8-K/A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K/A

 (Amendment No. 1)

 CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 11, 2021

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.)

12400 High Bluff Drive, Suite 600, San Diego, CA 92130

(Address of principal executive offices and zip code)

(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	The Nasdaq Stock Market LLC (Nasdaq Capital Market)
Series A Preferred Stock Purchase Rights, par value $0.0001 per share	N/A	The Nasdaq Stock Market LLC (Nasdaq Capital Market)

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.  ☐

Explanatory Note

This Current Report on Form 8-K/A (the “Amendment Filing”) updates the disclosures made in the Current Report on Form 8-K filed on August 11, 2021 (the “Original 8-K”) by Evofem Biosciences, Inc. (the “Company”) solely to include the form of press release as was actually disseminated on August 11, 2021 as Exhibit 99.1. Exhibit 99.1 of the Original Filing erroneously included a reference to 61% growth in the prescriber base for the second quarter of 2021 as compared to the first quarter of 2021 in the body of the press release, but in the press release actually disseminated by the Company on August 11, 2021 the number was correctly reflected as 52% growth in the prescriber base for the periods indicated. Except as expressly set forth herein, this Amendment Filing does not amend, modify or update the disclosures contained in the Original Filing.

Item 2.02. Results of Operations and Financial Condition.

On August 11, 2021, the Company issued a press release announcing its financial results for the three and six months ended June 30, 2021. 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 August 11, 2021

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: August 12, 2021	By:	/s/ Justin J. File
		Justin J. File Chief Financial Officer

EX-99.1

Exhibit 99.1

Evofem Biosciences Reports Second Quarter 2021

Financial Results and Provides Corporate Update

-- 68% increase in net product sales Q1 to Q2 --

-- 47% increase in Phexxi prescriptions --

-- 65% increase in dispensed units --

-- 52% increase in Phexxi prescriber base --

-- Conference call scheduled for 4:30 p.m. ET today --

SAN DIEGO, August 11, 2021 - Evofem Biosciences, Inc., (NASDAQ: EVFM) (“Evofem" or the “Company"), today reported financial results for the three- and six-month periods ended June 30, 2021.

“We are pleased to show strong and sustainable growth in Phexxi prescriptions and dispensed units in the second quarter. This momentum allows us to further accelerate the growth trajectory with our celebrity campaign launching in early September,” said Saundra Pelletier, Evofem's Chief Executive Officer.

Second quarter and recent highlights include:

•12,763 Phexxi® (lactic acid, citric acid and potassium bitartrate) prescriptions were filled and 14,810 units were dispensed to patients during the second quarter of 2021, an increase of 47% and 65%, respectively, compared to the first quarter of 2021.

•52% growth in the prescriber base in the second quarter of 2021 compared to the first quarter of 2021, and over 7,700 healthcare providers have prescribed Phexxi from launch through mid-July.

•National brand ambassador campaign featuring an Emmy Award-winning celebrity launching in September 2021 to accelerate growth in Phexxi brand awareness and prescriptions.

•On track to complete enrollment in EVOGUARD by year-end 2021. This pivotal Phase 3 clinical trial is evaluating safety and efficacy of EVO100 for the prevention of chlamydia and gonorrhea in women.

Financial Results

For the three months ended June 30, 2021, Phexxi net product sales increased 68% to $1.9 million, compared to $1.1 million in the three months ended March 31, 2021. There were no net product sales in the second quarter of 2020, since Phexxi was launched in the U.S. in September 2020.

Total operating expenses decreased 6% to $43.0 million for the second quarter of 2021 compared to $46.0 million in the first quarter of 2021.

•Cost of goods sold was $0.8 million, compared to $0.5 million in the first quarter of 2021, reflecting higher Phexxi sales.

•Research and development costs increased 17% to $8.5 million, compared to $7.3 million in the first quarter of 2021, reflecting higher enrollment in the Phase 3 EVOGUARD trial. This trial is funded in part by the proceeds from the Adjuvant convertible notes issued in 2020.

•Selling and marketing costs decreased 11% to $27.2 million, compared to $30.5 million in the first quarter of 2021 due primarily to lower media and agency fees, which were offset in part by costs related to the Phexxi sample rollout.

•General and administrative costs were $6.4 million compared to $7.7 million in the first quarter of 2021, primarily reflecting lower headcount, recruiting, and outside services.

During the second quarter, the Company implemented cost containment measures across all departments. These included reductions in spend and headcount, elimination of certain consulting roles, and eliminating hires planned for 2021. These measures are expected to result in aggregate savings of $9.5 million on an annualized basis.

Total other income, net, was $7.7 million in the second quarter of 2021, and mainly included a $8.9 million change in fair value as a result of mark-to-market adjustments and $1.2 million in interest expense for the convertible notes issued in 2020.

Net loss attributable to common stockholders improved to $33.4 million, or $(0.27) per share, for the quarter ended June 30, 2021, compared with a net loss of $46.2 million, or $(0.56) per share, in the first quarter of 2021 and a net loss of $52.7 million, or $(0.91) per share, for the prior year quarter.

Cash and cash equivalents was $47.0 million at June 30, 2021. In addition, at June 30, 2021, $14.9 million in restricted cash from the Adjuvant notes was available for use.

Conference Call

As previously announced, the Evofem management team will host a conference call to discuss its financial results for the second quarter ended June 30, 2021 and business highlights on Wednesday, August 11, 2021 at 4:30 p.m. ET (1:30 p.m. PT).

The webcast (live and archived) and related slide presentation can be accessed through https://evofem.investorroom.com/2021Q2Results or https://edge.media-server.com/mmc/p/h6zpy9h5.

Please connect to the webcast at least 15 minutes prior to the start of the call to download any software that may be required.

If participating by phone, please dial in approximately 15 minutes prior to the start of the call using (866) 503-5561 (U.S. toll-free) or (253) 336-2965, and referring to conference ID 9190716.

A telephone replay will be available for 24 hours after the call at (855) 859-2056 (U.S.) or (404) 537-3406 (International), conference ID 9190716.

About Evofem Biosciences, Inc.

Evofem Biosciences, Inc., (NASDAQ: EVFM) is developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from certain sexually transmitted infections (STIs). The Company

launched its first FDA-approved commercial product, Phexxi® (lactic acid, citric acid and potassium bitartrate), in the United States in September 2020. The Company is evaluating lead product candidate EVO100 for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection in women in the ongoing Phase 3 clinical trial, 'EVOGUARD.' For more information, please visit www.evofem.com.

Phexxi® is a trademark of Evofem Biosciences.

About PHEXXI

Phexxi is an on-demand method of birth control used to prevent pregnancy. Phexxi is not effective when used after sex. For more information about Phexxi, talk to your healthcare provider and see full Product Information, which is available at https://www.phexxi.com/pdf/PhexxiUSPI.pdf.

IMPORTANT SAFETY INFORMATION

•Rare cases (0.36%) of bladder and kidney infection have been reported. If you have a history of urinary tract problems that keep coming back, you should not use Phexxi.

•Contact your healthcare provider if you are experiencing genitourinary side effects such as vaginal burning, itching, discharge, genital discomfort (including in male partners), yeast infection, urinary tract infection or bacterial vaginosis.

•Phexxi does not protect against any sexually transmitted infections, including HIV.

Please report side effects by contacting Evofem Biosciences toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 potential growth, momentum and trajectory, the potential results of celebrity campaigns, matters relating to the ongoing development of EVO100 and potential results of any cost containment measures. Various factors could cause actual results to differ materially from those discussed or implied in the forward-looking statements, and 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, or that could impair the value of Evofem Biosciences' assets and business, are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 4, 2021. 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 Relations Contact

Amy Raskopf

Evofem Biosciences, Inc.

araskopf@evofem.com

Mobile: (917) 673-5775

Media Contact

Ellen Thomas

Evofem Biosciences, Inc.

ethomas@evofem.com 

Mobile: (718) 490-3248

(Tables follow)

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEET DATA

(Unaudited)

(In thousands)

	June 30, 2021		December 31, 2020
Cash and cash equivalents	$	46,982	$	48,892
Restricted cash	15,206		22,559
Trade accounts receivable, net	3,108		1,067
Total current liabilities	68,321		77,283
Total liabilities	99,784		108,621
Total stockholders’ equity	8,964		1,347

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except share and per share data)

	Three Months Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
Product sales, net	$	1,857	$	—	$	2,962	$	—
Operating expenses:
Cost of goods sold	839		—		1,345		—
Research and development	8,507		2,640		15,769		6,887
Selling and marketing	27,237		9,997		57,762		17,852
General and administrative	6,416		9,735		14,100		16,877
Total operating expenses	42,999		22,372		88,976		41,616
Loss from operations	(41,142)		(22,372)		(86,014)		(41,616)
Other income (expense):
Interest income	4		29		11		131
Other expense	(1,186)		(349)		(2,331)		(353)
Loss on issuance of financial instruments	—		(64,049)		—		(64,049)
Change in fair value of financial instruments	8,910		34,075		8,768		34,075
Total other income (expense), net	7,728		(30,294)		6,448		(30,196)
Loss before income tax	(33,414)		(52,666)		(79,566)		(71,812)
Income tax expense	(12)		—		(11)		—
Net loss	$	(33,426)	$	(52,666)	$	(79,577)	$	(71,812)
Net loss per share, basic and diluted	$	(0.27)	$	(0.91)	$	(0.77)	$	(1.36)
Weighted-average shares used to compute net loss per share, basic and diluted	125,168,570		57,696,519		103,625,627		52,946,235

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XML

Cover	Aug. 11, 2021
Entity Information [Line Items]
Document Type	8-K/A
Document Period End Date	Aug. 11, 2021
Entity Registrant Name	EVOFEM BIOSCIENCES, INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-36754
Entity Tax Identification Number	20-8527075
Entity Address, Address Line One	12400 High Bluff Drive
Entity Address, Address Line Two	Suite 600
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92130
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
Amendment Description	This Current Report on Form 8-K/A updates the disclosures made in the Current Report on Form 8-K filed on August 11, 2021 by Evofem Biosciences, Inc. solely to include the form of press release as was actually disseminated on August 11, 2021 as Exhibit 99.1. This Current Report on Form 8-K/A does not otherwise amend, modify or update the disclosures contained in the Original Filing.
Entity Emerging Growth Company	false
Amendment Flag	true
Entity Central Index Key	0001618835
Common Stock
Entity Information [Line Items]
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	EVFM
Security Exchange Name	NASDAQ
Preferred Stock
Entity Information [Line Items]
Title of 12(b) Security	Series A Preferred Stock Purchase Rights, par value $0.0001 per share
No Trading Symbol Flag	false
Security Exchange Name	NASDAQ