May 09, 2013 1:10pm EDT
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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
Expected mid-2014
Entered Into Definitive Agreement to Acquire PROLOR Biotech,
Enhancing OPKO’s Pipeline of Significant Products, Which Will Include
Four Phase 3 Products
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--(BUSINESS WIRE)--
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 growth-hormone.”
Business Highlights
Our CTAP101 Capsules, a vitamin D prohormone to treat SHPT in patients
with stage 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
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 2013 launch.
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
Source: OPKO Health, Inc.
Released May 9, 2013
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