OPKO Announces Fourth Quarter and Full Year 2013 Results

OPKO Announces Fourth Quarter and Full Year 2013 Results

Fourth Quarter Revenue Increases About 30%; Full Year Revenue More      Than Doubled to $96.5 Million

Company Has Strong Liquidity, Including Cash and Cash Equivalents of       $185.8 million as of December 31, 2013

Launch of 4Kscore™ Planned in Q1 2014

OPKO Health Inc(OPK:NYSE, US)

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As of 04 Mar 2014 at 9:31 AM EST.

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Open 9.57 P/E Ratio (TTM)
Last Bid/Size 9.60 / 5 EPS (TTM) -0.29
Last Ask/Size 9.64 / 7 Next Earnings
Previous Close 9.40 Beta 1.05
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52 Week Low 6.14 Short Interest as % of Float 21.53%

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.

Financial Highlights

  •         For the fourth quarter of 2013, consolidated revenues increased about        30% to $20.7 million from $16.2 million in the prior year period. For        the year ended December 31, 2013, consolidated revenues more than        doubled to $96.5 million from $47.0 million in the prior year. Revenue        for the year ended December 31, 2013, included $12.5 million of        revenue resulting from a strategic partnership in the field of RNA        interference with RXi Pharmaceuticals Corporation.
  •         Cash and cash equivalents were $185.8 million as of December 31, 2013,        providing OPKO with liquidity to fund research and development and the        Company’s operations.
  •         Cash used in operations was $58.2 million during the year ended         December 31, 2013, as compared with $25.4 million of cash used in        operations during the year ended December 31, 2012. The increase in        cash used in operations during 2013 reflects the full impact of our        August and March 2013 acquisitions of PROLOR Biotech, Inc. and         Cytochroma Inc., respectively. During 2013, we also utilized        approximately $8.8 million for transaction-related expenses.
  •         Net loss for the 2013 fourth quarter was $16.8 million compared to a        net loss of $1.1 million for the 2012 period. The increase in net loss        for the 2013 fourth quarter was principally related to research and        development expenses incurred in connection with our ongoing Phase 3        clinical trials of Rayaldy™ and human growth hormone        (“hGH-CTP”), and interest expense related to the January 2013        convertible senior notes due in 2033 (the “2033 Senior Notes”), which        expenses were partially offset by $18.9 million in gains recorded on        the successful exit from strategic investments. The 2012 fourth        quarter results also included $9.7 million in net tax benefits        principally related to the acquisition of our laboratory business in        late 2012.
  •         Net loss for the full 2013 year was $114.8 million compared to $31.3        million for the 2012 period. The increase in net loss for the 2013        full year was primarily related to the previously mentioned research        and development expenses related to our Rayaldy™ and hGH-CTP        clinical trials, interest expense on the 2033 Senior Notes, and        non-recurring costs related to strategic and business development        activities, as well as the following non-cash charges:
    • $36.5 million related to the change in fair value of derivative            instruments, principally related to embedded derivatives that are            part of the 2033 Senior Notes;
    • $11.5 million on losses from investments in equity method            investees;
    • $8.7 million loss from early conversion of some of the 2033 Senior            Notes; and
    • $6.9 million related to the change in fair value of contingent            consideration payable in connection with prior acquisitions.

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.”

Business Highlights

  • Finalizing Steps Toward 4Kscore Launch: In         February 2014, OPKO announced successful initial results of the        clinical validation study of the 4Kscore™ test currently        underway at 21 large urology centers in the United States. The study,        involving more than 1,200 men, is now more than 50% complete and        supports the U.S. launch of the 4Kscore™ test later this month.
  • Completed Patient Recruitment In The Second Phase 3 Trial of Rayaldy™:         This trial is the second of two identical randomized,        double-blind, placebo-controlled, multi-site studies for Rayaldy™        — to treat patients with secondary hyperparathyroidism (SHPT), stage        3 or 4 chronic kidney disease (CKD) and vitamin D deficiency. Top-line        results from both trials are expected in mid-2014.
  • Positive Pre-Clinical Results on Long-acting Factor VIIa-CTP        Presented at the 7th Annual Congress of the European Association for        Haemophilia and Allied Disorders (EAHAD); Orphan Drug Designation also        Granted by FDA. Preclinical data presented at EAHAD on February        26-28 in Brussels, showed that OPKO’s long-acting Factor VIIa-CTP        exhibited a four times longer half-life and a four times improved drug        exposure versus Novo Nordisk’s $1.7 billion Factor VIIa product,        NovoSeven. Additionally, on February 27, 2014, the FDA granted orphan        drug designation to OPKO’s long-acting Factor VIIa-CTP for the        treatment and prophylaxis of bleeding episodes in patients with        hemophilia A or B with inhibitions against Factors VIII or IX.
  • TESARO Achieves Successful Primary Endpoints in Phase 3 Trials of        Rolapitant. TESARO recently announced that two Phase 3 trials of        oral rolapitant, one in patients receiving moderately emetogenic        chemotherapy (MEC) and one in patients receiving cisplatin-based        highly emetogenic chemotherapy (HEC), each met the primary endpoint of        complete response (CR) in the delayed (24 to 120 hour) timeframe        following chemotherapy. Enrollment in the third and final Phase 3        trial of oral rolapitant, which is being conducted in patients        receiving cisplatin-based HEC, is expected to conclude during the        first quarter of 2014. TESARO anticipates that results from this study        will be available in the second quarter of 2014. Further, the clinical        trial of intravenous (IV) rolapitant is well underway, and TESARO        anticipates finalizing the dose that will provide comparable exposure        to the oral formulation by the end of the first quarter of 2014.
  • Completed Acquisition of Laboratorio Arama de Uruguay Limitada:        OPKO has continued to grow its Latin American presence with the early         January 2014 acquisition of Laboratorio Arama de Uruguay Limitada        (“Arama”). Arama broadens the global commercial prospects for OPKO’s        product pipeline by establishing a footprint in Uruguay that may        facilitate the Company’s future commercial expansion into neighboring         Argentina, as well as by providing another platform to commercialize        the 4Kscore™ product.
  • OPKO Investee, Neovasc, Successfully Completes First Human Implant        of Tiara™ Transcatheter Mitral Valve: In early February 2014,        Neovasc Inc., announced that a human implantation of its Tiara™        transcatheter mitral valve was successfully performed on January 30th        by physicians at St. Paul’s Hospital in Vancouver, BC. The transapical        procedure resulted in the elimination of mitral regurgitation (MR) and        significantly improved heart function in the patient, without the need        for cardiac bypass support and with no procedural complications.        OPKO’s investment in Neovasc continues to appreciate.
  • Exit from Sorrento Therapeutics: In mid-December 2013, OPKO        reported the highly successful exit of its investment in Sorrento        Therapeutics, Inc. The sale of Sorrento shares added to OPKO’s cash        position and represented an approximate ten-fold return of OPKO’s 2009        investment
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