August 09, 2013 2:54pm EDT
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Revenue More Than Doubles to $23.8 million for the Second Quarter
2013; Nearly Triples to $55.2 million for the First Half of 2013
Citicoline Products Approved in Spain
More than 50% enrollment in Phase 3 Trial for Rayaldy ™
Acquisition of PROLOR Biotech Expected to be Completed in Third
Quarter 2013
Top-Line Phase 3 Trial Results for Rolapitant Expected to be
Announced by TESARO in Second Half of 2013
Preparing U.S. Commercial Launch of 4Kscore ™
Cash and Marketable Securities at $169.1 million as of June 30, 2013
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE: OPK), a multi-national biopharmaceutical and
diagnostics company, today reported operating and financial highlights
for the second quarter of 2013.
Second Quarter 2013 Financial Highlights
Consolidated revenues more than doubled to $23.8 million during the
three months ended June 30, 2013, from $10.2 million in the prior year
period and nearly tripled to $55.2 million for the six months ended
June 30, 2013, from $19.0 million in the prior year period. Revenue
for the six months ended June 30, 2013, includes $12.5 million of
revenue resulting from a strategic partnership in the field of RNA
interference with RXi Pharmaceuticals Corporation.
Net loss for the three months ended June 30, 2013, was $ 3.4 million,
compared to a net loss of $10.8 million for the 2012 period. Net loss
for the three months ended June 30, 2013, includes the impact of:
$9.9 million non-cash benefit related to the change in fair value
of embedded derivatives which are part of our January 2013
convertible senior notes due in 2033 (the “2033 Senior Notes”).
This non-cash benefit resulted principally from the decrease in
the closing market price of our common stock as of June 30, 2013,
as compared to the previous quarter end; and
$8.5 million related to other income from the sale of available
for sale securities.
Net loss for the six months ended June 30, 2013, was $38.0 million,
compared to a net loss of $20.0 million for the 2012 period. Net loss
for the six months ended June 30, 2013, includes the impact of:
$14.9 million in net non-cash charges related to the change in
fair value of embedded derivatives which are part of our 2033
Senior Notes, principally as a result of the increase in the
closing market price of our common stock as of June 30, 2013, as
compared to the date of issuance of such notes; and
$10.8 million related to other income from the sale of available
for sale securities.
Cash, cash equivalents and marketable securities were $169.1 million
as of June 30, 2013.
Business Highlights
Our Spanish subsidiary, Pharmadiet, S.L.U., received regulatory
approval for commercialization of its oral and injectable formulations
of citicoline to treat memory disorders and behavior related to
stroke, head injury, chronic disease, as well as degenerative brain
disorders.
The two Phase 3 trials of Rayaldy ™ , our vitamin D
prohormone to treat patients with secondary hyperparathyroidism with
stage 3 or 4 chronic kidney disease and vitamin D insufficiency, are
progressing on schedule. We anticipate top-line data from this pivotal
program in mid-2014.
Our acquisition of PROLOR Biotech, Inc. (NYSE MKT: PBTH), a
biopharmaceutical company focused on developing longer-acting
proprietary forms of presently marketed therapeutic proteins and
peptides, is expected to close during the third quarter of 2013.
PROLOR has reported that its long-acting version of human growth
hormone, hGH-CTP, can reduce the dosing frequency from one injection
per day to a single weekly injection. A Phase 2 trial in children with
GHD is currently ongoing, and a Phase 3 trial in adults with GHD was
initiated in June 2013. PROLOR also recently announced results from
preclinical studies of its long-acting clotting factor VIIa (Factor
VIIa-CTP), a next-generation investigational therapy in advanced
preclinical development for the potential treatment of hemophilia. The
data indicate that Factor VIIa-CTP can be administered by subcutaneous
(SC) injection in contrast to presently used products which must be
given intravenously; this would facilitate its prophylactic at home
use.
Enrollment, now surpassing 90%, continues by our licensee, TESARO,
Inc. in each of three Phase 3 trials of Rolapitant for the prevention
of chemotherapy induced nausea and vomiting. TESARO anticipates that
top-line data from this pivotal program will be announced by year end.
TESARO also presented results from a pharmacokinetic study of
Rolapitant at the recent Multinational Association of Supportive Care
in Cancer/International Society of Oral Oncology (MASCC/ISOO)
International Symposium in Berlin. These data support concomitant
administration of Rolapitant with other pharmaceutical products that
are metabolized by the liver microsomal enzyme CYP3A4, without a
requirement for dose adjustment of the co-administered product.
The U.S. commercial launch of the OPKO 4Kscore™ prostate cancer test
as a laboratory developed test will be through our CLIA-certified
laboratory based in Nashville, TN.
“We continue to build and strengthen the foundation for a sound
profitable business,” said Phillip Frost, M.D., OPKO’s Chairman and
Chief Executive Officer. “We are pleased that Pharmadiet, our Spanish
subsidiary, has received regulatory approval for our oral and injectable
formulations of citicoline, and we are beginning the process for
marketing them in Spain as well as through our Latin American units.
These products will be sold by prescription to improve memory in certain
patients,” continued Dr. Frost. “We are also very proud of the pipeline
of new products in various stages of development in OPKO and soon to be
acquired PROLOR. They can provide the basis for an important health care
company.”
About OPKO Health, Inc.
We are a multi-national biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large and rapidly
growing medical markets by leveraging our discovery, development and
commercialization expertise and our novel and proprietary technologies.
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," and other words of similar
meaning, including statements regarding expected financial performance,
continued revenue growth and our ability to build a profitable business,
our product development efforts, including whether the Phase 3 clinical
trials for Rayaldy™, PROLOR's hGH-CTP product, rolapitant, or any of our
products in development will be completed on a timely basis or at all,
the expected timing for launch of our products in development, including
the 4kscore™, the expected timing of our clinical trials, enrollment in
clinical trials, and disclosure of results for the trials, our ability
to market and sell any of our products in development, including
Rayaldy™, citicoline, the 4KScore™, and PROLOR’s hGH-CTP product, the
timing of and anticipated closing of our acquisition of PROLOR, as well
as other non-historical statements about our expectations, beliefs or
intentions regarding our business, technologies and products, financial
condition, strategies or prospects. Many factors could cause our actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements. These factors include
those described in our filings with the Securities and Exchange
Commission, as well as the risks inherent in funding, developing and
obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments, that earlier clinical results of
effectiveness and safety may not be reproducible or indicative of future
results, that Rayaldy™, rolapitant, PROLOR's hGH-CTP product, and/or any
of our compounds or diagnostic products under development, including our
4KScore™ test, may fail, may not achieve the expected results or
effectiveness and may not generate data that would support the approval
or marketing of products for the indications being studied or for other
indications, that currently available over-the-counter and prescription
products, as well as products under development by others, may prove to
be as or more effective than our products for the indications being
studied, and that we may not be able to successfully complete the
acquisition of PROLOR. In addition, forward-looking statements may also
be adversely affected by general market factors, competitive product
development, product availability, federal and state regulations and
legislation, the regulatory process for new products and indications,
manufacturing issues that may arise, patent positions and litigation,
among other factors. The forward-looking statements contained in this
press release speak only as of the date the statements were made, and we
do not undertake any obligation to update forward-looking statements. We
intend that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.
OPKO Health, Inc.
Steven D. Rubin or Juan F. Rodriguez, 305-575-4100
Source: OPKO Health, Inc.
Released August 9, 2013
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