novo nordisk 0 a focused healthcare company investor presentation – autumn 2003
TRANSCRIPT
Novo Nordisk
1
A focused healthcare company
Investor presentation – Autumn 2003
2
Agenda
• Highlights
• Diabetes care
• Haemostasis management (NovoSeven®)
• Research and development
• Financials and outlook for 2003
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.
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 March 2003. Please also refer to the section 'Financial Risk Factors' in the Annual Financial Report 2002. 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. © 2003 Novo Nordisk A/S.
4
Highlights
First nine months 2003:• Sales: +5% as reported and +15% in local currencies• Operating profit: +5%• Net profit: +20%
Outlook for 2003: • Operating profit now expected to grow by around 5%• Net profit now expected to grow by around 15%
Insulin detemir: • Approvable Letter received from the FDA in the US• Targeting a CPMP opinion around year-end in Europe
NovoSeven®:• Three studies on the use of NovoSeven® to report in Q1 2004• Positive CPMP opinion received for use of NovoSeven® for Factor VII
deficiency and Glanzmann’s thrombasthenia
5
Sales in the first nine months - by therapy and region
By therapy By region
Total DKK 19.3 billion +5% reported and +15% in local currencies
HRT-7%
Haemostasis management
(NovoSeven®)+11%
Diabetes care+4%
Growth hormone therapy
+4%
15%
5%
70%
8%
North America+8%
International Operations
0%Europe
+7%
Japan & Oceania-1% 44%
25%
16%
15%
6
Diabetes care
Sales by quarter
Ke
y o
bse
rva
tion
s•
Gro
wth
in lo
cal c
urre
ncie
s w
as 1
0%
in th
e th
ird q
uart
er. A
ll re
gion
s co
ntrib
uted
to g
row
th
•In
loca
l cur
renc
ies
insu
lin a
nd
deliv
ery
syst
ems
grew
by
12%
in th
e th
ird q
uart
er a
nd 1
7% in
the
first
ni
ne m
onth
s
•A
nalo
gues
the
mai
n gr
owth
driv
er.
Pen
etra
tion
of b
oth
Nov
oRap
id® a
nd
Nov
oMix
® c
ontin
ues
DK
K m
illio
n
2000 2001 2002 2003
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
Q1 Q3 Q1 Q3 Q1 Q3 Q1 Q3
+3%
7
Market characteristics
• Epidemic growth in number of people with diabetes
• Worldwide diabetes prevalence 5.1%, worldwide IGT prevalence (a pre-state to diabetes) 8.2%1
• The number of people with diabetes is expected to more than double by 2030
• In Europe and the US, 10-15% of total healthcare expenditure goes to type 2 diabetes2
0
5
10
15
20
25
0 5 10 15 20 25% CAGR 2002-06 expected
% C
AG
R 1
99
8-2
00
2
Diabetes care
CNS
Infectious disease
Cancer
RespiratoryCardiovascular
Arthritis
Diabetes
A high-growth market
Source: IMS data & SG Cowen estimates 2003 1 In the age group of 20-79 years, Diabetes Atlas, IDF, Second edition2 Diabetes News, WHO
Diabetes - a growth market
8
Type 2 - slope
Out of ‘guideline’ control
HbA1c
10%
9%
8%
7%
6%
Target USTarget Europe
Source: Novo Nordisk type 2 diabetes market research, Roper Starch, ADA, EASD, IDF, AACE, Wright A., Burden et al, Diabetes Care 2002; 25:330–336, Turner RC, Cull et al, JAMA 1999; 281:2005–2012
It is estimated that more than
2/3 of the patients are
not in control
Real-life insulin initiation
-ce
ll fu
nctio
n
Time from diagnosis
50%
9
Insulin therapy
-C
ell
fun
ctio
n
Diet and exercise alone
Oral therapy
Oral/insulin
Time from diagnosis
Type 2 - slope
Type 1 - Immediate need for insulin
Novo Nordisk’s primary market continues to be insulin
• More than 50% of Novo Nordisk’s insulin is sold to type 2 patients
• Focus on devices results in competitive edge
Insulin market trends are favourable• Earlier switch from OADs to
insulin• Intensified insulin treatment
Novo Nordisk has a secondary focus on the OAD market
Novo Nordisk’s main focus within diabetes care is insulin
Novo Nordisk provides a complete portfolio of diabetes products
10
Disposable Durable Int.BGM/DoserPumpsInhaled
Existing products
Delivering the insulin – the portfolio approach continues
FlexPen® NovoPen® 3 InDuo
Projects in development
AERx® iDMS
YesYes YesYes*
No product onmarket yetComments
Inventor andmarket leader
in segment
Inventor andmarket leader
in segment
Novo Nordisk markets only
pump approved analogue
Note: * Focused on ‘next generation pumps’
Inventor andonly
companypresent
11
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 Q2 2003 and growth as MAT Q2 2003 versus MAT Q2 2002. The arrows next to the market shares illustrate the direction of change compared to MAT Q2 2002.
Novo Nordiskmarket share
59% ▲
75% ▼
48% ▲World
Japan
Europe
USA
Market
42%
47%
5%
Market size
100% 10.2%
8.1%
7.6%
6.4%
10.6%
6.7%
30% ▲17.8%
5.8%
Novo Nordisk
Growth rates
12
Market dynamics
Source: IMS/BW
Q1 2000 Q2 2003 Q1 2000 Q2 2003
Market segmentation Novo Nordisk market shares
Note: Quarterly data, volume figures
0 %
10 %
20 %
30 %
40 %
50 %
Vo
lum
e s
ha
re
Long-actingPremixShort-acting
20 %
30 %
40 %
50 %
60 %
Vo
lum
e sh
are
Long-acting
Premix
Short-acting
13
Strong development in analogues
Analogue conversion
Q1 2000 Q2 2003
27%
Source: IMS/BW
Note: Quarterly data, volume figures
0%
10%
20%
30%
40%
50%
60%
No
vo
No
rdis
k m
ark
et
sh
are
Novo Nordisk market shares
Q1 2000 Q2 2003
Human insulin
Analogues
Human insulinAnalogues
59%
20%
7%
Meg
a un
it
14
Market dynamics - the US
0 %
10 %
20 %
30 %
40 %
50 %
Vo
lum
e s
ha
re
Long-acting
PremixShort-acting
Source: IMS/BW
Q1 2000 Q2 20030 %
10 %
20 %
30 %
40 %
50 %
Vo
lum
e s
ha
re
Long-acting
PremixShort-acting
Q1 2000 Q2 2003
Market segmentation Novo Nordisk market shares
Note: Quarterly data, volume figures
15
Analogues - a key growth driver
Source: IMS/BW
Note: Quarterly data, volume figures
Short-acting segment
US
Q1 2000 Q2 2003 Q1 2000 Q2 2003
Premix segment
US
0%
10%
20%
30%
40%
50%
60%
70%
0%
5%
10%
15%
20%Analogue penetration
Novo Nordisk analoguemarket share
0%
10%
20%
30%
0%
5%
10%
15%
20%
Analogue penetration
Novo Nordisk analoguemarket share
16
.
Novo Nordisk - a clear competitive edge
Positioned to capture the growth
Profitable manufacturing of insulin requires
economies of scale and know-how
Analogue conversion resulting in insulin
market going back on patent
Delivery systems, a key differentiating factor and
a key competitive advantage
Being profitable in the insulin market requires the right infrastructure
Novo Nordisk has 80 years of
experience with insulin production
Novo Nordisk is the only company with a full range of analogue products
Novo Nordisk is the market leader
and innovator within devices
Novo Nordisk has extensive
collaborations with key opinion
leaders, healthcare authorities etc
17
The insulin business case
Volumedrivers
Valuedrivers
• Conversion from human insulin to insulin analogues
• Conversion from vials and syringes to devices
• Conversion from durable to disposable devices
• Epidemic growth in number of people with diabetes
• One third are diagnosed• Trend towards earlier and
more intensive therapy
10%+
18
Haemostasis management - NovoSeven®
Ke
y o
bse
rva
tion
s•
Gro
wth
in lo
cal c
urre
ncie
s of
20%
in
the
third
qua
rter
. All
regi
ons
cont
ribut
ed to
the
grow
th
•F
or th
e fir
st n
ine
mon
ths
sale
s gr
ew b
y 25
% in
loca
l cur
renc
ies
•E
urop
e an
d N
orth
Am
eric
a th
e m
ain
grow
th d
river
s
•S
ales
gro
wth
con
tinue
s to
ben
efit
from
incr
ease
d in
vest
igat
iona
l us
e
Sales by quarter+11%
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 2003Q3
19
Existing indication - still some growth potential
In total approximately 3,500 congenital inhibitor patients in the developed world.
In addition there are close to 1,000 patients with acquired haemophilia
Inhibitor patients require first-line treatment with NovoSeven®
• 2 bleeds per month• 2-3 doses/bleed• 90 micrograms/kg
As well as additional treatment + Surgical intervention
Estimated cost per inhibitor patient per year: = DKK 1-2 million*
Total market sizex 3,500 patients at DKK 1-2 million ~ DKK 5-6 billion
* A non-inhibitor haemophilia A patient: Yearly cost of treatment around DKK 800,000.Journal of Medical Economics 2002; 5
Distribution of inhibitor patients
North America
63%
Europe31%
Japan & Oceania
6%
20
Towards a general haemostatic agent
Marketed indication
NovoSeven®Identify and
capture value-
creating
opportunities
early
Congenital bleeding disorders
Intracerebral haemorrhage
Upper gastro-intestinal bleeding
Stem cell transplantation
Liver transplantation
Trauma
Other indications
Liver resection
21
Compound Phase Status Next update
NovoRapid® 30 Mix
(in Japan)
Approved To be launched in Q1
2004
Q1 2004
Insulin detemir Filed • Approvable Letter
received from the FDA
• In the EU, CPMP opinion
is targeted around year-
end
Q1 2004
Q1 2004
NN414 Phase 2 Discontinued NA
Pipeline update - diabetes care
22
Pipeline update - biopharmaceuticals
Compound/Indication Phase Status Next update
NovoSeven®
Factor VII deficiency Filed in EU Positive CPMP opinion Q1 2004
Glanzmann’s thrombasthenia Filed in EU Positive CPMP opinion Q1 2004
Liver transplantation Phase 2 Enrolment completed Q1 2004
Trauma Phase 2 Enrolment completed Q1 2004
Stem cell transplantation Phase 2 Enrolment completed Q1 2004
Intracerebral haemorrhage Phase 2 Enrolment ongoing H2 2004
Growth hormone
Small for Gestational Age Approved* Launch ongoing NA
NordiFlex® & NordiLet® Approved Launch ongoing NA
* In EU
23
Insulin detemir - an update
Current status in US
• Approvable Letter received
• Average FDA approval time for industry: 19-23 months**
• FDA has performed pre-approval inspection of the insulin detemir manufacturing facilities, with few minor observations
Outlook for US
• Discussions with the FDA are scheduled to clarify whether available clinical data may be adequate for approval, or additional clinical data will be required
Current status in Europe
• Filed November 2002
• Median EMEA CP approval time for industry: 16-17 months*
Outlook for Europe
• Novo Nordisk is now finalising answers to remaining questions on preclinical data and process documentation
• A CPMP opinion is targeted around year-end
NovoLog® and NovoRapid® experience
NovoLog®: FDA approval time: 21 months
NovoRapid®: EU approval time: 13 months
* Source: CMR international, 2001-2002
** Source: FDA Pink Sheets, 2001-2002
24
Financials
25
Financial results
* EPS on a fully-diluted basis.
Net turnover 19,333 18,479 5 6,703 6,445 4
Operating profit 4,575 4,374 5 1,636 1,518 8
Net financials 739 123 501 77 24 221
Profit before tax 5,314 4,497 18 1,713 1,542 11
Net profit 3,507 2,928 20 1,130 1,003 13
EPS (DKK)* 10.18 8.38 21 3.30 2.87 15
DKK million First nine months Third quarter
2003 2002 % change 2003 2002 % change
26
Currency impact - first nine months of 2003
Growth in local currencies Growth in Danish kroner
International Operations
Europe
North America
Japan & Oceania
Total
Therapy area Region
Diabetes care
Haemostasis management
Growth hormone therapy
Hormone replace- ment therapy
Total5
-7
4
11
4
15
-3
14
25
15
-10 -5 0 5 10 15 20 25 30
5
-1
0
8
7
15
10
16
28
9
-5 0 5 10 15 20 25 30
27
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
5,75
6,25
6,75
7,25
7,75
8,25
8,75
avg = 8.32
avg = 6.85
2001 2002 2003
avg = 6.30
avg = 7.88
USD
JPY
YTD 2003 avg = 5.67
YTD 2003 avg = 6.65
28
Outlook for 2003
Note: Above outlook is based on the assumption that exchange and interest rates remain at the current level (27 October 2003)
• Operating profit now expected to grow by around 5%
• Net financial income still expected at DKK 900 million
• Tax rate of 34%
• Net profit now expected to grow by around 15%
Key currency ratesDKK
per 1002002
average
USD 788
JPY 6.30
GBP 1182
Current rate*
633
5.83
1072
* As of 27 October 2003
2003 ytd avg
666
5.67
1076
29
Key growth drivers
Novo Nordisk sales*• Leadership in diabetes care
with full portfolio of insulin analogues
• NovoSeven® expanding into general haemostasis
• Strong IP portfolio with low exposure to patent expirations
Bil
lio
n D
KK
13Y CAGR 13+%
* Since the merger between Novo and Nordisk in 1989
0
5
10
15
20
25
19
89
19
91
19
93
19
95
19
97
19
99
20
01
30
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
31
Sales by therapy - first nine months of 2003
DKK million 2003 2002 % of total % change (2003)
Insulin and delivery systems 12,495 11,725 65 7
Oral antidiabetic drugs 1,050 1,242 5 (15)
Diabetes care, total 13,545 12,967 70 4
Haemostasis management 2,934 2,635 15 11
Growth hormone therapy 1,613 1,553 8 4
HRT 932 1,007 5 (7)
Other 309 317 2 (3)
Total 19,333 18,479 100 5
32
DKK million 2003 2002 % of total %
change (2003)
Europe 8,578 8,030 44 7
North America 4,741 4,409 25 8
International Operations 2,995 2,991 15 0
Japan & Oceania 3,019 3,049 16 (1)
Total 19,333 18,479 100 5
Sales by region - first nine months of 2003
33
Diabetes – an unfolding epidemic
370 million people with diabetes expected by 2030
Source: WHO, January 2003
# of
peo
ple
with
dia
bete
s (m
illio
n)
0
50
100
150
200
250
300
US Japan Europe Rest ofWorld
2000
2030
34
Insulin - the ultimate treatment
-C
ell f
unc
tion
Diet and exercise alone
Oral therapy(66%)
Insulin therapy(27%)
Oral/insulin(7%)
Time from diagnosis
Type 2 - slope
Type 1 - Immediate need for Insulin
35
Adding value to volume – key to delivering high growth
Hum
an in
sulin
(73%
)
Vials (47%)
Dur
able
s
(32
%)
Dis
posa
bles
(2
1%)
Insu
lin a
nalo
gues
(27%
)
Source: IMS/BW
Note: IMS World, Q2 2003, volume figures
Impr
oved
con
trol
Improved accuracy and compliance
36
Insulin segmentation - Europe and the US
Europe US
Source: IMS/BW
Q3 1997 Q2 2003Q3 1997 Q2 20030%
10%
20%
30%
40%
50%
Vo
lum
e sh
are
Long-acting
Premix
Short-acting
0%
10%
20%
30%
40%
50%
Vo
lum
e s
ha
re
Long-acting
Premix
Short-acting
37
Launch of NovoMix® 30 - still in progress
Share of segment in Europe (volume)
Sales development in Europe (MU)
Quarters from launch Quarters from launch
Source: IMS/BW
0
200
400
600
800
1,000
1,200
1,400
1 3 5 7 9
11 13 15
NovoMix® 30
NovoRapid®
LisproMix 250%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
1 3 5 7 9
11 13 15
NovoMix® 30
NovoRapid®
LisproMix 25
38
Novo Nordisk market share since Lantus launch
Total insulin(MU)
Month of Lantus launch
August 2003
US 26% 33%
Europe 57% 58%
Germany 44% 45%
UK 67% 65%
Europe
Source: IMS/BW
Jan 2002 August 200340%
45%
50%
55%
60%
65%
70%
Vo
lum
e s
ha
re
Long-acting
Premix
Short-acting
39
Lantus impact?- volume
Source: IMS/BW
Months since Lantus launch
90
95
100
105
110
115
120
125
130
1 6 11 16 21 26 31 36
Ind
ex -
Mo
nth
of
lau
nch
eq
ual
s 10
0 Novo Nordisk Indexedmarket share Germany
Novo Nordisk Indexedmarket share UK
Novo Nordisk Indexedmarket share US
40
Source: IMS/BW
Months since Lantus launch
Lantus impact?- value
90
95
100
105
110
115
120
125
130
1 6 11 16 21 26 31 36
Ind
ex -
Mo
nth
of
lau
nch
eq
ual
s 10
0
Novo Nordisk Indexedmarket share Germany
Novo Nordisk Indexedmarket share UK
Novo Nordisk Indexedmarket share US
41
Growth hormone therapy
Sales by quarter
DK
K m
illio
n
0
100
200
300
400
-3%
500
600
700
Ke
y o
bse
rva
tion
s
•G
row
th in
loca
l cur
renc
ies
of 5
%
for
the
third
qua
rter
. N
orth
Am
eric
a th
e m
ain
grow
th d
river
•G
row
th f
or t
he f
irst
nine
mon
ths
4% r
epor
ted
or 1
4% in
loca
l cu
rren
cies
•M
ore
than
90%
of
sale
s is
N
ordi
trop
in®
Sim
pleX
x®.
Con
tinui
ng
stro
ng p
enet
ratio
n in
all
mar
kets
•In
crea
sing
mar
ket
shar
e in
bot
h th
e U
S a
nd E
urop
e
2001 2002 2003
Q1 Q3 Q1 Q3 Q1 Q3
42
HRT
Sales by quarter
DK
K m
illio
n
0
100
200
300
400 12%
Ke
y o
bse
rva
tion
s
•H
RT
sal
es in
crea
sed
by 2
0% in
lo
cal c
urre
ncie
s in
the
thi
rd q
uart
er
•A
djus
ted
for
the
chan
ge in
set
-up
in t
he U
S,
sale
s de
clin
ed b
y 11
%
in t
he q
uart
er in
loca
l cur
renc
ies
•N
ovo
Nor
disk
’s lo
w-d
ose
port
folio
ha
s be
nefit
ed f
rom
the
cha
nges
in
the
mar
ket
•U
ncer
tain
ty a
bout
the
mar
ket
deve
lopm
ent
rem
ains
hig
h
2001 2002 2003
Q1 Q3 Q1 Q3 Q1 Q3
43
• The most effective product for treatment of haemophilia with inhibitors
• The only recombinant product, that is, no substitutable recombinant products
• Fewer transfusions/transfusion-free surgery
• Reduced re-bleeding
• Faster recovery
• Reduced morbidity and mortality
• Improved quality of life
NovoSeven®
- a life-saving product…
44
NovoSeven® - a unique mechanism of action
NovoSeven® directly
activates factor X on
the surface of the locally activated platelets
45
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
46
Segmentation and targeting
Introduce& build
confidence
First-lineposition in
haemophiliaIntensive care
Surgery
Acquiredhaemophilia
Haemophilia Treatment Centres HaematologistsInternists
Intensive care Anaesthesiologists
Newphysician
groups
47
Low exposure to patent expiration
Accumulated % of 2002 Novo Nordisk sales with
patents expiring
% of 2001 sales with patents expiring in 2002-2006
Source: Nordea Securities and Novo Nordisk.
No
vo N
ord
isk0
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
Lill
y
48
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
49
Diabetes care pipeline
Compound Type Indication Phase
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
NN344 Insulin Type 1+2 diabetes Phase 1
NN2501 OAD Type 2 diabetes Phase 1
50
Biopharmaceuticals - pipeline outside diabetes care
Compound Indication Phase
NovoSeven® Liver transplantation Phase 2
NovoSeven® Trauma Phase 2
NovoSeven® Stem cell transplantation Phase 2
NovoSeven® Intracerebral haemorrhage Phase 2
NovoSeven® Upper gastro-intestinal bleeding Phase 2
Growth hormone Complicated fractures Phase 2
ASIS* ARDS Phase 2
* ASIS - Active Site Inhibited Seven/ARDS - Acute Respiratory Distress Syndrome