evp usa - novo nordisk€¦ · 19/11/2015 · slide 2capital markets day 2015 us market structure...

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US market structure

and dynamics

Jesper Høiland

EVP USA

Rob Taub, USA

Rob has type 2 diabetes

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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 approved in the US and EU for the treatment of obesity only

Capital Markets Day 2015 US market structure and dynamics

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Hospital & related services

32%

27%

20%

9%

7% 5%

Hospital care

Other

Physicians & clinics

Prescriptions drugs

Other professional services

Long-term care

100

150

200

US healthcare spending by category

Growth in hospital & related services costs well above growth in prescription medicines

Increased US healthcare spending is predominantly driven by increasing costs for hospital services

Note: “other” includes dental services, other health, residential & personal care services, home health care, durable medical equipment and other non-durable medical products Source: Centres for Medicare and Medicaid Services, Office of the Actuary, National Health Statics Group, 2013 Source: PhRMA analysis based on Bureau of Labour Statistics

Consumer Price Index

2003 2014

Index All medical costs

Prescription medicines


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US pharmaceutical market

Source: IMS Market Prognosis, November 2015 for overall pharmaceutical market; IMS Therapy Prognosis – Diabetes, November 2015 for diabetes share

Diabetes share of the US pharmaceutical market is projected to increase

Other 94%

546 USD billion

Diabetes 6%

386 USD billion

Diabetes 11%

Other 89%

2019 – Forecast 2014 – Actual


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Novo Nordisk’s products in the US are provided through a complex health care system

Example of patients

Insured via employer

People above 65 years

Low income group

Veterans Affairs & Department of Defence

All but federal hospital care

Patients with 24-hour nurse supervision

Commercial

Medicare Part D

Medicaid

Federal facilities

Non-federal hospitals

Long-term care

Reimbursement channel

Reta

il

No

n-

reta

il

Wh

ole

sale

rs

No

vo

No

rd

isk

Distribution channel


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52% 51% 50% 49%

15% 16% 17% 18%

15% 18% 18% 18%

15% 9% 7% 7% 3% 4% 5%

3% 3% 3% 3%

0%

20%

40%

60%

80%

100%

2012 2015 2018E 2021E

Managed Care Medicare Medicaid Uninsured Public Exchanges Other

312

Managed Care, Medicare and Medicaid expected to continue to cover the bulk of the insured US population

US population by health insurance status

Note: Medicaid expansion and Public Exchange estimates are based on implementation of existing Affordable Care Act. Medicaid Rx figures do not include dual eligibles covered in Part D or CHIP. Exchanges include Public Exchanges only; Private Exchanges are part of Managed Care; Centers for Medicare and Medicaid Services Office of the Actuary, Congressional Budget Office (CBO), National Association of State Budget Officers (NASBO), US Census and HSG estimates Source: Adapted from Health Strategies Group 2015 report

321 329 336

US population (million)


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17%

19%

19%

Prime Therapeutics

In 2005 PBMs covered 170 million lives and the market was fragmented

US Pharmacy Benefit Manager landscape has consolidated in the past 10 years

In 2015 PBMs covered 245 million lives and the market has consolidated1

1 2015 chart reflects current year contractual status; estimates based on press releases and public information. PBM: Pharmacy Benefit Manager Note: Both charts cover all main channels (Managed Care, Medicare Part D and Medicaid); market share based on claim adjudication coverage, ie not on formulary/rebate decision power Source: Health Strategies Group

22% 8%

10%

SXC (Catamaran)

31%

24%

9%

4%

9% 2%

21%

Express Scripts

CVS Health

United Healthcare Group (OptumRx)

& Catamaran

Prime

Humana

MedImpact

All other PBMs Express

Scripts

Medco

Caremark & Advance PCS

All other PBMs

MedImpact

WellPoint & AnthemRX

Humana

OptumRx


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The pressures on HCPs and market trends point in the same direction: Towards organisation and corporatisation of primary care

New Customer Organised Providers

Integrated Delivery Network Medical Group

Hospital Health Plan

Traditional Customer Solo Physicians (HCP)

Pressure to reduce costs

Misaligned incentives

Health information technology

Federal & state health reform

New models of care delivery

Growing patient empowerment

Patient Management

Population Management

The health care professionals are consolidating into Integrated Delivery Networks


HCP: Healthcare professional

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0

50

100

150

200

250

1 CAGR for 10-year period; OAD: oral anti-diabetic Source: IMS Monthly MAT value figures

US diabetes care market by treatment class US diabetes care value market share

Novo Nordisk maintains leadership position within the growing diabetes care market in the US

Source: IMS NSP Monthly MAT value figures

DKK billion

OAD Insulin GLP-1

Total market: CAGR1 16.0%

CAGR1 23.8%

Injectables: CAGR1 25.3%

CAGR1 5.0%

Sep 2005

Sep 2015

28%

0%

10%

20%

30%

GSK

Merck Lilly/BI Sanofi

Takeda

Novo Nordisk

AstraZeneca J&J

Sep 2005

Sep 2015


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Market position of key Novo Nordisk products in the US

Source: IMS NSP for insulin and NPA for GLP-1 based on September 15; IMS NPA for anti-obesity medication based on weekly data ending October 2015; NovoSeven® RT share based on September 2015 MAT; Norditropin® share based on Specialty Pharmacy Integrated data, September 2015

Novo Nordisk is the market leader in four of seven market segments with basal insulin being the largest opportunity

Insulin Market value USD 24.2 bn

GLP-1 Market value USD 3.5 bn

58% TRx

share

Basal Insulin

Market value USD 13.2 bn

25% volume share

Rapid-acting insulin


43% volume share

Haemophilia bypass. agent


MARKET LEADER

~75% value share

MARKET LEADER

Growth Hormone


52% volume share

MARKET LEADER

MARKET LEADER

Haemophilia A Market value USD 2.0 bn

Anti-obesity medication Market value USD 0.3 bn

6% TRx

share


launched

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US sales as reported – First nine months of 2015 US growth analysis – First nine months of 2015

1 Predominantly oral antidiabetic products, needles and Saxenda®

2 Predominantly hormone replacement therapy

Sales of DKK 39.8 billion (+34%)

Levemir® and Victoza® are main growth drivers

Other biopharm +48% Norditropin®

+38%

7% Haemophilia

+20% 11%

Levemir® +39%

79%

3%

23%

10%

7% 5% NovoLog®

+23% 22%

NovoLogMix® +14%

5%

Human insulin +14%

Victoza® +51%

3%

23%

2% Other diabetes & obesity care

+71%

Local currencies Growth Share of growth

Modern insulin 6% 32%

Human insulin (6%) (2%)

Victoza® 24% 48%

Other diabetes and obesity care1 41% 6%

Diabetes and obesity care 11% 84%

Haemophilia (1%) (1%)

Norditropin® 14% 9%

Other biopharmaceuticals2 22% 8%

Biopharmaceuticals 8% 16%

Total 10% 100%


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46%

25%

12%

17%

0%

20%

40%

60%

80%

100%

Source: IMS NPA MAT, September 2015

US GLP-1 market development

Source: IMS LRx Weekly, 10 September 2015, data shown are rolling 4-week averages

Victoza® share of new patients has stabilised in the expanding US GLP-1 market

Sep 2015

Sep 2012

Total TRx Growth rate

0%

5%

10%

15%

20%

25%

0

1,000

2,000

3,000

4,000

5,000

6,000

Thousands

US GLP-1 market shares exenatide Victoza®

albiglutide dulaglutide GLP-1 TRx (x1,000)

NBRx GLP-1 class share

Volume growth rate

Sep 2012

Sep 2015


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Novo Nordisk now offers three generations of basal insulin products in the US

Premium product, premium price

New-generation insulin

On par with market leader, competitive price

Modern insulin

Essential, low cost

Human insulin


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Tresiba® approved in the US for glycaemic control in adults with diabetes mellitus

Competitive US label for Tresiba®

• Reduction in HbA1c confirmed to be non-inferior in all trials against all comparators

• Numerically greater fasting plasma glucose reduction

• Numerically lower insulin dose observed in majority of comparator trials

• Injection at any time of day

• Two concentrations enabling dosing of up to 80 and 160 units per injection, respectively

• Half-life of 25 hours and duration of action of at least 42 hours

• Day to day variability of 20%

Convenience

Safety

Efficacy

Profile

• Overall safety consistent with insulin

• Hypoglycaemia rates included for Tresiba®, but not comparators


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Duration of action1

Note: Comparison based on US Package Inserts (PI) for listed products, not based on head to head comparisons. 1 Based on Glucose Infusion Rate (GIR) data from euglycemic clamp studies; 2 Tresiba PI section 12.2; 3 glargine U100 PI section 12.2; 4 glargine U300 PI section 12.2; 5 Tresiba PI Highlights section; 6 glargine U100 PI Highlights section; 7 glargine U300 PI Highlights section; 8 Tresiba PI section 14; 9 glargine U300 PI section 14.1; 10 Tresiba U200 PI

Administration and dosing

Pen device

In-use time

• Up to 24 hours3

• Once daily at any time of day, at the same time every day6

• 300 units/pen

• 80 units max per injection

• Push button extension

• 28 days at room temperature

• Up to 36 hours4

• Once daily at any time during the day, at the same time every day7

• Higher dose needed vs glargine U1009

• 450 units/pen

• 80 units max per injection

• Push button extension


• At least 42 hours2

• Once daily at any time of day5

• Numerically lower dose needed vs glargine U1008

• 600 units/pen10

• 160 units max per injection10

• No push button extension


glargine U100 glargine U300


Tresiba® has distinctly different product features than competitor basal insulins

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Key challenges with current insulin therapy

1 2015 ROPERS report; 2 Peyrot M et al. Diabetic Medicine. 2012;29(5):682-689; 3 Peyrot M et al. Diabetes Care. 2010;33(2):240-245; 4 IMS LRx analysis, July 2015

• 28% of insulin patients find it difficult to take insulin at the prescribed time daily2

• 22% of US insulin patients plan their daily activities around insulin injections3

• 63% of US type 2 diabetes patients treated with insulin have an HbA1c >7%1

>1 injection per day due to max 80 units per injection

Challenging for patients to inject at same time every day

Patients not reaching treatment goal

• 17% of US basal insulin patients use >80 units per day4

Tresiba® has the potential to address patients struggling with the limitations of current insulin offerings


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Tresiba® market access Tresiba® launch execution

Tresiba® launch execution on track – focus on market access and specialist engagement

> >

Q4 2015 2016

Field force trained

Available in pharmacies

First script written

Approval of promotion material

DTC campaign

Commercial launch (full diabetes field force)

Optimise contracting opportunities

• Deliver convincing payer value story

• Leverage published clinical data and real world data

• Mainly commercial coverage expected in 2016

• Medicare Part D coverage expected to emerge in 2017

Savings program to reduce cost barrier

• Pay no more than USD 15 with co-pay card

• Pay no more than USD 25 with co-pay e-voucher

• Available for insured commercial patients

Specialist engagement


DTC: direct to consumer

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Key mid-term opportunities and challenges for Novo Nordisk in the US

2015 2016 2017

Insulin and GLP-1 volume market growth

Continued Saxenda® uptake and market expansion

Continued pricing pressure from competitors and payers

Continued challenging regulatory environment

Launch of biosimilar insulin glargine

Opportunities

Challenges

Launch of Xultophy®

Launch and penetration of Tresiba®

Launch of generic Vagifem®


evp usa - novo nordisk€¦ · 19/11/2015 · slide 2capital markets day 2015 us market structure...

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