SAN
DIEGO, May 15, 2024 /PRNewswire/ -- The company
behind the hormone-free contraceptive Phexxi® (lactic acid,
citric acid and potassium bitartrate), Evofem Biosciences, Inc.
("Evofem" or "the Company") (OTCQB: EVFM) today announced financial
results for the first quarter of 2024. Highlights of and since the
quarter include:
- Received $1 million
from Aditxt, Inc. (Nasdaq: ADTX) in May
2024 in consideration for reinstating and amending the
Merger Agreement, as amended, between the companies. Aditxt agreed
to invest an additional $2.5 million
in Evofem by July 1, 2024. The
companies are working to close the contemplated transaction in the
second half of 2024.
- Strengthened Phexxi intellectual property with the
allowance of a new Composition of Matter Patent by the USPTO. Once
issued, this will be the fifth U.S. patent covering Evofem's
hormone-free contraceptive.
- Launched a partnership with Modern Remedies, one of the top
pharmacies dispensing Phexxi in the Northeast, effective
May 2024.
- Successfully renegotiated the rebate for Phexxi with Medi-Cal,
the California state Medicaid program serving more than
15.4 million beneficiaries. Effective July 1, 2024, Evofem will pay a 7.4% lower rebate
to Medi-Cal on Phexxi prescriptions dispensed to its
beneficiaries.
- Net sales were $3.6 million for
the first quarter of 2024, reflecting anticipated cyclical softness
following the wholesale acquisition cost (WAC) increase on
January 1, 2024, and the impact of
the cyberattack on Change Healthcare on February 19, 2024.
- Total operating expenses decreased 31% vs. the first quarter of
2023 to $6.4 million.
- Narrowed loss from operations to $2.8
million, a 21% improvement compared to the first quarter of
2023.
"We expect 2024 will be our fourth consecutive year of net sales
growth, driven in part by continued execution of our market access
strategy with payer wins and successful rebate reductions," said
Saundra Pelletier, Evofem's CEO. "We
also expect lift from increasing use of Phexxi for supplemental
contraception among women of reproductive age who take oral birth
control pills in conjunction with GLP-1 agonists like Mounjaro
and Zepbound. These drugs may make oral contraceptives less
effective at certain points in the dosing schedule – specifically
for four weeks after initiation and for another four weeks after
each dose escalation. Adding a hormone-free, woman-controlled
contraceptive like Phexxi is a logical choice for these patients
for additional protection against unintended pregnancy during these
times."
Financial Results
For the three months ended March 31,
2024, net sales were $3.6
million compared to $5.8
million in the prior year period. The 38% decrease reflects
cyclical softness related to the timing of orders relative to WAC
increases and the unfavorable impact of the cyberattack on Change
Healthcare.
The typical cycle is that our customers A) place larger orders
ahead of a price increase, B) sell from this inventory for several
months after the price increase, and C) resume ordering the
following quarter. Phexxi WAC increased on January 1, 2024, resulting in softer first
quarter 2024 net sales (stage B). By contrast, following the
October 2022 WAC increase and the
near-absence of sales in the fourth quarter of 2022, net sales in
the first quarter of 2023 were strong (stage C).
Following the cyberattack on Change Healthcare on February 19, 2024, retail pharmacies across the
country experienced delays processing prescriptions and were unable
to send orders through insurance plans, and there were delays in
the processing of insurance claims, which lowered dispensed units
of many prescription products, including Phexxi. Additionally,
Change Healthcare was the sole adjudicator (processor) used by
Evofem's co-pay card vendor and Evofem received no claims for
several weeks following the cyberattack. In mid-March, our co-pay
card vendor established an alternative adjudicator. Initially the
cost to Evofem was significantly higher, which negatively impacted
our first quarter results. Costs have dropped back down in the
second quarter of 2024 to approximately 8% above pre-cyberattack
levels.
Total operating expenses decreased 31% to $6.4 million, compared to $9.4 million in the prior year period. The
improvement reflects a 39% decrease in selling and marketing costs
and 22% decrease in general and administrative costs.
As a result, loss from operations improved to $2.8 million, compared with a loss from
operations of $3.6 million for the
three months ended March 31, 2023.
Liquidity
At March 31, 2024, we had $0.7
million of restricted cash, as compared to $0.6 million of restricted cash at December 31, 2023.
Subsequent to the quarter close, in April
2024 Evofem made the required quarterly payment of
$0.1 million to a U.S.-based,
healthcare-focused institutional investor as required by
the Fourth Amendment to the Securities Purchase and
Security Agreement dated April 2020, as amended, under which
this investor purchased $25 million of convertible
senior secured promissory notes from Evofem in 2020.
In May 2024, Evofem received
$1 million from Aditxt in
consideration of reinstating and amending the Agreement and Plan of
Merger, as amended on January 10,
2024, January 30, 2024,
February 29, 2024, and May 2, 2024, by and between the companies.
Under the Fourth Amendment to the Agreement and Plan of Merger,
Aditxt agreed to invest an additional $2.5
million in Evofem by July 1,
2024. The companies are working to close the contemplated
transaction in the second half of 2024.
About Evofem Biosciences
Evofem Biosciences, Inc., is
developing and 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. Learn more at phexxi.com and evofem.com.
Phexxi® is a registered trademark 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, the anticipated benefits of the contemplated
Aditxt transaction, and timing thereof. 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, its Quarterly Report
on Form 10-Q for quarter ended March 31,
2024, filed with the SEC on May 15,
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
-- Financial Tables Follow --
EVOFEM BIOSCIENCES,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In
thousands)
|
|
|
As of
|
|
March 31,
2024
|
|
December 31,
2023
|
Cash and cash
equivalents
|
$
-
|
|
$
-
|
Restricted
cash
|
689
|
|
580
|
Trade accounts
receivable, net
|
4,306
|
|
5,738
|
Total current
liabilities
|
74,239
|
|
72,463
|
Total stockholders'
deficit
|
(70,666)
|
|
(66,510)
|
Total liabilities,
convertible and redeemable preferred
stock and stockholders' deficit
|
8,217
|
|
10,554
|
EVOFEM BIOSCIENCES,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except
share and per share data)
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2024
|
|
|
2023
|
|
Product sales,
net
|
|
$
|
3,603
|
|
|
$
|
5,809
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
684
|
|
|
|
1,376
|
|
Research and
development
|
|
|
594
|
|
|
|
540
|
|
Selling and
marketing
|
|
|
2,345
|
|
|
|
3,854
|
|
General and
administrative
|
|
|
2,824
|
|
|
|
3,618
|
|
Total operating
expenses
|
|
|
6,447
|
|
|
|
9,388
|
|
Loss from
operations
|
|
|
(2,844)
|
|
|
|
(3,579)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
4
|
|
|
|
18
|
|
Other expense,
net
|
|
|
(616)
|
|
|
|
(318)
|
|
Loss on issuance of
financial instruments
|
|
|
(3,275)
|
|
|
|
(84)
|
|
Gain on debt
extinguishment
|
|
|
1,120
|
|
|
|
-
|
|
Change in fair value of
financial instruments
|
|
|
802
|
|
|
|
1,612
|
|
Total other income
(expense), net
|
|
|
(1,965)
|
|
|
|
1,228
|
|
Loss before income
tax
|
|
|
(4,809)
|
|
|
|
(2,351)
|
|
Income tax
expense
|
|
|
-
|
|
|
|
(3)
|
|
Net loss
|
|
|
(4,809)
|
|
|
|
(2,354)
|
|
Convertible preferred
stock deemed dividends
|
|
|
(47)
|
|
|
|
-
|
|
Net loss attributable
to common stockholders
|
|
$
|
(4,856)
|
|
|
$
|
(2,354)
|
|
Net loss per share
attributable to common stockholders
|
|
|
|
|
|
|
|
|
(basic and
diluted):
|
|
$
|
(0.16)
|
|
|
$
|
(1.85)
|
|
Weighted-average shares
used to compute net loss per share
|
|
|
|
|
|
|
|
|
attributable to common
shareholders (basic and diluted):
|
|
|
31,194,393
|
|
|
|
1,271,524
|
|
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SOURCE Evofem Biosciences, Inc.