Opko Health, Inc. · NASDAQ:OPK
Opko Health — Investor Presentation (September 2015)
22 slides from Opko Health's investor presentation, Sep 24, 2015
Slide 1: Advancing Deep Pipeline of Pharmaceuticals and Diagnostics
Exhibit 99.1 Exhibit 99.1Our2015 SEPTEMBER Advancing Deep Pipeline of Pharmaceuticals and Diagnostics
Slide 2: Cautionary Statement
CAUTIONARY This “plans,” projections, ability 4Kscore, candidates long-term significant currently infrastructure our data such including collaboration associated may obtaining 2Risk product will arise, presentation outcomes statements. Factors to“projects,” benefit Factor develop, marketed results i
Slide 3: OPKO is positioned for strength and growth
OPKO is positioned 3expertise a multinational for strength biopharmaceutical and growth and in large diagnostics target markets companywith thatsignificant seeks to establish unmet needs industry-leading positions in large growth markets by leveraging its discovery, development, and commercializatio
Slide 4: Value drivers
VALUE GLOBAL $295 Up Pfizer’s Profit GHD TRANSFORMATIVE Acquisition Bio Generated Will RAYALDEE’S OPKO’s Addresses Rayaldee TESARO OPKO Double 4U.S. to Reference provide market million encompassing an sharing and licensee to digit Genotropin DRIVERS Rayaldee additional targets receive RECEIVES AGREE
Slide 5: Near-term catalysts and potential market size
NEAR SIZE ADDRESSABLE DATE Coverage 2015 4Kscore Commercial Begin Q4 VII-CTP Significant March Phase Rayaldee 2H 5adults 2015 2016 /OF 3patient U.S. 2016 POTENTIAL 29, TERM clinical test VARUBI™ Phase results reduced decisions 2016 unmet and Reimbursement launch Simple dosing CATALYSTS 2a EU trial f
Slide 6: OPKO deep pipeline
OPKO PRODUCT PDUFA Rayaldee™ (CTAP101) hGH-CTP Alpharen™ (Fermagate) VARUBI CINV (rolapitant) CTAP201 (CKD Factor Phase 2015 Oxyntomodulin Q1 AntagoNAT 6Platform 2016 I2a Launch Stage VIIa-CTP PHARMACEUTICALS’ trial date orphan Outlicensed Mild hGH 2015 (CKD INDICATION SHPT Hyperphosphatemia Cancer,
Slide 7: Rayaldee product and PDUFA date
PDUFA RAYALDEE Product Rayaldee 20 Modified-release Safe Existing Achieves Lower Additional 25-Hydroxyvitamin 71,25-Dihydroxyvitamin million and risk launch DATE therapies effective is more patients potential of expected side MARCH reliable estimated (MR) have treatment effects inD3 for to theincrea
Slide 8: Rayaldee steps to commercialization
RAYALDEE NDA Stage Vitamin being July Initial Launch 8•2H Additional Initial Other 2016 29, accepted 3line hired indications or clinical Expected 2015 Dnew 4extension Insufficency inCKD phase –oncology Q4 for STEPS trial planned 2015 and SHPT 3being ongoing clinical plans: PDUFA TO March indication
Slide 9: Rayaldee market opportunity
RAYALDEE—MARKET The Obesity % Stage 3Insufficiency 4Moderate ofChronic Severe CKD Kidney Sources: 92015; Hypertension 18.7 1.4 5impairment *US Renal Patients Kidney Million* (?25D) Function etwith Million* Failure 10:98-109 Levin, Data 0.5 A Disease (? Diabetes 71% 83%CKD PTH) Million* Service al.,
Slide 10: Rayaldee differentiated comparison of alternative therapies
RAYALDEE Effect Drug Rayaldee (25-hydroxyvitamin Vitamin Drisdol™* (vitamin Rocaltrol™* (1á,25-dihydroxyvitamin Hectorol™* (1á-hydroxyvitamin Zemplar™* (19-nor-1á,25-dihydroxyvitamin *And **25-hydroxyvitamin Active generics onD D3 D2 Blood Calcifediol Cholecalciferol/Ergocalciferol Ergocalciferol )/
Slide 11: Long-acting human growth hormone: Pfizer financial terms
LONG-ACTING Terms FINANCIAL $275 OPKO •DEVELOPMENT Initial COMMERCIAL combined Pfizer Genotropin exceeding 11 All Pediatric Development Post Commercialization million responsible Genotropin double of responsible Global Marketing sales $700 Short to $295 digit programs for OPKO million; Collaboration
Slide 12: hGH-CTP competitive advantages
hGH-CTP—COMPETITIVE PHASE New A Human Growth SGA, Final The Injected in 12 key thedrug molecular Presentation: U.S. PWS, differentiator growth hormone 3using product ENROLLMENT &ISS EU ahormone entity disposable deficient for will isthe that be a once-a-week treatment is amaintains children refriger
Slide 13: Daily hGH market established and growing
DAILY ESTABLISHED Adult Other $3B+ ~$4B ISS, 80% Syndrome GHD Daily ($1.5B) Projected market Roche Others FRAGMENTED (Nutropin) Merck 31% (Norditropin) Eli (Omnitrope) Sandoz 8% Serostim) (Saizen, (Humatrope) 12% Competition 23% Source: 13 Lilly Turner Pediatric Novo (Genotropin) GHD 2013 GHD 6% KGa
Slide 14: Varubi commercial launch
VARUBI™ COMMERCIAL Rolapitant Additional Double-digit Differentiated Potent Opportunity Long Lack ²¹Oral 14 Moderately Highly and of acting, neurokinin-1(NK-1) CYP emetogenic IVout-licensed milestone (ROLAPITANT): formulations to sustained tiered emetogenic 3A4 cancer differentiate LAUNCH drug-drug
Slide 15: Bio-Reference leverage
BIOReference LEVERAGE Leverage ~420 ~5,000 Bio 4Kscore 15 REFERENCE sales people continues the andnational BIO working Labs marketing REFERENCE’S toLABS isbe generated marketing, the together expanded personnel third ACQUISITION: $832 largest tosales, support CHANNELS million full andservice the dis
Slide 16: 4Kscore test
4KSCORE MORE 4Kscore Reimbursement Clinical Over Identifies 40–55% 16 1,000 THAN utility is cost the the TEST: urologists savings actual only is 2toMILLION based MINIMALLY be blood risk to expanded have on potentially oftest three aggressive used BIOPSIES that throughout decades the INVASIVE accurat
Slide 17: The 4Kscore test predicts metastases within 20 years
THE 4KSCORE 4Kscore Improving 17 Test the7.5% >Specificity 7.5% TEST PREDICTS of Screening METASTASES for Lethal Prostate WITHIN Cancer 20 YEARS1 Using Prostate- specific Antigen and a Panel of Kallikrein Markers: A Nested Case–Control Study European Urology (in press)
Slide 18: Claros modular testing platform
CLAROS 30 Modular Claros Rapid Finger sample 18 MILLION Testing stick 1Sangia™ Platform PMA 1 PLATFORM blood PSA in filing the cassette will Snap TESTS Physician with leverage cartridge ADDRESSES Claros®1 the INFDA THE Office Bio into expected U.S. Reference analyzer with Insert LARGE GENERATING sim
Slide 19: CTP technology extends half-life of protein drugs
OPKO Developing proteins Significant CTP Potential Maintain 19 Technology BIOLOGICS: and expanded drug reduction biobetter peptides bio-activity Reversible safety prophylactic in long EXTENDS profile injection acting Pegylation isuses frequency comparable THEwith HALF-LIFE Technology longer to non-m
Slide 20: MOD-5014: long-acting Factor VIIa for hemophilia
MOD-5014: PHASE Market Current 3-4 1-2 In Potential Reduced Enable Orphan 20 pharmacological times prophylactic is drug product 2a frequency for agrowing STUDY day LONG-ACTING subcutaneous designation during for (NovoSeven®) 7% prophylactic of studies TO treatment injection annually bleeding COMMENC
Slide 21: MOD-6031 meets market need in obesity and diabetes
MOD-6031—MEETS MARKET (in MOD-6031 SIGNIFICANTLY IMPROVES IS Phase A 21 battery EXPECTED animal 1 study ofstudies) SIZE comprehensive GLYCEMIC LIPID toTO will be FOR evaluate INHIBITS initiated PROVIDE PROFILE DIABETES SIGNIFICANT CONTROL the toxicological inFOOD Q1 safety EFFECTIVE 2016 ANDINTAKE a
Slide 22: MOD-6031: OPKO's oxyntomodulin development
MOD-6031—OPKO’S 1/Glucagon Secreted Crosses Increases DEVELOPMENT Oxyntomodulin OPKO MOD-6031, 22 SOLUTION: blood-brain by glucose receptor the a reversible digestive istolerance hasaCHALLENGE: short natural barrier agonist SOLUTION PEG30 system half-life in to appetite insulin induce formulation fo