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Innovative Leader in Pharmaceutical Film Investor Presentation | September 2018 WE MAKE APPROVED DRUGS BETTER
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Page 1: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

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

Page 2: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

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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Page 3: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

Company Snapshot

3

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

Page 4: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

4

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

Page 5: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

Oral Film Formulations Offer Tangible Medical BenefitsThin Oral Films as a Better Alternative to Conventional Dosage Forms

5

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

Page 6: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

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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Page 7: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

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

Page 8: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

8

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

Page 9: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

Manufacturing AbilitiesValidation of Strategic Shift

9

• 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

Page 10: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

Low RiskTargeted Business Model

10

• 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

Page 11: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

11

Established Strategic PartnershipsValidating Our Technology Platforms

Page 12: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

12

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

Page 13: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

13

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

Page 14: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

14

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

Page 15: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

15

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)

Page 16: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

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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.

Page 17: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

17

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

Page 18: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

18

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

Page 19: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

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

Page 20: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

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

20

Phase I Clinical Study CompletedPositive Results

• Clear advantage of delivering Montelukast via oral film

• Crossed the blood-brain barrier

Page 21: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

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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

Page 22: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

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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

Page 23: Innovative Leader in Pharmaceutical Films2.q4cdn.com/.../2018/Sept-2018-IntelGenx...update.pdf · Company Snapshot 3 1) As of September 21, 2018 2) As of June 30, 2018 IntelGenx Corp.

Thank You!

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Stephen KilmerInvestor Relations+1-514-331-7440 ext. [email protected]

André GodinExecutive VP & CFO +1-514-331-7440 ext. [email protected]

Dana Matzen, Ph.D. VP Corp & BD+1-514-331-7440 ext. [email protected]

IntelGenx Corporate Offices6420 AbramsSaint-Laurent (Quebec)H4S 1Y2 Canadawww.intelgenx.com

Contact Information


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