leader in pharmaceutical films - intelgenx" · 2019. 7. 12. · company snapshot 3 1) as at...

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Leader in Pharmaceutical Films Investor Presentation | May 2019 WE MAKE APPROVED DRUGS BETTER

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Page 1: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

Leader in Pharmaceutical Films

I n v e s t o r P r e s e n t a t i o n | M a y 2 0 1 9

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: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

Company Snapshot

3

1) As at March 31, 2019

IntelGenx Corp. Founded 2003

TSX-V (IGX)1

CDN$0.87

OTCQX (IGXT)1

US$0.67

Market Capitalization1 CDN$81M

Shares Issued1 93.5M

Outstanding Warrants1 13M

Insider Beneficial Ownership1 11%

Cash/Short Term Investments1

US$8.6M

Analyst CoverageFirm Analyst

H.C. Wainwright Swayampakula Ramakanth

Maxim Group Jason McCarthy

SEC Registered

Page 4: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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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 FilmsProlonged duration of action

while reducing the frequency

of dosing and reducing

adverse effects

Transdermal Patches

Page 5: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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

Page 6: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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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

• Health Canada approved dealer’s license for controlled substances

Page 8: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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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

Page 9: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

Manufacturing AbilitiesValidation of Strategic Shift

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• Agreements with commercialization partners (e.g. Gensco® Pharma, ENDO, Exeltis 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

• Definitive agreement with Tilray® to manufacture commercial volumes of cannabis-infused film products for adult-use and medicinal purposes

Page 10: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

Low RiskTargeted Business Model

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• Commercial deals are usually structured such that partners are granted exclusive rights to market and sell products in exchange for potential 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 film products

• Payments would be 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

• IntelGenx may also receive R&D tax credits for product development

Page 11: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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Established Strategic PartnershipsValidating Our Technology Platforms

Page 12: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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Accomplished Management Team>40 Employees

Andre Godin, CPA, CA

President, 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 & CEO

• Co-inventor of Listerine oral strips

• 30+ years drug delivery / pharma experience (Lohmann Therapy Systems, 3M Pharmaceuticals, SmartrixTechnologies)

• 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 transactions,

7 new product launches

Rodolphe Obeid, Ph.D.

VP, Operations

• 5+ years experience in manufacturing & scale-up of oral film products

• Author and co-author of numerous scientific papers, patents, book chapters, and scientific communications

Page 13: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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Robust Product PipelineAddressing Significant Market Opportunities

IndicationPartnering

StatusFormulation

DevelopmentClinical Filing Launch Partner

Migraine – RIZAPORT®

(Rizatriptan)

Availableex-US, ES & KR

Erectile Dysfunction(Tadalafil)

Partnered

Schizophrenia (Loxapine)

Available

Neurodegenerative Brain

Diseases(Montelukast)

Available

Opioid Dependence(Buprenorphine/ Naloxone)

Partnered

Undisclosed Partnered

Undisclosed Partnered

Undisclosed Partnered

Adult-Use and Medical(Cannabinoids)

Partnered

Tab

lets Hypertension Partnered

Pain(Dronabinol)

Availableex-US & CAN

Page 14: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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RIZAPORT® VersaFilm®For Migraines

Leverages VersaFilm® Technology

• Oral Film containing 10 mg Rizatriptan

• Marketing Approval granted in Spain in October 2018

• Definitive agreement for Spain signed in July 2016 with Grupo Juste (now Exeltis Healthcare)

• Definitive agreement for South Korea signed in Dec 2016 with Pharmatronic

• Definitive agreement for US signed in Dec 2018 with Gensco® Pharma

• US Patent granted in April 2016 and EP Patent granted in October 2018 protecting RIZAPORT®

• FDA resubmission planned for Q3 2019

Page 15: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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Tadalafil VersaFilm®Erectile 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 was $1.7B in 2016

• Tadalafil substance patent expired, but Orange Book ‘166 dosing patent still in force until October 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

• Definitive worldwide agreement signed with Aquestive Therapeutics, Inc. in May 2019

$1,703 $1,429

$175

$11 $48

$18

Cialis

Viagra

Levitra

Staxyn

Stendra

Edex

US ED Market by Sales ($M)

*Market data taken from IMS Health 2016

Page 16: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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Cannabis-Infused VersaFilm®For Medicinal and Adult-Use Purposes

• IntelGenx signed a definitive license, development and supply agreement with Tilray® to develop and manufacture cannabis-infused VersaFilm® for medical and adult-use use in human applications

• Dissolvable films are a highly unique and relevant approach to consuming cannabis, appealing to both medicinal and adult-use 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 Adult-UsePurposes

For MedicinalPurposes

SPEND PER YEAR $1,212 $1,476

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 17: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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AdVersa® 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 patents

• Competitive advantages vs. capsules

®

Page 18: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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 Alzheimer’s Disease (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

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Already Approved and Established Drug

Supporting Epidemiology Data

Strong Preclinical Evidence

Supporting Ph1 Data

IP Strategy

Page 19: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

Improves Learning and Memory in aged animals

Crosses the Blood-Brain Barrier in rats and humans

Restores Blood Vessel Structural Integrity

Returns Generation of New Neurons

Restores Learning and Memory in a Model of LewyBody dementia

Improves function in a number of models of acute andchronic neurodegenerative diseases

Note: MMSE = Mini-Mental State Examination; is a test to measure cognitive impairment19

Improves Cognitive Functions & Structural Integrityof the Brain

Early Clinical EvidencePreclinical Demonstration

Before:MMSE 13: moderate to severe dementia

After 2 Months: MMSE 22: Mild

Dementia

Page 20: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

CSF ng/mL

Average at 3

hours3.6

Average at 7

hours4.2

A Single-Dose, Non-Randomized, Open-Label, Two-Way, Pilot, Comparative Bioavailability Study of Montelukast 10 mg Oral Film (IntelGenx Corp.) and Singulair® 10 mg Film-coated Tablet (Merck & Co., Inc., approved for Asthma in 1998) in Healthy Male and Non-pregnant Female Volunteers under Fasting Conditions

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Phase I Clinical Study CompletedPositive Results

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

Mo

nte

luka

stco

nce

ntr

atio

n (

ng/

mL)

Time (hrs)

Montelukast Mean Plasma Profile

Test buccal film 10mg

Ref tablet 10mg

CSF level measured for Buccal Film (average of 8)

Safety Results: A total of 2 possibly related adverse events to the buccal film were reported. A total of 2 subjects experienced somnolence when taking the buccal film.

Page 21: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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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

• Only known cysLT-1 receptor antagonist clinical study against Alzheimer’s Disease

• Study Drug: 10 mg Montelukast VersaFilm® buccal film and matching placebo

• Treatment duration for each patient: 26 weeks

• Assessment of the treatment effect: SIB, MMSE, ADCS-CGIC, ADCS-ADL23 and NPI

• Number of patients: 70 (35 per arm)

• Patients: ≥50 years of age with mild to moderate Alzheimer’s Disease and treated daily with donepezil, rivastigmine or galanthamine for ≥3 months

• 9 Canadian sites; retained services of contract research organizations Cogstate and JSS Medical Research

• Patient screening and enrolment commenced Q3-2018; 16 subjects enrolled as of May 8, 2019

• First data evaluation anticipated in Q4 2019

Page 22: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

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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 (gastrointestinal), sublingual & buccal absorption

3. Clearly Defined Corporate Strategy & Business Model

- Focus on lifecycle management, patient benefits, first-to-file 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: Leader in Pharmaceutical Films - IntelGenx" · 2019. 7. 12. · Company Snapshot 3 1) As at March 31, 2019 IntelGenx Corp. Founded 2003 TSX-V (IGX)1 CDN$0.87 OTCQX (IGXT)1 US$0.67

Thank You!

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

André GodinPresident & 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