presentation - Novo Nordisk

Transcription

Slide 1
Investor presentation
First six months of 2015
Mexico City – part of Cities Changing Diabetes
Agenda
Highlights and key events
Sales update
R&D update
Financials and outlook
Slide 2
Slide 3
Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the company’s Annual Report 2014 and Form 20-F,
both filed with the SEC in February 2015, and written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forwardlooking statements. Words such as ‘believe’, ‘expect’, ‘may’, ‘will’, ‘plan’, ‘strategy’, ‘prospect’, ‘foresee’, ‘estimate’, ‘project’, ‘anticipate’, ‘can’, ‘intend’, ‘target’ and other words and terms of
similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include, but
are not limited to:
• Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions
and product approvals as well as cooperation in relation thereto
• Statements containing projections of or targets for revenues, costs, income (or loss), earnings per share, capital expenditures, dividends, capital structure, net financials and other
financial measures
• Statements regarding future economic performance, future actions and outcome of contingencies such as legal proceedings, and
• Statements regarding the assumptions underlying or relating to such statements.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific.
Novo Nordisk cautions that a number of important factors, including those described in this document, could cause actual results to differ materially from those contemplated in any forwardlooking statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations,
delay or failure of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, product recall, unexpected contract breaches or
terminations, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, reliance on information technology, Novo Nordisk’s
ability to successfully market current and new products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation
thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to
ethical marketing practices, investments in and divestitures of domestic and foreign companies, unexpected growth in costs and expenses, failure to recruit and retain the right employees,
and failure to maintain a culture of compliance.
Please also refer to the overview of risk factors in ‘Be aware of the risk’ on p 42-43 of the Annual Report 2014 on the company’s website novonordisk.com.
Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this document, whether as a
result of new information, future events or otherwise.
Important drug information
•
•
Victoza® (liraglutide 1.2 mg & 1.8 mg) is approved for the management of type 2 diabetes only
Saxenda® (liraglutide 3 mg) is approved in the US and EU for the treatment of obesity only
Slide 4
Highlights – first six months of 2015
Sales development
•
Sales increased by 25% in Danish kroner and 9% in local currencies
• North America and International Operations grew by 35% and 26% in Danish kroner, respectively
• Victoza® increased by 41% in Danish kroner and continues to drive the growth of the GLP-1 market
• Levemir® increased by 28% in Danish kroner and continues to capture market share in the US
•
Tresiba® continues to perform well in countries with similar reimbursement as insulin glargine
Research and Development
•
SUSTAIN® 1, comparing once weekly GLP-1 semaglutide with placebo in people with type 2 diabetes, successfully completed
•
Encouraging results from phase 3a study with liraglutide in people with type 1 diabetes (ADJUNCT TWO)
•
Saxenda® shows sustained weight loss and reduced risk of type 2 diabetes vs placebo after three years in SCALE® trial
Financials
•
Operating profit growth of 57% in Danish kroner; adjusted for partial NNIT divestment, growth was 16% in local currency
•
Diluted earnings per share increased 38% to 7.02 DKK per share and 6.20 DKK when adjusted for partial divestment of NNIT
•
2015 financial outlook:
•
Sales growth is still expected to be 7-9% in local currencies (around 14% higher as reported)
•
Operating profit growth is now expected around 19% in local currencies compared to 17% previously
(around 23% higher as reported)
Slide 5
North America is the main contributor to growth
Sales as reported – First six months of 2015
Japan & Korea
+10%
Region China
+25%
5%
Local currencies
14%
Europe
+5%
Growth
Share of growth
10%
56%
4%
10%
17%
28%
Region China
3%
3%
Japan & Korea
5%
3%
Total sales
9%
100%
North America
Europe
10%
International
Operations
+26%
Growth analysis – First six months of 2015
51%
North America
+35%
International Operations
20%
Sales of DKK 52.3 billion (+25%)
Slide 6
Decelerated growth in China reflects timing of shipments,
lower market growth and intensified competition
Decelerating sales growth
in the first six months of 2015
Sales as reported
bDKK
3.0
MAT quarterly local currency growth
Average local currency growth
20%
2.5
15%
2.0
1.5
+
5%
0.5
Q1
2013
Q2
2015
0%
Increased modern insulin penetration
÷ Timing of shipments to distributors
in the growth of the overall diabetes care
÷ Decline
market:
•
•
10%
1.0
0.0
Key factors impacting sales growth
in the first six months of 2015
÷
Cost containment measures in the healthcare system
Restrictions on access to healthcare professionals
Intensified competition
Slide 7
Growth is driven by Victoza® and modern insulin
Sales as reported – First six months of 2015
Norditropin®
+30%
Other
+29%
Growth analysis – First six months of 2015
Local currencies
3%
3%
7%
7%
Haemophilia
+20%
11%
11%
79%
79%
Diabetes and
obesity care
+24%
Sales of DKK 52.3 billion (+25%)
Growth
Share of growth
New-generation insulin
N/A
10%
Modern insulin
6%
34%
Human insulin
0%
0%
Victoza®
22%
35%
Other diabetes and obesity care1
(2%)
(1%)
Diabetes and obesity care
9%
78%
Haemophilia
5%
6%
Norditropin®
15%
12%
12%
4%
Biopharmaceuticals
9%
22%
Total
9%
100%
Other
1
2
biopharmaceuticals2
Predominantly oral antidiabetic products, needles and Saxenda®
Predominantly hormone replacement therapy
Slide 8
Victoza® maintains leadership in the faster growing US
GLP-1 market
Thousands
US GLP-1 market development
MAT GLP-1
TRx (000)
6,000
Growth rate
Total TRx
US GLP-1 market shares
MAT volume
growth rate
25%
5,000
GLP-1 TRx
market share
100%
Victoza®
albiglutide
exenatide
dulaglutide
20%
80%
15%
60%
10%
40%
28%
5%
20%
6%
6%
0%
0%
59%
4,000
3,000
2,000
1,000
0
Jun
2012
Source: IMS NPA MAT, June 2015
Jun
2015
Jun
2012
Source: IMS NPA MAT, June 2015
Jun
2015
Slide 9
Novo Nordisk’s modern insulins perform well within their
respective segments in the US
Levemir®
NovoLog®
TRx volume MS
NBRx volume MS
TRx segment volume
MU
1,200
70%
1,000
60%
800
50%
40%
600
30%
400
20%
0%
10%
Aug
2013
Jul
2015
NovoLog® Mix
TRx volume MS
NBRx volume MS
TRx segment volume
MU
1,200
70%
1,000
60%
800
50%
TRx volume MS
NBRx volume MS
TRx segment volume
MU
1,200
70%
1,000
60%
800
50%
600
600
40%
30%
400
30%
400
200
20%
200
20%
200
0
10%
0%
0
0%
10%
40%
Aug
2013
Source: IMS Xponent Plan Trak Weekly and IMS LRx Weekly, July 2015; excludes Medicaid
Note: Includes analogue insulins only
Jul
2015
Aug
2013
Jul
2015
0
Slide 10
Roll-out of degludec portfolio is progressing
Key launch observations
•
Switzerland
Japan
Mexico
•
•
• Ryzodeg® commercially launched in Mexico, India and
Bangladesh
India
Sweden
Denmark
35%
United Kingdom
Germany
Argentina
Brazil
30%
27%
Tresiba®
•
launched in 30 countries
®
Tresiba has shown solid penetration in markets with
similar reimbursement as insulin glargine
Penetration of Tresiba® remains modest in markets with
restricted market access compared to insulin glargine
Tresiba® distribution in Germany to cease by end
September following the negative price negotiation
outcome with the German national association of
statutory health insurance funds (GKV Spitzenverband)
Tresiba® value share of basal insulin segment
in selected countries
25%
20%
15%
11%
10%
8%*
5%
5%
16%
14%
10%
3%
3%
0%
• Xultophy® launched in Switzerland as the first country,
followed by Germany and the United Kingdom
30%
1
3
5
7
9 11 13 15 17 19 21 23 25 27
Months from launch
Note: Limited IMS coverage in India
Source: IMS Monthly value figures, May 2015
*Tresiba® distribution in Germany to cease by end September 2015
Slide 11
Encouraging early prescription development for Saxenda®
Prescription volume uptake of anti-obesity
medications recently launched in the US
TRx
volume
Naltrexone HCI & bupropion HCI
Lorcaserin
Phentermine & topiramate
Saxenda®
8,000
6,929
Key launch observations
• Encouraging initial Saxenda® uptake
• Positive early feedback from physicians and patients
6,000
• Expanding formulary access remains a main priority
4,000
• The SCALE® Obesity and Pre-diabetes manuscript was
published in the New England Journal of Medicine (NEJM) on
1 July 2015
3,882
1,420
2,000
1,204
0
0
1
2
3
4
5 6 7 8 9 10 11 12 13 14 15 16
Weeks from launch
Note: IMS reporting for new launches may reflect data instability due to small volume and/or supplier
reporting
Source: IMS NPA TRx, Weekly data, July 2015
Slide 12
Semaglutide shows superior HbA1c reduction and weight
loss compared with placebo in SUSTAIN® 1 trial
SUSTAIN® 1 trial design
Headline results
0.5 mg
1.0 mg
Placebo
semaglutide semaglutide
Semaglutide 0.5 mg
388 drugnaïve people
with type 2
diabetes1
0
Change in HbA1c
(8.1% baseline)
-1.5%*
-1.6%*
0.0%
74%*
73%*
25%
Semaglutide 1.0 mg
Proportion of
patients reaching
HbA1c target of <7%
Placebo
Change in body weight
(92 kg baseline)
-3.8 kg*
-4.6 kg*
-1.0 kg
Discontinuation rate
due to adverse events
6%
5%
2%
30 weeks
Inclusion criteria: Type 2 diabetes, treated with diet and exercise at least 30 days before screening,
HbA1c 7.0-10.0% (53 - 86 mmol/mol) (both inclusive)
1
*Statistically
significantly greater compared to placebo
Slide 13
Liraglutide as adjunct to insulin therapy leads to greater
HbA1c reduction and weight loss in ADJUNCT TWO trial
ADJUNCT TWO trial design1
835 people
with type 1
diabetes2
Headline results
Liraglutide 1.8 mg + capped insulin
• Greater improvement in HbA1c between 0.2% and 0.3% for
people with type 1 diabetes compared with no improvement
for people with type 1 diabetes treated with placebo
• Weight loss of between 2 kg and 5 kg from mean baseline of
84 kg versus stable weight development with placebo
• No difference in severe hypoglycaemia or nocturnal
symptomatic hypoglycaemia for any of the doses. However,
a higher rate of symptomatic hypoglycaemia was observed
among people treated with liraglutide 1.2 mg compared to
people treated with placebo
Liraglutide placebo + capped insulin
• Liraglutide appeared to have a safe and well-tolerated
profile
Screening
1
2
-2
0
4
Week
26
Capped insulin defined as upper limit on total daily insulin dose corresponding to pre-trial average total
daily insulin dose
Inclusion criteria: Type 1 diabetes as diagnosed clinically 12 mths or prior to visit 1, 18 years or older,
treatment with basal bolus or Continuous Subcutaneous Insulin Infusion 6 mths or longer prior to visit 1,
stable insulin treatment 3 mths or longer prior visit 1, HbA1c 7.0-10.0% (53 - 86 mmol/mol) (both incl.)
• Results of the second and final pivotal phase 3a trial
ADJUNCT ONE are expected to be reported shortly
Slide 14
Saxenda® shows sustained weight loss and reduced risk of
type 2 diabetes vs placebo after three years in SCALE® trial
Sustained weight loss with Saxenda® in
SCALE® obesity and prediabetes trial
Saxenda®
(placebo)
56 weeks1
Mean weight
reduction
8% (3%)
Proportion achieving
5% weight reduction
63% (27%)
Proportion achieving
10% weight reduction
33% (11%)
Saxenda®
(placebo)
160 weeks2
6% (2%)
50% (23%)
24% (9%)
p<0.0001. 2 p<0.0001
Source: Pi-Sunyer et al. AACE. 2014. Abstract number: 700; Novo Nordisk data on file (NN8022-1839)
1
Saxenda® effect on emerging type 2 diabetes
• Approximately 80% reduced risk of developing type 2
diabetes for people treated with Saxenda®3
• Time to onset of type 2 diabetes was 2.6 times longer for
the Saxenda® group compared to placebo
• At 160-week, completion rate of 53% and 45% for
Saxenda® and placebo respectively
• Saxenda® appeared to have a safe and well tolerated profile
with most frequently reported adverse events being
gastrointestinal in nature
p<0.0001
Source: Novo Nordisk data on file (NN8022-1839)
3
Key development milestones
DEVOTE trial now expected to be completed mid-2016 compared to previously in the second half of 2016
First phase 2a proof-of-principle trial with oral insulin analogue OI338GT (NN1953) initiated in June 2015
First phase 1 trial with new oral insulin analogue OI320GT (NN1957) initiated in June 2015
Slide 15
Slide 16
Significant news flow from late-stage diabetes and obesity
pipeline
Results available
Project
Past 6 months
Past 3 months
Oral GLP-1
Phase 2
√
Faster-acting
insulin aspart
ONSET® 1
√
√
Saxenda®
LATIN T1D
ONSET® 2
SCALE® ext. data
ADJUNCT TWO
Within 3 months
In ~3-6 months
In ~6-9 months
√
√
ADJUNCT ONE
SUSTAIN®
1
√
SUSTAIN® 3
Semaglutide
SUSTAIN® 2
SUSTAIN® 4
SUSTAIN® 5
SUSTAIN® 6
Victoza®
Tresiba®
Note: Indicated timeline as of financial release of first six months of 2015 on 06 August
LEADER®
SWITCH 1
SWITCH 2
Slide 17
Financial results – first six months of 2015
DKK million
Sales
Gross profit
Gross margin
Sales and distribution costs
Percentage of sales
Research and development costs
Percentage of sales
Administration costs
Percentage of sales
Other operating income, net
Non-recurring income from the IPO of NNIT
Operating profit
Net financials
Profit before income tax
Tax
Effective tax rate
Net profit
Diluted earnings per share (DKK)
Diluted earnings per share (DKK) adjusted for NNIT IPO
H1 2015
52,259
44,526
H1 2014
41,972
34,835
Change
25%
28%
85.2%
83.0%
13,322
10,645
25.5%
25.4%
6,285
6,243
12.0%
14.9%
1,741
1,600
3.3%
3.8%
3,161
419
N/A
16,766
524
17,290
3,838
57%
N/A
33%
25%
25%
1%
9%
2,376
26,339
(3,306)
23,033
4,814
20.9%
22.2%
18,219
7.02
13,452
5.09
35%
38%
6.20
5.09
22%
Slide 18
Non-hedged currencies
Index (1 Jan 2014 = 100)
Hedged currencies
Index (1 Jan 2014 = 100)
Appreciation of key currencies against the Danish krone
drive significant positive currency impact in 2015
USD/DKK
135
130
125
120
115
110
105
100
95
90
CNY/DKK
RUB/DKK
140
INR/DKK
JPY/DKK
ARS/DKK
GBP/DKK
BRL/DKK
CAD/DKK
TRY/DKK
120
Hedged
Currencies
2014
average
2015
average2
Spot
rate2
USD1
562
671
680
1,675
CNY1
91.2
107.8
109.5
270
104
JPY1
5.32
5.55
5.48
115
13
GBP1
925
1,025
1,062
80
11
CAD1
509
539
518
60
11
Non-hedged
Currencies5
2014
average
2015
average2
14.8
11.7
10.8
INR1
9.20
10.65
10.7
80
ARS1
0.69
0.75
0.74
60
BRL1
239
223
198
TRY1
257
259
245
40
1
2
3
2014
4
1
2
2015
11
Spot
rate2
RUB1
100
Impact of a Hedging
5% move3 (months)
DKK per 100; 2 As of 04 August 2015; 3 Operating profit in DKK million per annum; 4 USD used
as proxy; 5 Operating profit impact of one of the non-hedged currencies fluctuating 5% is in the
range of DKK -15 to +25 million
1
Slide 19
Financial outlook for 2015
Expectations
6 August 2015
Sales growth - local currencies
Previous expectations
30 April 2015
7-9%
7-9%
Around 14 percentage points higher
Around 19%
Around 17%
Loss of around DKK 5.7 billion
Loss of around DKK 6 billion
Around 21%
Around 21%
Capital expenditure
Around DKK 5.0 billion
Depreciation, amortisation and
impairment losses
Around DKK 33-35 billion
Around DKK 32-34 billion
Sales growth - reported
Operating profit growth - local
currencies
Operating profit growth - reported
Net financials
Effective tax rate
Free cash flow
The financial outlook is based on an assumption of a continuation of the current business environment and given the current scope of business activities and has been prepared assuming that currency
exchange rates remain at the level as of 04 August 2015
Slide 20
Closing remarks
Solid market performance
>≥10% annual diabetes care market growth driven
•>
by diabetes prevalence
• 28%
market share in diabetes care and solid
leadership position
• 47%
insulin volume market share with leadership
position across all regions
• 46%
modern and new-generation insulin volume
market share
c
• 71%
GLP-1 value market share with strong global
leadership position
Source: IMS MAT May 2015 volume and value (DKK) figures
Promising pipeline
• The only company with a full portfolio of novel
insulin products
• GLP-1 portfolio offers expansion opportunity within
type 1 and 2 diabetes
• Xultophy® supports promising outlook for insulin and
GLP-1 combination therapy
• Saxenda® holds potential within obesity
• Promising pipeline within haemophilia and growth
hormone disorders
Slide 21
Investor contact information
Share information
Novo Nordisk’s B shares are listed on the stock exchange in
Copenhagen under the symbol ‘NOVO B’. 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
Upcoming events
29 Oct 2015
Financial statement for the first nine months of 2015
03 Feb 2016
Financial statement for 2015
Investor Relations contacts
Novo Nordisk A/S
Investor Relations
Novo Allé, DK-2880 Bagsværd
Kasper Roseeuw Poulsen
+45 3079 4303
[email protected]
Daniel Bohsen
+45 3079 6376
[email protected]
Melanie Raouzeos
+45 3075 3479
[email protected]
In North America:
Frank Daniel Mersebach
+1 609 235 8567 [email protected]
Appendix
1. Novo Nordisk at a glance
2. Diabetes
3. Biopharmaceuticals
4. Financials
Slide 22
Slide 23
Novo Nordisk at a glance
Global leader in diabetes care
• A focused pharmaceutical company with leading positions
in diabetes, haemophilia and growth hormone
Global insulin market leadership
Global insulin market share: 47%
Europe:
Market share 47%
• Double digit top line growth driven by diabetes pandemic
Japan & Korea:
Market share 49%
• Significant growth opportunities fuelled by global
presence and strong R&D pipeline
• High barriers to entry in biologics
• Operating margin targeting 40%
• Operating profit growth targeting 15%
North America:
Market share 37%
China:
Market share 57%
International Operations:
Market share 55%
• Earnings conversion to cash targeting 90%
• Cash generated returned to shareholders
Global/regional headquarter
Source: IMS MAT May 2015 volume figures
Manufacturing
R&D facility
Slide 24
Novo Nordisk works with four strategic focus areas based
on five core capabilities
Core capabilities
Strategic focus areas
Expand leadership in DIABETES
Establish presence in OBESITY
Engineering,
formulating,
developing
and
delivering
proteinbased
treatments
Deep
disease
understanding
Pursue leadership in HAEMOPHILIA
Expand leadership in GROWTH DISORDERS
The Novo Nordisk Way
Efficient
Planning
large-scale
and
Expand leadership
production
executing
of proteins
global
launches
of new
products
Building
and
maintaining
a leading
position in
emerging
markets
Slide 25
Novo Nordisk has leading positions in diabetes,
haemophilia and growth disorders
Diabetes
DKK
billion
Haemophilia
Market value
Novo Nordisk value market share
Global market position
350
#1
300
100
CAGR1
value: 15.6%
May
2010
CAGR for 5-year period
Source: IMS MAT value figures
1
35%
60
20%
50
0
70
25%
200
150
40%
30%
250
DKK
billion
15%
Growth disorders
Market value
#2
35%
30%
50
25%
40
30
40%
20
Market value
#1
16
CAGR1 value: 4.9%
5%
10
5%
0%
May
2015
0
0%
FY
2014
20%
8
10%
Note: Annual sales figures for Haemophilia A,B and inhibitor
segment.
1 CAGR for 5-year period
Source: Company reports
35%
25%
12
15%
10%
40%
30%
20%
20
FY
2010
DKK
billion
CAGR1 value: 5.8%
10%
4
0
5%
May
2010
Source: IMS MAT value figures
1
15%
0%
May
2015
Slide 26
Double digit top line growth driven by diabetes pandemic
Novo Nordisk reported quarterly sales
by therapy
DKK
billion
30
25
20
2
500
China
200
387
Haemophilia includes NovoSeven®, NovoThirteen® (as of Q1 2013) and NovoEight® (as of Q1 2014)
0
355
215
151
100
Q2
2015
Europe
Japan & Korea
592
CAGR1: 7.0%
300
13.8%
Q2
2005
North America
400
8.2%
5
Million
people
600
Reported sales
CAGR1: 12.6%
11.5%
10
1
Diabetes and obesity
Haemophilia2
Norditropin®
Other
6.6%
15
0
The number of people with diabetes
according to IDF
2000
99
146
10
34
29
13
45
33
2014
2035E
Note: 20-79 age group
1 CAGR for 14-year period
Source: International Diabetes Federation: Diabetes Atlas, 2000 and 2014
Slide 27
Novo Nordisk has a strong leadership position within the
growing diabetes care market
Global diabetes care market
by treatment class
DKK
billion
GLP-1
Insulin
Global diabetes care
value market share
OAD
350
Novo Nordisk
Sanofi
AstraZeneca
Novartis
30%
250
200
Injectables:
CAGR1 19.2%
20%
CAGR1 17.7%
10%
Takeda
Eli Lilly
GSK
28%
Total market:
CAGR1 14.0%
300
Merck
150
100
50
0
1CAGR
CAGR1 8.7
May
2005
for 10-year period
Source: IMS Monthly MAT value figures
May
2015
0%
May
2005
May
2015
Slide 28
Significant growth opportunities fuelled by strong R&D
pipeline across all four strategic focus areas
PHASE 1
PHASE 2
PHASE 3
OG987GT – Oral GLP-1
OG217SC – Oral GLP-1
OG987SC – Oral GLP-1
insulin1
SUBMITTED
APPROVED3
Faster-acting insulin aspart
Levemir®
Semaglutide – QW GLP-1
NovoRapid®
LAI287 – QW basal insulin
LATIN – Type 1 diabetes
NovoMix®
LAI338 – QD basal insulin
N8-GP – Long-acting rFVIII
Tresiba® (EU/Japan)
OI320GT – Oral insulin
N9-GP – Long-acting rFIX
Ryzodeg® (EU/Japan)
OI338GT – Oral
G530L – Glucagon analogue
NN8640 – Once-weekly
GH2
Xultophy® (EU)
NN9838 – Amylin analogue
Victoza®
NN7415 – Concizumab
Saxenda® (US/EU4)
NovoSeven®
NovoEight®
NovoThirteen®/TRETTEN®
Norditropin®
1
2
3
4
Diabetes
Haemophilia
Obesity
Growth disorders
Phase 2a proof-of-principle trial initiated in June 2015
Phase 3 initiated in adult growth hormone disorder
Approved in all triad markets (US, EU and Japan), unless noted
Approved in the US on 23 Dec 2014 and EU 23 Mar 2015
Slide 29
Growth opportunities supported by strong global presence
in both sales and manufacturing
FTEs in sales regions1
North America:
~5,400
Europe:
~2,800
International Operations:
~5,000
Japan & Korea:
~1,100
China:
Total non-HQ/manufacturing FTEs:
1
2
Global manufacturing setup
~3,100
17,4001
•
•
•
•
•
• API production
New Hampshire2
•
•
•
API production
Formulation & filling
Assembly
•
Packaging
Device & needle manufacturing
Kaluga
Packaging
Denmark
Clayton
Formulation
& filling
Assembly
Packaging
•
•
•
Chartres
Formulation & filling
Assembly
Packaging
Montes Claros
• Formulation & filling
• Assembly
• Packaging
FTEs represent full-time employee equivalents in Novo Nordisk’s sales regions (excludes a.o. employees in headquarter, research sites and manufacturing sites) as of June 2015
New Hampshire is expected to start producing during 2017
•
•
•
•
•
Koriyama
Packaging
Tianjin
Formulation
& filling
Assembly
Packaging
Device
manufacturing
High barriers to entry in biologics
Novo Nordisk’s position is protected
by patents and value chain setup
Patent protection1
Unique value chain position
EU/US0
Research &
Development
202832
2028/302
Manufacturing
2028/302
Commercialisation
2014-15/1722
20234/2352
•
History of protein engineering
•
Highly efficient, flexible and
capital intensive manufacturing
•
Global commercial footprint
2017/172
exp/exp
Research & Development
•
•
•
Need to show comparability in PK/PD trials
Strict regulatory requirements in EU and US
Requirement for both drug and device offering
Manufacturing
2018/192
20172/172
Significant barriers to entry
for biosimilar players
List is not exhaustive of all marketed Novo Nordisk products. 2 Formulation patent expiration year
3 Protected by patents on the individual compounds insulin degludec and liraglutide as listed. 4 Assuming
paediatric extension 5 Saxenda patent identical to the Victoza® patent
Source: Novo Nordisk
•
•
Significant economies of scale with incumbents
Significant up-front CAPEX requirements with slow return on
investment
Commercialisation
•
•
•
Large and fragmented target audience
Cost pressure from payers
On-going conversion to next generation drugs and slow market
dynamics
1
PK: Pharmacokinetic, PD: Pharmacodynamics
Slide 30
Slide 31
Long-term financial targets
Performance against long-term financial targets
Average
2009-20131
Result
2014
Operating profit growth
Operating profit growth in local currencies
21%
18%
10%
13%
15%
Operating margin
34%
39%
40%
Operating profit after tax to net operating assets
77%
101%
125%
108%
93%
90%
Cash to earnings (three years’ average)
Note: The long term financial targets are based on an assumption of a continuation of the current business environment and given the current scope of business activities and has been prepared
assuming that currency exchange rates remain stable
1 Simple average of reported figures 2009-2013; 2 The long-term financial targets were last updated in connection with the FY2012 Financial Release
Target2
Diabetes and obesity
Slide 32
Slide 33
Diabetes – the inability to manage blood sugar levels
appropriately
Facts about diabetes
Insulin secretion profile
Diabetes is a chronic disease that occurs either when the
pancreas does not produce enough insulin or when the body
cannot effectively use the insulin it produces1
Type 1 diabetes: Complete insulin deficiency due to
destruction of beta-cells in pancreas
Type 2 diabetes: Characterised by some degree of insulin
resistance and insulin deficiency
60
Insulin (µ U/ mL)
Primary classifications2:
70
50
40
3
0
20
10
0
6:00
10:00
14:00
18:00
22:00
2:00
6:00
Time of day
Breakfast
Diabetes fact sheet N˚312, WHO, October 2013
2 Polonsky et al. J Clin Invest 1988;81:442–48
1
Lunch
Dinner
Slide 34
Insulin – a hormone enabling blood sugar to enter cells
Insulin enables glucose to become energy
The aim of insulin therapy is to recreate normal
blood insulin profile
70
• Facilitates uptake of blood sugar into cells
Fat cell
Insulin (µ U/ mL)
60
• Inhibits glucose release from the liver
Liver
Short-lived, rapidly generated
meal-related peaks (prandial)
50
40
3
0
20
Sustained
Insulin profile (basal)
10
Pancreas
Muscle
0
6:00
10:00
14:00
18:00
22:00
2:00
6:00
Time of day
Breakfast
Polonsky et al. J Clin Invest 1988;81:442–48
Lunch
Dinner
Slide 35
Diabetes pandemic is fuelled by growing rates of obesity
US CDC data on obesity and diabetes prevalence among adults
1994
2000
2012
Obesity prevalence
(BMI ≥30 kg/m2)
No Data
<14.0%
14.0-17.9%
18.0-21.9%
22.0-25.9%
>26.0%
No Data
<4.5%
4.5-5.9%
6.0-7.4%
7.5-8.9%
>9.0%
Diabetes prevalence
CDC: Centers for Disease Control and Prevention
Source: CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at http://www.cdc.gov/diabetes
Slide 36
Poor diagnosis rates, lack of access to optimal treatment
and poor glycaemic control remain global problems
Diagnosis and optimal treatment
remains a challenge – the rule of halves
The worldwide challenge of glycaemic control:
mean HbA1C in type 2 diabetes
100%
All people with
diabetes
Canada
US
Latin America
Germany
Greece
Italy
Poland
Portugal
Romania
Spain
Sweden
Turkey
UK
50%
50% are diagnosed
50% have access to
care
China
India
Japan
Korea
Russia
7.35
7.2%6
7.6%1
25%
12%
50% get decent
care
50%
50%reach
reachtarget
target
7.2-9.5%8
7.3-9.3%8
7.3–7.7%4
7.9–8.7%3
7.2-9.5%8
6.7-9.2%2
7.1–9.7%2,7,8
7.7-8.3%8
7.3-8.9%8
7.9-9.7%2
7.9-9.9%2
7.6-9.2%7
7.4-8.7%2
7.6-10.6%2
7.4-8.7%9
Lopez Stewart et al. Rev Panam Salud Publica 2007;22:12–20; 2 Oguz et al. Curr Med
Res Opin 2013;29:911–20; 3 Ko et al. Diab Med 2007;24:55–62; 4 Arai et al. J Diabetes
Investig. 2012 Aug 20;3(4):396-401; 5 Harris et al. Diabetes Res Clin Pract
2005;70:90–7; 6 Hoerger et.al. Diabetes Care 2008;31:81–6; 7 Liebl et al. Diab Ther
2012;3:e1–10; 8 Valensi et al. Int J Clin Pract 2009;63(3):522-31; 9Blak et al. Diab Med
2012;29:e13-20
1
Slide 37
UKPDS: Tight glycaemic control reduces risk of micro- and
macrovascular complications
Risk reduction by lowering HbA1c by 1%-point
Incidence risk (%)
0
Diabetesrelated
death
Myocardial
infarction
Microvascular
complications
Peripheral
vascular
disease
Relative risk reduction of intensive vs.
conventional treatment (%)
SU/Insulin
SU/Insulin
treated patientes
–10
–14%
–20
–21%*
–30
–40
–50
UKPDS 10 year follow-up:
Legacy effect of tight glycaemic control
–37%*
*p<0.0001
Source: UKPDS, Stratton et al. BMJ 2000; vol. 321:405–12
1997
2007
Microvascular disease
25
24
Diabetes-related death
10
17
Myocardial infarction
16
15
6
13
All-cause mortality
–43%*
Statistically significant improvement
Source: NEJM, vol. 359, Oct 2008
Slide 38
Insulin is the ultimate care for people with diabetes
Progression of type 2 diabetes and treatment
intensification
Distribution of patients and value across
treatment classes
Insulin
100%
Diet and exercise
-cell function
80%
OAD
60%
GLP-1
Insulin
40%
20%
Time
OAD: Oral Anti-diabetic Drugs
GLP-1
0%
Patients
Value
Note: Patient distribution across treatment classes is indicative and based on data for
US, UK, Germany and France. Value figures based on IMS MAT May 2015
Source: IMS PharMetrix claims data, IMS disease analyser, IMS Midas
OAD
Slide 39
The insulin market is comprised of three segments
Insulin action profiles
Global insulin volume market by segment
tMU
Fast-acting
CAGR volume1: 5.3%
CAGR value1: 19.3%
450
400
350
Premix
Fast-acting
300
250
34%
200
Long-acting
150
100
50
6:00
10:00
Breakfast
14:00
Lunch
18:00
Dinner
22:00
0
2:00
6:00
Time of day
34%
30%
36%
May
2010
Premix
Long-acting
27%
39%
May
2015
CAGR for 5-year period. Value in DKK
Note: US trend data reflect changes to IMS data collection coverage and methodology as of January 2012
Source: IMS Monthly MAT volume and value (DKK) figures
1
Slide 40
Medications used for the treatment of type 2 diabetes
Commonly prescribed products for the treatment of type 2 diabetes
Class
HbA1C
change
Hypoglycaemia
Weight
change
CVD risk
factors
Dosing
(pr. day)
Contraindication/
undesired effects
Metformin
1.5
No
Neutral
Minimal
2 OADs
Kidney, liver
Sulfonylurea
1.5
Yes
Gain
None
1 OAD
Essentially none
TZDs
0.5 - 1.4
No
Gain
Variable
1 OAD
CHF, liver
DPP-IV inhibitors
0.6 - 0.8
No
Neutral
TBD
1-2 OAD
None
SGLT-2 inhibitors
0.5 - 0.9
No
Loss
TBD
1 OAD
Genital infections, urinary
tract infections
GLP-1
1.0 - 2.0
No
Loss
TBD
Varies
GI side effects, MTC
Long-acting insulin
1.5 - 2.5
Yes
Gain
TG and HDL
1 injection
Hypoglycaemia
Fast-acting insulin
1.5 - 2.5
Yes
Gain
TG and HDL
1-4 injections
Hypoglycaemia
Note: TG and HDL: Beneficial effect on triglycerides and HDL cholesterol; CHF: Congestive heart failure; GI: Gastro intestinal; MTC: Medullary thyroid cancer. TBD: to be defined.
Sources: Adapted from: Nathan DM, et al. Diabetes Care. 2006; 29:1963-1972; Nathan DM, et al. Diabetes Care. 2007;30:753-759; Nathan DM, et al. Diabetes Care. 2008;31:173-175. ADA. Diabetes
Care. 2008;31:S12-S54. WelChol PI. 1/2008.
Slide 41
Sustained double-digit growth in insulin market
Global insulin market growth
May 2010 – May 2015
Volume
DKK
billion
CAGR:
14.0%1
160
140
CAGR:
5.3%1
120
100
60
20
0
185
139
bDKK
77
bDKK
May
2010
• Rising prevalence of diabetes
• Growing overweight and obesity prevalence
• Ageing of populations
• Rising diagnosis rates and treatment rates
• Intensification of insulin regimens
Value
• Conversion to modern insulin and new-generation insulin
• Continued device penetration
66
Volume
Mix/price
contribution contribution
1
CAGR:
19.3%1
76
bDKK
32
bDKK
80
40
The fundamental growth drivers
of the insulin market
May
2015
Slide 42
Solid insulin volume growth in key regions
Novo Nordisk
regions
North America
Europe
Market
value size & growth
94.8
3%
42%
Market volume
composition
136.7
50%
39%
11%
26.1
2%
2%
27.3
39%
Region China1
Japan & Korea
9.0
2%
10.3
31%
24%
45%
5.0
7%
16%
6.2
14%
4.3
-1%
Volume
growth
2%
Mix/price
growth2
only covers part of the channels in China and International Operations. 2 Measured in DKK.
Source: IMS May 2014 & 2015 Monthly MAT volume and value (DKK) figures
4.4
2015
bDKK
35%
27%
37%
53%
47%
45%
55%
43%
57%
51%
49%
21%
65%
2014
bDKK
1IMS
12%
Premix
63%
Long-acting
40%
21%
International
Operations1
Fast-acting
Volume market
shares
38%
Novo Nordisk
Others
Slide 43
Stable global insulin volume growth
Regional insulin volume growth
Regional insulin volume market split
North America
North America
Europe
Int. Operations
China
Japan & Korea
World
Europe
China
Int. Operations
Japan & Korea
100%
40%
35%
9%
22%
80%
30%
3%
25%
60%
35%
20%
40%
15%
10%
4.8%
5%
0%
May
2010
0.00
0.00
May
2015
0.00
Millions
Note: Data is sensitive to changes in IMS data collection and reporting methodology
Source: IMS Monthly MAT volume figures
20%
0%
31%
May
2010
May
2015
Slide 44
Maintaining insulin leadership by sustaining modern
insulin market share
Novo Nordisk volume market share across insulin classes
tMU
450
100%
Market value2:
DKK 19 billion
400
350
80%
300
60%
250
200
40%
150
100
20%
50
0
450
Market value2:
DKK 165 billion
400
350
300
100%
80%
60%
250
200
40%
150
100
20%
May
2010
May
2015
0%
0
450
class volume
Market value2:
DKK 185 billion
400
350
300
100%
80%
60%
250
200
40%
150
100
20%
50
50
May
2010
Includes animal insulin 2 Annual value of total insulin class 3 Includes new generation insulin
Source: IMS, Monthly MAT value and volume figures
1
Novo Nordisk class MS (%)
tMU
Total insulin
Modern insulin3
Thousands
Human insulin1
Thousands
Thousands
tMU
May
2015
0%
0
May
2010
May
2015
0%
Slide 45
Strong underlying insulin market growth and steady
market share development
Global insulin market
Device penetration
tMU
500
Global modern insulin1 volume market shares
Modern insulin penetration1
Penetration
100%
CAGR volume2: 5.3%
CAGR value2: 19.3%
400
80%
300
60%
200
0
40%
20%
Human insulin
May
2010
May
2015
Includes new generation insulin. 2 CAGR for 5-year period
1
Sanofi
Eli Lilly
60%
50%
46%
40%
35%
30%
Modern insulin1
100
Novo Nordisk
18%
20%
10%
0%
0%
May
2010
Includes new generation insulin
Note: Data is sensitive to changes in IMS data collection and reporting methodology,
does not add up to 100% due to other players
1
May
2015
Slide 46
Novo Nordisk’s modern insulins continue strong
performance within their respective segments
Fast-acting insulin
tMU
180
160
Segment volume
NovoRapid® market share
CAGR1 volume: 6.0%
MI penetration: 76.1%
140
120
100%
80%
60%
100
80
40%
60
40
20%
20
0
Premixed insulin
May
2010
May
2015
0%
tMU
180
160
Segment volume
NovoMix® market share
CAGR1 volume: 3.4%
140
120
100%
80
40%
60
40
20%
20
May
2010
May
2015
tMU
180
160
80%
60%
100
0
Long-acting insulin
0%
140
Segment volume
Levemir® market share
CAGR1 volume: 7.1%
MI/NG penetration:
79.5%
120
80%
60%
100
80
40%
60
40
20%
20
0
May
2010
May
2015
Note: Modern insulin (MI) penetration is of total segment, i.e. including animal and human insulin; NG: new generation; Data is sensitive to changes in IMS data collection and reporting methodology
1
100%
0%
Slide 47
NovoRapid® remains the preferred modern fast-acting
insulin in all key markets
Fast-acting insulin market by volume
Share of total
insulin market
60%
40%
3%
Example of NovoRapid® promotional sales aid1
Segment volume growth
NovoRapid®
Other modern insulin
Others
3%
1%
19%
6%
8%
20%
0%
North Europe
America
IO
Japan & Region
Korea
China
Global
Note: Segment volume growth May 2015 vs 2014. IO: International Operations. Human insulin incl.
animal insulin
Picture of sales aid is not intended for promotional purposes
Source: NovoRapid® Summary of Product Characteristics
1
Slide 48
Continued growth potential for NovoMix® in the
premix insulin segment in key markets
Premix insulin market by volume
Share of total
insulin market
80%
Example of NovoMix® promotional sales aid1
®
NovoMix
Other modern insulin
Others
6%
60%
9%
40%
20%
0%
-10%
-3%
2%
-7%
North Europe
America
IO
Japan & Region Global
Korea
China
Note: Segment volume growth May 2015 vs 2014. IO: International Operations. Human insulin incl.
animal insulin
Source: NovoMix® Summary of Product Characteristics
1
Slide 49
Solid growth potential for Levemir® in the long-acting
insulin segment
Basal insulin market by volume
Share of total
insulin market
60%
®
Example of Levemir® promotional sales aid1
®
Tresiba
Levemir
Other modern insulin Others
4%
40%
6%
5%
13%
20%
0%
6%
15%
North Europe
America
IO
Japan & Region
Korea
China
Global
Note: Segment volume growth May 2015 vs 2014. IO: International Operations. Human insulin incl. animal
insulin
Sources: Blonde L. et al. Diabetes, Obesity and Metabolism 2009; Hermansen K. et al.
Diabetes Care 2006; Levemir® EU Summary of Product Characteristics, April 2012;
Philis-Tsimikas A. et al. Clinical Therapeutics 2006; Rosenstock J et al. Diabetologia
2008; IMS Worldwide Data Q3 2012; Reimer T. et al. Clinical Therapeutics 2008
1
Slide 50
Still a significant potential for Novo Nordisk on the US
modern insulin market
US insulin market by segments
Device penetration
tMU
140
CAGR volume1: 2.1%
CAGR value1: 27.1%
Penetration
100%
2
120
80%
100
Fast-acting
60%
80
40%
40
20
20%
Long-acting
May
2010
Novo Nordisk
May
2015
0%
US trend data reflect changes to IMS data collection coverage and methodology as of January 2012
Sanofi
Eli Lilly
60%
50%
41%
40%
38%
30%
Premix
60
0
US modern insulin volume market shares
Modern Insulin penetration
20%
21%
10%
0%
May
2010
1
2
May
2015
Slide 51
Novo Nordisk’s modern insulins have gained market share
in expanding US insulin market
US fast-acting insulin
tMU
70
60
US premixed insulin
Segment volume
NovoLog® market share
CAGR volume1: 3.4%
100%
80%
50
tMU
70
60
US long-acting insulin
Segment volume
NovoMix® market share
CAGR volume1: (7.5%)
100%
80%
50
tMU
70
60
Segment volume
Levemir® market share
CAGR volume1: 4.1%
100%
80%
50
40
60%
40
60%
40
60%
30
40%
30
40%
30
40%
20
20
20%
10
0
May
2010
May
2015
0%
20%
10
0
May
2010
May
2015
0%
20
20%
10
0
May
2010
Note: US trend data reflect changes to IMS data collection coverage and methodology as of January 2012. Modern insulin (MI) penetration is of total segment, i.e. including human insulin
1
May
2015
0%
Slide 52
Sustained leadership position on the European modern
insulin market
European modern insulin1
volume market shares
European insulin market by segments
Device penetration
tMU
180
CAGR volume1: 2.4%
CAGR value1: 3.8%
Penetration
100%
160
80%
140
120
100
Fast-acting
60%
Premix
40%
60
40
May
2010
2
20%
Long-acting
20
1
Sanofi
Eli Lilly
60%
47%
50%
40%
34%
30%
80
0
Novo Nordisk
Modern Insulin penetration2
May
2015
18%
20%
10%
0%
0%
May
2010
Source: IMS Monthly MAT volume figures, numbers do not add up to 100% due to
smaller insulin manufacturers
1
May
2015
Slide 53
Stable leadership position in International Operations
International Operations insulin
market by segments
Device penetration
tMU
100
90
80
70
60
50
40
30
20
10
0
International Operations insulin
volume market shares
CAGR volume1: 13.9%
CAGR value1: 13.0%
Penetration
100%
80%
Fast-acting
Premix
May
2015
60%
40%
30%
CAGR for 5-year period. 2 Includes new generation insulin.
Note: IMS only covers the following 13 markets in IO (retail data): Algeria, Argentina, Australia, Brazil,
Colombia, Egypt, India, Mexico, NZ, Russia, Saudi Arabia, South Africa & Turkey
Source: IMS Monthly MAT volume and value (DKK) figures.
Eli Lilly
Biocon
55%
50%
40%
0%
Sanofi
70%
60%
20%
Long-acting
May
2010
Novo Nordisk
19%
20%
18%
3%
10%
0%
May
2010
1
Note: Only top-4 shown
Source: IMS Monthly MAT volume figures, numbers do not add up to 100% due to smaller
insulin manufacturers
May
2015
Slide 54
Sustained leadership position on the rapidly growing
Chinese insulin market
Chinese insulin market by segments
Device penetration
tMU
40
CAGR volume1: 16.5%
CAGR value1: 26.6%
Penetration
100%
35
30
Fast-acting
25
20
Novo Nordisk
Shanghai Fosun
Sanofi
Eli Lilly
Tonghua Dongbao
70%
57%
60%
50%
60%
40%
40%
30%
14%
20%
10
20%
5
May
2010
Long-acting
0%
May
2015
Note: IMS covers around 50% of the total Chinese market (hospital data)
1
80%
Premix
15
0
Chinese insulin volume market shares
Modern Insulin penetration
9%
8%
10%
0%
May
2010
Note: Only top-5 shown
Source: IMS Monthly MAT volume figures, numbers do not add up to 100% due to
smaller insulin manufacturers
6%
May
2015
Slide 55
Expanding market leadership position in Japan
Japanese insulin market by segments
Device penetration
tMU
14
CAGR volume1: -0.2%
CAGR value1: -0.2%
Penetration
100%
12
80%
10
Fast-acting
8
6
Premix
4
2
0
Japanese modern insulin volume market shares
Includes next generation insulin
May
2015
60%
Eli Lilly
50%
50%
40%
40%
30%
0%
Sanofi
70%
60%
20%
Long-acting
May
2010
Novo Nordisk
27%
20%
23%
10%
0%
May
2010
1
2
May
2015
Slide 56
Promising Tresiba® performance strengthens total insulin
market share in Japan
Japanese basal value market shares
glargine
Tresiba®
Japanese total insulin value market shares
Levemir®
NPH
NN Total Basal
80%
Novo Nordisk
Eli Lilly
80%
57%
60%
42%
40%
55%
60%
40%
26%
30%
20%
0%
Sanofi
9%
May
2012
Source: IMS Monthly May 2015 value figures
4%
May
2015
20%
0%
19%
May
2012
Source: IMS Monthly May 2015 value figures
May
2015
Slide 57
GLP-1 effect dependent on level of blood glucose − which
reduces risk of hypoglycaemia
GLP-1 mechanism of action when blood
sugar levels increase
•
•
•
•
Increases insulin secretion in the pancreas
Reduces glucagon secretion in the liver
Slows gastric emptying in the gut
Creates sense of satiety in the brain
GLP-1 lowers blood glucose in patients
with type 2 diabetes
Type 2 diabetes patients, no GLP-1
Type 2 diabetes patients, with GLP-1
Healthy controls receiving saline
Glucose
(mmol/L)
18
16
14
Brain
12
10
8
6
Liver
Gut
4
2
0
Breakfast
22.00
Pancreas
02.00
06.00
10.00
Time
Source: Rachman et al. Diabetologia 1997;40:205–11
Lunch
Snack
14.00
18.00
Slide 58
Victoza® has a strong position in the global DPP-IV, GLP-1
and SGLT-2 segment
Segment value
Share of segment value growth
DKK
billion
120
110
100
90
80
70
60
50
40
30
20
10
0
100%
CAGR1 value: 38.2%
19%
15%
80%
Other GLP-1
SGLT-2
DPP-IV
80%
60%
60%
40%
40%
May
2010
May
2015
0%
15%
20%
20%
2013 vs.
2014
Note: Segment only includes DPP-IV, GLP-1 & SGLT-2. Other oral anti-diabetic agents and insulin excluded
Source: IMS MAT May 2015 value figures
1
Segment value market shares
Victoza®
2014 vs.
2015
0%
May
2010
May
2015
Slide 59
Victoza® has a strong leadership in the global GLP-1
market
North America constitutes the majority
of the GLP-1 value market1
Global GLP-1 market
Share of total
diabetes care market
8%
GLP-1 sales in bDKK (right axis)
Europe
Japan & Korea
China (0.3%)
25
CAGR value1: 40.0%
7%
North America
4%
2%
4%
3%
20
6%
5%
22%
15
4%
Victoza®
3%
2%
0%
May
2010
CAGR for 5-year period,
Source: IMS Monthly MAT, value figures (DKK)
1
5
Other GLP-1
1%
10
May
2015
74%
0
Annual value of diabetes market May 2015
Source: IMS Monthly value figures (DKK)
1
Slide 60
The US GLP-1 market continues to expand
US GLP-1 market
GLP-1 TRx scripts
(thousands)
500
450
400
350
300
250
200
150
100
50
0
Key observations for Victoza® in the US market
GLP-1 % of diabetes care market
Victoza®
exenatide
Jun
2010
albiglutide
dulaglutide
Jun
2015
• Victoza® market share within the GLP-1 segment is 59%1
8%
• Roughly 67% of Commercial and roughly 79% of Medicare
Part D lives are covered without restrictions2
6%
• Around 63% of new patients are new to treatment or from
OAD-only regimens3
4%
2%
0%
• More than two-thirds of prescriptions are for the 3-pen
pack1
• Victoza® represents 1.6% of total prescriptions in the US
diabetes care market1
1
2
Source: IMS TRx retail value, monthly NPA data, June 2015
3
IMS monthly NPA data, June 2015
Fingertip Formulary, July 2015
IMS Monthly LRx Weekly, July 3, 2015
Slide 61
First three months of 2015
Key Novo Nordisk diabetes care products remain broadly
available in the US
Value market shares of key
Novo Nordisk products in the US
Value market
share
Victoza®
NovoLog®
% unrestricted market access of key
Novo Nordisk products in the US
Levemir®
Unrestricted
Market access
Victoza®
NovoLog®
Levemir®
100%
80%
80%
60%
60%
40%
40%
20%
0%
20%
May
2010
May
2015
Source: IMS NSP Monthly Custom Feed, May 2015; data displayed as MAT value share
Note: Market shares: NovoLog®=share of rapid acting insulin segment, Levemir®=share of basal insulin
segment, Victoza®=share of GLP-1 segment
0%
Jul
2010
Source: FingerTip Formulary, July 2015
Note: Unrestricted access excludes prior authorisation, step edits and other restrictions
Levemir® access based on FlexTouch® Pen; NovoLog® access based on FlexPen®
Jul
2015
Slide 62
Victoza® maintains GLP-1 class leadership position in key
European markets
Development in key European markets following Victoza® launch
Diabetes market share (value)
Victoza®
14%
Germany
Market value1: DKK 13 billion
14%
12%
12%
12%
10%
10%
10%
8%
8%
8%
6%
6%
6%
4%
4%
4%
2%
2%
2%
0%
May
2010
MAT value of diabetes market, May 2015
Source: IMS Monthly value figures
1
14%
UK
exenatide
May
2015
0%
May
2010
May
2015
0%
lixisenatide
dulaglutide
France
May
2010
May
2015
Slide 63
Strong Victoza® position in the GLP-1 segment across all
markets
GLP-1 market by value
Share of total
diabetes care market
10%
47%
Victoza ®
lixisenatide
Example of Victoza® promotional sales aid1
exenatide
albiglutide
dulaglutide
GLP-1 value growth
15%
8%
38%
6%
4%
9%
21%
2%
0%
44%
North Europe
America
IO
Japan & Region
Korea
China
Global
Source: Victoza® Summary of Product Characteristics
1
Source: IMS MAT May 2015 vs MAT May 2014 figures in value
Slide 64
R&D pipeline: Diabetes and obesity
Product/project
Type
Indication
Tresiba® (NN1250)1
New-generation once-daily basal insulin analogue
Type 1+2
Ryzodeg® (NN5401)1
Co-formulation of insulin degludec and insulin aspart
Type 1+2
Xultophy®
Combination of insulin degludec and liraglutide
Type 2
1
(NN9068)2
Faster-acting insulin aspart (NN1218) New formulation of insulin aspart
Type 1+2
Semaglutide (NN9535)
Once-weekly GLP-1 analogue
Type 2
LATIN T1D (NN9211)
Once-daily GLP-1 analogue
Type 1
OG217SC (NN9924)
Long-acting once-daily oral GLP-1 analogue
Type 2
OI338GT (NN1953)3
Long-acting oral basal insulin analogue
Type 2
OG987GT (NN9926)
Type 2
OG987SC (NN9927)
Type 2
Long-acting oral basal insulin analogue
Type 2
LAI287 (NN1436)
Long-acting once-weekly basal insulin analogue
Type 1+2
LAI338 (NN1438)
Long-acting once-daily basal insulin analogue
Type 1+2
Saxenda®
Once-daily GLP-1 analogue
Obesity
G530L (NN9030)
Novel glucagon analogue
Obesity
NN9838
Novel long-acting amylin analogue
OI320GT
(NN1957)4
(NN8022)5
Approved in EU, Japan and a number of other markets. 2 Approved in EU on 18 Sep 2014.
5 Approved in US on 23 Dec 2014 and in EU on 23 March 2015
1
3
First Phase 2a trial initiated June 2015.
Obesity
4
First Phase 1 trial initiated June 2015.
Status (phase)
2
3
Filed
Appr.
Slide 65
Novo Nordisk current and future product portfolio covers
the type 2 diabetes treatment flow1
Type 2 diabetes progression and Novo Nordisk ideal treatment flow
Diet &
exercise
OAD’s
GLP-1
Insulin initiation
Intensification
OR
Metformin
OR
1
Optimisation
Pending clinical development programmes and regulatory processes for semaglutide and faster-acting insulin aspart
BEGIN® phase 3a programme confirms stable and
efficacious profile of insulin degludec
Tresiba® OD vs insulin glargine OD1 results from BEGIN phase 3a trial
Profile
Efficacy
Safety
Convenience
•
Basal insulin with flatter, less variable profile and a doubling in half-life
•
Improved fasting glucose control
•
Less impact of missed dose
•
Lower rate of overall hypoglycaemia
•
Lower rate of nocturnal hypoglycaemia
•
Dosing flexibility, enabling administration at any time on any day
•
Reduced injection volume (U200) – one injection for all
•
Superior pen with easy-touch dosing mechanism
OD: once-daily
1 Based on trial NN1250-3579, NN1250-3586, NN1250-3668, NN1250-3672, NN1250-3770, NN1250-3582 and NN1250-3583
Slide 66
Slide 67
Two SWITCH trials ongoing with Tresiba® vs insulin
glargine to further assess hypoglycaemia profile
SWITCH 2
SWITCH 1
Trial designs
446 people
with type 1
diabetes
668 people
with type 2
diabetes
Randomised 1:1
Double-blinded
IDeg once daily
+ 2-4 x IAsp
IDeg once daily
+ 2-4 x IAsp
IGlar once daily
+ 2-4 x IAsp
IGlar once daily
+ 2-4 x IAsp
Purpose
• NN1250-3995: To document hypoglycaemia benefit in
type 1 diabetes
• NN1250-3998: To solidify hypoglycaemia benefit in
type 2 diabetes
IDeg once daily
± metformin
IDeg once daily
± metformin
Primary confirmatory endpoint
• Symptomatic confirmed hypoglycaemic events in HbA1c
stable period
IGlar once daily
± metformin
IGlar once daily
± metformin
16 week 16 week
washout1
HbA1c
HbA1c< 7
stable
16 week
washout1
HbA1c< 7
From pre-treatment
Note: IDeg=insulin degludec; IGlar=insulin glargine
1
Purpose and endpoints
16 week
HbA1c
stable
Secondary confirmatory endpoints
• Symptomatic nocturnal confirmed hypoglycaemic events
events in HbA1c stable period
• Proportion of subjects with ≥ 1 severe hypoglycaemic event
events in HbA1c stable period
Slide 68
Improvement in early glucose lowering with faster-acting
insulin aspart vs insulin aspart in phase 1 trial
PD: Mean GIR profiles (0–30 minutes) for
faster-acting insulin aspart vs insulin aspart
PD: Mean GIR profiles (0–30 minutes) for
insulin aspart vs human insulin
Faster-acting insulin aspart
Insulin aspart
8
AUCGIR,0–30 min ratio [95% CI]
faster aspart / insulin aspart
1.48 [1.13; 2.02]
6
4
2
0
0
5
10
15
20
Nominal time (min)
Source: Haahr et al. ADA 2014, Abstract number 910-P
Human insulin
10
Glucose infusion rate
(mg/kg*min)
10
Glucose infusion rate
(mg/kg*min)
Insulin aspart
25
30
8
AUCGIR,0–30 min ratio [95% CI]
IAsp / human insulin
1.38 [0.78; 2.89]
6
4
2
0
0
5
10
15
20
Nominal time (min)
25
Source: Heise T et al. Diabet Obes Metab 2015; DOI: 10.1111/dom.12468 [Epub ahead
of print]
30
Slide 69
Phase 3a trials comparing faster-acting insulin aspart with
NovoRapid® shows potential benefits
Trial design
Headline results
Onset® 1
Faster-acting insulin aspart (MT)
1,290 people
with type 1
diabetes1
Run-in
Onset® 2
-8
NovoRapid® (MT)
Faster-acting
insulin aspart (PM)
0
26
Run-in
0
26
weeks
Inclusion criteria: Type 1 diabetes, optimised on Levemir®. 1,143 people randomised
Inclusion criteria: Type 2 diabetes, optimised on basal insulin and OAD; HbA1c of 7.5-9.5%. 689 people
randomised
MT: Mealtime; PM: Post-meal
2
•
Statistically larger improvements in 1- and 2-hour PPG increments
with meal-time faster-acting insulin aspart
•
Similar overall rate of hypoglycaemia for all treatment groups, with
a higher rate within first hour after meal if dosed at mealtime
•
Similar reduction of HbA1c in both treatment groups
•
Statistically larger improvement in 1-hour PPG increment with
faster-acting insulin aspart and numerically larger reduction for 2hour PPG increment
•
Similar overall rate of hypoglycaemia, with a higher rate of
hypoglycaemia for faster-acting insulin aspart within first two hours
after meal
NovoRapid® (MT)
-8
1
Greater improvement of HbA1c with mealtime faster-acting insulin
aspart and similar HbA1c improvement when dosed post-meal
52
weeks
Faster-acting insulin aspart (MT)
881 people
with type 2
diabetes2
•
Note: Previously reported safety and tolerability profiles of insulin aspart confirmed
PPG: Postprandial glucose
Slide 70
Competitive European label for Xultophy®
Xultophy® is indicated for the treatment of adults with type 2 diabetes
in combination with oral glucose-lowering agents
•
Xultophy® is a fixed combination product consisting of insulin degludec and liraglutide having complementary
mechanisms of action to improve glycaemic control
Administered as dose steps: One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide
•
On average HbA1c reduction of 1.9%1 from baseline to end of trial confirmed to be superior against all comparators2
•
On average 2.7 kg weight loss from baseline in patients inadequately controlled on basal insulin
•
Once-daily administration at any time of the day, preferably at the same time of the day
•
The pre-filled pen can provide from 1 up to 50 dose steps in one injection
•
Lower rates of confirmed hypoglycaemia than with insulin degludec in patients on metformin +/- pioglitazone
•
Fewer experienced gastrointestinal side effects than patients treated with liraglutide
•
Profile
Efficacy
Convenience
Safety
1
2
Source: DUAL® I (NN9068-3697), DUAL® II (NN9068-3912)
Insulin degludec, liraglutide and placebo
Slide 71
Xultophy® has documented strong efficacy across the
treatment cascade
Xultophy® key clinical results
DUAL® I
Add-on to
metformin ± Pio
n = 833
DUAL® II
Add-on to
metformin ± basal
insulin
n = 199
DUAL® III
Switch from GLP-1
n = 292
DUAL® IV
Add-on to SU ±
metformin
n = 289
DUAL® V
Switch from insulin
glargine
n = 557
Mean trial start HbA1c (%)
8.3
8.7
7.8
7.9
8.4
Mean trial end HbA1c (%)
6.4
6.9
6.4
6.4
6.6
HbA1c change (%)
-1.9
-1.9
-1.3
-1.45
-1.8
% to target < 7% (%)
80.6
60.3
75.3
79.2
71.6
% to target < 6.5% (%)
69.7
45.2
63.0
64.0
55.4
180.2
153.4
282
351.7
343.3
-0.5
-2.7
+2.0
+0.5
-1.4
Confirmed hypoglycaemia
(Episodes per 100 PYE)
Weight change (kg)
Note: Typical confirmed hypoglycaemia event rates for treatment with basal insulin are 142-369 episodes per 100 PYE (based on insulin glargine event rates from trials NN1250-3586, 3579 and 3672)
where the FPG target and hypoglycaemia definition is similar to the DUAL trials
Source: Novo Nordisk Trial IDs: DUAL® I (NN9068-3697), DUAL® II (NN9068-3912), DUAL® III (NN9068-3851), DUAL® IV (NN9068-3951), DUAL® V (NN9068-3952)
Slide 72
SUSTAIN® phase 3a programme to support a broad
competitive label for semaglutide1
2013
2014
2015
SUSTAIN® 1: Monotherapy
30 weeks, n= 400
SUSTAIN® 2: Semaglutide vs sitagliptin
56 weeks, n= 1,200
SUSTAIN® 3: Semaglutide vs exenatide once-weekly
56 weeks, n= 800
SUSTAIN® 4: Semaglutide vs
insulin glargine
30 weeks, n=1,000
SUSTAIN® 5: Add-on to
basal insulin
30 weeks, n=400
SUSTAIN® 6: Long-term outcomes trial
Min. 104 weeks, n=3,200
In the SUSTAIN® phase 3a programme, 0.5 mg and 1.0 mg doses of semaglutide are being tested in people with type 2 diabetes.
Note: Estimated timing of trials as listed on www.clinicaltrials.gov excl. data analysis; n= approximate no of randomised patients
1
2016
Slide 73
Oral peptide delivery − the gastro-intestinal route poses
many challenges to absorption of intact macromolecules
Challenges
Solutions
1. Breakdown of drug in the
stomach/gastrointestinal tract
1. Stabilisation of peptide backbone
and side chain
2. Passage across the gut barrier
into the circulation
2. Tablet formulation including
carrier and/or coating
3. Ensuring a long circulation
half-life
3. Engineered systemic protraction
mechanism
Slide 74
Positive results for phase 2 trial with oral semaglutide
Phase 2 trial design
Headline results
Oral semaglutide 2.5 mg (QD)
Oral semaglutide 5 mg (QD)
632 T2DM
patients
diabetes
drug naïve
or on
metformin1
Oral semaglutide 40 mg (QD)2
Oral placebo (QD)
Sc semaglutide 1.0 mg (QW)
0
26 weeks
• From a baseline HbA1c of 7.9% people achieved the following
improvements:
• Oral semaglutide: 0.7% to 1.9% (dose dependent)
• Sc semaglutide: 1.9%
• Oral placebo: 0.3%
• From a baseline of 92 kg people experienced a comparable
weight loss of 6.5 kg with subcutaneous and the highest
doses of oral semaglutide versus 1 kg for placebo
• Semaglutide appeared to have a safe and well-tolerated
profile; the most common adverse events were transient
nausea and vomiting
• Phase 3 decision to be made after consultations with
regulatory authorities and commercial assessment
Key inclusion criteria: People with type 2 diabetes treated with diet and exercise and/or on a stable dose
of metformin; HbA1c 7.0-9.5% (both inclusive); BMI 25-40 (both inclusive). 2 Fast and slow escalation
arms
T2DM: Type 2 diabetes; Sc: Subcutaneous; QD: Once daily; QW: Once weekly
1
Slide 75
ADJUNCT phase 3a programme for LATIN T1D − liraglutide
as adjunct therapy to insulin in type 1 diabetes
ADJUNCT phase 3a programme
ADJUNCT phase 3a trials and design
• Global clinical phase 3 program in type 1 diabetes with more
than 2,000 patients
2013
ADJUNCT ONE:
Liraglutide versus placebo
as adjunct to insulin1,
52 weeks, n=1,400
• Designed to demonstrate efficacy and safety of liraglutide as
adjunct therapy to insulin in type 1 diabetes
ADJUNCT TWO:
Liraglutide versus
placebo as adjunct
to insulin2,
26 weeks, n=800
• Trials will seek to demonstrate:
•
Lower HbA1c or decrease in insulin dose
•
Lower body weight and/or lower number of
hypoglycaemic episodes
2014
ADJUNCT ONE: Treat-to-target trial with no upper limit on total daily insulin dose
ADJUNCT TWO: Upper limit on total daily insulin dose corresponding to pre-trial
average total daily insulin dose
1
2
2015
Slide 76
Long-acting insulin LAI287 intended for once-weekly
dosing
Glucose Infusion Rate vs. time
(predicted
mean
at steady
state)
Glucose
Infusion
Rate vs. Time
Key observations
(Predicted Mean)
6
Rate
Infusion
Glucose
Rate (mg/kg/min)
Glucose Infusion
1 (mg/kg/min)
2
3
4
5
0
LAI287, 18 nmol/kg
Insulin glargine, 0.4 U/kg
18 nmol/kg
IGlar 0.4 U/kg
5
4
• Half-life deemed adequate for once-weekly dosing
3
2
1
0
• The peak-to-trough ratios for Glucose Infusion Rate are
comparable for ultra-long-acting insulin LAI287 and oncedaily insulin glargine (approx. 65% for both)
0
0
1
22
3
44
5
66
7
Time
Time
(days)
Time (days)
(days)
2013-Oct-25T11:20:20 E:/Project/NN1436/NN1436-3955/current/Splus/Final/09_MultipleDoseComparison.ssc
Note: Pharmacokinetic simulation
Slide 77
Obesity burden in the US
Incidence of obesity in the US
Comments to the US obesity burden
• Cost of obesity to health care systems of USD 147 billion
annually2 with continued growth
Obese
Million
people
Overweight
BMI
25-29.9
Class I
BMI
30-34.9
Class II
BMI
35-39.9
Class III
BMI
40+
TOTAL
• Around 35% of the US adult population (over 20 years) are
clinically obese (BMI>27)3
Normal
Glucose
39
17
x7
-
62
• Only around 23% of all obesity cases in the US were
diagnosed in 20103
PreDiabetes1
34
21
10
x9
74
Type 2
diabetes
• In 2010, only 3 million people in the US or around 3% of the
adult obese population were treated with anti-obesity
medication4
x7
x6
x4
x4
22
TOTAL
80
44
21
13
158
2
Impaired Fasting Glucose
Source: NHANES and revised 2011 CDC estimates
1
3
4
Finkelstein et al. Health Affairs 28, no. 5 (2009): w822-831
Flegal, KM. JAMA. 2012;307(5): Doi:10.1001/jama.2012.39
Obesity. Decision resources, Inc. December 2010:38
Slide 78
Significant unmet need in obesity management
Insufficient treatment options
Significant gaps in obesity treatment
100%
Bariatric surgery
30%
People Rx treated*
Anti-obesity medication
with weight loss of
5-10%
Low
People diagnosed
Medium
High
All people with obesity
Mean
weight loss
Diet and exercise
4%
Low
Source: Diagnosis rate, Practice Fusion March 2014 & Treatment rate, Understanding the Treatment
Dynamics of the Obesity Market, IMS Database (NPA), August 2014
*Rx=prescription, i.e. treated with anti-obesity medication (AOM)
Medium
High
Complexity of treatment
Slide 79
First three months of 2015
Small but growing market for anti-obesity medication in
the US
Value of the US obesity market remains small
compared to the US diabetes market
USD
million
Few people treated with AOM in US, but recent
launches have contributed to market growth
TRx volume
(thousands)
350
AOM TRx volume
Phentermine TRx volume
1,000
300
800
250
600
200
150
400
Lorcaserin
launch
100
200
50
0
0
2010
2011
Note: 2015 is MAT June 2015
Source: IMS NSP Monthly, June 2015
2012
2013
2014
2015
Phentermine
and topiramate
launch
Naltrexone
HCI and
bupropion
HCI
launch
Jun
2010
Note: Phentermine and topiramate is the fixed combination; naltrexone HCI and bupropion
HCI is the second fixed dosed combination to market. AOM: anti-obesity medication
Source: IMS NPA Monthly, June 2015
Saxenda®
launch
Jun
2015
Slide 80
Saxenda® demonstrated weight loss in all SCALE® trials
Overview of weight loss (%) in the SCALE® programme
Saxenda®
Obesity & Pre-diabetes2
(56 weeks and n=3,731)
Diabetes3
(56 weeks and n=846)
Placebo
Sleep Apnoea4
(32 weeks and n=359)
% patients with ≥5% weight loss
Maintenance1,5
(56 weeks and n= 422)
0.2%
1.6%
2.0%
2.6%
5.7%
5.9%
6.2%
8.0%
63.2%
27.1%
49.9%
13.8%
46.3%
18.5%
50.5%
21.8%
Note: Observed means, last observation carried forward (LOCF) at end of trial. N=number of randomised participants
1Trial includes 12 week run-in period before randomization
Source: 2Fujioka K et al, Diabetologia 2014; 57 (Suppl 1): Abstract 904-OR at EASD 2014; 3Davies M, Diabetologia 2014; 57 (Suppl 1): Abstract 39-OR at EASD 2014; 4Wadden et al. Int J Obes (Lond).
2013;37:1443-51; 5Blackman A, Diabetologia 2014; 57 (Suppl 1): Abstract 184-OR at EASD 2014
Slide 81
Competitive US label for Saxenda®
Saxenda® approved in the US for chronic weight management in individuals with a BMI ≥30,
or ≥27 in the presence of at least one weight-related comorbidity1
Profile
Effect on body
weight
Effect on
comorbidities
Safety
1
•
GLP-1 receptor agonist – a physiological regulator of appetite and calorie intake
•
Saxenda® is the first and only GLP-1 receptor agonist approved for weight management
•
9 in 10 lose weight and 1 in 3 people lose more than 10% of their body weight2
•
Average weight loss of 9.2% in completers at one year2
•
Improvements in cardiometabolic risk factors such as hypertension and dyslipidaemia
•
Boxed warning on thyroid C-cell tumours
•
Precautions on acute pancreatitis, acute gallbladder disease, serious hypoglycaemia 3, heart rate increase,
renal impairment, hypersensitivity and suicidal ideation
Examples include hypertension, type 2 diabetes and dyslipidemia. 2 Saxenda® US Package Information. 3 When used with an insulin secretagogue
Slide 82
Saxenda® targeted at patients with BMI ≥35 and weightrelated comorbidities
Focused patient profile
Market approach
Saxenda® aspiration
Clear patient
segmentation
Focused prescriber
targeting
All people
with BMI ≥30
Build the market
Clear product value
proposition
Diagnosed
with obesity
Treated with
Saxenda®
Treated for
obesity
Focus on engaging
prioritised payers and
employers
Biopharmaceuticals
Slide 83
Slide 84
Haemophilia: Location of bleedings and the consequences
Locations
Consequences of bleedings
• Bleeding in the joint space causes a strong inflammatory
reaction which predisposes to further bleeding
Head and neck
Nose and gums
Joints
• Inadequate or delayed treatment of repeated joint bleeds
results in a “target joint”
Gut
Joints
Kidneys
• The joint is tense, swollen and extremely painful and the
mobility is restricted
• Eventually the cartilage erodes completely and permanent
joint damage (arthropathy) occurs
Muscles
Joints
Joints
• Treatment of arthropathy is orthopaedic surgery
Slide 85
Haemophilia is a rare disease with severe unmet medical
needs
Number of people with haemophilia A and B
and haemophilia with inhibitors
Low diagnosis and treatment rates
within haemophilia
Average percentage of people
with haemophilia
Thousand
people
450
Haemophilia A
App. 350,000 patients
Haemophilia B
App. 70,000 patients
400
350
300
45%
250
Inhibitor
segment app.
3,500-4,000
patients
200
150
6%
100
3%
50
0
Note: The inhibitor segment represents people with haemophilia and high titre inhibitors to their normal
replacement treatment
Source: Estimates based on prevalence data in literature (Stonebraker JS et al. Haemophilia. 2010; 16:
20-32), World Federation of Haemophilia – Annual Global Survey 2012, UDC database in the US
15%
People with
haemophilia
Diagnosed
Treated
Prophylactic Pristine joints
Source: World Federation of Haemophilia – Annual Global Survey 2012
Slide 86
The global haemophilia market is growing by mid-single
digits
Strategic positioning of Novo Nordisk’s
haemophilia portfolio
Sales of recombinant coagulation factors
Coagil VII®
Xyntha®/Refacto®
Benefix®
DKK NovoSeven®
Kogenate®/Helixate®
Recombinate®/Advate®
billion
30
CAGR1: 6%
Novo Nordisk
compound
Status
Strategic position
NovoSeven®
Launched
Maintain market leadership
NovoEight®
Launched
Establish presence in a competitive
market place
N8-GP
Phase 31
Contribute to market conversion
N9-GP
Phase 32
Establish new treatment paradigm
NovoThirteen®
Launched
Launch first recombinant product
25
20
15
10
CAGR1: 6%
CAGR1: 9%
5
0
2009 2014
rFVIIa
Source: Company reported sales for 2014
1
2009 2014
rFVIII
2009 2014
rFIX
1
2
Submission of N8-GP expected 2017/2018 pending expansion of production capacity
Submission expected in 2015
Slide 87
NovoSeven® − a unique biologic for the treatment of rare
bleeding disorders
NovoSeven® reported sales
Key NovoSeven® properties
DKK
billion
• Product characteristics: powder and solvent for solution
for intravenous injection, available in multiple doses, stable
at room temperature
CAGR1 4.0%
3.0
• MixPro® administration system launched in 2013
2.5
• Indications: treatment of spontaneous and surgical
bleedings in:
2.0
• Haemophilia A or B patients with inhibitors
1.5
• Acquired haemophilia
1.0
• Congenital FVII deficiency
0.5
0.0
1
• Glanzmann’s thrombasthenia1
Q2
2010
Q2
2015
1
Only indicated in Europe and the US
Slide 88
NovoEight® is launched in the US, Europe and Japan for the
treatment of people with haemophilia A
Example from NovoEight®
promotional campaign1
NovoEight® properties and launch performance
Indications:
• Treatment and prophylaxis of bleeding in patients with
congenital factor VIII deficiency for all age groups1
Key product characteristics:
• Reliability: No inhibitor development in largest pivotal trial
programme of any approved rFVIII (n=213)1,2
• Purity and safety: First rFVIII to use a 20nm filter in its
purification process3
• Portability: Room temperature stability with storage at 30
degrees celsius1
Launch status:
• NovoEight® is available in the US, Japan and ten European
countries
1Picture
is not intended for promotional purposes
Sources:1 NovoEight® Summary of Product Characteristics. 2 Iorio A et al., Blood 2012;
120(4): 720 – 727. 3 NovoEight® Prescribing Information
Slide 89
NovoThirteen®, a recombinant FXIII, provides efficacious
and safe haemostatic coverage
Example from NovoThirteen®
promotional campaign1
NovoThirteen® properties and launch
performance
Indication:
• Long term prophylactic treatment of bleeding in adult and
paediatric patients with congenital factor XIII A-subunit
deficiency
Key product characteristics:
•
•
•
NovoThirteen® is the only effective recombinant product for
prophylaxis
NovoThirteen® is well tolerated and has low volume dosing
NovoThirteen® effectively prevents bleeds and provides a
convenient once-monthly regimen
Launch status:
• NovoThirteen® is available in nine countries
1Picture
is not intended for promotional purposes
Source: European Medicines Agency, summary of opinion (post-authorisation) 23
January 2014. NovoThirteen® Summary of product characteristics.
Slide 90
R&D pipeline: Haemophilia and growth disorders
Product/project
Type
Indication
Status (phase)
1
N9-GP (NN7999)
GlycoPEGylated long-acting rFIX
Haemophilia B
N8-GP (NN7088)
GlycoPEGylated long-acting rFVIII
Haemophilia A
Concizumab (NN7415)
Monoclonal anti-TFPI
Haemophilia A, B and with inhibitors
NN86401
Once-weekly human growth hormone
Growth disorder
1
Phase 3 initiated in AGHD
2
3
Filed Appr.
Slide 91
Positive results from phase 3 trial with long-acting factor
IX for treatment of haemophilia B
N9-GP phase 1 pharmacokinetics
rFIX
FIX activity
(IU/mL)
1.2
pdFIX
Paradigm 2 headline results (phase 3)
N9-GP
Dose normalised
50 IU/kg (N=15)
One stage clot assay
1.0
0.8
•
Median bleeding rate for patients treated on demand was
15.6 episodes per year
•
Patients on prophylactic treatment had a median bleeding
rate of 2.9 and 1.0 episodes per year when treated with
doses of 10 U/kg and 40 U/kg, respectively
•
Among patients receiving 40 U/kg:
0.6
0.4
0.2
0.0
0
24
Source: Novo Nordisk data on file
48
72
96
Time (h)
120
144
•
99% of bleeding episodes were treated with only one
infusion
•
Two thirds of patients experienced complete resolution
of bleeding in their target joints
•
Steady-state half-life of 110 hours
•
N9-GP appeared to have a safe and well tolerated profile
with no patients developing inhibitors
168
Source: Negrier et al. Blood. 2011;115:2693-2701
Slide 92
Positive results from phase 3 trial with long-acting factor
VIII for treatment of haemophilia A
N8-GP phase 1 pharmacokinetics
FVIII
FVIII activity
(IU/mL)
Pathfinder 2 headline results (phase 3)
N8-GP
•
Median bleeding rate for patients treated on demand was
30.9 episodes per year
•
Patients on prophylactic treatment had a median bleeding
rate of 1.3 per year
•
0.8
Pharmacokinetic documented single dose half-life of 18.4
hours
•
Mean trough level of 8%
0.6
•
N8-GP appeared to have a safe and well tolerated profile
•
One patient developed an FVIII inhibitor, which is in-line
with expectations for a population of previously treated
haemophilia A patients
Dose 50 IU/kg (N=8)
One stage clot assay
1.2
1.0
0.4
0.2
0.0
0
24
48
72
96
120
144
168
Time (h)
Source: Novo Nordisk data on file
Source: Tiede et al. J Thromb Haemot. 2013;11:670-675
Slide 93
Novo Nordisk continues to expand leadership within
growth hormone market
Development in global hGH market
Thousands
DKK
billion
MAT volume kg
100
80
15
CAGR volume1: 3.9%
CAGR value DKK1: 2.9%
10
Novo Nordisk
Eli Lilly
MAT value DKK
kg
20
35%
Pfizer
Merck Kgaa
Sandoz
Roche
32%
30%
25%
60
20%
40
15%
10%
5
0
Growth hormone volume market share
20
May
2010
Source: IMS Monthly MAT volume figures and value (DKK) figures
May
2015
0
5%
0%
May
2010
1
May
2015
Slide 94
Solid Norditropin® sales growth
Norditropin® reported sales
Key Norditropin® properties
DKK
billion
2.0
• Product characteristics: Premixed, prefilled multi-use
delivery systems available in multiple strengths, and stable
at room temperature
CAGR1 10.8%
• Expanded indications: GHD, GHDA, Noonan Syndrome,
Turner Syndrome, SGA indication, Idiopathic short stature
1.5
• Easy to use FlexPro® device
1.0
• Medical and Clinical support programmes
• Patient support programmes
0.5
0.0
1
Q2
2010
Q2
2015
Financials
Slide 95
Slide 96
Novo Nordisk has delivered sustained double digit growth
throughout the last decade
Sales growth in local currencies
2005–2014
Sales growth
2005–2014
Average growth
30%
30%
20%
20%
Average growth
19%
12%
10%
10%
0%
2005
2014
0%
2005
Note: Numbers for 2007 and 2008 are adjusted for the impact of the discontinuation of
pulmonary insulin projects
2014
Thousands
Slide 97
Solid sales growth with especially North America,
International Operations and Region China expanding
Reported annual sales
Diabetes
DKK
billion
100
90
80
70
60
50
40
30
20
10
0
1
Reported annual sales split by region
Biopharmaceuticals
North America
China
CAGR1 9.9%
75%
2010
1
76%
2011
2
78%
78%
79%
9%
6%
9%
21%
14%
31%
39%
2012
3
2013
4
2014
5
Europe
Int. Operations
Japan & Korea
2010
23%
49%
2014
Note: China was separated as an independent sales region in connection with the release
of 2010 full year results
Slide 98
Solid operating profit growth driven by diabetes
Operating profit
DKK
billion
45
35
32%
30
20
27%
7%
5
0
Biopharm
10%
30%
26%
36%
18%
20%
64%
15
10
Diabetes
Operating profit
Operating profit as % of sales
Operating profit growth vs last year
40%
40
25
Operating profit therapy split
16%
22%
20%
15%
13%
2010
1
2011
2
2012
3
2013
4
2014
5
74%
10%
0%
2010
2014
Slide 99
Profitability per segment
Diabetes P&L – full year 2014
Biopharmaceuticals1 P&L – full year 2014
DKK
billion
80
DKK
billion
80
-18%
70
70
-29%
60
50
60
50
-13%
40
-4%
30
40
+1%
36%
30
20
20
10
10
0
0
Sales
COGS
S&D
R&D
Admin
OOI
OP
-11%
Sales
1
COGS
Excluding inflammation
-15%
S&D
-15%
-4%
+1%
56%
R&D
Admin
OOI
OP
Thousands
Slide 100
Continued decline in relative COGS level combined with
stable investment level
Cost of Goods Sold (COGS)
Capital Expenditure (CAPEX)
COGS as % of sales
DKK
billion
COGS
15
25%
20%
10
CAPEX as % of sales
DKK
billion
CAPEX
4
6%
3
4%
15%
2
10%
5
5%
0
2010
2011
2012
2013
2014
0%
2%
1
0
2010
1
2011
2
2012
3
2013
4
2014
5
0%
Slide 101
Organic growth enables steady cash return to shareholders
via dividends and share repurchase programmes
Share repurchase programmes have enabled
continued reduction in share capital
Annual cash return to shareholders
DKK
billion
Free cash flow
Share repurchase
Expanded share
35
30
Dividend
repurchase1
2.5
25
20
15
10
5
0
12
12
14
15
15
8
10
12
13
6
2011
2012
2013
2014
2015E
Share capital
CAGR -2.7%
600
-3%
550
-2%
-4%
-2%
500
450
580
560
550
530
520
2012
2013
2014
2015
400
350
0
300
Based on improved outlook for free cash flow generation primarily related to partial divestment of NNIT
Note: Dividends are allocated to the year of dividend pay. For 2015 expected free cash flow is DKK 33-35
billion. Share repurchase programmes run for 12 months starting February until end January of the
following year
1
DKK
million
2011
Slide 102
Long term financial targets:
Operating profit growth and operating margin
Operating margin
Current long term financial target
Previous long term financial targets
35%
45%
30%
25%
30%
20%
15%
15%
10%
5%
0%
2010
2011
2012
2013
2014
Note: The long term financial targets are based on an assumption of a continuation of the current
business environment and given the current scope of business activities and has been prepared assuming
that currency exchange rates remain stable
0%
2010
2011
2012
2013
2014
Slide 103
Long term financial targets:
Operating profit after tax to net operating assets and cash to earnings
Operating profit after tax to
net operating assets
Cash to earnings
(three years’ average)
140%
140%
120%
120%
100%
100%
80%
80%
60%
60%
40%
40%
20%
20%
0%
2010
2011
2012
2013
2014
Note: The long term financial targets are based on an assumption of a continuation of the current
business environment and given the current scope of business activities and has been prepared assuming
that currency exchange rates remain stable
0%
2010
2011
2012
2013
2014
Slide 104
Stable ownership structure
- secured through A and B-share structure
Share structure
Novo Nordisk Foundation
Novo A/S
Institutional and private
investors
74.7% of votes
27.0% of capital
25.3% of votes
73.0% of capital
A shares
537m shares
B shares
2,063m shares
Novo Nordisk A/S
Note: Treasury shares are included in the capital but have no voting rights
The Novo Nordisk Foundation
• The Novo Nordisk Foundation is a self-governing institution
that:
• provides a stable basis for Novo Nordisk
• supports scientific, humanitarian and social purposes
• All strategic and operational matters are governed by the
board and management of Novo Nordisk
• Overlapping board memberships ensure that the Novo
Nordisk Foundation and Novo Nordisk share vision and
strategy

presentation - Novo Nordisk

Transcription

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