Evofem signs exclusive SOLOSEC distribution deal for sub-Saharan Africa

Evofem Biosciences, Inc. signed an exclusive distribution agreement with Clovis Davis Pharmaceuticals, LLC to commercialize SOLOSEC in sub-Saharan Africa. The company announced the agreement in a press release dated April 27, 2026, which it furnished with a Form 8-K. SOLOSEC is the company's single-dose oral treatment for bacterial vaginosis and trichomoniasis.

The agreement

Clovis Davis will lead the distribution, promotion, marketing and sales of SOLOSEC within the territory. Local regulatory filings for approval of SOLOSEC will be based on Evofem's registration dossier, which was submitted to and approved by the U.S. Food and Drug Administration. The release does not state financial terms of the agreement: no upfront payment, no minimum orders and no royalty rate, so it is unclear what the deal is worth to Evofem.

Clovis Davis Chief Operating Officer Jeff Reichman said the company is developing women's health initiatives in Ethiopia and Uganda, beginning with the OSOM BVBlue test, an FDA-cleared, CLIA-waived point-of-care diagnostic for bacterial vaginosis. Clovis Davis describes itself as a distributor of pharmaceuticals, radioisotopes and diagnostic tests.

Saundra Pelletier, Chief Executive Officer of Evofem, said: "Women everywhere deserve access to effective drugs that treat common sexual health conditions with simple, patient-friendly dosing regimens."

The market

The release estimates that bacterial vaginosis affects 25% of women in sub-Saharan Africa. That estimate is attributed to a 2019 systematic review. In Ethiopia alone, of 43.8 million women aged 12 years and older, 10.9 million women may be eligible for treatment with SOLOSEC, according to the company.

The release also cites World Health Organization figures for trichomoniasis. The WHO estimated 156 million new cases among people aged 15 to 49 in 2020, and about one third of new infections in that age group occur in the WHO African Region. Trichomoniasis requires testing and a complete course of antibiotic treatment for all infected partners. The parasite that causes trichomoniasis is Trichomonas vaginalis.

The company and its products

Evofem describes itself in its annual report on Form 10-K, filed March 11, 2026, as a San Diego-based commercial-stage biopharmaceutical company. The company acquired global rights to SOLOSEC in July 2024 and relaunched the brand in November 2024. PHEXX, its other product, is the first and only hormone-free, on-demand prescription contraceptive vaginal gel.

SOLOSEC is FDA-approved for bacterial vaginosis in females 12 years of age and older and for trichomoniasis in people 12 years of age and older. The 10-K describes it as a complete course of therapy in one dose.

The 10-K cites National Center for Health Statistics data showing that approximately 15.9 million women in the U.S. do not want to get pregnant and will not use a hormonal contraceptive.

Financial position

Financial data tagged in the company's SEC filings show net income of $391,000 for the fiscal year ended December 31, 2025, compared with a net loss of $8.9 million for 2024. Cash from operations was negative $2.0 million for 2025 and negative $3.9 million for 2024. Year-end cash and cash equivalents were $578,000 at the end of 2025, against $741,000 at the end of 2024.

What comes next

The release says the anticipated reception of SOLOSEC in the territory and the outcome of regulatory reviews of SOLOSEC marketing applications, once filed, are uncertain. Local approvals are still to be filed, so sales are some way off, and the market figures in the release are estimates, not orders. Year-end 2025 cash of $578,000 was set against $2.0 million used in operations that year.

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