SAN DIEGO, Nov. 6, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM) a clinical-stage biopharmaceutical
company, today reported financial results for the three- and
nine-month periods ended September 30,
2019. Third quarter and recent highlights:
- Presented final results from the Phase 3 AMPOWER study
evaluating the safety and efficacy of Amphora®, an
investigational Multipurpose Vaginal pH Regulator (MVP-R™), at the
2019 American Society for Reproductive Medicine (ASRM) Scientific
Congress. The study met its primary endpoint and demonstrated the
safety and efficacy of Amphora in preventing pregnancy.
- Presented new patient satisfaction data from the AMPOWER study
during a poster session at ASRM. More than 85% of women in the
AMPOWER trial reported being satisfied or very satisfied with
Amphora, which is nearly double the percentage reporting
satisfaction with their baseline contraceptive method.
- Completed the treatment phase of the Phase 2b AMPREVENCE trial evaluating Amphora for the
prevention of urogenital acquisition of Chlamydia
trachomatis and Neisseria gonorrhea (primary and
secondary endpoints, respectively) in women. Top-line data will be
reported in November 2019.
"This is an exciting time at Evofem as we prepare for our
evolution from a clinical-stage company into a commercial
organization," said Saundra
Pelletier, Evofem's Chief Executive Officer. "We remain
focused on two critical fourth quarter milestones – the
resubmission of the Amphora NDA for the prevention of pregnancy and
top-line results from the AMPREVENCE trial evaluating Amphora for
the prevention of chlamydia and gonorrhea. Simultaneously, the team
is moving forward with pre-commercial activities to ensure we are
prepared for the potential FDA approval and launch of Amphora as
the first hormone-free, on-demand, female-controlled contraceptive
drug product in the U.S., where millions of women eagerly await a
new option."
Financial Results
For the quarter ended September 30, 2019, total operating expenses
decreased 22% to $14.3 million,
compared to $18.4 million for the
quarter ended September 30, 2018.
Research and development costs decreased by $4.2 million, or 43%, to $5.7 million in the third quarter of 2019 versus
$9.9 million in the prior year
quarter, primarily driven by lower clinical trial expenses.
General and administrative costs were $8.6 million in both the third quarter of 2019
and 2018. There was a $1.1 million
increase in pre-commercialization sales and marketing related
expenses, a $0.7 million increase in
payroll related expenses due to increased headcount, and a
$0.5 million increase in recruiting
and consulting services as compared to the prior year period. These
aggregated increases were partially offset by a $2.4 million decrease in noncash stock-based
compensation mainly associated with restricted stock awards granted
in July 2018, the majority of which
vested at grant, and stock-based awards granted in March 2018, the majority of which vested during
the first year after grant.
Total other income was $0.5
million in the third quarter of 2019, and included a
one-time noncash item, as well as higher interest income compared
to the prior year period. Total other income in the comparative
quarter was immaterial.
As a result, net loss attributable to common stockholders was
$13.8 million, or $(0.30) per share, for the quarter ended
September 30, 2019, compared with a
net loss of $18.4 million, or
$(0.71) per share, for the prior year
quarter.
For the nine months ended September 30,
2019, total operating expenses decreased 36% to $39.9 million, compared to total operating
expenses of $62.7 million for the
nine months ended September 30,
2018.
Research and development costs decreased 44% to $18.8 million versus $33.6
million in the prior year period, largely attributable to a
$17.3 million decrease in clinical
trial costs during the nine months ended September 30, 2019, primarily related to
completion of the clinical phase of AMPOWER in December 2018.
General and administrative costs decreased 27% to $21.1 million versus $29.0
million in the prior year period. A $7.3 million decrease in noncash stock-based
compensation in the current period was mainly associated with the
aforementioned stock-based awards granted in March and July 2018, while professional services and
personnel costs were $3.7 million
lower due to the absence of one-time costs associated with the
Company's January 2018 merger.
These were offset by increased pre-commercialization sales and
marketing related expenses of $1.6
million during the current period, while payroll related
expenses and consulting services increased by $1.3 million and $0.4
million in the current period, respectively.
Total other expense was $27.4
million in the nine months ended September 30, 2019 and was primarily attributable
to noncash charges related to the closing of our private placement
during the second quarter of 2019, and to recognize various changes
in the fair value of warrants of $4.4
million in the first quarter of 2019. Total other expense in
the prior year quarter was $48.1
million and included noncash losses on the issuance of
warrants and for the change in fair value of the Series D 2X
liquidation preference.
As a result, net loss attributable to common stockholders was
$67.3 million, or $(1.83) per share, for the nine months ended
September 30, 2019, compared with a
net loss of $110.8 million, or
$(5.38) per share, for the prior year
period.
Liquidity and Subsequent Material Events
Unrestricted
cash was $32.1 million at
September 30, 2019, as compared to
$50.7 million at June 30, 2019. Short-term investments
were $3.7 million at September 30, 2019; there were no short-term
investments at June 30, 2019.
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 7,
2019
|
Time
|
11:00 a.m.
EST
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
3857878
|
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 Tuesday, November 12, 2019
at (855) 859-2056 (U.S.) or (404) 537-3406
(International), access code 3857878. The webcast will be archived
at https://evofem.investorroom.com/events.
About Evofem Biosciences
Evofem Biosciences, Inc. is a
clinical-stage biopharmaceutical company committed to developing
and commercializing innovative products to address unmet needs in
women's sexual and reproductive health. Evofem Biosciences aims to
advance the lives of women by developing novel solutions, such as
woman-controlled contraception and potential protection from
certain sexually transmitted infections. The Company is
leveraging its proprietary Multipurpose Vaginal pH Regulator
(MVP-R™) platform to develop Amphora® (L-lactic acid,
citric acid and potassium bitartrate) for hormone-free birth
control and prevention of chlamydia. For more information, please
visit www.evofem.com.
Amphora® is a registered trademark and Multipurpose
Vaginal pH Regulator (MVP-R™) is a trademark of Evofem Biosciences,
Inc.
Forward-Looking Statements
This press release contains
"forward-looking statements" within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including statements related to the quarterly use of cash, the
anticipated results of the Phase 2b clinical trial of
Amphora to prevent urogenital acquisition of Chlamydia
trachomatis and Neisseria gonorrhea in
women, and any expected completion date or general timing for this
clinical trial, the potential FDA approval of Amphora, and the
potential commercial launch of Amphora. Each of these
forward-looking statements involves risks and uncertainties. Actual
results may differ materially from those, express or implied, in
these forward-looking statements. Important factors that could
impair the value of Evofem Biosciences' assets and business are
disclosed in the risk factors contained in its Annual Report on
Form 10-K filed with the Securities and Exchange
Commission and subsequent filings. All forward-looking
statements are expressly qualified in their entirety by such
factors. Evofem Biosciences does not undertake any duty to update
any forward-looking statement except as required by law.
Investor Contact
Amy
Raskopf
Evofem Biosciences
araskopf@evofem.com
M: (917) 673-5775
Media Contact
Cara
Miller
Evofem Biosciences, Inc.
cmiller@evofem.com
O: (858) 550-1900 x272
(Tables follow)
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In
thousands)
|
|
|
|
|
|
September 30,
2019
|
|
December 31,
2018
|
Cash and cash
equivalents
|
$
|
32,120
|
|
|
$
|
1,330
|
|
Restricted
cash
|
386
|
|
|
431
|
|
Short-term
investments
|
3,715
|
|
|
—
|
|
Note
payable
|
—
|
|
|
4,010
|
|
Total current
liabilities
|
14,914
|
|
|
27,329
|
|
Total stockholders'
equity (deficit)
|
24,075
|
|
|
(23,356)
|
|
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,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
|
5,663
|
|
|
$
|
9,851
|
|
|
$
|
18,798
|
|
|
$
|
33,643
|
|
General and
administrative
|
8,634
|
|
|
8,582
|
|
|
21,072
|
|
|
29,018
|
|
Total operating
expenses
|
14,297
|
|
|
18,433
|
|
|
39,870
|
|
|
62,661
|
|
Loss from
operations
|
(14,297)
|
|
|
(18,433)
|
|
|
(39,870)
|
|
|
(62,661)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
212
|
|
|
35
|
|
|
338
|
|
|
97
|
|
Other income
(expense), net
|
287
|
|
|
(33)
|
|
|
266
|
|
|
(115)
|
|
Loss on issuance of
warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
(47,920)
|
|
Loss on issuance of
Purchase Rights
|
—
|
|
|
—
|
|
|
(674)
|
|
|
—
|
|
Change in fair value
of warrants
|
—
|
|
|
—
|
|
|
(7,755)
|
|
|
—
|
|
Change in fair value
of Purchase Rights
|
—
|
|
|
—
|
|
|
(19,617)
|
|
|
—
|
|
Change in fair value
of Series D 2X liquidation preference
|
—
|
|
|
—
|
|
|
—
|
|
|
(130)
|
|
Total other income
(expense), net
|
499
|
|
|
2
|
|
|
(27,442)
|
|
|
(48,068)
|
|
Loss before income
tax
|
(13,798)
|
|
|
(18,431)
|
|
|
(67,312)
|
|
|
(110,729)
|
|
Income tax
expense
|
—
|
|
|
—
|
|
|
(4)
|
|
|
(2)
|
|
Net loss
|
(13,798)
|
|
|
(18,431)
|
|
|
(67,316)
|
|
|
(110,731)
|
|
Accretion of Series D
redeemable convertible preferred stock dividends
|
—
|
|
|
—
|
|
|
—
|
|
|
(66)
|
|
Net loss attributable
to common stockholders
|
$
|
(13,798)
|
|
|
$
|
(18,431)
|
|
|
$
|
(67,316)
|
|
|
$
|
(110,797)
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
|
(0.30)
|
|
|
$
|
(0.71)
|
|
|
$
|
(1.83)
|
|
|
$
|
(5.38)
|
|
Weighted-average
shares used to compute net loss attributable to common
stockholders, basic and diluted
|
46,239,225
|
|
|
25,778,316
|
|
|
36,760,013
|
|
|
20,580,017
|
|
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SOURCE Evofem Biosciences, Inc.