Evofem Biosciences, Inc.
For the period ended Dec 31, 2025. Filed Mar 11, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 11, 2026
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
For the fiscal year ended December 31,2025
OR
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|---|
FOR THE TRANSITION PERIOD FROM TO
Commission File Number 001-36754
EVOFEM BIOSCIENCES, INC.
(Exact name of Registrant as specified in its Charter)
| Delaware | 20-8527075 |
|---|---|
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| 7770 Regents Rd, Suite 113-618 San Diego, CA | 92122 |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:(858) 550-1900
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| None | ||
Securities registered pursuant to Section 12(g) of the Act:Common Stock, par value $0.0001 per share.
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐No ☒
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definition of “large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
|---|---|---|---|
| Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| 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. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No☒
The aggregate market value of the Common Stock held by non-affiliates of the registrant was approximately $1.2 million as of June 30, 2025, based upon the closing sale price on the OTCID Basic Market reported for such date. Shares of Common Stock held by each executive officer and director and certain holders of more than 10% of the outstanding shares of the registrant’s Common Stock have been excluded in that such persons may be deemed to be affiliates. Shares of Common Stock held by other persons, including certain other holders of more than 10% of the outstanding shares of Common Stock, have not been excluded in that such persons are not deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.
The number of shares of Registrant’s Common Stock outstanding as of March 9, 2026 was 132,530,081.
DOCUMENTS INCORPORATED BY REFERENCE
None.
Table of Contents
| Page | |||
|---|---|---|---|
| PART I | |||
| Item 1. | Business | 2 | |
| Item 1A. | Risk Factors | 32 | |
| Item 1B. | Unresolved Staff Comments | 79 | |
| Item 1C. | Cybersecurity | 79 | |
| Item 2. | Properties | 80 | |
| Item 3. | Legal Proceedings | 80 | |
| Item 4. | Mine Safety Disclosures | 80 | |
| PART II | |||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 81 | |
| Item 6. | [RESERVED] | 82 | |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 82 | |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 94 | |
| Item 8. | Financial Statements and Supplementary Data | 94 | |
| Item 9. | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 94 | |
| Item 9A. | Controls and Procedures | 95 | |
| Item 9B. | Other Information | 96 | |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions That Prevent Inspections | 96 | |
| PART III | |||
| Item 10. | Directors, Executive Officers and Corporate Governance | 96 | |
| Item 11. | Executive Compensation | 105 | |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 121 | |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 124 | |
| Item 14. | Principal Accounting Fees and Services | 127 | |
| PART IV | |||
| Item 15. | Exhibits and Financial Statement Schedules | 127 | |
| SIGNATURES | 132 | ||
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This annual report on Form 10-K (Annual Report), contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” All statements, other than statements of historical facts, contained in this Annual Report, including statements regarding our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. Words such as, but not limited to, “anticipate,” “aim,” “believe,” “contemplate,” “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 forward-looking statements include, among other things, statements about:
| ● | our ability to continue as a going concern; |
|---|---|
| ● | our ability to remediate the material weaknesses in our internal controls and procedures identified by management; |
| ● | our ability to obtain necessary approvals of any corporate action(s) needing stockholder, FINRA, Nasdaq, or other approvals; |
| ● | our ability to file Annual and Quarterly Reports on a timely basis; |
| ● | our ability to raise additional capital to fund our operations if and as needed; |
| ● | our ability to achieve and sustain profitability; |
| ● | our estimates regarding expenses, revenues, financial performance, and capital requirements, including the length of time our capital resources will sustain our operations; |
| ● | the Notices of Default and cancellation of Forbearance Agreement received from Future Pak, LLC and any potential legal action(s) against the Company related thereto, including that its assets that could be taken and potential negative outcome(s) thereof; |
| ● | our ability to comply with the provisions and requirements of our debt arrangements, to avoid future defaults pursuant to our debt arrangements, and to pay amounts owed, including any amounts that may be accelerated, pursuant to our debt arrangements; |
| ● | our ability to successfully commercialize PHEXX® (lactic acid, citric acid and potassium bitartrate) vaginal gel (PHEXX) (formerly known as PHEXXI®) and SOLOSEC® (secnidazole) 2g oral granules (SOLOSEC); |
| ● | estimates regarding market size; |
| ● | estimates regarding health care providers’ (HCPs’) recommendations of PHEXX and SOLOSEC to patients; |
| ● | the rate and degree of market acceptance of PHEXX and SOLOSEC; |
| ● | our ability to successfully commercialize and distribute our products and continue to develop our sales and marketing capabilities; |
| ● | our strategic plans for our business, including the commercialization of our products; |
| ● | the potential for changes to current regulatory mandates requiring health insurance plans to cover U.S. Food and Drug Administration (FDA) -cleared or -approved contraceptive products without cost sharing; |
| ● | our ability to obtain or maintain third-party payer coverage and adequate reimbursement, and our reliance on the willingness of patients to pay out-of-pocket for our products absent full or partial third-party payer reimbursement; |
| ● | our ability to protect and defend our intellectual property position and our reliance on third party licensors; |
| ● | our ability to obtain additional patent protection for our products; |
| ● | our dependence on third parties for the manufacture of our products; |
| ● | our ability to expand our organization to accommodate potential growth; and |
| ● | our ability to retain and attract key personnel. |
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that these statements are based on our projections of the future which are subject to known and unknown risks and uncertainties and other factors that may cause our actual results, level of activity, performance, or achievements to differ from those expressed or implied by these forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement. Forward-looking statements should be regarded solely as our current plans, estimates and beliefs. You should read this Annual Report and the documents that we have filed as exhibits to this Annual Report and incorporated by reference herein completely and with the understanding that our actual results may be materially different from the plans, intentions and expectations disclosed in the forward-looking statements we make. Moreover, we operate in a very competitive and rapidly changing environment and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. The forward-looking statements contained in this Annual Report are made as of the date of this Annual Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.
This Annual Report contains estimates and other statistical data made by independent parties and by the Company relating to market size and growth and other data about its industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.
Unless the context requires otherwise, references in this Annual Report to “Evofem,” “Company,” “we,” “us” and “our” refer to Evofem Biosciences, Inc. and its subsidiaries.
This Annual Report includes our trademarks, trade names and service marks, including “EVOFEM®”, “PHEXX®”, “FEMIDENCE™”, and “SOLOSEC®”, which are protected under applicable intellectual property laws and are the property of Evofem Biosciences, Inc. or its subsidiaries. Solely for convenience, trademarks, trade names and service marks referred to in this Annual Report may appear without the®, ™ or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.