May 09, 2016 4:13pm EDT
Download as PDF
Related Documents
10-Q
HTML
XBRL
ZIP
Consolidated Revenue Increased to $291.0 Million From $30.1 Million
for the First Quarter of 2016 as compared to the 2015 period
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and OPKO Health
Entered into Agreement for OPKO’s RAYALDEE® ; OPKO to Receive up
to $282 Million in Upfront and Milestone Payments, Plus Tiered
Double-Digit Royalties; Vifor Fresenius also Acquired an Option for
Rights to the U.S. Dialysis Market for a New Dosage Form of RAYALDEE
Which Provides for Payment to OPKO of up to $555 Million in Additional
Milestone Payments Plus Double-Digit Royalties if Exercised
RAYALDEE PDUFA Date Set for October 22, 2016
New Leadership at Bio Reference Laboratories and Senior Vice
President of Pharmaceutical Sales for RAYALDEE launch appointed
4Kscore® Recommended in 2016 European Association of Urology
Prostate Cancer Guidelines
First Patient Dosed in Phase 2a Clinical Trial of Long Acting
Factor VIIa
First Patient Dosed in Phase 1 Clinical Trial of Long-Acting
Subcutaneous Oxyntomodulin for Obesity and Diabetes
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) , a multinational biopharmaceutical
and diagnostics company, today reported financial and operating results
for the three months ended March 31, 2016.
Business Highlights
Vifor Fresenius Medical Care Renal Pharma and OPKO Health Enter
into Agreement for OPKO’s RAYALDEE : VFMCRP, a common
company of Galenica and Fresenius Medical Care, and OPKO Health, have
entered into a collaboration and license agreement for the development
and commercialization of RAYALDEE in Europe, Canada, Mexico,
Australia, South Korea and certain other markets for the treatment of
secondary hyperparathyroidism (SHPT) in patients with chronic kidney
disease (CKD) and vitamin D insufficiency. Under the terms of the
agreement, VFMCRP will make an upfront payment to OPKO of $50 million,
plus up to an additional $52 million in regulatory and launch
milestones, and $180 million in sales-based milestones. In addition,
VFMCRP will pay OPKO tiered, double-digit royalties on sales of the
product. The parties will also collaborate to develop and
commercialize a new dosage form of RAYALDEE for the treatment
of SHPT in dialysis patients, and OPKO has granted VFMCRP an option to
acquire rights to the US market for dialysis patients. If VFMCRP
exercises its option for rights to the US dialysis market for the new
dosage form, VFMCRP will pay OPKO up to $550 million in additional
milestones, as well as double-digit royalties.
RAYALDEE New PDUFA Date Set for October 22, 2016: OPKO
resubmitted the New Drug Application (NDA) for RAYALDEE
following receipt of a complete response letter (CRL) from the U.S.
Food and Drug Administration on March 29, 2016, in which the FDA
indicated the NDA could not be approved due to deficiencies observed
during a facility inspection of OPKO's third party manufacturer. The
observations were not specific to RAYALDEE manufacturing, and
the CRL did not cite any safety, efficacy or labeling issues with
regard to RAYALDEE , nor did it request any additional studies
to be conducted prior to FDA approval.
Key Executive Additions - New Leadership at Bio Reference
Laboratories and Senior Vice President of Pharmaceutical Sales: Gregory
Henderson, M.D., Ph.D. was appointed President, Bio Reference
Laboratories; James Demarco was appointed Senior Vice President of
Pharmaceutical Sales; Ronald Trust, Ph.D. was named Vice President of
Regulatory Affairs – OPKO expects to make key additional
commercial hires in 2Q 2016.
4Kscore Recommended in 2016 European Association of
Urology Prostate Cancer Guidelines: The European Association of
Urology (EAU) Prostate Cancer Guidelines Panel included the 4Kscore
in the 2016 EAU Guidelines for Prostate Cancer. The panel concluded
that the 4Kscore , as a blood test with greater specificity over
the PSA test, is indicated for use prior to a first prostate biopsy or
after a negative biopsy to assist patients and physicians in further
defining the probability of high grade cancer.
Topline Phase 3 Results for hGH-CTP in Adults Expected 2H 2016;
Pediatric Phase 3 Initiation Anticipated in 2H 2016: OPKO expects
to report top line results from its Phase 3 trial evaluating
the safety and efficacy of once weekly injections of hGH-CTP with a
primary endpoint of superiority compared with placebo in decreasing
fat mass in adults with growth hormone deficiency (GHD) in the second
half of 2016. The trial is a randomized, double-blind, placebo
controlled, multicenter, global study in adults with GHD. The study is
divided into two treatment periods: a 26 week, double blind, placebo
controlled period, followed by a 26 week, open label extension period.
A Phase 3 trial in pediatric patients is anticipated to commence in
the second half of 2016.
Factor VIIa for the Treatment of Hemophilia: In February 2016, the
first patient was dosed in OPKO’s Phase 2a clinical trial for its long
acting Factor VIIa. The study is a dose escalation study to determine
safety and explore efficacy endpoints of OPKO's long-acting version of
coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of
bleeding episodes in hemophilia A or B patients with inhibitors to
Factor VIII or Factor IX. The study is intended to enroll 24 patients
in the United States.
First Patient Dosed in Clinical Study for Long Acting Oxyntomodulin
for Obesity and Diabetes: In March 2016 the first patient was
enrolled in OPKO’s Phase 1 single dose escalation study evaluating the
safety and pharmacokinetics of a long acting oxyntomodulin (MOD-6031)
in healthy, overweight or obese subjects. The study is intended to
enroll 40 subjects. Oxyntomodulin is a peptide hormone that acts as a
dual GLP-1/glucagon receptor agonist, with the potential to promote
weight loss while improving glycemic control. Oxyntomodulin has been
shown to increase energy expenditure, while reducing food intake and
body weight, although its clinical utility is limited by its short
circulating half life. OPKO's MOD-6031 has been designed, using a
proprietary bifunctional hydrolysable linker, as a long acting version
of oxyntomodulin for the treatment of Type 2 Diabetes and obesity, and
is intended to reduce the required dosing frequency by prolonging the
half life, while improving the hormone's pharmacokinetic and
pharmacodynamic profiles.
“We started 2016 with strong results from our diagnostics business
driven by an increase in patient volume at Bio-Reference Laboratories,
including our GeneDx business, and continued growth in the utilization
of our innovative 4Kscore Test. On the pharmaceutical side, we
are looking forward to the launch of RAYALDEE and our
collaboration with a leader in the chronic kidney disease field that
will allow us to expand the reach of this product to patients outside
the US and expand development of the product for patients undergoing
dialysis. We are steadily building our commercial team as we work with
the FDA to finalize regulatory approval for RAYALDEE . We also
made progress advancing our earlier stage development programs including
the next program utilizing our CTP technology, with the first patients
being administered our long acting Factor VIIa-CTP, and the initiation
of a Phase 1 clinical trial for long acting oxyntomodulin,” stated
Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.
Financial Highlights
Consolidated revenues for the three months ended March 31, 2016
increased to $291.0 million from $30.1 million for the three months
ended March 31, 2015. The 2016 period include revenue from
Bio-Reference Laboratories and EirGen which were acquired in August
and May 2015, respectively.
Net loss for the three months ended March 31, 2016 was $12.0 million
compared with net loss of $117.1 for the 2015 period. Net loss during
the three month periods include significant non-recurring and/or
$20.5 million of income tax benefit, primarily reflecting a change
in the statutory tax rate in Israel during 2016;
$17.2 million of severance expense related to the resignation of
certain Bio-Reference executives during the first quarter of 2016,
which is included in selling, general and administrative expense.
Of this expense, $8.9 million is a non-cash expense related to the
acceleration of stock options;
The first three months of 2015 include $25.9 million of
non-recurring operating expense related to the repayment of a
grant to the Office of the Chief Scientist in Israel related to
the Pfizer transaction; and,
Other income and (expense) was ($2.6) million and ($53.9) million
in the 2016 and 2015 periods, respectively, primarily related to
the change in fair value of derivative instruments. The change in
fair value is principally related to an embedded derivative in
OPKO’s January 2013 convertible senior notes due in 2033.
Cash, cash equivalents and marketable securities were $175.0 million
as of March 31, 2016.
OPKO’s senior management will provide a business update and discuss its
results in greater detail in a conference call and live audio webcast at
4:30 p.m. Eastern time today.
The conference call dial-in information is listed below. To access the
webcast, please log on to the OPKO website at www.opko.com .
WHEN: Monday, May 9, 2016, 4:30 p.m. ET
DOMESTIC DIAL-IN: (866)
INTERNATIONAL DIAL-IN: (330) 863-3454
For those unable to participate in the conference call or webcast, a
replay will be available beginning May 9, 2016 at 7:30 p.m. ET until May
15, 2016 at 11:59 p.m. ET. To access the replay, dial (855) 859-2056 or
(404) 537-3406. The replay passcode is: 2590322.
The replay can also be accessed for a period of time on OPKO’s website
at www.opko.com .
About OPKO Health, Inc.
OPKO Health, Inc. is a diversified healthcare company that seeks to
establish industry-leading positions in large, rapidly growing markets.
Our diagnostics business includes Bio-Reference Laboratories, the
nation's third-largest clinical laboratory with a core genetic testing
business and a 420-person sales force to drive growth and leverage new
products, including the 4Kscore® prostate cancer test and the Claros®1
in-office immunoassay platform. Our pharmaceutical business features RAYALDEE ,
a treatment for SHPT in stage 3-4 CKD patients with vitamin D
insufficiency (PDUFA date is October 22, 2016) and VARUBI™ for
chemotherapy-induced nausea and vomiting (oral formulation launched by
partner Tesaro, IV formulation in Phase 3). Our biologics business
includes hGH-CTP, a once-weekly human growth hormone injection (in Phase
3 and partnered with Pfizer), a long-acting Factor VIIa drug for
hemophilia (in Phase 2a) and a long acting oxyntomodulin for diabetes
and obesity (in Phase 1). We also have production and distribution
assets worldwide, multiple strategic investments and an active business
development strategy. More information is available at www.opko.com .
Cautionary Statement Regarding Forward-Looking Statements
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
and revenue growth, whether we have sufficient liquidity to fund
development of our product candidates and operations, our product
development efforts and the expected benefits of our products, including
whether our ongoing and future clinical trials will be completed on a
timely basis or at all and whether the data from any of our trials 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, expectations about
potential milestone payments from our partners, our ability to obtain
broad reimbursement coverage for the 4Kscore test, increased adoption
rates for the 4Kscore by Urologists in the U.S. and abroad, expectations
about the RAYALDEE PDUFA date, 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 integration challenges for
Bio-Reference, EirGen and other acquired businesses, 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, Varubi™, 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
(unaudited)
(in millions)
As of
March 31,
December 31,
Cash and cash equivalents
$
175.0
$
193.6
Other current assets
278.5
260.5
Total Current Assets
453.5
454.1
In-process Research and Development and Goodwill
1,540.6
1,535.6
Other assets
799.1
809.5
Total Assets
$
2,793.2
$
2,799.2
Current liabilities
$
267.2
$
251.9
2033 Senior Notes, net
49.6
49.0
Deferred tax liabilities
202.7
226.0
Other long-term liabilities, principally deferred revenue and
contingent
consideration
275.8
292.5
Total Liabilities
795.3
819.4
Equity
1,997.9
1,979.8
Total Liabilities and Equity
Condensed Consolidated Statements of Operations
(unaudited)
(in millions, except per share data)
For the three months ended March 31,
Revenues
$
291.0
$
30.1
Costs and expenses
Cost of revenues
147.5
10.3
Selling, general and administrative
128.0
17.4
Research and development
27.8
25.5
Contingent consideration
1.8
5.2
Amortization of intangible assets
13.4
2.7
Grant repayment
-
25.9
Total Costs and expenses
318.5
87.0
Operating loss
(27.5
)
(56.9
)
Other income and (expense), net
(2.6
)
(53.9
)
Income (loss) before income taxes and investment losses
(110.8
)
Benefit from (provision for) income taxes
20.5
(5.5
)
Income (loss) before investment losses
(9.6
)
(116.3
)
Loss from investments in investees
(2.4
)
(1.7
)
Net income (loss)
(12.0
)
(118.0
)
Less: Net loss attributable to non-controlling interests
-
(0.9
)
Net income (loss) attributable to common shareholders
(117.1
)
Basic income (loss) per share
$
(0.02
(0.26
)
Diluted income (loss) per share
View source version on businesswire.com: http://www.businesswire.com/news/home/20160509006580/en/
OPKO Health, Inc.
Tara Mackay, 305-575-4100
Investor
Apply on OPKO Health (Ireland)’s careers page