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Revance Therapeutics (RVNC) Q1 2019 Earnings Call Transcript

Motley Fool Transcribing, The Motley Fool
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Revance Therapeutics (NASDAQ: RVNC)
Q1 2019 Earnings Call
May. 08, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Welcome to the Revance Therapeutics first-quarter 2019 financial results and corporate update conference call. [Operator instructions] As a reminder, this call is being recorded today, May 8th, 2019. I would now like to turn the conference call over to Jeanie Herbert, senior director of investor relations and corporate communications for Revance. Please go ahead.

Jeanie Herbert -- Senior Director of Investor Relations and Corporate Communications

Thank you, Gigi. Joining us on the call today from Revance is President and Chief Executive Officer Dan Browne; 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 March 31st, 2019.

If you have not received this news release or if 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 2019 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.

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Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our annual report on Form 10-K for the year ended December 31st, 2018, as filed with the SEC on February 28th, 2019.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. I will now turn the call over to Dan Browne. Dan?

Dan Browne -- President and Chief Executive Officer

Thank you, Jeanie. Good afternoon, and thank you for joining our first-quarter 2019 conference call. Revance is creating a new standard in neuromodulators with DaxibotulinumtoxinA for Injection, or DAXI, by addressing the No. 1 unmet patient and physician need enduring results.

DAXI has proven to deliver unprecedented response rates and long duration of effects in glabellar lines, and we anticipate approval and market introduction next year. DAXI is targeted to disrupt the 4.5 billion-dollar global market for neuromodulators, first, in the cash-pay facial aesthetics segment and then in the larger reimbursed therapeutics market. During the first quarter, we made progress on the BLA for DAXI in glabellar lines, advanced our pipeline in both aesthetics and therapeutics, and further strengthened our balance sheet. Let me update you on each of our three main business areas which are: aesthetics, therapeutic neurosciences, and biosimilars.

I will begin with our aesthetics business. In aesthetics, we have developed a road map to approval and market-disrupting launch for DAXI in glabellar lines. DAXI will be the first neuromodulator to upgrade the treatment experience by providing a safe, natural, long-lasting look for consumers with just two treatments per year. Launch readiness and precommercial activities are well under way.

We have assessed the market opportunity and are engaged in key opinion leaders in designing our approach. In April, we hosted an innovation think tank with 39 of this country's leading medical aesthetic physicians. They provided insights into how best to position DAXI and collaborated on how to successfully ensure a smooth upgrade within their practices. We also heard, loud and clear, three key messages.

First, DAXI delivering consistent results with just two treatments a year unlocks a major opportunity and will play a significant role in aesthetics. Second, attendees felt strongly that DAXI's differentiated efficacy and duration results were due to DAXI's unique proprietary formulation and not attributable to an increased dose. And third, concern for market commoditization and decreased profitability exists despite increased list price for new market entrants. We are also busy developing the preliminary go-to-market model.

In support of that, we recently strengthened our commercial team with the addition of Taryn Conway as VP of marketing. Taryn is a seasoned marketing veteran in specialty pharma having built brands and managed product launches at Allergan for more than 16 years. Her competitive drive, innovative thinking, and leadership skills are the perfect addition to our growing commercial infrastructure. Also, to support the launch in glabellar lines, we now have two Phase 2 upper face studies under way for DAXI in forehead lines and in crow's feet.

We expect based on preclinical data and our expertise that these results from these studies will further strengthen DAXI's robust clinical data set. In the press release, we provided an update in our progress and timeline for the BLA submission. We continue to compile the largest clinical data package for an aesthetic indication, which will include Belmont, the active comparator study to BOTOX and SAKURA studies 1, 2 and 3 for DAXI, with 3,300 patients followed for up to 84 months. We have also been working in parallel to develop a 100-unit vial in addition to the 50-unit vial.

We are completing drug substance and drug product validation with stability to file our BLA. This includes both the 50-unit and 100-unit vials. We now plan on submitting our BLA in the fall of 2019 and are tracking to pursue potential approval and launch in 2020. Now let me turn to our therapeutic neurosciences business.

Revance is focused on developing DAXI in a broad range of potential indications to maximize shareholder value through the widespread application of the drug's ability to dramatically change the quality of life for patients suffering from muscle movement, pain, and other neurologic conditions. We currently have clinical trials enrolling patients in three chronic and debilitating conditions: a Phase 3 trial in cervical dystonia, Phase 2 trial in upper limb spasticity, and a Phase 3 trial in plantar fasciitis. All three trials are ongoing with the last patient enrolled scheduled in all three trials later this year. This comprehensive therapeutics program should provide multiple top-line readouts in the second half of 2020.

In the billion-dollar muscle movement segment, which includes cervical dystonia and spasticity, a long-lasting treatment option could have a significant quality-of-life implications. For plantar fasciitis, there is currently no approved drug treatment to help manage this painful foot affliction. We see an opportunity for both the reimbursed and cash-pay as patients are often anxious to resume normal activities as quickly as possible. In support of our therapeutic initiatives, we recently hired Dr.

Atul Mahableshwarkar to oversee clinical science programs for cervical dystonia, upper limb spasticity, plantar fasciitis, and migraine. Prior to Revance, Dr. Mahableshwarkar held key clinical development and medical director roles at BlackThorn and Takeda, which led to approvals of several drugs in the neuroscience areas.Finally, let me update you on our biosimilar program. Revance continues to collaborate with Mylan on developing a biosimilar to BOTOX.

A successful biosimilar program will drive shareholder value by monetizing assets that would otherwise have been underutilized, creating a third pillar of potential value for shareholders. This biosimilar program provides several key benefits. It could allow us to participate in the short-acting neuromodulator market segment in addition to the long-acting segment we are targeting with DAXI. It would also, subject to approval, able targeting of the portfolio of approved BOTOX aesthetic and therapeutic indications.

And lastly, the program will be a source of nondilutive short-term funding. Our biosimilar could provide a meaningful source of ongoing royalty revenue, which will enable us to build out our growing portfolio of indications for the premium long-acting DAXI. In April, we received a Biosimilar Initial Advisory Meeting minutes from the FDA, which confirmed our takeaways from the face-to-face meeting, principally that a potential 351(k) biosimilar pathway is viable. We are currently in discussions with Mylan on a detailed development plan under such 351(k) pathway, which could lead to a near-term milestone payment to Revance.

We will share more details on the progression of the partnership as it develops. That covers our recent highlights. Now let me turn the call over to Toby to summarize our first-quarter financial results, then I'll have a few closing comments before we begin the Q&A session. Toby?

Toby Schilke -- Chief Financial Officer

Thank you, Dan. Starting with our cash, cash equivalents, and short-term investment balance, we ended the first quarter with $271 million. In the quarter, we strengthened our balance sheet from 2018 year-end with the Fosun upfront payment and our January equity offering. Revenue for the first quarter of 2019 consisted of $278,000 recognized from the Mylan collaboration.

We expect to recognize additional revenue as we advance both the biosimilar development program and the Fosun partnership. Our opex was $36.9 million. And excluding depreciation and stock-based compensation, it was $32.1 million. The earnings release we issued today outlines our financial results in full, so I won't go through the details on this call.

We are reiterating our 2019 guidance. We expect 2019 GAAP operating expense to be in the range of $173 million to $185 million; and non-GAAP operating expense, which excludes depreciation and stock-based compensation, in the range of $148 million to $158 million. We expect our cash runway to extend through 2020 and the anticipated approval of DAXI for glabellar lines. Revance's shares outstanding as of March 31st, 2019, were approximately 44 million with 48.4 million fully diluted shares.

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

Dan Browne -- President and Chief Executive Officer

Thank you, Toby. We are confident in DAXI's disruptive commercial potential both in aesthetics and therapeutics. We are laser-focused on assembling a complete and compelling BLA submission to assure approval in 2020 and finalizing our commercialization plans. Moreover, we are positioning ourselves for a differentiated launch in aesthetics and progressing a broad pipeline of expansion indications to show the safety, efficacy and, durability of DAXI in a wide range of additional doses, anatomies, and indications.

Finally, we believe the biosimilar opportunity has the potential to fuel the expansion of our business by providing us with an additional revenue source in both the near and long term. With that, I'll now open up the call for questions. Operator?

Questions & Answers:


Operator

[Operator instructions] And our first question is from Seamus Fernandez from Guggenheim. Your line is now open.

Seamus Fernandez -- Guggenheim Securities -- Analyst

Great. Thanks for the questions. So just first off, in terms of the impact of the biosimilar and the magnitude of the milestone, can you guys just give us a general sense of how impactful you would say this milestone would be relative to a potential approval milestone? And then I guess, separately, as we think about the timing -- one of the things that we've heard -- that we're talking to, physicians and also investors about, is the importance of the cervical dystonia indication. Can you guys just give us a general sense of when you anticipate that coming in, in 2020 and the likelihood that you think we are to see a longer-acting profile there? Thanks.

Dan Browne -- President and Chief Executive Officer

Seamus, hi. I think coming out of the AAN meeting this past weekend, the neurologists that we spoke to, and we had several advisory board meetings, came away very excited about DAXI in therapeutic indications, not only in cervical dystonia, but I would say more broadly on movement. But as you know, across a number of the therapeutic indications, pain being another one of the key areas that that neurology group thinks that DAXI is going to play a role. It's interesting, in neurology, it's not only the durability.

It's the response rates and how to be able to profoundly change both without changing the safety profile. So I think given the balance between aesthetics and therapeutics, we feel very good about it. I think, relative to the biosimilar, we think the milestones have not been articulated, but we think it's a meaningful milestone that would really sort of reinforce the value of this biosimilar and represents the challenge, if you will, to do something that would meet the 351(k). We recognize we have a long way to go.

We're still working with Mylan on a potential development plan, and so we'll give additional color on that. But I think the feasibility that for the first time, this might be a viable approach, I think is something that the regulatory authorities will have under review. And hopefully, we can progress that accordingly.

Toby Schilke -- Chief Financial Officer

I can provide a bit more color on the milestone, as well. Upon the signing of the collaboration Mylan paid Revance a nonrefundable upfront payment of $25 million, and we have $100 million in contingent clinical and regulatory development milestones. The net effect of that is that any further progress on this is cash flow positive to cash flow neutral. So when you consider modeling the milestone, take that through.

Seamus Fernandez -- Guggenheim Securities -- Analyst

Thank you.

Operator

Thank you. Our next question is from Annabel Samimy from Stifel. Your line is now open.

Annabel Samimy -- Stifel Financial Corp. -- Analyst

Hi, thanks for taking my questions. Just going back to the biosimilar. Can we expect this development plan to sort of emerge this year? And if it emerges as you expect it to, is this -- is the biosimilar something that we can see ahead of any therapeutic indications, behind therapeutic indications? What are you thinking of in terms of a broader timeline for the biosimilars and its impact? Thanks.

Dan Browne -- President and Chief Executive Officer

Annabel, hi. We do expect to have a development plan agreed to this year. It would not -- the approval would not be in front of any of the DAXI indications in development at this point. But I think, once again, we need to refine the development plan for DAXI in cervical dystonia and probably one of the other indications will be improved in front of that.

So we'll just have to wait and see.

Annabel Samimy -- Stifel Financial Corp. -- Analyst

OK. And if I could just get a follow-up question. I guess, over the last week, we've gained a little bit more granularity around the investments and the efforts some of the players in the top of the space are making to penetrate and grow the market. Can you yet share with us some of the efforts that you're taking right now to, I guess, essentially create a parallel segment of the market? I think that with the long-acting toxins, it seems like you have an opportunity to bifurcate that market.

So anything that you can share with us there?

Dan Browne -- President and Chief Executive Officer

I think you have to speak to both patients and physicians. And I think that both the dermatology, plastic surgery, aesthetic physicians, as well as the neurologists we've just met with, get it. They understand the importance of both durability and response rates. And so I think it's about how we tell that story.

But quite frankly, this is the first, not just new. Because I think people use new very often. This is innovative, and it's innovated and supported by clinically meaningful data that will end up in peer review in some of the most prominent journals, in some of the most dominant investigators in North America. So when I think about growing this market at its current growth rate and expanding it, it's not about just another entrant.

It's about providing an unmet need that has been unsatisfied for decades. And it's not because others have not tried. We can go through all the different technologies where others have tried to advance duration and improve response rates, and they haven't been successful. And for the first time, Revance has been able to put together a preclinical data set, a clinical data set, and soon a filing that will be the first in its label to have extended duration and improved response rates.

I think that that's a story that's going to resonate not only with physicians who understand that chasing the price downward by essentially, I guess, other products that are competing based on price, but for the first time can look at treatment twice a year. Can you imagine that with a patient who's got cervical dystonia and upper limb spasticity, they don't have to go back four times? Can you imagine the convenience and the natural look that would go for an aesthetic patient? That is a story that, quite frankly, I think resonates on Wall Street, and it resonates with patients whether they are in aesthetic treatments or whether they are in the sidelines waiting to jump in. We see a large number of patients who are not in neuromodulators today that for the first time with the concept around twice a year are going to resonate to that. I think we're excited about that, and we expect we can get that approved with a strong label next year.

Annabel Samimy -- Stifel Financial Corp. -- Analyst

Thank you.

Operator

Thank you. Our next question is from Ken Cacciatore from Cowen & Company. Your line is now open.

Ken Cacciatore -- Cowen and Company -- Analyst

Hey, good afternoon, guys. I just wanted to ask about preparations for the BLA filing, for your disclosure on the 100-unit vial. Just talk about work you're doing in CMC and manufacturing, just understand if that's all moving correctly forward. And also, Dan, you said you had, I think, you said 39 thought leaders.

I think that's the exact number. But you had a lot of folks that sounds like in the room. Can you just talk about some of the advice they maybe were giving you? And I'm also thinking about in terms of pricing. I understand from a meeting early this year, you talked about maybe -- making a premium pricing, but not every patient is going to likely get to the sixth-month mark.

So if it's a premium-priced product and a patient doesn't get there, how do we handle that? How do we rescue them? Would we just lose them to the shorter-acting toxins again? So just wanted to know how you'd handle that. Thank you.

Dan Browne -- President and Chief Executive Officer

Yeah. Ken, thanks for the three questions. If I missed any, please ask for a follow-up. I'll start with a color on the manufacturing.

I think, in my view, this is going to be one of the most comprehensive data package that's ever been assembled in our sector with neuromodulators. I think with the addition of the 100-unit on top of the 50-unit is just simply resulted in additional work streams in two areas. We've been trying to be very transparent around the process validation and the stability. And in our view in the press release today is we wanted to provide that updated timeline not because it's a setback but because it's the right thing to do.

And we believe the additional time in combining the BLA submission will result in an even stronger filing. I mean, Ken, you've been following the space for a long time. Look, despite the delay, it's not ideal, but all the neuromodulation companies that have had this issue around the CMC side of it, even the most recent approval. So I think it's better to focus on the near term and get this done now, have both products, versus coming back after approval and having to invest another year and a half or two years on a post approval supplement.

I think we feel good about that. Relative to the key opinion leaders, I think -- we tried to touch on the three sort of take-home messages around this concept around treatment twice a year is going to resonate with consumers: those who are not in treatment and those who are. And also around -- this formulation of DAXI is unique. There is no other anywhere in the world that uses Daxibotulinumtoxin neuromodulator with this very proprietary peptide.

This formulation is giving results that no one has seen before. I think advice of opinion leaders is don't focus on what others have been doing for three decades. Focus what they cannot do. No other product, regardless of dose or endpoint, can provide what DAXI is doing.

Stay focused on what you can do, and tell that story to both of us. Tell it to the physicians and tell it to the consumers because it will be an easy story for patients who come in for treatment. They get their hands around it. They don't have to come in three or four times a year.

They can come in once or twice. Now to your point, not every patient has a median duration is going to be six months. But that's true today with all the existing products. They don't last three to four months.

Some last 60 days. Males and other different sort of segments of the population. You're going to see extended duration across all those segments. We saw it above and below 65.

We saw it in previous uses of neuromodulators to naive. We see it in gender. We're seeing that propagation of response rates and durability across the broad section. And relative to price, I think, for our perspective, this is about outcomes.

The best way to grow this space is to provide a fundamentally better outcome. We are a premium product. We are an innovative product. And I think we've got to incorporate that durability or response rates into our pricing and make sure that it's reflective of the broadest possible population, but we also want to make sure that it doesn't handicap us on the therapeutic side, where we even see as much, if not more, compelling advantages with DAXI.

So I think we've got 18 months. We'll see where the market sort of settles out on price, but I don't believe that we're going to have to come in with the introductory strategy that's buy x and you get y free. That's not a strategy that we're going to pursue. We base on outcomes and a better experience.

Ken Cacciatore -- Cowen and Company -- Analyst

Great. Thank you.

Operator

Thank you. Our next question is from David Amsellem from Piper Jaffray. Your line is now open.

David Amsellem -- Piper Jaffray -- Analyst

Thanks. So just a hypothetical, Dan. Let's say that over the next 12 to 18 months we do see some real degradation in pricing, and we do see some real changes in pricing dynamics. How do you respond to that as you're entering the market with DAXI? I know you talked a lot about this being a premium product, premium experience.

But if there are certain market realities that are staring you in the face regarding pricing, how do you address that? And what's, I guess, the plan B, if you will, so to speak?

Dan Browne -- President and Chief Executive Officer

David, I think it's a fair question. And I think from our perspective, you should go where the market is in today. That price competition is based on commoditization strategy. They're all good companies, good product.

They all work about the same. The only way to get traction is to discount your price. We're seeing that today, right? And that will ultimately bear itself out. And I think, for us, strategically, where we go is where others, at least today, are not.

And we sort of articulate that experience and the meaningfulness of that experience. There is still going to be a segment of this market that's going to compete on price. Today, you can argue that it's about 30% of the aesthetic opportunity that may or may not change. But as we do all our market research, we don't see price as the most constraining to grow in this market.

It's about a better outcome. And look, I think that there's been decades where the market leaders has done a fabulous job. I think Revance has the utmost respect for the market leader in what they built and the predictability, and the safety of this sort of landscape of neuromodulators. We went into this with our eyes wide open.

We had to take into a whole another sort of level, and it's about that experience. If that experience matches what's in our label and what we expect and what the key opinion leaders and those investigators, we have 65 sites that we're in our SAKURA program, if you deliver that type of performance as a commercial product, I believe that that market will follow us, and it will grow. But the short-acting is not going away, and that's been a whole thesis around the biosimilar. Now that's not necessarily where we want to focus.

We want to focus on innovation, but that doesn't mean it's not a role for someone on the biosimilar side. And that's how we kind of approach the space. If we haven't had longer duration and more response rates, then we'd be faced where I think the hypothetical was going, but I don't believe that's where we're going to end up with this type of performance and this type of experience.

David Amsellem -- Piper Jaffray -- Analyst

OK. That's helpful. And one more question. So the market leader that who shall not be named CEO, which shall also not be named, has said that most practices are not going to want to be trained on a multitude of talks and products.

In other words, they are going to stick to just a couple. I wanted to get your thoughts on that line of thinking. And as the market becomes more crowded, and especially as we contemplate biosimilars several years down the road, I mean, is that an assertion that you think is based in reality?

Dan Browne -- President and Chief Executive Officer

I'm going to speak for myself, and I'll let the other sort of support their thesis. I think that -- look, you're going to have centers that are going to stock multiple products, but they are not going to be multiple of the same products. They're going to have a short-acting, and they're going to have a long-acting. Because I think they recognize there is a movement of long-acting.

That's why others are starting to work on it, right? We're trying to increase the dose, even argue based on 30 years of literature that doesn't support that thesis. Or they're going to talk about future long-acting programs. That's where the market is going, right? David, this is what made Wayne Gretzky the great hockey player. What made him great? I'm going to go not where the puck is.

I'm going where the puck is going. So to the point, I think there will be practices -- there will be multi-brand practices, but they're not going to be multi-brand of the same short-acting products that don't work any differently. They're going to pick one of those, and they're going to pick the long-acting. Because I think what happened with other examples in aesthetics, whether they be fillers, they be neuromodulators, whether they be some of the body contouring, is when those patients want a better experience.

And if that physician doesn't have it, they go elsewhere. So I think you're going to have some single-brand practices, but you're going to have multi-brand, but they're going to break it out in the long-acting and short acting. And that's how the market expands. Dustin, why don't you pick up from that?

Dustin Sjuts -- Head of Commercial, Aesthetics, and Therapeutics

Yeah. I think it's clear in that the sense that this product can offer something that no one else has, that's what drives the desire to train and bring in new products. Today, if you look at some of the market entrants that come in, if the consumer value isn't different, the only value the physician had increased margin, and then I will have to get trained on the new product. Quite honestly, this being something that nothing else can reach as it relates to efficacy and duration, there's a high desire to train.

And that was shown the innovation summit that we had. They want the product, and they want to train on it quickly.

Dan Browne -- President and Chief Executive Officer

David, let me just say one other point is some people construe our balanced approach on aesthetics and therapeutics as a negative -- that you should just be focused on aesthetics to be successful. We reject that thesis. I think if you want to grow this space. Patients need to know it's safe and effective, and they need to see that it's in therapeutic applications.

When they see the response rates and patients who got chronic debilitating disease, the carryover into that experience on aesthetics will be very powerful. And I think it's what made the brand leader as strong as it was because they had that combined balanced synergistic approach. In many ways, we're imitating that initial strategy because I think it's been very effective. Yes, there's some sort of consideration on pricing, but having both is a more powerful platform across more indications.

David Amsellem -- Piper Jaffray -- Analyst

OK. Thank you very much.

Operator

Thank you. Our next question is from Douglas Tsao from HC Wainwright. Your line is now open.

Douglas Tsao -- H.C. Wainwright -- Analyst

Hi, good afternoon. Thanks for taking the questions. Just Dan, maybe just -- I sort of understand the issue in terms of delaying the filing for the 100-unit vials. Just curious at what point did it sort of bubble up to such great importance to potentially delay the filing a little bit? Thank you.

Dan Browne -- President and Chief Executive Officer

Doug, hi. Thanks for the question. Look, we wanted to jump right out in front of this. I mean I think up until very recently, we thought we had a really good shot to meet that target.

It was ambitious. We recognize that going into it. And this is a complex biologic, as you know. You've covered this space for a long time.

And as I mentioned before, I think all the neuromodulator companies, at one point or another, had to wrestle with these. I think for us is the additional time to do it right was, I think, an investment worth taking. It was the right thing to do to get out in front of it and just be transparent with that. The addition of the 100-unit vial is going to be helpful to our commercialization strategy, to have both the 100 and 50.

And quite frankly, the additional workloads around the process validation stability came back -- take longer than we thought going into the year. But all in all, I think we feel really good about it. It reminds me of a conversation that I had with David Piatt in the very early stages of Revance: that the clinical trials with a potent neuromodulator like this are relatively straightforward. I think the one thing that all the companies need to be focused on is on your manufacturing.

We have a state-of-the-art facility with a group of people who are very experienced working with this. And I think it's an infrastructure, an intellectual horsepower that will come back and service very well. So a few months into the long-term aspects to work through this with multiple units was the right thing to do.

Douglas Tsao -- H.C. Wainwright -- Analyst

OK, great. Thank you.

Operator

Thank you. [Operator instructions] And our next question is from Timothy Lugo from William Blair. Your line is now open.

Myles Minter -- William Blair -- Analyst

Myles on for Tim. Thanks for taking the question. Just following on the manufacturing and the stability of the 50-unit and 100-unit vial. I'm just wondering if there's any unique challenges between those two in that manufacturing process.

So whether that translates to a potential difference in shelf life.

Dan Browne -- President and Chief Executive Officer

No. There's no differences in shelf life. It's just generating the data. There are no formulation differences between the 50-unit and 100-unit.

It's just about having that data set to include both in your package. Abhay, you want to pick up on that, please?

Abhay Joshi -- Chief Operating Officer

No. I think in terms of any unique challenges, the answer is no. I think it's a matter of completing the process validation work to make sure that it's done right.

Myles Minter -- William Blair -- Analyst

Great. Fantastic. And just on your meetings at AAN. Obviously, the neurologists very excited about the cervical dystonia as is everyone else.

But if you had any extra thoughts on the migraine trial you've been potentially talking about? Any updates on the design of that? And how you're thinking about the marketplace with CGRP, biologics? And also I think the market leader also saying that there's not much erosion from the neuromodulatory sharing in migraine prevention? What do you update on that program?

Dan Browne -- President and Chief Executive Officer

Yes. There's two things that really jumped at it -- at me based on the conversation we had. One is the neurology community really understands this is a unique formulation. This combination of this neuromodulator and this peptide, it's not dosed.

They got it very, very easily. And I think it's because they've got a longer experience, if you will, across more indications, more anatomies, more soft tissues. And so I think the concept that this was really unique and different over the other commercially available products really borne itself out. I think the other one is what you mentioned on the headache, I'll say pain indications that I think there is going to continue to be a role for neuromodulators, and there is going to continue to be a need for a better neuromodulator, a more responsive, a longer durable.

Now which form does that ends up being a priority for Revance is under determination. We have a lot of good suggestions. These were some of the best thinkers in the headache community who are helping us work through that study design. And if you can imagine as we work through this and trying to tighten up what that study would look like, and I know we've talked about it on a couple of calls, there are a lot of opportunities.

And I think we're trying to be smart about it. We're trying to be patient. We're going to see how the market place evolves with the CGRPs and the neuromodulators. But I think, unanimously, people believe that the market is -- for neuromod is not going away, and it's finding that population that are going to be responders and could respond better with DAXI.

Abhay, you want to take that? Anything else?

Abhay Joshi -- Chief Operating Officer

No. I think I would also for the fact that definitely one thing which we came out from this AAN was that despite of new CGRPs in the marketplace, the CGRPs and TOXINS can definitely coexist. And given that, we feel further mold into continue looking at different trial designs and work with our key opinion leaders and experts to come with a design that will most likely initiate sometime later this year or early next year.

Myles Minter -- William Blair -- Analyst

Fantastic. That's helpful. Thanks for the questions.

Operator

Thank you. Our next question is from Difei Yang from Mizuho. Your line is now open.

Alex Lim -- Mizuho Securities -- Analyst

Hey. Good afternoon, guys. This is Alex on for Difei. Thank you for taking the question.

With respect to the aesthetics market, how important is it, in your view, to eventually add a filler to your portfolio and have your own bundle? I'm wondering if the topic came up in your discussions with KOLs.

Dustin Sjuts -- Head of Commercial, Aesthetics, and Therapeutics

Yeah. Listen, this is Dustin. I think that it's obviously bundling works, and it's an important thing when there is no product differentiation. The fact that DAXI has a differentiated profile and can unlock the potential for new experience, allows us to focus on DAXI.

Of course, we look at all different types of innovations and business development opportunities that will help support DAXI, but our focus is mainly on DAXI. So we don't believe a filler is necessary to compete in the space. However, we do look at different value opportunities that are out there.

Alex Lim -- Mizuho Securities -- Analyst

Great. Thank you.

Operator

Thank you. At this time, I'm showing no further questions. I would like to turn the call back over to Dan Browne for closing remarks.

Dan Browne -- President and Chief Executive Officer

Thank you, operator. In terms of our travel schedule in May, we'll be at the RBC healthcare conference in New York. And in June, we'll be at the Goldman Sachs healthcare conference in Ranchos, Palos Verdes. Please let Jeanie know if you'd like us to meet when we're in your area or schedule a call.

So with that, I'd like to thank each of you for your time today, and have a good day. Thank you.

Operator

[Operator signoff]

Duration: 39 minutes

Call participants:

Jeanie Herbert -- Senior Director of Investor Relations and Corporate Communications

Dan Browne -- President and Chief Executive Officer

Toby Schilke -- Chief Financial Officer

Seamus Fernandez -- Guggenheim Securities -- Analyst

Annabel Samimy -- Stifel Financial Corp. -- Analyst

Ken Cacciatore -- Cowen and Company -- Analyst

David Amsellem -- Piper Jaffray -- Analyst

Dustin Sjuts -- Head of Commercial, Aesthetics, and Therapeutics

Douglas Tsao -- H.C. Wainwright -- Analyst

Myles Minter -- William Blair -- Analyst

Abhay Joshi -- Chief Operating Officer

Alex Lim -- Mizuho Securities -- Analyst

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