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Edited Transcript of RVNC earnings conference call or presentation 26-Feb-19 9:30pm GMT

Q4 2018 Revance Therapeutics Inc Earnings Call

Newark Mar 1, 2019 (Thomson StreetEvents) -- Edited Transcript of Revance Therapeutics Inc earnings conference call or presentation Tuesday, February 26, 2019 at 9:30:00pm 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. - Interim 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, CEO, President & Director

* Tobin C. Schilke

Revance Therapeutics, Inc. - CFO

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Conference Call Participants

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* David A. Amsellem

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

* Difei Yang

Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research

* Etzer Darout

Guggenheim Securities, LLC, Research Division - Senior Analyst

* Myles Robert Minter

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

* Nicholas Carl Rubino

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

* Sameer Singh Sandhu Kandola

Piper Jaffray Companies, Research Division - Former Research Analyst

* Stacy Ku

Cowen and Company, LLC, Research Division - Equity Research Associate

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Presentation

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Operator [1]

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Welcome to the Revance Fourth Quarter and Full Year 2018 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded today, February 26, 2019.

I would now like to turn the conference 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, Candace. 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 and full year ended December 31, 2018. If you have not received the news release or if you would like to be added to the company's distribution list, you can do so on the Investor Relations page of the company's website at www.revance.com.

During this conference call, Revance management will make forward-looking statements, including statements related to Revance's 2018 financial results and 2019 guidance; 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 titled Risk Factors in our quarterly report on Form 10-Q for the quarter ended September 30, 2018, as filed with the SEC on November 2, 2018.

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.

I will now turn the call over to Dan Browne. Dan?

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

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Thank you, Jeanie. Good afternoon, and thank you for joining our fourth quarter and year-end 2018 conference call.

Our business model is to be a fully-integrated premier neuromodulator provider that can provide new solutions to long-standing unmet needs. We plan to address and expand the $4.5 billion global opportunity in both aesthetics and therapeutics. Our DaxibotulinumtoxinA injection, or DAXI, will be the first and only next-generation premium product, which uses a proprietary peptide excipient technology to deliver unprecedented response rates and duration of effect. Revance is creating a whole new category of neuromodulator that has significant value across both aesthetic and therapeutic marketplaces. DAXI is not a [ME2] short-acting neurotoxin. The combination of high response rates and extended duration delivers a new user experience.

In aesthetics, DAXI promises to provide safe, natural, enduring wrinkle reduction for consumers with just 2 treatments or less per year. In therapeutics, DAXI may improve the quality of life for patients who suffer prolonged pain and debilitation from a variety of chronic therapeutic conditions by providing a long-acting treatment option that results in better pharmacoeconomics.

To that end, Revance had a highly productive year in 2018. I'd like to express my gratitude to the Revance team as we asked a lot, and they worked tirelessly to deliver the SAKURA Phase III open-label safety study trial with exceptional results; initiate 3 important clinical programs to broaden our portfolio of therapeutic indications; and signed 2 significant partnering agreements. More specifically, in December, the SAKURA 3 results confirmed the safety, efficacy and long duration of effect for DAXI in treating glabellar lines. The SAKURA Phase III program represented the largest-ever aesthetic neuromodulator clinical trial, which included up to 3 treatments and monthly follow-up conducted over 1.5 years. DAXI was well-tolerated and delivered unprecedented safety and efficacy across more than 3,800 treatments in total. DAXI also recorded the highest 2-point composite efficacy response rates seen in Phase III glabellar trials at week 4, with high response rates carried through week 28 before patients return to baseline. It is response rates over continuous key prespecified time points that determines duration. That is where DAXI excelled.

It's important to note DAXI demonstrated its superiority using the most stringent FDA protocol standards. Time to loss of none or mild on the investigator scale remains the standard measure for duration. The goalpost has not moved.

On the heels of our pre-BLA meeting completed in December, we believe our powerful Phase III clinical data, along with well-established label precedents, will result in a strong and differentiated label allowing for direct promotion of DAXI's extraordinary patient benefits in terms of safety, efficacy and duration. In therapeutics, we initiated the ASPEN Phase III trial in cervical dystonia, a Phase II trial in plantar fasciitis and the JUNIPER Phase II trial in adult upper limb spasticity. All 3 trials are actively enrolling patients, and we expect to have top line results in the second half of 2020.

We signed 2 significant strategic business development agreements, yielding $55 million in upfront cash payments. The first was with Mylan for a potential biosimilar to the reference BOTOX. The second signed in December was within -- with Fosun Pharma, a leading biopharmaceutical company in Asia, to develop and commercialize DAXI in China in both aesthetic and therapeutic indications. The infusion of cash from these partnerships, as well as our recent stock offering, had put Revance in excellent position to execute our plans, launch DAXI in aesthetics and advance our current therapeutic clinical trials.

Looking ahead, 2019 is shaping up as the year of rapid transition. We are laser-focused on submitting our BLA package to FDA for DAXI in the treatment of glabellar lines in the first half of this year, which puts us on track for a 2020 PDUFA date and launch. While other companies are trying to increase their doses of their current neuromodulators or tweak diluents to produce marginal improvements in performance, DAXI is delivering meaningfully longer durations and enhanced efficacy. And it is doing it with comparable amount of active cord neurotoxin found in today's market-leading, short-acting products. Our patented peptide technology stabilizes the neurotoxin molecule, providing stability at room temperature for at least 2 years. And because DAXI is highly purified neurotoxin, it presented no immune responses in the SAKURA Phase III trials.

Based on DAXI's highly differentiated product characteristics, our aesthetic launch will focus on 4 key areas: creating the long-acting neuromodulator category, redefining the value of long-lasting results, updating the treatment paradigm and resonating with today's consumer. We will continue to build our commercial team against these priorities.

Throughout 2019, Revance is planning significant podium publication and one-on-one presence in the physician community, highlighting DAXI's unmatched efficacy and duration demonstrated in the SAKURA program. At the recent talks in 2019 meeting in Copenhagen, where we had 2 podium presentations and 11 posters, the main topic of discussion throughout the meeting hall was duration. It is the most desired attribute of a neuromodulator by physicians and patients alike. As we look to commercial launch, we're expanding our robust clinical data package in the upper phase, already initiating a study in forehead lines, soon to be followed by another study in crow's feet.

In addition, we continue to advance our plans to fully monetize our manufacturing assets and analytic capabilities. Last week, we held a biosimilar initial advisory meeting with FDA. At that meeting, FDA provided guidance on their expectations for a development program to establish biosimilarity to BOTOX. Based on this feedback, we believe that a 351(k) pathway for the development of a biosimilar to DaxibotulinumtoxinA is viable. Successful completion of a biosimilar program could potentially result in approval for all 11 FDA-approved BOTOX indications.

After review of the final advisory meeting minutes expected in March, Mylan or Revance will plan to discuss the development path, timing and next steps. Revance is entering 2019 with tremendous momentum, a broad neuromodulator pipeline and the capital to make it all happen.

That covers the recent highlights. Let me turn the call over to Toby to summarize our fourth quarter and year-end results. Then I'll have a few closing comments before the Q&A session. Toby?

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Tobin C. Schilke, Revance Therapeutics, Inc. - CFO [4]

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Thank you, Dan. The company met its 2018 financial guidance, with operating expenses of $146.4 million and a cash burn of $135.6 million. Revenue for the fourth quarter of 2018 consisted of $0.5 million recognized from the upfront payment from Mylan under the biosimilar program. Please see the earnings release for the full year and year-end results.

We ended the year with $175.8 million in cash and short-term investments with no debt. When including the upfront payment from the Fosun Pharma licensing agreement and the net proceeds from the recent public stock offering, the same balance was $295.5 million as of January 31, 2019. This provides the company a cash runway through 2020.

Today, we are issuing our 2019 guidance. We expect the 2019 GAAP operating expense to be in the range of $173 million to $185 million, and the non-GAAP operating expense, which excludes depreciation and stock-based compensation, in the range of $148 million to $158 million, driven by increased research and development expenditure and launch preparation activities.

With the new aesthetic studies outlined in our earlier press release, 3 clinical programs on the therapeutic side, and preparation to file the BLA underway, Revance expects the 2019 non-GAAP research and development expense to be $93 million to $100 million. Revance's shares outstanding as of December 31, 2018, were approximately 37 million. As of February 22, 2019, there were 44 million shares outstanding, with 48.4 million fully diluted shares.

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

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

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Thank you, Toby. Only Revance is providing true innovation, pioneering a new first-in-class, long-acting neuromodulator with the proprietary peptide excipient technology that meets a clear unmet need. The neuromodulator market opportunity continues to grow double digits in both aesthetics and therapeutics, and we know DAXI can drive significant adoption as it appeals not only to patients already in treatment but will also attract new patients. DAXI addresses the lifestyles, the needs and convenience of today's consumer.

We are validating DAXI in a range of doses, indications, anatomies and geographies to maximize the full potential of this next-generation neuromodulator. In the near term, we plan to enter the lucrative cash pay facial aesthetics arena while expanding our R&D focus into a growing number of neuroscience indications. We have a clearly differentiated product set to drive value. Our success in the aesthetics market will fuel our neuroscience pipeline and allow us to meet patient needs in the therapeutics market. At the same time, success with a biosimilar allows us to participate in the short-acting neuromodulator category, including all the currently approved indications. The team and I look forward to updating you on our progress on future calls.

In terms of travel schedule, at the end of this week, we'll be in Washington, D.C. for the American Academy of Dermatology. In March, we'll be in Boston at the Cowen conference followed by the Barclays conference in Miami. In April, we'll be at the Needham conference in New York followed by nondual road show on the East Coast. Let Jeanie know if you'd like to meet with us in your area.

With that, thank you all for joining us today. I will now open it up 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 comes from Stacy Ku of Cowen and Company.

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Stacy Ku, Cowen and Company, LLC, Research Division - Equity Research Associate [2]

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My first question. Have you spoken to any clinicians about Evolus' Jeuveau? And if so, what has been the feedback you're getting? If not, can you provide additional clarity on their commercialization efforts? Do you think that their competitive fears are warranted? How will the Jeuveau launch change the landscape and potentially impact DAXI when it's launched?

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

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Stacy, this is Dan. Thank you for the question. We spend a lot of time with physicians, but quite frankly, they ask us predominantly about DAXI. This premium category is new. It's been long sought after for decades. We don't spend a lot of time talking about the Evolus product line. That's something you'll need to talk to them about. I think for us, it's about the differentiation for physicians. What makes DAXI unique. What makes it address their physician practices in a better way. And how do they get more patients into treatment, how do they get better outcomes. And we do that both in the aesthetic side as well as the therapeutics side. I think for us, it's taking this really powerful SAKURA 3 data and making sure as much of that data makes it into the label because we want the breadth -- you have to realize, this is the largest, longest-followed aesthetic trial ever. We want to make sure that, that label is differentiated. And we want to shift from the short-acting neuromodulators to the long-acting category, which we will be first and will be only for a period of time. So I think that's probably the best way to answer that question.

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Stacy Ku, Cowen and Company, LLC, Research Division - Equity Research Associate [4]

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And second question, can you provide some insight into your conversations with the FDA? What -- do you know exactly what they require for you and Mylan to prove biosimilarity?

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

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Abhay, you want to take that one?

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Abhay Joshi, Revance Therapeutics, Inc. - COO [6]

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Yes. This is Abhay Joshi. So with regards to our biosimilar discussion with the FDA, I guess, suffice it to say that the information that we provided to the FDA was in compliance with the draft guidance by industry, which is about how to have a formal meeting between FDA and sponsors and applicants for the Biosimilar User Fee Act. And with regards to that, we probably -- we gave them sufficient information dealing with the initial necessity data on analytical similarities or functional characterization, clinical and nonclinical plans, and that was the basis of our discussion with the FDA.

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Operator [7]

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And our next question comes from David Amsellem of Piper Jaffray.

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David A. Amsellem, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [8]

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So just a question on how you're thinking about DAXI pricing given that the new entrant is coming into the market as a fairly deep discounter. Does that dynamic change your views regarding DAXI pricing? And then as a follow-up to that, can you just remind us how you were thinking about, not just pricing but how you're going to make the margins for practices more attractive, if that is part of the strategy as well?

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

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David, we'll break this up into 2 parts. I'll take the first part, and Dustin will take the second part. I think, for us, is we really focus on the premium category and on the experience associated with that. I think when you look at the last 20 years, you've had products that competed on price. That market share has been fairly stable over a long period of time, and we've been in the 20% to 30% discount. And so I think for our perspective, that's where the short-acting market is today. We really see the premium based on the data, the consumer experience, the convenience, the look and feel that comes with SAKURA that was reported in the Phase III program to support that premium price. And we'll have more data next year on the therapeutic side as well. So I think for us is how do we sort of look at that technology and provide that practice-better economics. And you want to sort of talk about the margins out of that, Dustin?

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Dustin Sjuts, Revance Therapeutics, Inc. - Interim Head of Commercial - Aesthetics & Therapeutics [10]

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Yes. I think we take a very thoughtful approach to this, right? If you look at why pricing is going up to the physician and down to the consumers, all products are offering 0 innovation to what the consumer demands are or those unmet needs. With DAXI, having the opportunity to meet the unmet need of the consumer, there's optionality to focus on what's the value of that treatment, what's the value of that convenience and what are the economics for the physician? So it allows us that opportunity to look at both sides of it. We are not an opportunity -- not in a situation where we have to compete on price. We have an opportunity to address the unmet need with value. And I think we'll be thoughtful over that, and we'll be bringing out more information as we get closer.

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [11]

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David, I find it interesting, if you look at the TOXINS 2019, physicians -- at least those we spoke to are not chasing price, they're chasing performance. And I think that's why you see everyone talking about duration, whether it's with the peptide or the Revance technology, or now, trying to sort of resurrect sort of this concept around more units and different diluents because they're all chasing duration. That is what people are chasing, not price. I think at the end of the day, physicians know that if they chase that price downward and that gets passed on to consumers, that's not attractive to their practices. So at the end of the day, this is all about innovation that grows markets, not price.

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Operator [12]

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And your next question comes from Annabel Samimy of Stifel.

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Nicholas Carl Rubino, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [13]

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This is Nick Rubino on for Annabel Samimy. So first, congratulations on the exciting BIAM meeting you guys had with Mylan. Is there any market or indication that's more readily accessible to you for the biosimilar, or markets that you guys are excited to enter? And who kind of has more control over the direction of where you guys head with that?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [14]

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Look, I think that the most attractive approach with the biosimilar is it's all 11 indications from one development program, as opposed to doing it indication by indication. We're attracted to all. When you look at this neuromodulator, it's split roughly 50-50 or 60-40, depending on how you look at it by geography. There's a role for this in both indications. The fact is we're interested in both. And we've made a tremendous investment in the capabilities here in the San Francisco Bay area with -- on the manufacturing and the analytics side. We'll focus on where the market is going, the long-acting, addressing that need. But there will still be a short-acting market. And this enables us to monetize, with the relationship with Mylan, a biosimilar that will have a role in both. So we don't favor one over the other, but I think when you look at the potential number of indications on the therapeutics side, it's a very attractive space for both companies, whether you're looking at long-acting DAXI or on the biosimilar.

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Nicholas Carl Rubino, Stifel, Nicolaus & Company, Incorporated, Research Division - Associate [15]

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Great. And actually, you touched on, I guess, where I'm going on the second question, but -- so your internal production facility has been such a large factor in terms of your partnership abilities, and it's going to be important for launch timing. Can you give us an update on maybe the state of the FDA inspections of your facilities? And then, I guess, just lastly, have you made any headway on a potential migraine study?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [16]

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Abhay, you want to take that one?

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Abhay Joshi, Revance Therapeutics, Inc. - COO [17]

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Yes, I'll take that one. So with regards to the FDA inspection, as you guys all know, that once we file the BLA, we will receive a PI, or post -- pre-approval inspection, and that can happen any time within 3 to 6 months of our BLA filing. So we anxiously wait for that. We are fully prepared to accept the FDA facility. And then when the time is right, we will probably up that inspection. With regards to the migraine program, we are still evaluating the potential design of a chronic migraine study. We are also watching the migraine dynamics, the CGRPs and the new lines of treatment. As we mentioned to you last time, the primary intent of our migraine program is basically to evaluate how can we do better in the injection paradigm of currently 31 injections over a reduced number of injections. And so we will provide you more update with expectation to maybe plan a trial and initiate it sometime in 2020 or late 2019.

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [18]

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If I could come back to the facility, we think this is an asset that has tremendous shareholder value. There probably won't be another commercial-scale botulinum facility ever built in the United States again. It's -- the barriers to entry are just so high. We go through annual select agent approval. And so to Abhay's point, we feel very confident in pre-approval inspection. Quality, analytics has really been at the forefront of our manufacturing operation. And I think when you look at the Mylan partnership and the Fosun partnership, what really resonated with them was the quality and our intense focus on drug substance and drug product at commercial scale. So we feel very confident with our capability, not only in those relationships but as we build our own commercial business.

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Operator [19]

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And our next question comes from Tim Lugo of William Blair.

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Myles Robert Minter, William Blair & Company L.L.C., Research Division - Associate [20]

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This is Myles on for Tim. Just to harp on more about the migraine space. You mentioned that you're constantly evaluating how the space is evolving with BOTOX, but also the CGRP biologics. I'm really curious to hear your thoughts on where you think that injection number must come down to, to increase some compliance for migraine patients. And even if we look further ahead with these oral CGRP antagonists that are currently in clinical trials as a once-a-day pill for prevention, how longer-acting neurotoxin, like RT002, would be positioned in that market? Interested to hear your thoughts on that.

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Abhay Joshi, Revance Therapeutics, Inc. - COO [21]

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Sure, yes. We can espouse our thoughts on the injection paradigm. Obviously, the reason why we chose migraine is that this is an opportunity with a large mass segment, there's an established and growth market, there's a clear regulatory pathway, and it's a targeted specialty. So the only downside we feel today is the number of injections that the patients have to go. And it's the only approved treatment for chronic migraine until the CGRPs came into existence. So we believe that it's very important for us not to come in with the same number of injections, but very thoughtfully think about how we can reduce the number of injections. We are working right now with regards to what that number would be. If I know I would tell you, but we are working very closely with our KOLs to make sure that we achieve an optimal injection paradigm. And once we have that, we will definitely use that into our consideration to launch our clinical studies sometime in the later part of this year. With regards to CGRP, I think the -- we are carefully tracking and monitoring what's happening out there. To your point, yes, there are CGRPs, which are oral daily, there are no subcu monthly, there are IV quarterly. And at the end of the day, as we all believe that they're probably is a market that will coexist for both CGRPs and for migraines. There's not a single winner here. There'll be a market for both, and that is why we are carefully monitoring the CGRP markets along with our chronic migraine indication for our toxin.

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

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Yes. I would say, to add onto Abhay's points, there's also the opportunity to look at combination care, the CGRPs and the neuromodulators, as well as where neuromodulators and the CGRPs have had patient failures. One of the things that was really resonated at the TOXIN 2019 meeting in Copenhagen is how many patients on either treatment still don't respond. So as we look at both the prophylactic treatment of chronic headache as well as other segments of this 40 million sufferers of chronic migraine headache, our view is the neuromodulators aren't going away. And there are opportunities to create new treatment paradigms with DAXI.

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Myles Robert Minter, William Blair & Company L.L.C., Research Division - Associate [23]

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And I guess just as a follow-up to that. When you're thinking about designing one of these trials, you've made mention now of the treatment failure patient. So would it potentially be a Phase II trial where we're enrolling straight-up standard prevention patients but also a refractory population? Or maybe even like a cluster migraine population to try and tease out where RT002 might be a fit for those patients?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [24]

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I think, at this point, we'll probably stay silent on the study design. I think what we typically do is once we dose the first patient, we have a very comprehensive study design. I think we've still got some homework to do. I think that work is coming together quite nicely as we continue to learn more where the CGRP patients are playing out and how well the neuromodulators continue to do. So I think for us, is we still want to do some homework, and we'll get back to you later in the year with, hopefully, some more information on that specific question.

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Operator [25]

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And our next question comes from Seamus Fernandez of Guggenheim Securities.

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Etzer Darout, Guggenheim Securities, LLC, Research Division - Senior Analyst [26]

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This is Etzer filling in for Seamus. Just one quick one for me. You commented earlier that you plan to meet with Mylan on next steps for biosimilar BOTOX. And I just wondered, following the conversation that you've had with the FDA, if you have a clearer sense of development time lines and when a biosimilar BOTOX could potentially enter the clinic?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [27]

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We have no comment on the time line. I think that we came out very encouraged with a very collaborative and a productive meeting. I think the guidance that FDA provided on the 351(k) pathway was very helpful. And as we said in the press release, we believe it is possible to have a biosimilar for all 11 approved indications for BOTOX. We want to take time to digest the minutes. We'll look at our development plan. We have a framework right now, and we'll work carefully with Mylan and come back once we have a better idea when we would file an IND and what that clinical development path would look like. But at this time, I think we feel very good coming out of this meeting, that we know what needs to be done, and FDA has set the right level of expectations.

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Operator [28]

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And our next question comes from Serge Belanger of Needham.

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Unidentified Analyst, [29]

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This is [Tien] actually on for Serge. So I just have one. Allergan recently stated in their earnings call that the aesthetics users are trending younger due to this millennial movement, which they say has tripled in the last 5 years. So what kind of impact do you expect this type of trend will have, if any, on DAXI or just the market in general?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [30]

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Dustin, you want to?

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Dustin Sjuts, Revance Therapeutics, Inc. - Interim Head of Commercial - Aesthetics & Therapeutics [31]

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Sure. I think, regardless of age, the unmet need around duration and convenience is met only by DAXI. There is no product in this space that addresses the need, whether the consumer is a millennial or whether she's a consumer that's been treated for a while. So we don't really see an impact overall on DAXI. We think how you market to consumers is definitely understood, and we'll make sure that our plans are associated with what markets are growing or not. But the need for duration and convenience actually suits both by those that have been treated for a while and those that are on the sidelines for treatment. All products today tell the consumer the same story. Only DAXI can talk to her in a different way regardless of how old she is.

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [32]

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Yes. And I would just add that -- we've said this repeatedly. We're still at a very high single-digit penetration with the number of consumers who have the right age demographics, the right interest in aesthetic products. We're as focused on the 9 out of 10 who are not in treatment in expanding this market in a material way, as we are on the existing market. We'll play a role in both. We're not afraid to compete on -- in the existing space because we have something fundamentally different, as Dustin shared. It's differentiated. It's been sought after. But for us it's really about expanding this pool, whereas when I think when you look over the last 20 years, there's been sort of a fixed share because there's really -- you got some good companies and some good products that all work about the same. And so for us, it's really go after what no one else has and get that on label in the most scientifically, clinically evidence-based way and then compete on differentiation.

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Operator [33]

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And our next question comes from Difei Yang of Mizuho.

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Difei Yang, Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research [34]

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Just a couple quick ones. With regards to BLA filing, could you update us if there are any gating items left? Or is it just a matter of putting together the package?

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Abhay Joshi, Revance Therapeutics, Inc. - COO [35]

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Yes, I can take that, Difei. This is Abhay Joshi again. So as you know, for completing BLA, there are 3 or 4 major modules under a common technical document, CTD. And so we are busy right now trying to compile all the documents. We just got our Phase III studies done a month ago. We are trying to finish in compiling clinical studies reports for that. So basically, it's a procedural thing for us, and we hope that we can wrap it up in the next few months.

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Difei Yang, Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research [36]

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And then I was wondering from the work that you have done, working with the physicians, interviewing them about patients' preference, I was wondering if there are common themes with regards to the ideal patient profiles on long-acting versus short-acting toxins.

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [37]

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Good question, Difei. I think this was a question we tried to present objectively at JPMorgan conference earlier this year. We had 2 physicians sort of speak to their current practices, both are key opinion leaders. I think are objective physicians who are highly respected. And I think they kind of work through their practice on where DAXI really resonates. And as -- there was an earlier question about millennials, but I think you sort of look at those patients who are either dropped out of treatment or don't want to jump into treatment, I think those are ideal candidates. Those who are men. Men typically don't like to look at treatment. Millennials probably don't need a lot of treatment, so this will be a premium-priced product. All those segments all play a role for longer duration. I think from our perspective, we still got additional work as we sort of think about this. But that convenience, that durability, that performance, that look really sort of dial in all those segments. And so I don't think there's one that jumps out at us at this point. And I think for us is how do you present this premium product in each of the segments, and then I think once you're in market, you'll be able to prioritize those.

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Difei Yang, Mizuho Securities USA LLC, Research Division - Executive Director of Americas Research [38]

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Then my final question on pricing. I know we're still maybe 18 months -- 12 to 18 months away from launch. At a very high level, how do you think about pricing for the aesthetics market versus therapeutics market?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [39]

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Difei, I don't think we've been bashful about this. We see our pricing as a premium price over where the existing short-acting neuromodulators are, not just because it's convenient to price it higher, but there's actual specific clinical benefit, pharmacoeconomic benefit, that we think warrants into a premium price. I think premium pricing will play a role into both. And I think for us, we've said that. We have to make a fundamental decision to price our product based on maximizing share in aesthetics, or to maximize value capture on the therapeutics side, or we fit something in the middle. And that's the work that Dustin and his team are going through to sort of understand where those lines break. At the end of the day, I think we're less focused on maximizing our share at the expense of lowering our price. That's not the way that we're going to compete. We see a more Apple-like model. We're going to provide better experience and, hopefully, better performance. And that will resonate with the patients. And certainly, physicians and patients alike so far have been very bullish on a premium product concept. But until we put it out there, and they have to put their credit cards and cash down, you don't know for sure, but we're testing that pretty aggressively. But we're really pleased that, look, this market is going to grow from innovation. We're going to provide something that no one has done in 30 years. And I think we're confident based on the data we can get it on label. We think that's going to resonate in market. And now, it's just a matter of how we tell that story and how we set that price. And I think we'll be very thoughtful, and I think we'll come up with the right answer.

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Operator [40]

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And our next question comes from Sameer Kandola, Wells Fargo Securities.

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Sameer Singh Sandhu Kandola, Piper Jaffray Companies, Research Division - Former Research Analyst [41]

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So I was just wondering, at what discount do you believe Evolus will launch Jeuveau at? And then kind of based on the commentary you already gave, do you believe RT002 will be a premium product to Jeuveau or to Allergan's BOTOX? Any commentary on that would be helpful.

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [42]

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You'll have to ask the Evolus folks on pricing of that product. It's not into our purview, and it's not up to us. Look, I think that we look at the gold standard of brand, and we look at BOTOX because we have great respect for that product, for what that company and what that product has achieved. I think we understand, when we went into this with our eyes wide open, that we have to provide meaningful innovation to grow the market. And I think that though some would pit the 2 companies against each other, I really don't think that either one of those companies is our direct competitor. We're trying to grow the space with a new technology that has been evasive for many. And so whatever the others price their product is entirely up to them, but we understand that there's a great brand in market, and we have to bring something else if we're going to grow it and capture the share that we expect.

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Sameer Singh Sandhu Kandola, Piper Jaffray Companies, Research Division - Former Research Analyst [43]

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Got it. And then maybe one quick follow-up on the biosimilar to BOTOX. How are you thinking about this product potentially taking some market opportunity away from RT002? How do you think about that? Or how should we think about that?

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L. Daniel Browne, Revance Therapeutics, Inc. - Co-Founder, CEO, President & Director [44]

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We don't see it taken away from 02. 02 is distinct. It's unique. It's fundamentally different. Its formulation is different. Its performance is different. And I think that from our perspective, there will be a short-acting market. It's been there for a couple of decades. We get to have the good fortune of monetizing our investments in our manufacturing and analytics. But I think that the biosimilars have been discounted biogenerics -- branded generics have been focused at about 30% discount. And for us, we want to sort of look at the premium side of this. And we don't see it changing because there isn't anything else like it.

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Operator [45]

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Thank you. And that concludes our question-and-answer session for today. Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone, have a great day.