Roth Capital Partners initiated coverage of Evofem Biosciences (NASDAQ:EVFM) with a “buy” rating and $15 price target. The stock closed at $3.30 on June 19.
Analyst Yasmeen Rahimi writes that the time is ripe for innovation in women’s contraception. “We believe Evofem’s lead asset, Amphora, fits into this opportune window for innovation as a non-hormonal, woman-controlled, on-demand contraceptive gel,” she added.
The company’s Phase 3 AMP-001 trial in 3,389 total women met its pre-specified non-inferiority primary endpoint, with Amphora’s 95.9% perfect and 89.5% typical use efficacies.
“We believe the confirmatory AMP-002 trial (enrollment complete in Feb. 2018), investigating six-month cumulative pregnancy rate in 1,400 women sufficiently addresses the complete response letter (Russian subjects, certain cycles excluded), with ample consideration in trial design to minimize risk, which include 112 U.S. sites only and use of electronic diaries to closely monitor subjects’ product use and compliance,” Ms. Rahimi said.
She said a second major differentiator for Amphora is sexually transmitted infection prevention, with bacterial vaginosis prevention as an upside.
