November 11, 2013 12:37pm EST
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Revenue Nearly Doubled to $20.6 million for the Third Quarter 2013;
Increased More Than Twofold to $75.8 million for the First Nine Months
of 2013
Initiation of Pivotal Clinical Validation Study for 4Kscore ™
Enrollment in Our Pivotal Rayaldy ™ Clinical Trials Surpassed
75% Completion; Top-Line Data Expected in Mid-2014
Continuing Progress Toward Completion by TESARO of Rolapitant Phase
3 Clinical Trials; Two of TESARO’s Phase 3 trials of Rolapitant Are
Now Fully Enrolled, Top-line Data Expected at Year End. TESARO Also
Initiated an Open-Label, Dose-Finding and Escalation Study to Evaluate
Intravenous (IV) Formulation of Rolapitant
Final Marketing Authorization for Citicoline Products in Spain
Completed Acquisition of PROLOR Biotech
Strategic Investment in Biotechnology Company Engaged in the
Development of a New Generation of Antibodies
Strategic Investment in Clinical Stage Biopharmaceutical Company
Focused in the Development of Oncology Therapeutics
New Listing on Tel Aviv Stock Exchange
Neovasc, an OPKO Investment Portfolio Company, Reported That the Neovasc
Reducer ™ Achieved Primary Endpoint in COSIRA Trial, Significantly
Improving Function in Patients with Refractory Angina
Cash and Marketable Securities at $180.8 million as of September
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 third quarter of 2013.
Third Quarter 2013 Financial Highlights
Cash, cash equivalents and marketable securities were $180.8 million
as of September 30, 2013.
Consolidated revenues nearly doubled to $20.6 million during the three
months ended September 30, 2013 from $11.8 million in the prior year
period. Consolidated revenue more than doubled to $75.8 million during
the nine months ended September 30, 2013 from $30.8 million in the
prior year period. Revenue for the nine months ended September 30,
2013 included $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 September 30, 2013 was $60.0
million, compared to a net loss of $10.2 million for the 2012 period.
The increase in net loss for the three months ended September 30, 2013
was primarily related to increased operating and clinical trial
$27.8 million in non-cash charges related to the change in value
of embedded derivatives which are part of our January 2013
convertible senior notes due in 2033 (the “2033 Senior Notes”).
This non-cash charge is principally a result of the increased
market price of our common stock since the previous quarter end;
and
$8.7 million in non-cash charges related to early conversion of
2033 Senior Notes.
Net loss for the nine months ended September 30, 2013 was $98.0
million, compared to a net loss of $30.2 million for the 2012 period.
The increase in net loss for the nine months ended September 30, 2013,
was primarily related to increased operating and clinical trial costs,
$38.7 million in non-cash charges principally related to the
change in value of embedded derivatives which are part of our 2033
Senior Notes, principally as a result of the increase in the
market price of our common stock since issuance of such notes; and
Net loss for the nine months ended September 30, 2013 also includes
$11.0 million of other income from the sale of securities, partially
offset by $10.1 million of interest expense principally related to our
2033 Senior Notes.
Business Highlights
On November 4, 2013, we announced the initiation of a multi-center
study expected to generate data to support the launch of the 4Kscore ™
test as a laboratory developed test through our Clinical Laboratory
Improvement Amendments of 1988 (CLIA)-certified laboratory in
Nashville, TN. We are enrolling men at the first of 19 sites across
the United States (U.S.) and are planning to enroll more than 1,200
men referred for a prostate biopsy over the next few months. This
clinical study is expected to be the last step before our planned
commercial launch of the 4Kscore ™ in the first quarter of 2014.
The data we generate in this clinical study will not only be used for
the required CLIA validation, but will also be used to secure 4Kscore ™
test reimbursement.
Our two ongoing Phase 3 trials for Rayaldy ™, our vitamin D
prohormone to treat patients with secondary hyperparathyroidism
(SHPT), stage 3 or 4 chronic kidney disease (CKD) and vitamin D
insufficiency, continues to progress well with aggregate enrollment
surpassing 75%. We anticipate top-line data from this pivotal program
in mid-2014.
Each of three Phase 3 trials of rolapitant being conducted by our
licensee, TESARO, Inc., for the prevention of chemotherapy-induced
nausea and vomiting, continues to progress well towards completion.
Two of TESARO’s phase 3 trials of oral rolapitant are fully enrolled,
with results from the third study becoming available in early 2014.
TESARO anticipates announcing top-line data from the two fully
enrolled studies at year end. Following completion of Phase 3 trials,
TESARO plans to submit a New Drug Application to the U.S. Food and
Drug Administration for oral rolapitant in mid-2014. Earlier this
year, TESARO also presented results from a pharmacokinetic study of
rolapitant at the 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.
Recently, TESARO also announced the initiation of an open-label,
dose-finding and escalation study to evaluate the pharmacokinetics,
safety and tolerability of an IV formulation of rolapitant in healthy
volunteers. The clinical trial of intravenous (IV) rolapitant is well
underway, and TESARO anticipates identifying a dose of IV rolapitant
that provides blood levels similar to those of the oral formulation by
year end.
Our Spanish subsidiary, Pharmadiet, S.L.U., received final marketing
authorization for commercialization of its oral and injectable
formulations of citicoline which are indicated for the treatment of
memory disorders and behavior related to stroke, head injury, chronic
disease, as well as degenerative brain disorders. We expect to begin
commercialization in Spain of these products, which can be significant
contributors to Pharmadiet's sales and earnings, beginning with the
first quarter of 2014.
We completed the acquisition of PROLOR Biotech, Inc., a
biopharmaceutical company focused on developing proprietary
long-acting forms of presently marketed therapeutic proteins and
peptides. In June 2013, PROLOR initiated a pivotal Phase 3 clinical
trial in adults of its proprietary long-acting version of human growth
hormone, hGH-CTP. The initiation of this Phase 3 clinical trial
followed a series of successful Phase 2 trials showing that hGH-CTP
can safely reduce the dosing frequency of human growth hormone from
the current standard of one injection per day to just one per week. A
Phase 2 trial in children with growth hormone deficiency (GHD) is
currently ongoing. hGH-CTP has been awarded orphan drug designation in
the U.S. and Europe for both adults and children with GHD. PROLOR
scientists presented new data at the 95 th Annual Meeting of
the Endocrine Society in June 2013 regarding MOD-630, our long-acting
oxyntomodulin (GLP-1 and Glucagon dual agonist) with potential for
treating obese and overweight individuals as well as type 2 diabetes.
This pre-clinical study concluded that MOD-630 induced marked weight
loss while improving glycemic control and lipid profile in mice with
diet-induced obesity after once-weekly administration. PROLOR
scientists also presented new data at the XXIV Congress of the
International Society of Hemostasis and Thrombosis from preclinical
studies of its long-acting clotting factor VIIa (Factor VIIa-CTP), a
next generation treatment for hemophilia. These data provided further
evidence that Factor VIIa-CTP can be administered by subcutaneous or
IV injection, which will facilitate regular prophylactic use.
Currently available commercial factor VIIa, which must be administered
through IV infusions, limits its prophylactic treatment and can
require frequent administrations if patients are treated only “on
demand” when a bleed occurs.
In October 2013, we made a strategic investment in Zebra Biologics,
Inc. ("Zebra"), a privately held biotechnology company focused on the
discovery and development of biosuperior antibody therapeutics and
complex drug targets. Zebra's patented platform is an advanced version
of a core technology developed by Richard Lerner, M.D. (also an OPKO
director) at The Scripps Research Institute, underlying the commercial
success of AbbVie Inc.'s Humira ™. This new technology allows
for the selection of antibodies for function rather than simple
binding affinity. Zebra has already developed an early pre-clinical
pipeline of candidate antibodies with significant commercial potential
in regulating diabetes and obesity, cancer and treatment of
neurological disease.
In October 2013, we made a strategic investment in Arno Therapeutics,
Inc, (OTCBQ: ARNI) (“Arno”), a clinical stage biopharmaceutical
company focused on the development of oncology drugs. We were
attracted to Arno based on the potential of its lead product and
cancer therapeutic, onapristone, in addressing the need for new and
effective treatment for breast and prostate cancer. In connection with
this investment, we were granted exclusive first rights to negotiate
with Arno regarding any potential strategic transactions that Arno
elects to pursue.
OPKO’s common stock began trading on the Tel Aviv Stock Exchange
("TASE") in August and is included in the following major TASE
indices: Tel Aviv 25, Tel Aviv 100, Tel Aviv Composite, Tel Aviv
Biomed, and Tel Aviv BlueTech-50.
Recently, Neovasc Inc. (NVC.V) (“Neovasc”), a specialty medical device
company in which we have a strategic ownership interest and that
develops, manufactures and markets products for the rapidly growing
global cardiovascular marketplace, reported topline results for its
COSIRA trial assessing the efficacy and safety of the Neovasc Reducer ™,
a novel stent delivered percutaneously to the cardiac sinus for the
treatment of refractory angina. The data show that the Neovasc Reducer ™
achieved its primary endpoint, significantly improving the symptoms
and functioning of patients disabled by previously untreatable
refractory angina. The COSIRA trial also confirmed that the Neovasc
Reducer ™ is safe and well-tolerated, with no reports of
device-related serious adverse events.
“We again made great progress during the past quarter across many
important business fronts,” said Phillip Frost, M.D., OPKO’s Chairman
and Chief Executive Officer. “Our 4Kscore ™ has the potential to
become a transformational medical tool in the diagnosis and treatment of
prostate cancer. We initiated an important pivotal clinical trial to
support our planned commercial 4Kscore ™ launch during the first
quarter of 2014. Progress in our two Rayaldy ™ clinical trials,
now more than 75% enrolled, coupled with the continued development of
the clinical-stage products from PROLOR and our recent strategic
investments in Zebra and Arno, continue to solidify our broad
development pipeline across a growing operating platform,” continued Dr.
Frost. “Our strategy to make small investments in other health care
companies is bearing fruit. We have monetized one of the investments at
a significant profit and the value of the remaining portfolio is far in
excess of our investment. These results, bolstered by broader
shareholder exposure attained through our recent TASE listing, fortify
the foundation 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™, hGH-CTP, rolapitant, and our clinical validation
study for the 4Kscore™ will be completed on a timely basis or at all and
whether the data will support approval, validation and/or reimbursement
for our products, our ability to enroll in our 4Kscore™ study
more than 1,200 patients referred for a prostate biopsy over the course
of the next few months, the expected timing for launch of our products
in development, including the 4Kscore™, Rayaldy™, hGH-CTP, and
citicoline, 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™, the 4Kscore™, hGH-CTP, and citicoline, whether the citicoline
products will be significant contributors to Pharmadiet's sales and
earnings, the timing for submission of a NDA by TESARO for rolapitant
and whether TESARO will identify a dose of IV rolapitant that provides
comparable exposure to the oral formulation by year end, whether the
4Kscore™ will become a transformational medical tool in the diagnosis
and treatment of prostate cancer, expectations regarding the performance
of companies in which we have a strategic investment and whether we will
monetize and realize a profit from our strategic investments, and
whether we will continue to solidify our broad development pipeline
across a growing operating platform, 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,
hGH-CTP, 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. 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 November 11, 2013
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