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VersaFilmTM Oral Films Present Opportunities for Drug Delivery Innovation
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TSX-V: IGX
OTCQX: IGXT
WE MAKE APPROVED DRUGS BETTER
Investor Presentation
November 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 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
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ā¢ IntelGenx Corp. Founded
ā¢ TSX-V (IGX)1
ā¢ OTCQX (IGXT)1
ā¢ Market Capitalization
ā¢ Shares Issued
ā¢ Shares Fully Diluted
ā¢ Insider Beneficial Ownership
ā¢ Cash/Equivalent
2003
CAD$0.94
US$0.75
CAD$63M
67M
70.8M
18.7%
US$6.9M
Analyst Coverage
Firm Analyst
H.C. Wainwright Swayampakula Ramakanth
Singular Research Greg Eisen
Company Snapshot
1 As at September 30, 2017
4. 3
Strengthened Management Team
Over 20 Employees, including 7 with Ph.D.ās
Andre Godin, CPA, CA
Executive VP, CFO
ā¢ 25+ years biotech/pharma industry
experience
ā¢ Member of the Canadian Chartered
Professional Accountants and the
Canadian Institute of Chartered
Accountants
Nadine Paiement, M. Sc.
VP, Research & Development
ā¢ Co-inventor of IntelGenx Trilayer
Technology
ā¢ 15 years experience in product
development and technology transfer
Stephen Kilmer
Investor Relations
ā¢ 20+ years experience in healthcare IR
and PR
ā¢ President of Kilmer Lucas, a health-
care only investor relations and capital
markets advisory company
Horst G. Zerbe, Ph. D.
Chairman, President & CEO
ā¢ 30+ years drug delivery / pharma
experience (Lohmann Therapy
Systems, 3M Pharmaceuticals,
Smartrix Technologies)
ā¢ Pioneer in development and
manufacturing of oral films and
transdermal products
ā¢ Numerous patents and scientific
publications
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Dana Matzen, Ph.D.
VP, Business & Corporate
Development
ā¢ 15 years experience in
pharmaceutical product licensing
ā¢ Prev. Director, BD at Paladin
ā¢ Completed 13 transaction,
7 new product launches
Rodolphe Obeid, M. Eng.,
Ph.D.
Senior Director Operations
ā¢ 5+ years experience in
manufacturing & scale-up of oral
film products
ā¢ Previously Director, R&D and
Process Development at IntelGenx
ā¢ Author and co-author of numerous
scientific papers, patents, book
chapters, and scientific
communications
5. 4
We Make Approved Drugs Better
IntelGenx Drug Delivery Technology Platforms
Rapidly disintegrating films improving
drug performance and easing administration
without the need for water
Films
VersaFilmā¢
Tablets
Controlled-release tablets for oral absorption
over an extended time period
AdVersaā¢
We Make Approved Drugs Better
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VersaFilmTM Oral Films
Oral Films Provide Significant Market Opportunities
for Improving Drug Delivery
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ā¢ IntelGenx CEO co-developer of the Listerine breath strips
ā¢ Oral films ideal for elderly, children, patients who have
difficulty swallowing traditional tablets
ā¢ Quicker action to relieve symptoms
VersaFilmā¢ Oral Films
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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:
ā¢ Reduced side effects
ā¢ Improved bio-availability
ā¢ Response time versus existing drugs
ā¢ Abuse resistant
ā¢ Convenience
ā¢ Lifecycle management
ā¢ Repurpose existing drugs for new indications using oral films
ā¢ āFirst-to-fileā generic drugs where high technology barriers to
entry exist in reproducing branded films
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Clearly Defined BD Strategy
Balancing 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 Focus
Deal Value
Low
Medium
High
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We Offer Full Service
to Foster the Growth of our Partners
We Offer Full Service
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ā¢ IntelGenx grants partners exclusive rights to market and sell its products in exchange for
upfront and milestone payments, together with a share of the partnerās net profits or a
royalty on net product sales
ā¢ IntelGenx retains manufacturing rights for its products
ā¢ Payments are received as the contracted services are performed or when certain
milestones are achieved:
ā¢ FDA submission
ā¢ FDA approval
ā¢ Commercial launch
ā¢ Annual net sales target, etc.
ā¢ Partners pay for part or all of the R&D expenses associated with developing a new
product and to obtain regulatory approval
Low Risk Development Model
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State-of-the-Art Oral Film Facility Established
For Development & Manufacturing
ā¢ 17,000 sq ft facility in Montreal -
construction completed in Q1 2016
ā¢ High capacity manufacturing and packaging
equipment
ā¢ Lower costs, controls quality
and de-risks investment
for new products
GROSS MARGINS of 40% PLUS
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For Migraines
Leverages VersaFilmā¢ Technology
VersaFilm
TM
Rizaport
ā¢ European Marketing Approval ā November 2015
ā¢ Co-development partnership with RedHill Biopharma
ā Definitive agreement signed July 2016 with Grupo Juste for Spain
& additional territories
ā Definitive agreement signed Dec 2016 with Pharmatronic for
South Korea
ā Actively pursuing several opportunities to open new markets
ā¢ Patent granted in April 2016 protecting Rizaport
ā¢ 505(b)(2) NDA resubmitted in November 2017
ā¢ PDUFA date expected for H1/2018
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For Erectile Dysfunction
VersaFilm
TM
Tadalaļ¬l
ā¢ A high value, pleasantly flavored, and convenient
VersaFilmā¢ dosage form of 2.5, 5, 10 and 20 mg
tadalafil that can be administered without water
ā¢ Pilot phase 1 clinical trial for safety and
pharmacokinetics have been successively
completed, confirming bioequivalence to CialisĀ®
(Eli Lilly)
ā¢ 2 patents protecting Tadalafil VersaFilm pending
VersaFilm
TM
Tadalaļ¬l
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Fr Erectile Dysfunction
ā¢ Tadalafil market in the US estimated at $1.7B
ā¢ Nov 2017 Lillyās tadalafil composition patent
to expire, but orange book dosing patent still in
force until April 2020
ā¢ IntelGenxā exclusive license to Lillyās tadalafil
ED dosing patent ā166 will allow entry of
Tadalafil VersaFilmā¢ into the ED US market
upon FDA approval, potentially before the
market entry of CialisĀ® generic competitors
ā¢ 505(b)(2) USA NDA submission in H2/2017
ā¢ Expected US FDA approval H2/2018
$1,703$1,429
$175
$11
$48
$18
US ED Market by Sales ($M)
Cialis
Viagra
Levitra
Staxyn
Stendra
Edex
VersaFilm
TM
Tadalaļ¬l Significant Market Opportunity
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For Schizophrenia & Bipolar 1 Disorder
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ā¢ Fast-acting loxapine oral dosage
ā¢ For treatment of acute agitation and anxiety
in non-institutionalized patients with
schizophrenia & bipolar 1 disorder
ā¢ Reduces risk of pulmonary problems
and potential risk of violence and injury to
patients and others
ā¢ US patent & PCT applications submitted
ā¢ Formulation optimization stage ā results
expected H1/2018
VersaFilm
TM
Loxapine
VersaFilm
TM
Loxapine
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Mild Cognitive Impairment
(MCI)
> 80 Mi persons
Dementia
> 30 Mi persons
Cognitive Disorder Stage and Prevalent Population in
nine major markets. (Global Data, 2013 )
Neurodegenerative Clinical Changes
(Global Data, 2013)
Issues with word selection
Misplacing of belongings
Inability to recall recent events
Memory loss
Cognitive impairment
Functional decline
Drastic reduction in quality of life
Requires full-time support
1 Mood and personality changes
Poor judgment
Frequently getting lost
2 Difficulty recognizing family or friends
Inability to learn new concepts
Hallucinations, delusions, or paranoia
3 Inability to communicate
Poor swallowing function
Incontinence
Global Sales for AD by Patients
Category (Global Data, 2013)
VersaFilm
TM
Montelukast Brain Degenerative Diseases
Sizeable Addressable Patient Population
Currently approved treatments for brain degenerative diseases are limited, resulting
in unmet clinical needs, which translates into a promising market opportunity.
Alzheimerās Disease
(AD)
1 Mild > 6.5 Mi persons
2 Moderate > 3.9 Mi persons
3 Severe > 2.1 Mi persons
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VersaFilm
TM
Montelukast A De-Risked Product Candidate
For the Treatment of Brain Degenerative Diseases
IntelGenx is developing montelukast VersaFilmā¢, the first oral thin
film containing montelukast for the treatment of brain degenerative
diseases.
Already Approved and Established
Drug Molecule
Supporting Epidemiology Data
Strong Preclinical Evidence
IP
Strategy
UNIQUE DRUG
REPURPOSING
OPPORTUNITY FOR
BRAIN
DEGENERATIVE
DISEASES
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VersaFilm
TM
Montelukast Rationale for Montelukast
An Anti-Brain Aging Molecule
Leukotrienes
Neurodegeneration
eg Schapira et al. 2011
Neuroinflammation
eg Hirsch et al. 2009
Blood Brain Barrier
eg Zlokovic et al. 2008
Neurogenesis
eg Regensburger et al. 2014
Neurotransmission
eg Calabresi et al. 2007
Demyelination
Axonal Damage
eg Franklin et al. 2008
Montelukast
Dementia
> X patients WW
Montelukast Sodium
Leukotriene receptor inhibitor
Singulair Ā®, FDA approved since 1998
For the chronic treatment of asthma
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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 30.00
Montelukastconcentration(ng/mL)
Time (hrs)
Montelukast Avg Plasma Profile
Test buccal film 10mg
Ref tablet 10mg
VersaFilm
TM
Montelukast
ā¢ Phase 1 clinical study in human successfully completed
ā¢ Significantly increased bioavailability after administration of VersaFilmā¢ compared to
commercial tablet
ā¢ Drug crosses blood/brain barrier when given as film
ā¢ CTA submitted to Health Canada for Phase II-a study (proof of concept) in November
2017; study expected to commence Q1/2018
ā¢ First efficacy data in humans available mid-2018
ā¢ Several pharma companies have expressed strong interest
Before
MMSE 13:
moderate to severe
dementia
MMSE 22:
mild dementia
After 2 Months of
Montelukast
Completed Phase 1 Study
Increased bioavailability using VersaFilmā¢ Oral Film
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Mucoadhesive Tablet
For Pain Management
ā¢ AdVersaĀ® mucoadhesive tablet adheres to the oral
mucosa and releases the drug onto the site of application
at a controlled rate
ā¢ Repurposing of synthetic THC dronabinol for use in pain
ā¢ Protected by several issued and pending patents
ā¢ Competitive advantages vs. MarinolĀ® capsules (Abbvie)
MarinolĀ® (dronabinol) capsule Dronabinol AdVersaĀ®
Conventional oral dosage form AdVerstaĀ® mucoadhesive tablet
High rate of metabolization Limited first-pass metabolism
Limited bioavailability Improved bioavailability
Undesired psycho activity
Reduced gastro-intestinal exposure
and side-effects
Limited shelf life Enhanced product stability
AdVersa
TM
DronabinolDronabinol
Mucoadhesive Tablet
For Pain ManagementAdVersa
TM
DronabinolDronabinol
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ā¢ Licensing and development agreements entered for four generic
products
ā¢ IntelGenx granted Chemo exclusive worldwide license to
commercialize two generic tablets and U.S. license for two other
generic oral films
ā¢ IntelGenx to receive upfront, milestone, R&D revenues and share of
profits ā total value of 7 digits
ā¢ Combined total market of four products is over $7B
ā¢ Chemo making a strategic move into novel drug delivery products
with IntelGenx as its partner
ā¢ Partnership could result in numerous future product agreements
About Chemo Group:
ā¢ Founded in 1978
ā¢ 5,000 employees
ā¢ Head office in Spain
ā¢ Revenues of $1.2B annually
ā¢ Markets over 300 products
ā¢ Operating in over 40 countries
ā¢ 20 state-of-the-art facilities
ā¢ 9 specialized R&D centers
Strategic Partnership with Chemo Group
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Robust Product Pipeline
Addressing Significant Market Opportunities
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Migraine ā RizaportĀ®
(Rizatriptan)
Available
ex-ES & SKR
Erectile Dysfunction
(Tadalafil) Available
Schizophrenia
(Loxapine) Available
Neurodegenerative Brain Diseases
(Montelukast) Available
Opioid Dependence - gSuboxoneĀ®
(Buprenorphine/ Naloxone)
Partnered
Undisclosed
Partnered
Undisclosed
Partnered
Undisclosed
Partnered
Major Depressive Disorder - Forfivo
XLĀ®
(Bupropion)
Available
ex-US
Hypertension
(undisclosed)
Partnered
Pain
(undisclosed)
Partnered
Pain
(Dronabinol)
Available
ex-US/ CAN
VersaFilmTMTablets
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The IntelGenx Advantage
1. History
ā¢ Dr. Zerbe a pioneer with over 30 plus years in oral films
2. Formulation Team
ā¢ Strong in applying biopharmaceutical aspects to formulation development
ā¢ Top quality scientists: highly creative, focused on problem solving & innovative approaches
ā¢ Experienced in developing films for oral (GI), sublingual & buccal absorption
3. Clearly Defined Corporate Strategy And Business Model
ā¢ Focus on drug repurposing, lifecycle management, patient benefits, and FTF
ā¢ Provider of comprehensive pharmaceutical services to industry partners
4. Competitive Manufacturing Capabilities
ā¢ First in Canada
ā¢ New state-of-the-art manufacturing facility
ā¢ Offer one-stop-shopping to our partners with lean operations keeping costs down
ā¢ Customized manufacturing equipment
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Net Comprehensive Income & Adjusted EBITDA ($M)
$M
Financial Performance: Income & EBITDA
27
-1.6
-1.5 -1.5
0.8
-0.85 -0.91
-0.3
1.7
-2
-1.5
-1
-0.5
0
0.5
1
1.5
2
First Nine Months 2017 First Nine Months 2016 2016 Full Year 2015 Full Year
Net Income Adjusted EBITDA
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Solid Platform for Growth
Significant Market Potential
ā¢ New manufacturing facility will offer many competitive advantages
ā¢ Strengthened management team to accelerate execution of business plan
ā¢ Implemented product sourcing strategy to identify high-value product opportunities
ā¢ Building strategic partnerships with relevant partners in the pharmaceutical industry
Solid Platform for Growth