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TSX-V: IGX OTCQX: IGXT
WE MAKE APPROVED DRUGS BETTER
Investor PresentationMarch 10, 2017
Innovative Drug Delivery Solutions
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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 finishedproducts, 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.
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Forward Looking Statements
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• IntelGenx Corp.Founded• TSX-V(IGX)• OTCQX(IGXT)• MarketCapitalization• SharesIssued• SharesFullyDiluted• InsiderOwnership• Cash/Equivalent(AsofSept30,2016)
2003CAD$1.03US$0.76US$50M65.4M70.8M15%
US$5.7M
Analyst CoverageFirm AnalystH.C. Wainwright Swayampakula RamakanthSingular Research Greg Eisen
Company Snapshot
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Advantages of Oral Thin Film Delivery
We are focused on areas where oral films are particularly well-suited:
Develop and commercialize products that provide therapeutic advantages to patients 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
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Clearly Defined BD StrategyBalancing Risks and Opportunities for an Optimized Portfolio
Overall Risk
Time to MarketSlow Fast
Low
High
Drug Repurposing
Patient Benefits
Lifecycle Mgmt
FTF Generics
IntelGenx Future FocusDeal Value
Low
Medium
High
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• 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 US$6M
• Development cost $2.5M, total revenue $15M = 6-fold ROI
• Non-dilutive source of funding, will be used to advance film projects
Successful Monetization of First In-House Development
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• Licensing and development agreements entered for four generic products
• IntelGenx granted Chemo exclusive worldwide license to commercialize two generic tablets and U.S. license for two other generic oral films
• IntelGenx to receive upfront, milestone, R&D revenues and share of profits – total value of 7 digits
• Combined total market of four products is over $7B
• Chemo making a strategic move into novel drug delivery products with IntelGenx as its partner
• Partnership could result in numerous future product agreements
Strategic Partnership with Chemo Group
About Chemo Group:• Founded in 1978• 5,000 employees• Head office in Spain• Revenues of $1.2B annually• Markets over 300 products• Operating in over 40 countries• 20 state-of-the-art facilities• 9 specialized R&D centers
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For Migraines
Leverages VersaFilm™ Technology
VersaFilmTM
Rizaport
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• European Mktg Approval – November 2015
• Co-development partnership with RedHill Biopharma
• Definitive agreement signed July 2016 with Grupo Juste for Spain & additional territories
• Definitive agreement signed Dec 2016 with Pharmatronicfor South Korea
• Actively pursuing several opportunities to open new markets- negotiations with future commercialization partners ongoing
• Planned USA submission to FDA Q3/17
• Expected USA approval Q1/18
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For Erectile DysfunctionVersaFilmTM
Tadalafil
• Will allow entry of Tadalafil VersaFilm™ into the ED US market upon FDA approval, potentially before the market entry of Cialis®generic competitors
• Accelerates our partnering of this product
• Containing tadalafil (Cialis® - Eli Lilly), a leading 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 Q2/17
• Expected USA approval H1/2018
VersaFilmTM
Tadalafil
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Granted license from Lilly for Tadalfil ED dosing patent ‘166
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For Schizophrenia & Bipolar 1 Disorder
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• The first oral thin film using IntelGenxproprietary drug delivery technology, VersaFilm™, for treatment of schizophrenia & bipolar 1 disorder
• Fast-acting loxapine oral dosage – to treat acute agitation and anxiety in non-institutionalized patients with schizophrenia & bipolar 1 disorder
• Reduces risk of pulmonary problems and potential risk of violence and injury to patients and others
• Formulation optimization stage – results expected H2 2017
VersaFilmTM
Loxapine
VersaFilmTM
Loxapine
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For Brain Degenerative DiseasesVersaFilmTM
Montelukast
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VersaFilmTM
Montelukast
• IntelGenx is repurposing Montelukastfor the treatment of brain degenerative diseases by leveraging its VersaFilm™ technology
• The drug is known and approved for a completely different indication (asthma)
Global Sales for AD by Patients Category (Global Data, 2013)
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Clinical Data
0.0
100.0
200.0
300.0
400.0
500.0
600.0
0.00 5.00 10.00 15.00 20.00 25.00 30.00Mon
telu
kast
conc
entra
tion
(ng/
mL)
Time (hrs)
Montelukast Avg Plasma Profile
Test buccal film 10mg
Ref tablet 10mg
VersaFilmTM
Montelukast
• Phase 1 clinical study in human successfully completed• Significantly increased bioavailability after administration of VersaFilm compared to
commercial tablet • Drug crosses blood/brain barrier when given as film• Phase II-a study (proof of concept) to commence Q1/17• First efficacy data in humans available Q4/17• Several Pharma companies have expressed strong interest
Before
MMSE 13: moderate to severe
dementia
MMSE 22: mild dementia
After 2 Months ofMontelukast
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Construction of Manufacturing Facility Completed
• 17,000 sq ft facility in Montreal -construction completed in Q1 2016
• Facility to be fully operational by Q1 2017
• High capacity manufacturing and packaging equipment
• Lower costs, controls quality and de-risks investment for new products
GROSS MARGINS of 40% PLUS
We have built a state-of-the-art oral film development and manufacturing facility
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Strengthened Management TeamOver 30 Employees, including 7 with Ph.D.’s
Andre Godin, CPA, CAExecutive 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.VP, Research & Development
• Co-inventor of IntelGenx Trilayer Technology
• 15 years experience in product development and technology transfer
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
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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
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
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The IntelGenx Advantage
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
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Financial Performance
Revenue ($M)
3.33.6
5.1
1.7
0
1
2
3
4
5
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First 9 mths 2016 First 9 mths 2015 2015 Full Year 2014 Full Year
Revenue
$M
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Net Comprehensive Income & Adjusted EBITDA ($M)
-1.5
0.60.8
-2.2
-0.9
1.3
1.7
-1.6
-2.5
-2
-1.5
-1
-0.5
0
0.5
1
1.5
2
First 9 mths 2016 First 9 mths 2015 2015 Full Year 2014 Full Year
Net Income Adjusted EBITDA
$M
Financial Performance
19
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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
Solid Platform for Growth