Revance Therapeutics Inc (RVNC) 2017 Q4 法說會逐字稿

Welcome to the Revance's Fourth Quarter and Full Year 2017 Financial Results Conference Call.

(Operator Instructions)

As a reminder, this conference is being recorded today, February 28, 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, Brian.

Joining us on the call today from Revance is President and Chief Executive Officer, Dan Browne; and Chief Financial Officer and Chief Business Officer, Lauren Silvernail; Abhay Joshi, Chief Operating Officer; and Todd Zavodnick, Chief Commercial Officer and President of Aesthetics and Therapeutics.

Earlier today, Revance released financial results for the quarter and full year ended December 31, 2017.

If you have not received this 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 the course of this conference call, Revance management will make forward-looking statements, including, but not limited to, statements related to Revance's 2018 financial guidance, clinical developments of our product candidates, business strategy and goals, plans and prospects, the markets in which we compete, potential product candidates and benefits of our current and future product candidates and our technologies, regulatory risks and ability to obtain regulatory approval and uncertainties and future performance.

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 result -- cause results to be different from these statements include factors the company describes in the section titled Risk Factors in our annual report on Form 10-K for the year ended December 31, 2015, as filed with the SEC on March 4, 2016, and subsequent quarterly reports on Form 10-Q and current reports on Form 8-K.

Revance cautions you not to place undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations.

I will now turn the call over to Dan Browne.

Dan?

Thank you, Jeanie.

Good afternoon, and thank you for joining our fourth quarter and year end 2017 conference call.

As a company, our goal is to be innovative pioneers in neuromodulators.

The clinical data from multiple clinical trials for DaxibotulinumtoxinA for Injection, or RT002, supports the fact that we have a highly differentiated and the first high-performing injectable neuromodulator capable of delivering 6-month duration.

We have confidence we can successfully build the growing demand from physicians and consumers for a long-acting neuromodulator and build a premium brand differentiated above and beyond the currently commercially available short-acting products.

The current $4 billion of sales for short-acting neuromodulators is forecasted to grow steadily, exceeding $7 billion by 2024.

So we also see continued opportunity for our short-acting offering.

Today, we announced Revance and Mylan will collaborate exclusively on a worldwide basis, excluding Japan, to develop, manufacture and commercialize a biosimilar to the branded biologic product onabotulinumtoxinA, known as BOTOX.

We're pleased to partner with Mylan, as Mylan has a large biosimilar portfolio in development, an additional focus in dermatology and other therapeutic areas that were aligned with the use of neuromodulators.

Mylan has significant expertise in global regulatory biosimilar development in a global commercial infrastructure.

In our view, this collaboration agreement is a major step forward towards validating our internal capabilities and allows us to monetize our significant investments in neuromodulator development and manufacturing.

For Mylan, Revance is the ideal partner as we uniquely possess platform neuromodulator assets and capabilities to manufacture a short-acting biosimilar formulation to U.S. and the EU standards, from a facility purposely built and operated here in The United States.

For Revance, this partnership provides $25 million paid up front, with contingent payments of up to $100 million upon the achievement of specified clinical and regulatory milestones and of specified tiered sales milestones of up to $225 million.

On approval and launch, there is a royalty stream on sales of biosimilar BOTOX, which we would use to support Revance's anticipated RT002 launch and expand our long-acting neuromodulator pipeline.

We're excited to work with Mylan to codevelop this biosimilar, utilizing our expertise in biosimilars to pursue approval and commercialization.

This partnership allows Revance to remain focused on continued development and launch of our next-generation RT002 pipeline, which remains unpartnered and completely under Revance's sole and exclusive control for all indications.

Moving on to review of 2017, it was a successful and productive year for Revance and RT002.

Clinical results for RT002 in both glabellar lines and cervical dystonia were exceptional, and we ended the year well-funded, with a robust pipeline to pursue.

In December, we shared the positive results from our SAKURA 1 and SAKURA 2 Phase III trials in glabellar lines which reinforced our BELMONT Phase II results.

We've now shown RT002 deliver 6-month duration of response on multiple secondary measurements, and plan to pursue a duration claim on the label with the FDA.

Success in SAKURA Phase III trials allows us to raise additional capital -- allowed us to raise additional capital last December, which will take us through the BLA filing in key prelaunch preparations.

In the fourth quarter, we provided 2 updates on our cervical dystonia clinical program: first, RT002 was granted Orphan Drug Designation for cervical dystonia; second, we finalized our end of Phase II discussions with the FDA, which led us to focus on a single Phase III pivotal trial for The United States with a concurrent open-label safety trial to support approval.

We are energized by the momentum behind our first potential therapeutic indication and are excited by the prospect of bringing a promising long-acting therapy to those suffering from this highly debilitating disease.

In both glabellar lines and cervical dystonia, RT002 has showed potential to the right patients with high-performance and enduring effect with just 2 treatments a year.

In aesthetics, where we believe there is already pent-up demand for a long-acting neuromodulator, RT002 would allow for the coordination of care with the longer duration dermal fillers, a meaningful outcome and benefit to patients.

As many as 5 independent surveys of dermatologist and plastic surgeons have indicated that 50% or more have high interest and enthusiasm for a longer-acting neuromodulator, and we find the enthusiasm for a longer-acting product continues to grow as investigators and physicians present the findings from SAKURA, BELMONT and our cervical dystonia trials.

And while RT002 has tremendous potential for facial aesthetics, it has even greater potential in therapeutic uses where it could profoundly enhance patients' quality of life across several specialty areas, particularly in the neurology, where -- which is a key therapeutic area for Revance's neuromodulation products.

At the beginning of 2018, we announced interim 8-week results from our Phase IIa trial in an exciting, new, underserved musculoskeletal indication, plantar fasciitis.

While not statistically significant to placebo, RT002 did provide significant pain reduction.

We are planning to initiate an additional Phase II trial in the second half of 2018.

That covers the recent highlights.

Let me turn the call over to Lauren to summarize our fourth quarter and year-end results.

Then I'll follow-up with our clinical and operational plans for 2018.

Lauren?

Thank you, Dan.

Starting with our cash and investment balance.

We ended 2017 in a strong position with $283 million.

Our cash burn, excluding financing, in the fourth quarter of 2017 was $30 million and $102 million for the fiscal year 2017, which came in at the low end of our annual cash burn guidance of $102 million to $112 million.

The earnings release we issued today details our financial results, so I won't go through them in detail on the call.

The bottom line is that our operating loss was $36 million for the quarter and $121 million for the full year, slightly higher than our guidance due to a $2.9 million noncash impairment primarily associated with RT001 planned assets.

In December of 2017, we completed a follow-on equity offering with net proceeds of $157 million.

We now expect our cash investments to fund our operations through 2019.

Today, we are reiterating our 2018 guidance issued last month, which remained unchanged after entering into the agreement with Mylan.

Excluding financing activities, we expect cash burn for 2018 to be in the range of $117 million to $137 million.

Revance's shares outstanding as of December 31, 2017, were approximately 36.5 million.

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

Thank you, Lauren.

Looking ahead to 2018, as we outlined in our January clinical milestone guidance release, we are on track with our clinical programs and are gearing up for our BLA filing.

On the Aesthetics side, the SAKURA 3 long-term safety study is fully enrolled, progressing as expected, in line with SAKURA 1 and SAKURA 2, and is expected to conclude in the second half of 2018.

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

Our first expected commercial launch will be in glabellar lines.

Even though treatment of brown lines with neuromodulators is estimated to represent nearly a $1 billion global opportunity, the U.S. penetration rate is below 10%.

We believe RT002 has the potential to expand global sales of neuromodulators by reaching consumers who avoid treatment due to the burden of frequent repeat office visits.

On the therapeutic side, we expect to initiate a Phase III trial in patients with cervical dystonia in the second quarter of this year.

As we have said before, we anticipate the need for only one U.S. pivotal trial, along with a concurrent safety trial, before seeking FDA approval.

The trial will be conducted in The United States, Canada and Europe.

We anticipate the Phase III trial will extend 36 weeks due to the duration extending beyond 24 weeks in Phase II.

Enrollment of the first patient is expected in the second quarter, and we'll share more on the trial design at that time.

Current estimates by global industry associates ink -- size annual global sales for cervical dystonia at $300 million, with 85% of it in The United States.

Plantar fasciitis is our first pain and inflammation indication in an area where we believe RT002 has the potential to address an unmet medical need.

While we complete the 16-week Phase IIa trial in plantar fasciitis, we are looking at the trial design, inclusion criteria and treatment parameters to see how we can improve the trial outcomes.

We plan to initiate a second Phase II trial for plantar fasciitis in the second half of 2018.

In terms of clinical data, this year we again have an active podium presence and publication program underway to build awareness and consensus in the medical communities.

We plan to present SAKURA 1 and SAKURA 2 data throughout the year at major medical conferences and are submitting the results for peer review publication.

More recently, data was presented at IMCAS in Europe and the AAD in San Diego.

We also expect the cervical dystonia Phase II results will be presented in a peer review publication.

In both aesthetic and therapeutic medicine, RT002 could translate into fewer office visits and higher patient satisfaction carried over a longer period of time.

More specifically, in therapeutic indications, RT002 may provide improved patient outcomes and deliver better pharmacoeconomics for payers.

Our commercial team is busy gearing up.

We expect our Revance product launch velocity in glabellar lines will allow us to aggressively enter and grow the $4 billion in global neuromodulator sales by generating greater adoption in aesthetics.

The team and I look forward to updating you on their progress on future calls.

In terms of our travel schedule, in March, we'll be in Boston at the Cowen Conference, followed by the Barclays Conference in Miami, and at the end of the month, we'll be at the Needham Conference in New York.

Also, I'm pleased to announce that in April, we will be hosting our first Investor Day in New York.

So mark your calendar for April 19.

Invitations have already gone out.

If you did not receive one and would like to attend, please reach out to Jeanie Herbert.

With that, thank you all for joining us today.

I will now open it up for questions.

Operator?

(Operator Instructions) And our first question will come from the line of Ken Cacciatore with Cowen and Company.

On the BOTOX, the agreement with Mylan.

Just trying to understand, Dan.

You're using the actual brand name BOTOX.

So can you help us understand what the pathway would be, kind of, any intellectual property?

But more importantly, on the pathway, would you need to do a clinical study or not?

And so trying to understand using that name -- actual brand name versus a branded generic strategy?

And then if you do -- you all understand or if you met with the FDA about kind of what the pathway forward would be?

Would it require different kind of studies in different indications?

Ken, thank you for the question.

I think it's an excellent question, because there are distinct differences between the long-acting RT002 product and biosimilar to the onabotulinumtoxinA, brand name, BOTOX.

Abhay, why don't you go in into the specifics of the differences?

Yes.

So Ken, thanks for the question here.

The key difference is that, as you know, Ken, that our Daxi product has a 150 kDa of toxin molecule as compared to a 900 kDa molecule that you have in the BOTOX formulation.

Further, the Daxi product does not contain any animal- or human-derived components to it, and we have a proprietary peptide in our Daxi product.

When compared to the BOTOX biosimilar or biogeneric, this will be formulated similar to what you have for the branded product in the market.

With regards to the development plan and pathway, as you can imagine, we just had the deal concluded, and so we'll be working with Mylan and with the expertise in global regulatory on biosimilar development areas and global commercial infrastructure, our plan is to sit down with them over the next few weeks and months to completely understand the development path -- a comprehensive development plan that we will develop, we'll work together and collaborate together to get that plan formulated.

So we'll let you know as we have that plan formulated.

Okay.

In absence of knowing that, I take it -- so it's not entirely clear.

Would you have to do kind of clinics against indications?

Or can you give us some sense of timing of this type of program, when you would have clarity on what the pathway would be?

Yes.

So I think in our -- absolutely, at least on a biosimilar pathway generally, you have to agree on some kind of a bioanalytical and biocompatibility, and that's why I think we are so excited that Mylan has vast experience in developing biosimilar in that area.

And with respect to a clinical trial, it may require potentially one clinical trial.

That may suffice the approval of other indications.

But that remains to be seen until we have that question answered and worked out in collaboration with Mylan and FDA.

And our next question will come from the line of Louise Chen with Cantor.

So my question here is on the BOTOX market.

And if there is a biosimilar, and there's other potential companies coming to market with less expensive products, how does that affect the RT002 market and the branded market for botulinum toxins?

And then my follow-up question was just on your plantar fasciitis Phase IIa trial.

Just curious when we will see that read out?

So Louise, I'll take the last one first, and then I'll ask Todd to comment on the commercial differences between the RT002 product and then the biosimilar, BOTOX product.

So as we mentioned on the call, we'll be completing the 16-week analysis, but moving forward with an additional Phase II trial in the second half of this year in plantar fasciitis.

We continue to be pleased with the reduction in pain that we saw.

We'll be going through some of the things that we mentioned on this earnings call around inclusion criteria, various assessments.

And then we'll be giving more clarity on that at the Investor Day, exactly what that trial will be looking at, and our steps for going forward on plantar fasciitis.

Relative to the commercial differences.

Todd, why don't you take that one?

Thanks, Louise, for the question.

I think it's very simple for us, and you've heard Dan and Lauren say this for years now, is that Revance were committed to long-acting and to the duration -- safety, efficacy and duration of RT002 that we saw at SAKURA 1 and 2, and it's been profound with regards to the results.

And I think from our standpoint, there will be a definite separation in the marketplace.

And you see this pharmaceutically across all molecules that are advanced.

There hasn't been innovation in this space in 30 years.

And so we look at it that, look, there the current short-acting toxin market or neuromodulation market is there.

We understand it's going to be there, it had first mover advantage.

But we do understand that the market is moving.

And as you heard in Dan's remarks, independent surveys are showing, at minimum, 50% or greater of core physicians, plastic surgeons and dermatologists, want a longer-acting neuromodulation effect for their patients to match with their dermal filler, and we know the market is going to move that way.

So at the end of the day, 2/3 of the market wants it, the specialists are asking for it, and we know the patients, it's just a lifestyle way for them to have kind of that beauty-for-life outcome.

So for us, we think it's natural.

It's 2/3 of the market or more will move to longer acting, and that's our focus.

And by partnering with Mylan, this allows us to stay 100% laser-focused on our premium technology story.

And our next question will come from the line of Morgan Williams with Barclays.

So may be digging a little bit deeper.

Just kind of wondering the rationale for the partnership with Mylan.

If you could elaborate there.

Just thinking through kind of, if there is a biosimilar BOTOX on the market, wouldn't the pricing for the overall toxin market erode significantly and kind of therein, kind of -- I don't know, affects the peak penetration for RT002?

And then, maybe just as a quick follow-up.

Just wondering how the deal kind of came about?

And whether there were any, or there are any, other biosimilar BOTOX products in development?

So, Morgan, I'll take the first shot at that, then I'll ask Todd or Abhay to comment on that.

I think, based on the data that we've generated and the confidence that we have that, whether it's the clinical data or whether we're following the draft guidance for modulators or predicate labels, we're going to have a -- I believe this will have a differentiated label.

And so as I -- as you look at the neurotoxins, you see the emergence of, essentially, branded generics.

And those products have essentially competed on price to some degree.

When you look at the biosimilars more globally, when you look at the 31 approvals in outside the U.S., the 5 to 9 in the U.S., you really sort of see discounts that are pretty comparable with what's already happening in the market.

So we don't know if the pricing will be for Mylan or any of the other companies will settle then on price.

But what's important to us is the technical performance differentiation, because that is something that I think is resonating, as Todd said, with 2/3 of the market.

There will be a long list of approved indications that we won't get to for some period of time with RT002.

And if we're successful with this biosimilar approach, allows us to accelerate a greater participation in those areas that we're not going to get to right away with RT002.

Todd, do you want to sort of add to that?

Yes.

Thanks, Morgan.

I mean, I think your comment on, what's the market dynamic that we anticipate.

I think, I'll go back to what I answered previously is -- and add a little more color.

It's that if you -- we've had these conversations.

Look at the market, and if we do have 2 to 3 million people in the space and we do have 30 million considers, and a market that's growing 8% to 10%, it's profound, right?

And there's still so much more room for market expansion.

And we know the market leader is focusing in that area, as should everybody be.

We need to make the pipe bigger.

At the end of the day, it is what it is, and the 2 to 3 million people that are in this space and the physicians in the core specialty that are addressing it want a longer-acting product.

So if you ask me what I think is happening, I think you are going to have the market look for a longer-acting product but, respectively, we understand that there will be a price-sensitive piece to this market.

And I think the eutopic piece, overall, [umbrellaing] the neuromodulation marketplace aesthetically to start is, you definitely want to make this marketplace bigger.

So I think, if you look at it from what it is today, it's a little bit myopic, and that we need to look at what a neuromodulation marketplace growing 8% to 10% today should be growing at, and we need to expand the market.

And we fielded a twice-a-year indication premium technology.

Our product will allow the market to grow, as Dan has said numerous times in the past.

Okay.

And I would just add, Morgan, that we've made significant investments in infrastructure or technical operations around manufacturing.

So we've got the capacity.

We will focus on RT002, but allows us to monetize and create additional differentiation.

Where you see all the other companies doing that already, whether it's liquid fuel or those types of things.

We can monetize in areas that we think are going to happen organically while we focus on what is really needed in the marketplace around longer-acting toxins.

And then maybe if you could just address the question of whether you know of any other biosimilars in development?

Well, I think at this point, we haven't seen any other biosimilar developments around botulinum neuromodulators.

They've essentially been branded generics.

You see some here in the U.S. You see some internationally.

They're essentially single indication.

They're not true biosimilars in the sense of a regulatory definition of a biosimilar.

Our next question will come from the line of Rohit Vanjani with Guggenheim.

Congrats on the deal.

What -- I might have missed it in the prepared remarks.

The agreement with Mylan, do they get commercialization rights over all indications in all regions, U.S., Europe and others?

That's right -- this is Lauren.

And they do.

They have global rights, except Japan, which we retained.

And that's been very common, Rohit, with biosimilars.

You see all the large companies, biosimilar have partnered with other companies in the case of biosimilars.

I think, what was important to us is we stay focused on what this company was built on, innovation, addressing needs that had been unsatisfied over the last 30 years, as part of those investments that allowed us to monetize, as we said, on the biosimilar.

But that's essentially how we're structured.

This is very similar to those other biosimilar partnerships.

Okay.

And the royalty sales, are there any bounds that you care to put on that potential royalty?

Yes.

We haven't announced the details of the royalty, but it's certainly in line with other deals.

We're very pleased with the deal that we stuck with Mylan.

And then the last one is the modified design for plantar fasciitis.

In the second Phase II, in second half '18, what are those modifications?

I think that we'll get into that later in the second quarter.

We're not prepared to have those today.

We -- the focus now is to wrap up the study at 16 weeks and get the clinical study report and then move forward with the next trial design.

Look, I think this is very consistent with what others have gone through in pain trials with neuromodulators, and we'll move to that in a methodical way.

And that's what comes when you're in first-mover positon for a new indication.

I'd add.

We really do need to finish up that analysis, Rohit, before we go ahead.

It's a 16-week study that isn't done yet.

And our next question will come from the line of David Amsellem with Piper Jaffray.

This is Mickey Ingerman on for David.

Just a quick one, but -- based off of somewhat mixed results in the plantar fasciitis study, how does that change your views on what other therapeutics, I think, you may choose to pursue?

Look, it doesn't change our confidence.

We have a unique drug in RT002, and we will go down the path of where other neuromodulators have been developed, and we'll also go down the path where they are not being developed because we think this drug has the differentiation.

And we know we have a drug that works, and so we just got to go through those clinical development process in a methodical way, prioritize around the indications that we see, marry with clinical need and the advantages of our technology.

And as you've seen today that, that sort of follows in some -- at least 2 of the 3, where there's labeled indications.

But like I said, we'll go after new ones too.

This is a unique product and a unique technology, and it's important to us to do both.

We want to lead the space.

As I said in the opening remarks, our task is to lead this neuromodulation space.

And our next question will come from the line of John Boris with SunTrust.

So on the deal,, I guess, first question is, why?

Why now?

Especially in light of the -- your branded strategy and your mission, it seems to conflict to a degree with your mission.

Are you going after, at least, a clinical trial that you have to conduct with the onabotulinumtoxin?

Or are you going after aesthetic?

Is it therapeutic?

Is it both?

What's the timing to complete that trial?

Have you thought about the ramifications of entering into a protracted litigation possibly down the road?

And then on the royalty.

Since you're the only game in town to be able to manufacture this possibly, one would assume that you're probably extracting a pretty high royalty.

So just want to press you a little bit on the royalty.

Would assume you wouldn't be doing this unless you're getting something that's in the double-digit range?

Is that safe to assume that?

So John, at this point, we're not going to comment on the royalty rate.

But in due course, I'm sure, that disclosure will be made.

I want to come back to the question, why now?

Because I think it's been really important to us, as we looked at the opportunity, and we thought this was the ideal time to monetize the investments that we've made in our assets.

And we did that also because we felt very strong in the clinical data in multiple trials, and our confidence in the label and that -- I think, when you look at the surveys, there's going to be some role for the branded generics.

They're already playing a role.

This is a way for us to participate in that and really sort of focus on 2/3 of the market, but that other 1/3 is to monetize it now and get a return on the investments that we've made.

And I think, looking at it from a true biosimilar path and looking at all the indications versus just a single indication, we thought this was the time to do it.

Approvals will most likely come well after we have approval for glabellar lines and cervical dystonia, but we'll certainly have the -- get with Mylan in that process and the regulatory agencies as well.

So I think this is a way for us to participate on both sides and deliver real high-quality products, both on the innovation side, but also on a true biosimilar side.

And on the -- John, on the financial side of this, we aren't disclosing the royalty rates today, but it's a very favorable deal for both parties.

But as you noticed, it's about $325 million in total milestones, about $25 million upfront, and then a very significant royalty rate.

So it really allows us to fund the expansion of our therapeutic pipeline in future years.

Sorry, are you responsible for funding the clinical trial?

Or is that split 50-50?

How does that work?

So if you look at the clinical trials, they're split between the parties for U.S. and Europe.

But because of how the milestones are structured, we've pooled back all the funds in advance from Mylan and more.

And is it an aesthetic trial?

Or is it a therapeutic trial?

If the parties need to -- we inked the deal today.

The parties really need to meet and sit down, and there are many options here for how to pursue this, and we really will rely heavily on Mylan for that.

And your timing assumption is well beyond or after the time period that you would launch RT002?

That's correct, yes.

That's a correct expectation.

And our next question will come from the line of Tim Lugo with William Blair.

This is Ashiq Mubarack on for Tim.

My first one was on the potential bundling opportunity between a biosimilar BOTOX and RT002.

Is that kind of in your plans?

Or given the potential price erosion with BOTOX, are you planning on countering them a little bit separately?

And then #2, on the modified design for the plantar fasciitis study.

I know you aren't giving too many details right now, but is your focus, when it comes to modifying the study on improving placebo rates?

Or were there other factors that you're kind of thinking through?

We don't intend to bundle the long-acting technology with the biosimilar.

So those will be separate commercialization processes.

Relative to the plantar fasciitis, I think that, look, we were pleased with the reduction in pain.

We saw placebo noise, and I think that's where the trial design and some of the modifications, whether it'd be inclusion criteria and some of the other assessments in study execution.

So obviously, we'll talk about those, but I think they're very consistent what we've seen in another neuromodulator trials as you work that -- work through that in a very thoughtful way.

Yes.

And on the deal side, remember that Revance is not commercializing a biosimilar, Mylan is.

If you look at the deal structure.

So they won't be bundled.

They're 2 separate companies marketing 2 separate products.

And our next question will come from the line of Donald Ellis with JMP Securities.

First question is, I assume, you had multiple meetings last week at the AAD.

Can you tell us if you've learned anything new about the potential acceptance by the physicians of RT002?

And the second question is about the biosimilar BOTOX.

Do you have a formulation yet?

Or do you still have to formulate a biosimilar BOTOX?

Yes.

Thanks, this is Todd.

I'll take the first question on the AAD question.

I think in contact with our various meetings that took place with physicians via medical affairs, that the feedback has been positive.

I think a lot of the physicians continue to comment on, I think, as Dan alluded to earlier, this coordination of care.

It's that the marketplace -- patients want a durable product.

They want that something that lasts longer, and they're seeing that with the Phase III release of SAKURA 1 and 2. And so the feedback has been very positive.

And I think what's really been reinforcing that to us, as we've said before is, there are surveys that are being done by Revance.

These are independent surveys that are touching core physicians, and not just the physicians that are your key opinion leaders, but physicians that are day-to-day in the office, seeing high volumes, and they realize that this is something that's going to allow them to have successful outcomes and provide benefit to themselves as well as to their patients.

So the feedback on our side has been exciting.

And then the last point I'll make, to be very directive, there hasn't been innovation in the injectable space with regards to neuromodulation for a long, long time, and that's really exciting for people to have something new to discuss and as well bring value to the practice and to the patient.

Abhay, you want to talk about the formulation?

Yes.

So with respect to the formation, I can tell you that, as a part of our working with Mylan, our -- with this deal, they have looked into the work that we've done so far, and they were quite pleased with the progress that we have made with respect to the 2 components, the drug substance and drug product manufacturing.

So those 2 combined together gave Mylan a good confidence in our ability to move further this program.

Thank you.

Ladies and gentlemen, this concludes our question-and-answer session.

Thank you very much for your participation on today's conference.

This does conclude our program, and we may all disconnect.

Everybody have a wonderful day.