American Diabetes Association 76th Scientific Sessions Investor and analyst event New Orleans, 13 June 2016
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Slide 1
American Diabetes Association
76th Scientific Sessions
Investor and analyst event
New Orleans, 13 June 2016
Shanghai – part of Cities Changing Diabetes
ADA 2016 investor and analyst event Slide 2
Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the company’s Annual Report 2015 and Form 20-F, which are both filed with
the SEC in February 2016 in continuation of the publication of the Annual Report 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 ‘Managing risks’ on p 42-43 of the Annual Report 2015.
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 2016 investor and analyst event Slide 3
Agenda
Time Topic
Welcome - Early insights from Tresiba® launch in the US
6.15 pm
Jakob Riis, EVP China, Pacific and Marketing
SWITCH 1 and 2 - Reduced risk of hypoglycaemia with Tresiba® versus insulin glargine U100
6.20 pm demonstrated in the SWITCH trials
Peter Kristensen, SVP Global Development
Faster-acting insulin aspart - Greater early glucose-lowering effect in type 1 diabetes demonstrated in
6.30 pm clinical trials
Peter Kurtzhals, SVP Global Research
LEADER - Statistically significant reduction in risk of major adverse cardiovascular events with Victoza®
6.40 pm in the LEADER trial
Mads Krogsgaard Thomsen, EVP and Chief Science Officer
SUSTAIN 2 and 3 - Superior HbA1c and weight reduction with once-weekly injectable semaglutide
6.55 pm demonstrated in the SUSTAIN 2 and 3 trials and phase 2 results from oral semaglutide
Alan Moses, SVP and Chief Medical Officer
7.05 pm Discussion and Q&A
ADA 2016 investor and analyst event Slide 4
Steady Tresiba® growth trajectory in the US, while market
share continues to grow in Japan despite biosimilar launch
Continued steady growth in total number of Tresiba® continues to grow basal market share
Tresiba® prescriptions in the US in Japan despite launch of biosimilar glargine
Tresiba® Levemir® NN total basal Tresiba® Levemir® NN total basal
Basal Basal
glargine U100 glargine U300 glargine U100 glargine U300
Value MS Value MS
biosimilar glargine
80% 80%
62%
60% 60%
43%
43%
40% 28% 40% 35%
26%
20% 20% 8%
6%
2% 8%
2%
0% 0%
Mar Apr Mar Mar
3/1/2013
2013 2016 2013 2016
Note: The graph does not show NPH, which accounts for the residual market share
Source: IMS monthly data, April 2016 Note: The graph does not show NPH, which accounts for the residual market share
TRx: total prescription count; MS: market share Source: IMS monthly data, May 2016
ADA 2016 investor and analyst event Slide 5
SWITCH 1 and 2
Reduced risk of hypoglycaemia with
Tresiba® versus insulin glargine U100
demonstrated in SWITCH trials
Peter Kristensen
SVP Global Development
ADA 2016 investor and analyst event Slide 6
SWITCH trials aimed to investigate the reduction of
hypoglycaemia with Tresiba® versus insulin glargine U100
SWITCH 1 and 2 trial designs Baseline characteristics
IDeg once daily IDeg once daily
SWITCH 1
501 people SWITCH 1 SWITCH 2
+ 2-4 x IAsp + 2-4 x IAsp
with type 1
diabetes IGlar once daily IGlar once daily Mean age (years) 45.9 61.4
+ 2-4 x IAsp + 2-4 x IAsp
Mean diabetes
23.4 14.1
duration (years)
IDeg once daily IDeg once daily
SWITCH 2
721 people ± OAD ± OAD Mean BMI (kg/m2) 27.5 32.2
with type 2
diabetes IGlar once daily Mean HbA1c 7.6% 7.6%
IGlar once daily
± OAD ± OAD
Mean FPG (mmol/L) 9.4 7.6
Basal once daily /
Randomised 1:1 16 weeks 16 weeks 16 weeks 16 weeks 44.7% / 35.7%** 84.2% / 15.8%
titration HbA1c titration HbA1c Basal twice daily*
Double-blinded 1,2 stable 1,2 stable
* In SWITCH 1, the pre-trial treatment regimen included 2-4 daily bolus insulin injections
1SWITCH 1: 20% dose reduction of basal and bolus insulin dose; 2 SWITCH 2: 20% dose reduction if ** Does not add up to 100% as 19.4% were pump users prior trial enrollment and one
coming from previous twice-daily treatment patient could not be classified to a regimen
Note: Daily injections of both Tresiba® and insulin glargine evenly split between morning and evening BMI: body mass index; FPG: fasting plasma glucose
IDeg: insulin degludec (Tresiba®) IGlar: insulin glargine U100; OAD: oral anti-diabetic; IAsp: insulin aspart Source: Lane et al., poster, 87-LB and Wysham et al., poster, 90-LB, ADA 2016
ADA 2016 investor and analyst event Slide 7
Tresiba® showed lower rate of hypoglycaemia than insulin
glargine U100 in maintenance period in the SWITCH 1 trial
Severe or BG confirmed Severe or BG confirmed
symptomatic events symptomatic nocturnal events Severe events
Cumulative events Tresiba® glargine U100
per patient
8 1.4 0.30
7 11%* 36%* 35%**
1.2 0.25
6 lower lower lower
rate 1.0 rate rate
0.20
5 with with with
0.8
4 Tresiba® Tresiba® 0.15 Tresiba®
0.6
3
0.10
2 0.4
0.2 0.05
1
0 0.0 0.00
16 20 24 28 32 16 20 24 28 32 16 20 24 28 32
Weeks1 Weeks1 Weeks1
1Since start of treatment period; BG: blood glucose; * (pADA 2016 investor and analyst event Slide 8
Tresiba® showed lower rate of hypoglycaemia than insulin
glargine U100 in maintenance period in the SWITCH 2 trial
Severe or BG confirmed Severe or BG confirmed
symptomatic events symptomatic nocturnal events Severe events
Cumulative events Tresiba® glargine U100
per patient
0.9 0.30 0.030
0.8 30%* 42%* 46%**
0.25 0.025
0.7 Lower Lower Lower
0.6 rate 0.20 rate 0.020 rate
with with with
0.5
Tresiba® 0.15 Tresiba® 0.015 Tresiba®
0.4
0.3 0.10 0.010
0.2
0.05 0.005
0.1
0.0 0.00 0.000
16 20 24 28 32 16 20 24 28 32 16 20 24 28 32
Weeks1 Weeks1 Weeks1
1Since start of treatment period; BG: blood glucose; * (pADA 2016 investor and analyst event Slide 9
Lower hypoglycaemia risk with Tresiba® than with insulin
glargine U100 in full treatment period in the SWITCH trials
SWITCH 1 – type 1 diabetes SWITCH 2 – type 2 diabetes
Maintenance period Full treatment period
Rate of severe or BG 0.89 [0.85;0.94]* 0.70 [0.61;0.80]*
confirmed symptomatic
hypoglycaemia 0.94 [0.91;0.98]** 0.77 [0.70;0.85]**
Rate of severe or BG 0.64 [0.56;0.73]* 0.58 [0.46;0.74]*
confirmed symptomatic
nocturnal hypoglycaemia 0.75 [0.68;0.83]** 0.75 [0.64;0.89]**
0.65 [0.48;0.89]** 0.54 [0.21;1.42]***
Rate of severe
hypoglycaemia
0.74 [0.61;0.91]** 0.49 [0.26;0.94]**
0.25 0.5 1 2 0.25 0.5 1 2
Favours Tresiba® Favours IGlar U100 Favours Tresiba® Favours IGlar U100
BG: blood glucose; * (pADA 2016 investor and analyst event Slide 10
Faster-acting insulin aspart
Greater early glucose-lowering effect
in type 1 diabetes demonstrated
in clinical trials
Peter Kurtzhals
SVP Global ResearchADA 2016 investor and analyst event Slide 11
Pooled1 pharmacological analysis demonstrated faster
onset of action with faster-acting insulin aspart in T1D
Twice as fast appearance in the bloodstream More than 50% greater insulin action
and twofold insulin exposure within first 30 min within the first 30 minutes
faster aspart insulin aspart faster aspart insulin aspart
IAsp serum
concentration (pmol/L) GIR (mg/kg/min)
n=261 8
300
250 n=256 n=163
6
200
n=160
150 4
100
2
50
0 0
0 4 9 30 60 0 30 60
Minutes Minutes
1 Pooled analysis of PK/PD properties of faster aspart vs insulin aspart included 218 adult subjects with
type 1 diabetes from 6 phase 1 randomized, double blind, crossover trials
Note: Based on a 0.2 U/kg dose across all studies for both faster aspart and insulin aspart T1D: type 1 diabetes; faster aspart: faster-acting insulin aspart; IAsp: insulin aspart;
Source: Heise T et al., poster: 929-P, ADA 2016 GIR: glucose infusion rate; n: number randomised patientsADA 2016 investor and analyst event Slide 12
Onset 1, a double-blind, treat-to-target trial investigating
efficacy and safety of faster-acting insulin aspart in T1D
Onset 1 trial design Baseline characteristics
Faster-acting insulin aspart faster insulin faster
(mealtime) aspart aspart aspart
1,143 people (mealtime) (mealtime) (post meal)
with type 1 Insulin aspart
Mean age
diabetes1 (mealtime) 46.1 43.7 43.5
(years)
Faster-acting Mean diabetes
insulin aspart duration 20.9 19.3 19.5
(post meal) (years)
Mean BMI
Run-in 26.4 26.7 26.9
(kg/m2)
-8 0 26 52
Weeks Mean HbA1c 7.6% 7.6% 7.6%
Mean FPG
8.4 7.9 8.1
(mmol/L)
1Inclusion criteria: Diagnosed with type 1 diabetes at least 12 months prior, age: 18 years or older,
basal-bolus insulin treatment for at least 12 months and insulin detemir or insulin glargine treatment for
at least 4 months prior to screening, HbA1C: 7.0-9.5%, BMI no higher than 35 faster aspart: faster-acting insulin aspart; BMI: body mass index; FPG: fasting plasma
Source: Russell-Jones et al., Oral 293-OR, ADA 2016 glucoseADA 2016 investor and analyst event Slide 13
Greater HbA1c and PPG reductions with faster aspart dosed
at mealtime vs insulin aspart in the onset 1 trial
Statistically significantly greater HbA1c reduction Lower PPG with faster-acting insulin aspart vs
with faster aspart (mealtime) after 26 weeks insulin aspart when administered at mealtime
HbA1c faster aspart (post meal) faster aspart (mealtime)
PPG increment
reduction (%) faster aspart (mealtime) (mmol/L) insulin aspart (mealtime)
0.0 insulin aspart (mealtime) 8.0
-0.13
-0.1
-0.2 6.0
-0.17
**
-0.3
-0.32* 4.0 *
-0.4
-0.5 2.0
-0.6
-0.7 0.0
0 2 4 6 8 10 12 14 16 18 20 22 24 26 0 60 120 180 240
Weeks Minutes
* pADA 2016 investor and analyst event Slide 14
Faster-acting insulin aspart appeared to have a safety
profile similar to that of insulin aspart in the onset 1 trial
Similar rates of treatment-emergent1
hypoglycaemia across onset 1 treatment arms Safety conclusions
faster aspart (post meal)
Severe or BG- • Overall, faster-acting insulin aspart appeared to have a
confirmed events per subject faster aspart (mealtime)
safety profile similar to that of insulin aspart
30 insulin aspart (mealtime)
• The overall rate of severe or blood glucose-confirmed
25
hypoglycaemia was not statistically significantly different
20 between faster aspart administered at mealtime,
administered postmeal and standard insulin aspart
15 administered at mealtime
Estimated ratio:
10 1.01 (0.88; 1.15)
• The overall adverse event rates were similar across the
5 Estimated ratio: three treatment arms
0.92 (0.81; 1.06)
0 • There was no difference in antibody development between
0 4 8 12 16 20 24 28 the three treatment arms
Weeks
1 Treatment-emergent was defined as an event that has onset up to 1 day after last day of randomised
treatment and excluding the events occurring in the run-in period. Estimated treatment ratios (faster
aspart/standard insulin aspart) are presented with 95% confidence intervals
BG: blood glucose; faster aspart: faster-acting insulin aspart Source: Russell-Jones et al., Oral 293-OR, ADA 2016ADA 2016 investor and analyst event Slide 15
LEADER
Statistically significant reduction in risk of
major adverse cardiovascular events
with Victoza® in the LEADER trial
Mads Krogsgaard Thomsen
EVP and chief science officerADA 2016 investor and analyst event Slide 16
The LEADER trial was designed to investigate the CV profile
of Victoza® versus placebo in addition to standard of care
LEADER trial design Baseline characteristics
Standard of care + Victoza® Victoza® Placebo
(0.6-1.8 mg once daily)
9,340 patients Mean age (years) 64.2 64.4
with type 2
diabetes Mean diabetes
12.8 12.9
Standard of care + placebo duration (years)
(daily blinded injection) Mean BMI (kg/m2) 32.5 32.5
Mean HbA1c 8.7% 8.7%
0 3.5-5.0 years
Systolic BP (mmHg) 135.9 135.9
Key inclusion criteria Diastolic BP (mmHg) 77.2 77.0
• Adults above 50 years with type 2 diabetes and
established cardiovascular disease, or above 60 years with Heart failure* 17.9% 17.8%
multiple cardiovascular risk factors
• HbA1c 7.0%
CV: cardiovascular
Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type BP: blood pressure
* Heart failure includes New York Heart Association class I, II and III
2 diabetes. The New England journal of medicine. 2016; In PressADA 2016 investor and analyst event Slide 17
Victoza® statistically significantly reduced the risk of major
adverse cardiovascular events in the LEADER trial
13% reduction in 3-point MACE Superiority of Victoza® vs placebo is
with Victoza® compared with placebo consistent across sensitivity analyses
Victoza® Placebo • Non-inferiority of Victoza® vs placebo was confirmed for
Patients with an
event (%) time to first MACE
25
Hazard ratio = 0.87
• Superiority of Victoza® vs placebo was confirmed for time to
95% CI (0.78;0.97)
20 first MACE
pADA 2016 investor and analyst event Slide 18
All components of 3-point MACE contributed to the
reduction in cardiovascular risk in the LEADER trial
Non-fatal
Cardiovascular death myocardial infarction Non-fatal stroke
Victoza® Placebo
Patients with an
event (%)
10 HR = 0.78 10 HR = 0.88 10 HR = 0.89
95% CI (0.66;0.94) 95% CI (0.75;1.03) 95% CI (0.72;1.11)
8 p=0.007 8 p=0.11 8 p=0.30
6 6 6
4 4 4
2 2 2
0 0 0
0 18 36 54 0 18 36 54 0 18 36 54
Months Months Months
HR: hazard ratio; CI: confidence interval
Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2
diabetes. The New England journal of medicine. 2016; In PressADA 2016 investor and analyst event Slide 19
Victoza® also statistically significantly reduced the risk of
expanded MACE in the LEADER trial
12% reduction in expanded MACE with Numerical reduction in selected secondary
Victoza® compared with placebo cardiovascular outcomes
Victoza® Placebo
Patients with an Incidence rate* Victoza® Placebo HR
event (%)
25 Transient ischemic
0.3 0.3 0.79
attack1
20 Coronary
2.3 2.5 0.91
revascularisation
15 Hospitalisation for
unstable angina 0.7 0.7 0.98
10 pectoris
Hazard ratio = 0.88
Hospitalisation for
5 95% CI (0.81;0.96) 1.2 1.4 0.87
heart failure
p=0.005
0
0 6 12 18 24 30 36 42 48 54
Months
MACE: major adverse cardiovascular events; Expanded MACE includes cardiovascular death, non-fatal
myocadial infarct, non-fatal stroke, coronary revascularization, or hospitalisation for unstable angina
pectoris or hospitalisation for heart failure; CI: confidence interval *Per 100 patient years of observation
Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 1Not prespecified
2 diabetes. The New England journal of medicine. 2016; In Press HR: hazard ratioADA 2016 investor and analyst event Slide 20
Reduced risk of all-cause-death and hospitalisation for
heart failure with Victoza® vs placebo in the LEADER trial
Statistically significant reduction in Numerical reduction in the proportion of
the rate of death from any cause patients hospitalised for heart failure
Victoza® Placebo Victoza® Placebo
Patients with an Patients with an
event (%) event (%)
14 HR = 0.85 14 HR = 0.87
95% CI (0.74;0.97) 95% CI (0.73;1.05)
12 p=0.017 12 p=0.14
10 10
8 8
6 6
4 4
2 2
0 0
0 6 12 18 24 30 36 42 48 54 0 6 12 18 24 30 36 42 48 54
Months Months
HR: hazard ratio; CI: confidence interval
Source: Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes
in type 2 diabetes. The New England journal of medicine. 2016; In Press
and Buse et al., Symposium 3-CT-SY24, ADA 2016ADA 2016 investor and analyst event Slide 21
Limited HbA1c difference, but lower severe hypoglycaemia
rate and greater weight loss with Victoza® in LEADER trial
Limited difference in HbA1c Reduction in severe Statistically significantly greater
maintained throughout trial hypoglycaemia weight loss with Victoza®
Mean episodes Victoza® Placebo
HbA1c (%) per 100 subjects Body weight (Kg)
10 70 96
ETD: -0.40% 65
ERR=0.68 ETD: -2.26 kg
95% CI [-0.45;-0.34] 60 60
95% CI (0.51;0.91) 94 95% CI [-2.54;-1.99]
55
9 50 50
45 92
40 40
8 35 90
30 30
25
88
7 20 20
15
10 10
86
5
0
6 0 0 0
84
0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60
0 6 12 18 24 30 36 42 48 54 0 6 12 18 24 30 36 42 48 0 6 12 18 24 30 36 42 48
Months Months Months
ETD: estimated treatment difference, ie estimated mean change from baseline to month 36; ERR: estimated rate ratio
Source: Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. The New England journal of medicine. 2016; In Press and Buse et al., Symposium
3-CT-SY24, ADA 2016ADA 2016 investor and analyst event Slide 22
Victoza® reduced the risk of microvascular events in the
LEADER trial driven by a reduction in nephropathy
16% reduction in overall microvascular Microvascular benefit is driven by 22%
events with Victoza® compared to placebo reduction in nephropathy
Victoza® Placebo Victoza® Placebo
Patients with an Patients with an
event (%) event (%)
10 10
Nephropathy
HR = 0.78
8 95% CI (0.67;0.92)
8 6 p=0.003
4
6 2
0
4 0 6 12 18 24 30 36 42 48 54
HR=0.84
10
2 95% CI (0.73;0.97) HR = 1.15
Retinopathy
p=0.016 8 95% CI (0.87;1.52)
6 p=0.33
0
4
0 6 12 18 24 30 36 42 48 54
2
Months
0
HR: hazard ratio 0 6 12 18 24 30 36 42 48 54
Source: Buse et al., Symposium 3-CT-SY24, ADA 2016
MonthsADA 2016 investor and analyst event Slide 23
Victoza® appeared to have a safe and well tolerated profile
in the LEADER trial
Selected adverse events
reported during the trial Safety conclusions
Adverse event Victoza® Placebo P-value • In the LEADER trial, Victoza® appeared to have a safe
and well tolerated profile, generally consistent with
Acute gallstone the previous Victoza® studies with a higher frequency of
3.1% 1.9%ADA 2016 investor and analyst event Slide 24
SUSTAIN 2 and 3
Superior HbA1c and weight reduction with
once-weekly injectable semaglutide
demonstrated in the SUSTAIN 2
and 3 trials and phase 2 results
from oral semaglutide
Alan Moses
SVP and chief medical officerADA 2016 investor and analyst event Slide 25
Data from all SUSTAIN phase 3a trials for semaglutide to
be presented at major conferences in 2016
2013 2014 2015 2016 Presentation
SUSTAIN 1: Monotherapy Oral:
30 weeks, n=388 ENDO 2016
SUSTAIN 2: Semaglutide vs sitagliptin Oral:
56 weeks, n=1,231 ADA 2016
SUSTAIN 3: Semaglutide vs exenatide once-weekly Oral:
56 weeks, n=813 ADA 2016
SUSTAIN 4: Semaglutide vs
Poster:
insulin glargine
AACE 2016
30 weeks, n=1,089
SUSTAIN 5: Add-on to
Poster:
basal insulin
EASD 2016
30 weeks, n=397
SUSTAIN 6: Long-term outcomes trial Oral:
Min. 104 weeks, n=~3,300 EASD 2016
Note: In the SUSTAIN phase 3a programme, 0.5 mg and 1.0 mg doses of semaglutide are being tested in people with type 2 diabetes
n: number randomised patients
ENDO: Endocrine Society Annual Meeting, April 2016; ADA: 76 th Scientific Sessions, American Diabetes Association, June 2016; AACE: American Association of Clinical Endocrinologists 25 th Annual
Scientific and Clinical Congress, May 2016; EASD: 52 nd Annual Meeting of the European Association for the Study of Diabetes, September 2016ADA 2016 investor and analyst event Slide 26
The SUSTAIN 2 trial compared the safety and efficacy of
injectable semaglutide to sitagliptin 100 mg in T2D
SUSTAIN 2 trial design Baseline characteristics
Sema Sema Sitagliptin
Semaglutide 0.5 mg QW 0.5 mg 1.0 mg 100 mg
+ sitagliptin placebo QD
Mean age
54.8 56.0 54.6
(years)
Semaglutide 1.0 mg QW
1,231 insulin- Mean diabetes
+ sitagliptin placebo QD 6.4 6.7 6.6
naïve people duration (years)
with type 2
diabetes1 Sitagliptin 100 mg QD Mean BMI
+ semaglutide 0.5 mg placebo QW 32.4 32.5 32.5
(kg/m2)
Sitagliptin 100 mg QD Mean HbA1c 8.0% 8.0% 8.2%
+ semaglutide 1.0 mg placebo QW Mean FPG
9.3 9.3 9.6
(mmol/L)
0 56 weeks
1Inclusion criteria: Type 2 diabetes, age: 18 years or older, insulin-naïve on stable diabetes treatment
with metformin, thiazolidinediones or metformin + thiazolidinediones 90 days prior to screening, HbA1c
7.0-10.5%. T2D: type 2 diabetes; QW: once weekly; QD: once daily
Source: Ahrén, Oral 185-OR, ADA 2016 Sema: semaglutide; BMI: body mass index; FPG: fasting plasma glucoseADA 2016 investor and analyst event Slide 27
Semaglutide showed superior HbA1c and weight reduction
compared to sitagliptin 100 mg in the SUSTAIN 2 trial
Statistically significantly greater reduction Statistically significantly greater weight loss
in HbA1c with semaglutide with semaglutide
Semaglutide 1.0 mg Semaglutide 0.5 mg Semaglutide 1.0 mg Semaglutide 0.5 mg
Weight
HbA1c (%) Sitagliptin 100 mg loss (Kg) Sitagliptin 100 mg
8.5 0
-1
8.0 -1.9
-2
7.5
7.5 -3
-4.3*
7.0 -4
6.8*
-5
6.5 6.5* -6.1*
-6
0.0
6.0 -7
0 8 16 24 32 40 48 56 0 8 16 24 32 40 48 56
Weeks Weeks
*pADA 2016 investor and analyst event Slide 28
The SUSTAIN 3 trial compared the safety and efficacy of
injectable semaglutide to exenatide 2.0 mg in T2D
SUSTAIN 3 trial design Baseline characteristics
Sema Exenatide
1.0 mg 2.0 mg
Semaglutide 1.0 mg QW
Mean age (years) 56.4 56.7
813 people
with type 2 Mean diabetes
diabetes1 9.0 9.4
duration (years)
Exenatide 2.0 mg QW
Mean BMI (kg/m2) 34.0 33.6
Mean HbA1c 8.4% 8.3%
0 56 weeks
Mean FPG (mmol/L) 10.6 10.4
1Inclusion criteria: Type 2 diabetes, age: 18 years or older, stable treatment with 1-2 oral antidiabetic
drugs (metformin, thiazolidinediones, sulfonylurea), HbA1c 7.0-10.5%
T2D: type 2 diabetes; QW: once weekly
Source: Ahmann, Oral 187-OR, ADA 2016 Sema: semaglutide; BMI: body mass index; FPG: fasting plasma glucoseADA 2016 investor and analyst event Slide 29
Semaglutide showed superior HbA1c and weight reduction
versus exenatide once-weekly in the SUSTAIN 3 trial
Statistically significantly greater reduction Statistically significantly greater
in HbA1c with semaglutide weight loss with semaglutide
Semaglutide 1.0 mg Exenatide 2.0 mg Semaglutide 1.0 mg Exenatide 2.0 mg
Weight loss
HbA1c (%) (kg)
8.5 0
-1
8.0 -1.9
-2
7.5 7.4
-3
7.0 -4
6.8*
-5 -5.6*
6.5
-6
0.0
6.0 -7
0 8 16 24 32 40 48 56 0 8 16 24 32 40 48 56
Weeks Weeks
*p-valueADA 2016 investor and analyst event Slide 30
Semaglutide appeared to have a safe and well tolerated
profile in the SUSTAIN 2 and 3 trials
Rates of nausea with semaglutide GLP-1-related run-in side effects reduced
in SUSTAIN 2 and 3 trials through selected titration scheme in trials
Semaglutide 1.0 mg Semaglutide 0.5 mg
• Generally, semaglutide appeared to have a safe and well-
Sitagliptin 100 mg Exenatide 2.0 mg tolerated profile in the SUSTAIN 2 and 3 trials
Subjects experiencing nausea
20%
SUSTAIN 2 • While semaglutide caused more GI adverse events than
15%
sitagliptin and exenatide, GI disorders were similar to
10% those reported with other GLP-1s
5%
0%
• Discontinuation rates due to adverse events for
0 6 12 18 24 30 36 42 48 54 60 semaglutide were low indicating that regular GLP-1-related
20%
run-in side effects have been reduced through the selected
15% SUSTAIN 3 titration scheme
10%
5%
0%
0 6 12 18 24 30 36 42 48 54 60
Weeks
GLP-1: glucagon-like peptide-1
Source: Ahrén, Oral 185-OR and Ahmann, Oral 187-OR, ADA 2016 GI: gastrointestinalADA 2016 investor and analyst event Slide 31
Oral semaglutide in five daily doses compared with
injectable semaglutide and placebo in phase 2 trial
Phase 2 trial design1,2 Baseline characteristics
Oral sema QD 2.5 mg Oral sema Placebo sc sema
Oral sema QD 2.5 5 mg Mean age
55.7-58.3 58.9 56.8
(years)
632 Oral sema QD 5 10 mg
Mean diabetes
people 7.8-8.1 6.7 5.6
duration (years)
with Oral sema QD 5 10 20 mg
type 2 Body weight (kg) 90.9-93.8 93.8 88.8
diabetes3 Oral sema QD 5 10 20 40 mg
Mean BMI
31.1-32.0 32.6 30.7
Placebo QD Placebo (kg/m2)
Mean HbA1c 7.8-8.1% 8.0% 7.8%
sc sema QW 0.25 0.5 1.0 mg
Treated with
84-87% 82% 84%
Weeks 0 4 8 12 26 metformin
1 Semaglutide sc arm was open-label, whereas all tablet arms were double-blind
2 Dosing conditions: Tablets administered in the fasting state, subjects abstained from food and fluid
intake for at least 30 minutes after tablet ingestion
3 Inclusion criteria: type 2 diabetes, age: 18 years or older, BMI higher than 25 and lower than 40 kg/m 2,
Sema: semaglutide
Source: Rosenstock et al., OR15-3, ENDO 2016
treated with diet and exercise with or without metformin, HbA 1c: 7.0-9.5%
sc: subcutaneous; QW: once weekly; QD: once dailyADA 2016 investor and analyst event Slide 32
Oral semaglutide dose dependently reduced HbA1c and
body weight in phase 2 trial
HbA1c reduction from a mean baseline of 7.9% Weight loss from a mean base line of 92 kg
Placebo Sema 2.5 mg Sema 5 mg Sema 10 mg Sema 20 mg Sema 40 mg Sema 1 mg sc
HbA1c (%) Weight loss (kg)
8.0 0
7.5
-2
7.0
-4
6.5
-6
6.0
0.0
5.5 -8
0 2 4 6 8 10 12 14 16 18 20 22 24 26 0 2 4 6 8 10 12 14 16 18 20 22 24 26
Weeks Weeks
Inclusion criteria: Type 2 diabetes, 7.0% ≤ HbA1c ≤ 9.5%, treatment with diet and exercise with or without metformin; sc: subcutaneous; sema: semaglutide
Dotted line indicates the target for HbA1c of 7.0% as recommended by the American Diabetes Association
Source: Rosenstock et al., OR15-3, ENDO 2016ADA 2016 investor and analyst event Slide 33
The safety and tolerability profile of oral semaglutide was
similar to injectable semaglutide in phase 2 clinical trial
GI adverse events with oral semaglutide were
comparable to injectable semaglutide Safety conclusions
Placebo Sema 2.5 mg Sema 5 mg
Proportion • Overall, oral semaglutide appeared to have a safe and
Sema 10 mg Sema 20 mg Sema 40 mg
of subjects well-tolerated profile in the trial
50% Sema 1 mg sc
• GI adverse events with oral semaglutide were similar to
40% injectable semaglutide
30% • Dose-dependent increase in discontinuation rates observed
in the trial
20%
• Only few events of pancreatitis, gallbladder disorders or
10%
malignant neoplasms were observed in the trial
0%
Nausea Vomiting Diarrhea
GI: gastrointestinal; sc: subcutaneous
Source: Rosenstock et al., OR15-3, ENDO 2016ADA 2016 investor and analyst event Slide 34 Concluding remarks Steady Tresiba growth in the US. In Japan Tresiba® market share continues to grow despite biosimilar launch Tresiba® demonstrated lower rates of hypoglycaemia than insulin glargine U100 in the SWITCH trials Early onset of faster-acting insulin aspart leads to improved HbA1c and PPG versus insulin aspart in onset 1 trial Victoza® demonstrated statistically significant 13% reduction in MACE and reduced cardiovascular and all cause mortality statistically significantly by 22% and 15 %, respectively, compared to placebo in the LEADER trial Semaglutide QW demonstrated superior HbA1c and body weight reductions against comparators in SUSTAIN 2 and 3 Oral semaglutide dose dependently reduced HbA1c and body weight in a 26-week phase 2 trial in type 2 diabetes PPG: postprandial plasma glucose; MACE: major adverse cardiovascular events; QW: once weekly
ADA 2016 investor and analyst event Slide 35
Q&A session
Jakob Riis, EVP China, Pacific and Marketing
Mads Krogsgaard Thomsen, EVP and CSO
Peter Kurtzhals, SVP Global Research
Peter Kristensen, SVP Global Development
Alan Moses, SVP and CMOADA 2016 investor and analyst event Slide 36
Investor contact information
Share information Investor Relations contacts
Novo Nordisk’s B shares are listed on the stock exchange in Novo Nordisk A/S
Copenhagen under the symbol ‘NOVO B’. Its ADRs are listed on Investor Relations
the New York Stock Exchange under the symbol ‘NVO’. For Novo Allé, DK-2880 Bagsværd
further company information, visit Novo Nordisk on the
internet at: novonordisk.com
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Upcoming events Melanie Raouzeos +45 3075 3479 mrz@novonordisk.com
05 Aug 2016 Financial statement for the first six months of 2016
In North America:
28 Oct 2016 Financial statement for the first nine months of 2016
Kasper Veje +1 609 235 8567 kpvj@novonordisk.com
02 Feb 2017 Financial statement for 2016ADA 2016 investor and analyst event Slide 37
Appendix – Glossary
Abbreviation Meaning Abbreviation Meaning Abbreviation Meaning
American Association of
AACE FPG Fasting plasma glucose MS Market share
Clinical Endocrinologists
ADA American Diabetes Association GIR Glucose infusion rate NS Not statistically significant
BG Blood glucose GLP-1 Glucagon-like peptide-1 OAD Oral anti-diabetic agent
BMI Body mass index (kg/m2) HbA1c Glycated haemoglobin A1c PPG Postprandial glucose
BP Blood pressure HR Hazard ratio QD Once daily
CI Confidence interval IAsp Insulin aspart QW Once weekly
CV Cardiovascular IDeg Insulin degludec SC Subcutaneous
European Association for the
EASD IGlar Insulin glargine Sema Semaglutide
Study of Diabetes
Major adverse cardiovascular
ENDO Endocrine Society MACE T1D/T2D Type 1 diabetes/type 2 diabetes
event
Medical dictionary for
ETD Estimated treatment difference MedDRA TRx Total prescriptions
regulatory activitiesYou can also read
