Innovative Drug Delivery Solutions

Transcription

1 TSX-V: IGX OTCQX: IGXT Innovative Drug Delivery Solutions Investor Presentation July 2017 WE MAKE APPROVED DRUGS BETTER 0

2 Forward-Looking Statements To the extent any statements made in this presentation contain information that is not historical, these statements are forwardlooking 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 forwardlooking 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 Company Snapshot IntelGenx Corp. Founded TSX-V (IGX) 1 OTCQX (IGXT) 1 Market Capitalization Shares Issued Shares Fully Diluted 2 Insider Beneficial Ownership Cash/Equivalent (As of March 31, 2017) 2003 CAD$1.25 US$0.97 CAD$82M 65.5M 70.8M 18.7% CAD$5.3M* * Does not include proceeds from July 2017 convertible debenture offering Analyst Coverage Firm Analyst H.C. Wainwright Swayampakula Ramakanth Singular Research Greg Eisen * As at June 30,

4 Strengthened Management Team Over 20 Employees, including 7 with Ph.D. s Horst G. Zerbe, Ph. D. Chairman, President & CEO Co-Founder of Listerine breath strips 30+ years drug delivery / pharma experience Holds over 40 patents in drug delivery and numerous scientific publications Andre Godin, CPA, CA Executive VP, CFO 25+ years biotech/pharma industry experience Member of the Canadian Chartered Professional Accountants and the Canadian Institute of Chartered Accountants John Durham, B. Sc. VP, Operations 20+ years experience in pharmaceutical manufacturing, quality management, product development Held executive positions with several Canadian and US companies Nadine Paiement, M. Sc. VP, Research & Development Co-inventor of IntelGenx Trilayer Technology 15 years experience in product development and technology transfer Dana Matzen, Ph.D. VP, Business & Corporate Development 15 years experience in pharmaceutical product licensing Prev. Director, BD at Paladin Completed 13 transaction, 7 new product launches Stephen Kilmer Investor Relations 20+ years experience in healthcare IR and PR President of Kilmer Lucas, a healthcare only investor relations and capital markets advisory company 4 3

5 We We Make Approved Drugs Drugs Better Better IntelGenx Drug Delivery Technology Platforms Films Rapidly disintegrating films improving drug performance and easing administration without the need for water VersaFilm Tablets Controlled-release tablets for oral absorption over an extended time period AdVersa 5 4

6 VersaFilm TM Oral Oral Films Films Oral Films Provide Significant Market Opportunities for Improving Drug Delivery 2 IntelGenx 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 6 5

7 Advantages of Oral Thin Film Delivery We are focused on areas where oral films are particularly well-suited: Develop and commercialize products that provide therapeutic advantages to patients leveraging oral films, such as: Reduced side effects Improved bio-availability Response time versus existing drugs Abuse resistant Convenience Lifecycle management Repurpose existing drugs for new indications using oral films First-to-file generic drugs where high technology barriers to entry exist in reproducing branded films 7 6

8 Clearly Defined BD Strategy Balancing Risks and Opportunities for an Optimized Portfolio Low Overall Risk IntelGenx Future Focus Lifecycle Mgmt Patient Benefits Drug Repurposing Deal Value Low Medium High FTF Generics High Slow Time to Market Fast 78

9 We Offer Full Service We Offer Full Service to Foster the Growth of our Partners 89

10 Low Risk Development Model IntelGenx grants partners exclusive rights to market and sell its products in exchange for upfront and milestone payments, together with a share of the partner s net profits or a royalty on net product sales IntelGenx retains manufacturing rights for its products Payments are received as the contracted services are performed or when certain milestones are achieved: FDA submission FDA approval Commercial launch Annual net sales target, etc. Partners pay for part or all of the R&D expenses associated with developing a new product and to obtain regulatory approval 9 10

11 State-of-the-Art Oral Film Facility Established For Development & Manufacturing 17,000 sq ft facility in Montreal - construction completed in Q High capacity manufacturing and packaging equipment Lower costs, controls quality and de-risks investment for new products GROSS MARGINS of 40% PLUS 11 10

12 Rizaport VersaFilmTM For Migraines Leverages VersaFilm Technology European Marketing Approval November 2015 Co-development partnership with RedHill Biopharma Definitive agreement signed July 2016 with Grupo Juste for Spain & additional territories Definitive agreement signed Dec 2016 with Pharmatronic for South Korea Actively pursuing several opportunities to open new markets Patent granted in April 2016 protecting Rizaport Re-submission of 505(b)(2) NDA planned for Q PDUFA date expected in early

13 Tadalafil TM VersaFilm For Erectile Dysfunction A high value, pleasantly flavored, and convenient VersaFilm dosage form of 2.5, 5, 10 and 20 mg tadalafil that can be administered without water Pilot phase 1 clinical trial for safety and pharmacokinetics have been successively completed, confirming bioequivalence to Cialis (Eli Lilly) Tadalafil VersaFilmTM 2 patents protecting Tadalafil VersaFilm pending 13 12

14 Tadalafil TM VersaFilm Significant Market Opportunity Fr Erectile Dysfunction Tadalafil market in the US estimated at $1.7B Nov 2017 Lilly s tadalafil composition patent to expire, but orange book dosing patent still in force until April 2020 IntelGenx exclusive license to Lilly s tadalafil ED dosing patent 166 will allow entry of Tadalafil VersaFilm into the ED US market upon FDA approval, potentially before the market entry of Cialis generic competitors 505(b)(2) USA NDA submission in Q Expected US FDA approval H1/2018 $175 $11 $1,429 $48 US ED Market by Sales ($M) $18 Cialis Viagra Levitra Staxyn $1,703 Stendra Edex 14 13

15 Loxapine TM VersaFilm For Schizophrenia & Bipolar 1 Disorder Fast-acting loxapine oral dosage For treatment of acute agitation and anxiety in non-institutionalized patients with schizophrenia & bipolar 1 disorder Reduces risk of pulmonary problems and potential risk of violence and injury to patients and others Loxapine VersaFilmTM US patent & PCT applications submitted Formulation optimization stage results expected H

16 Montelukast VersaFilmTM For Mild Cognitive Impairment IntelGenx is repurposing Montelukast for the treatment of MCI by leveraging its VersaFilm technology The drug is known and approved for a different indication (asthma) and has an excellent safety profile Strong preclinical evidence Global Sales for AD by Patients Category (Global Data, 2013) Montelukast TM VersaFilm 16 15

17 Montelukast VersaFilmTM Clinical Data Before MMSE 13: moderate to severe dementia After 2 Months of Montelukast MMSE 22: mild dementia 2 Montelukast concentration (ng/ml) Montelukast Avg Plasma Profile Test buccal film 10mg Ref tablet 10mg Time (hrs) Phase 1 clinical study in human successfully completed Significantly increased bioavailability after administration of VersaFilm compared to commercial tablet Drug crosses blood/brain barrier when given as film Phase II-a study (proof of concept) to commence Q3/2017 First efficacy data in humans available Q4/2017 Several pharma companies have expressed strong interest 17 16

18 Dronabinol Dronabinol AdVersaTM Mucoadhesive Tablet For Pain Management Mucoadhesive Tablet For Pain Management AdVersa mucoadhesive tablet adheres to the oral mucosa and releases the drug onto the site of application at a controlled rate Repurposing of synthetic THC dronabinol for use in pain Protected by several issued and pending patents Competitive advantages vs. Marinol capsules (Abbvie) Dronabinol Dronabinol TM AdVersa Marinol (dronabinol) capsule Conventional oral dosage form High rate of metabolization Limited bioavailability Undesired psycho activity Limited shelf life Dronabinol AdVersa AdVersta mucoadhesive tablet Limited first-pass metabolism Improved bioavailability Reduced gastro-intestinal exposure and side-effects Enhanced product stability 18 17

19 Successful Monetization of First In-House Development High dose version of Wellbutrin XL Only approved, once-daily, bupropion HCl 450mg dose in a single tablet Launched commercially October 2013 in partnership with Edgemont Pharmaceuticals Sold US revenue to SWK Holdings for US$6M Development cost $2.5M, total revenue $15M = 6-fold ROI Non-dilutive source of funding, will be used to advance film projects 19 18

20 Strategic Partnership with Chemo Group Licensing and development agreements entered for four generic products IntelGenx granted Chemo exclusive worldwide license to commercialize two generic tablets and U.S. license for two other generic oral films IntelGenx to receive upfront, milestone, R&D revenues and share of profits total value of 7 digits Combined total market of four products is over $7B Chemo making a strategic move into novel drug delivery products with IntelGenx as its partner Partnership could result in numerous future product agreements About Chemo Group: Founded in ,000 employees Head office in Spain Revenues of $1.2B annually Markets over 300 products Operating in over 40 countries 20 state-of-the-art facilities 9 specialized R&D centers 20 19

21 Robust Product Pipeline Addressing Significant Market Opportunities VersaFilm TM Migraine Rizaport (Rizatriptan) Erectile Dysfunction (Tadalafil) Schizophrenia (Loxapine) Neurodegenerative Brain Diseases (Montelukast) Opioid Dependence - gsuboxone (Buprenorphine/ Naloxone) Undisclosed Available ex-es & SKR Available Available Available Partnered Partnered Undisclosed Partnered Undisclosed Partnered Tablets Major Depressive Disorder - Forfivo XL (Bupropion) Hypertension (undisclosed) Pain (undisclosed) Pain (Dronabinol) Available ex-us Partnered Partnered Available ex-us/ CAN 21 20

22 The IntelGenx Advantage 1. History Dr. Zerbe a pioneer with over 30 plus years in oral films 2. Formulation Team Strong in applying biopharmaceutical aspects to formulation development Top quality scientists: highly creative, focused on problem solving & innovative approaches Experienced in developing films for oral (GI), sublingual & buccal absorption 3. Clearly Defined Corporate Strategy And Business Model Focus on drug repurposing, lifecycle management, patient benefits, and FTF Provider of comprehensive pharmaceutical services to industry partners 4. Competitive Manufacturing Capabilities First in Canada New state-of-the-art manufacturing facility Offer one-stop-shopping to our partners with lean operations keeping costs down Customized manufacturing equipment 22 21

23 Financial Results 23 22

24 Financial Performance: Revenue REVENUE ($M) $M First Quarter 2017 First Quarter Full Year 2015 Full Year Revenue

25 Financial Performance: Income & EBITDA Net Comprehensive Income & Adjusted EBITDA ($M) $M First Quarter 2017 First Quarter Full Year 2015 Full Year -1.5 Net Income Adjusted EBITDA 25 24

26 Conclusion 26 25

27 Solid Platform for Growth Significant Market Potential New manufacturing facility will offer many competitive advantages Strengthened management team to accelerate execution of business plan Implemented product sourcing strategy to identify high-value product opportunities Building strategic partnerships with relevant partners in the pharmaceutical industry 27 26

28 Thank You! Contact Info: Stephen Kilmer André Godin Investor Relations Executive VP & CFO ext ext IntelGenx Corporate Offices 6420 Abrams Saint-Laurent (Quebec) H4S 1Y2 Canada