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Forward Looking Statements

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Presentation on theme: "Forward Looking Statements"— Presentation transcript:

0 Innovative Drug Delivery Solutions
We Make Approved Drugs Better November 24, 2015 TSX-V: IGX OTCQX: IGXT

1 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," "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 Oral Thin Films Provide Significant Market Opportunities for Improving Drug Delivery
IGX CEO co-developer of the Listerine breath strips Oral films ideal for elderly, children, patients who have difficulty swallowing traditional tablets Quicker action to relieve symptoms

3 IntelGenx Drug Delivery Technology Platforms
Making Approved Drugs Better Through Innovative Drug Delivery Solutions IntelGenx develops and manufactures faster and more efficient drug delivery systems for top pharmaceuticals IntelGenx Drug Delivery Technology Platforms Tablets Films Controlled-release tablets for oral absorption over an extended time period Rapidly disintegrating film improving drug performance and easing administration without the need for water Rizaport™

4 Investment Highlights
$17B TAM Developing proprietary oral drug delivery technologies to address $19B TAM Market momentum with Forfivo XL ® tablets Achieved first European marketing approval of RIZAPORT™ for Migraines Robust product pipeline to enable expansion into other market segments with significant TAM Achieved record Q3 revenue and profitability VersaTab™ $1.7B TAM

5 First 450mg tablet approved by FDA for major depressive disorder
FORFIVO XL® Technology First 450mg tablet approved by FDA for major depressive disorder 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 Q net sales grew 16% compared to Q2 2015, with net sales at $2.5 million ($4.7 million gross) For the past nine months, net sales totaled $6.3 million ($12 million gross), an increase of 117% compared to the nine month period in 2014 FORFIVO XL® NET SALES ($Thousands) $3,000 $2,500 $2,132 $2,000 $1,756 $1,697 $1,195 $1000 3Q14 4Q14 1Q15 2Q15 3Q15

6 Oral Thin Films Drug Delivery Technology
Over $17B Market Opportunity and Growth Platform for IGX Benefits of VersaFilm™ Improves patients compliance who have problems swallowing tablets and capsules to more easily take medication Rapid disintegration without the need for water Improves absorption – faster onset of action Potential for reduced adverse effects $17B Addressable Market Successful pivotal bioequivalence studies Two film products awaiting FDA approval Limited number of competitors OPIOD DEPENDENCE Targeted Suboxone Sales $1.7B SCHIZOPHRENIA Targeted Sales $5.2B MIGRAINE Targeted Rizatriptan Market $2B ERECTILE DYSFUNCTION Targeted Cialis® Sales $4.2B

7 Leverages VersaFilm™ Technology to Treat Migraines
Rizaport™ Leverages VersaFilm™ Technology to Treat Migraines European Mktg Approval – November 2015 Filed 505(b)(2) NDA - March 2013 for USA Co-development partnership with RedHill Biopharma Negotiations with commercialization partner ongoing

8 A Robust Product Pipeline to Address Significant Market Opportunities
Indication Market Opportunity Partnering Availability Formulation Development Pilot Study Pivotal Study Filing Launch Films Migraine – Rizaport TM - Rizatriptan $2B Available Erectile Dysfunction - Tadalafil $4.2B Opioid Dependence – Buprenorphine & Naloxone $1.78B Par Pharmaceuticals Schizophrenia $5.2B Undisclosed N/A Pain $100M Central Nervous System 2.7B 1.1B Respiratory 77M Cardiovascular Tablets Major Depressive Disorder – Forfivo XL® Bupropion 400M Edgemont Pharmaceuticals Available ex-USA Hypertension - Metoprolol 1.2B Pain - Dronabinol 130M

9 Commercialization Initiatives Strategic Partnerships Will Drive Growth
9

10 In-House Manufacturing Approach
Full Manufacturing Capabilities Establishing manufacturing capability to increase profitability Integrate pharmaceutical services and IP protection Reduce dependence by IntelGenx on external manufacturing partners Offer clients the advantage to obtain all services from one source (“one-stop shopping”) Increase R&D capabilities with expanded laboratories and technologies Blending Coating Packaging

11 Future Commercialization Strategy Key milestones suggest near term catalysts
2017 2016 Milestones Anticipated approval for opioid dependence VersaFilm™ Anticipated submission of 505(b)(2) NDA for ED VersaFilm™ Anticipated approval for migraine – USA FDA, Rizaport™ Milestones Anticipated launch for opioid dependence VersaFilm™ Anticipated approval for ED VersaFilm™ Start of commercial manufacturing operations Anticipated submission of 505(b)(2) NDA for Schizophrenia VersaFilm™ FORFIVO XL® milestone payments anticipated

12 Record Results in Q3 Demonstrates Strong Execution of Strategy
Revenue ($M) $M

13 Record Results in Q3 Demonstrates Strong Execution of Strategy
Net Income & Adjusted EBITDA ($M) $M

14 Visionary, Experience Leadership
100+ years of combined industry experience 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 André 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 Nadine Paiement, M. Sc. Director R&D Co-inventor of IntelGenx Trilayer Technology 15 years experience in product development and technology transfer John Durham, B. Sc. VP, Manufacturing Operations 20+ years experience in pharmaceutical manufacturing, quality management, product development Held executive positions with several Canadian and US companies Laëtitia Rodes, Ph. D. Manager, BD 7+ years experience in medical R&D Ph. D. In Biomedical Engineering (McGill University) Numerous peer-reviewed scientific publications (17+) Edward Miller, B. Comm Director, Investor Relations 15 years experience in investor relations 10 + years experience in pharmaceutical / biotech Currently 18 Employees, 8 Ph.D.’s

15 Solid Platform for Growth Core Technologies Address $19B Market Potential
Continue to grow commercialization efforts of Forfivo XL® to drive revenue growth Advance product pipeline towards commercialization Continue to develop distribution channel relationships Leverage VersaFilm manufacturing expertise to enhance profitability

16 Thank You.


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