NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in treating aesthetic and therapeutic conditions, today announced results for the second quarter ended June 30, 2017.
Recent Highlights and Upcoming Milestones for DaxibotulinumtoxinA for Injection (RT002)
- Reported positive topline 24-week duration of effect results in all three cohorts of RT002 injectable for the treatment of moderate to severe isolated cervical dystonia. Study investigators presented two posters highlighting this and additional data at the 21st International Congress of Parkinson’s Disease and Movement Disorders in June.
- Published results from its successfully completed BELMONT Phase 2 trial in glabellar (frown) lines in the peer-reviewed journal, Dermatologic Surgery.
- Announced expansion of its leadership team with the addition of industry veteran Todd Zavodnick, who will join Revance in September as its Chief Commercial Officer and President, Aesthetics & Therapeutics to lead the company’s commercial operations along with the launch of RT002 injectable.
- SAKURA 1 & 2 Phase 3 pivotal trials of RT002 injectable for the treatment of glabellar (frown) lines remain on track to report topline results in the fourth quarter of 2017.
- Phase 2 trial of RT002 injectable in the management of plantar fasciitis continues to enroll subjects, and Revance plans to report topline results in the fourth quarter of 2017.
“The recent clinical results from our Phase 2 cervical dystonia program, along with the peer-reviewed publication of results from the BELMONT Phase 2 clinical trial for glabellar lines, reinforce the potential advantages we believe RT002 injectable has over commercially available toxins in terms of safety, response rates and duration of effect,” said Dan Browne, President and Chief Executive Office at Revance. “The totality of the evidence is building and we look forward to reporting topline results for our SAKURA Phase 3 pivotal trials for glabellar lines and Phase 2 trial for plantar fasciitis in the fourth quarter of this year. We believe these trial results will validate our differentiation and put us on track to file for our first regulatory approval. Long term, we believe we can build a meaningful aesthetics business around RT002 that will allow us to fund and support a fast-growing therapeutics portfolio.”
Summary Financial Results
Cash and investments as of June 30, 2017 were $165.5 million.
Research and development expenses for the three and six months ended June 30, 2017 were $18.3 million and $37.7 million compared to $15.2 million and $27.6 million for the same periods in 2016, respectively. The change in research and development expenses is primarily due to increased clinical trial activity for RT002 injectable, including the SAKURA Phase 3 program, the plantar fasciitis Phase 2 trial, the Phase 2 cervical dystonia trial, along with increased pre-commercial manufacturing activities.
General and administrative expenses for the three and six months ended June 30, 2017 were $8.6 million and $16.4 million compared to $7.0 million and $14.5 million for the same periods in 2016, respectively. The increase in general and administrative expenses is primarily due to increased personnel, pre-commercial, and information technology expenses.
Total operating expenses for the three and six months ended June 30, 2017 were $26.9 million and $54.1 million compared to $24.2 million and $44.0 million for the same periods in 2016, respectively. Stock-based compensation for the three and six months ended June 30, 2017 was $3.5 million and $6.7 million, respectively. When excluding depreciation and stock-based compensation, total operating expenses for the three and six months ended June 30, 2017 were $23.0 million and $46.7 million, respectively.
Net loss for the three and six months ended June 30, 2017 was $26.9 million and $54.0 million compared to $24.6 million and $44.5 million for the same periods in 2016, respectively.
2017 Financial Outlook
Revance reaffirmed its financial guidance provided in January 2017. Revance expects cash burn for 2017 to be in the range of $102 to $112 million. Revance expects 2017 GAAP operating expense to be in the range of $108 to $119 million, which when excluding depreciation of $1 to $2 million and estimated stock-based compensation of $13 to $15 million, results in projected 2017 non-GAAP operating expense of $94 to $102 million. With three clinical programs underway, Revance anticipates 2017 GAAP research and development expense to be in the range of $75 to $83 million, which when excluding depreciation of $1 to $2 million and estimated stock-based compensation of $5 to $6 million, results in projected 2017 non-GAAP research and development expense of $69 to $75 million.
Conference Call
Individuals interested in listening to the conference call today, August 3, at 1:30pm PT/4:30pm ET, may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 51659239; or from the webcast link in the investor relations section of the Company’s website at: http://investors.revance.com/index.cfm.
A replay of the call will be available beginning today at 4:30pm PT/7:30pm ET through 4:30pm PT/7:30pm ET on August 4, 2017. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 51659239. The webcast will be available in the investor relations section on the Company’s website for 30 days following the completion of the call.
