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Intelgenx may 20 2016

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0 Investor Presentation May 20, 2016 Innovative Drug Delivery Solutions
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Page 1: Intelgenx may 20 2016

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Investor Presentation

May 20, 2016

Innovative Drug Delivery Solutions

Page 2: Intelgenx may 20 2016

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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: Intelgenx may 20 2016

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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 ideal for elderly, children,

patients who have difficulty swallowing

traditional tablets

• Quicker action to relieve symptoms

Page 4: Intelgenx may 20 2016

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Making Approved Drugs Better

Rapidly disintegrating film improving

drug performance and easing administration

without the need for water

Films

VersaFilm™

TabletsControlled-release tablets for oral

absorption over an extended time period

IntelGenx Drug Delivery Technology Platforms

VersaTab™ AdVersa™

Page 5: Intelgenx may 20 2016

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Investment Highlights

VersaTab™

$1.7B TAM

• Developing proprietary

oral drug delivery technologies to address

significant market potential

• 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

• Achieved record 2015 revenue and

profitability

VersaFilm™

$17B TAM

Page 6: Intelgenx may 20 2016

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IndicationPartnering

Availability

Formulation

Development

Pilot

StudyPivotal Study Filing Launch

Films Migraine – Rizaport TM - Rizatriptan Available ex- ES

Erectile Dysfunction - Tadalafil Available

Opioid Dependence Par

Pharmaceuticals

Schizophrenia - Loxapine Available

Undisclosed Term Sheet

Pain Term Sheet

Central Nervous System Term Sheet

Central Nervous System Available

Respiratory (Cough & Cold) In Discussion

Cardiovascular In Discussion

Tablets Major Depressive Disorder –

Forfivo XL®

Bupropion

Edgemont

Pharmaceuticals

Available ex-USA

Hypertension - Metoprolol Available

Pain - Dronabinol Available

A Robust Product Pipeline to AddressSignificant Market Opportunities

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Page 7: Intelgenx may 20 2016

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Forfivo XL

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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

• Q1 2016 net sales grew 39% compared

to Q1 2015, with net sales at $2.5 million

($4.9 million gross)

First 450mg tablet approved by FDA for major depressive disorder

$0.00

$500.00

$1,000.00

$1,500.00

$2,000.00

$2,500.00

$3,000.00

$3,500.00

1Q15 2Q15 3Q15 4Q15 1Q16

Forfivo XL Net Sales ($,000s)

Page 8: Intelgenx may 20 2016

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Over $17B Market Opportunity and Growth Platform for IGX

VersaFilmTM

Oral Thin Film Drug Delivery Technology

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

MIGRAINE

Targeted

Rizatriptan Market

$2B

ERECTILE

DYSFUNCTION

Targeted

Cialis® Sales

$4.2B

OPIOID

DEPENDENCE

Targeted

Suboxone Sales

$1.7B

SCHIZOPHRENIA

Targeted

Loxapine Sales

$5.2B

Page 9: Intelgenx may 20 2016

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For Migraines

Leverages VersaFilm™ Technology

• 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

• Patent granted in April 2016 protecting Rizaport

• Term Sheet signed March 2016 with

Grupo Juste for Spain & additional territories

• Planned USA submission to FDA Q4/2016

• Expected USA launch Q2/2017

Page 10: Intelgenx may 20 2016

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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

Q4/2016

• Expected USA launch Q4/2017

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Page 11: Intelgenx may 20 2016

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For Schizophrenia & Bipolar 1 Disorder

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• 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

Page 12: Intelgenx may 20 2016

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Strategy Update

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Page 13: Intelgenx may 20 2016

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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

Robert Bechard, M. Sc.

VP, Corporate Development

• 20+ years experience in

biopharmaceutical and

venture capital

• Managing Partner of

Lifescience venture fund at

RBC Capital

• Director on 25 lifescience

boards

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 Development

• 15 years experience in

pharmaceutical product

licensing

• Former Director,

BD at Paladin Labs

• 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 14: Intelgenx may 20 2016

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Completion of Constructionof Manufacturing Facility

• 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

We have built a state-of-the-art

oral film development and manufacturing facility

Page 15: Intelgenx may 20 2016

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Strong Demographics for Oral Films

Many patient applications are compatible

with oral film characteristics

• Those who have difficult swallowing large pills:

pediatric, geriatric, or dysphagic

• North Americans over 65 will grow from 54MM to 85MM

over the next 15 years

• Patients who suffer gastrointestinal side effects

from their medication

• Normal patients who would prefer a more discrete

or pleasant administration of the drug

Page 16: Intelgenx may 20 2016

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We are Now Poised for Success

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

• First-to-file generic drug where high technology barriers to

entry exist in reproducing branded films

• Repurpose existing drugs for new indications using oral films

• Lifecycle management

Page 17: Intelgenx may 20 2016

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Financial Results

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Page 18: Intelgenx may 20 2016

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Record Results in 2015 Demonstrates Strong Execution of Strategy

Revenue ($M)

0.820.63

5.1

1.7

0

1

2

3

4

5

6

Q1 2016 Q1 2015 2015 Full Year 2014 Full Year

Revenue

$M

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Page 19: Intelgenx may 20 2016

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Net Comprehensive Income & Adjusted EBITDA ($M)

-0.71

-0.38

0.8

-2.2

-0.56

0.05

1.7

-1.6

-2.5

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

Q1 2016 Q1 2015 2015 Full Year 2014 Full Year

Net Income Adjusted EBITDA

$M

Transforming IntelGenx for a Strong Future

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Page 20: Intelgenx may 20 2016

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Conclusion

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Page 21: Intelgenx may 20 2016

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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

Page 22: Intelgenx may 20 2016

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Thank You

www.IntelGenx.com


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