Corporate Presentation Proactive One2One. Investor Forum. Presented by: Rachelle MacSweeney June 6, 2013

Transcription

1 Corporate Presentation Proactive One2One Investor Forum Presented by: Rachelle MacSweeney June 6,

2 Company Overview Specialty Pharmaceutical Company with a Focus on Cardiovascular Disease (CVD) and Overall Health Proven Company Model Reprofiling Drugs Early Revenues and Minimized Regulatory Risk/ Uncertainty Products Positioned in Unique & Significant Markets Experienced Management Team Revenue Flow Public Company listed on: Canadian (CNSX: PVO) and a US (OTCQX: PVTTF) Stock Exchanges 2

3 Canadian Product: OMAZEN Prescription Grade, Ultra High Purity Omega-3 Provides Over 90% Pure Omega-3 in Each Capsule Canadian Natural Health Product (NPN ) Indication: for the Maintenance of Good Health Dosage: 2.4g of Omega-3 (Three Soft Gel Capsules/Day) Positioned for: Wellness Clinics, Cardiac Rehabilitation Clinics, Sports Medicine Clinics and Private Executive Healthcare Clinics 3

4 U.S. Product: FDA Regulated Prescription Omega-3 (Second to Market) We Are Cardiovascular Disease & Omega-3 Indication: Dietary Management of Omega-3 Therapeutics Inc. is a specialty pharmaceutical Cardiovascular disease is one of the (CVD) main causes of death in Deficiency in Cardiovascular Patients ny with a focus on the treatment of cardiovascular developing countries. It is a multi-factorial age related disease affected e and the study of the science and benefits of by an individual s lifestyle, including, but not limited to dietary habits. >90% Total Omega-3 Ultra High Purity a-3 fatty acids. Evidence suggests a diet high in Omega-3 fatty acids decreases the risk factors associated with cardiovascular disease. Unique Formulation (6:1 Ratio of EPA:DHA) Therapeutics is introducing its lead product,, a >90% pure prescription product for the Dietary Deficiency of Omega-3 in dietary management of Omega-3 deficiency in Clinically Shown (REVEAL Trial) to Correct an Cardiovascular Patients s with cardiovascular disease. Therapeutics is a publicly traded company X: PVTTF; CNSX: PVO). ortance of Omega-3 Omega-3 Deficiency by 121% and Reduce According to a US study and the Dietary Guidelines Committee, Triglycerides by 48% in Eight Weeks 70% of Americans are Omega-3 deficient due to a lack of consumption of these essential fatty acids in the typical western Dosage:diet. 3.0g ofomega-3 Omega-3 (Four Soft Gel Chronic deficiency contributes to the riskcapsules/ factors day) associated with cardiovascular disease. a-3 is a fatty acid naturally found in many cold water Increasing dietary levels of EPA and DHA have been shown to have he two major health promoting essential Omega-3 Companion a host ofdiagnostic cardio-protective benefits. Data suggests a correlation cids are: Eicosapentaenoic acid (EPA), which has a between high circulating blood levels of EPA and DHA with a anti-inflammatory component, and reduction in the risk & of cardiovascular events. Beneficial effects of Third Tested Quality Assured ahexaenoic acid (DHA), an important component of Party EPA and DHA have been documented in a number of clinical studies. mbranes that provides significant positive include positive effects on lipid metabolism, blood pressure, vascular effects. US andthese International Patents heart rate, platelet aggregation, atherosclerotic plaque stabilization, cardiac arrhythmia stabilization, and protection from sudden 4

5 Market Potential Omega-3 Dietary Deficiency/ Consequences include but is not limited to patients who are under medical supervision for: Triglycerides Cholesterol Hypertension Post-Coronary Artery Bypass Graft Surgery (CABG) Post-Stent Angioplasty Acute myocardial infarction Arrhythmias Heart failure Diabetes Obesity All Other Forms of Chronic Ischemic Coronary Heart Disease (CHD) Total CVD Patient Population (80 million Americans) 10% 90% Omega-3 Deficient (72 million) 5

6 Market Potential Omega-3 Deficient CVD Population Triglycerides GSK (LOVAZA) ($1.2B) Amarin (VASCEPA) Omthera/AstraZenica (Not Commercialized) Acasti (Not Commercialized) (72 million Americans) 5% 25% VASCAZEN 70% Acceptable Triglycerides (<200 mg/dl) (17.9 million) High Triglycerides ( mg/dl) (50.7 million) Very High Triglycerides ( 500 mg/dl) (3.4 million) 6

7 Omega-3 Characteristics & Properties Two major health promoting Omega-3 fatty acids are: Eicosapentaenoic acid (EPA) Strong anti-inflammatory component Docosahexaenoic acid (DHA) Important component of cell membranes & Significant cardiovascular effects (antiarrhythmic properties) Importance of Purity: Purity is two-fold and refers to: 1. Total Omega-3 content 2. Amount of contamination with heavy metals and toxins Not all fish oils are the same Over-the-Counter (OTC) Dietary Supplements vs. Prescription OTC Brands contain 30-60% total Omega-3s vs. 90+% for Prescription Brands 7

8 Omega-3 Characteristics & Properties American Heart Association Recommends 2-4 grams of EPA+DHA everyday 1. In order to reach these levels recommended by the AHA 1. American Heart Omega-3 Recommendations. NutritionCenter/Fish-101_UCM_305986_Article.jsp#aha_recommendation * PCB: Polychlorinated biphyenyl 8

9 Omega-3 Characteristics & Properties When Omega-3 fatty acids are incorporated into vascular cell membranes: Improved Blood Flow Reduced Inflammation Positive Effects on Lipid Metabolism What is not generally known is that these effects are determined by: Purity (>90%) Ratio/Formulation of EPA:DHA Dose (>2 g) Source: Surette M E CMAJ 2008;178:

10 Omega-3 Deficiency Negative Effects of Omega-3 Deficiency Patient Profile: FEMALE (Age: 45) Cardiovascular Conditions: Omega-3 Deficient (OM3D) Triglycerides: 309 mg/dl LDL: 112 mg/dl HDL: 40 mg/dl Hypertensive Coronary Heart Disease Lifestyle Habits: Eats out 3-4 times per week No fish consumption 10

11 DRUG (Rx) DRUG Indication: Treat a Disease Pre-Marketing Approval (~$500M) Time-to-Market: 7+ years VASCAZEN Strategy: Prescription Omega-3 s MEDICAL FOOD (Rx) MEDICAL FOOD Indication: Treat a Deficiency No Pre-Marketing Approval (<$7M) Time-to-Market: years FDA Regulated Requires FDA Good Manufacturing Practices Safety & Efficacy Data Traditional Pharmaceutical Distribution Channel Sales Reps Call on Physicians & Healthcare Professionals Both by Prescription Reimbursed by Private Payors Listed in Drug Compendiums (e.g. Physician Desk Reference - PDR) Comparable Pricing 11

12 Clinical Data Comparison VASCAZEN vs. Other Prescription Omega-3 s Study Length/Treatment Period Study Group Triglyceride Levels Correction of Omega- 3 DeTiciency VASCAZEN 1 (6:1 EPA:DHA) LOVAZA 2 (1.2:1 EPA:DHA) VASCEPA 3 (Pure EPA) 8 Weeks 16 Weeks 12 Weeks mg/dl 500 mg/dl 500 mg/dl +121%* Effect on Triglycerides - 48%* - 52%* - 33%* Effect on LDL BAD Cholesterol Effect on HDL GOOD Cholesterol +11% (Not SigniTicant) +49.3%* +9%* +9%* - 2% (Not SigniAicant) - 3.6% (Not SigniAicant) * Statistically Significant 1 Presentated at the Atherosclerosis, Thrombosis and Vascular Biology (American Heart Association) Conference (May 2013) and submitted for presentation at the European Society of Cardiology (August 2013). 2 LOVAZA Package Insert 3 Eicosapentaeonic Acid Ethyl Ester (AMR101) Therapy in Patients With Very High Triglyceride Levels (Taken from Fig. 3, Bays et. Al. Am J Cardiol 2011; 108:

13 VASCAZEN vs. Other Prescription Omega-3 s VASCAZEN (Pivotal) LOVAZA (GSK) VASCEPA (Amarin) Indication Dietary Management of Omega-3 Deficiency (OM3D) in CVD Patients Lowering of Very High Triglycerides (>500mg/dL) Lowering of Very High Triglycerides (>500mg/dL) By Prescription Only Regulated by FDA >90% Purity (Prescription-only Medical Food) (Drug) (Drug) Proven Clinical Effectiveness Sales Force (US North East) (US National) (US National) Distribution System (McKesson, Cardinal, Amerisource) Reimbursement Currently Available in Pharmacies (US) Patent Position 20 years 5 years 20 years EPA:DHA Ratio (Specifically Formulated Optimal 6:1 EPA:DHA Ratio) (1.2:1 EPA:DHA Ratio) (98% EPA Formulation) Market Size Significant (>$5B US Market) Limited ($2B US Market) Limited ($2B US Market) 13

14 Pivotal s Objectives for the Coming Year Continue to Develop Significant Brand Leadership Expand Sales Force Grow Revenues Grow in New Geographies New Drug Indication for VASCAZEN Formulation (Not Triglyceride Lowering) Continue Clinical Programs Expand Product Pipeline and Seize New Opportunities 14

15 Valuation Comparables * ** Market Cap $11.9 Million $1.0 Billion $198.3 Million Stock Statistics EXCHANGE: CNSX SYMBOL: PVO STOCK PRICE: $0.150 SHARES OUTSTANDING:79,453, WEEK LOW/HIGH: $0.080-$0.290 EXCHANGE: NASDAQ-GM SYMBOL: AMRN STOCK PRICE: $6.81 SHARES OUTSTANDING: 150,680, WEEK LOW/HIGH: $6.25-$15.96 EXCHANGE: TSX Venture SYMBOL: APO STOCK PRICE: $2.71 SHARES OUTSTANDING: 73,188, WEEK LOW/HIGH: $1.60-$2.80 Data as at June 5 th, 2013 *Pure EPA **Krill Oil BREAKING INDUSTRY NEWS: AstraZeneca bought Omthera Pharmaceuticals for as much as $443 million USD representing an 88 percent premium or $12.70 per share with contingent value rights of about $4.70 per share EPANOVA (Omthera s product) is a 2:1 EPA:DHA Omega-3 which has completed final-stage Phase III clinical trials and is at pre-us regulatory approval stage expected launch

16 Company Information Share Capital Shares Issued 79,453,509 Share Options Outstanding 4,449,000 Shares to be Issued 11,065,092 Major Shareholders Founders, Directors, Employees 30.3% Institutional Investor 16.5% Public Float 53.2% Warrants to be Issued 5,532,546 Fully Diluted 100,500,147 Market Cap 1 CAD $11.9 Million Trading Details Canada: CNSX United States: OTCQX Ticker: PVO Ticker: PVTTF Contact Details Corporate Head Office: US Subsidiary: Pivotal Therapeutics Inc. Pivotal Therapeutics (US), Inc. 81 Zenway Blvd., Unit FAU Blvd., Suite 400 Woodbridge, Ontario, CANADA Boca Raton, Florida, USA Tel: (905) Tel: (561) Data as at June 5 th,

17 Management Team Founder, Chairman, Chief Scientific Officer - George Jackowski, Ph.D Ø Biotech Entrepreneur with over 25 years experience - Created 9 biotech companies, 4 of which are public (Nasdaq, TSX, Venture Exchange) Ø Trained at UC San Francisco - Cardiovascular Biochemist and Cardiac In-Vitro Diagnostic Pioneer (developed cardiac panel markers currently generating US$500M per year in global sales) Ø Experience in designing clinical trials and getting product approved through regulatory agencies (US & ROW) Ø Served roles as Chairman, CEO, President and CSO Ø Grew companies to market caps of over $350 million Ø 153 Patents Filed and Issued - Significant Experience in designing patent claims, litigation and interferences Ø Taken ideas from Bench-to-Product Ø Raised from public capital markets over $125 million Ø Completed deals with: Baxter, Dade, J&J, Ortho, Roche, Abbot, Fisher, Becton Dickinson, Genzyme, Nanogen, Schering-Plough - approximately US$100 million in transactions Founder, Chief Executive Officer, Chief Financial Officer Eugene Bortoluzzi, MBA Ø Senior Finance Executive with significant experience in public and private companies ranging from entrepreneurial business environments to TSE and NASDAQ listed international organizations Ø Executive leader with over 12 years experience in managing biotechnology companies Ø Areas of expertise: Strategic Planning, Operational & Financial Management, Mergers and Acquisitions, Raising Capital, Business Development, US and Canada Regulatory Reporting, Investor Relations Founder, President, Chief Operating Officer Rachelle MacSweeney, B.Sc., MBA Ø Extensive experience in marketing and business development Ø Prior experience with companies including biotechnology, healthcare & homecare products, aerospace and defense Ø Has been instrumental in bringing a prescription product to market Ø Has successfully raised $7.5 million from the public capital markets 17

18 Investment Opportunity þ High Demand Products Addressing Large Markets þ Low-Cost Development Platform/Faster Time to Market þ Strong Reimbursement þ Established Sales þ Growing Adoption of Medical Foods þ Strong and Valuable Intellectual Property Portfolio þ Proven Safety & Efficacy Through Clinical Trials þ Strong Growth Potential 18

19 THANK YOU! 19