Form 8-K - Current report

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): February 1, 2024

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
Common Stock, par value $0.0001 per share		EVFM		OTCQB

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 February 1, 2024, Evofem Biosciences, Inc. issued a press release announcing its preliminary financial results for the year ended December 31, 2023. 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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated February 1, 2024
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: February 1, 2024	By:	/s/ Ivy Zhang
		Ivy Zhang
		Chief Financial Officer

Exhibit 99.1

Evofem Biosciences Announces Strong Preliminary Results, Record Phexxi Net Sales for Fiscal 2023

Evofem Delivers Third Consecutive Year of Phexxi Net Sales Growth

Total Operating Expense Reduced More Than 60% from 2022 Levels

SAN DIEGO, CA, February 1, 2024 —Evofem Biosciences, Inc. (OTCQB: EVFM) today announced strong preliminary, unaudited results for fiscal 2023, including record net sales of Phexxi^® (lactic acid, citric acid, and potassium bitartrate), its hormone-free contraceptive gel, and the Company’s lowest total operating expenses since becoming a commercial stage company in 2020.

●	Achieved preliminary net product sales in the range of $18.1 to $18.3 million in 2023, an impressive increase compared to 2022 given the 73% reduction in field force and absence of growth capital in 2023.

●	Company reached a key milestone with net product sales higher than sales and marketing expense for 2023.

●	Reduced total operating expense by more than 60% from 2022 levels.

●	Improved loss from operations by more than 75% versus 2022 levels.

“Strong consumer demand for Phexxi and the expansion of coverage and reimbursement enabled us to achieve our third consecutive year of revenue growth,” said Saundra Pelletier, CEO of Evofem Biosciences. “We delivered more than $18 million in net sales for 2023 despite ongoing austerity measures that whittled our sales force down to just 16 and permitted no investment in growing the brand. Our growth testifies to the strength and persistence of Evofem’s current team as well as the loyal users and prescribers of Phexxi nationwide.”

In December 2023, Evofem, a commercial stage women’s health innovator, entered into a definitive agreement to be acquired by Aditxt, Inc. (Nasdaq: ADTX), which Evofem believes is a compelling opportunity to accelerate its growth trajectory, as a subsidiary of Aditxt, into a multi-product women’s health franchise. The companies are working toward a mid-2024 close.

Evofem expects to report full results for the three- and twelve-month periods ended December 31, 2023, in mid-March 2024.

About Evofem Biosciences

Evofem Biosciences, Inc., (OTCQB: EVFM) is commercializing innovative products to address unmet needs in women’s sexual and reproductive health. The Company’s first FDA-approved product, Phexxi^® (lactic acid, citric acid, and potassium bitartrate), is a 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. Learn more at phexxi.com and evofem.com.

Phexxi® is a registered trademark 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, including, without limitation, to Evofem’s expected financial results for 2023 including net sales growth, the result of gross-to-net improvements, and operating expenses; statements, evaluations and judgments related to, among other things, demand for Phexxi; and closing of the contemplated Aditxt transaction and timing thereof. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on April 27, 2023, Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 14, 2023 and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

Investor Contact

Amy Raskopf

Evofem Biosciences, Inc.

araskopf@evofem.com

Mobile: (917) 673-5775

###

Cover	Feb. 01, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 01, 2024
Entity File Number	001-36754
Entity Registrant Name	EVOFEM BIOSCIENCES, INC.
Entity Central Index Key	0001618835
Entity Tax Identification Number	20-8527075
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	7770 Regents Road
Entity Address, Address Line Two	Suite 113-618
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92122
City Area Code	(858)
Local Phone Number	550-1900
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	EVFM
Entity Emerging Growth Company	false