Title: Agenda
1Agenda
- Company Highlights
- Drug Delivery Market
- Business Strategy
- Scientific Expertise
- Technology Platforms
- Intellectual Property
- Product Pipeline
- Competition
- Management
- Use of Proceeds
- Summary
2Disclaimer
The presentation of this information may contain
forward looking statements that are based on
current expectations, forecasts and assumptions
that include risks and uncertainties that could
cause actual outcomes and results to differ
materially. These risks and uncertainties
include, but are not limited to pricing,
competition, dependency on new product
development, reliance on major customers,
customer demand for our products and services,
control of costs and expenses, general industry
and market conditions and growth rates, and
general domestic and international economic
conditions including interest rate and currency
exchange rate fluctuations. For a further list
and description of such risks and uncertainties,
see the reports filed by IntelGenx Technologies
Corp. with SEDAR. While the information herein is
collected and compiled with care, neither
IntelGenx Technologies Corp. nor any of its
affiliated companies represents, warrants or
guarantees the accuracy or the completeness of
the information. The information is presented
solely for educational purposes, and is not to be
considered as either legal or accounting advice.
3Company Overview
- Operating in high growth, oral controlled release
drug delivery space - Focused on developing improved versions of
existing drugs, and other novel products - Product candidates address large markets with
unmet needs - Osteoarthritis USD 10B
- Acute Pain USD 10B
- Depression USD 15B
- Smoking Cessation USD 1B
- Strategic partnerships in place for key
development programs - 25 years experience in pharmaceutical product
development - Broad IP coverage three issued patents, five
applications currently pending (three US, two PCT)
4Corporate Profile
- Established in 2003 as Canadian Corporation
- Incorporated as IntelGenx Technologies, Corp.
(Delaware) in 2006 - 3,500 sqft RD facility in St-Laurent, Quebec
- 8 Employees
- 16,457,489 common shares outstanding
- 17,317,180 shares fully diluted
- 5,116,489 shares floating
5US Drug Delivery Market
Drug delivery market dominated by oral delivery
systems
Global DDS sales in 2005 US52 bn
Source IMS America - Drug delivery based
products
6Drug Delivery Market
- Drug delivery market set to double to 96mm by
2010 - Products involving drug delivery growing at more
than twice the rate of regular pharmaceutical
products - DD viewed by brand companies as effective tool to
manage brand life cycle - DD technology improves brand product
7Drug Delivery Market
- Key drivers for DDS growth
- Fewer novel drugs being approved by FDA (45-50 in
late 90s vs. 30-31 from 2003 to 2005) - Significant decrease of development risk (90
probability of success) - Producing better drugs than the original novel
drug leads to increased patient compliance - Multiple doses cause spikes in drug plasma
levels, adverse side effects
FDA Novel Drug Approvals
60
50
40
30
of NAS Launched
20
10
0
1995
1997
1999
2001
2003
2005
Biotech NAS
Non-Biotech NAS
Source Pharmaceutical Research and Manufactures
of America (PhRMA)
8Drug Delivery Market
- Partnering deals involving DDS are increasing due
to - DDS being viewed by brand companies as effective
tool for brand life cycle management - Lower risk and lower development costs compared
to NCEs
9Business Model
- Main Strategic Focus
-
- Leverage platform technologies to improve
existing products - Create life cycle management opportunities -
505(b)(2) - Novel controlled release formulations Super
Generics - Creating new business opportunities
- Leverage platform technologies to access new
markets - PNV - Specialty products
10Revenue Model
- Mitigate upfront development risk
- Develop projects to proof of concept stage,
then - Seek partner to fund remaining development
- Maximize revenue
- Receive up front payments and ongoing research
and development fees - Receive milestone payments and sales royalties
- Receive manufacturing royalties via strategic
partnership with approved manufacturer
11Building Value
- Growth Strategy
- Continue growing pipeline of partnered products
- Source new opportunities from partners and
in-house initiatives - Internally fund blockbuster potential, 505(b)(2)
opportunities beyond proof of concept stage and
out-license at premium terms
12Key Scientific Expertise
- Horst G. Zerbe, Ph.D.
- Founder and Co-inventor of over 30 patents in
drug delivery related technologies - Held key RD positions in drug delivery at LTS
Lohmann Therapy Systems, 3M Pharmaceuticals,
Schwarz Pharma - Instrumental in development of oral once-a-day
ISMN, Theophyllin, transdermal Estradiol and
Nitroglycerin, breath films - One of Canadas foremost experts in transdermal
drug delivery technologies - Published numerous scientific papers
13Trilayer Tablet Overview
Trilayer Tablet
Advantages
- Superior alternative to osmotic pump delivery
systems - High drug loading capacity (important for
once-daily formulations) - Ability to co-release drug combinations with
different release rates - Suitable for large number of actives
- Highly versatile, broad range of delivery
profiles - Manufacturing cost savings of 50 compared to
other oral delivery technologies - Reduces IP litigation risks
14Release Mechanism
IntelGenx Trilayer Tablets Controlled erosion
as an efficient tool to achieve zero-order drug
release
15In Vitro Dissolution
In Vitro release profile of Metoprolol Succinate
from IntelGenx trilayer tablets compared to
Toprol XL tablets
16In Vivo Performance
Plasma concentrations of Metoprolol Succinate
after administration of IntelGenx trilayer
tablets compared to Toprol XL tablets (single
dose, fasted, n6)
17Quick Release Wafer Overview
Quick Release Wafer
- Advantages
- Instant delivery / onset of action
- Avoids first-pass effect
- Ability to swallow is not required
- FDA approved for pharmaceutical products
- Increases patient compliance
- Adjustable flavours and textures
18Quick Release Wafer
Comparison of Cmax ( ) and Tmax ( ) after
oral and buccal administration of Isosorbide
Dinitrate
19Intellectual Property
20Product Pipeline
Pipeline Status
Preclinical Development
Pilot BE Study
Mfg. Scale-Up
Pivotal BE Study
Regulatory Submission
INT005 Osteoarthritis INT003 Smoking
Cessation INT004 Antidepressant INT001
Antihypertensive INT006 PNV INT0010 Pain
Management INT002 Antihypertensive INT007
Erectile Dysfunction
21(No Transcript)
22Pipeline
Other Pipeline Candidates
23Competitive Environment
Competitive Positioning
24Public Market
Comparables
25Management Team
Horst G. Zerbe, Ph.D., President and CEO, Prior
to founding IntelGenx, he served as the president
of Smartrix Technologies Inc. in Montreal, and as
Vice President of RD at LTS Lohmann Therapy
Systems in West Caldwell, NJ. He holds over 40
patents in drug delivery related fields and has
published numerous scientific papers in
recognized journals. Joel Cohen, CFA, CFO, has
extensive experience in biotechnology financings
and in financial analysis. He is a former
investment banker at Canaccord Capital, where he
specialized in biotechnology financings. He has
worked on numerous IPOs, private and public
financings for various companies. Nadine
Paiement, M.Sc., Manager, Pharmaceutical RD,
holds a M.Sc. degree in Polymer Chemistry from
Sherbrooke University, and is co-inventor of
IntelGenx trilayer technology.
26Board of Directors
Horst G. Zerbe, Ph.D., CEO, IntelGenx Corp. Joel
Cohen, CFA, CFO, IntelGenx Corp. J. Bernard
Boudreau Sr. VP, PharmEng Inc. Prior to joining
the pharmaceutical industry, Mr. Boudreau served
as the Minister of Finance and Minister of Health
of the provincial government of Nova Scotia.
David Coffin-Beach, Ph.D., President, ATP
Solutions, Inc. As the former President and CEO
of TorPharm and Associate Director at Schering
Plough, Dr. Coffin-Beach brings a wealth of
experience in the pharmaceutical industry to the
table. Reiza Rayman, M.D., M.Sc., Principal
Investigator, Robotic Tele-surgery and Hybrid
Cardiac Surgery. Dr. Rayman is one of the
pioneers of robotic open-heart surgery. He is
currently completing his Ph.D. in Medical
Biophysics.
27Building the Future
- Upcoming Milestones for next 18 months
- Launch INT006 on US market
- Submit NDA for INT004
- Complete pivotal biostudy for INT005
- Prepare pilot biobatch for INT0010
- Complete second round of financing
28Delivering Value
- Investment Highlights
- Unique, proprietary drug delivery platform
technologies - Strong IP portfolio 3 US patents issued, 5
applications pending - Broad product pipeline
- Addressing multi-billion dollar markets
- Strategic RD and commercial partnerships in
place - Strong management and key scientific expertise
- Near-term revenue expectations