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): October 24, 2023

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 October 24, 2023 Evofem Biosciences, Inc. issued a press release announcing its preliminary financial results for the three months ended September 30, 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 October 24, 2023
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: October 24, 2023	By:	/s/ Ivy Zhang
		Ivy Zhang
		Chief Financial Officer

Exhibit 99.1

Evofem Biosciences Announces Preliminary Results for the Third Quarter of 2023

— On track to achieve third consecutive year of net product sales growth —

— Third consecutive quarter of favorable net product sales- to- sales and marketing expense ratio —

— Reduced loss from operations more than 80% vs. prior year quarter —

SAN DIEGO, CA, October 24, 2023 —Evofem Biosciences, Inc. (OTCQB: EVFMD) (“Evofem”) today announced preliminary results for the third quarter of 2023, including sequential growth in net product sales of its hormone-free prescription contraceptive gel, Phexxi^®(lactic acid, citric acid and potassium bitartrate) and the positive impact of ongoing cost containment initiatives.

●	Phexxi net product sales expected to be $5.0 to $5.2 million for the third quarter of 2023.

●	Evofem remains on track to deliver its third consecutive year of net product sales growth.

●	Selling and marketing expenses were more than 75% lower and total operating expenses were more than 65% lower in the third quarter of 2023 than the third quarter of 2022.

●	Reduced loss from operations by more than 80% in the third quarter of 2023 as compared to the third quarter of 2022.

“For the third consecutive quarter, Evofem’s net product sales surpassed our sales and marketing costs and we expect to report the Company’s lowest quarterly operating loss to date, both of which testify to the successful execution of our strategy to deliver annual revenue growth with a lean, focused organization supporting our small but mighty sales team,” said Saundra Pelletier, CEO of Evofem.

Notable developments in the third quarter include the successful negotiation of a fourth amendment to Evofem’s Securities Purchase and Security Agreement dated April 2020, as amended (the “Fourth Amendment”), with a U.S.-based, healthcare-focused institutional investor (the “Investor”), under which the Investor purchased $25 million of convertible senior secured promissory notes (the “Notes”) from Evofem in 2020. Under the Fourth Amendment, the Company may repurchase the Notes for as little as $14 million. Evofem made the $1 million initial payment required by the Fourth Amendment on September 29, 2023; this will be applied toward the eventual Notes repurchase price. Furthermore, the Investor waived and withdrew the March 2023 Notice of Default and removed the cumulative net product sales covenant.

Also during the quarter, a generic drug maker that earlier this year filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration (“FDA”) amended its filing and will no longer seek FDA approval to market a generic version of Phexxi® until Evofem’s Phexxi patents all expire. The latest-expiring Phexxi patents do not expire until 2033. This is a highly favorable result for Evofem and its investors.

Management will discuss these developments and answer investor questions at the Virtual Investor Ask the CEO Conference today, Tuesday, October 24, 2023 at 10:00 a.m. ET. Visit https://evofem.investorroom.com/AskTheCEO to learn more and register for the event.

The Company expects to report full unaudited results for the three- and nine- months ended September 30, 2023, in mid-November.

About Evofem Biosciences

Evofem Biosciences, Inc., 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, statements related to anticipated financial results and the expected reporting date of final results of the third quarter of 2023. 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 June 30, 2023 filed with the SEC on August 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.

Contact

Amy Raskopf

Evofem Biosciences, Inc.

araskopf@evofem.com

(917) 673-5775

###

Cover	Oct. 24, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 24, 2023
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