novo nordisk a focused healthcare company investor presentation – august 2004
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Novo Nordisk
A focused healthcare companyInvestor presentation – August 2004
2
Agenda
• Introduction
• Sales update• Diabetes care
• NovoSeven®
• North America update
• Research & development update
• Financial results
• Outlook for 2004
3
Forward-looking statements
This presentation contains forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995. Forward-looking statements provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘project’, ‘intend’, ‘plan’, ’believe’ and other words and terms of similar meaning in connection with a discussion of future operating or financial performance.
Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. 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, and 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 27 February 2004. Please also refer to the section ‘Financial risk factors and financial risk management' in the Annual Financial Report 2003. Novo Nordisk is under no duty to update any of the forward-looking statements or to conform such statements to actual results, unless required by law.
Novo Nordisk has the copyright to the information contained in this presentation. © 2004 Novo Nordisk A/S.
4
Highlights
Market development:• Continued solid performance of Novo Nordisk’s analogues
• Market share gains for both NovoRapid® and NovoMix® 30• Levemir® launched in UK and Finland
• NovoSeven® growth continues
Research and development:• NovoMix®50 and NovoMix®70 filed for approval in Europe Novo Nordisk expects to file for European approval of NovoSeven® in
connection with blunt trauma
Financials:• Sales: +10% as reported and +14% in local currencies• Operating profit: +12% as reported Operating profit is now expected to grow by slightly more than 5%
5
Key products continues to drive growth
Total sales DKK 13,789 billion +14% Y/Y in local currencies
NovoSeven®
Note: Share of growth is in local currency
Share of sales
Other biopharmaceuticals
Insulin analogues
Other diabetes care
Share of growth
Other diabetes care
Other biopharmaceuticals
Insulin analogues
NovoSeven®
11%
16%
18%
55%
0% 20% 40% 60%
6
Solid volume growth in the insulin market
Note: Wal*Mart figures not included. Market size and share as MAT Q1 2004 and growth as MAT Q1 2004 versus MAT Q1 2003. The arrows next to the market shares illustrate the direction of change compared to MAT Q1 2003. Source: IMS/BW
Novo Nordiskmarket share
32% ▲
58% -
76% -
49% ▲World
Japan
Europe
USA
Market
41%
49%
5%
Market size
100% 10.1%
10.9%
7.7%
15.6%
6.1%
10.7%
7.6%
4.1%
Novo Nordisk
Growth rates
7
Analogues - local currency growth of 90%
Key o
bserv
ati
on
s
•G
row
th in s
eco
nd q
uart
er
of
86
% in loca
l cu
rrenci
es
•G
row
th o
f 9
0%
in loca
l cu
rrenci
es
for
the fi
rst
half o
f 2
00
4
•Str
ong N
ovoR
apid
® a
nd
NovoM
ix®
30
mark
et
share
gain
s in
all
regio
ns
•A
nalo
gue g
row
th d
riven b
y
Nort
h A
meri
ca a
nd E
uro
pe
•C
onti
nuin
g L
evem
ir®
launch
es
to u
nderp
in f
urt
her
gro
wth
Q12002
Q22004
Analogues sales development
Mill.DKK
+81%
0
200
400
600
800
1,000
1,200
8
A continued increase in analogue market share
Source: IMS/BW
Note: Quarterly data, volume figures
Q12000
Q12004
Q12000
Q12004
Analogue penetrationNovo Nordisk’s analogue
market share
Analogues
Human insulin
33%
7%0%
5%
10%
15%
20%
25%
30%
9
NovoRapid® - driver in short-acting segment
Source: IMS/BW
Note: Quarterly data, volume figures
Q12000
Q12004
NovoRapid®’s share of short-acting analogues
Key o
bserv
ati
on
s
•Pro
vid
ing fl
exib
le a
nd m
eal-
tim
e
rela
ted d
osi
ng
•Pro
ven e
ffica
cy a
nd s
afe
ty
•2
/3 o
f N
ovoR
apid
are
sold
in d
evic
es
•A
vaila
ble
in F
lexPen®
, N
ovoPen®
and v
ials
•Fl
exPen®
is
the p
refe
rred d
evic
e
am
ong p
ati
ents
and h
ealt
hca
re
pro
fess
ionals
0%
10%
20%
30%
40%
10
NovoMix® - the starter insulin
Note: Quarterly data, volume figures
Q12000
Q12004
NovoMix®’s share of premixed analogues
Sources: IMS/BW and data presented at ADA 2004 involving 233 insulin naive patients in an open-label 28-week study.
Percentage of patients with HbA1c <
7%
0%
10%
20%
30%
40%
71%
45%
0%
20%
40%
60%
80%
NovoLog® Mix70/30
Insulin glargine(Lantus)
11
Levemir®- completing the portfolio
Less hypo- and hyperglycemic events with Levemir®
Source: Diabetes, Vol 53, June 2004
Key o
bserv
ati
on
s
•Pro
vid
ing p
redic
tabili
ty w
ithout
weig
ht
gain
s
•Le
vem
ir®
launch
ed in S
wit
zerl
and in
Marc
h.
Mark
ets
hare
of
about
10
% o
f th
e long-a
ctin
g s
egm
ent
•La
unch
ed in U
K late
June a
nd
rece
ntl
y in F
inla
nd
•Le
vem
ir t
o b
e launch
ed in o
ther
key
Euro
pean m
ark
ets
late
r th
is y
ear
•U
S a
ppro
val st
ill e
xpect
ed m
id 2
00
5
Hypoglycemia (too low blood sugar)
Hyperglycemia (too high blood sugar)
0,5
10
2
27
Insulin detemir(Levemir®)
Insulin glargine(Lantus)
# o
f even
ts p
er
year
12
Device penetration continues- driven by FlexPen™
Q12000
Pen market shares
Q12004
Disposable share of overall market
FlexPen™ share of disposable market
% of patients feeling device will result in better
compliance
Note: Quarterly data, volume figures, 15 % of patients feeling device will result in better compliance could not decide.Sources: IMS/BW and Lawton S, Berg B. Comparative evaluation of FlexPen®, a new prefilled insulin delivery system, among patients and healthcare professionals. Diabetes 2001; 50 (Suppl 2): A440
0%
5%
10%
15%
20%
25%
30%74
11
0
FlexPen™ Lilly NPH pen Aventis'prefilled pen
# in
%
13
The insulin business case
Volume growth drivers:
• Epidemic growth
• Increased life expectancy
• Increasing awareness leading to increasing diagnosis rate
• Earlier switches from tablets to insulin
• Insulin is the ultimate treatment
Vials
Du
rab
les
Dis
posa
ble
s
Improving convenience, compliance and control
Animal insulin
Human insulin
Insulin analogues
14
NovoSeven - growth continues
NovoSeven sales development
Q12002
Q22004
Mill.DKK
+10%
Key o
bserv
ati
on
s
•G
row
th in s
eco
nd q
uart
er
of
13
% in loca
l cu
rrenci
es
•G
row
th o
f 1
7%
in loca
l cu
rrenci
es
for
the fi
rst
half
•G
row
th d
riven b
y E
uro
pe a
nd
Nort
h A
meri
ca
•G
row
th in N
ort
h A
meri
ca d
riven
by a
cquir
ed h
aem
ophili
a a
nd
invest
igati
onal use
•G
row
th in E
uro
pe d
riven b
y
ele
ctiv
e s
urg
ery
and
invest
igati
onal use
0
200
400
600
800
1,000
1,200
15
North America is the key growth driver
Total sales DKK 13,789 billion +14% Y/Y in local currencies
Europe
Note: Share of growth is in local currency
Share of sales
International Operation
North AmericaJapan &Oceania
Share of growth
Japan & Oceania
International operations
North America
Europe
10%
14%
21%
55%
0% 20% 40% 60%
16
US headquarters
Formulation, filling,and packaging
Clayton
Novo Nordisk in North America - an expanding organisation
Development, sales,and marketing
Princeton
Number of employees 365 employees comparedto 198 in Q1 2000
North America
457
993 1,0141,143
1,381
Q12000
2001 2002 2003 June2004
17
North America- a significant contributor to growth
Q12000
Q22004CAGR 24%
Sales index(local currency)
Share of Novo Nordisk growth (local currency)
North America
0
50
100
150
200
250
300
0%
10%
20%
30%
40%
50%
60%
70%Sales index
Share of Novo Nordiskgrowth (right axis)
18
North America in early 2000- a strategic change needed
North AmericaSales composition Q2 2000
Other biopharmaceuticals
NovoSeven®Diabetes care
Key strategic issues
• Several unsuccessful partnerships
• Prandin focused strategy, though less than of 2% volume market share of overall OAD market
• Lack of penetration in the insulin market:
• 24% volume market share
• Retail market share 17%
• Analogue market share 0%
• 9% of Novo Nordisk insulin sold in devices
• Around 20% formulary coverage
• No corporate brand recognition
North America
19
Key strategic changes
Refocus in 2000
• Change of focus. Insulin first detailing
• Establishing own diabetes care sales force
• New management team in place
• Prioritised and increased managed care group
• New HR strategy in place
Product launches
• NovoLog®
• NovoLog® Mix 70/30 FlexPen
• NovoLog® FlexPen
• NovoLog® Mix 70/30 in vials
• Norditropin®
Other changes
• Corporate branding
• Diabetes field force expansion
• Managed care and trade team expanded
• NovoSeven® sales effectiveness and medical liaisons expanded
• Dedicated hGH sales reps
• Major partnerships
North America
20
Insulin analogues
NovoSeven®
Other diabetes care
Other biopharmaceuticals
Strategic new products driving growth
Q12000
Q22004
Sales in local currencies
Sales North America
North America
21
Diabetes care - expansion strategy paying off
Q12000
Q12004Overall market share
Analogue market sharePremix market shareShort-acting market share
Long-acting market share
Source: IMS/BW, volume, quarterly data
Novo Nordisk’s US insulin market shares
Q12000
Q12004
North America
0%
5%
10%
15%
20%
25%
30%
35%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
22
US pen penetration growing
Diabetes care - expansion strategy paying off
Source: IMS/BW, quarterly data, volume
Novo Nordisk now US device leaderNovo Nordisk’s pen market shares
Q1 2000 Q1 2002 Q1 2004
North America
0% 5% 10% 15% 20%
Insulinanalogues
Total insulinmarket
0% 20% 40% 60%
Insulinanalogues
Total insulinmarket
23
Status 2004
•Competitive diabetes sales force
• Insulin analogue focused strategy, significant player in the insulin market
•Significant growing presence in the insulin market
• 33% volume market share
• Retail market share 24%
• Analogue market share 17%
• 12% of Novo Nordisk insulin sold in devices
•More than 70% formulary coverage
•Extensive corporate branding program, several partnerships
North America
24
Further upside ahead- diabetes care
0%
10%
20%
30%
40%
50%
60%
70%
Q12000
Q12004
The US insulin market
Retail
Nonretail
Novo Nordisk’s market shares
Retail market share
Non retail market share
Source: IMS/BW, volume, quarterly data
Volume
North America
• Analogue insulin focused strategy is targeting the retail segment
• Significant value upgrade opportunities via conversion to analogues and devices
• Novo Nordisk has a highly competitive portfolio of analogues and devices
25
Further upside ahead- biopharmacuticals
Q12000
Q12004
NovoSeven®Expanding the use
• Field force effectiveness
• Increasing the number of medical liaisons
• New indications pursued• Trauma study to be initiated within the
next 6 months
• Explorative phase 2 study in spinal surgery
• ICH study completed
• Ongoing clinical trials within the inhibitor population
• NovoSeven® patient assistance programme: SevenSecure
Novo Nordisk’s growth hormone market share
Source: IMS/BW, volume, quarterly data
North America
• Dedicated hGH reps
• Expanding the label for Norditropin®
Simplexx
0%
2%
4%
6%
26
R&D pipeline update
• “High mix” NovoMix® filed for marketing approval in Europe (NovoMix® 50&70) and Japan (NovoMix® 50)
• AERx iDMS pharmacokinetic study, added to the ongoing phase 3 safety trial, to report in the first half of 2005.
Diabetes care
NovoSeven ®
• Filing for EU approval within blunt trauma expected first quarter 2005.
Trauma study in the US to be initiated within the next six months
ICH regulatory meetings scheduled with EU/US agencies later this year
Exploratory phase 2a study within spinal surgery initiated
27
NovoSeven® in trauma - less transfusions and fewer complications
Complications
Note: Data on blunt trauma victims. MOF is multiple organ failure, ARDS is acute respiratory distress syndromeSource: Data presented at World Congress on Trauma, Shock, Inflammation and Sepsis, March 2004.
• 1.5 million trauma victims in the Western world
• 100,000 trauma victims receive more than two bags of red blood cells (RBC)
NovoSeven showed• Statistically significant effect on
RBC transfusion• Reduction in complications and
mortality (strong trend)• Less days in ICU (strong trend)• No increase in adverse events
Key o
bserv
ati
on
s
Perc
en
t of
pati
en
ts -
blu
nt
0
5
10
15
20
25
30
MOF ARDS 30-daymortality
PlaceborFVIIa
28
NovoSeven® in ICH- significant effect on disability
Source: Data presented at World Stroke Conference, Vancouver, Canada, July 1 2004
• No existing treatment for ICH• 100,000 patients eligible for
treatment with NovoSeven®
NovoSeven showed• Significant reduction in ICH
volume expansion• Significant improvement in
rating on stroke scales• No significant difference in
safety end-points
Modified Rankin Scale at Day 90
100% 80% 60% 40% 20% 0%
160 μg/kg
80 μg/kg
40 μg/kg
Placebo
Key o
bserv
ati
on
s
mRS 0-1 (none)
mRS 6 (dead)
mRS 4-5 (severe)
mRS 2-3 (moderate)
29
Financial results
* EPS on a fully diluted basis.
Sales 13,789 12,533 10 7,222 6,477 12
Operating profit 3,427 3,062 12 1,911 1,665 15
Net financials 107 521 (79) 20 287 (93)
Profit before tax 3,534 3,583 (1) 1,931 1,952 (1)
Net profit 2,367 2,361 - 1,293 1,288 -
EPS (DKK)* 6.97 6.87 1 3.81 3.76 1
DKK million First half year Second quarter
2004 2003 % change 2004 2003 % change
30
5.0
6.0
7.0
8.0
9.0
Currency exposureEffect of 5%
depreciation on full-year operating profit*
(DKK million)USD -210JPY -130GBP -75USD rel -50
* currency hedging income is recorded as financial income
avg = 6.59
avg = 6.30
2002 2003 2004
avg = 5.68
avg = 7.88
USD
JPY
YTD 2004 avg = 5.59
YTD 2004 avg = 6.07
31
Outlook for 2004
Note: Above outlook is based on the assumption that exchange and interest rates remain at the current level (9 August 2004)
• Sales growth expectations:
• 11–14% growth in local currencies
• Close to 10% as reported
• Operating profit growth expectations:
• Underlying growth now expected to grow by 17-20%
• By slightly more than 5% as reported
• Net financial income expected at DKK 100 million
• Tax rate expected to be 33%
• Investments around DKK 3 billion
• Free cash flow around DKK 3 billion
Key currency ratesDKK
per 1002003
average
USD 659
JPY 5.68
GBP 1075
Current rate*
607
5.48
1116
* As of 9 August 2004
2004
ytd avg
607
5.59
1108
Note: Transition to IFRS financial reporting from 2004
32
Investor information
Investor Relations contactsNovo Nordisk A/S Investor Relations Novo Allé, DK 2880 BagsværdFax (+45) 4443 6633
Peter HaahrTel (direct): (+45) 4442 1207 E-mail: [email protected]
Palle Holm Olesen Tel (direct): (+45) 4442 6175 E-mail: [email protected]
In North America
Christian KanstrupTel (direct): (+1) 609 919 7937 E-mail: [email protected]
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
33
Appendix
34
0600
People without diabetes
Type 2 diabetes
1000 1400 1800 2200 0200 0600
800
700
600
500
400
300
200
100
Insu
lin
Sec
reti
on
(p
mo
l/m
in)
Source: O'MEARA et al. Am. J. Medicine, 1990; 89.
Insulin secretion in people without diabetes and people with type 2 diabetes
35
Type 2 - slope
Diagnosed - but not adequately treated
Note: Study on type 2 patients. Number of patients according to HbA1c level
% o
f su
bje
cts
0
20
40
60
80
100
OAD treated
Insulin treated
>9% 8%–9% 7%–8% <7%
38 27
20
15
27
22
19
32
HbA1c
Only 1/3 are at goalInsulin is the ultimate treatment
Source: HDS Omnibus Study, fall 2003
-C
ell
funct
ion
Diet and exercise alone
Oral therapy
Oral/insulin
Time from diagnosis
Type 1 - Immediate need for insulin
Insulin
36
European analogue conversion - NovoRapid®
Short-acting segment in Europe
Q1 2000
Q1 2004
Short-acting human insulin
Short-actinginsulin analogues
Q12000
NovoRapid® market share 21%
Share of short-acting segment
Q1 2004
47%
Humalog market share 25%
Source: IMS/BW
Note: Quarterly data, volume figures
22%
0%
5%
10%
15%
20%
25%
30%
37
US analogue conversion - NovoLog®
Short-acting segment in the US
Q1 2000
Q1 2004
Short-acting human insulin
Short-actinginsulin analogues
62%
Q12000
NovoLog® market share 17%
Share of short-acting segment
Q12004
Humalog market share 45%
33%
Source: IMS/BW
Note: Quarterly data, volume figures
0%
10%
20%
30%
40%
50%
60%
38
Insulin segmentation - Europe and the US
Europe US
Q12000
Q12004
Q12000
Q12004
Source: IMS/BW
Note: Quarterly data, volume figures
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Long-acting
Premix
Short-acting
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Long-actingPremixShort-acting
39
Superior treatment with Levemir® and NovoRapid® versus human insulin regimen
-0.8 ±2.4 kg
0.1 ±2.0 kg
-1
1 0
Better effect with fewer side
effects
0.9
2.1
1
3
28.6
11.1
5
15 10
Change in Hb1Ac
-0.5
-0.28 -0.5
0.5
0
p < 0.001p < 0.001 p < 0.001
p < 0.001
Hypoglycaemia allNocturnal hypoglycaemiaChange in body weight
Levemir®/NovoRapid®
Human insulin
Source: Diabetologia (2004) 47:622-629. Study design: 18-week study, 1:1 randomised, open-labelled, parallel trial, 595 patients with type 1 diabetes mellitus received insulin detemir or NPH insulin in the morning and at bedtime in combination with mealtime insulin aspart or regular human insulin respectively.
40
Liraglutide - the first once-daily human GLP-1 analogue
Fasting serum glucose
Weight change
1
0
-1
-2
-3
0
-1
-2
-3
-4
mM
%
Note: Data from the double-blind, double-dummy, randomised, parallel group dose titration phase 2 study including a total of 144 patients with an average HbA1c of 9.4-9.5%. All changes are from baseline; that is, FSG of 13.0-13.2 mM and an average weight of 91-94 kg.
p<0.0001
p<0.015
• Rapid and sustained glycaemic control, weight control, increased beta-cell mass and improved beta-cell function, safe
• Phase 3 expected to start by end of 2004
• Following optimization of the liraglutide process, including up-scaling and work on the final formulation
• Number of patients in phase 3a – total 3,500 patients where over 2,300 are on liraglutide
Liraglutide and metforminGlimepiride and metformin
41
NovoSeven® - a unique mechanism of action
NovoSeven® directly
activates factor X on the surface
of the locally activated platelets
42
NovoSeven® - expanding into general haemostasis
Critical bleedings in elective surgery
Congenital clotting disorders Bleedings in
emergencies
Intracerebral haemorrhage
Trauma
UGI
Prophylaxis
High single-dose
Liver transplantation
Spinal surgery
Hepatectomy
Glanzmann’s
FVII deficiency
Orthopedic surgery
Acquired haemophilia
Variceal bleedings
43
Many trauma patients require blood transfusion
• ~ 10-20% of all trauma patients receive one or more transfusions1
• ~ 50% of trauma patients admitted to an ICU will receive transfusions2
• 1-2% of trauma patients require “massive transfusion” (>20 units of red blood cells)3
1. Annual Report German Trauma Register 2002 2. MOF is multiple organ failure: Shapiro, J. Trauma 2003; 55:269-2743. Wudel, J. Trauma 1991; 31: 1-7
0 0-5 6-10 11-15 16-200
0.1
0.3
0.2
0.4
0.6
0.5
11-15
Units transfused
Incid
en
ce o
f M
OF
Relationship between no of units of blood transfused in the first 12h and the incidence of MOF2
44
rFVIIa (n=52)
rFVIIa reduces the need for transfusion in blunt trauma
Perc
en
t of
pati
en
ts
0
10
20
30
40
50
60
70
80
90
100
RBC units within 48 hours in patients alive
0 5 10 15 20 25 30 35 40 45 50
Placebo (n=59)
P= 0.019
Source: Data presented at World Congress on Trauma, Shock, Inflammation and Sepsis, March 2004.
45
Adverse events
Placebo (n=64) rFVIIa (n=70)n % n %
All adverse events (patients)
40 62.5 43 61.4
All adverse events (events)
113 85
Placebo (n=74) rFVIIa (n=69)n % n %
All adverse events (patients)
54 73.0 49 71.0
All adverse events (events)
135 112
Penetrating
Blunt
Source: Data presented at World Congress on Trauma, Shock, Inflammation and Sepsis, March 2004.
46
Incidence of thrombo-embolic events similar to placebo
Placebo (n=64) rFVIIa (n=70)n % Events n % Events
Thrombo-embolic events
3 4.7 3 3 4.3 3
All adverse events
40 62.5 113 43 61.4 85
Placebo (n=74) rFVIIa (n=69)n % Events n % Events
Thrombo-embolic events
3 4.1 3 3 4.1 3
All adverse events
54 73.0 135 49 71.0 112
Penetrating
Blunt
Source: Data presented at World Congress on Trauma, Shock, Inflammation and Sepsis, March 2004.
47
Intracerebral haemorrhage – key observations
Intracerebral haemorrhage
• In the Western world, stroke is the 3rd most common cause of death and the 2nd of neurologic disability after Alzheimer
• The number one leading cause of institutional placement for loss of independence among adults
15% of all cases of stroke are caused by intracerebral haemorrhage (ICH)
No current treatment option for ICH
Around 250,000
Around 100,000
Number of patients in triad markets
Note: * Late CT scan of a patient occurs more than three hours after onsetSources: Japanese Stroke Association 2002 (Japan); Hospital discharge statistics HCUP 2000 (US); Krankenhausstatistik, Stat. Bundesamt, 2001 (Germany); Les Pathologies Traitees en 1993 dans les services de soins de courte duree (France); Hospital discharges: Ministero della Salute, SDO, 1999, 2000 (Italy); Hospital Episode Statistics, 2001 (UK); EU15: extrapolated Europe 5 rates; NEJM, Qurshe, A., May 2001
Total ICHpopulation
Less patientsdead at ICU
arrival
Less late CTscans*
Patients eligiblefor NovoSeven®
48
Intracerebral haemorrhage- the deadliest form of stroke
Correlation between haematoma volume and mortality*
Source: Stroke 1993, Vol 24, 987-993 & International Task Force for Prevention Of Coronary Heart Disease. Note: * 30 day mortality as a function of haematoma volume
19%
46%
75%
Less than 30mL Between 30mL and 60mL More than 60mL
49
Significantreduction
ICH volumeexpansion
Data on primary end point
Significantimprovement
Data on secondary end points
No significantdifference
Data on overall safety
Being analysed
Data on pharmaco-economics
Score on stroke scales:day 15 and 90
Safety end points (AEs and SAEs)
• Days in hospital
• Quality of life at day 90
Results of the study
50
Symptomatic treatment:
• Anticonvulsants • Antihypertensives• Intubation and mechanical
ventilation• Intraventricular catheter and
ICP monitoring• Intravenous mannitol• Hyperventilation
Diagnosis through CT scan:
• Ischaemic or • haemorrhagic stroke
Surgery*:
•Open craniotomy•Stereotactically guided endoscopic evacuation
Return to ICU or death
*Surgery can take place earlier on. Poor results obtained historically
Today’s treatment of intracerebral haemorrhage
51
New share repurchase programme initiated
In % 1999 2000 2001 2002 2003 Targets
Operating profit growth 20.3 36.5 16.6 6.5 6.8 15
Operating margin 21.5 23.1 23.6 23.7 24.1 25
Cash to earnings* 76.6 87.9 4.8 12.1 79.2 60
ROIC 15.3 22.0 23.1 20.1 19.1 25
Long-term financial targets
Returning cash to shareholders
*Long-term target defined as three-year average
Note! All numbers according to Danish GAAP
Average
17%
23%
52%
20%
0.0
1.0
2.0
3.0
4.0
1999 2000 2001 2002 2003
DK
K b
illion
Dividends Share repurchase
52
Medicare Reform
Positives Negatives
Key o
bse
rvati
on
s•
Cre
ate
s p
art
ial pre
scri
pti
on d
rug c
overa
ge
to 6
5+
pop
ula
tion, fr
om
200
6•
6.1
mill
ion insu
lin p
resc
ripti
ons
for
am
ong
65+
pop
ula
tion
•Pro
vid
es
volu
nta
ry d
rug d
isco
unt
card
s un
til 2
006 (
curr
entl
y 4
mill
ion e
nro
llees)
•Sh
ifts
“Part
B”
reim
burs
em
ent
(fro
m A
WP
to A
SP)
•In
stit
ute
s ch
ronic
care
in
itia
tives
and
dia
bete
s sc
reenin
g
•A
llow
s H
HS a
nd F
DA
to a
pp
rove p
ara
llel
imp
ort
ati
on
•M
od
ifies
Hatc
h-W
axm
an A
ct t
o e
nhance
generi
c co
mpeti
tion
•In
crease
in
covera
ge
•Earl
ier
dia
gn
osi
s
•Im
pro
ved p
ati
ent
com
plia
nce
•In
trodu
ctio
n o
f dis
ease
m
an
ag
em
ent
•Pri
ce p
ress
ure
/ re
bate
s, w
ith F
ed
govern
ment
to
pu
rchase
50%
of
U.S
. d
rugs
in 2
00
6
•R
eim
port
ati
on?
•A
ddit
ional
legis
lati
on
?