— Improved loss from operations by 81%
—
— Acquired SOLOSEC, a commercially
attractive, single-dose oral antibiotic FDA-approved to treat two
pervasive sexual health infections —
— Forged ex-U.S. commercial agreement for
Phexxi in Middle East
—
SAN
DIEGO, Aug. 14, 2024 /PRNewswire/ -- Women's
health innovator Evofem Biosciences, Inc. ("Evofem" or "the
Company") (OTCQB: EVFM) today announced financial results for the
second quarter and first half of 2024. Highlights include:
- Acquired global rights to SOLOSEC® (secnidazole) 2g oral
granules, a single-dose oral antibiotic FDA approved to treat two
common sexual health infections - bacterial vaginosis and
trichomoniasis.
- Licensed Phexxi® (lactic acid, citric acid and potassium
bitartrate) commercial rights in the Middle East to Emirati pharmaceutical company
Pharma 1 Drug Store.
- Partnered with leading telemedicine company Hello Alpha to add
Phexxi to its commercial offering as a hormone-free contraception
solution for women, especially those on GLP-1s and others looking
for hormone-free birth control.
- Negotiated a 7.4% lower rebate on Phexxi prescriptions to
Medi-Cal, the California state
Medicaid program service covering more than 15.4 million
lives.
- Launched a partnership with Modern Remedies, one of the top
pharmacies in the Northeast, to dispense Phexxi.
- Strengthened intellectual property with the issuance and
Orange Book listing of the fifth U.S. patent covering
Phexxi.
- Delivered net sales of $4.2
million for the second quarter of 2024, an increase of 69%
compared to the prior year quarter.
- Reduced total operating expenses to $5.5
million, a 43% decrease compared to the prior year
quarter.
- Improved loss from operations 81% versus the prior year quarter
to $1.4 million.
- Received $2.0 million from
Aditxt, Inc. (Nasdaq: ADTX), including $1.0
million in May 2024 to
reinstate the Merger Agreement and $1.0
million from the sale of preferred stock to Aditxt in July
and August 2024. Under the recently
amended and restated Merger Agreement, the companies are working to
close the contemplated transaction in late 2024.
"Evofem continues to prove that with a disciplined and committed
team we can maneuver through challenges in the market and
successfully execute our strategy to expand and diversify our
revenue stream. In addition to delivering strong second quarter
results, we closed two transformative business development deals
that will improve access to differentiated treatment options that
impact women's daily lives," said Saundra
Pelletier, CEO of Evofem Biosciences. "Women don't need more
choices; they need better ones, and Evofem will continue to deliver
on that promise."
Financial Results
For the three months ended June 30,
2024, net product sales were $4.2
million compared to $2.5
million in the prior year period. The 69% increase primarily
reflects an atypically high volume of product returns in the prior
year quarter, which was not repeated in the current period.
An 8% increase in Phexxi ex-factory unit sales in the current
period also contributed to the year-over-year growth.
Total operating expenses were $5.5
million, a decrease of 43% compared to the
prior year period.
- Selling and marketing costs were essentially unchanged at
$2.2 million for the second quarter
of each year.
- General and administrative costs were $2.3 million, a decrease of 54% compared to the
prior year quarter.
- Research and development costs were $0.3
million, a decrease of 33% compared to the prior year
quarter.
- Cost of goods sold (COGS) were $0.8
million, a 66% decrease compared to the prior year period
primarily due to two items that resulted in atypically high COGS in
the second quarter of 2023: i) a recorded increase in the inventory
excess and obsolescence reserve, and ii) the effect of re-packaging
to reflect the extended shelf life approved by the FDA in
June 2022.
As a result, operating loss improved to $1.4 million for the second quarter of 2024 as
compared to an operating loss of $7.3
million in the second quarter of 2023.
Net income attributable to common stockholders was $1.3 million, or $0.02 per share, for the three months ended
June 30, 2024, due to a gain in other
income/expense related primarily to the fair value adjustment of
the financial instruments. This compares to a net loss attributable
to common shareholders of $8.6
million, or $(5.43) per share,
for the prior year quarter.
Liquidity
In May 2024,
we received $1.0 million from Aditxt
in consideration for reinstating and amending the Merger Agreement,
as amended, between the companies (A&R Merger Agreement).
At June 30, 2024, Evofem had
$0.7 million of restricted cash, as
compared to $0.6 million of
restricted cash at December 31,
2023.
In July and August 2024, we raised
$1.0 million in aggregate net
proceeds through the sale and issuance of 1,000 shares of Series
F-1 Convertible Preferred Stock to Aditxt pursuant to the A&R
Merger Agreement.
About Evofem Biosciences
Evofem Biosciences, Inc., is
commercializing innovative products to address unmet needs in
women's sexual and reproductive health. The Company's first
FDA-approved product, Phexxi® (lactic acid, citric
acid and potassium bitartrate), is a hormone-free, on-demand
prescription contraceptive vaginal gel. It comes in a box of 12
pre-filled applicators and is applied 0-60 minutes before each act
of sex.
In July 2024 Evofem broadened its
commercial offering with the acquisition of SOLOSEC® (secnidazole)
2g oral granules, an FDA-approved oral antibiotic for the
treatment of two sexual health diseases: bacterial vaginosis (BV),
a common vaginal infection, in females 12 years of age and older,
and trichomoniasis, a common sexually transmitted infection (STI),
in people 12 years of age and older. SOLOSEC provides a complete
course of therapy in just one dose.
In December 2023, Evofem entered into a Merger Agreement
with Aditxt, Inc. (Nasdaq: ADTX) under which Aditxt
intends to acquire Evofem. The parties amended and restated the
Merger Agreement, as amended, in its entirety in July 2024 and
are targeting to close in late 2024.
Follow us on:
LinkedIn:
https://www.linkedin.com/company/evofem
Facebook: http://www.facebook.com/Evofem
X (f/k/a Twitter): https://x.com/Evofem
Phexxi® and SOLOSEC® are
registered trademarks of Evofem Biosciences, Inc.
Forward-Looking Statements
This press release includes "forward-looking statements" within
the meaning of the safe harbor for forward-looking statements
provided by Section 21E of the Securities Exchange Act of 1934, as
amended, and the Private Securities Litigation Reform Act of 1995
including, without limitation, statements related to the Company's
anticipated financial performance, expected timing to relaunch
SOLOSEC, and the likelihood of success and anticipated timing to
close the contemplated Aditxt transaction. You are cautioned not to
place undue reliance on these forward-looking statements, which are
current only as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties.
Important factors that could cause actual results to differ
materially from those discussed or implied in the forward-looking
statements are disclosed in the Company's SEC filings, including
its Annual Report on Form 10-K for the year ended December 31,
2023 filed with the SEC on March 27, 2024, Quarterly
Report on Form 10-Q for the three months ended March 31,
2024 filed with the SEC on May 12, 2024, and any
subsequent filings. All forward-looking statements are expressly
qualified in their entirety by such factors. The Company does not
undertake any duty to update any forward-looking statement except
as required by law.
Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
(917) 673-5775
ir@evofem.com
-- Financial Tables Follow –
EVOFEM BIOSCIENCES,
INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(Unaudited)
|
(In thousands, except
par value and share data)
|
|
|
|
As of
|
|
|
|
June 30,
2024
|
|
|
December 31,
2023
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
-
|
|
|
$
|
-
|
|
Restricted
cash
|
|
|
692
|
|
|
|
580
|
|
Trade accounts
receivable, net
|
|
|
4,617
|
|
|
|
5,738
|
|
Total current
liabilities
|
|
|
73,178
|
|
|
|
72,463
|
|
Total stockholders'
deficit
|
|
|
(69,315)
|
|
|
|
(66,510)
|
|
Total liabilities,
convertible and redeemable preferred stock and stockholders'
deficit
|
|
$
|
8,551
|
|
|
$
|
10,554
|
|
EVOFEM BIOSCIENCES,
INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(Unaudited)
|
(In thousands, except
share and per share data)
|
|
|
|
2024
|
|
|
2023
|
|
|
2024
|
|
|
2023
|
|
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
2024
|
|
|
2023
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales,
net
|
|
$
|
4,160
|
|
|
$
|
2,458
|
|
|
$
|
7,763
|
|
|
$
|
8,267
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
769
|
|
|
|
2,293
|
|
|
|
1,453
|
|
|
|
3,669
|
|
Research and
development
|
|
|
270
|
|
|
|
402
|
|
|
|
864
|
|
|
|
942
|
|
Selling and
marketing
|
|
|
2,243
|
|
|
|
2,197
|
|
|
|
4,588
|
|
|
|
6,051
|
|
General and
administrative
|
|
|
2,267
|
|
|
|
4,902
|
|
|
|
5,091
|
|
|
|
8,520
|
|
Total operating
expenses
|
|
|
5,549
|
|
|
|
9,794
|
|
|
|
11,996
|
|
|
|
19,182
|
|
Loss from
operations
|
|
|
(1,389)
|
|
|
|
(7,336)
|
|
|
|
(4,233)
|
|
|
|
(10,915)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
6
|
|
|
|
8
|
|
|
|
10
|
|
|
|
26
|
|
Other income (expense),
net
|
|
|
(558)
|
|
|
|
(1,127)
|
|
|
|
(1,174)
|
|
|
|
(1,445)
|
|
Loss on issuance of
financial instruments
|
|
|
(25)
|
|
|
|
(27)
|
|
|
|
(3,300)
|
|
|
|
(111)
|
|
Gain on debt
extinguishment
|
|
|
-
|
|
|
|
-
|
|
|
|
1,120
|
|
|
|
-
|
|
Change in fair value of
financial instruments
|
|
|
3,325
|
|
|
|
(73)
|
|
|
|
4,127
|
|
|
|
1,539
|
|
Total other income
(expense), net
|
|
|
2,748
|
|
|
|
(1,219)
|
|
|
|
783
|
|
|
|
9
|
|
Income (loss) before
income tax
|
|
|
1,359
|
|
|
|
(8,555)
|
|
|
|
(3,450)
|
|
|
|
(10,906)
|
|
Income tax
expense
|
|
|
(8)
|
|
|
|
(3)
|
|
|
|
(8)
|
|
|
|
(6)
|
|
Net income
(loss)
|
|
|
1,351
|
|
|
|
(8,558)
|
|
|
|
(3,458)
|
|
|
|
(10,912)
|
|
Convertible preferred
stock deemed dividends
|
|
|
(47)
|
|
|
|
-
|
|
|
|
(94)
|
|
|
|
-
|
|
Net income (loss)
attributable to common stockholders
|
|
$
|
1,304
|
|
|
$
|
(8,558)
|
|
|
$
|
(3,552)
|
|
|
$
|
(10,912)
|
|
Net income (loss) per
share attributable to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.02
|
|
|
$
|
(5.43)
|
|
|
$
|
(0.07)
|
|
|
$
|
(6.60)
|
|
Diluted
|
|
$
|
(0.00)
|
|
|
$
|
(5.43)
|
|
|
$
|
(0.07)
|
|
|
$
|
(6.60)
|
|
Weighted-average shares
used to compute net income (loss) per share attributable to common
shareholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
66,773,313
|
|
|
|
1,576,158
|
|
|
|
48,983,853
|
|
|
|
1,654,026
|
|
Diluted
|
|
|
1,613,722,212
|
|
|
|
1,576,158
|
|
|
|
48,983,853
|
|
|
|
1,654,026
|
|
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SOURCE Evofem Biosciences, Inc.