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0 Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions

Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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Page 1: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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Investor Presentation

January 6, 2017

Innovative Drug Delivery Solutions

Page 2: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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 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.

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Forward Looking Statements

Page 3: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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• IntelGenx Corp. Founded

• TSX-V (IGX)

• OTCQX (IGXT)

• Market Capitalization

• Shares Issued

• Shares Fully Diluted

• Insider Ownership

• Cash/Equivalent (As of Sept 30, 2016)

2003

CAD$1.14

US$0.85

US$55M

64.7M

70.8M

15%

US$5.7M

Analyst Coverage

Firm Analyst

H.C. Wainwright Swayampakula RamakanthSingular Research Greg Eisen

Company Snapshot

Page 4: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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Oral Thin Films

Oral Thin Films Provide Significant Market Opportunities for Improving Drug Delivery

• 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

Page 5: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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

Page 6: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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Prioritization of Future Product SourcingBalancing 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

Page 7: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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A Robust Product Pipeline to Address Significant Market Opportunities

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Page 8: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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

Page 9: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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

Page 10: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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For Migraines

Leverages VersaFilm™ Technology

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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 Pharmatronic for South Korea

• Actively pursuing several opportunities to open new markets -negotiations with future commercialization partners ongoing

• Planned USA submission to FDA Q1/2017

• Expected USA launch Q3/2017

Page 11: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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For Erectile Dysfunction

• Accelerates our partnering of this product for commercializing Tadalafil in the U.S.

• 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 Q2/2017

• Expected USA launch Q2/2018

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IntelGenx secured license from Lilly for Tadalfil ED dosing patent ‘166

Page 12: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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 Q2 2017

Page 13: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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For Mild Cognitive Impairment

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• IntelGenx is repurposing Montelukastfor the treatment of MCI 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)

Page 14: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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 30.00Monte

lukast

concentr

atio

n (

ng/m

L)

Time (hrs)

Montelukast Avg Plasma Profile

Test buccal film 10mg

Ref tablet 10mg

• 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 Q1/2017

• First efficacy data in humans available Q4/2017

• Several Pharma companies have expressed strong interest

Before

MMSE 13: moderate to severe

dementia

MMSE 22: mild dementia

After 2 Months ofMontelukast

Anecdotal of Human

Page 15: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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

Page 16: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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Strengthened Management TeamOver 20 Employees, including 7 with Ph.D.’s

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

Nadine Paiement, M. Sc.

VP, Research & Development

• Co-inventor of IntelGenx Trilayer Technology

• 15 years experience in product development and technology transfer

Edward Miller, B. Comm

Director, Investor Relations

• 15 years experience in investor relations

• 10 + years experience in pharmaceutical / biotech

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

Page 17: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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

Page 18: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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Financial Results

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Page 19: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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Financial Performance

Revenue ($M)

3.33.6

5.1

1.7

0

1

2

3

4

5

6

First 9 mths 2016 First 9 mths 2015 2015 Full Year 2014 Full Year

Revenue

$M

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Page 20: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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

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Page 21: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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Conclusion

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Page 22: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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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

Page 23: Innovative Drug Delivery Solutions - InvestorIntel · 2017. 1. 6. · Investor Presentation January 6, 2017 Innovative Drug Delivery Solutions. 1 2 To the extent any statements made

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Thank You!www.IntelGenx.com

Contact Info:

Edward Miller, B.Comm.

Director, Investor Relations

+1-514-331-7440 ext. [email protected]

IntelGenx Corporate Offices

6420 Abrams

Saint-Laurent (Quebec)

H4S 1Y2 Canadawww.intelgenx.com