Evofem Biosciences, Inc. announced that its hormone-free contraceptive vaginal gel has been approved by the Nigerian Regulatory Agency NAFDAC (National Agency for Food and Drug Administration and Control). This marks the Company's first approval outside the United States. Regulatory dossiers have also been submitted in Ghana, Ethiopia and Mexico.

The product will be potentially marketed under the brand name Femidence(TM).Nigeria is the most populous country in Africa and the seventh largest country in the world, with 45 million women of reproductive age. With nearly half of the population under the age of 18 years, a record number of young people will enter reproductive age in the next decade. In October 2020, Adjuvant Capital made a $25 million strategic investment to expand global market access for Phexxi(R) (lactic acid, citric acid, potassium bitartrate) vaginal contraceptive gel and to support EVOGUARD, Evofem's registration Phase 3 clinical trial evaluating Phexxi for the prevention of chlamydia and gonorrhea in women.

Evofem is on track to report top-line data from this landmark trial in mid-October 2022. Positive study outcomes would enable regulatory submissions and potential U.S. approval for prevention of these sexually transmitted infections in 2023. Evofem is grateful to DKT Nigeria, its distribution partner in Nigeria, for their support of this registration.