SAN DIEGO, March 3, 2022 /PRNewswire/ -- Evofem Biosciences,
Inc. (Nasdaq: EVFM), a commercial stage biopharmaceutical company,
today reported financial results for the three- and twelve-month
periods ended December 31, 2021.
"In our first full year as a commercial company Evofem delivered
strong growth, capped by an exceptional fourth quarter," said
Saundra Pelletier, Chief Executive
Officer. "Additionally, we achieved a significant milestone today:
we completed enrollment in our Phase 3 clinical trial evaluating
Phexxi for two potential new indications - the prevention of
chlamydia and gonorrhea in women. Every sexually active woman is at
risk to contract these STIs and there are no FDA-approved
preventive measures; we believe this is a significant market
opportunity for Evofem. We are eager to report top-line data in the
second half of this year and submit to the FDA in the first half of
2023."
Fourth Quarter and Recent Highlights include:
- Net product sales increased 109% to $3.6
million in the fourth quarter of 2021, driven by a 73%
increase in Phexxi® (lactic acid, citric acid and potassium
bitartrate) units shipped;
- Reduced net cash burn rate to $16.8
million in the fourth quarter of 2021 versus $32.0 million in Q3;
- The U.S. Department of Labor and Health Resources and Services
Administration updated guidelines in an effort to ensure women have
access to all FDA-approved contraceptives, including Phexxi, at
zero copay under the Affordable Care Act;
- Completed enrollment in EVOGUARD, the registrational
Phase 3 trial evaluating Phexxi for the prevention of chlamydia and
gonorrhea in women - two potential new indications;
- Secured a $50 million equity line
of credit; and,
- Strengthened the balance sheet with aggregate gross proceeds of
$10 million from registered direct
offerings of notes in January and March
2022.
Fourth Quarter Financial Results
For the three months ended December 31,
2021, net product sales were $3.6
million, an increase of 109% versus $1.7 million for the three months ended
September 30, 2021, driven by a 73%
increase in Phexxi units shipped.
Total operating expenses decreased to $41.0 million for the fourth quarter of 2021,
compared to $45.1 million in the
third quarter of 2021.
- Research and development costs were $8.7
million in both the fourth and third quarter of 2021,
reflecting clinical trial expenses for the Phase 3 EVOGUARD
trial of Phexxi for two potential new indications - prevention of
urogenital chlamydia and gonorrhea in women.
- Selling and marketing costs decreased 18% to $24.9 million in the fourth quarter of 2021
compared to $30.5 million in the
prior quarter, due primarily to lower media expenses related to the
"House Rules" DTC marketing campaign.
- General and administrative costs increased 14% to $5.7 million, compared to $5.0 million in the prior quarter, primarily due
to higher outside services and payroll-related expenses, including
stock-based compensation.
Net loss attributable to common stockholders was $(52.6) million, or $(0.33) per share, for the fourth quarter of 2021
compared with a net loss of $74.1
million, or $(0.48) per share,
for the quarter ended September 30,
2021.
Full Year Financial Results
For the year ended December 31,
2021, net product sales were $8.2
million compared to $0.4
million in net product sales in the prior year. The increase
was primarily due to a full year of sales in 2021 versus four
months of sales in 2020, ex-factory unit sales growth, and an
increase in both gross and net sales from the impact of promotional
strategies and gross-to-net initiatives implemented since the
commercial launch of Phexxi in September 2020.
Total operating expenses were $175.0
million for the year ended December
31, 2021, compared to total operating expenses of
$104.1 million for the year ended
December 31, 2020.
- Selling and marketing costs were $113.2
million in 2021, compared to $56.5
million in the prior year. The increase largely reflects
higher media and marketing costs in 2021, in particular
direct-to-consumer activities including the "Get Phexxi" campaign
and the ongoing "House Rules" campaign featuring celebrity
ambassador Annie Murphy.
- Research and development costs increased to $33.1 million, compared to $17.1 million in the prior year period, due to
higher clinical trial expenses for EVOGUARD, which was
initiated in October 2020.
- General and administrative costs decreased to $24.7 million, compared to $30.1 million in the prior year, primarily
reflecting lower consulting fees and reductions in payroll-related
expenses, including stock-based compensation and headcount.
As a result, net loss attributable to common stockholders was
$206.2 million, or $(1.58) per share, for the year ended
December 31, 2021, compared with a
net loss of $142.3 million, or
$(2.12) per share, for the year ended
December 31, 2020.
Liquidity
In the fourth quarter of 2021, Evofem strengthened its balance
sheet with $10 million in gross
proceeds from the sale of Series B Convertible Preferred Stock to
an institutional investor.
At December 31, 2021, the Company
had $7.7 million of unrestricted cash
and $5.1 million of restricted cash,
as compared to $14.9 million of
unrestricted cash and $9.4 million of
restricted cash at September 30,
2021.
Subsequent Material Events
The Company raised aggregate gross proceeds of approximately
$10 million from registered direct
offerings of notes in January and March
2022 to fund the EVOGUARD trial and other ongoing
initiatives.
Additionally in February 2022,
Evofem secured a $50 million equity
line of credit.
Conference Call
As previously announced, the Evofem management team will host a
conference call to discuss its financial results and business
highlights as follows:
Date
|
Thursday March 3,
2022
|
Time
|
4:30 p.m. ET (1:30
p.m. PT)
|
Webcast (live and
archived)
|
https://evofem.investorroom.com/2021Q4YEResults
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
9976995
|
Please connect to the Company's website at least 15 minutes
prior to the start of the event to download any software that may
be required. If participating by phone, please also dial in
approximately 15 minutes prior to the start of the call.
The webcast will be archived at
https://evofem.investorroom.com/2021Q4YEResults. A telephone replay
will be available for 24 hours after the call at (855) 859-2056
(U.S.) or (404) 537-3406 (International), conference ID
9976995.
About Evofem Biosciences
Evofem Biosciences, Inc., (NASDAQ: EVFM) is 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 (chlamydia and gonorrhea). 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 (the Exchange Act), and the Private Securities Litigation
Reform Act of 1995 including, without limitation, statements
related to the ongoing development of Phexxi, including related
timelines and FDA submissions, and future growth of sales of Phexxi
and the Company generally. Various factors could cause actual
results to differ materially from those discussed or implied in the
forward-looking statements, and 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, or that could impair the value of Evofem Biosciences'
assets and business, are disclosed in the Company's SEC filings,
including its Annual Report on Form 10-K for the year ended
December 31, 2020 filed with the SEC
on March 4, 2021 and subsequently
filed Exchange Act Reports. 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. This press release 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.
Investor Contact
Amy
Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
(Tables follow)
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In
thousands)
|
|
December 31,
2021
|
|
December 31,
2020
|
Cash and cash
equivalents
|
$
7,732
|
|
$
48,892
|
Restricted
cash
|
5,056
|
|
22,559
|
Trade accounts
receivable, net
|
6,449
|
|
1,067
|
Total current
liabilities
|
137,663
|
|
77,283
|
Total
liabilities
|
142,087
|
|
108,621
|
Convertible and
redeemable preferred stock
|
4,740
|
|
—
|
Total stockholders'
equity (deficit)
|
(104,315)
|
|
1,347
|
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except
share and per share data)
|
|
Quarter Ended
December 31,
|
|
Year Ended
December 31,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Product sales,
net
|
$
3,570
|
|
$
168
|
|
$
8,244
|
|
$
446
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
1,755
|
|
151
|
|
4,055
|
|
468
|
Research and
development
|
8,659
|
|
5,946
|
|
33,129
|
|
17,050
|
Selling and
marketing
|
24,922
|
|
23,914
|
|
113,152
|
|
56,467
|
General and
administrative
|
5,652
|
|
6,008
|
|
24,709
|
|
30,085
|
Total operating
expenses
|
40,988
|
|
36,019
|
|
175,045
|
|
104,070
|
Loss from
operations
|
(37,418)
|
|
(35,851)
|
|
(166,801)
|
|
(103,624)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
1
|
|
17
|
|
15
|
|
169
|
Other
expense
|
(1,211)
|
|
(1,072)
|
|
(4,732)
|
|
(2,082)
|
Loss on issuance of
financial instruments
|
—
|
|
—
|
|
—
|
|
(64,049)
|
Change in fair value
of financial instruments
|
(12,920)
|
|
(3,690)
|
|
(33,657)
|
|
27,281
|
Total other expense,
net
|
(14,130)
|
|
(4,745)
|
|
(38,374)
|
|
(38,681)
|
Loss before income
tax
|
(51,548)
|
|
(40,596)
|
|
(205,175)
|
|
(142,305)
|
Income tax
expense
|
(6)
|
|
(2)
|
|
(17)
|
|
(4)
|
Net loss
|
(51,554)
|
|
(40,598)
|
|
(205,192)
|
|
(142,309)
|
Series B-1 and B-2
convertible preferred stock deemed dividends
|
(1,047)
|
|
—
|
|
(1,047)
|
|
—
|
Net loss attributable
to common stockholders
|
$
(52,601)
|
|
$
(40,598)
|
|
$
(206,239)
|
|
$
(142,309)
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
(0.33)
|
|
$
(0.50)
|
|
$
(1.58)
|
|
$
(2.12)
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
161,228,820
|
|
81,221,603
|
|
130,908,794
|
|
67,157,278
|
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SOURCE Evofem Biosciences, Inc.