SAN DIEGO, Nov. 9, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"),
today reported financial results for the three- and nine- month
periods ended September 30, 2020.
"We are excited by the early momentum of our commercial launch
of Phexxi, the first and only hormone-free, prescription
contraceptive vaginal gel, which became available in the United States in September," said
Saundra Pelletier, Evofem's Chief
Executive Officer. "Our investments in consumer brand awareness and
telemedicine have been critical drivers of our early success. The
reported financial results represent a small snapshot of our
commercial launch, and we continue to expect Phexxi to reach its
full market potential based on key launch metrics including the
number of women who have taken advantage of our Phexxi Concierge
Experience, Phexxi.com website visitors, and interest among
healthcare providers.
"Our commitment to develop and deliver innovative solutions to
unmet needs in women's health does not stop with hormone-free
contraception. Last month we initiated EVOGUARD, our pivotal Phase
3 trial of EVO100 vaginal gel for prevention of chlamydia and
gonorrhea infection in women. There are no FDA approved drugs to
prevent these common infections, and the need continues to increase
every year. Assuming timely completion and positive study results,
we would expect to file an NDA for these indications in 2022.
"The recent $25 million strategic
investment in Evofem by Adjuvant Capital, a healthcare investor
aligned with our vision, at a premium to market, provides
significant funding for EVOGUARD and strengthens our ability to
transform women's health in the United States and around
the world," concluded Ms. Pelletier.
Third quarter and recent highlights include:
- Launched Phexxi™ (lactic acid, citric acid and potassium
bitartrate) as the first and only hormone-free, prescription
vaginal gel approved in the United
States for the prevention of pregnancy;
- Initiated EVOGUARD, the pivotal Phase 3 clinical trial to
evaluate safety and efficacy of EVO100 for the prevention of
chlamydia and gonorrhea in women;
- Secured a $25 million strategic
investment from Adjuvant Capital at a premium to market, with
proceeds earmarked to fund EVOGUARD and expand global market access
for Phexxi;
- The Phase 3 AMPOWER study of Phexxi for prevention of pregnancy
was published in the peer-reviewed journal
Contraception, and six AMPOWER abstracts were
presented at major medical society meetings; and,
- Outcomes of the Phase 2b
AMPREVENCE study of EVO100 for the prevention of chlamydia and
gonorrhea in women were presented at three major medical society
meetings, including pivotal results presented in a poster at the
2020 STD Prevention Virtual
Conference.
Financial Results
The third quarter of 2020 was
Evofem's first quarter reporting product sales, following
the United States commercial
launch of Phexxi on September 8, 2020
as the first and only hormone-free, prescription vaginal gel
approved for the prevention of pregnancy. Net product sales
were $0.3 million for the three
months ended September 30, 2020. Cost of goods sold was
$0.3 million, which included a
$0.1 million one-time charge
predominantly related to reworking the Phexxi product label, which
was initially printed at-risk before approval, to reflect the final
approved label.
Research and development costs for the third quarter of 2020
were $4.2 million, compared to
$5.7 million in the prior year
quarter, primarily due to the absence in the current period of
service fees associated with the Phexxi New Drug Application and of
AMPREVENCE clinical trial costs, which were submitted to the FDA
and completed, respectively, in the fourth quarter of 2019. The
decrease was partially offset by clinical trial expenses for
EVOGUARD, which was initiated in October
2020, and higher payroll-related expenses and noncash
stock-based compensation due to increased headcount in the current
period.
Selling and marketing costs for the third quarter of 2020
were $14.7 million. For the third quarter of 2019,
selling and marketing costs of $3.8
million were reclassified from general and administrative
expenses to conform to the current period presentation.
The increased expense in the current period primarily reflects
a $6.9 million increase in media and
advertising costs, combined with higher marketing and market access
service costs incurred in preparation for the Phexxi commercial
launch. Higher payroll-related expenses due to increased headcount
and an uptick in facilities costs also contributed.
General and administrative costs for the third quarter of 2020
were $7.2 million, compared to
$4.8 million in the prior year
quarter. The increase is primarily related to an aggregate
$2.9 million increase in costs
associated with various operational items associated with legal,
audit and financing advisory fees, sales force recruiting costs,
payroll related costs due to increased headcount, and other general
business expenses. This was partially offset by a $0.5 million decrease in noncash stock-based
compensation.
As a result, total operating expenses increased to $26.4 million for the third quarter of 2020,
compared to $14.3 million for the
prior year period.
Total other expense, net, was $3.7
million in the third quarter of 2020, and mainly included a
$3.1 million change in fair value as
a result of mark-to-market adjustments and $0.7 million in accrued interest expense for the
convertible notes issued in the second quarter of 2020. This
compares to total other income of $0.5
million in the prior year quarter, which included higher
interest income.
Net loss attributable to common stockholders was $29.9 million, or $(0.37) per share, for the quarter ended
September 30, 2020, compared with a
net loss of $13.8 million, or
$(0.30) per share, for the prior year
quarter.
Unrestricted cash and short-term investments were $86.7 million at September 30, 2020,
compared to $23.8 million at
December 31, 2019.
In October 2020, Evofem
sold $25 million of unsecured convertible promissory
notes to funds affiliated with Adjuvant Capital, LP ("Adjuvant
Capital"). The notes are convertible into shares of Evofem
common stock at a conversion price of $3.65 per share.
Proceeds from the sale of the notes will be used to support
EVOGUARD, Evofem's ongoing Phase 3 clinical trial of EVO100 for the
prevention of urogenital chlamydia and gonorrhea in women, and to
expand global market access for Phexxi.
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
|
November 9,
2020
|
Time
|
5:00 p.m. ET (2:00
p.m. PT)
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
2639368
|
Webcast (live and
archived)
|
www.evofem.com under
"Investors" or click here
|
The live webcast and related slide presentation can be accessed
on the Company's Investor page
at https://evofem.investorroom.com/events. 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 10 minutes
prior to the start of the call.
A telephone replay will be available approximately two hours
after the call through Thursday, November 12, 2020
at (855) 859-2056 (U.S.) or (404) 537-3406
(International), conference ID 2639368. The webcast will be
archived at https://evofem.investorroom.com/events.
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's first commercial product, Phexxi™ (lactic acid,
citric acid and potassium bitartrate), is the first and only
hormone-free, prescription vaginal gel approved in the United
States for the prevention of pregnancy. The Company is
evaluating EVO100 in a Phase 3 clinical
trial, 'EVOGUARD,' for the prevention of urogenital
Chlamydia trachomatis and Neisseria
gonorrhoeae infection in women. For more information,
please visit www.evofem.com.
Phexxi™ is a trademark of Evofem Biosciences.
About PHEXXI™
Phexxi™ (lactic acid, citric acid,
and potassium bitartrate) is a prescription vaginal gel used to
prevent pregnancy in females who choose to use an on-demand method
of birth control. Phexxi™ is only effective when used
immediately before (or up to one hour before) each
act of vaginal sex. Phexxi™ is not effective when used after
vaginal sex.
IMPORTANT SAFETY INFORMATION
WHAT ARE THE POSSIBLE SIDE EFFECTS OF PHEXXI™ (lactic
acid, citric acid, and potassium bitartrate) vaginal gel 1.8%, 1%,
0.4%?
If you have had a history of repeated urinary tract
infections or other urinary tract problems, avoid Phexxi™.
The most common side effects were vaginal
burning, vaginal itching, vaginal yeast infection, urinary tract
infection, vaginal area discomfort, bacterial vaginosis, and
vaginal discharge. Women also reported genital discomfort, pain
while urinating, and vaginal pain. Some male partners reported
genital discomfort.
What else should I know about using
Phexxi™?
Phexxi™ does not protect against any sexually
transmitted diseases, including HIV. Avoid using Phexxi™ with
a vaginal ring.
Contact your healthcare provider if you are experiencing severe
genital irritation or discomfort or urinary tract symptoms. Avoid
Phexxi™ if you or your sexual partner is allergic to lactic
acid, citric acid, potassium bitartrate, or any of the ingredients
in Phexxi™. Stop using Phexxi™ if you develop an allergic
reaction.
Please see full Prescribing Information for Phexxi™,
including Patient 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 Evofem's expectation regarding
the success of achieving the market potential of Phexxi, the
success of the Phexxi Concierge Experience, and timely completion
of and the success of the EVOGUARD clinical trial. 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 Evofem's
SEC filings, including its Annual Report on Form 10-K for the year
ended December 31, 2019 filed with the SEC on March
12, 2020, its Quarterly Report on Form 10-Q for the quarter
ended September 30, 2020 filed with the SEC
on November 9, 2020 and August 4, 2020, and its
Current Report on Form 8-K filed with the SEC on June 2, 2020.
All forward-looking statements are expressly qualified in their
entirety by such factors. Evofem 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, Inc.
Evofem Biosciences
ethomas@evofem.com
Mobile: (718) 490-3248
(Tables follow)
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In
thousands)
|
|
|
September 30,
2020
|
|
December 31,
2019
|
Cash and cash
equivalents
|
$
|
86,697
|
|
|
$
|
15,571
|
|
Restricted
cash
|
337
|
|
|
304
|
|
Trade accounts
receivable, net
|
1,243
|
|
|
—
|
|
Short-term
investments
|
—
|
|
|
8,233
|
|
Total current
liabilities
|
65,692
|
|
|
12,659
|
|
Total
liabilities
|
72,117
|
|
|
12,659
|
|
Total stockholders'
equity
|
40,210
|
|
|
15,636
|
|
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except share and per share
data)
|
|
|
Three Months
Ended
September 30,
|
|
Nine Months
Ended
September 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Product sales,
net
|
$
|
278
|
|
|
$
|
—
|
|
|
$
|
278
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
317
|
|
|
—
|
|
|
317
|
|
|
$
|
—
|
|
Research and
development
|
4,217
|
|
|
5,663
|
|
|
11,104
|
|
|
$
|
18,798
|
|
Selling and
marketing
|
14,700
|
|
|
3,791
|
|
|
32,553
|
|
|
6,222
|
|
General and
administrative
|
7,200
|
|
|
4,843
|
|
|
24,077
|
|
|
14,850
|
|
Total operating
expenses
|
26,434
|
|
|
14,297
|
|
|
68,051
|
|
|
39,870
|
|
Loss from
operations
|
(26,156)
|
|
|
(14,297)
|
|
|
(67,773)
|
|
|
(39,870)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
21
|
|
|
212
|
|
|
152
|
|
|
338
|
|
Other (expense)
income
|
(657)
|
|
|
287
|
|
|
(1,010)
|
|
|
266
|
|
Loss on issuance of
financial instruments
|
—
|
|
|
—
|
|
|
(64,049)
|
|
|
(674)
|
|
Change in fair value
of financial instruments
|
(3,105)
|
|
|
—
|
|
|
30,971
|
|
|
(27,372)
|
|
Total other (expense)
income, net
|
(3,741)
|
|
|
499
|
|
|
(33,936)
|
|
|
(27,442)
|
|
Loss before income
tax
|
(29,897)
|
|
|
(13,798)
|
|
|
(101,709)
|
|
|
(67,312)
|
|
Income tax
expense
|
(2)
|
|
|
—
|
|
|
(2)
|
|
|
(4)
|
|
Net loss
|
$
|
(29,899)
|
|
|
$
|
(13,798)
|
|
|
$
|
(101,711)
|
|
|
$
|
(67,316)
|
|
Net loss per share,
basic and diluted
|
$
|
(0.37)
|
|
|
$
|
(0.30)
|
|
|
$
|
(1.63)
|
|
|
$
|
(1.83)
|
|
Weighted-average
shares used to compute net loss per share, basic and
diluted
|
81,206,101
|
|
|
46,239,225
|
|
|
62,434,949
|
|
|
36,760,013
|
|
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SOURCE Evofem Biosciences, Inc.