SAN DIEGO, May 6, 2021 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"),
today reported financial results for the three-month period ended
March 31, 2021.
First quarter and recent highlights include:
- Direct-to-consumer (DTC) marketing campaign launched on
February 14, 2021 resulting in:
-
- 83% total prescription growth for Phexxi® (lactic
acid, citric acid and potassium bitartrate) in March vs.
February;
- A 78% increase in healthcare providers prescribing Phexxi in
March vs. February;
- Expanded Phexxi total brand awareness growth, reaching 12% in
March vs. 4% in January;
- Net revenues increased to $1.1
million compared to $0.2
million in the fourth quarter of 2020;
- Advanced enrollment in EVOGUARD, the pivotal Phase 3 clinical
trial evaluating safety and efficacy of EVO100 for the prevention
of chlamydia and gonorrhea in women, toward goal of completing
enrollment by year-end 2021;
- American Journal of Obstetrics and Gynecology published
the Phase 2b/3 AMPREVENCE clinical
trial manuscript; this double-blinded, placebo-controlled study of
EVO100 met its primary and secondary efficacy endpoints, with
statistically significant reductions in the risk of chlamydia and
gonorrhea infections.
- Data sets from the Phase 3 AMPOWER trial of Phexxi for
prevention or pregnancy were presented in April 2021 at the American College of
Obstetricians and Gynecologists (ACOG) and National Community
Oncology Dispensing Association (NCODA) annual meetings.
"Our 'Get Phexxi' DTC campaign launched nationwide on
Valentine's Day, resulting in strong first quarter growth. More
than 5,000 healthcare providers have prescribed Phexxi to date, and
Phexxi prescriptions increased 83% from February to March," said
Saundra Pelletier, Evofem's Chief
Executive Officer. "Contraception is the most
promotionally-sensitive pharmaceutical category, and we expect this
ongoing campaign will continue to drive Phexxi uptake."
Financial Results
The first quarter of 2021 was
Evofem's second full quarter of product sales following
the United States commercial
launch of Phexxi on September 8,
2020, and included the impact of the "Get Phexxi" DTC
campaign.
Net product sales were $1.1
million for the three months ended March 31, 2021. For perspective, in the fourth
quarter of 2020 net product sales were approximately $170,000. The increase reflects higher gross
revenues and more favorable gross-to net (GTN) adjustments in the
current period. The Company expects GTN adjustments will
significantly improve throughout the remainder of 2021, driven by a
series of GTN improvement initiatives that Evofem began
implementing in April 2021 as part of
its overall strategy to build Phexxi trial usage and loyalty.
Total operating expenses increased to $46.0 million for the first quarter of 2021,
compared to $19.2 million for the
prior year period. In the current period:
- Cost of goods sold was $0.5
million.
- Research and development costs were $7.3
million, primarily clinical trial expenses for EVOGUARD, the
pivotal Phase 3 trial of EVO100 for the prevention of chlamydia and
gonorrhea in women, and employee-related expense. EVOGUARD was
initiated in October 2020 and 80 of
90 planned study sites have been activated.
- Selling and marketing costs were $30.5
million, which includes media, advertising and public
relations costs for Phexxi commercialization initiatives and
campaigns, including the February DTC launch, and healthcare
provider advertising and costs of the telehealth platform. Higher
payroll-related expenses due to increased headcount in the current
period also contributed.
- General and administrative costs were $7.7 million.
Total other expense, net, was $1.3
million in the first quarter of 2021, and mainly included a
$0.1 million change in fair value as
a result of mark-to-market adjustments and $1.1 million in accrued interest expense for the
convertible notes issued in 2020.
Net loss attributable to common stockholders was $46.2 million, or $(0.56) per share, for the quarter ended
March 31, 2021, compared with a net
loss of $19.1 million, or
$(0.40) per share, for the prior year
quarter.
Cash and cash equivalents was $45.3
million at March 31, 2021,
which includes $28.0 million in net
proceeds from an underwritten public offering completed in March.
In addition, at March 31, 2021,
$18.6 million in restricted cash from
the Adjuvant notes was available for use.
Net proceeds of $4.2 million from
the underwriters' exercise of the full over-allotment option in
April will be recorded in the second quarter of 2021.
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
|
May 6,
2021
|
Time
|
4:30 p.m. ET (1:30
p.m. PT)
|
Webcast (live and
archived)
|
https://edge.media-server.com/mmc/p/qspnf9o8
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
1899453
|
The live webcast and related slide presentation can be accessed
directly at https://edge.media-server.com/mmc/p/qspnf9o8. Please
connect to the Company's website 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.
The webcast will be archived at
https://edge.media-server.com/mmc/p/qspnf9o8. 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
1899453.
About Evofem Biosciences, Inc.
Evofem Biosciences,
Inc., (NASDAQ: EVFM) is a commercial-stage biopharmaceutical
company committed to 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) contraceptive vaginal gel, in the United States in September 2020. The Company's lead product
candidate, EVO100, is being evaluated 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.
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.
For more information about Phexxi®, talk to your
healthcare provider and see full Product Information.
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 the anticipated impact of
gross-to-net improvement strategies, evaluations regarding
promotional sensitivity and future growth, the success of our 'Get
Phexxi' DTC campaign, our clinical trials and development efforts
for EVO100 and our ability to successfully commercialize Phexxi.
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)
|
|
|
|
|
|
March 31,
2021
|
|
December 31,
2020
|
Cash and cash
equivalents
|
$
|
45,318
|
|
|
$
|
48,892
|
|
Restricted
cash
|
18,975
|
|
|
22,559
|
|
Trade accounts
receivable, net
|
2,914
|
|
|
1,067
|
|
Total current
liabilities
|
75,706
|
|
|
77,283
|
|
Total
liabilities
|
107,102
|
|
|
108,621
|
|
Total stockholders'
equity (deficit)
|
(13,638)
|
|
|
1,347
|
|
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
(In thousands, except
share and per share data)
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2021
|
|
2020
|
|
Product sales,
net
|
$
|
1,105
|
|
|
$
|
—
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Cost of goods
sold
|
506
|
|
|
—
|
|
|
Research and
development
|
7,262
|
|
|
4,247
|
|
|
Selling and
marketing
|
30,525
|
|
|
7,855
|
|
|
General and
administrative
|
7,684
|
|
|
7,142
|
|
|
Total operating
expenses
|
45,977
|
|
|
19,244
|
|
|
Loss from
operations
|
(44,872)
|
|
|
(19,244)
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
income
|
7
|
|
|
102
|
|
|
Other
expense
|
(1,145)
|
|
|
(4)
|
|
|
Change in fair value
of financial instruments
|
(142)
|
|
|
—
|
|
|
Total other (expense)
income, net
|
(1,280)
|
|
|
98
|
|
|
Loss before income
tax
|
(46,152)
|
|
|
(19,146)
|
|
|
Income tax
expense
|
1
|
|
|
—
|
|
|
Net loss
|
$
|
(46,151)
|
|
|
$
|
(19,146)
|
|
|
Net loss per share,
basic and diluted
|
$
|
(0.56)
|
|
|
$
|
(0.40)
|
|
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
81,843,319
|
|
|
48,195,951
|
|
|
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SOURCE Evofem Biosciences, Inc.