OPKO Health, Inc. · NASDAQ:OPK
OPKO Health — Jefferies 2013 Global Healthcare Conference
26 slides from OPKO Health's conference presentation, Jun 4, 2013
Slide 1: Jefferies 2013 Global Healthcare Conference
Jefferies 2013 Global Healthcare Conference June 4, 2013
Slide 2: Cautionary Statement
Cautionary Statement 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,” “sho
Slide 3: OPKO — A High Growth Medical Products Company with a Diversified Pipeline
OPKO — A High Growth Medical Products Company with a Diversified Pipeline – Microfluidics system for rapid, lab-quality point-of-care tests – CLIA-certified central lab with next generation prostate cancer Diagnostics laboratory developed test (“LDT”) – Platform to develop diagnostic tests for neuro
Slide 4: Key Milestones in H1 2013
Key Milestones in H1 2013 • Phase 3 trials for RayaldyTM (CTAP101 Capsules) for treatment of SHPT continuing on schedule – top line results expected mid-2014 • Entered into definitive agreement to acquire PROLOR BioTech • Issued $175 million aggregate principal amount of 3.00% convertible senior not
Slide 5: OPKO Pharmaceuticals — Clinical Pipeline
OPKO Pharmaceuticals — Clinical Pipeline Product Indication Preclinical Phase 1 Phase 2 Phase 3 Milestone SHPT Phase 3 results RayaldyTM (CKD Stage 3-4 Patients) expected H1 2014 Hyperphosphatemia Phase 3 results Fermagate (CKD Stage 5 Patients) expected H1 2017 Phase 3 results Rolapitant CINV and P
Slide 6: Pending Acquisition of PROLOR BioTech
Pending Acquisition of PROLOR BioTech • OPKO to acquire all outstanding equity of PROLOR o Pre-revenue biopharmaceutical company developing longer- acting proprietary versions of approved therapeutic proteins Late-stage product targeting growth hormone deficiency (GHD) Preclinical products targe
Slide 7: Effective hGH Therapy in Growth Hormone Deficient Adults
Effective hGH Therapy in Growth Hormone Deficient Adults hGH-CTP is designed to: Increase bone density Decrease fat mass Increase lean body mass Improve physical performance Improve cardiac function 7
Slide 8: PROLOR Pipeline
PROLOR Pipeline Market Indication Product Preclin. Ph 1 Ph 2 Ph 3 Size hGH –CTP $3.5B 1/week injection Growth (Adults) Hormone hGH –CTP Disorders (Children) 1/week injection Factor VIIa- $1.3B 1-2/week injection CTP Hemophilia Factor IX - CTP $0.7B 1/week injection Diabetes Type II & Oxyntomodulin ?
Slide 9: PROLOR: hGH-CTP Clinical Program
PROLOR: hGH-CTP Clinical Program • Adult Pivotal Phase 3 trial • 189 patients, >40 centers in US, EU, Israel • 12 months duration (6 months efficacy + 6 months safety) • Weekly injection compared to placebo control • Primary endpoint: Change in truncal fat mass after 6 months vs placebo • Ongoing Pe
Slide 10: Cytochroma Acquisition — Product Highlights
Cytochroma Acquisition — Product Highlights • RayaldyTM Capsules is a Highly Differentiated Lead Asset – First-in-class modified-release vitamin D prohormone that is designed to effectively control SHPT* in patients with Stage 3 or Stage 4 CKD and vitamin D insufficiency • Unmet Medical Need: No cur
Slide 11: Rayaldy: Significant Commercial Opportunity
RayaldyTM: Significant Commercial Opportunity Low serum 25D and high plasma PTH are prevalent in CKD Stage 3-4 patients • 8.0M CKD Stage 3-4 patients in the U.S. ─ 4.0M patients with low serum 25D and high plasma PTH ~1.0M patients seen by nephrologist ~1.0M patients seen by endocrinologist
Slide 12: Rayaldy: Phase 2b Results
RayaldyTM: Phase 2b Results 40 n=17 n=14 30 80 Percent Change in Plasma iPTH 70 * 20 Change in Serum Total 25D 60 n=12 n=16 n=14 10 50 (ng/mL; mean ± SE) * 0 (mean ± SE) 40 * 30 -10 20 * -20 10 0 -30 * -10 Placebo 30 µg/day Placebo 60 µg/day 90 µg/day -40 ** Cohort 2 Cohort 1 *** Treatment Group -50
Slide 13: Fermagate: Product Profile
Fermagate: Product Profile A phosphate binder (magnesium iron hydroxy carbonate) Overview Clinical Status A non-calcium, inorganic compound Two Phase 3 studies stopped early by (Mg/Fe) with demonstrated efficacy and previous sponsor due to cash shortfall safety Partial Phase 3 efficacy data co
Slide 14: Rayaldy & Fermagate: Clinical Timelines
RayaldyTM & Fermagate: Clinical Timelines 2012 2013 2014 2015 2016 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 End of Phase 2 Meeting Final Phase w/ FDA 3 Data SPA Two Phase 3 trials NDA NDA Filing Approval Open Label Extension Rayaldy Meetings with FDA & EU Fermagate API & Tablet Ma
Slide 15: Rolapitant Overview
Rolapitant Overview • Rolapitant out-licensed to Tesaro in December 2010 – Schering-Plough (S-P) divested to OPKO as FTC condition for S-P merger with Merck – Payments of up to $121 million – Double-digit tiered royalties • Potentially best-in-class cancer supportive care product – Potent neurokinin
Slide 16: OPKO Diagnostics — Our Vision
OPKO Diagnostics — Our Vision Low Cost / Highly Innovative Quantitative Technology to CLIA Lab Point-of-Care Discover New System Diagnostics Easy-to-use Profitable CLIA lab Alzheimer’s Disease with urologic Inexpensive Pancreatic Cancer pathology focus, Significant based in Nashville L
Slide 17: OPKO Diagnostics — Initial Applications
OPKO Diagnostics — Initial Applications • Total-PSA, Testosterone Point-of-Care tests • Next Generation Prostate Cancer Markers (4KScore™): – Combines PSA, free PSA, intact PSA and human kallikrein 2 markers as a Laboratory Developed Test (LDT) with the goal of significantly greater accuracy – Marke
Slide 18: OPKO Point-of-Care Diagnostics Technology
OPKO Point-of-Care Diagnostics Technology Key Requirements – High Quantitative Performance / Low Cost • Inexpensive Disposable – Injection-molded microfluidics – On-board delivery of multiple reagents – Multiplex platform • Robust Signal Detection – Sensitive proprietary amplification chemistry for
Slide 19: OPKO Dx Card Technology Target Applications
OPKO Dx Card Technology Target Applications Women’s Infectious Urology Cardiology GPs Health Disease Urologist Ob/Gyn Emergency Clinic and GP Office Office Office Room Blood Bank PCa Panel: Panel Tests: Cardio Panel: STD Panel: Key Tests: • total-PSA • Pre-term bleed • CTnI • HIV • Vitamin D • free-
Slide 20: Diagnostic & Pharmaceutical Product Launches: US
Diagnostic & Pharmaceutical Product Launches: US 2013 2014 2015 2016 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Urologic Pathology Laboratory – Urology 4K Score as Laboratory Developed Test - Urology Point Of Care PSA Test - Urology Point Of Care Testosterone Test - Urology Poi
Slide 21: OPKO European Union
OPKO European Union Farmadiet Group • Established 20-year presence within EU – Based in Barcelona, Spain • Fully integrated specialty pharmaceutical entity – 42-person sales force – Production/research facility in Banyoles, Spain • Broad pharmaceutical, nutritional and veterinary products lineup – P
Slide 22: OPKO Emerging Markets
OPKO Emerging Markets • OPKO Chile — Pharma Genexx, S.A. – Rapidly growing sales from >100 products – Acquired ALS Distribution Limited, the exclusive product distributor of Arama Laboratories, in April 2012 • OPKO Mexico — Pharmacos Exakta S.A. de C.V. – 25 products across a range of therapeutic in
Slide 23: OPKO Emerging Markets (cont'd)
OPKO Emerging Markets (cont’d) OPKO Israel • Fine Tech Pharmaceuticals, Ltd. – Acquired in December 2011 – Develops and produces high value, high potency, difficult to make active pharmaceutical ingredients – FDA registered state of the art facility in Nesher, Israel • SciGen Israel, Ltd. – Acquired
Slide 24: Strategic Investments
Strategic Investments Proprietary Technologies with Significant Upside Potential • CoCrystal Discovery, Inc. (~16% equity interest*) – New approach to develop broad spectrum anti-viral drugs – Development program with Teva for Hepatitis C drug • RXi, Inc. (~21% equity interest*) – RNA interference p
Slide 25: Additional Information About the PROLOR Transaction and Where to Find It
Additional Information About the PROLOR Biotech, Inc. (“PROLOR”) Transaction and Where to Find It This presentation is being made pursuant to and in compliance with Rules 165 and 425 of the Securities Act of 1933 and does not constitute an offer of any securities for sale or a solicitation of an off
Slide 26: Jefferies 2013 Global Healthcare Conference
Jefferies 2013 Global Healthcare Conference June 4, 2013
OPKO Health — Jefferies 2013 Global Healthcare Conference on 6ix