Revance Releases Fourth Quarter and Full Year 2015 Results
http://investors.revance.com/releasedetail.cfm?ReleaseID=958517 (Revance Releases Fourth Quarter and Full Year 2015 Results (NASDAQ:RVNC))
NEWARK, Calif., March 02, 2016 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc.(NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, announced today results for the fourth quarter and full year ended December 31, 2015 and provided its 2016 financial outlook.
Recent Highlights and Upcoming Milestones
- Clinical Development - DaxibotulinumtoxinA Topical Gel (RT001)
- Continued active enrollment in REALISE 1, a Phase 3 trial for patients with moderate to severe lateral canthal lines (crow's feet). Revance plans to release 28-day top-line results from this Phase 3 trial by the end of the second quarter of 2016.
- Announced positive interim results from a Phase 2 trial for axillary hyperhidrosis inDecember 2015, showing measurable reduction in excessive underarm sweating following a single application at the time of treatment. Revance expects to initiate an additional, larger Phase 2 hyperhidrosis trial in the second half of 2016.
- Clinical Development - DaxibotulinumtoxinA for Injection (RT002)
- Reported positive top-line interim data from BELMONT Phase 2 Active Comparator Trial of RT002 injectable for the treatment of glabellar (frown) lines in October 2015 and have begun preparing for an End-of-Phase 2 meeting with the U.S. Food and Drug Administration planned for the first half of 2016. Revance expects to initiate a Phase 3 clinical program in the second half of 2016.
- Completed enrollment in first cohort of the Phase 2 dose-escalating clinical trial for the treatment of cervical dystonia. Revance expects to report interim results in the first half of 2016.
- Appointed Abhay Joshi, PhD, a seasoned executive with global experience in neurotoxins, biopharmaceuticals, and medical devices, as Chief Operating Officer.
"With positive clinical trial results reported for both RT001 topical and RT002 injectable in 2015, we were able to demonstrate the viability of our two neurotoxin drug candidates, while simultaneously establishing a foundation of financial and operational stability as we move closer to commercialization," said Dan Browne, President and Chief Executive Officer of Revance. "We currently have four active clinical development programs well underway, targeting both aesthetic and therapeutic indications, with many more opportunities on the horizon as we work to establish a powerful new botulinum toxin franchise. The $3 billion neurotoxin market continues to expand, with a growing number of physicians and patients looking forward to the first differentiated botulinum toxin to be introduced in nearly 30 years. Revance is building a reputation for advancing drug delivery by fueling innovations we believe can have a lasting impact on people's lives."
Summary Financial Results
Research and development expenses for the fourth quarter and full year ended December 31, 2015 were $15.0 million and $47.5 million, respectively, compared to $9.1 million and $33.4 million for the same periods in 2014, respectively. The increase in research and development expenses is primarily attributable to increased personnel costs and expenditures related to our ongoing clinical trials.
General and administrative expenses for the fourth quarter and full year ended December 31, 2015 were $6.9 million and $25.1 million, respectively, compared to $4.8 million and $19.0 millionfor the same periods in 2014, respectively. The increase in general and administrative expenses is primarily attributable to increased personnel costs, legal matters, and administrative activities.
Total operating expenses for the fourth quarter and full year ended December 31, 2015 were$21.9 million and $72.6 million, respectively, compared to $13.9 million and $52.4 million for the same periods in 2014, respectively. Stock-based compensation for the fourth quarter and full year ended December 31, 2015 was $5.1 million and $12.4 million, respectively. When excluding depreciation and stock-based compensation, total operating expenses for the fourth quarter and full year ended December 31, 2015 were $16.4 million and $58.2 million, respectively.
Net loss for the fourth quarter and full year ended December 31, 2015 was $22.1 million and$73.5 million, respectively, compared to $14.2 million and $62.9 million for the same periods in 2014, respectively. Upon completion of the IPO in February 2014, Revance recorded non-cash interest expense, including loss on extinguishment, of $9.6 million in connection with the settlement of previously outstanding convertible notes.
Cash and investments as of December 31, 2015 were $254.1 million.
2016 Financial Outlook
Revance expects its 2016 non-GAAP operating expense to be in the range of $95 to $105 million, excluding depreciation of $2 to $3 million and estimated stock-based compensation of $15 to $17 million. The company expects its cash burn for 2016 to be in the range of $105 to $115 million. Revance anticipates 2016 non-GAAP research and development expense to be in the range of $72to $78 million, excluding depreciation of $2 to $3 million and estimated stock-based compensation of $8 to $9 million.
For modeling purposes and assuming no material issuances of equity, we expect 2016 weighted average number of shares outstanding will be approximately 28 to 29 million.
