Revance Therapeutics (RVNC) Announces Projected 2018 Clinical Milestones and Financial Outlook

Revance Therapeutics, Inc. (NASDAQ: RVNC) today announced key 2018 clinical milestones for DaxibotulinumtoxinA for Injection (RT002) and provided its financial outlook for 2018. The company also announced its unaudited December 31, 2017 cash and investments balance exceeded $280 million and now expects its cash and investments to fund the company through 2019.

“We’re making rapid progress towards bringing a platform of innovative treatments to patients who have conditions that lack sustained treatment effect with current neuromodulators, as well as treatments for new indications not approved by the FDA today,” said Dan Browne, President and Chief Executive Officer of Revance. “In 2017, we announced positive clinical results for our clinical programs for RT002 in treating glabellar lines and cervical dystonia. These trials demonstrated that RT002 has unique characteristics, delivering high patient response rates and long-acting 6-month performance.”

Mr. Browne continued, “As we enter 2018, we are preparing for a 2019 BLA filing for RT002 to treat glabellar lines, while also expanding our sales and marketing initiatives to execute our Revance Product Launch Velocity Plan in facial aesthetics. From a clinical development perspective, we will pivot to focus on accelerating therapeutic uses for RT002, with plans to expand the overall sales of neuromodulators with our uniquely differentiated neuromodulator.”

RT002 INJECTABLE 2017 CLINICAL MILESTONES

SAKURA Phase 3 Program for Treatment of Glabellar (Frown) Lines – Expects to Complete Open-Label, Long-Term Safety Study in Second Half of 2018

In December 2017, Revance announced highly statistically significant results for both the primary and secondary endpoints for its two SAKURA Phase 3 pivotal trials of RT002 injectable for the treatment of glabellar lines. Glabellar lines are the vertical lines that develop between the eyebrows because of repeated frowning, scowling, or merely focusing while listening or reading. As a person ages, the skin becomes less elastic and glabellar lines typically become more pronounced.

With the SAKURA 3 open-label, long-term safety study fully enrolled, the company plans to complete the safety study in the second half of 2018, and assuming successful completion of SAKURA 3, to file its biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in the first half of 2019.

Phase 3 Trial for Treatment of Cervical Dystonia – Expects to Initiate Trial in Second Quarter of 2018

In May of 2017, Revance reported positive results from its Phase 2 dose-escalating clinical trial of RT002 injectable for the treatment of cervical dystonia. In November, Revance announced the completion of its End-of-Phase 2 meeting with the FDA and receipt of Scientific Advice from the Europe Medicines Agency (EMA). Also in November, the FDA granted RT002 orphan drug designation for this indication. Patients with cervical dystonia suffer from painful, embarrassing twisting movements of the neck, often impairing their ability to work, drive and perform activities of daily living. The company expects to initiate a Phase 3 trial in patients with cervical dystonia in the second quarter of 2018 and anticipates the need for only one pivotal along with a safety trial before seeking FDA approval.

Phase 2a Proof of Concept Trial for Treatment of Plantar Fasciitis – Expects to Report Interim Results by Mid-January 2018

In mid-January of 2018, the company expects to report interim 8-week results from its Phase 2a clinical trial of RT002 injectable for the management of plantar fasciitis. The plantar fascia is the foot’s shock absorber. Repeated pressure on this tissue, whether from sport activities, aging, or obesity, can result in plantar fasciitis, characterized by inflammation accompanied by sharp, constant pain in the heel that can become highly debilitating. Several publications have reported neuromodulators may reduce the pain for patients suffering from a range of acute and chronic plantar fasciitis conditions. The company plans to complete the 16-week trial and then expects to initiate a Phase 2b trial for plantar fasciitis in the second half of 2018.

FINANCIAL OUTLOOK FOR 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 Biologics License Application (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. Revance’s unaudited shares outstanding as of December 31, 2017 were approximately 36.5 million.

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