November 09, 2015 4:13pm EST
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Consolidated Revenue Increased to $143.0 Million From $19.8 million
for the Three Months Ended September 30, 2015, and Increased to $215.5
Million from $65.6 Million for the Nine Months Ended September 30, 2015
Closed Acquisition of Bio-Reference Laboratories on August 20, 2015
Announced Genomics Collaboration with Vanderbilt University School
of Medicine
4Kscore® Blood Test to Identify Risk of Aggressive Prostate Cancer
Included in the National Comprehensive Cancer Network Guidelines for
Cancer Early Detection
Rayaldee TM New Drug Application (NDA)
Accepted by FDA; Expected PDUFA Date is March 29, 2016
Completed Enrollment in hGH-CTP Phase 3 Trial in Growth Hormone
Deficient Adults
Presented Positive 12-month Clinical Data on hGH-CTP Phase 2 Trial
in Growth Hormone Deficient Children
Reported New Preclinical Data Supporting Subcutaneous
Administration for Long-Acting Factor VIIa-CTP for Hemophilia; Phase
2a Clinical Trial of Long Acting IV Form Expected to Commence in Q4
Phase 1 Clinical Trial for Long-Acting Subcutaneous Oxyntomodulin
for Obesity and Diabetes Expected to Commence in Q1 2016
VARUBI™ (rolapitant) Approved by the FDA; Commercial Sales Expected
to Commence this Month by TESARO with OPKO Eligible to Receive Up To
an Additional $110 Million of Milestone Payments Plus Ongoing Royalties
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) , a multinational biopharmaceutical
and diagnostics company, today reported financial and operating results
for the three and nine months ended September 30, 2015.
Business Highlights
Completed the Acquisition of Bio-Reference Laboratories on August
20, 2015: Bio-Reference Laboratories is the third largest
full-service clinical laboratory in the United States and is known for
its innovative technological solutions and pioneering leadership in
the areas of genomics and genetic sequencing. Through GeneDx,
Bio-Reference Laboratories' genetic sequencing laboratory, and GenPath
Diagnostics, its Oncology and Women's Health business units,
Bio-Reference Laboratories has accumulated a vast array of genetic and
genomic data that OPKO will make available to industry and academic
scientists to enhance their drug discovery and clinical trial
programs. Since closing, OPKO has begun to leverage the national
marketing, sales and distribution resources of Bio-Reference
Laboratories to enhance sales of OPKO’s 4Kscore® test, a blood test
that provides a personalized risk score for aggressive prostate
cancer, and plans to further leverage the Bio-Reference capabilities
with OPKO’s other diagnostic products under development.
4Kscore® Recommended in National Comprehensive Cancer Network
Guidelines for Prostate Cancer Early Detection: The National
Comprehensive Cancer Network (NCCN) included 4Kscore® as a recommended
test in their 2015 Guidelines for Prostate Cancer Early Detection. The
panel making this recommendation 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.
Rayaldee™ PDUFA Date is 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.
Completed Enrollment in Ongoing Phase 3 Trial in Growth Hormone
Deficient Adults: The trial 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 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. The study is expected to
conclude in the second half of 2016; with positive results, a
regulatory submission to the FDA will follow study completion.
IND for Long-Acting Factor VIIa-CTP for Hemophilia Filed and
Accepted: In March 2015, the FDA accepted OPKO’s IND application
to initiate a Phase 2a trial for its long-acting intravenous
coagulation Factor VIIa-CTP to treat hemophilia. Clinical trials are
expected to commence during Q4 2015.
Clinical Studies for Long-Acting Oxyntomodulin for Obesity and
Diabetes Expected to Begin During 2016: OPKO expects to commence
studies for its long-acting subcutaneous oxyntomodulin for diabetes
and obesity in Q1 2016.
VARUBI TM (Rolapitant) was Approved by the
FDA on September 2, 2015 and Commercial Launch is Expected to Commence
this Month: 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 expects to commence commercial sales
in the U.S. this month. 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. Following commercialization, OPKO is eligible to receive
up to $110 million in additional milestones and tiered, double-digit
royalties.
“OPKO has already achieved numerous important milestones during 2015,”
said Phillip Frost, M.D., Chairman and CEO. “We believe that the Pfizer
transaction for hGH-CTP and the acquisitions of EirGen and Bio-Reference
Laboratories have had a positive impact on our financial operations and
will provide significant revenue opportunities and an expanded
commercial platform for us going forward. The addition of our 4Kscore®
Test to the NCCN guidelines was an important step toward obtaining
reimbursement from healthcare payors, a key factor for obtaining broad
access to men for the test. Our NDA filing for Rayaldee™ continues to
advance through the FDA drug approval process and we have high
expectations for our new treatment option for patients with stage 3 or 4
chronic kidney disease and secondary hyperparathyroidism. Our clinical
development programs for Factor VIIa-CTP and oxyntomodulin, each with
great commercial potential, are advancing on plan and we expect to
initiate human trials for both products in the near future,” continued
Dr. Frost.
Financial Highlights
Consolidated revenues increased to $143.0 million from $19.8 million
for the three months ended September 30, 2015 compared to three months
ended September 30, 2014, and increased to $215.5 million from $65.6
million for the nine months ended September 30, 2015 as compared to
the 2014 period. The 2015 periods include revenue from Bio-Reference
and EirGen beginning with their acquisitions in August and May 2015,
respectively. Revenue for the three and nine months ended September
30, 2015 also includes $17.7 million and $47.8 million, respectively,
from OPKO’s collaboration with Pfizer.
Net income for the three months ended September 30, 2015 was $128.2
million compared with net loss of $48.7 for the 2014 period and net
losses for the nine months ended September 30, 2015 decreased to $31.6
million compared and $118.7 million for the 2014 period. The 2015
three and nine month periods include significant non-recurring and/or
$93.0 million and $87.2 million of income tax benefit 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 the three and nine month periods of 2015,
respectively;
17.3 million gain related to the deconsolidation of OPKO’s
previously consolidated variable interest entity, SciVac, in the
three month period of 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 $32.2 million and ($34.1) million
related to the change in fair value of derivative instruments in
the three and nine months of 2015, respectively, compared with
$3.3 million and $3.8 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 $212.1 million
as of September 30, 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.
WHEN: Monday, November 9, 2015, 4:30 p.m. ET
DOMESTIC & CANADA DIAL-IN: (866) 634-2258
INTERNATIONAL DIAL-IN: (330) 863-3454
LIVE WEBCAST LINK: http://edge.media-server.com/m/p/j2oc63ro
For those unable to participate in the conference call or webcast, a
replay will be available beginning November 9, 2015 at 7:30 p.m. ET
until November 15, 2015 at 11:59 p.m. ET. To access the replay, dial
(855) 859-2056 or (404) 537-3406. The replay passcode is 66021053.
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, the timing for
approval of the NDA for Rayaldee, our ability to manufacture products at
EirGen and achieve expected synergies, 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
September 30,
December 31,
Cash and cash equivalents
$
212.1
$
96.9
Other current assets
305.3
46.0
Total Current Assets
517.4
142.9
In-process Research and Development and Goodwill
1,574.0
1,017.4
Other assets
924.5
107.4
Total Assets
$
3,015.9
$
1,267.7
Current liabilities
$
357.6
$
83.1
2033 Senior Notes, net
44.2
131.5
Deferred tax liabilities
408.2
167.2
Other long-term liabilities, principally deferred revenue and
contingent consideration
236.5
50.1
Total Liabilities
1,046.5
431.9
Equity
1,969.4
835.8
Total Liabilities and Equity
Condensed Consolidated Statements of Operations
(unaudited)
(in millions, except per share data)
For the three months ended
September 30,
Revenues
$
143.0
$
19.8
Costs and expenses
151.3
68.0
Operating loss
(8.3
)
(48.2
)
Other income and (expense), net
47.0
(1.5
)
Income (loss) before income taxes and investment losses
38.7
(49.7
)
Benefit from (provision for) income taxes
93.0
(0.3
)
Income (loss) before investment losses
131.7
(50.0
)
Loss from investments in investees
(3.5
)
(0.0
)
Net income (loss)
128.2
Less: Net loss attributable to non-controlling interests
-
(1.3
)
Net income (loss) attributable to common shareholders
(48.7
)
Basic income (loss) per share
$
0.26
$
(0.11
)
Diluted income (loss) per share
$
0.25
For the nine months ended
September 30,
215.5
$
65.6
Costs and expenses
306.0
179.0
Operating loss
(90.5
)
(113.4
(23.6
)
(4.3
)
Loss before income taxes and investment losses
(114.1
)
(117.7
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