Presentation is loading. Please wait.

Presentation is loading. Please wait.

0 Novo Nordisk A focused healthcare company Exane’s Pharma Seminar May 14, 2002.

Similar presentations


Presentation on theme: "0 Novo Nordisk A focused healthcare company Exane’s Pharma Seminar May 14, 2002."— Presentation transcript:

1 0 Novo Nordisk A focused healthcare company Exane’s Pharma Seminar May 14, 2002

2 1 Forward-looking statements Forward-looking statements This presentation contains forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk's products, introduction of competing products, Novo Nordisk's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, unexpected growth in costs and expenses. Risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC) including the company's Form 20-F, which was filed on 26 April 2002. Novo Nordisk is under no duty to update any of the forward-looking statements after the date of this report or to conform such statements to actual results, unless required by law. Novo Nordisk has the copyright to the information contained in this presentation. © 2002 Novo Nordisk A/S.

3 2 Agenda Diabetes care Haemostasis management Update on the first quarter of 2002 Q&As

4 3 HRT HRT Growth hormone therapy Intellectual property Diabetes care Haemostasis management Primary growth drivers Novo Nordisk – future key drivers Diabetes care Secondary value drivers

5 4 Diabetes - an unfolding epidemic Million people with diabetes Source: World Health Organisation September 1998 150 300 20002025

6 5 Insulin – the ultimate diabetes therapy  -cell function Diet and exercise alone Oral therapy (66%) Insulin therapy (27%) Oral/insulin (approx 7%) Time from diagnosis Type 2 - slope Type 1 - Immediate need for Insulin

7 6 The miracle of insulin Patient J.L., December 15, 1922 February 15, 1923

8 7 Strong insulin market growth drivers  Obesity  Population age  Prevalence  Diagnosis  Improved insulins insulins  Improved devices devices Worldwide 5Y CAGR: Value +9% (USD) Volume +6% Source: Historic growth rates based on IMS data.

9 8 The insulin business case Volume Number of people with diabetes expected to double by 2025 Less than half of those affected are diagnosed Ageing population and a move towards affluent lifestyle leading to increased prevalence A drive towards intensified therapy 5% annual growth + Product upgrades Conversion from human insulin to insulin analogues Conversion from vials and syringes to delivery systems

10 9 Novo Nordisk positioned for value upgrade NovoRapid ® >35 NovoMix ® 30>15 FlexPen ® >15 InDuo ® >10 InnoLet ® >10 Innovo ® >20 NovoPen ® Jr>25 Number of countries launching in 2002/2001 #1 in Europe and Japan and #2 in the US Completely new line of disposable devices and the world’s only combined insulin doser and glucose meter Rapid-acting and premixed insulin analogues under roll-out Long-acting analogue to be filed at the turn of the year

11 10    Expansion opportunities for Novo Nordisk Oral antidiabetics Oral drug failures NN622 (dual-acting sensitiser) NN2211 (GLP-1) NN1998 (AERx ® iDMS) Strong market position and demand growth Significant potential in value upgrades Penetrate highly competitive market Expand presence Product upgrades Injectable insulin Value of OAD market: > USD 6 bn Value of insulin market: > USD 3 bn

12 11 NovoNorm TM /Prandin ® NN304 NN1998 NN2344 Glucose-induced insulin secretion Tissue response to insulin Hepaticglucoseproduction Glucoseuptake Impaired beta cell function Basal hyper- insulinemia Postreceptordefect Glucosetransport Insulinbinding NN414 Genetic Acquired Obesity Age Genetic Acquired Obesity Age Insulin deficiency Insulin resistance NovoRapid Type 2 Diabetes – the Metabolic Syndrome Insulin deficiency Insulin resistance Hyperglycemia NN2211 NN2211 NN622 NN622 Genetic Acquired Glucotoxicity Lipotoxicity Genetic Acquired Glucotoxicity Lipotoxicity NN344 NovoMix

13 12 Diabetes – Source of Innovation R&D Projects Clinical research Steno Diabetes Centre Oxford Diabetes Centre Clinical research centres worldwide Evidence-based medicine NN disease mgt programmes Outcomes data from > 100.000 individuals with diabetes Molecular diversity & design Protein chemistry since ’23 Medicinal chemistry since ’68 Computational chemistry since ’75 Rational drug design since ’83 Combinatorial chemistry since ’93 Trinomics Genomics: Incyte since ’95 Proteomics: CPA since ’97 Metabonomics since ’99 Drug target & screening Molecular biology since ’80 HT screening: Amersham since ’92 Chemoinformatics since ’95 Dundee MRC consortium since ’98 Ultra HT Screening since ’00 Basic research Hagedorn Research Institute Oxford and Steno Diabetes Centre Academic collaborations Consortia

14 13 Identify & clone target Establish biological function High throughput screening In vitro biological profile Chemistry In vivo diabetes models PLPc Stable cell lines DiabetesexpertiseDiabetesmodels Evolution of a Diabetes Project

15 14 Diabetes pipeline NN2211 (GLP-1 analogue) NN344 (Basal analogue) NN344 (Basal analogue) NN1998 (AERx®iDMS) NN304 (Insulin detemir) NN414 (Insulin secretion) NN622 (Dual-acting sensitiser) Phase 1 Phase 2 Phase 3 NN2344 (Insulin sensitiser)

16 15 NN622: The dual acting PPAR  /  agonist concept insulin Glucoseclearancerate Glucoseproduction + - Inhibition of lipolysis, fat re-distribution Fattyacids PPAR PPAR Triglycerides,LDL/HDL AGGTCA N AGGTCA Target gene Transcription PPRE Nucleus RXR PPAR  AGGTCA N AGGTCA Target gene Transcription PPRE Nucleus RXR PPAR 

17 16 Diabetic dyslipidaemia Type 1 Type 2 Elevated blood glucose xxxxxx Ketosisxx0 Insulin resistance xxxx Hypertensionxxx Obesityxxxx Increased LDL x/0x/0 Increased triglycerides/FFA 0xxx Decreased HDL 0xxx

18 17 NN622 – Adding lipid control to glucose regulation Key observations: Improves glucose tolerance HbA1C reduced by 1-1.5% Improves insulin sensitivity Plasma insulin reduced by 50% Corrects dyslipidaemia Dose-dependent side effects as observed with other PPAR compounds Phase 3 ongoing Eleven presentations at the upcoming ADA Lipid control HDL 0 10 20 30 40 % difference from baseline NN622 - 1 mg NN622 - 2 mg Actos - 45 mg Avandia - 8 mg Triglycerides -80 -60 -40 -20 0 20 % difference from baseline Source:Two NN622 phase studies including a total of 400 patients. US Patient Package Inserts for Actos and Avandia.

19 18 Insulin detemir versus NPH insulin Night-time glucose profile Insulin detemir versus NPH insulin Night-time glucose profile Treatment: Insulin detemir NPH insulin BG (mM) N = 21 N = 52 5 6 7 8 9 10 111211pm3am7am J. L. Selam et al. :Oral presentation EASD 2001 Findings: Predictable glucose profiles over night with detemir Insulin detemir showed reduced variability compared to NPH

20 19 Insulin detemir versus NPH insulin Hypoglycaemic events: reduced for insulin detemir at all times Hermansen et al. Diabetes Care 2001;24:296-301 36% 39% 26% 62% 50 40 30 20 10 0 NPH insulin Insulin detemir Time unknown 22:30-8:008:00-12:0012:00-22:00 Number of episodes Findings: Statistatically fewer hypoglycaemic events

21 20 Strong presence at ADA ProjectStage Number of presentations* Basic research Pre-clinical5 NN414 (Insulin secretion) Phase 1 8 NN2211 (GLP-1 analogue) Phase 2 7 NN1998 (Pulmonary insulin) Phase 2 5 NN622 (Dual-acting sensitiser) Phase 3 11 NN304 (Basal insulin analogue) Phase 3 5 NovoMix® (Premixed insulin analogue) Phase 3/ approved 5 NovoRapid®/NovoLog® (Meal-related insulin analogue) Marketed8 Insulin delivery systems Approved/ Marketed 8 NovoNorm®/Prandin® Marketed6 * will become available in the ADA abstract book

22 21 Novo Nordisk – future key drivers Diabetes care Haemostasis management Primary growth drivers Secondary value drivers HRT HRT Intellectual property Growth hormone therapy

23 22 The key advantages of NovoSeven ® are: Injury site selective activation of platelets creates high local thrombin generation which secures a tight fibrin clot Efficacy independent of inhibitor titer Effective during & after surgery Low thrombogenicity Good safety profile Home treatment Attractive cost/benefit ratio Advantages of NovoSeven ® A bleeding episode ® FVIIa/NovoSeven ® Tissue factor

24 23 Beyond haemophilia treatment HaemostasisManagement NovoSeven ® in bleeding conditions Coagulation factor deficiencies Platelet defects General haemostasis Reduction of blood and plasma transfusions No product offers this safety and efficacy profile Increasing supportive data from investigational use Haemophilia Treatment

25 24 Upper gastrointestinal bleedings *) Orthotopic liver transplantations *) Liver resection *) Spontaneousbleeding Single SingleFactorMultipleFactorsSurgicalbleeding Lack of plateletsDefectiveplatelets Coagulation Factor Deficiency Platelet Disorder General Haemostasis Haemophilia with inhibitors Intra-cerebral bleedings Trauma Vitamin K- antagonists Stem cell transplantation Liver resection *) =Patients with chronic liver disease NovoSeven ® indication expansions Current indication

26 25 Haemophilia & congenital bleeding disorders NovoSeven® update Haemophilia with inhibitors Acquired haemophilia FVII and FXI deficiency GlanzmannBernard-Soulier Other coagulation factor defects Surgery & Intensive care Trauma study now initiated *) = Patients with chronic liver disease Upper gastro- intestinal bleeding *) Orthotopic liver transplantation *) Liver resection *) Reversal of anti- coagulation therapy Stem cell transplantation Intra-cerebral bleedings Liver resection Trauma Liver resection study now completed Unchanged estimated market potential : USD 450 million

27 26 NovoSeven® liver resection study completed Exploratory Phase 2 study confirmed the good safety profile in patients without coagulopathy More than 30% reduction in number of patients needing blood transfusion and in the observed blood loss (0.05 < p < 0.1) Options for maximising the value of this positive outcome include a larger pivotal study with optimised dosing regimen First step into a potential array of surgical indications

28 27 Financials - first quarter 2002

29 28 Sales by therapy first quarter 2002 Insulin growth hit by de-stocking in Europe and timing of orders in International Operations North America, Japan & Oceania and International Operations continue to grow Growth in Europe and the US, but Japan hit by depreciation of JPY, increased competition and low market growth ® Activelle ® growing in the US and France. Insulin growth hit by de-stocking in Europe and timing of orders in International Operations North America, Japan & Oceania and International Operations continue to grow Growth in Europe and the US, but Japan hit by depreciation of JPY, increased competition and low market growth ® Activelle ® growing in the US and France. Diabetes care +2% Haemostasis management +10% (2%) hGH HRT +2% Key observations: Total turnover of DKK 5,481 mn: +2%

30 29 Key observations: De-stocking of insulin and weak NovoSeven ® sales. High NovoRapid ® growth, but below expectations NovoSeven ®, insulin and hGH continue to grow. Decreasing Prandin ® sales Growth affected by depreciation of JPY and weak market development Growth driven by insulin, but at a lower rate than usual due to timing of orders. Europe (0%) (0%) International Operations +4% North America +11% Japan & Oceania (4%) Sales by region first quarter 2002 Total turnover of DKK 5,481 mn: +2%

31 30 Timing-related issues Insulin inventory build-up in Europe Timing of insulin sales to emerging markets Performance and market related issues Lower sales of Prandin® in the US Lower growth rate of NovoSeven® in Europe Lower market growth and market share of Norditropin® SimpleXx® in Japan Slower conversion to NovoRapid® in Europe Breakdown of main sales shortfall in first quarter

32 31 Financial results first quarter Net turnover5,4815,350 2 Operating profit 1,250 1,358 (8) Net financials17237(93) Profit before tax1,2671,595(21) Net profit824 1,021 (19) Earnings per share (DKK) - diluted2.36 2.93 (19) DKK million 20022001% change

33 32 Outlook for 2002 Expected sales growth between 7-10% Growth in operating profit of 5-10% expected Net financial income is expected to be approximately DKK 150 million Tax rate expected at the level of 35% Investments expected at DKK 4.5 billion Slightly negative free cash flow Above outlook is based on the assumption that exchange and interest rates remain at the current level (30 April 2002).

34 33 Entered 7 new clinical areas with 8 new studies Three Phase 2 studies to be reported on in 2002 Estimated market potential for NovoSeven ® within haemophilia and congenital bleeding disorders of USD 450 million Patent protection in Europe and the US until 2011, in Japan until 2008 Primary growth drivers Secondary value drivers Novo Nordisk – key drivers Insulin market growing >10% pa In process of launching the most comprehensive portfolio of insulin and insulin devices Expansion opportunity in faster growing Oral Anti-Diabetes market with dual-acting sensitiser NN622, currently in Phase 3 Strong diabetes pipeline including GLP-1 analogue (NN2211) and pumonary insulin Diabetes care Haemostasis management HRT HRT Growth hormone therapy Intellectual property

35 34 Investor Information Investor Relations contacts: Novo Nordisk A/S Investor Relations Novo Allé DK­2880 Bagsværd Denmark Fax (+45) 4444 2314 Peter Haahr Phone (+45) 4442 1207 E-mail: pehr@novonordisk.com Palle Holm Olesen Phone (+45) 4442 6175 E-mail: phoo@novonordisk.com Rasmus Jorgensen Phone (+1) 212 867 0123 E-mail: rrhj@novonordisk.com Share information Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol "NVO". For further company information, visit Novo Nordisk on the Internet at http://www.novonordisk.com

36 35 Appendix

37 36 Sales by therapy in first quarter DKK million20022001% of total % change (2002) Insulin etc3,4863,39964 3 NovoNorm®/Prandin®3503556 (1) Diabetes care, total3,8343,754 70 2 Haemostasis management*80073015 10 Growth hormone therapy450 4578 (2) HRT3353276 2 Other62821 (24) Total5,4815,350 100 2 * NovoSeven ® * NovoSeven ®

38 37 Sales by region in first quarter DKK million20022001 % of total % change (2002) (2002) Europe 2,4062,41044 (0) North America1,3541,2162511 Japan & Oceania87991616 (4) International Operations842808154 Total 5,4815,350100 2

39 38 ’In-market’ sales Growth compared to previous year Q1 2001 Q2 2001 Q3 2001 Q4 2001 Jan/Feb 2002 Total market growth: VolumeValue6%12%9%14%9%11%9%13%8%12% Novo Nordisk growth: VolumeValue5%8%8%10%7%8%8%11%7%12% Insulin sales in Europe – ‘in-market’ sales’ Source: IMS ‘company market data’. Preliminary information for Jan/Feb 2002 Note: ‘In market data’ reflects sale of insulin products from the wholesalers to the pharmacists.

40 39 Insulin de-stocking in Europe – the supply chain Novo Nordisk Patient Wholesalers - Approx 1,200 in Europe Local wholesalers’ inventory and parallel importers Pharmacists - Estimated 150,000 in Europe ’ex-factory’sales ’In-market’ sales Patient payment Sales booked at Novo Nordisk

41 40 Corrective measures Enhanced focus on analogue conversion NovoRapid® to be backed by NovoMix® 30 Consolidation of European management Strategic changes implemented in Japan Dedicated cross-functional Norditropin SimpleXx® sales team Several upcoming clinical trials Cost-containment programme targeting areas not affecting key production, sales or R&D activities Improved control measures


Download ppt "0 Novo Nordisk A focused healthcare company Exane’s Pharma Seminar May 14, 2002."

Similar presentations


Ads by Google