Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (May 2016)
35 slides from Oramed Pharmaceuticals's investor presentation, May 23, 2016
Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations May 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 $ 36 M in cash and investments, no debt ▪ Strong management team backed by world - class scientific exp
Slide 4: Funneling Huge Injectable Drug Markets to Novel Oral Formulations
Funneling Huge Injectable Drug Markets to Novel Oral Formulations 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 Challenge: Proteins and Peptides do Not Survive the Digestive System 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 Protects Drug Integrity and Increases Absorption 6 pH shield for passage through stomach pH sensitive enteric coating protects capsule contents. Capsule dissolves only once in small intestine Protease protection Protease inhibitors stave off and protect the active agent from protea
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 4.9 M deaths in 2014 1 in 12 People on the Planet Have Diabetes 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 Are Different ▪ T1DM is autoimmune: The body destroys its own insulin - producing (beta) cells, leaving patients completely dependent on external insulin sources ▪ 10% of diabetics have T1DM: Up to 37 million people worldwide have T1DM ▪ Projected Market: $13 billion by 20
Slide 10: ORMD-0801: Oramed's Flagship Product for Oral Treatment of Diabetes
ORMD - 0801 : Oramed’s Flagship Product for Oral Treatment of Diabetes 10 >300 study subjects > 5000 human doses Clean safety profile
Slide 11: The Drawbacks of Injected Insulin vs. the Advantages of Oral Insulin
The Drawbacks of Injected Insulin vs. the Advantages of Oral 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 in
Slide 12: 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 12
Slide 13: 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 14: ORMD-0801: Consistent Lowering of Glucose Levels, Day and Night
ORMD - 0801 : Consistent Lowering of Glucose Levels - Day and Night in Preliminary Study Design: ▪ Monitor glycemic stability of orally administered ORMD - 0801 ▪ Uncontrolled T 1 DM patients ▪ 1 capsule of 8 mg insulin administered before meals, three times daily at mealtime ▪ Continuous glucose mo
Slide 15: Phase IIa FDA Study: 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 15 Reduction in FBG 25 T1DM patients 7 days of treatment 3 times a day (at mealtime) To evaluate the change in exogenous insulin requirements in T 1 D
Slide 16: 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: 16 Decreased use of rapid - acting insulin levels of post - meal glucose levels of
Slide 17: ORMD-0801: Better type 2 diabetes treatment by interacting like natural insulin
ORMD - 0801 : Better type 2 diabetes (T 2 DM) treatment by interacting with the body like natural insulin 17
Slide 18: The Type 2 Diabetes Treatment Paradigm
The Type 2 Diabetes Treatment Paradigm 18 ADA guidance: Earlier use of insulin equals better outcome (source) 01 Stage 1 : Initial Treatment - Lifestyle modification - Diet & exercise 02 Stage 2 : Oral Therapies - Reduce insulin resistance - Stimulate insulin secretion 03 Stage 3: Late - Stage Treat
Slide 19: Excessive Production of Glucose at Night: A Significant Challenge
Excessive Production of Glucose at Night: A Significant Challenge in Diabetes 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 20: Simple Oral Administration at Bed Time Managing Diabetes
Simple Oral Administration at Bed Time Managing Diabetes 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 20 Reduction of FBG levels Increased patient compliance via simple oral adminis
Slide 21: 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 Safe With no Serious Adverse Events 21 Placebo N= 10 Mean (SD) 176.06 ( 63.70 ) ORMD - 0801 N= 10 Mean (SD) 153.23 ( 40.16
Slide 22: Completed: Patient FDA Phase IIb Study
Completed: 180 Patient FDA Phase IIb Study 22 ▪ Safety of ORMD - 0801 ▪ Evaluate PD effects of ORMD - 0801 on mean night glucose 33 US sites 28 day treatment 1 time a day at night Primary objectives: 180 patients
Slide 23: Phase IIb FDA Study: Primary Endpoints Successfully Met
▪ Safe and well tolerated – No drug related serious adverse events. Phase IIb FDA Study: Primary Endpoints Successfully Met Demonstration of Safe and Effective Oral Insulin Delivery 23 * Indicates Statistically Significant Difference from Placebo (p - Value< 0.05 ) 8.48 2.0 1 * Nighttime CGM Glucose
Slide 24: Phase IIb FDA Study: Primary & Secondary Endpoints
▪ Observed to be safe and well tolerated for dosing regimen ▪ No drug related serious adverse events ▪ Dose group showed a statistically significant effect over placebo ▪ Sustained reduction observed at night Phase IIb FDA Study: ORMD - 0801 Primary & Secondary Endpoints Safe and well tolerated Sust
Slide 25: China License Deal
China License Deal: 500 M patient potential 25 * 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 26: ORMD-0901: Oral GLP-1 Analog
ORMD - 0901 : Oral GLP - 1 Analog 26
Slide 27: 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 28: Oral exenatide delivery in dogs and humans
Dogs: Oral exenatide delivery amounted to a > 50 % reduction in mean glucose (similar to SC) 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 suc
Slide 29: 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 29 Phase I Phase II Phase III Timeline Q 2 , ’ 16 : Phase IIb study completed Q 3 , ’ 14 : Phase IIa completed Q 2 , ’ 16
Slide 30: Corporate Overview: On route to meet unmet market needs
Corporate Overview: On route to meet unmet market needs 30
Slide 31: 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 ▪ $ 36 M cash and investments ▪ 13.1 M shares outstanding ( 15.7 M fully diluted 2 ) ▪ No Debt Analyst Coverage ▪ Rodman & Renshaw (PT $ 25 ) ▪ Aegis
Slide 32: Lead Team
Lead Team 32 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 33: Scientific Advisory Board
Scientific Advisory Board 33 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 34: Oramed: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Oramed: Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations ▪ 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 globally
Slide 35: Thank You
THANK YOU www.oramed.com Nadav Kidron CEO nadav@oramed.com Josh Hexter COO josh@oramed.com
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