Company Update

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Transcript Company Update

Innovative Drug
Delivery Solutions
We Make Approved Drugs Better
November 24, 2015
TSX-V: IGX
OTCQX: IGXT
© 2015 IntelGenX Corp.
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.
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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
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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
Films
Rapidly disintegrating film improving
drug performance and easing administration
without the need for water
Tablets
Controlled-release tablets for oral
absorption over an extended time period
Rizaport™
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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
$17B TAM
• Robust
product pipeline to enable
expansion into other market segments
with significant TAM
• Achieved
record Q3 revenue and
profitability
VersaTab™
$1.7B TAM
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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
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 ($12 million gross), an
increase of 117% compared to the nine
month period in 2014
FORFIVO XL® NET SALES ($Thousands)
$3,000
$2,500
$2,132
$2,000
$1,697
$1,756
$1,195
$1000
0
3Q14
4Q14
1Q15
2Q15
3Q15
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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
MIGRAINE
Targeted Rizatriptan
Market
$1.7B
$2B
SCHIZOPHRENIA
Targeted Sales
ERECTILE
DYSFUNCTION
Targeted Cialis®
Sales
$5.2B
$4.2B
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Rizaport™
Technology
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
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A Robust Product Pipeline to Address
Significant Market Opportunities
Market
Opportunity
Partnering
Availability
$2B
Available
$4.2B
Available
$1.78B
Par
Pharmaceuticals
$5.2B
Available
N/A
Par
Pharmaceuticals
$100M
Available
Central Nervous System
2.7B
Available
Central Nervous System
1.1B
Available
Respiratory
77M
Available
Cardiovascular
N/A
Available
Indication
Films
Migraine – Rizaport TM - Rizatriptan
Erectile Dysfunction - Tadalafil
Opioid Dependence –
Buprenorphine & Naloxone
Schizophrenia
Undisclosed
Pain
Tablets
Major Depressive Disorder –
Forfivo XL®
Bupropion
400M
Formulation
Development
Pilot
Study
Pivotal Study
Filing
Launch
Edgemont
Pharmaceuticals
Available ex-USA
Hypertension - Metoprolol
1.2B
Available
Pain - Dronabinol
130M
Available
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Commercialization Initiatives
Strategic Partnerships Will Drive Growth
9
9
In-House Manufacturing Approach
Full Manufacturing Capabilities
Establishing manufacturing capability to
increase profitability

Integrate pharmaceutical services
and IP protection

Reduce dependence by IntelGenx
on external manufacturing partners

Offer clients the advantage to obtain
all services from one source
(“one-stop shopping”)

Increase R&D capabilities with
expanded laboratories and
technologies
Blending
Coating
Packaging
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Future Commercialization Strategy
Key milestones suggest near term catalysts
2016
Milestones
•
Anticipated approval for opioid dependence
VersaFilm™
•
•
2017
Milestones
•
Anticipated launch for opioid dependence
VersaFilm™
Anticipated submission of 505(b)(2) NDA for ED
VersaFilm™
•
Anticipated approval for ED VersaFilm™
Anticipated approval for migraine – USA FDA,
Rizaport™
•
Start of commercial manufacturing operations
•
Anticipated submission of 505(b)(2) NDA for
Schizophrenia VersaFilm™
•
FORFIVO XL® milestone payments anticipated
11
Record Results in Q3 Demonstrates
Strong Execution of Strategy
Revenue ($M)
$M
4
3.59
3.5
3
2.5
2.38
2
1.5
0.83
1
0.45
0.5
0
Q3 2015
Q3 2014
2015 Nine
Months Ended
2014 Nine
Months Ended
Revenue
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Record Results in Q3 Demonstrates
Strong Execution of Strategy
$M
Net Income & Adjusted EBITDA ($M)
2
1.5
1.35 1.39
1.26
1.02
1
0.5
0
-0.5
-0.43 -0.41
-0.5
-1
-1.5
-1.51
-2
Q3 2015
Q3 2014
Net Income
2015 Nine
Months Ended
2014 Nine
Months Ended
Adjusted EBITDA
13
Visionary, Experience Leadership
100+ years of combined industry experience
Horst G. Zerbe, Ph. D.
André Godin, CPA, CA
Nadine Paiement, M. Sc.
Chairman, President & CEO
Executive VP, CFO
Director R&D
• Co-Founder of Listerine breath strips
• 30+ years drug delivery / pharma experience
• Holds over 40 patents in drug delivery and
numerous scientific publications
• 25+ years biotech/pharma industry experience
• Member of the Canadian Chartered
Professional Accountants and the Canadian
Institute of Chartered Accountants
• Co-inventor of IntelGenx Trilayer
Technology
• 15 years experience in product
development and technology transfer
John Durham, B. Sc.
Laëtitia Rodes, Ph. D.
Edward Miller, B. Comm
VP, Manufacturing Operations
Manager, BD
Director, Investor Relations
• 20+ years experience in pharmaceutical
manufacturing, quality management,
product development
• Held executive positions with several
Canadian and US companies
• 7+ years experience in medical R&D
• Ph. D. In Biomedical Engineering
(McGill University)
• Numerous peer-reviewed scientific
publications (17+)
• 15 years experience in investor relations
• 10 + years experience in pharmaceutical /
biotech
Currently 18 Employees, 8 Ph.D.’s
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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
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Thank You.
WWW.INTELGENX.COM
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