Revance Therapeutics Inc (RVNC) 2022 Q3 法說會逐字稿

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  • Operator

  • Welcome to the Revance Therapeutics Third Quarter 2022 Financial Results and Corporate Update Conference Call. (Operator Instructions) 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.

  • Jessica Serra - Head of IR & ESG

  • Thank you, Daniel. Joining us on the call today from Revance are Chief Executive Officer, Mark Foley; President, Dustin Sjuts; 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 our products, 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 manufacture of DAXXIFY, 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. Revance undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations.

  • With that, I will turn the call over to Mark Foley, Chief Executive Officer of Revance. Mark?

  • Mark J. Foley - CEO & Director

  • 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 DAXXIFY, the first and only long-acting peptide formulated neuromodulator for glabellar lines. This significant milestone positions Revance 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 sBLA submission for cervical dystonia, our first therapeutic indication.

  • Further, upon DAXXIFY's approval, we closed a $230 million follow-on offering, which bolstered our balance sheet and positions us to launch DAXXIFY 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 DAXXIFY 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. DAXXIFY's 24-week median 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 uptake and adoption upon launch.

  • Progress is also made on our supply chain as we prepare to bring DAXXIFY 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 Aji, based in San Diego, California. Aji 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 Aji'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 LSNE, which will meaningfully enhance our capacity. And as our CMOs come online and as our volume increases, we expect DAXXIFY's cost of goods to decrease over time. Beyond aesthetics, we have long talked about DAXXIFY'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 3 clinical trial DAXXIFY demonstrated that it was effective and generally safe and well-tolerated and 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 retreatment 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 reemergence between treatment sessions.

  • And notably, the mean time to the reemergence of symptoms was about 10.5 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, DAXXIFY'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 DAXXIFY to the CD market and to providing patients with a compelling option.

  • Following the approval of DAXXIFY for glabellar lines, we worked hard to finalize and submit our sBLA for cervical dystonia. Our submission is supported by data from our ASPEN Phase 3 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 DAXXIFY 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 DAXXIFY 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 DAXXIFY'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. Dustin?

  • Dustin S. Sjuts - President

  • Thank you, Mark. I'm very proud of our team for achieving our key priority of getting DAXXIFY 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 Redensity in market, all in parallel with preparing for the highly anticipated launch of DAXXIFY. 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 as ready to launch DAXXIFY. In looking at our innovative aesthetics portfolio, which includes DAXXIFY, RHA and OPUL, 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 model 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.

  • And particularly, 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 DAXXIFY, giving us confidence that the disruptive innovations like ours will have a meaningful impact in the market.

  • With that said, let me turn to our launch preparations for DAXXIFY. As we previously noted, we plan to initiate PrevU, 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 DAXXIFY to our existing elite practice partners. Over the past few months, we've hosted our DAXXIFY launch meeting with the full commercial team, trained our faculty for PrevU and enrolled our PrevU accounts for the upcoming live training sessions.

  • As a reminder, we are taking a thoughtful approach to launching DAXXIFY that is consistent with our strategy for RHA. The purpose of PrevU is not to validate the duration of DAXXIFY, and this has been demonstrated in our Phase 3 SAKURA program while PrevU is focused on educating injectors on DAXXIFY's innovative formulation while gaining valuable clinical insights to real-world applications for optimizing aesthetic outcomes. In addition, PrevU allows us to provide practices of 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 PrevU will set the right foundation for commercial launch and ensure DAXXIFY's long-term success. Turning to OPUL; we continue to make progress upon adding new accounts, building practice loyalty and customer membership capabilities and migrating legacy HintMD customers to the OPUL platform. Gross processing volume or GPV for Q3 was $164 million, up 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 PrevU program. As we move from PrevU 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.

  • Tobin C. Schilke - CFO & Principal Accounting Officer

  • 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 continue 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 DAXXIFY. Recall according to GAAP that we have been expensing manufacturing costs related to DAXXIFY as an R&D cost until the product is approved. Following our approval in September, we began capitalizing the Newark 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 DAXXIFY inventory costs on the condensed consolidated balance sheet. As a result of the ramp-up in DAXXIFY commercial investments post approval and the pull forward of our PrevU 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 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 DAXXIFY innovation in both aesthetic and therapeutic applications. We plan to use the proceeds with continued focus on disciplined capital allocation to principally fund the commercialization of DAXXIFY, the commercial growth of RHA Collection in OPUL and to begin the advancement of our therapeutics program.

  • Our total cash, cash equivalents and short-term investments as of September 30, 2022, were $378.6 million. With our cash balance, the $100 million of additional notes available for issuance through Athyrium Capital and our anticipated revenues and expenditures, we believe we will be able to fully fund our U.S. aesthetics portfolio, which includes DAXXIFY, RHA and OPUL 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 DAXXIFY from Fosun Pharma. Finally, Revance's shares of common stock outstanding as of October 31, 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.

  • Mark J. Foley - CEO & Director

  • Thank you, Toby. To conclude, I'm incredibly proud of the entire Revance organization for delivering on DAXXIFY'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 DAXXIFY 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?

  • Operator

  • (Operator Instructions) And our first question comes from Chris Shibutani with Goldman Sachs.

  • Chris Shibutani - Research Analyst

  • Great. 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-shape 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?

  • Mark J. Foley - CEO & Director

  • 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 challenged right now is there's no doubt that there are macroeconomic 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 the 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 was a practice. So it's really hard for us to-date to speculate on what a potential recovery might look like given that we're not seeing an impact in the accounts that we're currently calling on.

  • Operator

  • And our next question comes from Ken Cacciatore with Cowen.

  • Kenneth Charles Cacciatore - MD & Senior Research Analyst

  • 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 can 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, when that might occur? And if you can then also just give a sense of when we may be substantially through the initial 4 to 4,500 accounts that you have, when should we think that the DAXXIFY launch is kind of fully moving forward?

  • Mark J. Foley - CEO & Director

  • Yeah. Thanks, Ken. We've tried to be pretty consistent in our commentary around our launch plans for DAXXIFY. And 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 our broader commercial launch. And in prior commentary, we said that we would use basically Q4 and Q1 is that early limited launch. And then by Q2, we would go to full commercial launch. In Toby's comments, we talked about pulling in the PrevU part of our launch from the beginning of Q1 to the beginning of December.

  • So we're very much on track. We've trained the physicians that will be part of the faculty for the PrevU launch program. That group will be coming on in early December as part of that PrevU launch will be in the low hundreds number. That group will get experience with the product, again, in a much more controlled environment in 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 PrevU 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 -- there'll be national training options. There'll be virtual training options, and there will be 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, 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 work very closely with those accounts that we have an existing relationship with. Again, so it's PrevU 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.

  • Operator

  • And our next question comes from David Amsellem with Piper Sandler.

  • David A. Amsellem - MD & Senior Research Analyst

  • So just a couple. So first, on the sales force 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 overtime and ultimately targeting a greater number of practices. So that's number one.

  • And then secondly, as you think about the launch for DAXXIFY, 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 DAXXIFY?

  • Mark J. Foley - CEO & Director

  • Thanks, David. Maybe I'll take the second one around DTC and then turn it over to Dustin to talk about sales force expansion and sizing criteria, that type of stuff. So 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 will be focused at the practice level to provide them the information that they can then share with their customers about alternative choices that they may 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 market. 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. Dustin, maybe you want to hit on the sales side of things.

  • Dustin S. Sjuts - President

  • Yeah, sure. Thanks Mark. I think, Dave, 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 accounts to continue to grow, meaning we don't have aspirations to go out to call on all those 40,000 accounts in this space. We've talked around trying to get to that 10,000 to 15,000 account based over time will really allow you to unlock the value for both RHA and DAXXI.

  • And 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're 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 accounts. So it will be measured and have a next phase of growth here likely in 2023.

  • Operator

  • Our next question comes from Stacy Lee with Stifel.

  • Stacy Lee

  • This is Stacy calling for Annabel. Congratulations on the great quarter. We wanted to know what kind of metrics you'll be sharing with the launch of DAXXIFY. This will not be a launch to the broad population initially, so the number of accounts may not matter. Will you maybe be telling us more about depth of penetration in initial prestige accounts and reordering rates or how many accounts trained (inaudible) sold? Just how should we think about the metrics here?

  • Mark J. Foley - CEO & Director

  • Yeah. Thanks, Stacy. 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 we're putting metrics out there. We have a lot of confidence in 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 PrevU 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 will be.

  • Operator

  • And our next question comes from Terence Flynn with Morgan Stanley.

  • Justin Phillips

  • This is Justin Phillips on for Terence. 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?

  • Mark J. Foley - CEO & Director

  • Yeah. Justin, this is Mark. I'll take the first one and then hand it to Toby for the second one on the expense outlook. In terms of revenue guidance for 2023, I think it's going to be premature as we're just now launching DAXXIFY into the marketplace, and we'll want to get 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 with our filler platform. So '23 is probably a little bit premature. Hopefully, by the time we get to the end of '23, we'll have enough 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 getting some form of revenue guidance. And then Toby, I'll let you hit on the expense side.

  • Tobin C. Schilke - CFO & Principal Accounting Officer

  • Yeah. If you look at our trailing 12-month non-GAAP OpEx, we're at about $257 million, and we've provided a guidance at the upper end of the $260 million to $280 million for the full year 2022. So 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 DAXXIFY. We haven't given guidance yet on 2023, and we typically do that in early 2023 at that point in time.

  • Operator

  • Our next question comes from Rohit Bhasin with Needham & Company.

  • Rohit Bhasin

  • This is Robin, on for Serge. Just a couple for me. In terms of pricing for DAXXIFY in the aesthetics therapeutics categories, how will the pricing for the two categories differ? And how do you plan to maximize shareholder value? And then can you just share any feedback on what you've seen on the physicians' willingness to go in for in-person training for DAXXIFY or are you seeing that a virtual format is preferred?

  • Mark J. Foley - CEO & Director

  • Yeah. So on the pricing side of it since there's price linkage between aesthetics and therapeutics, 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, that will be how we end up informing the overall therapeutic pricing. And then on the second question.

  • Dustin S. Sjuts - President

  • Yeah, I can take that. In terms of the willingness to train and educate live virtually, I think we've shown with RHA, we've posted probably more than two dozen in live trainings here at our office with our [injection] studio as well as [RevanceULive] and then supported virtual follow-ons to that, where you get different education component, and we're doing the same thing for DAXXIFY. 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 DAXXIFY, the live part was not a rate limiter for us choosing the appropriate folks that we want to put into our PrevU program.

  • Mark J. Foley - CEO & Director

  • And I think it's part of the reason we were able to move up the PrevU 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 have a lot more flexibility as we move through PrevU 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 PrevU program.

  • Operator

  • (Operator Instructions) Our next question comes from Balaji Prasad with Barclays.

  • Makeela

  • This is actually [Makeela] on for Balaji. Just wondering if you could provide a bit more color on when we can expect to hear more updates on the progress of additional DAXXIFY indications for both aesthetics and therapeutics, but outside of cervical dystonia?

  • Mark J. Foley - CEO & Director

  • From the indication side, as you mentioned, cervical dystonia, we filed the sBLA for that. We've also on the therapeutics side, completed a Phase 2 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 what additional therapeutic programs are we going to lean in, in 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 2 studies in lateral canthal lines and forehead lines and upper face. So there is Phase 2 data that's already out there, and we'll continue to evaluate the timing of whether or not we want to move forward with Phase 3 programs in additional aesthetic indications. So that's a TBD as well.

  • Operator

  • That concludes our Q&A session and today's conference call. Thank you for your participation. You may disconnect at this time.