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Innovative Leader in Pharmaceutical Film
I n v e s t o r P r e s e n t a t i o n | S e p t e m b e r 2 0 1 8
W E M A K E A P P R O V E D D R U G S B E T T E R
Forward-Looking Statements
To the extent any statements made in this presentation contain information that is not historical, these statementsare forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, andSection 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statementson our current expectations and projections about future events. Our actual results could differ materially fromthose 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 othercharacterizations of future events or circumstances are forward-looking statements. Forward-looking statementsinclude, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food andDrug Administration and Canadian Therapeutic Products Directorate approvals, acceptance and demand for newpharmaceutical 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 detailedfrom time to time in the Company's filings with the Securities and Exchange Commission and the Ontario SecuritiesCommission. IntelGenx undertakes no obligation to update or revise any forward-looking statement.
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Company Snapshot
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1) As of September 21, 20182) As of June 30, 2018
IntelGenx Corp. Founded 2003
TSX-V (IGX)1
CAD$1.50
OTCQX (IGXT)1
US$1.21
Market Capitalization1 CAD$109M
Shares Issued1 73M
Shares Fully Diluted1 89M
Insider Beneficial Ownership1 14%
Cash/Short Term Investments2
CAD$4.8M
Analyst CoverageFirm Analyst
H.C. Wainwright Swayampakula Ramakanth
Maxim Group Jason McCarthy
SEC Registered
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We Make Approved Drugs BetterIntelGenx’s VersaFilm Drug Delivery Technology Platform
Rapidly disintegrating films improving
drug performance and easing administration
without the need for water
Oral Thin FilmsSlow release buccal films improving
drug absorption and avoiding first pass
metabolism
Buccal Films
Oral Film Formulations Offer Tangible Medical BenefitsThin Oral Films as a Better Alternative to Conventional Dosage Forms
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We are focused on areas where oral films are particularly well suited:
• Reduced side effects
• Improved bioavailability
• Enhanced efficacy
• Response time versus existing drugs
• Convenience
• Especially useful for patients with difficulty in swallowing or chewing solid dosage forms, e.g. the elderly and children
Products with Therapeutic
Advantages to Patients
Lifecycle Management
Repurposing Existing Drugs
for New Indications
First-to-file Generics with
High Technology Barriers to Entry
VersaFilm Technology Focused on Four Growth StrategiesOral Films are Value-Added Alternative Dosage Forms with Multiple Advantages
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7
State-of-the-ArtFilm Manufacturing Facility
• 17,000 sq ft facility in Montreal fully GMP compliant
• Health Canada certified – Drug Establishment License (DEL) obtained in December 2017
• Customized manufacturing equipment
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ComprehensiveService Portfolio
R&D• Formulation
• Feasibility Study
• Analytical Method Development
ClinicalTrials
• CTA/ IND Applications
• Trial monitoring
Operations• State-of-the-Art
Manufacture
• Full Scale Manufacturing
• Finished Product Testing
• Cost Effective
Regulatory& Quality
• Dossiers in Multiple Territories (EU, US)
• Compliant to ICH, GMP & ISO
• Health Canada Approved Mfg Site
IP• Patented Products
& Technologies
• Patent Filings
• FTO Opinions
Manufacturing AbilitiesValidation of Strategic Shift
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• Agreements with commercialization partners (e.g. PAR and Tilray®) validate IntelGenx’s strategic shift from an exclusively R&D company (dependent on royalty and license revenues) to a full-service company
• Our added manufacturing ability represents a profitable business opportunity
• Partnership with PAR to manufacture commercial volumes of generic Suboxone®
• Non-binding LOI with Tilray® to manufacture commercial volumes of thin film cannabis products
Low RiskTargeted Business Model
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• Grant partners exclusive rights to market and sell products in exchange for upfront and milestone payments, together with a share of partner’s net profits or a royalty on net sales
• IntelGenx retains manufacturing rights for its products
• Payments are received as the contracted services are performed or when certain agreed-upon 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 product development and obtaining regulatory approval
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Established Strategic PartnershipsValidating Our Technology Platforms
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Accomplished Management Team>40 Employees
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
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
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
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Robust Product PipelineAddressing Significant Market Opportunities
IndicationPartnering
StatusFormulation
DevelopmentPilot
StudyPivotal Study Filing Launch Partner
Vers
aF
ilm™
Migraine – Rizaport® (Rizatriptan)
Availableex-ES & SK
Erectile Dysfunction(Tadalafil)
Available
Schizophrenia (Loxapine)
Available
Neurodegenerative Brain
Diseases(Montelukast)
Available
Opioid Dependence(Buprenorphine/ Naloxone)
Partnered
Undisclosed Partnered
Undisclosed Partnered
Undisclosed Partnered
Tab
lets
Hypertension Partnered
CNS Partnered
Pain
(Dronabinol)Availableex-US/ CAN
IndicationPartnering
StatusFormulationDevelopment
PilotStudy
Pivotal Study Filing Launch Partner
Vers
aF
ilm™
Migraine –Rizaport® (Rizatriptan)
Availableex-ES & SK
Erectile Dysfunction(Tadalafil)
Available
Schizophrenia (Loxapine)
Available
Neurodegenerative Brain
Diseases(Montelukast)
Available
Opioid Dependence(Buprenorphine/ Naloxone)
Partnered
Undisclosed Partnered
Undisclosed Partnered
Undisclosed Partnered
Tab
lets
Hypertension Partnered
CNS Partnered
Pain
(Dronabinol)Availableex-US/ CAN
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RizaportFor Migraines
Leverages VersaFilm™ Technology
• Oral Film Containing 10 mg Rizatriptan
• European Marketing Approval – November 2015
- Definitive agreement signed July 2016 with Grupo Juste for Spain
- Definitive agreement signed Dec 2016 with Pharmatronic for South Korea
• Patent granted in April 2016 protecting Rizaport
• 505(b)(2) NDA resubmitted in October 2017
• Responding to FDA additional info request
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TadalafilErectile Dysfunction: Significant Market Opportunity
• Pilot Phase 1 clinical trial for safety and pharmacokinetics successfully completed, confirming bioequivalence to Cialis® Tablets (Eli Lilly)
• 2 patent applications protecting Tadalafil VersaFilm pending
• Tadalafil market in the US estimated at $1.7B
• Tadalafil substance patent expired, but orange book ‘166 dosing patent still in force until April 2020
• IntelGenx has an exclusive license to ‘166 dosing patent will allow entry of Tadalafil VersaFilm™ into the ED US market upon FDA approval, potentially before the market entry of Cialis® generic competitors
• Commercialization subject to FDA approval
$1,703 $1,429
$175
$11
$48 $18
Cialis
Viagra
Levitra
Staxyn
Stendra
Edex
US ED Market by Sales ($M)
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gSuboxone®For the Treatment of Opioid Dependence
• IntelGenx entered into a development, manufacturing and supply agreement with Endo Ventures for a generic version of Subxone® sublingual film product, which is indicated for the treatment of opioid dependence
• IntelGenx will have exclusive rights to manufacture and supply product to Endo, the commercialization partner, while Endo will have exclusive rights to market and sell IntelGenx-supplied gSubxone® in the U.S.
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Cannabinoid FilmFor Medicinal and Recreational Purposes
• IntelGenx signed a non-binding letter of intent with Tilray® to enter a world-wide agreement to develop and produce cannabis-infused Versafilm™ for medical and recreational use in human applications
• Dissolvable films are a highly unique and highly relevant approach to consuming marijuana, appealing to both medicinal and recreational markets
• We believe that a significant portion of those likely to use cannabis will find a dissolvable film appealing, due to its ease-of-use, discreetness and lack of harmful smoke
The market for cannabis is expected to see significant growth under the new Canadian legal regime, both in terms of number of participants and dollar value
* From Statistics Canada, based on a total Canadian population of 35,151,728
For RecreationalPurposes
For MedicinalPurposes
SPEND PER YEAR $1212 $1476
INCIDENCE 17% 12%
LEGAL AGE POPULATION*
26,469,251 26,469,251
ANNUAL SPEND $5,453,724,514 $4,688,233,770
TOTAL ANNUAL SPEND $10,141,958,284
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Mucoadhesive TabletFor Pain Management
Dronabinol
• 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. capsules
Montelukast for Mild-to-Moderate Alzheimer's disease Major Repurposing Opportunity
• Blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT1
• Evidence that leukotriene receptor antagonists have the potential to reduce neuroinflammation and restore brain cell function
• Montelukast has potential to be the first disease modifying treatment for AD
Global Sales for AD by Patients Category
(Global Data, 2013)
MCI
Mild
Moderate
2 Severe
57%
10%
23%
10%
68%
15%
12%
5%
2013Total: $4.9bn
2023Total: $13.3bn
Demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces first-pass-effect and has a 52% higher bioavailability compared to the regular Montelukast tablet
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Phase I Clinical Study CompletedPositive Results
• Clear advantage of delivering Montelukast via oral film
• Crossed the blood-brain barrier
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Phase IIa Clinical StudyUnderway
A randomized Phase IIa, multi-center, double-blind, placebo-controlled study to assess the safety, feasibility, tolerability, and efficacy of a new buccal film of Montelukast in patients with mild to moderate Alzheimer’s Disease
• Study protocol approved by Health Canada
• Study Drug: 10 mg montelukast buccal film and matching placebo
• Treatment duration: 26 weeks
• Number of patients: 70 (35 per arm)
• 8 Canadians sites; retained services of contract research organizations Cogstate and JSS Medical Research
• Patient screening and enrolment to commence Q3-2018
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IntelGenx AdvantageIn Summary
1. Leadership
- Leader in oral film development and manufacturing with 30+ years experience
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 & Business Model
- Focus on lifecycle management, patient benefits, FTF generics and drug repurposing
- Provider of comprehensive pharmaceutical services to industry partners
4. Competitive Manufacturing Capabilities
- New, Health Canada approved, state-of-the-art, GMP compliant manufacturing facility
- Offering one-stop-shopping to partners with lean operations keeping costs down
- Customized manufacturing equipment
Thank You!
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Stephen KilmerInvestor Relations+1-514-331-7440 ext. 232Stephen@intelgenx.com
André GodinExecutive VP & CFO +1-514-331-7440 ext. 203Andre@intelgenx.com
Dana Matzen, Ph.D. VP Corp & BD+1-514-331-7440 ext. 220Dana@intelgenx.com
IntelGenx Corporate Offices6420 AbramsSaint-Laurent (Quebec)H4S 1Y2 Canadawww.intelgenx.com
Contact Information
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