SAN DIEGO, May 7, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), a
clinical stage biopharmaceutical company, today reported financial
results for the three- month period ended March 31, 2019. First quarter and recent
highlights include:
- Entered into a securities purchase agreement pursuant to which
Evofem may raise up to $80 million
through a private placement of common stock from new and existing
investors, including a strategic investment from PDL BioPharma
(NASDAQ: PDLI), and closed $30
million in the first tranche;
- Held positive and constructive Type B meeting with the U.S.
Food and Drug Administration (FDA) regarding the New Drug
Application (NDA) for Amphora®, the Company's lead
Multipurpose Vaginal pH Regulator™ (MVP-R) candidate, for the
prevention of pregnancy; and,
- Completed patient enrollment in AMPREVENCE, the Company's 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,
from which top-line data are expected in fall 2019.
"I am very pleased with our continued execution on all fronts
and especially our recently announced financing," said Saundra Pelletier, Chief Executive Officer of
Evofem. "This quarter, our dynamic leadership team successfully
navigated strategic investments, made significant progress toward
the resubmission of the Amphora NDA for the prevention of
pregnancy, and advanced a landmark clinical trial of Amphora for
prevention of certain sexually transmitted diseases. This momentum
will continue through 2019 as we prepare for the commercialization
of the first hormone-free MVP-R birth control method in the U.S. in
2020, assuming FDA approval."
First Quarter Financial Results
For the quarter ended March 31,
2019, total operating expense was $13.6 million, compared to total operating
expense of $21.0 million for the
quarter ended March 31, 2018.
Research and development costs were $7.9
million in the first quarter of 2019 versus $12.0 million in the prior year quarter.
This $4.1 million decrease was
primarily related to clinical trial activity, with a $7.5 million decrease in AMPOWER trial costs
offset by a $3.0 million increase in
AMPREVENCE trial costs in the first quarter of 2019.
General and administrative costs were $5.7 million in the first quarter of 2019 versus
$9.0 million in the prior year
quarter. The $3.3 million decrease
was mainly due to a $3.7 million
decrease in professional services and personnel costs attributable
to one-time costs associated with our merger completed in
January 2018. The decrease associated
with these one-time costs was partially offset by a $1.2 million increase in noncash stock-based
compensation recognized in the current period mainly associated
with stock-based awards granted during 2018 for which no
stock-based compensation was recognized prior to March 31, 2018.
Total other expense was $4.4
million in the first quarter of 2019 versus $48.1 million in the prior year quarter. Total
other expense in the current period included a noncash change in
fair value of warrants as a result of modifications to the warrants
exercised and related issuance of reload warrants in February 2019. Total other expense in the prior
year quarter 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
$18.1 million, or $(0.67) per share, for the quarter ended
March 31, 2019, compared with a net
loss of $69.1 million, or
$(4.62) per share, for the prior year
quarter.
Liquidity and Subsequent Material Events
Unrestricted cash was $0.2 million
at March 31, 2019, as compared to
$1.3 million at December 31, 2018.
In April 2019, the Company raised
$30 million from the sale of
6,666,667 shares of common stock to PDL BioPharma at $4.50 per share and warrants to purchase up to
1,666,667 shares of Evofem common stock at an exercise price
of $6.38 per share. This strategic investment is
expected to be the first of two tranches under a securities
purchase agreement. The second tranche, if closed, would
provide further financing, on or before June
10, 2019, of up to $50
million, comprised of PDL's right to invest up to another
$30 million and the right of Woodford
Investment Management and Invesco Asset Management, LTD, both
current investors in Evofem, to invest up to $20 million, in aggregate, at a purchase price of
$4.50 per share.
If the second tranche of financing is completed, additional
warrants to purchase up to 2,777,779 shares of common stock will be
issued at a strike price of $6.38 per
share, assuming the full additional $50
million is invested, and Dominique
Monnet, President and CEO of PDL BioPharma, is expected to
be appointed to the Evofem Board of Directors as PDL's
designee.
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
|
Tuesday May 7,
2019
|
Time
|
11:00 a.m.
EDT
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
9851099
|
Webcast (live and
archived)
|
www.evofem.com under
"Investors" or click here
|
The teleconference replay will be available approximately two
hours after completion through Sunday, May 12, 2019,
at (855) 859-2056 (U.S.) or (404) 537-3406
(International). The replay access code is 9851099. The
archived webcast will be available via the aforementioned URLs for
one year.
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 innovative solutions, such as woman-controlled
contraception and potential protection from certain sexually
transmitted infections ("STIs"). 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 birth control and prevention of
urogenital acquisition of certain STIs.
Amphora is 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. For
more information, please visit www.evofem.com.
Amphora® is a registered trademark and
Multipurpose Vaginal pH Regulator™ 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
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)
|
|
|
March 31,
2019
|
|
December 31,
2018
|
Cash and cash
equivalents
|
$
|
184
|
|
|
$
|
1,330
|
|
Restricted
cash
|
416
|
|
|
431
|
|
Note
payable
|
4,010
|
|
|
4,010
|
|
Total current
liabilities
|
32,085
|
|
|
27,329
|
|
Total stockholders'
deficit
|
(28,851)
|
|
|
(23,356)
|
|
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except
share and per share data)
|
|
|
Three Months Ended
March 31,
|
|
2019
|
|
2018
|
Operating
expenses:
|
|
|
|
Research and
development
|
$
|
7,889
|
|
|
$
|
11,959
|
|
General and
administrative
|
5,743
|
|
|
9,027
|
|
Total operating
expenses
|
13,632
|
|
|
20,986
|
|
Loss from
operations
|
(13,632)
|
|
|
(20,986)
|
|
Other income
(expense):
|
|
|
|
Interest
income
|
18
|
|
|
30
|
|
Other expense,
net
|
(14)
|
|
|
(50)
|
|
Loss on issuance of
warrants
|
—
|
|
|
(47,920)
|
|
Change in fair value
of warrants
|
(4,440)
|
|
|
—
|
|
Change in fair value
of Series D 2X liquidation preference
|
—
|
|
|
(130)
|
|
Total other expense,
net
|
(4,436)
|
|
|
(48,070)
|
|
Loss before income
tax
|
(18,068)
|
|
|
(69,056)
|
|
Income tax
expense
|
—
|
|
|
—
|
|
Net loss
|
(18,068)
|
|
|
(69,056)
|
|
Accretion of Series D
redeemable convertible preferred stock dividends
|
—
|
|
|
(66)
|
|
Net loss attributable
to common stockholders
|
$
|
(18,068)
|
|
|
$
|
(69,122)
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
|
(0.67)
|
|
|
$
|
(4.62)
|
|
Weighted-average
shares used to compute net loss attributable to common
stockholders, basic and diluted
|
26,883,734
|
|
|
14,974,458
|
|
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SOURCE Evofem Biosciences, Inc.