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Transcript of Novo Nordisk 0 A focused healthcare company Investor presentation – Merrill Lynch Global...
Novo Nordisk
1
A focused healthcare companyInvestor presentation – Merrill Lynch Global Pharmaceutical ConferenceLondon, 24 September 2003
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 27 March 2003. 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. © 2003 Novo Nordisk A/S.
3
Agenda
• Novo Nordisk in brief
• Diabetes care
• The diabetes care business case
• Realising the diabetes care business case in the US
• Haemostasis management
• Research and development
• Diabetes care
• Biopharmaceuticals
• Financial update and outlook 2003
4
Novo Nordisk in brief
• Consistent, strong organic growth• Focused on few therapeutic
areas with large unmet medical needs
• Leadership in diabetes and most extensive diabetes pipeline in the industry
• Becoming an established player in general haemostasis management
• Proven biotech and drug delivery capabilities
• Low exposure to patent expirations
Long-term financial targets:
EBIT growth of 15%
EBIT margin of 25%
ROIC of 25% (post-tax)
Cash to earnings of 60%
Balancing growth and value
5
Sales in first half year 2003
North America
Japan & Oceania Europe
InternationalOperations 45%
24%
16%
15%
HRT
Haemostasis management
Diabetes careGrowth hormone therapy
14%
5%
70%
8%
By therapy By region
Total DKK 12.6 billion +5% reported and +17% in local currencies
6
Diabetes - an unfolding epidemic
Source: Mokdad et al., Diabetes Care 2000;23:1278-83; J Am Med Assoc 2001;286:10.
No Data <4% 4%-6% 6%-8% 8%-10% >10%
1990
1995
2001
Diabetes prevalence
.
7
Insulin – the ultimate treatment
-ce
ll fu
nctio
n
Diet and exercise alone
Oral therapy
Insulin therapy
Oral/insulin
Time from diagnosis
Type 2 – slope
Type 1 – immediate need for insulin
8
Insulin market overview – volume
Source: IMS/BW. Volume data for USA, Europe, Japan, Canada, New Zealand, South Africa and Australia. Wal*Mart figures not included. Market size and share as MAT Q1 2003 and growth as MAT Q1 2003 versus MAT Q1 2002. The arrows next to the market shares illustrate the direction of change compared to MAT Q1 2002.
Novo Nordiskmarket share
28% ▲
59% ▲
76% ▼
47% ▲World
Japan
Europe
USA
Market
41%
48%
5%
Market size
100% 8.7%
8.4%
7.0%
13.6%
5.7%
12.0%
6.3%
4.3%
Novo Nordisk
Growth rates
9
Hum
an in
sulin
Vials
Dur
able
Ani
mal
insu
linAdding value to volume
Pre
fille
d
Insu
lin a
nalo
gue
Impr
oved
con
trol
Improved accuracy and compliance
10
Increasing the analogue market share
Source: IMS/BW
Note: quarterly data, volume figures
Q1 2000 Q1 2003
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
Q1 2000 Q1 2003
Analogue penetration Novo Nordisk’s analogue market share
Analogues
Human insulin
26%
11
50
55
60
65
70
75
80
No
vo
No
rdis
k m
ark
et
sh
are
Continued conversion
Pen penetration
Q1 2000 Q1 2003
32%
Source: IMS/BW
Novo Nordisk market shares
Q1 2000 Q1 2003
Note: quarterly data, volume figures
21%
Vial
Prefilled
Durable
PrefilledDurable
63%
59%
28%
13%
Meg
a un
its
12
The insulin business case
5%
Volumedrivers
Valuedrivers
• Conversion from human insulin to insulin analogues
• Conversion from vials and syringes to devices
• Conversion from durable to prefilled devices
• Epidemic growth in number of people with diabetes
• One third are diagnosed• Trend towards earlier and
more intensive therapy
5%
+
13
The diabetes business case - on regional basis
North America:• Analogue conversions • Volume growth• Device penetration
Europe:• Analogue conversions• Volume growth Japan & Oceania:
• Volume growth• Conversion to disposable devices
International Operations:• Volume growth • Conversion to devices • Insulin conversion5%
5%
+
14
0
0.5
1
1.5
2
MAT Q1/97 MAT Q1/99 MAT Q1/01 MAT Q1/03
$Bn
US insulin market
Volume market Value marketCAGR: 15%CAGR: 3%
Source: IMS/BW
CAGR: 22%
CAGR: 4%
45,000
50,000
55,000
60,000
65,000
70,000
75,000
80,000
85,000
MAT Q1/97 MAT Q1/99 MAT Q1/01 MAT Q1/03
Vol (MU)
43%
24%
17%
16%
North America
15
Key strategic changes in 2000
Prior to change
Strategic decision
Current status
Distribution Partnership Alone
First detailing Prandin® Insulin
Own field people Approx 175 Increase to some 600
Approx 675
Type of products Human insulin and few devices
Focus on analogues and
new devices
All newest analogues and
devices launched
Drug development Mostly out of Europe
Increase US presence
Significantly increased
Insurance coverage Less than 30% of insured life's
Increase More than 60% of insured life’s
43%
24%
17%
16%
North America
16
Outcome of strategic initiatives – so far
Source: IMS/BWNote: US, Quarterly data, volume figures
Q1 2000 Q1 2003
Novo Nordisk market shares
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
Human insulin Analogues
Key observations:• Overall market share now
above 30% from 26%• Retail market share increased
to above 15% from about 13%• Non-retail market share
increased to above 75% from below 70%
• Selected product launches• NovoLog® - 2001• FlexPen® - 2002• NovoLog® Mix 70/30 – 2002• InnoLet® - 2002
43%
24%
17%
16%
North America
17
NovoLog® driver of market share
Source: IMS/BW
Note: US, Quarterly data, volume figures
Short-acting segment - US
Q1 2000 Q1 2003
Key observations:
• Short-acting segment 28% of insulin sold – 56% being analogues
• NovoLog® launched in September 2001
• NovoLog® only analogue approved for pump use
• NovoLog® in FlexPen®
launched in February 20030%
10%
20%
30%
40%
50%
60%
70%
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
Analogue conversion
NovoLog® market share oftotal segment (right axis)
43%
24%
17%
16%
North America
18
NovoLog® Mix a future contributor
Source: IMS/BW
Note: US, Quarterly data, volume figures
Premix segment - US
Q1 2000 Q1 2003
Key observations:
• Premixed segment 32% of insulin sold – 23% being analogues
• NovoLog® Mix 70/30 in FlexPen® launched in September 2002
• NovoLog® Mix in vials launched in March 2003
0%
5%
10%
15%
20%
25%
0%
1%
2%
3%
4%
5%
6%
7%
8%
9%
10%
Analogue conversion
NovoLog® Mix market shareof total segment (right axis)
43%
24%
17%
16%
North America
19
Growth set to continue
Q1 2000 index 100
Novo Nordisk insulin salesNorth America, local currencies
CAGR 22%
0
50
100
150
200
Q100
Q200
Q300
Q400
Q101
Q201
Q301
Q401
Q102
Q202
Q302
Q402
Q103
Q203
43%
24%
17%
16%
North America
Insulin market growth potential• “An epidemic”• Increased diagnosis rate• Earlier switches to insulin• >2/3 of patients are not in control
with current treatment
Product Upgrade Potential• Human insulin (65% MS)
Analogue
• Vial (89% MS) Devices
• Human vial (61% MS) Analogue Devices
20
Adding value to volume – key to delivering high growth
Hum
an in
sulin
(65%
)
Vials (89%)
Dur
able
s
(3%
)
Dis
posa
bles
(8
%)
Insu
lin a
nalo
gues
(35%
)
Source: IMS/BWNote: US, Q1 2003, volume figures
Impr
oved
con
trol
Improved accuracy and compliance
43%
24%
17%
16%
North America
21
Only Novo Nordisk offers full range of analogues
NovoLog®
NovoLog® Mix 70/30
Levemir™, launch 2004
Short-acting
Premix
Long-acting
FlexPen®
PenFill®
Vial
43%
24%
17%
16%
North America
22
US – a huge upgrade potential
US
Source: IMS/BW
Note: Q1, 2003, volume figures
0% 20% 40% 60% 80% 100%
DENMARK
NETHERLANDSPOLAND
PORTUGAL
GERMANYNORWAY
SPAINJAPAN
FRANCESWITZERLANDNEW ZEALAND
IRELANDBELGIUM
UNITED KINGDOMAUSTRALIA
CANADAITALY
SOUTH AFRICA
Durable Disposable Vial
43%
24%
17%
16%
North America
23
Novo Nordisk offers the most advanced devices
DurableDisposable
InDuo®
NovoPen® Junior
Innovo®
FlexPen®
InnoLet®
43%
24%
17%
16%
North America
24
Trends to look out for:• Volume growth
• Demographics• Obesity• Intensified treatment
• Value growth• Analogue conversion will continue• Device conversion will continue
Novo Nordisk’s strategy:• Volume growth
• Further increase contract and partner developments
• Facilitate education and awareness
• Value growth• Continue focus on NovoLog® and
NovoLog® Mix 70/30• Continue pushing device penetration
concept via newly launched devices• Convert contract segment to
analogues and devices• Launch Levemir™ in 2004
Novo Nordisk’s US insulin strategy
43%
24%
17%
16%
North America
25
Haemostasis management -NovoSeven®
Ke
y o
bse
rva
tion
s•
In lo
cal c
urre
nci
es g
row
th w
as
24%
in th
e se
con
d q
uart
er. A
ll re
gio
ns c
ont
ribu
ted
to th
e g
row
th
•S
ale
s g
row
th w
as d
rive
n b
y in
cre
ased
use
in th
e in
hib
itor
segm
ent b
oth
with
in c
ong
eni
tal
and
acq
uire
d h
aem
oph
ilia
an
d a
pe
rce
ived
incr
eas
e in
in
vest
iga
tiona
l use
•N
orth
Am
eric
a th
e m
ain
gro
wth
dr
ive
r
Sales by quarter+8%
0
100
200
300
400
500
600
700
800
900
1,000
Q1 Q3 Q1 Q3 Q1 Q3
DK
K m
illio
n
Q1
2000 2001 2002 2003
26
NovoSeven®
– current business
Key observations
• Penetration increases as confidence in NovoSeven® increases
• Increased treatment intensity and earlier onset of treatment
• Increased confidence in elective surgery with NovoSeven®
• Awareness creation within acquired haemophilia progressesConfidence/Awareness
Pe
netration
Elective surgery within haemophilia
Acquired haemophilia
Spontaneous bleedings in congenital haemophilia
27
Low exposure to patent expiration
Accumulated % of 2002 Novo Nordisk sales with
patents expiring
0
5
10
15
20
25
30
35
40
2003
2004
2005
2006
2007
2008
2009
2010
2011
0
5
10
15
20
25
30
35
40
Bay
er
GS
K
Tak
eda
Pfi
zer
Mer
ck
No
vart
is
BM
S
Ave
nti
s
Eli
Lil
ly
% of 2001 sales with patents expiring in 2002-2006
Source: Nordea Securities and Novo Nordisk.
No
vo N
ord
isk
28
R&D
Diabetes expertise
Protein expertise
NovoSeven® expansion
liraglutide
balaglitazone
NN2501
AERx® iDMS
insulin analogues
NN414
hGH expansion
ASIS
Drug delivery expertise
Protein Delivery System unit
(PDS)
29
Diabetes care pipeline
Compound Type Indication Phase
Levemir™ (insulin detemir) Insulin Type 1+2 diabetes Filed EU+US
NovoMix® 50 and 70 Insulin Type 1+2 diabetes Phase 3
AERx® iDMS (NN1998) Insulin Type 1+2 diabetes Phase 3
Liraglutide (NN2211) GLP-1 analogue Type 2 diabetes Phase 2
Balaglitazone (NN2344) OAD Type 2 diabetes Phase 2
NN414 OAD Type 1+2 diabetes Phase 2
NN344 Insulin Type 1+2 diabetes Phase 1
NN2501 OAD Type 2 diabetes Phase 1
30
Levemir™ – better efficacy with fewer side effects
HbA1c reduction
Relative nocturnal
hypoglycaemia 100
0
% Index
Note: data from phase 3b study presented at International Diabetes Federation, August 2003, involving 595 type 1 diabetes patients over 18 weeks. LevemirTM and NovoRapid® versus long- and short-acting human insulin.
p<0.001
p<0.005
0
1
LevemirTM and NovoRapid®
Long- and short-acting human insulin
Key observations:• Intensive analogue therapy
superior to human insulin regime on HbA1c
• Significant weight improvement• Very high predictability
resulting in significantly improved side-effect profile:
• 24-hour hypoglycaemia, p<0.05
• Nocturnal hypoglycaemia, p<0.001
100
31
A dual approach towards proof of concept
General haemostatic agent
Bleeding in emergenciesElective bleeding
32
Biopharmaceuticals – pipeline outside diabetes care
Compound Indication Phase
Growth hormone IUGR/SGA* Approved by EU
NovoSeven® Upper gastro-intestinal bleeding Phase 2
NovoSeven® Liver transplantation Phase 2
NovoSeven® Trauma Phase 2
NovoSeven® Stem cell transplantation Phase 2
NovoSeven® Intra-cerebral haemorrhage Phase 2
NovoSeven® Hepatectomy Phase 2
Growth hormone Complicated fractures Phase 2
ASIS** ARDS Phase 2
* Intra-uterine Growth Retardation/Small for Gestational Age** ASIS - Active Site Inhibited Seven/ARDS - Acute Respiratory Distress Syndrome
33
Towards general haemostasis management
Haemophilia treatment
Haemostasis management
34
Financials
35
Net turnover 12,630 12,034 5
Operating profit 2,939 2,856 3
Net financials 662 99 569
Profit before tax 3,601 2,955 22
Net profit 2,377 1,925 23
EPS (DKK)* 6.88 5.51 25
Financial results
* EPS on a fully-diluted basis.
DKK million First half year 2003 2002 % change
36
Currency exposure
Effect of 5% depreciation on full-
year operating profit* (DKK million)
USD -160
JPY -130
GBP -75* currency hedging income
is recorded as financial income
5.25
6.25
7.25
8.25
avg = 8.32
avg = 6.85
2001 2002 2003
avg = 6.30
avg = 7.88
USD
JPY
YTD 2003 avg = 5.65
YTD 2003 avg = 6.71
37
Outlook for 2003
Note: the above outlook is based on the assumption that exchange and interest rates remain at the current levels (4 August 2003)
• Operating profit still expected to grow by a low single-digit percentage rate
• Expectations for net financial income increased to DKK 900 million
• Tax rate of 34%
• Net profit now expected to grow by more than 10%
Key currency ratesDKK
per 1002002
average
USD 788
JPY 6.30
GBP 1182
Current rate*
657
5.45
1059
* As of 4 August 2003
2003 ytd avg
671
5.65
1082
38
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]
Christian KanstrupTel (direct): (+45) 4443 7801 E-mail: [email protected]
Investor Relations Office USTel (direct): (+1) 609 919 7846
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