TRANSFORMING ETHYPHARM INTO A FULLY FLEDGED SPECIALTY COMPANY BY BUILDING ON OUR STRENGTHS

Transcription

1 TRANSFORMING ETHYPHARM INTO A FULLY FLEDGED SPECIALTY COMPANY BY BUILDING ON OUR STRENGTHS 1

2 HIGHLIGTHS Ethypharm designs, develops and produces complex drug formulations 166 M global turnover 2013 # 15% of its global turnover invested in R&D 3 plants / 1 R&D center (Grand Quevilly) 2 EU GMP & FDA approved plants 140 Licensing partners 50 products commercialized in 52 countries 825 employees worldwide Over 2 Billion doses produced in 2013 Key figures

3 A SOLID GROWTH OVER THE LAST YEARS CONSOLIDATED SALES (MILLION )

4 50 PRODUCT FAMILIES ON THE MARKET (through more than 600 marketing authorizations) Fexofenadine Fentanyl Doxycycline Theophyline 8% OTHERS PAIN & ADDICTION 36% Morphine Sulfate Oxycodone Tramadol Buprenorphine GASTRO ENTEROLOGY Esomeprazole CARDIOVASCULAR Fenofibrate Omeprazole Mesalazine 27% 29% ISMN Diltiazem % of sales by therapeutics areas 4

5 A STRONG POSITION IN THE THREE STEPS OF PAIN MANAGEMENT Treatment of Intense Pain Fentanyl Morphine LP Oxycodone Treatment of Moderate to Severe Pain Tramadol Treatment of Mild to Moderate pain Ibuprofen Ketoprofen - Omeprazole Paracetamol 5

6 MORE THAN 100 MARKETING PARTNERS ALL OVER THE WORLD 20%* North America / LATAM Europe / MEA 70%* 10%* Asia Pacific * % of global turnover 6

7 DIRECT MARKETING IN CHINA THROUGH A COMPREHENSIVE NETWORK OF AGENTS Lipifen (Fenofibrate) Etimonis (ISMN) Etiasa (Mesalazine) New Contact NT (Ambroxol) Head office, R&D center and GMP manufacturing site 4 liaison offices Level-1 wholesale agents -> 850 in-market distributors covering 3500 hospitals 7

8 A PROVEN PROFITABLE BUSINESS Product Concept Formulation & Development Market Authorization Manufacturing Sales & Marketing PROJECTS INITIATED AND FINANCED BY ETHYPHARM R&D: 15 % OF SALES SALES: PRODUCT SALES, MILESTONES, ROYALTIES & PROFIT SHARING EBITDA MARGIN: OVER 20 % OF SALES 8

9 A TWO PRONGED PIPELINE STRATEGY «New indication» Pain & Addiction SPECIALTY PRODUCTS «COMPLEX» GENERICS DEVELOPMENT KEY SUCCESS FACTORS MEDICAL POSITIONING & CLINICAL STUDY FOR EFFICACY MARKET ACCESS BIO EQUIVALENCE SPEED, FIRST TO MARKET PROTECTION EXCLUSIVITY NONE ECONOMICS LIFE CYCLE > 7 YEARS LONG TERM AGREEMENT OWN SALES FORCE IN SOME TERRITORIES SHORT LIFE CYCLE PEAK SALES < 3 YEARS PRICE PRESSURE QUICK SALES AND CASH RAMP-UP 9

10 NET PRESENT VALUE M A RICH PIPELINE LARGELY FOCUSED ON PAIN & ADDICTION «CNS Disorder» «Alcohol addiction» «Breakthrough pain» Pain & Addiction Projects Other Therapeutics area Projects Oncology Projects 20 Specialty Projects DATE OF LAUNCH 10

11 ADDING MARKETING & SALES CAPABILITIES FOR SPECIALTY PRODUCTS Product Concept Formulation & Development Market Authorization Manufacturing Laboratoires ETHYPHARM European Platforms RATIONALE Capture value by marketing & distributing high value products in selected territories STRATEGY Focus on specialty for pain, addiction and selected CNS indications that have a specific and well defined patient populations Internalization of existing products + launch internally developed products + acquisition of existing infrastructures Focus first on France (50 m by 2017), then extend to other European countries 11

12 ADDING NEW WEAPONS TO OUR GENERIC ARM Product Concept Formulation & Development Market Authorization Manufacturing FILM TECHNOLOGY BASED PRODUCTS : BUPRE-NALOXONE TADALAFIL HIGH-POTENT DEVELOPMENT CAPABILITIES & EQUIPMENT : 8 M CAPEX AND DEVELOPMENT COSTS HIGH POTENT OPIOIDS 4 ONCOLOGY PROJECTS INITIATED 12

13 A UNIQUE EXPERTISE IN DEVELOPPING MODIFIED RELEASE PRODUCTS 30 years experience for formulating oral modified release drugs A world class know-how for opoids FORMULATION Unique accumulated expertise for pharmacokinetics : 15~20 human studies per year A solid medical and clinical team : phase III and market access PHARMACEUTICAL Mastering EU, US & China registration processes 20 products successfully developped over the last 5 years up to commercial production for EMA and FDA standards CLINICAL REGISTRATION INDUSTRIAL 13

14 STATE OF THE ART TECHNOLOGIES FOR ORAL FORMULATION Oral modified release (25 patent families) Bioavailability enhancement (24 patent families) Orally disintegrating and taste-masking (22 patent families) Multicaps Transmucosal Flashtab & T-Mask Locktab Tamper resistance Nanosizing Thin film 14

15 OVER 2 BILLION DOSES PRODUCED AT 3 HIGH STANDARD MANUFACTURING SITES Châteauneuf Grand-Quevilly Shanghai MAIN FOCUS -High volumes -Complex Fluid Bed Coating Process -Opioids and controlled subtances -Nanonization -Serving mainland China & South East Asia CAPACITY million doses -700 million doses -300 million doses QUALITY Standards - FDA, EMA & JAPAN - FDA, EMA - Chinese GMP 15 15

16 QUALITY AT HEART 16

17 A COMPELLING STRATEGIC POSITION A STABLE SHAREHOLDER A GROWING, PROFITABLE, GEOGRAPHICALLY DIVERSIFIED BUSINESS A SOLID KNOW-HOW FOR PRODUCT DEVELOPMENT FROM IDEA GENERATION UP TO LAUNCH MITIGATING RISK THANKS TO STRATEGY BALANCING SPECIALTY PRODUCTS WITH COMPLEX GENERICS SIGNIFICANT CASHFLOW GENERATION TO STEADILY FUEL OUR R&D AND SEIZE ALLIANCE OPPORTUNITIES A SIZE FIT FOR FAST DECISION-MAKING AND FLEXIBILITY 17

18 THANK YOU 18