8-K

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): September 10, 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.  ☐

Item 7.01. Regulation FD Disclosure.

Evofem Biosciences, Inc. (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 99.1. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.

The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) 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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Corporate presentation prepared as of September 10, 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: September 10, 2021	By:	/s/ Justin J. File
		Justin J. File Chief Financial Officer

EX-99.1

Revolutionizing Women’s Sexual and Reproductive Health September 2021 NASDAQ: EVFM evofem.com © 2021 Evofem Biosciences, Inc. | For investor discussions only.

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 2 Forward-Looking Statements This presentation contains forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. In some cases, you can identify forward looking statements by terms such as “may,” ”will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “strategy,” “objective,” “designed,” “suggest,” “currently,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Factors that may cause differences between current expectations and actual results include, but are not limited to, the following: o The rate and degree of market acceptance of Phexxi® (lactic acid, citric acid and potassium bitartrate) vaginal gel o Evofem’s ability to successfully commercialize Phexxi and its ability to develop sales and marketing capabilities o Evofem’s ability to maintain and protect its intellectual property o Evofem’s ability to rely on existing cash reserves to fund its current development plans and operations and to raise additional capital when needed o Evofem’s reliance on third-party providers, such as third-party manufacturers and clinical research organizations o The presence or absence of any adverse events or side effects relating to the use of Phexxi and EVO100 o The outcome or success of Evofem’s clinical trials including EVOGUARD o Evofem’s ability to retain members of its management and other key personnel o General risks to the economy represented by spread of the COVID-19 virus o Evofem’s ability to obtain the necessary regulatory approvals for its product candidates and the timing of such approvals, and, o Any other risk factors detailed in Evofem’s filings from time to time with the U.S. Securities and Exchange Commission including, without limitation, the 10-K filed on March 4, 2021, and subsequent filings. The forward looking statements in this presentation represent Evofem’s views only as of the date of this presentation, September 8, 2021, and Evofem expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evofem’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this presentation are qualified in their entirety by this cautionary statement.

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 3 Multi-billion $$ addressable U.S. market opportunity for current and late-stage investigational indications Shattering the hormone glass ceiling with hormone-free, on-demand prescription contraceptive vaginal gel Top-line data in Q2 2022 from Pivotal Phase 3 trial in prevention of chlamydia and gonorrhea • Expected to be first Rx product approved for prevention of these common STIs Evofem Biosciences (Nasdaq: EVFM)

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 4 An Innovative Prescription Contraceptive • FDA-approved for the prevention of pregnancy • Hormone-free • Applied 0-60 minutes before each act of sex • Box of 12 pre-filled applicators

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 5 Vaginal pH Modulator MOA When semen (pH 7.1 - 8) enters the vagina, it raises the environmental pH level • Allows sperm to be mobile and swim up the reproductive canal Phexxi works to keep vaginal pH in the baseline range Vaginal pH modulation underlies current pipeline programs • Many bacterial & viral pathogens require higher vaginal pH for survival • Initial targets: - Gonorrhea: Pivotal Phase 3 - Chlamydia: Pivotal Phase 3 - Bacterial vaginosis: Phase 2-ready Baseline vaginal pH levels can range from 3.5 - 4.5

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 6 $1.5B – $2.4B U.S. Opportunity U.S. CONTRACEPTIVE COMMERCIAL OPPORTUNITY 1. Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2015-2017. NCHS Data Brief. 2018; 327: 1-14. 2. Example market penetration in segment 3. Gross value of Phexxi user = $267.50 WAC x 7 annual refills = $1,872.50 (does not reflect net pricing to Evofem) Other Non- Targets – 12.3M Surgical Sterilization – 17.7M Non-Rx Contraceptive Users - 10.3M No Contraceptive – 13.1M Rx Contraceptive Users – 18.8M U.S. Contraceptive Market: 72.2M Women1 360k – 460k users Potential Acquisition 3.5% – 4.5% (2) 10.3 M women $670M – $860M (3) 260k – 460k users Potential Acquisition 2.0% – 3.5% (2) 13.1 M women $490M – $860M (3) 190k – 380k users Potential Acquisition 1.0% – 2.0% (2) 18.8 M women $350M – $710M (3) Non-Rx Contraceptives: 6.3M barrier methods; 2.8M withdrawal; 1.0M periodic abstinence; 0.1M other + +

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 7 Strong Quarter over Quarter Growth: Prescriptions and Dispensed Units Source: IQVIA (including Knipper) monthly data; excludes 340b/VA dispenses Note: Some Phexxi prescriptions are for more than one unit 65% INCREASE IN DISPENSED UNITS AND 47% TRx INCREASE IN Q2 379 3,855 8,681 12,763 3,903 8,986 14,810 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 - 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Di sp en se d U ni ts TR xs TRx Dispensed Units

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 8 CUMULATIVE PHEXXI PRESCRIBERS OVER 8,600 HCPS HAVE PRESCRIBED PHEXXI FROM LAUNCH THROUGH AUGUST 20, 2021 Strong Quarter over Quarter Growth: Phexxi Prescriber Base Source: XPO Dispensed NRx by HCP, including Knipper and excludes 340b/VA dispenses (data unavailable at HCP level) 231 1,828 4,784 7,252 0 2,000 4,000 6,000 8,000 at 9/30/20 at 12/31/20 at 3/31/21 at 6/30/21 52%

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 9 User Demographics • 49% were not on a method of contraception in the past year • 29% switching from oral contraceptives • 7% switching from hormonal rings and patches Age demographic: early 20s to 35 No Contraception 49% Oral Contraceptives 29% Rings & Patches 7% Other Method 15% PRIOR CONTRACEPTION AMONG WOMEN SWITCHING TO PHEXXI

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 10 Phexxi for Cancer Patients WHY • ~800,000 new cancer cases reported annually among women1 • Many women with cancer are contraindicated to hormones • Phexxi uniquely offers hormone-free, non-invasive prescription contraception WHAT • Launched NCODA collaboration Q1 2021 • Keynote address, Phexxi data presented at 2021 NCODA Spring Forum • Positive Quality Intervention (PQI) published in connection with Phexxi • Virtual education platforms - Phexxi featured on PQI Podcast • White papers Source: 1. U.S. Cancer Statistics: Highlights from 2017 Incidence. U.S. Cancer Statistics Data Briefs, No. 17, June 2020. https://www.cdc.gov/cancer/uscs/about/data-briefs/no17-USCS-highlights-2017-incidence.htm

MY STORY. MY RULES.

Testimonial TELL HORMONES TO TAKE A HIKE.

Annie Murphy’s Journey to Finding Phexxi To view Annie Murphy’s Phexxi story, please visit https://www.phexxi.com/annie-murphy

To view the :60 Annie Murphy x Phexxi commercial please visit https://www.phexxi.com/annie-murphy

House Rules will Extend through a Full Omni-Channel Rollout Campaign Videos ●:60 & :45 second commercial ●Annie’s personal birth control testimonial video Online Video Series ●:15 videos focused on Phexxi House Rules for online and social channels Social Media ●Phexxi social media organic content ●Phexxi social media paid Ads ●Annie Murphy social activation Influencers ● Influencer amplification & content extensions Digital Media ●Banners & media integration across lifestyle and endemic channels Phexxi.com ●Phexxi.com home page integration + dedicated campaign microsite Digital Currency ●Phexxi Gify channel on Instagram PR ●Top tier earned media coverage; lifestyle & trade outlets

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 16 I. Increase Access through ACA Affordable Care Act (ACA) currently mandates 18 specific methods of contraception be covered without any out-of- pocket costs Aggressively advancing strategy to gain new “vaginal pH modulator” category for Phexxi • Would provide increased access to Phexxi for women across the U.S. House Appropriations Committee included in a funding memo that they expect the Office of Women’s Health to take action on the contraceptive categories chart Federal Health Resources & Services Administration is currently reviewing its guidance regarding contraceptive coverage for insurers; expects to complete its review late this year

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 17 Current Reimbursement OVER 65% of prescriptions currently covered 100% of Medicaid recipients have access to Phexxi through National Drug Rebate agreement Medi-Cal (California) added Phexxi to a preferred drug position Covered means patient has access to Phexxi, whether unrestricted or restricted access (i.e. prior authorizations or step therapy (trial of another product before Phexxi would be approved)) Medicaid - Per our agreement with CMS as of 1/1/21 Phexxi must be generally covered (cannot be excluded).

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 18 Expand Global Reach: ex-U.S. Licenses • Discussions underway with potential licensees for commercialization of Phexxi in multiple international markets • Anticipated structure: - Upfront capital - Milestone payments - Tiered royalties on future sales • Targeting first license agreement in place by YE 2021

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 19 Successfully Develop EVO100 for STI Prevention • Goal – expand Phexxi label to include prevention of urogenital chlamydia and gonorrhea in women • Ongoing pivotal Phase 3 trial builds on highly positive Phase 2B/3 trial1 1. Chappell T et al. EVO100 Prevents Chlamydia and Gonorrhea in Women at High-Risk for Infection. Am. J. Obstet Gynecol, 2021. https://doi.org/10.1016/j.ajog.2021.03.005 2. Assumes timely enrollment 3. Assumes favorable outcomes of EVOGUARD 4. Assumes FDA approval Potential U.S. Approval & Commercial Launch4 sNDA Submission3Top-Line Results2Complete Enrollment in Pivotal Phase 3 Trial ‘EVOGUARD’ 2 Patient Screening & Enrollment (n=1730) 2021 2022 2023 EVO100 is investigational and safety and efficacy have not been established.

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 20 Opportunity: Prevention of Chlamydia & Gonorrhea 1. US Centers for Disease Control and Prevention (2019): CDC detailed fact sheet on gonorrhea and CDC detailed fact sheet on chlamydia 2. Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2015-2017. NCHS Data Brief. 2018; 327: 1-14. 3. World Bank staff estimates using the World Bank's total population and age/sex distributions of the United Nations Population Division's World Population Prospects: 2019 Revision. https://data.worldbank.org/indicator/SP.POP.TOTL.FE.IN EVO100 is investigational and safety and efficacy have not been established. Any sexually active person can be infected with chlamydia or gonorrhea1 72.2 million women in the U.S. alone2 3.84 billion women worldwide3

© 2021 Evofem Biosciences, Inc. | For investor discussions only. Page | 21 Breaking the Hormone Glass Ceiling Additional value creating opportunities Phexxi: hormone-free prescription contraception women control and use only when needed Aggressively pursuing ACA strategy Advancing ex-U.S. partnership discussions Advancing pivotal Phase 3 trial for prevention of two common STIs $2.4B peak U.S. market opportunity All sexually active women at risk

1.858.550.1900 ir@evofem.com 12400 High Bluff Drive, Suite 600 San Diego, California 92130 NASDAQ: EVFM evofem.com Thank You

XML

Cover	Sep. 10, 2021
Entity Information [Line Items]
Document Type	8-K
Document Period End Date	Sep. 10, 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
Entity Emerging Growth Company	false
Amendment Flag	false
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