Novo Nordisk A focused healthcare company

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  • Duration of Action, Pharmacodynamic Profile and Between-Subject Variability of Insulin Detemir in Subjects with Type 1 Diabetes THOMAS R. PIEBER, JOHANNES PLANK, EVELYN GOERZER, ROMANA SOMMER, ANDREA WUTTE, FRANK SINNER, MANFRED BODENLENZ, LARS ENDAHL, EBERHARD DRAEGER, MILAN ZDRAVKOVIC. Graz, Austria and Bagsvaerd, Denmark. Insulin detemir represents a new class of soluble, basal insulin analogues with a protracted, predictable and flat pharmacodynamic profile. The objective of this double-blind, six-period crossover study was to investigate the pharmacodynamic profile and duration of action for five s.c. doses of insulin detemir, and one s.c. dose of NPH. A total of twelve subjects with type 1 diabetes (C-peptide ≤0.03 nmol/L) were randomized to one s.c. dose of NPH (0.3 IU/kg; 1 IU = 6 nmol) and five s.c. dose levels of insulin detemir (0.1, 0.2, 0.4, 0.8, 1.6 U/kg; 1 U = 24 nmol). The study was carried out as a 24 h isoglycemic clamp, where plasma glucose (PG) was kept at 7.2 mM (as described by Lepore et al. Diabetes 2000; 49: 2142-8). In the run-in period this was accomplished by insulin infusion. After trial drug administration insulin infusion was gradually reduced and withdrawn when PG < 6.9 mM. The clamp was stopped when PG > 11.1 mM or after 24 hours. Duration of action was defined as the time from 50% reduction of i.v. insulin infusion to PG > 8.3 mM or after 24 hours. Mean glucose infusion rate (GIR) profiles for 0.3 IU/kg NPH showed a peak around 6-8 hours, followed by a marked decline. Based on AUC(GIR), the insulin detemir dose comparable to 0.3 IU/kg NPH was found to be between 0.2 U/kg and 0.4 U/kg. However, at these doses the GIR profiles obtained with insulin detemir were both flatter and less variable in comparison to the NPH profiles. Assessment of endogenous glucose production (EGP) and peripheral glucose uptake (Rd) indicated that insulin detemir may have a more pronounced effect on EGP and a lesser effect on Rd compared to NPH. Duration of action for insulin detemir was dose dependent, and at the higher dose levels the clamp was terminated after 24 h despite a substantial GIR. At 0.4 U/kg of insulin detemir the average GIR was around 1 mg/kg/min, and at this therapeutically relevant dose, duration of action was 20 h . Finally, there was a lower between-subject variation for insulin detemir in duration of action, AUC(GIR) and max(GIR) compared to NPH. In conclusion, this study shows that insulin detemir provides a flat, and protracted pharmacodynamic profile, with a high degree of between-subject predictability.
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  • This slide gives an overview of which tasks to be carried out at IR in order to pro-actively peruse the strategy set out for the department. A strategy will shall revert to later on. Looking at the small four circles on the left the can be understood as the marketing process. Defining…First it is necessary to define the market. At investor relations this means segmenting the investors and analysts. This is a multi-dimensional task looking geographically as well as on the type of investor – for example mutual funds, analysts, private investor etc. Understanding…Next its about understanding the product we want to sell. In our case is about always righting and selling the the optimal equity story Identifying…Than its about setting up the various tools which can be used. At IR these include conference calls, shareholder magazine, road shows, one-on-one, phone calls etc. Managing…Final part of the marketing process is than to manage the tools, which at IR primarily is about when to do what Before moving into action via a targeted marketing the positioning of the company in the minds of the investor community is necessary. As I think you might finds this subjects a have address this with a few slides
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  • This was an open labeled, randomized single dose trial of 61 type 2 diabetes. Novomix 20 and Mix25 were injected immediately before a test meal, and BHI30 was injected 15 min before a test meal. The primary target of analysis was serum glucose excursion 0-5 h after meal. This trial demonstrates that NovoMix30 improves postprandial glycemic control compared with both Mix25 and BHI30 in subjects with type 2 diabetes
  • Long-term Efficacy and Safety of Insulin Detemir in Subjects with Type 1 Diabetes. Favorable Weight Development and Risk Reduction of Nocturnal Hypoglycemia EBERHARD STANDL, ANTHONY ROBERTS, HANNE LANG, Munich, Germany; Ashford, Australia; Bagsvaerd, Denmark Insulin detemir is a soluble basal insulin analog with neutral pH and a unique mechanism of protraction providing a smooth and predictable action profile. This trial compared the safety and efficacy of insulin detemir and NPH insulin in adult subjects with type 1 diabetes. The trial was a multi-center, multinational, open-label, parallel-group, 6-month extension study of a 6-month randomized, comparative study of insulin detemir and NPH insulin. All subjects were on a basal (twice-daily)-bolus regimen with human soluble insulin as meal related insulin: 288 subjects were exposed to trial medication in the extension trial (154 on insulin detemir and 134 on NPH insulin; 184 males and 104 females; mean (SD) age: 41.6 (12.9) years). A total of 252 subjects (134 on insulin detemir, 118 on NPH insulin) completed the 12 month treatment period. Similar glycemic control as measured by HbA1c, 9-point blood glucose profiles and fasting plasma glucose was observed in the two treatment groups after 12 months of treatment. HbA1c values of 7.9% and 7.8% were found for insulin detemir and NPH insulin, respectively. Insulin detemir showed a trend towards lower risk of hypoglycemia during the night (relative risk (detemir/NPH) = 0.71, p=0.067). A weight loss of 0.3 kg was observed in the insulin detemir group, while a 1.4 kg weight gain was observed in the NPH insulin group, resulting in a significant and clinically relevant difference between groups after 12 months of treatment (1.7 kg, p=0.002). The proportion of subjects with serious adverse events during 12 months was lower in the insulin detemir group (9.1% versus 13.4%). In conclusion, insulin detemir and NPH insulin provided similar glycemic control and comparable safety profiles after 1 year of treatment. The favorable development in weight and the trend towards lower risk of nocturnal hypoglycemia in the insulin detemir group indicate promising potential of this new basal insulin analog.
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  • Novo Nordisk A focused healthcare company

    1. 1. Novo Nordisk A focused healthcare company Investor Presentation August 2002
    2. 2. 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. 3. Agenda <ul><li>Update on the first half year of 2002 </li></ul><ul><li>Diabetes care </li></ul><ul><li>Haemostasis management </li></ul><ul><li>Growth hormone therapy </li></ul><ul><li>Hormone replacement therapy </li></ul><ul><li>Financial results </li></ul><ul><li>Outlook 2002 </li></ul>
    4. 4. First half year 2002 in brief <ul><ul><li>Sales up 6% from first half 2001 </li></ul></ul><ul><ul><li>Operating profit up 4% from first half 2001 </li></ul></ul><ul><ul><li>Second quarter sales up 9% and operating profit up 16% compared to Q2 2001 </li></ul></ul><ul><ul><li>Continued depreciation of USD, JPY and GBP versus DKK </li></ul></ul><ul><ul><li>Full-year outlook maintained at 5-10% operating profit growth </li></ul></ul>
    5. 5. Sales by therapy first half year 2002 Insulin sales growth in International Operations (IO), Europe and North America. NovoNorm ® growth in Europe and IO North America and Europe both drive growth Growth in Europe and the US, but Japan hit by depreciation of JPY, increased competition and low market growth Negatively affected by parallel trade within Europe and by lower market growth Diabetes care +6% Haemostasis management +15% (1%) hGH HRT (1%) Key observations: Total turnover of DKK 12,035 mn: +6%
    6. 6. Sales by region first half year 2002 Key observations: Weak Q1, but both insulin and NovoSeven ® growth returned in Q2 NovoSeven ® , insulin and hGH continue to grow. Growth affected by depreciation of JPY, increasing competition, price decreases and weak market development Weak Q1, but strong Q2 growth driven by insulin and oral anti-diabetes products Europe +4% International Operations +20% North America +10% Japan & Oceania (4%) Total turnover of DKK 12,035 mn: +6%
    7. 7. HRT Growth hormone therapy Intellectual property Diabetes care Haemostasis management Primary growth drivers Novo Nordisk – future key drivers Secondary value drivers Diabetes care
    8. 8. Diabetes care S ales by quarter <ul><li>Key observations: </li></ul><ul><li>Insulin growth primarily realised in International Operations and North America, followed by Europe </li></ul><ul><li>Japan & Oceania was impacted negatively by the depreciation of JPY and decreased slightly </li></ul><ul><li>The roll-out of NovoRapid® and NovoMix® continues - analogue sales up by 171% in 1H 2002 </li></ul><ul><li>NovoNorm®/Prandin® growth driven by Europe and International Operations </li></ul>DKK million 1999 2000 2001 2002 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 5,000 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 + 9%
    9. 9. Insulin market overview (MATQ1 2002 Volumes) Notes: Industrialised world only. Based on IMS data. Monthly data used for Canada. Wal*Mart figures not included. Growth in Europe effected by conversion of formulation. Novo Nordisk market share 2 6 % 5 8 % 78 % 60% 4 6 % World Rest of IMS world Japan Europe USA Market growth 43 % 48 % 4% 6 % % market size 100% 3.6% 7.9% 7.0% 7.8% 6.1%
    10. 10. Insulin sales in Europe – ‘in-market’ sales Source: Based on IMS ‘brand market data’. Preliminary information for YTD May 2002 Note: ‘In market data’ reflects sale of insulin products from the wholesalers to the pharmacists. 8% 13% 8% 12% Jan/Feb 2002 Growth compared to previous years 6% 10% 6% 10% YTD May 2002 5% 10% 9% 12% 8% 9% 9% 11% <ul><li>Novo Nordisk growth: </li></ul><ul><li>Volume </li></ul><ul><li>Value </li></ul>Q1 2002 Q4 2001 Q3 2001 Q2 2001 5% 9% 9% 13% 9% 11% 9% 13% <ul><li>Total market growth: </li></ul><ul><li>Volume </li></ul><ul><li>Value </li></ul>’ In-market’ sales
    11. 11. European analogue conversion - NovoRapid ® Short-acting segment in Europe Q2 1996 Q1 2002 Short-acting human insulin 37% Short-acting insulin analogues Short-acting human insulin June 2000 NovoRapid ® market share 12.3%* Humalog market share 26.5%* * IMS ‘brand’ volume market share of short-acting insulin. Preliminary information for Apr/May 2002 Share of short-acting segment May 2002 37% * IMS ‘brand’ volume market share of short-acting insulin.
    12. 12. US analogue conversion - NovoLog ® <ul><li>Key observations: </li></ul><ul><li>Market share increase backed by continued penetration of NovoLog® </li></ul><ul><li>NovoLog® launched September 2001 - pump indication added in December 2001 </li></ul><ul><li>Launch of NovoLog ® Mix to follow this year </li></ul>0% 5% 10% 15% 20% 25% 30% Q1 1999 Q2 1999 Q3 1999 Q4 1999 Q1 2000 Q2 2000 Q3 2000 Q4 2000 Q1 2001 Q2 2001 Q3 2001 Q4 2001 Q1 2002 Novo Nordisk total market share (vol) in the US NovoLog ® share Novo Nordisk share of the US short-acting market
    13. 13. NovoMix ® 30 – simple control <ul><li>Key observations: </li></ul><ul><li>NovoMix ® 30 covers the basal insulin need while adding the benefit of targeting post-prandial glucose control </li></ul><ul><li>NovoMix ® 30 comes in FlexPen ® - the preferred disposable device </li></ul><ul><li>Full premix analogue programme scheduled </li></ul>Blood glucose control Convenience Basal- Bolus OADs Human Mix NPH NovoMix® 30
    14. 14. Analogue case still intact <ul><li>Strong analogue penetration continues </li></ul><ul><li>NovoRapid®/NovoLog ® continues to increase share in the short-acting segment </li></ul><ul><li>NovoMix ® 30 being rolled out in Europe </li></ul><ul><li>NovoMix ® 30 to be launched in the US later this year </li></ul><ul><li>Analogues backed by new devices: InDuo ® , FlexPen ®, InnoLet® and NovoPen ® Jr </li></ul>Analogues share of insulin sales worldwide Novo Nordisk's share of short-acting analogue market worldwide Notes: Volumes in industrialised world IMS 1996 1997 1998 1999 2000 2001 2002 17% 20%
    15. 15. The insulin business case <ul><li>Volume </li></ul><ul><li>Number of people with diabetes expected to double by 2025 </li></ul><ul><li>Less than half of those affected are diagnosed </li></ul><ul><li>Ageing population and a move towards affluent lifestyle leading to increased prevalence </li></ul><ul><li>A drive towards intensified therapy </li></ul>5% annual growth 5% annual growth + <ul><li>Product upgrades </li></ul><ul><li>Conversion from human insulin to insulin analogues </li></ul><ul><li>Conversion from vials and syringes to delivery systems </li></ul>
    16. 16. Diabetes pipeline <ul><li>NN2211 (GLP-1 analogue) </li></ul><ul><li>NN344 (Basal analogue) </li></ul><ul><li>NN1998 (AERx ®iDMS ) </li></ul><ul><li>NN304 (Insulin detemir) </li></ul><ul><li>NN414 (Beta cell rest) </li></ul>Phase 1 Phase 2 Phase 3 <ul><li>NN2344 (Insulin sensitiser) </li></ul>Note: Clinical development of ragaglitazar (NN622) was suspended in July 2002. <ul><li>NovoMix ® 50 (Premixed analogue) </li></ul>
    17. 17. Insulin detemir to be filed at the turn of the year <ul><li>Detemir compared with NPH : </li></ul><ul><li>Has significantly less within-subject variability </li></ul><ul><li>Results in a slight decrease in body weight </li></ul><ul><li>Has significantly less nocturnal hypoglycaemic events </li></ul><ul><li>Produces a smoother nocturnal glucose profile </li></ul><ul><li>The duration of action of detemir is 20 hours at a therapeutically relevant dose of 0.4 U/kg. </li></ul>C max CV (%) AUC 0-24h, CV insulin conc . (%) Insulin detemir 13 20 NPH insulin 26 37 Reduction 51% 45% p- value <0.001 0.001 Significantly lower within-subject variability Within-subject variability of pharmacokinetics
    18. 18. Our inhaled insulin – ready to enter Phase 3 AERx ® s.c. HbA 1c (%) HbA 1c mean profiles, ITT population, 7 7.5 8 8.5 9 ADA2002 -0.74% -0.74% HbA 1c (%) reduction <ul><li>Key observations: </li></ul><ul><li>Deep lung deposition of aerosols </li></ul><ul><li>“ Breath Check”, one unit increments, highly reproducible delivery </li></ul><ul><li>Rapid-acting profile, one unit increments and patient-friendly features </li></ul><ul><li>1 oral presentation and 4 posters at ADA </li></ul><ul><li>3 posters accepted for EASD </li></ul><ul><li>Phase 3 to start later this year </li></ul>mean ± 2 SEM
    19. 19. Novo Nordisk – future key drivers Diabetes care Haemostasis management Primary growth drivers Secondary value drivers HRT Intellectual property Growth hormone therapy
    20. 20. Haemostasis management (NovoSeven ® ) <ul><li>Key observations: </li></ul><ul><li>Growth in North America continues </li></ul><ul><li>Solid Q2 growth in Europe, partly due to large single orders in several European countries </li></ul><ul><li>Pan European Haematology Business Unit now established </li></ul>1999 2000 2001 2002 0 100 200 300 400 500 600 700 800 900 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 DKK million S ales by quarter + 20%
    21. 21. NovoSeven® – current indication Create confidence First-line position in haemophilia Acquired haemophilia <ul><li>Estimated close to 1,000 patients in industrialised world </li></ul><ul><li>75-100% efficacy in acquired haemophilia </li></ul><ul><li>Awareness creation and outcome data </li></ul><ul><li>~ 300,000 doses with excellent safety data </li></ul><ul><li>Effective haemostasis established in orthopaedic surgery </li></ul><ul><li>Early treatment provides faster recovery </li></ul><ul><li>3,500 pts in industrialised world </li></ul><ul><li>93% efficacy in bleeding episodes treated at home </li></ul>
    22. 22. Unmet needs in haemostasis management <ul><li>Bleeding a is serious clinical challenge </li></ul><ul><ul><li>Common cause of death </li></ul></ul><ul><ul><li>Morbidity associated with blood transfusions is of great concern </li></ul></ul><ul><li>Surveys indicate large unmet clinical need </li></ul><ul><ul><li>10 million severe bleeding conditions annually </li></ul></ul><ul><ul><li>Severe bleeding conditions growing in relation to medical procedures </li></ul></ul><ul><li>Growing industry attention </li></ul><ul><ul><li>EPO manufacturers </li></ul></ul><ul><ul><li>Oxygen carriers </li></ul></ul><ul><li>Alternatives are scarce </li></ul><ul><ul><li>Blood products are becoming more scarce and expensive </li></ul></ul>
    23. 23. NovoSeven® expansion project Haemophilia & congenital bleeding disorders <ul><li>Haemophilia with inhibitors </li></ul><ul><li>Acquired haemophilia </li></ul><ul><li>FVII and FXI deficiency </li></ul><ul><li>Glanzmann </li></ul><ul><li>Bernard-Soulier </li></ul><ul><li>Other coagulation factor defects </li></ul>Surgery & Intensive care *) = Patients with chronic liver disease <ul><li>Upper gastro- intestinal bleeding *) </li></ul><ul><li>Orthotopic liver transplantation *) </li></ul><ul><li>Liver resection *) </li></ul><ul><li>Reversal of anti-coagulation therapy </li></ul><ul><li>Stem cell transplantation </li></ul><ul><li>Intra-cerebral bleedings </li></ul><ul><li>Liver resection </li></ul><ul><li>Trauma </li></ul>
    24. 24. Novo Nordisk – future key drivers Diabetes care Primary growth drivers Secondary value drivers Intellectual property HRT Haemostasis management Growth hormone therapy
    25. 25. Growth hormone therapy DKK million S ales by quarter 1999 2000 2001 2002 <ul><li>Key observations: </li></ul><ul><li>Norditropin® SimpleXx® still growing in Europe and the US </li></ul><ul><li>Growth in Japan affected by depreciation of JPY, a mandatory price reduction as well as increased competition in general and a relatively slow market development </li></ul><ul><li>Sales and marketing team under restructuring in Japan   </li></ul>0 100 200 300 400 500 600 700 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 - 1%
    26. 26. Novo Nordisk – future key drivers Diabetes care Primary growth drivers Secondary value drivers Intellectual property HRT Haemostasis management Growth hormone therapy
    27. 27. Hormone replacement therapy DKK million S ales by quarter 1999 2000 2001 2002 0 50 100 150 200 250 300 350 400 450 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 - 4% <ul><li>Key observations: </li></ul><ul><li>Lack of growth primarily due to increased parallel trade within Europe, but also lower market growth </li></ul><ul><li>Low-dose sequential product, Novofem ™ , will be launched in Europe during 2002 </li></ul><ul><li>The termination of the Women’s Health Initiative study (WHI) increases market uncertainty, but will most likely favour low-dose products </li></ul>
    28. 28. F inancial results Net turnover 12,034 11,351 6 6,553 6,001 9 Operating profit 2,856 2,740 4 1,606 1,382 16 Net financials 99 241 (59) 82 4 - Profit before tax 2,955 2,981 (1) 1,688 1,386 22 Net profit 1,925 1,908 1 1,101 887 24 EPS (DKK)* 5.51 5.48 1 3.15 2.55 24 * Earnings per share on a diluted basis, ie 349.6 million shares in H1 2002 and 349.4 million Q2 2002. DKK million First half year Second quarter 2002 2001 % change 2002 2001 % change
    29. 29. Currency exposure 2001 avg = 8.32 2001 avg = 6.85 2000 2001 2002 Effect of 5% appreciation on operating profit* (DKK million) JPY +140 USD +110 GBP +50 * ie before hedging activities. 1H 2002 avg = 6.39 1H 2002 avg = 8.29 Aug 5 Apr 30 DKK per USD 7.55 8.25 (8.5%) DKK per 100 JPY 6.34 6.43 (1.4%)
    30. 30. Outlook for 2002 <ul><li>Expected sales growth between 6-8% </li></ul><ul><li>Growth in operating profit of 5-10% is reaffirmed </li></ul><ul><li>Net financial income now expected to be approximately DKK 250 million </li></ul><ul><li>Tax rate still expected at the level of 35% </li></ul><ul><li>Investments still expected at DKK 4.5 billion </li></ul><ul><li>Share repurchasing programme of DKK 2 billion initiated </li></ul><ul><li>Above outlook is based on the assumption that exchange and interest rates remain at the current level (6 August 2002). </li></ul>
    31. 31. Investor Information <ul><li>Investor Relations contacts: Novo Nordisk A/S Investor Relations Novo Allé DK­2880 Bagsværd Denmark </li></ul><ul><li>Fax (+45) 4444 2314 Peter Haahr Phone (+45) 4442 1207 E-mail: pehr@novonordisk.com </li></ul><ul><li>Palle Holm Olesen Phone (+45) 4442 6175 E-mail: phoo@novonordisk.com </li></ul><ul><li>Rasmus Jorgensen Phone (+1) 212 878 9607 E-mail: rrhj@novonordisk.com </li></ul>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 &quot;NVO&quot;. For further company information, visit Novo Nordisk on the Internet at http://www.novonordisk.com
    32. 32. Appendix
    33. 33. Sales by therapy in first half year 2002 DKK million 2002 2001 % of total % change ( 2002 ) Insulin etc 7,611 7,169 63 6 OAD * 801 769 7 4 Diabetes care, total 8,412 7,938 70 6 Haemostasis management 1,726 1,499 14 15 Growth hormone therapy 998 1,011 8 (1) HRT 684 692 6 (1) Other 214 211 2 1 Total 12,034 11,351 100 6 * Oral antidiabetes products (OAD) include NovoNorm®/Prandin® as well as GlucoFormin ® (generic metformin) sales by Biobrás in 1H 2002.
    34. 34. Sales by region in first half year 2002 DKK million 2002 2001 % of total % change ( 2002 ) Europe 5,214 5,030 43 4 North America 2,852 2,601 24 10 Japan & Oceania 1,998 2,079 17 (4) International Operations 1,970 1,641 16 20 Total 12,034 11,351 100 6
    35. 35. 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
    36. 36. Improved postprandial control vs lispromix 25 S-glucose excursion 0-5h (mmol/l h) Hermansen K et al. Diabetes Care 2002;25:883-888. -10% -17% p < 0.05 p < 0.0001
    37. 37. Weight change over 12 months -0.5 0 0.5 1 1.5 Insulin detemir NPH Change in Weight ( Kg) E. Standl et al. Abstract number 467 ADA 2002 Body weight control with insulin detemir p = 0.002 Type 1 diabetes -1.7 Kg
    38. 38. Advantages of NovoSeven ® FVIIa/NovoSeven ® Tissue factor <ul><li>Faster haemostasis leads to </li></ul><ul><li>Fewer transfusions/ transfusion- free surgery </li></ul><ul><li>Reduced rebleeding </li></ul><ul><li>Faster recovery </li></ul><ul><li>Reduced morbidity and mortality </li></ul><ul><li>Improved quality of life </li></ul>A bleeding episode
    39. 39. Corrective measures <ul><ul><li>Enhanced focus on analogue conversion </li></ul></ul><ul><ul><ul><li>NovoRapid ® to be backed by NovoMix ® 30 </li></ul></ul></ul><ul><ul><ul><li>Consolidation of European management </li></ul></ul></ul><ul><ul><li>Strategic changes implemented in Japan </li></ul></ul><ul><ul><ul><li>Dedicated cross-functional Norditropin ® SimpleXx ® sales team </li></ul></ul></ul><ul><ul><ul><li>Several upcoming clinical trials </li></ul></ul></ul><ul><ul><li>Cost-containment programme targeting areas not affecting key production, sales or R&D activities </li></ul></ul><ul><ul><li>Improved control measures </li></ul></ul>Slide from Q1 / 02 conference call
    40. 40. Status on NN622 <ul><li>Current clinical trials stopped and new planned studies postponed </li></ul><ul><li>Tumour mechanism studies initiated </li></ul><ul><li>Several possible outcomes of mechanism studies </li></ul><ul><ul><li>Mechanism not of human relevance </li></ul></ul><ul><ul><li>Mechanism of human relevance </li></ul></ul><ul><ul><li>Mechanism unresolved </li></ul></ul><ul><li>Renewed ragaglitazar assessment Q1 2003 </li></ul><ul><li>The decision to suspend the clinical development of ragaglitazar will not impact Novo Nordisk’s expectations for the financial results for 2002 </li></ul>Slide from 22 July conference call
    41. 41. No major patent expirations Source: Nordea Securities % of 2000 sales with patents expiring in 2001-2005 0% 10% 20% 30% 40% 50% 60% AstraZ. S-Plough Merck Eli Lilly Pfizer Aventis BMS GSK Roche N o vartis Pharmacia J&J AHP Abbott Amgen Novo Nordisk <ul><li>No significant patent expirations on this side of 2010 </li></ul>
    42. 42. Selected volume market share development Source: Based on IMS data. 44% 43% 37% 42% 57% 26% February 2002 36% 51% <ul><li>Basal segment </li></ul>45% 42% <ul><li>Short-acting </li></ul>45% 43% <ul><li>Mix-segment </li></ul>43% 44% Germany 57% 57% Europe 27% 26% USA May 2002 Month of Lantus launch

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