Revance Therapeutics, Inc.

Revance Therapeutics, Inc.

$3.28
-0.01 (-0.3%)
NASDAQ Global Market
USD, US
Biotechnology

Revance Therapeutics, Inc. (RVNC) Q1 2017 Earnings Call Transcript

Published at 2017-05-09 22:30:04
Executives
Jeanie Herbert - Senior Director of IR and Corporate Communications Dan Browne - President and CEO Lauren Silvernail - Chief Business Officer and CFO
Operator
Welcome to the Revance First Quarter 2017 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded today, May 09, 2017. I would now like to turn the call over to Jeanie Herbert, Senior Director of Investor Relations and Corporate Communications for Revance. Please go ahead.
Jeanie Herbert
Thank you, Victoria. Joining us on the call today from Revance is President and Chief Executive Officer, Dan Browne; and Chief Financial Officer and Chief Business Officer, Lauren Silvernail. Earlier today, Revance released financial results for the quarter ended March 31, 2017. [Audio Gap] distribution list you can [Audio Gap] potential product candidates and benefits of our current and future product candidates and our technologies, regulatory risks and ability to obtain regulatory approval and uncertainties and future performance. These forward-looking statements are based on the Company's current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements, as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the Company describes in the section entitled, Risk Factors, in our annual report on Form 10-K for the year ended December 31, 2016, as filed with the SEC on February 28, 2017. Revance cautions you not to place any undue reliance on forward-looking statements and undertakes no duty [Audio Gap]…
Dan Browne
…neuromuscular disease. Revance's neuromodulator combines our patented peptide technology with a highly purified botulinum and toxin type A, which is free of animal derived components or human albumin. We currently have Phase 2 and Phase 3 active clinical trials underway in large and small muscles that are designed to demonstrate not only a strong safety profile but also demonstrate that this next generation neuromodulator delivers high response rates, long-duration of effect, and satisfaction. Our initial indications within the facial wrinkles, muscle movement, and musculoskeletal categories target a market of more than $2 billion in annual sales and could help to significantly grow the $3.7 billion neurotoxin global market. This is a value-enhancing year for Revance with a number of key catalysts in our clinical programs. We expect to report results from our SAKURA 1 & 2 Phase 3 pivotal trials in glabellar lines, the 24-week Phase 2 results for cervical dystonia, and topline Phase 2 results for our new indication, plantar fasciitis, all within the next seven months. We have been very active at medical conferences this year. Our top investigators presented BELMONT and/or cervical dystonia results at TOXINS 2017, the International Master Course on Aging Skin, the American Academy of Dermatology, the American Academy of Neurology, [Audio Gap]… ….and then I’ll open the call for your questions. In the fall of 2016, we completed enrollment in the Phase 2 trial of RT002 to treat cervical dystonia. We expect the 24-week Phase 2 results in the coming weeks. You’ll remember, in the cervical dystonia interim results, our first cohort achieved higher reduction of symptoms and significantly longer duration of effect than comparable studies completed with all other approved neurotoxins. In fact, the median duration of effect was at least 24 weeks. We aspire to duplicate the strong results from Cohort 1 and take the results to the U.S. international regulatory authorities to discuss next steps. In March, we announced the completion of enrollment in our Phase 3 pivotal trials of RT002 injectable for glabellar lines and remain on-track to report topline results in the fourth quarter of 2017. We fully expect to achieve statistically significant efficacy at four weeks on the primary endpoint, as have all other approved neurotoxins. We are also pursuing a collection of secondary endpoints to obtain a six-month duration claim. We plan to enter the $1 billion cosmetic neurotoxin market from a position of strength. We have been pursuing a global development strategy for glabellar lines, and we are planning to first file in the United States, followed by Canada, Europe, and Latin America. We plan to commercialize RT002 for glabellar lines ourselves in North America as a premium product [Audio Gap]… So we would have a first mover advantage. The market opportunity could be sizable, as the U.S. market for plantar fasciitis currently exceeds $250 million and could be much larger if patients were better served. All in all, our RT002 studies conducted to date show clinical results like no others in the neuromodulator space. We’ve been actively generating data and sharing results on daxi. Dermatologists and plastic surgeons understand the value of our long-acting and high response rate neuromodulator, enabling them to reach more patients and to enhance their own practice. Neurologists are extremely excited about our interim cervical dystonia results, which showed almost double the duration and efficacy in trials for the currently available neurotoxins. We look forward to delivering new [Audio Gap]… …first quarter financials and outlook for 2017. Lauren?
Lauren Silvernail
Thank you, Dan. The earnings release issued today details our financial results and reiterates our 2017 guidance, so I won’t go through all the details on this call. I will highlight that our cash and investments balance, at quarter-end was [Audio Gap]… …with this offering completed, our operations are fully funded through the end of 2018. As to our outlook, we continue to expect cash burn from operating activities for 2017 to be in the range of $102 to $112 million. I’ll turn the call back to Dan.
Dan Browne
Thank you, Lauren. During March and April, we traveled extensively to meet with both physicians and investors. There is great excitement surrounding our neuromodulator that has the potential [Audio Gap] commercial manufacturing capabilities to meet our anticipated demand. We are planning for partnerships to reach international markets. And, we are evaluating further indications to take into clinical programs that would give us additional first mover advantages with our differentiated neuromodulator. In terms of our travel schedule, in June we will be at the Jefferies Healthcare Conference in New York, followed by the William Blair Growth Conference in Chicago. We also are in the process of planning trips to Minneapolis, Denver, and Southern California in the coming months to meet with investors. Please let us know if you’d like to catch up when we’re in your city. With that, thank you all for joining us today. I will now open it up for questions. Operator?