Q3 2019 Earnings Call
Welcome to the rebates Therapeutics third quarter 2019 financial results and corporate update conference call.
Operator: Welcome to the Revance Therapeutics 3rd Quarter 2019 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press star followed by 1 on your touch-tone telephone. If anyone has difficulty hearing the conference, please press star then zero for operator assistance. As a reminder, this call is being recorded today, November 4th, 2019. I would now like to turn the conference over to Janai Herbert, Senior Director of Investor Relations and Corporate Communications for Revance. Ma'am, please go ahead.
At this time all participants on in listen only mode.
Following management's prepared remarks, we will hold at Q1 nice session.
Asked a question at that time. Please press star followed by why don't you touched on telephone.
If anyone has difficulty hearing the conference. Please press Star then zero will operate assistant.
As a reminder, this call is being recorded today November the full 2019.
I would now like to turn the conference over to Jeanie Herbert.
Senior director of Investor Relations and corporate Communications fourth we financed ma'am. Please go ahead.
Janai Herbert: Thank you, Towanda. Joining us on today's call from Revance is President and Chief Executive Officer Mark Foley. Chief Financial Officer, Toby Schilke, Chief Operating Officer, Dr. Abhay Joshi, and Head of Commercial Aesthetics and Therapeutics, Dustin Sjuts. Earlier today, Revance released financial results for the quarter ended September 30th, 2019. If you have not received this news release or would simply like to be added to the company's distribution list to receive future releases, please call 1-866-325-7000.
Thank you Twanda joining us on today's call firmer the answer is president and Chief Executive Officer, Mark Foley.
Chief Financial Officer, Toby showcase Chief operating officer, Dr., API, Juicy and head of commercial aesthetics and therapeutics destined to.
Earlier today Romance released financial results for the quarter ended September Thirtyth 2019, if you've not received this news release or would simply like to be added to the company's distribution list to receive future releases. Please go to the Investor Relations section of romances website, which can be found at www dot revamps Dot com.
Janai Herbert: Please go to the Investor Relations section of Revance's website, which can be found at www.revance.com. During this conference call, management will make forward-looking statements, including statements related to Revance's 2019 financial results and guidance, the clinical development of our product candidates, business strategy and planned operations, anticipated pre-commercial and launch plans, and potential product candidates and technologies. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company describes in the section entitled Risk Factors in our quarterly report on Form 10-Q for the quarter ended September 30, 2019, as filed with the SEC on November 4, 2019. Revance cautions you not to place any undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations
During this conference call management will make forward looking statements, including statements related to romances 2019 financial results and guidance the clinical development of our product candidates business strategy and planned operations anticipated pre commercial and launch plans and potential product candidates and technologies before.
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 at these risks and uncertainties.
Factors that could cause results to be different from these statements include factors. The company described in his section entitled Risk factors in our quarterly report on Form 10-Q for the quarter ended September Thirtyth 2019, as filed with the FCC on November 4th 2019.
Events 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, but that I'll now turn the call over to Mark fully Mark.
Janai Herbert: With that, I'll now turn the call over to Mark Foley. Mark.
Mark J. Foley: Thank you, Jeanne. Good afternoon, everyone, and thank you for joining our third quarter 2019 conference call. First, I want to say how thrilled I am to be stepping into the CEO role at this very exciting time in the company's evolution. I assume the role with a deep understanding of Revance's strategy and potential, having served on the board of directors for more than two years.
Thank you Jeanie good afternoon, everyone and thank you for joining our third quarter 2019 conference call.
First I want to say, how thrilled I am to be stepping into the CEO role at this very exciting time in the company's evolution.
I assumed the role with the deep understanding of Rebalances strategy and potential having served on the board of directors for more than two years.
Mark J. Foley: Part of the reason that I stepped back into an operating role is that I view Revance as one of the best opportunities in all of healthcare today. Based on my extensive healthcare experience, where I most recently served as chairman, president, and CEO of Zeltik Aesthetics, and based on the Revance team that is already in place, I have high confidence in our ability to successfully commercialize our novel neuromodulator in the aesthetic market while unlocking significant longer-term value in the therapeutic space. We're entering very exciting times at Revance as we are on the verge of several significant milestones and data readouts that have the ability to significantly enhance Revance's value.
The reason that I stepped back into an operating role is that have you rebound is one of the best opportunities and all of health care today.
Based on my extensive health care experience, where most recently I served as chairman President and CEO of Zeltiq aesthetics and based on the revamps team that is already in place I have high confidence in our ability to successfully commercialize our novel Neuromodulator in these static market, while unlocking significant longer term value in a therapy.
Space.
We're entering very exciting times at Rebounce as we're on the verge of several significant milestones and data read outs that have the ability to significantly enhance refinances value.
Mark J. Foley: First, we plan to submit our Biologics License Application, or BLA, for Daxibotulinum Toxin A for injection, or DAXI, for the treatment of glabellar lines by the end of November. This filing will initiate and lead to a number of important achievements in 2020, including our first anticipated product approval for DAXI. The commercial launch of Daxi and the validation of its long-acting value proposition in the market. Additionally, we expect important data readouts that will provide valuable dosing information for our aesthetic launch by informing use of DAXI in the upper face and in therapeutics with top-line results for both our Phase II plantar fasciitis and Phase III cervical dystonia trials. One of the reasons I'm excited about leading Revance is that DAXI represents the first and only true innovation in the neuromodulator market in more than 30 years. The clinical results across more than 3,800 treatments are consistent, unmatched, and unprecedented.
First we plan to submit our biologics license application or B.L.A. for Daxibotulinumtoxina, a for injection or doxey in the treatment of Glabellar lines by the end of November .
This filing will initiate and lead to a number of important achievements in 2020, including.
Our first anticipated a private product approval for doxey.
The commercial launch of taxi and the validation of its long acting value proposition in the market.
Additionally, we expect important data read outs that will provide valuable dosing information for our static launch by informing use of doxey in the upper phase in a therapeutics with topline results for both our phase two plantar fasciitis in phase three cervical dystonia trials.
One of the reasons I'm excited about leading revamps is that doxey represents the first and only true innovation in the neuromodulator market in more than 30 years.
Cynical results across more than 3800 treatments are consistent unmatched and unprecedented.
Mark J. Foley: In our clinical trials, DAXI delivered exceptional response rates and a long duration of effect, attributes that we think will make DAXI a disruptive force in aesthetics and therapeutics upon approval. Our BLA package for DAXI is nearing completion, and we plan to submit it to the FDA in November. Assuming approval in the second half of 2020, we expect AXI would require as few as two treatments per year to provide patients with lasting, natural-looking frown line correction all year long. In support of our commercialization efforts, we're making excellent progress on many fronts.
And our clinical trials doxey delivered exceptional response rates and a long duration of effect.
Attributes that we think we'll make doxey, a disruptive force anesthetics and therapeutics upon approval.
Our ballet package for it actually is nearing completion and we plan to submitted to the FDA in November .
Assuming approval in the second half of 2020, we expect ACSI would require as few as to treatments per year to provide patients with lasting natural looking frown line correction all year long.
In support of our commercialization efforts, we're making excellent progress on many fronts.
Mark J. Foley: The Sakura study is now online in the peer-reviewed medical journal, Plastic and Reconstructive Surgery, and is soon to be published in the prestigious Journal of the American Academy of Dermatology, or JAD. Our Sakura data was also on the podium with three key opinion leaders at the October American Society of Dermatologic Surgery Annual Meeting in Chicago. They shared pooled data and segmentation analysis to support that DAXI is an appropriate, effective, and predictable treatment option for all types of patients, whether they are switching from another neuromodulator or new to treatment. From a launch perspective, Dustin Sjuts, our head of commercial, continues to fill out our commercial management organization with several key new hires, and I'm very pleased with the quality and experience of the people that we have been able to attract to the company.
The current study is now online in the peer reviewed medical journal plastic and reconstructive surgery and as soon to be published in the prestigious journal of the American Academy of dermatology or Jad.
Our Suckered data was also on podium with three key opinion leaders at the October American Society of Dermatologic surgery annual meeting in Chicago.
They shared pull data and segmentation analysis to support the doxey is inappropriate effective and predictable treatment option for all types of patience, whether they are switching from another neuromodulator or new treatment.
From a launch perspective, Dustin shoots our head of commercial continues to fill out our commercial management organization with several key new hires and I'm very pleased with the quality and experience of the people that we have been able to track to the company.
Mark J. Foley: We now have the infrastructure and experience in place for a successful launch of the market's first premium and differentiated neuromodulator. To further explore the performance of DAXI in facial lines, we are completing trials for forehead lines and crow's feet, which, together with glabellar lines, represent the majority of neuromodulator use in the billion-dollar U.S. facial aesthetics market. Both of these exploratory trials are now fully enrolled and should have readouts in the first half of 2020. We believe the dosing and injection pattern protocols could provide additional information to healthcare professionals should they ask and want to integrate DAXI into their practice.
We now have the infrastructure and experience in place for a successful launch of the markets first premium and differentiated neuromodulator.
To further explore the performance of vaccine facial lines, we're completing trials for forehead lines and crow's feet, which together with Glabellar lines represents the majority of neuromodulator use in the billion dollar U.S. facial aesthetics market.
Both of these exploratory trials are now fully enrolled and should have read out in the first half of 2020.
We believe the dosing and injection pattern protocols can provide additional information to health care professionals should they ask and want to integrate daxing into their practice.
Mark J. Foley: Turning to our therapeutic efforts, we have a robust pipeline in this larger $2.5 billion global segment, where we believe Daxi can bring significant benefit and provide a long-term way of value. I'm excited to announce that we completed enrollment in our Aspen 1 Phase 3 Cervical Dystonia randomized trial with 301 patients. As you recall, Aspen is a 60-center international study comparing DAXI to placebo. This data will inform how DAXI performs at larger doses in muscle movement disorders.
Turning to our therapeutic efforts, we have a robust pipeline in this larger 2.5 billion dollar global segment, where we believe doxey can bring significant benefit and provide a long runway of value.
I'm excited to announce that we completed enrollment in our Aspen, one phase three cervical dystonia randomized trial with 301 patients.
As you recall Aspen is 60 center International study comparing doxey to placebo.
This data will inform how doxey performs at larger doses in muscle movement disorders.
Mark J. Foley: Further, based on our discussions with the FDA, the Aspen program will form the basis of the registrational package for potential improvement in cervical dystonia. As previously guided, we expect to announce top-line results for that trial in the second half of 2020. Enrollment in our plantar fasciitis phase 2 trial is on track and is expected to be completed before the end of the year. Top-line results from that trial should also be released in the second half of 2020. Turning to upper limb spasticity, enrollment continues in our Juniper Phase 2 trial and should be complete in the first half of 2020 with a top-line readout of results in the first half of 2021. We continue to be very excited about DAXI's opportunity in the therapeutic segment and believe DAXI can potentially achieve a leadership position in the initial indications we are pursuing. In the aggregate, our clinical team has accomplished an incredible feat in the last 12 months, completing the Sakura Phase 3 studies in glabellar lines.
Further based on our discussions with the FDA. The Aspen program will form the basis of the Registrational package for potential approval in cervical dystonia.
As previously guided we expect to announce topline results for that trial in the second half of 2020.
Enrollment in our plantar fasciitis phase two trial is on track and is expected to be completed before the end of the year.
Topline results from that trial should also read out in the second half or 2020.
Turning to upper limb spasticity enrollment continues and our juniper phase two trial and should be complete in the first half of 2020 with a topline read out of results in the first half of 2021.
We continue to be very excited about DAC sees opportunity in the therapeutic segment and believe doxey can potentially achieve a leadership position in the initial indications we are pursuing.
In the aggregate our clinical team has accomplished an incredible feet in the last 12 months.
Leading this occur a phase three studies in Glabellar lines.
Mark J. Foley: Fully enrolling the Aspen 1 Phase 3 trial for cervical dystonia. Initiating four phase two studies in aesthetics and therapeutics and completing enrollment in two of them, all while working with our regulatory, quality, R&D, and manufacturing teams to compile a submission for our first ever BLA. This has been a truly momentous achievement for a company of this size. That covers our recent corporate highlights. Now, I'll turn the call over to Toby to summarize our third quarter financial results. Afterward, I'll have a few closing comments before we begin today's Q&A session. Toby.
Fully enrolling the Aspen, one phase three trial for cervical dystonia.
Initiating for phase two studies in aesthetics, and therapeutics and completing enrollment in two of them.
All working with our regulatory quality R&D and manufacturing teams to compile the submission for our first ever be delay.
This has been a truly momentous achievement for a company of this size.
That covers our recent corporate highlights now let me turn the call over to Toby to summarize our third quarter financial results.
Afterwards, afterwards I'll have a few closing comments before we begin today's QNX session.
Cobi.
Tobin C. Schilke: Thank you, Mark. Starting with our cash, cash equivalents, and short-term investment balance, we ended the third quarter with $209 million. This figure does not include a $5 million milestone payment from Mylan under our collaboration and license agreement to extend their decision to move forward with the development of a biosimilar to Botox. We anticipate that payment in the fourth quarter 2019 and expect a decision from Mylan by April 30, 2020, on whether they've decided to proceed. In the meantime, we will progress the program with limited spending through pre-IND activity.
Thank you Mark.
Starting with our cash cash equivalents and short term investment balance we ended the third quarter with $209 million.
This figure does not include a 5 million dollar milestone payment from my from Milan under our collaboration and license agreement to extend their decision to move forward with the development of a biosimilar to botox.
We anticipate that payment for in fourth quarter 2019 unexpected decision from Milan by April Thirtyth 2020 on whether they've decided to proceed.
In the meantime, we will progress the program.
With limited spend through pre I Andy activities.
Revenue for the third quarter 2019 consisted of $46000 recognized from the Milan collaboration.
Tobin C. Schilke: Revenue for the third quarter of 2019 consisted of $46,000 recognized from the MyLand collaboration. Revenue from the Mylan and Fosun collaborations will fluctuate in the coming quarters as we make progress on the development of the Biosimilar and Daxi, respectively. Our OPEX during the quarter was $42.6 million, and excluding depreciation and stock-based compensation, it was $37.5 million.
Revenue from the Milan and focus on collaborations will fluctuate in the coming quarters as we make progress on the development of the Biosimilar and doxey respectively.
Our opex during the quarter was $42.6 million.
And excluding depreciation and stock based compensation it was $37.5 million.
Tobin C. Schilke: The earnings release we issued today outlines our financial results in full, so I won't go through the details on this call. As we said in the release, we have no change in our 2019 guidance. Revance expects 2019 GAAP operating expenses to be in the range of $173 to $185 million and our non-GAAP operating expense, which excludes depreciation and stock-based compensation, to be in the range of $148 to $158 million. We continue to monitor our funding profile in a thoughtful and prudent manner. Currently, we expect our cash runway to extend through 2020 and the anticipated approval of DAXI and Globel Airlines. Finally, Revance's outstanding shares as of October 24, 2019 were approximately 45.1 million, or 50 million on a fully diluted basis.
The earnings release, we issued today outlines our financial results and fall. So I won't go through the details on this call.
As we said in the release, we have no change in our 2019 guidance rebalance expects 2019, GAAP operating expense to be in the range of $173 million to $185 million and our non gap.
Operating expense, which excludes depreciation and stock based compensation to be in the range of.
$148 million to $158 million.
We continue to monitor or funding profile in a thoughtful and prudent manner.
Currently we expect our cash runway to extend through 2020, and the anticipated approval doxey in Glabellar lines.
Finally, rebalances outstanding shares as of October 24, 2019 for approximately 45.1 million or 50 million on a fully diluted basis.
Tobin C. Schilke: With that, I will turn the call back to Mark. Thank you, Toby.
With that I will turn the call back to Mark.
Thank you Toby we are weeks away from submitting the dock CBLI physical behler lines indication.
Mark J. Foley: We are weeks away from submitting the DAXI BLA for the Gobeller Lines indication. Following this submission, Revance enters a catalyst-rich calendar year of meaningful clinical and corporate events that we believe will culminate in the approval and launch of DAXI in the second half of 2020. We are busy readying ourselves to optimize DAXI's aesthetics launch following approval, while also continuing to advance our therapeutic programs in order to unlock longer-term value. I look forward to introducing the first truly novel neuromodulator since the category was created. With that, I will now open up the call for questions. Operator?
Following the submission rebalance enters a catalyst rich calendar year of meaningful clinical and corporate events that we believe will culminate in the approval and launch of taxi in the second half of 2020.
We are busy readying ourselves to optimize taxis aesthetics launch following approval, while also continuing to advance our therapeutic programs in order to unlock longer term value.
I look forward to introducing the first truly novel Neuromodulator since the category, which created.
With that I will now open up the call for questions operator.
Operator: Thank you. Ladies and gentlemen, to ask a question at this time, you will need to press star then 1 on your telephone. To withdraw your question, you may do so by pressing the pound key.
Thank you, ladies and gentlemen to ask the question at this time you would need to press Star then one on your telephone.
To withdraw your question you may do so by pressing the pound cake again its style I want to ask the question. Please standby, while we've compiled the culinary roster.
Operator: Again, it's Star 1 to ask the question. Please stand by while we compile the Q&A roster. Our first question comes from the line of Annabel Samimy with Stifle. Your line is open.
First question comes from the line of Annabel Samimy with Stifel. Your line is open.
Annabel Eva Samimy: Hi. Thanks for taking my question. So I guess my first question is, well, first of all, Mark, congratulations on your move back into an operating role. Thanks, Annabel. You're welcome. And I guess maybe it's fair to ask you, sitting from this perspective now at the helm, what specific strategic initiatives or strategic plans that you envision might evolve over time as you're looking at this from a different position right now? And then I'm going to have a few followers.
Hi, Thanks for taking my question.
So I guess my first question is well first of all.
Mark Congratulations on your move back into an operating ROE.
Thanks Annabel.
Okay, and I guess, maybe it's fair to ask.
Sitting from from this perspective.
Are there any.
[noise] specific strategic initiatives are strategic and say you envision.
Might evolve over time is.
From a different position right now.
Annabel Eva Samimy: It's a great question, but more specifically from a commercial perspective, I would say.
And then I'm going to have a few follow up questions.
Yes, a great question, specifically from a commercial perspective I would say.
Annabel Eva Samimy: Yeah, well, first, I'll just... Sorry, go ahead.
Yeah, well first of all just.
Sorry go ahead.
Mark J. Foley: No problem. Well, first, I'll just address sort of at a broader level. You know, I've been on the board for the last two and a half years, so I'm obviously very familiar with the strategy and some of the key decisions that were made. So I would not expect any sort of material change in the strategy.
No problem, well personal just hit sort of at a broader level I bet on the board for the last two and a half years. So I'm, obviously very familiar with the strategy and some of the key decisions that were made so I would not expect any sort of material change in the strategy, we need to continue to focus on making sure that we have a successful launch in aesthetics.
Mark J. Foley: You know, we need to continue to focus on making sure that we have a successful launch in aesthetics while also continuing to unlock significant value on the therapeutic platform. The deeper we get into it, and the market research that we're doing, we recognize that a long-acting neuromodulator has meaningful value and can take a meaningful share in the therapeutic space. You know, having said that, coming into my role, I certainly want to spend more time with the team, focusing on, you know, capital allocation. We know that we're going to want to do all of this over time. But the question is, you know, which things should we focus on? And at what point in time? We just need to make sure that we've got our rationalized spend for, you know, what we're delivering. For your question about the launch of, you know, DAXI in the aesthetics market, we're in the middle of, you know, going through some additional market research, looking at different ways that we want to enter the market. So we're making great progress on that, but I don't necessarily have anything incremental to add at this point in time.
While also continuing to unlock significant value on the therapeutic platform, which the deeper we get into it in the market research that we're doing we recognize that a long acting neuromodulator has meaningful value and can take meaningful share in the therapeutic space.
Having said that yeah coming into my role I do certainly want to spend more time with the team.
Focusing on capital allocation.
We know that we're going to want to do all this over time, but the question is which things do we focus on and at what point in time, and we just need to make sure that we've got to rationalize spend for what we're delivering on for your question about the launch of.
Doxey in these statics market, we're in the middle of going through some additional market research looking at different ways that we want to enter the market. So we're making great progress on that but I don't necessarily have anything incremental to add at this point in time.
Annabel Eva Samimy: Okay, so why don't I just move on to the therapeutic indications for a minute. So FDA clearly wants to see how well DAXI performs in movement disorders, and the activity of a toxin, in general, is pretty well known in movement disorders, given Botox is broad, you know, labeled there. Transcripts provided by Transcription Outsourcing, LLC. Unknown Attendee, Chris Shibutani, Mikaela Franceschina, Douglas Tsao, Uy Ear, Dustin
Okay. So.
Therapeutic indication for men so.
Clearly wants to see how well taxi performance in movement disorders and the activity.
Evan talks and in general is pretty well known and movement towards given so talk this broad.
So I guess a question I have is you mentioned that.
And to be a registrational studies, where the chances.
Is that each of the studies for after you get a couple under about they're going to.
Mark J. Foley: Yeah, I mean, it's a good question. Obviously, CD is going to be our first and sort of leading therapeutic indication that we're going after. You know, it's hard to speculate how the agency will look at subsequent submissions. Following this one, you know, we'll continue to work closely with the agency to structure the appropriate prowls and the data as we have more information. So I don't know that we've got any unique insights there. It's kind of, "let's focus on running the right trials, getting the right endpoints, and then, you know, charting our path forward from there."
Come much more comfortable with.
Axes performance and movement disorders, and it's going to sort of facilitate the path for additional movement disorders.
That said you may not be.
But clearly have.
I have.
Talk since it sounds great utility in those areas.
Yeah. It means to good question, obviously Cts is going to be our first in sort of leading a therapeutic indication that we're going after it's hard to speculate how the agency will look at subsequent submissions. Following this one will continue to work closely with the agency to structure the appropriate problems in the data and as we have more in.
Information So I don't know that we've got any unique insights there. So it's kind of let's focus on running the right trials getting the right endpoints and then charting our path forward from there.
Okay and beyond.
Mark J. Foley: Okay, and beyond the CD, what was the next, sorry I missed it, what was the next trial that you expected to have sort of reading out after that?
What was the next.
Sorry, I missed what was the next.
They expect to have.
Reading out after that.
Mark J. Foley: We've got two. We've got plantar fasciitis and upper limb spasticity. Those are the two next readouts that we'll have.
We've got to we've got plantar fasciitis.
An upper limb spasticity those are the two next to read outs that will have.
Annabel Eva Samimy: Okay. All right. Great. Thank you very much.
Okay, Alright, great. Thank you very much.
Mark J. Foley: You're welcome.
You're welcome.
Thank you next question comes from the line of David Amsellem with Piper Jaffray. Your line is open.
David A. Amsellem: Thank you. Our next question comes from the line of David Amsellem with Piper Jeffrey. Your line is open.
Thanks, So just just a couple.
David A. Amsellem: Thanks, so just a couple, and I apologize if you kind of covered this, but Mark, just philosophically with the fourth neuromodulator launching recently and having their results reported this morning, I wanted to get your views on how Unknown Attendee, Chris Shibutani, Mikaela Franceschina, Douglas Tsao, Uy Ear, Dustin Schilke, Seamus Fernandez, Serge Belanger, Douglas T Unknown Attendee, Chris Shibutani, Mikaela Franceschina, Navann Dietschi, Jessica Serra, Douglas Tsao, Uy Ear, Douglas Tsao, Alana Lelo, Karishma Raghuram, Charles Wang, Revance Therapeutics Inc.
Apologize if you kind of covered covered this but mark just philosophically, though with.
The fourth.
There are launching recently and.
Having their results reported this morning.
I wanted to get your.
Views on how.
Pricing will evolve and in this landscape and this whole idea of.
A premium priced product or premium experience product as your predecessor has.
Referred to that actually is being.
So the question is just how do you feel philosophically about this idea of a premium experience product is that supportable and this kind of competitive landscape and is there any daylight between you and your predecessor on on how you think philosophically.
Mark J. Foley: Yeah, that's a great question. So, first off, I think that Daxi, with its duration of benefit, is really going to be sort of a first in the market from a launch perspective. I think all of the other neurotoxins you can lump into the category of short acting.
Thanks.
Yeah. So great question, So I think first off.
I think that.
Doxey with the duration of benefit is really going to be sort of a first in the market from a launch perspective, I think all of the other neurotoxins you can lump into the category of short acting so.
Mark J. Foley: So I think this will be new. It will be differentiated. We're bringing innovation into the marketplace. And so, you know, I do think that our ability to generate excitement and interest will be even greater than what we've seen in the past. You know, as we think about kind of pricing and positioning, if you look at not only the aesthetics market but other markets, innovation in material differentiated value propositions command premiums in the market. And I think right now, in today's environment, where more and more neurotoxins in the short acting category are coming into the market, that's inevitably going to put pressure on price over time. However, I think with a premium product, you can certainly look to command a premium price in the marketplace.
I think this will be new it will be differentiated we're bringing innovation into the marketplace and so I do think that.
Our ability to generate excitement and interest will be even greater than kind of what we've seen in the past. It was we think about kind of pricing and positioning if you look at not only the aesthetics market, but but other markets you know innovation in material differentiated value propositions command premiums in the market and I think right now.
In today's environment, where more and more neurotoxins in the short acting category are coming into the market, that's inevitably going to put pressure on price overtime.
However, I think with a premium product you can certainly look to command a premium value in the marketplace and I think that consumers are willing to pay for a premium outcome I think physicians will get rewarded more for providing a premium outcome as well so we stuff to work through the differences, but I think there'll be.
Mark J. Foley: And I think that, you know, consumers are willing to pay for a premium outcome. I think physicians will get rewarded more for providing a premium outcome as well. So we still have to work through the differences, but I think there'll be a little bit of a decoupling in terms of what's happening in the short-acting market and what we can deliver and command in the longer-acting space. Because, you know, to the extent that the trial results that we've seen and, you know, the large number of patients that we've done remain reproducible in the broad market, then I think there So, again, I think we're going to stand out as sort of a very differentiated product offering versus looking at the market as a whole.
A little bit of a decoupling in terms of what's happening in the short acting market and what we can deliver in command in the longer acting space because to the extent that.
The trial results that we've seen in the large number of patients that we've done remain reproducible and the broad based market that I think there it will be good for the industry and we will follow the typical innovation curve were innovation that drives more value commands more price. So again, I think we're going to stand out as sort of a very.
Traded product offering versus looking at the market as it stands today.
Okay. That's helpful and that's I mean, just sneak in a question on the the therapeutic.
The therapeutic development program and the question here this.
David A. Amsellem: Okay, that's helpful. Now, if I may just sneak in a question on the therapeutic development program. And the question here is this: as you look at the various programs, and I realize that your decisions are going to be driven by data,
As you look at the various programs and I realize that that.
Your decisions are going to be driven by by data but.
In a perfect world, where you're not concerned about.
Are there.
David A. Amsellem: Unknown Speaker
All of her.
Mark J. Foley: Are there other therapeutic areas that you think would be worthwhile for further exploration? Do you think that, or put another way, do you think that Revance is focusing on the right things in terms of therapeutic development programs?
There are few <expletive> areas.
You think would be worthwhile for further exploration.
Do you think that well put another way do you think that that that revenge is focusing on the right things in terms of in terms of therapeutic development programs.
Mark J. Foley: Well, for now, I do. I mean, if you look at the therapeutic market, I mean, globally, it's a two and a half billion dollar market. And with a very differentiated product and the fact that, you know, certainly, if I go back to the aesthetic side, you know, you've got a very under-penetrated market. It's, it's obviously a lot more straightforward to go into the therapeutics market as it stands today with a product that, based on the data today, suggests a meaningful duration benefit. And in a healthcare system where fewer treatments drive significant cost efficiencies, we think that, you know, coming in with this product in the existing therapeutic categories makes a lot of sense. We know that those markets are already fairly mature in terms of how care is delivered.
Well for now I do I mean, if you look at the therapeutic market I mean globally to $2.5 billion market and with a very differentiated product in the fact that you know certainly if I go back to the set aside you know you've got a very underpenetrated market. It's it's obviously a lot more straightforward to go into the therapeutics market as it staff.
Today with the products that based on the data today suggest a meaningful duration benefit in health care system, where fewer treatments drive significant cost efficiencies, we think that by coming in with this product in the existing therapeutic categories makes a lot of sense. We know that those are markets are already fairly mature.
In terms of how care is delivered and so those are the most logical ones to go into.
Mark J. Foley: And so those are the most logical ones to go into. And so, if you look at the trials that we've already embarked upon, we think that those are going to give us really good information and insight into how our product works in muscle movement disorders. Obviously, migraine remains a very large market and is, you know, the biggest single category on the therapeutic side. So we have to rationally think about how we can unlock that value over time. In terms of areas that fall outside of current treatment indications today, obviously, we've gone into plantar fasciitis, which is sort of a category that's yet to be, you know, or is yet to see toxins or neuromodulators move into that market. But in terms of any other areas, I think right now, we will primarily focus on the existing category with what we think is a better product.
And so if you look at the trials that we've already embarked upon we think that those are going to give us really good information and insight into how our product works in muscle movement disorders, obviously migraine remains a very large market and as you know the biggest single category in the therapeutic side. So we have to rationally think about how we unlock that value overtime.
In terms of areas that fall outside of current treatment indications today, obviously, we've gone into plantar fasciitis, which is sort of a a category that's yet to be or would you have to see toxins or neuromodulators move into that market, but in terms of any other areas I think right now we will primarily focus on the exist.
And category with what we think that better product.
Okay, great. Thanks for the insights and I'll jump back in the Q.
David A. Amsellem: Okay, great. Thanks for the insight, and I'll jump back in the queue.
Great. Thank you.
Mark J. Foley: Great, thank you.
Thank you next question comes from a lot of Jacobs with Wells Fargo Silanis open.
Jacob Hughes: Thank you. Our next question comes from the line of Jacob Hughes with Wells Fargo. The line is open.
Hi, good afternoon.
Jacob Hughes: Hi, good afternoon.
Jacob Hughes: Hey Jacob,
Hey, Jacob.
Hey.
Jacob Hughes: Hey, I have two questions. One is, can you just comment on what kind of share you think the company can capture over the next few years? And then, secondly, if Mylan chooses not to opt in for the biosimilar program, what are your options for that asset?
Could you.
I've two questions. One is a key just comment on what kind of share you think the company. It can capture over the next few years and then secondly, if Milan chooses not to opt in for the Biosimilar program. What are your what are your options for that asset.
Sure. So in terms of the sheer I think it's premature to necessarily look at you know kind of what kind of share. We're gonna take that's going to somewhat be related to our launch strategy and commercialization footprint certainly from our market research work that we've done thus far we found that over 50% of consumers indicate that long.
Mark J. Foley: Sure. So, in terms of the share, I think it's premature to necessarily look at, you know, kind of what kind of share we're going to take. That's going to be somewhat related to our launch strategy and commercialization footprint. Certainly, from the market research work that we've done thus far, we found that over 50% of consumers indicate that, you know, a long-acting neuromodulator would drive some of their decision-making. And based on our work with both physicians and consumers, we think it is the, you know, the most important improvement that you could make on a neuromodulator today. So, it's hard to say shares, but I do think with a very differentiated product and the right sort of commercial execution, we could be meaningful sharetakers in that market.
Reacting neuromodulator would drive or some of their decision, making and based on our work with both physicians and consumers. We think it is the.
The most important improvement that you could make on it on a neuromodulator today. So it's hard to say shares, but I do think with a very differentiated product and the right sort of commercial execution that we could be meaningful share takers in that market.
Mark J. Foley: And then your second question was, you know, on the Myelin side of it. If you step back, when we started sort of this whole program, we had a number of other parties that expressed interest at the time, but we felt that Myelin was the best partner at that time. We've continued to advance that program. Obviously, Myelin looked to delay their decision date a little bit because of some of the internal things that they had going on. And for that, they paid us another $5 million. So, we'll get clarity in terms of whether or not they're going to opt in by the end of April. And, you know, based on that decision, we'll then figure out, obviously, whether we continue to move forward with them or whether we pursue an alternative path.
And then your second question was on the Mylan side of that if you step back when we started sort of this whole program. We had a number of other parties that expressed interest at the time, we felt like Mylan was the best partner at that time.
We've continued to advance that program, obviously mylan looks to delay their decision date, a little bit because of some of the internal things that they have going on and for that they paid us to another $5 million. So we'll get clarity in terms of whether or not they are going to opt in by the end of April and.
Based on that decision will then figure out obviously weather, we continue to move forward with them or whether we pursue a an alternative path.
Okay. Thank you and congrats on an overall.
Mark J. Foley: Okay, thank you, and congrats on the new role.
Mark J. Foley: Thank you. I appreciate it.
Thank you appreciate it.
Stacy Ku: Thank you. Our next question comes from Alana Stacy Ku with Cohen & Company. Your line is open.
Thank you next question comes on the line <unk> with Cowen and company. Your line is open.
Stacy Ku: Hi all, thank you for taking my questions. Congratulations on the progress. I have a few. As you approach launching DAX next year, can you remind us how we should be thinking about operating spend in 2020? And I have two more questions.
Hi, Thank you for taking my questions congratulation on the progress have few.
As you approach watching vaccine next year can you remind us how we should be thinking about operating spend and Tony Tony.
And I have to my question.
Yeah, we haven't given got clarity on our 2020 spend yet certainly as we get through the details of this will be able to give you more color in terms of the spend side of it.
Mark J. Foley: We haven't given clarity on our 2020 spend yet. Certainly, as we get through the details of this, we'll be able to give you more color in terms of the spend side of it.
Stacy Ku: Okay, that's fair. And also, can you comment on timelines to file DACC internationally? How might this timing coexist with ex-U.S. commercial partnering discussions?
Okay and also can you comment on timelines to file taxi internationally.
At this timing coexist with ex us commercial partnering discussion.
Abhay Joshi: Yeah, that's a good question. For that, I'm going to turn it over to Abhay to comment on that.
Yeah. That's a good question for that I'm going to turn it over to how high to comment on that showed so as we talk initially that up lastly international would be about six months after finding us filings.
Abhay Joshi: Sure, so as we talked initially, our plans for international would be about six months after filing U.S. filings, and the goal would be that after you file the U.S., in about six months or so, we'll start doing the files for international markets, starting with the EU first.
And.
The going would be that offer you filed the U.S. and about six months or so this stock.
Defies when your national marketing, starting with you first.
That's perfect finally regarding your Mylan program I should we be expecting any incremental updates.
Stacy Ku: And finally, regarding your Myelin program, should we be expecting any incremental updates prior to April 2020? And can you remind us of Myelin's financial contribution to the IND enabling studies?
Paul 2020, and can you remind us of Mylan financial contribution to T. I M D enabling studies.
So to date Mylan contributed 25 million upfront in an incremental five so we stated that that so there are $30 million in there are some opt in milestone payments and other payments that we'd be associated with this.
Mark J. Foley: So, you know, to date, Mylan has contributed $25 million up front in an incremental five. So we've stated that there are $30 million in total, and there are some, you know, opt-in milestone payments and other payments that would be associated with this.
Tobin C. Schilke: But you know, I don't expect us to give any more clarity prior to the end of April, unless, for whatever reason, Mylan chooses to make a decision prior to that. But that's really going to regulate and dictate the timing, and Toby. Toby, I'll add a little bit to that too.
But I don't expect us to give any more clarity prior to the end of April unless for whatever reason Mylan chose to make a decision prior to that.
But that's really going to regulate in dictate the timing on this.
Thank you until.
Thanks, Tobey I had a little bit to that too if you're looking for modeling purposes.
Tobin C. Schilke: If you're looking for modeling purposes, you can look at how we recognize revenue.
Good how we recognize revenue.
Our effort.
Stacy Ku: Alright, thank you so much.
The spend on my line.
Okay. Thank you so much.
Douglas Dylan Tsao: Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open.
<unk>.
Thank you next question comes from the line of Douglas sale with H.C. Wainwright. Your line is open.
Douglas Dylan Tsao: Hi, good afternoon. Thanks for taking the questions. Mark, a couple of questions in terms of development. Just curious, as we get the phase two data and four headlines and crow's feet, would you plan on then conducting phase three studies for those, or do you think the data in terms of the phase twos, especially around dosing and technique, would be sufficient to drive or have physicians use it on their own?
Hi, good afternoon, thanks for taking the questions just.
Mark a couple in terms of development just curious on as we get the phase two data is and for headlines and crow's feet would you plan on then conducting phase three studies for those or do you think the data in terms of the phase twos, especially around dosing in tech.
Nick would be sufficient to drive or to have physicians use it.
On their own.
Mark J. Foley: Yeah, it's a great question. I mean, you know, the phase two data readouts that we're planning for will have sort of efficacy data. We won't necessarily have the full duration data at the time that we release them, but I think we'll wait and see. You know, right now in today's market, there's only one player that has indications beyond a single indication on the facial side of it, and clearly, they have commercialized their product and aesthetics with a single indication, but we'll continue to sort of look at that and decide whether or not we think there are advantages to, you know, advancing that into phase three.
Yes, great question I mean, the phase two data Readouts that we're planning for will have sort of the efficacy data we won't be necessarily have the full duration data at the time that we released those.
But I think we'll wait and see.
Right now in today's market.
Theres only one player that has indications.
Beyond a single indication on the facial side of it.
And clearly they have commercialize their product anesthetics with a single indication.
But we'll continue to sort of look at that and decide whether or not we think there are advantages to advancing that into phase three.
Okay, Great and then in terms of therapeutic how could you maybe give it an update in terms of where the company is with migraine.
Douglas Dylan Tsao: Okay, great. And then, in terms of therapeutics, how, um, could you maybe give an update in terms of where the company is with migraines?
Mark J. Foley: Well, I think what we previously said is that, you know, we would look to potentially initiate trials in 2020 for the migraine program. Obviously, the other therapeutic programs that are already enrolling, we've reported on and provided updates on. So I think that's one that we're going to continue to look at. You know, as a senior team, we're continuing to, you know, kind of go through the strategy and capital allocation decisions around that. So we certainly recognize the importance of migraines. So to me, it's not an if; it's just a question of when. And, you know, at this time, I'm not really in a position to give any more clarity on that.
Well I think what we previously said is that we would look to potentially initiate trials in 2020 for the migraine program. Obviously, the other therapeutic programs that are already enrolling we've reported on in provided updates. So I think that's one that we're going to continue to look out.
As a senior team, we're continuing to kind of go through the strategy and capital allocation decisions around that so we certainly recognize the importance of migraine. It. So to me it's not an f.. It's just a question of win and you know at this time I'm not really in a position to give any more clarity on that.
Okay fair enough. Thank you very much.
Douglas Dylan Tsao: Okay, fair enough. Thank you very much.
Mark J. Foley: Great, thank you.
Great. Thank you.
Thank you. Our next question comes from the line of Tim Lugo with William Blair. Your line is open.
Timothy Francis Lugo: Thank you. Our next question comes from the line of Tim Lugo with Wim Blair. Your line is open.
Thanks for taking my question then congratulations on what seems like a smooth transition.
Timothy Francis Lugo: Maybe from a higher-up view, you know, Daxi is obviously coming to market as a differentiated product. However, it still is only one product. How do you currently view the bundle that you'll be competing against and just marketing against that suite of products from the larger competitor? And also, your larger competitor is obviously having some transition of its own. So can you talk maybe if you're hearing about anything from the, you know, Salesforce disturbances or anything from that transition, which could be beneficial for the Daxi launch?
Maybe from a higher a view taxis, obviously coming to market. The differentiated product. However, still is only one product.
Currently view the bundle that you'll be competing against and just marketing against that suite of products from a larger competitor.
And also your larger competitors, obviously, having from.
Transition of its own so can you talk maybe feeling about anything from the.
Salesforce disturbances or anything from that transition, which could be beneficial for but that's the launch.
Mark J. Foley: I mean, it's a great question. You know, I think because we have a product that is so unique and so differentiated, I think it's certainly possible to have a successful commercial launch in aesthetics without any other products in the bundle. And I think that, you know, certainly physicians will have alternative choices and other products in the bundle. Certainly, we've seen with recent competitive entrants that with a single neuromodulator, they've been able to successfully generate physician interest and patient interest in trying the product. So we don't believe that we need other products to be successful in the market because of our value proposition. But you know, having said that, we'll continue to be mindful. And if there are things along the way that we think can contribute to our success, create efficiencies, or create a more compelling offer for either the physician or their consumer, we will, of course, continue to look at that. But I think right now we feel pretty good about how we're able to launch it. And then the other part of your question. I'm sorry.
I mean, it's great question I think because we have a product that is so unique and so differentiated I think it's certainly possible dabaa successful commercial launch in aesthetics without any other products in the bundle and I think that certainly physicians will have alternative choices and other products in the bundle.
Only we've seen with recent competitive entrants that in it with a single neuromodulator that they've been able to successfully generate a physician interest in patient interest in trying the product. So we don't believe that we need other products to be successful in the market because of our value proposition.
Having said that we'll continue to be mindful and if there are things along the way that we think can contribute to our success create efficiencies Craig create a more compelling offer for either the physician of their consumer we will of course continue to look at that but I think right now we feel pretty good about how we're able to launch it and then the.
The other part of your question I'm sorry.
Are you hearing anything about salesforce disturbances or anything but could be occurring from.
Timothy Francis Lugo: Are you hearing anything about Salesforce disturbances or anything that could be occurring from your large competitor's own acquisition that could potentially benefit your product launch?
In a large competitors don't acquisition that could potentially benefit during your product launch.
Mark J. Foley: Not necessarily. I think it's kind of business as usual there. But I think we all know that in any, you know, acquisition, there's going to be some efficiencies that you try and capture in it, some people that are changing. And so, you know, if you look at the two large players in the market right now, both of them are undergoing or will be undergoing sort of meaningful changes in the way that those organizations are structured. And it was because the aesthetics market is very much a high-touch business, really focus well, and serve the customer.
Not necessarily I think it's kind of business as usual there, but I think we all know that in any acquisition that there's going to be some efficiencies that you try and capturing it some people that are changing and so if you look at the two large players in the market right now both of them are undergoing or will be undergoing.
Sort of meaningful changes in the way that those organizations are structured and it was the aesthetics market is very much of a high touch business certainly on the margin. It gives us an opportunity as a single products too.
Really focus well it answered the customer needs.
Understood. Thank you for the questions.
Timothy Francis Lugo: Understood. Thank you for the question. Thanks.
Thank you.
Desai Yang: Thank you. Our next question comes from the line of Desai Yang with Mizudo Securities. Your line is open.
Our next question comes from the line up Difei Yang.
Security Your line is open.
Hi.
Desai Yang: Hi. Good afternoon. Thanks for taking my questions. Just a few here. The first one relates to the evolving neurotoxin aesthetics market. Given that we're expecting millennials will play a major role in expanding future markets, how important do you think DAX's longer acting duration will be accepted by millennials who are new to the market?
Good afternoon. Thanks for taking my question just feel here on the first one relates to the.
Newer pop evolving neurotoxin sabic market.
Even Bob or were you expecting millennials will be.
I will play a major Raleigh is spending filter market how important.
Do you think vaccines longer acting will play.
We'll be accepted by the millennial.
Mark J. Foley: Yeah, it's a good question. I mean, we've got a lot of market research that we've done in these different categories, and you know, I think the reality is this market is still so under penetrated that a long-acting neurotoxin, I think, resonates across all segments. So I don't know that it's fair to look at any given segment to sort of say, is long acting going to be more valuable in this segment or not. I think that with the work that we've done, it's going to resonate across all segments. And certainly, we are seeing the millennials or, you know, the engagement of younger people in aesthetic procedures earlier. And I would like to think that, you know, a longer acting neuromodulator would certainly have strong appeal there as well, just because it allows somebody to have, you know, full correction just coming into the physician's office twice a year.
Our new to the market.
Yes. Good question I mean, we've got a lot of market research that we've done in these different categories that I think the reality is this market is still still underpenetrated that long acting neurotoxin I think resonates across all segments. So I don't know that it's fair to look at any given segment to sort of say is long acting it'd be more valuable in this segment or not I.
I think that with the work that we've done it it's going to resonate across all segments and certainly we are seeing the millennials or you know the engagement of younger people in aesthetic procedures earlier, and I would like to think that no longer acting neuromodulator would certainly have strong appeal there as well just because it allows so.
Nobody to have full correction just coming into the physician's office twice a year.
Yes. Thank you.
Desai Yang: Yeah, thank you. And then, most recently, one of your competitors, a short-acting neurotoxin, received its European approval with a label that's longer than, with a label of 139 days, which is typically, which is longer than our typical three, four months sort of wrinkled kind of label. How do you view that?
And then most recently one of your competitors a short acting neurotoxin received.
Yeah approval with the label longer than that.
So with the label up 39 days, which is typical which is longer than our typical three four months.
Wrinkled kind of label, how do you feel that.
Mark J. Foley: Well, again, we're just very focused on running very robust clinical trials to demonstrate that the benefit of our neurotoxin is consistent across a wide variety of groups. And so, I think to the extent that our neurotoxin has really compelling data on duration, I think it speaks to the fact that, you know, the agencies are certainly open to looking at the data and having that data reflected in the label. Certainly, if you look at our product and the reason that we're different, you can point to reasons for because of the stabilizing peptide in terms of why that might be.
Well again, we're just very focused on running very robust clinical trials to demonstrate that the benefit of our neurotoxin is consistent across a wide variety of groups and so.
I think to the extent that are neurotoxin has really compelling data on duration I think to me it speaks to the fact that.
You know the agencies are certainly open to looking at the data and having that data reflected in the label.
Certainly if you look at our product and the reason that were different you can 0.2 reasons for it because of the stabilizing or peptide in terms of why that might be and we think it's really important in any of these said if you're going to show a duration a benefit that they need to be randomized trials and so we feel.
Mark J. Foley: And we think it's really important in any of these that if you're going to show a duration benefit, they need to be randomized trials. And so, you know, we feel that we're running the type of gold-standard clinical research that's going to be needed in these markets. I think that was evidenced by the acceptance of our Sakura data in PRS. I think that that reflects the, you know, the caliber of the clinical trials that we're running. And we think that that's ultimately going to be really important in terms of demonstrating duration.
We are running in the type of gold standard clinical research that's going to be needed in these markets I think that was evidenced by the acceptance of our sukkary data in Prs I think that that reflects the the caliber of the clinical trials that were running it and we think that that's ultimately going to.
B B really important in terms of demonstrating duration.
Thank you.
Desai Yang: Thank you. Then my final question is on any updates from China.
Well My final question is on any.
Any updates from China.
Mark J. Foley: No real updates there. As you might recall from the deal that we structured with them, we're holding on to all the IP, and they're going to do all the commercial and clinical trial work on their end. And so we're still working through the, or they're still working through the process. You know, to define what the clinical trial requirements are going to be to get approval in that market.
No real no real updates there as you might recall from the deal that we structured with them, we're holding on to all the IP.
And they're going to do all the commercial and clinical trial work on their end and so we're still working through the or they're still working through the process define what the clinical trial requirements going to be to get approval in that marketplace.
Thank you for taking my question.
Desai Yang: Thank you for taking my questions.
Great. Thank you.
Mark J. Foley: Great, thank you.
Our next question comes from the line of search Blender.
Operator: Operator Thank you. Our next question comes from the
Needham Your line is open.
Hi, good afternoon, and a couple of questions for me Mark you mentioned in your prepared remarks, you made some some key hires on the commercial side.
Seamus Christopher Fernandez: Good afternoon. I have a couple of questions. Mark, you mentioned in your prepared remarks that you made some key hires on the commercial side. Can you just tell us whether additional key positions need to be filled there? What should we be thinking about sales force sizing at this point?
Can you just.
Tell us whether additional key positions needs to be feel there and.
Should we be thinking about sales force sizing at this point.
Mark J. Foley: Yeah, so I think on the whole, for where we're at right now, we believe that we've got the right senior leadership, and we just hired a head of sales that's very experienced in the aesthetic marketplace. And I think that if you look at the caliber of the people in the pedigree of where these people come from, you know, they're coming from leading players in the space and know the market very well. And so I think right now we've got the right senior leadership team in place on the commercial side. And we believe we've got all the right market research data to inform our go-to-market strategy.
Yes, so I think on the you know for where we're at right now we believe that we've got the right senior leadership and we just hired ahead of sales, it's very experienced in the aesthetic marketplace and I think that if you look at the caliber of the people in the pedigree of where these people come from.
They are coming from leading players in this space and know the market very well and so I think right now we've got the right senior leadership team in place on the commercial side and we believe we've got all the right market research data to inform our go to market strategy in terms of the number of salespeople we haven't given.
Mark J. Foley: In terms of, you know, the number of salespeople, we haven't given that information yet. And I think as we refine and tailor our launch strategy and plan, which, frankly, we probably won't be sharing until launch time, partly for competitive reasons. But we'll be able to give a little bit more clarity, just a high level in terms of the operating spend that we're planning to invest on the commercial side as we get further along. But we haven't really, I think, articulated yet what we're going to be doing in terms of the number of sales reps.
That information, yet and I think as we refine and tailor our launch strategy and plan, which frankly, we probably won't be sharing until launch time, partly for competitive reasons.
But we'll be able to give a little bit more clarity just a high level in terms of the the operating spend that we're planning to invest on the commercial side as we get further along but we havent really I think articulated yet what we're going to be doing in terms of the number sales reps.
Mark J. Foley: And then on the business development front, I think you've been asked about out-licensing ex-U.S. commercial rights, but is there also any appetite to in-license an additional aesthetic product that could complement DAXI?
And then on the business development front as even asked.
Our outlicensing ex us commercial rights, but is there also any appetite to end license and additional extended product as a complement taxi.
Mark J. Foley: Yeah, so certainly, you know, the strategy of outlicensing ex-US rights is something that we continue down the path on, and we'll continue to look for kind of who's the best partner in these other markets, as evidenced by the folks in the relationships that we have. You know, as I mentioned earlier, we don't feel that we need any additional aesthetic products to have a successful vaccine launch; we think that the product can be successful on its own. Having said that, you know, if we feel there are products that would bring value that wouldn't dilute our efforts to successfully launch Daxi and can provide more value to either the practice or the consumer, then we would absolutely look at those things. But, you know, as it stands right now, we think that we can be successful with Daxi alone. And so that's not a necessary part of our strategy. Great, thank you.
Yes, so certainly.
The strategy of Outlicensing ex US rights is something that we continue down the path on and we'll continue to look for kind of who is the best partner in these other markets as evidenced by the folks and relationship that we have you as I mentioned earlier, we don't feel that we need any additional acetic products to have a successful is actually launch we think that the product.
Can be successful on its own having said that.
If we feel there are products that would bring value that wouldn't delude. Our efforts to successfully launched ACSI and can provide more value to the practice or the consumer than than we would absolutely look at those things, but you know as it stands right now we think that we can be successful with doxey alone and so that's not a necessary part of our strategy.
Thank you.
Thank you.
Mark J. Foley: Thank you. Our next question, Kim, comes from the line of Seamus Fernandez with Guggenheim. Your line is open.
Thank you next question Tim comes from Milan, Seamless Fernandez Guggenheim.
Your line is open.
Seamus Christopher Fernandez: Great, thanks for the question. So, just a couple, Mark.
Great. Thanks for the question so.
Just a couple of Mark can you help us understand I mean as we.
Seamus Christopher Fernandez: Can you help us understand, I mean, as we look forward to the cervical dystonia data in the second half of 2020, which I believe is the timeline, can you just help us understand the profile of the product and what would be clinically meaningful from your perspective in terms of treatment duration and where the Botox treatment profile is getting us today in CD? And again, if you can maybe break out, it doesn't seem like that would be necessary in aesthetics, but perhaps in therapeutics, where choosing a comparator asset would likely be required. So, I was just wondering how you guys would think about the partners and the choice of competitor products in that type of a situation. Thanks.
Look forward to the cervical dystonia data in the second half of.
2020.
I believe is a timeline can you just help us understand the profile of the product and what would be clinically meaningful.
From your perspective in terms of treatment duration, and where the botox treatment profile is getting us today.
CD and then separate question is actually on Outlicensing.
To specifically European markets, given the fact that most European.
Regulators require.
A head to head type trial.
What would be Youre your typical comparator.
Target product in that type of market and again, if you can maybe break out it would it doesn't seem like that would be necessary anesthetics, but perhaps in therapeutics that are.
Mark J. Foley: Great, great questions. So I'm going to turn the question over to Abhay as it relates to sort of the CD, the comparator, what's meaningful, and then we'll take the second one from there.
Choosing a comparator asset likely would be required. So just wondering how you guys would.
I would think about the partners and the choice of competitor product in that type of the situation. Thanks.
Great great questions, So I'm going to turn to the question over to our buys it relates to sort of CD compared or whats meaningful and then we'll we'll take the second one from there.
Abhay Joshi: So Shim, I think the first part of the question was about how we think about launching CD and how the CD trial was designed. To go back to our Phase II program, we very strongly showed that compared to other approved products in the market, where you have Xeomin or Dysport as competitors, who did the trial comparing the end point that we chose. Daxi performed superbly with 24 weeks of duration or longer for the clinical endpoints we chose based on twisters. So, we had tremendous confidence based on that data and trial to go to the agency, and as you all know, we launched our Phase 3 program directly after that. So, the Phase 3 program is designed similar to our Phase 2 study, where the primary endpoint is indeed based on the twister, which is the Toronto Veterans Spasmodic Twister Scale, and there are two components to it.
So Jim I think the flex part of the question was about how do we think about lunging CD and how CD was traveling design to go back to a phase two program I'll be very strongly showed that compared to other approved products in the market, where you have no dysport as competitors, who did the trial.
Comparing the endpoint that we chose.
Taxi performs so part of with a 24 weeks of duration or longer for the clinical endpoints. We chose based on just a score. So we had tremendous confident based on that data and trials to go to the agency and as you all know that we launched our phase three program directly.
After that so the phase three program is designed similar to our phase two study were the primary endpoint in do you just based on the Twister, which is a Toronto.
And Scott specificity twist to scale back down to two components to our primary endpoint is active do show that change from baseline for the distance score.
Abhay Joshi: Our primary endpoint is actually to show a change from baseline for the twister score at an average of four to six weeks, and that is consistent with what we have done before in our Phase 2 program and what other neuromodulators have done. And then a secondary endpoint for this trial is our duration of effect, and again, going back based on our Phase 2 data, we expect to see a similar profile.
Average of four to six weeks on Dec is consistent with what we have done before you're not phase two program and what other neuromodulators have done and then a secondary endpoints like this draws on duration on effect and again going back based on phase two data.
Expect to see similar profile.
Abhay Joshi: Then you want to comment on the duration difference between what we're seeing and kind of what's typically in the marketplace.
Then you want to comment on that the duration difference between what we're seeing and.
Which typically in the marketplace like so then I think if predict the twister out of the equation than that a couple of fee products out there, which have been approved based on different endpoints and defend scales.
Abhay Joshi: So then, I think if you take the twister out of the equation, then there are a couple or three products out there which have been approved based on different endpoints and different scales. So generally, for cervical dystonia, the product label is about 10 to 12 weeks, and 10 to 12 weeks is the optimal level, but the patient actually starts seeing wear on the label around eight to 10 weeks. Compared to our Phase 2 data, where we took the product all the way up to 450 units, we have shown in all categories, in all different escalating doses, that DAX-C, in an open-label study, the duration of effect, the median duration for DAX-C was at least 24 weeks. So you're comparing 24 weeks of median duration with 8 to 12 weeks of the currently approved product. That's almost twice as much delta as you can imagine for DAXI.
So generally for some of their dystonia.
The product label is about 10 to 12 weeks and 10 to 12 weeks is the optimal level, but the patients actually start seeing it reading off the label around eight to 10 weeks.
Compared that to our phase two data then we have taken the product all divvy up to 450 units.
Have shown in all categories in all different.
Escalating doses that taxi open label study the duration of effect. The median duration for doxey was at least 24 weeks. So you are comparing 24 weeks of median duration vis-a-vis eight to 12 weeks off the currently approved products.
Yes, that's the almost two times as much does tell you can imagine for a four taxi and before we answer. The next question about Europe in sort of trial design and everything I will say that we've done extensive market research to look at.
Mark J. Foley: And before we answer the next question about Europe and sort of trial design and everything, I will say that, you know, we've done extensive market research to look at, you know, share taking in the therapeutic area based on a profile with longer duration. And it's meaningful if you look at the health care costs and what's involved there. So, as Abai pointed out, the 8 to 12 weeks in the existing sort of, you know, label of products today versus 24 weeks, we think, you know, provides, you know, meaningful enough value to drive definitely share capture. And then maybe on the other side, but also turn this one over to Abai as it relates to kind of how we think about the EU trials and the endpoints and whether there's any difference between aesthetic and therapeutic.
Share taking in the therapeutic area based on a profile with longer duration and it's meaningful if you look at the health care cost in what's involved there. So it was Abi pointed out the eight to 12 weeks in the existing sort of label products today versus 24 weeks, we think.
Provides meaningful enough value to drive definitely share capture.
And then maybe on the second side, but also turned this went over to Abi as it relates to kind of how we think about the EU trials and the endpoints and whether there's any difference between aesthetic and therapeutic yeah. So I think is a pretty simple answer here for the you tried as far as tactics.
Abhay Joshi: Yeah, so I think it's a pretty simple answer here for the EU trials for aesthetics. As you know, we have our current global trial that will stand as the testimony for filing in Europe based on our data that we acquired in the US. In regards to the therapeutics, I wish I had a better answer for you because we don't have a partner yet. As you know, Mark mentioned that we are trying to have some collaborators to work with us in the EU marketplace. And depending upon who we work with, we'll decide who the right competitor would be for this trial going forward. So at this point, I would say, stay tuned.
As you know be how our couldn't global trial that was down to the testimonial filing in Europe based on data the didn't quite in the U.S. and.
In regards to that kind of Unix I wish everybody RASM for you because you don't have a partner yet as Mark mentioned that we are trying to have some continued to work with us in the marketplace and depending upon who will be worked with will decide who that might compare it would be but its trial going forward. So.
At this point I would say stay tuned.
Seamus Christopher Fernandez: If I can just ask one quick follow-up question, is it reasonable to, uh, consider the prospect of carving up the therapeutic and aesthetic opportunity in Europe with separate partners? I know that pricing can be a bit dynamic, and I just, I don't have a great sense of how pricing would come into, would play into that. So just thanks for that follow-up.
If I can just ask one quick follow up question.
Is it.
Reasonable to.
Consider the prospect of carving up the therapeutic and.
Acetic opportunity in Europe with separate partners I.
I know that pricing can be a bit dynamic can I, just I don't have a great sense of how pricing would come in to.
I would play into that.
Just thanks for that follow up.
Yes, I'll I'll hand, it over to dust into a hit that one.
Dustin S. Sjuts: Yeah, I'll hand it over to Dustin to hit that one. Yeah, I think it
Yeah, I think as we look at it theres.
Dustin S. Sjuts: [inaudible] They were able to do that, but I think we should look at who's the best partner for aesthetics and who's the best partner for therapeutics, and we'll make that evaluation from there.
There are some nuances.
People.
So they can be able to do that but I think look at who's the best partner first that he's the best partner for therapeutic make that evaluation upon there.
Mark J. Foley: So I think, yeah, we do feel that we could split them. We would just need to be mindful of the pricing side of things. But whether we find a single partner to do both, or whether we divide them up, we certainly feel that's an option for us.
So I think yeah, we do feel that we could split them. We would just need to obviously be mindful of sort of the pricing side of things, but whether we find a single partner to do both or whether we divide them up we certainly feel that's an up an option for us.
Seamus Christopher Fernandez: Thanks very much.
Thanks very much.
Mark J. Foley: Great, thank you.
Great. Thank you. Thank you.
Operator: Thank you.
I'm not showing any further questions at this time I would now like from the call over to Mark Foley for closing remarks.
Mark J. Foley: I'm not showing any further questions at this time. I would now like to send the call over to Mark Foley for closing remarks.
Mark J. Foley: Great, thank you, operator. I'm very excited about my new role with Revance and I'm looking forward to meeting with many of you face-to-face in the coming months. In terms of our travel schedule, we will be conducting near-term investor roadshows in San Francisco, New York, and Boston, plus attending the Credit Suisse, Guggenheim, Stiepel, and Piper healthcare conferences.
Great. Thank you operator, I'm very excited about my new role with three Vance and I'm looking forward to meeting with many of you face to face in the coming months.
In terms of our travel schedule, we will be conducting near term Investor Road shows in San Francisco York and Boston.
US attending the credit Suisse, Guggenheim Steeple, and Piper healthcare conferences, please reach out to Genie, if you'd like to meet with us when you're in when you're in our area or if you'd like to schedule a call.
Mark J. Foley: Please reach out to Jeanne if you'd like to meet with us when you're in our area, or if you'd like to schedule a call. With that, I would like to thank you all for participating in today's call. Have a great rest of the day. Thank you.
With that I would like to thank you all for participating in today's call have a great rest of the day. Thank you.
Ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect everyone have a wonderful day.
Operator: Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect. Everyone have a wonderful day.
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