Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (January 2016)
34 slides from Oramed Pharmaceuticals's investor presentation, Jan 14, 2016
Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations January 2016
Slide 2: Safe Harbor
Safe Harbor Certain statements contained in this material are forward - looking statements . These forward - looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ m
Slide 3: Oramed Snapshot
Oramed Snapshot ▪ Proprietary oral protein delivery platform ▪ Insulin first - initially targeting the lucrative insulin market. Additional huge markets in the pipeline ▪ Strong financial position $ 39M in cash and investments, no debt ▪ Strong management team backed by world - class scientific expe
Slide 4: Funneling Huge Injectable Drug Markets to Novel Oral Formulations
Funneling H uge I njectable D rug M arkets to Novel Oral F ormulations 4 Insulin 2014: $24 b GLP - 1 Analog 2014: $3 b Vaccines 2014: $33 b Flu vaccines 2011: $2.9 b Interferon 2015: $10+ b
Slide 5: An Unsolved Challenge: Proteins and Peptides Do Not Survive the Digestive System
Harsh pH Stomach acidity cleaves and shreds protein Protease attack Proteases attack and break down proteins An Unsolved C hallenge: Proteins and Peptides do Not S urvive the Digestive S ystem 5 Absorption barrier Most therapeutic proteins fail to be absorbed via the intestinal wall (barrier )
Slide 6: Oramed Technology Protects Drug Integrity and Increases Absorption
Oramed Technology P rotects D rug I ntegrity and Increases A bsorption 6 pH shield for passage through stomach pH sensitive enteric coating protects capsule contents. Capsule dissolves only once in small intestine Protease protection Special cocktail of protease inhibitors stave off and protect the
Slide 7: Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
Diabetes: Millions of diabetics inject insulin today and wish for oral dosage 7
Slide 8: 1 in 12 People on the Planet Have Diabetes
every 7 SECONDS 1 person dies from diabetes 4.9M deaths in 2014 1 in 12 People on the Planet H ave D iabetes 8 https://www.idf.org/worlddiabetesday/toolkit/gp/facts - figures WORLD 387 M People living with diabetes PREVALENCE 8.3% healthcare 1 in 9 Is spent on diabetes 2014 2035 MILLION expected inc
Slide 9: Type 1 and Type 2 Diabetes Are Different
Type 1 and Type 2 Diabetes A re Different ▪ T1DM is autoimmune: The body destroys its own insulin - producing (beta) cells, leaving patients completely dependent on external insulin sources ▪ 5 - 10% of diabetics have T1DM: Up to 37 million people worldwide have T1DM ▪ Projected Market: $13 billion
Slide 10: ORMD-0801: Oramed's Flagship Product for Oral Treatment of Diabetes
ORMD - 0801: Oramed’s Flagship P roduct for Oral T reatment of Diabetes 10 * Total number of study subjects: 196 . Total number of human doses: 2 , 063 ~200 study subjects * ~2000 human doses * Clean safety profile
Slide 11: The Drawbacks of Injected Insulin vs. the Advantages of Oral Insulin
The Drawbacks of Injected I nsulin vs. the Advantages of O ral Insulin ENDOGENOUS INSULIN produced by the pancreas and delivered to the body via the liver INJECTED INSULIN introduced directly to the bloodstream with only a fraction of it reaching the liver. This can cause excess sugar to be stored i
Slide 12: ORMD-0801: Better type 2 diabetes treatment by interacting with the body like natural insulin
ORMD - 0801: Better type 2 diabetes (T2DM) treatment by interacting with the body like natural insulin 12
Slide 13: The Type 2 Diabetes Treatment Paradigm
The T ype 2 Diabetes T reatment P aradigm 13 ADA guidance: Earlier use of insulin equals better outcome (source ) 01 Stage 1 : Initial Treatment - Lifestyle m odification - Diet & exercise 02 Stage 2: Single & Combination Oral Therapies - Reduce insulin resistance - Stimulate insulin secretion 03 St
Slide 14: Excessive Production of Glucose at Night: A Significant Challenge in Diabetes Management
Excessive Production of Glucose at Night: A S ignificant Challenge in D iabetes Management ▪ Excessive nocturnal glucose production by the liver is frequently demonstrated in diabetes patients ▪ Results of high blood sugar are measured by a fasting blood sugar (FBG) test, done after an 8 - hour fast
Slide 15: Simple Oral Administration at Bed Time Managing Diabetes
Simple Oral A dministration at Bed T ime Managing D iabetes Oramed’s first indication, ORMD - 0801 , reduces excessive nocturnal glucose production in the liver, by acting the same way that natural insulin does. Key benefits 15 Reduction of FBG levels Increased patient compliance via simple oral adm
Slide 16: Phase IIa FDA Study: ORMD-0801 Drug Safe With no Serious Adverse Events
▪ 30 T 2 DM patients ▪ Primary objective: Safety and tolerability ▪ Secondary objective: Pharmacodynamic effects on mean nighttime glucose Phase IIa FDA Study: ORMD - 0801 Drug S afe With no Serious A dverse E vents 16 Placebo N= 10 Mean (SD ) 176.06 ( 63.70 ) ORMD - 0801 N=10 Mean (SD ) 153.23 (40.
Slide 17: Phase IIa FDA Study: ORMD-0801 Demonstrates Sustained Glucose Reduction
▪ Observed to be safe and well tolerated for dosing regimen ▪ No hypoglycemic events at any point during the study in any member of treatment group ▪ No related adverse events observed ▪ Dose group showed a pronounced effect over placebo ▪ Sustained reduction observed at night, day and mean fasting
Slide 18: Ongoing Patient FDA Phase IIb Study
Ongoing 180 Patient FDA Phase IIb Study 18 ▪ Safety of ORMD - 0801 ▪ Evaluate PD effects of ORMD - 0801 on mean night glucose ! 30 US sites 28 day treatment 1 time a day at night Primary objectives: 180 patients
Slide 19: ORMD-0801 Type 1 Diabetes: Potentially eliminating the need for insulin before each meal
ORMD - 0801 Type 1 Diabetes (T 1 DM): Potentially eliminating the need for insulin before each meal 19
Slide 20: Oramed: Potentially Superseding Bolus Replacement Therapy
▪ Long - acting insulin (basal) helps maintain stable insulin levels during fasting periods ▪ Rapid - acting insulin (bolus) prior to each meal to stabilize blood sugar ▪ Administration is via injection or pump ▪ Easier use and reduced systemic exposure ▪ Potentially reducing multiple daily injectio
Slide 21: ORMD-0801: Consistent Lowering of Glucose Levels - Day and Night in Preliminary Study
ORMD - 0801: Consistent Lowering of Glucose L evels - Day and Night in P reliminary Study Design: ▪ Monitor glycemic stability of orally administered ORMD - 0801 ▪ Uncontrolled T1DM patients ▪ 1 capsule of 8 mg insulin administered before meals, three times daily at mealtime ▪ Continuous glucose mon
Slide 22: Phase IIa FDA Study: Shows Consistent and Accumulative Effect of ORMD-0801
Blood glucose levels are lower, day and night, compared to control group Phase IIa FDA Study: Shows Consistent and Accumulative Effect of ORMD - 0801 22 Reduction in FBG 25 T 1 DM patients 7 days of treatment 3 times a day (at mealtime) To evaluate the change in exogenous insulin requirements in T 1
Slide 23: Phase IIa FDA Study Demonstrates Oral Insulin Reduces Exogenous Insulin Requirements
ORMD - 0801: Phase IIa FDA Study Demonstrates Oral Insulin Reduces Exogenous Insulin Requirements Safe and well tolerated for the pre - meal dosing regimen in this study. Encouraging trends in key areas vs. placebo: 23 Decreased use of rapid - acting insulin levels of post - meal glucose levels of d
Slide 24: China License Deal
China License Deal: 500 M patient potential 24 * Journal of the American Medical Association ▪ License: Exclusive right to ORMD - 0801 in Greater China ▪ Licensee: Hefei Tianhui ("HTIT") Owns with Sinopharm a state - of - the - art GMP API insulin manufacturing facility ▪ $ 50 M Payments + Royalties
Slide 25: ORMD-0901: Oral GLP-1 Analog
ORMD - 0901: Oral GLP - 1 Analog 25
Slide 26: GLP-1 Analog: ORMD-0901 for Oral GLP-1 Clinical Status
▪ T 2 DM medication ▪ Mimics the natural hormone in the body ▪ Good safety profile ▪ Decreases blood glucose levels ▪ Does not cause hypoglycemia ▪ Effectively reduces HbA 1 c ▪ Preserves beta cell function ▪ Promotes weight loss ▪ Current therapy is via injection only ▪ IND - enabling tox studies i
Slide 27: ORMD-0901 Preclinical and Human Data
Dogs: Subcutaneous exenatide delivery amounted to a 51 % reduction in mean glucose Oral GLP - 1 - ORMD - 0901 0 20 40 60 80 100 120 S.C. AG 4 AG 3 - + + + + Exenatide Glucose * * * Area (mg/dl)/minutes * 10 2 Preserved the biological activity of orally delivered exenatide . ORMD - 0901 successful
Slide 28: Rich Pipeline: Multiple Value-Creation Events
ORMD - 0801 (Oral Insulin) Type 2 Diabetes ORMD - 0801 (Oral Insulin) Type 1 Diabetes ORMD - 0901 (Oral GLP - 1 ) Type 2 Diabetes Rich Pipeline: Multiple Value - Creation Events 28 Phase I Phase II Phase III Timeline Q 1 , ‘ 14 : Phase IIa completed Q 2 , ’ 15 : Phase IIb study initiated Q 2 , ‘ 16
Slide 29: Corporate Overview: On route to meet unmet market needs
Corporate Overview: On route to meet unmet market needs 29
Slide 30: Oramed: Corporate Overview
Oramed (NASDAQ: ORMP): Corporate Overview 1 1 As of January 12 , 2016 . 2 Including 1.7 M options, 0.7 M warrants and 0.3 M RSUs Financial Highlights ▪ $ 39 M cash and investments ▪ 13.1 M shares outstanding ( 15.7 M fully diluted 2 ) ▪ No Debt Analyst Coverage ▪ Rodman & Renshaw (PT $ 25 ) ▪ Aeg
Slide 31: Lead Team
Lead Team 31 Michael Berelowitz , MD Chairman of Oramed SAB SVP Clinical Development & Medical Affairs, Pfizer (former) Harold Jacob, MD Chief Medical Officer, Given Imaging (former) Gerald Ostrov CEO, Bausch&Lomb (former) Senior level executive J&J (former) Leonard Sank Entrepreneur and business le
Slide 32: Scientific Advisory Board
Scientific Advisory Board 32 Michael Berelowitz , MD Chairman of SAB Former SVP Clinical Development and Medical Affairs, Specialty Care Business at Pfizer Inc. Strong background in the Diabetes field John Amatruda , MD Former SVP and Franchise Head of the Diabetes and Obesity Unit at Merck & Co. Av
Slide 33: Oramed: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Oramed: Addressing the Multibillion - Dollar I njectable D rug M arkets with Oral F ormulations ▪ Proprietary platform for oral delivery of drugs, proven in clinical studies ▪ Initially targeting the lucrative insulin market . Additional huge markets in the pipeline ▪ Strong lead team backed by glob
Slide 34: Thank You
THANK YOU www.oramed.com Nadav Kidron CEO nadav@oramed.com Josh Hexter COO josh@oramed.com
Oramed Pharmaceuticals — Investor Presentation (January 2016) on 6ix