EVP Corporate Development - Novo Nordisk · EVP Corporate Development . Slide 2 5,05 4,10 3,50 4,72 11,82 11,82 ... including those related to Novo Nordisk’s products, product research,

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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


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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%


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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%


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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


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


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


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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


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


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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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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


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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


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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


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


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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


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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


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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


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Insulin market dynamics

Jakob Riis

EVP China, Pacific and Marketing

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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


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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)


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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)


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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


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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


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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%


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


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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


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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


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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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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


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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%


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


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


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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5,05

4,10

3,50

4,72

11,82 11,82

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


Sep 2012

Sep 2015

Tresiba®

NN Total Basal

glargine Levemir®

Human Insulin

Xultophy®

30%

69%

24%

4%

28%

14%


Slide 39

5,05

4,10

3,50

4,72

11,82 11,82

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


Documents

EVP Corporate Development - Novo Nordisk · EVP Corporate Development . Slide 2 5,05 4,10 3,50 4,72 11,82 11,82 ... including those related to Novo Nordisk’s products, product research,