Evofem Biosciences, Inc. (NASDAQ:EVFM) Q3 2019 Earnings Conference Call - Final Transcript
Nov 07, 2019 • 11:00 am ET
Good morning, and thank you for joining the Evofem Q3 Financial Results Call. I'll now turn the call over to Amy Raskopf.
Thank you, Crystal. This is Amy Raskopf, Evofem Biosciences' Head of Investor Relations. Thank you for participating in today's call. If you haven't done so already, I encourage you to access the Q3 2019 presentation and the press release we issued aftermarket yesterday, both of which are at evofem.com under the investors tab. During this call, management will make forward-looking statements regarding the company's future expectations, plans and prospects that constitute forward-looking statements for the purposes of the Safe Harbor Provision under the Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those expressed in or implied by these forward-looking statements as a result of various important factors including those noted on slide 2 and described in the company's SEC filings which are available at sec.gov and in the Investors section of evofem.com.
The forward-looking statements made during this call should be considered accurate only as of today, November 7, 2019. Although the company may elect to update forward-looking statements from time-to-time in the future, we specifically disclaim any duty or obligation to do so even as new information becomes available or other events occur in the future.
With that, I'll turn the call over to Saundra Pelletier, Evofem's CEO.
Thank you so much, Amy. And Hello, everyone, and thank you for joining us. The indisputable truth is that in the United States today, millions of sexually active women are no longer using hormonal contraception. They are beyond hormones, because their journeys have been emotional and they've been frustrating. They're dissatisfied with the options that are available to them, and they're eagerly awaiting a new alternative. So today we're excited to share some compelling new consumer research later in the call that will further define who we view as the Amphora women.
But first I'm thrilled to provide you with an update on our progress this quarter as we prepare for our evolution from a clinical stage company to a commercial organization. In the coming weeks, we will deliver on three significant milestones that have the potential to transform the Evofem story. Number one, the resubmission of the Amphora NDA for the prevention of pregnancy to the FDA. Number two, reporting of top line AMPREVENCE results. And number three, acceleration of our pre-commercial activities and launch preparation. Amphora is our lead Multipurpose Vaginal pH regulator or MVP-R candidate. This innovative hormone-free, surfactant-free, vaginal gel regulates vaginal pH in the normal 3.5 to 4.5 range. This maintains an acidic vaginal environment which is inhospitable to sperm and also to various bacterial pathogens. Our NDA includes data from the Phase 3 AMPOWER study which were presented last month at two significant medical society conferences. The American Society for Reproductive Medicine and the Nurse Practitioners in Women's Health. In this important study, the primary endpoint was met, demonstrating efficacy of Amphora for the prevention of pregnancy.