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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 13, 2025

 

EVOFEM BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-36754   20-8527075

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

7770 Regents Road, Suite 113-618

San Diego, CA 92122

(Address of Principal Executive Offices)

 

(858) 550-1900

(Registrant’s telephone number, including area code)

 

Not applicable.

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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        

 

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 Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ☐

 

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On November 13, 2025, Evofem Biosciences, Inc. issued a press release announcing its financial results for the three and nine months ended September 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information set forth under this Item 2.02 and in Exhibit 99.1 is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the registrant under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date hereof, regardless of any general incorporation language in any such filing, except as shall be expressly set forth by specific reference in such a filing.

 

Forward-Looking Statements

 

The press release incorporated into this Current Report on Form 8-K 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,” “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 statements include but are not limited to Evofem’s expectations regarding the anticipated impact of COGS reduction initiatives, future sales trends, cost-reduction initiatives, manufacturing efficiencies, international market expansion, and the Company’s ability to obtain additional financing or other strategic alternatives. 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, 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, the nonrecurring nature of certain recent gains, 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, 2024 filed with the SEC on March 24, 2025, amended on March 28, 2025, Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 13, 2025, 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.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release dated November 13, 2025
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

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.
     
Date: November 13, 2025 By: /s/ Ivy Zhang
    Ivy Zhang
    Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

 

Evofem Reports Financial Results for Third Quarter of 2025, Provides Business Update

 

— Increased Net Sales 10% while lowering Operating Expenses 42% vs. Prior Year Quarter —

 

— Delivered $1.0 Million of Operating Income in Q3 2025 —

 

SAN DIEGO, CA, November 13, 2025 — Women’s health innovator Evofem Biosciences, Inc. (Evofem or the Company) (OTCID: EVFM), today announced financial results for the three- and nine-month periods ended September 30, 2025 and provided a business update.

 

“Sales rebounded in the third quarter and were 10% higher than the same quarter last year, reflecting the joint effort of our sales team combined with our smart, provocative social media initiatives and the great press coverage we garnered this summer,” said Saundra Pelletier, CEO of Evofem Biosciences.

 

Notable developments since July 1st include:

 

Increased net sales to $5.0 million in the third quarter of 2025 compared to $4.5 million in the prior year quarter.
   
Posted operating income of $1.0 million, compared to a loss from operations of $2.4 million in the prior year quarter.
   
Advanced strategies to reduced manufacturing costs by approximately 50% for both PHEXX® (lactic acid, citric acid and potassium bitartrate) and SOLOSEC® (secnidazole) 2g oral granules. In addition to increasing per-unit profit, the lower COGS are expected to facilitate entry into price-sensitive global markets for both products.
   
SOLOSEC® was submitted for marketing approval in the United Arab Emirates in the third quarter of 2025 under our June 2025 License and Supply Agreement with Pharma 1.
   
Patient recruitment is ongoing in an investigator-led, NIH-funded Phase 4 clinical trial evaluating the effectiveness and cost-effectiveness of SOLOSEC® (single-dose, one time) versus metronidazole (twice daily for seven days) for the treatment of Trichomonas vaginalis in men and women. Study investigators hypothesize that the rate of repeat infections with T. vaginalis will be 1.75 lower in the SOLOSEC group versus the multi-dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. 1

 

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Following the Special Meeting of Stockholders on October 20, 2025 at which Evofem’s stockholders did not approve the merger transaction with Aditxt, Evofem exercised its rights to terminate the Merger Agreement.

 

Third Quarter Financial Results

 

For the three months ended September 30, 2025, net sales were $5.0 million compared to $4.5 million in the prior year period. The increase reflects the impact of the PHEXX wholesale average cost (WAC) increase that took effect on January 1, 2025, a slight increase in PHEXX ex-factory unit sales, and a full quarter of SOLOSEC net sales in the current year period.

 

Total operating expenses decreased to $4.0 million in the third quarter of 2025, versus $6.9 million in the prior year period. The $2.9 million improvement was driven by a $1.0 million decrease in general and administrative expenses in the current year quarter and a one-time gain of $1.9 million due to a change in the accounting estimates related to the contingent Rush royalty liability because of the now-expired Rush patent.

 

As a result, Evofem reported $1.0 million of operating income for the third quarter of 2025, versus a loss from operations of $2.4 million in the prior year quarter.

 

Net loss attributable to common stockholders was $1.7 million in the third quarter of 2025, versus a net loss attributable to common stockholders of $2.4 million in the third quarter of 2024. This equates to net loss of $0.01 per basic and diluted share for the third quarter of 2025, versus net loss of $0.02 per basic and diluted share for the third quarter of 2024.

 

Liquidity

 

The Company had restricted cash of $0.8 million as of September 30, 2025 as compared to $0.7 million as of December 31, 2024.

 

About Evofem

 

Evofem Biosciences is commercializing innovative products to address unmet needs in women’s sexual and reproductive health. The Company generates revenue from the sale of two FDA-approved products.

 

PHEXX® (lactic acid, citric acid, and potassium bitartrate) is the first and only hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Visit phexxi.com to learn more and for important safety information.
  
SOLOSEC® (secnidazole) 2 g oral granules is 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.

 

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PHEXX®, PHEXXI® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc.

 

Sources

 

1.National Institute of Allergy & Infectious Diseases (NIAID) of the National Institutes of Health. Award number R01AI183266: Refining Trichomonas vaginalis treatment in women and men.

 

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,” “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 statements include but are not limited to Evofem’s expectations regarding the anticipated impact of COGS reduction initiatives, future sales trends, cost-reduction initiatives, manufacturing efficiencies, international market expansion, and the Company’s ability to obtain additional financing or other strategic alternatives. 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, 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, the nonrecurring nature of certain recent gains, 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, 2024 filed with the SEC on March 24, 2025, amended on March 28, 2025, Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 13, 2025, 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.

 

Connect with Us

 

Join the Dialogue

 

LinkedIn@evofem + @saundrapelletier
TikTok@phexxi + @saundrapelletier
Instagram@evofem, @phexxi + @saundrapelletier
X@evofem + @SaundraCEO
Facebook@evofem + @phexxi

 

Media

[email protected]

 

Investors and Potential Partners

Amy Raskopf, Chief Business Development Officer

Evofem Biosciences, Inc.

[email protected]

(917) 673-5775

 

Financial tables follow

 

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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(In thousands)

 

   As of 
   September 30, 2025   December 31, 2024 
Cash and cash equivalents  $-   $- 
Restricted cash  $840   $741 
Trade accounts receivable, net  $4,435   $9,832 
Total current liabilities  $78,186   $80,448 
Total stockholders’ deficit  $(75,066)  $(71,257)
Total liabilities, convertible and redeemable preferred stock and stockholders’ deficit  $13,807   $23,789 

 

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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(In thousands, except share and per share data)

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2025   2024   2025   2024 
                 
Product sales, net  $4,952   $4,496   $10,622   $12,259 
                    
Operating Expenses:                    
Cost of goods sold   905    869    2,025    2,322 
Gain on change in accounting estimates on contingent royalty liability   (1,933)   -    (1,933)   - 
Amortization of intangible asset, net   80    301    410    301 
Research and development   470    332    (3,819)   1,196 
Selling and marketing   2,391    2,382    7,616    6,970 
General and administrative   2,088    3,052    6,296    8,143 
Total operating expenses   4,001    6,936    10,595    18,932 
Income (loss) from operations   951    (2,440)   27    (6,673)
Other income (expense):                    
Interest income   3    3    13    13 
Other expense, net   (682)   (562)   (1,944)   (1,736)
Loss on issuance of financial instruments   -    -    -    (3,300)
Gain (loss) on debt extinguishment, net   -    (143)   -    977 
Change in fair value of financial instruments   (1,845)   769    (490)   4,896 
Total other income (expense), net   (2,524)   67    (2,421)   850 
Loss before income tax   (1,573)   (2,373)   (2,394)   (5,823)
Income tax benefit (expense)   4    8    (3)   - 
Net loss   (1,569)   (2,365)   (2,397)   (5,823)
Convertible and redeemable preferred stock deemed dividends   (111)   (5)   (115)   (99)
Net loss attributable to common stockholders  $(1,680)  $(2,370)  $(2,512)  $(5,922)
Net loss per share attributable to common stockholders, basic and diluted  $(0.01)  $(0.02)  $(0.02)  $(0.09)
Weighted-average shares used to compute net loss per share attributable to common shareholders, basic and diluted   119,578,093    96,459,121    116,229,614    64,924,454 

 

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