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TSX-V: IGX OTCQX: IGXT
WE MAKE APPROVED DRUGS BETTER
Investor PresentationSeptember 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 finishedproducts, 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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• IntelGenx Corp.Founded• TSX-V(IGX)1
• OTCQX(IGXT)1
• MarketCapitalization• SharesIssued• SharesFullyDiluted• InsiderBeneficialOwnership• Cash/Equivalent
(AsofJune30,2017)
2003CAD$1.25US$0.97
CAD$83M66.6M70.8M18.7%
CAD$3.7M*
Analyst CoverageFirm AnalystH.C. Wainwright Swayampakula RamakanthSingular Research Greg Eisen
Company Snapshot
1 As at June 30, 2017
* Does not include proceeds from July-August 2017 convertible debenture offering
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Strengthened Management TeamOver 20 Employees, including 7 with Ph.D.’s
Andre 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.VP, Research & Development
• Co-inventor of IntelGenx Trilayer Technology
• 15 years experience in product development and technology transfer
Stephen KilmerInvestor Relations
• 20+ years experience in healthcare IR and PR
• President of Kilmer Lucas, a health-care only investor relations and capital markets advisory company
Horst G. Zerbe, Ph. D.Chairman, President & CEO
• 30+ years drug delivery / pharma experience (Lohmann Therapy Systems, 3M Pharmaceuticals, Smartrix Technologies)
• Pioneer in development and manufacturing of oral films and transdermal products
• Numerous patents and 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
Rodolphe Obeid, M. Eng., Ph.D.Senior Director Operations• 5+ years experience in
manufacturing & scale-up of oral film products
• Previously Director, R&D and Process Development at IntelGenx
• Author and co-author of numerous scientific papers, patents, book chapters, and scientific communications
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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
VersaFilm™
TabletsControlled-release tablets for oral absorption
over an extended time period
AdVersa™
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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• 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
VersaFilm™ 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:
• Reduced side effects • Improved bio-availability • Response time versus existing drugs
• Abuse resistant• Convenience
• 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
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Clearly Defined BD StrategyBalancing 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
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We Offer Full Service to Foster the Growth of our Partners
We Offer Full Service
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910
• IntelGenx grants partners exclusive rights to market and sell its products in exchange for upfront and milestone payments, together with a share of the partner’s net profits or a royalty on net product sales
• IntelGenx retains manufacturing rights for its products
• Payments are received as the contracted services are performed or when certain milestones are achieved:
• FDA submission• FDA approval• Commercial launch• Annual net sales target, etc.
• 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 EstablishedFor Development & Manufacturing
• 17,000 sq ft facility in Montreal -construction completed in Q1 2016
• High capacity manufacturing and packaging equipment
• Lower costs, controls quality and de-risks investment for new products
GROSS MARGINS of 40% PLUS
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For Migraines
Leverages VersaFilm™ Technology
VersaFilmTM
Rizaport
• European Marketing 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
• Patent granted in April 2016 protecting Rizaport
• Re-submission of 505(b)(2) NDA planned for Q4 2017
• PDUFA date expected in early 2018
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For Erectile DysfunctionVersaFilmTM
Tadalafil
• A high value, pleasantly flavored, and convenientVersaFilm™ dosage form of 2.5, 5, 10 and 20 mg tadalafil that can be administered without water
• Pilot phase 1 clinical trial for safety and pharmacokinetics have been successively completed, confirming bioequivalence to Cialis® (Eli Lilly)
• 2 patents protecting Tadalafil VersaFilm pending
VersaFilmTM
Tadalafil
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Fr Erectile Dysfunction
• Tadalafil market in the US estimated at $1.7B
• Nov 2017 Lilly’s tadalafil composition patent to expire, but orange book dosing patent still in force until April 2020
• IntelGenx’ exclusive license to Lilly’s tadalafil ED dosing patent ‘166 will allow entry of Tadalafil VersaFilm™ into the ED US market upon FDA approval, potentially before the market entry of Cialis® generic competitors
• 505(b)(2) USA NDA submission in H2/2017
• Expected US FDA approval H1/2018
$1,703 $1,429
$175 $11
$48
$18
US ED Market by Sales ($M)
Cialis
Viagra
Levitra
Staxyn
Stendra
Edex
VersaFilmTM
Tadalafil Significant Market Opportunity
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For Schizophrenia & Bipolar 1 Disorder
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• Fast-acting loxapine oral dosage
• For treatment of 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
• US patent & PCT applications submitted
• Formulation optimization stage – results expected H2 2017
VersaFilmTM
Loxapine
VersaFilmTM
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 selectionMisplacing of belongingsInability to recall recent events
Memory lossCognitive impairmentFunctional declineDrastic reduction in quality of lifeRequires full-time support
1 Mood and personality changesPoor judgmentFrequently getting lost
2 Difficulty recognizing family or friendsInability to learn new conceptsHallucinations, delusions, or paranoia
3 Inability to communicatePoor swallowing functionIncontinence
Global Sales for AD by Patients Category (Global Data, 2013)
VersaFilmTM
Montelukast Brain Degenerative DiseasesSizeable Addressable Patient Population
Currently approved treatments for brain degenerative diseases are limited, resulting in unmet clinical needs, which translates into a promising market opportunity.
Alzheimer’s Disease(AD)
1 Mild > 6.5 Mi persons2 Moderate > 3.9 Mi persons3 Severe > 2.1 Mi persons
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VersaFilmTM
Montelukast A De-Risked Product CandidateFor the Treatment of Brain Degenerative Diseases
IntelGenx is developing montelukast VersaFilm™, the first oral thin film containing montelukast for the treatment of brain degenerative diseases.
Already Approved and Established Drug Molecule
Supporting Epidemiology DataStrong Preclinical Evidence
IP Strategy
UNIQUE DRUG REPURPOSING OPPORTUNITY FOR BRAIN DEGENERATIVE DISEASES
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VersaFilmTM
Montelukast Rationale for MontelukastAn Anti-Brain Aging Molecule
Leukotrienes
Neurodegenerationeg Schapira et al. 2011
Neuroinflammationeg Hirsch et al. 2009
Blood Brain Barriereg Zlokovic et al. 2008
Neurogenesiseg Regensburger et al. 2014
Neurotransmissioneg Calabresi et al. 2007
DemyelinationAxonal Damage
eg Franklin et al. 2008
Mon
telu
kast
Dementia> X patients WW
Montelukast SodiumLeukotriene receptor inhibitorSingulair ®, FDA approved since 1998For 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 30.00Mon
telu
kast
conc
entra
tion
(ng/
mL)
Time (hrs)
Montelukast Avg Plasma Profile
Test buccal film 10mg
Ref tablet 10mg
VersaFilmTM
Montelukast
• 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 Q4/2017• First efficacy data in humans available H1/2018• Several pharma companies have expressed strong interest
Before
MMSE 13: moderate to severe
dementia
MMSE 22: mild dementia
After 2 Months ofMontelukast
Completed Phase 1 StudyIncreased bioavailability using VersaFilm™ Oral Film
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Mucoadhesive TabletFor Pain Management• AdVersa® mucoadhesive tablet adheres to the oral
mucosa and releases the drug onto the site of application at a controlled rate
• Repurposing of synthetic THC dronabinol for use in pain
• Protected by several issued and pending patents
• Competitive advantages vs. Marinol® capsules (Abbvie)
Marinol® (dronabinol) capsule Dronabinol AdVersa®
Conventional oral dosage form AdVersta® mucoadhesive tablet
High rate of metabolization Limited first-pass metabolism
Limited bioavailability Improved bioavailability
Undesired psycho activity Reduced gastro-intestinal exposureand side-effects
Limited shelf life Enhanced product stability
AdVersaTM
DronabinolDronabinol
Mucoadhesive TabletFor Pain ManagementAdVersaTM
DronabinolDronabinol
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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 and R&D revenues – total value of 7 digits
• IntelGenx will receive shared profits at commericalization
• 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
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
Strategic Partnership with Chemo Group
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Robust Product Pipeline Addressing Significant Market Opportunities
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Migraine – Rizaport® (Rizatriptan)
Availableex-ES & SKR
Erectile Dysfunction(Tadalafil) Available
Schizophrenia (Loxapine) Available
Neurodegenerative Brain Diseases(Montelukast) Available
Opioid Dependence - gSuboxone®
(Buprenorphine/ Naloxone) Partnered
Undisclosed Partnered
Undisclosed Partnered
Undisclosed Partnered
Major Depressive Disorder - Forfivo XL®
(Bupropion)
Availableex-US
Hypertension(undisclosed) Partnered
Pain (undisclosed) Partnered
Pain(Dronabinol)
Availableex-US/ CAN
Vers
aFilm
TMTa
blet
s
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The IntelGenx Advantage
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
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Financial Results
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Financial Performance: Revenue
$M
2.5
1.5
5.2 5.1
0
1
2
3
4
5
6
First Half 2017 First Half 2016 2016 Full Year 2015 Full Year
Revenue
REVENUE ($M)
2326
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Net Comprehensive Income & Adjusted EBITDA ($M)
$M
Financial Performance: Income & EBITDA
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-1
-1.5 -1.5
0.8
-0.5
-1.2
-0.3
1.7
-2
-1.5
-1
-0.5
0
0.5
1
1.5
2
First Half 2017 First Half 2016 2016 Full Year 2015 Full Year
Net Income Adjusted EBITDA
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Conclusion
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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
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ThankYou!www.IntelGenx.com
ContactInfo:
StephenKilmerAndréGodinInvestorRelationsExecutiveVP&CFO+1-514-331-7440ext.232+1-514-331-7440ext.203Stephen@intelgenx.com [email protected]
IntelGenx CorporateOffices6420AbramsSaint-Laurent(Quebec)H4S1Y2Canadawww.intelgenx.com