Intellipharmaceutics Corporate Presentation, February 2012
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Transcript of Intellipharmaceutics Corporate Presentation, February 2012
February 2012
Forward-looking Statements Certain 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, statements regarding the Company’s plans and milestones; status of developments, funding or expenditures; partnering activities; regulatory submissions; strategies; future operations, financial positions, sales, revenues costs, and market penetration. In some cases, you can 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 could cause actual results, future circumstances or events to differ materially from those stated in or implied by such statements. These risks and uncertainties include, but are not limited to, securing and maintaining corporate alliances, the need for additional capital and the effect of capital market conditions and other factors, including the current status of our programs; capital availability; the potential dilutive effects of any financing; the timing, costs and uncertainties of our R & D and regulatory efforts to commercialize our present and future products; and estimates regarding capital requirements and future revenues. Additional risks and uncertainties relating to the Company can be found in the “Risk Factors” sections of our annual information form dated February 28, 2011 and Form 20-F for the year ended November 30, 2010, and in our other public filings. We disclaim any intention or obligation, except as required by law, to update or revise such statements, whether as a result of new information, future events or otherwise. The projections and/or illustrative examples, as the case may be, are included solely to provide certain overview information concerning the variable financial results of drug commercialization in this industry sector when certain assumptions are used, and how those results could impact the potential future operating results of the Company. No assurance can be made that such results will be achieved. The Company may conduct the business in a manner different from that set forth in the assumptions, as changing circumstances may require. Actual results of operations are likely to vary from the projections and the variations may be material and adverse. The projections should 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 receive regulatory approval for any of the Company’s drug formulations.
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Overview
Specialty 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 candidates
Controlled-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 margins
Strategic alliance with Par Pharmaceutical (NYSE: PRX) for generic Focalin XR
Broad range of drug delivery solutions • 30+ patents issued and pending (1) Source: Emerging Opportunities in Controlled-Release Generic Drugs; Episcom 2009.
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Experienced Management Team
Dr. 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 drugs
Dr. 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 drugs
John 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 companies
Dr. 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 LOM
Ira Baeringer, MBA, B.A.-Vice President, Business Development
20 years of experience in pharmaceutical licensing, development, supply, acquisitions, divestitures, and alliance management.
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Pharmaceutical Industry Profile
NDA 505 (b)(1) DRUGS
ANDA GENERICS
NDA 505 (b)(2) DRUGS
Identical Drug Copies Novel Patented Drugs Novel Proprietary Modifications of Approved Drugs
2-4 years 3-4 years 10-12 years
Estim
ated
de
velo
pmen
t tim
elin
e
Intellipharmaceutics Focus
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HypermatrixTM Technology
Drug matrix technology defined as multi-dimensional in nature
Group of technologies based on Hypermatrix™ concept
Broad range of release profiles taking into account • Physical and chemical characteristics of a drug • Therapeutic use • Optimal site for release of API in GIT
Used alone or in combination to optimize development and performance
IntelliMatrix™
IntelliPaste™
IntelliFoam™
IntelliPellets™
IntelliOsmotic™
IntelliShuttle™
IntelliGITransporter™
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HypermatrixTM Technology
Capabilities
Controlled release Extended release Pulsatile release Chrono mimicry Quick disintegrating release Site specific delivery Prevention of dose dumping Abuse resistance Alcohol resistance Enhanced bioavailability
Key Advantages
Shorter development timelines Cost effective development Once-a-day dosing Chrono therapeutic dosing Suitable for hydrophilic/hydrophobic,
potent, and high dose compounds
Capabilities have been repeatedly substantiated in vitro and in vivo
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Disclosed Product Candidates
dexmethyl-phenidate
Focalin XR® $596M ADHD
venlafaxine HCI
Effexor XR® $2.5B* Depression
pantoprazole sodium
Protonix® $1.8B* GERD
metformin HCl
Glucophage® XR
$431M* Diabetes
quetiapine fumarate
Seroquel XR® $1.1B Schizophrenia,
bipolar disorder, major depressive
disorder
lamotrigine Lamictal®
XR™ $217M Epilepsy
carvedilol phosphate
Coreg CR® $314M CHF
Product Brand U.S. Sales**
Indication Formulation Pilot
Studies Scale-up
Clinical / BE Studies
FDA review
oxycodone CR
Oxycontin
$2.9B Pain
Partnered with Par Pharmaceutical (NYSE:PRX)
*includes sales of generics ** Wolters Kluwer Health data for the 12 months ending Dec 2011
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1st ANDA: Generic Focalin XR®
Indicated for ADHD Partnered with Par Pharmaceutical (NYSE:PRX) ANDA filed with FDA for 5, 10, 15, 20, 30mg strengths Paragraph IV certification; patent litigation settled with
Novartis, Elan, Celgene for 5, 10, 15, 20mg strengths Potential launch Q4 2012 for first four strengths
(~90% of brand sales)
Overview & Highlights
License & Commercialization Agreement (Nov. 2005 / expanded Aug. 2011 to include additional strengths)
IPCI pays development costs / Par responsible for others (2)
10 year profit-sharing agreement from commercial launch
of product
Par is a top 10 U.S. Pharma company with an approximate
$1 billion market cap
Par Pharmaceutical (NYSE:PRX) Partnership
(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, based on 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 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 Par 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) Other costs include bioequivalence, API, scale up / scalability and commercialization costs. (3) Wolters Kluwer Health data for the 12 months ending Dec 2011. 9
Examples of US Economic Potential (1)
Brand Sales
$596M(3)
Discount
70% 50%
Market Penetration
10% 20%
Potential Revenue to PAR/IPCI partnership
$18M $60M
2nd ANDA: Generic Effexor XR®
Indicated for major depressive disorders
Available for partnering
ANDA accepted by the FDA as of Jan. 2010 for all
strengths of the approved brand product
Paragraph IV certification; litigation settled
Potential launch upon FDA approval
Overview & Highlights
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Examples of US Economic Potential (1)
Brand and Generic Sales
$2.5B(2)
Discount
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, based on 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 Company forecasts 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.
3rd ANDA: Generic Protonix®
Indicated for conditions associated with GERD
(i.e.. ulcers)
Available for partnering
ANDA accepted by the FDA as of June 2010 for all
strengths of the approved brand product
Paragraph IV certification; no litigation
Potential launch upon FDA approval
Overview & Highlights
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Examples of US Economic Potential (1)
Brand and Generic Sales
$1.8B(2)
Discount
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, based on 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 Company forecasts 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.
4th ANDA: Generic Glucophage® XR
Overview & Highlights
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Examples of US Economic Potential (1)
Brand and Generic Sales
$421M(2)
Discount(3)
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, based on 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 Company forecasts 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
Indicated for the management of type 2 diabetes
Available for partnering
ANDA accepted by the FDA as of Aug 2010 for two
strengths of the approved brand product
Paragraph IV certification; no litigation
Potential launch upon FDA approval
5th ANDA: Generic Seroquel XR®
Indicated for the treatment of schizophrenia, bipolar
disorder, and major depressive disorder
Available for partnering
ANDA accepted by the FDA as of Feb 2011 for four
strengths of the approved brand product
Paragraph IV certification; litigation initiated
Overview & Highlights
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Examples of US Economic Potential (1)
Brand Sales
$1.1B(2)
Discount
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, based on 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 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.
6th ANDA: Generic Lamictal® XR™
Indicated for the treatment of epilepsy (anticonvulsant)
Available for partnering
ANDA accepted by the FDA as of Sep 2011 for four
strengths of the approved brand product
Paragraph I certification; no litigation
Overview & Highlights
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Examples of US Economic Potential (1)
Brand Sales
$217M(2)
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, based on 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 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.
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
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www.oxycontinabuse.com
Oxycodone 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 inject
On April 19, 2011 the FDA announced the requirement of an Opioids Risk Evaluation and Mitigation Strategy (REMS) as part of a broader action plan to address the national prescription drug abuse epidemic in the US
Oxycodone and its Abuse
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Growing Interest in Abuse Resistance DURECT, PAIN THERAPEUTICS, KING, and PFIZER CASE STUDY
Nov 2005
March 2011
$400M +15/20% of sales
King Pharma completes a deal with Pain for Remoxy and other
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)
$3.6B Pfizer completes
acquisition of King.
Dec 2002 Pain completes a deal with Durect to develop and
commercialize selected long-acting oral opioid products – incl.
abuse resistant Remoxy.
$9M +6%-11.5% of sales
(also includes reimbursment of R&D efforts; % dependant on volume of sales)
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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
Rexista technology platform applicable to additional opioid drug candidates (i.e., oxymorphone, hydrocodone, and morphine)
Designed to resist the release of the entire dose when chewed or consumed with alcohol
The FDA’s move to restrict the prescribing of extended-release opioid analgesics should benefit tamper-resistant
formulations such as IPCI’s Rexista™
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RexistaTM Oxycodone XR PILOT PROOF-OF-CONCEPT CLINICAL TRIAL
Randomized 12 subject cross-over study
Comparing:
• single dose of RexistaTM oxycodone CR (40 mg capsule, once-daily) with
• two doses of OxyContin® (20mg, twice-daily)
Rexista oxycodone demonstrated sustained release pharmacokinetic activity
→ blood plasma concentrations maintained at clinically significant levels over a 24 hour period
The bioavailability of a single dose of RexistaTM oxycodone was comparable to that of two doses of Oxycontin® dosed at 12 hour intervals
RESULTS
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Clinical stage
Phase 1 proof-of-concept study completed
Primary manufacturing equipment has been delivered
and qualified
Manufacturing scale-up of clinical batches for use in
Phase 1 & 2 studies in progress
Overview & Highlights
RexistaTM Oxycodone XR
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Examples of US Economic Potential (1)
Controlled-release Oxycodone Sales
$2.9B(2)
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, based on 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 Company forecasts 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 (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.
State-of-the-Art Facility
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
TORONTO, ONTARIO
In-house manufacturing of clinical batches saves valuable time
and protects proprietary technologies
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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
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Selected Financial Data
Shares outstanding (Q4/11.30.11 ) 15.9M
Fully-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
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