Revance Therapeutics, Inc.

Q3 2022 Earnings Conference Call

11/8/2022

spk02: Welcome to the Revance Therapeutics third quarter 2022 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question during the session, you will need to press star 1-1 on your telephone. As a reminder, this call is being recorded today, Tuesday, November 8, 2022. I would now like to turn the conference call over to Jessica Serra, Head of Investor Relations and ESG for Revance. Please go ahead.
spk05: Thank you, Daniel. Joining us on the call today from Revance are Chief Executive Officer Mark Foley, President Dustin Suits, and Chief Financial Officer Toby Schilke. During this conference call, management will make forward-looking statements, including statements related to our regulatory submissions and approvals, consumer preferences and behavior, the benefits to us, practices and consumers of a product, 2022 guidance, cash flow breakeven, future capital expenditures and capital allocation plans, our ability to draw on our debt, our ability to effectively compete, our blockbuster and growth potential, the supply and manufacturing of Daxify, the impact of economic headwinds on our business and consumers, and our strategy, planned operations, and commercialization plans and timing. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our quarterly report on Form 10-Q filed with the SEC today, November 8, 2022. Remance undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. With that, I will turn the call over to Mark Foley, Chief Executive Officer of Remance. Mark?
spk11: Thank you, Jessica. Good afternoon, everyone, and thank you for joining our third quarter 2022 financial results conference call. The third quarter of this year marked an inflection point for the company, given the FDA's approval of Daxify, the first and only long-acting peptide-formulated neuromodulator for glabellar lines. This significant milestone positions Revans as the innovation leader in facial injectables and will enable us to realize our blockbuster potential in the U.S. aesthetics market. We're also providing the foundation for our SPLA submission for cervical dystonia, our first therapeutic indication. Further, upon Daxify's approval, we closed the $230 million follow-on offering which bolstered our balance sheet and positions us to launch Daxify from a position of strength. The third quarter was also strong from a commercial standpoint, as we delivered record RHA revenue of $26.1 million, representing a 43% year-over-year increase despite broader economic factors. Our solid performance in the quarter reflected our continued market share growth and the successful launch of RHA Redensity, which Dustin will cover later in the call. Enthusiasm for Daxify continues to be very strong, as evidenced by the over 1.1 billion impressions from earned media post-approval, along with the countless inquiries we continue to receive from injectors and consumers. Daxify's 24-week media duration, unique peptide formulation, and strong value proposition have all been highlighted as key drivers of interest. we are very encouraged by this high level of engagement and support, which we believe will bode well for the product's uptake and adoption upon launch. Progress is also made on our supply chain as we prepare to bring Daxify to market. We recently filed and received the FDA's acceptance of our prior approval supplement, or PAS, for our dual-source, fill-finish contract manufacturer, Ajinomoto Biopharma, or AGI, based in San Diego, California. AGI is already in the process of building inventory, and we anticipate the FDA's approval of that site in 2023. Recall that we have a wholly owned, FDA-approved manufacturing facility in Newark, California that produces both drug substance and drug product, and we've been building inventory at that site in advance of approval. So, between Newark's existing inventory, production capacity, and AGI's anticipated approval, we believe we are well-positioned to execute on our launch strategy. Additionally, to support our longer-term production needs, we have an agreement in place with an additional contract manufacturer, Lyophilization Services of New England, or LS&E, which will meaningfully enhance our capacity. And as our CMOs come online and as our volume increases, we expect DACtify's cost of goods to decrease over time. Beyond aesthetics, we have long talked about Daxify's compelling opportunity in therapeutics, beginning with cervical dystonia. Cervical dystonia is a painful and disabling condition that affects the muscles in the neck. In our phase three clinical trial, Daxify demonstrated that it was effective and generally safe and well tolerated in reducing the signs and symptoms of cervical dystonia while providing a median duration of effect of 20 to 24 weeks. Neuromodulators are the standard of care for treating cervical dystonia patients, Yet, re-treatment is not allowed by payers prior to week 12. In fact, a published peer-reviewed article in the Journal of Neurology titled, An International Survey of Patients with Cervical Dystonia, reported results from a survey of over 1,000 patients in 38 countries, which revealed that 88% of patients experienced symptom re-emergence between treatment sessions. And notably, the mean time to the re-emergence of symptoms was about 10 and a half weeks. As a result, patients who have symptom recurrence prior to week 12 have to manage without treatment effect. Based on the current treatment landscape, Daxify's differentiated clinical profile and potential to provide significant pharmacoeconomic benefits could represent an important advance in care for patients, providers, and payers. We look forward to bringing Daxify to the CD market and to providing patients with a compelling option. Following the approval of Daxify for 12-dollar lines, we worked hard to finalize and submit our SPLA for cervical dystonia. Our submission is supported by data from our Aspen Phase III Clinical Development Program, which included the Aspen 1 and Aspen OLS studies. We are anticipating a PDUFA date in 2023 and, if approved, Look forward to launching Dactify into the nearly $1 billion U.S. muscle movement disorder market, which includes both cervical dystonia and spasticity. This category also represents the largest single opportunity within the therapeutic neuromodulator market, followed by migraine. The total U.S. market size for therapeutic neuromodulators sits at about $2.3 billion. In short, Dactify is our innovation foundation across aesthetics and therapeutics, allowing for tremendous value to be unlocked over time. Before I turn the call over to Dustin, I'd like to welcome David Hollander as Chief Medical Officer, overseeing clinical development, data science, medical affairs, scientific innovation, pharmacovigilance, and regulatory affairs. David is a proven executive with broad operational experience and someone who has familiarity with both toxins and aesthetics. David will be a strong contributor as we set our eyes on Daxify's commercial launch, our international regulatory strategy and timing, and our therapeutics program following our SBLA filing for cervical dystonia. He will also play an important role in guiding our biosimilar to Botox program. With that, I'll turn the call over to Dustin, who will cover our performance in the third quarter.
spk10: Dustin? Thank you, Mark. I'm very proud of our team for achieving our key priority of getting Daxify approved in addition to driving top-line growth of our aesthetics portfolio. In the third quarter, we expanded our aesthetic accounts across products and services to over 4,500, increased account productivity, and brought RHA redemptivity to market, all in parallel with preparing for the highly anticipated launch of Daxify. Our focused efforts resulted in $26.1 million in RHA sales, representing a 43% year-over-year increase. On a sequential basis, sales were particularly strong as well, up 2% from Q2 despite the impact of traditional seasonality. Recall that Q3 and Q1 are typically slower quarters and as a result are normally down from the prior quarter. Put that all into context, these are solid results that continue to demonstrate our ability to gain share despite broader economic headwinds and seasonality. We introduced RHA Redensity in August and as part of that, conducted multiple training and education programs with top injectors, achieving nationwide reach. Combined with our targeted sales and marketing initiatives, we saw a healthy uptick, supported by consistent and positive feedback from both consumers and injectors. We're very pleased to see that the launch is off to a good start and that the product's unique rheologic properties are being embraced across a number of aesthetic practices. Overall, the RHA collection, which includes RHA 2, 3, 4, and Redensity, has proven to be a valuable and differentiated product line. And with our partnership with Teoxane SA, we anticipate expanding our indications across our existing portfolio, as well as introducing new HA formulations to meet the evolving needs of consumers and providers. Additionally, with the RHA collection, we've built a solid foundation of elite practice partners and a proven 100-plus sales force that is ready to launch DAXify. In looking at our innovative aesthetics portfolio, which includes Daxify, RHA, and Opal, we believe we have a differentiated and compelling suite of products and services that could counter some of the bundling programs of our larger competitors. We remain bullish on the long-term growth potential of the $3.2 billion U.S. facial injectables market, and importantly, where we fit into this opportunity. First, while we cannot predict the impact of current economic environment, this market has historically been resilient. Even during the severe 08-09 financial crisis, neuromodulator sales worldwide declined in the low single digits and dermal fillers in the low double digits before demonstrating a V-shaped recovery. Second, we believe we are uniquely positioned for growth given our proven and resilient business models that is guided by our prestige strategy, our focus on innovation, and our measured approach to commercial launch. This is evident by our solid commercial track record over the past two-plus years since launching RHA without the benefit of a neuromodulator and despite macro-level impacts, including a challenging COVID-19 pandemic. In particular, we believe our strategy has the potential to insulate us from current economic headwinds. To date, we have not yet seen an impact on facial injectable volumes in the accounts that we are calling on, supporting our belief that the consumers in our target segment are amongst the most resilient with discretionary spending. And finally, we are looking to disrupt the market with the launch of our highly anticipated neuromodulator. We are very encouraged by the excitement for Daxify, giving us confidence that disruptive innovations like ours will have a meaningful impact in the market. With that said, let me turn to our launch preparations for Daxify. As we previously noted, we plan to initiate preview our early experience program with a select group of practice partners prior to broad commercial launch. We're looking forward to kicking off this program in December at our national headquarters and expect it to run through Q1 of 2023. Following this, we plan to offer Daxify to our existing elite practice partners. Over the past few months, we've hosted our Daxify launch meeting with the full commercial team, trained our faculty for preview, and enrolled our preview accounts for the upcoming live training sessions. As a reminder, we are taking a thoughtful approach to launching Daxify that is consistent with our strategy for RHS. The purpose of PREVIEW is not to validate the duration of DAXify, as this has been demonstrated in our Phase 3 Sakura program. Rather, PREVIEW is focused on educating injectors on DAXify's innovative formulation while gaining valuable clinical insights through real-world applications for optimizing aesthetic outcomes. In addition, PREVIEW allows us to provide practices with all the necessary tools and training to help them seamlessly integrate this new category of neuromodulator alongside the rest of the Revance Aesthetics portfolio. We believe our holistic approach to preview will set the right foundation for commercial launch and ensure Daxify's long-term success. Turning to Opal, we continue to make progress on adding new accounts, building practice loyalty and customer membership capabilities, and migrating legacy HintMD customers to the Opal platform. Growth processing volume, or GPV, for Q3 was $164 million, of 24.8% year-over-year on a trailing 12-month basis, GPV totaled over $630 million at the end of the quarter. In summary, I'm very pleased with our execution in the third quarter, setting us up for the significant growth opportunities ahead. In the fourth quarter, our focus is to drive deeper penetration of the RHA collection, as well as executing our Preview program. As we move from Preview to broader commercial launch, we will offer a variety of live and virtual training options centered on our two key initiatives, optimizing aesthetic outcomes and practice integration with this novel neuromodulator. With that, I'll turn the call over to Toby to cover our third quarter financials.
spk01: Thank you, Dustin. Total revenue for the third quarter of 2022 increased 46.9% from the same period in 2021 to $29 million, primarily driven by increased sales of the RHA collection. Revenue in the third quarter included $26.1 million of product revenue, $2 million of service revenue, and approximately $1 million of collaboration revenue. Turning to our operating expenses, we continued to execute on our corporate priority of disciplined capital allocation. GAAP operating expenses for the third quarter were $106.5 million. compared to $92.5 million for the same period last year. Excluding depreciation, amortization, and stock-based compensation, our non-GAAP operating expenses were $72.3 million, a 2% increase over the same period last year due to higher SG&A expenses related to the RHA collection of dermal fillers and expenses related to the commercialization of Daxify. Recall, according to GAAP, that we have been expensing manufacturing costs related to DAXify as an R&D cost until a product is approved. Following our approval in September, we began capitalizing the new work manufacturing costs. For the three months ended September 30, 2022, manufacturing and quality expenses decreased compared to the same period in 2021, primarily due to the capitalization of DAXify inventory costs on the condensed consolidated balance sheet. As a result of the ramp up in DAXify commercial investments post-approval and the pull forward of our preview program to December, we expect operating expenses to be on the upper end of our previously announced GAAP and non-GAAP guidance ranges of $375 million to $400 million and $260 million to $280 million respectively. Turning to our balance sheet, we were very pleased to have enhanced our cash position on the heels of the FDA approval with a successful offering of an upsized $230 million follow-on offering. The offering of 9.2 million shares of our common stock raised $215.9 million in net proceeds. We view the strong demand for our stock, even under uncertain economic times, as a reflection of investors' conviction in our growth story that is grounded by Daxify's innovation in both aesthetic and therapeutic application. We plan to use the proceeds with continued focus on disciplined capital allocation to principally fund the commercialization of Daxify, the commercial growth of RHA Collection and Opal, and to begin the advancement of our therapeutics program. Our total cash, cash equivalents, and short-term investments as of September 30th, 2022 or $378.6 million. With our cash balance, the $100 million of additional notes available for issuance through Ethereum Capital, and our anticipated revenues and expenditures, we believe we will be able to fully fund our U.S. aesthetic portfolio, which includes DAXify, RHA, and Opal to cash flow breakeven. Subsequent to the quarter, we received a milestone payment of $7 million before foreign withholding taxes related to the FDA approval of Daxapy from Fosun Pharma. Finally, Revance's shares of common stock outstanding as of October 31st, 2022, were approximately $82.3 million with $90.3 million fully diluted shares, excluding the impact of convertible debt. And with that, I'll turn the call back over to Mark.
spk11: Thank you, Toby. To conclude, I'm incredibly proud of the entire revamps organization for delivering on Daxify's FDA approval, in addition to securing a great label and a great name that will enhance our launch. Additionally, I continue to be impressed with our ongoing commercial execution that led to excellent results for the third quarter. We look forward to our continued momentum, including the commercialization of Daxify and our potential label expansion for cervical dystonia. I remain convinced that we have the right people and strategy in place to leverage our innovative products and drive sustainable revenue growth. Thank you all for participating on today's call, and I look forward to updating you on our progress. With that, I will now open the call up for questions. Operator?
spk02: As a reminder, to ask a question, you will need to press star 1-1 on your telephone. In the interest of time, we ask that you please lend yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. And our first question comes from Chris Shibutani with Goldman Sachs. Your line is now open.
spk06: Great. Thank you very much. Very helpful on the update and good to hear about so much of the progress that you're making. I think a lot of us are trying to understand what the tone and pace of a recovery could look like. I think you've framed well and consistently how resilient the aesthetics markets are during more challenging economic times. But maybe you can help us a little bit with the historical recovery from the recession. Was there an element of procedure volumes, trading up, trading down? What drove those V-shaped recoveries? And if we had to reflect about on the forward here, thinking about 2009 and using that as a proxy, should we expect similar patterns? Or are you seeing something that's distinctly different, particularly with the prestige segment that you're targeting primarily, that could affect the shape and the trajectory of that recovery? Thank you.
spk11: Yeah, Chris, this is Mark. So if you look at the downturn in the 2008-2009 financial crisis, clearly there was a reduction in the number of procedures that was influenced by consumers not being willing to spend in that environment. What's challenging right now is there's no doubt that there are macro and economic factors affecting the consumer. But as we stated in our prepared remarks, we're just not seeing those right now in the accounts that we're calling on. So it's hard for us to speculate sort of what a potential rebound might look like, given that right now we're not seeing an impact in today's market. Now, that's not to say we wouldn't experience some of that going forward, but I think it has to do with, again, we've got innovative products that we're bringing into the market. We're still in our launch phase across all of our different product and services platforms. And with our prestige strategy, we're really targeting those higher end accounts where the customers that go there are less likely to be going there for discounting and couponing and more because they've made a commitment and a decision that this is a practice. So it's really hard for us today to speculate on what you know, a potential recovery might look like, given that we're not seeing an impact in the accounts that we're currently calling on.
spk03: Next question. Thank you. And our next question comes from Ken Cacciatore with Callen.
spk02: Your line is now open.
spk09: Hey, team. Congratulations on continuing to move everything forward. Just wondering, I know you're taking a very, very peaceful approach to this launch and there's a lot going on, but the way that you're looking to train the clinicians and then broaden that, I just wanted to ask specifically on that. Can you give us a sense of how many clinicians will be trained when we enter 2023? I know you're just starting in December. I think you talk about at what point we're going to be transitioning from more of this personal kind of in-house training to broadening to the next level of clinicians. you know, when that might occur. And if you can then also just give a sense of when we may be substantially through the initial four to 4,500 accounts that you have, when should we think that the DAXify launch is kind of fully moving forward? Thanks so much.
spk11: Yeah, thanks, Ken. You know, we've tried to be pretty consistent in our commentary around our launch plans for Daxify. And, you know, we're following the same plan that we did with RHA, where we start in a very controlled limited launch initially, and then we expand to a broader commercial launch. And in prior commentary, we've said that we would use basically, you know, Q4 and Q1 is that, you know, early limited launch. And then by Q2, we would go to full commercial launch. In Toby's comments, we talked about, you know, pulling in the, you know, the preview part of our launch from the beginning of Q1 to the beginning of December. So we're very much on track. We've trained, you know, the physicians that will be part of the faculty for the preview launch program. That group that will be coming on in early December as part of that preview launch will be in the low hundreds number. That group will get experience with the products, again, in a much more controlled environment and setting, and all of those folks will come through our national training centers. We think that that's going to be the best way as part of this early phase of the preview launch. As we move forward, we will offer a variety of different training options to those accounts that we bring on as part of the full commercial launch. Some of that will be national training options. There will be virtual training options. And there will be, you know, in-office or in-practice training options, very similar, again, to what we did with RHA collection. But we think in this first phase, it's very important that we have a much more controlled setting so that we can optimize for, again, you know, clinical outcomes and practice integration as we move forward. So it's a little premature to look at what the introduction into accounts post Q2 looks like, but we do plan to, obviously, you know, work very closely with those accounts that we have an existing relationship with. Again, so it's, you know, preview running starting in early December, running through Q1, full commercial launch in Q2, and we'll update you, obviously, as we have more feedback from that session.
spk03: Thanks so much. Thanks, Ken. Thank you.
spk02: And our next question comes from David Amsell with Piper Sandler, your line is now open.
spk07: Hey, thanks. So just a couple. So first on the Salesforce sizing, can you just remind us when or I guess if you have an expansion of headcount in the cards and talk about some of the criteria for expanding the sales force over time and ultimately targeting a greater number of practices. So that's number one. And then secondly, as you think about the launch for Daxify, help us understand how you're thinking about direct-to-consumer initiatives, not just in 2023, but longer term. I know you have a methodical strategy that you've laid out and a more fulsome launch in the second quarter, getting doctors trained. But at what point do you really go full bore on DTC efforts regarding Daxify? Thanks.
spk11: Thanks, David. Maybe I'll take the second one around DTC and then turn it over to Dustin to talk about Salesforce expansion and sizing criteria, that type of stuff. From a DTC perspective, we've long talked about our prestige strategy really focused at the account level. So we believe that everything that we're doing is focused on the account, the education, the training, and part of our belief there is that they're best positioned to inform that switch discussion with the customer. And so a lot of our tools early on We'll be focused at the practice level to provide them the information that they can then share with their customers about alternative choices that they might want to make. And again, they're also the ones that are going to be making the ultimate pricing decisions around how do they think they should price this in the markets. So as a new product in the market, we will certainly surround the launch with awareness efforts. But in today's environment, you can be a lot more judicious with social media and different digital approaches to create that brand visibility. But our strategy does not rely on a big DTC consumer activation strategy, certainly not at this initial phase because it's going to be much more driven, we believe, at the account level because of the win-win that the product offers. Over time, we'll have to assess sort of how much spend on the marketing side makes sense. But in this early phase, we will certainly support the launch with, again, marketing spend and digital social media, but it will be much more focused at the account level. And then we'll continue to assess that as we move forward. Justin, maybe you want to hit on the sales side of things.
spk10: Yeah, sure. Thanks, Mark. I think, David, we've talked briefly about this previously in terms of how we look at what's the right time, knowing that you will need to expand the sales force at some point. If you look at the strategy that we've had, it is trying to drive as much deep penetration through relationships, value of our products and services with the least amount of counts to continue to grow. meaning we don't have aspirations to go out to call in all those 40,000 accounts in this space. We've talked around trying to get to that 10 to 15,000 account base over time will really allow you to unlock the value for both RHA and DAXY. So now that you have had a sales force of a little over 100 focused with one product, adding in another product, you go through the analysis on the productivity of number of accounts they can call in as well as just kind of overall ranges for revenue for that. And so we are in that process currently, and we'll be looking at kind of at the right time to expand, which would likely be in 2023. And with that expansion, it wouldn't be to the point of where you're going to be rep for rep for those other kind of competitive benchmarks because they're calling on that 40,000 account. So we'll be measured and have a next phase of growth here likely in 2023. Okay. Thank you. Great. Thanks, David.
spk02: Thank you. Our next question comes from Stacy Lee with Stiegel. Your line is now open.
spk00: Hi. This is Stacy calling for Annabelle. Congratulations on the great quarter, and thanks for taking our questions. We wanted to know what kind of metrics you'll be sharing with the launch of Daxify. This will not be a launch to the broad population initially. the number of accounts may not matter. Will you maybe be telling us more about depth of penetration, initial prestige accounts, and reordering rates, or how many accounts trained, vials sold? Just how should we think about the metrics here?
spk11: Yeah, thanks, Stacey. If you look at what we've been doing with RHA, we've talked about the number of accounts that we've been onboarding on a quarterly basis. So this last quarter, over 4,500 accounts. And then obviously on the revenue side, I think it's a little premature to talk about what different metrics that we report on. We want to make sure that when we're putting metrics out there, we have a lot of confidence and that they're not just sort of an anomaly and that they're going to represent the best way to look at the business going forward. So we'll be thoughtful about what we share. Obviously, we're going to have a lot of information as we get into this preview phase, so we'll try and share things that we believe to be useful and helpful and indicative of the trends that we're seeing in the market. But I think it's a little bit early to make any commitments in terms of what exactly that would be.
spk00: That makes sense. Thank you.
spk03: That was very helpful. Thanks, Jason. Thank you. And our next question comes from
spk02: Terrence Flynn with Morgan Stanley. Your line is now open.
spk08: Hi, this is Justin Phillips on for Terrence. Thank you for taking my questions. Just two for me. Are you guys planning to provide revenue guidance for 2023 in conjunction with 4Q earnings? And then any preliminary thoughts you can share regarding the expense outlook for next year? Is 3Q a good baseline to think about the run rate for next year? Thank you.
spk11: Yeah, Justin, this is Mark. I'll take the first one and hand it to Toby for the second one on the expense outlook. You know, in terms of revenue guidance for 2023, I think it's going to be premature as we're just now launching Dactify into the marketplace and we'll want to get, you know, some feedback from the market in terms of how that launch is going and how we should be thinking about it now that we partner it with our filler platform. So 23 is probably a little bit premature. Hopefully, you know, by the time we get to the end of 23, we'll have enough uh you know familiarity with sort of the product and how it's performing in the market where as we look at 24 that that would be a time when probably better for us to be looking at giving some form of revenue guidance and then so they'll let you hit on the expense side yeah if you look at um our trailing 12-month uh non-gap opex we're at about 257 million dollars and we've provided a guidance at the upper end of the 260 to 280 million dollars for the full year 2022
spk01: So I wouldn't, you know, I would take all that into consideration when you start to model out 2022. When you think about 2023, you can think about our commentary on field force expansion and continued investment in DAXify. We haven't given guidance yet on 2023, and we typically do that, you know, as in early 2023 at that point in time.
spk03: Thank you.
spk02: Thank you. Our next question comes from Rohit Bhasin with Needleman Company. Your line is now open.
spk12: Hi, this is Rohit on for Surge. Thanks for taking our questions. Just a couple for me. In terms of pricing for Dactify in the aesthetics and therapeutics categories, how will the pricing for the two categories differ, and how do you plan to maximize shareholder value? And then can you share any feedback on what you've seen on physicians' willingness to go in for in-person training for Daxify, or are you seeing that a virtual format is preferred? Thank you.
spk11: Yeah, so on the pricing side of it, since there's price linkage between aesthetic and therapeutic, there will be alignment between the price that we charge in the aesthetic market and what we charge ultimately in the therapeutic market. And since we're launching an aesthetic, we'll start to develop a baseline of pricing that will have some read-through into the therapeutic side. And so as we get into the marketplace, you know, that will be how we end up informing the overall therapeutic pricing. And then on the second question.
spk10: Yeah, I can take that. In terms of the willingness to train and educate live versus virtually, I think we've shown with RHA we've hosted you know, probably more than two dozen live trainings here at our office with our injection studio, as well as revanche you live and then supported virtual follow ons to that where you get different education components and we doing the same thing for Daxify. So we don't think it's an or it's really an and about having those options. But I'll say that coming to Nashville for Daxify, the live part was not a rate limiter for us choosing the appropriate folks. that we want to put into our Preview program.
spk11: Yeah, and I think part of the reason we were able to move up the Preview program to early December versus early in Q1 is that in reaching out to a lot of these accounts, we found that there was strong interest in actually participating in an in-person session. So we'll have a lot more flexibility as we move through Preview to offer virtual sessions and in practice, but we've been very pleased with the receptivity of this group to want to travel to Nashville for the Preview program.
spk03: Thank you.
spk02: Thank you. As a reminder, to ask a question, you will need to press star 1-1 on your telephone. Our next question comes from Balaji Prasad with Barclays. Your line is now open.
spk04: Hi, this is actually Michaela on for Bellagio. Thanks for taking our questions. Just wondering if you could provide a bit more color on when we can expect to hear more updates on the progress of additional DOXIFY indications for both aesthetics and therapeutics, but outside of cervical dystonia. Thank you.
spk11: From the indication side, as you mentioned, you have cervical dystonia. We filed the SPLA for that. We've also, on the therapeutic side, completed a phase two program for upper limb spasticity. And as a reminder, when we received the CRL, we implemented some austerity measures, so we stopped enrolling additional clinical programs or initiating additional clinical programs. So part of our strat planning for 2023, we're looking at, you know, what additional therapeutic programs are we going to lean in? And 2023, we'll have a little bit more color on that at the beginning of 23 when we start to provide operating expense guidance for the full year. And then on the aesthetic side, we've already done phase two studies in lateral canthal lines and forehead lines and upper face. So there is phase two data that's already out there. And, you know, we'll continue to evaluate the timing and whether or not we want to move forward with, you know, phase three programs in additional aesthetic indications. So that's a TBD as well.
spk04: Thanks so much.
spk03: Great. Thank you. Thank you.
spk02: That concludes our Q&A session and today's conference call. Thank you for your participation. You may disconnect at this time.
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