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Diabetes care strategy
Lars Fruergaard Jørgensen
EVP Corporate Development
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Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company’s Annual Report 2014 and Form 20-F, both filed with the SEC in February 2015, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking 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 presentation, could cause actual results to differ materially from those contemplated in any forward-looking 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 presentation, 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 approve in the US and EU for the treatment of obesity only
Capital Markets Day 2015 Diabetes care strategy
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Global diabetes care market by treatment class Regional insulin volume growth
Diabetes care market has historically been growing double digit partly driven by underlying insulin volume growth
0
50
100
150
200
250
300
350
1 CAGR for 10-year period; OAD: oral anti-diabetic Source: IMS MIDAS Monthly MAT value figures
DKK billion
OAD Insulin GLP-1
Total market: CAGR1 14.5%
CAGR1 18.1%
Injectables: CAGR1 19.6%
CAGR1 9.4%
Sep 2005
Sep 2015
0%
5%
10%
15%
20%
25%
30%
35%
0.00 0.00 0.00
Millions
Sep 2010
Sep 2015
North America Int. Operations
World China Japan & Korea
Europe
4.4%
Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS MIDAS Monthly MAT volume figures
Capital Markets Day 2015 Diabetes care strategy
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0
20
40
60
80
2,010 2,011 2,012 2,013 2,014
Th
ou
san
ds
Reported annual diabetes care sales Global diabetes care value market share
Novo Nordisk has generated double-digit diabetes sales growth and holds a strong diabetes market leadership
1 CAGR for 2010-2014
Other diabetes care Insulin
2010 2011 2012 2013 2014
CAGR1 11.2%
DKK billion
GLP-1
Source: IMS MIDAS Monthly MAT value figures
Sep 2005
Sep 2015
28%
GSK
Merck Eli Lilly Sanofi
Takeda
Novo Nordisk
AstraZeneca Novartis
0%
10%
20%
30%
Capital Markets Day 2015 Diabetes care strategy
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4%
10%
15%
6%
-5% -2%
9%
-4%
-3%
2%
1%
3%
3%
2%
2%
-10%
-5%
0%
5%
10%
15%
20%
North America Europe International
Operations
Japan & Korea Region China Global
Estimated composition of Novo Nordisk insulin sales growth 2010-2015
Note: Mix = conversion from vial/syringe to devices and conversion from human insulin to modern insulin and from modern insulin to new-generation insulin Source: Realised sales in local currencies, IMS market share estimates for the period Q3 2010 to Q3 2015
Volume growth and value upgrade have been the main insulin sales growth drivers for Novo Nordisk
Market share Price Mix Market growth Total insulin sales CAGR
17%
-7% 0%
8%
15%
8%
Capital Markets Day 2015 Diabetes care strategy
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Significant growth opportunities but the complexity of the injectable diabetes care market is increasing
... although entry barriers are high
• High volume production with significant capital investment required
• A pen device providing simple product delivery is crucial
Capital Markets Day 2015 Diabetes care strategy
Continued growth opportunities ...
• Notable unmet need for new and better treatments
• Less than half of people are diagnosed
• Continued willingness to pay for innovation in private markets
… and competitive pressure continues …
• All incumbent players pursue portfolio strategies
• Biosimilar competition expected to increase
… but commercial landscape is complex ...
• Price pressure is expected to increase including considerable rebating
• Large number of prescribers and complex distribution channels
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-5%
0%
5%
10%
15%
4%
Sales by main categories of the pharmaceutical market – expected CAGR for 2014-2020
Source: EvaluatePharma, 11 November 2015
The diabetes care market is expected to grow faster than the average of the pharmaceutical market
Capital Markets Day 2015 Diabetes care strategy
Anti-coagulant
Central nerve
system
Diabetes care
Musculo-skeletal
Oncology Respiratory Vaccines
Average
Cardiovascular
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Overview of current and future products in Novo Nordisk’s diabetes portfolio
Portfolio strategy provides opportunity to treat patients throughout the treatment cascade and across segments
When basal insulin is not enough
Once-daily optimisation
When metformin is not enough
When it's time for insulin
Mealtime insulin control
semaglutide
Actrapid® Mixtard® 30 Insulatard®
or
Faster acting insulin aspart
First generation analogues
Second generation analogues
Human insulin
or
Capital Markets Day 2015 Diabetes care strategy
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Mix: conversion from vial/syringe to devices and conversion from human insulin to modern insulin and from modern insulin to new-generation insulin Source: IMS market share estimates for the period Q3 2010 to Q3 2015
Components of insulin sales growth Composition of product mix growth
6%
-1%
1%
2%
-2%
0%
2%
4%
6%
8%
10%
Upgrade to higher value products is expected to continue contributing to growth
Capital Markets Day 2015 Diabetes care strategy
Market share Price Mix Market growth
Sales growth
2010-2015 Future
Continued conversion from vial/syringe to devices
Continued upgrade from human insulin to modern insulin
Roll-out of insulin/GLP-1 combination
Upgrade from modern insulin to new- generation insulin
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Value of diabetes market will be driven by North America
Volume of diabetes market will be driven by International Operations and China
The diabetes care market will continue to be driven by both value and volume
Note: Illustration of expected future value and volume drivers of insulin market by region. Size of circles refers to size of market
Europe North America International Operations Japan & Korea China
Capital Markets Day 2015 Diabetes care strategy
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GLP-1 market dynamics
Jakob Riis
EVP China, Pacific and Marketing
TEAM NOVO NORDISK professional cycling team
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Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company’s Annual Report 2014 and Form 20-F, both filed with the SEC in February 2015, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking 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 presentation, could cause actual results to differ materially from those contemplated in any forward-looking 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 presentation, 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 approve in the US and EU for the treatment of obesity only
Capital Markets Day 2015 GLP-1 market dynamics
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0%
20%
40%
60%
80%
100%
Distribution of patients and value across treatment classes
Progression of type 2 diabetes and treatment intensification
The majority of people with diabetes are on oral anti-diabetic drugs
Note: Patient distribution across treatment classes is indicative and based on data for US, UK, Germany and France. Value figures based on IMS MAT September 2015 Source: IMS Pharmetrics claims data, IMS disease analyser, IMS Midas OAD: oral anti-diabetic
OAD GLP-1 Insulin
Patients Value Time
-c
ell f
un
cti
on
Diet and exercise
OAD
GLP-1
Insulin
Capital Markets Day 2015 GLP-1 market dynamics
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0%
20%
40%
60%
80%
100%
2012 2013 2014 2015
Source of patients for GLP-1s Patient retention on GLP-1s and OADs
GLP-1 patients are primarily coming from OAD and have comparable patient retention rates to DPP-IV and SGLT-2
Note: OAD other refers to all other oral anti-diabetics than DPP-IV and SGLT-2 Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmetrics (US)
Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmametrics (US). Patients started on the brand of interest during Jun 2012 – Jun 2013
SGLT-2 DPP-IV Insulin OAD other Naïve
0%
20%
40%
60%
80%
100%
1 2 3 4 5 6 7 8 9 10 11 12 13
Months on product
SGLT-2 DPP-IV Victoza® exenatide
Capital Markets Day 2015 GLP-1 market dynamics
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NBRx market share
0%
20%
40%
60%
80%
100%
1 CAGR for 5-year period Source: IMS MAT September 2015 value figures
Market value of the DPP-IV, SGLT-2 and GLP-1 segment
Continued growth of the GLP-1 class in the US despite the rapidly growing SGLT-2 class
Source: IMS LRx Weekly, September 2015 rolling 4-week averages
Capital Markets Day 2015 GLP-1 market dynamics
Sep 2012
Market shares in the DPP-IV, SGLT-2 and GLP-1 segment
Sep 2015
0
10
20
30
40
50
60
70
80
90
Sep 2010
Sep 2015
SGLT-2 Victoza® Other GLP-1 DPP-IV GLP-1 SGLT-2 DPP-IV
DPP-IV/SGLT-2 combo
46%
28%
24%
2%
DKK billion
CAGR value1: 37.0 %
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NBRx GLP-1 class share
0
10
20
30
Value of GLP-1 segment
Victoza® prescriptions continue to increase as new GLP-1 products contribute to further market expansion
Source of business for new GLP-1s NBRx shares for GLP-1s
0%
20%
40%
60%
80%
100%
albiglutide dulaglutide
DKK billion
Sep 2010
Sep 2015
Victoza®
Other GLP-1 0%
20%
40%
60%
80%
100%
exenatide Victoza® Insulin GLP-1 Insulin + GLP-1
SGLT-2 DPP-IV OAD other albiglutide dulaglutide
Sep 2015
Sep 2012
46%
25%
17%
12%
Note: OAD other refers to all other oral anti-diabetics than DPP-IV and SGLT-2 Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmametrics (US)
Source: IMS LRx Weekly, 10 September 2015; data shown in rolling 4-week averages Source: IMS MAT September 2015 value figures
Capital Markets Day 2015 GLP-1 market dynamics
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0%
1%
2%
3%
4%
5%
6%
7%
8%
9%
10%
0
5
10
15
20
25
30
0
2
4
6
8
10
1 CAGR for 5-year period Source: IMS Monthly MAT, value figures (DKK)
Global GLP-1 market Victoza® sales and GLP-1 value market share
of total diabetes care market
The 8% GLP-1 share of the global diabetes care market is increasing with opportunities for further penetration
Source: Novo Nordisk reported sales first nine months of 2015 and IMS data, September 2015
DKK billion
GLP-1 share of diabetes care market
9%
9%
2% 1% 2%
North America
Europe IO China Japan & Korea
GLP-1 value in bDKK
Victoza®
CAGR value1: 39.5%
Share of total diabetes care market
Other GLP-1
Sep 2010
Sep 2015
Capital Markets Day 2015 GLP-1 market dynamics
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• Key messages for Victoza®
• Quick and lasting HbA1c reductions
• The additional benefit of quick and lasting weight loss
• Opportunity for utilising new data and indications
• Well-known and prescribed by both endocrinologist and primary care physicians
1 Picture of sales aid is not intended for promotional purposes
Promotional focus Example of current Victoza®
promotional sales aid1
The key focus with Victoza® is to continue leading the growth of the GLP-1 class
Capital Markets Day 2015 GLP-1 market dynamics
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Three key opportunities to expand the GLP-1 market and grow Novo Nordisk’s GLP-1 franchise
Drive further GLP-1 market expansion with Victoza®
Ensure long term leadership with semaglutide
Leverage LEADER data for further LCM activities
LCM: life cycle management
Expand access
Expand label eg renal impairment
Expand usage
Semaglutide once-weekly
Oral semaglutide
Capital Markets Day 2015 GLP-1 market dynamics
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Insulin market dynamics
Jakob Riis
EVP China, Pacific and Marketing
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Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company’s Annual Report 2014 and Form 20-F, both filed with the SEC in February 2015, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking 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 presentation, could cause actual results to differ materially from those contemplated in any forward-looking 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 presentation, 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 approve in the US and EU for the treatment of obesity only
Capital Markets Day 2015 Insulin market dynamics
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Global insulin volume market by segment Global insulin market volume by generations
The global insulin market is comprised of three different segments and three generations of insulin
2 Includes new-generation insulin Note: Data is sensitive to changes in IMS data collection and reporting methodology Source: IMS Monthly MAT volume
Sep 2015
0%
20%
40%
60%
80%
100%
0
100
200
300
400
500
Modern insulin
Human insulin
tMU Penetration
Device penetration Modern insulin penetration2
Sep 2010
0
100
200
300
400
500
1 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
CAGR volume1: 4.9% CAGR value1: 19.6%
Sep 2010
CAGR volume1: 5% Fast-acting
tMU
Premix CAGR volume1: 3%
Long-acting CAGR volume1: 6%
Sep 2015
New-generation insulin
Capital Markets Day 2015 Insulin market dynamics
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Share of patients by type of first line treatment
Share of patients by type of first injection
Diabetes treatment varies between countries despite common treatment guidelines
0%
20%
40%
60%
80%
100%
Germany United States
Other OAD DPP-VI Insulin
SU Metformin
GLP-1
0%
20%
40%
60%
80%
100%
Germany United States
Basal bolus Premix
Basal
Bolus GLP-1
Note: OAD other refers to all other oral anti-diabetics than DPP-IV and SGLT-2 Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmametrics (Germany and the US). Period of analysis 2010-2011. Combo treatment not taken into account and hierarchy structure of treatment groups applied eg a patient on insulin and a OAD counts as an insulin patient.
Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmametrics (Germany and the US)
Capital Markets Day 2015 Insulin market dynamics
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Age when diagnosed with type 2 diabetes
58
59
60
61
62
63
64
Earlier diagnosis and extended use of OADs result in patients starting insulin at the same age as ten years ago
Age when starting insulin treatment
Average number of days from first OAD to insulin
Age
2005 2014 0
600
1,200
1,800
Number of days
60
62
64
66
68
70
Age
2005 2014 2005 2014
United Kingdom France Germany
OAD: oral anti-diabetic Source: Patient Data Warehouse (PADAWA), IMS disease analyser, IMS LRx & Pharmetrics (UK, France and Germany)
Capital Markets Day 2015 Insulin market dynamics
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The global insulin market (value)
0%
20%
40%
60%
80%
100%
Source: IMS value figures (DKK) from May 1993 to September 2015
Dynamics of the insulin market are sticky with new generations of insulin slowly replacing the older
2015 1993
New-generation insulin Modern insulin Animal insulin Human insulin
Capital Markets Day 2015 Insulin market dynamics
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0
2
4
6
8
10
12
14
16
0%
20%
40%
60%
80%
100%
Long-acting insulin starts Long-acting insulin switches
In Japan, the launch of Tresiba® has changed the market dynamics
Note: Basal insulin starts defined as patients who are starting insulin treatment with a basal insulin Source: IMS LRx (Japan)
Note: Basal insulin switches defined as patients who are switching from basal or another insulin Source: IMS LRx (Japan)
% of starts # of starts (x1,000)
Tresiba® glargine Levemir® Human insulin Tresiba® glargine Levemir® Human insulin
% of switches # of switches (x1,000)
Jan 2015
May 2012
0
5
10
15
20
25
30
35
0%
20%
40%
60%
80%
100%
Jan 2015
May 2012
Capital Markets Day 2015 Insulin market dynamics
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0%
20%
40%
60%
80%
Japanese basal value market shares Japanese total insulin value market shares
The strong Tresiba® performance is increasing Novo Nordisk’s total insulin market share in Japan
Source: IMS Monthly September 2015 value figures Source: IMS Monthly MAT September 2015 value figures
Sep 2012
Sep 2015
Tresiba®
NN Total Basal
glargine Levemir® NPH
43%
53%
31%
8% 4%
0%
20%
40%
60%
80%
Eli Lilly Novo Nordisk Sanofi
Sep 2012
Sep 2015
55%
20%
25%
Capital Markets Day 2015 Insulin market dynamics
biosimilar glargine
4%
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• First-ever basal insulin and GLP-1 analogue combination in one pen
• Positioned as once-daily optimisation – when basal insulin is not enough
• Most people with type 2 diabetes are not in good control and at increased risk of developing diabetes complications2
• To be launched in around 20 countries in 2015/2016
• US FDA regulatory decision expected Q3 2016
1 Picture of sales aid is not intended for promotional purposes
Example of Xultophy® promotional sales aid1 Objective to maximise strong clinical profile
Xultophy® is an efficacious alternative to insulin intensification
2 Dale J et al. Insulin initiation in primary care for patients with type 2 diabetes: 3-year follow-up study. Prim Care Diabetes. 2010;4:85–9. Giugliano D et al. Efficacy of insulin analogs in achieving the hemoglobin A1c target of <7% in type 2 diabetes. Diabetes Care. 2011;34:510–17
Capital Markets Day 2015 Insulin market dynamics
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Insulin segments and Novo Nordisk new-generation insulin products
Note: Illustration of future insulin market segments
Novo Nordisk’s new generation insulins provide best-in-class treatment options in all insulin segments
Time
Long-acting
Premix
Fast-acting
Basal insulin + GLP-1
1 Based on EU label for Tresiba®
Tresiba®
• Successful reductions in HbA1c1
• Lower risk of nocturnal hypoglycaemia versus glargine U1001
• Flexibility in day-to-day dosing time and one daily dose1
Xultophy® • First-ever basal insulin and GLP-1 analogue in one pen • Positioned as once-daily optimisation – when basal
insulin is not enough
Ryzodeg®
• First combination of a basal insulin with an ultra-long duration of action and a mealtime insulin in one pen
• Simple regimen with fewer injections than basal and bolus
Faster-acting insulin aspart
• Greater earlier glucose lowering effect • Opportunity to dose after the meal while maintaining
glucose control
Illustrative insulin segments
Capital Markets Day 2015 Insulin market dynamics
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0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
Faster-acting
insulin aspart
Xultophy®
Ryzodeg®
Tresiba®
Launch country segment volume as share of global segment volume
Source: IMS volume figures September 2015 and Novo Nordisk launch plans
Novo Nordisk’s growth opportunities are supported by numerous planned launches within the coming years
% of global segment volume
®
®
®
2017E 2016E 2015 2018E 2013 & 2014
Capital Markets Day 2015 Insulin market dynamics
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CHERYL ANN BORNE
USA
Cheryl has type 2 diabetes
Experiences from Tresiba® launch in Europe
Jerzy Gruhn
EVP Region Europe
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Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), as well as the company’s Annual Report 2014 and Form 20-F, both filed with the SEC in February 2015, and presentations made, written information released, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain forward-looking 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 presentation, could cause actual results to differ materially from those contemplated in any forward-looking 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 presentation, 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 approve in the US and EU for the treatment of obesity only
Capital Markets Day 2015 Experiences from Tresiba® launch in Europe
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Key facts about Novo Nordisk Europe Seven business areas spanning 36 countries
Novo Nordisk Europe is a diverse region spanning 36 countries
Sales of 15 bDKK first nine months of 2015
~ 2,850 FTEs
Seven business areas and 36 countries
34 languages spoken across the region
20 different currencies
3% local currency growth first nine months of 2015
FTE: full-time employee equivalents
Capital Markets Day 2015 Experiences from Tresiba® launch in Europe
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0%
10%
20%
30%
40%
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31
Tresiba® value market share in the basal insulin segment
Basal insulin value market share in countries where Tresiba® is launched1
Strong uptake of Tresiba® in countries with competitive reimbursement drives basal insulin market share gains
Source: IMS Monthly value figures, September 2015 1 In addition to the countries depicted in the graph to the left, Tresiba® is launched in Austria, Czech Republic, Finland, Lithuania, Netherland, Norway, Poland and Slovakia
Eli Lilly Novo Nordisk Sanofi Other
Months from launch
Luxembourg Greece
Sweden Italy Switzerland
Germany
0%
10%
20%
30%
40%
50%
60%
70%
Jan 2013
Sep 2015
56%
39%
4%
58%
36%
4% 1% 2%
Capital Markets Day 2015 Experiences from Tresiba® launch in Europe
Source: IMS Monthly value figures, September 2015 Note: Tresiba® distribution in Germany to be ceased following the negative price negotiation outcome with the German national association of statutory health insurance funds
United Kingdom
Denmark
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0%
10%
20%
30%
40%
50%
60%
70%
Source: IMS Monthly September 2015 value figures
• Market access challenges remain for both Tresiba® and Xultophy®
• For both products, access is in most cases limited to particular patient groups or to a finite number of patients
• Tresiba® now has a 51% value share of growth in the basal insulin segment and continuous steady, albeit slow, uptake
• Positive opinion on Xultophy® granted from the All Wales Medicines Strategy Group and the Scottish Medicines Consortium
• Continuous effort to increase market access for both brands based on key lessons learnt and using spill-over effect from positive opinions
UK basal insulin value market shares Key launch observations
Penetration of Tresiba® in the UK remains low, but positive opinion from Scotland and Wales on Xultophy®
Sep 2012
Sep 2015
Tresiba®
NN Total Basal
glargine Levemir®
Human Insulin
Xultophy®
glargine U300
56%
37%
29%
4%
11%
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0%
10%
20%
30%
40%
50%
60%
70%
• Continued steady uptake of Tresiba®
• Xultophy® launched in August with strong sales force execution
• Reimbursement on national level. Market access gradually improves due to Swedish regional payer set-up
• Real-world data for Tresiba® confirms strong clinical profile and is enabling further uptake
Sweden basal insulin value market shares Key launch observations
Steady penetration of Tresiba® in Sweden
Source: IMS Monthly September 2015 value figures
Sep 2012
Sep 2015
Tresiba®
NN Total Basal
glargine Levemir®
Human Insulin
Xultophy®
50%
41%
14%
12%
24%
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Study design – Danderyd Diabetes Clinic Study aim and key results
Real-world data for Tresiba® confirms strong clinical profile and enables uptake
Source: Changes in HbA1c, insulin dose and incidence of hypoglycaemia in patients with type 1 diabetes after switching to insulin degludec in an outpatient setting: an observational study, Lena Landstedt-Hallin, CMRO, 8 June 2015
• Study aim: exploring whether the higher cost of insulin degludec compared with insulin detemir or insulin glargine is justified by improved clinical outcomes
• Key results (all statistically significant)
• mean reduction in HbA1c from 8.5% to 8.2%
• median reduction of 12% of total insulin dose
• reduction of hypoglycaemic events of 22% and reduction of nocturnal hypoglycaemic events of 56%
• Conclusion: Insulin degludec was clinically useful and economically justifiable for the patients with type 1 diabetes
• Controlled studies are needed to confirm these benefits in a larger sample of real-world patients
Capital Markets Day 2015 Experiences from Tresiba® launch in Europe
20 weeks2
1 The study followed 347 consecutive type 1 diabetes patients who switched to Tresiba® from existing insulins according to predefined switching criteria such as twice daily injection, HbA1c outside acceptable levels or unstable glucose and/or repeated hypoglycaemic events. A total of 10 patients were on human insulin and continuous subcutaneous insulin infusion 2 Median follow-up time
0
Tresiba®
An independent, prospective, open-label, single-armed, observational study
Insulin glargine N=216
Levemir®
N=131
357 people with type 1 diabetes1
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0%
10%
20%
30%
40%
50%
60%
70%
• Strong Tresiba® and Xultophy® launch execution
• Positive patient and physician feedback on both Tresiba® and Xultophy®
• Tresiba® and Xultophy® are the only brands with positive share of growth, indicating that they take the whole growth of the basal market
• Reimbursement on par with insulin glargine
• Best practices of launch execution identified and used for future launch excellence
Switzerland basal insulin value market shares Key launch observations
Driven by Tresiba® and Xultophy®, Novo Nordisk is now the clear market leader in the Swiss basal insulin segment
Source: IMS Monthly September 2015 value figures
Sep 2012
Sep 2015
Tresiba®
NN Total Basal
glargine Levemir®
Human Insulin
Xultophy®
30%
69%
24%
4%
28%
14%
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Concluding remarks
Penetration is strong in countries with market access comparable to that of competitors
Market access remains a challenge in a number of countries, but persistency and close communication with payers, patients and health care professionals is paying off
Real-world data studies to support continuous penetration
Positive physician and patient feedback
Capital Markets Day 2015 Experiences from Tresiba® launch in Europe