Evofem Biosciences, Inc., was founded in 2007 with the sole purpose of improving women’s lives by developing and commercializing innovative sexual and reproductive health products.
In 2020, following years of rigorous clinical development, we launched PHEXX® (lactic acid, citric acid and potassium bitartrate) – the first and only FDA-approved hormone-free contraceptive vaginal gel. Since then, we have consistently delivered year-over-year net sales growth for four consecutive years. We aim to continue and amplify this trend.
PHEXX appeals to women of all ages who want to prevent pregnancy and – whether by choice or by necessity – are beyond hormones. 23.3 million women in the U.S. fit this profile. Whether they survived or have high risk of developing hormone-sensitive cancer; tried a hormonal method but couldn’t stand the side effects; need a supplemental method while dose-escalating their GLP-1; or just don’t want exogenous chemicals circulating through their bodies, PHEXX offers women an FDA-approved, non-hormonal option. It is applied zero-to-sixty minutes before each act of intercourse using a convenient, discreet, pre-filled applicator. PHEXX, then sex.
In addition to organic growth in our core U.S. market, we are executing our strategy to diversify and expand our revenue stream with new products and from new markets around the world.
In July 2024, Evofem acquired global rights to a second FDA-approved sexual health product – SOLOSEC® (secnidazole) 2g oral granules – adding a valuable and synergistic sexual health asset to our commercial portfolio.
With just one dose, administered by mouth, SOLOSEC® provides a complete course of treatment for two sexual health conditions:
1) Bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older. BV is estimated to affects 29% of women in the United States – 48.9 million women based on 2020 U.S. Census data. Symptoms include vaginal odor and discharge, and BV is associated with an increased risk of acquisition of HIV and other STIs as well as pelvic inflammatory disease and adverse birth outcomes.
2) Trichomonas vaginalis, the parasite that causes the common sexually transmitted infection (STI) trichomoniasis, in people 12 years of age and older. Trichomoniasis is the most common non-viral STI in the world, affecting both men and women. The WHO estimates there are 156.3 million new cases worldwide each year.
Outside the U.S., our strategy is to forge strategic alliances that will bring PHEXX® and SOLOSEC® to people in new parts of the world while diversifying and expanding our revenue. We licensed commercial rights to both products to Pharma 1— initially for the United Arab Emirates (UAE), Kuwait, Saudi Arabia, Qatar, Oman, and Jordan with potential expansion into 15 other countries in the Middle East and North Africa (MENA). Both products are filed with and under review by the UAE Emirates Drug Establishment, and we look forward to product launches once approved followed by subsequent filings in the licensed territory. Meanwhile, we are working with our distributor Clovis Davis to advance regulatory submissions for SOLOSEC® in sub-Saharan Africa.
We intend to continue exploring additional partnership, license, and distribution opportunities to further expand the reach of our products and maximize their global potential.
Meanwhile, we are carrying out cost-reduction initiatives for both PHEXX® and SOLOSEC® which, once fully implemented, are expected to significantly improve our operating margins. This in turn should enable us to better navigate U.S. drug pricing policy shifts, facilitate entry into price sensitive global markets, and expedite our path to profitability.