Revance Therapeutics Inc (RVNC) 2019 Q3 法說會逐字稿

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 now like to turn the conference over to Jeanie Herbert, Senior Director of Investor Relations and Corporate Communications for Revance.

Ma'am, please go ahead.

Thank you, Twanda.

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 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 strategy and planned operations, anticipated pre-commercial 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?

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 am to be stepping into the CEO role at this very exciting time in the company's evolution.

I assumed the role with a deep understanding of Revance's strategy and potential, having served on the Board of Directors for more than 2 years.

Part of the reason that I stepped back into an operating role is that I view Revance as one of the best opportunities in all of health care today.

Based on my extensive health care experience, where most recently, I served as Chairman, President and CEO of 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 therapeutics space.

We're entering very exciting times at Revance as we are 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 or 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 face.

And in Therapeutics, with top line results for both our Phase II plantar fasciitis and Phase III 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 3,800 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 a 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 as few as 2 treatments per year to provide patients with lasting, natural-looking frown line correction all year long.

In support of our commercialization efforts, we're 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 3 key opinion leaders at the October American Society of Dermatologic Surgery annual meeting in Chicago.

They shared pool 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 very pleased with the quality and experience of the people that we have been able to attract to the company.

We now have the infrastructure and experience in place for a successful launch of the market's first premium and differentiated neuromodulator.

To further explore the performance of DAXI in facial lines, we are completing trials for forehead lines and crow’s feet, which, together with glabellar lines, represents the majority of neuromodulator use in the billion dollar U.S. 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 health care professionals should 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 benefit and provide a long runway of value.

I'm excited to announce that we completed enrollment in our ASPEN-1 Phase III 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 registrational 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 plantar fasciitis Phase II trial is on track and is expected to be completed before the end of the year.

Top line 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 a top line readout of results in the first half of 2021.

We continue to be very excited about DAXI's 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 III studies in glabellar lines, fully enrolling the ASPEN-1 Phase III trial for cervical dystonia, initiating 4 Phase II studies in aesthetics and therapeutics and completing enrollment in 2 of them all while working with our regulatory, quality, R&D and manufacturing teams to compile the submission for our first-ever BLA.

This has been a truly momentous achievement for a 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?

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 fourth quarter 2019 and expect a decision from Mylan by April 30, 2020, on whether they've decided to proceed.

In the meantime, we will progress 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 in 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.

Thank you, Toby.

We are weeks away from submitting the DAXI BLA for the glabellar lines indication.

Following the 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 readying ourselves to optimize DAXI's 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 was created.

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

Operator?

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

So I guess my first question is, well, first of all, Mark, congratulations on your move back into an operating role.

Thanks, Annabel.

You're welcome.

And I guess, maybe it's fair to ask you from sitting from this perspective now at the helm, are there any specific strategic initiatives or strategic plans that you envision might evolve over time as you're looking at this from a different position right now.

And then I'm going to have a few follow-up questions.

Yes, great questions.

More specifically, from a commercial perspective, I would say.

Yes.

Well, first I'll just...

Just sorry, go ahead.

No problem.

Well, first of all, this hits sort of like a broader level.

I've been on the Board for the last 2.5 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 sort of 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 and the market research that we're 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 we're going to want to do all of this over time.

But the question is, which things do we focus on and at what point in time?

Then we just need to make sure that we've got a rationalized spend for what we're delivering on.

For your question about the launch of DAXI in the aesthetics market.

We're 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 add at this point in time.

Okay.

So why don't I just move on to the therapeutic indications for a minute.

So FDA clearly wants to see how well DAXI performs in movement disorders and the activity of a toxin in general is pretty well known in movement disorders given BOTOX's broad label there.

So I guess the question I have is you mentioned that CD is going to be a registrational studies.

What are the chances that each of the studies -- after you get a couple under your belt, they're going to become much more comfortable with DAXI's performance in movement disorders -- and it's going to sort of facilitate the path for additional movement disorders that you may not be studying, but clearly have toxins that found great utility in those areas?

Yes.

Amy (sic) [Annabel], it's a good question.

Obviously, CD is going to be our first and sort of leading therapeutic indication that we're going after.

It's hard to speculate how the agency will look at subsequent submissions following this one.

We'll continue to work closely with the agency to structure the appropriate [trials and] the data and as we have more information.

So I don't know that we've got any unique insights there.

It's kind of let's focus on running the right trials, getting the right endpoints and then charting our path forward from there.

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?

We've got 2. We've got plantar fasciitis and upper limb spasticity.

Those are the 2 next readouts that we'll have.

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

So just a couple, and I apologize if you kind of covered this.

But Mark, just philosophically, though, with the fourth neuromodulator launching recently and having their results reported this morning, I wanted to get your views on how pricing will evolve in this landscape.

And this whole idea of a premium-priced product or a premium-experienced product, as your predecessor has referred to DAXI as being.

So the question is just how do you feel philosophically about this idea of a premium-experienced 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 about that?

Yes, it's a great question.

So I think, first off, I think that 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.

We're bringing innovation into the marketplace.

And 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 kind of 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 where 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 still have to work through the differences, but I think there'll be a little bit of a decoupling in terms of what's 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've seen in the large number of patients that we've done remain reproducible in the broad-based market, then I think the -- it will be good for the industry, and then we'll follow the typical innovation curve or innovation that drives more value commands more price.

So again, I think we're going to stand out as sort of a very differentiated product offering versus looking at the market as it stands today.

Okay, that's helpful.

And if I may just sneak in a question on the therapeutic development program.

And the question here is this.

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 [this,] are there other therapeutic areas that you think would be worthwhile for further exploration?

Do you think that -- or put another way, do you think that Revance is focusing on the right things in terms of therapeutic development programs?

Well, for now, I do.

I mean if you look at the therapeutic market, I mean, globally, it's a $2.5 billion market.

And with a very differentiated product and the fact that, certainly, if I go back to the aesthetic side, you've 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, suggests a meaningful duration benefit.

And in health care 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've already embarked upon, we think that those are going to give us really good information and insight into how our product works in muscle movement disorders.

Obviously, migraine remains a very large market and is the biggest single category in the therapeutic side.

So we have to rationally think about how we unlock that value over time.

In terms of areas that fall outside of current treatment indications today, obviously, we've gone into plantar fasciitis, which is sort of a category that's yet to be -- or you which have to see toxins or 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.

Our next question comes from the line of Jacob Hughes with Wells Fargo.

Could you -- kind of have 2 questions.

One is, can you just comment on what kind of share you think the company can capture over the next few years?

And then secondly, if Mylan chooses not to opt in for the biosimilar program, what are your options for that asset?

Sure.

So in terms of the share, I think it's premature to necessarily look at kind of what kind of share we're going to take.

That's going to somewhat be related to our launch strategy and commercialization footprint.

Certainly, from our market research work that we've done thus far, we found that over 50% of consumers indicate that a long-acting neuromodulator would drive some of their decision-making.

And based on our work with both physicians and consumers, we think it is the -- the most important improvement that you could make on a 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.

And then your second question was on the Mylan side of it.

If you step back, when we started sort of this whole program.

We had a number of other parties that expressed interest.

At the time, we felt like Mylan was the best partner at that time.

We've continued to advance that program.

Obviously, Mylan looks to delay their decision date a little bit because of some of the internal things that they have going on.

And for that, they paid us another $5 million.

So we'll get clarity in terms of whether or not they're going to opt in by the end of April.

And based on that decision, we'll then figure out, obviously, whether we continue to move forward with them or whether we pursue an alternative path.

Okay.

And congrats on the new role.

Thank you.

Appreciate it.

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

Congratulations on the progress.

I have a few.

Thank you.

As you approach launching DAXI next year, can you remind us how we should be thinking about operating spend in 2020?

And I have 2 more questions.

We haven't given clarity on our 2020 spend yet.

Certainly, as we get through the details of this, we'll be able to give you more color in terms of the spend side of it.

Okay, that's fair.

And also, can you comment on time lines to file DAXI internationally?

How might this timing coexist with ex U.S. commercial partnering discussions?

Yes, that's a good question.

For that, I'm going to turn it over to Abhay to comment on that.

Sure.

So as we talked initially, that our plans for international would be about 6 months after filing U.S. filings.

And the goal would be that after we file the U.S., in about 6 months or so, we start doing the files for international market starting with EU first.

That's perfect.

And finally, regarding 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?

So to date, Mylan contributed $25 million upfront and an incremental $5 million.

So we've stated that -- so they're $30 million in.

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, unless 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 will add a little bit to that, too.

If you're looking for modeling purposes, you can look at how we recognize revenue for [effort -- we'll have to] spend on the Mylan.

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

Mark, a couple in terms of development.

Just curious, as we get the Phase II data in forehead lines and crow’s feet, would you plan on then conducting Phase III studies for those?

Or do you think the data in terms of the Phase IIs, especially around dosing and technique, would be sufficient to drive or to have physicians use it on their own?

Yes, it's a great question.

I mean, the Phase II 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'll 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 commercialized their product in aesthetics with a single indication.

But we'll continue to sort of look at that and decide whether or not we think there are advantages to advancing that into Phase III.

Okay, great.

And then in terms of therapeutic, how -- could you maybe give an update in terms of where the company is with migraine.

Well, 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 enrolling, we've reported on and provided updates.

So I think that's one that we're going to continue to look at.

As a senior team, we're continuing to kind of go through the strategy in 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 really in a position to give any more clarity on that.

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

Congratulations on what seems like a smooth transition.

Maybe from a higher-up view, DAXI is obviously coming to market as a differentiated product.

However, it still is only one product.

How do you currently view the bundle that you'll 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 the DAXI launch?

I mean, it's a 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 and other products in the bundle.

Certainly, we've seen with recent competitive entrants that, with a single neuromodulator, that they've been able to successfully generate physician interest and patient interest 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'll continue to be mindful.

And if there are things along the way that we think can contribute to our success, create efficiencies, create a more compelling offer for either the physician or the consumer, we will of course continue to look at that.

But I think right now, we feel pretty good about how we're able to launch it.

And then the other part of your question?

I'm sorry.

Are you hearing anything about sales force disturbances or anything that could be occurring from your large competitor's own acquisition that could potentially benefit during your product launch?

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 capture in it, some people that are changing.

And so if you look at the 2 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 as 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.

Our next question comes from the line of Difei Yang with Mizuho Securities.

Just a few here.

The first one relates to the neurotoxin, evolving neurotoxin aesthetics market.

Given that, [we're] expecting millennials will be -- will play a major role in expanding future markets, how important do you think that DAXI's longer-acting will play, will be accepted by the millennials who are new to the market?

Yes, it's a good question.

I mean, we've got a lot of market research that we've done in these different categories.

I think the reality is, this market is still so underpenetrated that a long-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 in this segment or not.

I think that with the work that we've done, it's going to resonate across all segments.

And certainly, we are seeing the millennials or the engagement of younger people in 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 into the physician's office twice a year.

Yes.

And then most recently, one of your competitors, a short-acting neurotoxin, received their European approval with a label that's longer than -- so with the label of 139 days, which is typical -- which is longer than our typical 3, 4 months sort of wrinkle kind of label.

How do you view that?

Well, again, 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, it speaks to the fact that the agencies are certainly open to looking at the data and having that data reflected in the label.

Certainly, if you look at our product and the reason that we're 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're going to show a duration benefit, that they need to be randomized trials.

And so we feel that we're running in the 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 that's ultimately going to be really important in terms of demonstrating duration.

Then my final question is on any updates from China.

No real updates there.

As you might recall from the deal that we structured with them, we're holding on to all the IT, and they're going to do all the commercial and clinical trial work on their end.

And so we're still working through the -- or they're still working through the process to define what the clinical trial requirement is going to be to get approval in that marketplace.

Our next question comes from the line of Serge Belanger with Needham.

A couple of questions for me.

Mark, you mentioned in your prepared remarks, that you made some key hires 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 sales force sizing at this point?

Yes.

So I think on the -- for where we're at right now, we believe that we've got the right senior leadership in.

And we just hired a head of sales that is very experienced in the aesthetic marketplace.

And I think that if you look at the caliber of the people and the pedigree of where these people come from, they're coming from leading players in the space and know the market very well.

And so I think right now, we've got the right senior leadership team in place on the commercial side.

And we believe we've got all the right market research data to inform our go-to-market strategy.

In terms of the number of salespeople, we haven't given that information yet.

And I think as we refine and tailor our launch strategy and plan, which, frankly, we probably won't be sharing until launch time, partly for competitive reasons, but we'll be able to give a little bit more clarity, just a high level in terms of the operating spend that we're planning to invest on the commercial side as we get further along, but we haven't really, I think, articulated yet what we're going to be doing in terms of the number of sales reps.

Okay.

And then on the business development front, I think you've been asked about out-licensing ex U.S. commercial rights.

But is there also any appetite to in-license an additional aesthetic product that could complement DAXI?

Yes.

So certainly, the strategy of out-licensing ex U.S. rights is something that we continue down the path on, and we'll continue to look for kind of who is the best partner in these other markets as evidenced by the Fosun relationship that we have.

As I mentioned earlier, we don't feel that we need any additional aesthetic products to have a successful DAXI launch.

We think that the product can be successful on its own.

Having said that, if we feel there are products that would bring value, that wouldn't dilute our efforts to successfully launch DAXI and can provide more value to either the practice or the consumer, then 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.

Our next question comes from the line of Seamus Fernandez, Guggenheim.

So just a couple, Mark.

Can you help us understand, I mean as we look forward to the cervical dystonia data in the second half of 2020, I believe, is the time line, can you just help us understand the profile of the product?

And what would be clinically meaningful from your perspective in terms of treatment duration, and where the BOTOX treatment profile is getting us today in CD?

And then a separate question is actually on out-licensing to specifically European markets, 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 can 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 product in that type of a situation?

Great.

Great questions.

So I'm going to turn the question over to Abhay as it relates to sort of CD comparator, what's meaningful, and then we'll take the second one from there.

So Seamus, I think the first part of the question was about how do we think about launching CD and how CD was -- trial was designed.

To go back to our Phase II program, we very strongly showed that compared to other approved products in the market where you have Xeomin and Dysport as competitors, who did the trial comparing the endpoint that we chose, DAXI performed superb with a 24 weeks of duration or longer for the clinical endpoints we chose based on TWSTRS score.

So we had tremendous confidence based on the data and trial 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 II study where the primary endpoint indeed is based on the TWSTRS, which is a Toronto Western Spasmodic Torticollis scale where there are 2 components to it.

Our primary endpoint [does actively] show that -- a change from baseline for the TWSTRS 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 neuromodulators have done.

And then a secondary endpoint for this trials are duration of effect.

And again going back, based on our Phase II data, we expect to see a similar profile.

Then you want to comment on the duration difference between what we've seen and kind of what's typically in the marketplace, right?

So then I think, if you take the TWSTRS out of the equation, then there are a couple or 3 products out there, which have been approved based on different endpoints 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 label, but the patient actually starts seeing a wearing off the label around 8 to 10 weeks.

You compare that to our Phase II data where we have taken the product all the way up to 450 units, we have shown in all categories, in all different escalating doses that DAXI in an open-label study, the duration of effect, the median duration for DAXI was at least 24 weeks.

So you're comparing 24 weeks of median duration vis-à-vis 8 to 12 weeks of the currently approved products to the market.

That's almost 2x as much delta, you can imagine, for DAXI.

And 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 a profile with longer duration, and it's meaningful if you look at the health care cost and what's involved there.

So as Abhay pointed out, the 8 to 12 weeks in the existing sort of label of products today versus 24 weeks, we think, provides meaningful enough value to drive definitely share capture.

And then maybe on the second side, I'll also turn this one over to Abhay as it relates to kind of how we think about the EU trials and the endpoints and whether there's any difference between aesthetic and therapeutic.

Yes.

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 will 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 had a better answer for you because we don't have a partner yet.

As you know, Mark mentioned that we are trying to have some collaborator to work with us in the EU marketplace.

And depending upon who we work with will decide who the right comparator would be for this trial going forward.

So at this point, I would say, stay tuned.

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.

And I just -- I don't have a great sense of how pricing would come into -- would play into that.

I'll hand it over to Dustin to hit that one.

Yes, I think as we look at it, there are some

(technical difficulty)

[there were some nuance of around 18] people but they have been able to do that.

But I think, look at who's the best partner for aesthetics and who's the best partner for therapeutics.

We'll make that evaluation upon there.

So yes, we do feel that we could split them.

We would just need to obviously be mindful of sort of the pricing side of things.

But whether we find a single partner to do both or whether we divide them up, we certainly feel that's an option for us.

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.

Great.

Thank you, operator.

I'm very 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 roadshows in San Francisco, New York and Boston, plus attending the Credit Suisse, Guggenheim, Stifel and Piper Healthcare Conferences.

Please reach out to Jeanie if you'd like to meet with us when you're in our area or if you'd 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.

Thank you.

Ladies and gentlemen, this concludes today's conference.

Thank you for participating.

You may now disconnect.

Everyone, have a wonderful day.