Revance Therapeutics, Inc.

Revance Therapeutics, Inc.

$3.28
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NASDAQ Global Market
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Biotechnology

Revance Therapeutics, Inc. (RVNC) Q1 2014 Earnings Call Transcript

Published at 2014-05-13 00:00:00
Operator
Good day, ladies and gentlemen, and welcome to the Revance Therapeutics' 2014 First Quarter Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to Ana Petrovic. Ma'am, you may begin. Ana Petrovic;Westwicke Partners: Thank you. Joining us on the call today from Revance Therapeutics is Chief Executive Officer and President, Dan Browne; and Chief Financial Officer, and Executive Vice President of Corporate Development, Lauren Silvernail. Earlier today, Revance Therapeutics released financial results for the quarter ended March 31, 2014. If you have not received this news release, or if you'd like added to the company's distribution list, please sign up at the company's website, revance.com, or call Westwicke Partners at (415) 513-1281. During the course of this conference call, Revance management will make forward-looking statements, including but not limited to statements related to Revance Therapeutics' financial performance, clinical development, business strategy and goals, plans and prospects, potential benefits of our product candidates and our technologies, and our future financial performance. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company described in the section entitled forward-looking statements and its press release of today. 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'll now turn the call over to Dan Browne. Dan? L. Browne;Co-Founder, President, CEO & Director: Thank you, Ana. Good afternoon, everyone and thank you for joining our First Quarter 2014 Earnings Conference Call. This afternoon, we'll break down our comments as follows: I will start up with comments regarding our recent achievements, followed by an update on our clinical programs. Then I'll turn the call over to Lauren to give a more detailed analysis of our first quarter financial results and our expectations for the remainder of the year. Next, I'll outline our upcoming clinical milestones and wrap up the call with closing remarks. We will then open the call up for questions. In the first quarter, we successfully completed our initial public offering, which brought in just under $99 million in net proceeds to the company. This capital is enabling us to continue our late-stage clinical programs and execute our corporate objective to build Revance into a premier dermatology company. We are focused on leveraging our proprietary transmits peptide technology across multiple indications and dose forms. Our core objective is to develop and commercialize our portfolio of botulinum toxin compounds that will address a large in growing aesthetic and therapeutic botulinum toxin market, expected to exceed $4.3 billion by 2018. As a reminder, we currently have 2 late-stage product candidates. Our lead asset is RT001, a novel topical botulinum toxin in Phase III for the treatment of crow's feet lines. Other indications for RT001 in clinical development include prophylactic treatment of chronic migraine and hyperhidrosis or excessive sweating, a dermatologic condition which typically presents in the underarms, hands, feet and face. Our second asset is RT002, which is designed to be a more targeted and longer-lasting injectable toxin for the treatment of frown lines. We recently announced positive results from our first RT002 clinical trial. We believe RT001 and RT002 represent a large commercial opportunity addressing multiple aesthetic and therapeutic conditions with 3 anticipated launches beginning in 2017, and the potential to reach annual sales in North America of $500 million and beyond. Importantly, we expect to achieve our potential through a targeted specialty selling organization in North America. We believe we'll be the first to market with the topical neurotoxin expected to launch in 2017. We have all of our rights to all assets across all geographies and all indications for both topical and injectable dose forms. I am incredibly pleased with the recent progress we've made. These highlights include: last month, the announcement of positive results from our first injectable RT002 clinical trial in frown lines; earlier in the quarter, we initiated our RT001 open-label Phase III safety study in crow's feet lines. We also continue to make significant progress on our manufacturing capabilities for both drug product and drug substance, including CMC, analytics and commercial scale fill/finish operations. Our achievements in clinical programs and progress on our operations capacity for RT001 is our testament of our ability to execute on all facets of our business and deliver on our stated goals. And finally, as we just announced last night, we added Mark Prygocki, former President of Medicis Pharmaceuticals to our Board of Directors and as Chair of our Audit Committee. Mark brings a wealth of financial, operational and industry experience to our board. Under his leadership, Medicis grew to become a multi-billion dollar enterprise and was acquired by Valeant in 2012 for $2.6 billion. We're thrilled to welcome another outstanding business leader with a proven track record to our board. And we look forward to Mark's contributions to Revance. Now turning to the clinical programs. Looking at the topical RT001 candidate, we started our Phase III open label safety study for RT001 in crow's feet lines in the first quarter. The open label safety study will enroll up to 1,800 patients, and it is a critical step in our path to an anticipated BLA in USA, and the associated MAA, finally, in the European Union. Both are on track to file in 2016. We expect to release interim data from our open-label study next year in 2015 and anticipate final data in 2016. Additionally, we are currently conducting start-up activities for our first RT001 Phase III U.S. pivotal trial in crow's feet lines. The study will have a similar design to our successful Phase IIb study, and will enroll approximately 170 subjects. We expect to report results in the second half of this year, 2014. We also plan to report results from our European and second U.S. RT001 Phase III pivotal trials in 2015. Moving on to our injectable product candidate, RT002. In April, we announced exciting data from our open-label dose escalating Phase I/II study in frown lines. The study enrolled 48 patients across 4 dose groups. The doses used in the trial ranged from approximately 1/2 the labeled dose to approximately twice the labeled dose of commercially available neurotoxins, based on potency aesthetics commonly used in the industry. All subjects had severe to moderate wrinkles at baseline, measured using the 4-point glabellar line severity scale. RT002 met both primary efficacy and safety endpoints of the trial; specifically, the results showed that 94% of subjects were rated with none or mild wrinkle-severity at maximum frown, 4 weeks posttreatment as assessed by the clinical investigator. 83% of subject assess themselves as -- has achieving none or mild wrinkles at maximum frown at the same time point. In the final cohort, the only one where durational effect was measured, RT002 achieved median duration of 7.3 months based on both the investigator and subject assessments. Across all cohorts, RT002 were shown to be generally safe and well tolerated throughout the study with minimal adverse events. An independent data safety committee, composed of neurology, dermatology and internal medicine experts, reviewed the data after each cohort. They confirmed that each dose was safe and approved each successive higher dose throughout the trial. Importantly, there was no evidence of spread of the neurotoxin beyond the treatment site at any dose. Adverse event rates did not change in frequency, severity or type with the increasing doses. This data is particularly compelling as it is completely consistent with the preclinical data that was published in 2012. As all of you know, botulinum toxin is a very well-characterized molecule and there are established qualitative and quantitative preclinical models to show both safety and efficacy. We use these standardized models and compared RT002 to the leading commercially available botulinum toxin products. In these studies, RT002 demonstrated duration of effect between 1.6x to over 2x longer than the comparator. The studies also show that the spread of drug beyond the treatment site was significantly less than what was seen with other injectable toxin products. Based on the results from the first RT002 clinical trial, and previous findings from the clinical data, we plan to start a Phase II active comparative study with the results expected next year in 2015. We believe our topical RT001 and injectable RT002 product candidates illustrate the potential of our proprietary technology platform and the innovation of our late-stage pipeline portfolio. Once approved, we expect RT001 and RT002 to expand the market by offering superior results and satisfying unmet needs in a large and growing aesthetic and therapeutic dermatology space. We look forward to updating you on important milestones across our portfolio throughout the remainder of these -- this year. With that, I'll turn the call over to Lauren to discuss the financials and 2014 outlook. Lauren Silvernail;Chief Financial Officer, and Executive Vice President of Corporate Development: Great. Thank you, Dan, very much. And good afternoon, everyone. Starting with the balance sheet, we ended the first quarter in a strong position with a cash balance just short of $88 million. During the quarter, our operating cash burn was $22 million, including a payment under our Medicis settlement agreement of $7.1 million. As you update your models after your call -- after this call, we caution you from projecting a similar cash burn during the remaining 3 quarters of 2014 as the payment under the Medicis settlement agreement was a onetime payment that increased our burn rates for the first quarter of 2014 only. Importantly, our full year 2014 cash burn guidance of $75 million to $85 million is unchanged, and we continue to believe we have sufficient cash to fund our operations for at least for next 15 months. Turning to the P&L. Our SG&A expense has increased year-over-year due to the cost of operating as a public company. R&D expense in the first quarter of 2014 was relatively unchanged compared to last year. We anticipate our R&D expense will increase during 2014 due to expenses related to our expanding Phase III clinical activity. In total, we anticipate it will be within our previously guided full year 2014 operating expense. I'd also like to provide some color on our interest expense below the line. For the first quarter of 2014, interest expense totaled $9.8 million. Interest expense in 2014 included cash and noncash components. Cash interest in the first quarter of 2014 was $372,000. Noncash interest expense for the same period totaled $9.5 million, and for the most part was incurred at the IPO upon the conversion of our 2013 notes in the common stock. We expect our interest to decrease substantially in future periods. Turning to our net loss. In the first quarter of 2014, we had a net loss of $21.4 million, which was primarily comprised of $11.6 million in operating expenses, plus the noncash interest expenses of $9.5 million, which we just discussed. Looking at our shares outstanding to use in your models. As of March 31, 2014, our common shares outstanding were 18.65 million and our fully diluted shares outstanding, not on the treasury basis, were 21 -- excuse me, 20.1 million. Turning to guidance. As I just mentioned, our outlook for the year is unchanged. Based on our current operating plans, we're reiterating our cash burn guidance, which again we expect to be in the range of $75 million to $85 million for the full fiscal year. Cash burn in 2014 again is anticipated to include the $7 million we've already paid under the Medicis settlement agreement, full year debt service of $10 million to $11 million, the cost incurred in the first quarter related to our IPO and the incremental cost of being a public company going forward. And with that, I'd like to thank you very much for your attention. And turn it back over to Dan. L. Browne;Co-Founder, President, CEO & Director: Thank you, Lauren. A couple of comments. Here at Revance, our focus is on execution. We are delivering on our promises and building momentum for the future: we announced positive results from our first RT002 clinical trial in frown lines; we initiated our RT001 open-label Phase III safety study in crow's feet lines; and we've continued with steady progress in our manufacturing capabilities for both our drug product and drug substance; and we've added yet another proven leader with extensive healthcare and dermatologic knowledge, Mark Prygocki, to our Board of Directors. Looking ahead at our next milestones, we plan to report results from the first RT001 Phase III pivotal trial during the second half of this year, 2014, followed by multiple Phase III catalysts from our pipeline in 2015. In closing, we are pleased with our progress. I hope you've been able to sense the enthusiasm the team has for the goals that we've set for ourselves for this year. We're executing on our strategy to build the premier dermatology company and commercialize our novel neurotoxin products, targeting a growing market, which is expected to exceed $4.3 billion by 2018. We look forward to providing updates on future calls. With that, thank you all for joining us today. And I now open it to questions. Operator?
Operator
[Operator Instructions] And the first question is from Ken Cacciatore of Cowen and Company.
Ken Cacciatore
I just had a couple of questions around the head-to-head study of RT002. If you could you give us how much -- any new ones behind that in terms of, maybe, doses that you're planning on taking forward maybe a little bit of trial size, a little bit more on the design? And then I have a follow-up question. L. Browne;Co-Founder, President, CEO & Director: Ken, this is Dan. We're obviously trying to digest the data coming back from this Phase I, Phase II study. I think at a high level, we'll most likely look at a couple of doses, to be determined; and then an active comparator arm and then a placebo arm. Beyond that, I want to refrain from sort of commenting to a specific study size. We would expect duration to be comparable to what we saw in the earlier trial. And that's how we would power those studies accordingly. We think from a development perspective, the next best step for us is to highlight the advantages of a longer duration, not versus a placebo, but to an active commercially available toxin, and that's how that trial will be designed.
Ken Cacciatore
Okay, great. And then I was just wondering in terms of it's -- clearly the early data is very exciting. And I don't know if it's capital limiting, but have you thought about parallel development looking at RT002 as you're doing this study to move it forward and maybe a therapeutic indication? Or to somehow try to elucidate the product in other indications as we're waiting for even the completion of the head-to-head against an active? L. Browne;Co-Founder, President, CEO & Director: I think given the clinical data that we released, we are actively looking at: What's the best therapeutic indication that would highlight both things? It's not only longer duration, but the ability to control the fusion of the drug. So we're evaluating a number of potential therapeutic indications. We want to remain focused on the dermatologic perspective, but we think an additional therapeutic indication for RT002 would obviously enhance the value of that technology in a therapeutic indication.
Operator
And the next question is from David Amsellem of Piper Jaffray.
David Amsellem
Just a couple. So first, any latest thoughts on timing of -- a European partnership on either RT001 or RT002? Now you talked about it in the past, but has anything changed there? And maybe just remind us what your preferred scenarios are in terms of partnership? And then, secondly, in terms of therapeutic indications for RT001 or RT002, are you wedded to the idea of partnering out in these last -- these therapeutic indications? Or is that something that down the road, you may look to keep and build additional sales and marketing infrastructure around? How should we think about that? Lauren Silvernail;Chief Financial Officer, and Executive Vice President of Corporate Development: David, thanks for the question. This is Lauren Silvernail. As far as partnering, we continue to look at what we have, and really want to assess the exact right time to partner. For us, we are sure it's not right now. And we think as we continue to generate data, each time we do, we are pleasantly surprise by what we find. And we think that continuing to build value in the franchise and partnering at the right time to help us with the commercial side and the launches around the world make sense. Which we're -- and that's really unchanged, I guess, would be a shorter answer to that. With regard to the United States or North America and outside of dermatology and our Core 4 that go with that, we continue to assess. When you look at us and our abilities, we will be on the commercial side a specialty pharmaceutical company; and anything that is a specialty as we grow, we should consider. So we will continue to look at that with an open mind. Down the road, we don't see ourselves as a large primary care player. And so as we look at each indication, and we are evaluating very heavily at this time: What are the right indications for us on the therapeutic side with toxins? You should think about this considering that for post dermatology, along with dermatology as the business grows. And let me turn it over to Dan in case there is anything he would like to add back to that. L. Browne;Co-Founder, President, CEO & Director: No, David, I think it's not a question of if, but a question for when. But we want to stay laser-focused on our core. And the value of this platform is our ability to be nimble and neither partner by geography or by therapeutic indications. We know these neuro modulators play a role in both, and I think it's just a question of when we've generated the appropriate clinical data to get a transaction that's been formed [ph] out for us to move forward with it.
Operator
[Operator Instructions] And the next question is from David Maris of BMO Capital Markets.
David Maris
I have a simple question. You mentioned the data that's coming in the second half of the year. Did you -- did I miss it, or did you not say when in the second half of the year? L. Browne;Co-Founder, President, CEO & Director: David, at this point we haven't given any more specific guidance in the second half of this year. We're getting ready to move obviously in the third quarter, but it will be the second half of this year.
David Maris
Well, then can you give us a little update on the gating factors for when it would be earlier? When it would be later? L. Browne;Co-Founder, President, CEO & Director: I think, David, it's just a matter of getting all those start-up activities in line and making sure that we've got everybody appropriately trained. We want to work around the summer months. You want to make sure you are funneling patients into the right intervals, you're not missing follow-up visits. I think, it's just a matter of the clinical regulatory teams checking all the boxes, and make sure that we appropriately execute that trial, so we can deliver that data that people are expecting later in the year.
David Maris
Great. And was there anything in the long-acting data in the response from investors that you thought was surprising? Or do you think that everyone had a pretty good handle on it? L. Browne;Co-Founder, President, CEO & Director: Our sense is, we didn't talk about it a lot on the roadshow, because we didn't have the data at that time. We had some indirect sort of feedback from the center that the duration felt like it could be longer. And I think for us, it's just a stay under the radar screen and not talk about the data until we had it in hand. And I think the challenge for us now is how do we take that 7.3 months, and now turn it into the next study design that is meaningful in a way that's sort of compare the advantages and features of this product versus the commercially available product. And our view is even though that trial is relatively small, it's highly informative, given how much is already known about the molecule, how well characterized glabellar lines have been evaluated through multiple sponsors. And now, we have good preclinical and now clinical data to really develop and design and execute a clinical trial that highlights why RT002 is something demonstrably different.
Operator
Thank you. And there are no further questions in queue at this time. I'd like to turn the call back over to Dan Browne for closing remarks. L. Browne;Co-Founder, President, CEO & Director: We thank you for your interest in following the Revance story. And we look forward to communicating with you on our future calls. Thank you very much.
Operator
Thank you. Ladies and gentlemen, this concludes today's conference. You may now disconnect. Good day.