Innovative Drug Delivery Solutions. Investor Presentation August 22, 2016

Transcription

1 Innovative Drug Delivery Solutions Investor Presentation August 22,

2 Forward Looking Statements To the extent any statements made in this presentation contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe," 2 "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration and Canadian Therapeutic Products Directorate approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials and finished products, the regulatory environment, tax rate assumptions, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities Commission. IntelGenx undertakes no obligation to update or revise any forward-looking statement. 2 1

3 Company Snapshot IntelGenx Corp. Founded TSX-V (IGX) OTCQX (IGXT) Market Capitalization Shares Issued Shares Fully Diluted 2 Insider Ownership Cash/Equivalent 2003 CAD$0.93 US$0.70 CAN$60M 63.6M 70.35M 15% US$6M Analyst Coverage Firm Analyst H.C. Wainwright Swayampakula Ramakanth Singular Research Greg Eisen 3 2

4 Oral Thin Films Oral Thin Films Provide Significant Market Opportunities for Improving Drug Delivery 2 IntelGenx CEO co-developer of the Listerine breath strips Oral films provide quicker action to relieve symptoms IntelGenx s goal to become a leader in pharmaceutical oral film development & manufacturing 4 3

5 Clearly Defined BD Strategy We are focused on areas where oral films are particularly well-suited: Develop and commercialize products that provide tangible patient benefits leveraging oral films, such as: Reduced side effects Improved bio-availability Response time versus existing drugs Lifecycle management Repurpose existing drugs for new indications using oral films First-to-file Generic drugs where high technology barriers to entry exist in reproducing branded films 5 4

6 Prioritization of Future Product Sourcing Balancing Risks and Opportunities for an Optimized Portfolio Low Overall Risk IntelGenx Future Focus Lifecycle Mgmt Patient Benefits Drug Repurposing Deal Value Low Medium High FTF Generics High Slow Time to Market Fast 6

7 A Robust Product Pipeline to Address Significant Market Opportunities Indication Partnering Availability Formulation Development Pilot Study Pivotal Study Filing Launch Films Migraine Rizaport TM - Rizatriptan Available except Spain Erectile Dysfunction - Tadalafil Available Schizophrenia - Loxapine Available Central Nervous System - Montelukast Available Respiratory (Cough & Cold) In Discussion Cardiovascular In Discussion Opioid Dependence Par Pharmaceutical Undisclosed Pain Central Nervous System Term Sheet Term Sheet Term Sheet 6 5 7

8 Successful monetization of first in-house development High dose version of Wellbutrin XL Only approved, once-daily, bupropion HCl 450mg dose in a single tablet Launched commercially October 2013 in partnership with Edgemont Pharmaceuticals Sold US revenue to SWK Holdings for $6M Development cost $2.5M, total revenue $15M = 6-fold ROI Non-dilutive source of funding, will be used to advance film projects 8 7

9 For Migraines Leverages VersaFilm Technology European Mktg Approval November 2015 Co-development partnership with RedHill Biopharma Definitive agreement signed July 2016 with Grupo Juste for Spain & additional territories Actively pursuing several opportunities to open new markets - negotiations with future commercialization partners ongoing Planned USA submission to FDA Q1/2017 Expected USA launch Q3/

10 For Erectile Dysfunction The first oral thin film using IntelGenx proprietary drug delivery technology, VersaFilm, for ED Containing tadalafil (Cialis - Eli Lilly), a major molecule in the ED market Demonstrated bioequivalence to Cialis Orally disintegrating films without need for water provide unprecedented patient convenience and a discrete dosing alternative 505(b)(2) USA NDA submission in Q1/2017 Expected USA launch Q1/

11 For Schizophrenia & Bipolar 1 Disorder The first oral thin film using IntelGenx proprietary drug delivery technology, VersaFilm, for Schizophrenia & Bipolar 1 disorder Fast-acting loxapine oral dosage to treat acute agitation with Schizophrenia & Bipolar 1 disorder in non-institutionalized patients Reduces risk of pulmonary problems and potential risk of violence and injury to patients and others Formulation optimization stage results expected Q

12 For Mild Cognitive Impairment IntelGenx is repurposing Montelukast for the treatment of MCI by leveraging its VersaFilm technology The drug is known and approved for a completely different indication (asthma) Strong preclinical experience Results from first phase 1 trial in humans available Looking for a commercial partner 12 11

13 Montelukast concentration (ng/ml) Clinical Data Montelukast Avg Plasma Profile Before After 2 Months of Montelukast Test buccal film 10mg Ref tablet 10mg MMSE 13: moderate to severe dementia MMSE 22: mild dementia Time (hrs) First clinical study successfully completed Significantly increased bioavailability after administration of VersaFilm product compared to commercial tablet Drug crosses blood/brain barrier when given as film Phase II-a study (proof of concept) to commence Q1/2017 First efficacy data in humans available Q4/2017 Several Pharma companies have expressed strong interest 13 12

14 Completion of Construction of Manufacturing Facility We have built a state-of-the-art oral film development and manufacturing facility 17,000 sq ft facility in Montreal - construction completed in Q Facility to be fully operational by Q High capacity manufacturing and packaging equipment Lower costs, controls quality and de-risks investment for new products GROSS MARGINS of 40% PLUS 14 13

15 Strengthened Management Team Over 20 Employees, including 7 with Ph.D. s Horst G. Zerbe, Ph. D. Chairman, President & CEO Co-Founder of Listerine breath strips 30+ years drug delivery / pharma experience Holds over 40 patents in drug delivery and numerous scientific publications Andre Godin, CPA, CA Executive VP, CFO 25+ years biotech/pharma industry experience Member of the Canadian Chartered Professional Accountants and the Canadian Institute of Chartered Accountants John Durham, B. Sc. VP, Operations 20+ years experience in pharmaceutical manufacturing, quality management, product development Held executive positions with several Canadian and US companies Nadine Paiement, M. Sc. VP, Research & Development Co-inventor of IntelGenx Trilayer Technology 15 years experience in product development and technology transfer Dana Matzen, Ph.D. VP, Business & Corporate Development 15 years experience in pharmaceutical product licensing Prev. Director, BD at Paladin Completed 13 transaction, 7 new product launches Edward Miller, B. Comm Director, Investor Relations 15 years experience in investor relations 10 + years experience in pharmaceutical / biotech 15 14

16 What Makes IntelGenx the Best in Oral Films 1. History Dr. Zerbe a pioneer with over 30 plus years in oral films 2. Formulation Team Strong in applying biopharmaceutical aspects to formulation development Top quality scientists: highly creative, focused on problem solving & innovative approaches Experienced in developing films for oral (GI), sublingual & buccal absorption 3. Clearly Defined Corporate Strategy And Business Model Focus on drug repurposing, lifecycle management, patient benefits, and FTF Provider of comprehensive pharmaceutical services to industry partners 4. Competitive Manufacturing Capabilities First in Canada New state-of-the-art manufacturing facility Offer one-stop-shopping to our partners with lean operations keeping costs down Customized manufacturing equipment 16 15

17 Financial Results 17 16

18 Financial Performance $M 6 5 Revenue ($M) H H Full Year 2014 Full Year Revenue 18 17

19 Financial Performance Net Comprehensive Income & Adjusted EBITDA ($M) $M H H Full Year 2014 Full Year Net Income Adjusted EBITDA 19 18

20 Conclusion 20 19

21 Solid Platform for Growth Significant Market Potential New manufacturing facility will offer many competitive advantages Strengthened management team to accelerate execution of business plan Implemented product sourcing strategy to identify high-value product opportunities Building strategic partnerships with relevant partners in the pharmaceutical industry 21 20

22 Thank You! Contact Info: Edward Miller, B.Comm. Director, Investor Relations ext. 217 IntelGenx Corporate Offices 6420 Abrams Saint-Laurent (Quebec) H4S 1Y2 Canada