Revance Therapeutics Inc (RVNC) 2018 Q3 法說會逐字稿

Welcome to the Revance's Third Quarter 2018 Financial Results Conference Call.

(Operator Instructions) As a reminder, this conference is being recorded today, November 1, 2018.

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.

Thank you, Sonia.

Joining us on the call today from Revance is President and Chief Executive Officer, Dan Browne; Interim Principal Financial Officer and Principal Accounting Officer, Cyril Allouche; and Chief Operating Officer, Abhay Joshi.

Earlier today, Revance released financial results for the quarter ended September 30, 2018.

If you've not received this news release or 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 the conference call, Revance management will make forward-looking statements, including statements related to Revance's 2018 financial results and guidance; clinical developments 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 quarterly report on Form 10-Q for the quarter ended June 30, 2018, as filed with the SEC on August 3, 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?

Thank you, Jeanie.

Good afternoon, and thank you for joining our third quarter conference call.

Revance is focused on true clinically meaningful innovation and creating next-generation neuromodulators for aesthetic and therapeutic uses.

In multiple well-controlled clinical trials, including 2 Phase III registration trials, only DaxibotulinumtoxinA for injection, RT002, has consistently shown high response rates and long duration of effect.

With a longer-lasting effect, patients may need treatment with RT002 just 2x a year to safely and effectively alleviate the appearance of glabellar lines.

Current neuromodulator treatments are needed 3 to 4x annually to maintain their aesthetic effect.

In our new facial aesthetics quantitative research, we found that over half of surveyed current toxin users say they desire a longer-lasting product and are comfortable asking their doctor to switch if they have this option.

That research also revealed that, if asked, physicians said they would fulfill their patients' request.

In therapeutic indications, the implications of a long-lasting neuromodulator are even more profound.

RT002 could mean the significant relief from debilitating life-altering symptoms over a longer period of time before retreatment is required.

This could lead to better patient reported outcomes and profound pharmacoeconomic benefits.

From an operational perspective, everything is on track.

The SAKURA 3 open label long-term safety study with repeat administration in glabellar lines should read out before year-end.

We expect this study to reinforce the results of SAKURA 1 and SAKURA 2 pivotal trials, demonstrating RT002's potential for a safe and effective twice a year dosing regimen.

And we'll have additional data on the effective repeat administration on both safety and duration.

Internally, we're meticulously preparing for the Biologics license application for the first indication for RT002.

We plan to file the BLA in the first half of 2019.

We're building the infrastructure and finalizing the Revance product launch velocity plan for RT002 in the United States, targeting commercialization in the first half of 2020.

In terms of recent highlights, over the summer and early fall, we were active at medical conferences and meetings and workshops throughout the United States and Europe.

At the American Society for Dermatologic Surgery, the American Academy of Facial Plastic and Reconstructive Surgery and the American Society of Plastic Surgeons Annual Meeting, key opinion leaders shared the SAKURA 1 and SAKURA 2 Phase III results and discussed the merits and potential of a long-lasting neuromodulator.

It's been clear that RT002's performance is based on the scientific and clinical evidence is strictly due to its unique proprietary stabilizing peptide formulation and not an increase in dose.

The excitement in the physician community for twice-a-year regimen is growing ahead of the SAKURA 3 read-out.

Last month, we appointed Toby Schilke as Chief Financial Officer.

Toby will be joining us on Monday and brings over 20 years of broad biopharmaceutical experience, deep analytic skills and global expertise.

Toby joins Revance from Achaogen where he was Chief Financial Officer.

Prior to Achaogen, he spent 13 years at Roche and Genentech in a variety of senior-level finance and operational roles.

We're really excited to add Toby to our executive team at this pivotal moment in our growth.

Today, we announced that Todd Zavodnick has accepted a CEO position with a private non-aesthetic pharmaceutical company and will be leaving later this month.

I'm pleased to promote Dustin Sjuts, Former Vice President of Strategy and Sales as our Interim Head of Commercial, Aesthetics and Therapeutics reporting to me.

Prior to joining Revance, Dustin held leadership positions at Nestle Skin Health and Allergan, having developed and executed key sales, marketing strategies in the United States and China.

Todd will assist in the smooth transition of his responsibilities to Dustin.

We wish Todd much success in his new venture.

These are the recent highlights.

I'll turn the call over to Cyril to cover third quarter financials and the outlook for 2018, then return with the clinical update before taking your questions.

Cyril?

Thank you, Dan.

We ended the third quarter with $208 million in cash and investments.

Our cash burn in the third quarter was $26.9 million.

Revenue for the third quarter of 2018 consisted of $2.4 million recognized from the $25 million upfront payment for the Mylan biosimilar program.

We expect to continue recognizing additional revenue in future quarters as we advance the biosimilar development program.

The earnings release we issued today outlines our full financial results.

Today, we are reiterating our 2018 outlook and expect to be within our guidance ranges.

We continue to expect our cash and investments to fund our operations into 2020.

Revance's shares outstanding as of September 30, 2018, were approximately 37 million.

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

Thank you, Cyril.

Revance's clinical programs underway in a range of diverse conditions spanning facial wrinkles to neuroscience indications.

Let me give you a quick update on the pipeline.

We have 3 clinical catalysts in the fourth quarter.

In addition to the significant SAKURA 3 long-term safety results in glabellar lines, we plan to initiate Phase II trial in plantar fasciitis with an enhanced protocol based on 2 doses of RT002 inject it into the plantar surface with the primary endpoint based on the VAS-pain score over 5 days.

We also plan to start the Phase II trial in upper limb spasticity, part of a $1 billion muscle movement segment.

This trial will leverage our learnings in cervical dystonia and follow well-established regulatory path with validated end points.

I also want to note that we're providing the foundation for the first biosimilar to the market leader.

In early November, together with Mylan, we plan to request the biosimilar meeting with the FDA and hope to have feedback on a potential 351(k) pathway for a biosimilar to Botox in the first quarter of 2019.

In summary, only Revance is driving true clinically meaningful innovation in the neuromodulator field.

We look forward to an impactful fourth quarter.

As to our travel before year-end, we'll be attending the William Blair biotech focused A series with one of our UCSF investigators in San Francisco, the Crédit Suisse Healthcare Conference in Phoenix, the Evercore ISI Health Content in Boston and the Piper Jaffray Healthcare Conference in New York.

Let Jeanie know if you would like to catch up when we're in you city.

With that, thank you all for joining us today.

I will now open it up for questions.

Operator?

(Operator Instructions) Our first question comes from Tim Lugo of William Blair.

I just wanted to start with, can you just address the 2 C level positions that occurred, I guess, the transitions, which occurred with Todd's now announced departure?

I guess, why shouldn't this be a concern for investors?

They both were very capable individuals.

And I'm sure, the new people are also very capable individuals, but can you just address before obviously such a pivotal time for the company, why this shouldn't be a concern?

Sure.

No, I think in our view we've developed a very strong bench.

And as you know, Tim, Todd's long-term aspiration was to become a CEO, that's dated back for quite some time, and he felt that he could build the right team and continue on as Chief Commercial Officer.

But this opportunity present, one never knows when those CEO opportunities presented, and he was compelled to move to that opportunity.

He is moving to a private non-aesthetics company, it's not competitive with Revance in any way.

And he's built a team and a leadership in Dustin that will allow us to move forward without delay, without missing any of our tactical and strategic activities that are underway.

And I think the timing works for both companies.

Dustin is very well qualified from his work with Nestlé and Allergan.

And I think he has got a lot of support internally within the executive and management team as well as from the Board of Directors.

So we don't see it as a limitation or any consequence on our long-term prospects.

Understood.

And as you're approaching commercialization in 2020, can you maybe talk about how you're doing a further build out the team over the next 1.5 years or so?

Tim, I also wanted to mention on the CFO.

I think as we move to a commercial organization, one that's global, and split between aesthetics and therapeutic, we really wanted someone who had that global biotech experience.

And we think that we're real excited to have somebody like Toby who has the experience in both launching the drug, but more importantly, running a commercial biologics business in the U.S. as well as outside the U.S. And as we look at strategic opportunities, he'll be instrumental in that analysis.

As far as your other question?

Sure.

Just where are you going to build and add to a team as we approach commercialization?

Yes.

So we're very focused on developing the strategy.

We built that, that team across both the strategic marketing as well as the customer interface with physicians.

And most importantly, the medical affairs specialist regionally to work with clinicians who are both in the investigator trials, but also beginning to work with physicians and set various meetings on the technology, on the science, on the data that's been generated.

So at this point, it's very much on building out the team in each of those categories.

We'll look at the opportunity to differentiate our technology, our product versus the commercially available products.

As we see, this is the first new meaningful innovation with neuromodulators in 30 years.

And much of the work that's been out there has been just with the existing products and looking at adding indications and essentially creating sort of branded generics to the market leader.

Our view is we have to be innovative and generate that data.

And now we're in the process of building that clinical team -- or excuse me, that commercial team to tell the story.

Tell the story to physicians, why it matters to them, and how do we get patients to come in and ask for the longer duration product, which they don't ask for.

Understood.

And maybe one last question.

Can you talk about the chronic migraine indication?

I know you thought about starting off Phase II in that indication.

Obviously, the CGRPs had a strong launch in the first quarter or so.

Is that market still as attractive as you maybe viewed it in the past?

Look, our focus is on the 2 largest markets for the neuromodulators, the facial aesthetics and then on the muscle movement.

Those are validated markets of which we believe we have a product that, with significantly longer duration, will differentiate itself.

And there isn't a competitive alternative that's within sight relative to the advantages that come with RT002.

We've said that we wouldn't move forward with the migraine trial until we had a chance to see how the CGRPs played out.

And if we could establish a proprietary position that had something demonstrably different in the current use of neuromodulators.

You've got 40 million sufferers of chronic migraine headache, and there's no one product in our view as we speak to the neurology key opinion leaders that will do all patients.

You've got 13 million that have prophylactic treatment, you've got about 10 million that are episodic and you've got 3 million to 4 million that are chronic.

What's interesting as the field plays out, you've got many of these new CGRPs that are new to the market, they're not existing in the market.

Most of the patients who've switched from Topamax and others have been the ones that switched, not the neuromodulators.

I think it was very encouraging when the market leader reported there was only about 1% or 2%, I believe, they reported that it's switched out at BOTOX.

So our view is this chronic migraine headache will continue to grow.

It may not grow at the same rate that it has historically.

But there will be a need from neuromodulators and as you look at the patient care of those 40 million sufferers, some will sort of move to the CGRPs, some will be Topamax and those type of molecules and some will stay and grow within the neuromodulator.

So will let that play out.

We're currently working on the proprietary position in the study protocol, and we'll get back to you.

We said we wouldn't start that work until 2019 at the earliest.

And by then, we'll have more information of how the CGRPs are gaining traction and in which patient population they're gaining traction.

Our next question comes from Dana Flanders of Goldman Sachs.

It's Chris Staral on for Dana.

So as we look to the SAKURA 3 results, can you talk how you're thinking about durability here, is there any deepening of an effect that you think we might be seeing through repeated dosing?

Or should we be expecting the same level of durability on a per procedure basis that we saw in SAKURA 1 and 2?

And then, I have one more after.

Yes, this is Abhay Joshi.

I would take your question and respond in the following way.

As Dan mentioned that we expect to complete SAKURA long-term study by the year-end, which will have the information.

But what we can tell you right now is, we are expecting high rate of patients opting into the long-term program.

That's a good news for us.

Secondly, we have designed OLS such a way that it's a 36-week study to allow us to observe and follow the full 36 weeks, the effects of the neuromodulator as we've seen in SAKURA 1 and SAKURA 2. And lastly, we have injections, over 3,000 injections over the course of the trials.

If you compare those 3,000 injections versus 400 active injections SAKURA 1 and SAKURA 2, we have roughly 7 to 8x more patients who have been exposed to this toxin as a part of OLS.

So we believe that all this information is a lot of information.

We will analyze that in the next couple of months, and we are confident that we'll provide you with a solid information on both safety and efficacy as we unroll our data.

Okay.

Excellent.

And then just touching on the management team departures, again.

Can you just walk us through what you're doing internally here specifically to ensure a smooth transition, especially given the importance of this role as you look forward?

And then how should we think about Dustin stepping into the interim role here?

How committed are you to finding someone external versus keeping this an internal promotion?

Look, I think Todd deserves a lot of credit for building a really strong commercial team, it's small.

We're still 18 months away from launch.

But we were fortunate to have someone such as Dustin who has both the global experience, the sales experience and the marketing experience that could step into that role.

As you see these changes at a management perspective, you start with an interim Head of Commercial.

We'll look at opportunities to continue to strengthen the commercial team.

I would expect that Dustin would be instrumental in helping us build that.

We'll look internally and externally as we get ready to launch this product in the first half of 2020.

As you can imagine, when you talk to commercial and salespeople, this concept around longer duration, and the meaningfulness and how evasive it has been over 3 decades.

It's not hard to recruit really good people in here.

And the downside of hiring top A talent is they attract a lot of opportunities.

We wish Todd the best.

He'll help Dustin and the team through the transition.

I would expect not only to this month, but he will always be available to help them.

It's very supportive on both sides.

We're disappointed to see him go, but on the other hand, we got a really good team.

We won't miss a beat, and we'll continue to add really strong A players to this commercial team.

Our next question comes from David Amsellem of Piper Jaffray.

This is Mickey Ingerman on for David.

It sounds based on your comments, but the protocol's still in the works, but for the study in chronic migraine, can you guys talk a little bit more about your thinking around the design of the study?

And specifically, whether or not you have plans to incorporate Botox as a competitor?

I'll take the high-level sort of strategic considerations.

I'll let Abhay talk about more of the specifics.

What we'd like to do is really go after that chronic population and much as we've done in other indications move from 4 treatments a year to something demonstrably less.

And if we see that same extended duration, we think that it's possible to go to twice-a-year dosing relative to what we're at today.

We also would like to look at a more tolerable procedure.

Today, out by label, you're at about 31 injections.

It varies a little bit from investigator and from clinician to clinician.

But if we think if we can get something to demonstrably less, that we would both address the long-term benefits and use of these neuromodulators, and have a more tolerable procedures for patients, but also a procedure that's easier for physicians to integrate into their practice.

We've never expected the CGRPs to address all patients.

I think when you look at the response rates, they will clearly find a role in those patients, but the chronic migraine market has continued to grow, and we'll see what happens.

We'll stand by and watch that, but I think from a study design, we want to look at those patients who are not responding to either the neuromodulators or to CGRPs and other molecules and see if we can capture a study design that differentiates this potential product.

If we, at the end of the day, don't feel that we can do that, there's no shortage of indications that we can go work on.

Got it.

And then, one quick follow-up.

Can you guys just talk about your thinking about your positioning of RT002 versus the Evolus product?

And also what are your thoughts on Allergan's acquisition of the short-acting toxin vis-a-vis Bonti acquisition?

And do you guys feel that there is a true need for a short-acting toxin?

When you look around the world, there are a number of neuromodulators.

From the larger botulinum toxin complexes to the more purified versions.

These are all good products, good companies, but they all work about the same.

Yes, they have some nuances to them.

But in our view, any of these clinicians can get these products to work.

And when you look at the history, and where products have been successful, or not successful, our view of the missing link was the innovation around longer duration.

And it's not longer duration relative to a p-value or a median duration, it's the experience that a consumer gets from that longer duration.

How long they hold it.

It's the look, it's the feel, it's the natural appearance to the skin.

To hold that into essentially an annualized correction over 1 year with only 2 treatments, it's game-changing in our view based on the patient's quantitative and qualitative research as well as what we've done with clinicians.

So there's no other product in market.

No other product that's in development that has those characteristics that have been reported in both SAKURA and in BELMONT, which was an active comparator trial to the market leader that have shown the data and the duration and the experience it comes with longer duration.

So that's what's key for us.

It's all about differentiation, it's all about performance.

And how we tell that story, we think will be very compelling when we launch in the first half of 2020.

The other ones are really competing on price.

And that's not an area that we want to compete.

And we wish the others who want to compete on price all the best.

As it relates to the short-acting toxins, I think many of us who've been working with neuromodulators for 10-plus years have never been asked for a short-acting 2-week product.

And in many ways, the adverse events can last longer than the actual results.

So I think that they will play a role.

But at the end of the day, we won.

If this is an innovative product and it brings more patients into treatment, we think that's great, because ultimately they're going to want a product that's more durable and that's where we think RT002 will play a role.

So we hope that the short-acting toxins or the uber short-acting toxins really are able to bring more patients into treatment.

We are still at high single-digit penetration.

So there's lots of opportunities for innovation in this space.

At the end of the day, this is what's going to make this space really continue to grow at that rates that it is now.

It's meaningful differences and innovation whether it would be long-term or potentially short-term.

Our next question comes from Louise Chen of Cantor.

So first question I had was between the aesthetic and medical indications, which opportunity is a larger priority for the company in terms of potential market expansion?

And the potential to takeaway share from existing players?

And then secondly, I was wondering if you could give more color on some of the preparation that you're doing in advance of the launch of RT002 for glabellar lines in 2020?

And then lastly, is just back on the migraine opportunity here, what really differentiates your product from the ones that are currently on the market?

Where is your competitive advantage?

Louise, this is a $4 billion market going to $7 billion, as you know.

And it's been fascinating to see what it historically started as therapeutic uses for neuromodulators really morphed themselves, the largest share into cosmetic, which started to change 4, 5 years ago.

This year, you could have neuromodulators account to about 60% -- 58% to 60% of the use of neuromodulators.

So therapeutic is now over passed cosmetic.

Our view is RT002 is not a glabellar line drug.

It is a platform.

It is a platform that will be exploited both in aesthetics and therapeutic.

So my first answer is this, we're going to do whatever we have to do with RT002 to have a successful launch in aesthetics.

It's our focus, it's our first product.

But we don't see working on aesthetics as an impediment for working on neuroscience indications both that are on label today, which you see with cervical dystonia, upper limb spasticity, potentially migraine.

But there will be other neuroscience indications.

You've got literally 700 potential therapeutic indications for the drug.

And it's really exciting for us to sort of look at the largest markets, have a product that's differentiated from all the other products that are currently approved that are in development, but also have this sort of open pallet to work on other therapeutic uses.

We'll grow into that.

And so the answer is, we think we can work on both.

We think that we can fund both.

We're going to have a successful launch.

And as we move into later stage neuroscience opportunities, we think there'll be an opportunity to partner those with the ideal partner of choice, whether that's in the neurosciences around headache or whether that's in the neurosciences around muscle movement, when we show those potential partners the differentiation that 60% of the market will be open to us when virtually all the other companies around the world have kind of moved away from the therapeutic indications.

And it's all that -- based on that need for differentiation, better outcomes and better pharmacoeconomics.

You have to do both.

And there won't be one product that will do all things, and in your case around chronic migraine headache, but it's pretty simple right?

You want a product that's more responsive in more patients than where the chronic neuromodulators are and an improvement in their headaches scores that goes over a longer period of time and it's more tolerable.

So I mean, that's the product concept and that's what we're trying to develop from a study design and from a proprietary position.

And we'll let watch all the CGRP data play itself out, and we'll see where it ends up.

There's clearly going to be some headwind in the near term.

But you still got 4 million chronic migraine sufferers that don't have the ideal alternative yet.

So we'll look for those opportunities to enter that if they continue to present.

And our next question comes from Serge Belanger of Needham.

I have a couple of questions on the upcoming SAKURA 3 read-out.

In terms of the safety data that we're going to see, I expect you'll be tracking the same adverse effects that we saw in SAKURA 1 and SAKURA 2. Are there any other safety items that you'll be tracking such as immunogenicity?

And then, fairly we're interested in seeing the product safety and duration after repeated administrations.

Can you just elaborate on the number of the 2,500 patients that have received repeated injections in this trial?

Right.

So this is Abhay.

What I can tell you is that, as I mentioned earlier on, that we are very encouraged with the fact that there's a very high rate of patient opting into the [read] injections of trials that got us still ongoing.

And we will be getting to a database log sooner in the next few weeks to announce results by the end of the year.

From a safety perspective, to your question, definitely, we'll be monitoring almost same areas of safety as we analyze for SAKURA 1 and SAKURA 2, including the effects of antibodies and immunogenicity.

With regards to the patient design, as I mentioned, that we'll be following patients up to 36 weeks.

So these are not -- that is why it is taking longer for us to complete the program for OLS because we would like to have almost identical observation on these patients who are enrolling into OLS as we saw in the SAKURA 1 and 2 studies.

With regards to your question of how many -- what is the number of patients who went to multiple treatment cycles, I can't tell you right now because I really don't know as we're still trying to make sure that we can completely analyze the data after we close the database log.

So you'll get the whole analysis in few weeks as announced the results of the study.

Got it.

And, Dan, can you just talk a little bit more about the upcoming meeting with the FDA with Mylan about the biosimilar program?

What kind of discussions do you expect or decisions you expect and when can we hear about the outcome?

Yes, I think as well, sort of it's pretty straightforward.

I think the meeting with FDA will happen sometime in the first quarter next year.

And it is -- it would be a initial bio-advisory meeting where we'll be proposing to agency a number of questions as to what makes this product qualify as a biosimilar.

We are working actively with Mylan and getting data in support of the application, and we expect to have that answer some time, as I said, in the first quarter of 2019.

Okay.

And one last one from me.

On CMC, can you talk about what needs to get done for BLA filing and whether any additional investments need to be done between now and when you are ready to launch the product?

Right.

So I'll take that one as well.

So in terms of investment, I mean, we are very nicely capitalized to be independent and self-sufficient to manufacture both drug substance and drug products.

So no further investment required.

With regards to CMC filing, we have been working on this for last 2 years.

And we are in very nice position, given the fact that we control our own destiny with regards to both manufacturing of drug substance and drug product.

So we're very well on track, waiting for our open-label safety data.

Once that comes out, it'll take us few months to lock that information up and file the BLA sometime in the first half of 2019.

So everything is on track.

This is an investment such that we've made over nearly a decade.

It's a state-of-the-art facility here in Northern California to produce commercial quantities of both drug substance and drug product at U.S. standards, obviously regulatory standards and other parts of the world as well.

We think this is a critical asset for us.

And it's not only the infrastructure and hardware but it's the people.

We've people who have been involved in other neuromodulation programs, other Biologics.

And that skill in those assets, really, in our view provides a competitive advantage as we look at the long-term commercialization of this.

We've got redundancy.

We've got capacity and good people.

So we will leverage this asset and hopefully, return to shareholders that investment that we've made over a long period of time, but all the evidence points just based on the regulatory inspections that we have had today with our select data process, this is a high-performing, high-capacity facility unlike anything in the United States today.

Our next question comes from Difei Yang of Mizuho Securities.

So just a couple.

First of all, on the planter fasciitis, could you highlight for us a few changes you mentioned a couple of changes, but could you highlight all the changes -- all the important changes that you think potentially can help to reduce the patient to patient variability?

And how many sites are you running the clinical trials with?

Great.

This is Abhay Joshi, again.

So I can offer you the following facts that Dan mentioned.

With regard to changes for this trial, number one, we'll have a duration between 6 and 12 months as opposed to 3 months for our first study.

Secondly, this trial will include a run-in period for about 10 days or so.

Thirdly, it'll include a pain score that will be in -- over 5 days versus single point that we had in the first study.

We'll be starting 2 doses for this program.

And lastly, the location of injection will be at the plantar surface.

So those are all, I would say 5 essential changes.

With regard to number of sites, we will disclose to you all the information once we announce our first patient in sometime this year.

Okay.

And then, for BLA filing for the glabellar lines, other than the safety data we're waiting for, is there anything else you perceive to be on the clinic -- on the critical path for BLA filing?

So I'll take as well.

So there are 3 essential elements for BLA as you all know, number one is the CMC section, and Dan talked elaborately around our preparedness for CMC.

We are quite convinced and comfortable in our progress to make that happen.

The second is a nonclinical section, which is -- has been going on for long time because that can approve the product safety, in the nonclinical way, and animals and that allows you to dose patients in humans.

And thirdly, the clinical program on SAKURA 1 and 2 and the open-label safety study, which is the last of the data points from the OLS that will be included into our BLA filing.

So combining all these together, we feel quite confident that we will be able to file the BLA as we told you for a long number of months now by first half of 2019.

Our next question comes from Seamus Fernandez of Guggenheim.

So just a quick couple here.

Dan, can you walk us through a little bit of how you're thinking about the dynamics around breaking the bundle?

Obviously Allergan has a fairly significant beachhead here.

I think there are some who suspect that the reductions in prices for CoolSculpting placements may have been a vehicle to impact the Evolus launch to some degree should it should happen.

So just wondering how you guys are thinking about your market position versus Evolus.

And then the second question is really around the, again, the comparisons that we've seen and you guys have talked about I think before, but maybe you can just remind us, again, the differentiation of your data versus some of the double dose data that was presented at anesthetics meeting conducted by Allergan.

Seamus, thanks for the questions.

Look, I think when you look at the dynamics of breaking the bundle or I think it's been described as the moats, if you will.

I think anybody who underestimates that is not playing it straight.

That is a powerful set of combination products to retard competition.

So I think in our view, when you look at the bundling strategy where they're most effective and when there is not a lot of technical differentiation between the products, whether it be neuromodulators, whether it be fillers, all these companies have their suite of products, right?

And when there's no really relative differences, we think that, that bundle and those moats really are quite strong and difficult to break through.

And you're only left with price.

And that sort of race downward isn't good for the space.

Yes, it'll help some short-term margin economics for physicians.

But until that starts getting passed on to physician -- or into patients it really doesn't bring more patients and at least in our view based on our research.

So the best way to break the bundle is by having something that no one else has.

And to have a product that patients come in and ask for by name.

And I think when you look at the analogs and we've looked at several different analogs, we presented a ophthalmology example at our Investor Day, when you look at CoolSculpting, it's very clear to us when a patient goes into a -- to a physicians' office and they know, they want, they resonate, they feel that experience.

If they don't have it, they go somewhere else.

And so, in our view, that is what's really the most important.

I think when you hear the feedback at both -- 3 Society meetings we've been to for some of those patients who've been in trials, they -- and they've had other neuromodulators, they don't want to go back to their neuromodulators, they want to stay on SAKURA treatment.

So I think that's anecdotal will see ultimately what the data resonates.

But it's all about the commercial team's ability to create that awareness and the meaningfulness of the experience that comes from longer duration.

In our view, this is the right way to grow the market from high single digits to something demonstrably better.

And I think you've seen that in the dry eye where there's -- first there's a competitive alternative the overall market grows.

And I think whenever organically you've addressed the compliance and the experience, the market grows and we think we can break through that bundle.

Relative to the comparison data to longer duration, it's really interesting.

I mean, you've got 30 years of history.

Right?

I don't know how many hundreds of millions of injection.

If it was so simple to just increase duration meaningfully, you would think you would see more of that.

In fact, I can remember 3 or 4 years ago, when no one thought duration mattered and now everyone is talking about duration.

So I think what's been reported in other trials and there are 3. None of that is really novel or new.

In fact, frankly, much of it is unconventional as it relates to FDA mandated end points.

And it's been tried to sort of create this perception that if I put more in, I'm going to get longer duration.

And I think you probably can squeeze out a few more weeks of duration by increasing the dose.

But it doesn't match the type of response rates, the duration that we've seen in RT002.

You didn't see it on a head-to-head comparison in the BELMONT trial and you certainly don't see those type of response rates in SAKURA -- that we saw in SAKURA to any of these other trials.

The most recent comparison data that was presented at an Investor Day, they used the 1 point improvement, which is meaningless from an FDA perspective.

But even if you look at that 1 point change, it's RT002 is about 10 points different at every single time point.

And I think it's really interesting when you look at all the different endpoints, all the different time intervals.

RT002 has consistently outperformed.

I can't think of a data set where any dose, even if you go up to the 80 units that was presented in that trial a month or so ago, didn't match what we saw at RT002 at our formulation.

So even if you put in 4x the dose of the market leader, you don't get results that match RT002 SAKURA trial.

So I think it's neither new, its novel -- neither novel and it's certainly unconventional.

And we expect we'll keep that leadership position for quite some time because it's a technology -- it's not a dosing scheme.

It's a stabilizing peptide that allows this product mechanistically to have longer duration than reported with other formations.

It's a unique formulation, a unique peptide of which no other product in market today has.

And our next question comes from David Maris of Wells Fargo.

(Operator Instructions)

And this does conclude our question-and-answer session.

Ladies and gentlemen, thank you for participating in today's conference.

This concludes today's program.

You may all disconnect.

Everyone, have great day.