Opko Health, Inc. · NASDAQ:OPK
Opko Health — Investor Presentation (September 2013)
31 slides from Opko Health's investor presentation, Sep 11, 2013
Slide 1: Corporate Presentation September 2013
Exhibit 99.1 Corporate Presentation September 2013
Slide 2: Safe Harbor Statement
Safe cause This made PROLOR’s may circumstances materially otherHarbor presentation factors pursuant from results business Statement discussed and tofuture the contains todevelopments. differ and safe results in prospects, OPKO’s harbor forward-looking materially expressed provisions The filings tha
Slide 3: OPKO – A Diversified Multi-National Biopharmaceutical and Diagnostics Company
OPKO –Secondary Late-stage Pharmaceuticals Revolutionary Diagnostics International Emerging Opportunistic Clinically 3(1) Amarkets and pipeline High Markets Investments commercially diagnostic Growth infrastructure of Hyperparathyroidism multi-billion Multi-National technology validated to propel do
Slide 4: Highly Experienced Management Team
Highly Demonstrated Phillip Chairman TEVA Jane Vice Steven Executive THCG Juan Senior Charles 4CEO H. Chairman F. –(Chairman), Vice Frost, D. (COO) OPKO Experienced Rodriguez Hsiao, Bishop, and Rubin Vice President M.D. Ability CEO Renal Ph.D. and President Ph.D. IVAX Chief Management Division Avri
Slide 5: Financial Highlights
Financial Cash Current 3% Other Shares Warrants, Market Total Average 5Employees Convertible Assets & Shareholders OPKO Long-Term Outstanding Cap Marketable Liabilities Daily Highlights Options, 600 ~$1.25 Share $3.3 Trading Notes, Liabilities bn 62mm Convertible Equity bn Purchases 400 Securities (
Slide 6: OPKO Pharmaceuticals
Pharmaceuticals OPKO
Slide 7: Pharmaceuticals Products
Pharmaceuticals SHPT RayaldyTM Patients) Hyperphosphatemia AlpharenTM Phase Rolapitant expected Moderate (CKD Mild CTA018 Products OPKO psoriasis Growth hGH-CTP Deficiency Factor GLP1/Glucagon dual 7agonist PROLOR receptor toIII Phase Stage VIIa—CTP IX Obesity moderate Hormone SHPT (Topical) expecte
Slide 8: Pharmaceuticals Products
Pharmaceuticals Products SR-3306 Neurodegenerative Mild diseases (CKD CTA091 Psoriasis OPK-0018 topical) AntagoNAT 8Platform OPKO toStage moderate >$2.0 and Indication NM (oral Asthma Cancer, 5genetic Patients) or BN–SHPT Pre-Clinical and Preclinical CV, disorders COPD metabolic NM Phase Pipeline I
Slide 9: Rayaldy Commercial Opportunity
Low serum treatments nutritional Stage Safety Untreated 1,25D Nutritional Efficacy RayaldyTM 9Source: 3Hormone 4concerns CKD BioTrends Concerns 26% 44% are vitamin Vitamin 25D –Treatment Capsules Significant not and and 36% 20% effective D Research D exacerbates high and expected 38% 36%hormones pla
Slide 10: Market Size and Treatment of SHPT with CKD Stages 3 and 4
27.4MMStage 11.0 Worldwide one-third CKD database 3.1 10 Confidential Patients Patients ofmarket Prevalence 3these and 4eligible The Market with being and worldwide SHPT treated patients Treatment Sizeand with are CKD Lowof being Rxstages SHPT 25D3 Vitamin treated (40%) 3 and Dwith 4 market an Rx is
Slide 11: Rayaldy Product Timelines
RayaldyTM 2012 Q1 Dose SPA DataCL-3002 Open Data CL-3002 Filing NDA Management Secondary Maintenance Safety Serum 11 Q2 CL-3001 2013 ranging Approval Safety Label Update Endpoint: Ca Q3 and Q4 Endpoint: 2014 Extension –of SPA trial Phase Q1 P,Product serum SHPT 2015 and Q2 TG CL-3001 III urinary Q3
Slide 12: OPKO Pharmaceuticals: PROLOR
Pharmaceuticals: PROLOR OPKO
Slide 13: Lead Product – hGH-CTP BioBetter to Reduce Injection Frequency
Lead Product – hGH-CTP BioBetter to Reduce Injection Frequency $3.5 billion market Growing 5% annually Requires daily injections Growth hormone deficient children Growth hormone deficient adults 13
Slide 14: Effect of GH in Deficient Adults
GHfatEffect Proper bone in Decrease lower Increase lean Improved 14 performance physical body density mass risk hGH inoverall mass of in Improved diseases treatment cardiac GH Deficient cardiac results Adults function, in: Increase in
Slide 15: hGH-CTP Phase II Conclusions
hGH-CTP Analysis Identified Post-Phase patients 15 within and kick-start Phase II Conclusions hGH-CTP theII normal Positive dosing Pilot A range for Data single Study Phase of weekly IGF-1 Supports III trial Estimated injection two hGH-CTP of COGhGH-CTP 50-75% Injections can of replace commercially
Slide 16: hGH-CTP Key Confirmed Phase II and III Results
hGH-CTP 440-50 12 6189 Key Confirmed 16cohorts; months months patients, outcome: patients efficacy 3Phase efficacy by receiving estimated FDA Height Improvement IIand and asvelocity once 6pivotal, $20 III safety months Pediatric weekly million inAdult planned truncal safety hGH-CTP study GHD Pivotal
Slide 17: hGH-CTP Competitive Advantages
hGH-CTP No 50-75% 17 additional need of forCompetitive commercial 2 drug injections product Advantages products sites, viscosity once Robust per Needle that week manufacturing is size typically Superb 31G clinical, associated processsafety Orphan withand long-acting drug immunogenicity designation f
Slide 18: Anticipated Clinical Milestones and Priorities
Anticipated Clinical hGH-CTP: Planned Preclinical Event MOD-6030: pharmaceutical Factor-VIIa-CTP: development 18 Timing Priorities marketing Priorities Phase Milestones Further to development INDIIprocess, IIIapproval pediatric diabetes submission adult pivotal analytical, 2016 to study studies IND
Slide 19: OPKO Diagnostics
Diagnostics OPKO
Slide 20: Innovative Quantitative Point-of-Care Diagnostics
Innovative Quantitative Point-of-Care Diagnostics benefit About 20 15+ to physicians Low person –CLIA Easy-to-use Our System Cost national Vision Lab Multiple / Highly Discover Alzheimer’s sales Sclerosis Technology force NewDisease focused through to Commercial onin-sourcing urology platform of Est
Slide 21: Point-of-Care Inexpensive Convenient Diagnostics
Point-of-Care Inexpensive Convenient 11 Collect 21 2 3 4Blood ––Only Diagnostics Inexpensive Snapainto finger-stick Cassette –analyzer Claros-1 is Insert required appropriate System into Dx from LabReader forthe test physician patient, results Resultsin and budget, in minutes no <10training tests mi
Slide 22: Claros-1 Total PSA Assay Performance
Claros-1 Total untrained Compared N R2 22==100 0.97, PSAkits, –users will to Laboratory slope serum multiple be0.97 thesamples first batches Quality Point-of-Care run Assay in laboratory Performance Assay(Roche run(Total on Elecsys) thePSA) Claros-1 System Dynamic Range of Assay o Demonstrated 15pg/
Slide 23: Initial Market: Men's Health and Specialty Practice
Initialmarket: Men’s WW 2014 General Market 23 tests/year) Point-of-Care Health Opportunity and Specialty —70 Total-PSA, million Projected Claros-1 Practice free-PSA PSA Product Launch Vitamin testsTestosterone annually Offerings WW D Point-of-Care market: • POC100 platform Tests million UStests Mar
Slide 24: Claros-1 Product Capabilities Roadmap
Claros-1 Women’s Urology Health Urologist GP Office PCa Novel Liquid 24 Office Panel: Markers Office Disease Sample Cardiology Product Infectious Ob/Gyn Panel Room Capabilities Other Roadmap Tests: Emergency Blood GPsCardio Bank Whole Clinic Panel: Blood and STDSemen Panel:Spinal Key Tests: Fluid to
Slide 25: The Current and Next Generation PSA Screening: 4KScore
Next The Current 750,000 Total multiple 1OPKO Gilligan Loeb Chou 25System 4KScoreTM Generation PSA et et4KScoreTM al. screening al. are 2009 patient in(tPSA) 2001 2011 negative(2) 4-5 cohorts years Prostate address o(based Free strategy o Will predict oPSA on aCancer 4.2% critical PSA) compete Labor
Slide 26: Near-term Milestones
Near-term 2013 Q1 4KScoreTM Vitamin –Total RayaldyTM AlpharenTM Citicoline Rolapitant Factor -hGH-CTP (1) 26Diagnostics—Pharmaceuticals Launch Q22014 PSA VIIa Q3 D Pediatric in –Test –Milestones Q4 Point-of-Care 2015 –Launch Adult US –Phase ––Begin Phase Q1 US FDA 2016 Phase Q2 LDT Phase III in Phas
Slide 27: OPKO International Markets
International Markets OPKO
Slide 28: OPKO Latin America: Brazil, Chile, Mexico
oOPKO BRAZIL 2012 CHILE Pharma MEXICO Source: 28 ANVISA Acquired 25commercial Primarily 212 Rapidly 720 products sales – Latin 2017 Market: Business growing and ALS February licensed branded CAGR: America across marketing operations $Distribution $3.3 $13.4 Monitor 26.8 sales pharmaceutical ophthalm
Slide 29: OPKO Europe: Farmadiet Pharma, Spain
OPKO o?Farmadiet Pharma Spain Source: 29 Projected Veterinary: BasedEuropean 42-person Production/research Medical OTC Citicoline 25-Hydroxyvitamin Novel nutritional: Market: Business raw in prescription: Group Barcelona, launch (supports sales material 50 Products $23.3 Union Established Monitor fo
Slide 30: OPKO Strategic Investments
Strategic Investments OPKO
Slide 31: Strategic Investments
Strategic Proprietary viral or equity countries Neovasc, distribution (1) 31 inhibit drugs interest(1)) As Investments oInc. scar oDevelop Technologies of rights Development (~ formation March 4% in o Next and Latin equity 31,commercialize in2013 with gen America program the interest(1)) technology