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Aug 8

OPKO Health Reports Second Quarter 2017 Business and Financial Results – GlobeNewswire (press release)

MIAMI, Aug. 08, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) (OPKO or the Company), reports business and financial results for the three and six months ended June 30, 2017.

Business Highlights

Sales force expansion for RAYALDEE underway. OPKO has made substantial progress in obtaining formulary access for RAYALDEE, with more than 68% of potential patient lives now covered under insurance plans. With the more extensive insurance coverage available, OPKO is continuing to expand its field-based sales force to 70 representatives from the original 35. Phase 2a trial for intravenously administered Factor VII-CTP and Phase 1 trial for subcutaneously administered Factor VII-CTP ongoing. These long-acting forms of Factor VII utilizing OPKOs CTP technology are expected to better support prophylaxis, provide easier administration and decrease dosing frequency for hemophilia patients. Enrollment for global pediatric Phase 3 hGH-CTP clinical trial continues and a Japanese pediatric registration trial for hGH-CTP is now underway.Clinical trials of Claros point-of-care (POC) prostate specific antigen (PSA) test completed and Premarket Approval (PMA) filing anticipated this fall. Analytic and clinical validation studies of OPKOs proprietary POC diagnostic test for PSA have been completed; PMA application to the FDA is planned for 4Q 2017. OPKO expects to begin an additional multicenter study of its POC testosterone test in late 2017 or early 2018, followed by a 510(k) submission to FDA. Initiation of five Phase 2 clinical trials anticipated in 2H 2017 and early 2018.

BioReference Laboratories is well positioned to accelerate revenue growth and expand operating margins through the second half of 2017 and 2018.

Financial Highlights

Conference Call and Webcast Information

OPKOs senior management will provide a business update and discuss 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 http://www.opko.com.

WHEN: Tuesday, August 8, 2017, 4:30 p.m. Eastern time.DOMESTIC DIAL-IN: (866) 634-2258 INTERNATIONAL DIAL-IN: (330) 863-3454PASSCODE: 65755948WEBCAST: http://investor.opko.com/events.cfm

For those unable to participate in the live conference call or webcast, a replay will be available beginning August 8, 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: 65755948. The replay can be accessed for a period of time on OPKOs 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), OPK88003, 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 OPK88004, an androgen receptor modulator for androgen deficiency indications. Our biologics business 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 http://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 and expectations regarding the market for and sales of our products, whether 4Kscore test utilization will continue to grow, 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 submission or approval, validation and/or reimbursement for our products, the expected timing for launch of our products in development, whether the data for hGH-CTP 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, expectations regarding revenue growth and operating margins for BioReference for the remainder of 2017 and 2018, 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, OPKO88003, OPK88004, 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.

CompanyOPKO Health, Inc.David Malina, 305-575-4100Investor Relationsdmalina@opko.com

LHAAnne Marie Fields, 212-838-3777afields@lhai.comorBruce Voss, 310-691-7100bvoss@lhai.com

Tables to Follow

OPKO Health, Inc. and SubsidiariesCondensed Consolidated Balance Sheets(unaudited)(in millions)

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OPKO Health Reports Second Quarter 2017 Business and Financial Results - GlobeNewswire (press release)

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