Cipher Pharmaceuticals Inc. · TSX:CPH
Cipher Pharmaceuticals — BioFinance 2005
29 slides from Cipher Pharmaceuticals's conference presentation, Aug 18, 2005
Slide 1: Investor Presentation
BioFinance 2005 Investor Presentation August May 2005 18, 2005
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains statements about expected future events and financial and operating results that are forward-looking and subject to uncertainties. Actual results, performance or achievement could differ materially from those expressed or implied by such statemen
Slide 3: Corporate Profile
Corporate Profile • Cipher Pharmaceuticals Ltd. established in Nov 2000 • Formerly pharmaceutical division of CML Healthcare Inc. • Began trading February 2004 (TSX: DND) – Core focus is drug delivery – Current portfolio consists of three late-stage products • Non-core pharmaceutical research servic
Slide 4: Senior Management & Board
Senior Management & Board Senior Management Dr. John Mull: CEO Paul Bristow: CFO Larry Andrews: President Dr. Kishna Kalicharran: VP, Business Development Dr. Ian French: Phase I Dr. Robert Burford: Phase II/III Dr. Jan Sedgeworth: Regulatory Board of Directors William Garriock Gerald McDole Dr. Joh
Slide 5: Drug Delivery Business Model
Drug Delivery Business Model PRODUCT INNOVATOR PHARMA COMPANY Proven drug delivery technology Commercial drug with applied to known molecule enhanced performance In-license Out-license Clinical development Regulatory approval
Slide 6: Benefits of Business Model
Benefits of Business Model • Speed to market – Development 3-4 years vs. 10+ years • Significantly lower R&D costs – $5-$20 MM vs. $300+ MM • Significantly lower regulatory approval risk • Faster ROI
Slide 7: Technology Partner
Technology Partner • Galephar Pharmaceutical Research Inc. – Privately held drug development company based in Puerto Rico – Technology platforms include Lidose® superbioavailability capsules, controlled release beads, dry powder inhalers – GMP manufacturing facility with pilot plant, commercial suit
Slide 8: Drug Delivery Technologies
Drug Delivery Technologies • Oral Lidose® • Oral Controlled-Release – Semi-solid or liquid capsule Bead Technology technology – Capsule filled with coated – Superbioavailability for relatively beads water-insoluble compounds – Smooth, consistent plasma – Low manufacturing costs levels over extended
Slide 9: Three Late-Stage Products
Three Late-Stage Products Product Pipeline Preclinical Phase I Phase II/III NDA Filing Commercialization CIP-FENOFIBRATE CIP-ISOTRETINOIN CIP-TRAMADOL ER
Slide 10: CIP-Fenofibrate: Overview
CIP-Fenofibrate: Overview • Lead compound; in-licensed in 2000 • Indicated for the treatment of hyperlipidemia • Territory: Americas and Pacific Rim • Patent Status: U.S. patent issued; Canada pending
Slide 11: CIP-Fenofibrate
CIP-Fenofibrate • Lipid Lowering Market • Statins Target high LDL-C – $15+ billion in U.S. sales • Fibrates – 149MM+ prescriptions Target high triglycerides, Niacin low HDL-C Fibrates – Fenofibrates: 55% – Gemfibrozil: 45% • Niacin Statins Targets low HDL-C Significant side effects limit use
Slide 12: CIP-Fenofibrate: Growing Market
CIP-Fenofibrate: Growing Market Fenofibrate Sales – U.S. (in US$ millions) 857.7 626.4 449.9 +37% 297.2 +39% +51% 2001 2002 2003 2004 (Source: IMS Health)
Slide 13: CIP-Fenofibrate: Market Opportunity
CIP-Fenofibrate: Market Opportunity • Participate in large and growing therapeutic segment – Cholesterol & triglyceride reducers the leading therapeutic class worldwide, with 2004 sales of $30.2 billion (+12% over 2003) • U.S. fenofibrate market underdeveloped • Opportunity to gain share from other
Slide 14: CIP-Fenofibrate Progress Report
CIP-Fenofibrate Progress Report – Received approvable letter from FDA in January 2004 • 2.5 years after IND submitted – TPD tentative approval in April 2004 – FDA tentative approval in July 2004 – U.S. patent litigation dismissed in May 2005 Milestones to Commercialization – U.S. marketing partner –
Slide 15: CIP-Tramadol ER: Overview
CIP-Tramadol ER: Overview • Indicated for the treatment of moderate to moderately severe pain (e.g. osteoarthritis) • Synthetic opioid analgesic without side effects of traditional opioids • Current tramadol products dosed three to five times daily • Cipher formulation: once-daily dosing • Territory
Slide 16: CIP-Tramadol ER: Market Opportunity
CIP-Tramadol ER: Market Opportunity Pain Spectrum MILD MODERATE SEVERE OTC (Tylenol/Advil) COX-2s (Celebrex/Vioxx) NSAIDs (Motrin/Naprosyn) Opioids Tramadol
Slide 17: CIP-Tramadol ER
CIP-Tramadol ER Tramadol Unit Volume – U.S. 1,513,771 1,295,572 Nearly 1,128,804 million people in the U.S. are affected by arthritis and chronic joint symptoms. 2002 2003 2004 in thousands (Source: IMS Health) Source: Center for Disease Control
Slide 18: CIP-Tramadol ER: Market Opportunity
CIP-Tramadol ER: Market Opportunity • Growing demand for drug despite limited promotion • Once-daily dosing a significant advantage • Favorable demographics – Aging population • Opportunity to gain larger share of pain market – Anti-arthritic, Cox-2s +$5B in U.S. sales • Two other companies developi
Slide 19: CIP-Tramadol ER Progress Report
CIP-Tramadol ER Progress Report – Biopharmaceutics program • Demonstrated rapid absorption • Maintained therapeutic plasma levels throughout 24 hours • Did not exceed Cmax of reference drug – Two Phase III trials completed • Did not meet all the primary endpoints • Substantial data toward NDA submis
Slide 20: CIP-Tramadol ER
CIP-Tramadol ER – Two Phase III studies ongoing • TRAMCT.02.04 – Positive results from interim efficacy analysis – 580 patients – Product achieved statistical significance for targeted efficacy endpoints – Data will be an important piece of NDA submission • TRAMCT.02.05 – Approved under Special Prot
Slide 21: CIP-Isotretinoin: Overview
CIP-Isotretinoin: Overview • In-licensed in 2001 • Indicated for the treatment of severe acne • Territory: Americas and Pacific Rim • Patent Status: U.S. patent pending; Canada pending • Current strengths: 10mg, 20mg, 30mg • 40mg in development
Slide 22: CIP-Isotretinoin
CIP-Isotretinoin Isotretinoin Unit Volume – U.S. 68,999 61,827 68,649 More than million Americans suffer from acne severe enough to leave permanent scarring. 2002 2003 2004 in thousands (Source: IMS Health) Source: American Dermatologist Association
Slide 23: CIP-Isotretinoin
CIP-Isotretinoin • Market Overview – Current products have substantial food effect - Absorption reduced by up to 65% between fed and fasted Market Share (by sales) Three “branded generics” 37% 63% Accutane
Slide 24: CIP-Isotretinoin
CIP-Isotretinoin Pivotal Studies – Bioequivalence studies comparing Cipher product to brand original at various doses – Continued to demonstrate competitive advantage • Substantial reduction in food effect: 30% vs. 61% • The higher the total aggregate dose the lower the relapse rate Milestones to Co
Slide 25: Building the Pipeline
Building the Pipeline Formulation patented or patents pending Market opportunity Cipher Target therapeutic area > US$250 million Pipeline Proof of concept (perceived competitive advantage)
Slide 26: 2005 Milestones
2005 Milestones Tramadol efficacy data Q2 √ NDA filing for CIP-Isotretinoin Q2 √ Successful litigation outcome for CIP-Fenofibrate √ CIP-Isotretinoin NDA accepted for filing Q3 Complete Phase III efficacy trial for CIP-Tramadol Q4 U.S. marketing partner for CIP-Fenofibrate H2 Final FDA approval for
Slide 27: Q2 2005 Financial Review
Q2 2005 Financial Review (In thousands of dollars) 3 months ended 3 months ended June 30, 2005 June 30, 2004 OG&A Expenses $ 1,225 $ 1,899 R&D Expenses 4,204 3,854 Loss from continuing operations (5,292) (5,584) Income from discontinued - 529 operation Net income (loss) (5,292) (5,055) Cash and cash
Slide 28: Summary
Summary • Late-stage product portfolio targeting large markets • Lower risk business model • Strong technology partnership • Experienced management team • Solid balance sheet
Slide 29: Market Facts
Market Facts Ticker: TSX: DND Shares Outstanding: Approx. 21 million Management: Approx. 48% Recent Price: $2.20 Market Cap: Approx. $46 million