H. Lundbeck A/S Q1-2003

Transcription

1 H. Lundbeck A/S Q1-2003

2 Safe Harbour Statement This presentation contains forward-looking statements that reflect the Management s current views with respect to certain future events and financial performance. Statements containing the outlook for 2003 and the following years naturally involve uncertainties, and consequently actual results may differ materially from those projected or implied in the forwardlooking statements. Further, certain forward-looking statements are based on assumptions of future events, which may prove not to be accurate. 2, Thursday, 15 May 2003

3 About Lundbeck H. Lundbeck A/S A unique fully-integrated pharmaceutical company focusing solely on the treatment of diseases of the central nervous system Our vision is to become the world leader in psychiatry and neurology Business and R&D focus areas Psychiatry Neurology Depression Schizophrenia Anxiety Dementia/Alzheimer s Disease Parkinson s Disease Epilepsy 3, Thursday, 15 May 2003

4 Mid-/Long-term Growth Drivers & Financial Outlook Mid/Long term Growth Drivers Establish US Salesforce Continue to strengthen pipeline through in-house R&D and licensing Leverage on existing sales infrastructure Utilize investments made in production facilities Long-term Financial Outlook Improve growth rates beyond IPO targets after transition year 2003 Drive margin expansion through enhanced operational efficiency Specific targets on cost structure elements will be given to the market after full year 2003 results 4, Thursday, 15 May 2003

5 Short-term Challenges & Financial Outlook 2003 Challenges Cipralex/Lexapro launch Intensified generic impact on citalopram franchise Ebixa launch Financial Outlook 2003 Approx 10% revenue growth Approx 12% EBIT growth Backend-loaded growth on EBIT and revenue growth 5, Thursday, 15 May 2003

6 Geographical Expansion 1992 Regional sales organisation 2002 Global sales organisation 100 sales reps Lundbeck sales reps Forest sales reps Lundbeck subsidiaries Lundbeck partner alliance 6, Thursday, 15 May 2003

7 Sales force expansion has made Lundbeck a dominant player in the antidepressant market with Cipramil Market leader in 22 countries Value Market Share rank, Depression < 4 *) Forest * 7, Thursday, 15 May 2003

8 N6A value market shares in Europe 25% 20% 21% 18% 15% 12% 12% 10% 5% 0% 8, Thursday, 15 May % 13% 6% MIRTAZAPINE VENLAFAXINE PAROXETINE CITALOPRAM SERTRALINE FLUOXETINE FLUVOXAMINE

9 Sensitivity to potential generic competition Loss of sales > 50% 25% - 50% < 25% 9, Thursday, 15 May 2003

10 Sensitivity to potential generic competition High generic exposure 32% Low generic exposure 58% Cipramil sales Q Medium generic exposure 10% 10, Thursday, 15 May 2003

11 Huge growth potential in depression market Treatment: Index 100 Treatment Diagnosed Prevalence Source: Decision Resources, November 2002, major 7 pharmaceutical markets 11, Thursday, 15 May 2003

12 Cipralex/Lexapro registration and launch overview Cipralex/Lexapro Launched Cipralex/Lexapro Registered 12, Thursday, 15 May 2003

13 Cipralex launch coverage of N6A Lundbeck markets 25% % of total N6A market (value) 8% 20% 15% 10% 5% 0% Q Q Q Q Q Q Q Q Source: IMS, , Thursday, 15 May 2003 Lundbeck markets: US: Japan: 25% of total N6A market 73% of total N6A market 2% of total N6A market

14 Cipralex launch Cipralex Launched Switzerland Sweden UK Estonia Latvia Denmark Austria Norway Bulgaria Ireland Finland Mexico South America New Zealand Belgium 14, Thursday, 15 May 2003 Launch first half 2003 India Spain Central Europe Eastern Europe Launch second half 2003 Lithuania South Africa Middle East Region France Germany Pakistan Canada Portugal Australia Turkey Italy

15 Cipralex total market share, value 14% From launch with reimbursement 12% % of N6A market 10% 8% 6% 4% 2% 0% Months after Cipralex/Lexapro launch CH S UK DK A IRL USA 15, Thursday, 15 May 2003

16 Cipralex value market penetration - Switzerland Value marketshare - N6A 5,0% 4,5% 4,0% 3,5% 3,0% 2,5% 2,0% 1,5% 1,0% 0,5% 0,0% Cipralex penetration vs. competitors Launch Q1 Q2 Q3 Q4 Time after launch Cipralex Effexor Remeron 16, Thursday, 15 May 2003

17 Cipralex value market penetration - Sweden 3,0% Cipralex penetration vs. competitors Value marketshare - N6A 2,5% 2,0% 1,5% 1,0% 0,5% 0,0% Launch Q1 Q2 Q3 Q4 Time after launch Cipralex Effexor Remeron 17, Thursday, 15 May 2003

18 Cipralex value market penetration - UK 2,5% Cipralex penetration vs. competitors Value marketshare - N6A 2,0% 1,5% 1,0% 0,5% 0,0% Launch Q1 Q2 Q3 Q4 Time after launch Cipralex Effexor Remeron 18, Thursday, 15 May 2003

19 Cipralex value market penetration - Denmark Value marketshare - N6A 5,0% 4,5% 4,0% 3,5% 3,0% 2,5% 2,0% 1,5% 1,0% 0,5% 0,0% Cipralex penetration vs. competitors Launch Q1 Q2 Q3 Q4 Time after launch Cipralex Effexor Remeron 19, Thursday, 15 May 2003

20 Cipralex value market penetration - Austria 7,0% Cipralex penetration vs. competitors Value marketshare - N6A 6,0% 5,0% 4,0% 3,0% 2,0% 1,0% 0,0% Launch Q1 Q2 Q3 Q4 Time after launch Cipralex Effexor Remeron 20, Thursday, 15 May 2003

21 Citalopram/escitalopram sales on the 7 largest markets for antidepressants Sales DKKm Q Q Change UK % - Cipramil % - Cipralex France % Germany % Spain % Italy % Canada % License sales (Forest) % 7 big countries 1, , % Other markets % Total sales 2, , % 21, Thursday, 15 May 2003

22 New Rx Market Share in USA 24,0% 21,0% 18,0% 15,0% 12,0% 9,0% 6,0% 3,0% 0,0% Week 35 Week 37 Week 39 Week 41 Week 43 Week 45 Week 47 Week 49 Week 51 Week 1 Week 3 Week 5 Week 7 Week 9 Week 11 Week 13 Week 15 Week 17 Lexapro, 18 April ,56% CELEXA LEXAPRO COMBINED SSRI Market (Celexa, Lexapro, Effexor /XR, Luvox, Paxil, Prozac, Zoloft) Source: IMS weekly RX s 22, Thursday, 15 May 2003

23 Forest income recognition Lundbeck P&L 1. Guaranteed minimum price booked as Forest income on revenue line 2. Actual sales price added as Forest income Lundbeck Balance sheet 1. Bulk delivery to Forest 2. Delivery sold in the US 1. Difference between minimum price and prepayment booked as Prepayment from Forest 2. Actual sales price deducted from Prepayments from Forest 23, Thursday, 15 May 2003

24 A market being created 46% growth within Alzheimer s in 2002 Treatment: Index 100 Treatment Diagnosed Prevalence , Thursday, 15 May 2003

25 Lundbeck Ebixa rights Exclusive Semi-exclusive 25, Thursday, 15 May 2003

26 Ebixa launch status Registered, not yet launched Launched Status April , Thursday, 15 May 2003

27 Ebixa launch coverage of N7D1 Lundbeck markets % of total N6A market (value) 30% 15% 25% 20% 15% 10% 5% 0% Q Q Q Q Q Q Q Source: IMS, 2001 Lundbeck markets: US: Japan: 31% of total N7D1 market 60% of total N7D1 market 9% of total N7D1 market 27, Thursday, 15 May 2003

28 Ebixa launch Ebixa Launched Austria Germany Holland Ireland Mexico Scandinavia UK Greece Spain Launch 2003 Australia Belgium France Portugal Switzerland Central Europe Eastern Europe Launch Asia Canada Latin America Middle East South Africa Turkey Italy 28, Thursday, 15 May 2003

29 Ebixa market share, value 12% From launch with reimbursement 10% % of N6A market 8% 6% 4% 2% 0% Months after Ebixa launch GER UK S N DK FIN IRL NL A MEX GR E Source: IMS 29, Thursday, 15 May 2003

30 Existing late-stage pipeline Compound Activity Indication Escitalopram SSRI SAD III/NDA Launch Rasagiline MAO-B Parkinson s NDA Launch Memantine NMDA antagonist Alzheimer s Mild to Moderate III NDA Launch Sertindole D 2-5HT 2 Schizophrenia PMS Launch Bifeprunox Dopamine/serotonin Schizophrenia II/III NDA Launch Gaboxadol GABA A agonist Sleep disorder II/III NDA CEP 1347 Kinase inhibitor Parkinson s+ II&III NDA Lu D 4 Schizophrenia I/II III 30, Thursday, 15 May 2003

31 Q Highlights Revenue amounts to DKK 2,395 million compared to DKK 2,378 for Q Sales of Cipralex amounts to DKK 78 million Sales of Cipramil decreased 17% to DKK 1,145 million Sales of Ebixa amounts to DKK 29 million Income from Celexa sales in the USA increased from DKK 484 million to DKK 555 million Income from Lexapro sales in the USA increased from DKK 259 million to DKK 360 million Profit from operations decreased by 27% to DKK 569 million Income from financial items amounts to DKK -44 million Profit before tax decreased by 21% and net profit decreased by 20% to DKK 523 million and DKK 356 million respectively 31, Thursday, 15 May 2003

32 Strong revenue growth CAGR : 31% Other turnover DKK billion 36% % Antipsychotics Other antidepressants Cipralex/Lexapro Cipramil/Celexa % Q Q , Thursday, 15 May 2003

33 70% of total revenue from the 7 largest CNS markets in the world Q Q US 32% Canada 6% RoW 6% UK 11% France 7% Rest of Europe 27% Germany 5% Spain 3% Italy 3% US 39% Canada 7% RoW 5% UK 7% France 7% Germany 3% Spain 3% Rest of Europe 25% Italy 4% 33, Thursday, 15 May 2003

34 Hedging an example USD exchange A 12 month forward deal contract 12 months Average hedging rate Current exchange rate The exchange rate is always locked 12 months ahead at the current exchange rate with 12 months delay Time 34, Thursday, 15 May 2003

35 Cost structure & operating margin development Operating Costs Operating Margin R&D 18.6% S,G&A 38.7% COGS 19.1% % % DKK Billion Q Q Q , Thursday, 15 May 2003

36 Cash flow (DKK million) Q Q Cash flow from operating activities Cash flow from investing activities Cash flow from operating and investing activities, net Cash flow from financing activities Increase in cash and cash equivalents , Thursday, 15 May 2003

37 H. Lundbeck A/S Appendix

38 More information please contact Investor Relations & Corporate Reporting Steen Juul Jensen Divisional Director Investor Relations & Corporate Reporting Tel: Fax: sjj@lundbeck.com Jacob Tolstrup Investor Relations Officer Investor Relations & Corporate Reporting Tel: Fax: jtl@lundbeck.com Anette Kirkeby Event Coordinator Investor Relations & Corporate Reporting Tel: Fax: anki@lundbeck.com 38, Thursday, 15 May 2003

39 Key figures Q Q Earnings per share EPS (DKK) Cash flow per share CFPS (DKK) Operating margin (%) Return on net assets (%) Return on equity (%) Solvency ratio (%) Net asset value per share (DKK) , Thursday, 15 May 2003

40 Depression 15.9 bill. USD 28% 72% Rest of world 7% North America 75% Fluvoxamine Fluoxetine Citalopram Europe Q USA Q Europe 18% Sertraline Paroxetine 0% 10% 20% 30% 40% Leading product Marketing Corporation Sales 2001 (USDm) Growth in % Seroxat /Paxil GlaxoSmithKline 2, Zoloft Pfizer 2, Prozac Eli Lilly 2, Cipramil /Celexa Lundbeck/Forest 1, Effexor American Home 1, Wellbutrin GlaxoSmithKline 1, Remeron Akzo Nobel Serzone Bristol-Myers Squib Fluoxetine Barr Barr Labs , Thursday, 15 May 2003

41 Mature but still growing healthy growth Euro Mill MAT Q2 02 Sales Growth 70% 60% 50% % 30% % 10% 0 0% Anaesthetics General Narcotic Analgesics Anti-Migraine Preps Anti- Epileptics Anti- Parkinson Preps Hypnotics & Sedatives Antipsychotics Antidepressants Anti- Alzheimer Products 41, Thursday, 15 May 2003

42 Patients achieved sustained remission 6.6 days faster on ESC than on venlafaxine XR 80 Montgomery et al, Poster presented at ECNP, 2002 Percentage of patients with sustained response ESC (N=125) VLF (N=124) * p 0.05 vs VLF ** p <0.01 vs VLF * ** ** * 0 Day Percent patients out of patients completing having achieved sustained remission by each time point 42, Thursday, 15 May 2003

43 Escitalopram offers significant tolerability advantages compared with venlafaxine * Montgomery et al, ECNP 2002 VLF (N=148) ESC (N=145) * p <0.05 No other TEAEs with an incidence above 5% showed any significant difference Percentage of patients * * 0 Nausea 43, Thursday, 15 May 2003 Sweating increased Constipation

44 Escitalopram compared to citalopram in severe depression Change from placebo in MADRS total score at endpoint CIT 40 mg (N=60) ESC 20 mg (N=51) Baseline MADRS total score 30 # p<0.05 vs CIT # 1 0 CIT 40 mg H. Lundbeck, data on file (study MD-01) ESC 20 mg 44, Thursday, 15 May 2003

45 Alzheimer s 1.2 bill. USD 2% 98% Rest of world 13% North America 63% Tacrine Galantamine Europe Q USA Q Rivastigmine Europe 24% Donepezil 0% 20% 40% 60% 80% Leading product Marketing Corporation Sales 2001 (USDm) Growth in % Aricept Pfizer Exelon Novartis Reminyl Johnson & Johnson , Thursday, 15 May 2003

46 Alzheimer s - high growth market Euro Mill MAT Q2 02 Sales Growth 70% 60% 50% % 30% % 10% 0 Anaesthetics General Narcotic Analgesics Anti-Migraine Preps Anti- Epileptics Anti- Parkinson Preps Hypnotics & Sedatives Antipsychotics Antidepressants Anti- Alzheimer Products 0% 46, Thursday, 15 May 2003

47 Overview of Marketed Compounds for AD Donepezil Rivastigmine Galantamine Memantine Indications Mild to moderate (M-M) Mild to moderate (M-M) Mild to moderate (M- M) Moderately severe to severe (MS-S) MMSE Launch Position in class 1 st 2 nd 3 rd 1 st Titration Not required Required Required Required (trial for improved titration) Administration Once daily Twice daily Twice daily Twice daily (trial for once-daily) Trials for new indications Mod-severe AD VaD MCI Lewy body VaD Mixed dementia VaD MCI Mixed dementia Mild to Moderate Diabetic Neuropathy 47, Thursday, 15 May 2003

48 Selected pipeline compounds for AD Name Class Company Phase Phenserine AchEI Axonyx II Lovastatin Statin Andrx II NS 2330 DA, NA and AchE activity NeuroSearch/BI II Colostrinin Xaliproden Immunomodulator NGF agonist ReGen Therapeutics Sanofi-Synthelabo III II Amyloid β vaccine Aggregate modulators/ gamma secretators Immunomodulator Elan I-II 48, Thursday, 15 May 2003

49 Antipsychotics 7.7 bill. USD 14% 86% Rest of world 11% Europe% 20% North America% 69% Amisulpride Europe Q USA Q Clozapine Ziprasidone Quetiapine Risperidone Olanzapine 0% 10% 20% 30% 40% 50% Leading product Marketing Corporation Sales 2001 (USDm) Growth in % Zyprexa Eli Lilly 3, Risperdal Johnson & Johnson 2, Seroquel AstraZeneca Leponex Novartis Zeldox Pfizer Solian Sanofi-Synthelabo Haldol Johnson & Johnson Tiapridal Sanofi-Synthelabo , Thursday, 15 May 2003

50 Antipsychotics - Major value conversion Euro Mill MAT Q2 02 Sales Growth 70% 60% 50% % 30% % 10% 0 Anaesthetics General Narcotic Analgesics Anti-Migraine Preps Anti- Epileptics Anti- Parkinson Preps Hypnotics & Sedatives Antipsychotics Antidepressants Anti- Alzheimer Products 0% 50, Thursday, 15 May 2003

51 Parkinson s 1.7 bill. USD 3% 97% North America 37% Europe 34% Rest of world 29% Cabergolin Europe Q Benserazid/Levodopa USA Q Pergolid Entacapon Ropinirol Pramipexol Carbidopa/Levodopa 0% 5% 10% 15% 20% 25% 30% 35% 40% 51, Thursday, 15 May 2003

52 Parkinson s - A mature & relatively stable market Euro Mill MAT Q2 02 Sales Growth 70% 60% 50% % 30% % 10% 0 Anaesthetics General Narcotic Analgesics Anti-Migraine Preps Anti- Epileptics Anti- Parkinson Preps Hypnotics & Sedatives Antipsychotics Antidepressants Anti- Alzheimer Products 0% 52, Thursday, 15 May 2003

53 Drugs in Development Parkinson s disease Compound Mode of action Company Clinical Phase Chiesi 1512 Levodopa methyl ester + carbidopa Dopamine precursor + decarboxylase inhibitor Chiesi Launch date 2004 Levodopa+ Carbidopa+ entacapone D presursor+ decarb+ COMT inhibitor Novartis Launch date 2003 KW 6002 Adenosine A2A antagonist Kyowa Hakko Phase II Rotigotine (transdermal) D2 selective DA Schwarz Pharma Phase III 53, Thursday, 15 May 2003