intelgenx corporate presentation
TRANSCRIPT
Innovation In Drug DeliveryAn introduction to unique pharmaceutical delivery technologiesJanuary 2015
TSX-V: IGX OTCQX: IGXT
FORWARD LOOKING STATEMENTSTo 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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Rapid and convenient dosage form for more immediate activity
Programmable drug release over an extended period of time
Controlled absorption in the oral cavity to maximize bioavailability
INTELGENX DEVELOPS FASTER AND MORE EFFICIENT DRUG DELIVERY SYSTEMS FOR TOP PHARMACEUTICALS
INNOVATIVE DELIVERY TECHNOLOGY
VERSATAB™ ADVERSA™VERSAFILM™
FOCUSING ON ORAL DRUG DELIVERY
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UNIQUE TECHNOLOGIES
TECHNOLOGY FOCUSED
Develop novel and high performance drug delivery systems – focus on oral film products.
TARGET HIGH-VALUE DIFFERENTIATED OPPORTUNITIES
INNOVATIVE DELIVERY TECHNOLOGY
• Use proprietary drug delivery technologies to develop products offering a therapeutic benefit to patients.
• Identify unique drug-repurposing opportunities.• Pursue high technological entry barrier products and first-to-file
opportunities.• Develop products addressing unmet therapeutic needs.
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PROVIDE COMPREHENSIVE PHARMACEUTICAL SERVICES TO INDUSTRY PARTNERS:
Pharmaceutical Research and Development Clinical monitoring; clinical supply manufacturing Regulatory services Process development and technology transfer Commercial product supply
REVENUE STREAM CONSISTING OF: Upfront payments R&D milestone payments Sales milestone payments Royalties on sales Manufacturing revenue
VALUE PROPOSITION
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PRODUCT PORTFOLIOA ROBUST PRODUCT PIPELINE ACROSS 3 TECHNOLOGY PLATFORMS
PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH
Forfivo XL® Major Depressive Disorder
INT0001 Hypertension
INT0024 Idiopathic Pulmonary Fibrosis (Pacific)
INT0008 Migraine (RedHill)
INT0027 Opioid Dependence (Par)
INT0037 Undisclosed (Par)
INT0039 Undisclosed (Par)
INT0007 Erectile Dysfunction
INT0036 Central Nervous System (CNS)
INT0010 Pain
Launched Q4 2012
Q1 2013
Q3 2013
Vers
a Ta b
TMVe
rsa F
i lmTM
Ad V
e rs a
TM
INTELGENX PARTNERSHIPSINTELGENX HAS STRATEGIC PARTNERSHIPS IN PLACE WITH MULTIPLE COMPANIES
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VersaTabTM
Addressable market for pipeline VersaTabTM products.
VersaFilmTM
Opportunity to convert existing tablet market into film technology
$8.1 Billion
$2.7 Billion
ADDRESSABLE MARKET FOR PRODUCT PIPELINESIGNIFICANT MARKET POTENTIAL
~$11BCombined,
addressable market for
product pipeline

25%
75%
$11b Total addressable
market
$1.2B 2013 Metroprolol
Sales
$1.1B Pentoxifylline - NAC
• Linear release profile; controlled erosion of inactive cover layers
• Multiple actives with independent release profiles
• Separation of active ingredients - avoidance of chemical incompatibility in fixed-dose combinations
• Cost-effective manufacturing
Depression Hypertension
Idiopathic Pulmonary Fibrosis Addressable
Market
$391M Wellbutrin XL &
Bupropion XL Sales
PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH
Forfivo XLMajor
Depressive Disorder
INT0001 Hypertension
INT0024Idiopathic Pulmonary
Fibrosis (Pacific)
VERSATAB®
PRODUCTS
Launched Q4 2012®
VersaTab® Addressable Market
~$2.7B
MULTILAYER TABLET TECHNOLOGYVERSATAB TM
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$3.0B
Current Market for Bupropion
• High dose version of Wellbutrin XL®
• Provides a once-daily, bupropion 450 mg dose in a single tablet
• Indicated for the treatment of major depressive disorder
• Launched commercially October 2012 in partnership with Edgemont Pharmaceuticals
• Paragraph IV litigation with with Wockhardt settled
$236M
Wellbutrin XL®Market
$2.7M
2013 SalesForfivo XL
FORFIVO XL® SCRIPT GROWTH
®
VERSATAB TM
VersaTab®
Addressable Market
~$2.7B
FORFIVO XL® COMMERCIALIZATION GROWTH OPPORTUNITY
1010/31/12
12/31/122/28/13
4/30/136/28/13
8/30/1310/31/13
12/31/132/28/14
4/30/146/30/14
8/29/1410/31/14
12/31/140
1,000
2,000
3,000
4,000
$0
$300,000
$600,000
$900,000
$1,200,000
$1,500,000
~$1.2M
DecemberGross Sales
3,466December
Prescriptions
VersaFilm™ Rapidly disintegrating pharmaceutical films for buccal or systemic drug delivery
VersaFilm Addressable Market
~$8.1B
®
Improved product performance:• Fast delivery translates into
rapid onset of action• Improved bioavailability• Buccal (topical) or systemic
drug exposure
Improved patient compliance:• Convenient delivery
improving compliance for pediatric and geriatric patients where swallowing is an issue
Increased barrier for generic competition:• Limited number of
competitors
ADVANTAGES OF FILM TECHNOLOGYVERSAFILM TM
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$1.3B
• Demonstrated ability to achieve bioequivalence
• Two applications currently under review at FDA: one ANDA, and one 505(b)(2)NDA
• Comprehensive VersaFilm™ development pipeline
• Limited number of
competitors, strong IP position
Opioid Dependence Migraine Erectile Dysfunction
$230M
Targeted Rizatriptan Market
Targeted Cialis Sales
®
$1.6B
Targeted Suboxone Sales
®
VersaFilm Addressable Market
~$8.1B
®
ADDRESSABLE MARKETSVERSAFILM TM
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PRECLINICAL
PILOT STUDY
PIVOTAL STUDY FILING LAUNCH
INT0008 Migraine (RedHill)
INT0027Opioid Dependence (Par)
INT0007 Erectile Dysfunction
INT0036 CNS
INT0037 Undisclosed (Par)
INT0039 Undisclosed (Par)
Q1 2013 2015
VERSAFILMPRODUCTS
Q3 2013 2017
Q4 2016 Q4 2017
Suboxone® Rx Quantities (Millions)
2008 2009 2010 2011 2012 20130
20
40
60
80Film Tablet
• Demonstrated ability to achieve bioequivalence
• Two applications currently under review at FDA: one ANDA, and one 505(b)(2)NDA
• Comprehensive VersaFilm™ development pipeline
• Limited number of
competitors, strong IP position
VersaFilm Addressable Market
~$8.1B
®
ATTRACTIVE LIFECYCLE MANAGEMENT OPPORTUNITYVERSAFILM TM
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Subo
xone
®
Subl
ingu
al Fi
lm
Subo
xone
®
Subl
ingu
al Ta
blet
s
0 12 24 36 48 60 720
0.35
0.7
1.05
1.4Buprenorphine plasma profile
Test product Test product
Time (hrs)
Mea
n co
ncen
trati
on (n
g/m
L) Reference product
Suboxone Addressable Market
~$1.6B
®
Completed development with successful pivotal bioequivalency study.
Abbreviated New Drug Application (ANDA) submitted to FDA in July 2013.
Marketing approval anticipated 2016.
Attractive partnership deal with Par Pharmaceutical
P4 litigation with Reckitt Benckiser progressing well
0 6 12 18 240
30
60
90
120
150Naloxone plasma profile
Test product reference product (Suboxone 8/2mg)
Time (hrs)
Mea
n co
ncen
trati
on (p
g/m
L)
OPIOD DEPENDENCE - BUPRENORPHINE/NALOXONEVERSAFILM TM
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Rizatriptan® Addressable Market$230M
Successfully completed development and stability testing
Filed 505(b)(2)NDA in March 2013
Co-development and licensing agreement in place with RedHill Biopharma
Negotiations with commercialization partner ongoing
0.0 3.0 6.0 9.0 12.0 15.00.0
4.5
9.0
13.5
18.0
Time (hrs)
Riza
trip
tan
Pl. C
onc.
(ng/
mL)
VersaFilm Rizatriptan
Maxalt MLT®
Orally disintegrating film containing Rizatriptan bioequivalent with orally disintegrating tablet (Maxalt
MLT®)
MIGRAINE FILM BIOEQUIVALENT TO MAXALT MLT®
VERSAFILM TM
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Cialis® Addressable Market
~$1.3BCP pending for OTC approval
Formulation development ongoing.
Worldwide patent application.
Pilot BE study on 10 mg strength suggests BE with RLD.
Confirmatory pilot BE study on 20 mg strength completed.
Successful pilot BE study (10 mg strength)
BIOEQUIVALENCE ACHIEVED VS. CIALIS® TABLETSVERSAFILM TM
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Schizophrenia Market1~$5.2B
CNS FILM INT0036 – A fast acting version of an existing schizophrenia treatment.VERSAFILM TM
Successfully completed pilot scale Phase I study
INT0036 demonstrated a significantly improved pharmacokinetic profile against the reference product1 According to Datamonitor Healthcare schizophrenia forecast published July 13, 2012
0 15 30 45 600
7,500
15,000
22,500
Time (min)
Riza
tript
an P
l. Co
nc. (
ng/m
L)
VersaFilm INT0036
RLD
A STRONG PLATFORM FOR GROWTH AND INNOVATIONVERSAFILM TM
• Addressable market of approximately $8.1 billion identified to-
date
• Strong intellectual property protection
• Successful pivotal bioequivalency studies
• Three applications for film products awaiting FDA approval
• Limited number of competitors
• Life cycle management opportunity
DEVELOPING FILM MANUFACTURING CAPABILITIES TO INCREASE PROFITABILITYOPERATIONAL INITIATIVES
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• Significantly increase IntelGenx' revenue stream
• Improve protection of IntelGenx' IP.
• Eliminate dependency on 3rd party manufacturing partners
• Provide full service from inception to product supply (one-stop-
shopping).
• Increase R&D capabilities and investments with expanded
laboratories and technologies.
Develop
• 2014, Identify a second supplier for Rizatriptan
• 2014, Submit application for Rizatriptan in Europe
• 2014, Acceptance of ANDA for INT0027 triggering a milestone payment from Par
• 2014, Clarity on ForFivo XL litigation with WockHardt
2014 2015 2016 2017
SUGGESTS NEAR TERM CATALYSTSKEY MILESTONES
Position
• 2015, Anticipated approval for migraine VersaFilmTM
• 2015, Anticipated submission of ANDA for Antihypertensive VersaTabTM
• 2016, Anticipated tentative approval for opioid dependence VersaFilm™
• 2016, Commence manufacturing capabilities of VersaFilm™
Grow
• 2016, Anticipated submission of 505(b)(2) NDA for ED VersaFilm™
• 2017, Anticipated launch for opioid dependence VersaFilm™
• 2017, Anticipated approval for ED VersaFilm™
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Horst G. Zerbe, Ph.D.Chairman, President and CEO
• Founder of IntelGenx• 30+ years Industry Experience• Holds over 40 patents in drug delivery, and numerous
scientific publications• Previously President Smartrix Tech. Inc. and VP R&D at
LTS Lohmann, USA
Nadine Paiement, M.Sc.Director R&D
Paul Simmons, AFCAChief Financial Officer
Alexandre Serrano, Ph.D.Associate Director, Bus. Dev.
• Co-inventor of IntelGenx Trilayer Technology• 10 years experience in product development and technology
transfer• Previously R&D Manager at Smartrix Tech. Inc.
• 25 + years multinational business and finance experience• Proven track record of exceeding targets in delivering
corporate growth• Held CFO and VP Finance positions with several European
corporations
• Responsible for Strategic Alliances, Licensing, Acquisitions, and Intellectual Property
• Ph.D. in Neuroscience (University of Montreal)• Previously actively involved in in-licensing at AstraZeneca
Montreal
65+ YEARS OF COMBINED INDUSTRY EXPERIENCEVISIONARY, EXPERIENCED LEADERSHIP
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John Durham, B.Sc.Vice President, Manufacturing Operations
• 20+ years experience in pharmaceutical manufacturing, quality management, product development
• Held executive positions with several Canadian and US companies
• Previously COO at Labopharm Inc. and President at Draxis Pharma
CORE TECHNOLOGIES ADDRESS LARGE MARKET POTENTIALA SOLID PLATFORM FOR GROWTH
• Continue to expand commercialization efforts of Forfivo XL and drive revenue growth
• Advance pipeline products towards commercialization
• Continue to develop commercialization relationships
• Leverage VersaFilm manufacturing expertise to provide full service
VERSATAB™ ADVERSA™VERSAFILM™
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Innovation In Drug DeliveryThank You
TSX-V: IGX OTCQX: IGXT