A focused healthcare company Investor presentation – Full year 2004
Mar 26, 2015
A focused healthcare company
Investor presentation – Full year 2004
2
• Introduction
• Diabetes care• Insulin – focus on analogues• Pipeline
• Biopharmaceuticals• NovoSeven®• Growth hormone• Pipeline
• Regions• North America• IO - focus on China
• Financial results
• Outlook for 2005
Agenda
3
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 Risk Management' in the Annual Report 2004. 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 on the information contained in this presentation. © 2005 Novo Nordisk A/S.
Forward-looking statements
4
Market development:• Gain of insulin market share continues, driven by analogues and US
performance• Solid NovoSeven® growth continues• Launch of NordiFlex® underpins the growth hormone franchise
Research and development: Encouraging clinical data from the NovoSeven® expansion programme Expansion of the NovoSeven® label in Europe on track European approval of Levemir®, US approval expected mid-2005
Financials:• Sales: +11% as reported and +15% in local currencies• Operating profit: +9% as reported 2005 operating profit growth expectations:
15% underlying Around 5% as reported
Highlights from 2004
5
0
5
10
15
20
0 5 10 15 20Expected % CAGR 2003-10
% C
AG
R 1
99
9-2
00
3
Diabetes careCNS
Infectious disease
Cancer
Respiratory
GI
Cardiovascular ArthritisGrowth hormone
5Y CAGR 31%
Million
US
D
… and NovoSeven® is on its way to becoming a blockbuster
Source: SG Cowen, IMS/BW and Novo Nordisk
A focused healthcare company within attractive therapy areas
Existing and new focus areas continue to offer attractive growth rates …
0
250
500
750
1,000
1999 2000 2001 2002 2003 2004
6
Key focus areas for 2005
Diabetes care
• Continued focus on analogue conversion as well as conversion to disposable
delivery devices
• Continuing the Levemir® roll-out
• Levemir® approval in the US
• Launch of new delivery devices (NovoPen® 4) and needles (Conical needle and
the Autocover™ needle)
Biopharmaceuticals
• Continue expanding the NovoSeven® label within congenital bleeding disorders
• Preparing for launch of NovoSeven® in new indications in Europe
• Leverage protein delivery technologies within growth hormone
• Exploiting protein competences in target therapy areas
7
Diabetes care +11%
NovoSeven® +13%
Other+7%Growth hormone
therapy +9%
Sales of DKK 29.0 billion (+11% reported and +15% in local currencies)
Local currencies Growth Share of growth
Insulin analogues 84% 55%
Human insulin and insulin-related sales
2% 7%
OAD 21% 8%
Diabetes care 15% 70%
NovoSeven® 19% 19%
Growth hormone therapy 11% 6%
Other products 11% 5%
Biopharmaceuticals 15% 30%
Sales as reported Growth analysis
Key products continue to drive growth – full year 2004
8
Key o
bserv
ati
on
s
•G
row
th in f
ourt
h q
uart
er
of
75
%
in loca
l cu
rrenci
es
•G
row
th o
f 8
4%
in loca
l cu
rrenci
es
for
full
year
20
04
•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
•Euro
pean r
oll-
out
of
Levem
ir®
co
ntr
ibute
s to
the s
olid
gro
wth
Q12002
Q42004
Analogue sales development
Million
DK
K
+68%
Insulin analogues - solid analogue growth continues
0
200
400
600
800
1.000
1.200
1.400
9Source: IMS/BW
Note: Quarterly data, volume figures
Q12000
Q32004
Q12000
Q32004
Analogue penetrationNovo Nordisk’s analogue
market share
Analogues
Human insulin
35%
7%
A continued increase in analogue market share…
0%
5%
10%
15%
20%
25%
30%
10Source: IMS/BW
Note: Quarterly data, volume figures
Q1 2000
Q3 2004
Composition of NovoRapid® sales
Q12000
Q32004
NovoRapid® share of short-acting analogues
Disposable devicesDurable devicesVials
… driven by NovoRapid® and FlexPen® …
28%
44%
28%
0%
10%
20%
30%
40%
50%
11Source: IMS/BW
Note: Quarterly data, volume figures
Q1 2000
Q3 2004
Q12000
Q32004
NovoMix® share of premixed analogues Composition of NovoMix® sales
Disposable devicesDurable devicesVials
… as well as NovoMix® and FlexPen®
68%
19%
13%0%
10%
20%
30%
40%
50%
12
Source: IMS/BW, monthly volume data
Novo Nordisk share of long-acting analogues in Europe
January2004
November2004
The European Levemir® roll-out is continuing
Key observations
•Le
vem
ir®
launch
ed in 1
0
Euro
pean c
ountr
ies
•C
onti
nued r
oll-
out
in 2
00
5
•Le
vem
ir®
has
by N
ovem
ber
20
04
obta
ined 9
% o
f lo
ng-a
ctin
g
analo
gues
in E
uro
pe
•A
mendm
ent
file
d w
ith t
he F
DA
in
Dece
mber
– appro
val expect
ed
mid
-20
05
•Subm
issi
on in Japan e
xpect
ed
earl
y 2
00
6
0%
2%
4%
6%
8%
10%
13
Less hypoglycaemic events with Levemir® than NPH insulin
Levemir® - Treat to target with less hypos and less weight gain – also in type 2 patients
Presented at EASD 2004as Poster 754:PS 64.
47% risk reduction p < 0.001
Events
per
pati
ent
per
year
55% risk reduction p < 0.001
0
2
4
6
8
10
12
14
16
18
Overall Nocturnal Hypoglycaemia
NPH + OAD Insulin detemir + OAD
Less weight gain with Levemir® than NPH insulin
0
p < 0.05
+ 1.2 kg
+ 2.8 kg
0.5
1
1.5
2
2.5
3
3.5
Change in w
eig
ht
from
base
line t
o e
ndpoin
t (k
g)
14
0%
10%
20%
30%
40%
50%
60%
Novo NordiskEli LillyAventis
10% growth in Novo Nordisk’s insulin franchise looks set to continue
IMS world insulin market shares, value
Q12002
Q32004
MAT Q32004
Volume and value size of the IMS world insulin market
MAT Q32000
22.4
bn
DK
K 34.4
bn
DK
K
157
tMU 200
tMU
CAGR
Volume:6.1%
Value:11.3%*
* Value growth in DKK, subject to currency fluctuations
Source: IMS/BW
Note: Quarterly data
15
R&D pipeline update- diabetes care
• Insulin
• Amended New Drug Application related to Levemir® filed with the FDA just before Christmas 2004. US marketing approval expected mid-2005
• NovoMix® 50 & 70 filed in Europe. Approval expected later in 2005
• NovoMix® 50 filed in Japan
• Restructuring transaction with Aradigm Corporation related to the AERx® insulin Diabetes Management System (iDMS) completed
• GLP-1• The liraglutide phase 2b study was initiated in January 2005. The phase 3
clinical trial to be initiated around the turn of 2005/6
• Supportive offerings• Launch in 2005 of NovoPen® 4 and new needles to underpin Novo Nordisk
device leadership
• Novo Nordisk and Medtronic Inc to develop the world’s first prefilled cartridge for use with Paradigm®, Medtronic’s external insulin pump
16
Biopharma growth opportunities
17
NovoSeven® sales development
Q12002
Q42004
Million
DK
K
+25%
Key o
bserv
ati
on
s
•G
row
th in f
ourt
h q
uart
er
of
32
% in
loca
l cu
rrenci
es
•G
row
th o
f 1
9%
in loca
l cu
rrenci
es
for
full
year
20
04
•G
row
th d
riven b
y N
ort
h A
meri
ca,
Euro
pe a
nd Inte
rnati
onal
Opera
tions
•G
row
th d
riven b
y invest
igati
onal
use
, acq
uir
ed h
aem
ophili
a a
nd
ele
ctiv
e s
urg
ery
•G
row
th in Inte
rnati
onal O
pera
tions
impact
ed b
y q
uart
erl
y fl
uct
uati
ons
NovoSeven® - growth continues
0
200
400
600
800
1.000
1.200
18
Further development of NovoSeven® within congenital bleeding disorders
Op
tim
ise t
he lab
el in
diff
ere
nt
reg
ion
s a
s m
uch
as p
ossib
le
•G
lanzm
ann’s
and F
VII d
efici
ency
appro
ved in t
he E
U in January
2
00
4
•A
cquir
ed h
aem
ophili
a a
ppro
ved in
Japan in N
ovem
ber
20
04
•N
ew
stu
die
s in
itia
ted
•H
igh d
ose
•Pro
phyla
ctic
stu
dy
•N
ew
convenie
nt
devic
e-k
it t
o b
e
launch
ed
•C
onti
nue t
he e
xpansi
on o
uts
ide
the U
S a
nd E
uro
pe
Approved indications
US EU Japan
Congenital haemophilia with inhibitors
- Spontaneous bleeds
- Surgery+
-
+
+
+
+
Acquired haemophilia - + +
FVII deficiency - + -
Glanzmann’s thrombasthenia - + -
19
Trauma – population characteristics
• Blunt trauma constitutes more than 80% of all trauma cases
• Bleeding is the major cause of death in trauma
• In EU 45,000 trauma victims receive more than one unit of RBC transfusion
• Anaesthesiologists and trauma surgeons are key decision-makers in the EU
Trauma population (x 1000) Key observations
0
100
200
300
400
Trauma patientsreceiving RBC
Trauma patientsreceiving morethan 8 units of
RBC
EuropeUSJapan
20
NovoSeven® in trauma
• Significant reduction in RBC transfusion requirements
• Reduction of reported co-morbidities like ARDS and MOF
• No safety concerns identified:– Adverse event rates not
different from placebo– Low frequency of thrombo-
embolic events reported: no difference between groups
NovoSeven® reduces the need for transfusion in blunt trauma
rFVIIa (n=52)
Perc
en
t of
pati
en
ts
0
10
20
30
40
50
60
70
80
90
100
RBC units within 48 hours
0 5 10 15 20 25 30 35 40 45 50
Perc
en
t of
pati
en
ts
0
10
20
30
40
50
60
70
80
90
100
0 5 10 15 20 25 30 35 40 45 50
Placebo (n=59)
P= 0.019
NovoSeven® proof-of-concept
21
Intracerebral haemorrhage (ICH) – population characteristics
• ICH causes 10-15% of US/EU stroke cases
• ICH is the deadliest form of stroke
• No medical or surgical therapy has shown benefit
• Some 30,000 patients are eligible for NovoSeven® treatment in the EU
• Emergency room staff and neurologists are primary target groups
ICH population (x 1000) Key observations
0
100
200
300
ICHpopulation
Less ptsthat
receiveOAT
Less CTscan > 3h
EuropeUSJapan
22
NovoSeven® in ICH
• Significant, dose-dependent reduction in haematoma growth
• Reduction in death/severe disability as measured by the modified Rankin scale
• No increase in the incidence of fatal or severely disabling thrombo-embolic events
• Data to be published in leading medical journal in Q1 2005
NovoSeven® proof-of-conceptModified Rankin scale at Day 90
100% 80% 60% 40% 20% 0%
160 μg/kg
80 μg/kg
40 μg/kg
Placebo
mRS 6 (dead)mRS 4-5 (severe)
mRS 0-1 (none) mRS 2-3 (moderate)
23
Norditropin® sales development
Q12002
Q42004
Million
DK
K
+11%
Growth hormone - progress continues in Europe and North America
Key o
bserv
ati
on
s
•G
row
th in f
ourt
h q
uart
er
of
15
% in
loca
l cu
rrenci
es
•G
row
th o
f 1
1%
in loca
l cu
rrenci
es
for
full
year
20
04
•G
row
th d
riven b
y E
uro
pe a
nd
Nort
h A
meri
ca, ro
ll-out
of
Nord
iFle
x®
conti
nues
•Sale
s develo
pm
ent
in Japan s
table
su
pport
ed b
y t
he launch
of
Nord
iFle
x®
0
200
400
600
800
24
R&D pipeline update- biopharmaceuticals
• NovoSeven®
• Trauma
• Regulatory dossier for blunt trauma submitted to EMEA early January 2005
• Trial targeting the US to be initiated in Q2 2005
• ICH
• Regulatory dossier expected to be submitted to EMEA by mid-2005
• A global phase 3 trial to be initiated in Q2 2005
• Congenital segment
• Acquired haemophilia approved in Japan. Filing in the US in H1 2005
• Growth hormone
• Norditropin® approved in the US for treatment of severe growth hormone deficiency in adults
• Following analysis of the commercial viability of the use of Norditropin® in complicated fractures, further clinical development has been discontinued
• HRT
• Ultra-low-dose continuous-combined therapy in phase 3 development
25
The regional mix
26
Europe +6%
North America +20%
Japan & Oceania +7%
International Operations
+15%
Sales of DKK 29.0 billion (+11% reported and +15% in local currencies)
Local currencies
Growth Share of growth
Europe 6% 18%
North America 32% 51%
International Operations
21% 22%
Japan & Oceania 9% 9%
Growth analysisSales as reported
Sales by region - full year 2004
27
Q12002
Q42004
North America sales development
Key o
bserv
ati
on
s
•G
row
th in f
ourt
h q
uart
er
of
25
% in
loca
l cu
rrenci
es,
15
% a
s re
port
ed
•G
row
th o
f 3
2%
in 2
00
4 in loca
l cu
rrenci
es
•G
row
th d
riven b
y insu
lin a
nalo
gues
and N
ovoSeven®
•A
round 1
/3 o
f to
tal analo
gue s
ale
s deri
ved f
rom
Nort
h A
meri
ca
•A
round 1
/2 o
f to
tal N
ovoSeven®
sa
les
deri
ved f
rom
Nort
h A
meri
ca
North America- a key driver of Novo Nordisk growth
Ind
ex local cu
rren
cy
+25%
0
50
100
150
200
250
28
Key o
bserv
ati
on
s
•Expanded s
ale
s fo
rce o
f 8
00
dia
bete
s ca
re s
peci
alis
ts in p
lace
•C
orp
ora
te b
randin
g a
ctiv
itie
s re
sult
ing in incr
ease
d a
ware
ness
•Fo
rmula
ry c
overa
ge incr
ease
d t
o
80
%
•La
unch
of
larg
e-s
cale
clin
ical tr
ial –
INIT
IATE P
lus
involv
ing 6
,00
0
pati
ents
•Expansi
on o
f th
e insu
lin p
roduct
ion
faci
lity in C
layto
n,
Nort
h C
aro
lina
•H
aem
ato
logy r
ese
arc
h u
nit
to b
e
est
ablis
hed in N
ew
Jers
ey
North America- a key driver of Novo Nordisk growth
Novo Nordisk’s US insulin market share
Q12000
Q32004
Source: IMS/BW
Note: Quarterly data
0%
10%
20%
30%
40%ValueVolume
29
Q12002
Q42004
International Operations sales development
Ind
ex local cu
rren
cy
International Operations- a key driver of Novo Nordisk growth
Key o
bserv
ati
on
s
•G
row
th in f
ourt
h q
uart
er
of
33
% in
loca
l cu
rrenci
es,
26
% a
s re
port
ed
•G
row
th o
f 2
1%
in 2
00
4 in loca
l cu
rrenci
es
•Sale
s co
mpri
se 1
7%
of
tota
l N
ovo
Nord
isk
sale
s
•G
row
th is
dri
ven b
y h
um
an insu
lin
and insu
lin-r
ela
ted s
ale
s; h
ow
ever,
als
o insu
lin a
nalo
gues
and
NovoSeven®
are
addin
g t
o g
row
th
•Q
uart
erl
y s
ale
s fluct
uate
due t
o
tender
ord
ers
and p
urc
hase
r re
quir
em
ents
+33%
0
50
100
150
200
250
30
International Operations- China, a future driver of growth
Q12002
Q42004
China sales development
Key o
bserv
ati
on
s
•1
6%
of
sale
s in
Inte
rnati
onal
Opera
tions,
gro
win
g b
y 4
9%
in 2
00
4
in loca
l cu
rrenci
es
•Som
e 9
0%
of
all
insu
lin s
old
in
devic
es
•W
ell-
est
ablis
hed r
ela
tionsh
ips
wit
h
auth
ori
ties
and h
ealt
hca
re
org
anis
ati
ons
•R
apid
ly e
xpandin
g o
rganis
ati
on,
aro
und 1
00
em
plo
yees
in 2
00
0,
now
m
ore
than 6
00
•Lo
cal R
&D
centr
e f
ocu
sing o
n e
arl
y-
stage p
rote
in r
ese
arc
h
Ind
ex local cu
rren
cy +54%
0
50
100
150
200
250
300
350
400
450
31
Financials
32
Financial results
* EPS on a fully diluted basis.** Dividend per share. Proposed dividend for 2004
Sales 29,031 26,158 11 7,944 7,111 12
Operating profit 6,980 6,422 9 1,855 1,731 7
Net financials 477 954 (50) 285 406 (30)
Profit before tax 7,457 7,376 1 2,140 2,137 0
Net profit 5,013 4,833 4 1,462 1,395 5
EPS (DKK)* 14.83 14.15 5 4.37 4.11 6
Dividend (DKK)** 4.80 4.40 9 - - -
DKK million Full year Fourth quarter
2004 2003 % change 2004 2003 % change
Financial results
33
Strong gross margin development impacted by currencies
Gross margin analysis
Key o
bserv
ati
on
s
•Pro
duct
and g
eogra
phic
al m
ix
posi
tively
im
pact
ing g
ross
marg
in
•Pro
duct
ivit
y g
ain
s co
ntr
ibuti
ng
posi
tively
to t
he d
evelo
pm
ent
•C
hange in H
RT s
et-
up in t
he U
S
contr
ibute
s posi
tively
in 2
00
3/0
4
•C
urr
enci
es
negati
vely
im
pact
ing t
he
gro
ss m
arg
in
•G
ross
marg
in im
pact
ed b
y
impair
ments
•C
onti
nued c
onvers
ion t
o a
nalo
gues
to u
nderp
in d
evelo
pm
ent
in g
ross
m
arg
in g
oin
g f
orw
ard
* Impairment impact includes change of threshold for capitalising investments in 2003
-2,0%
-1,0%
0,0%
1,0%
2,0%
2002 2003 2004Reported change Currency impactImpairment impact* Underlying change
34
5.0
6.0
7.0
8.0
9.0
* currency hedging income is recorded as financial income
avg = 6.59
avg = 6.30
avg = 5.68
avg = 7.88
USD
JPY
avg = 5.54
avg = 5.99
-280-130 -80 -70
Currency exposure
Effect of 5% depreciation on full-year operating profit
in 2005* (DKK million)
USD
JPY
GBP
USD rel
2002 2003 2004 2005
YTDavg = 5.48
YTDavg = 5.67
35
Note: Above outlook is based on the assumption that exchange and interest rates remain at the current level (26 January 2005)
• Sales growth expectations:
• 10%-15% in local currencies
• Around 10% as reported
• Operating profit growth expectations:
• 15% underlying
• Around 5% as reported
• Net financial expenses expected at DKK 100 million
• Tax rate expected to be 32%
• Investments close to DKK 4 billion*
• Free cash flow of more than DKK 2 billion
Key currency ratesDKK
per 1002004
average
USD 599 JPY 5.54 GBP 1097
Current rate*
5725.531074
* As of 26 January 2005
2005 ytd avg
5675.481063
Outlook for 2005
*Capital expenditure includes purchase of fixed assets from Aradigm Corporation of approximately DKK 300 million related to the transfer of the AERx® iDMS project to Novo Nordisk
36
• Leadership in diabetes care with full portfolio of insulin analogues
• NovoSeven® expanding into critical bleeding
• Expanding the presence in North America
• Continued growth in International Operations driven by China
• Low exposure to patent expirations
• Strong IP portfolio
Key growth driversgoing forward
Balancing growth and
value
Novo Nordisk going forward
37
Investor Relations contactsNovo Nordisk A/S Investor Relations Novo Allé, DK 2880 BagsværdFax (+45) 4443 6633
Mogens Thorsager JensenTel (direct): (+45) 4442 7945 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 informationNovo 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:
novonordisk.com
Investor Information
38
Appendices
39
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
40
Type 2 - slope
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
Diagnosed
- but not adequately treated
41
Insulin is the ultimate treatment
Key observations
• A clear focus on the need for intensifying treatment of diabetes, both via the use of OADs and insulin
• The number of type 2 patients using insulin is outgrowing the number of type 1 patients
• In 2004, in Europe more than 80% of all insulin consumed by type 2 patients compared to 70% in 1997
• An increasing focus on post-prandial glucose regulation
Insulin is the ultimate treatment
-C
ell f
un
cti
on
Time from diagnosis
Diet and exercise
OADs
Insulin
42
Insulin is the ultimate treatment… - also for type 2 patients
Share of type 2 patients using insulin in Europe
Type of insulin regimen for type 2 patients – Europe
Source: Roper Starch 2004
0%
10%
20%
30%
2000 2002 2004
0%
20%
40%
60%
80%
100%
2000 2002 2004
IntensiveConventional
43
Novo Nordisk is the only company offering the full range of analogues
Con
ven
ien
ce
Meeting physiological need for control
Analogues
supported by
strong device
portfolio
44
0,5
10
2
27
Insulin detemir(Levemir®)
Insulin glargine(Lantus)
# o
f even
ts p
er
year
Intensified treatmentLevemir® - The ideal basal insulin
Source: Diabetes, Vol 53, June 2004
Hypoglycaemia (too low blood sugar)
Hyperglycaemia (too high blood sugar)
Percentage of patients with HbA1c < 7%
Convenience-based treatmentNovoMix® 30 - The ideal starter insulin
Source: Data presented at ADA 2004 involving 233 insulin naive patients in an open-label 28-week study. Total daily insulin dose: NovoMix® 30 0.82, glargine 0.55
Mean prandial blood glucose increment
NovoMix® 30Insulin glargine
40%
66%
0%
20%
40%
60%
80%
97
129
0
20
40
60
80
100
120
140
mg
/dl
Novo Nordisk offers the optimal insulin …
45
Claims NovoLog®/NovoRapid®
Humalog Apidra
Pump use √ √ √
Type 2 pump data √ No data No data
Predictability vs HI *) √ √ No data
Twice as fast as HI √ No data No data
Defined duration of action
3-5 hrs No data No data
Defined time to peak action
1-3 hrs No data No data
Mixing with NPH √ √ √
PPG (vs HI) No data √ √
Post-prandial dosing (√ EU) √ √
Decrease in severe hypo vs HI
No data No data √
% of patients feeling device will result in better
compliance
With small differences in label, the delivery system is very important
Source: Diabetes, Vol 52, September 2003, Biochemical and Biophysical Research Communications 310 (2003), www.fda.gov & Novo Nordisk
*) HI = human insulin
74
11
0
FlexPen® Lilly NPH pen Aventis'prefilled pen
# in
%
… in all segments
46
Solid insulin market growth- volume
Note: Wal*Mart figures not included. Market size and share as MAT Q3 2004 and growth as MAT Q3 2004 versus MAT Q3 2003. The arrows next to the market shares illustrate the direction of change compared to MAT Q3 2003. Source: IMS/BW
Novo Nordiskmarket share
33% ▲
58% -
75% -
49% ▲World
Japan
Europe
USA
Market
39%
51%
5%
Market size
100% 7.2%
7.2%
5.6%
10.4%
4.5%
7.7%
6.4%
1.7%
Novo Nordisk
Growth rates
47Source: IMS/BW
Note: Quarterly data, volume figures
Q12000
Q32004
Q12000
Q32004
Analogue penetrationShort-acting segment
Analogues
Human insulin
45%
21%
Share of short-acting segment
Humalog
NovoRapid®
European analogue conversion - NovoRapid®
0%
5%
10%
15%
20%
25%
30%
48Source: IMS/BW
Note: Quarterly data, volume figures
Q12000
Q32004
Q12000
Q32004
Analogue penetrationPremixed segment
Analogues
Human insulin
20%
2%
Share of premixed segment
Humalog Mix 25
NovoMix®
European analogue conversion - NovoMix® 30
0%
5%
10%
15%
49Source: IMS/BW
Note: Quarterly data, volume figures
Q12000
Q22004
Q12000
Q32004
Analogue penetrationShort-acting segment
Analogues
Human insulin63%
33%
Share of short-acting segment
Humalog
NovoLog®
US analogue conversion - NovoLog®
0%
10%
20%
30%
40%
50%
60%
70%
50Source: IMS/BW
Note: Quarterly data, volume figures
Q12000
Q32004
Q12000
Q32004
Analogue penetrationPremixed segment
Analogues
Human insulin
25%
0%
Share of premixed segment
Humalog Mix 25
NovoLog® Mix 70/30
US analogue conversion - NovoLog® Mix 70/30
0%
5%
10%
15%
20%
25%
30%
51
Europe US
Q12000
Q32004
Q12000
Q32004
Source: IMS/BW
Note: Quarterly data, volume figures
Insulin segmentation - Europe and the US
0%
10%
20%
30%
40%
50%
60%
Long-actingPremixShort-acting
0%
10%
20%
30%
40%
50%
60%
Long-acting
Premix
Short-acting
52
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
Dis
posa
ble
s
Improving convenience, compliance and control
Vials
Dura
ble
s
Animal insulin
Human insulin
Insulin analogues
The insulin business case
53
NovoSeven® - a unique mechanism of action
A bleeding episode
FVIIa/NovoSeven®®
Tissue factor
Fas
ter
haem
osta
sis
lead
s to
•F
ew
er tr
ans
fusi
ons
/ tr
ans
fusi
on
- fr
ee
su
rger
y
•R
ed
uce
d re
ble
edi
ng
•F
ast
er
reco
very
•R
ed
uce
d m
orb
idity
and
mo
rtal
ity
•Im
pro
ved
qu
ality
of l
ife
54
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
Orthopaedic surgery
Acquired haemophilia
Variceal bleedings
TBI
Cardiac surgery
NovoSeven® - expanding into general haemostasis
55
Research and developmentCommer-
cialisationProduction
• Protein capabilities from laboratory bench to large-scale production
• Leader within protein delivery
• Strong protein IP platform
• Expertise within immunobiology
• Large network with universities and other centres of excellence
• Science-driven culture
• International R&D set-up
• A leading protein producer
• Production track record within three expression systems
• Yeast
• Bacterial
• Mammalian
• Leader in construction of protein manufac-turing facilities
• Protein leadership
• Significant insight into management of chronic diseases
• History of specialist relationship building
• Proven lifecycle management capabilities
• Global sales force
Leveraging our core competences
56
Target identification and validation
Research DevelopmentCommer-cialisation
Diabetes Haemostasis Inflammation
Cancer
Novo Nordisk or sourcing
from biotech and academia
Novo Nordisk
Novo Nordisk and
biotech partner
Novo Nordisk
Novo Nordisk
Novo Nordisk and
pharma partner
Out-licensing/
divest
Novo Nordisk and partner
Structured business model
57
1. Insight into the biological disease mechanisms
2. Therapeutic advantage of protein over NCE
3. Unmet need justifies early stage R&D project
4. Strong IP platform can be established
5. Disease severity allows for injection acceptance
6. A specialist sales force can handle the sales effort
7. Long-term growth outlook must be attractive
Deciding which new areas to pursue: - based on competences and unmet need
Leveraging our core competences
58
Immunotherapy of cancer and inflammation fulfils the criteria
1. Novo Nordisk expertise in immunological research (linked to type 1 diabetes)
2. NCEs generally lack efficacy or selectivity
3. Significant need: fatal or debilitating diseases
4. Rich in patentable protein opportunities
5. Disease-modifying potential of proteins
6. Highly specialised fields with data-driven sales
7. Immunotherapy is poised to become a high growth area
Leveraging our core competences
59
Key observations
• Biotech platform explored within immunotherapy
• R&D networks established
• Eight targets outside established areas being investigated
– One in phase 1/2 and seven in
preclinical phase
– # of targets expected to increase
over the next year
• Targets meet upfront defined criteria
• Novo Nordisk established as a partner of choice in focus areas
Cancer
Diabetes
Haemostasis
Growth deficiency
Inflammation
Leveraging our core competences
60
HRT sales development
Q12002
Q42004
Million
DK
K
-8%
HRT – flattening out
Key o
bserv
ati
on
s
•Sale
s decl
ined b
y 4
% in loca
l cu
rrenci
es
in t
he f
ourt
h q
uart
er
•G
row
th o
f 1
7%
in loca
l cu
rrenci
es
for
full
year
20
04
•Sale
s posi
tively
im
pact
ed b
y t
he
change in d
istr
ibuti
on s
et-
up in
the U
S
•A
dju
sted f
or
the c
hange in
dis
trib
uti
on s
et-
up, sa
les
decl
ined b
y 7
%, pri
mari
ly d
ue t
o
a c
onti
nued d
epre
ssed E
uro
pean
mark
et
0
100
200
300
400
500