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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
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. |
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.
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).
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 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).
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).
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 | ) |
| |
| 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).
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).
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