Evofem Biosciences, Inc.
For the period ended Jun 30, 2025. Filed Aug 14, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 14, 2025
Contents
FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q (Quarterly 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 Quarterly 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.
| ● | the consummation of the transactions contemplated by the Merger Agreement and documents related thereto; |
|---|---|
| ● | our ability to continue as a going concern; |
| ● | the Notice of Default and cancellation of Forbearance Agreement received by Future Pak, LLC and any potential legal action(s) against the Company, including that its assets that could be taken and potential negative outcome(s) thereof; |
| ● | our ability to successfully commercialize SOLOSEC® (secnidazole) 2g oral granules (SOLOSEC); |
| ● | 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, 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 our future performance including, without limitation, any estimates of potential future revenues; |
| ● | estimates regarding market size; |
| ● | our estimates regarding expenses, revenues, financial performance, and capital requirements, including the length of time our capital resources will sustain our operations; |
| ● | 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; |
| ● | estimates regarding health care providers’ (HCPs’) recommendations of PHEXXI® (lactic acid, citric acid, and potassium bitartrate) vaginal gel (PHEXXI) to patients; |
| ● | estimates regarding HCPs’ recommendations of SOLOSEC to patients suffering from the sexual health infections for which it is indicated; |
| ● | the rate and degree of market acceptance of our products; |
| ● | our ability to successfully commercialize and distribute our products and continue to develop our sales and marketing capabilities, particularly after any product rebrand; |
| ● | the requirement to change the name of PHEXXI and our estimates regarding the timing and cost thereof; |
| ● | our estimates regarding the effectiveness of our marketing campaigns; |
| ● | 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; |
| ● | the potential substantial negative impact on contraception access and STI treatment, especially for low-income and uninsured women after the passage of the One Big Beautiful Bill Act; |
| ● | 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 Quarterly Report, we caution you that these statements are based on our projections of the future that are subject to known and unknown risks and uncertainties and other factors that may cause our actual results, level of activity, performance or achievements expressed or implied by these forward-looking statements, to differ. 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 Quarterly Report and the documents that we have filed as exhibits to this Quarterly 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 Quarterly Report are made as of the date of this Quarterly 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 Quarterly 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 Quarterly Report to “Evofem,” “Company,” “we,” “us” and “our” refer to Evofem Biosciences, Inc. and its subsidiaries.
This Quarterly Report includes our trademarks, trade names and service marks, including “EVOFEM®” “PHEXXI®”, “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 Quarterly 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.
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