Revance Therapeutics, Inc. (NASDAQ:RVNC) Q2 2019 Results Earnings Conference Call August 5, 2019 4:30 PM ET
Jeanie Herbert – Senior Director of IR & Corporate Communications
Daniel Browne – Co-Founder, President, CEO
Tobin Schilke – CFO & Principal Accounting Officer
Conference Call Participants
Annabel Samimy – Stifel
Ken Cacciatore – Cowen & Company
Seamus Fernandez – Guggenheim
David Amsellem – Piper Jaffray
David Maris – Wells Fargo
Tim Lugo – William Blair
Douglas Tsao – H.C. Wainwright
Welcome to the Revance Therapeutics Second Quarter 2019 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, August 5, 2019. I would like to turn the conference call over to Jeanie Herbert, Senior Director of Investor Relations and Corporate Communications for Revance. Please go ahead.
Thank you, Michelle. 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 June 30, 2019. If you have not received this news release or you would simply like to be added to the company’s distribution list to receive future releases, please go to the Investor Relations section of Revance’s website, which can be found at www.revance.com.
During this conference call, management will make forward-looking statements, including statements related to Revance’s 2019 financial results and guidance. The clinical development of our product candidates, business strategies and planned operations; anticipated precommercialization 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 March 31, 2019, as filed with the SEC on May 9, 2019.
Revance cautions you not to place any undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations. With that, I’ll now turn the call over to Dan Browne. Dan?
Thank you, Jeanie. Good afternoon, and thank you for joining our second quarter 2019 conference call. Revance’s pioneering new developments in neuromodulators from a long-lasting potential treatment for aesthetic and therapeutic indications to a prospective biosimilar to BOTOX. Our lead candidate, DaxibotulinumtoxinA for Injection, or DAXI, will be a disruptive offering in the aesthetic and therapeutic neuromodulator markets by providing patients and physicians with exceptional response rates and long-lasting results. In the largest aesthetic indication for neuromodulators, glabellar lines. DAXI is expected to require just 2 treatments per year to provide patients with lasting, natural-looking frown line correction all year long.
We anticipate our first approval for DAXI, quickly followed by a commercial launch in 2020. Revance plans to transform the patient experience, raising the bar from what could be expected from a neuromodulator treatment today.
As we enter the second half of the year, we continue to make excellent progress in all 3 areas of our business.
In aesthetics, our main near-term focus is obtaining approval for DAXI in glabellar lines. We’re on track to submit a BLA this fall with both 50- and 100-unit vial configurations, followed by a dynamic launch in 2020 that we believe will be the first truly differentiated neuromodulator compared to today’s short-acting offerings.
To substantiate that fact, I’m excited to announce that Revance SAKURA trial results have been accepted for publication in the upcoming issues of 2 prestigious journals. First, the Blue Journal, the peer-reviewed journal of the American Academy of Dermatology or JAAD. We believe this validates the robustness and significance of our securable glabellar line trial results. Upon publication, the unprecedented results generated for DAXI will become part of an elite group of aesthetic papers published in JAAD, the most widely-read dermatology journal in the world. In addition, this occurred data will also be published in plastic and reconstructive surgery. This peer-reviewed medical journal and official publication of the American Society of Plastic Surgeons is the reference for the latest new procedures and techniques for all areas of plastics and reconstructive surgery. We expect publication online later this year. We continue to share the clinical results for DAXI in podium and poster sessions as well as in person at all the major aesthetics, dermatology and plastic surgery conferences to build strong awareness among thought leaders on the power of DAXI prior to launch.
In support of our commercialization efforts, we continue to build an experienced team of aesthetic professionals to lead our efforts in sales, marketing, regulatory and medical affairs. Many have at least 20 years experience in the aesthetic industry. They have strong commitment and passion for facial aesthetics, which will serve us well as we position DAXI to disrupt the market and accelerate our progress towards commercialization.
In terms of clinical progress, I’m pleased to announce that we have completed enrollment for our Phase II study in 4 headlines and expect to complete enrollment in our crow’s feet Phase II trial by the end of this month.
These 2 dosing and injection site studies are the final pieces of a comprehensive program to determine how best to apply DAXI across the Upper Face. They are strategically important as they will help maximize the potential of DAXI in facial aesthetics.
As you’ve seen recently, we’ve made tremendous progress in strengthening our Board of Directors as we gear up for continued growth of the company. To support our brand efforts, we are pleased to welcome new Director, Jill Beraud, who will chair our brand strategy committee. Jill has more than 25 years experience building luxury, fashion, beauty and consumer brands, and we look forward to her contribution in helping us forge the new standard in neuromodulators with the first truly premium offering. We followed Jill’s announcement in June with the addition of another board member in July, Chris Nolet. Chris is an active business adviser and former Ernst & Young partner. He brings extensive experience in capital structuring, licensing and mergers and acquisitions. We are thrilled to welcome Jill and Chris to our board that is now 9 members strong, 8 of which are independent directors.
Turning to our therapeutic efforts. We continue to build a robust clinical development pipeline in the larger $2.5 billion therapeutics segment of the neuromodulator market.
Revance recently completed the first phase of a research project intended to provide deep insights surrounding the value of each therapeutic indication for the DAXI franchise. We complied — compiled data for both providers and payers. The finding suggests there is definitely an unmet need for surrounding duration of current treatments that creates an opportunity for a profound shift in treatment patterns. On the provider side, the results suggest that large potential for DAXI to become the first-line botulinum toxin treatment. Furthermore, on the payer side, 75% interviewed would not restrict utilization of DAXI, even at a premium price to the current end-market neuromodulators. This market research has reinforced our excitement about the therapeutic opportunities for DAXI.
In terms of our therapeutic pipeline. Enrollment is on track for our Phase III trial in cervical dystonia, for which we plan to release top line results in the second half of 2020. Our Phase II upper limb spasticity trial continues to enroll patients with full enrollment now expected in the first half of 2020.
For our Phase II plantar fasciitis trial, patient enrollment is well underway, and we plan to announce top line data for this trial in the second half of 2020.
We’d also like to briefly mention the biosimilar to BOTOX program. We received the formal minutes from the FDA on the February 2019 Biosimilar Initial Advisory Meeting. As we said on our last call, we got encouraging feedback that a biosimilar pathway for onabotulinumtoxinA is viable. Revance has since been in discussions with Mylan on the potential development path, and we’ll share more details on this valuable asset as our conversations with Mylan proceed.
That covers our recent highlights. Now let me turn the call over to Toby to summarize our second quarter financial results. Afterwards, I’ll have a few closing comments before we begin today’s Q&A session. Toby?
Thank you, Dan. Starting with our cash, cash equivalents and short-term investment balance, we ended the second quarter with $241.9 million. There was no revenue recognized for the second quarter. The revenue recognized in 2018 represented the portion of revenue earned from the $25 million upfront payment from Mylan under the biosimilar collaboration and license agreement.
Our OpEx during the quarter was $39.1 million. And excluding depreciation and stock-based compensation, it was $33.9 million. The earnings release we issued today outlines our financial results in full, so I won’t go through the details on this call. I will note, we are reiterating our 2019 guidance.
Revance expects 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 to be in the range of $148 million to $158 million. We expect our cash runway to extend through 2020 and the anticipated approval of DAXI in glabellar lines. Finally, Revance’s outstanding shares as of June 30, 2019 were approximately $44 million or $48.6 million on a fully diluted basis. And with that, I will turn the call back to Dan.
Thank you, Toby. Revance has continued to make substantive progress on our BLA submission and our clinical development program for DAXI in both aesthetics and therapeutics. Between now and year-end, we are on track to submit our BLA in the fall, complete enrollment in nearly all of our clinical trials and advance our partnership opportunities. This should springboard us for a number of potentially significant value-creating events through year-end and in 2020. With that, I’ll now open up the call for questions.
[Operator Instructions] Our first question comes from the line of Annabel Samimy with Stifel.
Congratulations on the progress. A few questions. So first, just want to get a sense Jeuveau of was launched in the marketplace. It seems like they’ve been able to generate a lot of excitement for the product there with minimal differentiation. So based on what you’re seeing from their experience, what you’re hearing, are you learning anything more about pricing, elasticity of the market and positioning that might inform your strategy?
Second question is just on the publication you expect in the AAD journal, are there any incremental data points that we may learn that we haven’t seen before?
And then if I may, with the third question. Any update on migraine development? And I guess, we’re about a year-plus, it’s a full CGRP market now. And I just want to know if you’ve seen any dynamics that give you greater impetus to move forward or greater comfort moving forward with that indication?
Annabel, we can’t speak to the specifics of the Jeuveau launch, but I think what we can say, based on the feedback from key opinion leaders and physicians as well as consumers, as this market just continues to grow, and we’re continuing to see a very high level in the space, I think physicians and consumers are really trying to signal their desire for something different. I think for both place for the current short-acting segment, we’re really trying to provide a differentiated formulation, a differentiated product that, as you know, moves us from the short-acting, and for the first time, a long-acting segment based on annualized correction of 2 treatments per year or less. So we think that’s really resonating.
I think more broadly, as you look at the Allergan-AbbVie transaction as well as the NestlÃ©-Galderma transaction with private equity, it really does validate neuromodulators as the gateway, the key differentiated product as part of our anesthetics portfolio. And I think, in our view, provides us for extraordinary growth that, for the first time, physicians and patients are going to see a new experience.
As to the publication of both in JAAD. And I think we’re just really excited. I think the clinical team deserves a lot of credit. This is such a prestigious journal. There’s so few aesthetic manuscripts in that journal, but there won’t be any materially new data points in the publication. It’s really validation, verification that this is new science, I think, that it’s unprecedented results, and I think it reflects in the peer review process in both of those journals. But you really won’t see new data.
Relative to the migraine opportunity, I think we still think that this is an opportunity as we continue to look at the use of DAXI in this particular indication. We are looking at different trial designs. This is a complicated pathology. As we continue to see the results with the CGRPs and the continued use of neuromodulators, we would not expect to start a clinical trial until the first half of 2020 at the soonest. But we’re continuing to look at that study protocol, kind of look at the existing growth. And really, when we do start, we’ll have something that’s materially different than the way neuromodulators have been used before.
And our next question comes from the line of Ken Cacciatore with Cowen & Company.
Just a question, and you alluded to it, Dan, talking about Allergan-AbbVie. AbbVie management has been suggesting that in a few years from now, around 2023, they’re expecting to still maintain with BOTOX about 60% share. So they’re actually kind of seeding maybe 10% to 15% share erosion and it sounds like primarily to the long-acting, which would be used. So as you think about launch and as we start getting hopefully excited about the opportunity, what do you think about that type of share gains for you over the next few years? And can you talk about market expansion versus market share conversion? You hit on a little bit but maybe help explain those that aren’t in the market yet, why maybe a product like yours could help expand the market.
And then lastly, just — it’s still a little bit far away, but can you talk about how many sales reps do you think you would need to appropriately position this product in the marketplace.
Thank Ken, thanks for the questions. Look, I think our view is the AbbVie-Allergan transaction really reflects growth, right? This is a growth segment. And I think you’re going to continue to see that with new entrants. We saw one this year. DAXI will be introduced next year. And so we see this pie expanding. Look, no matter which way you cut the data, we’re still at high single-digit penetration in this space. This market is going to continue to grow. And I think where you’re kind of going out in the pie is there will be much larger growth in the pie than there will be cannibalization of the existing pie. And I think for us, what we’ve said strategically, competitively from a science perspective, from an innovation, from a protected technology is, we’re going to approach this space in a materially different way. And I think for us is regardless of where that share ends up being, I think, this experience around annualized correction with 2 or frequent treatments per year resonates with 2 groups. Some of those will be the existing patients in neuromodulators today. They’re comfortable with neuromodulators. They’ve integrated them into their facial aesthetics, and they will be looking at sort of upgrading their treatment into something that’s 3 to 4x per year to 2 or less per year.
I think the other segment where we’ve seen a lot of growth is the de novo patients, patients for whatever reason, may have had pillars, they’re in the dermatologist’s office having other procedures that they didn’t want to take on a 4x per year treatment. And so they’ve looked at something else. I think now when you look at the SAKURA data, and it varied from trial to trial, but you have a large number of de novo patients. And I think what they’re seeing with that experience and the compliance. And by that is, how it integrates in their daily life. They don’t have to come back and get an appointment, they don’t have to park and stay at a physician’s office. And they look at the natural look.
And I think what you’re seeing with DAXI is higher response rates at all the intervals, not just at 6 months, but at any interval, and you’re seeing a practice that allows them to have a natural look. And then as a result, they get this better experience. We just think the combination of those is going to be very attractive. We realize in aesthetics, we’re not going to get all the patients. But we think we’re going to be a sizable driver of growth in this space.
And I would just say also, Ken, on the therapeutic side. I think it’s even, even try to touch upon that in the script and the qualitative and quantitative research that we’re seeing, that we’re seeing both providers and payers seeing what 2 treatments per year could resonate. We’re seeing that utilization, not only in the existing trials that are underway, but in other indications for neuromodulators. And so we think the combination of having the aesthetics as the engine to drive continued growth on therapeutics really becomes both a better outcome clinically, patient-reported outcome, a better pharmacoeconomic benefit to payers, and you’ve got patients who’ve got really debilitating disease and conditions that now, for the first time, have a product that they extend that efficacy that they’ve seen with neuromodulators up till today.
Relative to sales reps, we’re still taking a look at that. We haven’t decided exactly what that specific number. But I think we’ve modeled everything from what you see today in the most recent launch to something larger than that. And I think as we get closer to approval, we finished up our labeling work, we’ll be able to come back to you with more specific guidance on the size of the selling organization.
And our next question comes from the line of Seamus Fernandez with Guggenheim.
Two questions. First, just on the journals, could you guys give us a general sense of the kind of data that we’re likely to see in there that would be differentiated from what we’ve already seen at the different conferences and then what you’ve presented so far from the SAKURA data sets. Just wondering if we might see the 2-point change. And if there’s anything different that we might see between and among the 2 journal articles.
And then the second question, Dan, you’ve taken opportunities to execute non-dilutive financing in the past. Can you just give us a sense, do you guys see non-dilutive financing opportunities on a go-forward basis? And if so, how are you guys thinking about that?
Yes, all good questions. Let me take the journal publications first. I think what you’re going to see in those publications first and foremost is safety. And I think we’ve been really pleased with the tolerability of the drug, of the use across what is the largest data set ever for facial aesthetics. So you’re going to see a very strong safety profile, nothing new than what’s been reported with neuromodulators before. You’re going to see efficacy on the 2-point composite at 30 days. The primary endpoint which is the most important, not only to clinicians, but to the regulatory authorities as well, which will dial into our label. And you’re going to see it response rates from 2 weeks all the way up to the 36 weeks that we follow patients. Remember, we have followed the patients almost twice as long as any of the other — any of the other sponsors to date.
We’re really going to focus to journal manuscripts on an endpoint, which is the most important, and that’s none to mild. The none to mild is the predicate endpoint that’s in the labeling for the existing neuromodulators, at least the 2 that have the strongest market share position because we think it’s not only the most important efficacy assessment for the regulatory authorities, it’s what’s the most important endpoint for consumers. They go into their physician’s office and say, “I have glabellar lines. I don’t like them. How long after treatment can I keep the none to mild?” That’s the one that matters most because that’s helped patients and consumers sort of dictate when they get primary treatment or whether they go back for repeat treatment. And I think you’ll see this data around 6 months.
This is really unprecedented how we’ve taken current neuromodulators from 3 or 4 months now to 6 months in a very large population that goes beyond the sixth month. And so I think having those in a journal like JAAD as well as the other plastic surgery journal reflect the science, the robustness of the data.
Relative to the question on non-dilutive partnering, I think we’ve been very successful of having very high profile, non-dilutive business development opportunities and transactions in areas that allow us to run our core business in the U.S. and to build value based on the science and the data that we’ve generated. We think the opportunity on — with Mylan and the biosimilar is a very unique opportunity. We see our strength on the innovative side. We think there will continue to be a short-acting market. And we think that’s better served with a company that’s more passionate and more focused on the biosimilar generic space.
I think relative to Fosun in China, it reflects an opportunity in a geographic area that’s poised for long-term growth that we’re not going to get to.
So I think those highlights that we have a platform that will enable us to look at other opportunities to monetize the technology and other indications in other geographies, and we will continue to do that, and we look forward to coming back and reporting those business development opportunities as those discussions continue to progress.
And our next question comes from the line of David Amsellem with Piper Jaffray.
Just a couple. First, can you just refresh our memory regarding your thought process of the development of the second vial size? And — specifically, I wanted to get your sense of how you see the different sizes being incorporated commercially. Is that a way to be more flexible regarding your volume discount strategy? Help us understand, again, your thought process there?
And then secondly, on migraine. We’ve heard anecdotally of the opinion leaders the migraine specialists, experimenting with the BOTOX injection protocol. So with that in mind — or I’m taking liberties — so I guess, with that in mind, can you talk about how a different kind of injection regimen, not so much frequency of this frequency visits but actual number of injections may change with your regimen for DAXI. So help us to understand that as well.
David, I’ll try to get to — there’s a number of primary questions and some increments thereof, I think, relative to the second biocides. I think, for us, it is a clinical work with 50 units, we always recognize that 100 units was going to be a workhorse because it will reflect in additional areas where the drug is used in the face. And as we sort of think about the continuum of our development, giving physicians the optionality to sort of look at single-use, whether as they look at other applications. Keep in mind, on the therapeutic side, we’ll have 200 units on that. And so we wanted to sort of have that optionality depending on, on how physicians prepare their syringes at the start of the day, how they’re looking at the use of the drug on a per treatment basis, on a per patient basis. And it also allows (inaudible) into our commercialization strategy on how we sample the drug and how we use it as part of our commercial business. So I think it was an important part of the commercialization that guided us to taking a very short delay. So we can have both of those into the BLA filing at the same time and not require subsequent amendments.
I think relative to the migraine opportunity. I think you’ve got 2 things that we’re looking at: one are the number of injection, site of injections, which you mentioned, but you also have an opportunity to approve upon the efficacy of neuromodulators. I think not only in the chronic migraine space, but potentially other indications where either neuromodulators or the CGRPs have not been as efficacious as maybe we would have hoped or maybe what was projected. So whether it’s a frontline strategy in a given indication, chronic or other, whether it’s part of a combination strategy, I think what’s clear based on, at least our conversations with key opinion leaders and what you’re seeing in the market, our neuromodulators are not going away. And there is going to be an opportunity to use greater responsiveness, longer duration without changing the safety profile of neuromodulators to once again kind of continue the growth of neuromodulators in this space. And so I think that we’ve continued to sort of refine a protocol. I think we’re feeling better about where we’re at, and we’ll certainly come back to you once we have a better clarity on when we would start those trials and what those trial designs would look like.
So if I may, I think of it as a follow-up. Is it safe to say you’re perceiving the value proposition of vaccine migraine as potentially efficacy-based and not just visits and number of injections-based? And if so, do you do a Phase II trial, like some sort of head-to-head comparison versus BOTOX as you did in the BELMONT study in the glabellar line setting?
Yes. There’s a lot of similarity in the way we pursue migraine to what we’ve done historically. I think, first and foremost, is safety. Whether you’re looking at sites of injections, you’re looking at total dose, you want to make sure you haven’t changed the safety profile and where you’ve changed it, you’ve improved it. So I think that’s first and foremost in our thinking.
Secondly, we think there’s a significant opportunity to improve the effectiveness of neuromodulators. I think we’ve learned a lot over the last 10 years, or plus, on how neuromodulators, either in spite a given conditioned state or whether it’s something more broad. I think we fundamentally believe the responsiveness, first and foremost, before you get to duration, needs to be better than what’s in market today.
I think the final piece is its duration. You want to look at opportunities to reduce the frequency of injection and the impact, not only on a patient basis, but on a payer basis.
As it relates to Phase III, I sort of want to comment on what will be the comparator. But I think you have to be able to compare where the market is today, what neuromodulators and CGRPs and what you’re trying to create that’s meaningfully different from those, as part of that Phase II trial, which will guide you into Phase III. And I think that’s something we want to get all aligned. We want to do it right. You want to get appropriately powered so you have meaningful data. And I think we continue to learn a lot this year on both — not only the neuromodulators, where it’s going to continue to play a role, but what are those CGRP populations that may be not be as responsive and are there ways to address that population either with the new neuromodulator, DAXI, or in combination. And that’s what we’re trying to address in this protocol.
And our next question comes from the line of Serge Belanger with Needham.
This is [indiscernible] for Serge. I just had a couple. So regarding the physician practices that are likely to, I guess, stop multiple brands as in having both a short-acting and a long-acting toxin. Is your plan to initially focus on the 60 or so sites from the SAKURA trials, given that they’ve already had some experience with DAXI? And how do you plan to expand that and potentially seek out other providers as you build out the awareness of the long-term potential that DAXI provides?
I think it was 65 centers as part of the SAKURA program. I think those become a core part of our learning, and those become the initial early adopters of the technology because they’ve got comfort and experience of using the product. Those physicians are already today teaching, they’re providing the data, the experience, that various podium presentations. They were instrumental in the publications of SAKURA and JAAD and plastic and reconstructive surgery. So I think they’re already sort of part of that process. I think it was not only the centers, but it’s the number of patients that were in SAKURA. It’s such a larger trial size than any other predicate trials that it gives us an experience with the drug over the broadest cross-section of patients and skin types and ethnicities, male, female and age and the like. I think that learning is one of the reasons and the size and scope of that trial why made it into the journals that it did, but we will start the process, as part of our commercial strategy, of identifying those practices that want to sort of look at a long-acting and how we sort of roll that out over time. And I think it will be a very quantitative. And I think we’ve got a good head start on that. As we look to come back in 2020, as we get closer to approval, we’ll map out to you of how we’ve identified those centers from the 65 today into something that’s obviously much larger than that as we commercialize the product.
Great. And also, I think you touched on this earlier, about the Fosun Pharma partnership. Is there any kind of update there? Has anything started on their end?
So we are looking at the opportunity in China, specifically, the teams worked very well together. Nothing to report as part of anything specific. But I think we continue to be very excited about the opportunity in China. Not only for aesthetics, but for therapeutic. I think there’s an interest from the Fosun team on both. And those teams are meeting and looking at the development path. And hopefully, we’ll be able to come back to you in the not-too-distant future with more specificity at when those trials will be starting and some projected time lines for approval.
DAXI actually will be very unique in that territory. I think the long-lasting in a market that has a lot of core experience with the market leader. And just looking for some innovation in that space. So we’re really excited about the China opportunity. And we think the Fosun team will do a good job with it.
And our next question comes from the line of David Maris with Wells Fargo.
If you could just give us some sense of the spending over the next 18 months or so? So specifically, what’s the rough percentage that you’d expect R&D to decline after the filings and if you expect it to decline? Because you did also mention that you’re going to be starting some new studies as well next year?
And is there a — do you expect there to be a meaningful ramp in SG&A in 2020 in the first part of the year? And all of this is just to try to understand the cash runway. So do you think the use of cash this quarter is going to be steady for the next 6 quarters or so? Any insight into that would be helpful.
Thanks, David. This is Toby Schilke. We’ve guided on our earnings and we’re consistent with our guidance of cash through 2020. Obviously, and we’ve also have some specific specificity on sort of the ratio of our R&D spend to our SG&A spend. And obviously, that balance will change as we get closer to commercialization. But I don’t want to get any more specific right now other than we’re funded through 2020.
And our next question comes from the line of Tim Lugo with William Blair.
Following up on David’s nondilutive financing question. It sounds like you’re looking more geographically? Is that safe to say? Or are you amenable to more specialty or indication-specific deals that you might entertain such as something focused on only neuroscience or something focused on neurology. Would you even look at carving up a U.S. indication?
Tim, I think that when we look at business development, we look at it agnostically. And we, first and foremost, to look at it, how do we create value for shareholders? And I think that the 2 areas that we’ve executed transactions with Mylan and the biosimilar and Boston in China that we felt, when we look at the value created to shareholders, it was better to do that in partnership than it was for us to do it directly and over a longer period of time.
I think when we now reached this point in the development of DAXI in aesthetics and therapeutics, what we’ve shown to potential partners, whether it’s small muscles in the case of aesthetics or larger muscles in the case of therapeutics, that the science and the data is different than what has been associated with other neuromodulators. And so it’s opened up a number of discussions both in aesthetics, which now given that the development work through Phase III is done, are more geographic-based to your question.
Are there opportunities to look at distribution and partnering opportunities from a commercialization? I think when you look at therapeutics, the challenge is, there’s tens, if not hundreds of potential opportunities. And so yes, they become very indication-specific. I think what we said is we want to keep the asset whole within Revance, and we want that to be North America. You should — we don’t expect that at this point, we would look at other type of partnering in North America, but there could be other indication specifics, either by geography or by indication, that we should continue to take a look at and we are. And we’ll certainly come back when those discussions are more mature. But I think that it’s all about now getting DAXI approved in glabellar lines in commercial, having the most successful launch that we can possibly have next year and then beginning to sort of roll out the therapeutic pipeline in a thoughtful way. Some of it will be all Revance. Some of it will be in partnership with someone else, either by geography or by indication. This what makes this DAXI molecule such a value-enriching opportunity is it’s not only the data that we’ve generated so far, but it’s a number of indications that could essentially grow those segments with something that’s more responsive or longer duration or better pharmacoeconomics. I think it’s an exciting opportunity. And therapeutics isn’t — doesn’t have as much visibility today as it should, but it will. And I think that’s reflective of the type of discussions we’re having with people who are in neurology and urology and other indications where neuromodulators are used today.
Okay, that’s understood. And you also added 2 new Board members this quarter. There were some transitions from the C-suite last year. How settled do you think the management is currently? And where else do you want to add within the organization ahead of which should obviously be a very active 2020?
I don’t think we could be more thrilled on behalf of the Board and the management team to attract people like Jill Beraud and Chris Nolet. I think these are seminal experts, executives in their field, who have lots of opportunities, and it reflects their excitement for the Revance platform and the future growth opportunities and for them to be a part of it. I am really honored and thrilled and not only are they just great executives, they are good people. And I think this is an extraordinarily talented, independent Board of Directors. It’s well positioned for growth.
And we’ve had a very stable management team and that’s been for a long period of time. We’ve operated the plan with the exception of a very short delay in the BLA filing. We’ve delivered and executed well. I think, really, it’s about building out the commercial infrastructure in trying to have the best-in-class organization and have that timed appropriately as you get closer to launching the product.
But I think when you look at aesthetics and therapeutics, they follow where there’s real clinically meaningful, commercially meaningful innovation. And I don’t believe that we’re going to have any problem continuing to attract great talent to this company.
Our next question our next question comes from the line [indiscernible] with Barclays.
It’s great to see the progress on DAXI. Can you — 2 questions. Firstly, on DAXI, can you give us an update on the duration front, have you seen anything incremental since your last call to get any greater confidence on the 6 months expectation.
And secondly, on biosimilar BOTOX. Recently on the call for the AbbVie-Allergan transaction, AbbVie made a statement that the BOTOX molecule is not very well characterized. And it’s highly unlikely that one will see a BOTOX — biosimilar BOTOX for a long time. So I’d also be very curious to know your comments on this, especially as it is core part of your growth pillars and why does there seem to be such a strong divergence of views on biosimilar BOTOX.
Let me take the DAXI and the labeling 6-month. We continue to feel very confident in our ability to get a 6-month label based on our discussions with the agency based on the draft guidance based on predicate labels, where the none to mild follow-up. So as part of the manuscript you see, won’t be materially different, but there’s nothing that changes our confidence, and we’re looking forward to having those clinical labeling discussions with the agency next year once they with — they’re filed.
Our confidence is high. And so I think the simple fact is that for the first time, there is clinically meaningful data at the FDA mandate endpoints that shows that this will be a endpoint that can be achieved. And it’s evolved over time from 3 months to 3 to 4 to up to 4, but there hasn’t been data historically.
Now for the first time there is data around this annualized correction of twice a year. So I think we don’t need to sort of belabor that point any further.
As it relates to a biosimilar, I think we’ve been very clear that this is a challenging, but not impossible opportunity. And I think it reflects the investments that we’ve made over 10-plus years in a state-of-the-art manufacturing facility in the U.S. operating under select agent guidance into a chemistry manufacturing and controls and the analytics to look at the predicate reference products relative to where we’re at today with API and drug product. And I think that’s been technology that’s been developed by Revance, its analytics and its required substantive R&D investment to get to this point. I think that there was tremendous uncertainty. I think anybody who’s applied in that prior to the biosimilar initial advisory meeting, we would have shared that. The bar is high, the complexity is high. But I think we came away from the BM meeting with the FDA very pleased that there is a route forward, but we also recognize there’s a lot of hard work in front of us. And that will be a path that once we finish up our discussions with Mylan, we will comment on.
But I think our view is it’s not impossible, but it’s challenging and we’ll continue to do the work. We think that asset has value. And we’re excited to continue that work further.
That’s helpful. Are the Optin discussion started?
Have the Optin discussions with Mylan started?
Yes. We’ve continued — those discussions have been initiated.
And our last question comes from the line of Douglas Tsao with H.C. Wainwright.
First of all, just in terms of Mylan. Just curious, given the recent news around the transaction that they’re involved in. Is there a change of control provision for you? And have you engaged them to reconfirm their sort of interest in continuing on?
I think the only thing we’re going to comment on today is that we’ve continued to have discussions with Mylan relative to the FDA biosimilar advisory meeting and they have an opportunity to opt-in or opt-out. We think based on the data that’s been generated, this is an asset regardless of which way that they — what they may proceed. And if they do opt-in, there will be a nondilutive payment associated with that and continued support of development. If they don’t, we’ll take a look at what’s the best way to create value with that asset going forward. As we all know, there’s a lot of discussions with Mylan on what’s a part of that portfolio, and they will certainly work through that in due course. And at the appropriate time, they’ll make a decision on whether a biosimilar to BOTOX makes sense in their portfolio or not.
And then, Dan, just as a follow-up. And then another question. In terms of the data for crow’s feet as well as forehead lines, do you have an expectation in terms of the value that DAXI might provide in those versus the value that it might provide, in say glabellar lines, which obviously, we’ve seen a whole host of data? And is there any reason to think that the data would be varied from what we saw in the SAKURA trial?
Look, I think the responsiveness of neuromodulators, the duration of neuromodulators, Doug, changes from indication and different patient conditions. And so I think for us is there’s nothing inherently different about a neuromuscular junction in area of facial aesthetics or neuromuscular junction in other areas of drug may be used, cervical dystonia, upper limb spasticity. Whatever that baseline duration is that we can advance it longer than what’s in market today. And I think a part of having the work with — for having crow’s feet lines is this is, as I said on a prior question, it’s not a glabellar line drug. This is a neuromodulator that has versatility across the face and across other anatomic areas. We want to make sure that we understand the safety, efficacy and the performance, and that is both responsiveness and duration in all the indications and know what the right injection pattern is to simplify that for consumers. There’s no reason for them to kind of sort of left that unanswered.
And I think for us, it’s about building out the label, building the clinical data set in a thoughtful way, rigorous way. And that’s what we intend to do. And I think that, that’s what’s required of an innovative molecule in an innovative space is to work with your physicians to make sure you’re getting the best possible result, whether it’s facial aesthetics or therapeutics.
And, I guess, Dan, as a follow-up to that. I mean, so would you think that 6 months is the right framework? Or just as we look forward to those data sets, should — would you think it’s possible that while longer than the existing on-market therapies, it might be somewhat therein?
Look, I think you want to look at a natural look, and you want to look at for us is that the annualized dosing with 2 or fewer treatments. But does not — every — if you look at the crow’s feet data, for example, in the existing part, it’s not very good. So I think for us, as you want to look at whatever the bar is in advancing the state-of-the-art. At the end of the day, the data is going to speak for itself. And I think for us is whether it’s glabellar lines or crow’s feet or forehead or platysmal bands. Pick your indication, whether cervical dystonia upper limb spasticity, migraine, physicians and patients want to see more response rates. They want to see greater duration, and they want to see that without creating an unusual look or creating adverse events. And I think that’s what we try to do as part of the DAXI program.
And this does conclude today’s Q&A session. And I would like to turn the conference back over to Mr. Dan Browne for any final remarks.
Thank you, operator. In terms of our travel schedule over the next few months, we’ll be at the Wells Fargo Healthcare Conference in Boston, the Morgan Stanley Healthcare Conference in New York and the Cantor Fitzgerald Healthcare Conference, which will also be in New York. Please let Jeanie know if you’d like to meet with us when you’re in the area or otherwise schedule a catch-up call.
With that, I’d like to thank each of you for taking part in today’s call. Have a great day, everyone. Take care.
Ladies and gentlemen, this concludes today’s program, and you may all disconnect. Everyone, have a great day.