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): May 15, 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 May 15, 2024, Evofem Biosciences, Inc. issued a press release announcing its financial results for the three months ended March 31, 2024. 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 May 15, 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: May 15, 2024	By:	/s/ Ivy Zhang
		Ivy Zhang
		Chief Financial Officer

Exhibit 99.1

Evofem Biosciences Announces Financial Results for the First Quarter of 2024

SAN DIEGO, CA, May 15, 2024 — The company behind the hormone-free contraceptive Phexxi® (lactic acid, citric acid and potassium bitartrate), Evofem Biosciences, Inc. (“Evofem” or “the Company”) (OTCQB: EVFM) today announced financial results for the first quarter of 2024. Highlights of and since the quarter include:

●	Received $1 million from Aditxt, Inc. (Nasdaq: ADTX) in May 2024 in consideration for reinstating and amending the Merger Agreement, as amended, between the companies. Aditxt agreed to invest an additional $2.5 million in Evofem by July 1, 2024. The companies are working to close the contemplated transaction in the second half of 2024.

●	Strengthened Phexxi intellectual property with the allowance of a new Composition of Matter Patent by the USPTO. Once issued, this will be the fifth U.S. patent covering Evofem’s hormone-free contraceptive.

●	Launched a partnership with Modern Remedies, one of the top pharmacies dispensing Phexxi in the Northeast, effective May 2024.

●	Successfully renegotiated the rebate for Phexxi with Medi-Cal, the California state Medicaid program serving more than 15.4 million beneficiaries. Effective July 1, 2024, Evofem will pay a 7.4% lower rebate to Medi-Cal on Phexxi prescriptions dispensed to its beneficiaries.

●	Net sales were $3.6 million for the first quarter of 2024, reflecting anticipated cyclical softness following the wholesale acquisition cost (WAC) increase on January 1, 2024, and the impact of the cyberattack on Change Healthcare on February 19, 2024.

●	Total operating expenses decreased 31% vs. the first quarter of 2023 to $6.4 million.

●	Narrowed loss from operations to $2.8 million, a 21% improvement compared to the first quarter of 2023.

“We expect 2024 will be our fourth consecutive year of net sales growth, driven in part by continued execution of our market access strategy with payer wins and successful rebate reductions,” said Saundra Pelletier, Evofem’s CEO. “We also expect lift from increasing use of Phexxi for supplemental contraception among women of reproductive age who take oral birth control pills in conjunction with GLP-1 agonists like Mounjaro and Zepbound. These drugs may make oral contraceptives less effective at certain points in the dosing schedule – specifically for four weeks after initiation and for another four weeks after each dose escalation. Adding a hormone-free, woman-controlled contraceptive like Phexxi is a logical choice for these patients for additional protection against unintended pregnancy during these times.”

Financial Results

For the three months ended March 31, 2024, net sales were $3.6 million compared to $5.8 million in the prior year period. The 38% decrease reflects cyclical softness related to the timing of orders relative to WAC increases and the unfavorable impact of the cyberattack on Change Healthcare.

The typical cycle is that our customers A) place larger orders ahead of a price increase, B) sell from this inventory for several months after the price increase, and C) resume ordering the following quarter. Phexxi WAC increased on January 1, 2024, resulting in softer first quarter 2024 net sales (stage B). By contrast, following the October 2022 WAC increase and the near-absence of sales in the fourth quarter of 2022, net sales in the first quarter of 2023 were strong (stage C).

Following the cyberattack on Change Healthcare on February 19, 2024, retail pharmacies across the country experienced delays processing prescriptions and were unable to send orders through insurance plans, and there were delays in the processing of insurance claims, which lowered dispensed units of many prescription products, including Phexxi. Additionally, Change Healthcare was the sole adjudicator (processor) used by Evofem’s co-pay card vendor and Evofem received no claims for several weeks following the cyberattack. In mid-March, our co-pay card vendor established an alternative adjudicator. Initially the cost to Evofem was significantly higher, which negatively impacted our first quarter results. Costs have dropped back down in the second quarter of 2024 to approximately 8% above pre-cyberattack levels.

Total operating expenses decreased 31% to $6.4 million, compared to $9.4 million in the prior year period. The improvement reflects a 39% decrease in selling and marketing costs and 22% decrease in general and administrative costs.

As a result, loss from operations improved to $2.8 million, compared with a loss from operations of $3.6 million for the three months ended March 31, 2023.

Liquidity

At March 31, 2024, we had $0.7 million of restricted cash, as compared to $0.6 million of restricted cash at December 31, 2023.

Subsequent to the quarter close, in April 2024 Evofem made the required quarterly payment of $0.1 million to a U.S.-based, healthcare-focused institutional investor as required by the Fourth Amendment to the Securities Purchase and Security Agreement dated April 2020, as amended, under which this investor purchased $25 million of convertible senior secured promissory notes from Evofem in 2020.

In May 2024, Evofem received $1 million from Aditxt in consideration of reinstating and amending the Agreement and Plan of Merger, as amended on January 10, 2024, January 30, 2024, February 29, 2024, and May 2, 2024 by and between the companies. Under the Fourth Amendment to the Agreement and Plan of Merger, Aditxt agreed to invest an additional $2.5 million in Evofem by July 1, 2024. The companies are working to close the contemplated transaction in the second half of 2024.

About Evofem Biosciences

Evofem Biosciences, Inc., is developing and 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 the Company’s anticipated financial performance, the anticipated benefits 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, 2023 filed with the SEC on March 27, 2024, its Quarterly Report on Form 10-Q for quarter ended March 31, 2024, filed with the SEC on May 15, 2024, 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

— Financial Tables Follow —

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEET DATA

(Unaudited)

(In thousands)

	As of
	March 31, 2024			December 31, 2023
Cash and cash equivalents	$	-		$	-
Restricted cash		689			580
Trade accounts receivable, net		4,306			5,738
Total current liabilities		74,239			72,463
Total stockholders’ deficit		(70,666	)		(66,510	)
Total liabilities, convertible and redeemable preferred stock and stockholders’ deficit		8,217			10,554

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except share and per share data)

	Three Months Ended March 31,
	2024			2023
Product sales, net	$	3,603		$	5,809

Operating Expenses:
Cost of goods sold		684			1,376
Research and development		594			540
Selling and marketing		2,345			3,854
General and administrative		2,824			3,618
Total operating expenses		6,447			9,388
Loss from operations		(2,844	)		(3,579	)
Other income (expense):
Interest income		4			18
Other expense, net		(616	)		(318	)
Loss on issuance of financial instruments		(3,275	)		(84	)
Gain on debt extinguishment		1,120			-
Change in fair value of financial instruments		802			1,612
Total other income (expense), net		(1,965	)		1,228
Loss before income tax		(4,809	)		(2,351	)
Income tax expense		-			(3	)
Net loss		(4,809	)		(2,354	)
Convertible preferred stock deemed dividends		(47	)		-
Net loss attributable to common stockholders	$	(4,856	)	$	(2,354	)
Net loss per share attributable to common stockholders (basic and diluted):	$	(0.16	)	$	(1.85	)
Weighted-average shares used to compute net loss per share attributable to common shareholders (basic and diluted):		31,194,393			1,271,524

###

Cover	May 15, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 15, 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
Entity Information, Former Legal or Registered Name	Not applicable.