Evofem (OTC: EVFM) grants Clovis Davis 5-year exclusive SOLOSEC rights in Africa
Rhea-AI Filing Summary
Evofem Biosciences has signed a five-year exclusive distributorship agreement with Clovis Davis Pharmaceuticals to commercialize SOLOSEC (secnidazole) 2 g oral granules in sub-Saharan Africa. Clovis Davis will handle distribution, promotion, marketing, and sales across the Territory.
Local regulatory filings will rely on Evofem’s existing U.S. FDA registration dossier for SOLOSEC, an approved single-dose oral antibiotic for bacterial vaginosis and trichomoniasis. The company highlights significant unmet need, noting that bacterial vaginosis is estimated to affect 25% of women in sub-Saharan Africa, and that in Ethiopia an estimated 10.9 million women may be eligible for SOLOSEC treatment.
Positive
- None.
Negative
- None.
8-K Event Classification
Key Figures
Key Terms
exclusive distributorship agreement financial
bacterial vaginosis medical
Trichomoniasis medical
point-of-care diagnostic test medical
forward-looking statements regulatory
Emerging Growth Company regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What agreement did Evofem Biosciences (EVFM) announce with Clovis Davis?
Which product is covered by Evofem Biosciences’ (EVFM) new distributorship deal?
How will SOLOSEC be approved for use in sub-Saharan Africa under Evofem’s (EVFM) deal?
What market opportunity does Evofem (EVFM) cite for SOLOSEC in Ethiopia?
What disease burden figures support Evofem’s (EVFM) SOLOSEC expansion?
What other women’s health initiatives will Clovis Davis pursue alongside SOLOSEC?
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction | (Commission | (I.R.S. Employer | ||
| of incorporation) | File Number) | Identification No.) |
(Address of principal executive offices)
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of exchange on which registered | ||
| None |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging Growth Company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01 Entry into a Material Definitive Agreement
Distributorship Agreement in Sub-Saharan Africa
On April 24, 2026 (the “Effective Date”), Evofem Biosciences, Inc. (the “Company”), entered into an exclusive distributorship agreement with Clovis Davis Pharmaceuticals, LLC., a Delaware Limited Liability Company (“Clovis Davis”) to commercialize SOLOSEC® (secnidazole) 2 g oral granules product in Sub-Saharan Africa (the “Territory”) for a period of five years commencing on April 24, 2026.
Under the distributorship 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 submitted and approved by the U.S. FDA.
Item 7.01 Regulation FD Disclosure
On April 27, 2026, the Company issued a press release announcing the exclusive distributorship agreement with Clovis Davis. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
The press release incorporated into this Current Report on Form 8-K includes “forward-looking statements,” within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “suggest,” “strategy,” “target,” “will,” “would,” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to those regarding the anticipated reception of SOLOSEC in the Territory by healthcare providers and patients; the timing and anticipated outcomes of the reviews of the SOLOSEC MA submissions, once filed, by regulatory authorities in the Territory; and the estimated prevalence of BV and Trich and estimated addressable patient population in the Territory. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 11, 2026 and any subsequent Form 10-Q filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 10.1+ | Exclusive Distributorship Agreement dated as of April 24, 2026 | |
| 99.1 | Press release dated April 27, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
+ Certain schedules, exhibits, annexes and similar attachments have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. A copy of any omitted schedule or exhibit will be furnished supplementally to the Securities and Exchange Commission upon request; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, for any schedule or exhibit so furnished.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EVOFEM BIOSCIENCES, INC. | ||
| Dated: April 30, 2026 | By: | /s/ Saundra Pelletier |
| Saundra Pelletier | ||
| Chief Executive Officer | ||
Exhibit 99.1
Evofem Announces Exclusive Agreement for the Distribution and Commercialization of SOLOSEC in Sub-Saharan Africa
— SOLOSEC® (secnidazole) 2g Oral Granules is an FDA-Approved Single-Dose Oral Treatment for Bacterial Vaginosis and Trichomoniasis —
SAN DIEGO, CA, April 27, 2026 — Women’s health innovator Evofem Biosciences, Inc. (OTCID: EVFM) (Evofem or the Company) today announced that it has entered into an exclusive Distribution Agreement with Clovis Davis Pharmaceuticals, LLC, a distributor of pharmaceutical and related products (Clovis Davis), to commercialize SOLOSEC® (secnidazole) 2g oral granules in sub-Saharan Africa (the Territory).
SOLOSEC is approved by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial vaginosis (BV) in females 12 years of age and older and to treat Trichomoniasis (Trich), a common sexually transmitted infection (STI), in people 12 years of age and older.
“Women everywhere deserve access to effective drugs that treat common sexual health conditions with simple, patient-friendly dosing regimens. We are delighted that Clovis Davis will distribute SOLOSEC—Evofem’s single-dose oral treatment for BV and Trich—in Africa, greatly increasing its global reach,” said Saundra Pelletier, Chief Executive Officer of Evofem.
“We believe SOLOSEC will be well received among healthcare providers and patients in our target markets because it delivers a complete treatment for BV and Trich with just one oral dose, enabling patients to quickly resume their normal, daily lives,” said Jeff Reichman, Chief Operating Officer of Clovis Davis. “In parallel with SOLOSEC distribution, Clovis Davis is developing comprehensive women’s health initiatives in Ethiopia and Uganda beginning with the OSOM® BVBlue® test, an FDA-cleared and CLIA-waived innovative point-of-care diagnostic test that enables rapid, accurate detection of bacterial vaginosis in clinical settings. This aligns with our commitment to not only treat, but also to improve early detection and diagnosis of BV in underserved markets where access to laboratory infrastructure may be limited.”
BV is estimated to affect 25% of women in sub-Saharan Africa1. In Ethiopia alone, of the 43.8 million women aged 12 years and older2, 10.9 million women may be eligible for treatment with SOLOSEC.
Trichomoniasis is caused by the parasite Trichomonas vaginalis; successful resolution of this common STI requires testing and a complete course of antibiotic treatment of all infected partners. Per the World Health Organization (WHO), there were an estimated 156 million new cases of Trichomoniasis among people aged 15–49 years old in 2020 (73.7 million in females and 82.6 million in males). Approximately one third of new infections in this age group occur in the WHO African Region.3
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 submitted and approved by the U.S. FDA.
About Evofem Biosciences
Evofem Biosciences, Inc. is commercializing two FDA-approved sexual and reproductive health products:
| ● | PHEXX® (lactic acid, citric acid, and potassium bitartrate)– the first and only hormone-free, on-demand prescription contraceptive vaginal gel. Visit phexx.com to learn more and for important safety information. |
| ● | SOLOSEC® (secnidazole) 2 g oral granules– an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. Visit solosec.com to learn more and for important safety information. |
PHEXX® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc.
About Clovis Davis Pharmaceuticals
Clovis Davis Pharmaceuticals, LLC, is dedicated to delivering sustainable global solutions in the production and distribution of pharmaceuticals, radioisotopes, and diagnostic tests, addressing the dynamic challenges of today’s healthcare landscape. Its services are at the forefront of innovation in human and veterinary medicine, offering high-quality, cost-effective, and pioneering tests, treatments, and therapies to meet the diverse needs of healthcare providers and their patients worldwide.
Sources
| 1. | Peebles K, Velloza J, Balkus JE, McClelland RS, Barnabas RV. High Global Burden and Costs of Bacterial Vaginosis: A Systematic Review and Meta-Analysis. Sex Transm Dis. 2019 May;46(5):304-311. doi: 10.1097/OLQ.0000000000000972. PMID: 30624309. |
| 2. | United Nations Department of Economic and Social Affairs: Population Division. World Population Prospects 2024. File POP/01-3: Female population by single age, region, subregion and country, annually for 1950-2100 (thousands): Estimates, 1950 – 2023. Accessed 09 April 2026 via https://population.un.org/wpp/downloads?folder=Standard%20Projections&group=Po pulation. |
| 3. | World Health Organization. Trichomoniasis Fact Sheet. 2025 November 21. Accessed 09 April 2026 via https://www.who.int/news-room/fact-sheets/detail/trichomoniasis. |
Forward-Looking Statements
This press release includes “forward-looking statements,” within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “suggest,” “strategy,” “target,” “will,” “would,” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to those regarding the anticipated reception of SOLOSEC in the Territory by healthcare providers and patients; the timing and anticipated outcomes of the reviews of the SOLOSEC MA submissions, once filed, by regulatory authorities in the Territory; and the estimated prevalence of BV and Trich and estimated addressable patient population in the Territory. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 11, 2026 and any subsequent Form 10-Q filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.
Contact
For Evofem Biosciences, Inc.
Amy Raskopf, Chief Business Development Officer
araskopf@evofem.com
(917) 673-5775
For Clovis Davis Pharmaceuticals, LLC.
Jeff Reichman, Chief Operating Officer
jreichman@KKMHealthcare.com
(513) 697-8557