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OPKO Announces First Quarter Operating Results

Stocks in this article: OPK

Net loss attributable to common shareholders increased to $45.1 million for the three months ended March 31, 2014 compared to $34.6 million in the comparable period of 2013 partially as a result of the 2013 period including $12.5 million of non-cash income related to the RXi transaction. In addition, OPKO continued to increase its investment in research and development activities related to its ongoing phase 3 programs for RAYALDEE and hGH-CTP as well as costs associated with the clinical validation study for the 4Kscore. As a result, OPKO’s spending on research and development increased $11.0 million to $21.0 million for the three months ended March 31, 2014 from $9.9 million for the three months ended March 31, 2013. Net loss for the three months ended March 31, 2014 included $10.5 million of non-cash expense related to the mark to market of certain derivative instruments related to our convertible debt instruments compared to $23.5 million for the three months ended March 31, 2013.

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 our research and development and operations, our product development effort and the expected benefits of our products, including whether the phase 3 clinical trials for RAYALDEE, hGH-CTP, and rolapitant will be completed on a timely basis or at all and whether the data 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 Spain and through our other subsidiaries, the timing for submission of an NDA by us for RAYALDEE and by TESARO for rolapitant, whether TESARO will complete a dose study for its IV formulation and the timing thereof, 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, whether the Irish operation will manage, oversee and contribute to the manufacturing and sale of the 4Kscore, RAYALDEE, and other products in development, 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

(in millions)

  As of

March 31,2014

 

December 31,2013

Assets:
Cash and cash equivalents $ 156.4 $ 185.8
Other current assets   48.8   56.9
205.2 242.7
In-process Research and Development and Goodwill 1,091.3 1,019.7
Other assets   59.1   129.1
Total Assets $ 1,355.6 $ 1,391.5
 
Liabilities, Series D Preferred Stock and Equity:
Current liabilities $ 84.5 $ 91.8
2033 Senior Notes, net 224.8 211.9
Other long-term liabilities   215.1   214.8
Total Liabilities 524.4 518.5
Series D Preferred Stock and Equity   831.2   873.0
Total Liabilities, Series D Preferred Stock and Equity $ 1,355.6 $ 1,391.5
OPKO Health, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(in millions, except per share data)

  For the three months ended March 31,
2014     2013  
 
Revenues $ 22.3 $ 31.3
Costs and expenses   52.6     38.1  
Operating loss (30.3 ) (6.8 )
Other income and (expense), net   (12.1 )   (24.1 )
Loss before income taxes and investment losses (42.4 ) (30.8 )
Benefit from (provision for) income taxes   (0.6 )   (0.1 )
Loss before investment losses (43.0 ) (30.9 )
Loss from investments in investees   (2.1 )   (3.9 )
Net loss (45.1 ) (34.8 )
Less: Net loss attributable to non-controlling interests (0.5 ) (0.5 )
Preferred stock dividend   -     (0.4 )
Net loss attributable to common shareholders $ (44.6 ) $ (34.6 )
Basic and diluted loss per share $ (0.11 ) $ (0.11 )




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