Revance Therapeutics Inc (RVNC) 2020 Q1 法說會逐字稿

Welcome to the Revance Therapeutics First Quarter 2020 Financial Results and Corporate Update Conference Call. (Operator Instructions) As a reminder, this call is being recorded today, May 7, 2020.

I would now like to turn the conference over to Jeanie Herbert, Senior Director of Investor Relations and Corporate Communications of Revance. Please go ahead, ma'am.

Thank you, Stacy. Joining us on the call today from Revance is 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 first quarter ended March 31, 2020. If you've 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 the Revance's 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 clinical development of our product candidates, business strategy and planned operations; anticipated pre-commercial and launch plans; financial estimates with respect to TEOXANE distribution agreement; 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-K as filed with the SEC on February 26, 2020, and Form 10-Q to be filed shortly on May 27, 2020 -- May 7, 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 will now turn the call over to Mark Foley. Mark?

Thank you, Jeanie. Good afternoon, everyone, and thank you for joining our first quarter 2020 financial results conference call. I hope that you are all safe and well and that you are successfully adapting to the evolving landscape.

Before we begin, I would like to pay special tribute to the medical professionals, caregivers, first responders and essential workers on the front line of the COVID-19 crisis. In support of their efforts, we have contributed personal protective equipment to our local hospitals.

I would also like to recognize and thank the entire Revance organization for their adaptability, flexibility and resilience during these unprecedented times. Together, we are supporting others in need within our communities by providing weekly meals to a local soup kitchen and through a matching gift program to help fund 3 local and national charities providing critical support.

Like all companies across the U.S. and around the globe, we find ourselves adjusting to unforeseen circumstances caused by the COVID-19 pandemic and shelter-at-home directives. To this end, we have implemented a detailed COVID-19 infectious disease preparedness and response plan that will govern our work environment and which will continue to evolve as more information and guidance becomes available.

As we adapt to the new world shaped by the COVID-19 pandemic, Revance does so from a position of financial, operational and product portfolio strength. We are very well funded with more than $0.5 billion in cash and investments as of March 31. We have an FDA-approved RHA dermal filler portfolio, we are readying for launch in the U.S. in the third quarter. Our PDUFA date for DaxibotulinumtoxinA for Injection remains on schedule for November 25, and our key clinical development plans remain on track to deliver top line results for multiple Phase II studies and a Phase III pivotal trial this year.

In short, despite the challenging environment, we continue to be very well positioned and remain focused on delivering on our previously communicated strategy while adjusting as necessary. As previously announced on March 26, we shifted the hiring of our sales organization by 1 quarter to align with the new RHA dermal filler launch date in the third quarter. In light of that shift, we anticipate a modest impact on filler revenue for 2020 along with the reduction in sales force costs. Thus, we anticipate 2020 non-GAAP operating expense to come in at the lower end of our previously announced guidance.

Despite the challenging COVID market landscape, Revance still has a catalyst-rich year with a number of important milestones occurring in the next 6 to 7 months. We continue to make very good progress towards the achievement of the remaining clinical, regulatory and commercial catalysts for 2020.

A couple of comments on our pending commercial launch. First, we feel very fortunate to approach the market with 2 truly novel and differentiated product lines that we believe will appeal to both physicians and consumers alike. And despite the current market disruption, our third quarter launch timing should coincide with a more stable or new normal environment, particularly as we plan for a targeted rollout strategy. With a very strong balance sheet, we are in a position to ensure a properly resourced launch while also making sure that we have the right practice, support tools to meet the needs of our aesthetic customers.

During this shelter-in-place period, our team moved quickly to implement a virtual education and engagement program called operation resilience. It was designed to support Revance's steering committee members, investigators and key health care advisers. Over multiple interactive webinars and events, we engaged a group of key physicians and outside experts to discuss market impact, return-to-work strategies, consumer engagement, social distancing and other relevant topics. In these sessions, we heard that many practices are anticipating pent-up demand and are eager to open or are already in the process of reopening with certain safety procedures in place. Thus, we put together a working group on return-to-work best practices, which is focused on practical issues such as access to PPE, office protocols and social distancing logistics. We received heartfelt thanks from this core health care group for the program content, engagement and for creating a space for the professional community to connect with each other via videoconferencing.

As far as the market dynamics in aesthetics, during the recession of 2008, 2009, while plastic and elective surgeries were down 20% to 30%, facial injectable procedures were fairly resilient. The U.S. aesthetic neuromodulator market shrank 5% in 2009 and returned to growth rather quickly. Likewise, hyaluronic acid fillers were also resilient with the U.S. dermal filler slowdown of 9% in 2009 and a quick rebound to growth in 2010.

While it's difficult to predict the true impact of the COVID-19 virus on aesthetic practices and consumers, we've heard from many leading practices that they do expect pent-up demand from their regular facial injectable consumers. To account for this, many of these leading practices are telling us they plan to work nights and weekends to accommodate consumer interest while taking into account the social distancing requirements and prevention strategies which will impact the number of patients they can see in a given day.

From our perspective, in the U.S., we anticipate that aesthetic procedures will experience a significant slowdown in the second quarter, followed by a modest recovery in Q3 and then a return to growth in Q4 off of a lower base. However, despite the economic impact, safety concerns and social distancing logistics associated with the coronavirus, the underlying growth drivers remain strong and will continue to create demand going forward.

Fortunately for us and where we are in our product launch cycle, Q3 for the RHA fillers and Q4 for our neuromodulator, we will be introducing our products into the market at a time when we expect that aesthetic practices and consumers will have settled into the new normal. Also, in taking into account our targeted launch strategy and phased rollout approach, we expect that we will be introducing our innovative products into a much more stable environment than we have today. And it will be at a time when we believe that new novel products with a differentiated value proposition will be well received.

In terms of our value drivers, our nearest commercial catalyst is the launch of our RHA 2, 3 and 4 dermal fillers. As shared previously, we shifted the launch of our RHA fillers by 1 quarter due to the COVID-19 situation, which caused a temporary close -- which was caused by the temporary closure of TEOXANE's Swiss manufacturing facility. We are currently targeting a third quarter launch while being pragmatic about timing. We remain in close contact with TEOXANE, who recently shared with us that they have reopened their manufacturing facility and that they plan to have sufficient product supply to support our third quarter launch.

Now let me hand the call over to Dustin to provide an update on our commercialization plans. Dustin?

Thanks, Mark. As Mark mentioned, Revance is fortunate to face this market situation with unique timing, products and strategy. Our commercial team is in a robust launch planning phase with the right flexibility in our sales team onboarding. We are maximizing this time to engage virtually with key investigators and health care professionals to learn from and to support them in this unusual situation.

In addition to physician training and engagement, we are using this time prior to the launch of our RHA dermal fillers to progress and refine all aspects of our commercialization infrastructure and plan. We've completed the hiring of our regional sales managers, who have, in turn, been utilizing web-based interview tools to select top field sales talent. We are making prudent decisions on the timing for each field rep while targeting a majority of the onboarding for mid-summer. Approximately 40% of our territories are filled with the remaining offers to be extended throughout the second quarter.

With the first shipment of the RHA dermal fillers just a few months away, our regional managers are planning hands-on training for select accounts and key opinion leaders. Our first step is to put samples of the products in the hands of key injectors to develop confidence in this new technology. This will be followed by a broader training and product sampling program scheduled to take place after our national sales meeting in the third quarter.

Our marketing initiatives and infrastructure build-out continues to progress against our launch imperatives. Our marketing team have leveraged this time to commence virtual faculty education and engagement sessions with experts and trainers from Europe, who bring knowledge and expertise on the RHA technology.

Finally, we've begun implementing multiple infrastructure systems, integrated platforms to support commercial operations, including a CRM system, physician training tool and customer service technologies. These systems are either live or nearing finalization. Our customer service team is fully hired and training is nearly complete. We've also welcomed new members of -- new team members leading HCP education, sales training and business analytics as well as new commercial HR and legal partners to support our imminent launch plans. With the addition of these new hires and our existing team, our commercial foundation is in place and well prepared to execute.

While COVID-19 continues to remain an evolving situation, some practices, depending on geographic location, began to schedule injectable appointment and elective surgeries starting May 1, and 12 states are already open for elective procedures. We know that luxury spending is surprisingly resilient during economic recovery with the aesthetics neuromodulator market growing 35% from 2009 to 2013, while the overall market growth was only 15%.

As the market for injectables has grown, many consumers consider treatment of personal care a necessity. The introduction of our innovative product portfolio will be part of our creation of a new prestige category in aesthetics. Our offerings in this category are comprised of products, services that are expertly created to produce an exceptional experience available exclusively through select medical aesthetic practitioners. Ultimately, it will give dermatologists and plastic surgeons something truly new to offer their patients that delivers real value and transforms patient experiences.

Overall, our team is on track and focused on the anticipated launches of FDA-approved RHA 2, 3 and 4, the first and only dermal fillers indicated for the correction of dynamic wrinkles and folds and Revance's next-generation neuromodulator, DaxibotulinumtoxinA for Injection.

With that, I'll turn it back over to Mark.

Thanks, Dustin. Now let me cover DaxibotulinumtoxinA for Injection. To date, we have not received any indication from the FDA that our PDUFA date will change and our commercial launch is still planned for year-end. Revance is a vertically integrated manufacturer with DaxibotulinumtoxinA for Injection produced at our headquarters in California. As a result, we've been fortunate to avoid any supply chain or production issues related to the COVID-19 situation, and we continue to work with the FDA toward our November 25 PDUFA date. Once we combine DaxibotulinumtoxinA for Injection with our range of RHA dermal fillers, we'll have a synergistic portfolio of products that will establish a whole new prestige segment in the facial injectables market and that will provide both physicians and consumers with a truly differentiated alternative.

As to our active clinical programs, we have been fortunate that most of our clinical trials have not been impacted by COVID-19. Notably, the ASPEN-1 Phase III cervical dystonia, Phase II plantar fasciitis and 2 of the 3 Phase II trials in the upper face studies were fully enrolled and dosed before the U.S. outbreak of COVID-19. All subjects in those trials have passed through the primary end points and are completing the final assessment visits, done either in person or remotely

The single exception is our JUNIPER Phase II adult upper limb spasticity trial in which enrollment has been paused due to challenges in subject assessments during a time of required social distancing. We will provide a new date for expected full enrollment after the trial is reopened and an enrollment trajectory is established.

We still expect to have top line results for the ASPEN-1 Phase III cervical dystonia and Phase II plantar fasciitis trials in the second half of 2020. I also want to note that the ASPEN open-label safety study has hit its target enrollment number, so the whole cervical dystonia program remains on track.

As to the 3 facial aesthetics programs, we continue to expect we'll complete the forehead lines and crow's feet trials in the second quarter and the upper facial lines trial in the fourth quarter. We plan to present those results at upcoming medical conferences.

A quick note on the biosimilar asset. As we noted in a brief press release on May 1, we are still in discussions with Mylan regarding the biosimilar to BOTOX program. Before making their decision as to whether or not they want to opt in, they asked for time to review the recently provided data with their team in the collective steering committee. We now expect a response by the end of May.

With that overview of our first quarter and recent activities, let me 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 first quarter with $511.3 million, which we believe is sufficient to fund the company into 2023. This balance includes proceeds from the $287.5 million convertible senior notes we issued in February.

Revenue for the first quarter 2020 consisted of $58,000 recognized from the Mylan collaboration. In the first quarter, our OpEx was $61 million. This included a onetime noncash purchase accounting charge of $11.2 million allocated to in-process research and development, reflecting the relative value of RHA 1 and other unapproved future advancements related to the TEOXANE distribution arrangement. Excluding depreciation, amortization, stock-based compensation and the RHA-related in-process R&D, our OpEx was $42.6 million.

The earnings release we issued today outlines our financial results in full, so I won't go through the details on this call.

As to our 2020 guidance, in February, we issued 2020 GAAP operating expense guidance of $270 million to $280 million; and non-GAAP operating expense, which excludes depreciation, amortization, stock-based compensation and the RHA-related in-process R&D, of $220 million to $230 million. Due to the shift in hiring of our field force, we expect both 2020 GAAP and non-GAAP OpEx to come in at the low end of that range. Revance still expects 2020 non-GAAP 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 our RHA filler line. We will, however, provide updates on our progress as we approach the market.

Finally, Revance's shares outstanding as of April 24, 2020, were approximately 57.1 million with 62.4 million fully diluted shares, excluding the impact of the convertible debt.

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

Thank you, Toby. We believe Revance is very well positioned to manage through the COVID-19 situation with minimal disruption to our previously stated commercial and clinical development plans. And as we look ahead to the remainder of the year, we are very excited about the many meaningful milestones and catalysts that we have in front of us to build out our aesthetics and therapeutics franchises. The excitement is mounting as we prepare for 2 significant product launches this year, and I'm personally looking forward to providing you with updates along the way.

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

(Operator Instructions) And your first question comes from Jacob Hughes, Wells Fargo Securities.

So I was wondering -- a couple of questions. Just given coronavirus and all, can you give some additional color on where TEOXANE is from a manufacturing standpoint? And what do you get to -- when do you expect to get to the right inventory levels?

And then secondly, just given the economic dynamics, how you're thinking about pricing for the filler launch and associated bundling with DAXI?

Yes. So great question. So first on the TEOXANE supply, I think as we've mentioned in our prepared remarks, they did shut down due to the virus. Similar to us here, they had a shelter in place, and so they couldn't manufacture. They've recently reopened their manufacturing facility, and we've been in routine communication with them. So they feel very good about their ability to provide us product for our Q3 launch. So we feel very good about that current launch timing.

In terms of pricing and bundling, again, we'll share that when we get closer to the market. But right now, we don't think that there's going to be a necessity to sort of change our overall strategy. We're going to be very targeted in our approach. If you look at these practices today, they're seeing fewer patients, even though the demand is there, because of the social distancing requirements. And as a result, there's frankly not a huge incentive for them to try and discount as they have sort of fewer office visits coming through. We expect that, that will ease over time. But our current thinking is that the pricing strategy that we have previously put in place still holds, and we'll provide more details on that once we're in the marketplace.

And your next question comes from Terence Flynn, Goldman Sachs.

This is Missy on for Terence. How far along would you say that you are in your commercial prep work? And how many of -- and how much of the costs are fixed versus variable? And then -- and kind of following up on that, what would you say the size is of your target prescribing audience relative to your competitors? I know in the past you guys have mentioned that you're targeting kind of higher-end customers for both products.

Yes. So Missy, great question. So the first one on the commercial preparations, we were originally planning to launch in Q2. So we had made pretty good progress in terms of a lot of the infrastructure and everything that we needed to have in place from a launch logistics standpoint. We had started moving down the path of bringing on our regional sales managers. And frankly, we were working on a pretty aggressive and tight time line. When obviously, it became apparent that with COVID 19, we weren't going to have product, the shelter in place, we delayed the hiring of our entire field sales organization. So we largely have the regional managers in place, of which there's 12 of those, and then we held on the others. But we made a lot of investments in the systems that were going to be needed to ship products and recognize revenue. And frankly, this extra time has given us a little bit more of an opportunity to make sure that we're fully ready on that side of it. So right now, we don't have any sales reps on board, so that's not a cost that we're currently incurring. And we've been able to shift the onboarding of those reps to Q3 to coincide with the launch of the product.

In terms of the size of the market, we've given context and color that said we're going to start with kind of 100-ish type of reps. And as a result, because of that size, there's obviously a limit to the number of accounts that reps can call on. And so because we're bringing sort of these premium or prestige products into the marketplace, we're going to be targeted in the physician and injector accounts that we call on, and they're naturally going to be the busier or the higher end practices. And so I don't know that we can actually give you a sense for exactly what portion of the market is, but we feel very good that with those 100 reps that we'll have a good number of accounts for each of them to manage and handle, and that will allow us to enter the market from a position of strength.

And your next question comes from Balaji Prasad, Barclays.

A couple from me. Firstly, you're in a good position with more than $0.5 billion of cash. And with the current COVID influence changing the situations, do you see a potential for any opportunistic business development activities as other businesses face cash flow issues? Do you think it's time to go shopping?

Well, I mean, I think we're always going to be sort of disciplined buyers of assets that we think can add value to the company. So even though we've got a strong cash position, that's not going to necessarily change our strategy. It's certainly true that there might be some assets that are a little more attractively priced, but we really like where we're positioned today in the injectable market. We think we've got 2 great assets where there's a ton of synergy and leverage with our field team and with the practices.

And so I think we're going to be very focused on, first and foremost, making sure that we can ensure a really good launch from those 2 products. But certainly, as we go forward, we recognize that there are a number of different factors that ultimately contribute to success in the marketplace. And if we find things that make sense and that we think are at the right value, then absolutely. We're looking forward to building out kind of a world-class aesthetics franchise and a therapeutics franchise. And so we will continue to be opportunistic as we move forward, while also being very thoughtful and disciplined about making sure we've got our priorities in the right place.

Great, Mark. Secondly, on the RHA launch being moved to Q3. I just wanted to understand if this is purely a question of change of timing or is there a change in strategy? And also on a related question, is there any impact on the RHA 1 launch for -- in 2021?

Yes. So I'll take the latter one first. The timing of the RHA 1, we're still looking at that as a 2021 approval, so we continue to feel good about that. On the overall strategy for our RHA launch, really no change. We've always talked in the past about starting with kind of a sampling program to get experience and to build sort of a good user base before we move into the next phase of the launch. I think that's still very much intact. Again, we feel like with this extra time, we are able to put sort of a few more materials and tools in place to ensure we've got the right launch. But at this point, no change in strategy. Of course, we'll continue to be very mindful of the environment. As we talked about in our prepared comments, we do like that we're starting obviously to see different states coming online, people starting to see patients and returning to what they do. So by the time we launch in September, we'll have the benefit of a couple of months of things coming back to normal. And so we'll certainly be sensitive to those things, but right now, we're not anticipating any change in our strategy.

Great. Just one final one on biosimilar BOTOX. I was under the impression that there was nothing to -- for you to provide in terms of data sets to Mylan, and you mentioned in your prepared remarks that you provided them some data recently. What was it about? And also, any updates on backup plan for -- versus Mylan?

Yes. Well, so first off, I think we continue to be very encouraged by this program. I think that with where we started and having natural questions about whether or not there was a true 351(k) biosimilar pathway, we obviously got -- had encouraging dialogue with the agency. And through some of the characterization work, it's continued to give us a lot of confidence in this program.

In terms of the delay in the opt-in decision by Mylan now being the end of May, no, I mean we've been working really well together with them. This is obviously a big decision for both sides. And while the steering committees have been working really closely together, there was some additional information that we provided them recently that they just wanted to make sure that they have the appropriate time to review before giving us a final decision. So we think Mylan has been a great partner, and so we look forward to getting their results, but we also have a lot of confidence in the program and feel that we've made a lot of progress with it.

And your next question comes from Annabel Samimy, Stifel.

So Mark, you've been pretty good staying in front of your KOLs and engage them to assess their sort of mood and readiness. How -- we've -- you talked about how a lot of these patients -- these physicians have pent-up demand. How do you think that they're going to reconcile the demand that they have with the appropriate social distancing that they need to not have a tremendous flow-through the office? And will they be able to accommodate the 2? And can we potentially see a slower recovery because of that?

I guess the other point I wanted to mention was that there's a lot of commentary around how TOXINS are the first product that these physicians will likely go to. So is the market ready for a new filler launch? When you think about that launch, will you have to potentially implement a longer sampling program to sort of wait for these practices to recover a little bit from that?

Great. Thanks, Annabel. Great question. So maybe first off on the physician side, what are we hearing out there? So I think the first thing is that they're not all the same, right? So it's easy to get a little bit myopic based on sort of the area that you live, but each state is different. And you find that if you're obviously in New York or another area that's been hit a little harder, I think that the process stack is going to be a little bit different. But having said that, I think that there's -- pretty much universally across the board, they are all going through a fair bit of effort to ensure a safe work environment, safe environment for their patients and are taking steps to clean and create more distancing for the patients. And so what that means at a high level is that they're not able to see as many patients as they were before in a given day, so it's created a little bit of a bottleneck.

I think to try and address this, some are going to have longer hours or more flexible hours, maybe even work some weekends. And so right now in this early phase, what we're hearing is that most have no shortage of patients, they just have a limit in terms of the number that they can move through their practice in a given day. And so I think that's going to evolve over time. I think as this plays out and they get more comfortable, patients get more comfortable, I'm sure they will figure out a way to try and take care of what is probably a larger demand than what they can deal with today. And so the fact that we won't be launching our filler until September and then our neuromodulator not being approved until later this year, we think that there is going to be an evolution. And that by the time we hit the market, they will probably have figured out some ways to address a little bit more of the throughput.

To your question on the filler, like is this a good time to be launching a filler and versus a neurotoxin? We've heard the same thing. There's no doubt that with regards to the facial injectables, which I think across the whole aesthetic landscape are probably going to be the ones that will recover first, but some has certainly expressed an interest in wanting to start with neuromodulators first than the fillers. Having said that, we know that filler procedures are going to take place. Patients are going to have an interest in it. Physicians will find out a way to safely do this. And so we think it's going to be there. And frankly, it aligns with our very targeted launch strategy. We're going to be working with these thought leaders. We're going to be working with accounts that are very comfortable with fillers that have figured their way out around this. And our neuromodulator is only a quarter behind. And even though we're going to do a very sort of phased launch with this, it's not going to be that far behind.

And one thing that I would note, we've long talked about what we believe is a really important value proposition with a longer-acting neuromodulator. But certainly in today's social distancing environment and the limited number of patients that you can move through a practice, we actually think that the long-duration profile is going to resonate even more with both consumers and with physicians that only have so much time in a day and want to deliver as much value as they can. So high level, we continue to feel good about our strategy, no change there. And hopefully, that gave you a little bit more color in terms of how we see the market right now.

Your next question comes from Difei Yang, Mizuho Securities.

This is Dan Clark on for Difei. Just one from me. On the Mylan decision, do you think there's a chance that they could come back to you asking for more data? Or would you say at this point, you've been pretty comprehensive in what you've given them?

Yes. We feel very good with this. I think we both understand sort of the importance to get this right. And through our discussions with them, we expect a final decision by the end of May.

Next question, Tim Lugo, William Blair.

Congratulations to the team as they're navigating with a difficult environment. I guess, Mark, following up on Annabel's question about what you're hearing from physicians, I assume training is going to be part of the filler launch in addition to sampling. When do you expect the market to kind of be amenable to training sessions and kind of the state by state marketing efforts that you'll likely have to deploy as part of the launch? And is it -- I almost assume when physician practices reach a new normal that kind of maybe new therapy and training seminars aren't the initial focus for physicians. Can you just kind of walk me through that a bit?

Yes. I mean I think like with everybody, we're having to sort of adapt and have 2 programs, right? One, our in-person; and two, our remote training tools, and so both -- with -- for our own internal training and then for physician training on new products. And so we believe that we can effectively accomplish whatever sort of the training requirements are going to be, either in-person or remotely. There's no doubt that with any new product, there's going to be some subtleties that need to be incorporated and that people need to understand, but this group that we're going to be targeting are pretty familiar with filler injections. And I think there's already a lot of excitement about getting their hands on this because it's a pretty well-known product line in Europe and many of them have talked to colleagues there.

So this isn't going to require sort of a huge readjustment in terms of how they think about it. And so we believe that for those physicians that are really excited about the product line or excited about offering their consumers something new that we can provide the right sort of remote training program to get them off to a good start if that's what's required. We'll be ready to go either way and we think we can be effective there.

And then certainly with our neurotoxin, as we get there as well, there's obviously going to be 3 Phase II studies around dosing and patterns. We've obviously got our Phase III studies that are out there as well. And likewise, I think there's a tremendous amount of interest in people using this. Again, particularly as people look at -- if there's a way to have something last longer and they don't have to go back into an office soon afterwards, we think that, that's going to create a lot of interest. So we're going to have to be creative there, but again, we feel really good that we'll have the tools to be able to navigate this environment.

Okay. That makes sense. And maybe pivoting over to the therapeutic side for cervical dystonia with the top line still expected in the second half of the year, have there been a number of patients that maybe have missed their protocol-defined windows for TWSTRS assessments at all in the trial? And how do you plan on handling any data that may come if patients aren't able to execute on their assessment or physicians can't execute on them given COVID?

Yes. No, I think, as we mentioned, we're fully enrolled in the trials, even on the open-label side. We're now kind of past sort of the minimum number that we need. There were some patients that we still need to follow-up, but we think that through either remote or in-person that we're going to be able to get all of the data that we need to wrap this up. So fortunately, that has not been an issue for us.

Next question comes from Georgi Yordanov, Cowen.

My first question is, if you could talk about your plans for DTC marketing such as social media and what would be your timing for it. And secondly, as we near the results for the forehead and canthal line programs, could you remind us of these 2 opportunities? And what should we be looking for in terms of results?

Go ahead, Dustin.

So on the -- thanks for the question. On the DTC side, I think, obviously, consumer demand definitely drives this market. However, the first thing we've got to focus on is making sure that the outcomes are aligned with the physicians and those practices have experience with the technology. So our focus will be, first, making sure that they are -- the physicians themselves have that product, they've been trained, they also are focusing on the right outcomes. And then at the right time, we'll pull through some of the digital components around our DTC strategy and consumer demand. We think we've got a compelling story with the combination of those 2 products, with both RHA and DAXI, and we'll look to leverage the uniqueness of that product profile together. On the second question, it's on the...

It's on the forehead and the lateral canthal lines. So that we've got the forehead, the lateral canthal and full upper face, so those Phase II trials will all be completed and data available by the time that we have our neuromodulator approved. And so those are going to provide additional details and data around sort of injection patterns, dosing and everything. So by the time that we go into the market, they'll not only have sort of the information from our SAKURA studies, but they'll have additional information around -- again, how these products are used in other areas. And again, these are largely focused on sort of the 30-day efficacy because this is really more of an efficacy, making sure we've got the right dosing there. So we think the combination of all this will address most of the areas where physicians inject today.

(Operator Instructions) Your next question comes from Seamus Fernandez, Guggenheim.

Great. So just a couple. Mark, as you look at the environment as it stands today, can you just help us understand. It seems to me like you have a really unique opportunity to maybe get even more aggressive with this launch. And I'm just wondering if you've -- or you've thought about considering whether it be through the -- the situation just seems optimal for getting more aggressive with the launch because physicians are going to be working harder to satisfy their patients. You've got a longer acting treatment here. So I don't know if there's opportunities that you see in the midst of this crisis to actually -- to drive more and potentially faster uptake.

And then the second question is just as we think about global out-licensing opportunities of DAXI, can you just help us understand how you're thinking about the pushes and pulls of out-licensing versus maintaining control of the assets as it relates to potential overall thoughts for Revance as a company?

Yes, Seamus, great questions. So first, in terms of the launch strategy and ramp, if you go back and you sort of look at what we're trying to accomplish in this early phase of our launch, we really feel strongly that with the new product, we need to make sure that we get it anchored on a really strong foundation with these physicians. And so that means getting some sampling programs, getting comfortable. If there's any tweaks or changes in technique that we give that opportunity for that to happen. And so as a result, I don't think we want to necessarily take what could be an opportunity to accelerate the launch and skip over that, what we think is a really important position.

Having said that, in this market today, certainly with a longer acting neuromodulator, there's some unintended and unexpected potential benefits there that obviously didn't exist before COVID-19. Certainly, we always felt like a long-acting profile was something that consumers wanted and that would be well received, but we looked at it more in the context of overall classic market segmentation. So in this market today, where, again, physicians can't see as many patients, are trying to make sure that they get fairly compensated for the work that they're doing, the only way that you tend to take price in these markets is if you have a product that has a very differentiated performance profile, and we think we can offer that. And certainly, on the consumer side, to the extent that they're trying to minimize the frequency of visits in the practice, certainly, in this time frame, we think that will resonate well.

The reality is this is going to continue to evolve and change. And so by the time we're in the market, we might be back to some new normal. And again, we really like the product profile. So right now, we don't necessarily see a change in our overall launch strategy or the pace of the uptake. Having said that, we'll continue to revisit it. If once we build the sort of anchor foundation, some of these poles exist in the marketplace, we will obviously toggle sort of our sales force coverage accordingly.

The second question that you had in terms of the global strategy and how we think about outside the U.S. We still look at this as where we'd like to control the rights to the product in the U.S. and that outside of the U.S., we will look to partner it. There might be some markets that lend themselves for us managing them directly. But overall, we think that, that's a winning strategy, is to find a good partner, partner with them outside of the U.S., both for the aesthetics and the therapeutics.

The aesthetics program has always sort of outpaced where we were on the therapeutic side. So we focused a lot more on the commercial side. But as we now move into the back half of the year, and we have 2 really important data readouts for cervical dystonia and plantar fasciitis, we think that the read-through on the CD program, in muscle movement disorders and the read-through on plantar fasciitis and pain disorders is going to bring our therapeutics program a lot more front and center. And so I think that's going to be the right time for us to dig in a little bit deeper on how do we think about the therapeutics program and opportunities. And so we're spending a lot of time on that, but I think that will come into clarity a little bit more in the back half of the year.

And there are no further questions.

Great. Thank you, operator. In these travel-constrained times, we are committed to using technology to keep in touch with our shareholder base. We plan to attend near-term conferences virtually, including the Goldman Sachs Healthcare and William Blair Growth Conferences in June, and welcome your request for calls over the next few months. Please reach out to Jeanie if you'd like to touch base. With that, I would like to thank you all for participating in today's call, and please stay safe. Thank you.

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