ADA 2018 outline - Novo Nordisk · ADA 2018 investor presentation 59% 72% 80% 34% 0% 20% 40% 60%...

Investor presentation

ADA 2018

Manato Ohara, diagnosed with type 1 diabetes Kanagawa, Japan

Shirley Adelia Stewart has type 2 diabetes

New Orleans, Louisiana, US

Agenda

ADA 2018 investor presentation

Status on phase 3 trials for oral semaglutide - PIONEER

CVOT study for Ozempic® and oral semaglutide

Phase 3 trials for semaglutide in obesity - STEP and SELECT

Tresiba® real world evidence study – CONFIRM

Discussion and Q&A

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2

Forward-looking statements

Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this presentation as well as the company’s statutory Annual Report 2017 and Form 20-F, which are both filed with the SEC in February 2018 in continuation of the publication of the Annual Report 2017, 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 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 recalls, 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.

For an overview of some, but not all, of the risks that could adversely affect our results or the accuracy of forward-looking statements in this presentation, reference is made to the overview of risk factors in ‘The Risks of Doing Business’ on pp 40-43 of the Annual Report 2017.

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

ADA 2018 investor presentation 3

Novo Nordisk’s total GLP-1 NBRx market share is improving following Ozempic® launch Commercial focus on Ozempic®

Novo Nordisk’s GLP-1 market share in the US is improving and commercial focus is now fully switched to Ozempic®

ADA 2018 investor presentation 4

Note: “Other” brands include Exenatide BID, Exenatide ER, Albiglutide, Lixisenatide NBRx: New-to-brand scripts Sources: IQVIA NPA, 8 June 2018

39.3%

10.6%

33.1%

17.0%

43.7%

0%

10%

20%

30%

40%

50%

Weekly NBRx share (in %)

dulaglutide Ozempic®

Victoza®

Novo Nordisk GLP-1

Other

May 2017

May 2018

• Market access for Ozempic® is gradually improving and Ozempic® now has more than 50% combined coverage across commercial and Medicare Part D

• The majority of sales districts have now switched

all promotional activities to Ozempic®

• Global Ozempic® sales is still expected to be at

least DKK 1 billion in 2018

• The volume growth of the US GLP-1 market continues to be more than 20%

4 out of 10 PIONEER trials for oral semaglutide are completed, rest are expected to read out during H2 2018

1 Expected to be published in the given quarter or in the subsequent quarterly company announcement. Estimated timing from first patient first visit to completion of trial 2 Primary endpoint after 26 weeks of treatment by using the statistical method: Treatment policy estimand approach 3 Primary endpoint after >122 major adverse cardiovascular events (MACE), defined by non-fatal stroke, non-fatal myocardial infarction or CV death 4 Primary endpoint after 52 weeks of treatment by using the statistical method: Treatment policy estimand approach Note: n = approximate number of randomised people; OAD: oral anti-diabetic

2016 2017

PIONEER 1: monotherapy2 26 weeks, n=704

PIONEER 2: vs empagliflozin2 52 weeks, n=816

PIONEER 3: vs sitagliptin2 78 weeks, n=1,860

PIONEER 4: vs liraglutide2 52 weeks, n=690

PIONEER 5: moderate renal impairment2 26 weeks, n=324

PIONEER 6: cardiovascular outcomes3 Event driven (>122 MACE), n=3,176

PIONEER 7: flexible dose escalation4 52 weeks, n=500

PIONEER 8: insulin add-on2 26+26 weeks, n=720

PIONEER 9: JAPAN monotherapy2 52 weeks, n=230

PIONEER 10: JAPAN OAD combination4 52 weeks, n=336


Q1 20181 Q2 20181 Q3 20181 Q4 20181

52 weeks extension trial

5

Inclusion criteria

• T2D ≥ 30 days

• HbA1c 7.0–9.5%

PIONEER 1 trial design Baseline characteristics

The PIONEER 1 trial was designed to investigate efficacy and safety of oral semaglutide vs placebo


704 patients with type 2

diabetes

Trial objective

• Evaluate the effect and safety of oral semaglutide in a monotherapy setting

Oral sema 3 mg

Oral sema 7 mg

Oral sema 14 mg

Placebo

Number of patients

175 175 175 178

Age (yrs) 55 56 54 54

Mean HbA1c (%) 7.9 8.0 8.0 7.9

Mean diabetes duration (yrs)

3.8 3.6 3.4 3.4

Body weight (kg)

87 89 88 89

Placebo

Oral semaglutide 3 mg

Randomised: 703 patients with type 2

diabetes

26 weeks



T2D: type 2 diabetes; sema: semaglutide

6

Mean change in HbA1c (%-point) Treatment policy estimand

Mean change in HbA1c (%-point) Hypothetical estimand

In PIONEER 1 oral semaglutide demonstrated a superior reduction in HbA1c at week 26 vs placebo


-2.0

-1.6

-1.2

-0.8

-0.4

0.0

Weeks

0

-1.4*

-1.2*

-0.9*

-0.3

1 Estimated means at week 26 – Pattern mixture model using multiple imputations for the treatment policy estimand and Mixed Model for Repeated Measurement (MMRM) for the hypothetical estimand * Statistically significant versus placebo Note: Mean baseline HbA1c: 8.0% sema: semaglutide Source: presented at the American Diabetes Association, 78th Annual Scientific Sessions, Orlando, FL, USA

Mean change in HbA1c (%-point)

Oral sema 3 mg Oral sema 7 mg

Oral sema 14 mg Placebo

261

-2.0

-1.6

-1.2

-0.8

-0.4

0.0

Mean change in HbA1C (%-point)

0

Weeks

26

Oral sema 3 mg

Oral sema 14 mg

-1.5* -1.3*

-0.8*

-0.1

261

Oral sema 7 mg

Placebo

7

26

Mean change in body weight (kg) Hypothetical estimand

In PIONEER 1 oral semaglutide 14 mg demonstrated a superior reduction in body weight at week 26 vs placebo


-5.0

-4.0

-3.0

-2.0

-1.0

0.0

0

-3.7*

-2.3*

-1.5 -1.4

Mean change in body weight (kg)


Oral sema 14 mg Placebo

Mean change in body weight (kg) Treatment policy estimand

-5.0

-4.0

-3.0

-2.0

-1.0

0.0

Mean change in body weight (kg) Oral sema 14 mg Placebo

Weeks

26 261


-4.1*

-2.5*

-1.7

-1.5

261 0

Weeks

26

1 Estimated means at week 26 – Pattern mixture model using multiple imputation for the treatment policy estimand and Mixed Model for Repeated Measurement (MMRM) for the hypothetical estimand * Statistically significant versus placebo Note: Mean baseline body weight : 88.1 kg sema: semaglutide Source: presented at the American Diabetes Association, 78th Annual Scientific Sessions, 2018, Orlando, FL, USA

8

1 Modelled data based on PIONEER 1 Source: Novo Nordisk data on file

Proportion of patients achieving HbA1c < 7.0% (ADA) after 26 weeks1

In PIONEER 1 80% of patients on oral semaglutide 14 mg achieved an HbA1c level below 7% after 26 weeks

Semaglutide exposure dose proportional

and maintained over time1


59%

72% 80%

34%

0%

20%

40%

60%

80%

100%

Oral sema

3 mg

Oral Sema

7 mg

Oral sema

14 mg

Placebo

Proportion of patients (%)

5 0 10 15 20 25

Weeks

2

5

10

20

Semaglutide (nmol/L)

30

Oral sema 14 mg


1 Hypothetical estimand, observed data sema: semaglutide; ADA: American Diabetes Association Source: presented at the American Diabetes Association, 78th Annual Scientific Sessions, Orlando, FL, USA

9

Inclusion criteria

• Stable dose of metformin for ≥ 90 days

• HbA1c 7.0–10.5%


The PIONEER 2 trial was designed to investigate efficacy and safety of oral semaglutide vs empagliflozin


Empagliflozin 25 mg

Oral semaglutide 14 mg Randomised: 822 patients with type 2

diabetes

Trial objective

• Evaluate the effect and safety of oral semaglutide against the leading SGLT-2i

52 weeks

Oral sema 14 mg

Empa 25 mg

Number of patients 411 410

Age (yrs) 57 58

Mean HbA1c (%) 8.1 8.1


7.2 7.7

Mean body weight (kg) 91.9 91.3

Note: Dose titration for oral semaglutide is 3 mg in 4 weeks, 7 mg in 4 weeks before initiating the 14 mg maintenance dose in week 9. Dose titration for empagliflozin is 10 mg for 8 weeks before initiating the 25 mg maintenance dose in week 9. PIONEER 2 was an open label trial. sema: semaglutide; empa: empagliflozin; SGLT-2i: sodium-glucose cotransporter 2 inhibitor

10

1

`



In PIONEER 2 oral semaglutide demonstrated a statistically significant reduction in HbA1c at week 52 vs empagliflozin


-2.0

-1.6

-1.2

-0.8

-0.4

0.0


-0.9

-1.3*

1 Estimated means at week 52 - Pattern mixture model using multiple imputations for the treatment policy estimand and Mixed Model for Repeated Measurement (MMRM) for the hypothetical estimand * Statistically significant versus empagliflozin Note: Mean baseline HbA1c: 8.1% sema: semaglutide; empa: empagliflozin Source: Novo Nordisk data on file

-2.0

-1.6

-1.2

-0.8

-0.4

0.0


-0.8

-1.3*

Oral sema 14 mg Empa 25 mg

0

Weeks

52 521 0

Weeks

52 521


11

26 26

Mean change in body weight at week 52 Treatment policy estimand

Mean change in body weight at week 52 Hypothetical estimand

In PIONEER 2 oral semaglutide demonstrated a statistically significant reduction in weight at week 52 vs empagliflozin1


-6.0

-5.0

-4.0

-3.0

-2.0

-1.0

0.0


-3.6 -3.8

1 Statistical significant reduction in body weight using the hypothetical estimand

2 Estimated means at week 52 – Pattern mixture model using multiple imputations for the treatment policy estimand and Mixed Model for Repeated Measurement (MMRM) for the hypothetical estimand * Statistically significant versus empagliflozin Note: Mean baseline body weight : 88.1 kg sema: semaglutide; empa: empagliflozin Source: Novo Nordisk data on file

-6.0

-5.0

-4.0

-3.0

-2.0

-1.0

0.0


-3.8

-4.7*


0

Weeks

52 522 0

Weeks

52 522


12

26 26


The PIONEER 4 trial was designed to investigate efficacy and safety of oral semaglutide vs Victoza® and placebo


Placebo



diabetes

52 weeks

Oral sema 14 mg

Victoza® 1.8 mg

Placebo

Number of patients

285 284 142

Age (yrs) 56 56 57

Mean HbA1c (%) 8.0 8.0 7.9


7.8 7.3 7.8

Body weight (kg) 92.9 95.5 93.2 Inclusion criteria

• Stable dose of metformin or metformin+SGLT-2i for ≥90 days

• HbA1c 7.0–9.5%

Trial objective

• Evaluate the effect and safety of oral semaglutide against the leading GLP-1 and placebo

Victoza® 1.8 mg

Note: Dose titration for oral semaglutide is 3 mg in 4 weeks, 7 mg in 4 weeks before initiating the 14 mg maintenance dose in week 9. Dose titration for Victoza® is 0.6 mg for 1 week, 1.2 mg for 1 week before initiating the 1.8 mg maintenance dose in week 3 sema: semaglutide; SGLT-2i: sodium-glucose cotransporter 2

13

-2.0

-1.6

-1.2

-0.8

-0.4

0.0

0.4

-2.0

-1.6

-1.2

-0.8

-0.4

0.0

0.4



In PIONEER 4 oral semaglutide demonstrated a statistically significant reduction in HbA1c at week 52 vs Victoza®



-0.9

-1.2*


-0.9

-1.2*

Oral sema 14 mg Victoza® 1.8 mg

0

Weeks

52 521 0

Weeks

52 521

Placebo

+0.2

-0.2

1 Estimated means at week 52 -– Pattern mixture model using multiple imputations for the treatment policy estimand and Mixed Model for Repeated Measurement (MMRM) for the hypothetical estimand * Statistically significant versus Victoza®

Note: Mean baseline HbA1c: 8.0% sema: semaglutide Source: Novo Nordisk data on file


Placebo

14

26 26

-6.0

-5.0

-4.0

-3.0

-2.0

-1.0

0.0

-6.0

-5.0

-4.0

-3.0

-2.0

-1.0

0.0

Mean change in body weight Treatment policy estimand

Mean change in body weight Hypothetical estimand

In PIONEER 4 oral semaglutide demonstrated a statistically significant change in body weight at week 52 vs Victoza®



-3.0

-4.3*


-3.1

-5.0*

0

Weeks

52 521 0

Weeks

52 521

-1.2 -1.0


Placebo


Placebo

1 Estimated means at week 52 - Pattern mixture model using multiple imputations for the treatment policy estimand and Mixed Model for Repeated Measurement (MMRM) for the hypothetical estimand * Statistically significant versus Victoza®

Note: Mean baseline body weight : 94.0 kg sema: semaglutide Source: Novo Nordisk data on file

15

26 26


The PIONEER 7 trial investigated efficacy and safety of oral semaglutide with flexible dose adjustment vs sitagliptin



diabetes

Oral sema 3, 7 or 14 mg

Sitagliptin 100 mg

Number of patients 253 251

Age (yrs) 57 58

Mean HbA1c (%) 8.3 8.3


8.6 9.0

Body weight (kg) 88.9 88.4

Inclusion criteria

• Stable dose of 1-2 OADs (metformin, SU, TZD, SGLT-2i) for ≥90 days

• HbA1c 7.5–9.5%

Trial objective

• Evaluate the effect and safety of oral semaglutide against the leading DPP-4i after flexible dose adjustment

Sitagliptin 100 mg

Oral semaglutide 3, 7 or 14 mg

52 weeks

Note: dose adjustment based on HbA1c level (<7%) and tolerability (moderate to severe nausea or vomiting) every 8 weeks throughout trial. There is no titration period for patients initiated on 100 mg sitagliptin. PIONEER 7 was an open label trial. OAD: oral anti-diabetics; DPP-4i: dipeptidyl peptidase 4 inhibitor; SU: sulfonylurea; TZD: thiazolidinediones; SGLT-2i: sodium-glucose cotransporter 2 inhibitor sema: semaglutide

16

58*

25

0

20

40

60

80

Oral sema flex Sitagliptin 100 mg

Proportion of patients achieving HbA1c levels below 7% at week 52 - Treatment policy estimand

Proportion of patients achieving HbA1c levels below 7% at week 52 - Hypothetical estimand

In PIONEER 7 around 60% of patients on oral semaglutide achieved an HbA1c level below 7% at week 52


Proportion of subjects (%) Proportion of subjects (%)

63*

28

0

20

40

60

80

Oral sema flex Sitagliptin 100 mg

* Statistically significant versus sitagliptin Note: Observed data. Mean baseline HbA1c: 8.3% sema: semaglutide; flex: flexible dose Source: Novo Nordisk data on file

17

Mean change in body weight Treatment policy estimand

Mean change in body weight Hypothetical estimand

In PIONEER 7 oral semaglutide demonstrated a superior body weight reduction at week 52 vs sitagliptin


-5.0

-4.0

-3.0

-2.0

-1.0

0.0

1.0

0

-2.6*

-0.7


Oral sema flex Sitagliptin Mean change in body weight (kg)

Weeks

52 521

Oral sema flex Sitagliptin

-5.0

-4.0

-3.0

-2.0

-1.0

0.0

1.0

0

-2.9*

-0.8

Weeks

52 521

1 Estimated means at week 52 - Pattern mixture model using multiple imputations for the treatment policy estimand and Mixed Model for Repeated Measurement (MMRM) for the hypothetical estimand * Statistically significant versus sitagliptin Note: the proportion of patients on treatment at week 52 were: 9% on 3 mg, 32% on 7 mg, 59% on 14 mg and 1% missing information. Mean baseline body weight : 88.6 kg sema: semaglutide; flex: flexible dose Source: Novo Nordisk data on file

18

Nausea rates across completed PIONEER trials

Overall safety across completed PIONEER trials

Oral semaglutide has demonstrated a consistent and well-tolerated profile across completed PIONEER trials


• Across completed PIONEER trials, oral semaglutide has been well-tolerated and with a safety profile consistent with GLP-1-based therapy

• The most common adverse event for oral semaglutide was mild-to-moderate nausea, which diminished over time

• Across completed PIONEER trials, the nausea rates range from 16–21% which is on par or lower than other GLP-1 products on the market

16% 20% 20% 21%

0%

25%

50%

75%

100%

PIONEER 1 PIONEER 2 PIONEER 4 PIONEER 7

Nausea rate (%)

Note: nausea rates in PIONEER 1, 2 and 4 are for oral semaglutide 14 mg, PIONEER 7 is a mixed dose of oral semaglutide. Duration of trials: PIONEER 1 26 weeks; PIONEER 2, 4 and 7 52 weeks Source: Novo Nordisk data on file

19

In completed PIONEER trials, oral semaglutide lowered body weight by ~3–5 kg by end of trial1

Oral semaglutide demonstrated a consistent reduction in HbA1c and body weight in the completed PIONEER trials

In completed PIONEER trials, oral semaglutide lowered HbA1c by 1.2–1.5%-point by end of trial1


-1.5%

-1.3% -1.2%

-1.4%

-2.0%

-1.5%

-1.0%

-0.5%

0.0%


1 Hypothetical estimand, Mixed Model for Repeated Measurement (MMRM) * Statistically significant vs comparator (PIONEER 1 vs placebo; PIONEER 2 vs empagliflozin 14 mg; PIONEER 4 vs Victoza® 1.8 mg, PIONEER 7 vs sitagliptin 100 mg) Note: results shown are: PIONEER 1 for 26 weeks with 14 mg oral semaglutide , PIONEER 2 and 4 for 52 weeks with 14 mg oral semaglutide; PIONEER 7 for 52 weeks with a mixed dose Source: Novo Nordisk data on file

Mean change in HbA1c (%-points)

-4.1

-4.7 -5.0

-2.9

-6.0

-5.0

-4.0

-3.0

-2.0

-1.0

-


0.0

Mean change in weight (kg)

20

*

* *

* *

* *

*

In completed PIONEER trials 28–49% of patients achieved a weight loss of ≥ 5%1

In the completed PIONEER trials between 63–80% of patients on oral semaglutide achieved an HbA1c level <7% In completed PIONEER trials 63–80% of patients achieved an HbA1c level <7.0% (ADA guidance)1


80% 72% 69%

63%

0%

20%

40%

60%

80%

100%



44% 47% 49%

28%

0%

20%

40%

60%

80%

100%



1 Hypothetical estimand, observed data * Statistically significant vs comparator (PIONEER 1 vs placebo; PIONEER 2 vs empagliflozin 14 mg; PIONEER 4 vs Victoza® 1.8 mg, PIONEER 7 vs sitagliptin 100 mg) Note: results shown are: PIONEER 1 for 26 weeks with 14 mg oral semaglutide , PIONEER 2 and 4 for 52 weeks with 14 mg oral semaglutide; PIONEER 7 for 52 weeks with a mixed dose Source: Novo Nordisk data on file

21

* * *

*

* *

*


KurtzhalStephen Gough

PeterGlobal Chief Medical Officer

CV label strategy for Ozempic® and oral semaglutide

22

The US FDA has agreed with Novo Nordisk on a bridging strategy between Ozempic® and oral semaglutide


Potential bridging strategy for Ozempic® and oral semaglutide to obtain a CV indication

Focus on minimising the number of large CVOTs to the benefit of patients

• 31 countries have obtained approval of Ozempic® with a CV indication based on the SUSTAIN 6 data

• Novo Nordisk has engaged in a constructive dialogue with the US FDA focusing on minimising the need for large cardiovascular outcomes trials to obtain a CV indication on the label

• Opportunity to obtain CV indication for Ozempic® based on SUSTAIN 6 and PIONEER 6

• The originally planned CVOT study (SOUL) for Ozempic® is expected to be replaced by a new CVOT study with oral semaglutide to pursue a CV indication for both products

SUSTAIN 6

PIONEER 6

Oral SOUL

Ozempic®

Oral semaglutide

Note: SUSTAIN 6 was a phase 3a cardiovascular pre-approval trial for Ozempic®. PIONEER 6 is a phase 3a cardiovascular pre-approval trial for oral semaglutide FDA: Food & Drug Administration; CV: cardiovascular; CVOT, cardiovascular outcomes trial

23

The CVOT for oral semaglutide is expected to demonstrate cardiovascular superiority versus placebo


Potential cardiovascular outcomes trial design for oral semaglutide Status and next steps

• Ongoing dialogue with the US FDA to finalise detailed trial design and requirements for a cardiovascular study for oral semaglutide

• Recruitment for a cardiovascular outcomes trial for oral semaglutide is expected to be initiated mid 2019

Inclusion criteria: • Established CVD or CKD • HbA1c levels between 6.5-10%

Primary endpoint: • Cardiovascular death, non-fatal myocardial infarction or non-

fatal stroke (MACE)

~12-15.000 patients with type 2 diabetes Placebo + standard of care

Oral semaglutide 14 mg + standard of care

Event driven (~3.5-5 years)

Note: Standard of care will allow all glucose lowering drugs except GLP-1s CVOT: cardiovascular outcomes trial; CVD, cardiovascular disease; CKD, chronic kidney disease; MACE, major adverse cardiovascular events

24


KurtzhalMartin Lange

PeterSVP Global Development

Injectable semaglutide

in obesity

25

-20

-15

-10

-5

0

0 4 8 12 16 20 28 36 44 52

Proportion of patients achieving a weight loss of >5, 10, 15 or 20% at week 52 in phase 22

In phase 2, semaglutide demonstrated an unprecedented weight loss after 52 weeks of treatment


16.2% weight reduction with the highest semaglutide dose in phase 2 obesity trial1

sema 0.05 mg sema 0.1 mg

sema 0.2 mg sema 0.3 mg

sema 0.4 mg lira 3.0 mg

Placebo

Change in body weight (%)

16.2%

1 Observed data

Note: All treatment arms are adjunct to diet and exercise Sema: semaglutide; lira: liraglutide Source: Novo Nordisk data on file

Weeks

26

83%

65%

41%

27%

0%

20%

40%

60%

80%

100%

Proportion of patients (in %) achieving weight loss

2 Baseline to week 52: estimated data

Note: data for 15 and 20% weight loss was a post-hoc analysis. Patients on sema in the phase 2 trial were titrated up to 0.4 mg with dose escalation every 4th week (0.05 mg, 0.1 mg, 0.2 mg and 0.3 mg). Sema: semaglutide Source: Novo Nordisk data on file

>5% >10% >15% >20%

sema 0.4 mg

Phase 3a programme STEP and CV outcomes study SELECT with semaglutide 2.4 mg in obesity to be initiated in 2018


1 Inclusion criteria: male or female, age ≥18 years, BMI: ≥30 kg/m2 or ≥27 kg/m2 and ≥1 comorbidity Note: all treatment arms are adjunct to diet and exercise CV: cardiovascular; T2D: type 2 diabetes

Semaglutide in obesity phase 3a programme, STEP, expected to include ~4,650 patients1

Expected phase 3a programme completion: 2020

STEP 1: Weight loss 1,950 patients, 68 weeks

STEP 2: T2D non-insulin patients 1,200 patients, 68 weeks

STEP 3: Maximising weight loss 600 patients, 68 weeks

STEP 4: Maintained weight loss 900 patients, 68 weeks

2018 2019 2020

Cardiovascular outcomes study, SELECT, planned for semaglutide in obesity

QW: once-weekly; sc: subcutaneous; CVD: cardiovascular disease; PAD: peripheral arterial disease

~17,500 people with obesity

Semaglutide 2.4 mg sc QW

Placebo

Event-driven (~5 years)

Inclusion criteria • BMI: ≥27 kg/m2 • Established CVD:

o MI ≥60 days ago o Stroke ≥60 days ago o Symptomatic PAD

• Screening HbA1c <6.5%

27

The STEP programme is designed to evaluate the effect of semaglutide in patients with and without diabetes


STEP 1 - Weight management STEP 2 - Weight management in people with

type 2 diabetes

Trial objective • To show superiority of semaglutide vs. placebo on weight

loss and to compare safety and tolerability in adults with obesity or overweight, but without T2D

Inclusion criteria: • BMI: ≥30 kg/m2 or ≥27 kg/m2 and ≥1 comorbidity • Without diabetes or with HbA1c <6.5%

~1.950 patients

Placebo1

Semaglutide 2.4 mg sc OW1

68 weeks

1 As adjunct to lifestyle intervention (-500 kcal/day diet + 150 min/week physical activity) Note: patients escalated up to 2.4 mg with dose escalation every 4th week (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) QW: once-weekly; sc: subcutaneous; BMI: body mass index; T2D: type 2 diabetes

Trial objective • To show superiority of semaglutide vs. placebo on weight

loss and to compare safety and tolerability in adults with T2D and either obesity or overweight

Inclusion criteria: • BMI: BMI: ≥27 kg/m2 • Type 2 diabetes (HbA1c 7–10%)

~1.200 patients

Placebo1


68 weeks

28


1As adjunct to lifestyle intervention (-500 kcal/day diet + 150 min/week physical activity) Note: patients escalated up to 2.4 mg semaglutide with dose escalation every 4th week (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg). Patients on 1.0 mg semaglutide escalated with dose escalation every 4th week (0.25 mg and 0.5 mg) QW: once-weekly; sc: subcutaneous; BMI: body mass index; T2D: type 2 diabetes

The STEP programme is designed to evaluate the maximum and maintained weight loss effect of semaglutide


STEP 3 - Maximising weight loss STEP 4 - Maintaining weight loss

Trial objective • To show superiority of semaglutide vs placebo as an

adjunct to IBT, including an initial 8-week LCD, on weight loss


~600 patients

Placebo + IBT incl. 8w LCD

Semaglutide 2.4 mg sc OW + IBT incl. 8w LCD

68 weeks

Note: patients titrated up to 2.4 mg with dose escalation every 4th week (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) QW: once-weekly; sc: subcutaneous; IBT: intensive behavioural therapy; LCD, low-calorie diet; T2D: type 2 diabetes

Trial objective • To evaluate the effect of semaglutide vs placebo on weight

loss in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period


~900 patients

Placebo2


48 weeks

Note: patients titrated up to 2.4 mg with dose escalation every 4th week (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) 1 16 weeks escalation + 4 weeks at target dose (2.4 mg) 2 As adjunct to lifestyle intervention (-500 kcal/day diet + 150 min/week physical activity)


20 weeks

29


Robin Evers

SVP Medical Affairs, Regulatory Affairs & Safety

Tresiba® - CONFIRM

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CONFIRM trial design Baseline characteristics

The CONFIRM real-world study was designed to investigate the effectiveness of Tresiba® versus glargine U300


IGlar U300: insulin glargine U300 Source: Presented at the American Diabetes Association 78th Scientific Sessions, Orlando, FL, USA

Tresiba® IGlar U300

Number of patients 2,028 2,028

Sex, Male 52% 52%

Mean HbA1c 9.6% 9.5%


4.8 4.8

Mean BMI (kg/m2) 34.0 34.7

4,056 patients

with type 2 diabetes

Insulin naïve (min. 12 months)

Insulin naïve (min. 12 months)

Tresiba® (min. 3 months)

IGlar U300 (min. 3 months)

6 months pre-index

Index date (baseline)

6 months post-index

Secondary endpoint:

• Rate of overall hypoglycaemic episodes from the index date until 6 months of follow-up

Primary endpoint:

• Change in mean HbA1c from the index date until 6 months of follow-up

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0.10 1.00 10.00

1 Measure used to compare the incidence rates of events occurring at any given point in time, i.e. there was a 30% lower risk of hypoglycaemia with Tresiba® vs IGlar U300 2 Represents the odds that an outcome will occur given a particular exposure, i.e. the proportion of patients experiencing ≥1 episode of hypoglycaemia was significantly lower with Tresiba® vs IGlar U300 IGlar U300: insulin glargine U300, hypos: hypoglycaemia events Source: Presented at the American Diabetes Association 78th Scientific Sessions, Orlando, FL, USA

-1.5%*

-1.2%

-2.0%

-1.5%

-1.0%

-0.5%

0.0%

Tresiba® Iglar U300

Tresiba® showed a statistically significant reduction of HbA1c vs IGlar U300 in CONFIRM

Tresiba® showed a statistically significant lower rate of hypos versus IGlar U300 in CONFIRM

Tresiba® showed a statistically significant HbA1c change with a lower rate of hypos vs insulin glargine U300 in CONFIRM


Note: For change in HbA1c for Tresiba n=671 and for IGlar U300 n=749, which reflects that only patients who had a follow-up check at a clinical check are included in the population

* Statistically significant versus IGlar U300 IGlar U300: insulin glargine U300 Source: Presented at the American Diabetes Association 78th Scientific Sessions, Orlando, FL, USA

Change in HbA1C

(in %-point)

Favors degludec Favors glargine U300

Proportion with hypoglycaemia, odds ratio2

Hypoglycaemia

rate ratio1 0.70 [0.49; 0.99]95% CI

0.64 [0.47; 0.88]95% CI

Tresiba® IGlar U300

Ratio

1.0 0.1 10.0

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R&D milestones in 2018

Project Q1 2018 Q2 2018 Q3 2018 Q4 2018

Tresiba®

Xultophy®

Ozempic®

Results available1 Regulatory milestone

√

DUAL I Japan Phase 3a

Oral semaglutide PIONEER 1 data

LAI287 Phase 1 data

DEVOTE and SWITCH2 US regulatory decision

EU and Japan regulatory decision

PIONEER 5 and 10 data PIONEER 2, 4 and 7 PIONEER 6, 8 and 9

data


Japan submission

Fiasp® Japan submission

Diabetes Haemophilia Growth disorders Obesity

1 Expected to be published in the given quarter or in the subsequent quarterly company announcement 2 Supplemental applications to include the two SWITCH trials have been withdrawn based on interactions with FDA GHD: Growth hormone deficiency; AGHD: Adult growth hormone deficiency

DUAL II Japan Phase 3a

N9-GP

Somapacitan REAL 3

Phase 2, GHD data

Japan regulatory decision

AM833 Phase 1 data

N8-GP US/EU submission Japan submission

Concizumab explorer 5 data explorer 4 data

REAL 1 (extension) Phase 3, AGHD data

EU variation application – SUSTAIN 7

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PIONEER 3

EU variation application - pens

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]

Anders Mikkelsen +45 3079 4461 [email protected]

Christina Kjær

+45 3079 3009

[email protected]

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

Upcoming events

08 Aug 2018 Financial statement for the first six months of 2018

01 Nov 2018 Financial statement for the first nine months of 2018

01 Feb 2019 Financial statement for 2018

34

mailto:[email protected]



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