May 11, 2015 4:00pm EDT
Download as PDF
Related Documents
10-Q
HTML
XBRL
ZIP
Pfizer Collaboration Agreement for Long Acting Human Growth Hormone
Closed in January 2015; OPKO Received $295 million of $570 Million
Total Potential Pre-Commercialization Payments
Acquired EirGen Pharma, A Growing, Profitable Specialty
Pharmaceutical Developer and Manufacturer
Rayaldee TM New Drug Application (NDA)
Submission Expected Later in May; Positive Rayaldee Phase 3 Clinical
Trial Results Presented at the National Kidney Foundation Spring
Clinical Meetings and 2015 ENDO Conference
Investigational New Drug (IND) Application for Long Acting Factor
VIIa-CTP for Hemophilia Accepted in Q1 2015; Phase 2a Clinical Trial
to Commence in 1H 2015
Phase 1 Clinical Trial for Long Acting Oxyntomodulin for Obesity
and Diabetes Expected to Commence During 2H 2015
Marketing for 4Kscore® Blood Test to Identify Risk of Aggressive
Prostate Cancer Began in Mexico in January 2015; Additional Latin
American Rollout Expected During 2015
Paper Supporting the 4Kscore Blood Test Published in Journal of the
National Cancer Institute
Expected Rolapitant™ PDUFA Date of September 5, 2015; OPKO to
Receive Up To $110 Million of Milestone Payments Upon Approval and
Commercialization
OPKO Consolidated Investee SciVac Entered into an Agreement
Pursuant to Which It Will Become a Public Company on the Toronto Stock
Exchange with over $19 Million in Working Capital
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, 2015.
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 up-front 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.
hGH-CTP for Pediatric GHD Data Presented at 2015 ENDO; Adult Phase
3 Clinical Trial Continues to Advance: OPKO presented positive
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.
Pharmaceutical Developer and Manufacturer: OPKO acquired EirGen
Pharma, Ltd., a growing, profitable and cash flow positive specialty
pharmaceutical company focused on the development and commercial
supply of high potency, high barrier to entry pharmaceutical products
for sale in the U.S., Canada, Japan, Australia, most European
countries, and more than 40 others around the world. EirGen, based in
Waterford, Ireland, was founded by two former executives of IVAX
Pharmaceuticals, Tom Brennan and Patsy Carney. The company, situated
in a state of the art high containment research and development and
manufacturing facility, is approved by the FDA, EMEA (European Health
Authorities) and the PMDA (Japanese Health Authorities). To date,
EirGen and its commercial partners have filed 10 product applications
with the FDA and 5 each in Europe and Japan. EirGen has a strong
research and development portfolio of over 20 niche, high barrier to
entry drugs. EirGen will rapidly expand its drug portfolio with access
to additional capital from OPKO, together with the benefits of Irish
government programs encouraging research and development in Ireland.
EirGen also offers significant synergies and benefits to OPKO through
its ability to manufacture OPKO’s current and future products.
Rayaldee Met Primary Endpoints in Both Pivotal Phase 3 Trials; NDA
Submission Scheduled Later in May: OPKO announced successful
top-line results from both of its pivotal Phase 3 trials with Rayaldee
in September 2014. 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 has
scheduled submission of NDA to the FDA later in May.
Positive Rayaldee Results Presented at the National Kidney
Foundation Spring Clinical Meetings and 2015 ENDO Conference: The
presentations of positive Rayaldee Phase 3 trial data were entitled
"Modified-Release Calcifediol Is Effective for SHPT in Both Stages 3
and 4 CKD" (March 2015 in Dallas TX) and "Modified-Release Calcifediol
Controls Elevated iPTH, Corrects 25(OH)D Levels and Reduces Bone
Markers in CKD Patients" (March 2015 in San Diego, CA).
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 Coagulation Factor
VIIa-CTP to Treat Hemophilia. Clinical Trials are expected to commence
shortly.
Clinical Studies for Long Acting Oxyntomodulin for Obesity and
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 Mexico and Expects Further Latin American
Launches in 2015; Adoption of 4Kscore Test Continues to Grow in the
U.S. and Europe: OPKO launched the 4Kscore Test 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 a Study Entitled “Predicting High-Grade
Cancer at Ten-Core Prostate Biopsy Using Four Kallikrein Markers
Measured in Blood in the ProtecT Study.”: The ProtecT study
is a prospective randomized controlled trial conducted in the UK for
the purpose of evaluating the cost effectiveness of conventional
treatments in PSA-detected, clinically localized prostate cancer. Of
the 82,428 men recruited for the trial, a total of 6,129 men with
elevated PSA (≥3.0 ng/mL) who underwent prostate biopsy and provided
an adequate blood sample were tested for the four kallikreins and
their 4Kscore results were determined. The study showed that the four
kallikrein panel enhanced aggressive prostate cancer detection
compared with PSA and age alone. The area under the curve (AUC) for
the 4K model was 0.820 (95% CI = 0.802 to 0.838) while the PSA model
was 0.738 (95% CI = 0.716 to 0.761) for high-grade cancer. The ProtecT
study is the latest in a series of peer-reviewed publications
demonstrating the superior clinical value that testing with four
kallikrein markers adds to risk prediction for aggressive prostate
cancer.
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. Upon
approval and following commercialization, OPKO will receive up to $110
Million in additional milestones and tiered, double digit royalties.
“We began 2015 with a number of significant activities including the
closing of the Pfizer transaction, the initiation of our clinical
development program for Factor VIIa-CTP and the imminent submission of
our NDA for Rayaldee,” said Phillip Frost, M.D., Chairman and CEO. “The
4Kscore Test continues to gain acceptance in the US, Mexico and Europe
and we are pleased with the recently published studies further
supporting the long-term outcomes of using this potentially
revolutionary blood test. With the EirGen acquisition, we added a
growing, profitable, cash flow positive business to our complement of
operating companies which we believe will lead to further growth and
profitability of our other businesses,” Dr. Frost continued.
Financial Highlights
Cash, cash equivalents and marketable securities were $348.2 million
as of March 31, 2015.
Reflects receipt of Pfizer upfront payments of $295.0 million,
partially offset by a non-recurring $25.9 million payment to the
Office of the Chief Scientist in Israel related to the Pfizer
transaction.
Consolidated revenues increased to $30.1 million during the three
months ended March 31, 2015 from $22.3 million in the comparable
period of 2014. Revenue for the three months ended March 31, 2015
included $12.5 million of revenue resulting from OPKO’s collaboration
agreement with Pfizer. OPKO is recording revenue in connection with
the Pfizer transaction on a straight-line basis over the expected
development period.
Net loss for the three months ended March 31, 2015 included increased
operating expenses including a $4.5 million increase in research and
development expense to $25.5 million, and non-recurring and non-cash
$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
$49.8 million in non-cash charges related to the change in value
of embedded derivatives which are part of our January 2013
convertible senior notes due in 2033 (the "2033 Senior Notes").
This non-cash charge is principally a result of the increased
market price of our common stock since December 31, 2014.
WHEN: Monday, May 11, 2015, 4:30 p.m. ET
INTERNATIONAL DIAL-IN: (201) 689-8562
LIVE WEBCAST LINK: http://public.viavid.com/index.php?id=114458
For those unable to participate in the conference call or webcast, a
replay will be available beginning May 11, 2015 at 7:30 p.m. ET until
May 18, 2015 at 11:59 p.m. ET. To access the replay, dial (877) 870-5176
or (858) 384-5517. The replay passcode is 13608883.
The replay can be accessed for a limited time on OPKO’s website at www.opko.com .
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 efforts 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, expectations about potential
milestone payments from our partners, our ability to launch sales of the
4Kscore Test in additional Latin American countries, increased adoption
rates for the 4Kscore by Urologists in the U.S. and abroad, the timing
for submission of a 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, 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 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
March 31,
December 31,
Cash and cash equivalents
$
348.2
$
96.9
Other current assets
45.8
46.0
Total Current Assets
394.0
142.9
In-process Research and Development and Goodwill
1,016.2
1,017.4
Other assets
102.0
107.4
Total Assets
$
1,512.2
$
1,267.7
Current liabilities
$
182.8
$
83.1
2033 Senior Notes, net
106.7
131.5
Other long-term liabilities
410.2
217.3
Total Liabilities
699.7
431.9
Equity
812.5
835.8
Total Liabilities and Equity
Condensed Consolidated Statements of Operations
(unaudited)
(in millions, except per share data)
For the three months ended March 31,
Revenues
$
30.1
$
22.3
Costs and expenses
87.0
52.6
Operating loss
(56.9
)
(30.3
)
Other income and (expense), net
(53.9
)
(12.1
)
Loss before income taxes and investment losses
(110.8
)
(42.4
)
Benefit from (provision for) income taxes
(5.5
)
(0.6
)
Loss before investment losses
(116.3
)
(43.0
)
Loss from investments in investees
(1.8
)
(2.1
)
Net loss
(118.1
)
(45.1
)
Less: Net loss attributable to non-controlling interests
(1.0
)
(0.5
)
Net loss attributable to common shareholders
$
(117.1
(44.6
)
Basic and diluted loss per share
$
(0.26
(0.11
)
OPKO Health, Inc.
Steve Rubin or Adam Logal, 305-575-4100
Source: OPKO Health, Inc.
Released May 11, 2015
email Email Alerts
location_city Company Profile
contact_page Contacts
rss_feed RSS News Feed
account_tree Sitemap
Apply on OPKO Health (Ireland)’s careers page