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IntelGenx Corporate Presentation

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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 Delivery September 2014 1 Confidential - IntelGenx Corp. Innovative Drug Delivery
Transcript
Page 1: IntelGenx Corporate Presentation

1

Innovative Drug DeliverySeptember 2014

Confidential - IntelGenx Corp. Innovative Drug Delivery

Page 2: IntelGenx Corporate Presentation

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

Page 3: IntelGenx Corporate Presentation

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

Page 4: IntelGenx Corporate Presentation

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

Page 5: IntelGenx Corporate Presentation

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

Page 6: IntelGenx Corporate Presentation

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

Page 7: IntelGenx Corporate Presentation

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

Page 8: IntelGenx Corporate Presentation

Confidential - IntelGenx Corp. Innovative Drug Delivery 8

IntelGenx has strategic partnerships in place with multiple companies :

IntelGenx Partnerships

Page 9: IntelGenx Corporate Presentation

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

Page 10: IntelGenx Corporate Presentation

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

Page 11: IntelGenx Corporate Presentation

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

Page 12: IntelGenx Corporate Presentation

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

Page 13: IntelGenx Corporate Presentation

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)

Page 14: IntelGenx Corporate Presentation

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™

Page 15: IntelGenx Corporate Presentation

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

Page 16: IntelGenx Corporate Presentation

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™

Page 17: IntelGenx Corporate Presentation

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™

Page 18: IntelGenx Corporate Presentation

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

Page 19: IntelGenx Corporate Presentation

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

Page 20: IntelGenx Corporate Presentation

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


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