May 09, 2014 9:02am EDT
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4Kscore™ Test successfully completed clinical validation study and
launched on March 31, 2014
All RAYALDEE™ Phase 3 clinical trials have completed enrollment on
schedule – top line data expected for release mid-2014
Cash and cash equivalents totaled $156.4 million providing
sufficient liquidity to fund development programs
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and
diagnostics company, today reported operating and financial results for
its first quarter ended March 31, 2014.
Business Highlights
4KscoreTest Launch: During the first quarter 2014, OPKO
successfully completed the 4Kscore Test clinical trial in the U.S. and
on March 31, 2014, launched the 4Kscore Test in the U.S. through its
CLIA-accredited OPKO Lab in Nashville, TN. OPKO expects to begin
offering the 4Kscore Test through its Spanish subsidiary in late 2014
and through its other subsidiaries shortly thereafter. The
laboratory-developed test is designed to enhance the prostate biopsy
decision making process that, in the U.S., leads to approximately 1
million biopsies being performed annually, with 80% of the results
indicating no cancer or a low-grade cancer. The 4Kscore Test will help
to reduce unnecessary prostate biopsies by providing information on
the risk (probability) of having high-grade prostate cancer.
4Kscore Data Presentations: OPKO will present data from its
recently completed U.S. clinical validation study at two upcoming
conferences: the American Urological Association (AUA) in Orlando,
which selected “The 4Kscore Test as a Predictor of High-Grade Prostate
Cancer on Biopsy” as a Late-Breaking Abstract for presentation in
Plenary I on Sunday, May 18, 2014; and, the 83 rd Annual
Meeting of the New England Section of the AUA in October 2014 in
Newport.
Completed Patient Enrollment in the Third Phase 3 Trial of RAYALDEE :
This trial is a 6-month open-label extension of two ongoing
identical randomized, double-blind, placebo-controlled, multi-site
pivotal phase 3 studies for RAYALDEE intended to support
marketing approval in the U.S. This third study is designed to
evaluate the product’s long-term safety and efficacy in treating
secondary hyperparathyroidism (SHPT) in subjects with stage 3 or 4
chronic kidney disease (CKD) and vitamin D insufficiency. OPKO is on
schedule for releasing top-line pivotal data in the third quarter of
2014 and filing a New Drug Application (NDA) with the FDA in
the first quarter of 2015.
Inspiro Acquisition: In April, OPKO entered into a definitive
agreement to acquire Inspiro Medical Ltd., an Israeli medical device
company with a new platform to deliver small molecule drugs such as
corticosteroids and beta agonists, as well as its own new drug working
with a novel mechanism of action, to treat respiratory diseases.
Inspiro's Inspiromatic™ is a "smart" easy-to-use dry powder inhaler
with several advantages over existing devices.
Rolapitant Continues on Schedule For a Mid-Year NDA Filing: OPKO’s
partner, TESARO announced it is on track for its NDA filing for
rolapitant mid-2014 and anticipates completing a dose study for the
intravenous (IV) formulation during the second quarter of 2014. The IV
formulation is expected to be launched approximately one year after
the oral product becomes available.
Key Management Positions Added: OPKO made a number of important
additions to its management team: Greg Stanley joined OPKO as Vice
President of Sales and Marketing for the Global Diagnostics Business
Unit, and Scott Toner joined OPKO as Vice President, U.S. Marketing
and Sales for the Renal Division.
Establishment of a Global Supply Chain Infrastructure and Holding
Company Based in Dublin, Ireland: OPKO is expanding its presence
by establishing a global supply chain operation and holding company in
Ireland. OPKO is recruiting employees to support the ongoing launch of
the 4Kscore diagnostic test and in anticipation of the commercial
launch of RAYALDEE . The Irish operation is also expected to
manage the global supply of other products over the next several years
and to serve as a holding company for many of OPKO's non-U.S.
subsidiaries.
In January, OPKO completed the acquisition of Laboratorio Arama
de Uruguay Limitada (“Arama Uruguay”), a privately-owned company
located in Montevideo, Uruguay. Arama Uruguay will expand OPKO’s
presence in Latin America and complement the business activities of
its operations in Chile and Mexico, as well as permit
commercialization of OPKO’s products currently commercialized and
those in development.
“We made significant progress during the first quarter of 2014,” stated
Dr. Phillip Frost, Chairman and CEO. “The completion of our validation
study for the 4Kscore and subsequent launch were significant milestones
which we expect will provide substantial benefits to both patients and
healthcare professionals by informing them of the risk of a patient
having high-grade prostate cancer and helping clarify the decision
process surrounding prostate biopsy. Our RAYALDEE phase 3
clinical trials continue on track for release of top line data later
this summer and our hGH-CTP clinical trials continue on schedule. In
addition to these important project developments, we expanded the global
footprint of our commercial platform with the entry into the Uruguayan
market. With our planned acquisition of Inspiro, we will also add an
innovative next generation platform drug delivery system.”
Financial Highlights
At March 31, 2014, OPKO had cash and cash equivalents of $156.4 million
providing OPKO with strong liquidity and the ability to continue the
development of its product candidates. During the three months ended
March 31, 2014, OPKO continued to invest in its research and development
programs and as a result, utilized cash in operations of $29.0 million
for the three months ended March 31, 2014. Cash used in operations
include the final deferred acquisition payments for OPKO Spain and
FineTech totaling $7.9 million. The remaining cash used in operations
reflects OPKO’s continued investment in research and development
activities including its ongoing phase 3 clinical trials for RAYALDEE
and hGH-CTP and the clinical validation study for 4Kscore Test which was
completed in March 2014.
Product revenue for the quarter increased approximately 28% to $19.8
million compared to $15.5 million for the 2013 period. The increase in
product revenue was principally the result of increased revenue from
OPKO Spain and FineTech. Total revenue for the three months ended March
31, 2014 was $22.3 million compared to $31.3 million for the 2013
period. Total revenue for the three months ended March 31, 2013 included
non-cash, non recurring revenue of $12.5 million related to OPKO’s
transaction with RXi, which was partially offset by increased product
revenue.
Net loss attributable to common shareholders increased to $45.1 million
for the three months ended March 31, 2014 compared to $34.6 million in
the comparable period of 2013 partially as a result of the 2013 period
including $12.5 million of non-cash income related to the RXi
transaction. In addition, OPKO continued to increase its investment in
research and development activities related to its ongoing phase 3
programs for RAYALDEE and hGH-CTP as well as costs associated
with the clinical validation study for the 4Kscore. As a result, OPKO’s
spending on research and development increased $11.0 million to $21.0
million for the three months ended March 31, 2014 from $9.9 million for
the three months ended March 31, 2013. Net loss for the three months
ended March 31, 2014 included $10.5 million of non-cash expense related
to the mark to market of certain derivative instruments related to our
convertible debt instruments compared to $23.5 million for the three
months ended March 31, 2013.
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,
whether we have sufficient liquidity to fund our research and
development and operations, our product development effort and the
expected benefits of our products, including whether the phase 3
clinical trials for RAYALDEE, hGH-CTP, and rolapitant will be completed
on a timely basis or at all and whether the data will support approval,
validation and/or reimbursement for our products, the expected timing
for launch of our products in development, including RAYALDEE and
hGH-CTP, 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
RAYALDEE, the 4Kscore, and hGH-CTP, our ability to launch sales of the
4Kscore Test in Spain and through our other subsidiaries, the timing for
submission of an NDA by us for RAYALDEE and by TESARO for rolapitant,
whether TESARO will complete a dose study for its IV formulation and the
timing thereof, whether the 4Kscore will provide substantial benefits to
patients and doctors by informing them of the risk of a patient having a
high-grade cancer and clarify the decision making process, whether the
4Kscore will reduce unnecessary biopsies, whether the Irish operation
will manage, oversee and contribute to the manufacturing and sale of the
4Kscore, RAYALDEE, and other products in development, 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 Annual Reports on Form 10-K filed and to be filed with
the Securities and Exchange Commission and in our other 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 the 4Kscore,
RAYALDEE, rolapitant, hGH-CTP, and/or any of our compounds or diagnostic
products under development 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. and Subsidiaries
Condensed Consolidated Balance Sheets
(in millions)
As of
March 31,
December 31,
Cash and cash equivalents
$
156.4
$
185.8
Other current assets
48.8
56.9
205.2
242.7
In-process Research and Development and Goodwill
1,091.3
1,019.7
Other assets
59.1
129.1
Total Assets
$
1,355.6
$
1,391.5
Current liabilities
$
84.5
$
91.8
2033 Senior Notes, net
224.8
211.9
Other long-term liabilities
215.1
214.8
Total Liabilities
524.4
518.5
Series D Preferred Stock and Equity
831.2
873.0
Total Liabilities, Series D Preferred Stock and Equity
Condensed Consolidated Statements of Operations
(in millions, except per share data)
For the three months ended March 31,
Revenues
$
22.3
$
31.3
Costs and expenses
52.6
38.1
Operating loss
(30.3
)
(6.8
)
Other income and (expense), net
(12.1
)
(24.1
)
Loss before income taxes and investment losses
(42.4
)
(30.8
)
Benefit from (provision for) income taxes
(0.6
)
(0.1
)
Loss before investment losses
(43.0
)
(30.9
)
Loss from investments in investees
(2.1
)
(3.9
)
Net loss
(45.1
)
(34.8
)
Less: Net loss attributable to non-controlling interests
(0.5
Preferred stock dividend
-
(0.4
)
Net loss attributable to common shareholders
$
(44.6
(34.6
)
Basic and diluted loss per share
$
(0.11
OPKO Health, Inc.
Steven D. Rubin or Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
Released May 9, 2014
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