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September 2017 NASDAQ: OPKDiagnostics & Pharmaceuticals for Large Markets with Unmet Needs
September 2017 NASDAQ: OPKDiagnostics & Pharmaceuticals for Large Markets with Unmet Needs
FORWARD -LOOKING STATEMENTS
2This presentation contains “forward -looking statements,” asthatterm isdefined under thePrivate Securities Litigation Reform Actof1995 (PSLRA), which statements may be
identified bywords such as“expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” “potential,” andother words ofsimilar meaning,
including statements regarding ourestimated revenues andfinancial projections, expected milestones androyalties from theoutlicense ofourproducts, ourability toachieve high
levels ofgrowth, thepotential forourproducts under development, thepotential ofthe4Kscore® toinfluence 89%ofbiopsy decisions andpredict theriskofaggressive prostate
cancer, theexpected timing oftheclinical studies andregulatory approval forourproducts under development, theoutcome ofourclinical trials andvalidation studies andthat
such outcomes willsupport marketing approval orcommercialization, theexpected market penetration and size ofthemarket forourproducts, including without limitation,
Rolapitant ,Rayaldee ®,hGH-CTP, the4Kscore, Factor VIIa-CTP, Alpharen ,oxyntomodulin ,theSARM candidate, ourpoint -of-care diagnostic products andouranimal health
products, thepotential benefits ofourproducts under development, including whether the4Kscore willpredict theriskof20year metastasis freesurvival andresult in40-55%cost
savings, theexpected submission dates forthePMA forPSA and510kfortestosterone andexpected launch date foreach, thatoxyntomodulin willprovide superior long-term
therapy forobesity andType IIdiabetes patients, ourability tosuccessfully commercialize ourproduct candidates such asRolapitant ,the4Kscore, hGH-CTP, Rayaldee ,Alpharen ,
theSARM, andoxyntomodulin ,andwhether Rayaldee willtake significant market share instage 3and4CKD patients with SHPT, whether Rayaldee willraise serum total 25-
hydroxyvitamin D(25D)more effectively than anyover-the-counter (OTC) orprescription (Rx) products currently marketed without theriskofhypercalcemia, ourability toobtain
commercial andPart Dcoverage for70%ofU.S.covered lives byendof2017 ,ourability todevelop Rayaldee fornew indications including stage 5CKD andthetimeline for
doing so,whether data from adult clinical studies ofhGH-CTP willsupport submission orapproval ofabiologics License Application, whether wewillberequired tomake any
changes toourdevelopment plans forhGH-CTP, expectations regarding patent coverage, theexpected timing forcommencing, completing andannouncing results forourclinical
trials, thetiming forrelease oftrialdata andseeking andobtaining FDA andEuropean regulatory approvals aswellasreimbursement coverage forourproducts, expectations
regarding growth insales ofour4Kscore andRayaldee ,ourability toobtain apositive coverage determination forthe4Kscore andwhether wehave enough scientific andclinical
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