August 05, 2015 4:00pm EDT
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Announced the Acquisition of Bio-Reference Laboratories; Closing
Anticipated by the End of August
Acquired EirGen Pharma, A Growing, Profitable Specialty
Pharmaceutical Developer and Manufacturer
Rayaldee TM New Drug Application (NDA)
Submission Accepted by FDA; Expected PDUFA date of March 29, 2016
Completed the Enrollment in hGH-CTP Phase 3 Trial in Growth Hormone
Deficient Adults
New Pre-Clinical Data Supporting Subcutaneous Administration for
Long Acting Factor VIIa-CTP for Hemophilia; Phase 2a Clinical Trial
Expected to Commence in Q3 2015
Phase 1 Clinical Trial for Long Acting Oxyntomodulin for Obesity
and Diabetes Expected to Commence During 2H 2015
4Kscore® Blood Test to Identify Risk of Aggressive Prostate Cancer
Further Validated by Inclusion in the National Comprehensive Cancer
Network Guidelines for Cancer Early Detection
Expected Rolapitant™ PDUFA Date of September 5, 2015; OPKO to
Receive Up To an Additional $110 Million of Milestone Payments Upon
Approval and Commercialization
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) , a multi-national biopharmaceutical
and diagnostics company, today reported operating and financial results
for its second quarter ended June 30, 2015.
Business Highlights
OPKO to Acquire Bio-Reference Laboratories: OPKO and Bio-Reference
Laboratories signed a definitive merger agreement on June 3, 2015
under which OPKO will acquire Bio-Reference Laboratories. 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 genomics data that OPKO will
make available to industry and academic scientists to enhance their
drug discovery and clinical trial programs. Under the terms of the
agreement, holders of Bio-Reference Laboratories common stock will
receive 2.75 shares of OPKO common stock for each share of
Bio-Reference Laboratories common stock. Closing of the transaction is
subject to approval of Bio-Reference Laboratories' shareholders, and
other customary conditions. OPKO intends 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 man's specific personalized risk score for aggressive
prostate cancer, and other OPKO diagnostic products under development.
Pharmaceutical Developer and Manufacturer: OPKO acquired EirGen
Pharma, Ltd., a growing, profitable, cash flow positive specialty
pharmaceutical company focused on the development, manufacturing, and
commercial supply of high potency, high barrier to entry
pharmaceutical products for sale in the U.S., Canada, Japan,
Australia, Europe, and in other countries around the world. 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 generous benefits of Irish government programs encouraging
research and development in Ireland. Eirgen also offers significant
synergies and benefits to OPKO through is ability to manufacture
OPKO’s current and future products which will contribute to a more
favorable tax rate in the future.
Rayaldee NDA Submission Accepted by FDA; Expected PDUFA date of
March 29, 2016: OPKO previously announced successful top-line
results from both of its pivotal Phase 3 trials with Rayaldee in late
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.
Completed the Enrollment in its 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 to placebo in decreasing fat mass in adults with GHD. The
trial is a randomized, double-blind, placebo-controlled, multi-center,
global study in adults with GHD. The study is divided into two
treatment periods: a 26-week, double-blind, placebo-controlled part,
followed by a 26-week, open-label extension. The study is expected to
end toward the second half of 2016; regulatory submission 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 Coagulation Factor
VIIa-CTP to Treat Hemophilia. Clinical Trials are expected to commence
during Q3 2015.
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.
OPKO’s 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 the 2015 NCCN Guidelines for Prostate Cancer Early
Detection. 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.
Rolapitant PDUFA Date is September 5, 2015: 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. Upon approval and
following commercialization, OPKO will receive up to $110 Million in
additional milestones and tiered, double digit royalties.
“The first half of 2015 was transformational for OPKO,” said Phillip
Frost, M.D., Chairman and CEO. “We believe that the closing of the
Pfizer transaction, the acquisition of EirGen and our pending
transaction with Bio-Reference will result in OPKO having significant
revenue opportunities and an expanded commercial presence to broadly
sell and market our products and services. The submission and acceptance
of our NDA filing for Rayaldee were also important parts of bringing to
market a new therapeutic option for patients with stage 3 or 4 chronic
kidney disease and vitamin D insufficiency. We expect the initiation of
our important clinical development programs for Factor VIIa-CTP and
oxyntomodulin, products with great commercial potential, during the
second half of the year,” continued Dr. Frost. “The 4Kscore Test’s
addition to the NCCN guideline represents a major step towards its
becoming the standard of care for early detection of aggressive prostate
cancer as well as obtaining reimbursement from the healthcare providers.”
Financial Highlights
Cash, cash equivalents and marketable securities were $221.2 million
as of June 30, 2015.
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 cash on hand of EirGen) and a
one-time $25.9 million payment to the Office of the Chief
Scientist in Israel related to the Pfizer transaction.
Consolidated revenues increased to $42.4 and $72.5 million during the
three and six months ended June 30, 2015 from $23.5 and $45.8 million
in the comparable periods of 2014. Revenue for the three and six
months ended June 30, 2015 included $17.7 and $30.2 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 and six months ended June 30, 2015 was $42.8
million and $159.9 million and included increased operating expenses
including increased research and development expense of $13.3 million
and $17.8 million, respectively, in comparison to the 2014 periods.
Further, the three and six month periods included significant
$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
$16.6 million and $66.3 million in non-cash charges related to the
change in value of embedded derivatives during the three and six
months of 2015, 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: Wednesday, August 5, 2015, 4:30 p.m. ET
DOMESTIC & CANADA DIAL-IN: (888) 283-6901
INTERNATIONAL DIAL-IN: (719) 457-2506
LIVE WEBCAST LINK: http://public.viavid.com/index.php?id=115768
For those unable to participate in the conference call or webcast, a
replay will be available beginning August 5, 2015 at 7:30 p.m. ET until
August 12, 2015 at 11:59 p.m. ET. To access the replay, dial (877)
870-5176 or (858) 384-5517. The replay passcode is 6203507.
The replay can also be accessed for a period of 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.
Important Information For Investors And Shareholders
This communication does not constitute an offer to buy or sell or the
solicitation of an offer to buy or sell any securities or a solicitation
of any vote or approval. This communication relates to a proposed
business combination between Bio-Reference Laboratories, Inc.
("Bio-Reference Laboratories") and OPKO Health, Inc. ("OPKO"). In
connection with this proposed business combination, Bio-Reference
Laboratories and/or OPKO will file relevant materials with the
Securities Exchange Commission (the "SEC"), including an OPKO
registration statement on Form S-4, which was filed with the SEC on July
2, 2015, was amended by Amendment No. 1 on July 15, 2015, and was
declared effective on July 17, 2015, and a definitive proxy
statement/prospectus in connection with the proposed transaction, which
was filed by Bio-Reference Laboratories and OPKO on July 20, 2015.
Bio-Reference Laboratories first mailed the definitive proxy
statement/prospectus to Bio-Reference Laboratories shareholders on July
20, 2015. INVESTORS AND SECURITY HOLDERS OF BIO-REFERENCE LABORATORIES
AND OPKO ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT/PROSPECTUS AND
OTHER DOCUMENTS THAT MAY BE FILED WITH THE SEC CAREFULLY AND IN THEIR
ENTIRETY AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION.
Investors and security holders may obtain free copies of the
definitive proxy statement/prospectus and other documents filed with the
SEC by Bio-Reference Laboratories and/or OPKO through the website
maintained by the SEC at www.sec.gov .
Copies of the documents filed with the SEC by Bio-Reference Laboratories
are available free of charge on Bio-Reference Laboratories' website at http://www.bioreference.com
or by contacting Bio-Reference Laboratories' Investor Relations
Department by email at tmackay@bioreference.com
or by phone at (201) 791-2600. Copies of the documents filed with the
SEC by OPKO are available free of charge on OPKO's website at www.opko.com
or by contacting OPKO's Investor Relations Department by email at contact@opko.com
or by phone at (305) 575-4100.
Participants in Solicitation
Bio-Reference Laboratories, OPKO, their respective directors and
certain of their respective executive officers may be considered
participants in the solicitation of proxies in connection with the
proposed transaction. Information about the directors and executive
officers of Bio-Reference Laboratories is set forth in its Annual Report
on Form 10-K for the year ended October 31, 2014, which was filed with
the SEC on January 13, 2015, its Quarterly Report on Form 10-Q for the
quarter ended April 30, 2015 which was filed with the SEC on June 9,
2015 and its Current Reports on Form 8-K, which were filed with the SEC
on March 5, 2015, April 29, 2015, June 4, 2015, June 8, 2015, June 10,
2015 and June 11, 2015. Information about the directors and executive
officers of OPKO is set forth in its amended Annual Report on Form 10-K
for the year ended December 31, 2014, which was filed with the SEC on
February 27, 2015 and April 30, 2015, its proxy statement for its 2015
annual meeting of stockholders, which was filed with the SEC on May 7,
2015, its Quarterly Report on Form 10-Q for the quarter ended March 31,
2015 which was filed with the SEC on May 11, 2015 and its Current
Reports on Form 8-K, which were filed with the SEC on March 19, 2015,
June 4, 2015, June 9, 2015, June 10, 2015, June 18, 2015 and July 2,
2015.
These documents can be obtained free of charge from the sources
indicated above. Additional information regarding the participants in
the proxy solicitations and a description of their direct and indirect
interests, by security holdings or otherwise, is contained in the
definitive proxy statement/prospectus and other relevant materials filed
with the SEC.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements in this communication regarding the proposed
acquisition of Bio-Reference Laboratories by OPKO, including any
statements regarding the expected timetable for completing the proposed
transaction, synergies, benefits and opportunities of the proposed
transaction, future opportunities for the combined company and products,
future financial performance and any other statements regarding OPKO's
and Bio-Reference Laboratories' future expectations, beliefs, plans,
objectives, financial conditions, assumptions or future events or
performance that are not historical facts are "forward-looking"
statements made within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. The words "anticipate," "believe," "ensure," "expect,"
"if," "intend," "estimate," "probable," "project," "forecasts,"
"predict," "outlook," "aim," "will," "could," "should," "would,"
"potential," "may," "might," "anticipate," "likely" "plan,"
"positioned," "strategy," and similar expressions, and the negative
thereof, are intended to identify forward-looking statements.
All forward-looking information are subject to numerous risks and
uncertainties, many of which are beyond the control of Bio-Reference
Laboratories and OPKO, that could cause actual results to differ
materially from the results expressed or implied by the statements.
These risks and uncertainties include, but are not limited to: failure
to obtain the required vote of Bio-Reference Laboratories' shareholders;
the timing to consummate the proposed transaction; the risk that a
condition to closing of the proposed transaction may not be satisfied or
that the closing of the proposed transaction might otherwise not occur;
the risk that a regulatory approval that may be required for the
proposed transaction is not obtained or is obtained subject to
conditions that are not anticipated; the diversion of management time on
transaction-related issues; ability to successfully integrate the
businesses; risk that the transaction and its announcement could have an
adverse effect on Bio-Reference Laboratories' ability to retain
customers and retain and hire key personnel; the risk that any potential
synergies from the transaction may not be fully realized or may take
longer to realize than expected; new information arising out of clinical
trial results; and the risk that the safety and/or efficacy results of
existing clinical trials will not support continued clinical
development, as well as risks inherent in funding, developing and
obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments. 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 communication may become outdated over time. OPKO and
Bio-Reference Laboratories do not assume any responsibility for updating
any forward-looking statements. Additional information concerning these
and other factors can be found in Bio-Reference Laboratories' and OPKO's
respective filings with the SEC and available through the SEC's
Electronic Data Gathering and Analysis Retrieval system at www.sec.gov ,
including Bio-Reference Laboratories' and OPKO's most recent Annual
Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports
on Form 8-K and the definitive proxy statement/prospectus. The foregoing
list of important factors is not exclusive. Bio-
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