Revance Therapeutics Inc (RVNC) 2020 Q2 法說會逐字稿

Welcome to the Revance Therapeutics Second Quarter 2020 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, today's call is being recorded today, August 6, 2020.

I would now like to turn the call over to Jeanie Herbert, Head of Investor Relations and Corporate Communications for Revance.

Thank you, Jonathan. 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; and Chief Commercial Officer of Aesthetics and Therapeutics, Dustin Sjuts.

Earlier today, Revance released financial results for the second quarter ended June 30, 2020. If you have not received this news release or you would like to be added to the company's distribution list to receive future releases, please go to the Investor Relations section of Revance's website, which can be found at www.revance.com.

During the conference call, management will make forward-looking statements, including statements related to Revance's 2020 financial results and guidance, the clinical development of our product candidates, business strategies and planned operations, anticipated pre-commercialization and launch plans, financial estimates with respect to the TEOXANE distribution agreement and the HintMD acquisition and potential product candidates and technologies. 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 titled Risk Factors in our current report on Form 10-Q to be filed this afternoon, August 6, 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.

With that, I'll now turn the call over to Mark Foley. Mark?

Thank you, Jeanie. Welcome to our second quarter 2020 financial results and corporate update conference call. As we continue to deal with the COVID-19 pandemic, our business is constantly and successfully adjusting to new guidelines and safety procedures. Most of our people are working productively from home, and we have modified both our clinical and commercial strategies to most effectively operate within the evolving landscape.

In most geographies, aesthetic practices have reopened with facial injectables in high demand. While office throughput is still constrained due to social distancing and cleaning regimens, we're hearing from physicians that patients are returning to their treatment routines, and some are requesting additional procedures to make up for lost time. Overall, Revance is weathering the ongoing COVID situation with minor disruption and continues to operate from a position of great strength.

In terms of our business, these are very exciting times. We're on the threshold of the company's very first commercial product launch as we prepare to introduce both the RHA collection of dermal fillers and HintMD fintech platform in the U.S. market this quarter. In addition, we have a number of important clinical and regulatory catalysts to head for DaxibotulinumtoxinA for Injection before year-end.

We are thrilled to provide you with an update on our second quarter accomplishments and update you on all that lies ahead for us in the second half of the year. The most significant progress in the second quarter centered around the expansion and commercialization of our aesthetics franchise. While COVID led to a 1 quarter delay in our launch plan for the RHA collection of dermal fillers, we successfully used the time to dial in on our launch strategy, complete the hiring of our commercial team and build out our operational infrastructure. Late in the second quarter, we received our first shipment of RHA 2, 3 and 4 from TEOXANE, ensuring a timely market introduction next month.

Having product for sampling allowed us to jump-start the preview early clinical experience program focused on building experience and confidence with the full range of innovative RHA fillers. In May, we announced an additional expansion of our aesthetics franchise with the acquisition of the HintMD fintech platform. This payment processing, subscription service and loyalty platform adds a unique service component to our prestige product offering and allows us to better support our physician partners. We believe there is tremendous logic and value in this combination.

HintMD provides Revance with access to a $500 million vertical payment processing opportunity, allowing us to access a near-term recurring revenue stream. HintMD's smart payment platform allows for secure, no-touch, point-of-sale payment processing, which is particularly relevant in today's COVID environment. The platform also enables customized subscription plans allowing physicians to create a tailored treatment and payment plan for each patient. Lastly, HintMD was designed as an open platform, meaning that it is able to integrate other brand loyalty programs and services offerings, which can increase adoption, engagement and create operational efficiencies within a practice. Importantly, we will leverage our new commercial infrastructure to launch the HintMD services in tandem with the RHA collection of dermal fillers and, upon approval, DaxibotulinumtoxinA for Injection. We plan to leapfrog conventional brand loyalty programs by enabling practice-centric loyalty programs made possible by a very experienced HintMD software and technology team.

We officially closed the HintMD deal on July 23 and are in the process of integrating their workforce and platform into the Revance structure. Aubrey Rankin, Co-Founder and CEO of HintMD, is now our President of Innovation and Technology and will soon step onto our Board of Directors. We are thrilled with the HintMD acquisition and believe that it will significantly enhance our ability to build a leading aesthetics franchise. We'll cover more on the HintMD and RHA collection rollout when Dustin discusses our launch plans in just a minute.

Now let me make a brief statement on our lead asset, DaxibotulinumtoxinA for Injection given the COVID-19 environment. Our PDUFA date for DaxibotulinumtoxinA for Injection in glabellar lines remains November 25, and as such, we are busy preparing for a potential commercial launch of our next-generation neuromodulator before year-end. As we enter the second half of the year, our commercial focus is on the introduction of our compelling offering for aesthetic practices with truly differentiated products and services.

Let me now hand the call over to Dustin to give you more details on our commercial launch. Dustin?

Thanks, Mark. In September, Revance will make the official leap from clinical stage to a fully commercialized public entity. We are ready and eager to officially introduce our RHA Collection, the first and only range of innovative, Swiss-made dermal fillers for the correction of dynamic facial wrinkles and folds.

While COVID has an impact on the market, our strategy has not changed. We have successfully moved all essential launch programs and commercial operation activities forward to set the foundation for multiple product and service launches as we enter fall. Our first order of RHA Collection product was shipped from Switzerland, passed through customs, proceeded through our supply chain and was delivered in the hands of Revance's first trainers and customers. Revance successfully built, tested and operationalized our entire commercial infrastructure, including international supply chain operations, customer service, e-commerce platform, sampling fulfillment and other key infrastructure elements, all of which culminated in the successful processing of multiple sales and sample orders. Our field force build-out is complete. Despite the environment, we successfully hired our entire customer-facing organization virtually, 100-plus experienced professionals who are currently in the process of training and will soon be engaging with the doctors across the country.

With the RHA Collection now in the country, our engagement with key physicians has transitioned from operation resilience in March to an in-depth clinical education program for select physicians. Over the past 2 months, through the RHA Collection preview program, we have already introduced and trained more than 100 key opinion leaders and influencers on RHA 2, 3 and 4. This group represents a prominent ensemble of thought leaders in the aesthetic community. They are collecting robust clinical experience and providing feedback that will inform and enhance our full rollout plan for September. We look forward to sharing some of these preview insights with you as the program comes to completion in the fall.

In tandem with preparations to launch the RHA Collection, we have completed the game-changing fintech acquisition of HintMD, which will complement our planned product launches this year. We plan to build upon the existing installed base of pilot HintMD users through an introduction to select aesthetic accounts across the U.S. beginning in September. We have sampled our products, tested our infrastructure, initiated training of our people and are now ready to go. Our Revance aesthetics launch strategy is clear: keep the physician at the center of everything we do. Our plans and strategies were developed to relieve the many pressures physicians have in a growing market.

We recognize the innovation gaps that exist in both the dermal filler and neuromodulator market and its inherent impact on commoditization. Physicians have increasing competition as manufacturers train more and more injectors each year, demonstrating their agnostic approach to physician segmentation. Physician profits are eroding as conventional manufacturers are creating a coupon economy where physician loyalty takes a backseat to discounts and patient outcomes and experience. As we address these physician pressures with our go-to-market strategy, our immediate focus is on a targeted professional launch for the innovative RHA Collection in September, which will include adaptable deliverables that can be deployed with virtual, live and small group engagements.

Towards the end of the year, subject to approval, we plan to implement a similar launch strategy for DaxibotulinumtoxinA for Injection in the treatment of glabellar lines or frown lines, starting with a phased preview program for a select group of physicians followed by a phased broader launch.

Prior to the anticipated approval of DaxibotulinumtoxinA for Injection in frown lines, we undertook 3 Phase II open-label trials in the upper face to provide further insights on the performance of this next-generation neuromodulator product. In late June, we announced top line results from our Phase II open-label studies in forehead lines and crow's feet. DaxibotulinumtoxinA for Injection demonstrated a measurable treatment effect on both forehead lines and crow's feet. In fact, at week 4, in at least one of the dose groups, 100% of these subjects had at least a 1-point change from baseline in wrinkle severity as assessed by the investigator.

In terms of duration of effect, defined as the medium time to return to baseline wrinkle severity based on both investigator and patient assessment, at least 1 dose in each study demonstrated a median duration of effect of 27 weeks in the forehead line study and 24 weeks in the crow's feet study. These 4-week data from these studies was used to optimize dosing and injection patterns for our ongoing Phase II open-label upper facial line study, and we expect to report that result in the fourth quarter.

The magnitude of our aesthetic commercial progress in light of such a unique time is significant. These achievements are the result of synergistic teamwork among world-class talent, deliberate planning, rapid execution and collective alignment to our mission. All this gives me great confidence that Revance has the products, the strategy and the people to make a real difference in the year ahead.

With that, I'll now turn the call back to Mark.

Thanks, Dustin. Now let me cover the progress we are making in our therapeutics franchise. Our overarching strategy is to leverage our core asset, DaxibotulinumtoxinA for Injection, and its differentiated duration profile by pursuing a number of different therapeutic indications where the benefits of the product have the ability to significantly improve the duration of symptom relief for patients suffering from a number of debilitating conditions while also providing a favorable cost profile to the health care system. Based on recently reported industry research and our own internal market data in cervical dystonia and upper limb spasticity, a longer-duration neuromodulator has the ability to provide significant benefit to both patients and their caregivers due to the frequency of symptom recurrence in between injection cycles.

To that end, I'm pleased to say that we're on track to report clinical data from 3 therapeutics programs in the next 6 months. First, we continue to expect top line results from the ASPEN-1 Phase III cervical dystonia pivotal trial in the fall. And in June, we completed the enrollment for the companion ASPEN open-label long-term safety study, which puts us in good shape for our first therapeutic regulatory filing. These results in cervical dystonia will not only provide us with insights into the potential for DaxibotulinumtoxinA for Injection in this indication but will also help inform its potential in other muscle movement disorders, which collectively make up a $1 billion market worldwide.

Second, also this fall, we expect to report the top line results from our Phase II plantar fasciitis trial. Plantar fasciitis is a painful affliction of the foot and heel with 1 in 10 people in the U.S. expected to get plantar fasciitis in their lifetime. Currently, there are no FDA-approved drug treatments for plantar fasciitis, so it is a true white space, and we look forward to the top line readout in this distinct pain indication.

And third, in June, we announced that we completed enrollment for a modified JUNIPER Phase II trial of DaxibotulinumtoxinA for Injection for the treatment of adult upper limb spasticity. Due to ongoing COVID-19 concerns related to subject enrollment and scheduling in-person study visits, we chose to end screening in our JUNIPER upper limb spasticity trial with a total of 83 subjects enrolled. We believe our proactive and pragmatic decision to complete enrollment will allow us to report top line data in early 2021 and potentially move into a pivotal Phase III upper limb spasticity trial sooner than originally planned.

Overall, I'm very pleased with the status of our therapeutics program, and we look forward to sharing the top line results from these 3 clinical trials in the not-too-distant future.

I will now turn the call over to Toby to summarize our financial results. Afterwards, I'll have a few closing comments before we begin today's Q&A session. Toby?

Thank you, Mark. Starting with our cash, cash equivalents and short-term investments balance, we ended the second quarter with $494 million, which we believe is sufficient to fund our planned operations into 2023. This balance includes the $30 million milestone payment received as a result of Mylan's decision in May to opt into the development program for a biosimilar to BOTOX.

Revenue for the second quarter of 2020 consisted of $299,000, a part of which comes from the recognition of our progress on our Mylan collaboration and part of which represents our first initial sale of RHA Collection for dermal fillers. The RHA product shipments in connection with the preview program were less than $100,000. For the second quarter, our OpEx was $57.4 million. Excluding depreciation and amortization, stock-based compensation and the RHA related in-process R&D, our OpEx was $48.6 million. The earnings release we issued today outlines our financial results in full, so I will not go through the details on this call.

In terms of outlook, we are reiterating our 2020 guidance provided upon the HintMD acquisition announcement in May. At that time, we noted that non-GAAP operating expense would be in the range of $220 million to $230 million. This excludes depreciation, amortization, stock-based compensation and the RHA-related in-process R&D. We are developing our acquisition accounting for HintMD, and once completed, we can provide GAAP operating expense guidance for 2020. Revance still expects 2020 non-GAAP research and development expense related to our non-HintMD business 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 our RHA Collection and the HintMD fintech platform. We will, however, provide updates and metrics as we progress. Finally, Revance's shares outstanding as of July 24, 2020, were approximately 65.9 million with 72.1 million fully diluted shares, excluding the impact of convertible debt.

With that, I'll turn the call back to Mark.

Thank you, Toby. This is a pivotal and exciting time at Revance. Having created what we believe to be a compelling portfolio of leading assets in aesthetics, we stand on the cusp of commercialization not just of our RHA Collection of dermal fillers and HintMD fintech platform but also, subject to approval, of the world's first, true, next-generation, long-acting neuromodulator, DaxibotulinumtoxinA for Injection. In tandem, we've continued to invest in our therapeutics franchise with 3 important data readouts over the next 6 months. All told, we will be addressing markets totaling more than $6 billion worldwide. I also want to note that we are excited about Mylan's recent opt-in decision to the biosimilar to BOTOX program, which gives us a path forward to financially participate in the short-acting neuromodulator category.

In summary, Revance has weathered the COVID-19 situation very well with little impact on our operations or clinical time lines and a war chest of nearly $500 million in cash and investments funding us through our new product launches, important therapeutic clinical readouts and into 2023.

With that, I will now open the call up for questions. Operator?

(Operator Instructions) Our first question comes from the line of Annabel Samimy from Stifel.

This is Avatar Jones on for Annabel. We have one broader question. Could you please sort of outline how the HintMD rollout will enhance the dermal filler launch, specifically just mapping out those synergies or hurdles, whatever they may be?

Yes, it's a great question. So as we've commented in our prepared remarks, our goal is to leverage the commercial team that we put in place to launch the RHA fillers. We mentioned we've hired all -- roughly 100 reps, and so that group is going to be introducing the filler and will be a lead-gen source for the HintMD platform. And so we plan to create leverage and synergy and that's going to be our target customer base, which is kind of the prestige category in this targeted physician group.

Our next question comes from the line of Terence Flynn from Goldman Sachs.

Congrats on the progress. Maybe 2 for me. I was just wondering, with respect to the fillers, if you can give us any guidance at this point on the gross margin side. And then on the sales force hiring, any additional details you can share there regarding kind of breadth of experience, average years, et cetera? And were these hires from other aesthetics companies, maybe a little bit more on -- kind of their background? And then any update on the status of the FDA inspection for DAXI manufacturing?

Great, Terence. Thanks for those questions. Maybe I'll take 1 and 3 and hand 2 over to Dustin. So first on the fillers on the gross margin. I think that's getting into obviously ASPs and sort of cost of goods. I think it's a little early right now to get into sort of the details of that. Once we sort of have a launch trajectory and we're in the market, we'll be better positioned to be able to give metrics as we move forward. So just to remind you, in terms of the nature of that relationship, it's a pure product transfer relationship where we acquire product from TEOXANE for a set price. And then based on what we sell it for, that will ultimately determine our gross margin.

And then on the last one that you asked just about sort of the FDA. Again, as we commented on in our scripted comments, right now, we're still very focused on our PDUFA date of November 25. There's been no change on that. It's sort of not company policy to talk about the specific details related to that. But we continue to march towards that date and, at this point, don't have anything that would suggest that there's anything other than that date to move towards. With that, why don't I turn it over to Dustin for your question on the sales force and some of the questions you had there.

Yes. Thanks, Mark. As far as the sales force goes, our strategy really was to select kind of the best of the best as it relates to experience but those that also can deliver in the environment that we're getting into, a competitive environment, those that can create a category and also launch innovation. And those skill sets are variable as it relates to different companies that they came from. We actually had more than 9,000 people apply to those 100 or so openings. We took that 9,000, broke it down to those that fit our profile and who we'd want to interview, interviewed a select group of those and actually hired less than 5% of those that made it through that process. So we're very confident in the profile that we've hired.

As it relates to experience, north of around 80% have aesthetic experience with more than half of those coming from the injectable market. On the company-specific-wise, there's a variety of organizational experiences they came from. So nothing -- one specific didn't stand out. All in all, all that leads us to believe that we have the best sales force and are very confident in our ability to deliver on the RHA Collection launch as well as with HintMD.

Our next question comes from the line of Stacy Ku from Cowen and Company.

Congratulations on the progress. So just a first question on the fillers. Do they have the same kind of brand loyalty? How should we be thinking about the level of awareness of RHA fillers clinicians versus consumers? And I guess more so just trying to think about the pacing of the filler launch and then how it might relate to the DAXI launch.

It's a great question. So this is the first introduction of the RHA filler line in the U.S. So there's really not much familiarity or awareness regarding the product, certainly not in the consumer market. Some physicians are aware of it because the RHA filler line has been available in Europe and some other markets outside of Europe for quite some time. And as physicians travel to international meetings, they hear about new products. But really, we're creating the brand here in the U.S., and that's why we're taking a very disciplined approach to how we roll this out, how we introduce it. With any given geography, there's going to be some differences in terms of the look that they're going for or injection technique. And our collective experience, and certainly mine at ZELTIQ back in the CoolSculpting days, is that you need to build a foundation of success, and that's what we're doing with this preview clinical program. And so we'll work closely with the right physicians to build it. But we are going to need to build this brand here in the U.S.

In terms of how you look at the DaxibotulinumtoxinA for Injection and that launch strategy, it's going to mirror a lot what we're doing on the RHA filler side. We're taking a very methodical approach where we're starting with the core group. We're getting them experienced with the product. We're using that engagement and feedback to inform some of the training and the targeting and the mapping that we're going to do. Then we'll go into a phased launch and ultimately a broader launch. And that's really the same strategy that we'll ultimately take with our neuromodulator once approved.

Our next question comes from the line of David Amsellem from Piper Sandler.

So I have a question about sampling. I guess this is sort of a high-level question, just philosophically, how aggressive you intend to be regarding sampling for both the RHA fillers and also for DAXI, particularly in the context of this challenging macroeconomic environment and the lower office throughput that you cited, Mark. And then my second question is on this idea of reduced office throughput, I mean, is that something that you expect to be a headwind as we move through 2021? I mean how worried should we be about it in the context of 2 new launches?

Yes. So maybe I'll take the first part of that and then hand it over to Dustin to talk a little more specifically about the sampling side of it. So with regards to sort of the throughput and does that have any spillover into sort of the way we think about sampling, of course, none of us has a crystal ball, and it's really difficult to know for sure exactly how this is going to play out. But relative to others, we feel we're incredibly well positioned. We've got a sales force of 100 people. We're going to be launching what are 3 products, very innovative products. And so we get leverage across all of these 3 product lines. And we've got a very sort of targeted approach where we're not trying to be everything to everybody. And so we've already mapped a lot of these early targets for us who have expressed interest in the differentiated products. And if you look at just this early preview clinical program with the RHA fillers, we've been very pleased, even in this challenging environment with sort of the volumes in these practices, how they've been receiving the product and how is that going.

So I mean, certainly, if this continues into 2021, and there's significant reduction in patient load, it would have an impact in terms of our plans relative to what our expectations were. Having said that, because of our targeted approach, our small sales force, we're just coming into the market, we're being very thoughtful and methodical with the rollout and we've got 3 product lines, we're very confident that we'll be successful in the targeted manner in which we're going after. And maybe on a little bit of a relative basis, there could be an impact. But again, we feel very well positioned. And since we don't have any revenue right now, and if you look at our balance sheet, we're very well positioned, I think, to weather all of this. And so with that, why don't I hand it to Dustin to make a little bit of a comment on the sampling approach.

Absolutely. Thanks, Mark. As you mentioned, this is the first time a company has been able to launch an entire range of products all at once. We've got RHA 2, 3 and 4. So with that, our sampling strategy is really designed to instill confidence in the injector in the United States to deliver the outcomes that they want. This filler was designed with the patient in mind. And so we're putting it in their hands to then utilize the experience that they hear verbally from the international physicians but then put it into their practice. We don't feel that kind of the COVID environment today really changes our sampling strategy. We found that early in preview that the samples are utilized in a manner which allows them to hone their skill sets, and the feedback has been excellent. So I believe that that's really the strategy for the near term.

Yes. And maybe, David, I'll just build on that because I think in your question, and maybe I'm making the leap here, you're potentially sort of questioning whether or not we need to provide more samples in today's market because of the economic climate. And we don't believe that's the case. If you look at the physicians that we're targeting, we've segmented the premium group. And these are practices that are making decisions around product quality and the outcomes there. And so while we certainly need to be mindful and thoughtful about our pricing, there exists a market today that is very susceptible to sort of price changes, and that will influence. The ones that we're calling on are very focused on patient outcomes, and I think they're going to ultimately make a decision on a -- the product needs to be reasonably priced, but if it delivers more value and it's got the right properties, we expect that, that will influence their decision more than whether or not we gave them an extra box of free product.

Our next question comes from the line of Balaji Prasad from Barclays.

A couple of questions from me. As you plan your RHA launch, I'm sure you all thought of a contingency plan if there's a recurrence of COVID, and hopefully, we can -- we don't come to that. But could you explain how the launch plans could change if that -- in such a situation? And secondly, could you also give us an update on what you're seeing on the ground with regard to the pent-up demand for fillers and toxins?

Yes. Well, thanks, Balaji. Great question. So on the contingency side of it, we're doing all the things right now to be prepared to address whatever the environment is. And as you're aware, each state or each area is different. And so I think you need to have different tools and techniques to make sure that you can engage physicians in whatever environment they're comfortable engaging. So we've got a variety of platforms that we can deploy to make sure that we're educating and engaging our physician customers whether that's completely virtual, whether there's different interactive modules or whether it's in person. So we've got all of that infrastructure in place.

It's hard on the crystal ball to know exactly what all the variety of scenarios are that could play out here. But again, I come back to my comments that I previously made that we're just getting started. We've got a relatively small sales force compared to many other players that are out there. And we have 3 products. And so we feel that we'll be able to target effectively the customers that are the right mix for us. So our contingency planning is more how do we make sure that we're prepared to engage physicians in their local area in a manner that they're comfortable with and that's compliant with whatever the guidelines are.

In terms of what we're seeing on the ground, we continue to be encouraged by what we're hearing. I think because of Q2 being largely a shutdown quarter in many markets, we are definitely seeing a return of many patients out there. We are seeing, as we talked about before, practices implementing new protocols in social distancing, which is maybe not allowing them to see quite as many patients in the same amount of time, but some are extending hours, working Saturdays. And what we are hearing is that some patients are engaging in more procedures to make up for lost time. So we remain cautiously optimistic, and we are definitely hearing some encouraging signs from our physicians based on the patient interest that they're seeing.

And just one more on probably next steps now. You seem to have -- you have the best-in-class filler and neurotoxin and also added a disruptive payment processing system. Now there's still a lot left with $0.5 billion of cash. And I'll ask the same question that I did last quarter, what next? Are there any other aspirational gaps that you would like to fill?

Yes. Great question. I mean not at this point. I think particularly in the facial aesthetics market, if we go back over time, certainly not having a filler we thought potentially created a disadvantage for us relative to just having a long-acting neuromodulator, even though we thought we could be successful there. And then the other gap was just how are we going to provide a services offering to practices to address their desire for loyalty efficiencies, more productivity. And we think with HintMD, again, we got sort of a leapfrog solution there. So we're very confident in the assets that we have in the facial aesthetic market and are very focused right now on execution.

I think the thing to note though is we're entering a phase now where certainly, we need to execute well on the aesthetics side, but with 3 data readouts in our therapeutics franchise, I think that that's going to start to become more front and center. I think if anything, that the cash position that we have right now gives us a lot of flexibility and certainly, I think, helps us to the extent that there are any challenges in the existing COVID market where we continue to weather it and make sure that we can focus on driving long-term value.

Our next question comes from the line of Tim Lugo from William Blair.

On the therapeutics side with ASPEN-1 coming in November, can you remind me how you managed capturing the TWSTRS scores during the dates when the shutdown was impacted, and how many data points maybe were impacted and also how the baseline criteria ended up in the patients that came in versus expectations?

So a great question. Tim, I'm going to throw that over to Abhay to answer that.

Right. So taking back to your question on the TWSTRS score, the good news for us was that all our patients were enrolled before COVID first for CD. But this TWSTRS score actually validated how do you do assessment remotely. So when it came to assessing patients remotely, we had almost no impact or minimal impact on the quality of the observations that both the patients and the physicians were making. So we believe that from overall quality of data standpoint, it had absolutely no impact on our CD data.

Great. And the baseline, was it similar to other trials in the space?

Yes, pretty much. So I think that was a question -- we have not yet commented on the quality of patient data and how baseline looks like. So when we give you all the complete analysis in the fourth quarter, we will talk about how does the baseline compare to other trials.

Okay. Understood. And for JUNIPER, you ended a little early, how did -- can you remind me again, you enrolled 83 patients, but how many was initially intended to enroll? Do you have a high-dose, low-dose arm for that study? And maybe should we now just expect it not to be powered for -- to show [efficacy], it's just more of a kind of true Phase II now?

Yes, right. So it's a great question, Tim. So I think the bottom line is that when we planned the trial for JUNIPER, we had -- it's a 4-arm study, which is a low dose, medium dose, high dose and a placebo arm and a total of 128 subjects in the entire program. When we did the evaluation sometime in March, we realized that due to COVID, we stopped the trial, and we enrolled about 73 patients. At that time, we were confident that the program would eventually pick up after COVID would go -- pass away. But we saw some light sometime in June, and we started reenrolling patients around June 1 time frame. And then we realized that given the surges in the different parts of the country, and we talked about that in our press release, it was a pragmatic call on our part to make sure that how do we try to optimize our trial and get the data at an optimal time frame. So about 2/3 of the patients were enrolled. And if you look at the overall quality of the data analysis, what we realized that it has almost minimal impact on the powering of the study. What we will see is that we'll have a sufficient number of patients in each arm to give us good confidence as to what dose to pick to advance this program into Phase III, that is our goal right now.

Next question comes from the line of Serge Belanger from Needham & Company.

This is Tian on for Serge. I just had a few questions. First on the HintMD. In terms of the metrics, can you just generally describe what types of metrics that you plan to provide in the coming quarters, for example, number of subscriptions by the physicians or the patients or even the number of payments or transactions? So any details there would be great. And then just moving on to DAXI, have you had any label discussions with the FDA so far? And then do you expect, I guess, a late-cycle meeting to be also had with the FDA?

It's a great question. So I'll take the last 2 first. So in terms of the DAXI label and late-cycle meeting, again, it's company policy not to comment on the specifics around the engagement with the agency. However, as we did say in our scripted remarks, we continue to march towards the November 25 PDUFA date. And so right now, we're very focused on that date and hopefully approval. As it relates to the HintMD side of it on the data points, again, we're still early. When we announced the HintMD deal and the rationale, we talked about them being in roughly 175 accounts. In 2019, they generated $1.4 million in revenue. They had sort of 3 buckets of revenue. They had sort of partnership revenue, they had subscription revenue and they had platform revenue, which is really driven by credit card processing.

As we roll this out in conjunction with the RHA product and through the commercial sales force that we've put together, we want to get into the market, get some of the feedback and the traction there before we come back and start putting data points out there. We get that there's interest in the investor community to sort of understand how to measure the success of this. And as we have more confidence in sort of that slope and that runway, we'll certainly share it.

Our next question comes from the line of Kushal Patel from Guggenheim.

Just on for Seamus here. So a couple on the therapeutic opportunity, then maybe one on just the preview program for the fillers. So I think for the cervical dystonia ASPEN trial just for the full time line, I presume that's by November end but could be wrong there, so just clarifying that. And then for JUNIPER, I think there was additional color there. But basically, yes, understanding that it was paused due to COVID, was expected to read out in the first half and, obviously, just optimizing the trial there for shooting for lower patients there. So maybe just why the 128 patients initially and then without power being impacted with recruiting fewer patients. And then also just with time lines leading up to the Phase III start, just how could that be occurring earlier, just hoping to have some color in trying to understand time lines there. And then lastly, for the dermal fillers, just any color in terms of physician targeting or potential read-throughs for the pull-through for the full launch. I believe I heard $100,000 in sales there so just maybe pricing or maybe how many units were sold, really appreciate it.

Sure. So I'll try and make sure we capture all these. And maybe I'll start on the therapeutic and then hand it over to Abhay on the JUNIPER question. But on the CD side, yes, we've tightened that range up. We've talked a little bit about it previously being a second half, and now we're saying fall. So we're taking that range up, and we're getting closer. As Abhay also mentioned, that we're fortunate in that we fully enrolled the patients in the trial before COVID hit. So that program continues on track, and we'll be able to report that out. And then before I hand it over to him, on the JUNIPER side, you asked a little bit about sort of the Phase III and timing. I think we'll capture all of that as part of our 2021 planning cycle when we kind of communicate out what sort of our spend and priorities will be for 2021. Obviously, this year, we had a lot of different clinical programs going on. I think getting these data readouts in the different therapeutic side of it is going to help inform sort of the priorities and the investments that we make next year. And so we'll be sharing that as part of our 2021 side of it. Abhay, do you want to comment a little bit more on the question around sort of JUNIPER why -- if we were targeting a larger number, now we're at 80-something that we continue to feel that that's powered.

Sure. That's a good question. So for JUNIPER, I think I'm going to just reemphasize what I said earlier on, which is that we paused due to COVID. And when we paused due to COVID, as we also mentioned, we also started the program back in June -- on June 1. And then we realized that because of surge, it was challenging for us to really predict what time and how long it would take for us to actually enroll all 128 patients. So at that point, we restarted our trial and we were able to enroll about 10 additional patients, so a total of 83. Now the question is that when we had 128 patients before, which is about 32 patients per group versus 83 patients now, that gives you about 20 patients per group, we realized that in this particular situation, we have sufficient power, I would say, sufficient information that we can obtain so that because it's a Phase II program, we can at least be able to choose which particular dose will be beneficial for patients to go into the Phase III program.

So because the Phase II program was not powered for any pivotal trials to make a decision for filing, we did have an opportunity here to make sure that we can pick a dose and advance into the Phase III program for our trial. Having done that, in terms of time lines, we believe that we'll be able to get our top line data sometime in early part of next year. And then after that, we will decide after our next stage, with the FDA meeting with the standard end-of-Phase II meetings and trial, we would divulge more information about what the plan would be for our Phase III programs and later on.

Great. And then your question about sort of the preview program, dermal fillers and pricing, I just -- I'll make one comment, and I'll hand it to Dustin on that. The revenue that we announced in the quarter, as we stated in our prepared remarks, this is really about making sure that our systems were ready. And so it was great that we were able to bring product supply in from TEOXANE, make sure that we pressure-tested our commercial systems, we could pull it through, we could ship it to our distributor that's handling the product for us, get it into the hands of customers. And so we were able to pressure test all those systems and that revenue reflected kind of the successful accomplishment of that. And so it was less about trying to drive any real revenue but make sure that we were ready to go once we launch in September. And so maybe I'll hand it over to Dustin to talk a little bit about preview dermal fillers pricing.

Absolutely. Thanks, Mark. So as it relates to preview, our targeting exercise for preview is really in line with our overall market targeting strategy. And that is we're looking to create the prestige category. These physicians are focused on delivering outcomes and orient that above driving value on price. And so with that, we chose those physicians that are influencing on the podium, really understand the technology today. With RHA, it's the first technology we launched since 2008. They got experience with that product, now we're getting comfortable and helping us orient our launch plans. As we broaden that out, we'll then take that same prestige category segmentation and build that to the marketplace of the physicians. When it comes to pricing, our strategy on pricing has been clear. We believe that innovation warrants a premium. We will likely be launching RHA with a slight premium to the consumer side and ensuring that the margins for the physicians maintain and are focused on growing in the dermal filler space. As far as specifics for pricing, for competitive reasons, we won't go into the specific pricing at this time.

Our next question comes from the line of Douglas Tsao from H.C. Wainwright.

This is Chris Bialas on the line for Doug. I just wanted to understand a little bit more about HintMD. Have you had any interaction with Allergan regarding their intent to remain or exit the platform? And I also want to learn a little bit more about do you have a sense about the capacity of the practices that are open? Have any of them been affected by the resurgence in COVID cases?

Great questions. So first on the HintMD platform side of it, just for context, previously, Allergan had entered into a partnership with HintMD to integrate their billing distinctions, patient loyalty program into it. Since we've acquired them, our overall focus is a little bit different. It's to make it an open platform so that all partners that want to participate on it, all brands can. We have heard from Allergan that at this point, they're going to pull back and not continue to move forward with the partnership with HintMD, which when we did our sort of deal assessment and model, we sort of took that into consideration. And frankly, if you look at the value of the platform, the real value to us and in the model comes down to sort of payment processing, subscription services and then a host of brand partnerships. So we will continue to keep it as an open platform for those brands that want to participate on it. But for us, we really think that the value is going to lie in the payment processing, subscriptions and then the ability for us to create our own kind of white label loyalty program that puts the physician front and center.

In terms of the capacity of the practices and what we're hearing out there, again, it's wide ranging with each market sort of being its own situation, right? You've got some that have certainly pulled back in and have become a little bit more conservative after opening up. You have some who continue to operate as though they are unaffected. I do think that universally, what we have heard, for those that did shut down for a period of time, is that there was no doubt there was a large pent-up demand, and then that's sort of now coming back to a little bit more normal. And we did hear that patients are anxious to spend perhaps a little bit more money and do more procedures just because there's sort of pent-up demand and there are now maybe a variety of things that they want to get done that -- whereas in the past, they would have just come in for one thing.

So it's still, I think, to be seen what happens in the back half of the year. But certainly, through the preview program and the number of practices that we're engaging with on a regular basis, people are definitely doing cases, and there's a lot of interest out there. And there's a lot of consumers, frankly, who are home and who aren't off vacationing or doing other things that they might this time of year that are also looking at having aesthetic treatments performed.

This does conclude the question-and-answer session of today's program. I'd like to hand the program back to Mark Foley for any further remarks.

Great. Thank you, operator. In September, we plan to virtually attend the Wells Fargo, Morgan Stanley and Cantor health care conferences. We welcome your request for meetings at these events and directly through us. Feel free to reach out to Jeanie if you'd like to schedule some time. And with that, I would like to thank you all for participating in today's call.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.