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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.
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
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 | |
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 | |