intelgenx q4 earnings presentation

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0 Conference Call & Webcast March 23, 2016 Q4 & Full Year 2015 Financial Results

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Page 1: Intelgenx Q4 Earnings Presentation

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Conference Call & Webcast

March 23, 2016

Q4 & Full Year 2015 Financial Results

Page 2: Intelgenx Q4 Earnings Presentation

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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

Page 3: Intelgenx Q4 Earnings Presentation

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WelcomeHorst G. Zerbe, Ph. D.

Chairman, President & CEO

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Page 4: Intelgenx Q4 Earnings Presentation

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IndicationPartnering

Availability

Formulation

Development

Pilot

StudyPivotal Study Filing Launch

Films Migraine – Rizaport TM - Rizatriptan Available

Erectile Dysfunction - Tadalafil Available

Opioid Dependence Par

Pharmaceuticals

Schizophrenia - Loxapine Available

Undisclosed Available

Pain Available

Central Nervous System Available

Central Nervous System Available

Respiratory Available

Cardiovascular Available

Tablets Major Depressive Disorder –

Forfivo XL®

Bupropion

Edgemont

Pharmaceuticals

Available ex-USA

Hypertension - Metoprolol Available

Pain - Dronabinol Available

A Robust Product Pipeline to AddressSignificant Market Opportunities

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Page 5: Intelgenx Q4 Earnings Presentation

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Forfivo XL

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• High dose version of Wellbutrin XL®

• Only approved, once-daily, bupropion

HCl 450mg dose in a single tablet

• Launched commercially October 2013

in partnership with Edgemont

Pharmaceuticals

• Q4 2015 net sales grew 24% compared

to Q3 2015, with net sales at $3 million

($5.4 million gross)

• For the past twelve months, net sales

totaled $9.3 million ($17.4 million gross),

an increase of 102% compared to the

twelve month period in 2014

First 450mg tablet approved by FDA for major depressive disorder

1697 1756

2108

2447

3022

$0.00

$500.00

$1,000.00

$1,500.00

$2,000.00

$2,500.00

$3,000.00

$3,500.00

4Q14 1Q15 2Q15 3Q15 4Q15

Forfivo XL Net Sales ($,000s)

Page 6: Intelgenx Q4 Earnings Presentation

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Rizaport™

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For Migraines

Leverages VersaFilm™ Technology

• European Mktg Approval – November 2015

• Filed 505(b)(2) NDA - March 2013 for USA

• Co-development partnership with

RedHill Biopharma

• Negotiations with commercialization

partner ongoing

• Patent granted in Feb 2016 protecting

Rizaport

Page 7: Intelgenx Q4 Earnings Presentation

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Leverages VersaFilm™ Technology

Par Projects

• Par Pharmaceuticals acquired by Endo Pharmaceuticals – Sept 2015

• Par has now returned two of three projects back to IntelGenx

• Par & IntelGenx now focused on Opioid Dependence Product

• Opioid Dependence product under review at FDA since July 2013

• Reckitt Benckiser vs. Par: Hatch/Waxman: court decision by May 1st,

2016

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Page 8: Intelgenx Q4 Earnings Presentation

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For Erectile Dysfunction

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• 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

Page 9: Intelgenx Q4 Earnings Presentation

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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

Page 10: Intelgenx Q4 Earnings Presentation

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Strategy Update

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Horst G. Zerbe, Ph. D.Chairman, President & CEO

Page 11: Intelgenx Q4 Earnings Presentation

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Strengthened Management TeamCurrently 21 Employees, 9 Ph.D.’s

André 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

Robert Bechard, M. Sc.

VP, Corporate Development

• 20+ years experience in

biopharmaceutical and

venture capital

• Managing Partner of

Lifescience venture fund at

RBC Capital

• Director on 25 lifescience

boards

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 Development

• 15 years experience in

pharmaceutical product

licensing

• Former Director, BD at

Paladin Labs

• 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

Page 12: Intelgenx Q4 Earnings Presentation

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Completion of Constructionof Manufacturing Facility

• 17,000 sq ft facility to be officially

commissioned in mid-2016

• High capacity manufacturing and

packaging equipment

• Lower costs, controls quality

and de-risks investment

for new products

We have built a state-of-the-art

oral film development and manufacturing facility

Page 13: Intelgenx Q4 Earnings Presentation

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Patents Coming Off Protection

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 side effects from their medication

• Normal patients who would prefer a more discrete or pleasant administration of the drug

Large numbers of

well-known drugs

are coming off

patent protection

in the next few years

• Sources: FDA “orange book” data; Larson & Co analysis

10041139 1196

979880

2016 2017 2018 2019 2020

Number of FDA patent expiries by year2016-2020

Page 14: Intelgenx Q4 Earnings Presentation

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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

or response time versus existing drugs

• First-to-file generic drug where high technology barriers to entry

exist in reproducing branded films

• Repurpose existing drugs for new indications using oral films

• Lifecycle management

Page 15: Intelgenx Q4 Earnings Presentation

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Q4 & 2015 Full-Year

Financial ResultsAndré Godin, CPA, CA

Executive VP, CFO

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Page 16: Intelgenx Q4 Earnings Presentation

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Record Results in 2015 Demonstrates Strong Execution of Strategy

Revenue ($M)

1.5

0.83

5.1

1.7

0

1

2

3

4

5

6

Q4 2015 Q4 2014 2015 Full Year 2014 Full Year

Revenue

$M

15

Page 17: Intelgenx Q4 Earnings Presentation

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Forfivo XL

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• Q4 2015 net sales grew 24% compared

to Q3 2015, with net sales at $3 million

($5.4 million gross)

• For the past twelve months, net sales

totaled $9.3 million ($17.4 million gross),

an increase of 102% compared

to the twelve month period in 2014

First 450mg tablet approved by FDA for major depressive disorder

1697 1756

2108

2447

3022

$0.00

$500.00

$1,000.00

$1,500.00

$2,000.00

$2,500.00

$3,000.00

$3,500.00

4Q14 1Q15 2Q15 3Q15 4Q15

Forfivo XL Net Sales ($,000s)

Page 18: Intelgenx Q4 Earnings Presentation

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Forfivo XL - Strong Growth

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• 4Q15 Trxs increased 42% vs. 4Q14 and 8% vs. 3Q15

• 4Q15 Net Sales nearly doubled vs. 4Q14 and increased 24% vs. 3Q15

Page 19: Intelgenx Q4 Earnings Presentation

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Net Comprehensive Income & Adjusted EBITDA ($M)

0.23

-0.33

0.8

-2.2

0.43

-0.23

1.7

-1.6

-2.5

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

Q4 2015 Q4 2014 2015 Full Year 2014 Full Year

Net Income Adjusted EBITDA

$M

Record Results in 2015 Demonstrates Strong Execution of Strategy

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Page 20: Intelgenx Q4 Earnings Presentation

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ConclusionHorst G. Zerbe, Ph. D.

Chairman, President & CEO

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Page 21: Intelgenx Q4 Earnings Presentation

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Solid Platform for Growth

Significant Market Potential

• Continue to grow commercialization efforts of Forfivo XL® to drive revenue growth

• 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

Page 22: Intelgenx Q4 Earnings Presentation

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Invitation – Grand Opening – May 10th

Page 23: Intelgenx Q4 Earnings Presentation

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Questions?

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Page 24: Intelgenx Q4 Earnings Presentation

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Thank You

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