Revance Therapeutics, Inc.

Revance Therapeutics, Inc.

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Biotechnology

Revance Therapeutics, Inc. (RVNC) Q3 2016 Earnings Call Transcript

Published at 2016-11-03 22:26:11
Executives
Jeanie Herbert - Senior Director of Investor Relations and Corporate Communications Dan Browne - President and Chief Executive Officer Lauren Silvernail - Chief Financial Officer and Chief Business Officer
Analysts
Brandon Folkes - Guggenheim Securities Ken Cacciatore - Cowen and Company Sameer Singh - Piper Jaffray John Boris - SunTrust Tim Lugo - William Blair
Operator
Welcome to the Revance Third Quarter 2016 Financial Results 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 [Operator Instructions]. As a reminder, this conference is being recorded today, November 3, 2016. I would now like to turn the conference over to Jeanie Herbert, Senior Director of Investor Relations and Corporate Communications for Revance. Please go ahead.
Jeanie Herbert
Thank you, Stephanie. Joining us on the call today from Revance Therapeutics is President and Chief Executive Officer, Dan Browne and Chief Financial Officer and Chief Business Officer, Lauren Silvernail. Earlier today, Revance Therapeutics released financial results for the quarter ended September 30, 2016. If you have not received this news or if you would like to be added to the Company's distribution list, you can do so on the Investor Relations page of the Company's website at www.revance.com. During the course of this conference call, Revance management will make forward-looking statements including, but not limited to, statements related to Revance's 2016 financial guidance, clinical development of our product candidates, business strategy and goals, plans and prospects, the markets in which we compete, potential product candidates and benefits of our current and future product candidates and our technologies, regulatory risks and ability to obtain regulatory approval and uncertainties in future financial performance. These forward-looking statements are based on the Company's current expectations, are inherently involved significant risks and uncertainties. The actual results from 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 period ended June 30, 2016, as filed with the SEC on August 5, 2016. Revance cautions you not to place undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in its expectations. I will now turn the call over to Dan Browne. Dan?
Dan Browne
Thank you, Jeanie. Good afternoon and thank you for joining our third quarter conference call. Revance is intensely focused on the advancement of science to improve the way botulinum toxin and other drugs perform today and in the futures. Our lead candidate, DaxibotulinumtoxinA for injection commonly known as RT002 injectable is highly differentiated and its performance is not, simply based on units administered. As we believe our current clinical trials will prove our unique peptide complex with our highly purified botulinum toxin type A as a potential to be the first long lasting injectable formulation botulinum toxin and thus the first truly new neurotoxin product in nearly 30 years. Reducing the frequency of injection improves safety, efficacy and the risk benefits associated with the use of highly potent neurotoxin drug products. In recent months we’ve advanced programs in glabellar lines, cervical dystonia and a new indication for plantar fasciitis. As of today we have three active insynergistic clinical programs for RT002 injectable. Here are the details. First, our Phase 3 program for RT002 injectable for glabellar lines, we have filed and successfully opened the IND with the U.S. FDA and a CTA with the Canadian Regulatory authorities and are moving forward with the Phase 3 clinical trials to treat frown lines. We have simultaneously initiated activities for both the Phase 3 pivotal trials and the long-term open label safety study. The Phase 3 program will be conducted in more than 50 sites in the United States and Canada. We’re now training the investigators, who are on track to start enrolling and dosing patients this quarter. We anticipate enrollment will proceed very quickly. We expect to enroll up to 400 patients in each pivotal trial and about 1,500 patients in the long-term safety study. You can expect top-line results for both pivotal trials in the fourth quarter of 2017. We estimate the worldwide glabellar line market is nearly $1 billion and the botulinum toxin market continues to grow in double digits. A long lasting highly differentiated toxin to capture significant share, while also helping to fuel continued growth in the category. Moving on to RT002 injectable for cervical dystonia, cervical dystonia is a debilitating condition characterized by involuntary muscle contractions in the neck. There are several strategic reasons, why we chose to pursue cervical dystonia. First and foremost, those patients are seeking a longer duration effect in the eight to ten weeks that it’s commonly seen at any dose of the commercial available botulinum toxin products. These products are labeled to be dosed no more frequently than every 12 weeks and can begin to wear off at eight to ten weeks, so patients go weeks without much needed relief. Second, just as glabellar line treatment is the ideal indication in which to evaluate and compare safety, efficacy and duration of botulinum toxin for static indications. Cervical dystonia is the ideal indication in which to demonstrate safety, efficacy and duration at higher doses for therapeutic indications. This is due to cervical dystonia having a clear primary and secondary end points, but they’re well validated quantitative scale, which enables assessment and improvement as well as the future related adverse events such as dysphagia and muscle weakness. Third, there is an established global regulatory path to approval and fourth, we believe demonstrating longer duration of RT002 in both glabellar lines and cervical dystonia along with delivering a strong safety profile has the potential to clearly demonstrate the value proposition for RT002 and that Revance’s technology does not deliver just another old generation show dock [ph] in botulinum toxin type A to the market. Our cervical dystonia dose escalating open label trial started last year with Cohort 1 dosing up to 200 units. Today, the Phase 2 continues according to plan. We’re pleased to report the Data Safety Monitoring Board reviewed the data from Cohort 2 at up to 300 units and approved moving ahead with Cohort 3 at up to 450 units. In fact, enrollment in Cohort 3 is nearly complete. Before the end of December, we expect to release interim results from Cohort 1 and Cohort 2, including safety, efficacy and duration. Finally, I’m excited to talk about our latest indication plantar fasciitis. As we announced this morning we’ve initiated a Phase 2 trial for plantar fasciitis, this new indication for neurotoxin. Revance has the opportunity to be the first to market with an approved neurotoxin therapy to treat this painful foot condition affecting [ph] an estimated 10% of the American population during their lives. More than 2 million adults undergo treatment for plantar fasciitis in the United States annually. The plantar fascia is the broad ligament that connects the heel bone to the waist of the toes. It acts like the shock absorber of the foot. Once injured, weakness, swelling, irritation or inflammation set in causing pain and stiffness in the heel, in the bottom of the foot. Based on my own personal experience as an aging athlete, I can tell you plantar fasciitis causes excruciating chronic pain making exercise and just ordinary walking very difficult. Publish literature indicates botulinum toxin administrated to the plantar structures decreases tension and blocks pain within the fascia, allowing healing to take place. Today the U.S. markets to evaluate and treat plantar fasciitis exceeds 250 million, this estimate includes generic, low priced corticosteroid that do not have to fully treat the condition on a timely basis for all patients, a new targeted approach that provides patients with sustained relief from chronic heel pain to significantly grow the market. Our Phase 2 placebo-controlled trial will evaluate the safety and efficacy of a single administration of RT002 injectable in reducing the signs and symptoms of plantar fasciitis. We plan to enroll 60 subjects in the United States. The primary efficacy end point is the improvement in the American Orthopedic Foot and Ankle Score. Subjects will be evaluated for 16 weeks after single treatment and we plan to report results next year in 2017. Strategically we picked plantar fasciitis for a number of reasons; first, there is a significant unmet clinical need. Second, it is a large market and it is complimentary to cervical dystonia and other muscle movement conditions. Third, there is an established clinical experience with botulinum toxin which increased this probability of technical success. Fourth, the primary end point is well characterized using American Orthopedic Foot and Ankle Score and finally the scale is the most widely used instrument for clinical studies of the foot and ankle. This trial allows us to target our first pain indication and generate proof of concept in Phase 2, without the time and expense and variability that comes with certain other pain trails such as migraine. It is important to note that success with this plantar fasciitis indication could support our exploration of RT002 to treat other pain and inflammation indications, some of which are covered by our newly acquired patents from BTRX. As I have indicated we are fully focused on RT002 injectable and moving our lead candidates forward on a number of fronts. With that update let me turn our call over to Lauren to cover the financials.
Lauren Silvernail
Thank you, Dan. Starting with our cash and investments balance, we ended the third quarter with $201 million. Our cash burn for the third quarter was just under 16 million and 53 million for the first nine months of 2016. Net loss for the third quarter was 18 million compared to 19.2 million for the prior year quarter, driven primarily by lower R&D expenses for RT001 topical, offset by an increase in clinical trial and manufacturing CMC expenses for RT002 injectable. Our common shares outstanding as of today are 28.5 million, our fully diluted shares outstanding not on a treasury basis at the end of September was 31.4 million shares including 2.9 million granted auctions and warrants. Turning to our guidance, we are updating our expense and cash expectations for 2016. We currently expect to end 2016 with cash and investment in excess of $165 million, which is an $11 million increase in cash and investment from our previous guidance. Tight expense management has resulted in lower than planned expenses. With three trails now underway, we expect our cash on hand will fund our operations into the second quarter of 2018. We will provide a more fulsome update on 2017 cash burn expectations early next year. For 2016 non-GAAP operating expense, we now expect to be in the range of $70 million to $80 million excluding desperation of 2 million to 3 million and estimated stock based compensation of 12 million to 13 million. With three RT002 injectable clinical trials underway in the fourth quarter, we now anticipate 2016 non-GAAP R&D expense to be in the range of 47 million to 53 million, excluding 2 million to 3 million of depreciation and estimated stock based compensation of 6 million to 7 million. For modeling purposes and assuming no material issuances of equity we expect our 2016 weighted average shares outstanding, excluding un-invested restricted stock will be approximately 28 million to 29 million shares. And with that, I'll turn it back to Dan.
Dan Browne
Thank you, Lauren. We have a busy fourth quarter with initiation of the Phase 3 program for glabellar lines. Enrollment and dosing in the new Phase 2 study for plantar fasciitis and a key milestone of reporting interim results of the Phase 2 trial for cervical dystonia, which we look forward to achieving before the end of this year. As we head into 2017 we continue to be excited by the prospects of RT002 injectable to be a game changer in the field of neurotoxin. Our unwavering goal is to become a global neurotoxin leader in both aesthetic medicine and underserved therapeutic specialties. In terms of travel, during November we will be in the U.K. at the Jefferies London Healthcare Conference and in New York for the 28th annual Piper Jaffray Healthcare Conference. In December, we will be in Boston to attend the fourth annual Guggenheim Healthcare Conference. Please let us know if you would like to meet 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
[Operator Instructions] our first question today comes from the line of Louise Chen with Guggenheim Securities. Your line is open.
Brendon Folkes
Hi, it is Brendon Folkes on for Louise, I have just got a few here, can you provide more color on the cost of the upcoming plantar fasciitis trial? And then secondly is your injectable toxin is approved for both cosmetic and medical indications? How do you think about processing between the two major categories and can you charge different process for cosmetic versus medical product and then on a touch note foot, you touched on sort of access but any publications or data presentations at medical conference to attend in the foreseeable future, thank you.
Lauren Silvernail
Hi and thanks for joining the call this is Lauren Silvernail, let me take the cost part of the question first and I will turn it back to Dan. On the cost side because this is a 60 patient tail we expect the full clinical cost will be in the range of $1 million to $2 million and really at the lower end of that range. So it is a great value for us to explore this indication for a whole host of reasons.
Dan Browne
We chatted about the core of the synergistic nature of this molecule allows us to do both aesthetic medicine and therapeutic. And we believe the best approach for us is to look at both and we move forward looking at establishing the value proposition in actually addressing these conditions both on the aesthetic side and the therapeutic side. You don’t have to make that choice on pricing today, but we think the performances as such that allowed us to drive a premium price for both the therapeutic and the aesthetic indications. We look the data sort of play itself out [ph] at the time approval, but making sure that we maximize the value to those patients and to those physicians and payers.
Louise Chen
Great thanks so much.
Operator
Our next question comes from Ken Cacciatore with Cowen and Company. Your line is open.
Ken Cacciatore
Hey guys good afternoon, just a couple of quick questions, first ahead of the cervical dystonia data I wonder if you want to help set some parameters of what we should be thinking in terms of what is a good hurdle to overcome? So I know you don’t have the data, but can you maybe frame these are the BOTOX what we should be considering as we go into it as good data. And then on plantar fasciitis, just wondering why we would we go to an indication that there is no kind of former BOTOX studies, it seems that we want to try the way that kind of create maximum value here would be the due thing that would compare like stroke or spasticity’s, where we kind of nowhere BOTOX does and we can show that 002 is really differentiated from BOTOX. So wondering why go outside? I know that there is kind of loose studies done on BOTOX, but nothing is definitive as an approved indication, so why wouldn't we be going after an approved indication and really keep on pushing that differentiation? Thanks.
Dan Browne
Ken, I think we will start with the cervical dystonia data, we based our discussion with physicians and patients and payers based on the labeled indication for neurotoxin. So if you got 13 up to no more frequently then every trail we’ve got patients who really are asking anywhere from 8 to 12 weeks depending on what data sets and severity they are underlying dystonia. Much like in the glabellar line we want to extend that in a clinical meaningful way beyond those data sets. The longer that is, as long as we don’t change the safety profile and we are continuing to add the therapeutic benefit allows us to have a much more differentiated product than the commercially available toxins, which are effectively performing at least five labels pretty similarly. Perhaps we want to extend that duration and still have that very strong safety profile. So longer that is, the better that it is and we will have that data on the first two Cohorts that allows us to come back and benchmark for that less than twelve week duration. As far as this indication for what’s next, we really like the pain indication as our next. We felt the cervical dystonia after doses that we are looking at 200, 300 and 450 could carry over and be very informative to what you would see in the upper limb spasticity that is bend down with the current products who are all behaving in about the same. For us, we really want to curve out a new opportunity, but yet not going too blindly, there is clinical data that looks at the performances of botulinum toxin. We picked the center that was very active in the early days of cerebral palsy and spasticity and help sort of build that initial use of toxins in those areas we wanted to take that initial thinking and move into a migraine that we could move very cost effectively. Lauren, highlighted the cost is relatively in expense of where cervical dystonia to address the muscle movement CD and upper lens spasticity, we use plantar fasciitis as an entry point in the pain gets the data in this plantar fasciitis address some of the pain mechanisms it will allows us to go ahead and reprioritize around other pain indications which we think are also equally attractive. So it was high probability of success, generating the data and do it in a very cost effective way. It is not that we won't get to the upper limb and lower limb spasticity, I expect that we will. It’s about really using the platform to show that the science of cross indications from low dose to high dose is not just another older generation toxin, this is meaningfully different whether it is pain, whether it is muscle movement or whether it is aesthetic line and that is the basis of our strategy moving forward.
Ken Cacciatore
Great make sense thank you.
Lauren Silvernail
Great and Ken this is Lauren, on the commercial side form a portfolio standpoint, as we grow this business it makes sense for us to have indications where there is lower competitive intensity across and so with absolute lack of competition today and plantar fasciitis combined with a strong published data, we felt there was a great place for us to go commercially.
Ken Cacciatore
Got it, thank you.
Operator
Our next question comes from David Amsellem with Piper Jaffray. Your line is open.
Sameer Singh
Hey guys this is Sameer on for David, just two quick ones here. I know you touched on this a bit but can you talk more about potential expansion opportunities for RT002, maybe in migraine or overactive bladder, also other market opportunities beyond what you just touched today that aren’t in the BOTOX label that you are considering exploring and the extent that you are, maybe could you provide more color on that? Thanks.
Dan Browne
Our challenge is to balance being laser focused and getting the product approved which is what you see with the glabellar line, we are attacking simultaneously with two pivotal trails in the open label and try to do whatever we can to accelerate the filing and ultimate approvability. Conversional as we want to go after the muscle movement that we just talked about, those are the two largest areas strictly around the dystonia and it’s the overall muscle movement where it represent anatomically. Our challenge is also without losing focus, look at other areas, we announced the plantar fasciitis, but there is virtually an unlimited opportunity of using a very unique highly differentiated, either to follow the existing path that is part of the 11, 12 approved indications or for us to sort of move where the toxin is being used clinically, where there is clinical data, there is manuscripts, there is evidence of some early encouraging findings and to cover own domain. So that’s really what we are conveying here in this strategy, in this call and I think it is an exciting time to at least sort of respond to the clinical community whether it is an dermatology, the neurology communities or whether what we are starting to see in the foot and ankle whether it be surgical or whether it is podiatry, they see the value of a new differentiated toxin.
Sameer Singh
Thanks.
Operator
Our next question comes from John Boris with SunTrust. Your line is open.
John Boris
Thanks for taking the questions and first one - I am not sure if you mentioned this earlier, I got on the call little late, but on cohort 1 and 2, where will you present the data from cohort 1 and 2 in cervical dystonia? And then on the plantar fasciitis opportunity, have there been any competitive trails that have been done with the botulinum toxin in plantar fasciitis? If so, what have you learned from that, what type of does and duration will you use and any thoughts on Kay Wells [ph] have indicated about the potential advantages of using a toxin versus over that of steroids or non-steroidal use there?
Dan Browne
Yeah, good questions John. Let me take the - where will we present the data. What we will do at the end of this year most likely start with press release and then will look at opportunities that one of the closest neurology meetings, whether it is the AAN or some other venue to actually have the data presented. We still have cohort 3 outstanding so we want to make sure that we don’t run any conflicts with that particular cohort, but we obviously want to get the data out. We think the safety particularly high dozes given the rate of dysphasia muscle weakens, if we can sort of present even at the higher does a very strong safety profile, but start to look at the duration from starting up to 200 to 300. We think those two cohorts if clinically meaningful this year allows us really to start looking at does that we are going to move forward with for the pivotal trails. So we will get it after as soon as we can. As far as the plantar fasciitis there is a fair amount of published literature, the doses range from very low to 40 or 50 to up to a couple of hundred units. What matters is where the drug is injected, the does is injected, the amount of diffusion. You don’t want a highly diffused very targeted approach. So we want to - our scientist has been very active in use of toxins all the way back to the very first days of cerebral palsy who is an orthopedist by training and we felt that institutional knowledge allowed us to sort of take what it had been done with neurotoxin for plantar fasciitis, to a whole another level. And as part of our proprietary platform as we look at this indication whether it would be composition in our RT002 or how we dose or where we inject to really make this a sustainable treatment alternative that what you see with boots, which are problematic expensive patients don’t comply and corticosteroids which are relatively short acting, but then days or weeks and limited in their ability to use chronically because what you don’t want to do is administer those corticosteroids more than two or three times because you start to run the risk of changing the fact [indiscernible] actually amplifying the condition and it is associated with the underlining fasciitis. So we think toxin visibility to address the underlying tension any inflammatory process gives us a very unique opportunity to treat the same condition. If we are successful here as we said we think that will open up opportunities in other pain indications whether it would be migraine or some of the other things where you not only be looking at underlying pain mechanisms, but you will be looking at duration as well.
John Boris
Thanks
Operator
Our next question comes from the line of Tim Lugo with William Blair. Your line is open.
Tim Lugo
Thanks for the question and the plantar fasciitis indication obviously pretty interesting, can you maybe talk about the Placebo ARM in the trail and are you going to allow pain medication and rescue medication also beyond the tool you are using, are you going to be collecting daily pain scores or any sort of a dairy?
Dan Browne
So we have randomized ten patients one to one between placebo and the RT002 group. Both follow the same regiment as far as stretching and then we will be following those patients out to 16 weeks. So we will be capturing those as part of that foot and ankle score, which is a clinical score that looks at both the pain as well as the alignment and function of the overall foot, so we will be capturing those scores. It is a very widely used scale, we think it was the best starting point for us that will be used as part of our development of our PRO, where a lot of those things that you are getting to because this is a such a unique treatment where you are sort of taking this to another level, it is either based on the corticosteroids or the boots. So we will be putting that package together once we get the data from the Phase 2 trial, it should be very highly informative relative to placebo and we think it is a controlled data set that hopefully takes us to the next stage of development.
Tim Lugo
Okay and will there be dosing and the next assessment using the score, will that be a 16 weeks or will it be maybe some interims in between. I'm just thinking about how many data points you will be collecting in the trial?
Dan Browne
Well, we think the 16 weeks is really critical because that is really the sustained durability of this over a corticosteroid, which is obviously much, much shorter. So that give the efficacy end point that we think that it’s most important. We’ll be looking at earlier parameters around safety and so we’ll be giving those earlier time points and collecting data along the way, but I want to come back and reinforce, when you’re addressing both the pain and the inflammation, you really need time for that to remodel following an injection. So it’s important to look at the sustainability of the treatment, not just what you see in the first couple of weeks.
Tim Lugo
Understood and I think in back pain, there is a protocol whether it’s multiple injections along the affected vertebrae, is this - will there be any sort of multi dose portion of this, maybe - I think you said there was only one injection.
Dan Browne
Well, there’s multiple injections, one in treatment study. So where we’re injecting, we’re commenting on today, we’d like to keep that proprietary for now. But as we look at that it will be addressing the underlying fascia as well as some other anatomic structures in the foot and ankle that goes to address this underlying inflammation and pain of the fascia.
Tim Lugo
Okay and maybe just one last question on the CD trial, it sounds like you’re tired of hearing about the dose differences between 002 and BOTOX , when we see the first two cohorts of data, do you think that there’s going to be enough data to kind of definitively compare the two in terms of dosing differences? It’s not just double X of BOTOX where it’s truly differentiated.
Dan Browne
Well, look I think that whether you look at the preclinical, whether you look at Bell Mark [ph], which is probably the best data set so far. This is not just doses, this is not just the number of units, I mean I think that 30 years plenty long. If you could simply add more units to extend the ratio, it would have happened by now and I think if you look approved drugs, I think we can find very few examples, once there is a labeled indication that if you just add more of it - pick your drug if anything that gets - the efficacy gets much better. So I don’t see that unit argument holding true preclinically, it’s certainly hasn’t trailed preclinically. And for us, we picked the dose that gave us the best triangulation of safety, efficacy and duration. And like said, this is a new generation of neuromodulation using the toxin and the peptide in a unique way. This is not just another type A toxin and we felt like that’s the best way for us to compete and do it in a way where you don’t have to change the reconstitution, you don’t have to change the dosing. You give the physicians who are already using neurotoxins a seamless way to move from the older generation to a new generation of toxins. That hopefully, if the data holds true, gives us the same safety profile, the same efficacy but fundamentally longer duration.
Tim Lugo
Well, thanks for all the answers and the detail. And I’ll be waiting on the data as well.
Lauren Silvernail
Thanks, Tim.
Operator
Thank you ladies and gentlemen, that concludes the Q&A session in today’s conference. You may all disconnect and everyone have a great day.