's some that will lean in and only offer the long-acting neuromodulator. I think it'll kind of be phased over time, because the value again is significant to both the practice, from an efficiency perspective as well as the consumer, and they both had it listed as an unmet need. From a DTC to patients, relative to our practices, yes, our strategy has been not to go out to build brand loyalty to consumers to our brand. We wanna build brand loyalty of consumers to the practices that are our partners, with Revance Aesthetics. That will not only be through our marketing efforts around our products with RHA and DAXXIFY, but also with our relational platform, OPUL, to tie those together to be agnostic to the consumer as long as they are focused on our practices that partner with us. We feel like they will get our brand and be loyal to our brand that way versus trying to drive loyalty without the provider. You mentioned me talking about, you know, the provider putting the choice and the power back in the provider's hands is a strategy that we wanna deploy. Lastly on the pricing, it's a bit hard to speculate. All the research showed that consumers have in both this category and other categories rewarded innovation with price, meaning they are willing to pay for price around convenience and innovation. Depending on the practice, we've heard wider ranges of how they're gonna charge the consumer between 50% and 100% more and vice versa. It's really gonna be dependent on what that practice deems appropriate in their geography. Also remember uniquely to Revance, we do not allow anyone to advertise a specific consumer price. We want the consumer to go and pick practices based off of the outcome that that provider can provide versus picking it based off of price. We don't want them to think that all injectors are exactly the same and so therefore products can be injected at any place and the outcomes are exactly the same. We believe that'll help the practices then decide what is the right price. We do believe it'll likely be an increase to what they're currently paying on a per treatment basis. I'll kick it over to Mark on the ULS side. Yeah, the last thing there on therapeutics, you know, we're excited to be in a position to file our sBLA for cervical dystonia, which will be our first entry into the therapeutics market. In terms of additional therapeutic indications that we might wanna continue to lean into, i.e., a phase 3 in ULS, migraine, you know, we'll provide more color and commentary about that as we move through the back half of the year and into next year. As you know, when we received the CRL, we streamlined our focus and wanted to make sure that upon the approval of DAXXIFY that we could be successful in the aesthetic launch. Obviously with CD coming, we feel like we'll be able to, you know, launch effectively into the therapeutics market and we'll come back to you later once we've had a chance to work through some of the details about what's next on the therapeutic side. Got it. Thanks so much. Congratulations again. Thanks, Annabel. Thank you. Our next question coming from the line of David Amsellem with Piper Sandler. Your line is open. Hey, thanks. Just have a few. First, can you talk about demographic targeting to the extent you're doing any? The reason I ask here is that the last entrant here sort of positioned their product more for millennials or younger patients. With that in mind, I wanted to get your thoughts on how you're thinking about, you know, demographics and which demographic buckets make the most sense in terms of targeting to the extent you're thinking about it in that way. That's number one. Number two is, sorry if I missed this, but can you talk about when it is realistic to think about when we should see the impact of bundling, whether it impacts DAXXIFY or RHA, or both? When do you think that really could start to kick in and help us set our expectations there? Lastly, what's your level of commitment to building out a sales force for cervical dystonia and upper limb spasticity? Just remind us what your thinking is there in terms of commercialization on your own, whether it's gonna be an internal sales force or a contract sales organization or you just partner it outright. Thanks. Thanks, David. I'll let Dustin take the first two around demographic targeting and the impact of bundling, and then I'll hit the one on the cervical dystonia. Yeah. If you look at both this market and other kind of analog markets, when you have a product that you're bringing to market with very entrenched competitors, that's a me too, you have to find your niche. You see that with the current neuromodulators that try to compete against the market leader in kind of the same me too category, not offering any value. They have to pick some sort of marketing segment that they can say that they can win in. You see that across all of the kind of me too neuromodulators trying to pick a segment. With innovation, it opens your opportunity beyond a specific niche and that the unmet need across all patients, young, old, millennials, you know, different skin types, different needs in the face, it's all been about duration being an unmet need. There hasn't been a specific niche that picked that up as, hey, this is more valuable than another. I think comes back to, again, making the practices more confident in this new product and how to deliver it, how they talk to their patients about it. We don't believe that there's going to be some specific demographic around a patient type that'll pick it up faster than the others, because it's the first time these patients, no matter who they are, have been able to be offered a different result than what they have today across all of the neuromodulators or marketing that they get, provided to them. On the bundling, again, it kinda comes down to if you look at the market today, the bundling is really a pricing strategy to be more of a stick strategy that they have kind of developed to where you've got to hit these huge hurdles, and if you don't, you're gonna be penalized, for using other products by pricing. Because again, as a me too product, all they have is price as the value to bundle. What Revance Aesthetics is trying to do is bring products and services that allow us to have deeper relationships and de-lever price. Price shouldn't be the only reason why they stay with the product because you see over time, then there's just more discounts, more coupons. It's got to be about the value you're able to provide. We think out of the gate, a portfolio strategy for value around OPUL, RHA, and DAXXIFY is appropriate, but I don't wanna link that always to, you just have to give a price discount to have stickiness or loyalty from your customers. Right out of the gate, we will leverage, of course, going directly to those elite partners that we've already had. We'll leverage our education platforms and others across the portfolio. Those that have deeper relationships and support of Revance Aesthetics will get more value. The value just won't always be price. I'll turn it over to Mark on the cervical dystonia launch plans. Yeah. In terms of commercial strategy on the therapeutic side, particularly cervical dystonia, which we'll enter the market with initially, obviously, as I've said in my prepared remarks, the muscle movement category in the U.S. is large and we believe a long-acting option for these patients will be well received. Previously, we talked about starting with a direct sales force in cervical dystonia. This will be a small targeted group that will probably be no more than 60 as we start out, and then we'll kind of see where that goes and how we build and grow from there. The mix of rep to support is something that we'll continue to work through, but we do plan to start with a direct sales organization in the U.S. On my prior comments too, we'll continue to evaluate, you know, what comes next on the therapeutic indication side. We're excited to get into the market in therapeutics. As we said, we do plan to file a supplemental BLA later this year and have a PDUFA action date in 2023. All right. Thank you. Great. Thanks, David. Thank you. Our next question coming from the line of Tim Lugo with William Blair. Your line is open. Thank you for the question. I would like to also pass along my congratulations. Quite an accomplishment for the whole team. I understand your all the commentary around pricing so far, but given kind of a combined offering now, should we expect some lumpiness in maybe the fillers as the rollout occurs? Or is this something where, you know, DAXXIFY is just gonna lift the whole product offering as it rolls out? Could you just maybe also talk about expanding the label with additional aesthetic indications, maybe not therapeutic, but the aesthetic indications. I think it took the market leader, you know, maybe 20 years to add crow's feet onto their label. I assume that probably won't take as long for DAXXIFY. Sure. Why don't I start, and then Dustin maybe can add a little bit on that. In terms of, you know, pricing and lumpiness with the bundle, you know, it's hard to tell right now. Obviously, the approval of DAXXIFY gives us a tailwind, and we think it's gonna generate and stimulate more interest on the practice side. Certainly on the rep side of things, they're gonna have to circle back up and focus more on the existing accounts that we're in versus expanding them. It could be a little bit choppy as we go forward, over the next quarter or two. Clearly, obviously, having both of those in the bag longer term, we believe is going to, you know, provide us greater opportunity and growth. More to come as we get into the market, but we believe we've got the right strategy certainly for long-term success. In terms of expanding the label, as you noted, with additional indications, those indications will get added to the label. This will be the one kind of label that we have for DAXXIFY that will cut across all the different indications that we go after. With each new indication, we would expect that there will be a section that is specific to that indication that will be added to the label to describe sort of the clinical trial performance of the product in that indication. That to us makes sort of this initial approval even that much more important. We're thrilled again with the inclusion of the entire data set in the glabellar lines indication, so it will get built on. Dustin, if you wanna add anything. Well, on the label side of things, I think if you look at some of the non-GL indications, we already have data, as you know, from our phase 2 programs in lateral canthal lines, upper facial lines, and forehead lines that inform dosing and allow the medical affairs team to educate utilizing that data. As you mentioned, Tim, there hasn't been others that have expanded their labels as it relates to aesthetic indication based off of kind of the now-known injection paradigms and efficacy in those areas. We'll evaluate that over time, but we feel very good about the data that we have to date across more than just GL from the aesthetic perspective. Then on the kind of RHA side, I think we continue to be pleased. We've got a launch right now of RHA Redensity going on. As you know, we've got ad boards here recently, and we're leveraging Nashville. We'll be hosting our Daxi launch meeting here in Nashville that first week of October. While we have a lot of priorities, there's a lot of pent-up excitement for the future for Revance Aesthetics, and we'll capitalize on that both for RHA and Daxi. Understood, and congratulations again. Thanks, Tim. Thank you. Our next question coming from the line of Balaji Prasad from Barclays. Your line is open. Hi. Good morning, everyone, and congratulations. It's Balaji here. A couple of questions, Mark and Dustin. Firstly, Mark, in your opening comments, you stated that you believe in the blockbuster potential of DAXXIFY in aesthetics. I mean, if I recollect right, this seems to be the first time you're kind of even hinted towards a number for DAXI in the longer run. Can you clarify what do you mean by the blockbuster potential, whether it is U.S. aesthetics alone, and potentially guide us towards the range of time by which you think you can achieve this? Secondly, when Dustin with some of the comments that he had on the $3.2 billion facial injectables market and the neuromodulator sales of $1.7 billion, does it make sense to further segregate the this market into glabellar lines, lateral canthal lines, or is that not meaningful at a clinical level? Thanks. Thanks, Balaji. In terms of blockbuster potential, yes, you are right that that is sort of new, a new statement that we put in there. We're directly referencing what we believe is the potential of our U.S. aesthetics portfolio that includes DAXXIFY, the RHA line of fillers, and- The clinical level. Thanks. Thanks, Balaji. In terms of blockbuster potential, yes, you are right that that is sort of new, a new statement that we put in there, and we're directly referencing what we believe is the potential of our US aesthetics portfolio that includes DAXXIFY, the RHA line of fillers, and the OPUL Relational Commerce Platform. That collection of assets, we believe, has blockbuster potential in the US. It's premature for us to talk about the timeframe, but we do feel very strongly that across that, you know, line of products that opportunity does exist for us here in the US. Certainly, as we get further out into the market and we better understand the adoption dynamics, now having both a toxin and a line of fillers in the market, you know, we'll be better positioned to start giving more clarity about how we think about the timing of that. But where we sit today, we really like where we're positioned and where we think we can take this over time. Yeah, Balaji, this is Dustin. On the segmenting by indication, in aesthetics I don't think that there's value in that. If you think about it from the consumer's perspective, they go in for a look that they want, and the provider then assesses kind of that, and then provides them that outcome. I think the majority of it, I think near half or close to it is in GL. But I think it's highly unlikely. It happens rarely where they'll use one product for one area and a different product for another area or, you know, they get something other than just, you know, GL plus, right? GL is usually the primary start, and then depending on their kind of patient needs, they go beyond that. It's the same with fillers. It's really hard to kind of build a market indication by indication. A little bit easier in the filler side of things because people will come in for one thing like the lips and vice versa. On the toxin side, it's pretty hard to kind of break it out. I think that there's not a smaller market for one or the other. Thanks for confirming, Dustin. I have just one more follow-up for you. In terms of your DTC strategy, at least your focus on building loyalty from the practices perspective, clearly very different, differentiated versus your, peers now. What led to the strategy and what kind of feedback did you have from your Yeah. Thanks, Balaji. I think what led us to the strategy first is when you have innovation, it allows you to kind of relook at a marketplace differently. As I mentioned before, models work for different products, and us doing the same thing that everyone else did and trying to do it better has been the model that others have tried, and you've seen it have, you know, medium to marginal success. With innovation that has something that's different, both with the provider and the consumer, it allows you to look at the market in a different, unique way. Largely, this market over the last 30 years hasn't evolved much in terms of how they market to their patients, how they price. You know, there's been a lot more injectors, but the model's the same. We think that really trying to focus on the provider is the right strategy. I think you've seen the research out there. People don't love these quote-unquote bundle programs. They like the price, of course, but they feel like every time the quota's raised and they have to meet these arbitrary numbers, and it's more of what you buy is the value versus how you're treating your patients, consumers. We've heard that loud and clear. The uniqueness of having Nashville is that we bring them here, and they interact with us in a different way, not just a PowerPoint presentation, one-way discussion. We build deep relationships to understand what they want, ask them questions, ask for the grace to fail on certain things and to improve. It's allowed us to kind of re-hone that strategy, and it's one that's worked with RHA, and we think will continue even more with DAXXIFY and OPUL. Yeah, to build on that, I think practices also understand and see the margin compression in the business. I think as couponing increases and advertised pricing becomes a strategy to engage consumers, it inherently puts pressure on end consumer pricing, which makes it harder for some of these practices to maintain the margin they want. They understand that, and as Dustin mentioned, we've had a chance to sort of trial the strategy, which we believe was the right strategy with the launch of the RHA line. We feel very good with the success that we've seen, you know, frankly, launching it in a pandemic in the absence of a neuromodulator. What we are hearing from the practices is they like the no advertised pricing so that we're not creating a commoditization strategy out in the marketplace, and they appreciate the different and innovative products that we're bringing to the market. We believe this is a winning strategy, and as Dustin mentioned, we have the ability to do this because of the innovation that we're bringing forward, where we can position things a little bit differently. Thank you. Thanks, Balaji. Thank you. Our next question coming from the line of Douglas Tsao with H.C. Wainwright, your line is open. Hi, good morning. Thanks for taking the questions. Maybe just in terms of the preview program, I'm just curious about your capacity and how many docs can you bring through Nashville sort of on a weekly basis? And, you know, what percent does that ever become sort of a rate limiter in terms of your ability to get through preview to targeted accounts? Doug, this is Dustin. I think I have prepared the marketing and training teams to handle a lot of folks here through Nashville, and we've built it purposefully to be able to kind of turn it quickly. We don't feel like it'll be a rate limiter in our early strategy around preview. As I mentioned in previous comments, as we move into 2023 and go broader into our commercial launch strategy, we'll have then a larger group of peers from the preview set that'll be able to help us educate kind of out in the market. You'll have your sales force, medical affairs team, they're able to educate. Then you'll offer different scalable opportunities, whether they be virtual, local, in-market, and then back in here through Nashville. We do think Nashville provides the best experience and the way to go deep with kind of our partnership. We don't feel it'll be rate limiting in the early days, and our strategy then expands into 2023 around how to accommodate more with the information that we've gathered. Okay. Just as a follow-up, just curious, you know, and I think you've mentioned some numbers, but when you think about the broad universe of people injecting neurotoxins today, you know, what percent do you think will be sort of the bulk of your customer base? Because you've always sort of highlighted that you think that you're gonna be a premium product that's not gonna necessarily be relevant for every account that is currently injecting. Yeah, I think Mark spoke to that a little bit earlier too. I think we're gonna target that top third, right? That 10,000-15,000 or so of those accounts that align with the value proposition that we wanna offer, as well as they align with kind of our go-to-market strategy around pricing and value and relationships. 10,000-15,000 is where that is today. We'll evolve and kind of adapt that as we need with the market in time. Okay, great. Thank you. Thanks, Doug. Thank you. Our last question in queue coming from the line of Serge Belanger from Needham. Your line is open. Hi, good morning. Also wanna offer my congratulations. It's a lot more pleasant than talking about 43 observations. I guess a lot of questions have been asked so far, so I'll keep it short. Can you just talk about the level of awareness for the product? When we talk to KOLs, all of them are aware of the product, but I'm sure there's some selection bias there. Maybe talk about that level of awareness, especially in your target 12,000 or 13,000 accounts, whether they're aware of the product and its differentiation. Thanks. Yes, Serge. I mean, a couple comments there. First off, obviously the data's been out there for a while in our clinical trials and the awareness of the long-acting performance profile. At medical meetings, and certainly different advisory board meetings, there's a broad group of clinicians that are certainly aware of the product. However, prior to being approved, there wasn't much that we could do around promotion, nor did it make a lot of sense. The good news is right now we do not believe that getting interest from the injector community is going to be an issue. I think as consumer awareness builds, as practices start to bring this in, we think that we're gonna have more than enough accounts that are certainly gonna want to partner with us and get access to the product. I think the awareness today is certainly high enough to support our initial launch and demand. We believe that, you know, with some of the things that we're gonna do over time, that getting injectors to, you know, have an interest in the product is not gonna be the issue. Yeah, the only thing I also wanna add to that is I think getting people, as Mark said, the hand raisers are already there. We probably have 40,000 emails currently that people are saying, "When can I get product?" This market has shown that they wanna sample it. We've also seen that that is hard to get ROI from all those dabblers, and you need lots of salespeople to go run around and try to kinda manage that. We believe that the awareness in the accounts that we are focused on with our strategy of RHA and OPUL in the portfolio is really high. We're excited about providing them more information. Okay. The training seems to be an important aspect of your preview program, but the training is not mandated by the FDA. Just curious if you expect any injectors to order the product and use the product without training, or is that something you'll try to minimize? Yeah. I think at the beginning we're gonna make sure at all times that they go through our training program, albeit different versions of it, from understanding the clinical data, understanding the formulation, and understanding the injection paradigm. I think when we say the word training in kind of some aspect, it's not as if it's a binary thing. They know how to use these products, but over the last 20 or 30 years, they've tweaked their recipe. They use their current products differently than what is happening in the clinical trial. That's just common in the aesthetic space. That's the artistry part of how they take a product and use it to deliver the specific outcome for the specific patient type for their specific needs. That's what we talk about around the DAXXIFY training. It's not that, "Hey, this is how you have to do this X, Y, or Z." It's giving them that real-world experience and opportunity to understand the uniquenesses and the benefits of this new formulation and how to hone their recipe that they will evolve over time. They will likely evolve their DAXXIFY recipe over the next couple of years. That is what we've seen in all neuromodulators in the past, and that's why we wanna provide an opportunity for them to do that together and for us to benefit from that knowledge. Great. Well, thank you. Thanks. Thanks, Serge. Thank you. I'm not showing any further questions at this time. I would now like to turn the call back over to Mr. Mark Foley for any closing remarks. Thank you, operator, and thank you all for participating on today's call. A special day for Revance, so we look forward to a really bright future. Thank you. Ladies and gentlemen, that does end our conference call today. Thank you for your participation. You may now disconnect.
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