Novo Nordisk Global Focused Pharmaceutical with Biotech Expertise Mads Krogsgaard Thomsen Chief...
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Transcript of Novo Nordisk Global Focused Pharmaceutical with Biotech Expertise Mads Krogsgaard Thomsen Chief...
Novo Nordisk
Global Focused Pharmaceutical with Biotech Expertise
Mads Krogsgaard ThomsenChief Science Officer
February 2001
2
Diabetes Carebusiness
ZymoGenetics HRT
Novo Nordisk – Key drivers
Primary growth drivers
Secondary value
drivers
Coagulation disorders
Human growth hormone
3
Novo Nordisk Net turnover split by therapy
DKK billion
0
5
10
15
20
25
1996 1997 1998 1999 2000
Coagulation disorderDiabetes careHuman growth hormoneHRTOther
Glo
bal
Fo
cuse
d
Ph
arm
aceu
tica
l w
ith
B
iote
ch E
xper
tise
L
ead
er
in d
iab
ete
s ca
re
S
tron
g m
ark
et p
rese
nce
in
hae
mat
olo
gy
and
gro
wth
d
iso
rde
rs
S
tron
g o
rga
nic
sale
s g
row
th
4
Primary growth drivers
Secondary value
drivers
Diabetes Carebusiness
Novo Nordisk – Key drivers
Coagulation disorders
ZymoGenetics HRTHuman growth hormone
5
Diabetes careSales by year
DKK million
NovoRapid®/NovoLog®:
EU: Under roll out
US: Approved
Japan: Filed
New innovative devices:
Innovo®: EU and Japan
InnoLet®: EU
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
1995 1996 1997 1998 1999 2000
6
Insulin market overview(’99/ ’00 MAT Q3 volumes)
Novo NordiskMarket share
Market growth (‘00/’99)
44%
46%
4%
6%
% market size MAT Q3.00
100%
25%
58%
80%
61%
44%
Notes: Industrialised world only. Mail-order panel now included in the US figures. Market growth in Europe is affected by above +4% point from conversion of formulation in Italy and France. The effect on the world market growth is estimated to be approx. +2% point.
9.3%
10.5%
10.1%
15.8%
2.9%
World
RoW
Japan
Europe
USA
7
Insulin market growth forecast
Volume
5%
5%
10%
+ = Price/Mix Value• Population growth• Ageing population• Increased prevalence• Better diagnosis• More patients should use insulin• More intensive therapy is necessary
• More sofiticated insulin• More sofisticated delivery systems
8
ß-cell
- PGR - PCO- GLP-1.
Liver- Hepatic enzyme inh.- PPAR- Glukokinase - Glucagon antagonists
- Insulin- Insulin mimetics.
Muscle/Fat
- Insulin sensitisers- Insulin- Insulin mimetics- PPAR - GLUT4- TNF - PTPase.
Brain
- GLP-1.
Diabetes – a complex disease
Gut- GLP-1.
9
Diabetes – sources of innovation
R&D projects
Clinical research• Steno Diabetes Centre• Oxford Diabetes Centre• Clinical research centres worldwide
Evidence-based medicine• NN disease mgt programmes• Outcomes data from > 100.000 individuals with diabetes
Molecular diversity & design• Protein chemistry since ’23• Medicinal chemistry since ’68• Computational chemistry since ’75• Rational drug design since ’83• Combinatorial chemistry since ’93
Trinomics• Genomics: Incyte since ’95• Proteomics: CPA since ’97• Metabonomics since ’99
Drug target & screening• Molecular biology since ’80• HT screening: Amersham since ’92• Chemoinformatics since ’95• Dundee MRC consortium since ’98• Ultra HT Screening since ’00
Basic research• Hagedorn Research Institute• Oxford and Steno Diabetes Centre• Academic collaborations• Consortia
10
Diabetes – evolution of a project
Identify & clone target
Establish biological function
High throughput screening
In vitro biological
profile
Chemistry
In vivo diabetes models
PLPc
Stable cell lines
Diabetesexpertice
Diabetesmodels
11
Diabetes pipeline
Phase 1Phase 1 Phase 2Phase 2 Phase 3Phase 3 RegistrationRegistration
NN2211 (GLP-1 analogue)
NN1215 (LABI)
NN1998 (AERx)
NN4201 (Hepatic glucose regulator)
NN304 (Basal analogue)
NovoMix® 30 (Premix analogue)
NN2344 (Insulin sensitiser)
NN414 (Insulin secretion)
NN622 (Dual acting sensitiser)
NovoMix® (other mixes) (Premix analogue)
12
Primary growth drivers
Secondary value
drivers
Diabetes Carebusiness
Novo Nordisk – Key drivers
Coagulation disorders
ZymoGenetics HRTHuman growth hormone
13
DKK million
Coagulation disordersNovoSeven® sales
Inhibitor indication:
Expected market potential
USD 350 million
Launched
EU: Feb 1996
USA: April 1999
Japan: May 20000
500
1,000
1,500
2,000
2,500
1996 1997 1998 1999 2000
14
NovoSeven® mechanism of action
(NovoSeven®)rFVIIa
Activation of platelets without NovoSeven®
Tissue factor - only at site of injury
FXa
Platelet activation
Thrombin activation and burst
Local activation of platelets & clot formation with NovoSeven®
The key impact of NovoSeven® is through injury site selective platelet activation to ensure high local thrombin formation which secures a tight fibrin clot
15
NovoSeven® update
Coagulation FactorDeficiency
PlateletDisorder
GeneralHaemostasis
Single Factor
MultipleFactors
Surgicalbleeding
Spontaneousbleeding
Lack ofplatelets
Defectiveplatelets
Haemophilia with inhibitors
Liver transplantationsUpper gastro intestinal bleeds
Liver resection
Intra-cerebral bleeds
Traumatology
Vitamin K-antagonists
Bone marrow transplantation
Liver resection
Hip replacements
Haemorrhagic dilution coagulopathy
Oozing after cardiac valve replacement
Colon cancer surgery
Glanzmann
Bernard-Souliers
Area of chronic liver disease
Upper gastro- intestinal
Current indication
16
Financial results 2000
Net turnover 20,811 16,423 27
Operating profit as reported 4,816 3,527 37Operating profit adjusted*) 4,555 3,151 45
Financial items 24 -178 -Profit before tax 4,840 3,349 45Net profit 3,087 2,001 54
Earnings per share (DKK) 44.20 27.98 58 Earnings per ADS**) (USD) 2.76 1.74 58
*) Excluding Seroxat® licence income, one-off income in 2000 and Seroxat® licence income and restructuring costs in 1999.
**) Translated for convenience at the end 2000 exchange rate of USD 100 = DKK 802.05
DKK million 2000 1999 % change
17
New long-term targets
Operating profit (EBIT) growth of 15% p.a.
Operating margin (EBIT-margin) of 25%
Return on invested capital (ROIC) of 25% p.a.
Cash to earnings ratio of 60%.
Notes: Cash to earnings target is based on a three-year rolling average for the cash flow.
18
Coagulation disorders
Peak sales potential for current NovoSeven® indication = USD 350 million
Entering 8 new clinical areas with studies in 2001
Strategy for making NovoSeven® the first general haemostatic agent
Moving towards haemostasis management
Patent protection until 2007-11.
Primary growth drivers
World leader with steady growth for 76 years
2/3 of business (insulin) growing >10% p.a.
Expansion strategy in the US
The most comprehensive insulin and insulin device portfolio in the industry – one new device per year
Sensitisers (NN2344 and NN622)
Liver programmes (NN4201)
NN2211 (GLP-1 analogue)
NN414 (insulin secretion).
Diabetes business
Secondary value
drivers
Novo Nordisk – Key drivers
ZymoGenetics HRTHuman growth hormone
19
0%
20%
40%
60%
Astra
Zeneca
Eli Lill
y
Scher
ing-P
l.
Mer
ck
RocheBM
S
Aventis
Novo Nord
isk
No major patent expirations% of 1999 sales with patents expiring in 2000-2004
Source: Aros Securities Research and Novo Nordisk
20
Forward-looking statements
This conference call 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 risk and uncertainties that may cause actual results to differ materially from expectations, including unexpected developments in the international currency exchange and securities markets, government-mandated or market-driven price decreases for Novo Nordisk's products in the company's major markets and the introduction of competing products within Novo Nordisk's core businesses.
These and other risks and uncertainties are further described in reports filed with the US Securities and Exchange Commission (SEC) by Novo Nordisk and readily available to the public, including the company's Form 20-F, which was filed on 2 May 2000. A Form 20-F for 2000 will be filed by the end of June 2001.
21
Investor Relations Contacts:
Novo Nordisk A/S Investor Relations Novo Allé DK 2880 BagsværdDenmark
Fax (+45) 4444 2314.
Peter HaahrPhone (+45) 4442 1207 E-mail: [email protected]
Palle Holm Olesen Phone (+45) 4442 6175 E-mail: [email protected]
Rasmus Holm-JørgensenPhone (+1) 212 878 0123 E-mail: [email protected]
Share information
Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADSs are listed on the New York Stock Exchange under the symbol "NVO". For further company information, visit Novo Nordisk on the World Wide Web at
http://www.novonordisk.com
Investor information
22
Appendix
23
Insulin etcSales by quarter
NovoRapid®/NovoLog®:
EU: Roll-out ongoing
US: Launch H2 2001
Japan: Filed
New innovative devices:
Innovo®: EU and Japan
InnoLet®: EU
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
DKK million
1997 1998 1999 2000
24
Human growth hormoneSales by quarter
Norditropin® SimpleXx™:
Launched
EU: April 1999
Japan: July 2000
USA: Oct 2000
DKK million
0
200
400
600
800
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
1997 1998 1999 2000
25
DKK million
Coagulation disorders (NovoSeven®)Sales by quarter
Inhibitor indication:
Expected market potential
USD 350 million
Launched
EU: Feb 1996
USA: April 1999
Japan: May 20000
200
400
600
800
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
1997 1998 1999 2000
26
Turnover by therapyDKK million 2000 1999 % of total % change
(2000)
Insulin etc 13,491 11,049 65 22NovoNorm™/Prandin® 1,087 728 5 49
Diabetes care, total 14,578 11,777 70 24
Coagulation disorders* 2,270 1,313 11 73Human growth hormone 2,107 1,721 10 22
HRT 1,306 1,130 6 16
Other 550 482 3 14
Total 20,811 16,423 100 27
* NovoSeven®
27
Turnover by geography
DKK million 2000 1999 % of total % change (2000)
Europe 9,905 8,286 47.6 20
Japan 4,385 3,404 21.1 29
USA 3,747 2,427 18.0 54
Rest of World 2,774 2,306 13.3 20
Total 20,811 16,423 100 27
28
Tissue factorTissue factor RuptureRupture
NovoSeven® mechanism of action
FVIIa / NovoSevenFVIIa / NovoSeven®®FVIIa / NovoSevenFVIIa / NovoSeven®®
29
NovoSeven® studies in 2001
Clinical area Status on project
Orthotopic liver transplantations* Ongoing Ph 2/3 projectLiver resection (normal coagulation) Exploratory Ph 2 study has been initiated
Upper GI bleeds* Ph 2 study expected to start in first half 2001Liver resection* Ph 2 study expected to start in first half 2001Reversal of anti-coagulant therapy Ph 2 study expected to start in first half 2001Bone marrow transplantation Ph 2 study expected to start in first half 2001
Intra-cerebral bleeds Exploratory Ph 2 study expected to start by mid-2001
Traumatology Ph 2 study expected to start by year-end 2001
* Patients with chronic liver disease
30
Current issues
Settlement on two patents with Aventis
Share buy-back programme completed
Proposed dividend of DKK 13.25 per share (DKK 6.63 per ADS) ie an increase in payout ratio from 29% to 30%
Reduction in B share capital of nominal DKK 45 million (4,500,000 B shares) corresponding to 6% of the total capital
Split of shares (1:5): 1 B share (nom DKK 10) 5 B shares (nom DKK 2 each) 1 ADS (nom DKK 5) 2.5 ADSs (nom DKK 2 each)
31
Financial key figures
Gross margin 75.8 74.3 72.5
R&D to sales 16.3 16.7 20.5
S&D to sales 30.1 29.3 30.9
Adm to sales 9.0 10.5 10.2
Operating margin 23.1 21.5 21.5Operating margin adjusted*) 21.9 19.2 16.9
Return on invested capital 22.3 15.1 14.4Cash to earnings ratio 87.9 76.6 35.0
Per cent 2000 1999 1998
Definitions: ROIC: Operating profit after tax as a percentage of average stocks, debtors, tangible & intangible assets less non-interest bearing liabilities (provisions included and proposed dividends excluded).
Cash to earnings: Cash flow before financing (free cash flow) as a percentage of net profit.
32
Outlook for 2001 Growth in operating profit of 15% is expected
Including the impact of the settlement with Aventis
Net financial income is expected to be approx. DKK 300 million
Tax rate expected at 36%
Investments expected to be up to DKK 2.8 billion
Above outlook is based on the assumption that exchange rates remain at the current level (February 20 2001).
33
Vision for Novo Nordisk
• The world’s leading diabetes care company• Our aspiration is to defeat diabetes by finding better methods of diabetes prevention,
detection and treatment
• We will work actively to promote collaboration between all parties in the health care system in order to achieve our common goals
• Offer products and services in other areas where we can make a difference
• Our research will lead to the discovery of new, innovative products also outside diabetes. We will develop and market such products ourselves whenever we can do it as well as or better than others
• Competitive business results• Our focus is our strength
• We will stay independent and form alliances whenever they serve our business purpose and the cause we stand for
34
Insulin sales growth drivers 1:
Increased number of diabetics
Increase in the number of diabetics from 150 million to 220 million – 10 years from now – yearly growth of 3.9%.
Source: Amos A.., McCarty DJ, Zimmet P: Diabet. Med. 1997; 14
35
Insulin sales growth drivers 2:
Increased rate of diagnostics
Only about one third of diabetics are diagnosed
Increased rate of diagnosis leads to higher insulin sales.
50
150
0
25
50
75
100
125
150
175
# of diagnosed # of diabetics
36
Insulin sales growth drivers 3:
More patients should use insulin
Number of diabetics using medication: 25-30 million
More patients should move to the use of insulin.
Oral products Oral/insulin Insulin
66% 7% 27%
37
Insulin sales growth drivers 4:
More intensive therapy
The major land mark study, UKPDS*),prescribed:
Early intervention
Intensified therapy
Use products in combination
More patients on insulin.
*) UKPDS = UK Prospective Diabetes Study
38
Insulin sales growth drivers 5a:
Increased product sophisticationCartridge & Prefilled penetration in the insulin market (volume) by region MAT Q3.00
6.8%
49.7%
71.5%
81.1%
90.2%
0%
20%
40%
60%
80%
100%
Scandinavia Japan Europe RoW USA
Pot
entia
l
Scandinavia excl.
39
Insulin sales growth drivers 5b:
Increased product sophisticationThe industry’s most comprehensive
insulin device portfolio
One new device to be introduced per year.
Conventionalsyringes
Insulin pens
Electronic insulin dosers
40
Insulin sales growth drivers 5c:
Increased product sophistication The industry’s most comprehensive portfolio of
insulin analogues
Rapid acting insulin analogue launched in EU, approved in US
Basal insulin analogue in phase 3
Premixed insulin analogue approved in EU
NVO LLY AVE
Rapid-acting Marketed Marketed Ph1/Ph2
Basal Ph3 Marketed
Premix, protracted Approved Marketed
41
Insulin sales growth drivers 6:
More aggressive US strategy
400 new sales reps. hired / rented during 2000
Total number of reps. by end 2004 = up to 1,000
US insulin market size = USD 1 billion
Pen penetration = 6.8% (vol. MAT Q3 2000)
50% price premium on pen products
US market share (vol.) 20.1% in ’98, 20.2% in ’99 and 24.6% MAT Q3 2000.
Note: Market shares now include mail-order panels.