SAN DIEGO and INCLINE VILLAGE, Nev., June 10, 2019 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM) (Evofem), a clinical-stage
biopharmaceutical company, and PDL BioPharma, Inc. (Nasdaq: PDLI)
(PDL) today announced the closing of the second tranche for
$50 million of an aggregate
$80 million strategic financing from
PDL and existing Evofem investors, Invesco Asset Management,
LTD. (Invesco) and Woodford Investment Management (WIM). The
initial $30 million investment from
PDL closed in April 2019.
"This investment from PDL and the support from two long-time
investors enables us to execute our commercialization strategy for
Amphora® and to prepare for its anticipated launch as the
first-in-class Multipurpose Vaginal pH Regulator for hormone-free
birth control in the second quarter of 2020, assuming FDA
approval," said Saundra Pelletier,
CEO of Evofem Biosciences. "Amphora could positively impact the
lives of the 16 million women of reproductive age in the U.S. who
do not want to conceive but are doing nothing to prevent pregnancy
and also be an enticing alternative for the additional 28 million
women who may have concerns about hormone exposure."
Dominique Monnet, President and
CEO of PDL, commented, "We at PDL are excited to support the
anticipated launch of Amphora and the growth of Evofem into a
leading women's health company. This important transaction
exemplifies our mission to create value for both patients and our
shareholders by enabling our partner companies to maximize the
potential of novel therapeutics that address underserved medical
needs." In conjunction with this transaction, Mr. Monnet has been
appointed to the Evofem Board of Directors.
The planned re-submission of the Amphora New Drug Application
for prevention of pregnancy is expected in the fourth quarter of
2019, with potential FDA approval in the second quarter of 2020.
Evofem also remains on track to report top-line data this fall from
an ongoing Phase 2b clinical trial of
Amphora for the prevention of chlamydia and gonorrhea in women.
This $50 million investment is the
second and final tranche associated with the securities purchase
agreement executed in April 2019 and
was made on the same terms as the initial $30 million investment. PDL, Invesco and WIM
invested approximately $30 million,
$10 million and $10 million, respectively, to acquire 6,666,667,
2,222,222 and 2,222,222 shares, respectively, at a price of
$4.50 per share, which represented a
26% premium to the per share market price at the time the
securities purchase agreement was signed. Associated with this
second tranche, the Company issued warrants to PDL, Invesco and WIM
to purchase up to 1,666,667, 555,556 and 555,556 shares of Evofem
common stock, respectively, which are exercisable for seven years
beginning six months after the issuance date at an exercise price
of $6.38. The warrant terms are
identical to those issued in connection with the previous
April 2019 financing.
Wells Fargo Securities acted as exclusive placement agent in
this transaction. Piper Jaffray
acted as advisor to Evofem's Board of Directors.
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 Amphora® (L-lactic acid, citric acid and potassium
bitartrate). 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 STIs but is integral to the
survival of healthy bacteria in the vagina. Evofem plans to
resubmit the Amphora New Drug Application (NDA) for hormone-free,
woman-controlled birth control in the fourth quarter of
2019. The MVP-R is also in development to prevent urogenital
acquisition of certain sexually transmitted infections. For
more information, please visit www.evofem.com.
NOTE: Amphora® is a registered trademark and MVP-R™ is a
trademark of Evofem Biosciences, Inc.
About PDL BioPharma
PDL's mission is to improve the
lives of patients and create value for our shareholders and our
people by applying our capital and expertise for the successful
development and commercialization of innovative therapeutics by our
partner companies. We deliver on our mission by entering into
strategic transactions involving innovative late clinical-stage or
early commercial-stage therapeutics with attractive revenue growth
potential.
NOTE: PDL, PDL BioPharma, the PDL logo and associated
logos and the PDL BioPharma logo are trademarks or
registered trademarks of, and are proprietary to, PDL
BioPharma, Inc. which reserves all rights therein.
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 timing of the planned Amphora
NDA resubmission for prevention of pregnancy, potential FDA
approval of Amphora, and the potential commercial launch of
Amphora, 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. 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' and PDL BioPharma's
respective assets and business are disclosed in the risk factors
contained in their respective Annual Reports 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 and PDL BioPharma do
not undertake any duty to update any forward-looking statement
except as required by law.
Contacts
For Evofem
Biosciences
|
|
Investor
Relations
|
Media
|
Amy
Raskopf
|
Greg
Jawski
|
Evofem Biosciences,
Inc.
|
Porter
Novelli
|
araskopf@evofem.com
|
Greg.jawski@porternovelli.com
|
M: (917)
673-5775
|
M: (917)
749-4964
|
|
|
For PDL
BioPharma
|
|
Peter Garcia,
CFO
|
Jody Cain,
SVP
|
775-832-8500
|
LHA Investor
Relations
|
Peter.garcia@pdl.com
|
310-691-7100
|
|
jcain@lhai.com
|
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SOURCE Evofem Biosciences, Inc.