igx investor presentation jan 14, 2016

17
© 2015 IntelGenX Corp. Innovative Drug Delivery Solutions We Make Approved Drugs Better January 14, 2016 TSX-V: IGX OTCQX: IGXT

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Page 1: Igx investor presentation jan 14, 2016

© 2015 IntelGenX Corp.

Innovative Drug

Delivery SolutionsWe Make Approved Drugs Better

J a n u a r y 1 4 , 2 0 1 6

TSX-V: IGXOTCQX: IGXT

Page 2: Igx investor presentation jan 14, 2016

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Forward Looking StatementsTo 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.

Page 3: Igx investor presentation jan 14, 2016

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

Page 4: Igx investor presentation jan 14, 2016

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Making Approved Drugs Better Through

Innovative Drug Delivery SolutionsIntelGenx develops and manufactures faster and more efficient drug

delivery systems for top pharmaceuticals

IntelGenx Drug Delivery Technology Platforms

Rapidly disintegrating film improving

drug performance and easing administration

without the need for water

TabletsControlled-release tablets for oral

absorption over an extended time period

Films

Rizaport™

Page 5: Igx investor presentation jan 14, 2016

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$17B TAM

Investment Highlights

• 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

Page 6: Igx investor presentation jan 14, 2016

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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

• Q3 2015 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®

0

$1000

$2,000

$3,000

3Q14 1Q15 2Q15 3Q15

FORFIVO XL® NET SALES ($Thousands)

Technology

4Q14

$1,195

$1,756

$2,132

$2,500

$1,697

Page 7: Igx investor presentation jan 14, 2016

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Oral Thin Films 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

Over $17B Market Opportunity and

Growth Platform for IGX

MIGRAINE

Targeted Rizatriptan

Market

$2B

ERECTILE

DYSFUNCTION

Targeted Cialis®

Sales

$4.2B

OPIOD DEPENDENCE

Targeted Suboxone

Sales

$1.7B

SCHIZOPHRENIA

Targeted Sales

$5.2B

Page 8: Igx investor presentation jan 14, 2016

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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

Rizaport™Technology

Page 9: Igx investor presentation jan 14, 2016

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A Robust Product Pipeline to Address

Significant Market Opportunities

IndicationMarket

Opportunity

Partnering

Availability

Formulation

Development

Pilot

StudyPivotal Study Filing Launch

Films Migraine – Rizaport TM - Rizatriptan $2B Available

Erectile Dysfunction - Tadalafil $4.2B Available

Opioid Dependence$1.78B

Par

Pharmaceuticals

Schizophrenia $5.2B Available

UndisclosedN/A

Par

Pharmaceuticals

Pain $100M Available

Central Nervous System 2.7B Available

Central Nervous System 1.1B Available

Respiratory 77M Available

Cardiovascular N/A Available

Tablets Major Depressive Disorder –

Forfivo XL®

Bupropion400M

Edgemont

Pharmaceuticals

Available ex-USA

Hypertension - Metoprolol 1.2B Available

Pain - Dronabinol 130M Available

Page 10: Igx investor presentation jan 14, 2016

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Commercialization InitiativesStrategic Partnerships Will Drive Growth

9

Page 11: Igx investor presentation jan 14, 2016

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Full Manufacturing CapabilitiesEstablishing 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

In-House Manufacturing Approach

Page 12: Igx investor presentation jan 14, 2016

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Future Commercialization StrategyKey milestones suggest near term catalysts

Milestones

• Anticipated approval for opioid dependence

VersaFilm™

• Anticipated submission of 505(b)(2) NDA for ED

VersaFilm™

• Anticipated approval for migraine – USA FDA,

Rizaport™

• FORFIVO XL® milestone payments anticipated

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

20172016

Page 13: Igx investor presentation jan 14, 2016

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Record Results in Q3 Demonstrates

Strong Execution of Strategy

Revenue ($M)

2.38

0.45

3.59

0.83

0

0.5

1

1.5

2

2.5

3

3.5

4

Q3 2015 Q3 2014 2015 NineMonths Ended

2014 NineMonths Ended

Revenue

$M

Page 14: Igx investor presentation jan 14, 2016

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Record Results in Q3 Demonstrates

Strong Execution of Strategy

Net Income & Adjusted EBITDA ($M)

1.35

-0.43

1.02

-1.51

1.39

-0.41

1.26

-0.5

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

Q3 2015 Q3 2014 2015 NineMonths Ended

2014 NineMonths Ended

Net Income Adjusted EBITDA

$M

Page 15: Igx investor presentation jan 14, 2016

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Visionary, Experience Leadership

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, 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.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. CommDirector, Investor Relations

• 15 years experience in investor relations

• 10 + years experience in pharmaceutical /

biotech

100+ years of combined industry experience

Currently 18 Employees, 8 Ph.D.’s

Page 16: Igx investor presentation jan 14, 2016

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Solid Platform for GrowthCore 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

Page 17: Igx investor presentation jan 14, 2016

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Thank You.WWW.INTELGENX.COM