Diabetes Seminar EASD 2015 Carnegie - Welcome to … · Slide 2Investor presentation ... including this document as well as the company’s Annual Report 2013 and Form ... Carnegie

Slide 1

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Diabetes Seminar EASD 2015

Carnegie

Mads Krogsgaard Thomsen

Chief Science Officer

Mexico City – part of Cities Changing Diabetes

Slide 2

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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 2013 and Form 20-F, both filed with the SEC in February 2014, and 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 document, 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 ‘Risks to be aware of’ on p 42-43 of the Annual Report 2013 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® is the intended brand name for liraglutide 3 mg for the treatment of obesity

Investor presentation Carnegie Seminar EASD 2015

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Slide 3

Novo Nordisk works with four strategic focus areas based on five core capabilities

Core capabilities

Expand leadership

Expand leadership in DIABETES

Pursue leadership in HAEMOPHILIA

Establish presence in OBESITY

Expand leadership in GROWTH DISORDERS

Strategic focus areas


Novo Nordisk Way and the Triple Bottom Line business principle

Engineering, formulating, developing and delivering protein- based treatments

Deep disease under- standing

Efficient large-scale production of proteins

Building and maintaining a leading position in emerging markets

Planning and executing global launches of new products

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Slide 4

SUBCUTANEOUS DELIVERY

INTRAVENOUS INFUSION

ORAL PROTEIN DELIVERY

Novo Nordisk core capabilities

90 years of innovation based on core capabilities within therapeutic proteins, coupled with disease insight

YEAST

E. COLI

MAMMALIAN CELLS

ACYLATION

AMINO ACID SUBSTITUTION

OTHER MODIFICATION

THERAPY AREA EXPERTISE

MEDICAL INSIGHT

TRIAL DESIGN AND EXECUTION PREFILLED PENS

DURABLE PENS


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Slide 5

OR

Optimisation

Type 2 diabetes progression and Novo Nordisk ideal treatment flow

1 Pending clinical development programmes and regulatory processes for oral semaglutide, semaglutide and faster-acting insulin aspart

Novo Nordisk current and future product portfolio covers the type 2 diabetes treatment flow1


Metformin

OAD’s GLP-1 Insulin initiation Intensification

OR

Diet & exercise

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Slide 6

OR

Optimisation





Metformin


OR

Diet & exercise

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Slide 7

Comparison of HbA1c and weight lowering effect of marketed GLP-1 analogues

* p < 0.05; BID: twice daily; QD: once daily; QW: once weekly. Source: Competitive Intelligence, June 2014, from AWARD-6: Dungan et al, Lancet 2014, HARMONY-7: Pratley et al, Lancet Diabetes Endocrinol 2014, DURATION-6: Buse et al, Lancet 2012; LEAD-6: Buse et al, Lancet 2009

Victoza® is the market leader in the GLP-1 segment due to superior efficacy on glycaemic control and weight loss


-1.1

-1.5

-1.0

-1.4

-0.8

-1.3

-0.8

-1.4

-1.6

-1.4

-1.2

-1.0

-0.8

-0.6

-0.4

-0.2

0.0

Change in HbA1c (%)

-3.2

-3.6

-2.2

-3.6

-2.9 -2.7

-0.6

-2.9

-4.0

-3.5

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

Liraglutide 1.8 mg QD Dulaglutide QW Exenatide BID Exenatide QW Albiglutide QW

LEAD-6 DURATION-6 AWARD-6 HARMONY-7

Change in weight (kg) LEAD-6 DURATION-6 AWARD-6 HARMONY-7

*

*

*

Non-inferior

non- significant *

*

*

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Slide 8

1 Inclusion criteria: Age ≥18 years, HbA1c 7.5–10.5%, BMI ≥20 kg/m2 Source: Nauck et al. EASD 2015. Oral presentation: 75

Headline results

Phase 3b trial shows superior HbA1c reduction for Victoza® compared to lixisenatide in people with type 2 diabetes

* Victoza® statistically significantly better than lixisenatide Source: Nauck et al. EASD 2015. Oral presentation: 75

Phase 3b trial design

Lixisenatide 20 µg + metformin

Victoza® 1.8 mg + metformin

0

404 people with type 2 diabetes1

26 weeks

Victoza® Lixisenatide

Mean baseline HbA1c 8.4% 8.4%

HbA1c reduction 1.8%* 1.2%

% reaching HbA1c target of <7%

74%* 46%

Fasting plasma glucose (mmol/L)

-2.9* -1.7

Weight change -4.3 kg -3.7 kg


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SUSTAIN 1 trial design Headline results

0.5 mg

semaglutide 1.0 mg

semaglutide Placebo

Change in HbA1c (8.1% baseline)

-1.5%* -1.6%* 0.0%

Proportion of patients reaching HbA1c target of <7%

74%* 73%* 25%

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%

Semaglutide shows superior HbA1c reduction and weight loss compared with placebo in SUSTAIN 1 trial

1 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) Source: Novo Nordisk data on file (NN9535-3623)

*Statistically significantly greater compared to placebo Source: Novo Nordisk data on file (NN9535-3623)


Placebo

Semaglutide 0.5 mg

0 30 weeks

388 drug-naïve people with type 2 diabetes1

Semaglutide 1.0 mg

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Slide 10

Source: Novo Nordisk data on file (NN9924-3790)

Phase 2 headline results PIONEER Phase 3a trial design

Phase 3a trials to be initiated with oral semaglutide following positive results for phase 2 trial

QD: once daily


• 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

• 6 efficacy and safety trials • 1 event-driven cardiovascular outcome trial • ~8,000 patients

• Three doses to be investigated: • 3 mg (QD) • 7 mg (QD) • 14 mg (QD)

• First trial to be initiated in Q1 2016, investigating three doses of once-daily oral semgalutide vs 100 mg sitagliptin

• Remaining trials all to be initiated during 2016

• Investment of 2 billion USD in new production facilities

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OR

Optimisation





Metformin


OR

Diet & exercise

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Slide 12

Clinical data demonstrate predictable profile with very low variability

Tresiba® QD vs insulin glargine QD results from BEGIN phase 3a trial

Clinical data demonstrate stable and efficacious profile of Tresiba®

Source: Heise et al. EASD 2010: Poster 971

QD: once daily

1Based on Novo Nordisk data on file (NN1250-3579, NN1250-3586, NN1250-3668, NN1250-3672, NN1250-3770, NN1250-3582 and NN1250-3583)


Glucose infusion rate (GIR) (mg/kg/min)

Time (hours)

Increasing risk of hypoglycaemia

Optimal glycaemic

control

Increasing risk of hyperglycaemia

0 4 16 20 24 8 12

• Dosing flexibility and superior pen

• Injection volume (U200) – one injection for all Conve- nience

• Lower rate of overall hypoglycaemia

• Lower rate of nocturnal hypoglycaemia Safety

• Improved fasting glucose control

• Less impact of missed dose Efficacy

• Basal insulin with flatter, less variable profile and a doubling in half-life Profile

Degludec Insulin glargine

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Optimisation





Metformin


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Diet & exercise

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Slide 14

DUALTM V trial design Headline results

People inadequately controlled on insulin glargine benefit from switching to Xultophy® in phase 3b trial

Insulin glargine + metformin

Xultophy® + metformin

0

1:1 randomisation Primary end-point: HbA1c reduction

557 people with type 2 diabetes, currently on insulin glargine + metformin1

* Xultophy® statistically significantly better than insulin glargine Source: Buse et al. EASD 2015. Poster number: 836

1 Inclusion criteria: Type 2 diabetes, 7.0% ≤ HbA1c ≤ 10.0%, BMI ≤ 40 kg/m2, age ≥ 18 years and insulin glargine dose 20-50 units Source: Buse et al. EASD 2015. Poster number: 836

Xultophy® Insulin glargine

Baseline HbA1c 8.4% 8.2%

HbA1c reduction 1.8%* 1.1%

% reaching HbA1c target of 7%

72%* 47%

Weight change -1.4 kg* +1.8 kg

Confirmed and nocturnal hypoglycaemia

-57%*

-83%* n/a 26

weeks


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Slide 15

Xultophy® key clinical results

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)

Xultophy® has documented strong efficacy across the treatment cascade


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

HbA1c change (%) -1.9 -1.9 -1.3 -1.4 -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

Confirmed hypoglycaemia (episodes per 100 PYE)

180.2 153.4 282 351.7 343.3

Weight change (kg) -0.5 -2.7 +2.0 +0.5 -1.4

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OR

Optimisation





Metformin


OR

Diet & exercise

Slide 17

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-2

0

2

4

6

8

-60 0 60 120 180 240

Faster-acting insulin aspart shows higher plasma glucose reduction in meal test

Greater glucose-lowering after meal with faster-acting insulin aspart

Faster-acting insulin aspart shows higher prandial glucose reduction in phase 1 trial

Source: Bode et al EASD 2015. Oral presentation: 39

* p<0.05

Source: Bode et al EASD 2015. Oral presentation: 39

Faster-acting insulin aspart vs insulin aspart

Change in plasma glucose following meal test after 14 days

ΔPGav,0–1h, mmol/L –0.50 [–1.07; 0.07]

ΔPGav,0–2h, mmol/L –0.99* [–1.95; –0.03]

Baselin

e a

dju

ste

d p

lasm

a

glu

co

se (

mm

ol/

L)

Nominal time (min)

Insulin aspart Faster-acting insulin aspart


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Slide 18

• Greater improvement of HbA1c with mealtime faster-acting insulin aspart and similar HbA1c improvement when dosed post-meal

• 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

1 Inclusion criteria: Type 1 diabetes, optimised on Levemir®. 1,143 people randomised

2 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 Source: Novo Nordisk data on file (NN1218-3852 T1D and NN1218-3853 T2D)

Trial design Headline results

Phase 3a trials comparing faster-acting insulin aspart with NovoRapid® shows clinical benefits

Note: Previously reported safety and tolerability profiles of insulin aspart confirmed PPG: Postprandial glucose Source: Novo Nordisk data on file (NN1218-3852 T1D and NN1218-3853 T2D)

881 people with type 2 diabetes2

Faster-acting insulin aspart (MT)

NovoRapid® (MT)

-8 0 Run-in 26

weeks

Faster-acting insulin aspart (PM)

Faster-acting insulin aspart (MT)

1,290 people with type 1 diabetes1

52 weeks

NovoRapid® (MT)

26

-8 0 Run-in

• 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 2-hour PPG increment

• Similar overall rate of hypoglycaemia, with a higher rate of hypoglycaemia for faster-acting insulin aspart within first two hours after meal

On

set®

1

On

set®

2


Slide 19

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NovoEight®

NovoSeven®

NovoThirteen®/TRETTEN®

Norditropin®

Significant growth opportunities fuelled by strong R&D pipeline across all four strategic focus areas

1 Phase 2a proof-of-principle trial initiated in June 2015 2 Phase 3 initiated in adult growth hormone disorder 3 Approved in all triad markets (US, EU and Japan), unless noted 4 Approved in the US on 23 Dec 2014 and EU 23 Mar 2015


Saxenda® (US/EU4)

Semaglutide – QW GLP-1

Faster-acting insulin aspart OI338GT – Oral insulin1 OG987GT – Oral GLP-1

OG217SC – Oral GLP-1

LATIN – Type 1 diabetes

OG987SC – Oral GLP-1

LAI287 – QW basal insulin

PHASE 1 PHASE 2 PHASE 3 SUBMITTED APPROVED3

NovoRapid®

NovoMix®

Victoza®

Levemir®

NN8640 – Once-weekly GH2

NN7415 – Concizumab

N8-GP – Long-acting rFVIII

N9-GP – Long-acting rFIX

Tresiba® (EU/Japan)

Ryzodeg® (EU/Japan)

Diabetes

Obesity

Haemophilia

Growth disorders

Xultophy® (EU) G530L – Glucagon analogue

LAI338 – QD basal insulin

NN9838 – Amylin analogue

OI320GT – Oral insulin

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Slide 20

Significant news flow from late-stage diabetes and obesity pipeline


Project Past 6 months Past 3 months Within 3 months In ~3-6 months

Oral GLP-1 Phase 2

Faster-acting insulin aspart

LATIN T1D ADJUNCT TWO

Results available

In ~6-9 months

Semaglutide

SUSTAIN® 1

SUSTAIN® 3

SUSTAIN® 2

SUSTAIN® 4

SUSTAIN® 5

Victoza®

SUSTAIN® 6

LEADER®

Saxenda® SCALE® ext. data

ONSET® 1 √

ONSET® 2 √

√

Tresiba® SWITCH 1

SWITCH 2

√

√

√

Note: Indicated timeline as of financial release of first six months of 2015 on 06 August

ADJUNCT ONE √

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Slide 21

Share information Investor Relations contacts

Investor contact 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

Peter Hugreffe Ankersen +45 3075 9085 [email protected]

Daniel Bohsen +45 3079 6376 [email protected]

Melanie Raouzeos +45 3075 3479 [email protected]

Kasper Veje +45 3079 8519 [email protected]

In North America:

Frank Daniel Mersebach

+1 609 235 8567

[email protected]

Novo Nordisk A/S Investor Relations Novo Allé, DK-2880 Bagsværd

29 Oct 2015 Financial statement for the first nine months of 2015

03 Feb 2016 Financial statement for 2015

Upcoming events


mailto:[email protected]





Documents

Diabetes Seminar EASD 2015 Carnegie - Welcome to … · Slide 2Investor presentation ... including this document as well as the company’s Annual Report 2013 and Form ... Carnegie