Evofem Biosciences, Inc. (NASDAQ: EVFM) is a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health.
The Company‘s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com.
The Company is evaluating Phexxi for two potential new indications: the prevention of urogenital chlamydia and gonorrhea in women. Top-line results are expected from its confirmatory Phase 3 clinical trial, EVOGUARD, in the second half of 2022. Positive outcomes could support submission to the FDA for these potential new indications in the first quarter of 2023, with an anticipated PDUFA date in the second half of 2023 due to the expedited review afforded by the Fast Track designations granted for these indications.
The addressable U.S. market opportunity for these current and investigational indications is estimated at $3.6 - $4.5 billion in aggregate.
Evofem intends to expand Phexxi’s global reach and further increase its commercial potential through ex-U.S. licenses. Discussions are underway with potential licensees for commercialization of Phexxi in multiple international markets.