SAN DIEGO, Nov. 7, 2018 /PRNewswire/ -- Evofem Biosciences,
Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), today reported
financial results for the three- and nine- month periods ended
September 30, 2018. Recent highlights
include:
- Last patient visit is imminent in AMPOWER, the second Phase 3
trial of Amphora, its lead Multipurpose Vaginal pH Regulator
(MVP-R) product candidate, for non-hormonal birth control;
anticipating top-line results by year-end 2018;
- Completed 'User Experience Satisfaction Survey' among women who
completed AMPOWER along with their male partners; and,
- Advanced patient enrollment in Phase 2b clinical trial evaluating the ability of
Amphora to prevent urogenital acquisition of Chlamydia
trachomatis (primary endpoint) and Neisseria gonorrhea
(secondary endpoint) in women (AMPREVENCE).
"We have made significant progress this quarter in our clinical
programs evaluating Amphora for critical areas in women's health
where current options are either insufficient or absent entirely,"
said Saundra Pelletier, Chief
Executive Officer of Evofem. "The last patient visit in the AMPOWER
study of Amphora for the prevention of pregnancy is scheduled for
this week. This will allow us to proceed with data analyses and
keeps us on track to announce top-line results in December of this
year, which is a major milestone for Evofem."
"Assuming positive results, Evofem will re-submit the Amphora
New Drug Application in the second quarter of 2019. Pending
FDA approval, we expect to launch Amphora in January 2020 as the first and only non-hormonal,
on-demand, woman-controlled prescription birth control method in
the U.S."
If approved, Amphora will be the first innovation in birth
control brought to market since the vaginal ring and transdermal
patch in 2001.
The Company believes Amphora is the appropriate birth control
for many of the 16.5 million women in the U.S. who are not using
any form of birth control but do not wish to get pregnant - a
population which has indicated significant demand per the Company's
market research.1 Women who quit their reversible
contraception and do nothing for birth control but continue to be
sexually active have an 85 percent risk of becoming pregnant within
a year.2
Evofem is also conducting a Phase 2b study, AMPREVENCE, to evaluate Amphora for
prevention of certain sexually transmitted diseases.
AMPREVENCE is actively enrolling women at U.S. study centers.
Financial Results
For the three months ended
September 30, 2018, total operating expense was $18.4 million, compared to total operating
expense of $9.1 million for the three
months ended September 30, 2017.
Research and development costs were $9.9
million versus $6.3 million in
the prior year quarter. The increase was driven by a $2.7 million increase in clinical trial costs
primarily related to AMPREVENCE, which commenced enrollment in
December 2017; a $0.6 million increase in costs incurred for
outside services associated with clinical trial activities; and a
$0.3 million increase in noncash
stock-based compensation associated with stock-based awards granted
in the current period.
General and administrative costs were $8.6 million in the third quarter of 2018 versus
$2.8 million in the prior year
quarter. The increase was mainly due to a $5.0 million increase in personnel costs, which
included a $4.2 million increase in
noncash stock-based compensation associated with stock-based awards
granted in the current period.
Total other expense was not significant in the third quarter of
2018, compared to $65.0 million of
total other expense in the prior year quarter, which included
noncash losses on the issuance of Series D redeemable convertible
preferred stock (Series D) and for the change in fair value of the
Series D liquidation preference in 2017. As a result, net loss
attributable to common stockholders was $18.4 million, or $(0.71) per share, for the three months ended
September 30, 2018, compared with a net loss of $75.1 million, or $(38.31) per share, for the prior year
quarter.
For the nine months ended September 30, 2018, total
operating expense was $62.7 million,
compared to total operating expense of $20.3
million for the nine months ended September 30, 2017.
Research and development costs were $33.6
million versus $12.3 million
in the prior year period. The increase was driven primarily by a
$17.0 million increase in clinical
trial costs related to AMPOWER and AMPREVENCE and a $2.6 million increase in noncash stock-based
compensation associated with equity grants during 2018.
General and administrative costs were $29.0 million versus $8.0
million in the prior year period. The increase was
predominantly due to one-time, merger-related costs of $4.3 million incurred in the first quarter of
2018 and $12.4 million of noncash
stock-based compensation associated with equity grants during
2018.
Total other expense for the nine months ended September 30,
2018 was $48.1 million, compared to
$65.5 million in the prior year
period. The decrease was driven primarily by noncash activity in
both periods, including a loss on the issuance of warrants
associated with the reverse merger in 2018, compared to a loss on
the issuance of Series D stock and a loss recognized in association
with a change in fair value of the Series D stock liquidation
preference in 2017. Net loss attributable to common stockholders
was $110.8 million, or $(5.38) per share, for the nine months ended
September 30, 2018, compared with a net loss of $88.7 million, or $(45.23) per share, for the prior year
period.
Unrestricted cash was $12.1
million at September 30, 2018, as compared to
$22.8 million at June 30, 2018. With the treatment and
follow-up phase of the AMPOWER study now complete, the Company
expects its quarterly cash burn will decrease to approximately
$7 to 9 million during the fourth
quarter of 2018.
Subsequent Material Event
On November 6, 2018,
the compensation committee of Evofem's Board of Directors approved
the grant of 94,000 stock options, in aggregate,
to four new employees as an inducement material to the
employees' acceptance of employment with the Company, in accordance
with Nasdaq Listing Rule 5635(c)(4). These stock options were
granted pursuant to the Evofem Biosciences, Inc. 2018
Inducement Equity Incentive Plan. Evofem uses employee equity
awards, including the inducement awards described herein, to
attract new employees and to retain and motivate current
employees. The stock options have an exercise price of $3.88,
which was the closing price of Evofem's common stock on the date of
the grant. The options will vest over a four-year period, with
one-fourth vesting on the first anniversary of the employment start
date and the remaining three-fourths vesting over the next 36
months in equal monthly installments subject to the employee's
continued service with the Company.
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,
2018
|
Time
|
11:00 a.m.
EST
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
9158219
|
Webcast (live and
archived)
|
www.evofem.com under
"Investors" or click here
|
The teleconference replay will be available approximately two
hours after completion through Monday, November 12, 2018,
at (855) 859-2056 (U.S.) or (404) 537-3406
(International). The replay access code is 9158219. The
archived webcast will be available via the aforementioned URLs.
About Amphora
Amphora® (L-lactic acid,
citric acid and potassium bitartrate) is an investigational
Multi-Purpose Vaginal pH Regulator (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 expects top-line data in December
2018 from AMPOWER, its Phase 3 clinical
trial evaluating Amphora for the prevention of pregnancy. This
single-arm, open-label trial enrolled approximately 1,400 women
aged 18-35 who are at risk of pregnancy at 112 centers in the
United States. The primary
endpoint of the study is the contraceptive efficacy of Amphora over
seven cycles of use.
The Company is actively enrolling AMPREVENCE, a double-blinded
placebo-controlled Phase 2b clinical trial of Amphora to
prevent urogenital acquisition of Chlamydia
trachomatis (primary endpoint) and Neisseria
gonorrhea (secondary endpoint) in women. This study
is designed to enroll 844 women at approximately 50 centers
in the United States for a four-month interventional
period and subsequent one-month follow-up period.
Chlamydia is the most frequently reported bacterial sexually
transmitted infection in the U.S. The CDC recently reported that
domestic rates of gonorrhea and chlamydia have climbed for the
fourth consecutive year. Nearly 2.3 million U.S. cases of
these STDs were diagnosed in 2017, according to preliminary data,
an increase of over 200,000 cases as compared with
20163. There are currently no FDA-approved products for
the prevention of chlamydia or gonorrhea.
About Evofem Biosciences
Evofem Biosciences, Inc.,
(NASDAQ: EVFM) 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 is leveraging its proprietary Multipurpose Vaginal pH
Regulator (MVP-R) to develop product candidates for multiple
indications, including the prevention of pregnancy, the prevention
of urogenital transmission of chlamydia and gonorrhea in women and
the prevention of recurrent bacterial vaginosis. For more
information regarding Evofem, please visit www.evofem.com.
Amphora® is a registered trademark of Evofem
Biosciences, Inc.
1 NHS Data Brief #173, December 2014, "Current
Contraceptive Status Among Women Aged 15-44 (Based on National
Survey of Family Growth data)
2 Trussell J. Contraceptive Efficacy. In Hatcher RA,
Trussell J, Nelson AL, Cates W, Kowal D, Policar M. Contraceptive
Technology: Twentieth Revised Edition. New York NY: Ardent Media, 2011.
3 Centers for Disease Control and Prevention (2018): STD
Preliminary Data Accessed August 2018.
Forward-Looking Statements
Statements in this press
release about Evofem's future expectations, plans and prospects, as
well as any other statements regarding matters that are not
historical facts, may constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. These statements, include, but are not limited to
statements regarding objectives, plans and strategies that address
activities, events or developments that the Company intends,
expects, projects, believes or anticipates will or may occur in the
future; statements about the anticipated results of the Phase 3
clinical trial evaluating Amphora for birth control and the Phase
2b clinical trial of Amphora to
prevent urogenital acquisition of Chlamydia trachomatis and
Neisseria gonorrhea in women, and any expected completion dates or
general timing for these clinical trials. These statements are
often characterized by terminology such as "believes," "hopes,"
"may," "anticipates," "should," "intends," "plans," "will,"
"could," "would," "expects," "estimates," "projects," "positioned,"
"strategy" and similar expressions and are based on assumptions and
assessments made in light of management's experience and perception
of historical trends, current conditions, expected future
developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties, many of which are
outside of the Company's control. Important factors that could
cause actual results, developments, and business decisions to
differ materially from forward-looking statements are described in
the sections titled "Risk Factors" in the Company's filings with
the Securities and Exchange Commission (SEC), including its
Quarterly Report for the period ended March
31, 2018, as filed with the SEC on Form 10-Q on May 14, 2018, and include but are not limited to
the following: the Company's ability to raise the additional
funds necessary to commercialize Amphora as a contraceptive and/or
to complete the development of Amphora to prevent urogenital
acquisition of Chlamydia trachomatis and Neisseria gonorrhea in
women; the Company's reliance on third parties to conduct its
clinical trials, research and development and manufacturing; the
availability of reimbursement from government authorities and
health insurance companies for the Company's products; the impact
of potential product liability lawsuits; the influence of extensive
and costly government regulation; the volatility of the trading
price of the Company's common stock, and the concentration of power
in its stock ownership. Forward-looking statements in this press
release are made as of the date of this press release, and the
Company undertakes no duty to update or revise any such statements,
whether as a result of new information, future events or otherwise.
These forward-looking statements should not be relied upon as
representing Evofem's views as of any date subsequent to the date
hereof. We have included certain information from government
publications and general publications and research, surveys and
studies conducted by third parties. This information has been
obtained from sources believed to be reliable, although they do not
guaranty the accuracy or completeness of such information. We
have not independently verified market and industry data from any
third-party sources.
Contact
Investor Relations
Amy Raskopf
Evofem Biosciences
araskopf@evofem.com
O: (858) 550-1900 x167
M: (917) 673-5775
Media
Charlotte Wray
RXMD
cwray@rxmedyn.com
O: (646) 599-8601
M: (646) 247-3405
(Tables follow)
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In
thousands)
|
|
|
|
|
|
September 30,
2018
|
|
December 31,
2017
|
Cash and cash
equivalents
|
$
|
12,076
|
|
|
$
|
1,211
|
|
Restricted
cash
|
446
|
|
|
490
|
|
Series D 2X
liquidation preference
|
—
|
|
|
79,870
|
|
Total current
liabilities
|
25,042
|
|
|
103,347
|
|
Total stockholders'
deficit
|
(10,065)
|
|
|
(289,546)
|
|
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,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
|
9,851
|
|
|
$
|
6,263
|
|
|
$
|
33,643
|
|
|
$
|
12,323
|
|
General and
administrative
|
8,582
|
|
|
2,807
|
|
|
29,018
|
|
|
8,018
|
|
Total operating
expenses
|
18,433
|
|
|
9,070
|
|
|
62,661
|
|
|
20,341
|
|
Loss from
operations
|
(18,433)
|
|
|
(9,070)
|
|
|
(62,661)
|
|
|
(20,341)
|
|
Other income
(expense):
|
|
|
|
|
—
|
|
|
—
|
|
Interest
income
|
35
|
|
|
32
|
|
|
97
|
|
|
95
|
|
Other expense,
net
|
(33)
|
|
|
(42)
|
|
|
(115)
|
|
|
(12)
|
|
Loss on issuance of
Series D redeemable convertible preferred stock
|
—
|
|
|
(5,740)
|
|
|
—
|
|
|
(5,740)
|
|
Loss on issuance of
warrants
|
—
|
|
|
—
|
|
|
(47,920)
|
|
|
—
|
|
Change in fair value
of Series D 2X liquidation preference
|
—
|
|
|
(59,211)
|
|
|
(130)
|
|
|
(59,811)
|
|
Total other income
(expense), net
|
2
|
|
|
(64,961)
|
|
|
(48,068)
|
|
|
(65,468)
|
|
Loss before income
tax
|
(18,431)
|
|
|
(74,031)
|
|
|
(110,729)
|
|
|
(85,809)
|
|
Income tax
expense
|
—
|
|
|
—
|
|
|
(2)
|
|
|
(3)
|
|
Net loss
|
(18,431)
|
|
|
(74,031)
|
|
|
(110,731)
|
|
|
(85,812)
|
|
Accretion of Series D
redeemable convertible preferred stock dividends
|
—
|
|
|
(1,054)
|
|
|
(66)
|
|
|
(2,839)
|
|
Net loss attributable
to common stockholders
|
$
|
(18,431)
|
|
|
$
|
(75,085)
|
|
|
$
|
(110,797)
|
|
|
$
|
(88,651)
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
|
(0.71)
|
|
|
$
|
(38.31)
|
|
|
$
|
(5.38)
|
|
|
$
|
(45.23)
|
|
Weighted-average
shares used to compute net loss attributable to common
stockholders, basic and diluted
|
25,778,316
|
|
|
1,959,904
|
|
|
20,580,017
|
|
|
1,959,904
|
|
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SOURCE Evofem Biosciences, Inc.