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