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Evofem (OTC: EVFM) Q1 2026 loss, low cash and ex-US growth push

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Evofem Biosciences, Inc. reported first quarter 2026 results, showing small revenue growth but a return to loss. Net sales were $0.9 million for the three months ended March 31, 2026, slightly above $0.8 million a year earlier, driven by higher pricing and a better gross-to-net mix for PHEXX and SOLOSEC.

Total operating expenses were $5.5 million, leading to a net loss of $5.5 million, or $(0.04) per share, compared with net income attributable to common stockholders of $1.0 million, or $0.01 per basic share, in the prior-year quarter. The balance sheet shows cash and cash equivalents of $1.5 million and a stockholders’ deficit of $77.6 million, highlighting ongoing financial strain.

The company is pursuing growth by commercializing its FDA-approved products PHEXX and SOLOSEC outside the U.S., including a new distribution agreement for SOLOSEC in Sub-Saharan Africa and ongoing regulatory review for both products in the United Arab Emirates. Management reiterates forward-looking statements that emphasize plans for cost reductions, manufacturing efficiencies, and ex-U.S. expansion, while warning about limited cash resources, dependence on new capital or business development transactions, and its ability to continue as a going concern.

Positive

  • None.

Negative

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Insights

Evofem posts modest Q1 sales, deeper loss, and remains financially strained.

Evofem generated product sales of $899,000 in Q1 2026, up slightly from $845,000 a year earlier, mainly from higher pricing and a better gross-to-net mix for PHEXX and SOLOSEC. However, operating expenses of $5.5M drove an operating loss of $4.6M.

Net loss attributable to common stockholders was $5.5M, versus net income of $953,000 in Q1 2025, with the prior period boosted by a one-time $5.6M research and development expense reduction. The balance sheet shows cash of $1.5M, total current liabilities of $78.8M, and a stockholders’ deficit of $77.6M, underscoring leverage and liquidity pressure.

The company’s strategy centers on ex-U.S. commercialization of PHEXX and SOLOSEC, including a Sub-Saharan Africa distribution deal and ongoing Emirates Drug Establishment review in the UAE. Forward-looking statements explicitly highlight limited cash resources and the ability to continue as a going concern as key risks, so subsequent filings will be important for updates on capital raising and regulatory milestones.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Net sales $0.9 million Three months ended March 31, 2026
Product sales, net $899,000 Q1 2026 vs $845,000 in Q1 2025
Net income (loss) attributable to common stockholders ($5.485 million) Q1 2026 vs $953,000 in Q1 2025
Total operating expenses $5.468 million Q1 2026 consolidated operations
Cash and cash equivalents $1.491 million As of March 31, 2026
Total current liabilities $78.752 million As of March 31, 2026
Stockholders’ deficit $77.630 million As of March 31, 2026
Income (loss) from operations ($4.569 million) Three months ended March 31, 2026
forward-looking statements regulatory
"This press release includes “forward-looking statements,” within the meaning of the safe harbor"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
cost of goods sold financial
"Operating Expenses: Cost of goods sold 410"
Cost of goods sold (COGS) is the direct cost of producing the products a company sells, including materials, labor and factory overhead tied to making those items. Think of it like the ingredients and cook time for a bakery’s cakes — the more you spend to make each cake, the less you keep when you sell it. Investors watch COGS because it directly reduces gross profit and reveals how efficiently a company turns inputs into profitable sales, affecting margins, pricing and competitiveness.
Phase 4 clinical trial medical
"an investigator-led, NIH-funded Phase 4 clinical trial evaluating the effectiveness"
Phase 4 clinical trials are studies done after a drug or medical product is approved and sold, designed to track long-term safety, rare side effects, and real-world effectiveness in broader patient groups. For investors, these trials matter because they can reveal new risks that hurt sales or trigger label changes or recalls, or they can uncover new uses that boost revenue—think of it like testing a car on everyday roads after showroom delivery to spot issues or extra strengths.
going concern financial
"the Company’s ability to continue as a going concern"
A going concern is a business that is expected to continue its operations and meet its obligations for the foreseeable future, rather than shutting down or selling off assets. This assumption matters to investors because it indicates stability and ongoing profitability, making the business a more reliable investment. Think of it as believing a restaurant will stay open and serve customers, rather than closing down suddenly.
stockholders’ deficit financial
"Total stockholders’ deficit $ (77,630 )"
Stockholders’ deficit is the situation where a company’s total liabilities exceed its total assets, so the book value attributed to shareholders is negative. Think of it like a household with more outstanding debts than the value of its house and possessions—this can signal past losses or aggressive payouts and raises the risk that shareholders may be wiped out, diluted, or face difficulty when the company needs new financing. Investors watch it as a warning about solvency and long‑term financial health.
convertible and redeemable preferred stock financial
"Total liabilities, convertible and redeemable preferred stock and stockholders’ deficit"
Net sales $0.9 million
Product sales, net $899,000
Net income (loss) attributable to common stockholders ($5.485 million)
Income (loss) from operations ($4.569 million)
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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): May 18, 2026

 

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 May 18, 2026, Evofem Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information set forth in 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, 2025 filed with the SEC on March 11, 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.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release dated May 18, 2026
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: May 18, 2026 By: /s/ Ivy Zhang
    Ivy Zhang
    Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

 

Evofem Reports First Quarter 2026 Financial Results and Provides Business Update

 

Advancing Strategy to Increase and Diversify Revenue through Ex-U.S. Commercialization

 

SAN DIEGO, CA, May 18, 2026 — Women’s health innovator Evofem Biosciences, Inc. (Evofem or the Company) (OTCID: EVFM), today announced financial results for the first quarter ended March 31, 2026.

 

“Evofem continues to execute our strategy to increase revenues and to diversify and reduce risk in our revenue stream,” said Saundra Pelletier, CEO of Evofem. “A key component of this strategy is commercializing our FDA-approved sexual health products outside the U.S. through strategic alliances such as the ones we have forged for MENA and Sub-Saharan Africa. We look forward to non-dilutive capital from each of these markets in 2026.”

 

Notable advances in 2026 to-date include:

 

Expanded our global reach into Sub-Saharan Africa through a distribution agreement with Clovis Davis Pharmaceuticals for SOLOSEC® (secnidazole) 2g oral granules.
  
The Emirates Drug Establishment (EDE) review of the submissions for marketing approval of PHEXX® (lactic acid, citric acid and potassium bitartrate) and SOLOSEC in the United Arab Emirates (UAE) is ongoing. The EDE issued favorable pricing certificates for PHEXX in late 2025.
  
Advanced patient recruitment 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

 

First Quarter Financial Results

 

For the three months ended March 31, 2026, net sales were $0.9 million, versus $0.8 million in the prior year period. The increase was primarily due to the higher WAC and more favorable gross-to-net ratio for both PHEXX and SOLOSEC and higher SOLOSEC ex-factory sales in the 2026 period, partially offset by lower ex-factory sales for PHEXX in the 2026 period following the exceptionally high level of PHEXX purchasing by wholesalers in December 2025 ahead of the January 2026 price increase.

 

1

 

 

Total operating expenses were $5.5 million in the first quarter of 2026, compared to $6.1 million in the prior year period, after excluding a one-time $5.6 million reduction in research and development expense as a result of its successful settlement of a portion of its trade payables with multiple vendors.

 

As a result, net loss was $5.5 million, or $(0.04) per basic and diluted share, in the first quarter of 2026. This compares to net income attributable to common stockholders of $1.0 million, or $0.01 per basic and $0.00 per fully diluted share, in the first quarter of 2025.

 

About Evofem

 

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. These statements include but are not limited to, Evofem’s expectations regarding the anticipated impact of COGS reduction initiatives, the commercialization of PHEXX and SOLOSEC, the timing and outcome of the EDE review of the submissions for PHEXX and SOLOSEC in the UAE, and the timing and magnitude of anticipated future commercial orders for and product launches in ex-U.S. markets. 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, the nonrecurring nature of certain recent gains, 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 March 31, 2026 filed with the SEC on May 15, 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.

 

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.

 

Connect with Us

 

ir@evofem.com

 

media@evofem.com

 

Financial Tables Follow

 

2

 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS

 

(unaudited)
(In thousands)

   As of 
   March 31, 2026   December 31, 2025 
Cash and cash equivalents  $1,491   $- 
Restricted cash and cash equivalents  $888   $578 
Trade accounts receivable, net  $560   $12,480 
Total current liabilities  $78,752   $84,820 
Total stockholders’ deficit  $(77,630)  $(74,336)
Total liabilities, convertible and redeemable preferred stock and stockholders’ deficit  $7,442   $20,274 

 

3

 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)
(In thousands, except share and per share data)

 

   Three Months Ended March 31, 
   2026   2025 
         
 Product sales, net  $899   $845 
           
Operating Expenses:          
Cost of goods sold   410    365 
Amortization of intangible asset   75    223 
Research and development, net   518    (5,035)
Selling and marketing   2,093    2,600 
General and administrative   2,372    2,365 
Total operating expenses   5,468    518 
Income (loss) from operations   (4,569)   327 
Other income (expense):          
Interest income   2    8 
Other expense, net   (737)   (600)
Change in fair value of financial instruments   (162)    1,221 
Total other income (expense), net   (897)    629 
Income (loss) before income tax expense   (5,466)   956 
Income tax expense   1    - 
Net income (loss)   (5,465)   956 
Convertible and redeemable preferred stock deemed dividends   (20)   (3)
Net income (loss) attributable to common stockholders  $(5,485)  $953 
Net income (loss) per share attributable to common stockholders:          
Basic  $(0.04)  $0.01 
Diluted  $(0.04)  $0.00 
Weighted-average shares used to compute net income (loss) per share attributable to common shareholders:          
Basic   133,246,864    118,164,046 
Diluted   133,246,864    6,155,035,291 

 

4

FAQ

How did Evofem Biosciences (EVFM) perform financially in Q1 2026?

Evofem reported Q1 2026 net sales of $0.9 million and a net loss of $5.5 million. The prior-year quarter showed net income attributable to common stockholders of $953,000, so results reflect a shift back to losses despite slightly higher product sales.

What were Evofem Biosciences (EVFM) product sales for Q1 2026?

Product sales for Evofem in Q1 2026 were $899,000, compared with $845,000 in Q1 2025. The increase was mainly driven by higher wholesale acquisition cost and a more favorable gross-to-net ratio for PHEXX and SOLOSEC, alongside higher SOLOSEC ex-factory sales.

What is Evofem Biosciences’ cash and debt position as of March 31, 2026?

As of March 31, 2026, Evofem held $1.5 million in cash and cash equivalents and $888,000 in restricted cash. Total current liabilities were $78.8 million, and stockholders’ deficit was $77.6 million, indicating significant leverage and a strained capital structure.

What strategic initiatives is Evofem Biosciences (EVFM) pursuing to grow revenue?

Evofem is focusing on ex-U.S. commercialization of its FDA-approved products PHEXX and SOLOSEC through strategic alliances. Initiatives include a Sub-Saharan Africa distribution agreement for SOLOSEC and ongoing Emirates Drug Establishment review for PHEXX and SOLOSEC in the United Arab Emirates.

What key risks does Evofem Biosciences highlight in its Q1 2026 update?

Evofem cites limited cash resources, dependence on new capital or business development transactions, potential delays in regulatory approvals, manufacturing and supply chain risks, and its ability to continue as a going concern as important factors that could cause results to differ from forward-looking statements.

Which products are central to Evofem Biosciences’ business model?

Evofem’s business centers on two FDA-approved products: PHEXX, a hormone-free, on-demand prescription contraceptive vaginal gel, and SOLOSEC, a single-dose oral antibiotic for bacterial vaginosis and trichomoniasis in patients 12 years and older.

Filing Exhibits & Attachments

5 documents