Opko Health, Inc. · NASDAQ:OPK
Opko Health — Investor Presentation (September 2017)
23 slides from Opko Health's investor presentation, Sep 7, 2017
Slide 1: Diagnostics & Pharmaceuticals for Large Markets with Unmet Needs
September 2017 NASDAQ: OPK Diagnostics & Pharmaceuticals for Large Markets with Unmet Needs Exhibit 99.1
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: Multinational biopharmaceutical and diagnostics company
A multinational biopharmaceutical and diagnostics company establishing important positions in large markets by leveraging its extensive health care industry expertise and experience.
Slide 4: Multi-faceted growth strategy
Multi-faceted growth strategy SARM BPH Stress Incontinence NK-1 Overactive Bladder 4Kscore Claros PSA Testosterone Vitamin D Tests Claros Vitamin D >2000 Tests GeneDx Rayaldee CKD Fermagate Phosphate binder NK-1 Antagonist Uremic Pruritus SARM Increase muscle mass Decrease fat mass Increase bone mas
Slide 5: Diversified investment highlights
Diversified investment highlights Bio-Reference Laboratories revenue of more than $1Billion in 2016 400-person sales and marketing team drives industry-leading esoteric testing, ~70% of revenues Facilitates uptake of 4Kscore® prostate cancer test and Claros® 1 in office platform Completed clinical s
Slide 6: OPKO diagnostics: near-term opportunities
OPKO diagnostics: near-term opportunities LEVERAGING NATIONAL MARKETING, SALES AND DISTRIBUTION RESOURCES TO DRIVE RAPID AND WIDESPREAD UPTAKE OF OPKO DX PLATFORMS BioReference Labs is the third largest full service reference laboratory in the U.S. ~400 person sales and marketing team ~5,000+ people
Slide 7: 4Kscore Test: blood test alternative to biopsy
4kSCORE TEST: BLOOD TEST Alternative to biopsy MORE THAN 2 MILLION PROSTATE BIOPSIES PER YEAR WORLDWIDE 4Kscore is the only blood test that accurately identifies risk for aggressive prostate cancer Clinical utility based on decades of biomarker research and >20,000 men tested in Europe and U.S. In l
Slide 8: Clinical and commercial update
CLINICAL AND COMMERCIAL UPDATE Significant YOY growth Novitas Solutions (Medicare Administrative Contractor for OPKO Elmwood Park, NJ facility) CMS national rate for 2017 $602.10 Novitas has been and continues to pay for 4Kscore Medicare submissions Strong showing at the recent AUA meeting Data from
Slide 9: Claros platform addresses large point of care test market
Claros 1 platform addresses Large point of care test market Claros 1 can run immunoassay tests in the physician’s office or hospital nurse’s station using a single draw of blood from a finger stick Negates the need for a full blood draw or a centralized reference lab for many common tests Completed
Slide 10: Robust & late-stage drug pipeline
ROBUST & LATE-STAGE DRUG Pipeline PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 MARKETED MILESTONE VARUBI (Rolapitant) CINV IV Launch 4Q 2017 EU Oral Launch 2H 2017 Rayaldee® (CTAP101) SHPT (CKD stage 3-4) 68% of U.S. potential lives have access; anticipate 70% by year end Rayaldee® (CTAP10
Slide 11: CKD is the 9th leading cause of death
CKD is the 9th leading cause of death, ahead of breast and prostate cancer CKD prevalence is expected to increase due to obesity, diabetes and hypertension Most CKD patients die from cardiovascular disease (CVD), precipitated by secondary hyperparathyroidism (SHPT) SHPT is driven by vitamin D insuff
Slide 12: Rayaldee overview
Rayaldee OVERVIEW Extended-Release (1x daily) oral formulation of 25D3* addresses significant unmet need FDA-approved for SHPT (elevated PTH) in patients with stage 3-4 CKD and VDI Reduces plasma PTH and increases serum 25D with a safety profile similar to placebo Minimal effects on serum calcium or
Slide 13: Rayaldee sends a clear message
Rayaldee sends a clear message
Slide 14: Rayaldee commercialization
Total prescriptions in Q2 increased by 140% compared to 1Q 2017 Number of nephrologists prescribing Rayladee in Q2 has almost doubled compared to Q1 50-person sales and marketing team launched Rayaldee on November 30, 2016 Increasing field sales force from 35 to 70 reps – roll out expected October 2
Slide 15: SARM: Selective Androgen Receptor Modulator for BPH
sarm–Selective Androgen Receptor Modulator OPK-88004 -Benign prostatic hypertrophy (BPH) ONCE DAILY ORAL Tablet Phase 2 study of 350 male subjects for another indication showed significantly increased lean body mass and muscle strength and significant fat mass reduction with no change or lower prost
Slide 16: hGH-CTP competitive advantages
hGH-CTP Competitive Advantages New molecular entity (NME) that maintains natural native sequence of growth hormone Once weekly injection vs. current products requiring daily injections Human growth hormone is used for: Growth hormone deficient children and adults SGA, PWS, ISS Final presentation: Re
Slide 17: hGH-CTP pediatric and adult Phase 3 studies
Initiated Phase 3 pediatric hGH-CTP study in December 2016 220 patients, non-inferiority comparison of weekly hGH-CTP to daily growth hormone Global study CROs selected; sites initiated in December Easy-to-use, disposable, refrigerated pen device Phase 3 adult hGH-CTP In December 2016 reported that
Slide 18: Long-acting Factor VIIa-CTP for Hemophilia A & B
Long-acting Factor VIIa-CTP for Hemophilia A & B Current product (NovoSeven®) requires frequent IV doses 3-4 times a day during bleeding episodes 1-2 times a day for prophylactic treatment In pharmacological studies in hemophilic mice and dogs, Factor VIIa-CTP: Demonstrated potential for subcutaneou
Slide 19: OPK-88003 oxyntomodulin analog for type 2 diabetes and obesity
FOR THE TREATMENT OF TYPE 2 DIABETES AND OBESITY OPK-88003 OXYNTOMODULIN ANALOG 26 million diabetics in US: drug development focused on: blood glucose control and reducing body weight OPK-88003 is an once-weekly analog with both GLP-1 and glucagon activity Data support that combining GLP-1 and gluca
Slide 20: OPK-88002 NK antagonist for pruritus in dialysis patients
OPK-88002 NK 1 ANTAGONIST FOR THE TREATMENT OF PRURITUS IN DIALYSIS PATIENTS Acute and chronic pruritus (“itching”) occurs in 10% to 15% of the population Most prevalent in skin, kidney and liver diseases Substance P is implicated in pruritus NK-1 antagonists block substance P activity and have been
Slide 21: Select financial information
Select financial information Cash, cash equivalents & marketable securities: $130.5 million Net investments: $34.5 million Current portion of line of credit and notes payable: $14.5 million Senior notes (net of embedded derivatives): $34.8 million Common shares outstanding: 559,995,118 Three months
Slide 22: Upcoming milestones
Upcoming milestones PROGRESS ACROSS MULTIPLE BUSINESS AREAS Expand Rayaldee field sales forceOctober 2017 SARM Phase 2Initiate in 4Q17 Claros 1 PSA clinical studyPMA filing 4Q17 Claros 1 testosterone clinical studyInitiate 1H18 Oxyntomodulin Phase 2b Initiate 1H18 hGH-CTP Phase 3 PediatricEnrollment
Slide 23: Thank you
OPKO THANK YOU