Revance Releases Fourth Quarter and Full Year 2017 Results
Recent Company Highlights and Upcoming Milestones for DaxibotulinumtoxinA for Injection (RT002)
- Today announced a collaboration and license agreement with Mylan N.V. on a biosimilar to BOTOX® that will provide an upfront payment of $25 million to Revance, with contingent payments upon achievement of additional clinical, regulatory and sales milestones, plus sales royalties worldwide (except Japan).
- Reported positive Phase 3 results from SAKURA 1 and SAKURA 2 pivotal trials of RT002 for the treatment of glabellar (frown) lines, which met all primary and secondary endpoints, and achieved 6-month duration in multiple secondary measurements. Revance expects to complete the SAKURA 3 open-label safety study in the second half of 2018.
- Received Orphan Drug Designation for RT002 from the FDA for the treatment of cervical dystonia.
- Completed an End-of-Phase 2 meeting with the FDA and received Scientific Advice from the Europe Medicines Agency (EMA) on its clinical program for RT002 in the treatment of moderate to severe isolated cervical dystonia. Revance plans to commence a Phase 3 program for the U.S. in the second quarter of 2018.
- Reported interim Phase 2a results for RT002 in treating plantar fasciitis. Revance plans to initiate a second Phase 2 trial in plantar fasciitis with a modified design in the second half of 2018.
"As a company, our goal is to be innovative pioneers in neuromodulators. In 2017, our clinical trials demonstrated RT002’s ability to provide patients long-acting performance and duration of effect, with potentially just two treatments a year in both glabellar lines and cervical dystonia. We believe that RT002 has the potential to meaningfully enhance the quality of life for patients suffering from a wide array of diseases," said Dan Browne, President and Chief Executive Officer at Revance. "As we announced today, we are not only pursuing development and commercialization of our premium, long-acting RT002 neuromodulator, we are also leveraging our capabilities to produce a biosimilar to BOTOX in collaboration with Mylan.
"Looking ahead, we are preparing for a 2019 Biologics Licensing Application (BLA) filing for RT002 to treat glabellar lines, while increasing our pre-commercial initiatives as part of the Revance Product Launch Velocity Plan in facial aesthetics. In the clinic, we plan to focus on accelerating development efforts of RT002 for therapeutic indications. Down the road, we expect RT002 to drive meaningful growth in the approximately $4 billion global neuromodulator market."
Summary Financial Results
Cash and investments as of December 31, 2017 were $282.9 million.
Research and development expenses for the fourth quarter and full year ended December 31, 2017 were $21.0 million and $80.4 million, respectively, compared to $12.5 million and $50.4 million for the same periods in 2016, respectively. The change in research and development expenses is primarily due to the ongoing clinical trials for RT002 for the treatment of glabellar lines, cervical dystonia, and plantar fasciitis and increased costs to support manufacturing, quality efforts and research.
General and administrative expenses for the fourth quarter and full year ended December 31, 2017 were $11.9 million and $37.4 million, respectively, compared to $7.1 million and $29.1 million for the same periods in 2016, respectively. The increase in general and administrative expenses is primarily due to increased costs related to personnel and consulting costs and pre-commercial activities to support future product launches.
Total operating expenses for the fourth quarter and full year ended December 31, 2017 were $35.8 million and $120.7 million, respectively, compared to $26.7 million and $88.5 million for the same periods in 2016, respectively. Stock-based compensation for the fourth quarter and full year ended December 31, 2017 was $3.4 million and $13.2 million, respectively. When excluding depreciation and stock-based compensation, total operating expenses for the fourth quarter and year ended December 31, 2017 were $32.0 million and $106.0 million, respectively.
Net loss for the fourth quarter and full year ended December 31, 2017 was $35.9 million and $120.6 million, respectively, compared to $26.8 million and $89.3 million for the same periods in 2016, respectively.
2018 Financial Outlook
Revance reiterates its financial guidance provided in January 2018. Revance expects cash burn for 2018 to be in the range of $117 to $137 million. Revance expects 2018 GAAP operating expense to be in the range of $128 to $154 million, which when excluding depreciation of $1 to $3 million and estimated stock-based compensation of $17 to $21 million, results in projected 2018 non-GAAP operating expense of $110 to $130 million, driven by increased research and development expenditure and launch preparation activities. With three clinical programs and preparations to file the BLA all underway, Revance anticipates 2018 GAAP research and development expense to be in the range of $84 to $101 million, which when excluding depreciation of $1 to $2 million and estimated stock-based compensation of $7 to $9 million, results in projected 2018 non-GAAP research and development expense of $76 to $90 million.
Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 5054928; or from the webcast link in the investor relations section of the company's website at: www.revance.com.
A replay of the call will be available beginning February 28, 2018 at 4:30pm PT/7:30pm ET to March 1, 2018 at 4:30pm PT/7:30pm ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 5054928. The webcast will be available in the investor relations section on the company's website for 30 days following the completion of the call.