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Pfizer Collaboration Agreement for Long Acting Human Growth Hormone
Closed in January 2015; OPKO Received $295 Million of $570 Million
Total Potential Up Front and Milestone Payments
Rayaldee TM New Drug Application (NDA)
Submission Planned for Q1 2015
Positive Rayaldee Phase 3 Clinical Trial Results Presented at
American Society of Nephrologists Meeting
Clinical Trial for Rayaldee as Adjunctive Cancer Therapy Began in
Q4 2014
Marketing for 4Kscore® Blood Test to Identify Risk of Aggressive
Prostate Cancer in the US and Europe Began During 2014 and in Mexico
in January 2015
Two Papers Supporting 4Kscore Blood Test in European Urology
Published
Rolapitant™ NDA Submitted by OPKO Licensee, TESARO; Accepted for
Review by FDA with a PDUFA date of September 5, 2015; OPKO Received $5
Million of $121 Million Total Potential Up Front and Milestone Payments
Investigational New Drug (IND) Application for Long Acting Factor
VIIa-CTP for Hemophilia Filed and Accepted in Q1 2015
Clinical Studies for Long Acting Oxyntomodulin for Obesity and
Diabetes Expected to Begin During 2015
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) , a multi-national biopharmaceutical
and diagnostics company, today reported operating and financial results
for its fourth quarter ended December 31, 2014.
Business Highlights
Closed in January 2015; OPKO Received Up-Front Payments totaling $295
million for global commercialization rights to hGH-CTP: In
connection with the collaboration, OPKO received upfront payments of
$295 million and will receive an additional $275 million upon
achievement of development related milestones. In addition, OPKO will
receive initial royalty payments upon the commercialization of hGH-CTP
for Adult growth hormone deficiency (GHD). Upon the launch of hGH-CTP
for Pediatric GHD, the royalties will transition to gross profit
sharing among all indications for both hGH-CTP and Pfizer's
Genotropin®. OPKO will lead clinical development and will be
responsible for funding the development programs for Adult and
Pediatric GHD and growth failure in children born small for
gestational age (SGA). Pfizer will be responsible for all development
costs for additional indications as well as all post-marketing
studies. In addition, Pfizer will fund the commercialization
activities for all indications and lead the manufacturing activities
covered by the global development plan.
End of Phase 2 Meeting for hGH-CTP for Pediatric GHD Scheduled for
Q1 2015; Adult Phase 3 Clinical Trial Continues to Advance: OPKO
will present twelve month data from its ongoing Phase 2 clinical trial
for pediatric GHD at the 97th Annual Meeting of the Endocrine Society
(ENDO) on March 5th, 2015 in San Diego, California.
Rayaldee Met Primary Endpoints in Both Pivotal Phase 3 Trials; NDA
Submission planned for Q1 2015: OPKO announced successful top-line
results from both of its pivotal Phase 3 trials with Rayaldee. These
trials were identical randomized, double-blind, placebo-controlled,
multi-site 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. OPKO plans to submit a NDA in the first
quarter of 2015.
Rayaldee Results Presented at American Society of Nephrologists
Meeting: Rayaldee Phase 3 trial data was presented in a
late-breaking clinical presentation entitled "Safety and Efficacy of
Modified-release Calcifediol for Secondary Hyperparathyroidism in
Patients with Stage 3 or 4 CKD and Vitamin D Insufficiency" on
November 15, 2014 during the American Society of Nephrology meeting in
Philadelphia, PA.
Clinical Trial for Rayaldee as Adjunctive Cancer Therapy Initiated
in Q4 2014: OPKO initiated a clinical trial to evaluate Rayaldee
as an adjunctive therapy for the prevention of skeletal-related events
(SREs) in breast and prostate cancer patients with bone metastases
undergoing anti-resorptive therapy during the fourth quarter of 2014.
IND for Long Acting Factor VIIa-CTP for Hemophilia Filed and
Accepted: In January 2015, OPKO submitted an IND to Initiate a
Phase 2a Trial for its Long-Acting Coagulation Factor VIIa-CTP to
Treat Hemophilia. Clinical trials are expected to commence shortly.
Diabetes Expected to Begin During 2015 : OPKO expects to commence
studies for its long acting Oxyntomodulin for diabetes and obesity in
the second half of 2015.
Launched 4Kscore Test in US, Europe and Mexico; Adoption of 4Kscore
Test Continues to Grow: OPKO launched the 4Kscore Test in the US
and Europe in 2014, and in Mexico in January 2015. OPKO also expects
to launch the 4Kscore Test in additional Latin America markets through
its subsidiaries during 2015. OPKO is working to obtain reimbursement
for the 4Kscore Test by payers in the U.S. and abroad and expects
adoption to rapidly increase once reimbursement is received.
Announced Publication of 20 Year Outcome Study for Lethal Prostate
Cancer Using Kallikrein Biomarkers in 4Kscore Test: A team of
researchers from Memorial Sloan Kettering Cancer Center and several
leading European institutions published results in the journal European
Urology concluding that the four kallikrein panel of biomarkers
utilized in the OPKO 4Kscore Test (Total PSA, Free PSA, Intact PSA and
hK2) accurately identify men more likely to develop distant prostate
cancer metastases, and men with a low 4Kscore were shown to have a
very low risk of developing metastatic prostate cancer in the 5-10
year timeframe a <2% risk in a 20-year follow up period.
Rolapitant NDA Filing Submitted in September and Accepted for
Review by FDA in November: OPKO’s partner, TESARO, submitted a NDA
to the FDA for approval of oral rolapitant, an investigational
neurokinin-1 (NK-1) receptor antagonist in development for the
prevention of chemotherapy-induced nausea and vomiting (CINV). The NDA
is supported by data from four controlled studies covering a spectrum
of patients receiving chemotherapy that commonly causes nausea and
vomiting. The top-line results of three of the Phase 3 studies were
previously announced by TESARO and were presented in detail at the
American Society for Clinical Oncology (ASCO) annual meeting in June
2014. On November 5, 2014, TESARO announced the FDA accepted its NDA
filing for rolapitant, with a PDUFA date of September 5, 2015, which
triggered a milestone payment of $5 million to OPKO under its license
agreement with TESARO.
“We accomplished a number of important objectives during 2014,” said
Phillip Frost, M.D., Chairman and CEO. “The completion of the Pfizer
transaction rounded out a watershed year for OPKO that saw us report two
successful Phase 3 clinical trials for Rayaldee, successful validation
of the 4Kscore Test and subsequent launch of the 4Kscore Test in the US
and Europe. In addition, we progressed many of our earlier stage
programs, particularly our long acting Factor VII and Oxyntomodulin,
that have the potential to make significant contributions to the
healthcare system and the quality of life of patients,” Dr. Frost
continued.
Financial Highlights
We believe that OPKO’s cash and cash equivalents of $96.9 million at
December 31, 2014, together with the $295.0 million in upfront payments
from Pfizer received in 2015, provide OPKO with adequate liquidity to
continue development of its product candidates.
Pharmaceutical product revenue for the three months ended December 31,
2014 increased to $18.5 million compared to $17.5 million for the 2013
period. This increase was principally the result of increased revenue
from OPKO’s active pharmaceutical ingredient business at FineTech. Total
revenue for the three months ended December 31, 2014 was $25.5 million
compared to $20.7 million for the 2013 period. The increase in total
revenue was the result of the 2014 period including a $5.0 million
payment from TESARO for the acceptance of the NDA for rolapitant.
Net loss for the three months ended December 31, 2014 was $53.0 million,
compared to $16.8 million in the comparable period of 2013. During the
three months ended December 31, 2014, OPKO recorded increased expense
associated with its derivative instruments of $14.4 million, principally
related to the derivative liability associated with the increased value
of its Senior 2033 Notes. Further, the three months ended December 31,
2013 benefited from the exit from a strategic investment, resulting in
an $18.9 million gain in that period. OPKO continued to increase its
investment in research and development activities during the three
months ended December 31, 2014 related to its ongoing Phase 3 programs
for Rayaldee and hGH-CTP. As a result, OPKO’s spending on research and
development increased $2.4 million to $25.8 million for the three months
ended December 31, 2014 from $23.4 million for the three months ended
December 31, 2013.
For the year ended December 31, 2014, pharmaceutical product revenue
increased approximately 13% to $77.0 million compared to $68.2 million
for the 2013 period. The increase in pharmaceutical product revenue was
principally the result of increased revenue from FineTech, OPKO Health
Europe and OPKO Mexico. Total revenue for the year ended December 31,
2014 was $91.1 million compared to $96.5 million for the 2013 period.
Total revenue for the year ended December 31, 2013 included non-cash,
non-recurring revenue of $12.5 million related to OPKO’s transaction
with RXi Pharmaceuticals partially offset by increased pharmaceutical
product revenue and the milestone payment from TESARO.
Net loss for the year ended December 31, 2014 was $171.7 million
compared to $114.8 million for 2013. OPKO’s increased investment in
research and development activities principally related to its Phase 3
programs for Rayaldee and hGH-CTP, as well as incurred costs associated
with the clinical validation study for the 4Kscore, the Claros 1
Analyzer point of care diagnostic platform and earlier stage development
programs. As a result, OPKO’s investment in research and development
increased $29.7 million to $83.6 million for the year ended December 31,
2014 from $53.9 million for the year ended December 31, 2013. As a
result of the successful achievement of the primary efficacy and safety
endpoints for the Rayaldee Phase 3 clinical trials, the valuation for
contingent consideration payable to the sellers of Cytochroma increased
significantly during the year ended December 31, 2014 resulting in $17.5
million of increased contingent consideration expense. In addition, net
loss for the year ended December 31, 2014 included a non-recurring
in-process research and development expense of $12.1 million due to a
write-off of in-process research and development expense in connection
with the acquisition of Inspiro and a payment to Merck in connection
with the NDA filing by TESARO for rolapitant. The year ended December
31, 2013 included $12.5 million of non-cash income related to the RXi
transaction and a $29.9 million gain realized from the successful exit
of a strategic investment.
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 development of our product
candidates and operations, our product development effort and the
expected benefits of our products, including whether our ongoing and
future Phase 3 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, our ability to launch sales of the
4Kscore Test in Latin America and through our other subsidiaries,
increased adoption rates for the 4Kscore by Urologists in the U.S. and
abroad, the timing for submission of an NDA by us for Rayaldee, 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, 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
(unaudited)
(in millions)
As of
December 31,
December 31,
Cash and cash equivalents
$
96.9
$
185.8
Other current assets
46.0
56.9
Total Current Assets
142.9
242.7
In-process Research and Development and Goodwill
1,017.4
1,019.7
Other assets
107.4
129.1
Total Assets
$
1,267.7
$
1,391.5
Current liabilities
$
83.1
$
91.8
2033 Senior Notes, net
131.5
211.9
Other long-term liabilities
217.3
214.8
Total Liabilities
431.9
518.5
Equity
835.8
873.0
Total Liabilities and Equity
Condensed Consolidated Statements of Operations
(unaudited)
(in millions, except per share data)
For the three months ended
December 31,
Revenues
$
25.5
$
20.7
Costs and expenses
58.0
56.6
Operating loss
(32.5
)
(35.9
)
Other income and (expense), net
(20.9
)
21.5
Loss before income taxes and investment losses
(53.4
)
(14.4
)
Benefit from (provision for) income taxes
1.0
0.6
Loss before investment losses
(52.4
)
(13.8
)
Loss from investments in investees
(1.1
)
(3.6
)
Net loss
(53.5
)
(17.4
)
Less: Net loss attributable to non-controlling interests
(0.5
Preferred stock dividend
Net loss attributable to common shareholders
$
(53.0
(16.8
)
Basic and diluted loss per share
$
(0.12
(0.04
)
For the year ended
December 31,
91.1
$
96.5
Costs and expenses
236.9
176.1
Operating loss
(145.8
)
(79.6
(25.2
)
(24.6
(171.0
)
(104.2
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