Evofem Biosciences filings document the regulatory record for a women’s health pharmaceutical company commercializing PHEXX® and SOLOSEC®. Current reports on Form 8-K cover financial results, Regulation FD presentations, distribution agreements for SOLOSEC, amendments to convertible note purchase arrangements, and product supply or manufacturing agreements for PHEXX.
Proxy materials and stockholder-vote disclosures describe annual-meeting proposals, governance matters, amendments to the certificate of incorporation, reverse stock split authority, and voting mechanics for common and preferred stock. The filing record also reflects capital-structure actions, material agreements and exhibit filings connected to the company’s sexual and reproductive health product portfolio.
Evofem Biosciences reports first-quarter 2026 results showing a small commercial base and significant financial strain. Product sales, net, were $0.9 million, up slightly from $0.8 million a year earlier, while total operating expenses were $5.5 million, leading to an operating loss of $4.6 million and a net loss of $5.5 million attributable to common stockholders, or $(0.04) per share.
Cash, cash equivalents and restricted cash totaled $2.4 million as of March 31, 2026, versus current liabilities of $78.8 million, leaving a working capital deficit of about $72.7 million and a stockholders’ deficit of $77.6 million. Management states that these conditions and dependence on new financing raise substantial doubt about the company’s ability to continue as a going concern.
The company continues commercial activities for non-hormonal contraceptive gel PHEXX and antimicrobial SOLOSEC, expanding through ex-U.S. licensing and distribution agreements in the Middle East, North Africa and sub-Saharan Africa. However, large outstanding convertible and senior notes and extensive potential dilution underscore that the capital structure remains highly leveraged and complex.
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.
Evofem Biosciences, Inc. entered into a fourth amendment to its Securities Purchase Agreement with Adjuvant Global Health Technology Fund entities covering previously issued convertible promissory notes. The amendment sets the notes’ maturity as the earlier of six months after April 10, 2026, an Adjuvant‑elected change of control, or any contractual acceleration, and restricts prepayment before six months without Adjuvant’s written consent.
Evofem Biosciences, Inc. reports that it has mutually terminated its License and Supply Agreement with Windtree Therapeutics, Inc., which had made Windtree a manufacturer and supplier of PHEXXI® (lactic acid, citric acid, and potassium bitartrate). The parties entered into a Termination Agreement effective March 13, 2026.
The company states that there are no termination or other fees payable in connection with ending this agreement, helping avoid an immediate financial charge from this change. Certain customary provisions of the original agreement that are meant to survive termination will remain in effect.
Evofem Biosciences reported its fifth consecutive year of net sales growth and a return to profitability for 2025. Full-year net sales were $20.2 million, up from $19.4 million, as higher PHEXX WAC, a better gross-to-net ratio, and a full year of SOLOSEC sales supported growth.
Total operating expenses fell to $16.8 million, a $10.2 million reduction, driving operating income of $3.4 million versus a $7.7 million loss in 2024. Net income attributable to common stockholders was $0.3 million, or $0.00 per basic and diluted share, compared with a $9.0 million net loss, or ($0.11) per share.
In the fourth quarter of 2025, net sales rose to $9.6 million from $7.1 million, a 35% increase, with operating income improving to $3.3 million from a $1.0 million loss. Quarterly net income reached $2.8 million, or $0.02 per basic share and $0.00 per diluted share, versus a $3.0 million net loss a year earlier.
Evofem Biosciences, Inc. is a San Diego-based commercial-stage biopharmaceutical company focused on women’s sexual and reproductive health. It markets two FDA-approved products: PHEXX, the first and only non-hormonal, on-demand contraceptive vaginal gel, and SOLOSEC, a single-dose oral antimicrobial for bacterial vaginosis and trichomoniasis.
The company targets U.S. women who avoid hormonal methods or seek hormone-free backup, including those using GLP-1 drugs that may reduce oral contraceptive effectiveness. Outside the U.S., Evofem pursues partnerships, starting with a MENA licensing deal where a partner has filed for PHEXX and SOLOSEC approval in the UAE.
Evofem outsources manufacturing and held about three months of PHEXX inventory as of December 31, 2025. It reversed a $1.9 million contingent royalty liability after a key patent-term extension was definitively denied, recording this as a gain. Protection now relies on Evofem-owned Orange Book-listed patents expected to extend U.S. exclusivity for PHEXX into 2033 and SOLOSEC into 2041. As of March 9, 2026, 132,530,081 common shares were outstanding, and the non-affiliate float was valued at about $1.2 million as of June 30, 2025.
Evofem Biosciences, Inc. reported that it has posted its current corporate slide presentation to the Investors section of its website. The same presentation is being used at various industry and investor conferences to provide updates and summaries of the company’s business.
The slide deck is included as Exhibit 99.1 to this report and is described as having been prepared as of January 12, 2026. Evofem states that it has no obligation to update, supplement, or amend these materials and clarifies that the information in the exhibit is being furnished, not filed, so it is not automatically subject to certain Exchange Act liabilities or incorporation by reference into other securities law documents.
Evofem Biosciences, Inc. reported results of its November 26, 2025 Annual Meeting of Stockholders. Stockholders approved an amendment to the Certificate of Incorporation authorizing a one-time reverse stock split of the outstanding Common Stock at a ratio of not less than 1-for-500 and not more than 1-for-1,500, with the exact ratio to be set by the Board any time before November 26, 2026. The total authorized Common Stock remains unchanged.
Stockholders also elected four directors to serve until the 2028 annual meeting, approved on a non-binding basis the compensation of named executive officers, and approved the Evofem Biosciences, Inc. 2025 Equity Incentive Plan. They further ratified the appointment of BPM LLP as independent registered public accounting firm for the year ending December 31, 2025.
Evofem Biosciences (EVFM) furnished earnings information via an Item 2.02 Form 8-K. The company announced it issued a press release with financial results for the three and nine months ended September 30, 2025, attached as Exhibit 99.1.
The disclosure is furnished, not filed, and is not incorporated by reference unless expressly stated. The company’s forward-looking statements address topics such as COGS reduction initiatives, future sales trends, cost-reduction efforts, manufacturing efficiencies, international expansion, and its ability to obtain additional financing or other strategic alternatives, and are subject to risks including limited cash resources, reliance on new capital, potential regulatory delays, market demand changes, supply chain factors, and the nonrecurring nature of certain gains.
Evofem Biosciences (EVFM) filed its Q3 2025 10‑Q, showing modest revenue and ongoing financial pressure. Net product sales were $4.952 million for the quarter and $10.622 million year‑to‑date. Q3 operating income was $0.951 million, aided by a $1.933 million gain from a change in accounting estimates on a contingent royalty liability, but other expenses led to a net loss of $1.569 million for Q3 and $2.397 million for the first nine months.
Liquidity remains tight: cash, cash equivalents and restricted cash were $840 thousand at period end. Total assets were $13.807 million versus total liabilities of $83.976 million, resulting in a stockholders’ deficit of $75.066 million. Management disclosed substantial doubt about the company’s ability to continue as a going concern and outlined plans to pursue product revenues, milestones from ex‑U.S. licensing, restructuring of payables, and additional financing. The company’s common stock moved from OTCQB to OTCPK on April 23, 2025, and to OTCID on July 1, 2025. Common shares outstanding were 123,956,354 as of September 30, 2025, and 126,685,925 as of November 12, 2025.