Revance Therapeutics (NASDAQ: RVNC) reported Q4 EPS of ($1.12), $0.18 worse than the analyst estimate of ($0.94). Revenue for the quarter came in at $487 thousand versus the consensus estimate of $1.3 million.

• DAXI demonstrated unprecedented efficacy and duration in alleviating moderate-to-severe glabellar (frown) lines in the SAKURA 3 Phase 3 open-label, long-term safety study. DAXI consistently produced long duration and high response rates and was well tolerated in over 3,800 treatments.
• Completed a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) in December of 2018, and is on-track to submit a Biologics Licensing Application (BLA) in the first half of 2019 for DAXI for the treatment of glabellar (frown) lines.
• Initiated two separate Phase 2 trials of DAXI for the management of plantar fasciitis, and for the treatment of adult upper limb spasticity. Expects to complete enrollment for both Phase 2 trials and its Phase 3 trial for cervical dystonia during the second half of 2019.
• Announced license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. to commercialize DAXI in mainland China, Hong Kong and Macau. Received upfront payment of $30 million, and is eligible to receive additional development and sales milestone payments, as well as tiered double-digit royalty payments on future net sales.
• Revance and Mylan recently had a Biosimilar Initial Advisory Meeting with the FDA on a proposed biosimilar to BOTOX®. In this meeting, the FDA provided guidance on their expectations for a development program to establish biosimilarity to BOTOX®. Based on the agency’s feedback, the companies believe that a 351(k) pathway for the development of a biosimilar to onabotulinumtoxinA is viable and provides the opportunity to develop and commercialize a biosimilar product for all 11 currently approved indications of BOTOX® and BOTOX® Cosmetic.

“The unprecedented results from our SAKURA Phase 3 trials for DAXI supplied us a with comprehensive data package for our BLA submission and provides a powerful springboard for our anticipated product launch to treat frown lines in 2020. Based on our unique peptide technology, only Revance is able to deliver the first true innovation in a neuromodulator by addressing the number one unmet need desired by physicians and patients alike -- longer duration,” said Dan Browne, president and chief executive officer at Revance. “We are taking steps to address the largest segments of the estimated $4.5 billion global neuromodulator opportunity and believe we can expand this fast-growing market by attracting new users and generating new approved uses. In facial aesthetics, we are commencing additional studies in the upper face, adding to our robust clinical data set. In therapeutics, we are advancing a sizable neuroscience pipeline. The combination of our DAXI long-acting and the biosimilar short-acting formulations uniquely position Revance to significantly expand the use of neuromodulators.”

For earnings history and earnings-related data on Revance Therapeutics (RVNC) click here.