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Investor Presentation
November 10, 2016
Innovative Drug Delivery Solutions
1
2
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
Forward Looking Statements
2
2
3
• IntelGenx Corp. Founded
• TSX-V (IGX)
• OTCQX (IGXT)
• Market Capitalization
• Shares Issued
• Shares Fully Diluted
• Insider Ownership
• Cash/Equivalent
2003
CAD$1.00
US$0.75
CAD$64M
64.7M
70.8M
15%
US$5.7M
Analyst Coverage
Firm Analyst
H.C. Wainwright Swayampakula Ramakanth
Singular Research Greg Eisen
Company Snapshot
3
2
4
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
4
5
Clearly Defined BD Strategy
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
6
Prioritization of Future Product Sourcing
Balancing Risks and Opportunities for an Optimized Portfolio
Overall
Risk
Time to MarketSlow Fast
Low
High
Drug Repurposing
Patient Benefits
Lifecycle Mgmt
FTF Generics
IntelGenx Future Focus
Deal Value
Low
Medium
High
6
A Robust Product Pipeline
to Address Significant Market Opportunities
7
7
8
• 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
• Sold US revenue to SWK Holdings for US$6M
• Development cost $2.5M, total revenue $15M = 6-fold
ROI
• Non-dilutive source of funding, will be used to advance
film projects
Successful Monetization of First
In-House Development
8
9
• Licensing and development agreement entered
September 12, 2016 for three generic products
• IntelGenx granted Chemo exclusive worldwide license
to commercialize one generic product and U.S.
license for two other generic products
• IntelGenx to receive upfront, milestone, R&D
revenues and share of profits – total value of 7 digits
• Combined total market of three products is over $3B
• Chemo making a strategic move into novel drug
delivery products with IntelGenx as its partner
• Partnership could result in numerous future product
agreements
Strategic Partnership with Chemo Group
About Chemo Group:
• Founded in 1978
• 5,000 employees
• Head office in Spain
• Revenues of $1.2B annually
• Markets over 300 products
• Operating in over 40 countries
• 20 state-of-the-art facilities
• 9 specialized R&D centers
9
For Migraines
Leverages VersaFilm™ Technology
10
• European Mktg Approval – November 2015
• Co-development partnership with RedHill Biopharma
• Definitive agreement signed July 2016 with
Grupo Juste for Spain & additional territories
• Term sheet signed Sept 21, 2016 with Pharmatronic for Korea
• 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
10
For Erectile Dysfunction
• Containing tadalafil (Cialis® - Eli Lilly),
a leading 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
Q2/2017
• Expected USA launch Q2/2018
11
11
For Schizophrenia &
Bipolar 1 Disorder
12
• The first oral thin film using IntelGenx
proprietary drug delivery technology,
VersaFilm™, for treatment of
schizophrenia & bipolar 1 disorder
• Fast-acting loxapine oral dosage – to
treat acute agitation and anxiety in non-
institutionalized patients with
schizophrenia & bipolar 1 disorder
• Reduces risk of pulmonary problems
and potential risk of violence and injury to
patients and others
• Formulation optimization stage – results
expected Q2 2017
12
For Mild Cognitive Impairment
13
• IntelGenx is repurposing Montelukast
for the treatment of MCI by leveraging
its VersaFilm™ technology
• The drug is known and approved for a
completely different indication (asthma)
Global Sales for AD by Patients Category
(Global Data, 2013)
13
2
14
Clinical Data
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
Montelukastconcentration(ng/mL)
Time (hrs)
Montelukast Avg Plasma Profile
Test buccal film 10mg
Ref tablet 10mg
• Phase 1 clinical study in human successfully completed
• Significantly increased bioavailability after administration of VersaFilm compared to
commercial tablet
• Drug crosses blood/brain barrier when given as film
• Phase II-a study (proof of concept) to commence Q1/2017
• First efficacy data in humans available Q4/2017
• Several Pharma companies have expressed strong interest
Before
MMSE 13:
moderate to severe
dementia
MMSE 22:
mild dementia
After 2 Months of
Montelukast
Anecdotal of Human
14
15
Construction of Manufacturing Facility Completed
• 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
15
Strengthened Management Team
Over 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
16
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
16
17
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. Clearly Defined Corporate Strategy And Business Model
• Focus on drug repurposing, lifecycle management, patient benefits, and FTF
• Provider of comprehensive pharmaceutical services to industry partners
4. 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
17
Financial Results
18
18
Financial Performance
Revenue ($M)
3.3
3.6
5.1
1.7
0
1
2
3
4
5
6
First 9 mths 2016 First 9 mths 2015 2015 Full Year 2014 Full Year
Revenue
$M
19
19
Net Comprehensive Income & Adjusted EBITDA ($M)
-1.5
0.6
0.8
-2.2
-0.9
1.3
1.7
-1.6
-2.5
-2
-1.5
-1
-0.5
0
0.5
1
1.5
2
First 9 mths 2016 First 9 mths 2015 2015 Full Year 2014 Full Year
Net Income Adjusted EBITDA
$M
Financial Performance
20
20
Conclusion
21
21
22
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
22
23
Thank You!
www.IntelGenx.com
Contact Info:
Edward Miller, B.Comm.
Director, Investor Relations
+1-514-331-7440 ext. 217
Edward@intelgenx.com
IntelGenx Corporate Offices
6420 Abrams
Saint-Laurent (Quebec)
H4S 1Y2 Canada
www.intelgenx.com

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Igxt nov 10 investor presentation

  • 1. 0 Investor Presentation November 10, 2016 Innovative Drug Delivery Solutions
  • 2. 1 2 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 Forward Looking Statements
  • 3. 2 2 3 • IntelGenx Corp. Founded • TSX-V (IGX) • OTCQX (IGXT) • Market Capitalization • Shares Issued • Shares Fully Diluted • Insider Ownership • Cash/Equivalent 2003 CAD$1.00 US$0.75 CAD$64M 64.7M 70.8M 15% US$5.7M Analyst Coverage Firm Analyst H.C. Wainwright Swayampakula Ramakanth Singular Research Greg Eisen Company Snapshot
  • 4. 3 2 4 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
  • 5. 4 5 Clearly Defined BD Strategy 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
  • 6. 6 Prioritization of Future Product Sourcing Balancing Risks and Opportunities for an Optimized Portfolio Overall Risk Time to MarketSlow Fast Low High Drug Repurposing Patient Benefits Lifecycle Mgmt FTF Generics IntelGenx Future Focus Deal Value Low Medium High
  • 7. 6 A Robust Product Pipeline to Address Significant Market Opportunities 7
  • 8. 7 8 • 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 • Sold US revenue to SWK Holdings for US$6M • Development cost $2.5M, total revenue $15M = 6-fold ROI • Non-dilutive source of funding, will be used to advance film projects Successful Monetization of First In-House Development
  • 9. 8 9 • Licensing and development agreement entered September 12, 2016 for three generic products • IntelGenx granted Chemo exclusive worldwide license to commercialize one generic product and U.S. license for two other generic products • IntelGenx to receive upfront, milestone, R&D revenues and share of profits – total value of 7 digits • Combined total market of three products is over $3B • Chemo making a strategic move into novel drug delivery products with IntelGenx as its partner • Partnership could result in numerous future product agreements Strategic Partnership with Chemo Group About Chemo Group: • Founded in 1978 • 5,000 employees • Head office in Spain • Revenues of $1.2B annually • Markets over 300 products • Operating in over 40 countries • 20 state-of-the-art facilities • 9 specialized R&D centers
  • 10. 9 For Migraines Leverages VersaFilm™ Technology 10 • European Mktg Approval – November 2015 • Co-development partnership with RedHill Biopharma • Definitive agreement signed July 2016 with Grupo Juste for Spain & additional territories • Term sheet signed Sept 21, 2016 with Pharmatronic for Korea • 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
  • 11. 10 For Erectile Dysfunction • Containing tadalafil (Cialis® - Eli Lilly), a leading 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 Q2/2017 • Expected USA launch Q2/2018 11
  • 12. 11 For Schizophrenia & Bipolar 1 Disorder 12 • The first oral thin film using IntelGenx proprietary drug delivery technology, VersaFilm™, for treatment of schizophrenia & bipolar 1 disorder • Fast-acting loxapine oral dosage – to treat acute agitation and anxiety in non- institutionalized patients with schizophrenia & bipolar 1 disorder • Reduces risk of pulmonary problems and potential risk of violence and injury to patients and others • Formulation optimization stage – results expected Q2 2017
  • 13. 12 For Mild Cognitive Impairment 13 • IntelGenx is repurposing Montelukast for the treatment of MCI by leveraging its VersaFilm™ technology • The drug is known and approved for a completely different indication (asthma) Global Sales for AD by Patients Category (Global Data, 2013)
  • 14. 13 2 14 Clinical Data 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 Montelukastconcentration(ng/mL) Time (hrs) Montelukast Avg Plasma Profile Test buccal film 10mg Ref tablet 10mg • Phase 1 clinical study in human successfully completed • Significantly increased bioavailability after administration of VersaFilm compared to commercial tablet • Drug crosses blood/brain barrier when given as film • Phase II-a study (proof of concept) to commence Q1/2017 • First efficacy data in humans available Q4/2017 • Several Pharma companies have expressed strong interest Before MMSE 13: moderate to severe dementia MMSE 22: mild dementia After 2 Months of Montelukast Anecdotal of Human
  • 15. 14 15 Construction of Manufacturing Facility Completed • 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
  • 16. 15 Strengthened Management Team Over 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 16 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
  • 17. 16 17 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. Clearly Defined Corporate Strategy And Business Model • Focus on drug repurposing, lifecycle management, patient benefits, and FTF • Provider of comprehensive pharmaceutical services to industry partners 4. 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
  • 19. 18 Financial Performance Revenue ($M) 3.3 3.6 5.1 1.7 0 1 2 3 4 5 6 First 9 mths 2016 First 9 mths 2015 2015 Full Year 2014 Full Year Revenue $M 19
  • 20. 19 Net Comprehensive Income & Adjusted EBITDA ($M) -1.5 0.6 0.8 -2.2 -0.9 1.3 1.7 -1.6 -2.5 -2 -1.5 -1 -0.5 0 0.5 1 1.5 2 First 9 mths 2016 First 9 mths 2015 2015 Full Year 2014 Full Year Net Income Adjusted EBITDA $M Financial Performance 20
  • 22. 21 22 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
  • 23. 22 23 Thank You! www.IntelGenx.com Contact Info: Edward Miller, B.Comm. Director, Investor Relations +1-514-331-7440 ext. 217 Edward@intelgenx.com IntelGenx Corporate Offices 6420 Abrams Saint-Laurent (Quebec) H4S 1Y2 Canada www.intelgenx.com