Innovative Drug Delivery...

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0 Investor Presentation Aug 11, 2016 Innovative Drug Delivery Solutions

Transcript of Innovative Drug Delivery...

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Investor Presentation

Aug 11, 2016

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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Oral Thin Films

Oral Thin Films Provide

Significant Market Opportunities

for Improving Drug Delivery

• IntelGenx CEO co-developer of the

Listerine breath strips

• Oral films provide quicker action to relieve

symptoms

• IntelGenx’s goal to become a leader in

pharmaceutical oral film development &

manufacturing

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• IntelGenx Corp. Founded• TSX-V (IGX)• OTCQX (IGXT)• Market Capitalization • Shares Issued• Shares Fully Diluted• Insider Ownership• Cash/Equivalent

2003CAD$0.93

US$0.70US$44M

63.6M70.35M

15%US$6M

Analyst Coverage

Firm Analyst

H.C. Wainwright Swayampakula Ramakanth

Singular Research Greg Eisen

Company Snapshot

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Strong Demographics for Oral Films

Many patient applications are compatible

with oral film characteristics

• Those who have difficult swallowing large pills:

pediatric, geriatric, or dysphagic

• North Americans over 65 will grow from 54MM to 85MM

over the next 15 years

• Patients who suffer gastrointestinal (GI) side effects

from their medication

• Normal patients who would prefer a more discrete

or pleasant administration of the drug

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A Robust Product Pipeline to Address Significant Market Opportunities

IndicationPartnering

Availability

Formulation

Development

Pilot

Study

Pivotal

StudyFiling Launch

Films Migraine – Rizaport TM -

RizatriptanAvailable

except Spain

Erectile Dysfunction -

TadalafilAvailable

Schizophrenia - Loxapine Available

Central Nervous System -

MontelukastAvailable

Respiratory (Cough & Cold) In Discussion

Cardiovascular In Discussion

Opioid DependencePar

Pharmaceutical

Undisclosed Term Sheet

Pain Term Sheet

Central Nervous System Term Sheet

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For Migraines

Leverages VersaFilm™ Technology

• European Mktg Approval – November 2015

• Co-development partnership with RedHill Biopharma

• Definitive agreement signed July 2016 with

Grupo Juste for Spain & additional territories

• Actively pursuing several opportunities to open new

markets - negotiations with future commercialization

partners ongoing

• Planned USA submission to FDA Q1/2017

• Expected USA launch Q3/2017

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For Erectile Dysfunction

• The first oral thin film using IntelGenx

proprietary drug delivery technology,

VersaFilm™, for ED

• Containing tadalafil (Cialis® - Eli Lilly),

a major molecule in the ED market

• Demonstrated bioequivalence to Cialis®

• Orally disintegrating films without need

for water provide unprecedented patient

convenience and a discrete dosing

alternative

• 505(b)(2) USA NDA submission in

Q1/2017

• Expected USA launch Q1/2018

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For Schizophrenia & Bipolar 1 Disorder

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• The first oral thin film using IntelGenx

proprietary drug delivery technology,

VersaFilm™, for Schizophrenia & Bipolar

1 disorder

• Fast-acting loxapine oral dosage – to

treat acute agitation with Schizophrenia &

Bipolar 1 disorder in non-institutionalized

patients

• Reduces risk of pulmonary problems

and potential risk of violence and injury to

patients and others

• Formulation optimization stage – results

expected Q2 2017

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For Mild Cognitive Impairment

• IntelGenx is repurposing Montelukast

for the treatment of MCI by leveraging

its VersaFilm™ technology

• The drug is known and approved

completely for a different indication

• Strong preclinical experience

• Phase 1 clinical trials started June 2016

with expected results September 2016

• Phase 2A clinical trial to begin Q4 2016

• Looking for a commercial partner

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Strategy Update

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Strengthened Management TeamOver 20 Employees, including 7 with Ph.D.’s

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

Edward Miller, B. Comm

Director, Investor Relations

• 15 years experience in

investor relations

• 10 + years experience in

pharmaceutical / biotech

Horst G. Zerbe, Ph. D.

Chairman, President & CEO

• Co-Founder of Listerine

breath strips

• 30+ years drug delivery /

pharma experience

• Holds over 40 patents in drug

delivery and numerous

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

John Durham, B. Sc.

VP, Operations

• 20+ years experience in

pharmaceutical

manufacturing, quality

management, product

development

• Held executive positions with

several Canadian and US

companies

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Completion of Constructionof Manufacturing Facility

• 17,000 sq ft facility in Montreal -

construction completed in Q1 2016

• Facility to be fully operational by Q1 2017

• High capacity manufacturing and

packaging equipment

• Lower costs, controls quality

and de-risks investment

for new products

GROSS MARGINS of 40% PLUS

We have built a state-of-the-art

oral film development and manufacturing facility

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We are Now Poised for Success

We are focused on areas where oral films

are particularly well-suited:

Develop and commercialize products that provide tangible patient benefits

leveraging oral films, such as:

• Reduced side effects

• Improved bio-availability

• Response time versus existing drugs

• 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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What Makes IntelGenx the Best in Oral Films

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. 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)

1.51.2

5.1

1.7

0

1

2

3

4

5

6

H1 2016 H1 2015 2015 Full Year 2014 Full Year

Revenue

$M

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Net Comprehensive Income & Adjusted EBITDA ($M)

-1.5

-0.6

0.8

-2.2

-1.2

-0.1

1.7

-1.6

-2.5

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

H1 2016 H1 2015 2015 Full Year 2014 Full Year

Net Income Adjusted EBITDA

$M

Financial Performance

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Monetization of Forfivo Future Royalties for $6 Million

• IntelGenx made a strategic decision to become completely focused on Oral Films

• Sale of Forfivo XL Royalty for $6M (CAD$8M) to SWK Holdings – August 5, 2016

• Largest influx of cash in history of corporation

• Non-dilutive source of cash to strengthen balance sheet

• SWK receives 100% of all royalties as of April 1, 2016

• SWK will have 100% of the $2 million milestone for net sales reaching $15M

• SWK will have 35% of all future milestones

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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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Thank You

www.IntelGenx.com