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Innovation In Drug Delivery
An introduction to unique pharmaceutical delivery technologies
May 2015
TSX-V: IGX
OTCQX: IGXT
FORWARD LOOKING STATEMENTS
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.
2
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
VERSATABā„¢ ADVERSAā„¢VERSAFILMā„¢
FOCUSING ON ORAL DRUG DELIVERY
3
UNIQUE TECHNOLOGIES
TECHNOLOGY FOCUSED
Develop novel and high performance drug delivery systems ā€“ focus on oral film products.
TARGET HIGH-VALUE DIFFERENTIATED OPPORTUNITIES
INNOVATIVE DELIVERY TECHNOLOGY
ā€¢ Use proprietary drug delivery technologies to develop products offering a
therapeutic benefit to patients.
ā€¢ Identify unique drug-repurposing opportunities.
ā€¢ Pursue high technological entry barrier products and first-to-file opportunities.
ā€¢ Develop products addressing unmet therapeutic needs.
4
PROVIDE COMPREHENSIVE PHARMACEUTICAL SERVICES TO INDUSTRY
PARTNERS:
ļƒ˜ Pharmaceutical Research and Development
ļƒ˜ Clinical monitoring; clinical supply manufacturing
ļƒ˜ Regulatory services
ļƒ˜ Process development and technology transfer
ļƒ˜ Commercial product supply
REVENUE STREAM CONSISTING OF:
ļƒ˜ Upfront payments
ļƒ˜ R&D milestone payments
ļƒ˜ Sales milestone payments
ļƒ˜ Royalties on sales
ļƒ˜ Manufacturing revenue
VALUE PROPOSITION
5
PRODUCT PORTFOLIO
A ROBUST PRODUCT PIPELINE ACROSS 3 TECHNOLOGY PLATFORMS
PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH
Forfivo XLĀ® 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
INTELGENX PARTNERSHIPS
INTELGENX HAS STRATEGIC PARTNERSHIPS IN PLACE WITH MULTIPLE COMPANIES
7
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 PIPELINE
SIGNIFICANT MARKET POTENTIAL
~$11BCombined,
addressable market
for product pipeline
25%
75%
$11bTotal addressable
market
$1.2B
2013 Metroprolol
Sales
$1.1B
Pentoxifylline - NAC
ā€¢ Linear release profile;
controlled erosion of inactive
cover layers
ā€¢ Multiple actives with
independent release profiles
ā€¢ Separation of active
ingredients - avoidance of
chemical incompatibility in
fixed-dose combinations
ā€¢ Cost-effective manufacturing
Depression Hypertension
Idiopathic Pulmonary
Fibrosis Addressable
Market
$391M
Wellbutrin XL &
Bupropion XL Sales
PRECLINICAL PILOT STUDY
PIVOTAL
STUDY
FILING LAUNCH
Forfivo XL
Major
Depressive
Disorder
INT0001 Hypertension
INT0024
Idiopathic
Pulmonary
Fibrosis
(Pacific)
VERSATABĀ®
PRODUCTS
Launched Q4 2012Ā®
VersaTabĀ®
Addressable
Market
~$2.7B
MULTILAYER TABLET TECHNOLOGY
VERSATAB TM
9
$3.0B
Current Market for
Bupropion
ā€¢ High dose version of
Wellbutrin XLĀ®
ā€¢ Provides a once-daily,
bupropion 450 mg dose in a
single tablet
ā€¢ Indicated for the treatment of
major depressive disorder
ā€¢ Launched commercially
October 2012 in partnership
with Edgemont
Pharmaceuticals
ā€¢ Paragraph IV litigation with
with Wockhardt settled
$236M
Wellbutrin XLĀ®
Market
$2.7M
2013 Sales
Forfivo XL
FORFIVO XLĀ® SCRIPT GROWTH
Ā®
VERSATAB TM
VersaTabĀ®
Addressable
Market
~$2.7B
FORFIVO XLĀ® COMMERCIALIZATION GROWTH OPPORTUNITY
10
$0
$300,000
$600,000
$900,000
$1,200,000
$1,500,000
$1,800,000
0
1,000
2,000
3,000
4,000
5,000
Over $1.5M
March 2015
Gross Sales
3,893
March 2015
Prescriptions
VersaFilmā„¢
Rapidly disintegrating pharmaceutical films
for buccal or systemic drug delivery
VersaFilm
Addressable
Market
~$8.1B
Ā®
Improved product performance:
ā€¢ Fast delivery translates into
rapid onset of action
ā€¢ Improved bioavailability
ā€¢ Buccal (topical) or systemic
drug exposure
Improved patient compliance:
ā€¢ Convenient delivery improving
compliance for pediatric and
geriatric patients where
swallowing is an issue
Increased barrier for generic
competition:
ā€¢ Limited number of competitors
ADVANTAGES OF FILM TECHNOLOGY
VERSAFILM TM
11
$1.3B
ā€¢ Demonstrated ability to
achieve bioequivalence
ā€¢ Two applications currently
under review at FDA:
one ANDA, and one
505(b)(2)NDA
ā€¢ Comprehensive
VersaFilmā„¢ development
pipeline
ā€¢ Limited number of
competitors, strong IP
position
Opioid Dependence Migraine Erectile Dysfunction
$230M
Targeted Rizatriptan
Market
Targeted Cialis
Sales
Ā®
$1.6B
Targeted Suboxone
Sales
Ā®
VersaFilm
Addressable
Market
~$8.1B
Ā®
ADDRESSABLE MARKETS
VERSAFILM TM
12
PRECLINICAL PILOT STUDY
PIVOTAL
STUDY
FILING LAUNCH
INT0008
Migraine
(RedHill)
INT0027
Opioid
Dependence
(Par)
INT0007
Erectile
Dysfunction
INT0036 CNS
INT0037
Undisclosed
(Par)
INT0039
Undisclosed
(Par)
Q1 2013 2015
VERSAFILM
PRODUCTS
Q3 2013 2017
Q4 2016 Q4 2017
SuboxoneĀ® Rx Quantities (Millions)
0
20
40
60
80
2008 2009 2010 2011 2012 2013
Film Tablet
ā€¢ Demonstrated ability to
achieve bioequivalence
ā€¢ Two applications currently
under review at FDA:
one ANDA, and one
505(b)(2)NDA
ā€¢ Comprehensive
VersaFilmā„¢ development
pipeline
ā€¢ Limited number of
competitors, strong IP
position
VersaFilm
Addressable
Market
~$8.1B
Ā®
ATTRACTIVE LIFECYCLE MANAGEMENT OPPORTUNITY
VERSAFILM TM
13
SuboxoneĀ®
SublingualFilm
SuboxoneĀ®
SublingualTablets
0.
0.35
0.7
1.05
1.4
0. 12. 24. 36. 48. 60. 72.
Meanconcentration(ng/mL)
Time (hrs)
Buprenorphine plasma profile
Test product Test productReference product
Suboxone
Addressable
Market
~$1.6B
Ā®
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.
30.
60.
90.
120.
150.
0. 6. 12. 18. 24.
Meanconcentration(pg/mL)
Time (hrs)
Naloxone plasma profile
Test product reference product (Suboxone 8/2mg)
OPIOD DEPENDENCE - BUPRENORPHINE/NALOXONE
VERSAFILM TM
14
RizatriptanĀ®
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
4.5
9.0
13.5
18.0
0.0 3.0 6.0 9.0 12.0 15.0
RizatriptanPl.Conc.(ng/mL)
Time (hrs)
VersaFilm Rizatriptan
Maxalt MLTĀ®
Orally disintegrating film containing Rizatriptan bioequivalent
with orally disintegrating tablet (Maxalt MLTĀ®)
MIGRAINE FILM BIOEQUIVALENT TO MAXALT MLTĀ®
VERSAFILM TM
15
CialisĀ®
Addressable
Market
~$1.3B
CP 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. CIALISĀ® TABLETS
VERSAFILM TM
16
Schizophrenia
Market1~$5.2B
CNS FILM INT0036 ā€“ 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 product
1 According to Datamonitor
Healthcare schizophrenia
forecast published July 13,
2012
0
7,500
15,000
22,500
30,000
0 15 30 45 60
RizatriptanPl.Conc.(ng/mL)
Time (min)
VersaFilm INT0036
RLD
A STRONG PLATFORM FOR GROWTH AND INNOVATION
VERSAFILM TM
ā€¢ Addressable market of approximately $8.1 billion identified to-date
ā€¢ Strong intellectual property protection
ā€¢ Successful pivotal bioequivalency studies
ā€¢ Three applications for film products awaiting FDA approval
ā€¢ Limited number of competitors
ā€¢ Life cycle management opportunity
DEVELOPING FILM MANUFACTURING CAPABILITIES TO INCREASE PROFITABILITY
OPERATIONAL INITIATIVES
19
ā€¢ Significantly increase IntelGenx' revenue stream
ā€¢ Improve protection of IntelGenx' IP.
ā€¢ Eliminate dependency on 3rd party manufacturing partners
ā€¢ Provide full service from inception to product supply (one-stop-shopping).
ā€¢ Increase R&D capabilities and investments with expanded laboratories and
technologies.
Develop
ā€¢ 2014, Identify a second
supplier for Rizatriptan
ā€¢ 2014, Submit application for
Rizatriptan in Europe
ā€¢ 2014, Acceptance of ANDA for
INT0027 triggering a milestone
payment from Par
ā€¢ 2014, Clarity on ForFivo XL
litigation with WockHardt
2014 2015 2016 2017
SUGGESTS NEAR TERM CATALYSTS
KEY MILESTONES
Position
ā€¢ 2015, Anticipated approval for migraine
VersaFilmTM
ā€¢ 2015, Anticipated submission of ANDA for
Antihypertensive VersaTabTM
ā€¢ 2016, Anticipated tentative approval for
opioid dependence VersaFilmā„¢
ā€¢ 2016, Commence manufacturing capabilities
of VersaFilmā„¢
Grow
ā€¢ 2016, Anticipated submission of
505(b)(2) NDA for ED VersaFilmā„¢
ā€¢ 2017, Anticipated launch for opioid
dependence VersaFilmā„¢
ā€¢ 2017, Anticipated approval for ED
VersaFilmā„¢
20
Horst G. Zerbe, Ph.D.
Chairman, President and CEO
ā€¢ Founder of IntelGenx
ā€¢ 30+ years Industry Experience
ā€¢ Holds over 40 patents in drug delivery, and numerous
scientific publications
ā€¢ Previously President Smartrix Tech. Inc. and VP R&D at
LTS Lohmann, USA
Paul Simmons, AFCA
Chief Financial Officer
Nadine Paiement, M.Sc.
Director R&D
ā€¢ 25 + years multinational business and finance experience
ā€¢ Proven track record of exceeding targets in delivering
corporate growth
ā€¢ Held CFO and VP Finance positions with several European
corporations
ā€¢ Co-inventor of IntelGenx Trilayer Technology
ā€¢ 10 years experience in product development and technology
transfer
ā€¢ Previously R&D Manager at Smartrix Tech. Inc.
65+ YEARS OF COMBINED INDUSTRY EXPERIENCE
VISIONARY, EXPERIENCED LEADERSHIP
21
John Durham, B.Sc.
Vice President, Manufacturing Operations
ā€¢ 20+ years experience in pharmaceutical manufacturing,
quality management, product development
ā€¢ Held executive positions with several Canadian and US
companies
ā€¢ Previously COO at Labopharm Inc. and President at Draxis
Pharma
CORE TECHNOLOGIES ADDRESS LARGE MARKET POTENTIAL
A SOLID PLATFORM FOR GROWTH
ā€¢ Continue to expand commercialization efforts of Forfivo XLĀ® and drive revenue
growth
ā€¢ Advance pipeline products towards commercialization
ā€¢ Continue to develop commercialization relationships
ā€¢ Leverage VersaFilmā„¢ manufacturing expertise to provide full service
VERSATABā„¢ ADVERSAā„¢VERSAFILMā„¢
22
Innovation In Drug Delivery
Thank You
TSX-V: IGX
OTCQX: IGXT

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IntelGenx Corporate Presentation

  • 1. Innovation In Drug Delivery An introduction to unique pharmaceutical delivery technologies May 2015 TSX-V: IGX OTCQX: IGXT
  • 2. FORWARD LOOKING STATEMENTS 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. 2
  • 3. 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 VERSATABā„¢ ADVERSAā„¢VERSAFILMā„¢ FOCUSING ON ORAL DRUG DELIVERY 3
  • 4. UNIQUE TECHNOLOGIES TECHNOLOGY FOCUSED Develop novel and high performance drug delivery systems ā€“ focus on oral film products. TARGET HIGH-VALUE DIFFERENTIATED OPPORTUNITIES INNOVATIVE DELIVERY TECHNOLOGY ā€¢ Use proprietary drug delivery technologies to develop products offering a therapeutic benefit to patients. ā€¢ Identify unique drug-repurposing opportunities. ā€¢ Pursue high technological entry barrier products and first-to-file opportunities. ā€¢ Develop products addressing unmet therapeutic needs. 4
  • 5. PROVIDE COMPREHENSIVE PHARMACEUTICAL SERVICES TO INDUSTRY PARTNERS: ļƒ˜ Pharmaceutical Research and Development ļƒ˜ Clinical monitoring; clinical supply manufacturing ļƒ˜ Regulatory services ļƒ˜ Process development and technology transfer ļƒ˜ Commercial product supply REVENUE STREAM CONSISTING OF: ļƒ˜ Upfront payments ļƒ˜ R&D milestone payments ļƒ˜ Sales milestone payments ļƒ˜ Royalties on sales ļƒ˜ Manufacturing revenue VALUE PROPOSITION 5
  • 6. PRODUCT PORTFOLIO A ROBUST PRODUCT PIPELINE ACROSS 3 TECHNOLOGY PLATFORMS PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH Forfivo XLĀ® 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
  • 7. INTELGENX PARTNERSHIPS INTELGENX HAS STRATEGIC PARTNERSHIPS IN PLACE WITH MULTIPLE COMPANIES 7
  • 8. 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 PIPELINE SIGNIFICANT MARKET POTENTIAL ~$11BCombined, addressable market for product pipeline 25% 75% $11bTotal addressable market
  • 9. $1.2B 2013 Metroprolol Sales $1.1B Pentoxifylline - NAC ā€¢ Linear release profile; controlled erosion of inactive cover layers ā€¢ Multiple actives with independent release profiles ā€¢ Separation of active ingredients - avoidance of chemical incompatibility in fixed-dose combinations ā€¢ Cost-effective manufacturing Depression Hypertension Idiopathic Pulmonary Fibrosis Addressable Market $391M Wellbutrin XL & Bupropion XL Sales PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH Forfivo XL Major Depressive Disorder INT0001 Hypertension INT0024 Idiopathic Pulmonary Fibrosis (Pacific) VERSATABĀ® PRODUCTS Launched Q4 2012Ā® VersaTabĀ® Addressable Market ~$2.7B MULTILAYER TABLET TECHNOLOGY VERSATAB TM 9
  • 10. $3.0B Current Market for Bupropion ā€¢ High dose version of Wellbutrin XLĀ® ā€¢ Provides a once-daily, bupropion 450 mg dose in a single tablet ā€¢ Indicated for the treatment of major depressive disorder ā€¢ Launched commercially October 2012 in partnership with Edgemont Pharmaceuticals ā€¢ Paragraph IV litigation with with Wockhardt settled $236M Wellbutrin XLĀ® Market $2.7M 2013 Sales Forfivo XL FORFIVO XLĀ® SCRIPT GROWTH Ā® VERSATAB TM VersaTabĀ® Addressable Market ~$2.7B FORFIVO XLĀ® COMMERCIALIZATION GROWTH OPPORTUNITY 10 $0 $300,000 $600,000 $900,000 $1,200,000 $1,500,000 $1,800,000 0 1,000 2,000 3,000 4,000 5,000 Over $1.5M March 2015 Gross Sales 3,893 March 2015 Prescriptions
  • 11. VersaFilmā„¢ Rapidly disintegrating pharmaceutical films for buccal or systemic drug delivery VersaFilm Addressable Market ~$8.1B Ā® Improved product performance: ā€¢ Fast delivery translates into rapid onset of action ā€¢ Improved bioavailability ā€¢ Buccal (topical) or systemic drug exposure Improved patient compliance: ā€¢ Convenient delivery improving compliance for pediatric and geriatric patients where swallowing is an issue Increased barrier for generic competition: ā€¢ Limited number of competitors ADVANTAGES OF FILM TECHNOLOGY VERSAFILM TM 11
  • 12. $1.3B ā€¢ Demonstrated ability to achieve bioequivalence ā€¢ Two applications currently under review at FDA: one ANDA, and one 505(b)(2)NDA ā€¢ Comprehensive VersaFilmā„¢ development pipeline ā€¢ Limited number of competitors, strong IP position Opioid Dependence Migraine Erectile Dysfunction $230M Targeted Rizatriptan Market Targeted Cialis Sales Ā® $1.6B Targeted Suboxone Sales Ā® VersaFilm Addressable Market ~$8.1B Ā® ADDRESSABLE MARKETS VERSAFILM TM 12 PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH INT0008 Migraine (RedHill) INT0027 Opioid Dependence (Par) INT0007 Erectile Dysfunction INT0036 CNS INT0037 Undisclosed (Par) INT0039 Undisclosed (Par) Q1 2013 2015 VERSAFILM PRODUCTS Q3 2013 2017 Q4 2016 Q4 2017
  • 13. SuboxoneĀ® Rx Quantities (Millions) 0 20 40 60 80 2008 2009 2010 2011 2012 2013 Film Tablet ā€¢ Demonstrated ability to achieve bioequivalence ā€¢ Two applications currently under review at FDA: one ANDA, and one 505(b)(2)NDA ā€¢ Comprehensive VersaFilmā„¢ development pipeline ā€¢ Limited number of competitors, strong IP position VersaFilm Addressable Market ~$8.1B Ā® ATTRACTIVE LIFECYCLE MANAGEMENT OPPORTUNITY VERSAFILM TM 13 SuboxoneĀ® SublingualFilm SuboxoneĀ® SublingualTablets
  • 14. 0. 0.35 0.7 1.05 1.4 0. 12. 24. 36. 48. 60. 72. Meanconcentration(ng/mL) Time (hrs) Buprenorphine plasma profile Test product Test productReference product Suboxone Addressable Market ~$1.6B Ā® 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. 30. 60. 90. 120. 150. 0. 6. 12. 18. 24. Meanconcentration(pg/mL) Time (hrs) Naloxone plasma profile Test product reference product (Suboxone 8/2mg) OPIOD DEPENDENCE - BUPRENORPHINE/NALOXONE VERSAFILM TM 14
  • 15. RizatriptanĀ® 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 4.5 9.0 13.5 18.0 0.0 3.0 6.0 9.0 12.0 15.0 RizatriptanPl.Conc.(ng/mL) Time (hrs) VersaFilm Rizatriptan Maxalt MLTĀ® Orally disintegrating film containing Rizatriptan bioequivalent with orally disintegrating tablet (Maxalt MLTĀ®) MIGRAINE FILM BIOEQUIVALENT TO MAXALT MLTĀ® VERSAFILM TM 15
  • 16. CialisĀ® Addressable Market ~$1.3B CP 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. CIALISĀ® TABLETS VERSAFILM TM 16
  • 17. Schizophrenia Market1~$5.2B CNS FILM INT0036 ā€“ 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 product 1 According to Datamonitor Healthcare schizophrenia forecast published July 13, 2012 0 7,500 15,000 22,500 30,000 0 15 30 45 60 RizatriptanPl.Conc.(ng/mL) Time (min) VersaFilm INT0036 RLD
  • 18. A STRONG PLATFORM FOR GROWTH AND INNOVATION VERSAFILM TM ā€¢ Addressable market of approximately $8.1 billion identified to-date ā€¢ Strong intellectual property protection ā€¢ Successful pivotal bioequivalency studies ā€¢ Three applications for film products awaiting FDA approval ā€¢ Limited number of competitors ā€¢ Life cycle management opportunity
  • 19. DEVELOPING FILM MANUFACTURING CAPABILITIES TO INCREASE PROFITABILITY OPERATIONAL INITIATIVES 19 ā€¢ Significantly increase IntelGenx' revenue stream ā€¢ Improve protection of IntelGenx' IP. ā€¢ Eliminate dependency on 3rd party manufacturing partners ā€¢ Provide full service from inception to product supply (one-stop-shopping). ā€¢ Increase R&D capabilities and investments with expanded laboratories and technologies.
  • 20. Develop ā€¢ 2014, Identify a second supplier for Rizatriptan ā€¢ 2014, Submit application for Rizatriptan in Europe ā€¢ 2014, Acceptance of ANDA for INT0027 triggering a milestone payment from Par ā€¢ 2014, Clarity on ForFivo XL litigation with WockHardt 2014 2015 2016 2017 SUGGESTS NEAR TERM CATALYSTS KEY MILESTONES Position ā€¢ 2015, Anticipated approval for migraine VersaFilmTM ā€¢ 2015, Anticipated submission of ANDA for Antihypertensive VersaTabTM ā€¢ 2016, Anticipated tentative approval for opioid dependence VersaFilmā„¢ ā€¢ 2016, Commence manufacturing capabilities of VersaFilmā„¢ Grow ā€¢ 2016, Anticipated submission of 505(b)(2) NDA for ED VersaFilmā„¢ ā€¢ 2017, Anticipated launch for opioid dependence VersaFilmā„¢ ā€¢ 2017, Anticipated approval for ED VersaFilmā„¢ 20
  • 21. Horst G. Zerbe, Ph.D. Chairman, President and CEO ā€¢ Founder of IntelGenx ā€¢ 30+ years Industry Experience ā€¢ Holds over 40 patents in drug delivery, and numerous scientific publications ā€¢ Previously President Smartrix Tech. Inc. and VP R&D at LTS Lohmann, USA Paul Simmons, AFCA Chief Financial Officer Nadine Paiement, M.Sc. Director R&D ā€¢ 25 + years multinational business and finance experience ā€¢ Proven track record of exceeding targets in delivering corporate growth ā€¢ Held CFO and VP Finance positions with several European corporations ā€¢ Co-inventor of IntelGenx Trilayer Technology ā€¢ 10 years experience in product development and technology transfer ā€¢ Previously R&D Manager at Smartrix Tech. Inc. 65+ YEARS OF COMBINED INDUSTRY EXPERIENCE VISIONARY, EXPERIENCED LEADERSHIP 21 John Durham, B.Sc. Vice President, Manufacturing Operations ā€¢ 20+ years experience in pharmaceutical manufacturing, quality management, product development ā€¢ Held executive positions with several Canadian and US companies ā€¢ Previously COO at Labopharm Inc. and President at Draxis Pharma
  • 22. CORE TECHNOLOGIES ADDRESS LARGE MARKET POTENTIAL A SOLID PLATFORM FOR GROWTH ā€¢ Continue to expand commercialization efforts of Forfivo XLĀ® and drive revenue growth ā€¢ Advance pipeline products towards commercialization ā€¢ Continue to develop commercialization relationships ā€¢ Leverage VersaFilmā„¢ manufacturing expertise to provide full service VERSATABā„¢ ADVERSAā„¢VERSAFILMā„¢ 22
  • 23. Innovation In Drug Delivery Thank You TSX-V: IGX OTCQX: IGXT

Editor's Notes

  1. IGXT is a company that has developed proprietary drug delivery technologies for oral drug delivery and is using these technologies to develop novel pharmaceutical products
  2. During this presentation, I will be making certain forward looking statements
  3. Our technologies include an oral film technology that we use to achieve rapid delivery of an active in the oral cavity, An extended release tablet technology for once-daily administration, and A mucoadhesive tablet technology for the controlled release of actives into the oral cavity with the aim to achieve controlled oral absorption
  4. Therapeutic benefits include simplifying dose regimen, increased bioavailability, less side effects
  5. The combined addressable market for the pipeline is 5.6 billion dollars, of which 2.9 are related to films, and 2.7 bn to tablets.