Evofem Biosciences (EVFM) Misses Q1 EPS by 26c
Get Alerts EVFM Hot Sheet
Join SI Premium – FREE
Evofem Biosciences (NASDAQ: EVFM) reported Q1 EPS of ($0.67), $0.26 worse than the analyst estimate of ($0.41).
- Entered into a securities purchase agreement pursuant to which Evofem may raise up to $80 million through a private placement of common stock from new and existing investors, including a strategic investment from PDL BioPharma (NASDAQ: PDLI), and closed $30 million in the first tranche;
- Held positive and constructive Type B meeting with the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Amphora®, the Company\'s lead Multipurpose Vaginal pH Regulator™ (MVP-R) candidate, for the prevention of pregnancy; and,
- Completed patient enrollment in AMPREVENCE, the Company's Phase 2b clinical trial evaluating the ability of Amphora to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women, from which top-line data are expected in fall 2019.
"I am very pleased with our continued execution on all fronts and especially our recently announced financing," said Saundra Pelletier, Chief Executive Officer of Evofem. "This quarter, our dynamic leadership team successfully navigated strategic investments, made significant progress toward the resubmission of the Amphora NDA for the prevention of pregnancy, and advanced a landmark clinical trial of Amphora for prevention of certain sexually transmitted diseases. This momentum will continue through 2019 as we prepare for the commercialization of the first hormone-free MVP-R birth control method in the U.S. in 2020, assuming FDA approval."
For earnings history and earnings-related data on Evofem Biosciences (EVFM) click here.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Equifax (EFX) shares tumble on weak Q1 revenue, guidance miss
- Alcoa (AA) Misses Q1 EPS by 19c
- Abbott Laboratories (ABT) narrows 2024 earnings guidance, shares slip
Create E-mail Alert Related Categories
Corporate News, Earnings, Management CommentsRelated Entities
Earnings, Definitive Agreement, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!