© 2015 IntelGenX Corp. Innovative Drug Delivery Solutions We Make Approved Drugs Better November 24, 2015 TSX-V: IGX OTCQX: IGXT
© 2015 IntelGenX Corp.
Innovative Drug Delivery Solutions
We Make Approved Drugs Better
N o v e m b e r 2 4 , 2 0 1 5TSX-V: IGX
OTCQX: IGXT
2
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.
3
Oral Thin Films Provide Significant Market Opportunities for Improving Drug Delivery - IGX CEO co-developer of the Listerine breath strips- Oral films ideal for elderly, children, patients who have
difficulty swallowing traditional tablets- Quicker action to relieve symptoms
4
Making Approved Drugs Better ThroughInnovative Drug Delivery SolutionsIntelGenx develops and manufactures faster and more efficient drug delivery systems for top pharmaceuticals
IntelGenx Drug Delivery Technology Platforms
Rapidly disintegrating film improving drug performance and easing administration
without the need for water
TabletsControlled-release tablets for oral absorption
over an extended time period
Films
Rizaport™
5
$17B TAM
Investment Highlights• Developing proprietary oral drug delivery technologies to address $19B TAM
• Market momentum with Forfivo XL ® tablets
• Achieved first European marketing approval of RIZAPORT™ for Migraines
• Robust product pipeline to enable expansion into other market segments with significant TAM
• Achieved record Q3 revenue and profitability VersaTab™
$1.7B TAM
6
First 450mg tablet approved by FDA for major depressive disorder
• 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
• Q3 2015 net sales grew 16% compared to Q2 2015, with net sales at $2.5 million ($4.7 million gross)
• For the past nine months, net sales totaled $6.3 million ($12 million gross), an increase of 117% compared to the nine month period in 2014
FORFIVO XL®
0
$1000
$2,000
$3,000
3Q14 1Q15 2Q15 3Q15
FORFIVO XL® NET SALES ($Thousands)
Technology
4Q14
$1,195
$1,756
$2,132
$2,500
$1,697
7
Oral Thin Films Drug Delivery Technology
Benefits of VersaFilm™• Improves patients compliance who have
problems swallowing tablets and capsules to more easily take medication
• Rapid disintegration without the need for water • Improves absorption – faster onset of action• Potential for reduced adverse effects
$17B Addressable Market• Successful pivotal bioequivalence studies• Two film products awaiting FDA approval• Limited number of competitors
Over $17B Market Opportunity and Growth Platform for IGX
MIGRAINETargeted Rizatriptan
Market
$2B
ERECTILE DYSFUNCTIONTargeted Cialis®
Sales
$4.2B
OPIOD DEPENDENCETargeted Suboxone
Sales
$1.7B
SCHIZOPHRENIATargeted Sales
$5.2B
8
Leverages VersaFilm™ Technology to Treat Migraines
• 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
Rizaport™ Technology
9
A Robust Product Pipeline to Address Significant Market Opportunities
Indication Market Opportunity
PartneringAvailability
FormulationDevelopment
PilotStudy Pivotal Study Filing Launch
Films Migraine – Rizaport TM - Rizatriptan $2B Available
Erectile Dysfunction - Tadalafil $4.2B Available
Opioid Dependence – Buprenorphine & Naloxone $1.78B Par
Pharmaceuticals
Schizophrenia $5.2B Available
Undisclosed N/A Par Pharmaceuticals
Pain $100M Available
Central Nervous System 2.7B Available
Central Nervous System 1.1B Available
Respiratory 77M Available
Cardiovascular N/A Available
Tablets Major Depressive Disorder – Forfivo XL®
Bupropion400M
Edgemont Pharmaceuticals
Available ex-USA
Hypertension - Metoprolol 1.2B Available
Pain - Dronabinol 130M Available
10
Commercialization InitiativesStrategic Partnerships Will Drive Growth
10
11
Full Manufacturing CapabilitiesEstablishing manufacturing capability to increase profitability
Integrate pharmaceutical services and IP protection
Reduce dependence by IntelGenx on external manufacturing partners
Offer clients the advantage to obtain all services from one source (“one-stop shopping”)
Increase R&D capabilities with expanded laboratories and technologies
Blending Coating Packaging
In-House Manufacturing Approach
12
Future Commercialization StrategyKey milestones suggest near term catalysts
Milestones• Anticipated approval for opioid dependence
VersaFilm™• Anticipated submission of 505(b)(2) NDA for ED
VersaFilm™• Anticipated approval for migraine – USA FDA,
Rizaport™
Milestones• Anticipated launch for opioid dependence
VersaFilm™
• Anticipated approval for ED VersaFilm™
• Start of commercial manufacturing operations
• Anticipated submission of 505(b)(2) NDA for Schizophrenia VersaFilm™
• FORFIVO XL® milestone payments anticipated
20172016
13
Record Results in Q3 Demonstrates Strong Execution of Strategy
Revenue ($M)
Q3 2015 Q3 2014 2015 Nine Months Ended
2014 Nine Months Ended
0
0.5
1
1.5
2
2.5
3
3.5
4
2.38
0.45
3.59
0.83
Revenue
$M
14
Record Results in Q3 Demonstrates Strong Execution of Strategy
Net Income & Adjusted EBITDA ($M)
Q3 2015 Q3 2014 2015 Nine Months Ended
2014 Nine Months Ended
-2
-1.5
-1
-0.5
0
0.5
1
1.5
2
1.35
-0.43
1.02
-1.51
1.39
-0.41
1.26
-0.5
Net Income Adjusted EBITDA
$M
15
Visionary, Experience Leadership
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
André Godin, CPA, CAExecutive 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.Director R&D
• Co-inventor of IntelGenx Trilayer Technology
• 15 years experience in product development and technology transfer
John Durham, B. Sc.VP, Manufacturing Operations
• 20+ years experience in pharmaceutical manufacturing, quality management, product development
• Held executive positions with several Canadian and US companies
Laëtitia Rodes, Ph. D.Manager, BD
• 7+ years experience in medical R&D• Ph. D. In Biomedical Engineering
(McGill University)• Numerous peer-reviewed scientific
publications (17+)
Edward Miller, B. CommDirector, Investor Relations
• 15 years experience in investor relations • 10 + years experience in pharmaceutical /
biotech
100+ years of combined industry experience
Currently 18 Employees, 8 Ph.D.’s
16
Solid Platform for GrowthCore Technologies Address $19B Market Potential
Continue to grow commercialization efforts of Forfivo XL® to drive revenue growth
Advance product pipeline towards commercialization
Continue to develop distribution channel relationships
Leverage VersaFilm manufacturing expertise to enhance profitability
17
Thank You.WWW.INTELGENX.COM