Intellipharmaceutics Corporate Presentation, February 2012

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Intellipharmaceutics Corporate Presentation, February 2012. Includes a products update.

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Intellipharmaceutics Corporate Presentation, February 2012

  1. 1. February 2012
  2. 2. Forward-looking StatementsCertain statements in this presentation, as well as certain oral statements made by management during the presentation,constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and/or“forward-looking information” under the Ontario Securities Act. These statements include, without limitation, statementsregarding the Company’s plans and milestones; status of developments, funding or expenditures; partnering activities; regulatorysubmissions; strategies; future operations, financial positions, sales, revenues costs, and market penetration. In some cases, youcan identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “plans”, “anticipates”, “believes”,“estimates”, “predicts”, “potential”, “continue”, “intends”, “could”, or the negative of such terms or other comparable terminology.You should not place undue reliance on these statements, which are subject to a multitude of risks and uncertainties that couldcause actual results, future circumstances or events to differ materially from those stated in or implied by such statements. Theserisks and uncertainties include, but are not limited to, securing and maintaining corporate alliances, the need for additional capitaland the effect of capital market conditions and other factors, including the current status of our programs; capital availability; thepotential dilutive effects of any financing; the timing, costs and uncertainties of our R & D and regulatory efforts to commercializeour present and future products; and estimates regarding capital requirements and future revenues. Additional risks anduncertainties relating to the Company can be found in the “Risk Factors” sections of our annual information form dated February28, 2011 and Form 20-F for the year ended November 30, 2010, and in our other public filings. We disclaim any intention orobligation, except as required by law, to update or revise such statements, whether as a result of new information, future events orotherwise.The projections and/or illustrative examples, as the case may be, are included solely to provide certain overview informationconcerning the variable financial results of drug commercialization in this industry sector when certain assumptions are used, andhow those results could impact the potential future operating results of the Company. No assurance can be made that such resultswill be achieved. The Company may conduct the business in a manner different from that set forth in the assumptions, as changingcircumstances may require.Actual results of operations are likely to vary from the projections and the variations may be material and adverse. The projectionsshould not be regarded as a representation or prediction that the Company will achieve or is likely to achieve any particular results.Without limiting the generality of the foregoing, no assurance can be given as to whether or when the Company will receiveregulatory approval for any of the Company’s drug formulations. 2
  3. 3. OverviewSpecialty Pharmaceuticals Company (NASDAQ: IPCI; TSX: I)Six ANDAs under review by the FDA for generics of: • Focalin XR®, Effexor XR®, Protonix®, Glucophage® XR , Seroquel XR®, Lamictal® XR™ (represents approximately $6.6B of branded and generic sales)Rexista™ Technology – abuse resistant drug delivery platform • Rexista Oxycodone XR - Phase I proof-of-concept study complete • Potential application to other opioid drug candidatesControlled-Release (CR) Focus: high-value products / alt. delivery systems • $15B+ of CR medicines off patent in the near term (1) • Technical barriers can result in fewer competitors and higher marginsStrategic alliance with Par Pharmaceutical (NYSE: PRX) for generic Focalin XRBroad range of drug delivery solutions • 30+ patents issued and pending (1) Source: Emerging Opportunities in Controlled-Release Generic Drugs; Episcom 2009. 3
  4. 4. Experienced Management TeamDr. Isa Odidi, MBA - Chairman & CEO, Co-Chief Scientific Officer Over 30 years of industry experience Held senior positions at Biovail Corp. (now merged with Valeant (NYSE & TSX: VRX)) Proven success in developing several approved CR drugsDr. Amina Odidi - President & COO, Co-Chief Scientific Officer Over 30 years of industry experience Extensive experience developing and applying proprietary technologies to the development of CR drugs Proven success in developing several approved CR drugsJohn Allport, B.A.Sc., M.A., LL.B. - Vice President, Legal Affairs and Licensing Over 20 years of experience in the field of IP law; served with Sim Lowman Ashton & McKay LLP of Toronto working for and against many Fortune 500 companiesDr. Patrick N. Yat - Vice President, Pharmaceutical Analysis and Chemistry Over 15 years of industry experience serving with Health Canada, Patheon, Inc., and Biovail Corp.Shameze Rampertab, CA, MBA, BSc. - CFO & Vice President, Finance and Administration Over 15 years of public company and industry experience Served as the Director, Finance and Secretary-Treasurer for then-public Drug Royalty Corp.; served as biotech analyst at several investment banking firms including Canaccord Capital; was a Partner, Healthcare Investment Banking at LOMIra Baeringer, MBA, B.A.-Vice President, Business Development 20 years of experience in pharmaceutical licensing, development, supply, acquisitions, divestitures, and alliance management. 4
  5. 5. Pharmaceutical Industry Profile Intellipharmaceutics Focus ANDA NDA 505 (b)(2) NDA 505 (b)(1) GENERICS DRUGS DRUGS Identical Drug Copies Novel Proprietary Modifications Novel Patented Drugs of Approved Drugsdevelopment Estimated timeline 2-4 years 3-4 years 10-12 years 5
  6. 6. HypermatrixTM TechnologyDrug matrix technology defined as multi-dimensional in natureGroup of technologies based on Hypermatrix™ conceptBroad range of release profiles taking into account • Physical and chemical characteristics of a drug • Therapeutic use • Optimal site for release of API in GITUsed alone or in combination to optimize development and performance IntelliMatrix™ IntelliOsmotic™ IntelliPaste™ IntelliPellets™ IntelliGITransporter™ IntelliFoam™ IntelliShuttle™ 6
  7. 7. HypermatrixTM Technology Capabilities Key Advantages Controlled release Extended release  Shorter development timelines Pulsatile release  Cost effective development Chrono mimicry  Once-a-day dosing Quick disintegrating release  Chrono therapeutic dosing Site specific delivery  Suitable for hydrophilic/hydrophobic, Prevention of dose dumping potent, and high dose compounds Abuse resistance Alcohol resistance Enhanced bioavailability Capabilities have been repeatedly substantiated in vitro and in vivo 7
  8. 8. Disclosed Product Candidates U.S. Pilot Clinical / Product Brand Indication Formulation Scale-up FDA review Sales** Studies BE Studies dexmethyl- Focalin XR® $596M ADHD phenidate Partnered with Par Pharmaceutical (NYSE:PRX) venlafaxine Effexor XR® $2.5B* Depression HCI pantoprazole Protonix® $1.8B* GERD sodium metformin Glucophage® $431M* Diabetes HCl XR Schizophrenia, quetiapine bipolar disorder, Seroquel XR® $1.1B major depressive fumarate disorder Lamictal® lamotrigine $217M Epilepsy XR™ carvedilol Coreg CR® $314M CHF phosphateoxycodone CR Oxycontin $2.9B Pain*includes sales of generics** Wolters Kluwer Health data for the 12 months ending Dec 2011 8
  9. 9. 1st ANDA: Generic Focalin XR® Overview & Highlights Examples of US Economic Potential (1)  Indicated for ADHD  Partnered with Par Pharmaceutical (NYSE:PRX) Brand Sales  ANDA filed with FDA for 5, 10, 15, 20, 30mg strengths  Paragraph IV certification; patent litigation settled with $596M(3) Novartis, Elan, Celgene for 5, 10, 15, 20mg strengths  Potential launch Q4 2012 for first four strengths Discount (~90% of brand sales) 70% 50% Par Pharmaceutical (NYSE:PRX) Partnership Market Penetration  License & Commercialization Agreement (Nov. 2005 / expanded Aug. 2011 to include additional strengths) 10% 20%  IPCI pays development costs / Par responsible for others (2) Potential Revenue  10 year profit-sharing agreement from commercial launch to PAR/IPCI partnership of product  Par is a top 10 U.S. Pharma company with an approximate $18M $60M $1 billion market cap(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, basedon available information concerning third party brand product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts orprojections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for Par and IPCI (if any) combined, and arebefore production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2) Other costs includebioequivalence, API, scale up / scalability and commercialization costs. (3) Wolters Kluwer Health data for the 12 months ending Dec 2011. 9
  10. 10. 2nd ANDA: Generic Effexor XR® Overview & Highlights Examples of US Economic Potential (1)  Indicated for major depressive disorders Brand and Generic Sales  Available for partnering  ANDA accepted by the FDA as of Jan. 2010 for all $2.5B(2) strengths of the approved brand product  Paragraph IV certification; litigation settled Discount  Potential launch upon FDA approval 90% 80% Market Penetration 2% 5% Potential Revenue to IPCI and partner $5M $25M(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, basedon available information concerning third party brand and generic product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Companyforecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI(if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based.(2) Wolters Kluwer Health data for the 12 months ending Dec 2011. 10
  11. 11. 3rd ANDA: Generic Protonix® Overview & Highlights Examples of US Economic Potential (1)  Indicated for conditions associated with GERD (i.e.. ulcers) Brand and Generic Sales  Available for partnering $1.8B(2)  ANDA accepted by the FDA as of June 2010 for all strengths of the approved brand product Discount  Paragraph IV certification; no litigation  Potential launch upon FDA approval 85% 75% Market Penetration 2% 5% Potential Revenue to IPCI and partner $5M $23M(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, basedon available information concerning third party brand and generic product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Companyforecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI(if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based.(2) Wolters Kluwer Health data for the 12 months ending Dec 2011. 11
  12. 12. 4th ANDA: Generic Glucophage® XR Overview & Highlights Examples of US Economic Potential (1)  Indicated for the management of type 2 diabetes  Available for partnering Brand and Generic Sales  ANDA accepted by the FDA as of Aug 2010 for two $421M(2) strengths of the approved brand product  Paragraph IV certification; no litigation Discount(3)  Potential launch upon FDA approval 0% 0% Market Penetration 1% 5% Potential Revenue to IPCI and partner $4M $20M(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, basedon available information concerning third party brand and generic product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Companyforecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI(if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based.(2) Wolters Kluwer Health data for the 12 months ending Dec 2011. (3) Discount not applied as product sales are almost all generic sales 12
  13. 13. 5th ANDA: Generic Seroquel XR® Overview & Highlights Examples of US Economic Potential (1)  Indicated for the treatment of schizophrenia, bipolar disorder, and major depressive disorder Brand Sales  Available for partnering $1.1B(2)  ANDA accepted by the FDA as of Feb 2011 for four strengths of the approved brand product Discount  Paragraph IV certification; litigation initiated 85% 75% Market Penetration 5% 20% Potential Revenue to IPCI and partner $8M $55M(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, basedon available information concerning third party brand product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts orprojections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI (if any)combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2)Wolters Kluwer Health data for the 12 months ending Dec 2011. 13
  14. 14. 6th ANDA: Generic Lamictal® XR™ Overview & Highlights Examples of US Economic Potential (1)  Indicated for the treatment of epilepsy (anticonvulsant) Brand Sales  Available for partnering  ANDA accepted by the FDA as of Sep 2011 for four $217M(2) strengths of the approved brand product  Paragraph I certification; no litigation Discount 70% 50% Market Penetration 10% 20% Potential Revenue to IPCI and partner $6M $21M(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, basedon available information concerning third party brand product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts orprojections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI (if any)combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2)Wolters Kluwer Health data for the 12 months ending Dec 2011. 14
  15. 15. IPCI’s RexistaTM Technology Platform TAMPER-DETERRENT ALCOHOL-RESISTANT CONTROLLED-RELEASE TECHNOLOGY Provides deterrence against intentional (drug abuse) and unintentional dose dumping dose dumping is the rapid release of active ingredient from a controlled-release drug into the blood stream that can result in increased toxicities, side effects, and a loss of efficacy - usually results if a tablet is crushed and consumed or taken with alcohol Utilizes a paste in a capsule - a novel dosage form designed specifically to prevent dose dumping 15
  16. 16. Oxycodone and its Abuse www.oxycontinabuse.comOxycodone abuse continues to increase; current products remain easy to abuse - easy to circumvent extended release mechanism - crush / chew and ingest; crush and snort; extract and injectOn April 19, 2011 the FDA announced the requirement of an OpioidsRisk Evaluation and Mitigation Strategy (REMS) as part of a broader action plan toaddress the national prescription drug abuse epidemic in the US 16
  17. 17. Growing Interest in Abuse Resistance DURECT, PAIN THERAPEUTICS, KING, and PFIZER CASE STUDY Dec 2002 Pain completes a deal with $9M +6%-11.5% Durect to develop and commercialize selected long- of sales acting oral opioid products – incl. (also includes reimbursment of R&D efforts; abuse resistant Remoxy. % dependant on volume of sales) Nov 2005 $400M +15/20% King Pharma completes a deal with Pain for Remoxy and other of sales abuse resistant opioids. ($150 million upfront, $150 million milestone payments, $100 million in R&D expenses; 15% royalty on first billion of sales, 20% thereafter) March 2011 Pfizer completes $3.6B acquisition of King. 17
  18. 18. RexistaTM Oxycodone XR NDA 505(b)(2) REGULATORY PATHWAY Controlled-release oxycodone in a novel dosage form (paste in a capsule) designed to deter abuse from - Snorting or inhalation - IV injection Designed to resist the release of the entire dose when chewed or consumed with alcohol Rexista technology platform applicable to additional opioid drug candidates (i.e., oxymorphone, hydrocodone, and morphine) The FDA’s move to restrict the prescribing of extended-release opioid analgesics should benefit tamper-resistant formulations such as IPCI’s Rexista™ 18
  19. 19. RexistaTM Oxycodone XR PILOT PROOF-OF-CONCEPT CLINICAL TRIALRandomized 12 subject cross-over studyComparing: • single dose of RexistaTM oxycodone CR (40 mg capsule, once-daily) with • two doses of OxyContin® (20mg, twice-daily) RESULTSRexista oxycodone demonstrated sustained release pharmacokinetic activity → blood plasma concentrations maintained at clinically significant levels over a 24 hour periodThe bioavailability of a single dose of RexistaTM oxycodone was comparableto that of two doses of Oxycontin® dosed at 12 hour intervals 19
  20. 20. RexistaTM Oxycodone XR Overview & Highlights  Clinical stage Examples of US Economic Potential (1)  Phase 1 proof-of-concept study completed  Primary manufacturing equipment has been delivered Controlled-release Oxycodone Sales and qualified $2.9B(2)  Manufacturing scale-up of clinical batches for use in Phase 1 & 2 studies in progress Market Penetration 10% 30% Potential Revenue to IPCI and partner $290M $870M(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, basedon available information concerning third party brand and generic product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Companyforecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for potential partner and IPCI (ifany) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2)Wolters Kluwer Health data for the 12 months ending Dec 2011. 20
  21. 21. State-of-the-Art Facility TORONTO, ONTARIO Granted FDA acceptable status following completion of cGMP and pre-approval inspection GLP QC labs and cGMP manufacturing plant Capacity of ~500m oral solid dosage / year All stages of development controlled in-house • Methods development • Formulation development • Manufacture of clinical batches • Regulatory filings In-house manufacturing of clinical batches saves valuable timeand protects proprietary technologies 21
  22. 22. Milestones Obtain FDA approval of our generic version of Focalin XR® File two additional ANDAs with the FDA Establish additional development/marketing alliances Schedule a pre-IND meeting with FDA to discuss Rexista™ oxycodone clinical development plan Complete manufacturing of clinical batches of Rexista™ oxycodone Initiate Phase I studies using clinical batches of Rexista™oxycodone 22
  23. 23. Selected Financial Data Shares outstanding (Q4/11.30.11 ) 15.9MFully-diluted shares outstanding (Q4/11.30.11 ) 23.8M Market capitalization (01.31.12) $49M % Owned by insiders 38% Cash (Q4/11.30.11 ) $4.8M 23

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