Evofem adds a second manufacturer for PHEXX

Evofem Biosciences, Inc. has contracted with a second pharmaceutical manufacturer to produce PHEXX, its hormone-free, on-demand prescription contraceptive vaginal gel. The company announced the step in a press release dated September 23, 2026, which it furnished with a Form 8-K. The additional source is subject to regulatory approval.

The new manufacturing source

Evofem says the new manufacturer is intended to complement its existing manufacturing operations and add supply flexibility as it pursues growth in the United States and internationally. Chief Executive Officer Saundra Pelletier said: "Expanding our manufacturing network is an important step in strengthening Evofem's ability to support future growth."

The company expects that, once approved, the additional facility will improve product economics and reduce unit costs by 40% or more. It also says it will continue to work closely with its existing manufacturing partner. Based on current development timelines, Evofem expects to submit a supplemental new drug application to the U.S. Food and Drug Administration in mid-2027 for PHEXX made at the additional facility. After FDA approval, it expects to begin commercial sale of this second supply. The 40% cost cut is the company's own expectation, and it depends on an FDA approval that has not been applied for yet, so nothing changes before mid-2027 at the earliest.

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. Its first product, PHEXX, was approved by the FDA on May 22, 2020, for the prevention of pregnancy and launched in the United States in September 2020. PHEXX is hormone-free and is inserted up to 60 minutes before intercourse.

Evofem acquired global rights to SOLOSEC in July 2024 and relaunched the brand in November 2024. SOLOSEC is a single-dose oral antimicrobial for bacterial vaginosis and trichomoniasis. Outside the United States, the company licenses its products to partners, including Pharma 1 Drug Store, LLC in the Middle East and North Africa.

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 company's 10-K says Pharma 1 Drug Store, LLC licensed PHEXX and SOLOSEC in the Middle East and North Africa in July 2024 and May 2025. Pharma 1 filed for regulatory approval of PHEXX in the United Arab Emirates in June 2025 and of SOLOSEC there in September 2025, and it is expected to launch PHEXX in the UAE in 2026.

The 10-K says Saundra Pelletier has served as Chief Executive Officer, President and Executive Director since February 2015, and as interim Chair of the Board since November 2021.

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. Research and development expense was $1.8 million for 2024.

Year-end cash and cash equivalents were $578,000 at the end of 2025 and $741,000 at the end of 2024. At June 30, 2026, cash and cash equivalents were $285,000, according to the company's 10-Q. That cash balance is small beside the cost of any scale-up, and the 8-K does not say who pays for the new manufacturer's work. The release's forward-looking statements list limited cash resources and the company's ability to continue as a going concern among the risks that could affect results.

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