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IntelGenx, through its cutting edge formulation platforms, has developed a broad and diverse product portfolio, including products for the treatment of severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder, idiopathic pulmonary fibrosis, allergies and pain management.
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Innovative Drug DeliverySeptember 2014
Confidential - IntelGenx Corp. Innovative Drug Delivery
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.
Forward Looking Statement
Confidential - IntelGenx Corp. Innovative Drug Delivery 2
IntelGenx SnapshotIntelGenx Snapshot
Confidential - IntelGenx Corp. Innovative Drug Delivery 3
TSX-V: IGX OTCQX:IGXT August, 2014
Founded 2003
Publicly Traded Since 2006
Shares Issued 63M
Shares Fully Diluted 72M
Insider Ownership 18%
Cash US $5M
IntelGenx, a Montreal-based drug delivery pharmaceutical company with 11 employees, the majority of which are highly skilled pharmaceutical scientists (5 Ph.D.’s), and operates out of it’s facility in St. Laurent, Quebec.
Analyst Coverage: Swayampakula Ramakanth, Ph.D., H.C. Wainwright
Muco-adhesive tabletRapidly disintegrating pharmaceutical films
Controlled-release high dose tablets
VersaTab™: VersaFilm™: AdVersa™:
Programmable drug release over an extended period of time
Rapid and convenient dosage form for more immediate activity
Controlled absorption in the oral cavity to maximize bioavailability
4Confidential - IntelGenx Corp. Innovative Drug Delivery
IntelGenx Platform Technologies
Confidential - IntelGenx Corp. Innovative Drug Delivery 5
Technology focus - Develop novel and high performance drug delivery systems – focus on oral film products.
Therapeutic differentiation - Use proprietary drug delivery technologies to develop products offering a therapeutic benefit to patients.
Comprehensive service portfolio Pharmaceutical R&D Technology transfer Clinical development Regulatory services Commercial product supply
Value Proposition
Target high-value differentiated opportunities Maximize use of 505(b)(2) potential. Pursue high technological entry barrier products and first-
to-file opportunities. Develop products addressing unmet therapeutic needs.
Establish manufacturing independence Better IP protection Increase revenue stream
Generate revenue stream from Development milestones, license royalties, and/or the
supply of finished product.
Strategy Focus
Confidential - IntelGenx Corp. Innovative Drug Delivery 6
IntelGenx – Development Pipeline
INT0008 Migraine (RedHill) Q1 2013
Ver
saTa
b™
Ver
saF
ilm
™A
dV
ersa
™
INT0001 Hypertension (Dava)
INT0024 Idiopathic Pulmonary Fibrosis (Pacific)
INT0007 Erectile Dysfunction
INT0036 CNS
INT0010 Pain
INT0027 Opioid Dependence (Par) Q3 2013
INT0037 Undisclosed (Par)
7Confidential - IntelGenx Corp. Innovative Drug Delivery
Forfivo XL® Depression Q4 2012
Q4 2016* Q4 2017*
*Expected launch dates
2015*
2017*
Product Indication Preclinical Pilot Study Pivotal Study Filing Launch
Confidential - IntelGenx Corp. Innovative Drug Delivery 8
IntelGenx has strategic partnerships in place with multiple companies :
IntelGenx Partnerships
Forfivo XL ® : high dose version of Wellbutrin XL®Forfivo XL ® : high dose version of Wellbutrin XL®
9
Edgemont Pharma acquired rights for commercialization of Forfivo XL® in the US
Privately held company with primary focus on neuroscience Experienced management with strong record in
commercialization of neurological products Edgemont Pharmaceutical launched Product in October, 2012
Confidential - IntelGenx Corp. Innovative Drug Delivery
10
Forfivo XL ® Market Performance
Confidential - IntelGenx Corp. Innovative Drug Delivery
4Q12 1Q13 2Q13 3Q13 4Q13 1Q14 2Q140
1,750
3,500
5,250
7,000
8,750
FORFIVO XL® QUARTERLY SCRIPT GROWTH
VersaFilm™ Oral Pharmaceutical Films
Confidential - IntelGenx Corp. Innovative Drug Delivery 11
Revenue Generating Strategy Short term opportunities: OTCs Mid and long-term opportunities: LCM, ANDA’s and 505(b)(2)NDA’s.
Status of IntelGenx Technology Demonstrated ability to develop products and
achieve bioequivalence Manufacturing partnerships, and plans for
implementing internal manufacturing capability Two applications currently under review at FDA:
one ANDA, and one (505)(b)(2)NDA Comprehensive VersaFilm™ development pipeline Limited number of competitors, strong IP position
VersaFilm™ - Attractive Life Cycle Management Strategy
Confidential - IntelGenx Corp. Innovative Drug Delivery 12
Potential to sustain a brand following a switch from tablet to film, with a reduced risk of genericization
Film formulation development, achieving bioequivalence, and tech transfer to manufacturing is technically challenging
Unlike tablets, very few companies exist with the skills and capabilities for pharmaceutical film development and manufacturing
Increased barrier for generic competition Convenient delivery improving compliance for pediatric
and geriatric patients where swallowing is an issue
Suboxone® - LCM Case Study
Confidential - IntelGenx Corp. Innovative Drug Delivery 13
Suboxone® tablets to film switch strategy:• Individually packaged in compact unit-dose pouches that are safer,
child-resistant and convenient to carry.• Increased brand value and extended brand life• Improved protection against generic competition
Suboxone®
Sublingual FilmSuboxone®
Sublingual Tablets
2008 2009 2010 2011 2012 2013
0
20
40
60
80
Film Tablet
Suboxone® Rx Quantities(Millions)
Confidential - IntelGenx Corp. Innovative Drug Delivery 14
Bup/Nal market size > $1.5B
Completed development with successful pivotal BE study.
ANDA submitted to FDA in July 2013. Marketing approval anticipated 2016.
0 12 24 36 48 60 720
0.2
0.4
0.6
0.8
1
1.2
1.4Buprenorphine plasma profile
Test product
reference product (sub-oxone 8/2mg)
Time (hrs)
Mea
n co
ncen
trati
on (n
g/m
L)
0 6 12 18 240
20
40
60
80
100
120
140Naloxone plasma profile
Test product
reference product (suboxone 8/2mg)
Time (hrs)
Mea
n co
ncen
trati
on (p
g/m
L)
IntelGenx VersaFilm™ IntelGenx VersaFilm™
Buprenorphine/Naloxone VersaFilm™
Confidential - IntelGenx Corp. Innovative Drug Delivery
Results from the pivotal bioequivalency study:
0 2 4 6 8 10 12 140
5
10
15
20
Time (hrs)
Riza
trip
tan
Pl. C
onc.
(n
g/m
L)
VersaFilm™ rizatriptan
Maxalt MLT
15
Rizatriptan VersaFilm™
Migraine market $24B 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
Confidential - IntelGenx Corp. Innovative Drug Delivery 16
Cialis market > $1.2B 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)
Tadalafil VersaFilm™
Confidential - IntelGenx Corp. Innovative Drug Delivery 17
2015• Anticipated approval for
migraine VersaFilm™• Submission of ANDA for
Antihypertensive VersaTabTM
2016• Anticipated tentative
approval for opioid dependence VersaFilm™
• Anticipated submission of 505(b)(2) NDA for ED VersaFilm™
IntelGenx Objectives
2017• Anticipated launch for opioid
dependence VersaFilm™• Anticipated approval for ED
VersaFilm™
Confidential - IntelGenx Corp. Innovative Drug Delivery 18
•Founder of IntelGenx•30+ years Industry Experience•Holds over 40 patents in drug delivery, and numerous scientific publications•Previously President Smartrix Tech. Inc. and VP R&D at LTS Lohmann, USA
Horst G. Zerbe, Ph.D.Chairman, President and CEO
Alexandre Serrano, Ph.D.,Associate Director, Business Development
Nadine Paiement, M.Sc.Director R&D
Paul Simmons, AFCAChief Financial Officer
•Co-inventor of IntelGenx Trilayer Technology•10 years experience in product development and technology transfer•Previously R&D Manager at Smartrix Tech. Inc.
• Responsible for Strategic Alliances, Licensing and Acquisitions, Intellectual Property
• Ph.D. in Neuroscience (University of Montreal)•Previously actively involved in in-licensing at AstraZeneca Montreal
•20 years multinational business and finance experience•Proven track record of exceeding targets in delivering corporate growth•Held CFO and VP Finance positions with several European corporations
Experienced Management Team
Confidential - IntelGenx Corp. Innovative Drug Delivery 19
• Horst G. Zerbe, Ph.D., Chairman Founder of IntelGenx and serving as President and CEO. Previously, he served as President and Scientific Director, Smartrix Technologies Inc. (1999 to 2005), VP of Research and Development, LTS Lohmann Therapy Systems Corp. (1994 to 1999), 3M Pharmaceuticals (1984-2004), and Schwarz Pharma (1980 – 1984).
• J. Bernard Boudreau, QC, PC was appointed by the Prime Minister of Canada in 1999 to the positions of Leader of the Government in the Senate of Canada and the Federal Minister responsible for Nova Scotia.
• John S. Marinucci, C.A., ICD.D, H.R.C.C.C. is the former President and CEO of New Flyer Industries Inc. Previously, he served as President and COO, National Steel Car and as President, Canadian Association of Railway Suppliers.
• Bernd J. Melchers recently served as the Managing Director, 3M Dyneon Holding GmbH, Germany and Global Chief Financial Officer, Dyneon Group, a subsidiary of 3M Corporation.
• Ian Troup, B.Sc. recently served as President and COO, Upsher-Smith Laboratories, a generic pharmaceutical company. He is currently a board member of Medisyn Technologies, a corporation involved in topological drug design and TwinWest PAC, a political action committee helping Minnesota businesses gain local, state and federal access to political officials.
IntelGenx Board of Directors
Confidential - IntelGenx Corp. Innovative Drug Delivery 20
Investor Relations - USAJeffrey BenisonLittle Gem Life Science PartnersOffice: 212-334-8709Mobile: [email protected]
Corporate:IntelGenx Corp.6425 Abrams, St-Laurent, QC, H4S 1X9, CanadaTel: [email protected]
Business Development:Alexandre Serrano, Ph.D.6425 Abrams, St-Laurent, QC, H4S 1X9, CanadaOffice: 514-331-7440 ext. 212Mobile: [email protected]
Contacts