SAN DIEGO, Aug. 5, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), a
clinical stage biopharmaceutical company, today reported financial
results for the three- and six- month period ended June 30, 2019. Second quarter and recent
highlights include:
- Raised $80 million through a
private placement of common stock from new and existing investors,
including a strategic investment from PDL BioPharma (NASDAQ:
PDLI);
- Additional data from Phase 3 'AMPOWER' study of
Amphora®, an investigational Multipurpose Vaginal pH
Regulator (MVP-R™), for prevention of pregnancy confirmed that an
increased number of women reported an improved sex life compared
with the contraceptive methods they used before entering the
AMPOWER study and confirmed certain previously reported safety and
efficacy data; and,
- The last subject is expected to complete her final visit this
month in the Phase 2b 'AMPREVENCE'
trial evaluating the ability of Amphora to prevent urogenital
acquisition of Chlamydia trachomatis (primary endpoint) and
Neisseria gonorrhea (secondary endpoint) in women, keeping
Evofem on track to report top-line data in November 2019.
"We are pleased to have closed the second quarter of 2019 with a
strengthened balance sheet supporting the planned resubmission of
the Amphora NDA for the prevention of pregnancy and our
preparations to commercialize this first-in-class hormone-free
birth control method in the U.S. in 2020, assuming FDA approval,"
said Saundra Pelletier, Chief
Executive Officer of Evofem.
Financial Results
For the quarter ended June 30, 2019, total operating expense decreased
49% to $11.9 million, compared to
$23.2 million for the quarter ended
June 30, 2018.
Research and development costs decreased 56% to $5.2 million in the second quarter of 2019 versus
$11.8 million in the prior year
quarter. The $6.6 million decrease
was primarily related to a $5.2
million decrease in AMPOWER trial costs compared to the
prior year period. A $2.0 million
decrease in noncash stock-based compensation also contributed.
These aggregate decreases were offset by a $0.9 million increase in costs incurred for
outside services associated with the planned Amphora NDA
resubmission for hormone-free prevention of pregnancy.
General and administrative costs decreased 41% to $6.7 million in the second quarter of 2019 versus
$11.4 million in the prior year
quarter. A $6.2 million decrease in
noncash stock-based compensation was mainly associated with
stock-based awards granted in March
2018, for which a significant amount of noncash stock-based
compensation expense was recognized during the second quarter of
2018. The decrease associated with noncash stock-based compensation
was partially offset by a $0.5
million increase in payroll related expenses due to
increased headcount, a $0.4 million
increase in public relations and pre-commercialization marketing
related expenses and a $0.3 million
increase in recruiting and consulting services.
Total other expense was $23.5
million in the second quarter of 2019, and included noncash
charges associated with our $80
million private placement that closed during the current
period. There was no total other expense in the comparative
quarter.
As a result, net loss attributable to common stockholders was
$35.5 million, or $(0.97) per share, for the quarter ended
June 30, 2019, compared with a net
loss of $23.2 million, or
$(1.11) per share, for the prior year
quarter.
For the six months ended June 30,
2019, total operating expense decreased 42% to $25.6 million, compared to total operating
expense of $44.2 million for the six
months ended June 30, 2018.
Research and development costs decreased 45% to $13.1 million versus $23.8
million in the prior year period, primarily related to
clinical trial activity. A $12.7
million decrease in AMPOWER trial costs was partially offset
by a $2.5 million increase in
AMPREVENCE trial costs in the first half of 2019. In addition,
there was a $1.9 million decrease in
noncash stock-based compensation during the current period mainly
associated with the aforementioned stock-based awards granted in
March 2018. These aggregate decreases were partially offset
by a $1.4 million increase in costs
incurred for outside services associated with the planned Amphora
NDA resubmission as previously mentioned.
General and administrative costs decreased 39% to $12.4 million versus $20.4
million in the prior year period. A $4.9 million decrease in noncash stock-based
compensation within the current period was mainly associated with
the aforementioned stock-based awards. Professional services and
personnel costs were $3.7 million
lower due to the absence of one-time costs associated with the
January 2018 merger, while public
relations and pre-commercialization marketing related expenses
increased by $0.6 million in the
current period.
Total other expense was $27.9
million in the first half of 2019 and included noncash
charges of $23.6 million associated
with the private placement that closed during the second quarter of
2019 and a noncash change in fair value of warrants of $4.4 million which resulted from modifications to
the warrants exercised and related reload warrants issued in
February 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
$53.5 million, or $(1.68) per share, for the six months ended
June 30, 2019, compared with a net
loss of $92.4 million, or
$(5.15) per share, for the prior year
period.
Liquidity and Subsequent Material Events
Unrestricted
cash was $50.7 million at
June 30, 2019, as compared to
$0.2 million at March 31, 2019.
During the second quarter of 2019, the Company raised
$80 million from the sale of an
aggregate of 17,777,779 shares of common stock to PDL BioPharma,
Woodford Investment Management and Invesco Asset Management, LTD at
$4.50 per share and warrants to
purchase up to 4,444,446 shares of Evofem common stock at an
exercise price of $6.38 per share.
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
|
August 6,
2019
|
Time
|
11:00 a.m.
EDT
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
1953988
|
Webcast (live and
archived)
|
www.evofem.com under
"Investors" or click here
|
If participating by phone, please dial in approximately 10
minutes prior to the start of the call.
A slide presentation related to the call will be available via
the aforementioned webcast link on the Evofem website
https://evofem.investorroom.com/investors-home. Please connect
to the website at least 15 minutes prior to the call to allow for
any software download that may be necessary.
A replay of the teleconference will be available approximately
two hours after completion through Sunday, August 11, 2019,
at (855) 859-2056 (U.S.) or (404) 537-3406
(International). The replay access code is 1953988. The
archived webcast will be available via the aforementioned URLs for
one year.
About AMPOWER
The Phase 3 'AMPOWER' clinical trial
assessed the effectiveness and safety of the investigational
product Amphora in preventing pregnancy over seven menstrual cycles
of use in approximately 1,330 women at 112 centers in the United States. Evofem's lead candidate
Amphora met the pre-specified primary endpoint of this trial, had a
favorable safety profile, and was well tolerated.
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. The Company is leveraging
its proprietary Multipurpose Vaginal pH Regulator (MVP-R™) platform
to develop its first product candidate, Amphora® (L-lactic acid,
citric acid and potassium bitartrate). Amphora is an
investigational MVP-R designed to regulate vaginal pH within the
normal range of 3.5 to 4.5. This maintains an acidic environment
which is inhospitable to sperm as well as certain viral and
bacterial pathogens associated with sexually transmitted infections
but is integral to the survival of healthy bacteria in the
vagina.
Evofem plans to resubmit the Amphora New Drug Application (NDA)
for prevention of pregnancy and vaginal lubrication in the fourth
quarter of 2019. If approved, the Company plans to launch Amphora
in 2020 as the first-in-class MVP-R for hormone-free,
woman-controlled birth control.
This investigational MVP-R is also in development for prevention
of certain sexually transmitted infections. Evofem expects to
report top-line data from AMPREVENCE, the ongoing Phase
2b trial of Amphora to prevent
urogenital acquisition of Chlamydia trachomatis (primary
endpoint) and Neisseria gonorrhea (secondary endpoint) in
women, in the fourth quarter of 2019.
For more information, please visit www.evofem.com.
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 closing of the
second tranche, 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.
Contact
Investor Relations
Amy Raskopf
Evofem Biosciences
araskopf@evofem.com
M: (917) 673-5775
Media
Greg Jawski
Porter Novelli
Greg.jawski@porternovelli.com
M: (917) 749-4964
(Tables follow)
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In
thousands)
|
|
June 30,
2019
|
|
December 31,
2018
|
Cash and cash
equivalents
|
$
|
50,679
|
|
|
$
|
1,330
|
|
Restricted
cash
|
401
|
|
|
431
|
|
Note
payable
|
—
|
|
|
4,010
|
|
Total current
liabilities
|
18,623
|
|
|
27,329
|
|
Total stockholders'
equity (deficit)
|
35,792
|
|
|
(23,356)
|
|
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,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
|
5,246
|
|
|
$
|
11,833
|
|
|
$
|
13,135
|
|
|
$
|
23,792
|
|
General and
administrative
|
6,695
|
|
|
11,409
|
|
|
12,438
|
|
|
20,436
|
|
Total operating
expenses
|
11,941
|
|
|
23,242
|
|
|
25,573
|
|
|
44,228
|
|
Loss from
operations
|
(11,941)
|
|
|
(23,242)
|
|
|
(25,573)
|
|
|
(44,228)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
108
|
|
|
32
|
|
|
126
|
|
|
62
|
|
Other expense,
net
|
(7)
|
|
|
(32)
|
|
|
(21)
|
|
|
(82)
|
|
Loss on issuance of
warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
(47,920)
|
|
Loss on issuance of
Purchase Rights
|
(674)
|
|
|
—
|
|
|
(674)
|
|
|
—
|
|
Change in fair value
of warrants
|
(3,315)
|
|
|
—
|
|
|
(7,755)
|
|
|
—
|
|
Change in fair value
of Purchase Rights
|
(19,617)
|
|
|
—
|
|
|
(19,617)
|
|
|
—
|
|
Change in fair value
of Series D 2X liquidation preference
|
—
|
|
|
—
|
|
|
—
|
|
|
(130)
|
|
Total other expense,
net
|
(23,505)
|
|
|
—
|
|
|
(27,941)
|
|
|
(48,070)
|
|
Loss before income
tax
|
(35,446)
|
|
|
(23,242)
|
|
|
(53,514)
|
|
|
(92,298)
|
|
Income tax
expense
|
(4)
|
|
|
(2)
|
|
|
(4)
|
|
|
(2)
|
|
Net loss
|
(35,450)
|
|
|
(23,244)
|
|
|
(53,518)
|
|
|
(92,300)
|
|
Accretion of Series D
redeemable convertible preferred stock dividends
|
—
|
|
|
—
|
|
|
—
|
|
|
(66)
|
|
Net loss attributable
to common stockholders
|
$
|
(35,450)
|
|
|
$
|
(23,244)
|
|
|
$
|
(53,518)
|
|
|
$
|
(92,366)
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
|
(0.97)
|
|
|
$
|
(1.11)
|
|
|
$
|
(1.68)
|
|
|
$
|
(5.15)
|
|
Weighted-average
shares used to compute net loss attributable to common
stockholders, basic and diluted
|
36,732,568
|
|
|
20,868,554
|
|
|
31,941,850
|
|
|
17,937,788
|
|
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SOURCE Evofem Biosciences, Inc.