Secnidazole

SAN DIEGO--(BUSINESS WIRE)--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). Under the newly-inked agreement, Clovis Davis will distribute SOLOSEC—Evofem’s single-dose oral treatment for BV and Trich—in Africa, greatly increasing the product’s global reach. 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 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. 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=Population . 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.

— Net sales surpassed $20 million mark in FY 2025 — — Income from operations increased to $3.4 million in FY 2025 — SAN DIEGO--(BUSINESS WIRE)-- $EVFM #BV --Women’s health innovator Evofem Biosciences, Inc. (Evofem or the Company) (OTCID: EVFM), today announced financial results for the fourth quarter and year ended December 31, 2025. Highlights include: Achieved record net sales of $20.2 million in 2025—Evofem’s fifth consecutive year of net sales growth—mainly driven by sales of PHEXX® (lactic acid, citric acid, and potassium bitartrate) , our hormone-free, on demand contraceptive vaginal gel. Reduced total operating expenses by 38% to $16.8 million in 2025 versus $27.0 million in 2024. The $10.2 million reduction included a $ 5.6 million gain from the settlement of a portion of the Company’s trade payables with vendors, and a $1.9 million non-cash gain on the change in accounting estimates on a contingent royalty liability. Income from operations increased to $3.4 million in 2025, versus a loss from operations of $7.7 million in 2024. Net income attributable to common stockholders increased to $0.3 million, or $0.00 per basic and diluted share, in 2025, versus a net loss of $9.0 million, or ($0.11) per basic and diluted share, in 2024. “In 2025 we delivered our fifth consecutive year of net sales growth, and posted record net sales of more than $20 million, despite ongoing capital constraints. This achievement is a testament to the quality of our products, PHEXX and SOLOSEC, which offer women innovation to address their unmet sexual health needs, and the grit and resilience of our team,” said Saundra Pelletier, CEO of Evofem Biosciences. Additionally, since October 1, 2025: Evofem advanced initiatives to lower manufacturing costs for both products, targeting estimated reductions of 55-60% for PHEXX and SOLOSEC® (secnidazole) 2g oral granules . The Emirates Drug Establishment (EDE) issued favorable pricing certificates for PHEXX, a preliminary administrative step toward anticipated regulatory approval in the United Arab Emirates (UAE). The EDE review of the SOLOSEC application in the UAE is underway. Patient recruitment is ongoing in an investigator-led, NIH-funded Phase 4 clinical trial evaluating the effectiveness and cost-effectiveness of SOLOSEC (single-dose, one time) versus metronidazole (twice daily for seven days) for the treatment of Trichomonas vaginalis in men and women. Study investigators hypothesize that the rate of repeat infections with T. vaginalis will be 1.75 lower in the SOLOSEC group versus the multi-dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. 1 Full Year Financial Results For the year ended December 31, 2025, net sales were $20.2 million compared to $19.4 million in the prior year. The 4% increase reflects the higher PHEXX wholesale average cost (WAC) and slight improvement in gross-to-net ratio. SOLOSEC net sales also contributed to the increase, with a full year of sales in 2025 vs. 5.5 months in the prior year; Evofem acquired the single-dose oral STI treatment in July 2024 and relaunched it in the U.S. in late 2024. Total operating expenses were $16.8 million, a $10.2 million reduction compared to the prior year which was driven by: A $5.3 million reduction in research and development expenses in 2025 due to the settlement of a portion of our trade payables and accrued liabilities, partially offset by an uptick in outside services costs; A $4.2 million reduction in general and administrative expenses in 2025 vs. 2024; and A one-time gain of $1.9 million in 2025 due to the expiration of the Rush patent and related royalty, which triggered a change in the accounting estimate for the contingent royalty liability. These aggregate savings were partially offset by a $0.5 million uptick in selling and marketing expenses in 2025 versus 2024. The increase reflects a full year of PDUFA fees, 3PL fees, and other commercial costs for SOLOSEC in 2025 vs. 5.5 months in 2024. As a result, Evofem reported $3.4 million of operating income in 2025, compared to a loss from operations of $7.7 million in the prior year. Net income attributable to common stockholders increased to $0.3 million, or $0.00 per basic and diluted share, in 2025, versus a net loss of $9.0 million, or ($0.11) per basic and diluted share, in 2024. Fourth Quarter Financial Results For the three months ended December 31, 2025, net sales were $9.6 million, versus $7.1 million in the prior year period. The 35% increase predominantly reflects the higher PHEXX WAC, more favorable gross-to-net ratio, and higher PHEXX ex-factory unit sales in the 2025 period. Total operating expenses decreased to $6.2 million in the fourth quarter of 2025 as compared to $8.1 million in the prior year period. Lower general and administrative and research and development expenses were offset in part by a $1.1 million increase in cost of goods sold (COGS), to a lesser extent, higher PHEXX sales in the 2025 period. As a result, Evofem reported $3.3 million of operating income for the fourth quarter of 2025, versus a loss from operations of $1.0 million in the prior year period. Net income was $2.8 million, or $0.02 per basic and $0.00 per diluted share, in the fourth quarter of 2025, versus a net loss of $3.0 million, or ($0.03) per basic and diluted share, for the fourth quarter of 2024. About Evofem Evofem Biosciences is a San Diego-based pharmaceutical company 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. 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, “anticipate,” “could,” “estimate,” “expect,” “target,” “hypothesize,” “intend,” “potential,” “strategy,” “will,” 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, Evofem’s expectations regarding the anticipated impact of COGS reduction initiatives, the timing and outcome of the EDE review of the submissions for PHEXX and SOLOSEC in the UAE, and the commercialization of PHEXX and SOLOSEC. Forward-looking statements are based on current assumptions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements include, but are not limited to, limited cash resources, the Company’s ability to continue as a going concern, dependence on new capital or business development transactions to fund operations, potential delays in regulatory approvals, changes in market demand, manufacturing and supply chain risks, and the nonrecurring nature of certain recent gains, together with those that 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 filings. All forward-looking statements are expressly qualified in their entirety by such factors. Evofem undertakes no obligation to update or revise any forward-looking statement except as required by law, and investors are cautioned not to place undue reliance on such statements given the Company’s current liquidity position and evolving business conditions. Sources National Institute of Allergy & Infectious Diseases (NIAID) of the National Institutes of Health. Award number R01AI183266 : Refining Trichomonas vaginalis treatment in women and men. Click here for financial tables Contacts Connect with Us ir@evofem.com media@evofem.com