SAN DIEGO, Aug. 11, 2021 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"),
today reported financial results for the three- and six-month
periods ended June 30, 2021.
"We are pleased to show strong and sustainable growth in Phexxi
prescriptions and dispensed units in the second quarter. This
momentum allows us to further accelerate the growth trajectory with
our celebrity campaign launching in early September," said
Saundra Pelletier, Evofem's Chief
Executive Officer.
Second quarter and recent highlights include:
- 12,763 Phexxi® (lactic acid, citric acid and
potassium bitartrate) prescriptions were filled and 14,810 units
were dispensed to patients during the second quarter of 2021, an
increase of 47% and 65%, respectively, compared to the first
quarter of 2021.
- 52% growth in the prescriber base in the second quarter of 2021
compared to the first quarter of 2021, and over 7,700 healthcare
providers have prescribed Phexxi from launch through mid-July.
- National brand ambassador campaign featuring an Emmy
Award-winning celebrity launching in September 2021 to accelerate growth in Phexxi
brand awareness and prescriptions.
- On track to complete enrollment in EVOGUARD by year-end 2021.
This pivotal Phase 3 clinical trial is evaluating safety and
efficacy of EVO100 for the prevention of chlamydia and gonorrhea in
women.
Financial Results
For the three months ended
June 30, 2021, Phexxi net product
sales increased 68% to $1.9 million,
compared to $1.1 million in the three
months ended March 31, 2021. There
were no net product sales in the second quarter of 2020, since
Phexxi was launched in the U.S. in September
2020.
Total operating expenses decreased 6% to $43.0 million for the second quarter of 2021
compared to $46.0 million in the
first quarter of 2021.
- Cost of goods sold was $0.8
million, compared to $0.5
million in the first quarter of 2021, reflecting higher
Phexxi sales.
- Research and development costs increased 17% to $8.5 million, compared to $7.3 million in the first quarter of 2021,
reflecting higher enrollment in the Phase 3 EVOGUARD trial. This
trial is funded in part by the proceeds from the Adjuvant
convertible notes issued in 2020.
- Selling and marketing costs decreased 11% to $27.2 million, compared to $30.5 million in the first quarter of 2021 due
primarily to lower media and agency fees, which were offset in part
by costs related to the Phexxi sample rollout.
- General and administrative costs were $6.4 million compared to $7.7 million in the first quarter of 2021,
primarily reflecting lower headcount, recruiting, and outside
services.
During the second quarter, the Company implemented cost
containment measures across all departments. These included
reductions in spend and headcount, elimination of certain
consulting roles, and eliminating hires planned for 2021.
These measures are expected to result in aggregate savings of
$9.5 million on an annualized
basis.
Total other income, net, was $7.7
million in the second quarter of 2021, and mainly included a
$8.9 million change in fair value as
a result of mark-to-market adjustments and $1.2 million in interest expense for the
convertible notes issued in 2020.
Net loss attributable to common stockholders improved to
$33.4 million, or $(0.27) per share, for the quarter ended
June 30, 2021, compared with a net
loss of $46.2 million, or
$(0.56) per share, in the first
quarter of 2021 and a net loss of $52.7
million, or $(0.91) per share,
for the prior year quarter.
Cash and cash equivalents was $47.0
million at June 30, 2021. In
addition, at June 30, 2021,
$14.9 million in restricted cash from
the Adjuvant notes was available for use.
Conference Call
As previously announced, the Evofem
management team will host a conference call to discuss its
financial results for the second quarter ended June 30, 2021 and business highlights on
Wednesday, August 11, 2021 at
4:30 p.m. ET (1:30 p.m. PT).
The webcast (live and archived) and related slide presentation
can be accessed through
https://evofem.investorroom.com/2021Q2Results or
https://edge.media-server.com/mmc/p/h6zpy9h5.
Please connect to the webcast at least 15 minutes prior to the
start of the call to download any software that may be
required.
If participating by phone, please dial in approximately 15
minutes prior to the start of the call using (866) 503-5561 (U.S.
toll-free) or (253) 336-2965, and referring to conference ID
9190716.
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 9190716.
About Evofem Biosciences, Inc.
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 (STIs). The
Company launched its first FDA-approved commercial product,
Phexxi® (lactic acid, citric acid and potassium
bitartrate), in the United States
in September 2020. The Company is
evaluating lead product candidate EVO100 for the prevention of
urogenital Chlamydia trachomatis and Neisseria
gonorrhoeae infection in women in the ongoing Phase 3 clinical
trial, 'EVOGUARD.' For more information, please
visit www.evofem.com.
Phexxi® is a trademark of Evofem
Biosciences.
About PHEXXI
Phexxi is an on-demand method of birth
control used to prevent pregnancy. Phexxi is not effective when
used after sex. For more information about Phexxi, talk to your
healthcare provider and see full Product Information, which is
available at https://www.phexxi.com/pdf/PhexxiUSPI.pdf.
IMPORTANT SAFETY INFORMATION
- Rare cases (0.36%) of bladder and kidney infection have been
reported. If you have a history of urinary tract problems that keep
coming back, you should not use Phexxi.
- Contact your healthcare provider if you are experiencing
genitourinary side effects such as vaginal burning, itching,
discharge, genital discomfort (including in male partners), yeast
infection, urinary tract infection or bacterial vaginosis.
- Phexxi does not protect against any sexually transmitted
infections, including HIV.
Please report side effects by contacting Evofem Biosciences
toll-free at 1-833-EVFMBIO or contact FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
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 potential growth, momentum and
trajectory, the potential results of celebrity campaigns, matters
relating to the ongoing development of EVO100 and potential results
of any cost containment measures. 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. 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.
Investor Relations Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775
Media Contact
Ellen
Thomas
Evofem Biosciences, Inc.
ethomas@evofem.com
Mobile: (718) 490-3248
(Tables follow)
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In
thousands)
|
|
|
June 30,
2021
|
|
December 31,
2020
|
Cash and cash
equivalents
|
$
|
46,982
|
|
|
$
|
48,892
|
|
Restricted
cash
|
15,206
|
|
|
22,559
|
|
Trade accounts
receivable, net
|
3,108
|
|
|
1,067
|
|
Total current
liabilities
|
68,321
|
|
|
77,283
|
|
Total
liabilities
|
99,784
|
|
|
108,621
|
|
Total stockholders'
equity
|
8,964
|
|
|
1,347
|
|
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
(In thousands, except
share and per share data)
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Product sales,
net
|
$
|
1,857
|
|
|
$
|
—
|
|
|
$
|
2,962
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
839
|
|
|
—
|
|
|
1,345
|
|
|
—
|
|
Research and
development
|
8,507
|
|
|
2,640
|
|
|
15,769
|
|
|
6,887
|
|
Selling and
marketing
|
27,237
|
|
|
9,997
|
|
|
57,762
|
|
|
17,852
|
|
General and
administrative
|
6,416
|
|
|
9,735
|
|
|
14,100
|
|
|
16,877
|
|
Total operating
expenses
|
42,999
|
|
|
22,372
|
|
|
88,976
|
|
|
41,616
|
|
Loss from
operations
|
(41,142)
|
|
|
(22,372)
|
|
|
(86,014)
|
|
|
(41,616)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
4
|
|
|
29
|
|
|
11
|
|
|
131
|
|
Other
expense
|
(1,186)
|
|
|
(349)
|
|
|
(2,331)
|
|
|
(353)
|
|
Loss on issuance of
financial instruments
|
—
|
|
|
(64,049)
|
|
|
—
|
|
|
(64,049)
|
|
Change in fair value
of financial instruments
|
8,910
|
|
|
34,075
|
|
|
8,768
|
|
|
34,075
|
|
Total other income
(expense), net
|
7,728
|
|
|
(30,294)
|
|
|
6,448
|
|
|
(30,196)
|
|
Loss before income
tax
|
(33,414)
|
|
|
(52,666)
|
|
|
(79,566)
|
|
|
(71,812)
|
|
Income tax
expense
|
(12)
|
|
|
—
|
|
|
(11)
|
|
|
—
|
|
Net loss
|
$
|
(33,426)
|
|
|
$
|
(52,666)
|
|
|
$
|
(79,577)
|
|
|
$
|
(71,812)
|
|
Net loss per share,
basic and diluted
|
$
|
(0.27)
|
|
|
$
|
(0.91)
|
|
|
$
|
(0.77)
|
|
|
$
|
(1.36)
|
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
125,168,570
|
|
|
57,696,519
|
|
|
103,625,627
|
|
|
52,946,235
|
|
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SOURCE Evofem Biosciences, Inc.