Revance Therapeutics Inc (RVNC) 2018 Q2 法說會逐字稿

Welcome to the Revance Second Quarter 2018 Financial Results Conference Call.

(Operator Instructions)

As a reminder, this conference is being recorded today, August 2, 2018.

I would like to turn the conference over to Jeanie Herbert, Senior Director of Investor Relations and Corporate Communications for Revance.

Please go ahead.

Thank you, Kevin.

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; Chief Operating Officer, Dr. Abhay Joshi; and Chief Commercial Officer and President of Aesthetics & Therapeutics, Todd Zavodnick.

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

If you've not received this news release or you'd 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 development of our product candidates, including the timing and results of the SAKURA III study and ASPEN Phase III program; business strategies and goals; plans and prospects, including our pre-commercialization plan, potential product candidates and benefits from our current and future product candidates and our technologies; regulatory risks and ability to obtain regulatory approval, including the timing of potential BLA filing; and uncertainties in 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 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 in the quarter ended March 31, 2018, as filed with the SEC on May 9, 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 second quarter conference call.

Revance is an emerging biotechnology leader actively pursuing new ways to advance the neuromodulator product category in both aesthetic medicine and the neuroscience specialties.

Our differentiation and competitive advantage is powered by remarkable science and driven by enduring performance supported by data.

Revance's DaxibotulinumtoxinA for Injection (RT002) is the only neuromodulator to consistently deliver high response rates and a long duration of effect.

This distinctly new neuromodulator has significant potential to increase demand and expand the neuromodulator arena in both facial aesthetics and therapeutics.

As we outlined at our Investor Day in April, we are currently in the pre-commercial phase for glabellar lines and have broadened our neuromodulator pipeline with 2 indications in Phase III, 2 indications entering Phase II this year and an additional Phase II trial next year.

With regards to our clinical progress in the second quarter, in June we initiated the ASPEN Phase III program for RT002 injectable in the treatment of cervical dystonia.

This will be our first therapeutic indication.

As recently published in the Journal of Movement Disorders Clinical Practice, RT002 demonstrated long-lasting relief with high response rates and sustained efficacy in treating this debilitating involuntary muscle movement disorder.

The ASPEN Phase III clinical program consists of 2 trials.

First, a randomized double-blinded placebo-controlled trial with a high dose and a low dose.

Post-treatment patients will be followed for a maximum of 36 weeks.

The primary efficacy endpoint of the trial will be the change from baseline in the TWSTRS-Total score, the same as we used in our Phase II trial.

Second, an open label long-term safety trial with patients receiving multiple treatment cycles of RT002 injectable over the 52-week observation period.

Primary endpoints of the trial are safety and immunogenicity after multiple treatments.

Each trial is expected to enroll a total of approximately 300 patients, with significant majority of patients expected to roll over from the pivotal into the long-term safety trial.

The trials will be conducted at multiple sites in the United States, Canada and Europe.

We anticipate the pivotal trial to be fully enrolled in 2019, with top line results expected in 2020.

Current botulinum toxin injections for cervical dystonia are administered approximately every 12-week interval.

With the potential for twice-yearly administration, RT002 could represent a meaningful advancement in patient treatment, providing significantly prolonged improvement of symptoms.

We believe that RT002 may also deliver improved patient outcomes in a number of other muscle movement disorders.

During the quarter, we made several additions to our management team, including Caryn McDowell, who joins us as Senior Vice President, General Counsel and Corporate Secretary.

Caryn was previously in legal roles at Cytokinetics, InterMune, Onyx, Genentech and Millennium Pharmaceuticals.

Early in her career, she served as Senior Counsel at the Office of Inspector General of the U.S. Department of Health and Human Services.

We added Susanne Fors as Vice President, Regulatory Affairs.

Susanne joined Revance from Genentech, where she held the position of Global and U.S Regulatory Affairs Franchise Head.

And we also welcomed Dr. Conor Gallagher as Head of Medical Affairs, Aesthetics.

Conor was formerly an executive director at Allergan, leading medical affairs for aesthetics.

During his 13-year tenure at Allergan, he designed and executed numerous Phase IV clinical trials and supported multiple new product launches in the United States and globally.

We are pleased to add such seasoned and experienced management and continue to look for veteran biopharma leaders to guide our teams.

As for our open CFO position, we have an active search underway for a healthcare executive with both commercialization and global experience.

Until we complete that new hire, we're pleased to have our current Head of Finance and Corporate Controller, Cyril Allouche, to step in as Interim Principal Financial Officer and Principal Accounting Officer.

We believe we have a strong, capable finance team in place through the CFO transition.

These are the recent highlights.

Now let me turn the call over to Cyril to cover second quarter financials and outlook for 2018.

Cyril?

Thank you, Dan.

Starting with our cash and investments balance, we ended the second quarter with $234 million.

Our cash burn in the second quarter was $38 million.

Revenue for the second quarter of 2018 consisted of $700,000 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 guidance.

We continue to expect

the cash burn for 2018 to be in the range of $117 million to $137 million.

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

Revance's shares outstanding as of June 30, 2018, were approximately 36.9 million.

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

Thank you, Cyril.

In the fourth quarter of 2018, we plan to report results from our SAKURA Phase III open label safety study for glabellar lines.

The results of SAKURA III will include more than 2,500 patients evaluated for over 2 years at 66 prominent sites using many of the best injectors in North America.

We plan to report the overall long-term safety results and expect to share additional efficacy and duration data.

We are preparing for BLA filing in 2019 and have invested strategically in our purpose-built, U.S.-based CGMP manufacturing facility in the San Francisco Bay area.

As we approach our filing, we plan to provide significant documentation for labeling discussion.

As you're aware, drug developers involved in product approvals know the label considerations are multifactorial and depend on the following key elements: clinical meaningfulness and relevance of data; strength of data and prespecified endpoints; FDA guidance, both prescriptive and descriptive; sponsor and FDA ongoing interactions; precedent labels for similar approved products; and a class label approach.

Thus, based on the totality of evidence, the predicate labels, our FDA interactions and the actual SAKURA trial results, we are confident we can earn a 6-month duration claim that will allow physicians to administer RT002 for frown lines just twice a year.

We believe it will provide us with clear product differentiation the marketplace has been longing for.

The Revance product launch velocity planned for RT002 in glabellar lines is under development, and we plan to commercialize in the first half of 2020.

It will be an innovative, highly targeted approach first aimed at core aesthetic consumers in the key geographic centers that make up a majority of the aesthetic volume.

Todd and his team have extensive physician and consumer research underway.

They are running the pricing models and assembling a comprehensive go-to-market strategy.

We will be ready to launch RT002 in the United States with velocity.

In addition to SAKURA III results anticipated for the fourth quarter, we also plan to initiate Phase II trials in plantar fasciitis and upper limb spasticity.

We'll provide more detail on those trials once we dose the first patients.

As we look ahead, we believe Revance's long-acting treatment will be a significant advantage vis-a-vis the short-acting treatments.

We believe our next-generation neuromodulator will be safe and well tolerated, deliver high response rates and a long duration of effect.

In addition to long-acting RT002, we plan to also monetize our neuromodulator assets to participate in the short-acting segment through our agreement with Mylan for a biosimilar to the reference product, BOTOX.

In fact, a Mylan-Revance team plans to meet with the FDA in the latter part of this year on the biosimilar pathway.

We have several significant milestones in the second half of the year.

We're excited about our potential as a leader in neuromodulation as we advance our rich pipeline in both aesthetic and therapeutic indications and look forward to our first product launch for RT002 in glabellar lines in 2020.

In terms of our travel this fall, we're in the process of planning marketing trips to southern California, the Midwest and the East Coast.

Let Jeanie know if you'd like to catch up when we're in your 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 Dana Flanders, with Goldman Sachs.

This is Chris Staral on for Dana.

So I know there's been some debate on sort of the decision to take RT002 into the clinic for migraines sort of given that CGRPs are obviously on the market now and that they will likely be sort of established in standard of care by the time RT002 would have the label expansion.

So would it just be possible to maybe extrapolate on the type of penetration you're looking to get in that market and what gives you the confidence that this is the right expansion on the label and how you see it being integrated in the treatment paradigm with CGRPs?

And then I have one more.

I'll take it.

This is Abhay Joshi here.

So there are a couple of ways I think we tried to answer this question before earlier.

As you know, (inaudible) value creation for both therapeutics and aesthetics, and migraine happens to be a really attractive indication.

Regards to CGRPs, we know that not all of them are very (inaudible).

They're not [always] very convenient and also not economical.

So some are delivered sub-Q, some are IV quarterly, some are oral daily.

So over all, what we believe that we will increase the patient pool, and by doing that both CGRPs and TOXINS will be coexisting with each other.

On the markets and margins, I will defer to Todd here.

This is Todd Zavodnick.

I think when you look at the marketplace, to Abhay's point, I think what you're going to see is a coexistence.

I think there's never -- whether it's been acute, chronic or episodic in the migraine space, you've never seen a one-size-fits-all when it comes to innovation.

And you know that there will be a new class of drugs, there will be patients that respond.

But I think when you look at the other toxin in this space and the leadership comments that have been made, we basically see that this market over the next 5 to 10 years with neuromodulation for migraines shows a 5% to 10% compound annual growth rate, and that's conservative.

So I think what you're going to see is you're going to see a new entry of class, you're going to see patients experience them, but you're going to see these really just exist together.

And then you really can't forget access.

And I think Abhay talked about that, is in this country with managed care and access to these products, that's going to be another angle that's going to have to be tangled with as CGRPs come to the marketplace.

So I think the key takeaway is there's going to be coexistence.

I think we've looked at the data.

I think it's conservative to date of the compound annual growth rates of neuromodulators in migraine for the next 5 to 10 years.

And we think you're going to see a lot of patients start to get treated when both are available.

Got it.

Okay.

That's very helpful.

And then one more for you guys.

So I know you haven't explicitly disclosed sort of the 2-point durability data for RT002 in glabellar lines.

But is it fair to assume that that data is consistent with the 1-point data that I know you guys have shown and the other endpoints that you've shown, as well?

And maybe can you just touch briefly on how you think all of these different data points are going to go into the durability claim?

Sure.

I'll take that one, too.

So the question isn't whether it's 2-point or 1-point.

And to go back to -- as Dan mentioned, there are multiple factors here, and one of the key factors is if there is a clinically meaningful (inaudible) elements of the data.

So even for the 2-point conversion for the primary endpoint, as you know, that none or mild grades are the 2 least severe grades for which we have demonstrated that beyond 2-point for the 2-point composite you have to have (inaudible) at least 2-point conversion.

So (inaudible) happens to be clinically meaningful.

And as we shared with you earlier on, if you look at our data both from 2-point conversion and 1-point conversion the data pretty much matches or beats the current label, the current predicate label.

And it's quite robust to give us the confidence that based on 2-point and 1-point conversion we will be able to hopefully get a 6-month duration (inaudible) for the product.

Our next question comes from David Amsellem, with Piper Jaffray.

So just wanted to drill down on [the underlying] opportunity in cervical dystonia and just a couple of questions tied up with that.

One is do you have a good sense as to what BOTOX does in sales in the U.S. or globally in cervical dystonia?

And then, second, as you think about commercialization, this is obviously a therapeutic area that I would look at as kind of a gateway therapeutic.

So in thinking about that, 2 questions.

One is what kind of sales organization do you

(technical difficulty)

on that indication?

And then beyond migraine

(technical difficulty)

kind of CNS indications do you start to think about, assuming that you get favorable data from ASPEN?

David, we very much see CD, as other sponsors, as the gateway into muscle movement.

It's the largest of the therapeutic indications for neuromodulators, albeit CD is a revenue stream that's less than the spasticity -- in lower limb spasticity.

We believe that the market for CD as an orphan disease is roughly -- is about $100 million.

But what it does, it's a validation of the platform.

You have a very well validated and consistent scale on the TWSTRS Scale, which allows you, as a totality of the subcomponents, the 3 components, to really give you good benchmark of how this long-acting product compares to the other short-acting products that are approved for cervical dystonia, and it guides you into the larger upper limb spasticity indications and lower limb.

So we really see this, as you mentioned, as a gateway that you get it on label and then expand it, much like other sponsors have done.

As far as the neurology neuroscience call point in the United States, it's very much a specialty organization, or specialty call point.

It will be roughly half the size of the aesthetic core positions.

And so we think that it is a call point that we can build around here in the United States.

Outside the U.S., we would look to partner.

Todd, would you like to give more information on that?

Again, it's 2018 and we covered the ASPEN, kind of the Phase III clinical trial, when Dan opened the call.

I think as we look, and we have a lot of runway here on product launch velocity and how we think about it, I would just share with you to think about it in 3 buckets.

I think you want to think about the providers, which is mainly your neurology and your physiatrists who are injecting TOXINS.

You want to think about the patients and the CD patients within, which are a very small collective targeted group.

And then you really in this country you've got to think about access and really the managed care.

So we feel very comfortable we can reach all of these 3 focus points and these groups, but I think in 2018 and '19, which is most important in the United States, which is really 90% of the opportunity from a reimbursement perspective and dollar perspective, you really have to put your time into access.

And that's what we're doing right now and spending time in understanding and focusing on managed care and the things that really from a pharmacoeconomic perspective they want to see not only in safety and in efficacy, but they want to see positive financial outcomes for their patients.

So that's how we'll start it.

Our next question comes from Tim Lugo, with William Blair.

With SAKURA III being an open label trial, how much do you currently know from the trial in terms of duration of effect and safety?

And when the data comes out in Q4 should the market expect the product profile to shift at all from what we've seen in I and II?

So I think -- Abhay Joshi again here.

With regards to SAKURA Phase III program, it's basically an open label safety trial.

It's an open label trial.

And there are over about 2,500 patients.

What we expect to see is, number one, safety in multiple cycles.

Because as you know, for approval we need to have not single, but multiple, treatment cycles.

So we have 3 treatment cycles for a certain number of patients.

And secondly, as we get the data and [mine] the data, we'll also get an additional peek into additional safety and additional efficacy of the product.

So once we have that, we'll share it with you, toward the end of the year.

But we have not seen any actual data (inaudible).

Even those it's open label we treat it as a blinded study, because we really think the integrity of that data set when we report it allows us to confirm the efficacy potentially of what we saw in other trials, as well as, what Abhay said, is capture efficacy, as well.

So its original intent was safety, but we think there will be opportunities to report on efficacy and duration, as well.

Okay.

Understood.

And Todd, it sounds like you're already looking into the pricing models and doing some work there.

I know in the past other companies in the space have talked about wanting in an ideal world to differentiate between the therapeutic and aesthetic markets.

Given that you are almost able to restart pricing a bit or at least start from scratch, to some extent, will you be able to differentiate at all in those markets?

Tim, this is Dan.

We think the differentiation is important.

Therapeutics is roughly 60% of the neuromodulator market, and both segments, aesthetics and therapeutic, continue to grow at double digits.

But our belief on the therapeutic side, there's a lot more value capture in treating those patients who've got truly debilitating chronic disease and that are subject to continued treatment, probably for the rest of their lives.

So Todd's work is really intended to look at pricing across the threshold of physicians, patients and the providers.

It's not only price to the physician, but price to the patient.

But fundamentally, at the end we have to make a decision whether we want to price RT002 to maximize share in aesthetics or do we want to price RT002 to maximize value on the therapeutic or do we fit a line in between.

And that's the analysis that we have.

We've got 18 months to look at pricing, trends in pricing, both in the U.S. and overseas.

And I think we'll make a thoughtful, smart decision once we have the data.

Tim, the only thing I would add to this process is the market today is going to be very different in the next 18 months, with other entrants and with what we see from the current marketplace where you see a really double-digit strong growth in units and you see some degradation in the value of the marketplace just to some of the competitors that are just flat out playing price games and really not bringing innovation.

And I think that's the key takeaway when you look at the market success and what we need to do to keep this growing aesthetically and therapeutically, is the only thing that drives the success is going to be innovation.

And that's what we have, and we're the only one with neuromodulation innovation coming in the future.

So that's going to be the key, as we look at it.

Our next question comes from Louise Chen, with Cantor.

I had a few here.

So you've highlighted that you've made a lot of significant new hires in the recent months, especially on the commercial side.

So between now and launch, what are your priorities for your commercial team?

And then what are you looking for with respect to a CFO and any time lines around that?

And then I also had a question on pricing, as a follow-up to something earlier.

Are you expecting pricing parity between the aesthetic and medical indications?

And if that's not clear yet, when will you know?

And then I just have a last question here, on the marketing, how you plan to market your product.

Is digital marketing going to be a significant focus for your commercial strategy?

Why?

Or why not?

And what are some innovative ways you'd like to market your product when you launch the RT002 for aesthetics?

Louise, this is Dan.

As I mentioned in the opening remarks, we have an active search underway.

We're pleased with that search.

We think that we're going to identify a candidate who has truly global experience, commercialization experience, and will be instrumental in adding to the management's expertise so we can launch this product initially in aesthetics but build out the pipeline both in the United States and outside the United States on the therapeutic side.

So I think by year-end, for sure, and hopefully sooner.

But in the interim, we've got a very strong finance team in place, and we expect to report our financial statements on time and accurately and feel very confident with the team that's in place.

From a management perspective, we think that we'll add to the executive team potentially in the areas around business development, corporate development, as we scale the business.

But I think for the most part it's really building that vertical leadership infrastructure, that hands-on expertise that is really focused on execution, execution in launching the product in the U.S. and using your Medical Affairs to understand how you want to expand the label.

We have got the first and only innovation in neuromodulator in several decades, and we think we want to stay laser-focused on that in broadening out the pipeline initially in aesthetics but moving into therapeutics.

And so that allows us to look at really looking at your Medical Affairs and identifying the target areas that have the greatest unmet needs and how RT002 solves those needs.

And Louise, commercially I think, going back to some of our comments at Analyst Day -- let me back up and just share with you again the comment I made on the previous question was we have an innovation.

And we have something that's new that's going to bring an attribute to the market that it hasn't seen before.

So within aesthetics we know that neuromodulation is the largest category.

It's growing double digits.

We know pretty much from every survey, whether it was done by internal or external, 60%, 65% of physicians and consumers want something that lasts longer, whether that's 1 month, 2 months, 3 months.

They want something that lasts longer than their current treatment.

So when I share we really have built up and added people within the sales, marketing, commercial operations, digital backgrounds from a commercial standpoint.

That's really been kind of our foundation of where we're starting at, and that's really where we'll build from.

I think it's interesting at this point that in the United States you have over 25,000 to 30,000 accounts that are injecting neuromodulators.

You have probably close to 10,000 that are injecting fillers.

And at this point, we're just honing in on where the target is.

We know people want the product, but at Revance we're going to have to be targeted in a thoughtful way as far as how we approach it.

We'll add people going into '19 and '20, and then we'll be ready to launch.

So I think what you're going to see from us is this is a product that -- physicians are not going to be able to get the duration with other brands.

And we feel comfortable that with our product they're going to be able to get results that they're going to have to use RT002 to get.

So we're not going to be everything to everybody; we're just going to be very targeted.

It's not just going to be one magic bullet.

So I think that's why I share with you within sales, marketing, sort of a straight digital approach as well as various commercial operation strategies that we won't release all of it to date will all be part of the plan.

And what about the pricing?

Do you have any commentary on the pricing parity between cosmetic versus aesthetic?

At this point we don't see parity.

We see the value propositions as differently, and we'll have to select a price that maximizes the opportunity in both.

And we've got time to make that decision.

We've got a lot of quantitative and qualitative work to do with physicians, patients.

As I mentioned, it's not only price to the physician, but price to the patient, as well.

And on the therapeutic side, we've got payers, as well.

And I think we've spent a lot of time and resources in understanding the payer reimbursement pricing side of it.

And we'll make a thoughtful decision on how we want to price this product.

Our next question comes from Douglas Tsao, with Barclays.

Just when you think about sort of development for RT002, obviously you have or will have glabellar lines.

How much value do you see in terms of some of the other potential indications in aesthetics for that product and other regions of the face?

And the reason I ask is just given some of the different characteristics of the product, is there incremental value being able to promote and sort of offer some training to your injectors beyond just the glabellar lines?

I think this is where somebody like a Conor Gallagher can be exceedingly helpful, leading our Medical Affairs aesthetic practice, because he will put together a team that will look at various indications on the face, Doug, and where are the priorities, how do we understand how the drug will be used and how we generate data by the time that we launch so we understand how the label will expand over time and what our priorities will be.

So glabellar lines is just one of several potential indications on the face.

And as other sponsors have done, we will thoughtfully go at an opportunity to expand the label based on the areas of greatest need and how this drug performs.

So we don't think it's a glabellar line drug; it's actually in facial aesthetics.

But it's about using your Medical Affairs and generating data and to look at that differentiation not only in glabellar lines but in forehead lines, lateral canthal lines and other areas of the face.

Our next question comes from John Boris, with SunTrust.

Dan, just on aesthetics and therapeutics, is there any reason why you wouldn't explore possibly using 2 separate trademarks, 1 for aesthetics, 1 for the therapeutic side of the equation, and possibly different pricing strategies for both sides?

The second question just has to do with the BLA.

Obviously, an important event for you coming up with the filing.

How are all of the elements that have to go into that coming along?

And then the third question just has to do with the ROI on 2 areas; most notably, plantar fasciitis versus migraine.

Both obviously have some significant technical hurdles, but one has some competition and the other doesn't.

But how do you think about ROI on those 2 indications?

John, let me start with the sort of separation between aesthetics and therapeutics.

We have been looking at ways to separate those, and it's not just pricing.

We'll look at different strategies.

Some will be some regulatory considerations on how we trademark products in the U.S. and then outside the U.S. But we'll look at the allays differences.

We'll look at (inaudible) differences.

We'll look at trademarks.

We'll look at pricing.

We're going to look comprehensively at how do we distinguish and differentiate aesthetics from therapeutics.

And so that's work in progress.

But we feel very good about our ability to once again generate data to understand the difference between those two and how we create that differentiation.

As it relates to BLA, I think it's a little bit like Louise's question.

We want to stay very focused on execution.

It's wrapping up SAKURA III and reporting that data.

It's also Abhay's group of having that intense discipline in a dedicated facility, both on active pharmaceutical drug substance as well as drug product, keeping the eye on the prize and that CMC and analytics.

That is a critical part of the BLA filing, on top of the clinical data.

So I think as we get ready to file in the first half of '20, it's -- I think we've been very pleased with not only the infrastructure, our ability to work with the regulators here in the United States.

We're a select agent facility working at commercial scale.

I think we've done that exceedingly well for a long period of time and put us in position to file a compelling BLA.

And hopefully it will be one that the FDA will accept on time and go through a review process that allows us to launch the drug in 2020, in the first half of 2020.

As it relates to the return on investment of PF and migraine, I think you have a track that bifurcates into one following the second largest of the indications on therapeutic muscle movement CD upper limb spasticity, lower limb is about $1.1 billion today; migraine in at about roughly $625 million.

Both are continuing to grow.

That's where you want to use RT002 to look at opportunities to grow the market and opportunities to expand the use of neuromodulators.

We actually see it very complementary between the short-acting TOXINS and the long-acting TOXINS as we grow that.

Having said that, we don't always believe that RT002 needs to follow what has been done in the past.

PF is one.

It's a very unique indication.

We don't think of it necessarily as just PF.

We think of it as muscular skeletal.

If we can show data and we can ultimately get the drug approved in PF, it opens up a number of muscular skeletal opportunities that we believe will have a very attractive return on that investment.

So I think what was critical in 2017 was validating the form from low dose to high dose, small muscles to large muscles, both on the movement and the pain considerations.

'18 is really put us in position to get the first drug approved.

And then as we show success in launching glabellar lines, we'll expand the pipeline into those other indications.

There's no shortage of indications, as you know, John, after following this for several decades, for a very unique neuromodulator that's been evasive for everyone in this space for a long period of time.

So once again, this is about looking at better outcomes, better performance, better pharmacoeconomics and providing more patients an opportunity to potentially have a different treatment than what they've had before.

So that all starts with data, and I think that to date that's been our modus operandi to kind of position this product based on the data that's been generated in each of those indications.

Our next question comes from [Bill Vigin], with Cowen.

So just looking ahead to the eventual commercialization for glabellar lines and then thinking about possibly sort of filling out the bag, is there -- what sort of opportunities do you have to maybe add to that sales force once it exists?

In particular, how commoditized are fillers at this point?

And how big of a deal would that take to add that into the fold at Revance?

We'll answer it 2 ways.

I think Todd and I will sort of tag team on this one.

I think we reject the thesis you've got to have this full suite of products in the bag.

I think this is about innovation.

It's about providing a better outcome.

And so I think that starts, first and foremost, with a differentiated neuromodulator.

Having said that, there potentially are other complementary products as part of your portfolio in the commercialization strategy that could play a role to help sell more RT002.

And we have a very active business development group looking at both the aesthetics side and on the therapeutic side.

If there is an opportunity to have a complementary product or products that allow us to accelerate or lift the revenue projections for RT002, it's something that we would take a look at.

If you just want to put a bunch of products in the bag and just because other aesthetic companies have a bunch of products in the bag and think that you compete, we think that that is not a strategy, at least in starting the business.

It's about innovation and performance.

I would just add a couple of things to think about as you think through the space.

I think to date whether -- let's just stay within injectables.

If you look at neuromodulators and dermal fillers, it's important to understand that there really isn't a lot of massive differentiation today.

Within the neuromodulations, you have a market leader and you have some smaller competition.

And in the dermal filler space, you really have it spread as well.

I think at the end of the day the thing that -- I'll say it over and over.

The thing that drives the space is innovation.

So to date, bundles have worked really well, and they deserve a lot of credit, the companies that have executed them.

But they work when there's absolutely no innovation or no differentiation.

And so RT002 is going to provide an attribute, attributes in safety, efficacy and longevity, that you just can't get in other products.

So that's first, on innovation.

I think to Dan's comment, you have to look at everything, right?

You have to look at dermal fillers, you have to look at some surgical options, you have to look at some topical options.

I would go back to the dermal filler space, and one of the dermal fillers that takes up almost 40%, 50% of the units in this space today, really their key attribute that they talk about to the physician and to the consumer is duration, is longevity, and it's duration for the patient that the physician provides.

And it's got almost half the units within that market space of dermal fillers.

So with us coming with RT002, that's why, to Dan's point, we believe on its attributes of innovation it stands alone.

Because in this space, patients want sort of this twice-a-year, they want to know that they have tremendous outcomes and they want really the ability to not have to come in so many times.

And I really think that's how we're thinking about it.

We'll look, but we really are going to bring innovation.

Our next question comes from Difei Yang, with Mizuho.

Just a couple.

On plantar fasciitis, would you give us an update on where things are?

I apologize if I might have missed an update on the program.

Then secondarily, should we be expecting additional indication expansion?

Because there are a lot of applications you could be looking at.

I'm just wondering if we should have any expectations in the coming 12 months to see additional indications brought into development.

Difei, this is Dan.

There's probably not a week that goes by where we don't get an inbound inquiry from a physician about another indication for a neuromodulator.

It truly is extraordinary, and I think the market leader deserves a lot of credit of showing how these neuromodulators, despite its potency, can be used safely and effectively across so many different indications.

So that is the challenge, to decide which one you're going to move into clinical development and try to expand the label, versus those that will just need to wait.

I think for us is we wanted to focus on the 2 largest indications for neuromodulator: glabellar lines and muscle movement.

I think we also wanted to focus on the highest growth of neuromodulators and potentially with a different target product profile that it can prove the tolerability or the dosing regimen, and that would the case in migraine.

If you could move from 4-cycle treatments a year to 2 and you could have something that was more tolerable, that that would be an attractive to, reinforcing Abhay's point, of bringing more patients into treatment.

We do believe that CGRPs and neuromodulators can cohabitate and work together.

I think as we talk to key opinion leaders, there's not a one-size-fits-all.

You'll have attractive CGRPs of the different sort of profiles, and you'll have neuromodulators, and they'll be used potentially together based on that patient population.

So for us is we think that we're appropriately focused on the largest indications.

We think that -- we moved migraine out to '19 to be focused on getting glabellar lines the BLA approved, but also beginning to build out the neuroscience pipeline.

Specific to PF, Abhay, do you want to take that one?

Absolutely.

So on PF, Dan mentioned that we plan to initiate enrollment of a trial in the fourth quarter of 2018.

So just about next 5 months, or so.

And that will hopefully have results (inaudible) 2019.

And we had mentioned multiple times earlier as to why and how this product differentiates from an earlier trial.

Because in the earlier trial we talked about the duration of the trial was about 3 months.

Here we plan to have between 6 and 12 months.

We talked about the endpoint.

Before, we had a static endpoint at 8 weeks.

Here we plan to have an average of 5 days over patient reporting and the duration.

We also are planning to have 2 doses, not a single dose.

And in terms of injection location, we also talked about having -- in the previous trial we had injection at the calf and the plantar surface.

(inaudible)

So if you take in totality of all the different changes, that will be all -- we'll be well positioned to implement that in the fourth quarter and then initiate that enrollment in 4Q 2018.

That's correct.

Ladies and gentlemen, this does end today's call.

You may all disconnect, and have a wonderful day.