February 29, 2016 4:16pm EST
Download as PDF
Related Documents
10-K
HTML
10-K/A
XBRL
ZIP
Consolidated Revenue Increased to $276.2 Million From $25.5 Million
for the Three Months Ended December 31, 2015, and Increased to $491.7
Million from $91.1 Million for the Year Ended December 31, 2015
Clinical Utility Study Demonstrates 4Kscore® Test Reduces Number of
Unnecessary Prostate Biopsies While Improving Risk Prediction for
Aggressive Prostate Cancer
4Kscore Blood Test to Identify Risk of Aggressive Prostate Cancer
Assigned Level 1 CPT Code
Rayaldee™ PDUFA Date Remains on Track For March 29, 2016
Topline Phase 3 Results for hGH-CTP in Adults Expected 2H 2016;
Pediatric Phase 3 Initiation Anticipated in 2H 2016
First Patient Dosed in Phase 2a Clinical Trial of Long Acting
Factor VIIa
Phase 1 Clinical Trial for Long Acting Subcutaneous Oxyntomodulin
for Obesity and Diabetes Expected to Commence in Q1
VARUBI™ (rolapitant) Commercial Sales by TESARO Commenced in
November 2015; OPKO is Eligible to Receive Up To an Additional $95
Million of Milestone Payments Plus Ongoing Double Digit Royalties
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK ) , a multinational biopharmaceutical
and diagnostics company, today reported financial and operating results
for the three months and year ended December 31, 2015.
Business Highlights
Clinical Utility Study Demonstrates 4Kscore Test Reduces
Aggressive Prostate Cancer: The results of a 611 patient
peer-reviewed study, "The 4Kscore® Test Reduces Prostate Biopsy Rates
in Community and Academic Urology Practices", written by Badrinath
Konety, MD, et al. (Reviews in Urology, January 2016), indicated that
the 4Kscore test led to 65% fewer prostate biopsies being performed
among participating patients and influenced approximately 89% of
decisions about performing a prostate biopsy. A higher 4Kscore test
result was significantly associated with a greater likelihood of
having a prostate biopsy.
Assigned a Level 1 CPT Code: The American Medical Association
(AMA) Current Procedural Terminology (CPT®) Editorial Panel granted a
Category I CPT code which will be effective in January 2017 for OPKO’s
4Kscore Test, the only blood test that accurately identifies an
individual patient's risk for aggressive prostate cancer. A Category I
CPT code is a designation reserved for established diagnostic tests,
and will provide broader access to the 4Kscore Test to urologists and
their patients across the United States.
Rayaldee PDUFA Date Remains on Track for March 29, 2016: In
late 2014, OPKO announced successful top-line results from both
pivotal Phase 3 trials with Rayaldee. These trials were identical
randomized, double-blind, placebo-controlled, multisite studies
intended to establish the safety and efficacy of Rayaldee as a new
treatment for secondary hyperparathyroidism (SHPT) in patients with
stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Pediatric Phase 3 Initiation Anticipated in 2H 2016: The Phase 3
trial in adults is designed to evaluate the safety and efficacy of
hGH-CTP with a primary endpoint of superiority compared with placebo
in decreasing fat mass in adults with GHD. The trial is a randomized,
double-blind, placebo-controlled, multicenter, global study in adults
with growth hormone deficiency (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. A Phase 3 trial in
pediatric patients is anticipated to commence in 2H 2016.
Factor VIIa for the Treatment of Hemophilia: In February 2016, the
first patient was dosed in OPKO’s Phase 2a clinical trial of its long
acting Factor VIIa, a dose escalation study to determine safety and
explore efficacy endpoints of OPKO's long acting form 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 will enroll 24 patients in the United States.
Clinical Studies for Long Acting Oxyntomodulin for Obesity and
Diabetes Expected to Begin: OPKO expects to commence studies for
its long acting subcutaneous oxyntomodulin for diabetes and obesity in
Q1 2016.
VARUBI™(Rolapitant) was Approved by the FDA on September 2, 2015
and Commercial Launch Commenced in November 2015: OPKO’s partner,
TESARO received FDA approval of oral VARUBI™, a neurokinin-1 (NK-1)
receptor antagonist, in combination with other antiemetic agents in
adults for the prevention of delayed nausea and vomiting associated
with initial and repeat courses of emetogenic chemotherapy. TESARO
commenced commercial sales in the U.S. in November 2015 and expects to
submit its Marketing Authorization Application to the European
Medicines Agency for oral VARUBI ™ in Q2. VARUBI™ has been
included in the NCCN Guidelines as a recommended option in combination
with other antiemetic agents for patients receiving both high emetic
risk intravenous chemotherapy (HEC) and moderate emetic risk
intravenous chemotherapy (MEC). Category 1, the highest level category
of evidence and consensus, was granted to VARUBI™ for both HEC and MEC
chemotherapy. OPKO is eligible to receive up to $95 million in
additional milestones and tiered, double-digit royalties.
Varubi™ (Rolapitant) IV Formulation NDA Submission. TESARO
expects to submit NDA for IV formulation of Varubi™ in Q1.
“We made great progress during 2015,” stated Phillip Frost, M.D.,
Chairman and Chief Executive Officer of OPKO. “We have recently begun to
expand the marketing and sales of our 4Kscore Test utilizing the
commercial infrastructure of Bio-Reference, with very promising results.
As we obtain broad reimbursement for the 4Kscore Test, we believe
patients, providers and insurers will realize the benefits of this test
in 2016 and beyond. We are now preparing for our launch of Rayaldee for
treatment of SHPT in patients with stage 3 or 4 CKD later this year. Our
commercial partner, TESARO, launched VARUBI ™ late in 2015 and the
launch is progressing as expected. Our collaboration with Pfizer is on
track and we expect to have topline data for our ongoing Phase 3
clinical trial for hGH-CTP in adults later this year and expect to
initiate the pivotal clinical trial for the pediatric indication later
this year. We continue to pursue other development programs as well and,
earlier this month, initiated a clinical study utilizing our CTP
platform technology for our long-acting Factor VIIa project. We expect
to begin a Phase 1 clinical trial for long acting oxyntomodulin next
month,” Dr. Frost continued.
Financial Highlights
Consolidated revenues increased to $276.2 million from $25.5 million
for the three months ended December 31, 2015 compared to the 2014
period, and increased to $491.7 million from $91.1 million for the
year ended December 31, 2015 as compared to 2014. The 2015 periods
include revenue from Bio-Reference and EirGen beginning with their
acquisitions in August and May 2015, respectively. Revenue for the
three months and year ended December 31, 2015 also includes $17.7
million and $65.5 million, respectively, from OPKO’s collaboration
with Pfizer. The 2015 periods also include a $15.0 million milestone
payment from TESARO related to the launch of VARUBI™ in November 2015.
Net income for the three months ended December 31, 2015 was $1.6
million compared with a net loss of $53.0 million for the 2014 period
and net losses for the year ended December 31, 2015 decreased to $30.0
million compared to $171.7 million for the 2014 period. In addition to
the revenue related items, the 2015 three month and year periods
$26.5 million and $113.7 million of income tax benefit,
respectively, reflecting the release of valuation allowances
against all of OPKO’s U.S.-based deferred tax assets as a result
of the Bio-Reference acquisition in 2015;
$15.9 million gain related to the deconsolidation of OPKO’s
previously consolidated variable interest entity, SciVac, in the
year ended December 31, 2015 as SciVac completed an initial public
offering by merger with Levon Resources Ltd. in July 2015;
$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 in the nine month period
of 2015; and,
Other income and (expense) of ($15.9) million and ($39.5) million
primarily related to the change in fair value of derivative
instruments as well as a ($7.3) million temporary impairment
charge of an available for sale investment in the three months and
year ended December 31, 2015, respectively, compared with ($20.9)
million and ($25.2) million in the 2014 periods. The change in
fair value is principally related to an embedded derivative in our
January 2013 convertible senior notes due in 2033.
Cash, cash equivalents and marketable securities were $193.6 million
as of December 31, 2015.
This reflects receipt of Pfizer upfront payments of $295.0
million, partially offset by a $94.7 million cash payment for the
acquisition of EirGen (net of EirGen’s cash on hand) and a
one-time $25.9 million payment to the Office of the Chief
Scientist in Israel related to the Pfizer transaction and cashed
used by operations, principally related to our research and
development expense.
CONFERENCE CALL & WEBCAST INFORMATION
WHEN: Monday, February 29, 2016, 4:30 p.m. Eastern time
DOMESTIC DIAL-IN: (866) 634-2258
INTERNATIONAL DIAL-IN: (330) 863-3454
PASSCODE: 56397388
WEBCAST: www.opko.com
For those unable to participate in the live conference call or webcast,
a replay will be available beginning February 29, 2016 at 7:30 p.m.
Eastern time. To access the replay, dial (855) 859-2056 or (404)
537-3406. The replay passcode is: 56397388. 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 salesforce 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 secondary hyperparathyroidism in stage 3-4
chronic kidney disease patients with vitamin D deficiency (March 29,
2016 PDUFA date) and VARUBI™ for chemotherapy-induced nausea and
vomiting (oral formulation approved by FDA and pending launch 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), and a long-acting Factor VIIa drug for
hemophilia (entering Phase 2a). 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, the success of our acquisitions of Bio-Reference and
EirGen, 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 timing of the NDA submission for an IV formulation of Varubi™ and
European approvals for Varubi™, and the timing for approval of the NDA
and launch for Rayaldee, 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
December 31,
December 31,
Cash and cash equivalents
$
193.6
$
96.9
Other current assets
260.5
46.0
Total Current Assets
454.1
142.9
In-process Research and Development and Goodwill
1,535.6
1,017.4
Other assets
809.9
107.4
Total Assets
$
2,799.6
$
1,267.7
Current liabilities
$
251.9
$
83.1
2033 Senior Notes, net
49.4
131.5
Deferred tax liabilities
226.0
167.2
Other long-term liabilities, principally deferred revenue and
contingent consideration
292.5
50.1
Total Liabilities
819.8
431.9
Equity
1,979.8
835.8
Total Liabilities and Equity
Condensed Consolidated Statements of Operations
(unaudited)
(in millions, except per share data)
For the three months ended
December 31,
Revenues
$
276.2
$
25.5
Costs and expenses
284.1
58.0
Operating loss
(7.9
)
(32.5
)
Other income and (expense), net
(15.9
)
(20.9
)
Income (loss) before income taxes and investment losses
(23.8
)
(53.4
)
Benefit from (provision for) income taxes
26.4
1.0
Income (loss) before investment losses
2.6
(52.4
)
Loss from investments in investees
(1.1
)
Net income (loss)
1.6
(53.5
)
Less: Net loss attributable to non-controlling interests
-
(0.5
)
Net income (loss) attributable to common shareholders
(53.0
)
Basic income (loss) per share
$
0.00
$
(0.12
)
Diluted income (loss) per share
For the years ended
December 31,
491.7
$
91.1
Costs and expenses
590.2
236.9
Operating loss
(98.5
)
(145.8
(39.5
)
(25.2
)
Loss before income taxes and investment losses
Apply on OPKO Health (Ireland)’s careers page