UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 _____________________________________________________
 
FORM 10-Q
  ____________________________________________________
(Mark One)
xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2020March 31, 2021
or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from            to                
Commission File Number: 001-36754
  _____________________________________________________
  EVOFEM BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
 ___________________________________________________ 
Delaware
(State or other jurisdiction
of incorporation)
20-8527075
(IRS Employer
Identification No.)
12400 High Bluff Drive, Suite 600
San Diego, CA
(Address of Principal Executive Offices)
92130
(Zip Code)
Registrant’s telephone number, including area code: (858) 550-1900
Not applicable.
(Former name or former address, if changed since last report.)
 ____________________________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.0001 per shareEVFM
The Nasdaq Stock Market LLC
(Nasdaq Capital Market)
Series A Preferred Stock Purchase Rights, par value $0.0001 per shareN/A
The Nasdaq Stock Market LLC
(Nasdaq Capital Market)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes xNo
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes xNo
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Accelerated filer
Non-accelerated filer x
Smaller reporting company x
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.  


Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No x


The number of shares of the registrant’s common stock, $0.0001 par value per share, outstanding as of July 31, 2020April 30, 2021 was 81,280,286.102,835,674



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Page
Page
PART I.
Item 1.
Item 2.
Item 3.
Item 4.
PART II.
Item 1.
Item 1A.
Item 2.
Item 3.
Item 4.
Item 5.
Item 6.





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FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q (Quarterly Report), contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sectionssection entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” All statements, other than statements of historical facts, contained in this Quarterly Report, including statements regarding our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. Words such as, but not limited to, “anticipate,” “aim,” “believe,” “contemplate,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “suggest,” “strategy,” “target,” “will,” “would,” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
These forward-looking statements include, among other things, statements about:


our projected financial position;
our strategic plans for our business;
our plans to launch and commercialize our product, PhexxiTM;
our commercialization, marketing and manufacturing capabilities and strategy with respect to Phexxi, including our plans regarding the Phexxi Concierge Experience, Coming Soon campaign, media and digital campaigns, and contracted tele-detailing vendors;
our estimates regarding expenses, future revenues and capital requirements;
our ability to continue as a going concern;
our ability to raise additional capital to fund our operations;
our ability to obtain achieve and sustain profitability;
our estimates regarding our future performance, including without limitation, any estimates of potential future revenues;
the necessary regulatory approvals torate and degree of market acceptance of Phexxi® (lactic acid, citric acid, and commercialize EVO100 for prevention of urogenital transmission of Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women, or any other product candidate we may seek to develop;potassium bitartrate) vaginal gel (Phexxi);
the success, cost and timing of our clinical trials;
our ability to obtain additional patent protectionsuccessfully commercialize Phexxi and continue to develop our sales and marketing capabilities;
our strategic plans for our productbusiness, including the commercialization of Phexxi;
our estimates regarding expenses, revenues, financial performance and product candidates;capital requirements, including the length of time our capital resources will sustain our planned operations;
our dependence on third parties in the conduct of our clinical trials;
our ability to establishcontinue as a going concern;
the impacts of the ongoing pandemic related to a novel strain of a virus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus), which causes coronavirus disease 2019 (COVID-19), including, without limitation, its impact on our business and develop sales, manufacturing and marketing capabilities or our ability to enter into agreements with third parties to manufacture or to market and sell any approved products or product candidates we may have, including our plans to recruit and train an internal salesforce and scale up commercial manufacturing for the launchcommercialization of Phexxi;
the potential for changes to current regulatory mandates requiring health insurance plans to cover U.S.United States (U.S.) Food and Drug Administration (FDA)-cleared or approved-approved contraceptive products without cost sharing, sharing;
our ability to obtain or maintain third-party payer coverage and adequate reimbursement, and our reliance on the willingness of patients to pay out-of-pocket for Phexxi absent full or partial third-party payer reimbursement;
the ongoing COVID-19 pandemic, including its impact on our business and commercialization plans and or ability to adaptobtain the necessary regulatory approvals to related challenges;market and commercialize EVO100 vaginal gel (EVO100) for prevention of urogenital transmission of Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women, and any other product candidate we may seek to develop;
the success, cost and timing of our clinical trials;
our top-line or initial clinical trial data, which are subject to adjustment and revision;
our ability to protect and defend our intellectual property position and our reliance on third party licensors;
our ability to obtain additional patent protection for our product and product candidates;
our dependence on third parties in the conduct of our clinical trials and for the manufacture of Phexxi and our product candidates;
our ability to expand our organization to accommodate potential growthgrowth; and for the launch of Phexxi; and
our ability to retain and attract key personnel.


OnlyTo date, only one of our products, Phexxi vaginal gel, has been approved by the FDA.FDA for marketing in the United States. Our other current product candidates are investigational and have not been submitted to or approved by the FDA, and neither Phexxi nor our other product candidates have been approved by the European CommissionMedicines Agency or any other regulatory commissionauthority anywhere else in the world. This Quarterly Report also contains estimates and other statistical data made by independent parties and by us relating to market opportunity, growth and other data about our industry. These data and estimates involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that these statements are based on our projections of the future that are subject to known and unknown risks and uncertainties and other factors that may cause our actual results, level of activity, performance or achievements expressed or implied by these forward-looking statements, to differ. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement. Forward-looking statements should be regarded solely as our current plans, estimates and beliefs. You should read this Quarterly Report and the documents that we have filed as exhibits to this Quarterly Report and incorporated by reference herein completely and with the understanding that our actual results may be materially different from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results to differ materially from those discussed in our forward-looking statements are discussed in Exhibit 99.2 (Risk Factors of Evofem Biosciences, Inc.) of our Current Report on Form 8-K, as filed with the Securities Exchange Commission on June 2, 2020. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially
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from those contained in any forward-looking statements we may make. The

forward-looking statements contained in this Quarterly Report are made as of the date of this Quarterly Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise except as required by applicable law.



Unless the context requires otherwise, references in this Quarterly Report to “Evofem,” “Company,” “we,” “us” and “our” refer to Evofem Biosciences, Inc. and our subsidiaries.



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PART I. FINANCIAL INFORMATION
ITEM 1. Financial Statements
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
  
(Unaudited)
(In thousands, except par value and share data)
June 30, 2020 December 31, 2019 March 31, 2021December 31, 2020
Assets   Assets
Current assets:   Current assets:
Cash and cash equivalents$123,556
 $15,571
Cash and cash equivalents$45,318 $48,892 
Restricted cash200
 304
Restricted cash18,975 22,559 
Short-term investments
 8,233
Trade accounts receivable, netTrade accounts receivable, net2,914 1,067 
Inventories1,440
 
Inventories8,990 7,162 
Prepaid and other current assets2,694
 2,313
Prepaid and other current assets4,138 18,050 
Total current assets127,890
 26,421
Total current assets80,335 97,730 
Property and equipment, net1,084
 394
Property and equipment, net5,614 4,334 
Operating lease right-of-use assets5,015
 160
Operating lease right-of-use assets6,493 6,856 
Other noncurrent assets1,067
 1,320
Other noncurrent assets1,022 1,048 
Total assets$135,056
 $28,295
Total assets$93,464 $109,968 
Liabilities and stockholders’ equity   
Liabilities and stockholders’ equity (deficit)Liabilities and stockholders’ equity (deficit)
Current liabilities:   Current liabilities:
Accounts payable$8,421
 $6,008
Accounts payable$6,501 $10,641 
Convertible notes payable44,302
 
Convertible notes payable (Note 5)Convertible notes payable (Note 5)53,218 52,409 
Accrued expenses2,597
 2,784
Accrued expenses8,978 4,476 
Accrued compensation5,944
 3,670
Accrued compensation3,004 6,514 
Operating lease liabilities - current542
 197
Operating lease liabilities – current Operating lease liabilities – current2,456 2,290 
Other current liabilitiesOther current liabilities1,549 953 
Total current liabilities61,806
 12,659
Total current liabilities75,706 77,283 
Operating lease liabilities - noncurrent4,711
 
Operating lease liabilities – noncurrentOperating lease liabilities – noncurrent5,602 6,030 
Long-term convertible notes payable (Note 5)Long-term convertible notes payable (Note 5)25,697 25,211 
Other noncurrent liabilitiesOther noncurrent liabilities97 97 
Total liabilities66,517
 12,659
Total liabilities107,102 108,621 
Commitments and contingencies (Note 7)
 
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding
 
Stockholders’ equity:   
Common stock, $0.0001 par value; 300,000,000 shares authorized; 81,300,667 and 48,137,880 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively;8
 5
Commitments and contingencies (Note 8)Commitments and contingencies (Note 8)00
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; 0 shares issued and outstandingPreferred stock, $0.0001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding
Stockholders’ equity (deficit):Stockholders’ equity (deficit):
Common stock, $0.0001 par value; 300,000,000 shares authorized; 100,264,246 and 81,351,533 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively;Common stock, $0.0001 par value; 300,000,000 shares authorized; 100,264,246 and 81,351,533 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively;10 
Additional paid-in capital653,522
 528,810
Additional paid-in capital687,991 656,827 
Accumulated deficit(584,991) (513,179)Accumulated deficit(701,639)(655,488)
Total stockholders’ equity68,539
 15,636
Total liabilities and stockholders’ equity$135,056
 $28,295
Total stockholders’ equity (deficit)Total stockholders’ equity (deficit)(13,638)1,347 
Total liabilities and stockholders’ equity (deficit)Total liabilities and stockholders’ equity (deficit)$93,464 $109,968 


See accompanying notes to the condensed consolidated financial statements (unaudited).

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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share and per share data)
 
Three Months Ended March 31,
Three Months Ended June 30, Six Months Ended June 30, 20212020
Product sales, netProduct sales, net$1,105 $
2020 2019 2020 2019
Operating expenses:       Operating expenses:
Cost of goods soldCost of goods sold506 
Research and development$2,640
 $5,246
 $6,887
 $13,135
Research and development7,262 4,247 
Selling and marketing9,997
 1,313
 17,852
 2,431
Selling and marketing30,525 7,855 
General and administrative9,735
 5,382
 16,877
 10,007
General and administrative7,684 7,142 
Total operating expenses22,372
 11,941
 41,616
 25,573
Total operating expenses45,977 19,244 
Loss from operations(22,372) (11,941) (41,616) (25,573)Loss from operations(44,872)(19,244)
Other income (expense):       Other income (expense):
Interest income29
 108
 131
 126
Interest income102 
Other expense(349) (7) (353) (21)Other expense(1,145)(4)
Loss on issuance of financial instruments(64,049) (674) (64,049) (674)
Change in fair value of financial instruments34,075
 (22,932) 34,075
 (27,372)Change in fair value of financial instruments(142)
Total other expense, net(30,294) (23,505) (30,196) (27,941)
Total other (expense) income, netTotal other (expense) income, net(1,280)98 
Loss before income tax(52,666) (35,446) (71,812) (53,514)Loss before income tax(46,152)(19,146)
Income tax expense
 (4) 
 (4)Income tax expense
Net loss$(52,666) $(35,450) $(71,812) $(53,518)Net loss$(46,151)$(19,146)
Net loss per share, basic and diluted$(0.91) $(0.97) $(1.36) $(1.68)Net loss per share, basic and diluted$(0.56)$(0.40)
Weighted-average shares used to compute net loss per share, basic and diluted57,696,519
 36,732,568
 52,946,235
 31,941,850
Weighted-average shares used to compute net loss per share, basic and diluted81,843,319 48,195,951 
See accompanying notes to condensed consolidated financial statements (unaudited).

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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
(In thousands, except share data)

 Common Stock Additional Paid-in Capital Accumulated Deficit Total Stockholders’ Equity (Deficit)
 Shares Amount
Balance at December 31, 201948,137,880
 $5
 $528,810
 $(513,179) $15,636
Issuance of common stock in connection with ATM (see Note 10)202,098
 
 1,082
 
 1,082
Issuance of common stock - exercise of stock options19,708
 
 73
 
 73
Restricted stock awards issued/restricted stock units released1,286,499
 
 
 
 
Shares withheld to cover taxes related to vesting of restricted stock awards(4,088) 
 (25) 
 (25)
Stock-based compensation
 
 3,401
 
 3,401
Net loss
 
 
 (19,146) (19,146)
Balance at March 31, 202049,642,097
 $5
 $533,341
 $(532,325) $1,021
Issuance of common stock in connection with the Public Offering (see Note 10)31,700,000
 3
 103,263
 
 103,266
Issuance of common stock in connection with ATM474,558
 
 2,280
 
 2,280
Issuance of common stock - ESPP and exercise of stock options69,398
 
 177
 
 177
Restricted stock awards issued/restricted stock units released60,168
 
 
 
 
Shares withheld to cover taxes related to vesting of restricted stock awards(645,754) 
 (2,777) 
 (2,777)
Issuance of common stock upon cash exercise of warrants and issuance of Reload Warrants200
 
 2
 
 2
Short-swing profit disgorgement
 
 187
 
 187
Reclassification from financial instruments liability to equity
 
 11,015
 
 11,015
Stock-based compensation
 
 6,034
 
 6,034
Net loss
 
 
 (52,666) (52,666)
Balance at June 30, 202081,300,667
 $8
 $653,522
 $(584,991) $68,539
 Common StockAdditional Paid-in CapitalAccumulated DeficitTotal Stockholders’ Equity (Deficit)
 SharesAmount
Balance at December 31, 202081,351,533 $$656,827 $(655,488)$1,347 
Issuance of common stock in connection with the 2021 Public Offering (see Note 10)17,142,857 27,707 — 27,709 
Restricted stock awards issued1,772,500 — — — — 
Shares withheld to cover taxes related to vesting of restricted stock awards(2,644)— (7)— (7)
Stock-based compensation— — 3,464 — 3,464 
Net loss— — — (46,151)(46,151)
Balance at March 31, 2021100,264,246 $10 $687,991 $(701,639)$(13,638)

 Common Stock Additional Paid-in Capital Accumulated Deficit Total Stockholders’ Equity (Deficit)
 Shares Amount
Balance at December 31, 201825,867,248
 $3
 $409,787
 $(433,146) $(23,356)
Issuance of common stock upon cash exercise of warrants and issuance of Reload Warrants (see Note 10)2,376,065
 
 10,617
 
 10,617
Restricted stock awards issued/restricted stock units released470,500
 
 
 
 
Shares withheld to cover taxes related to vesting of restricted stock awards(1,639) 
 (6) 
 (6)
Stock-based compensation
 
 1,962
 
 1,962
Net loss
 
 
 (18,068) (18,068)
Balance at March 31, 201928,712,174
 $3
 $422,360
 $(451,214) $(28,851)
Issuance of common stock in connection with the Private Placement (see Note 10)17,777,779
 2
 68,322
 
 68,324
Issuance of common stock - exercise of stock options16,823
 
 46
 
 46
Restricted stock awards issued/restricted stock units released6,000
 
 
 
 
Shares withheld to cover taxes related to vesting of restricted stock awards(86,461) 
 (518) 
 (518)
Reclassification from financial instruments liability to equity
 
 29,726
 
 29,726
Stock-based compensation
 
 2,515
 
 2,515
Net loss
 
 
 (35,450) (35,450)
Balance at June 30, 201946,426,315
 $5
 $522,451
 $(486,664) $35,792

 Common StockAdditional Paid-in CapitalAccumulated DeficitTotal Stockholders’ Equity
 SharesAmount
Balance at December 31, 201948,137,880 $$528,810 $(513,179)$15,636 
Issuance of common stock in connection with ATM (see Note 10)202,098 — 1,082 — 1,082 
Issuance of common stock - exercise of stock options19,708 — 73 — 73 
Restricted stock awards issued/restricted stock units released1,286,499 — — — — 
Shares withheld to cover taxes related to vesting of restricted stock awards(4,088)— (25)— (25)
Stock-based compensation— — 3,401 — 3,401 
Net loss— — — (19,146)(19,146)
Balance at March 31, 202049,642,097 $$533,341 $(532,325)$1,021 


See accompanying notes to condensed consolidated financial statements (unaudited).

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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
Six Months Ended June 30, Three Months Ended March 31,
2020 2019 20212020
Cash flows from operating activities:   Cash flows from operating activities:
Net loss$(71,812) $(53,518)Net loss$(46,151)$(19,146)
Adjustments to reconcile net loss to net cash, cash equivalents and restricted cash used in operating activities:   Adjustments to reconcile net loss to net cash, cash equivalents and restricted cash used in operating activities:
Loss on issuance of financial instruments64,049
 674
Change in fair value of financial instruments(34,075) 27,372
Change in fair value of financial instruments142 
Stock-based compensation9,435
 4,477
Stock-based compensation3,464 3,401 
Depreciation123
 132
Depreciation195 69 
Noncash lease expenses364
 319
Noncash lease expenses330 164 
Noncash interest expense344
 
Noncash interest expensesNoncash interest expenses1,152 
Changes in operating assets and liabilities:   Changes in operating assets and liabilities:
Accounts receivableAccounts receivable(1,847)
Inventories(872) 
Inventories(1,676)
Prepaid and other assets(853) (985)Prepaid and other assets13,606 (1,027)
Accounts payable1,697
 (478)Accounts payable(4,647)996 
Accrued expenses and other liabilities(563) (4,176)Accrued expenses and other liabilities4,713 (205)
Accrued compensation2,274
 (665)Accrued compensation(3,510)1,069 
Operating lease liabilities(39) (378) Operating lease liabilities(229)(197)
Net cash, cash equivalents and restricted cash used in operating activities(29,928) (27,226)Net cash, cash equivalents and restricted cash used in operating activities(34,458)(14,876)
Cash flows from investing activities:   Cash flows from investing activities:
Proceeds from sale of Softcup line of business250
 250
Proceeds from sale of Softcup line of business250 250 
Maturities of short-term investments8,233
 
Maturities of short-term investments6,747 
Purchases of property and equipment(536) 
Purchases of property and equipment(956)(95)
Net cash, cash equivalents and restricted cash provided by investing activities7,947
 250
Net cash, cash equivalents and restricted cash (used in) provided by investing activitiesNet cash, cash equivalents and restricted cash (used in) provided by investing activities(706)6,902 
Cash flows from financing activities:   Cash flows from financing activities:
Proceeds from issuance of common stock - exercise of warrants2
 6,273
Proceeds from issuance of common stock, warrants and purchase rights in connection with the 2019 Private
Placement, net of financial advisory fees

 75,400
Proceeds from issuance of common stock, net of discounts and commissions - Public Offering103,738
 
Proceeds from issuance of common stock, net of discounts and commissions - Public Offering28,050 
Proceeds from issuance of common stock, net of commissions - ATM transactions3,781
 
Proceeds from issuance of common stock, net of commissions - ATM transactions1,424 
Proceeds from issuance of common stock - ESPP and exercise of stock options337
 46
Proceeds from issuance of common stock - ESPP and exercise of stock options160 
Borrowings under convertible notes25,000
 
Short-swing profit disgorgement173
 
Repayment of Vendor Note
 (4,010)
Cash paid for financing costs(317) (890)Cash paid for financing costs(37)(195)
Payments for tax withholdings related to vesting of restricted stock awards(2,802) (524)
Payments of tax withholdings related to vesting of restricted stock awardsPayments of tax withholdings related to vesting of restricted stock awards(7)(25)
Net cash, cash equivalents and restricted cash provided by financing activities129,912
 76,295
Net cash, cash equivalents and restricted cash provided by financing activities28,006 1,364 
Net change in cash, cash equivalents and restricted cash107,931
 49,319
Net change in cash, cash equivalents and restricted cash(7,158)(6,610)
Cash, cash equivalents and restricted cash, beginning of period16,625
 1,761
Cash, cash equivalents and restricted cash, beginning of period72,251 16,625 
Cash, cash equivalents and restricted cash, end of period$124,556
 $51,080
Cash, cash equivalents and restricted cash, end of period$65,093 $10,015 
Supplemental disclosure of noncash investing and financing activities:   Supplemental disclosure of noncash investing and financing activities:
Right-of-use assets obtained in exchange for operating lease liabilities$5,219
 $802
Right-of-use assets obtained in exchange for operating lease liabilities$$266 
Financing costs included in accounts payable and accrued expenses$550
 $257
Financing costs included in accounts payable and accrued expenses$304 $13 
Purchases of property and equipment included in accounts payable and accrued expenses$278
 $
Purchases of property and equipment included in accounts payable and accrued expenses$519 $201 
Reclassification of financial instruments liability to equity$11,015
 $6,120


See accompanying notes to condensed consolidated financial statements (unaudited).

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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1.Description of Business and Basis of Presentation

1.Description of Business and Basis of Presentation

Description of Business

On January 17, 2018, Neothetics, Inc., a Delaware corporation (Neothetics), now known as Evofem Biosciences, Inc. (the Company), completed its merger (the Merger) with privately-held Evofem Biosciences Operations, Inc. (Private Evofem), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated October 17, 2017, whereby Nobelli Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Neothetics, merged with and into Private Evofem, with Private Evofem surviving as Neothetics’ wholly-owned subsidiary. Unless otherwise noted, (i) references in this report to “Evofem” and the “Company” refer to Evofem Biosciences, Inc. and its subsidiaries following the closing of the Merger.


Evofem is a San Diego-based, commercial-stage biopharmaceutical company committed to 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’s first commercial product, Phexxi™ (lactic acid, citric acid, and potassium bitartrate) vaginal gel,Phexxi, was approved by the U.S. Food and Drug Administration (FDA)FDA on May 22, 2020 and is the first and only FDA-approved, hormone-free, female-controlled,woman-controlled, on-demand prescription contraceptive gel for women. The Company commercially launched Phexxi in September 2020.

Evofem’s pipeline product candidate, EVO100, is being evaluated for the prevention of chlamydia and gonorrhea in women - two of the most pervasive sexually transmitted diseasesSTIs in the United States. Currently, there are no FDA-approved prescription products for the prevention of either of these dangerous infections.


Basis of Presentation and Principles of Consolidation


The Company prepared the unaudited interim condensed consolidated financial statements included in this Quarterly Report in accordance with accounting principles generally accepted in the U.S. (GAAP) for interim financial information and the rules and regulations of the Securities and Exchange Commission (SEC) related to quarterly reports on Form 10-Q.


The Company’s financial statements are presented on a consolidated basis, which include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements do not include all information and disclosures required by GAAP for annual audited financial statements and should be read in conjunction with the Company’s consolidated financial statements and notes thereto for the year ended December 31, 20192020 included in its Annual Report on Form 10-K as filed with the SEC on March 12,4, 2021 (the 2020 (the 2019 Audited Financial Statements).


The unaudited interim condensed consolidated financial statements included in this report have been prepared on the same basis as the Company’s audited consolidated financial statements and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the financial position, results of operations, cash flows, and statements of convertible preferred stock and stockholders’ deficit for the periods presented. The results for the three and six months ended June 30, 2020March 31, 2021 are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 20192020 was derived from the 20192020 Audited Financial Statements.

Reclassification

We have separated the presentation of selling and marketing expenses from the total general and administrative expenses in the current period condensed consolidated statement of operations. As a result, a total $1.3 million and $2.4 million of reclassifications from general and administrative expenses to selling and marketing expenses for the three and six months ended June 30, 2019, respectively, have been made to prior year amounts to conform to the current period presentation.
Risks, Uncertainties and Going Concern


The condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities, in the normal course of business, and dodoes not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty.


The Company’s principal operations have been related to research and development, (R&D), including the development of Phexxi, as well asand to its commercially related sales and marketing efforts. Additional activities have included raising capital, recruiting personnel and establishing and maintaining a corporate infrastructure to support a commercial product. The Company has no revenues and, as such, has incurred operating losses and negative cash flows from operating activities since inception. As described in Note 4-5- Convertible Notes and Note 10- Stockholders' Equity (Deficit), during the six months ended June 30, 2020, the Company received net proceeds of approximately $28.0 million upon the sale and issuance of common stock from an underwritten public offering in March 2021, gross proceeds of $25.0$50.0 million from the issuance of convertible notes in Aprilthe second and Junefourth quarter of 2020, net proceeds of approximately $103.7 million upon the sale and issuance of common stock pursuant to the Public Offeringfrom an underwritten public offering in June 2020, and $3.8 million from its “at the market” (ATM) program, net of commissions.commissions, in 2020. As of June 30, 2020,March 31, 2021, the Company had cash and cash equivalents of $123.6$45.3 million, $18.6 million in restricted cash from the Adjuvant Notes (as defined in Note 5- Convertible Notes) that is available for use, working capital of $66.1$4.6 million and an accumulated deficit of $585.0$701.6 million.

The Company is subject to risks common to other life science companies in the development and early commercial stage including, but not limited to, uncertainty regarding the commercial success and timing of both its launch of Phexxi and the development of its pipeline
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product candidate, EVO100,EVO100; potential disruption of its research and development andpre-commercializationcommercialization activities as a result of the COVID-19 pandemic,pandemic; lack of marketing and sales history,history; potential development by its competitors of new and competitive technological innovations,innovations; dependence on key personnel,personnel; market acceptance of Phexxi or any other future approved products, if any,any; product liability,liability; protection of proprietary technology,technology; ability to raise additional financing,financing; and compliance with the FDA and other government regulations, including post marketing regulations. If the Company does not successfully commercialize Phexxi as planned, it will be unable to generate recurring product revenue or achieve profitability. Management’s plans to meet its short- and long-term operating cash flow requirements include generating recurring product revenue and obtaining additional funding, such as through the issuance of its common stock, from other equity or debtnon-dilutive financings, or through collaborations or partnerships with other companies.


TheWhile the Company has recognized limited revenues since the launch of Phexxi in September 2020, the Company anticipates it will continue to incur net losses for the foreseeable future and incur additional costs associated with being a public company. R&D expenses are expected to decrease in 2020 due to completion of the clinical phase of the AMPREVENCE Phase 2b clinical trial of EVO100 in December 2019, partially offset by the anticipation of initiating a Phase 3 clinical trial of EVO100 in the fourth quarter of 2020. Selling and marketing expenses are expected to increase significantly in 2020 due to the pre-commercialization activities in preparation for the anticipated launch of Phexxi in the United States, the initiation of full commercialization activities in September 2020, and post-launch commercialization activities for the remainder of 2020 and future periods.future. According to management estimates, liquidity resources as of June 30, 2020March 31, 2021 are not sufficient to maintain its planned level of operations for the 12twelve months from the date of issuance of thethese condensed consolidated financial statements.


These circumstances and the uncertainties associated with the Company’s ability to (i) obtain additional equity or debt financing on terms that are favorable to the Company, (ii) enter into collaborative agreements with strategic partners, and (iii)otherwise succeed in its future operations raise substantial doubt about the Company’s ability to continue as a going concern.


If the Company is not able to obtain the required funding in the near term, through equity or debt financings or other means, or is unable to obtain funding on terms favorable to the Company, this will have a material adverse effect on its commercialization and development operations and strategic development plan for future growth. If the Company cannot successfully raise additional funding and implement its strategic development plan, the Company may be forced to make reductions in spending, including spending in connection with its commercialization activities, extend payment terms with suppliers, liquidate assets where possible at a potentially lower amount than as recorded in the condensed consolidated financial statements, suspend or curtail planned programsoperations or cease operations entirely. Any of these could materially and adversely affect its liquidity, financial condition and business prospects and the Company would not be able to continue as a going concern.

Subsequent eventsEvents


Subsequent events were evaluated through the filing date of this Quarterly Report, August 4, 2020.May 6, 2021. See Note 7- Commitments and Contingencies10- Stockholders' Equity for the discussion of adiscussions on subsequent eventevents which occurred in July 2020.April 2021.


2.Summary of Significant Accounting Policies
2.Summary of Significant Accounting Policies

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and the notes thereto.


Significant estimates affecting amounts reported or disclosed in the condensed consolidated financial statements include, but are not limited to: the assumptions used in measuring the revenue gross-to-net variable consideration items, the trade accounts receivable credit loss reserve estimate, the discount rate used in estimating the fair value of the lease right-of-use (ROU)right-of-use assets and lease liabilities, the assumptions used in estimating the fair value of convertible notes, warrants and purchase rights issued, the useful lives of property and equipment, the recoverability of long-lived assets, clinical trial accruals, the assumptions used in estimating the fair value of stock-based compensation expense and in assessing the probability of achieving certain milestones associated with the performance-based

restricted stock awards. The Company’sawards (performance-based RSAs). These assumptions regarding the measurement of the Private Placement First Closing Warrants, the Private Placement Second Closing Warrants, the Baker First Closing Warrants, the Baker Second Closing Warrants, the Private Placement Purchase Rights, the Baker Purchase Rights, the lease ROU assets and lease liabilities, and stock-based compensation are more fully described in Note 4-3- Revenue, Note 5- Convertible Notes, Note 6-7- Fair Value of Financial Instruments, Note 7-8- Commitments and Contingencies, and Note 11- Stock-based Compensation. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances and adjusts when facts and circumstances dictate. The estimates are the basis for making judgments about the carrying values of assets and liabilities and recorded expenses that are not readily apparent from other sources. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.

Segment Reporting

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker, who is the Chief Executive Officer (CEO) of the Company, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one1 operating segment.


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Concentrations of Credit Risk


Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. Deposits in the Company’s checking, time deposit and investment accounts are maintained in federally insured financial institutions and are subject to federally insured limits or limits set by Securities Investor Protection Corporation. The Company invests in funds through a major U.S. bank and is exposed to credit risk in the event of default to the extent of amounts recorded on the consolidated balance sheets.


The Company has not experienced any losses in such accounts and believes it is not exposed to significant concentrations of credit risk on its cash, cash equivalents and restricted cash balances due to the financial position of the depository institutions in which these deposits are held.


The Company is also subject to credit risk related to its trade accounts receivable from product sales. Its customers are located in the United States and consist of wholesale distributors and a specialty retail pharmacy. The Company extends credit to its customers in the normal course of business after evaluating their overall financial condition and evaluates the collectability of its accounts receivable by periodically reviewing the age of the receivables, the financial condition of its customers, and its past collection experience. Historically, the Company has not experienced any credit losses. As of March 31, 2021, based on the evaluation of these factors the Company did not record an allowance for doubtful accounts. For the three months ended March 31, 2021, the Company’s three largest customers combined made up approximately 87% of its gross product sales. For the three months ended March 31, 2020, the Company had no product sales. As of March 31, 2021 and December 31, 2020, the Company's three largest customers combined made up 89% and 95%, respectively, of its trade accounts receivable balance.

Significant Accounting Policies


There have been no changes to the significant accounting policies that were described in Note 2 to the 20192020 Audited Financial Statements during the secondfirst quarter of 2020, except the accounting policy for inventories and the Company's election of fair value option (FVO) to account for certain financial liabilities as described in Note 3- Inventories and Note 4- Convertible Notes, respectively.2021.

Cash, Cash Equivalents and Restricted Cash

Cash and cash equivalents consist of readily available cash in checking accounts and money market funds, and investments in fixed income debt securities with original maturities of less than three months.funds. Restricted cash consists of cash held in monthly time deposit accounts and letters of credit, which are collateral for the Company’s credit cards, facility leases and fleet leases as described in Note 7-8- Commitments and Contingencies. As of March 31, 2021, the Company maintained letters of credit of $0.8 million and $0.3 million for its office lease and fleet leases, respectively. Additionally, the remaining $18.6 million of the $25.0 million received from the issuance of Adjuvant Notes in the fourth quarter of 2020, is classified as restricted cash as the Company is contractually obligated to use the funds for specific purposes.

The following table provides a reconciliation of cash, cash equivalents and restricted cash, reported within the condensed consolidated statements of cash flows (in thousands): 
Three Months Ended March 31,
20212020
Cash and cash equivalents$45,318 $8,785 
Restricted cash18,975 480 
Restricted cash included in other noncurrent assets800 750 
Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows$65,093 $10,015 
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 Six Months Ended June 30,
 2020 2019
Cash and cash equivalents$123,556
 $50,679
Restricted cash200
 401
Restricted cash included in other noncurrent assets800
 
Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows$124,556
 $51,080
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Net Loss Per Share

Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their

effect would be anti-dilutive and, therefore, basic and diluted net loss per share were the same for all periods presented. Potentially dilutive securities excluded from the calculation of diluted net loss per share are summarized in the table below.
Three Months Ended March 31,
20212020
Unvested restricted common stock subject to repurchase1,845,833 1,345,000 
Unvested restricted stock units40,168 
Common stock to be purchased under the 2019 ESPP244,433 54,387 
Options to purchase common stock11,385,846 7,769,999 
Warrants to purchase common stock10,426,107 5,303,357 
Total23,902,219 14,512,911 
 Three and Six Months Ended June 30,
 2020 2019
Unvested restricted stock awards subject to repurchase120,000
 344,325
Unvested restricted stock units
 151,500
Common stock to be purchased under the 2019 ESPP67,324
 42,290
Options to purchase common stock8,449,016
 6,134,179
Warrants to purchase common stock10,426,107
 6,369,270
Total19,062,447
 13,041,564

Recently AdoptedIssued Accounting Pronouncements — Not Yet Adopted


In June 2016,August 2020, the Financial Accounting Standards Board (FASB) issued ASU No. 2016-13, Financial Instruments - Credit Losses2020-06, Debt (ASU No. 2020-06), removing, modifying and adding certain disclosure requirements of ASC 326, Measurement of Credit Losses on Financial Instruments (ASU No. 2016-13)470, Debt with Conversion and Other Options, which requires credit losses relating to held-to maturity debt securities should be recorded through an allowance for credit losses. and ASC 815, Derivatives and Hedging—Contracts in Entity’s Own Equity. ASU No. 2016-13 was2020-06 will be effective for the Company onbeginning January 1, 2020.2024. The adoption of this new standard did not have a materialCompany is currently evaluating when to adopt ASU 2020-06 and the expected impact on the Company's condensed consolidated financial statements.


3.Revenue

The Company recognizes revenue from the sale of Phexxi in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; (5) recognize revenue when (or as) the entity satisfies a performance obligation.

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (ASU No. 2018-13), which removes, modifies and adds certain disclosure requirements on fair value measurements inaccordance with ASC 820, Fair Value Measurements and Disclosures. ASU No. 2018-13 was effective for606, the Company recognizes revenue when its performance obligation is satisfied by transferring control of the product to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the United States and consist of wholesale distributors and a specialty retail pharmacy. Payment terms typically range from 45 to 66 days, include prompt pay discounts, and vary by customer. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Trade Accounts Receivable policy in Note 2- Summary of Significant Accounting Policies to the 2020 Audited Financial Statements.

The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when the performance obligation is satisfied. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue.

Phexxi is sold to customers at the wholesale acquisition cost (WAC). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration reduce revenue and include the following:

Distribution services fees
Prompt pay and other discounts
Product returns
Chargebacks
Rebates
Patient support programs, including our co-pay programs

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An estimate for variable consideration is made with each sale and is recorded in conjunction with the revenue being recognized. To calculate the variable consideration, the Company uses the expected value method. If the estimated amount is payable to a customer, it is recorded as a reduction to accounts receivable. If the estimated amount is payable to an entity other than a customer, it is recorded as a current liability. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed and adjustments are made if necessary. Any adjustments made to these provisions would also affect net product revenue and earnings.

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relies on January 1, 2020. historical sales data showing the amount of various end-user consumer types, inventory reports from the wholesale distributors and specialty pharmacy, and other relevant data reports. Because Phexxi was launched in September 2020, this historical data is limited. Due to limits on historical data, the Company has also used trend analysis, industry standard data, and professional judgment in developing these estimates.

The adoptionspecific considerations that the Company uses in estimating these amounts related to variable consideration are as follows:

Distribution services fees – The Company pays distribution service fees to its wholesale distributors and specialty pharmacy. These fees are a contractually fixed percentage of this new standard did not have a material impactWAC, and are calculated at the time of sale based on the Company'spurchase amount. The Company considers these fees to be separate from the customer’s purchase of the product, therefore, they are recorded in other current liabilities on the condensed consolidated financial statements.balance sheet.


In August 2018,Prompt pay and other discounts – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice, and the FASB issued ASU No. 2018-15, Intangibles—GoodwillCompany offers a prompt pay discount to each wholesale distributor customer. The specific prompt pay terms vary by customer and Other removing, modifyingare contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the purchase amount. Prompt pay discount estimates are recorded as contra trade accounts receivable on the condensed consolidated balance sheet.

The Company may also give other discounts to its customers to incentivize purchases and adding certain disclosure requirementspromote customer loyalty. The terms of ASC 350, Internal-Use Software (ASU No. 2018-15), which requires capitalizing implementation costs incurredsuch discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recognized.

Chargebacks – Certain government entities and covered entities (e.g. Veterans Administration, 340B covered entities) will be able to developpurchase the product at a price discounted below WAC. The Company has finalized agreements with these types of entities. The difference between the government or obtain internal-use softwarecovered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount of each chargeback channel based on the expected number of claims in a cloud computing arrangementeach channel and related chargeback that is a service contract. ASU No. 2018-15 was effectiveassociated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the consolidated balance sheet.

Rebates – The Company is subject to mandatory discount obligations under the Medicaid and Tricare programs. The Company has finalized agreements with Medicaid and Tricare. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company on January 1, 2020.has been invoiced. Rebates for Medicaid and Tricare are typically invoiced in arrears. The adoption of this new standard did not have a material impactCompany estimates the amount in rebates based on the Company's condensed consolidated financial statements.

3.Inventories

Inventories, consistingexpected number of purchased materials, direct laborclaims and manufacturing overheads, are statedrelated cost that is associated with the revenue being recognized for product that remains in the distribution channel at the lowerend of each reporting period. Rebate estimates are recorded as other current liabilities on the consolidated balance sheet.

Patient support programs – One type of patient support program the Company offers is a co-pay program to commercially insured patients whose insurance requires a co-pay to be made when filling their prescription. This is a voluntary program that is intended to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of financial assistance for these programs based on the expected number of claims and related cost or net realizable value. Costthat is determined on a first-in, first-out basis. Net realizable value isassociated with the estimated selling pricerevenue being recognized for product that remains in the ordinary coursedistribution channel at the end of business,each reporting period. Patient support programs estimates are recorded as other current liabilities on the consolidated balance sheet.

Product returns – Retail pharmacies and wholesalers have the right to return product that is within six months or less reasonably predictable costs of completion, disposal,the labeled expiration date or that is past the expiration date by no more than six months. Phexxi was commercially launched in September 2020 and transportation. there were no returns as of March 31, 2021. The Company uses historical sales and return data to estimate future product returns. Product return estimates are recorded as other current liabilities on the consolidated balance sheet.
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As of March 31, 2021, the accrued balance associated with variable considerations discussed above was approximately $1.6 million.

4.Inventories

At each balance sheet date, the Company evaluates ending inventories for excess quantities, obsolescence, or shelf-life expiration. The evaluation includes an analysis of the Company’s current and future strategic plans, anticipated future sales, the price projections of future demand, and the remaining shelf life of goods on hand.hand. To the extent that management determines there are excess or obsolete inventory or quantities with a shelf life that is too near its expiration date for the Company to reasonably expect that it can sell those products prior to their expiration,before they expire, the Company adjusts the carrying value to estimated net realizable value.value in accordance with the first-in, first-out inventory costing method.


Prior to regulatory approval from the FDA, the Company incurred expenses for the manufacture of its lead product Phexxi in order to ensure adequate supply of Phexxi to support its commercial launch. The Company began to capitalize the inventory costs associated with Phexxi in April 2020 when it was determined that the inventory had a probable future economic benefit. Allinclude all purchased materials, direct labor and manufacturing overheadsoverhead. Prior to April 2020, costs incurred afterfor the FDA approval are capitalized.manufacture of Phexxi were recorded as research and development expenses.

AsInventories consist of June 30, 2020, inventories consisted of $0.2 million and $1.2 million of raw materials and work in process, respectively. the following (in thousands) for the period indicated:
March 31, 2021December 31, 2020
Raw materials$486 $332 
Work in process(1)
4,173 4,162 
Finished goods4,331 2,668 
Total$8,990 $7,162 
_____________________
(1) The work in process balance
represents all production costs incurred for partially completed goods.


4.Convertible Notes

5.Convertible Notes

Baker Bros. Notes

On April 23, 2020, the Company entered into a Securities Purchase and Security Agreement (the SecuritiesBaker Bros. Purchase Agreement) with certain affiliates of Baker Bros. Advisors LP, as purchasers (the Baker Purchasers), and Baker Bros. Advisors LP, as designated agent, pursuant to which the Company agreed to issue and sell to the Baker Purchasers (i) convertible senior secured promissory notes (the Baker Notes) in an aggregate principal amount of up to $25.0 million and (ii) warrants to purchase shares of common stock (the Baker Warrants) in a private placement.



At the initial closing date of April 24, 2020 (the Baker Initial Closing), the Company issued and sold Baker Notes with an aggregate principal amount of $15.0 million (the Baker First Closing Notes) and Baker Warrants exercisable for 3,073,770 shares of common stock (the Baker First Closing Warrants).stock.


Following the Baker Initial Closing, the Baker Purchasers had an option to purchase from the Company up to $10.0 million of Baker Notes (the Baker Purchase Rights) at the Baker Purchasers’ discretion at any time prior to the Company receiving at least $100.0 million in aggregate gross proceeds from one or more sales of equity securities.


On June 5, 2020 (the Exercise Date), the Baker Purchasers exercised the Baker Purchase Rights. At the second closing date of June 9, 2020, the Baker Purchasers acquired the remaining Baker Notes with an aggregate principal amount of $10.0 million (the Baker Second Closing Notes) and Baker Warrants exercisable for 2,049,180 shares of common stock (the Baker Second Closing Warrants).stock. With the completion of the Public Offeringunderwritten public offering in June 2020 as further discussed in Note 10- Stockholders' Equity, the conversion price of the Baker Notes and the exercise price of the Baker Warrants is $2.44. The Baker Warrants have a five-yearfive-year term with a cashless exercise provision and are immediately exercisable at any time from their respective issuance date.


The Baker Notes have a five-yearfive-year term, with no pre-payment ability. Interest on the unpaid principal balance of the Baker Notes (the Baker Outstanding Balance) accrues at 10.0% per annum with interest accrued during the first year from the two respective closing dates recognized as payment-in-kind. Accrued interest beyond the first year of the respective closing dates are to be paid in arrears on a quarterly basis in cash or recognized as payment-in-kind, at the direction of the Purchasers. Interest expense pertaining to the Baker Notes for the three and six months ended June 30, 2020March 31, 2021 was approximately $0.3$0.6 million which was accrued and is included in the total fair value ofshort-term convertible notes payable on the accompanying condensed consolidated balance sheet as of June 30, 2020.March 31, 2021.


The Baker Notes are convertible at any time at the option of the Baker Purchasers at the conversion aforementioned price.price of $2.44 per share. The Baker Notes are callable by the Company on 10 days’ written notice beginning on the third anniversary of the Baker
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Initial Closing. The call price will equal 100% of the Baker Outstanding Balance plus accrued and unpaid interest if the Company’s common stock as measured using a 30-day volume weighted average price (VWAP) is greater than the benchmark price of $4.99 as stated in the SecuritiesBaker Bros. Purchase Agreement, or 110% of the Baker Outstanding Balance plus accrued and unpaid interest if the VWAP is less than such benchmark price. The Baker Purchasers also have the option to require the Company to repurchase all or any portion of the Baker Notes in cash ifupon the occurrence of certain events occur.events. In a repurchase event, as defined in the SecuritiesBaker Bros. Purchase Agreement, the repurchase price will equal 110% of the Baker Outstanding Balance plus accrued and unpaid interest. In an event of default or the Company’s change of control, the repurchase price will equal to the sum of (x) three3 times of the Baker Outstanding Balance plus (y) the aggregate value of future interest that would have accrued. Collectively, these options are the “Embedded Features” of the Baker Notes.


The Company's stockholders approved the issuance of the shares issuable upon conversion of the Baker Notes and the exercise of the Baker Warrants in order to comply with Nasdaq Listing Rules 5635(b) and 5635(d) at its special meeting of stockholders held on June 18, 2020 (the Approval Date).


The Company evaluated whether any of the Embedded Features required bifurcation as a separate component of equity. The Company elected the FVOfair value option (FVO) under ASC 825, Financial Instruments(ASC 825), foras the Baker Notes as they are qualified financial instruments and are, in whole, classified as liabilities. Under the FVO, the Company recognized the hybrid debt instrument at fair value inclusive of embedded features.the Embedded Features. The Company also determined that the Baker Warrants and the Baker Purchase Rights were free standing financial instruments and were classified as liabilities at the time of issuance in accordance with ASC 480, Distinguishing Liabilities From Equity(ASC 480) due to the required stockholders’ approval noted above.


Under the valuation methods as described in Note 6-7- Fair Value Financial Instruments, the Company recorded the following in the condensed consolidated financial statements related to the Baker Notes and Baker Warrants during the quarter ended June 30, 2020: (i) an aggregate of $58.1 million in convertible notes and an aggregate of $46.7 million for warrants and purchase rights liability at the Baker Initial Closing and Exercise Date; (ii) a $64.0 million loss on issuance of financial instruments recognized at the Baker Initial Closing and Exercise Date in the condensed consolidated statement of operations; (iii) an aggregate $34.1 million change ingain on fair value changes of financial instruments as a result of mark-to-market adjustments on the Baker Notes, Baker Warrants and Baker Purchase Rights recognized respectively at the Exercise Date, Approval Date and the quarter ended June 30, 2020, in the condensed consolidated statement of operations; (iv) a $15.8 million reclassification from purchase rights liability to the convertible notes and warrants liability on the Exercise Date; and (v) aan $11.0 million reclassification from warrants liability to additional paid-in capital in the condensed consolidated balance sheet on the Approval Date. In addition, the Company concluded that there was no change in the underlying instrument-specific credit risk between the issuance dates for the Baker Notes and June 30, 2020,March 31, 2021, and, therefore there was no change recognized in the fair value of the convertible notes associated with differences in credit risk that would be presented separately as a component of other comprehensive income.

Using the same valuation methods discussed in Note 7- Fair Value Financial Instruments, the Company recorded a $0.1 million loss on fair value changes of financial instruments as a result of mark-to-market adjustments recognized on the Baker Notes for the quarter ended March 31, 2021 in the condensed consolidated financial statements.

The Baker Notes contain various customary affirmative and negative covenants agreed to by the Company. The Company was in compliance with all applicable covenants at June 30, 2020.March 31, 2021. The Baker Notes also include customary events of

default as definedset forth in the SecuritiesBaker Bros. Purchase Agreement, such that, in an event of default, the Baker Purchasers will have the right to accelerate repayment of the aggregate loan balance then outstanding.


As of March 31, 2021, the Baker Notes are recorded in the condensed consolidated balance sheet as short-term convertible notes payable with a total balance of $53.2 million. The balance is comprised of a $50.9 million fair value of the Baker Notes and $2.3 million in accrued interest.
5.    
Adjuvant Notes

On October 14, 2020, the Company entered into a Securities Purchase Agreement (the Adjuvant Purchase Agreement) with Adjuvant Global Health Technology Fund, L.P., and Adjuvant Global Health Technology Fund DE, L.P. (together, the Adjuvant Purchasers), pursuant to which the Company sold unsecured convertible promissory notes (the Adjuvant Notes) in aggregate principal amount of $25.0 million.

The Adjuvant Notes have a five-year term with interest accruing at 7.5% per annum on a quarterly basis in arrears to the outstanding balance of the Notes and are recognized as payment-in-kind. Interest expense pertaining to the Adjuvant Notes for the three months ended March 31, 2021 was approximately $0.5 million and is included in long-term convertible notes payable on the accompanying consolidated balance sheet as of March 31, 2021. In connection with certain Company change of
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control transactions, the Adjuvant Notes may be prepaid at the option of the Company or will become payable at the option of the Adjuvant Purchasers.

The Adjuvant Notes are convertible, subject to customary 4.99% and 19.99% beneficial ownership limitations, into shares of the Company’s common stock, par value $0.0001 per share, at any time at the option of the Adjuvant Purchasers at a conversion price of $3.65 per share. To the extent not previously prepaid or converted, the Notes will automatically convert into shares of the Company’s common stock at the Conversion Price immediately following the earliest of the time at which the (i) 30-day value-weighted average price of the Company’s common stock is $10.00 per share, or (ii) Company achieves cumulative net sales from the sales of Phexxi of $100,000,000, provided such net sales are achieved prior to July 1, 2022.

The Adjuvant Notes contain various customary affirmative and negative covenants agreed to by the Company. The Company was in compliance with all applicable covenants at March 31, 2021. The Adjuvant Notes also include customary events of default as set forth in the Adjuvant Purchase Agreement, such that, in an event of default, the Adjuvant Purchasers will have the right to accelerate repayment of the aggregate loan balance then outstanding.

The Adjuvant Notes are accounted for in accordance with authoritative guidance for convertible debt instruments. The $25.0 million in proceeds is considered to be restricted cash for financial reporting purposes due to contractual stipulations that specify the types of expenses the money can be spent on and how it must be allocated. As of March 31, 2021, there is $18.6 million in proceeds remaining that is included in restricted cash on the accompanying consolidated balance sheet.

As of March 31, 2021, the Adjuvant Notes are recorded in the condensed consolidated balance sheet as long-term convertible notes payable with a total balance of $25.7 million. The balance is comprised of $24.8 million in principal and $0.9 million in accrued interest.

6.Balance Sheet Details
Short-term Investments
Short-term investments consist of held-to-maturity securities that will be due in one year or less. The following table illustrates the held-to-maturity securities’ amortized costs at purchase and the fair value for the period presented (in thousands). All the short-term investments at December 31, 2019 matured during the six months ended June 30, 2020.
December 31, 2019Amortized Cost Basis
 Unrealized Gains
 Fair Value
Fixed income debt securities$8,233
 $42
 $8,275
Total held-to-maturity securities$8,233
 $42
 $8,275

Prepaid and Other Current Assets
Prepaid and other current assets consist of the following (in thousands):
June 30, 2020
 December 31, 2019
March 31, 2021December 31, 2020
Selling and marketing related costs$614
 $491
Selling and marketing related costs$1,568 $15,414 
Prepaid manufacturing costs608
 
Other receivables461
 436
InsuranceInsurance402 900 
Manufacturing related costsManufacturing related costs482 382 
Clinical trial related costsClinical trial related costs630 304 
Subscriptions for IT platformsSubscriptions for IT platforms312 
Flex note receivable (1)
250
 250
Flex note receivable (1)
250 
Short-term deposit150
 150
Insurance127
 481
Other484
 505
Other744 800 
Total$2,694
 $2,313
Total$4,138 $18,050 
_______________________
(1) In June 2016, Private Evofem’s board of directors committed to a plan to sell its Softcup line of business (Softcup) and re-direct its available cash resources to further develop Phexxi. In July 2016, the Company entered into an Asset Purchase Agreement with The Flex Company (Flex), whereby Flex would acquire certain assets and assume certain liabilities associated with Softcup. Total consideration for the Softcup sale was $1.9 million, with $0.6 million received in cash at closing and the remaining $1.3 million due and payable under a note in favor of the Company (the Flex Note) through January 1, 2021 (the Maturity Date). The Flex Note bears simple interest at a rate of 5.0% per annum on the remaining principal amount outstanding. An annual principal payment of approximately $0.3 million and the annual accrued and unpaid interest are payable each January 1, beginning in 2017 through the Flex Maturity Date. The note was paid off on January 4, 2021.


The Flex Note is secured by the Softcup assets and has been recorded at fair value. The Company’s incremental borrowing rate and the stated interest rate of the Flex Note are materially consistent.

14

Table of Contents
Property and Equipment, Net

Property and equipment, net, consists of the following (in thousands):
Useful LifeMarch 31, 2021December 31, 2020
Useful Life
 June 30, 2020
 December 31, 2019
Research equipment5 years
 $615
 $608
Research and production equipmentResearch and production equipment5 years$623 $623 
Computer equipment and software3 years
 164
 13
Computer equipment and software3 years494 444 
Office furniture5 years
 205
 205
Office furniture5 years881 629 
Leasehold improvements5 years or less
 340
 340
Leasehold improvements5 years or less3,489 1,540 
Construction in-process
 732
 77
Construction in-process— 1,473 2,249 
  2,056
 1,243
6,960 5,485 
Less: accumulated depreciation  (972) (849)Less: accumulated depreciation(1,346)(1,151)
Total, net  $1,084
 $394
Total, net$5,614 $4,334 

Depreciation expense was approximately $0.2 million and $0.1 million for both the three months ended June 30,March 31, 2021 and 2020, and 2019, and for both the six months ended June 30, 2020 and 2019, respectively.


Other Noncurrent Assets

Other noncurrent assets consist of the following (in thousands):
March 31, 2021December 31, 2020
Restricted cash included in noncurrent assets$800 $800 
Prepaid directors & officers' insurance188 214 
Other34 34 
Total$1,022 $1,048 
 June 30, 2020
 December 31, 2019
Flex note receivable, net of current portion$
 $250
Prepaid directors & officers' insurance267
 320
Restricted cash included in noncurrent assets800
 750
Total$1,067
 $1,320


Accrued Expenses

Accrued expenses consist of the following (in thousands):
 June 30, 2020
 December 31, 2019
Clinical studies$72
 $585
Marketing and public relations758
 
Legal and other professional fees730
 1,652
Manufacturing related costs516
 
Other521
 547
Total$2,597
 $2,784
March 31, 2021December 31, 2020
Clinical studies$2,977 $1,417 
Marketing, market access and public relations3,558 564 
Legal and other professional fees1,156 1,631 
Manufacturing related costs452 498 
Other835 366 
Total$8,978 $4,476 


6.    
15

Table of Contents
7.Fair Value of Financial Instruments

The fair values of the Company’s assets, including the money market funds, investments in marketable fixed income debt securities classified as cash and cash equivalents, investments in marketable fixed income debt securities classified as held-to-maturity andrestricted cash, Flex Note receivable, and the fair value of the Company’s convertible notesBaker Notes, measured on a recurring basis are summarized in the following tables, as applicable (in thousands).
:
June 30, 2020 
Quoted Prices in Active Markets for Identical Assets
(Level 1)
 
Significant Other Observable Inputs
(Level 2)
 
Significant Unobservable Inputs
(Level 3)
March 31, 2021Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Unobservable Inputs
(Level 3)
Money market funds (1)
$122,163
 $122,163
 $
 $
Money market funds (1)
$62,667 $62,667 $$
Flex note receivable250
 
 250
 
Total assets$122,413
 $122,163
 $250
 $
Total assets$62,667 $62,667 $$
       
Convertible notes payable$43,958
 $
 $
 $43,958
Convertible notes payable (2)
Convertible notes payable (2)
$50,894 $$$50,894 
Total liabilities$43,958
 $
 $
 $43,958
Total liabilities$50,894 $$$50,894 

December 31, 2019 
Quoted Prices in Active Markets for Identical Assets
(Level 1)
 
Significant Other Observable Inputs
(Level 2)
 
Significant Unobservable Inputs
(Level 3)
December 31, 2020Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Unobservable Inputs
(Level 3)
Money market funds (1)
$7,064
 $7,064
 $
 $
Money market funds (1)
$53,485 $53,485 $$
Fixed income debt securities classified as cash and cash equivalents6,749
 
 6,749
 
Fixed income debt securities classified as cash and cash equivalents16,498 16,498 
Fixed income debt securities classified as short-term investments8,275
 
 8,275
 
Flex note receivable500
 
 500
 
Flex note receivable250 250 
Total assets$22,588
 $7,064
 $15,524
 $
Total assets$70,233 $69,983 $250 $
Convertible notes payable (3)
Convertible notes payable (3)
$50,752 $$$50,752 
Total liabilitiesTotal liabilities$50,752 $$$50,752 
_______________________
(1) Included as a component of cash and cash equivalents on the accompanying condensed consolidated balance sheet.
The Baker Warrants and the Baker Purchase Rights, and the Private Placement First Closing Warrants and the Private Placement Purchase Rights as discussed in Note 4- Convertible Notes and Note 9- 2019 Private Placement, respectively, were determined to be classified as liabilities. Therefore, they were stated at fair value at issuance and subject to mark-to-market at each reporting date until a subsequent event occurs that would change their classification. They were considered Level 3 instruments because the fair value measurement was based, in part, on significant inputs not observed in the market.

The following table summarizestables summarize the changes in Level 3 financial liabilities measured at fair value on a recurring basis for the three and six months ended June 30, 2020 and 2019.March 31, 2021. There was no activity for the three months ended March 31, 2020.
 Baker First Closing Notes Baker Second Closing Notes Total
Balance at December 31, 2019$
 $
 $
 Initial liability at issuance37,405
 20,715
 58,120
 Change in fair value(11,030) (3,132) (14,162)
Balance at June 30, 2020 (2)
$26,375
 $17,583
 $43,958
 Baker First Closing NotesBaker Second Closing NotesTotal
Balance at December 31, 2020$30,451 $20,301 $50,752 
 Change in fair value85 57 142 
Balance at March 31, 2021 (2)
$30,536 $20,358 $50,894 
_____________________
(1) Included as a component of cash and cash equivalents and restricted cash on the accompanying condensed consolidated balance sheet.
(2) The convertible notes payable as of June 30, 2020March 31, 2021 on the accompanying condensed consolidated balance sheet also includes approximately $0.3$2.3 million accrued interest on the Baker Notes.

(3) The convertible notes payable as of December 31, 2020 on the accompanying consolidated balance sheet also includes approximately $1.7 million accrued interest on the Baker Notes.
 Baker First Closing Warrants Baker Purchase Rights Baker Second Closing Warrants Total
Balance at December 31, 2019$
 $
 $
 $
 Initial liability at issuance14,007
 27,636
 5,098
 46,741
 Change in fair value(7,408) (11,823) (682) (19,913)
 Reclassification from liability to equity(6,599) 
 (4,416) (11,015)
 Exercise of Baker Purchase Rights for convertible notes
 (10,715) 
 (10,715)
 Exercise of Baker Purchase Rights for warrants
 (5,098) 
 (5,098)
Balance at June 30, 2020$
 $
 $
 $
 Private Placement Warrants 
Private Placement
Purchase Rights
Balance at December 31, 2018$
 $
 Initial liability at issuance3,611
 3,183
 Change in fair value3,315
 19,617
 Reclassification from liability to equity(6,926) (22,800)
Balance at June 30, 2019$
 $


Baker Notes


The fair value of the Baker Notes issued as described in Note 4-5- Convertible Notes, and subsequent changes in fair value recorded at the June 30, 2020March 31, 2021 reporting date, were determined using a lattice model forMonte Carlo simulation-based model. Monte Carlo simulation was used to take into account several factors including the future value of the Company's common stock, which incorporated the impact of assumptions related to a potential change of control event, the maturity term of the Baker Notes, the probability of an event of voluntary conversion of the Baker Notes, exercise of the put right, and exercise of the Company's call right. A Monte Carlo simulation was used to determine the occurrence

16

Table of such events in the lattice model.

Baker Warrants and Private Placement Warrants

The fair value of the Baker Warrants issued during the second quarter of 2020 as described in Note 4- Convertible NotesContents, and the fair value of the Private Placement First Closing Warrants issued during the second quarter of 2019 as described in Note 9- 2019 Private Placement, and the respective changes in fair value of these warrants as a result of mark-to-market, were determined using the Black-Scholes option pricing model based on the following weighted-average assumptions for the periods indicated.
 Three and Six Months Ended June 30,
 2020 2019
Expected volatility93.7% 75.0%
Risk-free interest rate0.4% 2.2%
Expected dividend yield% %
Expected term (years)4.9
 6.9



Baker Purchase Rights and Private Placement Purchase Rights

The fair value of the Baker Purchase Rights, and the subsequent change in fair value of these rights upon exercise of such rights, was determined as the maximum of (i) the fair value of rights to purchase the additional $10 million Baker Notes and (ii) the fair value of the shares of on as-if converted basis, which was determined by the lattice model. The fair value of rights to purchase an additional 2,049,180 Baker Warrants was valued using a Geske option-pricing model. The Geske model was based on the applicable assumptions, including the underlying stock price, warrant exercise price, the exercise price of the rights to purchase the Baker Warrants, the term of the Baker Warrants, the term of the rights to purchase the Baker Warrants, the expected volatility of the Company’s peer group, risk-free interest rate and expected dividend.

The fair value of the Private Placement Purchase Rights issued in connection with the 2019 Private Placement, and the change in fair value of the Private Placement Purchase Rights as a result of the mark-to-market upon stockholder approval of the 2019 Private Placement, was determined using a combination of a lattice model and a Black-Scholes option-pricing model. The lattice model was used to determine a range of future value of the Company's common stock. The Black-Scholes option-pricing model was based on the applicable assumptions, including the future value of the Company's common stock as determined by the lattice model, warrant exercise price, time to expiration, expected volatility of our peer group, risk-free interest rate and expected dividend.

7.    8.Commitments and Contingencies

Operating Leases

Fleet LeaseLeases


In December 2019, the Company (the Lessee) and Enterprise FM Trust (the Lessor) entered into a Master Equity Lease Agreement (the Fleet Lease Agreement), whereby the Company leases vehicles to be delivered by the Lessor from time to time with various monthly costs depending on the vehicles delivered for a term of 24 or 36 months, commencing on each corresponding delivery date. The leased vehicles are for use by eligible employees of the Company's commercial operations personnel (the Fleet Lease).personnel. There werewas a total of 5 and 1674 leased vehicles delivered during the three and six months ended June 30, 2020, respectively.as of March 31, 2021. The Company maintains a letter of credit as collateral in favor of the Lessor, which was included in restricted cash in the condensed consolidated balance sheet. ThisAs of March 31, 2021 and December 31, 2020, this letter of credit decreasedwas $0.3 million during the second quarter of 2020 and was $0.1 million as of June 30, 2020. In July 2020, the Company provided an additional $0.2 million to a total of $0.3 million in the letter of credit. There was no such amount as of December 31, 2019.million. The Company determined that the leased vehicles are accounted for as operating leases under ASC 842,, Leases(ASC 842).


2020 Lease and the First Amendment

On October 9,3, 2019, the Company entered into an office lease for approximately 24,474 square feet (Existing Premises) pursuant to a non-cancelable lease agreement (the 2020 Lease). The 2020 Lease commenced on April 1, 2020 and will expire on September 30, 2025, unless terminated earlier in accordance with its terms. The Company has a right to extend the term of the lease for an additional five years and does not anticipate to exerciseexercising such extension. The Company provided the landlord with a $750,000 security deposit in the form of a letter of credit for the Existing Premises. On April 14, 2020, the Company entered into the first amendment to the 2020 Lease for an additional 8,816 rentable square feet of the same office location (Expansion Premises), which shall commencecommenced on the earlier of the date of substantial completion of the leasehold improvements in the Expansion Premises or September 1, 2020 (Expansion Premises Commencement Date), and will expire on September 30, 2025. The Company provided an additional $50,000 in a letter of credit for the Expansion Premises. As of June 30, 2020March 31, 2021 and December 31, 2019,2020, restricted cash maintained as collateral for the Company’s security deposit was $0.8 million, respectively.million.


2015 Lease

Effective January 30, 2015, Private Evofemthe Company entered into a sublease for office space under a noncancelable lease agreement that expired in March 2020 (the 2015 Lease), which is the Company’s primary office space. The sublease provided for two renewal periods of five years each, but the sub-lessor did not renew its lease. In lieu of paying a security deposit directly to the sub-lessor, the Company maintained a time deposit in favor of the sub-lessor (the Deposit), which is included in restricted cash in the condensed consolidated balance sheets. During months 13 through 58 of the 2015 Lease term, subject to certain restrictions, approximately $5,000 of the Deposit was released each month through November 2019 and approximately $66,000 of the Deposit was released each month between December 2019 and March 2020. The 2015 Lease expired on March 31, 2020. As of June 30, 2020 and December 31, 2019, restricted cash maintained as collateral for the Company’s Deposit was zero and $0.3 million, respectively.


Leased Space
In August 2017, the Company entered into a manufacturing and supply agreement with an outside supplier for a term of one year from August 2017. This agreement was further renewed by both parties to cover the period from August 2018 to September 2019. Under the agreement, the supplier provides a dedicated packaging space for the Company at a fixed monthly cost. The Company determined that this dedicated space is accounted for as an operating lease under ASC 842. The lease for this space expired in September 2019.
Supplemental Financial Statement Information
Three Months Ended March 31,
Lease Cost (in thousands)Classification20212020
Operating lease expenseResearch and development$144 $50 
Operating lease expenseSelling and marketing246 55 
Operating lease expenseGeneral and administrative203 75 
Total$593 $180 
Lease Term and Discount RateMarch 31, 2021December 31, 2020
Weighted Average Remaining Lease Term (in years)4.224.43
Weighted Average Discount Rate12 %12 %
Maturity of Operating Lease Liabilities (in thousands)March 31, 2021
Remainder of 2021$1,961 
Year ending December 31, 20222,497 
Year ending December 31, 20232,166 
Year ending December 31, 20242,192 
Year ending December 31, 20251,502 
Total lease payments10,318 
Less: imputed interest(2,260)
Total$8,058 
17

Table of Contents
Lease Assets and Liabilities (in thousands) June 30, 2020
 December 31, 2019
Operating right-of-use assets $5,015
 $160
Operating lease liabilities- current $542
 $197
Operating lease liabilities- noncurrent $4,711
 $
Three Months Ended March 31,
Other information (in thousands)20212020
Cash paid for amounts included in the measurement of lease liabilities:
     Operating cash outflows in operating leases$486 $201 
    Three Months Ended June 30, Six Months Ended June 30,
Lease Cost (in thousands)
Classification 2020
 2019
 2020
 2019
Operating lease expense
Research and development $105
 $83
 $155
 $165
Operating lease expense
Selling and marketing 76
 20
 131
 41
Operating lease expense
General and administrative 171
 83
 246
 171
Total   $352
 $186
 $532
 $377
Lease Term and Discount Rate June 30, 2020
 December 31, 2019
Weighted Average Remaining Lease Term (in years) 5.10
 0.25
Weighted Average Discount Rate 12% 12%
Maturity of Operating Lease Liabilities (in thousands)
June 30, 2020

December 31, 2019
Remainder of 2020
$(92)
$201
Year ending December 31, 2021
1,543


Year ending December 31, 2022
1,673


Year ending December 31, 2023
1,599


Year ending December 31, 2024
1,612


Year ending December 31, 2025
1,104


Total lease payments
7,439

201
Less: imputed interest
(2,186)
(4)
Total
$5,253

$197
  Six Months Ended June 30,
Other information (in thousands) 2020
 2019
Cash paid for amounts included in the measurement of lease liabilities:    
     Operating cash outflows in operating leases $225
 $427


Other Contractual Commitments
In November 2019, the Company entered into a supply and manufacturing agreement with a third-party to manufacture Phexxi and potentially other product candidates in accordance with all applicable current good manufacturing practices (cGMP)practice regulations, pursuant to which the Company has certain contractualminimum purchase commitments commencing in 2020.based on the forecasted product sales.
In accordance with the aforementioned Fleet Lease Agreement, the Company has certain contractual commitments for the vehicles to be delivered for use by the Company's sales force, for which ROU assets and lease liabilities will be recognized upon delivery. The Company also has certain contractual obligations upon the Expansion Premises Commencement Date.
Contingencies

From time to time the Company may be involved in various lawsuits, legal proceedings or claims that arise in the ordinary course of business. There were no0 claims or actions pending against the Company as of June 30, 2020March 31, 2021 and December 31, 2019,2020, which management believes would have, individually or in the aggregate, a material adverse effect on its

business, liquidity, financial position, results of operations or cash flows. However, litigation is subject to inherent uncertainties and an adverse result in these or other mattersany matter that may arise from time to time that maycould harm the Company’s business.

Intellectual Property Rights

In 2014, Private Evofemthe Company entered into an amended and restated license agreement with Rush University (the Rush License Agreement) with Rush University Medical Center (Rush University) pursuant to which Rush University granted Private Evofemthe Company an exclusive, worldwide license of certain patents and know-how related to its multipurpose vaginal pH modulator technology authorizing Private Evofem to make, distribute and commercialize products and processes for any and all therapeutic, prophylactic and/or diagnostic uses, including, without limitation, use for female vaginal health and/or birth control.technology. Pursuant to the Rush License Agreement, the Company is obligated to pay to Rush University an earned royalty based upon a percentage of net sales in the range of mid-single digits. Commencing on January 1 of year three after a product has received regulatory approval and has been introduced to market,In September 2020, the Company may becomeentered the first amendment to the Rush License Agreement, pursuant to which the Company is also obligated to pay a minimum annual royalties,royalty amount of $100,000 to the extent the earned royalty or sublicensing fees, as applicable,royalties do not equal or exceed the minimum annual royalties.
In October 2015, the Company entered into separate sublicense agreements (the Sublicenses) with WomanCare Global Trading CIC (WCGCIC) for a contraceptive vaginal ring for aggregate consideration of (i) payments or potential payments to WCGCIC of (a) an upfront payment of $10.0 million, (b) potential regulatory and commercial milestone payments up to $32.0 million, (c) potential$100,000 commencing January 1, 2021. Such royalty payments on net product sales and (d) potential royalty payments on net sales of an equivalent generic product and (ii) $5.0 million in annual sublicense fees through October 1, 2019 to WCGCIC.were immaterial for the three months ended March 31, 2021.
During the first quarter of 2019, the Sublicenses were reassigned to WCG Cares, upon which, the unpaid sublicense fees ceased accruing interest and all accrued sublicense fees and interest expense of $1.3 million were transferred and became payable to WCG Cares. During the third quarter of 2019, the Company and WCG Cares entered into a settlement agreement, whereby the Company paid $1.0 million to WCG Cares to settle the entire outstanding balance. The Company recorded the difference of $0.3 million as a concession recorded within other income (expense) in its condensed consolidated statement of operations during the third quarter of 2019. See Note 8-

9.Related-party Transactions for a summary of the Company’s transactions with WCGCIC, WomanCare Global International, a non-profit organization registered in England and Wales (WCGI) and related entities, and WCG Cares.


8.    Related-party Transactions
Consulting Agreements
Effective April 1, 2017, the Company entered into a two-year consulting agreement with Thomas Lynch, the former chairman of the Company’s board of directors (the 2017 Consulting Agreement). The 2017 Consulting Agreement expired in accordance with its terms on March 31, 2019. This 2017 Consulting Agreement provided for (i) annual compensation of $0.4 million, including $0.1 million related to his board services and (ii) a stock option for the purchase of 6,416 shares of common stock that was to vest quarterly through March 31, 2018, which remained unissued at the time of the Merger.
Effective April 1, 2019, the Company entered into a new two-yeartwo-year consulting agreement with Mr.Thomas Lynch (the 2019 Consulting Agreement). The 2019 Consulting Agreement providesprovided for (i) annual compensation of $0.4 million, including $0.1 million related to Mr. Lynch’s board services, (ii) an annual grant of 150,000 restricted stock units (RSUs), which vested quarterly over one year from the grant date and (iii) an annual bonus of up to 100% of Mr. Lynch’s annual consulting fees based upon the achievement of the Company’s corporate goals and objectives as determined by and subject to approval of the board of directors. The 2019 Consulting Agreement terminated on April 1, 2020 upon the passing of Mr. Lynch.

Consulting fees incurred under the 2017 and 2019 Consulting Agreements were zero0 and $0.3approximately $0.1 million for the three months ended June 30,March 31, 2021 and 2020, and 2019, respectively, and $0.1 million and $0.4 million for the six months ended June 30, 2020 and 2019, respectively. As of June 30, 2020March 31, 2021 and December 31, 2019, accrued compensation,2020, excluding board fees, there was no accrued compensation owed to Mr. Lynch was zero and $0.4 million, respectively.Lynch.

Transactions with WCGI and Related Entities
From 2009 to 2016, Ms. Saundra Pelletier was the founding CEO of WCGI. In February 2013, Private Evofem and WCGI formed an alliance (the WCGI Alliance) and Ms. Pelletier also became Private Evofem’s CEO. Concurrent with the forming of the WCGI Alliance, Private Evofem and WCGI entered into (i) a service agreement to which the companies shared resources and employees and (ii) a three-year grant agreement under which Private Evofem provided funding to WCGI.
From 2011 to 2017, Ms. Pelletier served as a director of the board of WomanCare Global Trading, Inc., a WCGI subsidiary. As described in Note 7- Commitments and Contingencies, in October 2015, Private Evofem, through its wholly-

owned subsidiaries, entered into two sublicense agreements whereby Private Evofem was responsible for paying $5.0 million in annual sublicense fees, net of amounts paid under the grant agreement during 2015, to WCGCIC, also a WCGI affiliate.
Effective January 2016, Private Evofem and WCGI entered into a shared-services agreement (the SSA), which replaced the prior service agreement. Under the terms of the SSA, Private Evofem and WCGI cross charged the other company’s services provided by each entity on behalf of the other. The SSA also allowed for netting of due to and due from shared-services fees. In July 2019, the SSA was terminated. Services provided under the SSA on behalf of WCGI were immaterial for the three and six months ended June 30, 2019. The amounts of receivables and payables related to the Company’s transactions with WCGI related entities as of June 30, 2019 and for the three and six months ended June 30, 2019 were immaterial. All accrued sublicense fees and interest expense related to the Sublicenses as of December 31, 2018 became payable to WCG Cares during the first quarter of 2019.
Transactions with WCG Cares
In 2013, WCG Cares, a 501(c)(3) nonprofit organization, was incorporated under the laws of the State of California. Its primary purpose is to directly engage in and/or fund the development and implementation of programs that promote reproductive health, education, research and increased access to high-quality, innovative and affordable reproductive healthcare and healthcare products around the world. Ms. Pelletier served as the CEO and President of WCG Cares from 2013 to November 2017. She was a member of its board from November 2017 to March 1, 2020, and also served as chair of its board of directors from November 2017 to May 2018. Additionally, Mr. Justin J. File served as WCG Cares' Chief Financial Officer from November 2017 to May 2018. Dr. Kelly Culwell served as WCG Cares' Chief Medical Officer from November 2017 to December 2018. Dr. Culwell was also appointed to its board of directors in January 2019 with a term of three years until December 31, 2021. See shared-services agreement discussion below.
In March 2018, the Company and WCG Cares entered into a shared-services agreement (the Cares Shared Services Agreement). Under the terms of the Cares Shared Services Agreement, the Company and WCG Cares cross charged services provided by each entity (or their subsidiaries) on behalf of the other. The Cares Shared Services Agreement also allowed for netting of due to and due from shared-services fees. In July 2019, the Company provided a notice of termination to WCG Cares to terminate the Cares Shared Services Agreement effective September 2019. Services provided under the Cares Shared Services Agreement on behalf of WCG Cares were immaterial for the three and six months ended June 30, 2019, and the net shared-services due to the Company were immaterial as of June 30, 2019.

Variable Interest Entity Considerations
Due to shared management and numerous agreements between the Company and WCGI and the Company and WCG Cares, management reviewed its relationship with both WCGI and its subsidiaries and WCG Cares in accordance with the authoritative guidance for variable interest entities within ASC 810, Consolidation. The Company concluded that due to WCGI’s and WCG Cares’ status as not-for-profit entities, the scope exception from qualifying as a variable interest entity was met and, therefore, the Company is not required to consolidate WCGI or WCG Cares.

9.    2019 Private Placement
On April 10, 2019, the Company entered into a Securities Purchase Agreement with PDL BioPharma, Inc., a Delaware corporation (PDL), funds discretionally managed by Invesco Ltd. (Invesco) and funds managed by Woodford Investment Management Ltd. (WIM, collectively with Invesco and PDL, the 2019 Purchasers), providing for the issuance and sale to the 2019 Purchasers of an aggregate of up to $80 million of the Company’s common stock, par value $0.0001 per share (the Private Placement Shares) at a purchase price of $4.50 per share, and warrants to purchase shares of common stock with an exercise price of $6.38 per share (collectively, the Private Placement Securities) in a private placement (the Private Placement) to be funded in up to two separate closings.

The first closing was completed on April 11, 2019 (the Private Placement First Closing), pursuant to which the Company (i) issued and sold to PDL 6,666,667 shares of its common stock and warrants to purchase up to 1,666,667 shares of common stock (the Private Placement First Closing Warrants) and (ii) provided to the 2019 Purchasers an option, but not an obligation, from the Company to issue and sell to each 2019 Purchaser the shares of common stock and warrants as specified in the aforementioned Securities Purchase Agreement during the period beginning on April 11, 2019 and ending on June 10, 2019 (the Private Placement Purchase Rights). The total consideration for the Private Placement First Closing was $30 million.

The second closing was completed on June 10, 2019 (the Private Placement Second Closing), pursuant to which the Company issued and sold to PDL, Invesco and WIM (i) 6,666,667, 2,222,222 and 2,222,223 shares of its common stock, respectively and (ii) warrants to purchase up to 1,666,667, 555,556 and 555,556 shares of common stock (the Private Placement Second Closing Warrants), respectively, for an aggregate purchase price of $50 million. Shares of common stock issued to WIM included one voting share issued in connection with the issuance of its warrants.

The Company’s stockholders approved the Private Placement at its 2019 Annual Meeting of Stockholders held on June 5, 2019 (the Private Placement Approval Date).

The warrants have a 7-year term and will become exercisable at any time on or after the date that is six (6) months following their respective issuance dates. The Company determined the Private Placement First Closing Warrants were free standing financial instruments and liability classified in accordance with ASC 480 due to the requirement to obtain stockholder approval pursuant to Nasdaq Listing Rule 5635(b). The Company utilized the Black-Scholes option-pricing model to calculate the fair value of warrants at issuance and on the Private Placement Approval Date for the Private Placement First Closing Warrants, and recorded the following in the condensed consolidated financial statements for the three months ended June 30, 2019: (i) $3.6 million warrant liability at issuance; (ii) $3.3 million change in fair value of warrants in the condensed consolidated statement of operations as a result of mark-to-market on the Private Placement Approval Date; and (iii) $6.9 million reclassification from warrant liability to additional paid-in capital in the condensed consolidated balance sheet on the Private Placement Approval Date.

The Private Placement Second Closing Warrants were determined to be free standing financial instruments and equity classified in accordance with ASC 815, Derivatives and Hedging. The Company utilized the Black-Scholes option-pricing model to calculate the fair value of warrants at issuance and recorded an estimated fair value of $12.7 million as additional paid-in capital in the condensed consolidated balance sheet.
The Company also determined the Private Placement Purchase Rights were free standing financial instruments and liability classified in accordance with ASC 480 due to the stockholder approval provision noted above. As described in Note 6- Fair Value Financial Instruments, the Company utilized a combination of a lattice model and a Black-Scholes option-pricing model to calculate the fair value of the Private Placement Purchase Rights at issuance and on the Private Placement Approval Date. The Company recorded the following in the condensed consolidated financial statements during the second quarter of 2019: (i) $3.2 million purchase rights liability at issuance for the purchase rights provided to PDL; (i) $0.7 million loss on issuance of purchase rights at issuance in the condensed consolidated statement of operations for the purchase rights provided to Invesco and WIM; (iii) $19.6 million change in fair value of purchase rights in the condensed consolidated statement of operations as a result of mark-to-market on the Private Placement Approval Date; and (iii) $22.8 million reclassification from purchase rights liability to additional paid-in capital in the condensed consolidated balance sheet on the Private Placement Approval Date.
Upon completion of the Private Placement First Closing and Private Placement Second Closing, the Company received proceeds of approximately $28.2 million and $47.2 million, net of $1.8 million and $2.8 million in advisory fees to financial advisors, respectively, and used these proceeds for clinical research and development purposes, including resubmission of the New Drug Application for Phexxi to the FDA, pre-commercialization activities, and for general corporate purposes.

Additionally, upon completion of the Private Placement Second Closing, the previously issued WIM Warrants and Reload Warrants (as defined below) to purchase up to 475,000 shares and 1,188,029 shares of common stock, respectively, were canceled. See Note 10- 10.Stockholders' Equity for additional details on the Reload Warrants. The Company included such cancellation in valuing the purchase rights described above. (Deficit)

10.    Stockholders' Equity


Warrants

On February 5, 2019, the Company entered into letter agreements (the Repricing Letter Agreements) with WIM and certain other holders of outstanding warrants to purchase common stock of the Company by exercising certain outstanding warrants. Upon execution of the Repricing Letter Agreements, investment funds affiliated with WIM exercised certain warrants received upon the completion of the Merger (WIM Warrants) to purchase an aggregate of 1,525,000 shares of common stock, and WIM and other holders of common warrants issued in the public offering in May 2018 (Public Offering Warrants) exercised their common warrants to purchase an aggregate of 851,062 shares of common stock at a reduced exercise price of $2.64 per share. The Company received gross proceeds of approximately $6.3 million from these exercises.

The Company determined that the incremental fair value as a result of the modification to these warrants from the change of the exercise price was approximately $1.4 million and $0.5 million for the WIM Warrants and Public Offering Warrants, respectively, which were recorded as a change in fair value of warrants in the condensed consolidated statement of operations for the three months ended June 30, 2019.

In addition, on February 8, 2019 and per the terms of the Repricing Letter Agreements, the Company issued warrants to purchase up to 1,188,029 shares of the Company’s common stock (Reload Warrants) to the holders' party to the Repricing Letter Agreements at an exercise price of $5.20 per share. The Company determined the Reload Warrants are free standing financial instruments and equity classified in accordance with ASC 480. Since the Reload Warrants were issued in addition to the reduced exercise price to induce Holders of WIM Warrants and common warrants to exercise their warrants, the Company determined the fair value of the Reload Warrants was also the incremental fair value as a result of the modification to the WIM warrants and common warrants exercised. To determine the fair value of the Reload Warrants, the Company utilized the Black-Scholes option-pricing model, which resulted in an estimated fair value of the Reload Warrants of $2.5 million, which was recorded as additional paid-in capital in the condensed consolidated balance sheet and change in fair value of warrants in the condensed consolidated statement of operations for the three months ended June 30, 2019.

On June 10, 2019, upon the Second Closing of the Private Placement as discussed at Note 9- 2019 Private Placement, the remaining WIM Warrants to purchase up to 475,000 shares of common stock and all Reload Warrants were cancelled. Warrants to purchase an aggregate of 4,444,446 shares of common stock were issued in connection with the Private Placement at an exercise price of $6.38 per share in April and June 2019.

In April and June 2020, pursuant to the SecuritiesBaker Bros. Purchase Agreement as discussed in Note 4-5- Convertible Notes, the Company issued warrants to purchase up to 5,122,950 shares of common stock in a private placement at an exercise price of $2.44 per share.


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As of June 30, 2020,March 31, 2021, warrants to purchase up to 10,426,107 shares of the Company’s common stock remain outstanding at a weighted average exercise price of $4.54 per share. These warrants are summarized below:

Type of WarrantsUnderlying Common Stock to be PurchasedExercise PriceIssue DateExercise Period
Common Warrants878 $51.24 March 30, 2012March 30, 2012 to March 30, 2022
Common Warrants1,171 $51.24 August 17, 2012August 17, 2012 to July 17, 2022
Common Warrants7,806 $3.69 June 11, 2014June 11, 2014 to June 11, 2024
Common Warrants848,674 $7.50 May 24, 2018May 24, 2018 to May 24 2025
Common Warrants182 $7.50 June 26, 2018June 26, 2018 to June 26, 2025
Common Warrants1,666,667 $6.38 April 11, 2019October 11, 2019 to April 11, 2026
Common Warrants2,777,779 $6.38 June 10, 2019December 10, 2019 to June 10, 2026
Common Warrants3,073,770 $2.44 April 24, 2020April 24, 2020 to April 24, 2025
Common Warrants2,049,180 $2.44 June 9, 2020June 9, 2020 to June 9, 2025
Total10,426,107 

Common Stock

Effective January 17, 2018, and in connection with the Merger, the Company amended and restated its certificate of incorporation, under which the Company is currently authorized to issue up to 300,000,000 shares of common stock, $0.0001 par value per share, and 5,000,000 shares of preferred stock, $0.0001 par value per share.


Public Offering


On June 5, 2020, the Company completed an underwritten public offering (the 2020 Public Offering), whereby the Company issued 28,500,000 shares of common stock at a price to the public of $3.50 per share (the 2020 Public Offering Price). The Company received proceeds from the 2020 Public Offering of $93.2 million, net of underwriting discounts. In addition, the Company granted the underwriters a 30-day option to purchase up to an additional 4,275,000 shares of its common stock at the 2020 Public Offering Price, less applicable underwriting discounts. On June 10, 2020, the Company issued an additional 3,200,000 shares of common stock upon exercise of the underwriters’ option and received $10.5 million in proceeds from this exercise, net of underwriting discounts. The common stock issued in the 2020 Public Offering were registered pursuant to a shelf registration statement on Form S-3 filed with the SEC on November 18, 2019 and declared effective on December 2, 2019.

On June 10, 2020,March 29, 2021, the Company completed an underwritten public offering (the 2021 Public Offering), whereby the Company issued an additional 3,200,00017,142,857 shares of common stock upon exerciseat a price to the public of the underwriters’ overallotment option and$1.75 per share (the 2021 Public Offering Price). The Company received proceeds from the exercise2021 Public Offering of $10.5$28.0 million, net of underwriting discounts. In addition, the Company granted the underwriters a 30-day overallotment option to purchase up to an additional 2,571,428 shares of its common stock at the 2021 Public Offering Price, less applicable underwriting discounts. On April 6, 2021, the underwriters exercised their overallotment option in full and the Company received proceeds of approximately $4.2 million, net of underwriting discounts. The common stock issued in the 2021 Public Offering were registered pursuant to a shelf registration statement on Form S-3 filed with the SEC on March 4, 2021 and declared effective on March 11, 2021.


At the MarketATM Program


In November 2019, the Company entered into an Equity Distribution Agreement (the Equity Distribution Agreement) with Piper Sandler & Co. (Piper Sandler), which provided the Company the ability to offer and sell, from time to time, shares of its common stock in ATM offerings (as defined in Rule 415 of the Securities Act of 1933, as amended) having an aggregate offering price up to $50 million from time to time through Piper Sandler acting as sales agent. On June 2, 2020, in connection with the 2020 Public Offering discussed in Note 10- Stockholders’ Equity (Deficit), the Equity Distribution Agreement was terminated. During the sixthree months ended June 30,March 31, 2021, the Company received no proceeds from the ATM program. During the three months ended March 31, 2020, the Company received proceeds of approximately $3.8$1.1 million, in cash and cash equivalents (including $0.3 million that was included in other receivables in the condensed consolidated balance sheet at December 31, 2019), net of commissions, from the sale of 676,656202,098 shares of its common stock.


Short-swing Profit Disgorgement
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In June 2020, the Company received an aggregateTable of $0.2 million from short-swing profit disgorgement, which is included as an increase to additional paid-in capital in the condensed consolidated statement of stockholders’ equity and as a financing activity in the condensed consolidated statement of cash flows.Contents


Common Stock Reserved for Future Issuance

Common stock reserved for future issuance is as follows in common equivalent shares as of June 30, 2020:
March 31, 2021:
Common stock issuable upon the exercise of stock options outstanding8,449,01611,385,846 
Common stock issuable upon the exercise of common stock warrants10,426,107
Common stock available for future issuance under the 2019 ESPP1,354,9682,293,721 
Common stock available for future issuance under the Amended and Restated 2014 Plan1,940,777744,089 
Common stock available for future issuance under the Amended Inducement Plan798,375552,819 
Total common stock reserved for future issuance22,969,24325,402,582 


Stockholder Rights Agreement


On March 24, 2020, the Company entered into a rights agreement (the Rights Agreement) with Philadelphia Stock Transfer, Inc., as rights agent. In connection with the adoption of the Rights Agreement and pursuant to its terms, the Company’s board of directors authorized and declared a dividend of one1 right (each, a Right) for each outstanding share of the Company’s common stock to stockholders of record at the close of business on April 8, 2020 (the Record Date), and authorized the issuance of one1 Right for each share of common stock issued by the Company (except as otherwise provided in the Rights Agreement) between the Record Date and the Distribution Date (as defined below). The Rights Agreement expired in accordance with its terms as of the close of business on March 24, 2021, and is no longer in force.


Each Right entitlesentitled stockholders to purchase from the Company, when exercisable and subject to adjustment, one one-thousandth of a share (a Unit) of Series A Preferred Stock (the Preferred Stock) at a purchase price of $17.50 per Unit (the Purchase Price). The Rights were generally to become exercisable (the Distribution Date) upon the earlier of (i) 10 business days following a public announcement that a person or group of affiliated or associated persons (an Acquiring Person) hashad acquired or otherwise obtained beneficial ownership of 32% or more of the then‑outstanding shares of common stock of the Company, (the date of such public announcement, the Stock Acquisition Date), and (ii) 10 business days (or such later date as may be determined by the board of directors of the Company) following the commencement of a tender offer or exchange offer that would resulthave resulted in a person or group becoming an Acquiring Person. If a person becomesbecame an Acquiring Person, then each holder of a Right willwould thereafter have had the right to receive, upon exercise, Units of Preferred Stock or, at the option of the Company, shares of common stock (or, in certain circumstances, cash, property or other securities of the Company) having a value equal to two

times the Purchase Price of the Right. If the Company iswere acquired in a merger or similar business combination transaction at any time after a person hashad become an Acquiring Person, each holder of a right (other than the Acquiring Person and certain related parties) will bewould have been entitled to purchase a similar amount of common stock of the acquiring entity.


11.Stock-based Compensation

Equity Incentive Plans
The following table summarizes stock-based compensation expense related to stock options, restricted stock awards (RSAs) and RSUsrestricted stock units (RSUs) granted to employees, and non-employee directors and consultants, and Employee Stock Purchase Plan included in the condensed consolidated statements of operations as follows (in thousands):
Three Months Ended March 31,
20212020
Research and development$543 $482 
Selling and marketing740 538 
General and administrative2,181 2,381 
Total$3,464 $3,401 
 Three Months Ended June 30, Six Months Ended June 30,
 2020 2019 2020 2019
Research and development$916
 $369
 $1,398
 $657
Selling and marketing1,121
 310
 1,659
 537
General and administrative3,997
 1,836
 6,378
 3,283
Total$6,034
 $2,515
 $9,435
 $4,477

In September 2012, Private Evofem adopted theThe 2012 Equity Incentive Plan (the 2012 Plan) that provides for the issuance of RSAs, RSUs, or non-qualified and incentive common stock options to its employees, non-employee directors and consultants, from its authorized shares. In general, the options expire ten years from the date of grant and generally vest either (i) over a four-yearfour-year period, with 25% exercisable at the end of one year from the employee’s hire date and the balance vesting ratably thereafter or (ii) over a three-yearthree-year period, with 25% exercisable at the grant date and the balance vesting ratably thereafter. Upon completion of the Merger, Private Evofem’s 2012 Plan was assumed by the Company and awards outstanding under the 2012 Plan became awards for the Company’s common stock. Effective as of the Merger, noNo further awards may be issued under the 2012 Plan.

On September 15, 2014, Neothetics’the Company's board of directors adopted, and stockholders approved, the 2014 Equity Incentive Plan (the 2014 Plan), which was amended and restated on each of May 2018 and February 26, 2019 (the Amended
20

and Restated 2014 Plan), which among other things, increased the number of authorized shares under the 2014 Plan from 749,305 to an aggregate of 7,800,000 shares. On February 25, 2020, the Company’s board of directors approved, subject to stockholder approval, and recommended its stockholders approve at the 2020 Annual Meeting, an additional 2,000,000 authorized shares reserved for issuance under the Amended and Restated 2014 Plan to an aggregate of 11,725,515 shares, including the Evergreen Shares discussed below. Such stockholder approval was obtained on May 12, 2020. Per the terms of the Amended and Restated 2014 Plan, the shares reserved will automatically increase on each January 1 through 2024, by an amount equal to the smaller of (i) 4% of the number of shares of common stock issued and outstanding on the immediately preceding December 31; or (ii) an amount determined by our board of directors. This provision resulted in an additional 1,925,5153,254,061 shares (Evergreen Shares) added to the total number of authorized shares on January 1, 2020. As of June 30, 2020, there were 1,940,777 shares available to grant under the Amended and Restated 2014 Plan.2021.

On July 24, 2018, upon the recommendation by the Compensation Committee, the Company's board of directors adopted the Evofem Biosciences, Inc. 2018 Inducement Equity Incentive Plan (the Inducement Plan), pursuant to which the Company reserved 250,000 shares for the issuance of equity awards under the Inducement Plan. The Inducement Plan was amended effective February 25, 2020 (the Amended Inducement Plan), which increased the number of authorized shares to an aggregate of 1,250,000 shares. The only persons eligible to receive awards under the Inducement Plan are individuals who satisfy the standards for inducement grant recipients under Nasdaq Marketplace Rule 5635(c)(4), generally, a person not previously an employee or director of the Company, or following a bona fide period of non-employment, as an inducement material to the individual’s entering into employment with the Company. As of June 30, 2020, there were 798,375 shares available to grant under the Inducement Plan.


Stock Options

There were 767,0002,478,025 and 384,0001,475,485 shares of stock options granted during the three months ended June 30,March 31, 2021 and 2020, and 2019, respectively, and 2,242,485 and 443,000 shares of stock options granted during the six months ended June 30, 2020 and 2019, respectively. Of the total stock options granted during the six months ended June 30, 2020, 1,027,400 were granted out of the share reserve increase approved by the board of directors under the Amended and Restated 2014 Plan on February 25, 2020 and were subject to the Company obtaining the requisite stockholder approval. This stockholder approval was obtained on May 12, 2020.

ely.As of June 30, 2020,March 31, 2021, unrecognized stock-based compensation expense for employees and non-employee stock options was approximately $11.2$13.8 million, which the Company expects to recognize over a weighted-average remaining period of 2.32.8 years, assuming all unvested options become fully vested.
Summary of Assumptions
The fair value of noncash stock-based compensation for stock options granted to employees and non-employees was estimated on the date of grant using the Black-Scholes option pricing model based on the following weighted-average assumptions for options granted for the periods indicated.
Three Months Ended June 30, Six Months Ended June 30,Three Months Ended March 31,
2020
 2019
 2020
 2019
20212020
Expected volatility80.7% 76.1% 80.1% 76.1%Expected volatility100.3 %77.5 %
Risk-free interest rate0.4% 2.1% 0.6% 2.1%Risk-free interest rate0.6 %1.3 %
Expected dividend yield% % % %Expected dividend yield%%
Expected term (years)5.9
 5.7
 5.9
 5.7
Expected term (years)6.05.9
Expected volatility. The expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biotechnology industry.
Risk-free interest rate. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the stock option grants.
Expected dividend yield. The expected dividend yield assumption is based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends.
Expected term. The expected term represents the period options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determines the expected term assumption using the practical expedient as provided for under ASC 718, Compensation-Stock Compensation - Stock Compensation, which is the midpoint between the requisite service period and the contractual term of the option.

Restricted Stock Awards and Units

There were 20,0001,772,500 and 5,0001,245,000 shares of RSAs granted under the Amended and Restated 2014 Plan during the three months ended June 30,March 31, 2021 and 2020, and 2019, respectively, and 1,265,000 and 475,500 shares of RSAs granted during the six months ended June 30, 2020, and 2019 respectively, to itsthe Company's executive management team, and certain non-executive employees.employees and consultants. The vesting conditions for 1,245,0001,767,500 shares of RSAs granted during the first quarter of 20202021 and 460,500 sharesall of the RSAs granted during the first quarter of 20192020 are connected to the Company’s achievement of certain performance milestones in the corresponding fiscal year (Performance-based RSAs).year.

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Table of Contents
For the Performance-based RSAs, (i) the fair value of the award was determined on the grant date, (ii) the Company assessed the probability of achieving each individual milestone associated with the award using reasonable assumptions based on the Company's operation performance towards each milestone and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. The non-performance based RSAs and RSUs were valued at the fair value on the grant date and the associated expenses will be recognized over the vesting period.
The
For the three months ended March 31, 2021, the Company recognized $4.4$1.6 million and $6.4in stock-based compensation expense related to RSAs. For the three months ended March 31, 2020, the Company recognized $2.0 million stock-based compensation expense during the three and six months ended June 30, 2020, respectively, forrelated to RSAs and RSUs. As of June 30, 2020,March 31, 2021, unrecognized stock-based compensation expense related to the unvested RSAs and RSUs was approximately $0.3$4.9 million, which the Company expects to recognize over a weighted-average remaining period of 1.30.6 years.
On April 1, 2020, under the Amended and Restated 2014 Plan, the Company issued 150,000 RSUs to the former chairman of the Company’s board of directors in consideration for certain consulting services to be provided to the Company in connection with the 2019 Consulting Agreement, which were immediately forfeited upon the passing of Mr. Lynch.
Employee Stock Purchase Plan


In November 2014, Neothetics adopted the 2014 Employee Stock Purchase Plan (the 2014 ESPP), which initially authorized the issuance of 28,333 shares of common stock pursuant to purchase rights granted to employees, and an additional 258,672 evergreen shares were added to the total shares authorized on January 1, 2019. Following completion of the Merger,

there was no enrollment in the 2014 ESPP. During the three and six months ended June 30, 2019, there were no shares of common stock purchased under the 2014 ESPP.

On May 7, 2019, the board of directors terminated the 2014 ESPP and approved a new 2019 Employee Stock Purchase Plan (the 2019 ESPP), which was approved by stockholders at the 2019 annual meeting held on June 5, 2019. The 2019 ESPP initially authorized the issuance of 500,000 shares of common stock pursuant to purchase rights granted to employees. In addition, the number of shares available for issuance under the 2019 ESPP will increase on January 1 of each year in an amount equal to the lesser of (i) 1,000,000 shares, (ii) 2% of the shares of common stock outstanding on December 31, or (iii) such lesser number of shares as is determined by the board of directors. As of June 30, 2020, there were 1,354,968This provision resulted in an additional 1,000,000 shares of common stock reserved and available for issuance pursuantadded to the 2019 ESPP.total number of authorized shares on January 1, 2021. The 2019 ESPP is intended to qualify as an employee stock purchase plan within the meaning of Section 423 of the Internal Revenue Code of 1986, as amended (the Code).amended.


The 2019 ESPP enables eligible full-time and part-time employees to purchase shares of the Company’s common stock through payroll deductions of between 1% and 15% of eligible compensation during an offering period. A new offering period begins approximately every June 15 and December 15. At the last business day of each offering period, the accumulated contributions made during the offering period will be used to purchase shares. The purchase price is 85% of the lesser of the fair market value of the common stock on the first or the last business day of an offering period. The maximum number of shares of common stock that may be purchased by any participant during an offering period will be equal to $25,000 divided by the fair market value of the common stock on the first business day of an offering period. The current active offering period under the 2019 ESPP commenced on JuneDecember 15, 2020 and will end on DecemberJune 14, 2020.2021. During the three and six months ended June 30,March 31, 2021 and 2020, there were 67,454no shares of common stock purchased under the 2019 ESPP.


The fair value of shares to be issued to employees under the 2019 ESPP is estimated using a Black-Scholes option-pricing model at the grant date, which requires the use of subjective and complex assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate and (iv) the expected dividend yield. The following weighted average assumptions were used in the calculation ofNo grant date fair value of shares under the 2019 ESPP at the grant dates for the period indicated.calculation was performed during three months ended March 31, 2021 and 2020.

 Three and Six Months Ended June 30,
 2020
 2019
Expected volatility108.9% 72.5%
Risk-free interest rate0.2% 2.2%
Expected dividend yield% %
Expected term (years)0.5
 0.5

ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations


The terms “we,” “us,” “our,” “Evofem” or the “Company” refer collectively to Evofem Biosciences, Inc. and its wholly-owned subsidiaries, unless otherwise stated. All information presented in this Quarterly Reportquarterly report on Form 10-Q (Quarterly Report) is based on our fiscal year. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ending December 31 and the associated quarters, months and periods of those fiscal years.

TheYou should read the following discussion and analysis of our financial condition and results of operations should be read in conjunctiontogether with our condensed consolidated financial statements and the correspondingrelated notes includedappearing elsewhere in this Quarterly Report. For additional context with which to understand our financial condition and results of operations, see the audited consolidated financial statements and accompanying notes contained therein as of December 31, 20192020 and 20182019 and related notes in ourthe Company’s Annual Report on Form 10-K as filed with the SEC on March 12, 2020 (the 20194, 2021 (2020 Audited Financial Statements). This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth in Exhibit 99.2 (Risk Factorsunder Item 1A of Evofem Biosciences, Inc.) to our Current Report on Form 8-K as filed withPart I of the SEC on June 2, 2020.2020 Audited Financial Statements. Unless otherwise defined in this section, the defined terms in this section have the meanings set forth in the 20192020 Audited Financial Statements.







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Table of Contents
Overview


We are a San Diego-based commercial-stage biopharmaceutical company committed to 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).health.



Our first commercial product, Phexxi™Phexxi® (lactic acid, citric acid, and potassium bitartrate), is the first and only hormone-free, prescription vaginal gel approved in the United States for the prevention of pregnancy. We are advancing EVO100 into Phase 3 clinical trials for the prevention of urogenital transmission of both Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women.

Phexxi as a Contraceptive and Launch Strategies

We will launch our first commercial product, Phexxi, the first and only FDA-approved, hormone-free, woman-controlled, on-demand prescription contraceptive gel, in September 2020.

Phexxi(Phexxi), was approved by the U.S.United States (U.S.) Food and Drug Administration (FDA) on May 22, 2020 and commercially launched in the United States in September 2020. Phexxi is the first and only FDA approved hormone-free, woman-controlled, on-demand prescription contraceptive gel for women. We are conducting a pivotal Phase 3 clinical trial to evaluate our lead product candidate EVO100 vaginal gel (EVO100) for the prevention of pregnancyurogenital transmission of both chlamydia and gonorrhea in females of reproductive potential for usewomen. We refer to this trial as an on-demand method of contraception.“EVOGUARD”.


After careful consideration of the impact of the COVID-19 pandemic on the various aspects of the health care landscape, particularly the restrictions on physician interactions, we made the strategic decision to launchPhexxi: Our Non-hormonal, On-Demand Birth Control

We commercially launched Phexxi in September 2020.2020 with a sales force promoting Phexxi directly to obstetrician/gynecologists and their affiliated health professionals, who collectively write the majority of prescriptions for contraceptive products. Our sales force comprises 59 regional business representatives, 11 regional business managers, and a self-guided virtual healthcare provider learning platform.


Our comprehensive commercial strategy for Phexxi launch strategy includes marketing and public relationsproduct awareness campaigns targeting the millions of women in the United States of reproductive potential, including the approximately 23 million women who our research has indicated are seeking non-hormonal birth control optionsnot using hormonal contraception and the approximately 18.8 million women who are using a prescription contraceptive, some of whom, particularly pill users, may be ready to move to an FDA-approved, non-invasive hormone-free contraceptive, as well as certain identified target health carehealthcare provider segments; salesforce recruitment and training; payer outreach; implementation of the Phexxi Concierge Experience, our comprehensive tele-medicine support system; and execution of our consumer digital and media strategy.


In December 2020 two U.S. patents that cover Phexxi and its labeled indication were listed in the U.S. FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The Orange Book listing of these two patents covering Phexxi’s composition of matter and its method of use in prevention of pregnancy is an important step in the ongoing development of our patent portfolio, which currently covers Phexxi into 2033. The newly listed method of use patent, number 10,568,855 (the ‘855 patent), covers contraception using the L-lactic acid Phexxi formulation. The ‘855 patent was issued by the U.S. Patent and Trademark Office (USPTO) in February 2020 and is expected to expire in March 2033. The newly listed patent number 6,706,276 (the ‘276 patent) is a composition of matter patent covering Phexxi. Evofem has an exclusive license to this patent, which is held by Rush University. The ‘276 patent was issued by the USPTO in March 2004 and is expected to expire in March 2026 based on the five-year patent term extension application that was timely filed by the patent owner.

On February 14, 2021, we launched a direct-to-consumer advertising campaign, known as “Get Phexxi,” designed to increase awareness and educate women on the benefits of Phexxi. The campaign highlights some of the struggles women face when choosing among the many available methods of contraception, including the lack of control with condoms, constant daily use of the pill, and abstinence required for cycle tracking. The “Get Phexxi” ads aired and continue to air nationally across broadcast, connected, and streaming television networks.

Also in February 2021, we announced our collaboration with the National Community Oncology Dispensing Association, Inc., a premier educational platform for community and academic oncology practices nationwide. Together we intend to develop educational resources and information to raise awareness about the importance and availability of Phexxi as a new non-hormonal birth control method for female patients living with, fighting and recovering from cancer. Every year in the United States, more than 800,000 new cases of cancer are reported among women, and many cancer treatment protocols require female patients of reproductive age to use birth control while undergoing treatment. Until the introduction of Phexxi, non-hormonal prescription contraception options were starkly limited; previously, women were generally steered toward condoms or the copper IUD, a prescription medical device that is implanted in the uterus where it releases copper ions and can cause inflammation.

We plancontinue to commercially launch Phexxi in September 2020 with a best-in-class hybrid sales force comprising regional business representatives, regional business managers, a tele-sales communication platform,increase the number of lives covered and a self-guided virtual health care provider learning platform. Sales force recruitment is underway, with an emphasis on hiring experienced, successful health care sales representatives who are able to leverage their established relationships to gain preferred formulary position for Phexxi. As of May 2021, we had obtained coverage for approximately 55% of U.S. commercial lives, including approximately 9 million lives covered at no out-of-pocket cost and approximately 13.7 million lives covered under our December 2020 contract award from the U.S. Department of Veterans Affairs. On January 1, 2021, the U.S. Medicaid population gained access to health care providers for Phexxi eventhrough our participation in the COVID-19 environment.Medicaid National Drug Rebate Program. Medicaid provides health coverage to approximately 68 million members, including approximately 16.8 million women 19-49 years of age.


Following FDA approval
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Table of Phexxi,Contents
In June 2020, Medi-Span and First Databank, two major drug information databases that payers consult for pricing and product information, granted Phexxi a new classification in their databases and pricing compendia as the first and only “Vaginal pH Modulator.” These listings, coupled with our timely response to payer clinical requests, have enabled us to mitigate coverage review times with payers, which can otherwise take up to 180 days.

We are in discussions with all major commercial payers, and several regional plans have already made positive coverage determinations for Phexxi. We anticipate that we will achieve 50 to 60% commercial review at launch,working with the remaining 40%FDA’s Office of payers reviewing by year-end 2020.

The Affordable Care Act (ACA) mandates that women must receiveWomen’s Health to update their contraceptionBirth Control Guide to also include a new category for no out-of-pocket cost, with at least one product in each ofvaginal pH modulators as we believe the 18 categories that have been defined. However, based on the above determinations regardingcurrent guide is outdated and medically inaccurate. Phexxi’s unique mechanism of action asis neither a vaginal pH modulator, we believe that Phexxi should be classified asspermicide nor a new 19th category of contraception. We are working with the Office of Women’s Healthbarrier contraceptive method and Health Resources and Services Administration to update their birth control tables accordingly.  

While we are confident in both our launch plans and our flexibility to pivot, as needed, in response to the evolving environment, it is important to note that there may be aspectsdoes not fit into any of the COVID-19 pandemic that are unknown at this timeexisting 18 contraceptive categories. Payers (including pharmacy benefit managers) use the Birth Control Guide to determine which methods they need to cover under the Patient Protection and that may have a material effect on our businessAffordable Care Act, as amended by the Health Care and strategies and that cause our resultsEducation Reconciliation Act of operation to materially differ from our current expectations and may also impact our future plans.2010 (collectively, the ACA).


EVO100: Our STI Preventive Product Candidate


In DecemberOur lead product candidate, EVO100, is an antimicrobial vaginal gel under evaluation for the prevention of chlamydia and gonorrhea in women - two of the most pervasive sexually transmitted infections (STIs) in the United States. Currently, there are no FDA‑approved prescription products for the prevention of either of these commonly reported STIs.

According to the Centers for Disease Control and Prevention (CDC), any sexually active person can be infected with chlamydia and/or gonorrhea. Despite the CDC recommendation for condom use to prevent STIs, U.S. rates of infection with chlamydia and gonorrhea climbed in 2019 we reported top-line results from our double-blind, placebo-controlled Phase 2b clinical trial for EVO100, known as AMPREVENCE. The trial enrolled 860the sixth consecutive year. Based on these reports, an estimated 78 million women at 50 sites18-65 years of age who are sexually active in the United States for a 4-month interventional period followed by a one-month follow-up period. AMPREVENCE met both the primary and the secondary endpoints with a 50% relativecould be at risk reduction in chlamydia infections and a 78% relative risk reduction in gonorrhea infections. Additionally, , the study demonstrated that EVO100 was generally safe and well tolerated. The number of adverse events was similar across both arms (7.2% for EVO100 and 7.5% for placebo) and no serious treatment-related adverse events were reported.     to contract these STIs.

BuildingBased on the positive AMPREVENCEand statistically significant top-line results andof our End of Phase 2 meeting with the FDA in May 2020,2B/3 AMPOWER trial, we plan to initiate ainitiated our Phase 3 EVOGUARD clinical trial of EVO100 for the prevention of urogenital transmission of both chlamydia infection and gonorrhoea infection in women in the fourth quarter ofOctober 2020. This randomized, placebo-controlled pivotal trial willis designed to enroll 1,730 women with a prior chlamydia or gonorrhea infection and who are at risk for future infectioninfection. Participants are enrolled for a 16-week interventional phase followed by a one-month follow-up period. All 90 planned study sites have been identified and 80 of the sites have been activated as of May 5, 2021. We expect to complete enrollment in the fourth quarter of 2021 and to report top-line EVOGUARD results in mid-2022. Assuming positive results from this Phase 3 clinicalthe trial, inwe expect to submit a New Drug Application for EVO100 by the end of 2022. According to the Centers for Disease Control and

Prevention (CDC), U.S. rates of infection for chlamydia and gonorrhea climbed in 2018 for the fifth consecutive year. Nearly 2.4 million domestic cases of these STIs were diagnosed in 2018, with 1.8 million newly reported chlamydia cases and approximately 580,000 newly reported gonorrhea cases. The CDC also reported that gonorrhea is increasingly becoming antibiotic resistant, making it much harder, or sometimes impossible, to treat. Currently, there are no FDA-approved prescription products for the prevention of either of these dangerous infections


The FDA has granted EVO100 Fast Track designation to EVO100 for the prevention of chlamydia in women and has designated it a Qualified Infectious Disease Product (QIDP) designation for the prevention of gonorrhea in women. QIDP designation provides several important potential advantages, including qualification for the FDA Fast Track program and longer market exclusivity, among others.


COVID-19 Pandemic


The current COVID-19 worldwide pandemic related to a novel strain of a virus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus), which causes coronavirus disease 2019 (COVID-19) has presented substantial public health and economic challenges and is affecting our employees, customers, communities and business operations, as well as the U.S. and global economies and financial markets. International and U.S. governmental authorities in impacted regions are taking actions in an effort to slow the spread of COVID-19, including issuing varying forms of “stay-at-home” orders, and restricting business functions outside of one’s home. In response, we have implemented a work-from-home policy for our employees. To date, our third-party manufacturer and suppliers have not experienced any interruptions or disruptions in their ability to manufacture Phexxi or to supply our manufacturer raw materials, respectively. Nevertheless the persistence of the COVID-19 pandemic may interrupt or disrupt such manufacture and/or supply. Further, if our sales force is unable to visit health care providers and/or if our patients are unable to visit health care providers, this may also materially adversely affect our ability to sell Phexxi commercially.  Similarly, the timing of the initiation or completion of our Phase 3 clinical trial of EVO100, may be affected by COVID-19 and COVID-19 may directly or indirectly impact the timeline for data readouts, initiation of, as well as monitoring, data collection and analysis and other related activities for, our Phase 3 clinical trial of EVO100 and our other clinical trials. Our current expectations for when we will initiate and how we will enroll our Phase 3 clinical trial of EVO100 are based on an assumption that clinical trial and healthcare activities begin to normalize in the second half of 2020.  Therefore, our assumptions around initiation timing may prove to be incorrect, in particular if COVID-19 continues to spread. In light of recent developments relating to the COVID-19 pandemic, and consistent with the FDA’s updated industry guidance for conducting clinical trials, clinical trials may be deprioritized in favor of treating patients who have contracted the virus or to prevent the spread of the virus. This may lead to clinical trial protocol deviations or to discontinuation of treatment for patients who are then enrolled in our trials.

Any delays or disruptions in the commercial launchcommercialization of Phexxi and/or the initiation or completion of our clinical trials, data analysis or readouts and/or any disruption in our supply chain could have a material adverse effect on our business, results of operations and financial condition. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the success of ongoing COVID-19 vaccination efforts, the emergence, prevalence and strength of variant strains, and the actions taken to contain or treat it,the disease, as well as the economic impact on local, regional, national and international markets.

Merger

As previously discussed, on January 17, 2018 (the Closing Date), Neothetics, Inc. (Neothetics), now known as Evofem Biosciences, Inc., completed its reverse merger (the Merger) with privately-held Evofem Biosciences Operations, Inc. (Private Evofem) in accordance with the terms of an agreement and plan of merger and reorganization, dated October 17, 2017.

We historically have funded our operations primarily through the sale of our common stock, convertible preferred stock, related-party advances and a note payable from Cosmederm Biosciences, Inc., a prior related party.

2019 Private Placement
As described in Note 9- 2019 Private Placement, on April 10, 2019, we entered into a Securities Purchase Agreement with PDL BioPharma, Inc., a Delaware corporation (PDL), funds discretionally managed by Invesco and funds managed by WIM (collectively, the Purchasers), pursuant to which we agreed to issue and sell an aggregate of $80 million of our common stock, par value $0.0001 per share at a purchase price of $4.50 per share, and warrants to purchase shares of common stock with an exercise price of $6.38 per share (collectively, the Private Placement Securities) in a private placement (the Private Placement) that was funded in two separate closings.
The first closing was completed on April 11, 2019 (the Private Placement First Closing), pursuant to which we (i) issued and sold to PDL 6,666,667 shares of our common stock and warrants to purchase up to 1,666,667 shares of common stock (the Private Placement First Closing Warrants) and (ii) provided to the Purchasers an option to purchase an aggregate of up to 11,111,111 shares of common stock and warrants to purchase up to an aggregate of 2,777,779 shares of our common stock as specified in the aforementioned Securities Purchase Agreement (the Second Closing Securities) during the period beginning

on April 10, 2019 and ending on June 10, 2019 (the Private Placement Purchase Rights). The total consideration for the Private Placement First Closing was $30 million.

The second closing was completed on June 10, 2019 (the Private Placement Second Closing), pursuant to which we issued and sold the Second Closing Securities to the Purchasers for an aggregate purchase price of $50 million.

2020 Debt and Equity Financing

As described in Note 4- Convertible Notes, we received an aggregate gross proceeds of $25.0 million upon the first and second closings of convertible senior secured promissory notes pursuant to the Securities Purchase Agreement with Baker Bros. Advisors LP.

As described in Note 10- Stockholder's Equity, we received net aggregate proceeds of $103.7 million in June 2020 upon the issuance and sale of 31,700,000 shares of our common stock pursuant to the Public Offering and net aggregate proceeds of $3.8 million, during the six months ended June 30, 2020 upon the issuance and sale of 676,656 shares of our common stock pursuant to the ATM program.


Financial Operations Overview


RevenueNet Product Sales


To date, we have not generated anyOur revenue recognition is based on unit shipments from our products orthird party logistics warehouse to our wholesalers. We have recognized net product candidates. We do not expect to generate any revenue until we commercialize Phexxi or enter into collaborative agreements with third parties. We expect to launch Phexxisales in the United States since the commercial launch of Phexxi in September 2020. If2020 and the quarter ended March 31, 2021 was our second full quarter of product sales.

For the quarter ended March 31, 2021, shipments to our wholesalers and mail order specialized pharmacy grew significantly compared to the quarter ended December 31, 2020 and resulted in higher sequential gross revenues quarter over quarter of approximately 290%. Gross revenues, as discussed in Note 3- Revenue, were adjusted for variable consideration,
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Table of Contents
including our patient support programs. The resulting increase in net revenues reflects the higher gross revenues as well as more favorable gross-to net (GTN) adjustments in the current period. The Company expects GTN adjustments will significantly improve throughout the remainder of 2021, driven by a series of GTN improvement initiatives that Evofem began implementing in April 2021 as part of its overall strategy to build Phexxi is approved for commercial sale outside of the United States, we expecttrial usage and loyalty.

We intend to out-license commercialization rights tofor Phexxi to one or more pharmaceutical companies or other qualified potential partners for countries or enter into collaborationsregions outside of the United States. We are currently in discussion with potential partners for the commercialization and distribution of Phexxi, from which we may generate licensing revenue. However, wevarious geographies. We cannot forecast when suchor if these arrangements will be secured, if at all, andthe structure or potential amount of revenues from these arrangements, whether upfront, milestone-related or related to future Phexxi sales, assuming approval of Phexxi for commercial sale outside of the United States, or to what degree suchthese arrangements would affect our development plans, future revenues and overall capital requirements.

Cost of Goods Sold

The Company began to capitalize the inventory costs associated with Phexxi in April 2020 when it was determined that this inventory had a probable future economic benefit. These inventory costs include all purchased materials, direct labor and manufacturing overhead. Prior to April 2020, costs incurred for the manufacture of Phexxi were recorded as research and development expenses.

In addition, we are obligated to pay quarterly royalty payments pursuant to our license agreement with Rush University Medical Center, in amounts equal to a single-digit percentage of the gross amounts we receive on a quarterly basis less certain deductions incurred in the quarter based on a sliding scale. We are also obligated to pay a minimum annual royalty amount of $100,000 to the extent these earned royalties do not equal or exceed $100,000 in a given year. A minimum annual royalty amount of $100,000 was first required for the annual period commencing on January 1, 2021. This royalty payment was immaterial for the three months ended March 31, 2021, and was included in the costs of goods sold in the condensed consolidated financial statements.

Operating Expenses


Research and development expenses


Our research and development expenses primarily consist of costs associated with the clinical development of EVO100 and post approval changes forcosts associated with the continuous improvement and/or expansion of manufacturing capabilities.improvements related to Phexxi commercialization efforts. These expenses include:

external development expenses incurred under arrangements with third parties, such as fees paid to clinical research organizations (CROs) relating to our clinical trials, costs of acquiring and evaluating clinical trial data such as investigator grants, patient screening fees, laboratory work and statistical compilation and analysis, and fees paid to consultants;
costs to acquire, develop and manufacture clinical trial materials, including fees paid to contract manufacturers;
costs related to compliance with drug development regulatory requirements;
continuous improvements of manufacturing and analytical efficiency;
on-going product characterization and process optimization;
back-up contract manufacturing organization's evaluation to support future commercial forecast and reduce cost of goods sold;
alternative raw material evaluation to secure an uninterrupted supply chain and reduce cost of goods sold;
employee-related expenses, including salaries, benefits, travel and noncash stock-based compensation expense; and
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, and research and other supplies.

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Table of Contents
We expense internal and third-party research and development expenses as incurred. The following table summarizes research and development expenses by product candidate (in thousands):

Three Months Ended March 31,
 2021 2020
Allocated third-party development expenses:
Phexxi for the prevention of pregnancy (AMPOWER)$—   $(27)
EVO100 for prevention of chlamydia/gonorrhea- Phase 2B/3 (AMPREVENCE)—   322 
EVO100 for prevention of chlamydia/gonorrhea- Phase 3 (EVOGUARD)4,262   — 
Total allocated third-party development expenses4,262   295 
Unallocated internal research and development expenses:
Noncash stock-based compensation expenses543 482 
Payroll related expenses1,634 1,388 
Outside services costs524 1,740 
Other299 342 
Total unallocated internal research and development expenses3,000   3,952 
Total research and development expenses$7,262   $4,247 
 Three Months Ended June 30, Six Months Ended June 30,
 2020 2019 2020 2019
Allocated third-party development expenses:       
     Phexxi for prevention of pregnancy (AMPOWER)$11
  $13
 $(16) $2,134
     EVO100 for prevention of chlamydia/gonorrhea (AMPREVENCE)(349)  2,107
 (27) 5,654
     EVO100 for prevention of chlamydia/gonorrhea (Phase 3)143
  
 143
 
Total allocated third-party development expenses(195)  2,120
 100
 7,788
Unallocated internal research and development expenses:       
Noncash stock-based compensation expenses916
 369
 1,398
 657
Payroll related expenses713
 1,053
 2,101
 1,926
Outside services costs898
 1,432
 2,638
 2,237
Other308
 272
 650
 527
Total unallocated internal research and development expenses2,835
  3,126
 6,787
 5,347
Total research and development expenses$2,640
  $5,246
 $6,887
 $13,135

Completion dates and costs for our clinical development programs may vary significantly for EVO100 and any future product candidate we may seek to develop and are difficult to predict. We anticipate that we will determine which programs and product candidates to pursue as well as the most appropriate funding allocations for each program and product candidate on an ongoing basis in response to the results of ongoing and future clinical trials, regulatory developments, and our ongoing assessments of the commercial potential of each current or future product candidate. We expect aggregate research and development expenses to decrease in 2020increase significantly primarily due to completion ofEVOGUARD, which was initiated in October 2020. Depending on the clinical phase of AMPREVENCE in December 2019, partially offset by the anticipated initiation of the EVO100 Phase 3 trial in the fourth quarter of 2020. Nevertheless,Phexxi revenue trajectory, we willmay need to raise significant additional capital in the future to complete clinical development for EVO100 and any future product candidates.


The costs of clinical trials may vary significantly over the life of a program owing to the following:


per patient trial costs;
the number of sites included in the trials;
the length of time required to enroll eligible patients;
���the number of patients participating in the trials;
the number of doses patients receive;
potential additional safety monitoring or other trials requested by regulatory agencies;
the phase of development of the product candidate; and
the efficacy and safety profile of the product candidate.


Selling and marketing expenses


Our selling and marketing expenses consist primarily of pre-commercialization salesPhexxi commercialization costs, including direct-to-consumer (DTC) and marketing expenses,healthcare provider advertising, the Phexxi Concierge Experience, training, salaries, benefits, travel, noncash stock-based compensation expense, and other related costs for our employees and consultants as well as other costs associated with conducting commercial assessments for our product candidates.consultants.

We expect our selling and marketing expenses to increase significantly in 2021 compared to 2020 due to the cost of our sales force, which was established in the third quarter of 2020, and as we hire and deploy a sales force, develop and commence associated marketing campaignscontinue to implement additional Phexxi promotional strategies and initiatives and hire additional personnel to support both the pre-commercialization activities and thedrive launch and initiation of full commercialization activities in the United States for Phexxi in September 2020.uptake.


General and administrative expenses


Our general and administrative expenses consist primarily of salaries, benefits, travel, business development expense, investor and public relations expense,expenses, noncash stock-based compensation, and other related costs for our employees and consultants inperforming executive, administrative, finance, legal and human resource functions. Other general and administrative expenses include facility-related costs not otherwise included in research and development or selling and marketing, and professional fees for accounting, auditing, tax and legal fees, and other costs associated with obtaining and maintaining our patent portfolio.


We expect our general and administrative expenses to increase as we hire additional personneldecrease slightly in 2021 compared to support the growth2020 due to lower recruiting fees and financing advisory fees.
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Table of our business and pre-commercialization activities and as we engage third parties to assist in the preparation of the anticipated launch of Phexxi in the United States in September 2020.Contents

Other Income (Expense)


Other income (expense) consists primarily of interest income, loss on issuance of financial instrumentsexpense and the change in fair value of financial instruments issued in various capital raise transactions. Loss on issuance of financial instruments was recognized upon issuance of such instruments to investors as they were determined as freestanding liability-classified financial instruments. The change in fair value of financial instruments was recognized as a result of mark-to-market adjustments for these financial instruments.


Results of Operations


Three Months Ended June 30, 2020March 31, 2021 Compared to Three Months Ended June 30, 2019March 31, 2020 (in thousands):


Net Product Sales

Three Months Ended March 31,2021 vs. 2020
 20212020$ Change% Change
Product sales, net$1,105  $— $1,105 100 %

Phexxi was commercially launched in September 2020. Net product sales were $1.1 million for the three months ended March 31, 2021.

Cost of Goods Sold

Three Months Ended March 31,2021 vs. 2020
 20212020$ Change% Change
Cost of goods sold$506 $— $506 100 %

Cost of goods sold was $0.5 million for the three months ended March 31, 2021.

Research and development expenses

Three Months Ended June 30, 2020 vs. 2019
 2020 2019 $ Change% Change
Research and development$2,640
 $5,246
 $(2,606)(50)%
Three Months Ended March 31,2021 vs. 2020
 20212020$ Change% Change
Research and development$7,262  $4,247 $3,015 71 %
 
The overall decreaseincrease in research and development expenses was mainlyprimarily due to a $2.3$4.0 million decreaseincrease in clinical trial costs primarilyassociated with EVOGUARD, and an increase of $0.2 million and $0.1 million in payroll related expenses and noncash stock-based compensation, respectively, due to completion of the clinical phase of AMPREVENCE in December 2019,increased headcount. These aggregated increases were partially offset by a $0.6$1.2 million decrease in costs incurred for outside services associated with the New Drug Application for Phexxi resubmissionquality and manufacturing activities in preparation for the anticipated commercial launch of Phexxi, and a $0.4 million decrease in payrollregulatory related expenses due to capitalization of such expenses for certain employees as work-in-process inventory. These aggregated decreases are partially offset by a $0.5 million increase in noncash stock-based compensation mainly associated with RSAs granted in February 2020.activities.


Selling and marketing expenses
Three Months Ended March 31,2021 vs. 2020
 20212020$ Change% Change
Selling and marketing$30,525 $7,855 $22,670 289 %
 Three Months Ended June 30, 2020 vs. 2019
 2020 2019 $ Change% Change
Selling and marketing$9,997
 $1,313
 $8,684
661%


The overall increase in selling and marketing expenses was mainlyprimarily due to a $3.9$17.7 million increase in marketingmedia, advertising costs and public relations costs related costs, a $1.9 million increase in payroll related expenses due to increased headcount, a $1.8 million increase in costs incurred for outside services associated with medical affairs and market access activities in preparation for the anticipated commercial launchcommercialization of Phexxi, a $0.8 million increase in noncash stock-based compensation mainly associated with RSAs granted in February 2020, and a $0.3 million increase in facilities costs.

General and administrative expenses

Three Months Ended June 30, 2020 vs. 2019
 2020 2019 $ Change% Change
General and administrative$9,735
 $5,382
 $4,353
81%
The overall increase in general and administrative expenseswhich was mainly due to a $2.2 million increase in noncash stock-based compensation primarily associated with RSAs granted in February 2020, a $0.9 million increase in costs incurred for outside consulting services mainly due to the issuance of convertible notes, a $0.5 million increase in payroll related expenses due to increased headcount, a $0.6 million increase in legal costs, and a $0.1 million increase in business insurance costs.

Total other expense, net
 Three Months Ended June 30, 2020 vs. 2019
 2020 2019 $ Change% Change
Total other expense, net$(30,294) $(23,505) $(6,789)29%

Total other expense, net, for the three months ended June 30, 2020 mainly included a $64.0 million loss on issuance of convertible notes, warrants and purchase rights issued in connection with the Securities Purchase Agreement as described in Note 4- Convertible Notes. This loss was offset by a $34.1 million gain from the change in fair value of these financial instruments as a result of mark-to-market adjustments.

The other expense, net, for the three months ended June 30, 2019 mainly included a $0.7 million loss on issuance of purchase rights issued in connection with the Private Placement as described in Note 9- 2019 Private Placement, and a $22.9 million loss from change in fair value of these financial instruments as a result of mark-to-market.

Six Months Ended June 30, 2020 Compared to Six Months Ended June 30, 2019 (in thousands):

Research and development expenses

Six Months Ended June 30, 2020 vs. 2019
 2020 2019 $ Change% Change
Research and development$6,887
 $13,135
 $(6,248)(48)%
The overall decrease in research and development expenses was mainly due to a $7.3 million decrease in clinical trial costs primarily related to completion of the clinical phase of AMPOWER in December 2018 and AMPREVENCE in December 2019. This decrease was offset by a $0.7 million increase in noncash stock-based compensation mainly associated with RSAs granted in February 2020, a $0.2 million increase in facilities costs and a $0.1 million increase in payroll related expenses due to increased headcount.

Selling and marketing expenses
 Six Months Ended June 30, 2020 vs. 2019
 2020 2019 $ Change% Change
Selling and marketing$17,852
 $2,431
 $15,421
634%

The overall increase in selling and marketing expenses was mainly due to a $7.5 million increase in marketing related costs, a $3.6 million increase in costs incurred for outside services associated with medical affairs and market access activities in preparation for the anticipated commercial launch of Phexxilaunched in September 2020, a $2.7an increase of $4.8 million increase in payroll related expenses, a $0.4 million increase in facilities costs due to increased headcount, and a $1.1 million increase in noncash stock-based compensation mainly associated with RSAs granted in February 2020.

General and administrative expenses

Six Months Ended June 30, 2020 vs. 2019
 2020 2019 $ Change% Change
General and administrative$16,877
 $10,007
 $6,870
69%
The overall increase in general and administrative expenses was mainly due to a $3.1 million increase in noncash stock-based compensation primarily associated with RSAs granted in February 2020, a $1.5 million increase in costs incurred for outside consulting services mainly due to the issuance of convertible notes and recruiting activities, a $1.1 million increase in payroll related expenses due to increased headcount, a $0.7 million increase in legal fees,facilities costs, and a $0.5$0.2 million increase in noncash stock-based compensation. These aggregated increases were partially offset by a $0.8 million decrease in market access consulting services.

27

General and administrative expenses
Three Months Ended March 31,2021 vs. 2020
 20212020$ Change% Change
General and administrative$7,684  $7,142  $542 %
The increase in general and administrative expenses was primarily due to a $0.4 million increase in facilities costs.costs, a $0.3 million increase in payroll related expenses due to increased headcount, and a $0.3 million increase in legal and audit fees. These aggregated increases were partially offset by a $0.2 million decrease in outside services primarily pertaining to recruiting, and a $0.2 million decrease in noncash stock-based compensation.


Total other (expense) income, (expense), net
Three Months Ended March 31,2021 vs. 2020
 20212020$ Change% Change
Total other (expense) income, net$(1,280)$98 $(1,378)(1,406)%
 Six Months Ended June 30, 2020 vs. 2019
 2020 2019 $ Change% Change
Total other income (expense), net$(30,196) $(27,941) $(2,255)8%


Total other expense, net, for the sixthree months ended June 30, 2020 mainlyMarch 31, 2021, primarily included a $64.0$1.1 million loss on issuancein accrued interest expense related to the convertible senior secured promissory notes issued to Baker Bros. Advisors LP (the Baker Notes) and the unsecured convertible promissory notes issued to each of convertible notes, warrantsAdjuvant Global Health Technology Fund, L.P. and purchase rights issued in connection with the Securities Purchase AgreementAdjuvant Global Health Technology Fund DE, L.P. (the Adjuvant Notes) as described in Note 4-5- Convertible Notes. This and a $0.1 million loss was offset by a $34.1 million gain from the change in fair value of these financial instrumentsthe Baker Notes as a result of mark-to-market adjustments.adjustments during the current quarter.



TheTotal other expense,income, net, for the sixthree months ended June 30, 2019 mainlyMarch 31, 2020, included a $0.7$0.1 million loss on issuance of purchase rights issued in connection with the Private Placement as described in Note 9- 2019 Private Placement, and a $22.9 million loss from change in fair value of these financial instruments as a result of mark-to-market, and a $4.4 million incremental expense recognized as a result of a modification to the warrants exercised in February 2019 as described in Note 10- Stockholders' Equity.interest income.


Liquidity and Capital Resources


Overview

As of June 30, 2020,March 31, 2021, we had working capital of $66.1$4.6 million and an accumulated deficit of $585.0$701.6 million. We have financed our operations to date primarily through the saleissuance of preferredcommon stock, and units, common stock,cash received from private placement transactions, the issuance of convertible notes interest earned on investments, and, cash received in the Merger. At June 30, 2020,to a lesser extent, product sales. As of March 31, 2021, we had approximately $123.6$45.3 million in cash and cash equivalents.equivalents, and $18.6 million in restricted cash from the Adjuvant notes that is available for use. Our cash and cash equivalents include amounts held in checking accounts, money market funds, and investments in fixed income debt securities with original maturities of less than three months. Our short-term investments consist of held-to-maturity securities that mature in one year or less. We invest cash in excess of immediate requirements in accordance with our investment policy, which limits the amounts we may invest in any one type of investment and requires all investments held by us to maintain minimum ratings from Nationally Recognized Statistical Rating Organizations so as to primarily achieve liquidity and capital preservation.


We have incurred losses and negative cash flows from operating activities since inception. During the sixthree months ended June 30, 2020,March 31, 2021, we received gross proceeds of $25.0 million from the issuance of convertible notes in April and June 2020, net proceeds of approximately $103.7$28.0 million upon the sale and issuance of common stock pursuant tofrom the Public Offeringunderwritten public offering in June 2020,March 2021. On April 6, 2021, the underwriters exercised their overallotment option in full and netwe received proceeds of $3.8approximately $4.2 million, from our ATM program.net of underwriting discounts.


We anticipate that we will continue to incur net losses for the foreseeable future. Although weWe expect research and development expenses to decreaseincrease in 20202021 compared to 20192020 due to completion of the clinical phase of our Phase 2b clinical trial for EVO100 in December 2019, partially offset by the anticipated initiation of our Phase 3 clinical trial of EVO100EVOGUARD study which was initiated in the fourth quarter of 2020, weOctober 2020. We expect selling and marketing expenses to increase significantly in 2021 compared to 2020 due to the deployment of our commercial sales force that was established in the third quarter of 2020, and as we hire and deploy a sales force, develop and commenceexecute associated marketing campaignspromotional strategies and initiatives, and hire additional personnel to support pre-commercialization activities in preparation for the anticipated launch of Phexxi in the United States and, the launch and initiation of full commercialization activities in September 2020. In addition,including our DTC programs. Lastly, we expect general and administrative expenses to increasedecrease slightly in 2021 compared to 2020 as we hire additional personneldue to support the growth of our businesslower recruiting fees and pre-commercialization activities and as we engage third parties to assist in the preparation of the anticipated launch of Phexxi in the United States in the September 2020.financing advisory fees. According to management estimates, our liquidity resources as of June 30, 2020March 31, 2021 are not sufficient to maintain our planned level of operations for the next 12 months. In addition, the uncertainties associated with our ability to (i) obtain additional equity financing on terms that are favorable to us (ii) launch and commercialize Phexxi, (iii)or at all, enter into collaborative agreements with strategic partners, and (iv) succeed in our future operations raise substantial doubt about our ability to continue as a going concern.


The opinion of our independent registered public accounting firm on our audited financial statements as of and for the years ended December 31, 20192020 and 20182019 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. Future reports on our financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern. Our unaudited condensed consolidated financial statements as of June 30, 2020March 31, 2021 and for the three and six months ended June 30,March 31, 2021 and 2020 and 2019 appearingincluded in this Quarterly Report do not include any adjustments relating
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to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should we be unable to continue our operations.


The COVID-19 pandemic has already caused us to delay the commercial launch of Phexxi until September 2020 and has impacted the terms on which we have been able to raise funds. Our ability to raise additional funds, and the terms on which those funds may be raised, will be dependent, in part, on how successful the launchcommercialization of Phexxi is and whether we are able to gain revenue traction prior to raising such additional funds. If the COVID-19 pandemic further delays our commercial launch of Phexxi, or otherwise disrupts orcontinues to disrupt and negatively impactsimpact the commercial launchcommercialization of Phexxi, our ability to raise additional funds may be negatively impacted, or we may not be able to obtain such funding on terms favorable to us.us or at all. If we are not able to obtain required additional funding, in the near term, through equity financings or other means, or if we are unable to obtain funding on terms favorable to us, the shortfall in funds raised, or such unfavorable terms, will likely have a material adverse effect on our operations and strategic development plan for future growth. If we cannot successfully raise the funding necessary to implement our current strategic development plan, we may be forced to make reductions in spending, suspend or terminate development programs, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs.programs, and/or cease operations. Any of these developments would materially and adversely affect our financial condition and business prospects and could even cause us to be unable to continue as a going concern. If we are unable to continue as a going concern, we may have

to liquidate our assets and, in doing so, we may receive less than the value at which those assets are carried on our financial statements. Any of these developments would materially and adversely affect the price of our stock and the value of your investment.
At
2021 Equity Financing

As described in Note 10- Stockholder's Equity, we received net proceeds of approximately $28.0 million in March 2021 upon the Market Program

In November 2019, we entered into an Equity Distribution Agreement with Piper Sandler & Co. (Piper Sandler), pursuant to which we were able to offer and sellissuance of 17,142,857 shares of our common stock in ATM offerings (as defined in Rule 415from our underwritten public offering, and approximately $4.2 million, net of underwriting discounts, from the issuance of 2,571,428 shares of its common stock upon exercise of the underwriters’ overallotment option in April 2021.

2020 Debt and Equity Financing

As described in Note 5- Convertible Notes, we received aggregate gross proceeds of $25.0 million upon the first and second closings of convertible senior secured promissory notes pursuant to the Securities ActPurchase and Security Agreement (the Baker Bros. Purchase Agreement) with certain affiliates of 1933,Baker Bros. Advisors LP as amended) having anpurchasers (the Baker Purchasers) during the second quarter of 2020. We also received gross proceeds of $25.0 million from the closing of convertible unsecured promissory notes pursuant to the Adjuvant Purchase Agreement during the fourth quarter of 2020.

As described in Note 10- Stockholder's Equity, we received net aggregate offering price up to $50proceeds of $103.7 million in gross proceedsJune 2020 upon the issuance and sale of 31,700,000 shares of our common stock from time to time through Piper Sandler acting as sales agent. During the six months ended June 30,our 2020 we receivedPublic Offering and net aggregate proceeds of approximately $3.8 million in cashduring the first half of 2020 upon the issuance and cash equivalents (including $0.3 million that was included in other receivables in the condensed consolidated balance sheet at December 31, 2019), net of commissions, from the sale of 676,656 shares of our common stock. Onstock pursuant to the “at the market” (ATM) program. The ATM program was terminated in June 2, 2020, in connection with the Public Offering discussed in Note 10- Stockholder’s Equity, this Equity Distribution Agreement was terminated.2020.


Summary Statement of Cash Flows


The following table sets forth a summary of the net cash flow activity for each of the periods set forth below (in thousands): 
 Three Months Ended March 31,2021 vs. 2020
 20212020$ Change% Change
Net cash, cash equivalents and restricted cash used in operating activities$(34,458)$(14,876)$(19,582)132 %
Net cash, cash equivalents and restricted cash (used in) provided by investing activities(706)6,902 (7,608)(110)%
Net cash, cash equivalents and restricted cash provided by financing activities28,006 1,364 26,642 1,953 %
Net decrease in cash, cash equivalents and restricted cash$(7,158)$(6,610)$(548)%
 Six Months Ended June 30, 2020 vs. 2019
 2020
2019 $ Change% Change
Net cash, cash equivalents and restricted cash used in operating activities$(29,928) $(27,226) $(2,702)10%
Net cash, cash equivalents and restricted cash provided by investing activities7,947
 250
 7,697
3,079%
Net cash, cash equivalents and restricted cash provided by financing activities129,912
 76,295
 53,617
70%
Net (decrease) increase in cash, cash equivalents and restricted cash$107,931

$49,319
 $58,612
119%


Cash Flows from Operating Activities. ForDuring the sixthree months ended June 30, 2020 and 2019,March 31, 2021, the primary use of cash, cash equivalents and restricted cash has beenwas to fund development and pre-commercializationcommercialization of our lead product, Phexxi, and to support selling and marketing, and general and administrative operations.


Cash Flows from Investing Activities. TheDuring the three months ended March 31, 2021, the change in net cash, cash equivalents and restricted cash used in investing activities was primarily due to $1.0 million in purchases of property and equipment, offset by a $0.3 million cash inflow from the sale of Softcup line of business.
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During the three months ended March 31, 2020, the change in net cash, cash equivalents and restricted cash provided by investing activities was primarily due to an $8.2a $6.7 million cash inflow from maturities of short-term investments, during the six months ended June 30, 2020, offset by $0.5$0.1 million purchases of property and equipment.


Cash Flows from Financing Activities. During the sixthree months ended June 30, 2020,March 31, 2021, the primary source of cash, cash equivalents and restricted cash was provided from the saleissuance of 31,700,00017,142,857 shares of common stock for net proceeds of approximately $28.0 million, net of underwriting commissions, of approximately $103.7 million, gross proceeds of $25.0 million from issuance of convertible notes and warrants, the sale of 676,656 shares of common stock under the ATM program for proceeds of approximately $3.8 million in cash and cash equivalents (including $0.3 million that was included in other receivables in the condensed consolidated balance sheet at December 31, 2019), net of commissions, the issuance of 89,106 shares of our common stock under the 2019 ESPP and exercise of stock options with proceeds of approximately $0.3 million, offset by $2.8 million payments of tax withholdings related to vesting of restricted stock awards and $0.3 million payments for financing and debt issuance costs.discounts.

During the six months ended June 30, 2019, the primary source of cash, cash equivalents and restricted cash was the issuance of 2,376,062 shares of common stock upon the exercise of warrants in February 2019 for gross proceeds of $6.3 million and the issuance of an aggregate of 17,777,779 shares of common stock and warrants to purchase 4,444,446 shares of common stock pursuant to the Private Placement during the second quarter of 2019 for gross proceeds of $75.4 million, net of financial advisory fees. The cash inflow was offset by the $4.0 million repayment of a 2018 note payable to our clinical research organization for AMPOWER (Vendor Note) during the second quarter of 2019, $0.9 million in payments of financing costs and $0.5 million payments of tax withholdings related to vesting of restricted stock awards.


Operating and Capital Expenditure Requirements


Our specific future operating and capital expense requirements are difficult to forecast. For example,forecast, however, we expect to incur additional capital expenditures to expand manufacturing capacity for Phexxi, but cannot adequately predictcan anticipate the future cost or other potential capital expenditure requirements, if any. We also have future contractual obligations for the 2020 Leasegeneral types of expenses and Fleet Leaseareas in which they might occur as discussed in Note 7- Commitments and Contingencies, and will incur additional capital expenditures for leasehold improvements associated with the 2020 Lease.

follows: We expect research and development expenses to decrease in 2020 due to completion of the clinical phase of Phase 2b clinical trial for EVO100 in December 2019. However, we expect research and development expenses will begin to accelerate in the fourth quarter of the year with the anticipated initiation of a Phase 3 clinical trial of EVO100. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming and we may never succeed in achieving regulatory approval for EVO100 or our other future product candidates. The probability of success for each product candidate will be affected by numerous factors, including preclinical data, clinical trial data, competition, manufacturing capability and commercial viability. We are responsible for all research and development expenses for our programs.

We expect selling and marketing expenses to increase significantly asin 2021, while we hire and deploy a sales force, develop and commence associated marketing campaigns and initiatives, and hire additional personnel to support both the pre-commercialization activities in preparation for the anticipated launch of Phexxi in the United States as well as the launch and initiation of full commercialization activities in September 2020.

We expect general and administrative expenses to increase as we hire additional personneldecrease slightly in 2021 due to support the growth of our business and pre-commercialization activities, and as we engage third parties to assist inreasons stated under the preparation of the anticipated launch of Phexxi in the United States in September 2020.Operating Expenses section above.


Off-Balance Sheet Arrangements


As of June 30, 2020March 31, 2021 and December 31, 2019,2020, we did not have any off-balance sheet arrangements, as suchthat term is defined under Item 303 of Regulation S-K, that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.


Other Matters


Recently Issued Accounting Pronouncements


For information with respect to recent accounting pronouncements, see Note 2- Summary of Significant Accounting Policiesto our condensed consolidated financial statements appearing in Part I, Item 1 of this report.


Critical Accounting Policies


Our condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the applicable periods. Management bases its estimates, assumptions and judgments, on historical experience and on various other factors it believes to be reasonable under the circumstances. Different estimates, assumptions and judgments may change the estimate used in the preparation of our condensed consolidated financial statements, which, in turn, could materially change our results from those reported. Management evaluates its estimates, assumptions and judgments on an ongoing basis. However, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material adverse effect on our consolidated statements of operations, liquidity and financial condition. We believe the following critical accounting policies involve significant areas where management applies estimates, assumptions and judgments in the preparation of our condensed consolidated financial statements. See Note 2 to our 20192020 Audited Financial Statements for our additional accounting policies.


Revenue Recognition and Trade Accounts Receivable

The Company recognizes revenue from the sale of its product Phexxi in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) Identify the contract(s) with a customer; (2) Identify the performance obligations in the contract; (3) Determine the transaction price; (4) Allocate the transaction price to the performance obligations in the contract; (5) recognize revenue when (or as) the entity satisfies a performance obligation.

In accordance with ASC 606, the Company recognizes revenue when its performance obligation is satisfied by transferring control of the product to a customer. Per the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers consist of wholesale distributors and a specialty pharmacy. Payment terms typically range from 45 to 66 days, include prompt pay discounts, and vary by customer. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances.

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The amount of revenue recognized by the Company is equal to the amount of consideration which is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine the amount of revenue to recognize, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue.

Phexxi is sold to customers at the wholesale acquisition cost. However, the Company records product revenue, net of estimates for applicable variable consideration.

Clinical Trial Accruals

As part of the process of preparing our financial statements, we are required to estimate expenses resulting from our obligations under contracts with vendors, CROs and consultants and under clinical site agreements relating to conducting our clinical trials. The financial terms of these contracts vary and may result in payment flows that do not match the periods over which materials or services are provided under such contracts.


Our objective is to reflect the appropriate clinical trial expenses in our condensed consolidated financial statements by recording those expenses in the period in which services are performed and efforts are expended. We account for these expenses according to the progress of the clinical trial as measured by patient progression and the timing of various aspects of the trial. We determine accrual estimates through financial models and discussions with applicable personnel and outside service providers as to the progress of clinical trials.



During a clinical trial, we adjust the clinical expense recognition if actual results differ from estimates. We make estimates of accrued expenses as of each balance sheet date based on the facts and circumstances known at that time. Our clinical trial accruals are partially dependent upon accurate reporting by CROs and other third-party vendors. Although we do not expect estimates to differ materially from actual amounts, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low for any reporting period. For the three and six months ended June 30,March 31, 2021 and 2020, and 2019, there were no material adjustments to our prior period estimates of accrued expenses for clinical trials.


Fair Value of the Baker Notes

We elected the fair value option under ASC 825, Financial Instruments,, for the Baker Notes issued pursuant to that certain Baker Bros. Purchase Agreement with the Baker Purchasers, and Baker Bros. Advisors LP, as designated agent, dated April 23, 2020, as they are qualified financial instruments and are, in whole, classified as liabilities. Under the fair value option, we recognized the hybrid debt instrument at fair value inclusive of embedded features. The fair value of the Baker Notes issued, and the change in fair value of the Baker Notes at the reporting date, were determined using a lattice model forMonte Carlo simulation-based model. Monte Carlo simulation was used to take into account several embedded features and factors including the future value of our common stock, which was incorporated the impact of assumptions related to a potential change of control event, the maturity term of the Baker Notes, the probability of an event of voluntary conversion of the Baker Notes, exercise of the put right, and exercise of our call right. A Monte Carlo simulation was used to determine the occurrence of such event in the lattice model.


Fair Value of Stock Options and Warrants

The fair value of stock options and warrants issued in various financing occasions in connection with the Merger and post- Merger,transactions, the change in fair value of options and warrants as a result of the modification,any modifications to these instruments, and mark-to-market adjustments for liability classified warrants were determined using the Black-Scholes Merton option-pricing model based on the applicable assumptions, which includesinclude the exercise price of these options and warrants, time to expiration, expected volatility of our peer group of companies, risk-free interest rate and expected dividend.

Fair Value of Purchase Rights


The fair value of the rights granted to the Baker Purchase RightsPurchasers to optionally purchase from the Company up to $10.0 million of Baker Notes, as described in Note 5- Convertible Notes, at the Baker Purchasers’ discretion at any time prior to the Company receiving at least $100.0 million in aggregate gross proceeds from one or more sales of equity securities issued in connection with the SecuritiesBaker Bros. Purchase Agreement, as described in Note 4-5- Convertible Notes, and the change in fair value of the Baker Purchase RightsPurchasers’ option to purchase from the Company up to $10.0 million of Baker Notes upon exercise of such rights, was determined as the maximum of (i) the fair value of rights to purchase the additional $10$10.0 million Baker Notes and; (ii) the fair value of the shares of on as-if converted basis, which was determined by the lattice model. The fair value of rights to purchase the accompanying 2,409,180 Baker Warrants2,049,180 warrants was valued using a Geske option-pricing model. The Geske model was based on the applicable assumptions, including the underlying stock price, warrant exercise price, the exercise price of the rights to purchase the Baker Warrants,warrants, the term of the Baker Warrants,warrants, the term of the rights to purchase the Baker Warrants ,warrants, expected volatility of the Company’s peer group, risk-free interest rate and expected dividend.

31

The fair value
Table of the Private Placement Purchase Rights issued in the Private Placement, and the change in fair value of the Private Placement Purchase Rights on the shareholder approval date, was determined using a combination of a lattice model and Black-Scholes option-pricing model. The lattice model was used to determine the future value of our common stock. The Black-Scholes option-pricing model was based on the applicable assumptions, including the future value of the Company's common stock as determined by the lattice model, warrant exercise price, time to expiration, expected volatility of our peer group, risk-free interest rate and expected dividend.Contents

Leases
We determine if an arrangement is a lease or implicitly contains a lease at inception based on the lease definition, and if the lease is classified as an operating lease or finance lease in accordance with ASC 842. Operating leases are included in operating lease right-of-use (ROU) assets and operating lease liabilities in its consolidated balance sheets. ROU assets and lease liabilities are recognized at commencement date or the adoption date of January 1, 2019 for existing leases based on the present value of lease payments over the lease term using an estimated discount rate. As our leases do not provide an implicit rate, we used an incremental borrowing rate based on the information available at commencement date or the adoption date in determining the present value of lease payments over a similar term. In determining the estimated incremental borrowing rate, we considered a rate obtained from its primary banker for discussion purposes of a potential collateralized loan with a term similar to the lease term, our historical borrowing capability in the market, and our costs incurred for underwriting discounts and financing costs in its previous equity financing. The ROU assets also include any lease payments made and exclude lease incentives. For operating leases, lease expense is recognized on a straight-line basis over the lease term. Lease and non-lease components within a contract are generally accounted for separately.




Inventories


Inventories, consisting of purchased materials, direct labor and manufacturing overheads, are stated at the lower of cost, or net realizable value. Cost is determined on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. At each balance sheet date, we evaluate ending inventories for excess quantities, obsolescence, or shelf-life expiration. The evaluation includes an analysis of our current and future strategic plans, anticipated future sales, the price projections of future demand, and the remaining shelf life of goods on hand. To the extent that we determine there are excess or obsolete inventory or quantities with a shelf life that is too near its expiration for us to reasonably expect that it can sell those products prior to their expiration, we adjust the carrying value to estimated net realizable value.


ITEM 3. Quantitative and Qualitative Disclosures about Market Risk


Not applicable.



ITEM 4. Controls and Procedures


Evaluation of Disclosure Controls and Procedures

Disclosure controls and procedures are controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Securities Exchange Act of 1934, as amended (the Exchange Act) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. As of the end of the period covered by this quarterly report on Form 10-Q, our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended.Act. Based on such evaluation, our principal executive officer and principal financial officer has concluded that, as of such date, our disclosure controls and procedures were effective.



Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during our latest fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


Inherent Limitations of Internal Controls


Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls over financial reporting will prevent or detect all error and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Due to the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.



PART II. OTHER INFORMATION


Item 1. Legal Proceedings


From time to time we may be involved in various disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any material legal proceedings.


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Item 1A. Risk Factors


Except as described in Exhibit 99.2 (Risk Factors of Evofem Biosciences, Inc.) to our Current Report on Form 8-K, as filed with the SEC on June 2, 2020 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed with the SEC on May 6, 2020, thereThere have not been any material changes to the risk factors disclosed in our Form 10-K for the year ended December 31, 2020.


Item 2. Unregistered Sales of Equity Securities and Use of Proceeds


Common Stock Purchases

The table below is a summary of purchases of our common stock we made during the quarter covered by this report. Other than as indicated in the table below, no such purchases were made in any other month during the quarter. We do not have any publicly announced repurchase plans or programs.
PeriodTotal Number of Shares Purchased (1)Average Price Paid per ShareTotal Number of Shares Purchased as Part of Publicly Announced Plans or ProgramsMaximum Number of Shares That May Yet be Purchased Under the Plans or Programs
March 1- March 312,644$2.57
PeriodTotal Number of Shares Purchased (1)Average Price Paid per ShareTotal Number of Shares Purchased as Part of Publicly Announced Plans or ProgramsMaximum Number of Shares That May Yet be Purchased Under the Plans or Programs
May 1- May 31371,626$5.03
June 1- June 30274,128$3.31
(1) These shares were surrendered to the Company to satisfy tax withholdings obligations in connection with the vesting of restricted stock awards.


Item 3. Defaults Upon Senior Securities


None.


Item 4. Mine Safety Disclosures


Not applicable.


Item 5. Other Information


None.



33


Item 6. Exhibits


The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index.


EXHIBIT INDEX
Exhibit
No.
Exhibit Title
Filed
Herewith
Incorporated by Reference
FormFile No.Date Filed
4.331.18-K001-367544/27/2020
10.18-K001-367544/27/2020
10.28-K001-367544/27/2020
10.38-K001-367544/27/2020
10.48-K001-367544/27/2020
10.5Δ8-K001-367545/12/2020
10.6**10-Q001-367544/17/2020
31.1X
31.2X
*32.132.1*X
†101.INS101.INS†XBRL Instance DocumentX
†101.SCH101.SCH†XBRL Taxonomy Extension Schema DocumentX
†101.CAL101.CAL†XBRL Taxonomy Extension Calculation Linkbase DocumentX
†101.DEF101.DEF†XBRL Definition Linkbase DocumentX
†101.LAB101.LAB†XBRL Taxonomy Extension Labels Linkbase DocumentX
†101.PRE101.PRE†XBRL Taxonomy Extension Presentation Linkbase DocumentX

Δ*Management Compensation Plan or arrangement.
*
Furnished herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation by reference language in such filing.
The financial information of Evofem Biosciences, Inc. Quarterly Report on Form 10-Q for the quarter ended June 30, 2020March 31, 2021 filed on August 4, 2020May 6, 2021 formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets, (ii) Parenthetical Data to the Condensed Consolidated Balance Sheets, (iii) the Condensed Consolidated Statements of Operations, (iv) the Condensed Consolidated Statements of Stockholders’ Equity (Deficit), (v) the Condensed Consolidated Statements of Cash Flows, and (vi) Notes to Unaudited Condensed Consolidated Financial Statements, is furnished electronically herewith.
**Certain confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.

34

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 6, 2021EVOFEM BIOSCIENCES, INC.
By:
Date: August 4, 2020By:
/s/ Justin J. File


Justin J. File


Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)







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