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 …

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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  • IGXT is a company that has developed proprietary drug delivery technologies for oral drug delivery and is using these technologies to develop novel pharmaceutical products
  • During this presentation, I will be making certain forward looking statements
  • Our technologies include
    an oral film technology that we use to achieve rapid delivery of an active in the oral cavity,
    An extended release tablet technology for once-daily administration, and
    A mucoadhesive tablet technology for the controlled release of actives into the oral cavity with the aim to achieve controlled oral absorption
  • Therapeutic benefits include simplifying dose regimen, increased bioavailability, less side effects
  • Our current project pipeline includes 9 projects,
    3 involving Versatab technology,
    5 involving Versatab technology, and
    1 Adversa project
  • The combined addressable market for the pipeline is 5.6 billion dollars, of which 2.9 are related to films, and 2.7 bn to tablets.
  • Therapeutic benefits include simplifying dose regimen, increased bioavailability, less side effects

Transcript

  • 1. TSX-V: IGX OTCQX: IGXT Innovation In Drug Delivery An introduction to unique pharmaceutical delivery technologies November 2014
  • 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. INNOVATIVE DELIVERY TECHNOLOGY FOCUSING ON ORAL DRUG DELIVERY VERSAFILM™ VERSATAB™ ADVERSA™ 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 AND MANUFACTURES FASTER AND MORE EFFICIENT DRUG DELIVERY SYSTEMS FOR TOP PHARMACEUTICALS 3
  • 4. UNIQUE TECHNOLOGIES INNOVATIVE DELIVERY TECHNOLOGY TECHNOLOGY FOCUSED Develop novel and high performance drug delivery systems – focus on oral film products. TARGET HIGH-VALUE DIFFERENTIATED OPPORTUNITIES • 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. VALUE PROPOSITION 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 5
  • 6. PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH PRODUCT PORTFOLIO Forfivo XL® Major Depressive Disorder INT0001 Hypertension INT0024 Idiopathic Pulmonary Fibrosis (Pacific) INT0008 Migraine (RedHill) INT0027 Opiod 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 A ROBUST PRODUCT PIPELINE ACROSS 3 TECHNOLOGY PLATFORMS 6
  • 7. INTELGENX PARTNERSHIPS INTELGENX HAS STRATEGIC PARTNERSHIPS IN PLACE WITH MULTIPLE COMPANIES 7
  • 8. VersaTabTM Addressable market for pipeline VersaTabTM products. SIGNIFICANT MARKET POTENTIAL VersaFilmTM Opportunity to convert existing tablet market into film technology $8.1 Billion $2.7 Billion ADDRESSABLE MARKET FOR PRODUCT PIPELINE ~$10B Combined, addressable market for product pipeline 8
  • 9. 2013 Metroprolol Sales $1.2B Pentoxifylline - NAC $1.1B VERSATAB TM MULTILAYER TABLET TECHNOLOGY • 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 Wellbutrin XL & Bupropion XL Sales $391M 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 9
  • 10. FORFIVO XL® COMMERCIALIZATION GROWTH OPPORTUNITY Current Market for Bupropion $3.0B • 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 • Negotiations on Paragraph IV with Wockhardt progressing well Wellbutrin XL® Market $236M 2013 Sales Forfivo XL $2.7M FORFIVO XL® SCRIPT GROWTH ® VERSATAB TM VersaTab® Addressable Market ~$2.7B $1,200,000 $900,000 $600,000 $300,000 10 $0 4,000 3,000 2,000 1,000 0 ~$1.1M October Gross Sales 3,038 October Prescriptions 10/31/12 2/28/13 6/28/13 10/31/13 2/28/14 6/30/14 10/31/14
  • 11. VERSAFILM TM ADVANTAGES OF FILM TECHNOLOGY 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 11
  • 12. VERSAFILM TM ADVANTAGES OF FILM TECHNOLOGY IMPROVED PRODUCT PERFORMANCE: • Fast delivery translates into rapid onset of action • Improve bioavailability • Buccal 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 VERSAFILM™ ~$2.9B ADDRESSABLE MARKET RAPIDLY DISINTEGRATING PHARMACEUTICAL FILMS FOR BUCCAL OR SYSTEMIC DRUG DELIVERY 12
  • 13. $1.3B VERSAFILM TM ADDRESSABLE MARKETS • 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 Targeted Rizatriptan Market $230M Targeted Cialis Sales ® Targeted Suboxone Sales $1.4B ® VersaFilm Addressable Market ~$8.1B 13 PRECLINICAL PILOT STUDY PIVOTAL STUDY FILING LAUNCH INT0008 Migraine (RedHill) INT0027 Opiod 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
  • 14. ATTRACTIVE LIFECYCLE MANAGEMENT OPPORTUNITY Suboxone® Rx Quantities (Millions) 80 60 40 20 0 Film Tablet 2008 2009 2010 2011 2012 2013 VersaFilm Addressable Market ~$8.1B • 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 TM 14 Suboxone® Sublingual Film Suboxone® Sublingual Tablets
  • 15. 1.4 1.05 0.7 0.35 0. Buprenorphine plasma profile Test product Test product 0. 12. 24. 36. 48. 60. 72. Mean concentration (ng/mL) Time (hrs) ® VERSAFILM TM Suboxone Addressable Market ~$1.4B 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 150. 120. 90. 60. 30. 0. Naloxone plasma profile Test product reference product (Suboxone 8/2mg) 0. 6. 12. 18. 24. Mean concentration (pg/mL) Time (hrs) OPIOD DEPENDENCE - BUPRENORPHINE/NALOXONE 15
  • 16. MIGRAINE FILM BIOEQUIVALENT TO MAXALT MLT® 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 18.0 13.5 9.0 4.5 0.0 Orally disintegrating film containing Rizatriptan bioequivalent with orally disintegrating tablet (Maxalt MLT®) VersaFilm Rizatriptan 0.0 3.0 6.0 9.0 12.0 15.0 Rizatriptan Pl. Conc. (ng/mL) Time (hrs) Maxalt MLT® VERSAFILM TM 16
  • 17. VERSAFILM TM 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 IN TADALAFIL 17
  • 18. VERSAFILM TM CNS FILM INT0036 – A fast acting version of an existing schizophrenia treatment. Schizophrenia ~$5.2B Market1 Successfully completed pilot scale PhI study INT0036 demonstrated a significantly improved pharmacokinetic profile against the reference product 1 According to Datamonitor Healthcare schizophrenia forecast published July 13, 2012 30,000 22,500 15,000 7,500 0 VersaFilm INT0036 0 15 30 45 60 Rizatriptan Pl. Conc. (ng/mL) Time (min) RLD
  • 19. VERSAFILM TM A STRONG PLATFORM FOR GROWTH AND INNOVATION • Addressable market of approximately $8.1 billion • Strong intellectual property protection • Successful pivotal bioequivalency studies • 3 film products close to FDA approval • Limited number of competitors • Life cycle management opportunity
  • 20. OPERATIONAL INITIATIVES DEVELOPING FILM MANUFACTURING CAPABILITIES TO INCREASE PROFITABILITY 20 • Significantly increase IntelGenx' revenue stream • Better protection of IntelGenx' IP. • Eliminate dependency of IntelGenx on external manufacturing partners by establishing commercial film manufacturing capability. • Give clients the advantage to obtain all services from one source (one-stop- shopping). • Increase R&D capabilities and investments with expanded laboratories and technologies.
  • 21. KEY MILESTONES SUGGESTS NEAR TERM CATALYSTS 2014 2015 2016 2017 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 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™ 21
  • 22. VISIONARY, EXPERIENCED LEADERSHIP 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 22
  • 23. A SOLID PLATFORM FOR GROWTH CORE TECHNOLOGIES ADDRESS LARGE MARKET POTENTIAL VERSAFILM™ VERSATAB™ ADVERSA™ • Continue to grow commercialization efforts of Forfivo XL to drive revenue growth • Develop delivery technology product platforms in pipeline towards commercialization • Continue to develop distribution channel relationships • Leverage VersaFilm manufacturing expertise to enhance profitability 23
  • 24. TSX-V: IGX OTCQX: IGXT Innovation In Drug Delivery Thank You