MIAMI -- (BUSINESS WIRE) -- OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and diagnostics company, today reported operating and financial results for its 2013 fourth quarter and full year ended December 31, 2013.
These expenses were partially offset by $29.9 million in gains recorded on the successful exit from strategic investments during 2013. OPKO’s 2012 results also included $9.6 million in net tax benefits principally related to the acquisition of our laboratory business in late 2012.
Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer, commented, “From an R&D perspective, all of our programs are progressing. We made significant strides in 2013 with our ongoing Phase 3 trials for Rayaldy™ and hGH-CTP; 2014 will be a pivotal year for our development programs. We look forward to announcing top-line results for Rayaldy™ in mid-2014 and filing a NDA during the first half of 2015. We are also enthusiastic about the planned launch later this month of our 4Kscore™ blood test for prostate cancer which we believe will lead to a great improvement in the diagnosis and management of prostate cancer.”
“Work has been continuing in our research laboratories on a program to utilize specific oligonucleotides to up regulate protein production. A pre-IND meeting has been scheduled with FDA in connection with the development of the first product to treat Dravet’s Syndrome, a congenital condition characterized by chronic seizures.”
Dr. Frost added, “During the year, we further strengthened our cash position by exiting certain strategic investments which provided attractive returns. Bolstered by our sound financial position, we look forward to continuing the advance of our robust product development pipeline of promising diagnostics and pharmaceuticals.”
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 efforts, including whether the Phase 3 clinical trials for Rayaldy™, hGH-CTP, rolapitant, and our clinical validation study for the 4Kscore™ will be completed on a timely basis or at all and whether the data will support approval, validation and/or reimbursement for our products, our ability to enroll in our 4Kscore™ study more than 1,200 patients referred for a prostate biopsy, the expected timing for launch of our products in development, including the 4Kscore™, Rayaldy™, 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 Rayaldy™, the 4Kscore™, hGH-CTP, and a treatment for Dravet’s Syndrome, the timing for submission of a NDA by us for Rayaldy™ and by TESARO for rolapitant, whether TESARO will identify a dose of IV rolapitant that provides comparable exposure to the oral formulation, whether the 4Kscore™ has great potential in the diagnosis and treatment of prostate cancer, expectations regarding the performance of companies in which we have a strategic investment and whether we will monetize and realize a profit from our strategic investments, and whether we will continue to solidify our broad development pipeline across a growing operating platform, 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 Rayaldy™, rolapitant, hGH-CTP, and/or any of our compounds or diagnostic products under development, including our 4Kscore™ test, 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|
|As of December 31,|
|Cash and cash equivalents||$||185.8||$||27.4|
|Other current assets||56.9||51.3|
|In-process R&D and Goodwill||1,019.7||92.0|
|Liabilities, Series D Preferred Stock and Equity:|
|2033 Senior Notes, net||211.9||-|
|Other long-term liabilities, principally contingent consideration and deferred tax liabilities||214.8||34.1|
|Series D Preferred Stock and Equity||873.0||203.3|
|Total Liabilities, Series D Preferred Stock and Equity||$||1,391.5||$||289.8|
|OPKO Health, Inc. and Subsidiaries|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in millions, except per share data)|
For the Three
|December 31,||December 31,|
|Costs and expenses||(56.5||)||(25.8||)||(176.1||)||(84.3||)|
|Operating loss from continuing operations||(35.8||)||$||(9.6||)||(79.6||)||(37.3||)|
|Other income and (expense), net||21.4||(0.3||)||(24.6||)||0.1|
|Benefit from/(Provision for) income taxes||0.6||9.7||(1.7||)||9.6|
|Loss from continuing operations before investment losses||(13.8||)||(0.2||)||(105.9||)||(27.6||)|
|Loss from investments in investees||(3.5||)||(0.6||)||(11.4||)||(2.1||)|
|Loss from continuing operations||(17.3||)||(0.8||)||(117.3||)||(29.7||)|
|Income from discontinued operations, net of tax||-||0.2||-||0.1|
|Less: Net loss attributable to noncontrolling interests||0.5||-||2.9||0.5|
|Preferred stock dividend||-||(0.5||)||(0.4||)||(2.2||)|
|Net loss attributable to common shareholders||$||(16.8||)||$||(1.1||)||$||(114.8||)||$||(31.3||)|
|Basic and diluted earnings per share||$||(0.04||)||$||(0.00||)||$||(0.32||)||$||(0.11||)|