MIAMI, March 01, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), reports financial and operating results for the three months ended December 31, 2016.
“OPKO reached a number of important milestones during 2016,” stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. “We launched RAYALDEE, the first new medicine we have developed and launched ourselves. The commercial team is making great strides in the early days of the launch and has so far secured formulary access for 60% of all U.S. insured patients.”
“Use of our innovative 4Kscore test for predicting the probability of aggressive prostate cancer increased to nearly 18,000 tests ordered in the fourth quarter. We have now set the stage for continued, profitable growth at BioReference with a revenue cycle management program that is expected to improve financial results on an ongoing basis.
“We have a number of important initiatives ahead of us in 2017 and early 2018. We will complete the recently initiated clinical trial for our Claros POC diagnostic test for PSA and plan to file a PMA as quickly as possible upon completion. Along with our partner, Vifor Fresenius, we plan to initiate a Phase 2 trial in dialysis patients with SHPT. We also plan to initiate a Phase 2b trial for our SARM for the treatment of BPH, a condition that affects approximately 50 million men in the U.S., as well as a Phase 2 dose escalation study for TT401 to treat obesity and type II diabetes.
“We are diligently working to complete analysis of the data from our Phase 3 clinical trial for hGH-CTP in adults and are aggressively advancing our pediatric Phase 3 clinical trial for hGH-CTP,” Dr. Frost concluded.
CONFERENCE CALL & WEBCAST INFORMATION:
OPKO’s senior management will provide a business update and discuss the results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today.
The conference call dial in information is listed below. To access the webcast, please log on to the OPKO website at www.opko.com.
WHEN: Wednesday, March 1, 2017, 4:30 p.m. Eastern time.
DOMESTIC DIAL-IN: (866) 634-2258
INTERNATIONAL DIAL-IN: (330) 863-3454
For those unable to participate in the live conference call or webcast, a replay will be available beginning March 1, 2017 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 80392791. The replay can be accessed for a period of time on OPKO’s website at http://investor.opko.com/events.cfm.
About OPKO Health, Inc.
OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator to treat men with BPH. Our biologics portfolio includes hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), and a long-acting Factor VIIa drug for hemophilia (in phase 2a). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com.
Cautionary Statement Regarding Forward-Looking Statements
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, whether we will experience continued, profitable growth at Bio-Reference, whether our revenue cycle management program will improve financial results, our product development efforts and the expected benefits of our products, including whether our ongoing and future clinical trials will be successfully completed on a timely basis or at all and whether the data from any of our trials will support approval, validation and/or reimbursement for our products, the expected timing for launch of our products in development, whether the data for the hGH-CTP study in adults will support approval of a BLA, the expected timing of commencing and concluding our clinical trials, enrollment in clinical trials, and disclosure of results for the trials, the timing of our regulatory submissions, our ability to market and sell any of our products in development, expectations about developing RAYALDEE for dialysis patients, our ability to obtain broad reimbursement coverage for the 4Kscore test, increased adoption rates for the 4Kscore, 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 integration challenges for Bio-Reference, EirGen, Transition, and other acquired businesses, 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, Varubi™, hGH-CTP, TT-401, TT-701, 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.
Tara Mackay, 305-575-4100
Rooney & Associates
Terry Rooney, 212-223-0689
Marion Janic, 212-223-4017
Anne Marie Fields, 212-838-3777
Bruce Voss, 310-691-7100
| OPKO Health, Inc. and Subsidiaries|
Condensed Consolidated Balance Sheets
|December 31, |
|December 31, |
|Cash, cash equivalents and marketable securities||$||168.7||$||193.6|
|Other current assets||314.9||260.5|
|Total Current Assets||483.6||454.1|
|In-process Research and Development and Goodwill||1,349.3||1,535.6|
|Liabilities and Equity:|
|2033 Senior Notes, net||43.7||49.0|
|Deferred tax liabilities||165.3||226.0|
|Other long-term liabilities, principally deferred revenue and contingent consideration||202.5||292.5|
|Total Liabilities and Equity||$||2,766.6||$||2,799.2|
| OPKO Health, Inc. and Subsidiaries|
Condensed Consolidated Statements of Operations
(in millions, except per share data)
|For the three months ended |
|For the years ended |
|Revenue from services||$||234.6||$||221.8||$||1,012.1||$||329.7|
|Revenue from products||20.2||21.1||83.5||80.1|
|Revenue from transfer of intellectual property||20.7||33.3||126.1||81.9|
|Costs and expenses|
|Cost of revenues||159.3||143.1||611.5||235.2|
|Selling, general and administrative||120.5||102.9||490.9||196.6|
|Research and development||27.6||25.5||111.2||99.5|
|Amortization of intangible assets||17.1||14.0||64.4||28.0|
|Total Costs and expenses||325.9||284.1||1,295.0||590.2|
|Operating (loss) income||(50.4||)||(7.9||)||(73.3||)||(98.5||)|
|Other income and (expense), net||7.7||(16.0||)||(0.2||)||(39.5||)|
|(Loss) income before income taxes and investment losses||(42.7||)||(23.9||)||(73.5||)||(138.0||)|
|(Provision for) benefit from income taxes||31.5||26.5||56.1||113.7|
|(Loss) income before investment losses||(11.2||)||2.6||(17.4||)||(24.3||)|
|Loss from investments in investees||(2.5||)||(1.0||)||(7.7||)||(7.1||)|
|Net (loss) income||(13.7||)||1.6||(25.1||)||(31.4||)|
|Less: Net loss attributable to non-controlling interests||-||-||-||(1.4||)|
|Net (loss) income attributable to common shareholders||$||(13.7||)||$||1.6||$||(25.1||)||$||(30.0||)|
|Basic income (loss) per share||$||(0.02||)||$||0.00||$||(0.05||)||$||(0.06||)|
|Diluted income (loss) per share||$||(0.04||)||$||0.00||$||(0.05||)||$||(0.06||)|