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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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IntelGenx Corporate Presentation

  1. 1. Innovation In Drug Delivery An introduction to unique pharmaceutical delivery technologies January 2015 TSX-V: IGX OTCQX: IGXT
  2. 2. 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. 2
  3. 3. Rapid and convenient dosage form for more immediate activity Programmable drug release over an extended period of time Controlled absorption in the oral cavity to maximize bioavailability INTELGENX DEVELOPS FASTER AND MORE EFFICIENT DRUG DELIVERY SYSTEMS FOR TOP PHARMACEUTICALS INNOVATIVE DELIVERY TECHNOLOGY VERSATAB™ ADVERSA™VERSAFILM™ FOCUSING ON ORAL DRUG DELIVERY 3
  4. 4. UNIQUE TECHNOLOGIES TECHNOLOGY FOCUSED Develop novel and high performance drug delivery systems – focus on oral film products. TARGET HIGH-VALUE DIFFERENTIATED OPPORTUNITIES INNOVATIVE DELIVERY TECHNOLOGY • Use proprietary drug delivery technologies to develop products offering a therapeutic benefit to patients. • Identify unique drug-repurposing opportunities. • Pursue high technological entry barrier products and first-to-file opportunities. • Develop products addressing unmet therapeutic needs. 4
  5. 5. PROVIDE COMPREHENSIVE PHARMACEUTICAL SERVICES TO INDUSTRY PARTNERS:  Pharmaceutical Research and Development  Clinical monitoring; clinical supply manufacturing  Regulatory services  Process development and technology transfer  Commercial product supply REVENUE STREAM CONSISTING OF:  Upfront payments  R&D milestone payments  Sales milestone payments  Royalties on sales  Manufacturing revenue VALUE PROPOSITION 5
  6. 6. PRODUCT PORTFOLIO A ROBUST PRODUCT PIPELINE ACROSS 3 TECHNOLOGY PLATFORMS PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH Forfivo XL® Major Depressive Disorder INT0001 Hypertension INT0024 Idiopathic Pulmonary Fibrosis (Pacific) INT0008 Migraine (RedHill) INT0027 Opioid Dependence (Par) INT0037 Undisclosed (Par) INT0039 Undisclosed (Par) INT0007 Erectile Dysfunction INT0036 Central Nervous System (CNS) INT0010 Pain Launched Q4 2012 Q1 2013 Q3 2013
  8. 8. VersaTabTM Addressable market for pipeline VersaTabTM products. VersaFilmTM Opportunity to convert existing tablet market into film technology $8.1 Billion $2.7 Billion ADDRESSABLE MARKET FOR PRODUCT PIPELINE SIGNIFICANT MARKET POTENTIAL ~$11BCombined, addressable market for product pipeline 25% 75% $11bTotal addressable market
  9. 9. $1.2B 2013 Metroprolol Sales $1.1B Pentoxifylline - NAC • Linear release profile; controlled erosion of inactive cover layers • Multiple actives with independent release profiles • Separation of active ingredients - avoidance of chemical incompatibility in fixed-dose combinations • Cost-effective manufacturing Depression Hypertension Idiopathic Pulmonary Fibrosis Addressable Market $391M Wellbutrin XL & Bupropion XL Sales PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH Forfivo XL Major Depressive Disorder INT0001 Hypertension INT0024 Idiopathic Pulmonary Fibrosis (Pacific) VERSATAB® PRODUCTS Launched Q4 2012® VersaTab® Addressable Market ~$2.7B MULTILAYER TABLET TECHNOLOGY VERSATAB TM 9
  10. 10. $3.0B Current Market for Bupropion • High dose version of Wellbutrin XL® • Provides a once-daily, bupropion 450 mg dose in a single tablet • Indicated for the treatment of major depressive disorder • Launched commercially October 2012 in partnership with Edgemont Pharmaceuticals • Paragraph IV litigation with with Wockhardt settled $236M Wellbutrin XL® Market $2.7M 2013 Sales Forfivo XL FORFIVO XL® SCRIPT GROWTH ® VERSATAB TM VersaTab® Addressable Market ~$2.7B FORFIVO XL® COMMERCIALIZATION GROWTH OPPORTUNITY 10 $0 $300,000 $600,000 $900,000 $1,200,000 $1,500,000 0 1,000 2,000 3,000 4,000 ~$1.2M December Gross Sales 3,466 December Prescriptions
  11. 11. VersaFilm™ Rapidly disintegrating pharmaceutical films for buccal or systemic drug delivery VersaFilm Addressable Market ~$8.1B ® Improved product performance: • Fast delivery translates into rapid onset of action • Improved bioavailability • Buccal (topical) or systemic drug exposure Improved patient compliance: • Convenient delivery improving compliance for pediatric and geriatric patients where swallowing is an issue Increased barrier for generic competition: • Limited number of competitors ADVANTAGES OF FILM TECHNOLOGY VERSAFILM TM 11
  12. 12. $1.3B • Demonstrated ability to achieve bioequivalence • 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 Opioid Dependence Migraine Erectile Dysfunction $230M Targeted Rizatriptan Market Targeted Cialis Sales ® $1.6B Targeted Suboxone Sales ® VersaFilm Addressable Market ~$8.1B ® ADDRESSABLE MARKETS VERSAFILM TM 12 PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH INT0008 Migraine (RedHill) INT0027 Opioid Dependence (Par) INT0007 Erectile Dysfunction INT0036 CNS INT0037 Undisclosed (Par) INT0039 Undisclosed (Par) Q1 2013 2015 VERSAFILM PRODUCTS Q3 2013 2017 Q4 2016 Q4 2017
  13. 13. Suboxone® Rx Quantities (Millions) 0 20 40 60 80 2008 2009 2010 2011 2012 2013 Film Tablet • Demonstrated ability to achieve bioequivalence • 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 Addressable Market ~$8.1B ® ATTRACTIVE LIFECYCLE MANAGEMENT OPPORTUNITY VERSAFILM TM 13 Suboxone® SublingualFilm Suboxone® SublingualTablets
  14. 14. 0. 0.35 0.7 1.05 1.4 0. 12. 24. 36. 48. 60. 72. Meanconcentration(ng/mL) Time (hrs) Buprenorphine plasma profile Test product Test productReference product Suboxone Addressable Market ~$1.6B ® Completed development with successful pivotal bioequivalency study. Abbreviated New Drug Application (ANDA) submitted to FDA in July 2013. Marketing approval anticipated 2016. Attractive partnership deal with Par Pharmaceutical P4 litigation with Reckitt Benckiser progressing well 0. 30. 60. 90. 120. 150. 0. 6. 12. 18. 24. Meanconcentration(pg/mL) Time (hrs) Naloxone plasma profile Test product reference product (Suboxone 8/2mg) OPIOD DEPENDENCE - BUPRENORPHINE/NALOXONE VERSAFILM TM 14
  15. 15. Rizatriptan® Addressable Market $230M 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 0.0 4.5 9.0 13.5 18.0 0.0 3.0 6.0 9.0 12.0 15.0 RizatriptanPl.Conc.(ng/mL) Time (hrs) VersaFilm Rizatriptan Maxalt MLT® Orally disintegrating film containing Rizatriptan bioequivalent with orally disintegrating tablet (Maxalt MLT®) MIGRAINE FILM BIOEQUIVALENT TO MAXALT MLT® VERSAFILM TM 15
  16. 16. Cialis® Addressable Market ~$1.3B 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) BIOEQUIVALENCE ACHIEVED VS. CIALIS® TABLETS VERSAFILM TM 16
  17. 17. Schizophrenia Market1~$5.2B CNS FILM INT0036 – A fast acting version of an existing schizophrenia treatment. VERSAFILM TM Successfully completed pilot scale Phase I study INT0036 demonstrated a significantly improved pharmacokinetic profile against the reference product 1 According to Datamonitor Healthcare schizophrenia forecast published July 13, 2012 0 7,500 15,000 22,500 30,000 0 15 30 45 60 RizatriptanPl.Conc.(ng/mL) Time (min) VersaFilm INT0036 RLD
  18. 18. A STRONG PLATFORM FOR GROWTH AND INNOVATION VERSAFILM TM • Addressable market of approximately $8.1 billion identified to-date • Strong intellectual property protection • Successful pivotal bioequivalency studies • Three applications for film products awaiting FDA approval • Limited number of competitors • Life cycle management opportunity
  19. 19. DEVELOPING FILM MANUFACTURING CAPABILITIES TO INCREASE PROFITABILITY OPERATIONAL INITIATIVES 19 • Significantly increase IntelGenx' revenue stream • Improve protection of IntelGenx' IP. • Eliminate dependency on 3rd party manufacturing partners • Provide full service from inception to product supply (one-stop-shopping). • Increase R&D capabilities and investments with expanded laboratories and technologies.
  20. 20. Develop • 2014, Identify a second supplier for Rizatriptan • 2014, Submit application for Rizatriptan in Europe • 2014, Acceptance of ANDA for INT0027 triggering a milestone payment from Par • 2014, Clarity on ForFivo XL litigation with WockHardt 2014 2015 2016 2017 SUGGESTS NEAR TERM CATALYSTS KEY MILESTONES Position • 2015, Anticipated approval for migraine VersaFilmTM • 2015, Anticipated submission of ANDA for Antihypertensive VersaTabTM • 2016, Anticipated tentative approval for opioid dependence VersaFilm™ • 2016, Commence manufacturing capabilities of VersaFilm™ Grow • 2016, Anticipated submission of 505(b)(2) NDA for ED VersaFilm™ • 2017, Anticipated launch for opioid dependence VersaFilm™ • 2017, Anticipated approval for ED VersaFilm™ 20
  21. 21. Horst G. Zerbe, Ph.D. Chairman, President and CEO • 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 Nadine Paiement, M.Sc. Director R&D Paul Simmons, AFCA Chief Financial Officer Alexandre Serrano, Ph.D. Associate Director, Bus. Dev. • Co-inventor of IntelGenx Trilayer Technology • 10 years experience in product development and technology transfer • Previously R&D Manager at Smartrix Tech. Inc. • 25 + 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 • Responsible for Strategic Alliances, Licensing, Acquisitions, and Intellectual Property • Ph.D. in Neuroscience (University of Montreal) • Previously actively involved in in-licensing at AstraZeneca Montreal 65+ YEARS OF COMBINED INDUSTRY EXPERIENCE VISIONARY, EXPERIENCED LEADERSHIP 21 John Durham, B.Sc. Vice President, Manufacturing Operations • 20+ years experience in pharmaceutical manufacturing, quality management, product development • Held executive positions with several Canadian and US companies • Previously COO at Labopharm Inc. and President at Draxis Pharma
  22. 22. CORE TECHNOLOGIES ADDRESS LARGE MARKET POTENTIAL A SOLID PLATFORM FOR GROWTH • Continue to expand commercialization efforts of Forfivo XL and drive revenue growth • Advance pipeline products towards commercialization • Continue to develop commercialization relationships • Leverage VersaFilm manufacturing expertise to provide full service VERSATAB™ ADVERSA™VERSAFILM™ 22
  23. 23. Innovation In Drug Delivery Thank You TSX-V: IGX OTCQX: IGXT