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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2023

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   20-8527075

(State or other jurisdiction

of incorporation)

 

(IRS Employer

Identification No.)

 

7770 Regents Road, Suite 113-618

San Diego, CA 92122

  92122
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (858) 550-1900

 

N/A

(Former name or former address, if changed since last report.)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.0001 per share   EVFM   OTCQB

 

Indicate by check mark whether the registrant: (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 ☒ No ☐

 

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 ☒ No ☐

 

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   Smaller reporting company
    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

 

The number of shares of the registrant’s common stock, $0.0001 par value per share, outstanding as of November 9, 2023 was 10,730,210.

 

 

 

 
 

 

Table of Contents

 

      Page
    FORWARD-LOOKING STATEMENTS 1
PART I.   FINANCIAL INFORMATION  
Item 1.   Financial Statements (Unaudited) 3
    Condensed Consolidated Balance Sheets 3
    Condensed Consolidated Statements of Operations 4
    Condensed Consolidated Statements of Comprehensive Operations 5
    Condensed Consolidated Statements of Convertible and Redeemable Preferred Stock and Stockholders’ Deficit 6
    Condensed Consolidated Statements of Cash Flows 8
    Notes to Unaudited Condensed Consolidated Financial Statements 9
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations 39
Item 3.   Quantitative and Qualitative Disclosures About Market Risk 49
Item 4.   Controls and Procedures 49
       
PART II.   OTHER INFORMATION  
Item 1.   Legal Proceedings 51
Item 1A.   Risk Factors 51
Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds 52
Item 3.   Defaults Upon Senior Securities 52
Item 4.   Mine Safety Disclosures 52
Item 5.   Other Information 52
Item 6.   Exhibits 53
Signatures 55

 

 
 

 

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 section 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 ability to continue as a going concern;
  our ability to remediate the material weaknesses in our internal controls and procedures identified by management;
  our ability to obtain necessary approvals of any corporate action needing stockholder, FINRA, or other approvals;
  our ability to file Annual and Quarterly Reports on a timely basis;
  our ability to raise additional capital to fund our operations;
  our ability to achieve and sustain profitability;
  our estimates regarding our future performance including, without limitation, any estimates of potential future revenues;
  estimates regarding market size;
  our estimates regarding expenses, revenues, financial performance and capital requirements, including the length of time our capital resources will sustain our operations;
  our ability to maintain the listing of our shares on the OTCQB® Venture Market;
  our ability to comply with the provisions and requirements of our debt arrangements, to avoid future defaults pursuant to our debt arrangements and to pay amounts owed, including any amounts that may be accelerated, pursuant to our debt arrangements;
  estimates regarding health care providers’ (HCPs) recommendations of Phexxi® (lactic acid, citric acid, and potassium bitartrate) vaginal gel (Phexxi) to patients;
  the rate and degree of market acceptance of Phexxi;
  our ability to successfully commercialize and distribute Phexxi and continue to develop our sales and marketing capabilities;
  our estimates regarding the effectiveness of our marketing campaigns;
  our strategic plans for our business, including the commercialization of Phexxi;
  the potential for changes to current regulatory mandates requiring health insurance plans to cover U.S. Food and Drug Administration (FDA)-cleared or -approved contraceptive products without cost 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;
  our ability to obtain the necessary regulatory approvals to market and commercialize any product candidate we may seek to develop;
  the success, cost and timing of our potential future clinical trials, if any;
  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 for the manufacture of Phexxi and in the conduct of potential future clinical trials, if any;
  our ability to expand our organization to accommodate potential growth; and
  our ability to retain and attract key personnel.

 

1
 

 

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. Moreover, we operate in a very competitive and rapidly changing environment and 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 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.

 

This Quarterly Report contains estimates and other statistical data made by independent parties and by the Company relating to market size and growth and other data about its industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

 

Our first commercial product, Phexxi, is approved by the FDA for marketing in the United States. Phexxi has not been approved by the European Medicines Agency (EMA) or any other regulatory authority anywhere else in the world except in Nigeria, where Phexxi was approved, on October 6, 2022, as Femidence™ by the National Agency for Food and Drug Administration and Control.

 

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

 

This Quarterly Report includes our trademarks, trade names and service marks, including “Phexxi®” and “Femidence™” which are protected under applicable intellectual property laws and are the property of Evofem Biosciences, Inc. or its subsidiaries. Solely for convenience, trademarks, trade names and service marks referred to in this Quarterly Report may appear without the ®, ™ or SM symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.

 

2
 

 

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)

 

           
   As of 
   September 30, 2023   December 31, 2022 
Assets        
Current assets:          
Cash and cash equivalents  $-   $2,769 
Restricted cash   410    1,207 
Trade accounts receivable, net   6,322    1,126 
Inventories   2,526    5,379 
Prepaid and other current assets   2,247    2,218 
Total current assets   11,505    12,699 
           
Property and equipment, net   1,631    3,940 
Operating lease right-of-use assets   151    4,406 
Other noncurrent assets   35    4,118 
Total assets  $13,322   $25,163 
Liabilities, convertible and redeemable preferred stock and stockholders’ deficit          
Current liabilities:          
Accounts payable  $16,199   $14,984 
Convertible notes – carried at fair value (Note 4)   13,110    39,416 
Convertible notes – Adjuvant (Note 4)   27,969    26,268 
Accrued expenses   5,100    4,124 
Accrued compensation   1,820    2,175 
Operating lease liabilities-current   138    2,311 
Derivative liabilities   -    1,676 
Other current liabilities   3,532    2,876 
Total current liabilities   67,868    93,830 
Operating lease liabilities- noncurrent   13    3,133 
Total liabilities   67,881    96,963 
Commitments and contingencies (Note 7)   -    - 
Convertible and redeemable preferred stock, $0.0001 par value, Senior to common stock          
Series B-1, B-2, C and E-1 convertible preferred stock, 5,000, 5,000, 1,700 and 2,300 shares authorized; 1,800 shares of E-1 issued and outstanding at September 30, 2023; no other shares issued and outstanding at September 30, 2023 and December 31, 2022   1,800    - 
Stockholders’ deficit:          
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding at September 30, 2023 and December 31, 2022   -    - 
Common stock, $0.0001 par value; 3,000,000,000 shares authorized; 5,680,210 and 984,786 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively   -    - 
Additional paid-in capital   828,552    817,367 
Accumulated other comprehensive income (loss)   (287)   49,527 
Accumulated deficit   (884,624)   (938,694)
Total stockholders’ deficit   (56,359)   (71,800)
Total liabilities, convertible and redeemable preferred stock and stockholders’ deficit  $13,322   $25,163 

 

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

 

3
 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(Unaudited)

(In thousands, except share and per share data)

 

                     
   Three Months Ended September 30,   Nine Months Ended September 30, 
   2023   2022   2023   2022 
                 
Product sales, net  $5,112    6,371   $13,379   $16,656 
                     
Operating Expenses:                    
Cost of goods sold   1,889    1,680    5,558    4,031 
Research and development   614    5,207    1,556    23,342 
Selling and marketing   2,985    11,948    9,036    36,951 
General and administrative   3,176    6,260    11,696    24,404 
Total operating expenses   8,664    25,095    27,846    88,728 
Loss from operations   (3,552)   (18,724)   (14,467)   (72,072)
Other income (expense):                    
Interest income   2    50    28    55 
Other expense, net   (596)   (436)   (2,041)   (1,322)
Loss on issuance of financial instruments   (5,175)   -    (5,286)   (72,002)

Gain (loss) on debt extinguishment

   

75,337

    

(24,487

)   

75,337

    

(24,487

)
Change in fair value of financial instruments   -   133,116    1,539    101,502 
Total other income, net   69,568    108,243    69,577    3,746 
Income (loss) before income tax   66,016    89,519    55,110    (68,326)
Income tax expense   (11)   (13)   (17)   (36)
Net income (loss)   66,005    89,506    55,093    (68,362)
Convertible preferred stock deemed dividends   -    -    -    1,827 
Net income (loss) attributable to common stockholders  $66,005   $89,506   $55,093   $(66,535)
Net income (loss) per share attributable to common stockholders:                    
Basic (Note 2)  $15.34   $135.72   $21.42   $(206.38)
Diluted (Note 2)  $0.10  $(4.39)  $0.09  $(206.38)
Weighted-average shares used to compute net income (loss):                    
Basic   4,236,477    659,480    2,524,302    322,385 
Diluted   729,979,486    4,441,972    694,561,898    322,385 

 

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

 

4
 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE OPERATIONS

 

(Unaudited)

(In thousands, except share and per share data)

 

   2023   2022   2023   2022 
   Three Months Ended September 30,   Nine Months Ended September 30, 
   2023   2022   2023   2022 
                 
Net income (loss)  $66,005   $89,506   $55,093   $(68,362)
Other comprehensive income (loss):                    
Change in fair value of financial instruments attributed to credit risk change   (455)   35,362    23,373    31,868 
Reclassification adjustment related to debt extinguishment   

(73,187

)   

-

    

(73,187

)   

-

 
Comprehensive income (loss)  $(7,637)  $124,868   $5,279   $(36,494)

 

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

 

5
 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE AND REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT

 

(Unaudited)

(In thousands, except share data)

 

   Shares   Amount   Shares   Amount   Capital   Income   Deficit   Deficit 
   Series E-1 Convertible and Redeemable Preferred Stock   Common Stock   Additional Paid-in   Accumulated Other Comprehensive   Accumulated   Total Stockholders’ 
   Shares   Amount   Shares   Amount   Capital   Income (Loss)   Deficit   Deficit 
Balance as of December 31, 2022   -   $-    984,786   $-   $817,367   $49,527   $(938,694)  $(71,800)
Issuance of common stock upon cash exercise of warrants   -    -    24,200    -    67    -    -    67 
Issuance of common stock upon cash exercise of purchase rights   -    -    718,704    -    180    -    -    180 
Issuance of February and March 2023 Notes (See Note 4)   -    -    -    -    1,629    -    -    1,629 
Stock-based compensation   -    -    -    -    417    -    -    417 
Change in fair value of financial instruments attributed to credit risk change (see Note 4)   -    -    -    -    -    15,460    -    15,460 
Net loss   -    -    -    -    -    -    (2,354)   (2,354)
Balance as of March 31, 2023   -   $-    1,727,690   $-   $819,660   $64,987   $(941,048)  $(56,401)
Issuance of common stock upon cash exercise of warrants   -    -    122,729    -    101    -    -    101 
Issuance of common stock upon noncash exercise of purchase rights   -    -    673,820    -    6    -    -    6 
Noncash reclassification of liability-classified derivatives to equity   -    -    -    -    53    -    -    53 
Issuance of April 2023 Notes (See Note 4)   -    -    -    -    499    -    -    499 
Stock-based compensation   -    -    -    -    268    -    -    268 
Change in fair value of financial instruments attributed to credit risk change (see Note 4)   -    -    -    -    -    8,368    -    8,368 
Net loss   -    -    -    -    -    -    (8,558)   (8,558)
Balance as of June 30, 2023   -   $-    2,524,239   $-   $820,587   $73,355   $(949,606)  $(55,664)
Issuance of common stock upon cash exercise of warrants   -    -    1    -    14    -    -    14 
Issuance of common stock upon noncash exercise of purchase rights   -    -    2,767,332    -    -    -    -    - 
Issuance of common stock upon conversion of notes   -    -    388,638    -    -    -    -    - 
Issuance of series E-1 convertible and redeemable preferred stock upon exchange of notes (Note 8)   1,800    1,800    -    -    (1,797)   

(3

)   -    (1,800)
Issuance of Q3 2023 Notes (See Note 4)   -    -    -    -    3,563    -    -   3,563 
Issuance of additional purchase rights due to price reset (Note 4)   -    -    -    -    

4,904

    -    -    

4,904

 
Down round feature adjustment to financial instruments (Note 6)   -    -    -    -    1,023   -    (1,023)   -
Stock-based compensation   -    -    -    -    258    -    -    258 
Extinguishment of Baker Notes (Note 4)   -    -    -    -    -    (73,187)   -    (73,187)
Change in fair value of financial instruments attributed to credit risk change (Note 4)   -    -    -    -    -    (452)   -    (452)
Net income   -    -    -    -    -    -    66,005    66,005 
Balance as of September 30, 2023   1,800   $1,800    5,680,210   $-   $828,552   $(287)  $(884,624)  $(56,359)

 

6
 

 

    Shares    Amount    Shares    Amount    Shares    Amount    Capital    Income    Deficit    Deficit 
    Series B Convertible and Redeemable Preferred Stock    Series C Convertible and Redeemable Preferred Stock    Common Stock    Additional Paid-in     Accumulated Other Comprehensive     Accumulated     Total Stockholders’  
    Shares    Amount    Shares    Amount    Shares    Amount    Capital    Income    Deficit    Deficit 
Balance as of December 31, 2021   5,000   $4,740    -   $-    86,666   $-   $751,276   $5,089   $(860,680)  $(104,315)
Issuance of common stock – Stock Purchase Agreement (see Note 8)   -    -    -    -    9,673    -    5,400    -    -    5,400 
Conversion of series B-2 convertible preferred stock   (650)   (619)   -    -    978    -    708    -    -    708 
Exchange of series B-2 convertible preferred stock (see Note 8)   (1,700)   (1,616)   1,700    1,616    -    -    -    -    -    - 
Convertible preferred stock deemed dividends   -    16    -    1    -    -    (81)   -    -    (81)
Restricted stock awards issued   -    -    -    -    1,259    -    -    -    -    - 
Change in fair value of financial instruments attributed to credit risk change (see Note 4)   -    -    -    -    -    -    -    181    -    181 
Modification of the Baker Warrants (see Note 8)   -    -    -    -    -    -    828    -    -    828 
Stock-based compensation   -    -    -    -    -    -    1,067    -    -    1,067 
Net loss   -    -    -    -    -    -    -    -    (31,888)   (31,888)
Balance as of March 31, 2022   2,650   $2,521    1,700   $1,617    98,576   $-   $759,198   $5,270   $(892,568)  $(128,100)
Issuance of common stock – Stock Purchase Agreement (see Note 8)   -    -    -    -    7,067    -    2,553    -    -    2,553 
Issuance of common stock – May 2022 Public Offering (see Note 8)   -    -    -    -    181,320    -    1,264    -    -    1,264 
Issuance of common stock upon cash exercise of warrants   -    -    -    -    327,719    -    32,889    -    -    32,889 
Issuance of common stock – ESPP   -    -    -    -    601    -    20    -    -    20 
Issuance of common stock – a360 Media   -    -    -    -    18,547    -    858    -    -    858 
Cash repurchase of fractional common stock after the reverse stock split   -    -    -    -    (88)   -    (18)   -    -    (18)
Conversion of series B-2 convertible preferred stock   (550)   (524)   -    (72)   1,369    -    543    -    -    543 
Convertible preferred stock deemed dividends   -    102    -    83    -    -    -    -    -    - 
May 2022 exchange transaction   (2,100)   (2,099)   (1,700)   (1,628)   (2,600)   -    3,655    -    (1,316)   2,339 
Restricted stock awards cancelled   -    -    -    -    (53)   -    -    -    -    - 
Change in fair value of financial instruments attributed to credit risk change (see Note 4)   -    -    -    -    -    -    -    (3,675)   -    (3,675)
Modification of the Baker Warrants (see Note 8)   -    -    -    -    -    -    231    -    -    231 
Stock-based compensation   -    -    -    -    -    -    1,081    -    -    1,081 
Net loss   -    -    -    -    -    -    -    -    (125,980)   (125,980)
Balance as of June 30, 2022   -   $-    -   $-    632,458   $-   $802,274   $1,595   $(1,019,864)  $(215,995)
Issuance of common stock upon cash exercise of warrants   -    -    -    -    57,479    -    9,043    -    -    9,043 
Issuance of common stock upon noncash exercise of Purchase Rights (see Note 4)   -    -    -    -    90,692    -    523    -    -    523 
Issuance of common stock – a360 Media   -    -    -    -    35,361    -    2,550    -    -    2,550 
Issuance costs in connection with May 2022 Public Offering   -    -    -    -    -    -    (25)   -    -    (25)
Restricted stock awards cancelled   -    -    -    -    (5)   -    -    -    -    - 
Change in fair value of financial instruments attributed to credit risk change (see Note 4)   -    -    -    -    -    -    -    35,362    -    35,362 
Modification of the Baker Warrants (see Note 8)   -    -    -    -    -    -    11    -    -    11 
Stock-based compensation   -    -    -    -    -    -    981    -    -    981 
Net Income   -    -    -    -    -    -    -    -    89,506    89,506 
Balance as of September 30, 2022   -   $-    -   $-    815,985   $-   $815,357   $36,957   $(930,358)  $(78,044)

 

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

 

7
 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

(Unaudited)

(In thousands)

 

           
   Nine months ended September 30, 
   2023   2022 
Cash flows from operating activities:          
Net income (loss)   55,093    (68,362)
Adjustments to reconcile net income (loss) to net cash and restricted cash used in operating activities:          
Loss on issuance of financial instruments   5,286    72,002 
(Gain) loss on debt extinguishment   

(75,337

)   

24,487

 
Change in fair value of financial instruments   (1,539)   (101,502)
Inventory write-down for excess & obsolescence   

1,505

    - 
Financial instrument modification expense   -    1,067 
Stock-based compensation   943    3,130 
Depreciation   455    765 
Noncash interest expense   1,702    1,605 
Noncash lease expenses   1,259    34 
Net gain on lease termination   (466)   - 
Net loss on disposal of property and equipment   1,858    926 
Noncash instrument exchange expense   -    514 
Changes in operating assets and liabilities:          
Trade accounts receivable   (5,196)   (6,314)
Inventories   1,348    2,495 
Prepaid and other assets   3,231    1,981 
Accounts payable   1,215    4,044 
Accrued expenses and other liabilities   1,632    (650)
Accrued compensation   (355)   176 
Operating lease liabilities   (1,432)   (277)
Net cash and restricted cash used in operating activities   (8,798)   (63,879)
Cash flows from investing activities:          
Purchases of property and equipment   (4)   (306)
Net cash and restricted cash used in investing activities   (4)   (306)
Cash flows from financing activities:          
Proceeds from issuance of common stock – Stock Purchase Agreement   -    7,438 
Proceeds from issuance of common stock and warrants, net of discounts, fees and commissions – Public Offerings   -    24,882 
Proceeds from issuance of common stock – exercise of warrants   174    25,211 
Proceeds from issuance of common stock – ESPP and exercise of stock options   -    20 
Borrowings under term notes   5,262    10,000 
Payments under term notes   (1,000)   (5,892)
Cash paid for financing costs   -    (1,202)
Cash repurchase of fractional common stock after the reverse stock split   -    (18)
Net cash and restricted cash provided by financing activities   4,436    60,439 
Net change in cash, cash equivalents and restricted cash   (4,366)   (3,746)
Cash, cash equivalents and restricted cash, beginning of period   4,776    13,588 
Cash, cash equivalents and restricted cash, end of period  $410   $9,842 
Supplemental disclosure of noncash investing and financing activities:          
Exchange of convertible notes to Series E-1 convertible preferred stock   1,800      
Borrowings under term notes included in prepaid and other current assets   375    - 
Issuance of common stock upon exercise of purchase rights   186    522 
Financing costs included in accounts payable and accrued expenses   -    302 
Purchases of property and equipment included in accounts payable and accrued expenses   -    113 
Conversion of Series B-2 convertible preferred stock to common stock   -    1,187 
Exchange of series B-2 convertible preferred stock to series C convertible preferred stock   -    1,616 
Issuance of common stock for prepaid advertising   -    3,412 
Exchange of Adjuvant Notes to purchase rights   -    634 
Exchange of term notes to purchase rights   -    4,806 

 

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

 

8
 

 

EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

1. Description of Business and Basis of Presentation

 

Description of Business

 

Evofem is a San Diego-based, commercial-stage biopharmaceutical company committed to commercializing innovative products to address unmet needs in women’s sexual and reproductive health.

 

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) on May 22, 2020, and is the first and only FDA-approved, hormone-free, woman-controlled, on-demand prescription contraceptive gel for women. The Company commercially launched Phexxi in September 2020. Phexxi net product sales were $16.8 million in 2022.

 

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 (GAAP) in the United States 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, 2022 included in its Annual Report on Form 10-K as filed with the SEC on April 27, 2023 (the 2022 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 and redeemable preferred stock and stockholders’ deficit for the periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 2022 was derived from the 2022 Audited Financial Statements.

 

Reverse Stock Split

 

On March 15, 2023, the Company’s shareholders approved a