Revance Therapeutics, Inc.

Revance Therapeutics, Inc.

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Biotechnology

Revance Therapeutics, Inc. (RVNC) Q3 2019 Earnings Call Transcript

Published at 2019-11-04 22:39:06
Operator
Welcome to the Revance Therapeutics Third Quarter 2019 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, November 4, 2019. I would like to turn the conference call over to Jeanie Herbert, Senior Director of Investor Relations and Corporate Communications for Revance. Ma'am, please go ahead.
Jeanie Herbert
Thank you, Towanda. Joining us on today's call from Revance is President and Chief Executive Officer, Mark Foley; Chief Financial Officer, Toby Schilke; Chief Operating Officer, Dr. Abhay Joshi; and Head of Commercial, Aesthetics and Therapeutics, Dustin Sjuts. Earlier today, Revance released financial results for the quarter ended September 30, 2019. If you have not received this news release 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 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 2019 financial results and guidance. The clinical development of our product candidates, business strategies and planned operations; anticipated precommercial and launch plans; 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 entitled, Risk Factors, in our quarterly report on Form 10-Q for the quarter ended September 30, 2019, as filed with the SEC on November 4, 2019. Revance cautions you not to place any 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?
Mark Foley
Thank you, Jeanie. Good afternoon everyone and thank you for joining our third quarter 2019 conference call. First, I want to say how thrilled I'm to be stepping into the CEO role at this very exciting time in the company's evolution. I assume the role with a deep understanding of Revance's strategy and potential, having served on the Board of Directors for more than two years. Part of the reason that I stepped back into an operating role is that Revance is one of the best opportunities in all of healthcare today. Based on my extensive healthcare experience were most recently, I served as Chairman, President and CEO at ZELTIQ Aesthetics and based on the Revance team that is already in place. I have high confidence in our ability to successfully commercialize our novel neuromodulator in the aesthetic market while unlocking significant longer term value in the therapeutic space. We are entering very exciting times of Revance as we're on the verge of several significant milestones and data readouts that have the ability to significantly enhance Revance's value. First, we plan to submit our Biologics license application for BLA for DaxibotulinumtoxinA for injection, or DAXI in the treatment of glabellar lines by the end of November. This filing will initiate and lead to a number of important achievements in 2020, including our first anticipated product approval for DAXI, the commercial launch of DAXI and the validation of its long-acting value proposition in the market. Additionally, we expect important data readouts that will provide valuable dosing information for our aesthetic launch by informing use of DAXI in the upper phase in therapeutics with top line results for both our phase II plantar fasciitis and phase 3 cervical dystonia trials. One of the reasons I'm excited about leading Revance is that DAXI represents the first and only true innovation in the neuromodulator market in more than 30 years. The clinical results across more than 3800 treatments are consistent, unmatched and unprecedented. In our clinical trials DAXI delivered exceptional response rates and a long duration of effect attributes that we think will make DAXI disruptive force in aesthetics and therapeutics upon approval. Our BLA package for DAXI is nearing completion and we plan to submit it to the FDA in November. Assuming approval in the second half of 2020, we expect DAXI would require a few as two treatments per year to provide patients with lasting, natural -looking frown line correction all year long. In support of our commercialization efforts were making excellent progress on many fronts. The SAKURA study is now online in the peer-reviewed medical Journal plastic and reconstructive surgery and is soon to be published in the prestigious Journal of the American Academy of Dermatology or JAAD. Our SAKURA data was also on podium with three key opinion leaders at the October American Society of Dermatologic Surgery annual meeting in Chicago. They shared pull data and segmentation analysis to support that DAXI is an appropriate, effective and predictable treatment option for all types of patients whether they are switching from another neuromodulator or new to treatment. From a launch perspective, Dustin Sjuts our Head of Commercial, continues to fill out our commercial management organization with several key new hires and I'm pleased with the quality and experience of the people that we have been able to track to the company. We now have the infrastructure and experience in place for successful launch of the market first premium and differentiated neuromodulator. To further explore the performance of DAXI in facial lines we're completing trials for four headlines in crow's feet, which together with glabellar lines represent the majority of neuromodulator used in the billion-dollar US facial aesthetics market. Both of these exploratory trials are now fully enrolled and should have readouts in the first half of 2020. We believe the dosing and injection pattern protocols can provide additional information to healthcare professionals they ask and want to integrate DAXI into their practice. Turning to our therapeutic efforts; we have a robust pipeline in this larger $2.5 billion global segment. Where we believe DAXI can bring significant benefits and provide a long runway of value. I'm excited to announce that we completed enrollment in our ASPEN 1 phase 3 cervical dystonia, randomized trial with 301 patients. As you recall ASPEN is a 60 center international study comparing DAXI to placebo. This data will inform how DAXI performs at larger doses in muscle movement disorders. Further, based on our discussions with the FDA, the ASPEN program will form the basis of the registerational package for potential approval in cervical dystonia. As previously guided we expect to announce top line results for that trial in the second half of 2020. Enrollment in our planter fasciitis phase II trial is on track and is expected to be completed before the end of the year. Topline results from that trial should also read out in the second half of 2020. Turning to upper limb spasticity, enrollment continues in our JUNIPER phase II trial and should be complete in the first half of 2020 with the topline readout of results in the first half of 2021. We continue to be very excited about DAXI opportunity in the therapeutics segment and believe DAXI can potentially achieve a leadership position in the initial indications we are pursuing. In the aggregate, our clinical team has accomplished an incredible feat in the last 12 months, completing the SAKURA phase 3 studies in glabellar lines, fully enrolling the ASPEN 1phase 3 trial for cervical dystonia, initiating four phase 2 studies in aesthetics and therapeutics and completing enrollment in two of them, all the working with the regulatory, quality, R&D and manufacturing teams compile the submission for our first ever BLA. This is been a truly momentous achievement for the company of this size. That covers our recent corporate highlights. Now let me turn the call over to Toby to summarize our third quarter financial results. Afterwards, I'll have a few closing comments before we begin today's Q&A session. Toby?
Tobin Schilke
Thank you, Mark. Starting with our cash, cash equivalents and short-term investment balance we ended the third quarter with $209 million. This figure does not include a $5 million milestone payment from Mylan under our collaboration and license agreement to extend their decision to move forward with the development of a biosimilar to Botox. We anticipate that payment for in the fourth quarter of 2019 and expect a decision from Mylan by April 30, 2020 on whether they have decided to proceed. In the meantime, we will address the program with limited spend through pre-IND activities. Revenue for the third quarter 2019 consisted of $46,000 recognized from the Mylan collaboration. Revenue from the Mylan and Fosun collaborations will fluctuate in the coming quarters as we make progress on the development of the biosimilar and DAXI respectively. Our OpEx during the quarter was $42.6 million, and excluding depreciation and stock-based compensation, it was $37.5 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 we said in the release, we have no change in our 2019 guidance. Revance expects 2019 GAAP operating expense to be in the range of $173 million to $185 million and our non-GAAP operating expense, which excludes depreciation and stock-based compensation to be in the range of $148 million to $158 million. We continue to monitor our funding profile in a thoughtful and prudent manner. Currently, we expect our cash runway to extend through 2020 and the anticipated approval of DAXI and glabellar lines. Finally, Revance's outstanding shares as of October 24, 2019 were approximately $45.1 million or $50 million on a fully diluted basis. With that I will turn the call back to Mark.
Mark Foley
Thank you, Toby. We are weeks away from submitting the DAXI BLA for the glabellar lines indication. Following this submission, Revance enters a catalyst rich calendar year of meaningful clinical and corporate events that we believe will culminate in the approval and launch of DAXI in the second half of 2020. We are busy writing ourselves to optimize DAXI aesthetics launch following approval while also continuing to advance our therapeutic programs in order to unlock longer term value. I look forward to introducing the first truly novel neuromodulator, since the category which created. With that I will now open up the call for questions. Operator?
Operator
[Operator Instructions] Our first question comes from the line of Annabel Samimy with Stifel. Your line is now open.
Annabel Samimy
Hi, thanks for taking my question. So I guess my first question, well first of all Mark congratulations on your move back into an operating role. And I guess maybe it's fair to ask you sitting from this perspective now it's a home. Are there any specific strategic initiatives or strategic plans that you envisioned might evolve over time as you're looking at this from a different position right now? And then I'm going to have few follow up questions. More specifically from a commercial prospective, I would say.
Mark Foley
Well first of this hits sort of at a broader level. I've been on the board for the last two and half years. So I'm obviously very familiar with the strategy and some of the key decisions that were made. So I would not expect any material change in the strategy. We need to continue to focus on making sure that we have a successful launch in aesthetics while also continuing to unlock significant value on the therapeutic platform which the deeper we get into it in the market research that were doing. We recognize that a long-acting neuromodulator has meaningful value and can take meaningful share in the therapeutic space. Having said that coming into my role I do certainly want to spend more time with the team, focusing on capital allocation. We know that were going to want to do all this over time. But the question is, you know which things do we focus on and at what point in time and we just need to make sure that we got our rationalize spend for we're delivering on. For your question about the launch of DAXI in the aesthetics market, we are in the middle of going through some additional market research, looking at different ways that we want to enter the market. So we're making great progress on that but I don't necessarily have anything incremental to at this point in time.
Annabel Samimy
Okay, so why don't I just move on the therapeutic indications for a minute. So FDA clearly wants to see how well DAXI performed movement disorders and the activity of a toxin in general is pretty well known and movement disorders given toxin broaden label there. So I guess the question I have is you mentioned that CD is going to be registrational studies, what are the chances as that each of the studies after you get a couple under your belt they are going to come much more comfortable with DAXI's performance and moment discipline order it's going to facilitate the path for additional moment detours that may not be studying but clearly have toxin sound great utilities in those areas?
Mark Foley
It's a good question; obviously CD is going to be our first in leading therapeutic indication that were going after. It's hard to speculate how the agency will look at subsequent submissions following this one. We will continue to work closely with the agency to structure the appropriate probably the data and as we have more information. So I don't know that we have got any unique insight there, it's kind of let's focus right trials getting the right endpoints and then charting a path forward from there.
Annabel Samimy
Okay and beyond CD what was the next? Sorry I missed what was the next trial that you expect to have sort of reading out after that?
Mark Foley
We got two, we got [indiscernible] and upper limb spasticity those are the two next readouts that we will have.
Annabel Samimy
Okay, alright great, thank you very much.
Mark Foley
You're welcome.
Operator
Thank you. Our next question comes from the line of David Amsellem with Piper Jaffray. Your line is now open.
David Amsellem
Just a couple and I apologize if you kind of covered this, but Mark just philosophically with look forth neuromodulator launching recently and having their results reported this morning. I want to get your views how pricing will involve in this landscape and this whole idea of a premium priced product or premium experience product as your predecessor has referred to actually its being. So the question is how do you feel philosophically about this idea of a premium experience product is that supportable in this kind of competitive landscape and is there any daylight between you and your predecessor on how you think philosophically got that? Thanks.
Mark Foley
Great, question. So I think first off, I think DAXI with the duration of benefit is really going to be sort of a first in the market from a launch perspective, I think all of the other neurotoxins you can lump into the category of short acting. So I think this will be new, it will be differentiated were bringing innovation into the marketplace. So I do think that our ability to generate excitement and interest will be even greater than kind of what we've seen in the past. As we think about pricing and positioning if you look at not only the aesthetics market, but other markets, innovation and material differentiated value propositions, command premiums in the market and I think right now in today's environment were more and more neurotoxins in the short acting category are coming into the market, that's inevitably going to put pressure on price over time. However, I think, with a premium product, you can certainly look to command a premium value in the marketplace and I think that consumers are willing to pay for a premium outcome. I think physicians will get rewarded more for providing a premium outcome as well. So we stopped work through the difference but I think there will be a little bit of a decoupling in terms of what happening in the short acting market and what we can deliver and command in the longer acting space because to the extent that the trial results that we see and the large number of patients that we've done remain reproducible in the broad base market then I think there, it will be good for the industry and we will follow the typical innovation curve or innovation that drives more value commands more price. So again I think we're going to stand out a sort of a very differentiated product offering versus looking at the market as it stands today.
David Amsellem
Okay that's helpful and again a question on the therapeutic program and the question here is as you look at the various programs and I realize that your decisions are going to be driven by data, but in a perfect world where you're not concerned about -- are there therapeutic areas that you think would be worthwhile for further exploration? Or put another way do you think that Revance is this focusing on the right things in terms of therapeutic development programs?
Mark Foley
For now I do, if you look at the therapeutic market, I mean globally it's $2.5 billion market and with a very differentiated product and the fact that you know, certainly if I go back to the aesthetic side, you got a very underpenetrated market. It's obviously a lot more straightforward to go into the therapeutics market as it stands today with a product that based on the data today suggest a meaningful duration benefit in healthcare system where fewer treatments drive significant cost efficiencies. We think that by coming in with this product in the existing therapeutic categories makes a lot of sense. We know that those markets are already fairly mature in terms of how care is delivered. And so those are the most logical ones to go into. And so if you look at the trials that we already embarked upon. We think that those are to give us really good information and insight into our product works in muscle movement disorders. Obviously migraine remains a very large market and as you know the biggest single category in the therapeutic side. So we have to rationally think about how we unlock value over time. In terms of areas that fall outside of current treatment indications today, obviously we gone into [indiscernible] which is sort of a category that's yet to see toxins neuromodulators move into that market but in terms of any other areas. I think right now we will primarily focus on the existing category with what we think is a better product.
David Amsellem
Thanks for the insight and I will jump back in the queue.
Operator
Thank you. Our next question comes from the line of Jacob Hughes with Wells Fargo. Your line is now open.
Jacob Hughes
Good afternoon. I have two questions, could you just comment on what kind of share you think the company can capture over the next few years? And secondly, if Mylan chooses not to obtain for the biosimilar program what are your options for that?
Mark Foley
Sure, so in terms of the share I think it's premature and necessarily to look at what kind of share we're going to take, that's going to somewhat related our launch strategy and commercialization footprint. Certainly, from our market research work that we've done thus far we've founded over 50% of consumers indicate that long-acting neuromodulator would drive some of their decision-making and based on the work with both physicians and consumers. We think it is the most important improvement that you could make on neuromodulator today. So it's hard to say shares but I do think with a very differentiated product and the right sort of commercial execution that we could be meaningful share takers in that market. Then your second question was on the Mylan side of it. If you step back, when we started this whole program, we had a number of other parties that expressed interest that the time we felt like Mylan was that the best partner at that time. We continue to advance that program, obviously Mylan looks to delay their decision a little bit because of some of the internal things that they going on and for that they paid us another $5 million. So we will get clarity in terms of whether or not they are going to opt in by the end of April and based on that decision we will then figure obviously whether we continue to move forward with them or whether we pursue an alternative path.
Jacob Hughes
Okay thank you and congrats on a new role.
Mark Foley
Thank you, appreciate it.
Operator
Thank you. Our next question comes from the line of Stacy Ku with Cowen & Company. Your line is now open.
Stacy Ku
Hi, all thank you for taking my questions. Congratulations on the progress. I have a few. As you approach one thing as to next year, can you remind us how we should be thinking about operating spend in 2020. And I have two more questions?
Mark Foley
We haven't given clarity on our 2020 spend certainly as we get through the details of this will be able to give you more color in terms of the spend side of it.
Stacy Ku
That's fair and also can you comment on timelines to file with DAXI internationally, how might this timing cogs with U.S commercial partner in discussions?
Mark Foley
That's a good question, for that I'm going to turn it over to Abhay to comment on that.
Abhay Joshi
So as we talked initially that our plans for international would be about six months after filing US filings and the goal would be that after you file the US and about six months or so we start doing to files for international market starting with EU first.
Stacy Ku
Finally regrind your Mylan program, should we be expecting any incremental updates prior to April 2020 and can you remind us of Mylan's financial contribution to the IND enabling studies?
Mark Foley
Today Mylan contributed $25 million upfront and an incremental $5 million so we stated out, $30 million and there are some opt in milestone payments and other payments that would be associated with this, but I don't expect us to give any more clarity prior to the end of April and less, for whatever reason, Mylan chose to make a decision prior to that, but that's really going to regulate and dictate the timing on this. Toby would add a little bit to that too.
Tobin Schilke
If you're looking for modeling purposes, you can look at how we recognize revenue or lead to spend on Mylan?
Stacy Ku
Alright, thank you so much.
Operator
Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open.
Douglas Tsao
Hi, good afternoon thanks for taking the questions. Mark a couple in terms of development. Just curious on as we get the phase 2 and for headlines and Crow's feet, would you plan on then conducting phase 3 study for those or do you think the data in terms of the phase 2, especially around dosing and technique would be sufficient to drive, or to have physicians use it on their own?
Mark Foley
Its great question, I mean the phase 2 data readouts that we're planning for will have sort of the efficacy data. We won't be necessarily have the full duration data at the time that we release those. But I think we will wait and see, right now in today's market, there's only one player that has indications beyond a single indication on the facial side of it. And clearly they have commercialize their product in aesthetics with a single indication, but will continue to sort of look at that and decide whether or not we think there advantages to advancing that into phase 3.
Douglas Tsao
Okay great. And then in terms of therapeutic, could you maybe give an update in terms of where the company is with migraine?
Mark Foley
I think what we previously said is that, we would look to potentially initiate trials in 2020 for the migraine program. Obviously, the other therapeutic programs that are already in rolling we reported on and provided update. So that's one that we are going to continue to look as a senior team, were continuing to go through the strategy and capital allocation decisions around that. So we certainly recognize the importance of migraine. So to me it's not an if, it's just a question of when and at this time I'm not willing to position to give any more clarity on that.
Douglas Tsao
Okay, fair enough. Thank you very much.
Operator
Thank you. Our next question comes from the line of Tim Lugo with William Blair. Your line is now open.
Tim Lugo
Thanks for taking my question and congratulations on what seems like a smooth transition. Maybe from a higher view DAXI is obviously coming to market with differentiated product. However, it still is only one product, how do you currently view the bundle that you would be competing against and just marketing against that suite of products from a larger competitor and also your larger competitor is obviously having some transition of its own. So can you talk maybe if you're hearing about anything from the sales force disturbances or anything from that transition which could be beneficial for that launched?
Mark Foley
I mean it's great question. I think because we have a product that is so unique and so differentiated I think it's certainly possible to have a successful commercial launch in aesthetics without any other products in the bundle and I think that certainly physicians will have alternative choices in other products in the bundle, certainly we seen with recent competitive entrance that with a single neuromodulator that they been able to successfully generate physician interest and patient interested in trying the product. So we don't believe that we need other products to be successful in the market because of our value proposition. Having said that we will continue to be mindful and if there are things along the way that we think can contribute to our success, create efficiencies, create more compelling offer for either the position of the consumer, we will of course continue to look at that. But I think right now we feel pretty good about how were able to launch it. And then the other party your question, I'm sorry.
Tim Lugo
Are you hearing anything about salesforce disturbances or anything that could be occurring from your large competitors own acquisition that could potentially benefit during your product launch?
Mark Foley
Not necessarily. I think it's kind of business as usual there, but I think we all know that in any acquisition that there's going to be some efficiencies that you try and capturing that, some people that are changing and so if you look at the two large players in the market right now both of them are undergoing or will be undergoing sort of meaningful changes in the way that those organizations are structured and it was the aesthetics market is very much of a high touch business certainly on the margin. It gives us an opportunity as a single product to really focus well and serve the customer needs.
Tim Lugo
Understood, thanks for the questions.
Operator
Thank you. Our next question comes from the line of Difei Yang with Mizuho Securities. Your line is now open.
Difei Yang
Good afternoon and thanks for taking my question, just a few here. The first one relate to the neuro-aesthetics [ph] market, given you where effecting millennial will play a major role in spending future market. How important do you think DAXI longer acting will play will be accepted by the millennial who are new to the market?
Mark Foley
It's a good question. We got a lot of market research that we done in this different category. I think the reality is this market is still so under underpenetrated along acting neurotoxin I think, resonates across all segments. So I don't know that it's fair to look at any given segment to sort of say is long-acting going to be more valuable on this segment or not. I think that with the work that we've done it it's going to resonate across all segments. And certainly we are seeing the millennial or the engagement of younger people in the aesthetic procedures earlier and I would like to think that a longer acting neuromodulator would certainly have strong appeal there as well just because it allows somebody to have full correction just coming in at a physician's office twice-a-year.
Difei Yang
Thank you and then most recently, one of your competitors assured acting neurotoxin received their European approval with a label that's longer than so with the label of 139 days which is typically, which is longer than our typical three, four months sort of wrinkle kind of label. How do you do that?
Mark Foley
Well, we're just very focused on running very robust clinical trials to demonstrate that the benefit of our neurotoxin is consistent across a wide variety of groups and so I think to the extent that our neurotoxin has really compelling data on duration. I think to me its speak to the fact that the agencies are certainly open to looking at the data and having a data reflected in the label. Certainly, if you look at our product and the reason that were different you can point to reasons for because of the stabilizing peptide in terms of why that might be. And we think it's really important in any of these that if you are going to show a duration benefit that they need to be randomized trials and so we feel that were running that type of gold standard clinical research that's going to be needed in these markets, I think that was evidenced by the acceptance of our SAKURA data in PRS. I think that that reflects the caliber of the clinical trials that we're running and we think that's ultimately going to be really important in terms of demonstrating duration.
Difei Yang
Thank you. Then my final question is on any updates from China?
Mark Foley
No real updates there, as you might recall from the deal that we structured with them. We are holding onto all the IT, and they are going to do all the commercial and clinical trial work on their end and so were still workings through, they are still working through the process to define what the clinical trial requirements going to be to get approval in that marketplace.
Difei Yang
Thank you for taking my questions.
Operator
Thank you. Our next question comes from the line of Serge Belanger with Needham. Your line is now open.
Serge Belanger
Good afternoon, couple of questions for me. Mark, you mentioned in the prepared remarks that you made some key higher on the commercial side. Can you just tell us whether additional key positions need to be filled there and what should we be thinking about salesforce sizing at this point?
Mark Foley
Yes, so I think on the where we're at right now. We believe that we got the right senior leadership and we just hired ahead of sales it's very experienced in the aesthetic marketplace and I think that if you look at the caliber of the people in the pedigree of where these people come from, they are coming from leading players in the space and know the market very well. And so I think right now we got the right senior leadership team in place on the commercial side and we believe we got all the right market research data to inform our go to market strategy. In terms of the number salespeople we haven't given that information yet and I think as we refine and tailor our strategy and planned which frankly, we probably won't be sharing until launch time probably for competitive reasons, but we will be a able to give a little bit more clarity just a high level in terms of the operating spend that were planning to invest on the commercial side as we get further along but we have it really articulated yet, what we're going to be doing in terms of the number sales reps.
Serge Belanger
And then on business development front, I think you been asked about, out licensing x-US commercial rights but is there also any appetite to in license an additional aesthetic products if you complement DAXI?
Mark Foley
Certainly the strategy of out licensing x-US rights is something that we continue down the path on an we will continue to look for who is the best partner in these other markets as evidenced by the close in relationship that we have. As I mentioned earlier, we don't feel that we need any additional aesthetic products to have a successful launch; we think that the product can be successful on its own. Having said that, we feel there are products that would bring value that would delude our efforts to successfully launch DAXI and can provide more value to the practice or the consumer than we would absolutely look at those things. But as it stands right now, we think that we can be successful with DAXI alone and so that's not a necessary part of our strategy.
Serge Belanger
Thank you.
Mark Foley
Great, thank you.
Operator
Thank you. Our next question comes from the line of Seamus Fernandez of Guggenheim. Your line is now open.
Seamus Fernandez
Great, thanks for the question. So just a couple Mark. Can you help us understand as we look forward to the cervical dystonia data in the second half of 2020. I believe there is a timeline, can you just help us understand the profile of the product and what would be clinically meaningful from your perspective and in terms of treatment duration and where the Botox treatment profile is getting us today in CD? And then the second question is actually on outlicensing to specifically European market, given the fact that most European regulators require a head-to-head type trial. What would be your typical comparator target product in that type of market. And again, if you could maybe break out it doesn't seem like that would be necessary in aesthetics, but perhaps in therapeutics that choosing a comparator asset likely would be required. So just wondering how you guys would think about the partners and the choice of competitor products in that type of situation. Thanks.
Mark Foley
Great questions. So I'm going to turn the question over to Abhay relates to sort of CD comparator what's meaningful and then we will take the second one from there.
Abhay Joshi
Seamus, the first part of the question was about how we think about launching CD and how CD trial was designed. If you go back to the phase II program we very strongly showed that compared to other approved products in the market where you have [indiscernible] as compared to as or did the trial comparing the endpoint that we chose. DAXI performed superb with 24 weeks of duration or longer for the clinical end points we chose based on twister score. So we had tremendous confident based on the data and trials to go to the agency. And as you all know that we launched our phase III program directly after that. So the phase III program is designed similar to our phase 2 study where the primary endpoint indeed based on the twister which is a Toronto specify twister scale two components to it, our primary endpoint is actively show that a change from baseline for the twister score at an average of 4 to 6 weeks and that is consistent with what we have done before in our phase II program and what other neuromodulars have done. And then secondary end points for this trial are duration of impact and again going back based on our phase 2 data. We expect to see similar profile.
Mark Foley
Then your comment on the duration difference between what we are seeing and what's typically in the marketplace?
Abhay Joshi
Then I think if you take the twister out of the equation, then there are couple of three products out there which have been approved based on different end points and different scales. So generally for cervical dystonia the product label is about 10 to 12 weeks and 10 to 12 weeks is the optimal level but the patient who actually start seeing a varying off a label around 8 to 10 weeks. You compare that to our phase 2 data where we have taken the product all the way up to 150 units we have shown in all categories in all different escalating doses that DAXI, open label study of effect, the [indiscernible] the million duration for DAXI was at least 24 weeks. So the comparing 24 weeks within duration vis-à-vis 8 to 12 weeks of the currently approved product in the market, that's almost two times as much delta you can imagine for DAXI.
Mark Foley
Before we answer the next question about Europe and sort of trial design and everything, I will say that we've done extensive market research to look at share taking in the therapeutic area based on the profile with longer duration and it's meaningful if you look at the healthcare cost and what's involved there. So, it was Abhay pointed out that 8 to 12 weeks in the existing sort of label products today versus 24 weeks, we think provides meaningful enough of value to drive share capture. And maybe on the second side also turn this one over to Abhay as it relates to think about the EU trials and the endpoints and whether there's any difference between aesthetic and therapeutic.
Abhay Joshi
So I think it's a pretty simple answer here, for the EU trials for aesthetics as you know we have our current global trial that was stand to the testimony of filing in Europe based on our data that we acquired in the U.S. In regards to the therapeutics I wish I better answer for you because you don't have a partner yet, as Mark mentioned that we're trying to have some collaborative work in your market place and depending upon who you work with will decide who the right competitor would be but its trial going forward. So at this point I would say stay tuned.
Seamus Fernandez
If I can just ask one quick follow-up question is it reasonable to consider the prospect of carving up the therapeutic and aesthetic opportunity in Europe with separate partners. I know that pricing can be a bit dynamic, I don't have a great sense of how pricing would come into would play into that, so just thanks for that follow up?
Mark Foley
I will hand it over to Dustin to hit that one.
Dustin Sjuts
I think as we look at it [Technical Difficulty] they are able to do that, but I think look at the best part of aesthetic and the best part of therapeutics and we make that valuation upon there.
Mark Foley
So we do feel that we can split them we would just need to obviously be mindful sort of the pricing side of things but whether we find a single [indiscernible] both or whether we divide them up, we certainly feel that's an option for us.
Seamus Fernandez
Thanks very much.
Operator
Thank you. I'm not showing any further questions at this time. I would now like to turn the call over to Mark Foley for closing remarks.
Mark Foley
Thank you, operator. I'm excited about my new role with Revance and I'm looking forward to meeting with many of you face-to-face in the coming months. In terms of our travel schedule, we will be conducting near term investor road shows in San Francisco, New York and Boston plus attending the credit Suisse, Guggenheim, Stifel and Piper health care conferences. Please reach out to Jeanie if you like to meet with us when you're in our area or if you like to schedule a call. With that, I would like to thank you all for participating in today's call. Have a great rest of the day.
Operator
Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect. Everyone, have a wonderful day.