Evofem sees 40% PHEXX unit cost cut if approved
Evofem expects the additional PHEXX source to reduce unit costs by 40% or more after regulatory approval.
Rhea-AI Filing Summary
Evofem Biosciences, Inc. (EVFM) entered into a Manufacturing Agreement on September 17, 2026 with Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited and Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited. The two Zhaoke companies agreed to manufacture and supply PHEXX, Evofem’s hormone-free, on-demand prescription contraceptive vaginal gel. The additional source is intended to complement Evofem’s existing manufacturing operations, and the company said it will continue working with its existing manufacturing partner.
Subject to regulatory approval, the additional manufacturing source is expected to reduce unit costs by 40% or more. Based on current development timelines, Evofem expects to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration in mid-2027 for PHEXX manufactured at the additional facility. The company expects commercial sales from this second supply to begin following FDA approval.
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8-K Event Classification
Key Figures
Key Terms
supplemental new drug application (sNDA) regulatory
regulatory approval regulatory
forward-looking statements regulatory
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
Who will manufacture PHEXX for EVFM under the new agreement?
How much could EVFM reduce PHEXX unit costs?
When does EVFM expect to seek FDA approval for PHEXX from the new facility?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
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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
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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.
On September 17, 2026, Evofem Biosciences, Inc. (the “Company”) entered into a Manufacturing Agreement with Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited, a Hong Kong company organized and existing under the laws of Hong Kong and Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited., a company organized under the laws of the People’s Republic of China (together, “Zhaoke”), pursuant to which Zhaoke agreed to become a manufacturer and supplier of PHEXX® (lactic acid, citric acid, and potassium bitartrate).
The foregoing summary of the Manufacturing Agreement does not purport to be complete and is qualified in its entirety by reference to the Manufacturing Agreement, a copy of which is filed as Exhibit 10.1, to this Current Report on Form 8-K, and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 10.1 † | Manufacturing Agreement by and between the Company and Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited and Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited. dated September 17, 2026 | |
| 99.1 | Press release dated September 23, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
† Certain confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.
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: September 23, 2026 | By: | /s/ Saundra Pelletier |
| Saundra Pelletier | ||
| Chief Executive Officer | ||
Exhibit 99.1
Evofem Biosciences Adds Additional Manufacturing Capacity for PHEXX® to Support Global Growth Strategy
— Additional manufacturing source expected to improve supply chain flexibility
and reduce unit costs by 40% or more following regulatory approval —
SAN
DIEGO, CA, September
“Expanding our manufacturing network is an important step in strengthening Evofem’s ability to support future growth,” said Saundra Pelletier, Evofem’s Chief Executive Officer. “The addition of a second qualified manufacturing partner for PHEXX enhances our supply chain flexibility and provides additional capacity to support anticipated demand in the United States and international markets. We remain committed to working closely with our existing manufacturing partner while developing this complementary source of supply. Upon approval, we expect this additional manufacturing capability to improve product economics and further support our goal to expand access to hormone-free, woman-controlled contraception around the world.”
The newly contracted manufacturer is intended to complement Evofem’s existing manufacturing capabilities and provide additional supply flexibility as the Company pursues domestic and international growth opportunities for PHEXX.
Based on current development timelines, Evofem expects to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration in mid-2027 for PHEXX manufactured at the additional facility and, following FDA approval, begin commercial sale of this second supply.
About Evofem Biosciences, Inc.
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) 2g 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. 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, risks related to the Company’s limited revenue base relative to operating expenses, and its reliance on third-party licensees and distributors for ex-U.S. commercialization, 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, Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 filed with the SEC on August 14, 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.
Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
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