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January 2017 NASDAQ: OPK Diagnostics & Pharmaceuticals for Large Markets with Unmet Needs
January 2017 NASDAQ: OPK Diagnostics & Pharmaceuticals for Large Markets with Unmet Needs
FORWARD -LOOKING STATEMENTS
2 This presentation 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,” “potential,” and
other words of similar meaning, including statements regarding our estimated revenues and financial projections, expected milestones and royalties from the
outlicense of our products, our ability to achieve high levels of growth, the potential for our products under development, the potential of the 4Kscore® to influence
89% of biopsy decisions and predict the risk of aggressive prostate cancer, our ability to develop, test and launch new products, the expected timing of the clinical
studies and regulatory approval for our products under development, the outcome of our clinical trials and validation studies and that such outcomes will support
marketing approval or commercialization , the expected market penetration and size of the market for our products, including without limitation, Rolapitant ,
Rayaldee ®, hGH-CTP, the 4Kscore, Factor VIIa-CTP, oxyntomodulin the SARM candidate, and our point -of-care diagnostic products, the potential benefits of our
products under development, including whether the 4Kscore will predict the risk of distant metastases and result in 40-55% cost savings, the expected submission
dates for the PMA for PSA and 510k for testosterone and expected launch date for each, that oxyntomodulin will provide superior long-term therapy for obesity and
Type II diabetes patients, our ability to successfully commercialize our product candidates such as Rolapitant , the 4Kscore, hGH-CTP and Rayaldee and whether
Rayaldee will take significant market share in stage 3 and 4 CKD patients with SHPT, whether Rayaldee will raise serum total 25-hydroxyvitamin D (25D) more
effectively than any over-the-counter (OTC) or prescription (Rx) products currently marketed without the risk of hypercalcemia, our ability to double our sales force
and the timeline for doing so, our ability to obtain commercial and Part D coverage for 70-80% of U.S. covered lives by mid-2017 , our ability to develop Rayaldee for
new indications including stage 5 CKD and the timeline for doing so, expectations surrounding the sensitivity analysis for primary and secondary endpoints for the
adult hGH-CTP study, whether the results of the analysis and any post-hoc efficacy analysis will be positive, whether the FDA would consider the analysis and
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