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Edited Transcript of RVNC.OQ earnings conference call or presentation 9-Nov-20 9:30pm GMT

·52 min read

Q3 2020 Revance Therapeutics Inc Earnings Call Newark Nov 10, 2020 (Thomson StreetEvents) -- Edited Transcript of Revance Therapeutics Inc earnings conference call or presentation Monday, November 9, 2020 at 9:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Dustin S. Sjuts Revance Therapeutics, Inc. - Chief Commercial Officer of Aesthetics & Therapeutics * Jeanie D. Herbert Revance Therapeutics, Inc. - Senior Director of IR & Corporate Communications * Mark J. Foley Revance Therapeutics, Inc. - President, CEO & Director * Tobin C. Schilke Revance Therapeutics, Inc. - CFO & Principal Accounting Officer ================================================================================ Conference Call Participants ================================================================================ * Annabel Eva Samimy Stifel, Nicolaus & Company, Incorporated, Research Division - MD * Balaji V. Prasad Barclays Bank PLC, Research Division - Director * Chris Bialas * David A. Amsellem Piper Sandler & Co., Research Division - MD & Senior Research Analyst * Kenneth Charles Cacciatore Cowen and Company, LLC, Research Division - MD & Senior Research Analyst * Kushal Patel Guggenheim Partners, LLC - Senior Associate * Serge D. Belanger Needham & Company, LLC, Research Division - Senior Analyst * Terence C. Flynn Goldman Sachs Group, Inc., Research Division - MD * Timothy Francis Lugo William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Welcome to the Revance Therapeutics Third Quarter 2020 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, this call is being recorded today, November 9, 2020. I would now like to turn the conference over to Jeanie Herbert, Head of Investor Relations for Revance. Please go ahead. -------------------------------------------------------------------------------- Jeanie D. Herbert, Revance Therapeutics, Inc. - Senior Director of IR & Corporate Communications [2] -------------------------------------------------------------------------------- Thank you, Daphne. Joining us on the call today from Revance are President and Chief Executive Officer, Mark Foley; Chief Financial Officer, Toby Schilke; Chief Operating Officer and President of R&D and Product Operations, Dr. Abhay Joshi; Chief Commercial Officer, Therapeutics and Aesthetics, Dustin Sjuts; President of Innovation and Technology, Aubrey Rankin; and Senior Vice President, Clinical Development, Dr. Roman Rubio. Earlier today, Revance released financial results for the third quarter ended September 30, 2020, and top line results from the Phase II trial of DaxibotulinumtoxinA for Injection in plantar fasciitis. If you have not received these news releases or you would simply like to be added to the company's distribution list to receive future releases, please go to the Investor Relations section of the Revance website, which can be found at www.revance.com. During this conference call, management will make forward-looking statements, including statements related to Revance's 2020 financial results and guidance, the current and anticipated clinical development of our product candidates, our business strategy and planned operations, anticipated pre-commercialization and launch plans, the timing of any potential approval of DaxibotulinumtoxinA for Injection by the FDA, financial estimates, the range and degree of commercial acceptance, potential market size, opportunity and growth with respect to the RHA Collection of dermal fillers and the HintMD fintech platform and our product candidates, if approved, and our financial outlook, milestone expectations and expected cash runway and financial performance. 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 the section entitled Risk Factors in our current report on Form 10-Q to be filed this afternoon, November 9, 2020. Revance cautions you not to place undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations. Also on today's call, we will present both GAAP and non-GAAP financial measures, which management believes are helpful to investors to evaluate our recurring operational performance. A reconciliation of non-GAAP to GAAP measures is included in our earnings release, which is available on our Investor Relations website at investors.revance.com. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results. With that, I will now turn the call over to Mark Foley. Mark? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Thank you, Jeanie. Welcome to Revance Therapeutics' Third Quarter 2020 Financial Results Conference Call. This has been a transformational year at Revance despite the challenging environment resulting from the COVID-19 pandemic. In addition to achieving most of our 2020 milestones, we diversified our Aesthetics franchise with 2 strategic transactions, significantly enhanced our cash position, reported out compelling clinical data across several Phase II and Phase III programs and transitioned to a commercial enterprise. In Q3, we successfully launched the RHA Collection of dermal fillers and HintMD fintech platform to the aesthetics market, and we are encouraged by their early traction. We believe that our success to date reflects the strength of the portfolio we've assembled, the quality of our sales organization and our prestige market positioning. We've also laid a strong foundation for our Therapeutics franchise with the recently reported ASPEN-1 Phase III results in cervical dystonia. In a moment, I'll touch on our BLA status, and we'll also go into more detail on our Therapeutics franchise. But before I do, let me hand the call over to Dustin Sjuts, our Chief Commercial Officer, to share with you more details regarding the strong start to our commercial launch. Dustin? -------------------------------------------------------------------------------- Dustin S. Sjuts, Revance Therapeutics, Inc. - Chief Commercial Officer of Aesthetics & Therapeutics [4] -------------------------------------------------------------------------------- Thank you, Mark. As of the third quarter, Revance has officially made the leap from clinical to commercial stage. We are very encouraged with the early results of the commercial launch and the responses from our customers to the RHA Collection and HintMD platform. As such, I am proud to announce that we generated $3 million of sales from products and services in our first partial commercial quarter. The high enthusiasm around the launch gives us great confidence that Revance has assembled the right products and team. In early September, we established and officially introduced Revance Aesthetics, the overarching customer-facing brand for our aesthetics portfolio. Our mission is to give customers an exquisite experience across our product and services portfolio. The Revance Aesthetics portfolio includes: one, the RHA Collection, the first and only hyaluronic acid filler, FDA-approved, for dynamic wrinkles and folds. This designer filler resembles the skin's natural hyaluronic acid and was curated to adapt to facial movement. Two, the HintMD fintech platform, the aesthetic industry's first payments, subscriptions and loyalty platform, engineered to transform aesthetic practices with tailored financial technology. And finally, upon approval, we will add the highly anticipated DaxibotulinumtoxinA for Injection, which is under review at the FDA for the treatment of glabellar lines. Turning to the launch of the RHA Collection. In the third quarter, we completed our PrevU early clinical education and experience program, established RevanceU, our premier injector training and education platform, created and tested clinical messaging, positioning and engagement programs with physicians across the country and launched the RHA Collection Flawless in Motion campaign, hosting nearly 30 national beauty media editors, an exclusive virtual event with Dr. Ava Shamban; Founder and CEO of TEOXANE, Madame Valérie Taupin; and New York Times Bestselling Author and Emmy award-winning television personality, Keltie Knight, generating more than 18 million impressions. We hired our 100-plus field force and completed sales force training necessary to launch the Revance Aesthetics portfolio and successfully integrated the HintMD organization, consolidating into one customer-facing business unit with an aligned vision. Results from all of these initiatives has been positive, setting the foundation for the successful launch of Revance Aesthetics. The PrevU program consisted of more than 100 leading aesthetic injectors who treated approximately 1,000 patients with the RHA Collection. Nearly 3,000 syringes of the RHA Collection, inclusive of RHA 2, 3 and 4 were administered to a variety of patients which helped to inform and enhance our education materials. More than 97% of physicians indicated that the results of the RHA Collection looked both natural while at rest and in motion. Through RevanceU and our sales team, we have trained more than 600 injectors across the country today. Despite the evolving COVID landscape, our team has leveraged face-to-face training efforts as well as a virtual training, utilizing 7 highly experienced trainers from across the globe to provide an interactive training experience. In August, we successfully and safely hosted Revance's first commercial launch meeting with live training for a 100-plus-person sales force, setting a standard for future live events required to commercially launch both the company and a collection of new products and services. As for our results, in September, we began selling the RHA Collection and the HintMD platform in select accounts in the U.S. with initial launch activities generating $3 million in revenues in the third quarter across less than 500 customer accounts. We are seeing orders across all 3 product SKUs, RHA 2, 3 and 4 reinforcing that all 3 products serve distinct needs. Turning to our fintech platform. With the integration of HintMD, we are positioned with a truly unique portfolio. In the last week, we are pleased to report that HintMD has processed $100 million in payment processing to date in 2020. Our initial strategic focus is to offer incremental value to practices through payment processing with touchless smart payments. While we are in the process of prioritizing our platform development pipeline, our goal is to deliver an even better user experience with industry-first features such as a white label loyalty program and an exciting patient-facing subscription experience. As for DaxibotulinumtoxinA for Injection in Aesthetics, having announced top line results in June from our informative Phase II trials in forehead lines and separately crow's feet, we remain poised to announce top line results from our Phase II open-label study in upper facial lines in December. The results from these open-label studies will further inform future aesthetic development programs. In terms of the market and access to customers, facial injectables continue to be in high demand, and players active in the industry are reporting a V-shaped revenue recovery with many returning to pre-COVID levels. Both plastic surgery and dermatology practices are reporting strong demand for procedures led by facial injectables. We're finding most practices have adapted to the evolving COVID environment. Across the portfolio and across the country, our sales team has had access to customers, both face-to-face and virtual with more than 2/3 of interactions being held safely in person. Leveraging the unique power of data across the HintMD platform, we were able to keep our finger on the pulse of the aesthetics market. Interestingly, payment processing over March and April decreased 64% and compared to the prior 5-month average. However, we saw a sharp recovery in May, up 33%, a trend which continued through Q3. Within plastic surgery practices, payment processing levels reached the strongest month on record. Overall, we are very pleased with our initial launch of the RHA Collection and the HintMD platform in the U.S. We deployed a trained sales force, integrated the HintMD offering, engaged world-renowned experts to train our U.S. physicians and executed on the prestige strategy, which has led to strong initial sales performance. The early yields have bolstered our confidence in our people, products and strategy. With that, I'll now turn the call back over to Mark. -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [5] -------------------------------------------------------------------------------- Thanks, Dustin. Now let me address the potential for a delay to our approval associated with our outstanding BLA submission for DaxibotulinumtoxinA for Injection in glabellar lines, which we shared in our third quarter financial release. As reported by several biotech companies, the FDA has been delaying some site inspections and corresponding drug approvals due to COVID-related travel restrictions. With just 16 days to go until our previously announced PDUFA date of November 25, we felt it was appropriate to provide an update on our status. As of today, the FDA has yet to schedule a site inspection of our U.S.-based manufacturing facility in Newark, California. The agency has previously noted that a site inspection is required prior to approval of our BLA. The FDA has also communicated that their ability to conduct inspections is limited based on their COVID-19 related guidance and travel restrictions currently in place. While there's still a chance that an inspection could be conducted prior to November 25, we wanted to acknowledge the possibility that our drug might not be approved on our PDUFA date. At this time, we do not have any additional information and do not plan to elaborate further. We continue to work proactively with the agency to secure an inspection at the earliest possible time. With the strategic transactions we made earlier this year of the RHA Collection and HintMD platform, Revance is more diversified than ever before and less dependent on any single revenue stream. Revance's cash guidance remains unchanged as we continue to project that the company is funded into 2023 due to the puts and takes associated with the new product launch. Should we have a delay to our FDA approval, we believe the company is in an excellent position, both commercially and financially, to weather any change to the timing of a potential approval. We also remain confident in the overall strength of our BLA submission, and we'll continue to work proactively with the agency to complete the necessary site inspection. Now let me turn to our Therapeutics franchise. We were thrilled to announce in October the positive results from our ASPEN-1 Phase III pivotal trial of DaxibotulinumtoxinA for Injection in the treatment of cervical dystonia, which we believe will underpin the next stage of growth for Revance beyond aesthetics. The ASPEN-1 trial met its primary endpoint and secondary endpoints across both doses with high statistical significance and the study revealed a potentially differentiated safety profile with a long duration of effect of 24 weeks. Importantly, we were able to deliver these results with a low dose of active neurotoxin with low adverse event rates, particularly as it relates to dysphasia and muscle weakness. We believe that being able to potentially reduce the number of treatments, along with corresponding practice visits by up to 50% a year is meaningful to patients, caregivers, physicians and payers alike. Based on these results, DaxibotulinumtoxinA for Injection could represent a material advancement in cervical dystonia care and result in significant pharmacoeconomic savings. The ASPEN-OLS, or open-label safety study for cervical dystonia continues with results expected in 2021. Accordingly, we are aiming for regulatory approval for our first therapeutic indication in 2023. Let me remind you that cervical dystonia is a $340 million market, sizable in and of itself but only a portion of the $2.3 billion global therapeutic market for botulinum toxins. In addition to cervical dystonia, we are pursuing another muscle movement disorder, upper limb spasticity, and plan to report results from the JUNIPER Phase II trial in the first quarter of 2021, which brings me to today's plantar fasciitis results. In conjunction with our third quarter earnings release this afternoon, we announced results from our Phase II trial of DaxibotulinumtoxinA for Injection for the management of plantar fasciitis, a painful affliction of the foot. In the trial, both the 80 unit and 120 unit doses resulted in measurable pain relief that was numerically greater than placebo on the Numeric Pain Rating Scale. However, neither dose met the primary efficacy endpoint of statistically significant improvement in the NPRS for foot pain at week 8 when compared to placebo. DaxibotulinumtoxinA for Injection appeared generally safe and well tolerated when injected into the foot. No other neuromodulator has been approved for the treatment of plantar fasciitis, so we were attempting to stake out a first-mover advantage in a new therapeutic category with underlying physiology that is different from existing muscle movement or pain disorders. While we plan to further analyze the data, our primary focus will be on indications where the market and pass-through approval are well-established for neuromodulators. Now with the strong Phase III cervical dystonia data, we can advance our initial commercial planning in Therapeutics, and we're looking forward to reporting the JUNIPER Phase II clinical results for upper limb spasticity in the first quarter of 2021. Combined, these results will help us formulate our clinical strategy in Therapeutics going forward. With that, I'll now turn the call over to Toby Schilke to cover the financials. -------------------------------------------------------------------------------- Tobin C. Schilke, Revance Therapeutics, Inc. - CFO & Principal Accounting Officer [6] -------------------------------------------------------------------------------- Thank you, Mark. Starting with our cash, cash equivalents and short-term investments balance. We ended the third quarter with $436 million, which we believe is sufficient to fund our planned operations into 2023. Revenue for the third quarter of 2020 consisted of $3.8 million, which primarily represents initial orders of RHA Collection of dermal fillers. You will note that our revenues are now broken out into 3 categories on the income statement. During the quarter, product revenues from the RHA Collection was $2.8 million. Collaboration revenues from our Mylan partnership was $0.8 million, and services revenue from the HintMD platform was $0.2 million. For the third quarter, our operating expense was $81 million. Excluding the cost of revenue, depreciation and amortization, stock-based compensation and the RHA related in-process R&D, our operating expense was $65.4 million. The earnings release we issued today outlines our financial results in full, so I'll not go through the details on this call. In terms of our 2020 outlook, GAAP operating expense, including the effects from the HintMD acquisition is expected to be $285 million to $295 million. Non-GAAP operating expense remains in the range of $220 million to $230 million. This excludes the cost of revenue, depreciation, amortization, stock-based compensation and the RHA related in-process R&D. We continue to expect our 2020 non-GAAP non-HintMD research and development expense to be $95 million to $100 million. In terms of future revenue, our policy remains to refrain from providing sales guidance until we can determine the launch trajectory of the RHA Collection and HintMD platform. Finally, Revance's shares outstanding as of October 30, 2020, were approximately 66.5 million shares with 72.4 million shares on a fully diluted basis, excluding the impact of convertible debt. And with that, I'll turn the call back over to Mark. -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [7] -------------------------------------------------------------------------------- Thank you, Toby. Revance is building a powerful aesthetics franchise and has now demonstrated through our positive ASPEN-1 cervical dystonia results, the company's potential to create a similarly strong franchise in Therapeutics. Importantly, we are entering established markets worth a combined $6 billion worldwide armed with the next-generation of products and services. With that, I will now open the call up for questions. Operator? ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Your first question comes from the line of Ken Cacciatore with Cowen & Company. -------------------------------------------------------------------------------- Kenneth Charles Cacciatore, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [2] -------------------------------------------------------------------------------- First RHA and Hint. Just along the lines of DAXI, Mark, I don't know if you'd just characterize for us where you stand outside of the manufacturing inspection. Do you feel you're far along with the rest of the review? Are you kind of engaged in a label at this point? So any color you could provide there would be great. And then second question, as we think about eventual approval and launch, there's been some recent launches in the toxin space that have gone a little bit less than stellar. So wondering if you could talk about lessons learned and how you might stage this launch in terms of getting experience and then broadening, if there's any kind of expectations you can set for us once we, knock on wood, get an approval? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Great. Thanks, Ken. Great question. So the first one, in terms of where we're at in the agency with other aspects of our BLA review, we're kind of breaking typical tradition here and commenting on the site inspection as it relates to where we are in the BLA process. And the reason that we're doing is that every quarter, we give an update. And oftentimes, we'll kind of reconfirm some of our different milestones and where we're at. Since the FDA resumed site inspections earlier in the year following the first COVID wave, we've been optimistic that our visit would happen in sort of the due course. However, our confidence in the FDA's ability to conduct a site visit in time for our PDUFA date of November 25 has reached a point where now 16 days out from our PDUFA approval, we thought it was appropriate to share the fact of a lack of inspection. There's still time that it could happen before the PDUFA time frame, but we thought it was appropriate given the COVID environment to share that. As it relates to sort of other parts of the review process, we -- consistent with our prior policy, we don't think it's appropriate to comment on where we are in that process since the discussions are ongoing. However, what I would say is we feel very confident in the quality of the submission that we put forward, and we continue to work collaboratively with the agency. On your second question about sort of lessons learned from other launches. I think each sort of launch is going to be unique and different. We've got the benefit of sort of looking at each of those and trying to learn certainly from those that have gone before us. However, what I would say is, our strategy is very different. I think because of the products that we've assembled and the differentiation, we're taking a different approach. We're creating a new category in the prestige segment. We're very targeted and focused in terms of the customers that we're going after, in addition to the quality of the products. We've got a little bit of a different strategy around sort of pricing and positioning in the market. And what I would point to is sort of the early traction that we're seeing with the RHA line of fillers. I think that the strategy that we've laid out seems to make a lot of sense. It's resonating. And I think as we've communicated before, we plan to take a similar approach once DaxibotulinumtoxinA for Injection gets approved, where we're going to be very measured in our approach. We're going to start with a small group to get good user experience. We'll then go through the PrevU program there and then sort of fully launch as we get into sort of the Q3 time frame. So I just think they're very different strategies. And certainly, we've tried to learn from what the market has said. We feel really good about our position and sort of the creation of this new prestige category. -------------------------------------------------------------------------------- Operator [4] -------------------------------------------------------------------------------- Your next question comes from the line of Annabel Samimy with Stifel. -------------------------------------------------------------------------------- Annabel Eva Samimy, Stifel, Nicolaus & Company, Incorporated, Research Division - MD [5] -------------------------------------------------------------------------------- So I had a few here. First, on the initial reception and training requirements around RHA, I did notice you started a revamped SKU. So can you talk a little bit about how much they need to be trained to use this new filler? And also, are you starting to incorporate some thoughts about how you're going to be training physicians around DAXI? I know it's not approved yet, but presumably some of the physicians have worked with it before. On the therapeutics front, now that plantar fasciitis is, I guess, sorted of out of the picture, any further thoughts on starting up in migraine or any other therapeutic indication? And then finally on HintMD. I guess you -- now that it's sort of up and running, can you see any trends? And is there anything that you can see right now that you can leverage beyond what you expected to be able to do with HintMD? Is the reception better or neutral, worse than what you would have expected? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [6] -------------------------------------------------------------------------------- Thanks, Annabel. I'll go ahead and let Dustin hit the first question, I'll take the next 2. -------------------------------------------------------------------------------- Dustin S. Sjuts, Revance Therapeutics, Inc. - Chief Commercial Officer of Aesthetics & Therapeutics [7] -------------------------------------------------------------------------------- Yes. Thanks, Annabel. On the RHA training requirements, right now, training for RHA Collection is not required, meaning it's not mandatory. However, what we've seen is the unique formulation, how this range of products was created, allows for a different injection technique, a bit more superficial than what's currently available with high safety metrics behind that. And so what we've done is, we've taken a bunch of the global experts, and we've kind of coalesced them under RevanceU. So it allows for the U.S. physician to get tips and tricks and also just to better understand the technology from the global ambassadors that have been injecting it for years. And then we've now trained also U.S. gurus that allow us to then kind of tease out the nuances. With the formulation of the RHA, it really allows you to do things differently. And so we're encouraging training, we've seen a high level of engagement in our platform, both virtually and also on demand. So I hope that answers your question on training. And then I'll turn it over back to Mark on the DAXI training side? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [8] -------------------------------------------------------------------------------- Yes. So to hit the second part of that question. I think on the DAXI side, what we've talked about in the past and still holds water today is, once we get approval for DaxibotulinumtoxinA for Injection, it will be the first time that we will have used it outside of clinical trials. And so therefore, we've always sort of indicated that we need to be very thoughtful and measured. And therefore, our rollout and launch strategy was going to be, start with a small group of physicians to get commercial experience outside of the trials, Q1. In Q2, we roll into our PrevU accounts, roughly 100 physicians or so that will use it then a little bit more broadly, but still in a pretty controlled way. And then use those learnings around feedback from those physicians, messaging and everything, to inform kind of the broader scale launch in Q3, similar to what we just recently did with the RHA Collection in September. So pretty similar strategy, except an extra quarter at the beginning there to get some real world experience. Again, from talking to the physicians, they're less concerned about injecting it and watching to see duration as they are injecting it to make sure that, that acute response is what they're looking for and they can turn those around pretty quickly. So we think that through the RHA launch, we've garnered a lot of insight into the right way to do this, and we continue to feel that, that will be the right launch strategy for a neuromodulator once it gets approved. Your second question on sort of now with the PF readout, how does that inform our therapeutic strategy going forward. We've always talked about, this is a really exciting and pivotal time for the company as we readout the cervical dystonia Phase III, the plantar fasciitis Phase II and the upper limb spasticity Phase II. Clearly, we're disappointed that we didn't see more separation between the treatment arm and placebo, but it has helped us sort of focus our attention and efforts going forward. Clearly, in muscle movement disorders, the promise of a longer-duration neuromodulator carry real value. So we're going to lean into CD. ULS fits in the same category of muscle movement disorder and is administered by neurologists. So we have, I think, greater visibility to a strategy that's going to center around the neurologist. And we want to see that Phase II data, but that's the direction that we're going. As it relates to migraine and other existing approved indications, I think that we'll finalize that as we kind of get these data package out and make our plans for 2021. But as we've always talked about, migraine, it's not an if, it's a when. And so we'll be thoughtful about kind of how we invest in the different therapeutics going forward. But we continue to like the optionality that exists as we move forward and continue to leverage this unique neuromodulator. The last one on HintMD in terms of, are there any additional sort of insights or trends, I will say that in this COVID environment, the one thing that has been nice is, in offices, they are going to a little bit more remote payments in contactless process payments. And so I think the promise of the platform offering that and allowing for secure transactions to take place has been attractive. Certainly as reported out today, we do have some visibility to overall volume trends. So it does give us a way to validate what we're seeing in the market with what's happening on the payment side of it. And I'm sure as we move forward, we'll continue to uncover additional insights that we can either share with our physician partners to help them run their business in a better way or insights that help us be a better partner on the corporate side. In terms of sort of how we're thinking about it, we're very excited. I think that we continue to have conviction that this is a really important part of our overall aesthetics franchise in that by combining sort of really leading services around loyalty and subscriptions and other things down the road are going to be an important point of differentiation above the product side of it. So we continue to really like where we're positioned. We thought that the integration has gone very well. The teams are working collaboratively. And so we're really looking forward to continuing to drive both of those products into the marketplace. -------------------------------------------------------------------------------- Operator [9] -------------------------------------------------------------------------------- Your next question comes from the line of Terence Flynn with Goldman Sachs. -------------------------------------------------------------------------------- Terence C. Flynn, Goldman Sachs Group, Inc., Research Division - MD [10] -------------------------------------------------------------------------------- I was just wondering, on the DAXI manufacturing inspection, if you can provide any sense as to what criteria the FDA is using to think about the travel restriction? Like, does it depend on the positivity rate in the city where the facility is located? Or is it more dependent on having personnel available? And then my next question is just on the revenue guidance. I know you're not providing it currently, but is that something that you think we should expect as we think about 2021? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [11] -------------------------------------------------------------------------------- Great questions, Terence. So first one, in terms of feedback from the agency. I think what they continue to point us to are the guidance that they put out back in July when they started resuming inspections. And it is everything you mentioned. If you look at the guidance, it has to do with sort of a hierarchy of priorities, and it also has to do with whatever sort of the travel-related restrictions are given the different geographies. So I think it's going to continue to be a dynamic situation. We don't have any additional insight other than that. We are a U.S.-based manufacturer. We are in Northern California. It's a single manufacturing site. So we're ready whenever they're ready. And I think that this will continue to be sort of a dynamic thing. But they, I think, continue to just point to the guidance that they've put out as it relates to that. On the revenue guidance, we're just -- we're early. And so what we don't want to do is to give you metrics or numbers to anchor on before we really have good visibility. We're sort of 1 month into our launch. We haven't been able to sort of observe reorder patterns or those types of things. And certainly, we've got a range of SKUs that are out there. Certainly, our goal is to be as transparent as possible as we have more visibility into the things. We will, of course, also be mindful of the competitive dynamics in the market. There are -- there's not a lot of data out there on filler peers out there. So we -- well, we want to make sure that we're giving you good information in terms of how you think about the business and how we think about the business. We also want to be mindful to what we put out there competitively. But I think we probably need another quarter or 2 as it relates to the RHA Collection of fillers and the HintMD platform to give more meaningful metrics. If we get those sooner or a little later, we'll give them to you when we have confidence in them. So just a little premature to give revenue guidance at this stage. -------------------------------------------------------------------------------- Operator [12] -------------------------------------------------------------------------------- Your next question comes from the line of David Amsellem with Piper Sandler. -------------------------------------------------------------------------------- David A. Amsellem, Piper Sandler & Co., Research Division - MD & Senior Research Analyst [13] -------------------------------------------------------------------------------- So just a couple. So -- and I apologize if I missed this earlier, but can you talk about the extent to which you're giving away free RHA fillers, and talk about how significant that is as a piece of the overall demand, at least initially? And then a tangentially related question is on DAXI. What's the extent to which you're going to be providing free product there? And how big of a piece of the initial launch will be free product as a means of demand stimulation? So that's number one. And then number two is, can you just remind us where things are in terms of line extensions for RHA. I think there was RHA 1. And just in general, what is down the pike in terms of adding to the franchise, given that all the other filler franchises certainly are multiproduct, and there's often a lot of refreshing of the franchises with new extensions. So if you can talk about that, that would be helpful. -------------------------------------------------------------------------------- Dustin S. Sjuts, Revance Therapeutics, Inc. - Chief Commercial Officer of Aesthetics & Therapeutics [14] -------------------------------------------------------------------------------- Okay. David, this is Dustin. Thanks for the question. As it relates to the free goods, you mentioned demand generation. And we really look at the market in a way in which price, based off price doesn't have to be what we use to generate demand. With innovation both in RHA and DAXI, we can use the products and their -- kind of their outcomes and what they deliver to the patients as what drives the demand as well as that exclusivity. So I think we've taken a unique approach to the market from that way. We don't currently provide free product for RHA and/or DAXI, obviously, for use of trying to drive that demand. We do use demonstration product to drive awareness of the clinical benefits of the product, both from the filler perspective. And so they use that to see themselves, injecting staff members most of the time and others to get experience for the unique properties of that product. And then ultimately, their confidence in the clinical outcomes is what drives demand as well as our ability to have it available and exclusive for select offices. Another unique piece is no, we don't even allow pricing to be advertised to the consumer. So we have basically a global brand policy that ensures that price is not the driver for the demand from a consumer's perspective either. We want the consumer going to the practices to deliver the best outcomes. So that approach will kind of transfer across all of Revance Aesthetics, not using free product as the driver. On your second question -- or your third question on RHA, I didn't quite get the pipeline. So for RHA 1, the clinical trial, RHA 1 is complete. Know that our partner, TEOXANE, manages kind of the clinical development pipeline in partnership with us. It is complete, and they will be filing that by the end of the year for approval. We're also looking at, obviously, other indications. We'll talk about those as those get into clinic and have more public information. -------------------------------------------------------------------------------- Operator [15] -------------------------------------------------------------------------------- Your next question comes from the line of Kush Patel with Guggenheim. -------------------------------------------------------------------------------- Kushal Patel, Guggenheim Partners, LLC - Senior Associate [16] -------------------------------------------------------------------------------- It's Kush on for Seamus here. Maybe a couple of questions. Maybe we'll go through DAXI and then a couple of other questions I had. We had recently spoke with some aesthetic physicians, and it seems really the biggest hurdle to a potential willingness to try it might be on the economic side of things. So just curious how the sales team could potentially address that concern with perhaps reduced appointment frequency per patient given the longer duration? And then potentially with CD out in 2023, just curious if you could provide some color as to why out 1.5 years, 2 years, given -- I assume the safety, but just some additional color on what the FDA is looking for there. And then maybe on planar fasciitis, I know going into the trial, there were a couple of changes. For example, the dosing as well as the endpoints. For example, the dosing was, I think, half of what was used in cervical dystonia. Just trying to understand of the potential aspects that led to the failure there. And then obviously, understanding there's been quite a few, if there's any potential learnings from additional analyses that the team is hoping to do? And then just lastly, on the RHA or HintMD launches, just trying to understand more of those launches. Maybe any additional metrics? For example, is HintMD kind of tied to DAXI, where potentially we could see an incremental step-up when DAXI is approved later? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [17] -------------------------------------------------------------------------------- Great questions. So we'll try and capture all of them here. So first one on DAXI and sort of feedback you've heard from the field in terms of willingness to try the product. We've not given out specific pricing information at this time. But what we have talked about is, based on our market research and because of the hundreds of millions of dollars that we've invested, that we would expect this to be a premium-priced neuromodulator because of the duration profile. And that in the discussions that we've had with physicians, we believe that they'll be able to charge more as well. And that consumers will pay more and then we should get more as a reward for the innovation. If you look at a lot of the market data out there, average consumers for neuromodulators only come in about twice a year as it is, which means that based on the duration profile of existing neuromodulators, they end up in a zone of undertreatment for a period of time. So we actually think that with a product with this duration profile, physicians will be able to charge more, patients will come in probably at a frequency level that's consistent with what they do today. And so everybody wins. The patient pays a little more, but gets a longer duration of the effect that they're paying to come in for. Physicians make more per visit. And we do well as a manufacturer for driving innovation. Again, we're looking to segment the market. I don't expect that in an account, they'll switch everything out, but we believe that there's a healthy part of the market that will opt in to sort of this prestige or premium product offering, and we think they coexist. If you look at a lot of accounts today, they will end up with more than one neuromodulator on the shelf, they'll have 1 or 2 different fillers on the shelf. And so they will offer the products that they think resonate the most with consumers. And so we think this sort of premium or prestige strategy resonates really well and aligns with our market data. We'll obviously give out the pricing information as we get into the launch cycle, but we do think that there's a premium for everybody. In terms of the CD side of things and what's gating the timing there, we talked about completion of our enrollment in the open-label study in August of this past year. We now need to complete all the follow-ups. We then have to have the end of Phase III meeting with the FDA. We've talked about a submission in 2022 and then an approval in 2023. So that's just basically driven by completing the trial, wrapping up the data, meeting with the agency. And so that's kind of how we get to that time line. On the PF and sort of some of the changes that we make. As you referenced, this is our second Phase II PF study. In the first PF study that we ran, we again saw really good pain reduction with both treatment groups. But we saw a surprisingly high placebo response rate. So the changes that we made were designed to try and better separate out placebo from treatment. Again, in this Phase II study, we showed really good pain reduction in both treatment arms, but also, again, an unusually high placebo response rate. And so we had done a variety of things. Before, we injected both the cap and the heel. So we went to just the heel because the cap can be a trigger point release for dry needling, and we thought maybe we could do that. We changed the way that's the inclusion criteria to make sure that we are capturing those with true plantar fasciitis pain. Rather than just measuring 1 single point in time for the pain measurement, we did it over the course of 5 days, so that we try to make sure that we captured it. Unfortunately, despite the changes that we made with really good input from a lot of clinicians out there and insight, we again ended up with a really high placebo response rate. So we're disappointed, but the product performed well, showed a really good safety profile as well. But I think that as we've gone back and we've sort of reflected on things, plantar fasciitis is a very different physiology. It's inflammation of the plantar fascia, it's secondary to injury. There's a lot of other things going on. And if we look at our other programs in muscle movement and existing indications for pain, those are categories which are much better characterized, and the performance of neuromodulators in those categories makes sense. And for us right now, the thing that we've demonstrated in 2 Phase III trials is an encouraging duration profile. So I think focusing on those indications that are known where our product profile has an opportunity to be very competitive is a more judicious investment of our resources and time. We will, to your point, do some additional subset analysis, see if there's other things that we can glean from it. But I think with where we are today, we're going to again focus more on kind of the muscle movement in existing indications as sort of our primary focus. And then the last one you had was on the RHA and HintMD and combination of the 2. I mean, it's early right now. We took 2 disparate organizations, put them together. We think we've done a great job of distilling down the message, making sure that we can get leverage where possible. We're early in that. We think that the products that we're introducing into the market fit very well with the discussion around services that can help the practices and vice versa. So while it's early, we do believe that there will be some pretty good synergies that we can unlock as we move forward and we link the 2 together. But it's still early, and I think more to come as we move forward. -------------------------------------------------------------------------------- Operator [18] -------------------------------------------------------------------------------- Your next question comes from the line of Tim Lugo with William Blair. -------------------------------------------------------------------------------- Timothy Francis Lugo, William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research [19] -------------------------------------------------------------------------------- And I just want to confirm if you know if the inspectors would need to come out and they're not regional inspectors. I know that there's been a movement kind of away from local inspectors and more towards national teams depending on the indications and, I guess, product. Or if you're just deducing that the travel restrictions are what is the hurdle? And maybe you mentioned this already, but can you just confirm if the inspection is the last major issue outstanding in the review? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [20] -------------------------------------------------------------------------------- Yes. So Tim, great questions. So in terms of the -- what we've heard from the agency, what they have confirmed is that they will need to perform a site inspection. I think that has to do with the fact that we have not qualified this manufacturing site for any other product. So this will be our first approval, which is why an inspection does need to take place. What they've pointed us to is kind of their prior guidance of saying that here's sort of the guidance. We've got protocols we've got to follow, and that travel-related restrictions will impact that. That's basically what we know today. We are continuing to work proactively. Our PDUFA date has not come yet. We're still hopeful that perhaps the inspection will take place prior to then. But as we mentioned earlier, with now being 16 days away from the PDUFA and no site visit scheduled, knowing that we need to have one, we thought it was appropriate to share with you. Again, we do feel good that we're a U.S. single-site manufacturing facility here in Northern California. So we are anxiously awaiting that. We've not commented on any other details around the actual BLA submission. We don't think it's appropriate other than to say that we continue to feel very good about the quality of the submission that we put in and we continue to work collaboratively with the agency. And was there a second part of the question? -------------------------------------------------------------------------------- Timothy Francis Lugo, William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research [21] -------------------------------------------------------------------------------- I guess you maybe touched on it, just if it was the kind of last outstanding issue for the review, but it sounds like you're very comfortable with the quality. If you were -- if the inspection were to occur tomorrow and there were some 483s, would you even be able to turn them around given the schedule? And should we just kind of assume a delay as of now? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [22] -------------------------------------------------------------------------------- I don't -- I mean, great questions. I think we're theorizing. I think we're just trying to share what information we definitely know. I think that as we start getting into the potential of this or that, it's hard to say. We're not to the clock. I know this is sort of atypical to report this out prior to the PDUFA date, but we just -- we thought it was the appropriate thing to do given the company update. So it's hard to theorize sort of whether or not we could, if there's anything that were to come up, but we're ready. We're ready for them whenever they show up. -------------------------------------------------------------------------------- Timothy Francis Lugo, William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research [23] -------------------------------------------------------------------------------- Okay. Understood. And maybe one last commercial question. You did $2.8 million in RHA revenue this quarter. It was only a partial quarter. What was kind of the underlying demand? And should we assume that its -- the demand might be $6 million and build off of there? Or can you just talk about if there were any kind of onetime loading or inventory stocking in that number? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [24] -------------------------------------------------------------------------------- Yes. So great question. I think that's why we're just not in a position to give guidance yet because it is so early. I mean the RHA sales really reflect our sales in September. But as you can imagine, these are initial purchases where if you look at the buying patterns for fillers, they -- every account is a little bit different. But given the fact that it's a new product, they tend to order a reasonable amount of product so they can get a really good experience with it. So I don't think that you should take sort of the September month and multiply it by 3 for Q4 because these are early accounts that our reps know that we're going to. Again, we're very focused on going deep, not wide, to make sure that people that partner with us are very committed to sort of this premium category that we're looking to create. So I just -- I think it's early right now. Again, it's obviously a very strong start given one month of launch. And the feedback we're getting is very positive, but it's just -- it's a little bit too early to know what that reorder cycle is going to look like, what the stickiness of the product is going to be. And certainly, we'll be able to give you more insight into that as we report out our Q4 numbers. -------------------------------------------------------------------------------- Operator [25] -------------------------------------------------------------------------------- Your next question comes from the line of Serge Belanger with Needham & Company. -------------------------------------------------------------------------------- Serge D. Belanger, Needham & Company, LLC, Research Division - Senior Analyst [26] -------------------------------------------------------------------------------- Just a couple of questions for me. The first one for Mark or Dustin. Can you just talk about current patient flow levels. Have they recovered from -- where have they recovered from pre-COVID levels? And are they still recovering through, I guess, mid-fourth quarter? And then secondly, on the RHA filler pricing. Can you tell us where you have priced the product relative to the competition? And what you're seeing physicians price the product for their consumers? -------------------------------------------------------------------------------- Dustin S. Sjuts, Revance Therapeutics, Inc. - Chief Commercial Officer of Aesthetics & Therapeutics [27] -------------------------------------------------------------------------------- Serge, it's Dustin. I think on the patient flow, I think we talked a little bit about it on the HintMD side as well. We've been really pleasantly surprised. The patient flow is coming back. Of course, some practices are different. But in most states, we're seeing that the aesthetic practices are doing well, even right at or above pre-COVID levels. Specifically with facial injectables, you think about the time that people have at home and times to get into practices, while their flow has changed, people are getting more procedures done at the office at a time. And so patient flow seems to be pretty good. We're keeping an eye on the trends in certain markets as we see upticks. But right now, we feel like the offices are in a good position to manage any new restrictions and other things. They caught them by surprise before, but now they really have been thoughtful about how they manage their staff, how do they manage the flow of the practice. So they feel they're in a good position. On the RHA side, similar to what I mentioned before, we really want the innovation to speak for itself in terms of how you drive the pricing to the consumer. So we do believe that RHA is a premium-priced product to the consumer. The practices set that price. And so what we've seen is a slight 5% to 10% premium to the consumer. Now again, we have a policy uniquely set to Revance where we don't allow for that price to be advertised. So therefore, the consumer gets its information by who delivers the best outcomes versus who's going to deliver the best price. We feel that philosophy is resonating, it's really allowing us to focus on a subset of accounts. And so -- however, pricing to the doctor is really in line with currently marketed hyaluronic acid products, which allows the margin in the practice to be at or above where they're at with current products. -------------------------------------------------------------------------------- Operator [28] -------------------------------------------------------------------------------- Your next question comes from the line of Balaji Prasad with Barclays. -------------------------------------------------------------------------------- Balaji V. Prasad, Barclays Bank PLC, Research Division - Director [29] -------------------------------------------------------------------------------- Most of it has been answered. Just a couple of questions left on HintMD. So can you kind of connect the total amount of payment process, which you mentioned was $100 million, to the revenues that you reported, which is around $0.2 million. I thought the opportunity for you was between 0.5% to 1%, but this seems more at 0.2%. Again, I understand it's early days. And secondly, on DAXI, the question that we're getting the most is on the label, and what it would mention on the duration. And so can you help us understand what we ought to be looking for? Is there going to be explicit mention of the label? Or is it more indirect where there is a contraindication for less than 24 weeks use or something along those lines? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [30] -------------------------------------------------------------------------------- Yes, Balaji, great questions. So first on the HintMD side of it. We've previously talked about sort of the overall credit card transaction processing charge and that of that, we would expect to participate in 50 or 100 basis points. So if you go to the low end of that, you're talking $500,000 in payment processing revenue between the beginning of the year and where we are today. So actually, that $200,000 in Q3 lines up pretty well with sort of the transaction processing side of things. Toby, do you want to? -------------------------------------------------------------------------------- Tobin C. Schilke, Revance Therapeutics, Inc. - CFO & Principal Accounting Officer [31] -------------------------------------------------------------------------------- Yes. And just to note that, that $100 million is cumulative for the year 2020. And the revenue number is in Q3 post Hint acquisition close, which was closed the 23rd of July, 2020. -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [32] -------------------------------------------------------------------------------- So that's very much in line, and we continue to feel good about that. As we've talked before, too, I think, how we allocate ultimately that revenue stream, whether we choose to figure out partnering ways, that could evolve over time, but we continue to feel very good with sort of the revenue that we're generating from the payment value that's being generated. Your question about the label, I think that falls in the category of -- it's just not appropriate for us to be commenting on kind of discussions with the agency. However, I will refer you back to prior commentary that we had. If you look at the quality of our SAKURA 1 and 2 programs, the largest ever in glabellar lines, guidance from the agency, precedent labels, feedback that we've had, we continue to feel very good about the data from our trials being reflected in the label. So that's -- other than sort of the inspection update, we're going to kind of follow our typical policy in terms of not commenting on active discussions with the agency. -------------------------------------------------------------------------------- Balaji V. Prasad, Barclays Bank PLC, Research Division - Director [33] -------------------------------------------------------------------------------- That's helpful, Mark. I can understand that. Just one follow-up on plantar fascitis. So with regard to migraine, are there any direct or indirect read-throughs from plantar fascitis studies towards how you develop the chronic migraine program when you think of starting it next year? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [34] -------------------------------------------------------------------------------- Yes. No, that's a great question, Balaji. And of course, it's one of the things that we looked at in terms of the Phase II results in plantar fascitis, are there any read-throughs into the other programs. Again, I think that the underlying physiology of plantar fascitis is very different. It's a fascial disease, it's secondary to injury. It's not all that well understood. We certainly looked at some of the data that have been published, talked to some clinicians as to why we thought it could be a good treatment opportunity. But it is very different from currently approved indications in muscle movement and pain disorders. And so we don't think it, in any way, impacts the way that we view the existing opportunities or frankly our ability to have a differentiated and sort of opportunity in those markets where a longer duration product would have value. So has it changed the way that we think about migraine? And again, it continues to be not an if, a when strategy. Clearly, with where we are with CD and the data that we have coming out in ULS, the Phase II data in Q1, that will help inform sort of our go-to-market strategy on those. And then kind of when we layer in the start of these other clinical programs, we'll get more clarity as we start to firm those up. -------------------------------------------------------------------------------- Operator [35] -------------------------------------------------------------------------------- The next question comes from the line of Doug Tsao with H.C. Wainwright. -------------------------------------------------------------------------------- Chris Bialas, [36] -------------------------------------------------------------------------------- Chris Bialas on for Doug today. So I was wondering if there is a delay in the DAXI BLA, how could this impact the commercial plans for the filler line or HintMD? I remember you guys mentioning that you were going to co-promote all 3. And what plans or what contingencies do you have in the event of a potential delay to mitigate this? -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [37] -------------------------------------------------------------------------------- It's a great question. Unfortunately, we've already been through this once with sort of the delay in the launch of the RHA filler line due to COVID already. There's always going to be puts and takes when there's something that impacts it. So again, I want to restate, we don't know whether or not there will be a delay. We're still hopeful that there will be an inspection before our PDUFA date. But if there is, what we've talked about is, first and foremost, we're in incredibly strong cash position. So we've got almost $450 million as of the end of Q3. We feel really good about sort of our ability to execute on the launch. So that's kind of number one. Number two, when we talked about sort of the launch plan for our neuromodulator, we talked about Q1 being sort of a limited with a small group to inform kind of optimal approach, Q2 being sort of the PrevU launch of 100 injectors and then Q3 being a launch similar to what we're going through right now with the RHA fillers. And so if we look at that time frame, obviously, if there were to be a delay, we'd be looking at ways to see whether or not we can compress any of that and if there are ways to minimize any kind of impact. However, it does help to be in the market with 2 great products with the RHA fillers and the HintMD. And while certainly the 3 together will add additional leverage from a bundling perspective, if anything, it allows us to a little bit more focus right now on these -- both these products in the early stages of their launch, where we can make sure that we get the necessary traction and focus and adoption of these platforms. I don't think that adding our neuromodulator in any way sort of changes that and really becomes additive over time. So we wish we had more clarity on this. We're ready, like I said, whenever they show up for the inspection. And we've got, we think, a really good opportunity to mitigate any impact because of our dollars, because of our end market assets and sort of our current launch strategy. -------------------------------------------------------------------------------- Operator [38] -------------------------------------------------------------------------------- And you have no further questions at this time. I will now turn the call back over to Mr. Mark Foley. -------------------------------------------------------------------------------- Mark J. Foley, Revance Therapeutics, Inc. - President, CEO & Director [39] -------------------------------------------------------------------------------- Great. Thank you, operator. Before year-end, we plan to virtually attend the Crédit Suisse, Stifel and Piper Sandler healthcare conferences. We welcome your request for meetings at these events directly through us. Feel free to reach out to Jeanie if you'd like to schedule some time. With that, I would like to thank you all for participating in today's call. -------------------------------------------------------------------------------- Operator [40] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.