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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): March 11, 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
March 11, 2026, Evofem Biosciences, Inc. (the “Company”) issued a press release announcing its financial results
for the year ended December 31, 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 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.
Item 7.01. Regulation FD Disclosure.
The Company from time to time presents and/or
distributes to the investment community at various industry and other conferences slide presentations to provide updates and summaries
of its business. The Company is posting to the “Investors” portion of its website at www.evofem.com a copy of its current
corporate slide presentation. These slides are attached to this Current Report on Form 8-K as Exhibit 99.2. The Company undertakes no
obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
The information in this Item 7.01 of this Current
Report on Form 8-K (including Exhibit 99.2) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall such information
be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, 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 March 11, 2026 |
99.2
|
|
Corporate
presentation prepared as of March 11, 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:
March 11, 2026 |
By: |
/s/
Ivy Zhang |
| |
|
Ivy
Zhang |
| |
|
Chief
Financial Officer |
Exhibit
99.1

Evofem
Reports Fifth Consecutive Year of Net Sales Growth
—
Net sales surpassed $20 million mark in FY 2025 —
—
Income from operations increased to $3.4 million in FY 2025
—
SAN
DIEGO, CA, March 11, 2026 — Women’s health innovator Evofem Biosciences, Inc. (Evofem or the Company) (OTCID: EVFM), today
announced financial results for the fourth quarter and year ended December 31, 2025. Highlights include:
| ● | Achieved
record net sales of $20.2 million in 2025—Evofem’s
fifth consecutive year of net sales growth—mainly
driven by sales of PHEXX® (lactic acid, citric acid, and potassium bitartrate), our hormone-free,
on demand contraceptive vaginal gel. |
| ● | Reduced
total operating expenses by 38% to $16.8 million in 2025 versus $27.0 million in 2024. The
$10.2 million reduction included a $ 5.6 million gain from the settlement of a portion of
the Company’s trade payables with vendors, and a $1.9 million non-cash gain on the
change in accounting estimates on a contingent royalty liability. |
| ● | Income
from operations increased to $3.4 million in 2025, versus a loss from operations of $7.7
million in 2024. |
| ● | Net
income attributable to common stockholders increased to $0.3 million, or $0.00 per basic
and diluted share, in 2025, versus a net loss of $9.0 million, or ($0.11) per basic and diluted
share, in 2024. |
“In
2025 we delivered our fifth consecutive year of net sales growth, and posted record net sales of more than $20 million, despite ongoing
capital constraints. This achievement is a testament to the quality of our products, PHEXX
and SOLOSEC, which offer women innovation to address their unmet sexual health needs, and
the grit and resilience of our team,” said Saundra Pelletier, CEO of Evofem Biosciences.
Additionally,
since October 1, 2025:
| ● | Evofem
advanced initiatives to lower manufacturing costs for both products, targeting estimated
reductions of 55-60% for PHEXX and SOLOSEC® (secnidazole) 2g oral granules. |
| ● | The
Emirates Drug Establishment (EDE) issued favorable pricing certificates for PHEXX, a preliminary
administrative step toward anticipated regulatory approval in the United Arab Emirates (UAE). |
| ● | The
EDE review of the SOLOSEC application in the
UAE is underway. |
| ● | 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 |
Full
Year Financial Results
For
the year ended December 31, 2025, net sales were $20.2 million compared to $19.4 million in the prior year. The 4% increase reflects
the higher PHEXX wholesale average cost (WAC) and slight improvement in gross-to-net ratio. SOLOSEC net sales also contributed to the
increase, with a full year of sales in 2025 vs. 5.5 months in the prior year; Evofem acquired the single-dose oral STI treatment in July
2024 and relaunched it in the U.S. in late 2024.
Total
operating expenses were $16.8 million, a $10.2 million reduction compared to the prior year which was driven by:
| ● | A
$5.3 million reduction in research and development expenses in 2025 due to the settlement
of a portion of our trade payables and accrued liabilities, partially offset by an uptick
in outside services costs; |
| ● | A
$4.2 million reduction in general and administrative expenses in 2025 vs. 2024; and |
| ● | A
one-time gain of $1.9 million in 2025 due to the expiration of the Rush patent and related
royalty, which triggered a change in the accounting estimate for the contingent royalty liability. |
| ● | These
aggregate savings were partially offset by a $0.5 million uptick in selling and marketing
expenses in 2025 versus 2024. The increase reflects a full year of PDUFA fees, 3PL fees,
and other commercial costs for SOLOSEC in 2025 vs. 5.5 months in 2024. |
As
a result, Evofem reported $3.4 million of operating income in 2025, compared to a loss from operations of $7.7 million in the prior year.
Net
income attributable to common stockholders increased to $0.3 million, or $0.00 per basic and diluted share, in 2025, versus a net loss
of $9.0 million, or ($0.11) per basic and diluted share, in 2024.
Fourth
Quarter Financial Results
For
the three months ended December 31, 2025, net sales were $9.6 million, versus $7.1 million in the prior year period. The 35% increase
predominantly reflects the higher PHEXX WAC, more favorable gross-to-net ratio, and higher PHEXX ex-factory unit sales in the 2025 period.
Total
operating expenses decreased to $6.2 million in the fourth quarter of 2025 as compared to $8.1 million in the prior year period. Lower
general and administrative and research and development expenses were offset in part by a $1.1 million increase in cost of goods sold
(COGS), to a lesser extent, higher PHEXX sales in the 2025 period.
As
a result, Evofem reported $3.3 million of operating income for the fourth quarter of 2025, versus a loss from operations of $1.0 million
in the prior year period.
Net
income was $2.8 million, or $0.02 per basic and $0.00 per diluted share, in the fourth quarter of 2025, versus a net loss of $3.0
million, or ($0.03) per basic and diluted share, for the fourth quarter of 2024.
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) 2 g 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 timing and outcome of the EDE review of the submissions for PHEXX and SOLOSEC in
the UAE, and the commercialization of PHEXX and SOLOSEC. 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, and 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.
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