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Edited Transcript of RVNC earnings conference call or presentation 8-May-19 8:30pm GMT

Q1 2019 Revance Therapeutics Inc Earnings Call

Newark May 22, 2019 (Thomson StreetEvents) -- Edited Transcript of Revance Therapeutics Inc earnings conference call or presentation Wednesday, May 8, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Abhay Joshi

Revance Therapeutics, Inc. - COO

* Dustin Sjuts

Revance Therapeutics, Inc. - Head of Commercial - Aesthetics & Therapeutics

* Jeanie D. Herbert

Revance Therapeutics, Inc. - Senior Director of IR & Corporate Communications

* L. Daniel Browne

Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director

* Tobin C. Schilke

Revance Therapeutics, Inc. - CFO & Principal Accounting Officer

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Conference Call Participants

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* Alexander Lim

Mizuho Americas Llc - MD & Head of Investment Banking

* Annabel Eva Samimy

Stifel, Nicolaus & Company, Incorporated, Research Division - MD

* David A. Amsellem

Piper Jaffray Companies, Research Division - MD and Senior Research Analyst

* Douglas Dylan Tsao

H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst

* Kenneth Charles Cacciatore

Cowen and Company, LLC, Research Division - MD and Senior Research Analyst

* Myles Robert Minter

William Blair & Company L.L.C., Research Division - Associate

* Seamus Christopher Fernandez

Guggenheim Securities, LLC, Research Division - Senior Analyst of Global Pharmaceuticals

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Presentation

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Operator [1]

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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 8, 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.

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Jeanie D. Herbert, Revance Therapeutics, Inc. - Senior Director of IR & Corporate Communications [2]

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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 31, 2019. If you've 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 2019 guidance; the clinical development of our product candidates; business strategy 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 titled Risk Factors in our annual report on Form 10-K for the year ended December 31, 2018, as filed with the SEC on February 28, 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?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [3]

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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 #1 unmet patient and physician need, enduring results. DAXI has proven to deliver unprecedented response rates and long duration of effect in glabellar lines, and we anticipate approval and market introduction next year.

DAXI is targeted to disrupt the $4.5 billion 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 3 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 2 treatments per year. Launch readiness and precommercial activities are well underway. We have assessed the market opportunity and are engaging 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 3 key messages. First, DAXI delivering consistent results with just 2 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 2 Phase II upper face studies underway 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 on our progress and time line 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- and 100-unit vials. We now plan on submitting our BLA in the fall of 2019 and are tracking to receive 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 3 chronic and debilitating conditions, a Phase III trial in cervical dystonia, a Phase II trial in upper limb spasticity and a Phase II trial in plantar fasciitis. All 3 trials are ongoing with the last patient enrolled scheduled in all 3 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, enable targeting of the portfolio of approved BOTOX aesthetic and therapeutic indications. And lastly, the program would 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?

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Tobin C. Schilke, Revance Therapeutics, Inc. - CFO & Principal Accounting Officer [4]

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Thank you, Dan. Starting with our cash, cash equivalents and short-term investments 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 31, 2019 were approximately 44 million with 48.4 million fully diluted shares.

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

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [5]

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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?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question is from Seamus Fernandez from Guggenheim.

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Seamus Christopher Fernandez, Guggenheim Securities, LLC, Research Division - Senior Analyst of Global Pharmaceuticals [2]

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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?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [3]

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Seamus, 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.

And 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.

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Tobin C. Schilke, Revance Therapeutics, Inc. - CFO & Principal Accounting Officer [4]

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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, think that through.

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Operator [5]

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Our next question is from Annabel Samimy from Stifel.

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Annabel Eva Samimy, Stifel, Nicolaus & Company, Incorporated, Research Division - MD [6]

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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 time line for the biosimilars and its impact?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [7]

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Annabel, we do expect to have the 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, cervical dystonia and probably one or more other indications will be improved in front of that, so we'll just have to wait and see.

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Annabel Eva Samimy, Stifel, Nicolaus & Company, Incorporated, Research Division - MD [8]

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Okay. 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 at the top of the space are making to penetrate and grow the market. Can you yet share with us some of your 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 toxin, it seems like you have an opportunity to bifurcate that market. So anything that you can share with us there?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [9]

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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, 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 from some of the most prominent 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 a treatment twice a year. And can you imagine that with a patient who's got cervical dystonia and upper limb spasticity, they don't have to go back 4 times? Can you imagine the convenience and the natural look that would go to 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 on 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. And so I think we're excited about that, and we expect we can get that approved with a strong label next year.

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Operator [10]

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Our next question is from Ken Cacciatore from Cowen & Company.

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Kenneth Charles Cacciatore, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [11]

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Just wanted to ask about preparations for the BLA filing, so -- but for your disclosure on the 100-unit vial, can you just talk about work you're doing in CMC and manufacturing, just to understand if that's all moving correctly forward?

And then 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, it 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 6-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.

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [12]

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Yes. Ken, thanks for the 3 questions. If I missed any, please ask a follow-up. I'll start with the 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. And I think the addition of the 100-unit on top of the 50-unit is just simply resulted in additional work streams in 2 areas.

We've been trying to be very transparent around the process validation and the stability, in our view, in the press release today, is we wanted to provide that updated time line not because it's a setback but because it's the right thing to do. And we believe the additional time in compiling the BLA submission will result in an even stronger filing.

I mean, Ken, you've been following this 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 1.5 or 2 years on a postapproval supplement. So -- look, I think we feel good about that.

Relative to the key opinion leaders, I think -- we tried to touch on the 3 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, this formulation of DAXI is unique. There is no other anywhere in the world that uses the botulinum neuromodulator with this very unique proprietary peptide. This formulation is giving results that no one has seen before. And I think the advice from key opinion leaders is, don't focus on what others have been doing for 3 decades. Focus what they cannot do. No other product, regardless of dose or endpoint, can provide what DAXI is doing. So 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 3 or 4 times a year. They can come in once or twice. Now to your point, not every patient, it's a median duration, is going to be 6 months. But that's true today with all the existing products. They don't last 3 to 4 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 in above and below 65. We saw it in previous users of neuromodulators to naive. We see it in gender. So 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 you 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. It'll be based on the outcomes and a better experience.

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Operator [13]

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Our next question is from David Amsellem from Piper Jaffray.

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David A. Amsellem, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [14]

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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've 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?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [15]

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David, I think it's a fair question. And I think from our perspective is you go where the market isn't today. That price competition is based on a commoditization strategy. They're all good companies, good products. They all work about the same. And so 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 of 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 have done a fabulous job. I think Revance has the utmost respect for the market leader in what they built in the predictability and the safety of this sort of landscape of neuromodulators. We went into this with our eyes wide open. We have to take it to 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 who are investigators, we have 65 sites that were in our SAKURA program. If we 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 the 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 that 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 based 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.

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David A. Amsellem, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [16]

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Okay. That's helpful. And then one more question. So the market leader that who shall not be named CEO, who shall also not be named, has said that most practices are not going to want to be trained on a multitude of tox and products. In other words, they're going to stick to just a couple. And 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?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [17]

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I can just speak for myself, and I'll let others sort of support their thesis. I think that -- look, you're going to have centers that are going to stock multiple products, but they're 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 to long-acting. That's why others are starting to work on it, right? They're trying to increase the dose, even argue based on 30 years of literature doesn't support that thesis. But -- 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 to 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'd be fillers, whether they'd be neuromodulators, whether they'd be some of the body contouring is when those patients want a better experience and that physician group 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 on that?

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Dustin Sjuts, Revance Therapeutics, Inc. - Head of Commercial - Aesthetics & Therapeutics [18]

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Yes. I think it's clear 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 a new product. Quite honestly, this being something that nothing else can reach as it relates to efficacy and duration, there is a high desire to train and that was shown at the innovation summit that we had. They want the product, and they want to train on it quickly.

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [19]

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David, I'll 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.

And 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've 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 is some sort of consideration on pricing, but having both is a more powerful platform across more indications.

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Operator [20]

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Our next question is from Douglas Tsao from H.C. Wainwright.

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Douglas Dylan Tsao, H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst [21]

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So 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?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [22]

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Doug, thanks for the question. Look, we wanted to jump right out in front of this. I think up until very recently, we thought we had a really good shot to meet that target. It was ambitious. We recognized 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 have had to wrestle with these. I think for us is the additional time to do it right was, I think, an investment worth taking, and 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 the 50. And quite frankly, the additional workloads around the process validation stability came back to 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 serve us very well. So a few months in the long-term aspects to work through this with multiple units was the right thing to do.

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Operator [23]

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(Operator Instructions) And our next question is from Timothy Lugo from William Blair.

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Myles Robert Minter, William Blair & Company L.L.C., Research Division - Associate [24]

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Myles on for Tim. Just following on the manufacturing and the stability of the 50- and the 100-unit vial. I'm just wondering whether there is any unique challenges between those 2 in that manufacturing process, so whether that translates to a potential difference in shelf life.

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [25]

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No. There is no differences in shelf life. It's just generating the data. There are no formulation differences between the 50- and 100-unit. It's just about having that data set to include both in your package. Abhay, do you want to pick up on that, please?

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Abhay Joshi, Revance Therapeutics, Inc. - COO [26]

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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 is done right.

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Myles Robert Minter, William Blair & Company L.L.C., Research Division - Associate [27]

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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?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [28]

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Yes. There's 2 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?

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Abhay Joshi, Revance Therapeutics, Inc. - COO [29]

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No. I think I would also (inaudible) 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.

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Operator [30]

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Our next question is from Difei Yang from Mizuho.

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Alexander Lim, Mizuho Americas Llc - MD & Head of Investment Banking [31]

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This is Alex on for Difei. 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.

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Dustin Sjuts, Revance Therapeutics, Inc. - Head of Commercial - Aesthetics & Therapeutics [32]

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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.

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Operator [33]

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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.

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, President, CEO & Director [34]

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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.

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Operator [35]

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Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect.