- IntelGenx is a drug delivery company that develops innovative oral thin film technologies to improve the performance of approved drugs.
- Their VersaFilm technology provides benefits like rapid disintegration without water, improved absorption, and potential for reduced side effects. This addresses a $17B market opportunity.
- They have a robust product pipeline targeting large markets like migraine ($2B), erectile dysfunction ($4.2B), and schizophrenia ($5.2B) that could drive future growth.
- In Q3 2015 they achieved record results with revenue of $2.38M and net income of $1.35M, demonstrating strong execution of their commercialization strategy.
2. 1
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.
3. 2
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. 3
Making Approved Drugs Better Through
Innovative Drug Delivery Solutions
IntelGenx 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
Tablets
Controlled-release tablets for oral
absorption over an extended time period
Films
Rizaportā¢
5. 4
$17B TAM
Investment Highlights
ā¢ Developing proprietary oral drug delivery
technologies to address $19B TAM
ā¢ Market momentum with
Forfivo XL Ā® tablets
ā¢ Achieved first European marketing
approval of RIZAPORTā¢ for Migraines
ā¢ Robust product pipeline to enable
expansion into other market segments
with significant TAM
ā¢ Achieved record Q3 revenue and
profitability
VersaTabā¢
$1.7B TAM
6. 5
First 450mg tablet approved by
FDA for major depressive disorder
ā¢ High dose version of Wellbutrin XLĀ®
ā¢ Only approved, once-daily, bupropion
HCl 450mg dose in a single tablet
ā¢ Launched commercially October 2013 in
partnership with Edgemont
Pharmaceuticals
ā¢ Q3 2015 net sales grew 16% compared to
Q2 2015, with net sales at $2.5 million
($4.7 million gross)
ā¢ 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 XLĀ®
0
$1000
$2,000
$3,000
3Q14 1Q15 2Q15 3Q15
FORFIVO XLĀ® NET SALES ($Thousands)
Technology
4Q14
$1,195
$1,756
$2,132
$2,500
$1,697
7. 6
Oral Thin Films Drug Delivery Technology
Benefits of VersaFilmā¢
ā¢ Improves patients compliance who have
problems swallowing tablets and capsules to
more easily take medication
ā¢ Rapid disintegration without the need for water
ā¢ Improves absorption ā faster onset of action
ā¢ Potential for reduced adverse effects
$17B Addressable Market
ā¢ Successful pivotal bioequivalence studies
ā¢ Two film products awaiting FDA approval
ā¢ Limited number of competitors
Over $17B Market Opportunity and
Growth Platform for IGX
MIGRAINE
Targeted Rizatriptan
Market
$2B
ERECTILE
DYSFUNCTION
Targeted CialisĀ®
Sales
$4.2B
OPIOD DEPENDENCE
Targeted Suboxone
Sales
$1.7B
SCHIZOPHRENIA
Targeted Sales
$5.2B
8. 7
Leverages VersaFilmā¢ Technology to Treat Migraines
ā¢ European Mktg Approval ā November 2015
ā¢ Filed 505(b)(2) NDA - March 2013 for USA
ā¢ Co-development partnership with
RedHill Biopharma
ā¢ Negotiations with commercialization
partner ongoing
Rizaportā¢
Technology
9. 8
A Robust Product Pipeline to Address
Significant Market Opportunities
Indication
Market
Opportunity
Partnering
Availability
Formulation
Development
Pilot
Study
Pivotal Study Filing Launch
Films Migraine ā Rizaport TM - Rizatriptan $2B Available
Erectile Dysfunction - Tadalafil $4.2B Available
Opioid Dependence ā
Buprenorphine & Naloxone
$1.78B
Par
Pharmaceuticals
Schizophrenia $5.2B Available
Undisclosed
N/A
Par
Pharmaceuticals
Pain $100M Available
Central Nervous System 2.7B Available
Central Nervous System 1.1B Available
Respiratory 77M Available
Cardiovascular N/A Available
Tablets Major Depressive Disorder ā
Forfivo XLĀ®
Bupropion
400M
Edgemont
Pharmaceuticals
Available ex-USA
Hypertension - Metoprolol 1.2B Available
Pain - Dronabinol 130M Available
11. 10
Full Manufacturing Capabilities
Establishing manufacturing capability to
increase profitability
ļ¼ Integrate pharmaceutical services
and IP protection
ļ¼ Reduce dependence by IntelGenx
on external manufacturing partners
ļ¼ Offer clients the advantage to obtain
all services from one source
(āone-stop shoppingā)
ļ¼ Increase R&D capabilities with
expanded laboratories and
technologies
Blending Coating Packaging
In-House Manufacturing Approach
12. 11
Future Commercialization Strategy
Key milestones suggest near term catalysts
Milestones
ā¢ Anticipated approval for opioid dependence
VersaFilmā¢
ā¢ Anticipated submission of 505(b)(2) NDA for ED
VersaFilmā¢
ā¢ Anticipated approval for migraine ā USA FDA,
Rizaportā¢
Milestones
ā¢ Anticipated launch for opioid dependence
VersaFilmā¢
ā¢ Anticipated approval for ED VersaFilmā¢
ā¢ Start of commercial manufacturing operations
ā¢ Anticipated submission of 505(b)(2) NDA for
Schizophrenia VersaFilmā¢
ā¢ FORFIVO XLĀ® milestone payments anticipated
20172016
13. 12
Record Results in Q3 Demonstrates
Strong Execution of Strategy
Revenue ($M)
2.38
0.45
3.59
0.83
0
0.5
1
1.5
2
2.5
3
3.5
4
Q3 2015 Q3 2014 2015 Nine
Months Ended
2014 Nine
Months Ended
Revenue
$M
14. 13
Record Results in Q3 Demonstrates
Strong Execution of Strategy
Net Income & Adjusted EBITDA ($M)
1.35
-0.43
1.02
-1.51
1.39
-0.41
1.26
-0.5
-2
-1.5
-1
-0.5
0
0.5
1
1.5
2
Q3 2015 Q3 2014 2015 Nine
Months Ended
2014 Nine
Months Ended
Net Income Adjusted EBITDA
$M