OPKO Announces First Quarter 2013 Operating and Financial Highlights
*Consolidated Revenue Nearly Triples to $31.4 million
*Net Cash Position at $181.6 million as of March 31, 2013
*Phase 3 Trial for CTAP 101 Capsules for Treatment of Secondary
Hyperparathyroidism (SHPT) Continuing on Schedule, Top Line Results
*Entered Into Definitive Agreement to Acquire PROLOR Biotech, Enhancing
OPKO’s Pipeline of Significant Products, Which Will Include Four Phase 3
*Top-Line Phase 3 Trial Results for Rolapitant Expected to be Announced by
TESARO in Second Half of 2013
*Acquired Interest in Growing Russian Pharmaceutical Company
*Entered Into Strategic Pooling of Assets with RXi Pharmaceuticals
*Preparing for 4Kscore™ Commercial Launch
MIAMI -- May 9, 2013
OPKO Health, Inc. (NYSE: OPK), a multi-national biopharmaceutical and
diagnostics company, today reported operating and financial highlights for the
first quarter of 2013.
“Consistent with our growth strategy, progress across most business fronts
accelerated during the first quarter of 2013,” said Phillip Frost, OPKO’s
Chairman and Chief Executive Officer. “We are pleased with the advances of our
operating businesses, as well as the progress made in the development of our
CTAP101 Capsules and 4Kscore™ prostate diagnostic test. Our solid financial
position, coupled with anticipated revenue growth, will facilitate progress of
our product pipeline, soon to include PROLOR’s once a week human
*Our CTAP101 Capsules, a vitamin D prohormone to treat SHPT in patients
withstage 3 or 4 chronic kidney disease (CKD) and vitamin D
insufficiency, is being evaluated in three ongoing Phase 3 trials, the
third of which was started during the first quarter of 2013. The trials
are on schedule and later this month subject enrollment is expected to
surpass 50% in the most advanced trial. A new patent covering CTAP101
Capsules was granted by the U.S. Patent and Trademark Office (the
“USPTO”), and a pending patent application was allowed.
*We entered into a definitive merger agreement to acquire PROLOR Biotech,
Inc. (NYSE MKT: PBTH), a biopharmaceutical company focused on developing
and commercializing longer-acting proprietary versions of already approved
therapeutic proteins and peptides. PROLOR's long-acting version of human
growth hormone, hGH-CTP, has successfully completed four clinical trials,
including a Phase 2 trial in adults with growth hormone deficiency (GHD).
PROLOR has reported that the trials showed that hGH-CTP has the potential
to reduce the required dosing frequency of human growth hormone from the
current standard of 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 is planned to begin in the second quarter of
2013. Recombinant human growth hormone (hGH) is used for the long-term
treatment of children and adults with GHD due to inadequate secretion of
endogenous growth hormone. hGH-CTP has been awarded orphan drug
designation in the U.S. and Europe for both adults and children with GHD.
PROLOR recently announced that it received a notice of allowance from the
USPTO for a patent application covering PROLOR’s long-acting CTP-enhanced
coagulation factors for the treatment of hemophilia: Factor VIIa-CTP,
Factor Vll-CTP and Factor IX-CTP. The allowed claims cover both product
composition and treatment methods. PROLOR also recently announced that it
received a notice of allowance from the USPTO for a new patent application
covering hGH-CTP.Upon issuance, the new patent will provide PROLOR with
additional intellectual property protection that covers methods for
decreasing body fat in humans through the use of hGH-CTP therapy.
*Enrollment continues by our licensee, TESARO, Inc. in each of three Phase
3 trials of rolapitant for the prevention of chemotherapy induced nausea
and vomiting. This global trial program is being conducted at more than
200 sites across 25 countries. Top line Phase 3 trial results are expected
to be announced by TESARO during the second half of 2013.
*We acquired an approximate ten percent stake in OAO Pharmsynthez (MICEX:
LIFE), a growing, fully-integrated Russian pharmaceutical company and the
only life science company listed on the Moscow Stock Exchange. OPKO will
partner with Pharmsynthez to develop and market several OPKO products for
sale in Russia and certain other Eastern European countries.
*We announced a strategic partnership in the field of RNA interference with
RXi Pharmaceuticals Corporation (“RXi”), received 50 million shares of RXi
common stock and will receive milestone payments from RXi up to an
aggregate of $50 million per product tied to the successful development
and commercialization of products utilizing the acquired OPKO intellectual
property. In addition, upon commercialization of these products RXi would
make royalty payments to OPKO.
*Development work toward the U.S. commercial launch of the OPKO 4Kscore™
prostate cancer test as a laboratory developed test through our
CLIA-certified laboratory based in Nashville, TN, remains on track for a
First Quarter 2013 Financial Highlights
*Cash and cash equivalents were $181.6 million as of March 31, 2013.
*Consolidated revenues nearly tripled to $31.4 million during the three
months ended March 31, 2013 from $8.8 million in the prior year period,
including $12.5 million of revenue related to the RXi transaction.
*Net loss for the three months ended March 31, 2013, exclusive of a $24.8
million non-cash charge related to the change in fair value of embedded
derivatives which are part of our January 2013 convertible senior notes
due in 2033, was $ 9.8 million, compared to a net loss of $9.2 million for
the comparable 2012 period. Net loss for the three months ended March 31,
2013, including the $24.8 million non-cash charge related to the change in
fair value of embedded derivatives which are part of our January 2013
convertible senior notes due in 2033, was $34.6 million.
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 other
commercial opportunities during the remainder of 2013, our product development
efforts, including whether the Phase 3 clinical trials for CTAP101 Capsules,
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, the timing of and anticipated closing of our acquisition of
PROLOR, the issuance of a new patent to PROLOR, and whether we will receive
milestone payments and royalties from TESARO and RXi, 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 CTAP101 Capsules, 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
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