OPKO – News

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Second Quarter 2013 Financial Highlights

opko-160x160MIAMI — OPKO Health, Inc. (NYSE: OPK), a multi-national biopharmaceutical and diagnostics company, today reported operating and financial highlights for the second quarter of 2013.

OPKO Health Inc. (OPK: Quote) on Friday said that its second quarter net loss improved as revenue more than doubled compared to the year-ago quarter.

TESARO_OPKO_DAYTRADERPICKSTop-line results from a phase III trial of Rolapitant, which OPKO out-licensed to biopharmaceutical company TESARO Inc., are anticipated in the second half of 2013. Rolapitant is under phase III testing for the treatment of chemotherapy-induced nausea and vomiting.

OPK closed Friday ( 8/9/13)  trading at $7.49. In after-hours, the stock was up 0.53% to $7.53.

Second Quarter 2013 Financial Highlights

Consolidated revenues more than doubled to $23.8 million during the three months ended June 30, 2013, from $10.2 million in the prior year period and nearly tripled to $55.2 million for the six months ended June 30, 2013, from $19.0 million in the prior year period. Revenue for the six months ended June 30, 2013, includes $12.5 million of revenue resulting from a strategic partnership in the field of RNA interference with RXi Pharmaceuticals Corporation.

Net loss for the three months ended June 30, 2013, was $ 3.4 million, compared to a net loss of $10.8 million for the 2012 period. Net loss for the three months ended June 30, 2013, includes the impact of:

$9.9 million non-cash benefit related to the change in fair value of embedded derivatives which are part of our January 2013 convertible senior notes due in 2033 (the “2033 Senior Notes”). This non-cash benefit resulted principally from the decrease in the closing market price of our common stock as of June 30, 2013, as compared to the previous quarter end; and

$8.5 million related to other income from the sale of available for sale securities.

Net loss for the six months ended June 30, 2013, was $38.0 million, compared to a net loss of $20.0 million for the 2012 period. Net loss for the six months ended June 30, 2013, includes the impact of:

$14.9 million in net non-cash charges related to the change in fair value of embedded derivatives which are part of our 2033 Senior Notes, principally as a result of the increase in the closing market price of our common stock as of June 30, 2013, as compared to the date of issuance of such notes; and

$10.8 million related to other income from the sale of available for sale securities.

Cash, cash equivalents and marketable securities were $169.1 million as of June 30, 2013.

Business Highlights

PHARMADIET_OPKO_DAYTRADERPICKS

Our Spanish subsidiary, Pharmadiet, S.L.U., received regulatory approval for commercialization of its oral and injectable formulations of citicoline to treat memory disorders and behavior related to stroke, head injury, chronic disease, as well as degenerative brain disorders.

The two Phase 3 trials of Rayaldy™, our vitamin D prohormone to treat patients with secondary hyperparathyroidism with stage 3 or 4 chronic kidney disease and vitamin D insufficiency, are progressing on schedule. We anticipate top-line data from this pivotal program in mid-2014.

Prolor-Biotech_OPKOOur acquisition of PROLOR Biotech, Inc. (NYSE MKT: PBTH), a biopharmaceutical company focused on developing longer-acting proprietary forms of presently marketed therapeutic proteins and peptides, is expected to close during the third quarter of 2013. PROLOR has reported that its long-acting version of human growth hormone, hGH-CTP, can reduce the dosing frequency from one injection per day to a single weekly injection. A Phase 2 trial in children with GHD is currently ongoing, and a Phase 3 trial in adults with GHD was initiated in June 2013. PROLOR also recently announced results from preclinical studies of its long-acting clotting factor VIIa (Factor VIIa-CTP), a next-generation investigational therapy in advanced preclinical development for the potential treatment of hemophilia. The data indicate that Factor VIIa-CTP can be administered by subcutaneous (SC) injection in contrast to presently used products which must be given intravenously; this would facilitate its prophylactic at home use.

Enrollment, now surpassing 90%, continues by our licensee, TESARO, Inc. in each of three Phase 3 trials of Rolapitant for the prevention of chemotherapy induced nausea and vomiting. TESARO anticipates that top-line data from this pivotal program will be announced by year end. TESARO also presented results from a pharmacokinetic study of Rolapitant at the recent Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium in Berlin. These data support concomitant administration of Rolapitant with other pharmaceutical products that are metabolized by the liver microsomal enzyme CYP3A4, without a requirement for dose adjustment of the co-administered product.

The U.S. commercial launch of the OPKO 4Kscore™ prostate cancer test as a laboratory developed test will be through our CLIA-certified laboratory based in Nashville, TN.

“We continue to build and strengthen the foundation for a sound profitable business,” said Phillip Frost, M.D., OPKO’s Chairman and Chief Executive Officer. “We are pleased that Pharmadiet, our Spanish subsidiary, has received regulatory approval for our oral and injectable formulations of citicoline, and we are beginning the process for marketing them in Spain as well as through our Latin American units. These products will be sold by prescription to improve memory in certain patients,” continued Dr. Frost. “We are also very proud of the pipeline of new products in various stages of development in OPKO and soon to be acquired PROLOR. They can provide the basis for an important health care company.”

About OPKO Health, Inc.

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.

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OPKO Health, Inc – In The News

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Increased Demand, Fast Track Designations, and Strong Sales Boost Revenue Growth 

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Research Report on Alexion, Baxter International, Align Technology, Transition, and OPKO

NEW YORK, July 23, 2013 /PRNewswire/ —

Today, Analysts’ Corner announced new research reports highlighting Alexion Pharmaceuticals Inc. (NASDAQ: ALXN), Baxter International Inc. (NYSE: BAX), Align Technology, Inc. (NASDAQ: ALGN), Transition Therapeutics Inc. (NASDAQ: TTHI), and OPKO Health Inc. (NYSE: OPK).

opko-160x160OPKO Health Inc. Research Report

On July 16, 2013, OPKO Health Inc. (OPKO) announced the appointment of David Okrongly, Ph.D. as the President of the Company’s Diagnostics Business Unit. According to OPKO, Dr. Okrongly brings extensive experience developing and commercializing advanced diagnostic platforms. Prior to his involvement with OPKO, Dr. Okrongly served as the Chief Operating Officer of Exosome Diagnostics, Inc., where he was responsible for establishing product, platform, and regulatory strategy for the Company’s proprietary technology for purifying RNA derivatives from exosomes. Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO, said, “David’s profound industry knowledge will be invaluable as we near the U.S. commercial launch for our 4Kscore prostate cancer diagnostic test, advance the development of our point of care diagnostic platform, and continue to execute our strategy of establishing industry-leading positions in large and rapidly growing medical markets.” The Full Research Report on OPKO Health Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/cd43_OPK]

Alexion Pharmaceuticals Inc. Research Report

On July 16, 2013, Alexion Pharmaceuticals Inc. (Alexion) announced that the Company’s first-in-class terminal complement inhibitor, Soliris (eculizumab) has received a positive opinion for orphan medicinal product designation from the Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMA) for the treatment of neuromyelitis optica (NMO), a life-threatening, ultra-rare neurological disorder. An orphan medicinal product status, granted by the European Commission, provides incentives to develop medicinal products to treat, prevent, or diagnose diseases or conditions that affect no more than five in 10,000 persons in the EU. The proposed status would provide Alexion with certain benefits and incentives, including a period of marketing exclusivity. According to the Company, the positive opinion of the COMP has now been forwarded to the European Commission for final approval and publication in the community register. The Full Research Report on Alexion Pharmaceuticals Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/4619_ALXN]

Baxter International Inc. Research Report

On July 18, 2013, Baxter International Inc. (Baxter International) announced its financial results for Q2 2013. Worldwide sales of the Company increased 3% YoY to $3.7 billion. According to the Company, BioScience sales rose 6% YoY on constant currency basis and 5% on actual basis to $1.6 billion, due to improved demand for the Company’s hemophilia therapies, including ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] and FEIBA (an inhibitor therapy) as well as accelerated growth of select plasma-based therapeutics and vaccines. The Company reported Medical Products sales of $2.0 billion, reflecting 1% growth, driven primarily by gains in peritoneal dialysis patients, as well as growth of certain injectable therapies and anesthesia products. Further, the Company reported net income of $590 million or $1.07 per diluted share compared to net income of $661 million or $1.19 per diluted share in Q2 2012. These results include after-tax special items totaling $49 million ($0.09 per diluted share) primarily for costs associated with Baxter’s planned acquisition of Gambro AB. Q2 2013 results also included a net after-tax benefit from special items totaling $42 million of income ($0.07 per diluted share). The Full Research Report on Baxter International Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/163d_BAX]

Align Technology, Inc. Research Report

On July 18, 2013, Align Technology Inc. (Align Technology) reported its financial results for Q2 2013. Total net revenues increased 6.6% QoQ to $163.8 million, with Invisalign clear aligner revenues increasing 8.3% QoQ to $153.3 million. Net profit was $29.3 million or $0.36 per diluted share compared to net loss of $42 million or $0.52 per diluted share in Q1 2013 and net profit of $28.5 million or $0.34 in Q2 2012. Commenting on the results, Thomas M. Prescott, President and Chief Executive Officer of Align Technology, said, “Strong second quarter results were driven by higher Invisalign volumes and ASPs, with sequential growth across all customer channels.” The Full Research Report on Align Technology, Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/69b3_ALGN]

Transition Therapeutics Inc. Research Report

On July 17, 2013, Transition Therapeutics Inc. (Transition) announced that the US Food and Drug Administration (FDA) granted Fast Track Designation to the development program for ELND005, which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer’s disease (AD). According to the Company, ELND005 is an orally bioavailable small molecule that is being investigated by Transition’s licensing partner, Elan Corporation plc (Elan), for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes beta-amyloid anti-aggregation and regulation of brain myo-inositol levels. Elan will be responsible for all development and commercialization activities as well as costs of ELND005. The Full Research Report on Transition Therapeutics Inc. – including full detailed breakdown, analyst ratings and price targets – is available to download free of charge at: [ http://www.analystscorner.com/r/full_research_report/09eb_TTHI]

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