Opko Health, Inc. · NASDAQ:OPK
Opko Health — Investor Presentation (September 2020)
24 slides from Opko Health's investor presentation, Sep 15, 2020
Slide 1: September 2020
September 2020 NASDAQ: OPK
Slide 2: Forward Looking Statements
Forward Looking Statements 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,
Slide 3: Diversified Assets Across Business Units
Diversified Assets Across Business Units Marketed Pharmaceuticals Pipeline Diagnostics • Rayaldee addresses unmet need in CKD market • Somatrogon once weekly (hGH-CTP) partnered with • BioReference Laboratories revenue of • Rayaldee revenue of $8.6 million in 2Q 2020 Pfizer • ~$251 million in 2Q 202
Slide 4: Somatrogon Summary
Somatrogon© Summary Achieved Primary Endpoint Secondary Endpoints Achieved • Somatrogon© (hGH-CTP), a once weekly growth hormone • Change in height standard deviation scores at six and 12 replacement therapy, was proven non-inferior to daily months were higher with somatrogon© in comparison to Genot
Slide 5: Somatrogon CTP Technology
Somatrogon© CTP Technology Somatrogon© (hGH-CTP) consists of the natural peptide sequence of native growth hormone and the 28 amino acids of the C-Terminus Peptide of CTP human chorionic gonadotropin hormone. This molecule, compared to current GH replacement therapies, is designed to reduce the inje
Slide 6: Somatrogon Phase 3 Participation
Somatrogon© Phase 3 Participation 106 CLINICAL SITES ACROSS 22 COUNTRIES Ukraine Belarus Russia Canada Great Britain Poland Spain Bulgaria South Korea USA Georgia Greece Turkey Japan* Israel Taiwan Mexico India Colombia Australia Argentina New Zealand * Additional separate Phase 3 clinical trial con
Slide 7: Somatrogon Phase 3 Study Design
Somatrogon© Phase 3 Study Design Randomized, open-label Long-term open-label extension 1:1 Randomization treatment period (52 weeks) (Until market approval) Screening (8-12 weeks) Somatrogon© 0.66 mg/kg/week Somatrogon© 0.66 mg/kg/week Genotropin® 0.034 mg/kg/day Eligibility • 224 subjects enrolled
Slide 8: Somatrogon Path To Approval
Somatrogon Path To Approval • BLA submission in US anticipated 2H 2020 • Completion of analysis of immunogenicity and safety data from pivotal Phase 3 study and open label extension study • Data from two abstracts was presented at the Endo Society’s “ENDO Online 2020” on June 8th, 2020 • “Somatrogon
Slide 9: Diversified Assets: Nephrology
Diversified Assets Nephrology Marketed Pharmaceuticals Pipeline Diagnostics September 2020 | 9
Slide 10: Rayaldee: Extended-release CKD prohormone of vitamin D3
First and only extended-release Chronic Kidney Disease (CKD) prohormone of active form of vitamin D3 The Silent Killer • 9th Leading cause of death, ahead of breast and • Once daily oral formulation of the prohormone 25D3* addresses significant unmet need prostate cancer • Only product approved by F
Slide 11: Rayaldee for Patients with Stage 5 CKD and Vitamin D Insufficiency
Rayaldee for Patients with Stage 5 CKD and Vitamin D Insuffiency • Phase 2 open label trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of higher strength Rayaldee in subjects with Vitamin D insufficiency and CKD requiring regular hemodialysis • Commenced September 2018 •
Slide 12: FDA-Approved Phase 2 Study with Rayaldee in COVID-19 Patients
FDA-Approved Phase 2 Study with Rayaldee in COVID-19 Patients Title: A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Rayaldee (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2 (REsCue) Screening Randomization Tre
Slide 13: Diversified Assets: Broad Development Pipeline
Diversified Assets Broad Development Pipeline Marketed Pharmaceuticals Pipeline Diagnostics September 2020 | 13
Slide 14: Rare Disease Pipeline In Development
Rare Disease Pipeline In Development MARKET INDICATION PRODUCT PRECLINICAL PHASE 1 PHASE 2 PHASE 3 SIZE hGH-CTP (Adults) Once-weekly injection Growth Hormone Deficiency (GHD) hGH-CTP (Children) Once-weekly injection Factor VIIa-CTP (IV) $0.6B Hemophilia Factor VIIa-CTP (SC) Once-/twice-weekly inject
Slide 15: Diversified Assets: One of the Nation's Largest Reference Laboratories
Diversified Assets One of the Nations Largest Reference Laboratories Marketed Pharmaceuticals Pipeline Diagnostics September 2020 | 15
Slide 16: BioReference Laboratories Overview
BioReference Laboratories Overview Leading National 80,000 4,000 Employees - Serving 11 Million First Class Logistics Clinical Laboratory Requisitions Daily 300+ Medical Staff Patients Annually • 1.5M+ pick-ups annually • 17M+ miles driven annually • 475+ cars in the fleet • 450+ drivers in logistic
Slide 17: Areas of Focus
Areas of Focus September 2020 | 17
Slide 18: Targeted Areas of Expertise for Physicians
Targeted Areas of Expertise for Physicians September 2020 | 18
Slide 19: Strategic Laboratory Collaboration
Strategic Laboratory Collaboration OPKO Health’s BioReference Laboratories and Westchester Medical Center Health Network Enter Into Strategic Laboratory Collaboration to Deliver Operational and Diagnostic Services, May 13, 2020 • WMCHealth, 10 hospitals through out the Hudson Valley performing over
Slide 20: Patient Empowerment
Patient Empowerment “BioReference: The Lab Patients Choose” Patient Portal Consumer-initiated Testing Now offering COVID-19 Antibody Testing September 2020 | 20
Slide 21: BioReference's COVID-19 Response
BioReference’s COVID-19 Response Serving all 50 states with testing locations in: Elmwood Park, NJ; Melbourne, FL; Gaithersburg, MD; Houston, TX; Campbell, CA • Currently, PCR and/or Antibody Testing is being performed out of NJ, FL, MD, TX and CA • PCR & Antibody turnaround time for “Priority” acco
Slide 22: Leverage Strategic Partnerships to Optimize COVID-19 Testing Access
Leverage Strategic Partnerships to Optimize COVID-19 Testing Access Westchester Multiple Large Municipalities Medical Medical and Center Health Groups Government Network September 2020 | 22
Slide 23: Looking Forward
Looking Forward • Many factors continue to drive demand for COVID-19 testing at BioReference Laboratories. o Hospitals desire more PCR testing for patients undergoing elective in- patient and outpatient procedures. o Hospitals will continue to test their employees for both PCR and antibody presence.
Slide 24: Select Financial Information June 30, 2020
Select Financial Information June 30, 2020 • Cash, cash equivalents & marketable securities: $21.6 million Balance Sheet • Un-utilized $100m unsecured credit facility and $15m available under ABL with J.P. Morgan Chase resulting in more than $136m of capital available • Net investments: $26.3 millio