Novo Nordisk A/S : Investor presentation
Novo Nordisk
-
a focused healthcare company
Investor presentation
First nine months of 2020
2
|
Investor presentation
|
First nine months of 2020
|
Progress on Strategic aspirations 2025 COVID-19 update
Commercial execution Innovation and therapeutic focus Financials
3
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
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 2019 and Form 20-F, which are both expected to be filed with the SEC in February 2020 in continuation of the publication of the Annual Report 2019, 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 Novo Nordisk's results or the accuracy of forward-looking statements in this presentation, reference is made to the overview of risk factors in 'Managing risks to protect value' on pp 33-35 of the Annual Report 2019.
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® is approved for the management of type 2 diabetes only
-
Saxenda® is approved in the USA and the EU for the treatment of obesity only
4
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Strategic aspirations 2025
- Highlights first nine months of 2020
Adding value to society:
-
Launch of new social responsibility strategy 'Defeat Diabetes'
-
Expansion of US affordability offerings
-
Lowered ceiling price of human insulin in 76 countries
Environment:
-
100% renewable power across all production sites
-
Launch of supplier target aiming at 100% renewable power by 2030
Diabetes sales increased by 8%:
-
Value market share leadership expanded by 0.8%- points to 29.2%
-
Sales of GLP-1 increased by 29% driven by continued performance of Ozempic®
Obesity sales increased by 6% to DKK 4.2 billion
Biopharm sales increased by 4% driven by IO
Diabetes:
-
Insulin icodec phase 2 trial successfully completed
-
Rybelsus® approved in the EU, the UK and Japan
Obesity:
-
Sema 2.4 mg obesity phase 3 programme and AM833 + sema 2.4 mg phase 1 trial successfully completed
Biopharm:
-
Concizumab phase 3 reinitiated
Other serious chronic disease:
-
Successful completion of phase 2 trials for zilti and semaglutide in NASH
Sales increased by 7% to DKK 94.8 billion
-
12% sales growth in IO
-
2% sales growth in NAO, with 47% of US sales transformed to products launched since 2015
Operating profit increased by 7% to DKK 42.9 billion
Free cash flow increased by 27% to DKK 41.6 billion and DKK 31 billion returned to shareholders
The strategic aspirations are objectives that Novo Nordisk intends to work towards and are not a projection of Novo Nordisk's financial outlook or expected growth Note: Unless otherwise specified growth rates are at constant exchange rates
IO: International Operations; NAO: North America Operations; Sema: Semaglutide; NASH: Non-alcoholic steatohepatitis
5
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk response to COVID-19 pandemic
Novo Nordisk status across the value chain
US GLP-1 prescription development during COVID-19 pandemic
Production
R&D
Commercial
-
Manufacturing sites are operational
-
Medicines available to patients worldwide
-
Continuation of all clinical trials already initiated
-
Trial recruitment still below pre-COVID-19 levels
-
Some new trials initiated
-
Gradual recovery of patient initiations in the third quarter
-
Operations are running accordingly
-
In many markets, sales representatives are partially back in the field
-
Increased utilisation of digital tools
TRx count
|
TRx
|
NBRx (RHS)
|
NBRx count
|
(thousands)
|
(thousands)
|
|
13 March, lockdown
|
|
|
|
implemented in most
|
2,000
|
|
|
states
|
140
|
|
|
|
1,600
|
|
|
|
120
|
|
|
|
|
|
|
|
|
100
|
1,200
|
|
|
|
80
|
|
|
|
|
800
|
|
|
|
60
|
|
|
|
|
|
|
|
|
40
|
400
|
|
|
|
20
|
|
|
|
|
0
|
Nov
|
|
|
Oct 0
|
|
2018
|
|
|
2020
|
TRx: Total prescriptions; NBRx: New-to-brand prescriptions; RHS: Right-hand side axis
Source: IQVIA, each data point represents 4 weeks total, Oct 2020
6
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Sales growth of 7% driven by International Operations and GLP-1
Reported geographic sales split for the first nine months of 2020
DKK
|
|
Insulin
|
|
|
GLP-1
|
|
|
Other diabetes
|
|
|
Obesity
|
|
|
Biopharm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
billion
|
|
Growth at CER
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2%
|
|
40
|
|
|
|
|
|
|
International Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12%
|
|
|
|
|
|
|
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IO
|
|
|
EMEA
|
|
|
|
China
|
|
RoW
|
|
|
|
NAO
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Added reported therapy area sales and growth
DKK
|
|
North America Operations
|
|
International Operations
|
Growth at CER
|
|
|
billion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7%
|
|
|
-3%
|
|
|
29%
|
|
|
6%
|
|
|
|
|
4%
|
|
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
|
|
|
|
|
|
|
27%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8%
|
|
|
|
|
|
|
|
10%
|
|
|
|
|
|
|
8%
|
|
|
|
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-2
|
|
2%
|
|
|
-22%
|
|
|
|
|
|
|
|
4%
|
|
|
|
-2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-6
|
|
Total1
|
Insulin
|
|
|
GLP-1
|
Obesity
|
Biopharm
|
|
|
|
|
|
|
|
1 'Other diabetes' is included in Total
IO: International Operations; EMEA: Europe, Middle East and Africa; China: Mainland China, Hong Kong and Taiwan; RoW: Rest of World; NAO: North America Operations
Note: Unless otherwise specified, sales growth rates are at CER
7
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Diabetes value market leadership continues to expand
Novo Nordisk global diabetes value market share
60%
|
|
Diabetes
|
GLP-1
|
Insulin
|
50%
|
48.8%
|
|
|
49.9%
|
46.7%
|
|
|
|
|
|
44.5%
|
|
42.4%
|
|
|
|
44.3%
|
|
|
40%
|
|
|
|
|
|
|
|
30%
|
27.4%
|
28.4%
|
|
29.2%
|
|
|
|
|
20%
|
2018
|
2019
|
|
2020
|
|
|
New generation insulins include: Tresiba®, Ryzodeg®, Fiasp® and Xultophy®
CER: Constant exchange rates
Source: IQVIA MAT, Aug 2020
Note: Unless otherwise specified, sales growth are at CER
Diabetes value market leadership expansion driven by the GLP-1
and insulin franchises
GLP-1 value market share has increased by ~3%-points since 2019, driven by:
-
Ozempic® launched in 48 countries
-
Uptake of Ozempic® and launch of Rybelsus® in North America Operations
Insulin value market share has increased by 0.2%-points since 2019, driven by:
-
New-generationinsulins in International Operations facilitated by our Market Fit approach
8
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Ozempic® and Rybelsus® continue to expand GLP-1 NBRx and TRx market leadership in the US
US GLP-1 NBRx market share
|
US GLP-1 TRx market size and market share
|
NBRx share
|
Ozempic®
|
Rybelsus®
|
dulaglutide
|
TRx share
|
|
|
70%
|
|
70%
|
|
NN GLP-1
|
Victoza®
|
|
|
60%
|
|
|
|
60.2%
|
60%
|
|
|
|
|
|
|
50%
|
|
|
|
|
50%
|
|
40%
|
|
|
|
34.7%
|
40%
|
|
|
|
|
|
|
|
30%
|
|
|
|
34.5%
|
30%
|
|
|
|
|
|
|
20%
|
|
|
|
13.5%
|
20%
|
|
|
|
|
|
|
|
10%
|
|
|
|
12.0%
|
10%
|
|
0%
|
Jun
|
|
|
Oct
|
0%
|
Jun
|
|
2019
|
|
|
2020
|
|
2019
|
Ozempic®
|
|
Rybelsus®
|
|
dulaglutide
|
|
|
NN GLP-1
|
|
Victoza®
|
|
|
|
|
|
Class growth around 30%
49.6%
44.3%
26.9%
22.7%
3.7%
Oct
2020
Source: NBRx-IQVIA National LRx Weekly, Sep 2020
NBRx: New-to-brand prescriptions; TRx: Total prescriptions; NN: Novo Nordisk
9
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Promising Rybelsus® launch in the US with European launches underway
Launch uptake of Rybelsus® vs SGLT-2s1 in the US
NBRx count
|
Rybelsus®
|
SGLT-2s
|
|
|
4,500
|
|
|
4,000
|
|
|
3,500
|
|
|
3,000
|
|
|
2,500
|
|
|
2,000
|
|
|
1,500
|
|
|
1,000
|
|
|
500
|
|
|
0
1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 Weeks
Rybelsus® re-gaining momentum in the US
and launches in Europe are underway
In the US:
-
Market access now around 85% across commercial and Medicare
-
More than 80% of new prescriptions are new to the GLP-1 class
-
Direct-to-consumeradvertising initiated 21 September 2020
Outside of the US, Rybelsus® has now been launched in eight countries
1 SGLT-2s is an average of empagliflozin and canagliflozin NBRx count. Source: IQVIA Xponent, weekly, Oct 2020
NBRx: New-to-brand prescriptions
10
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
International Operations had double digit diabetes sales growth across all regions and expanded Novo Nordisk market share
Reported diabetes sales and growth per IO geography
|
Diabetes value market share and share of growth in IO
|
DKK billion 40
35
30
25
20
15
10
5
0
|
|
|
|
|
|
Insulin
|
|
|
GLP-1
|
Growth at CER
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Geographical area
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10%
|
|
|
35%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12%
|
|
|
17%
|
|
|
|
|
|
|
|
|
24%
|
|
|
51%
|
|
|
|
|
|
6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14%
|
|
|
12%
|
|
|
IO
|
EMEA
|
|
China
|
|
RoW
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Market
|
NN market share
|
NN share of growth
|
share
|
|
|
35%
|
|
|
|
30%
|
|
|
30.0%
|
|
|
|
25%
|
|
|
|
20%
|
|
|
22.7%
|
15%
|
|
|
Market share
|
10%
|
|
|
+0.7-pp vs. 2019
|
|
|
|
5%
|
|
|
|
0%
|
Aug
|
|
Aug
|
|
2018
|
|
2020
|
Source: IQVIA moving annual total, spot rate, Aug 2020
IO: International operations; NN: Novo Nordisk; pp: Percentage points; EMEA: Europe, Middle East and Africa; China: Mainland China, Hong Kong and Taiwan; RoW: Rest of World
11
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Saxenda® sales growth of 6% is impacted by COVID-19 as fewer patients initiated treatment
Reported sales split in operational units
|
Novo Nordisk remains global market leader
|
|
|
NAO
|
|
IO
|
Market share (RHS)
|
Growth at CER
|
|
DKK
|
|
|
|
|
|
|
|
|
|
|
Market
|
billion
|
|
|
|
|
|
42%1
|
6%2
|
share
|
1.6
|
|
|
|
|
|
|
|
|
|
|
80%
|
|
|
|
|
51%1
|
|
|
|
|
63%
|
|
1.2
|
|
|
|
|
|
|
|
|
|
|
60%
|
0.8
|
64%1
|
|
|
|
|
|
|
|
|
40%
|
|
|
|
|
|
|
|
|
|
|
0.4
|
|
|
|
|
|
|
|
|
|
|
20%
|
0
|
|
|
|
|
|
|
|
|
|
|
0%
|
|
Q4
|
Q1
|
Q2
|
Q3
|
Q4 Q1
|
Q2
|
Q3
|
Q4
|
Q1 Q2
|
Q3
|
|
|
2017
|
|
2018
|
|
2019
|
|
2020
|
|
-
Annual growth at CER
-
Year-to-dategrowth at CER
EMEA: Europe, Middle East and Africa, NAO: North America operations, IO: International operations, RHS: Right hand side axis
Note: Sales growth at constant exchange rates
-
Novo Nordisk expands market leadership to 63%
-
Saxenda® is now launched in 54 countries
-
Sales growth impacted by fewer patients initiating treatment due to COVID-19 pandemic
-
Sales growth of 8% driven by EMEA and Rest of World
-
Novo Nordisk currently has a value market share of 40% in the obesity prescription drug market
-
Sales growth of 4% driven by both the USA and Canada
-
Novo Nordisk currently has a value market share of 78% in the obesity prescription drug market
12
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Biopharm sales growth of 4% driven by Norditropin® and launches of new haemophilia products
Added reported Biopharm sales (YTD 2020 vs YTD 2019)
DKK
|
|
|
Growth at CER
|
|
|
billion
|
4%
|
-7%
|
1%
|
38%
|
13%
|
0.8
|
|
|
|
|
|
0.6
|
|
|
Haemophilia
|
|
|
|
|
|
|
|
0.4
|
|
|
|
|
|
0.2
|
|
|
|
|
|
0.0
|
|
|
|
|
|
-0.2
|
|
|
|
|
|
-0.4
|
|
|
|
|
|
-0.6
|
|
|
|
|
|
|
|
Novo-
|
Novo-
|
Other
|
Nordi-
|
|
Total
|
haemo-
|
|
Seven®
|
Eight®
|
tropin®
|
|
|
philia®
|
|
|
|
|
|
Biopharm sales driven by global commercial execution
Biopharm sales growth driven by:
-
8% growth in International Operations
-
Norditropin® and launches of new haemophilia products
Haemophilia sales decreased by 2% as:
-
Successful Esperoct® and Refixia® launches are countering the Novoseven® sales decline
Norditropin® sales increased by 13%
-
Novo Nordisk is the leading company in the global human growth disorder market with a value market share of 35.3%
-
Driven by new indications and global roll-out of the next generation device
YTD: Year-to-date
Note: 'Other haemophilia' includes the new products Esperoct® and Refixia® as well as NovoThirteen® . Unless otherwise specified, sales growth is at constant exchange rates
13
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Ziltivekimab phase 2b RESCUE trial has successfully completed
In the RESCUE trial, zilti QM showed reduction
in hsCRP at all dose levels
|
|
placebo
|
|
ziltivekimab 7.5 mg
|
|
ziltivekimab 15 mg
|
|
ziltivikemab 30 mg
|
|
|
|
|
|
% change1
|
12 weeks of treatment
|
2
|
|
|
|
|
End of treament
|
0%
|
|
|
|
|
|
|
|
|
|
-5%
|
|
|
-3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-20%
|
|
|
|
|
|
|
|
|
-40%
|
|
|
|
|
|
|
|
|
-60%
|
|
|
|
|
|
|
|
|
-80%
|
|
-77%*
|
|
|
*
|
|
|
|
|
|
|
|
|
-79%
|
-100%
|
|
-88%* -92%*
|
-91%* -93%*
|
|
Zilti QM showed reductions in inflammation biomarkers3
Zilti QM appeared to have a safe and well-tolerated profile
Addressing the residual risk of CVD for more than 5 million patients with ASCVD, CKD, and inflammation4
The phase 3 cardiovascular outcomes trial is expected to be initiated in H2 2021
-
Primary endpoint was the median percent change in hsCRP, * Indicates statistical significance, p < .0001
-
End of treatment is defined as the average of values at week 23 and week 24
-
Inflammation biomarkers include: Fibrinogen, serum amyloid A, haptoglobin and NTproBNP
-
Inflammation is defined as c-reactive protein levels greater than 2
Zilti: Ziltivekimab; QM: Once-montly; hsCRP: High-sensitivityc-reactive protein; CVD: Cardiovascular disease; ASCVD: Atherosclerotic cardiovascular disease; CKD: Chronic kidney disease
14
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
R&D milestones for Q3 2020 through 2021
|
|
|
|
|
|
|
Clinical milestones1
|
|
|
|
|
|
|
|
Regulatory milestones1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Project
|
Q3 2020
|
Q4 2020
|
2021
|
|
|
|
|
|
|
|
|
|
|
Diabetes
|
|
✓
|
SUSTAIN FORTE -
|
|
SUSTAIN FORTE -
|
|
|
Ozempic®
|
Phase 3b initiation -
|
|
|
|
Peripheral artery disease
|
Phase 3 results
|
|
US/EU submission
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Xultophy®
|
✓China submission
|
|
|
|
|
|
|
|
Icodec
|
|
Phase 3 initiation
|
|
|
|
|
|
Glucose sensitive insulin
|
✓Phase 1 initiation
|
|
|
|
Phase 1 results
|
|
|
|
|
|
|
|
|
|
|
|
Oral semaglutide
|
✓Phase 1 initiation -
|
|
|
|
|
|
|
|
25 mg and 50 mg
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obesity
|
Semaglutide 2.4 mg
|
|
|
US/EU submission/decision
|
|
|
AM833 + semaglutide 2.4 mg
|
|
|
|
|
Phase 3 initiation
|
|
|
|
|
|
|
|
|
|
|
|
LA-GDF15
|
|
|
|
|
Phase 1 results
|
|
Biopharm
|
Sogroya®
|
✓
|
EU decision
|
Japan decision
|
|
|
|
|
|
(somapacitan, AGHD)
|
US decision
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Concizumab
|
✓Phase 3 trials reinitiated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mim8
|
|
|
|
|
Phase 1/2 results
|
|
Other serious chronic
|
Semaglutide NASH
|
✓Phase 2 results (PoC, Gilead)
|
|
|
|
Phase 3 initiation
|
|
diseases
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ziltivekimab
|
✓Phase 2 results
|
|
|
|
Phase 3 initiation
|
|
|
|
|
|
|
|
|
|
|
1 Expected to be published in the given quarter or in the subsequent quarterly company announcement
Note: Trial initiations could be impacted by COVID-19 status. Timeline for the FGF-21 in NASH project has moved
LA-GDF:Long-acting growth differentiation factor; AGHD: Adult growth hormone deficiency; PoC: Proof of Concept; NASH: Non-alcoholic steatohepatitis
15
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Financial results - First nine months of 2020
|
First nine
|
First nine
|
Change
|
Change
|
|
months of
|
months
|
(reported)
|
(CER)
|
In DKK million
|
2020
|
of 2019
|
|
|
Sales
|
94,808
|
89,604
|
6%
|
7%
|
Gross profit
|
79,495
|
74,948
|
6%
|
|
Gross margin
|
83.8%
|
83.6%
|
|
|
Sales and distribution costs
|
23,162
|
22,287
|
4%
|
5%
|
Percentage of sales
|
24.4%
|
24.9%
|
|
|
Research and development costs
|
10,979
|
9,836
|
12%
|
12%
|
Percentage of sales
|
11.6%
|
11.0%
|
|
|
Administration costs
|
2,760
|
2,772
|
0%
|
1%
|
Percentage of sales
|
2.9%
|
3.1%
|
|
|
Other operating income, net
|
354
|
557
|
(36%)
|
|
|
|
|
|
|
Operating profit
|
42,948
|
40,610
|
6%
|
7%
|
Operating margin
|
45.3%
|
45.3%
|
|
|
Financial items (net)
|
(1,820)
|
(3,136)
|
(42%)
|
|
Profit before income tax
|
41,128
|
37,474
|
10%
|
|
Income taxes
|
8,308
|
7,240
|
15%
|
|
Effective tax rate
|
20.2%
|
19.3%
|
|
|
Net profit
|
32,820
|
30,234
|
9%
|
|
Diluted earnings per share (DKK)
|
14.00
|
12.68
|
10%
|
|
CER: Constant exchange rates
16
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Financial outlook for 2020
|
Expectations
|
Expectations
|
|
30 October 2020
|
6 August 2020
|
Sales growth - at CER
|
5% to 8%
|
3% to 6%
|
Sales growth - reported
|
Around 3 percentage points lower
|
Around 2 percentage points lower
|
Operating profit growth - at CER
|
5% to 8%
|
2% to 5%
|
Operating profit growth - reported
|
Around 4 percentage points lower
|
Around 3 percentage points lower
|
Financial items (net)
|
Loss of around DKK 1.4 billion
|
Loss of around DKK 1.2 billion
|
Effective tax rate
|
20% to 22%
|
20% to 22%
|
Free cash flow
|
DKK 34 to 39 billion
|
DKK 33 to 38 billion
|
The financial outlook is based on an assumption of a continuation of the current business environment and given the current scope of business activities and has been prepared assuming that currency exchange rates remain at the level as of 26 Oct 2020.
17 Investor presentation First nine months of 2020
Strategic aspirations 2025
-
Being respected for adding value to society
-
Progress towards zero environmental impact
-
Ensure distinct core capabilities and evolve culture
-
Strengthen Diabetes leadership - aim at global value market share of more than 1/3
-
Strengthen Obesity leadership and double current sales1
-
Secure a sustained growth outlook for Biopharm
Novo Nordisk®
-
Further raise the innovation-bar for diabetes treatment
-
Develop a leading portfolio of superior treatment solutions for obesity
-
Strengthen and progress the Biopharm pipeline
-
Establish presence in Other serious chronic diseases focusing on CVD, NASH and CKD
-
Deliver solid sales and operating profit growth
-
-
Deliver 6-10% sales growth in IO
-
Transform 70% of sales in the US2
-
Drive operational efficiencies across the value chain to enable investments in future growth assets
-
Deliver free cash flow to enable attractive capital allocation to shareholders
1 Based on reported sales in 2019, 2 From 2015 to 2022. IO: International Operations; CVD: Cardiovascular disease; NASH: Non-alcoholic steatohepatitis; CKD: Chronic kidney disease.
18 Investor presentation First nine months of 2020
Investor contact information
Share 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:
www.novonordisk.com
Upcoming events
03 Feb 2021 Financial statement for the full year of 2020
25 March 2021 Annual General Meeting
5 May 2021 Financial statement for the first three months of 2021
5 August 2021 Financial statement for the first six months of 2021
3 November 2021 Financial statement for the first nine months of 2021
Novo Nordisk®
Investor Relations contacts
Novo Nordisk A/S
Investor Relations
Novo Allé
DK-2880 Bagsværd
Daniel Muusmann Bohsen
|
+45 3075 2175
|
dabo@novonordisk.com
|
Valdemar Borum Svarrer
|
+45 3079 0301
|
jvls@novonordisk.com
|
Ann Søndermølle Rendbæk
|
+45 3075 2253
|
arnd@novonordisk.com
|
Mark Joseph Root
|
+45 3079 4211
|
mjhr@novonordisk.com
|
Kristoffer Due Berg (USA)
|
+1 609 235 2989
|
krdb@novonordisk.com
|
19
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk corporate strategy
|
20
|
Diabetes care
|
32
|
Obesity care
|
49
|
Biopharm & Other serious chronic diseases
|
59
|
Regional information
|
75
|
Financials
|
108
|
Sustainability
|
117
|
20
|
Investor presentation
|
First nine months of 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
21
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk's opportunity is in the large unmet needs across all therapy areas in scope
DIABETES
|
OBESITY
|
HAEMOPHILIA
|
~650million
~463million
~0.5million
|
~6%
|
|
~2%
|
|
~25%
|
Peoplewith
|
Peopleingood
|
Peoplewith
|
Peoplemedically
|
Peoplewith
|
Peoplebeing
|
diabetes
|
control
|
obesity
|
treated
|
haemophilia
|
treated
|
OTHER SERIOUS CHRONIC
DISEASES
80%ofdiagnosedNASH patientsareobese
and35%haveT2DM
70%ofdiabetespatientsdie fromatheroscleroticCVD
40%ofpatientshospitalised forheartfailurearediabetic
~50%ofthetotalCKD populationsuffersfrom diabeticnephropathy
NASH: Non-alcoholic steatohepatitis, T2DM: Type 2 diabetes mellitus, CVD: Cardiovascular disease, CKD: Chronic kidney disease
Source: International Diabetes Federation; Diabetes Atlas 9th Edition 2019, IQVIA MIDAS 2017, World Federation of Haemophilia - Annual survey 2018; Abera SF et al. Global, Regional, and National Burden of Cardiovascular Diseases for 10 Causes, 1990 to 2015, 2017; Heart Disease and Stroke Statistics, American Heart Association, 2017; Williams CD et al. Prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis among a largely middle-aged population utilising ultrasound and liver biopsy, 2011; Addressing the global burden of chronic kidney disease through clinical and translational research, 2014
22
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk has leading positions in diabetes, obesity and haemophilia
DKK
|
|
Diabetes care
|
|
|
DKK
|
Obesity care
|
|
|
|
|
|
|
|
billion
|
|
|
|
billion
|
|
|
700
|
|
|
#1
|
50%
|
12
|
|
|
#1
|
600
|
|
|
|
40%
|
10
|
|
|
|
500
|
|
|
|
|
|
|
|
|
|
|
|
8
|
|
|
|
|
|
|
|
30%
|
|
|
|
400
|
|
|
|
|
|
|
|
|
|
|
|
6
|
|
|
|
300
|
|
|
|
|
|
|
|
|
|
|
20%
|
|
|
|
|
|
|
|
|
4
|
|
|
|
200
|
|
|
|
|
|
|
|
|
|
|
10%
|
|
|
|
|
100
|
|
CAGR1 value: 12.0%
|
|
2
|
|
CAGR2 value: 10.1%
|
|
0
|
Aug
|
|
Aug
|
0%
|
0
|
Aug
|
|
Aug
|
|
2015
|
Market value
|
2020
|
|
|
2018
|
Market value
|
2020
|
|
|
NN value market share
|
|
|
|
NN value market share
|
|
|
Global market position
|
|
|
|
Global market position
|
|
DKK
|
Haemophilia
|
|
|
|
|
|
|
|
billion
|
|
|
|
80%
|
80
|
|
|
#2
|
50%
|
|
|
|
|
60%
|
60
|
|
|
|
40%
|
|
|
|
|
40%
|
|
|
|
|
30%
|
40
|
|
|
|
|
|
|
|
|
|
20%
|
20%
|
20
|
|
CAGR3 value: 2.0%
|
|
10%
|
|
|
|
|
0%
|
0
|
FY
|
|
FY
|
0%
|
|
|
|
|
|
|
2015
|
Market value
|
2019
|
|
-
value market share Global market position
1 CAGR for 5-year period; 2 CAGR for 2-year period; 3 CAGR for 5-year period; Note: Annual sales figures for haemophilia A, B and bypassing agents segment. Recombinant and plasma derived products Source: Company reports, IQVIA MAT, Aug 2020
NN: Novo Nordisk
23
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Continued single digit volume growth within the insulin segments globally
tMU
|
|
Long-acting insulin
|
|
|
tMU
|
|
Premix insulin
|
|
|
tMU
|
|
|
|
|
|
|
|
|
250
|
|
CAGR volume1: 5.0%
|
|
100%
|
160
|
|
CAGR volume1: 1.0%
|
|
100%
|
200
|
|
|
|
|
|
|
|
|
|
|
|
MI penetration2: 77.4%
|
|
|
|
|
MI penetration2: 47.7%
|
|
|
|
200
|
|
|
|
80%
|
120
|
|
|
|
80%
|
160
|
|
|
|
|
|
|
|
|
|
|
150
|
|
|
|
60%
|
|
|
|
|
60%
|
120
|
|
|
|
|
|
80
|
|
|
|
|
|
100
|
|
|
|
40%
|
|
|
|
|
40%
|
80
|
50
|
|
|
|
20%
|
40
|
|
|
|
20%
|
40
|
|
|
|
|
|
|
|
0
|
Aug
|
Segment volume
|
Aug
|
0%
|
0
|
Aug
|
Segment volume
|
Aug
|
0%
|
0
|
|
2015
|
2020
|
|
|
2015
|
®
|
2020
|
|
|
|
|
®
|
|
|
|
|
NovoMix 30
|
|
|
|
|
|
Levemir
|
|
|
|
|
Ryzodeg®
|
|
|
|
|
|
®
|
|
|
|
|
|
|
|
|
|
Tresiba
|
|
|
|
|
Combined
|
|
|
|
|
|
Combined
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fast-acting insulin
|
CAGR volume1: 4.6%
|
|
100%
|
|
|
|
|
MI penetration2: 80.3%
|
|
|
|
|
|
80%
|
|
|
|
|
60%
|
|
|
|
|
40%
|
|
|
|
|
20%
|
Aug
|
Segment volume
|
Aug
|
0%
|
2015
|
NovoRapid
|
®
|
2020
|
|
|
|
|
|
|
Fiasp®
|
|
|
|
|
Combined
|
|
|
|
-
CAGR for 5-year period
-
Includes new-generation insulin. tMU: Thousand mega units; NN: Novo Nordisk
Note: Modern insulin (MI) penetration is of total segment, i.e. including animal and human insulin; Data is sensitive to changes in IQVIA data collection and reporting methodology.
Source: IQVIA MAT, Aug 2020 volume figures
24
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Sales growth of 7% at CER, mainly driven by the Diabetes and Obesity care segment
|
Novo Nordisk reported quarterly sales
|
Reported sales for the first
|
DKK
|
by therapy
|
|
nine months of 2020
|
billion
|
|
|
|
|
40
|
|
|
|
Other Biopharm
|
35
|
|
Reported sales
|
|
|
CAGR1: 6.7%
|
Growth disorders
|
|
30
|
|
|
Haemophilia
|
1%
|
|
|
(4.3%)1
|
6%
|
25
|
|
|
8%
|
|
|
|
20
|
|
4.3%1
|
Obesity
|
4%
|
|
|
1.5%1
|
|
|
|
|
|
|
|
|
15
|
|
7.9%1
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
5
|
|
|
|
|
80%
|
|
|
|
|
|
0
|
Q3
|
Other
|
Q3
|
|
Diabetes care
|
|
|
|
|
2010
|
Norditropin®
|
2020
|
|
|
Haemophilia
|
Sales of DKK 94.8 billion (+7%)
|
Diabetes and Obesity care
|
Reported sales and growth breakdown for
the first nine months of 2020
Therapy
|
Sales
|
Growth
|
Share of
|
|
(mDKK)
|
|
growth
|
|
|
|
|
Long-acting insulin2
|
13,426
|
(13%)
|
(33%)
|
Premix insulin3
|
8,220
|
6%
|
8%
|
Fast-acting insulin4
|
14,082
|
(1%)
|
(2%)
|
Human insulin
|
7,195
|
8%
|
9%
|
Total insulin
|
42,923
|
(3%)
|
(18%)
|
GLP-15
|
30,051
|
29%
|
107%
|
Other Diabetes care6
|
3,056
|
(4%)
|
(2%)
|
Total Diabetes care
|
76,030
|
8%
|
87%
|
Obesity care (Saxenda®)
|
4,223
|
6%
|
4%
|
|
|
|
|
Diabetes and Obesity care
|
80,253
|
8%
|
91%
|
|
|
|
|
Haemophilia7
|
7,522
|
(2%)
|
(2%)
|
Growth disorders
|
5,872
|
13%
|
11%
|
(Norditropin®)
|
Other Biopharm8
|
1,161
|
1%
|
0%
|
|
|
|
|
Biopharm
|
14,555
|
3%
|
9%
|
Total
|
94,808
|
7%
|
100%
|
|
|
|
|
-
CAGR for 10-year period; 2 Comprises Tresiba®, Xultophy® and Levemir®; 3 Comprises Ryzodeg® and NovoMix®; 4 Comprises Fiasp® and NovoRapid®; 5 Comprises Victoza® ,Ozempic®, Rybelsus® ; 6 Primarily Novonorm®, needles and GlucaGen® HypoKit®;
-
Comprises NovoSeven®, NovoEight®, NovoThirteen® , Refixia®, and Esperoct®;8 Primarily Vagifem®, Activelle®, Macrilen® Note: Refixia® and NovoThirteen® are launched as Rebinyn® and TRETTEN®, respectively, in North America. Note: Sales numbers are reported in Danish kroner; Growth is at constant exchange rates
25
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Sales growth of 7% at CER, driven by IO sales growth of 12% and 2% sales growth in NAO
Historic sales by geography
8%9%
9%11%
32%31%
51%50%
2015
|
|
|
2019
|
|
|
|
North America
|
|
EMEA
|
|
China
|
|
RoW
|
|
|
|
|
|
|
|
|
Reported sales for the first
|
Reported sales and growth breakdown for the
|
nine months 2020
|
first nine months 2020
|
|
|
|
|
|
|
|
RoW
|
North America
|
Regions
|
Sales
|
Growth
|
Share of
|
|
Operations
|
(mDKK)
|
growth
|
14%
|
|
International Operations
|
50,399
|
12%
|
83%
|
Region
|
|
EMEA
|
26,159
|
11%
|
39%
|
China
|
|
|
|
|
|
|
11%
|
47%
|
Region China
|
10,836
|
12%
|
19%
|
|
|
RoW
|
13,404
|
13%
|
25%
|
|
|
|
|
North America Operations
|
44,409
|
2%
|
17%
|
28%
|
|
Here of USA
|
41,947
|
2%
|
11%
|
EMEA
|
|
|
|
|
|
|
Total sales
|
94,808
|
7%
|
100%
|
|
|
|
|
|
|
|
|
Sales of DKK 94.8 billion (+7%)
IO: International Operations; NAO: North American Operations; EMEA: Europe, Middle East, and Africa; RoW: Rest of World; Region China covers mainland China, Hong Kong and Taiwan.
Note: Numbers do not add up to 100% due to rounding; Growth at Constant exchange rates
Note: Sales numbers are reported in Danish kroner; Growth is at constant exchange rates
26
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Insulin sales remain important with more than 40% share of revenue but with less dependence on the US insulin sales
Q3 2015 sales split
|
Q3 2020 sales split
|
42%
57%
13%
28%
IO insulin NAO insulin Other products
27
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk has a set of strategic aspirations including an innovation and therapeutic focus
Further raise the innovation bar for diabetes treatment
InsulinGLP-1
Curative
|
treatment
|
Glucose-sensitive
|
Oral GLP-1
|
Insulin
|
analogue
|
Once-weekly
|
Weekly GLP-1
|
|
analogue
|
Long-
|
GLP-1
|
acting
|
analogue
|
Insulin
|
Native GLP-1
|
analogue
|
Develop a leading portfolio of superior treatment solutions for obesity
%
0
5
|
Today's marketed
|
treatment options
|
|
10
|
|
|
Semaglutide 2.4 mg
|
15
|
|
20
|
|
|
Pipeline
|
25
|
|
Bariatric surgery
|
|
30
Strengthen and
|
Establish presence in
|
progress the Biopharm
|
Other serious
|
pipeline
|
chronic diseases
|
Curative
|
CVD
|
CKD
|
|
|
therapy
|
|
|
Non-invasive
|
|
|
therapy
|
|
|
Mim8
|
|
|
Concizumab
|
|
|
Esperoct®
|
|
|
Refixia®
|
NASH
|
Stem Cells
|
|
NovoEight®
NovoThirteen®
NovoSeven®
CVD: Cardiovascular disease; CKD: Chronic kidney disease; NASH: Non-alcoholic steatohepatitis
28
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
The future of R&D is to focus on increasing the number of clinical assets while maintaining industry-leadinglate-stage success
R&D investments will expand
|
Increased clinical assets
|
Industry-leading success rate1 from
beyond historic focus
|
Pipeline
|
driving R&D investment
|
|
|
|
|
|
|
Assets
|
|
|
Diabetes
|
Obesity
|
|
|
|
|
ILLUSTRATIVE
|
Biopharm
|
Devices
|
CVDCKD
2019
|
|
|
|
Future
|
|
|
Phase 1
|
|
Phase 3
|
|
|
|
|
Phase 2
|
|
Submission
|
|
|
|
|
ILLUSTRATIVE
80%
60%
40%
20%
0%
Phase 1
|
Phase 2
|
Phase 3 Submission
|
Novo
|
|
Industry
|
Industry
|
Future
|
|
Nordisk
|
|
range
|
average
|
|
|
NASH: Non-alcoholic steatohepatitis; CVD: Cardiovascular disease; CKD: Chronic kidney disease. 1Probabilities of success to market were calculated using substances entering phase between 2008 and 2014 and year of assessment 2017. Source: CMR International, 2017
29
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Pipeline supports significant growth opportunities across all four strategic focus areas
PHASE 1
|
PHASE 2
|
PHASE 3
|
SUBMITTED
|
NN1535 - Icosema (LAIsema)
|
NN1436 - Icodec (LAI287)
|
Semaglutide obesity
|
Somapacitan - QW AGHD1
|
NN1965 - Insulin 965
|
NN9838 - Amylin AM833
|
SELECT - Semaglutide 2.4 mg in
|
|
obesity CVOT
|
|
|
|
|
NN1147 - Insulin 147
|
EX2020 - Macrilen, GHD5
|
Somapacitan - QW GHD2
|
|
NN9389 - QW Sema + GIP
|
NN9931 - Semaglutide NASH
|
Concizumab
|
|
NN1845 - Glucose sensitive
|
NN9931 - Gilead NASH
|
SUSTAIN FORTE - Semaglutide 2.0 mg
|
|
insulin
|
|
|
|
|
NN9775 - PYY 1875 analogue
|
NN6018 - Ziltivekimab
|
SOUL - Oral semaglutide CVOT
|
|
NN9215 - LA-GDF15
|
|
FLOW - Semaglutide 1.0 mg in
|
|
|
chronic kidney disease
|
|
|
|
|
NN9838 - AM833 and Sema
|
|
FOCUS - Semaglutide 1.0 mg in
|
|
|
diabetic retinopathy
|
|
|
|
|
NN7769 - Mim8 (Phase 1/2)
|
|
|
|
NN7533 - Eclipse
|
|
|
|
NN9500 - FGF-21 NASH
|
|
|
|
NN6434 - PCSK9i
|
|
|
|
NN6177 - GG-co-agonist4
|
|
|
|
STT-5058 - STATEN, ApoC3 mAb
|
|
|
|
|
|
|
|
APPROVED
Tresiba®
Xultophy®
Levemir®
Ryzodeg®
NovoMix®
Fiasp®
NovoRapid®
Victoza®
Ozempic®
Rybelsus®3
Saxenda®
NovoSeven®
NovoEight®
NovoThirteen®
Refixia®/Rebinyn®
Norditropin®
Sogroya®6
Diabetes
|
|
Obesity
|
|
Haemophilia
|
|
Growth Disorders
|
|
Other serious chronic diseases
|
|
|
|
|
|
|
|
|
1 Study conducted in adult growth hormone disorder; 2 Study conducted in growth hormone disorders; 3 Approved in the US, the EU, and Japan; submitted in Canada; 4 Study conducted in NASH; 5 Novo Nordisk only holds the commercial rights in North America; 6 Approved in the US
LAIsema: Long-acting insulin combined with semaglutide; PYY: Peptide YY; QW: Once-weekly; GG: Glucagon GLP-1; mAb: monocolonal antibody; GDF15: Growth differentiation factor 15; Sema: Semaglutide; FGF-21: Fibroblast growth factor 21; LAI: Long-acting
insulin; AGHD: Adult growth hormone disease; GHD: Growth hormone disorder; lira: Liraglutide; Note: the obesity co-agonist and tri-agonist projects have been terminated
30
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk holds solid patent protection, high barriers to entry, and a collaborative approach to innovation
Novo Nordisk's position is protected by patents and value chain setup
EU/US patent
protection1
20312
Barriers to entry for biosimilar players
Research & Development
•
|
Need to show comparability in PK/PD trials
|
•
|
Strict regulatory requirements in the EU and the US
|
Partnerships and acquisitions support
future R&D
20312,3
20304
2034/322
2028/29
2028/29
2028/29
2027/282
2023
•
|
Requirement for both drug and device offering
|
Manufacturing
-
Economies of scale
-
Up-frontCAPEX requirements with slow return on investment
Commercialisation
-
Large and fragmented target audience
-
Cost pressure from payers
-
On-goingconversion to next-generation drugs and slow market dynamics
siRNA treatments
Novel treatments for CVD
Combination treatments for
NASH
Gene editing for haemophilia
1 List does not include all marketed products. 2 Current estimates; 3 Tablet formulation and once-daily treatment regimen are protected by additional patents expiring in 2031-2034;4 Formulation patent; active ingredient patent has expired; Saxenda® patent identical to Victoza® patent. PK: Pharmacokinetic, PD: Pharmacodynamic; CAPEX: Capital expenditure; siRNA: Silencing ribonucleic acid; NASH: Non-alcoholic steatohepatitis; CVD: Cardiovascular disease
31
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk's core capabilities provide a competitive advantage to continue to defeat diabetes
Engineering, formulating,
|
Efficient large-scale
|
Global commercial reach and
|
Deep disease
|
developing and delivering
|
production of proteins
|
leader in chronic disease care
|
understanding
|
protein-based treatments
|
|
|
|
Today: Oral solutions to
|
Today: The world's
|
differentiate from
|
largest producer of
|
competition
|
insulin and GLP-1
|
Tomorrow: Expand oral
|
Tomorrow: Expand capacity by
|
platforms and transformational
|
completion of the US diabetes
|
medicines via Novo Nordisk stem
|
API facility and continued
|
cell platform
|
efficiency gains
|
Today: Global reach and
|
Today: Provide value and
|
Ozempic® was the fastest
|
outcomes beyond HbA1c
|
blockbuster in diabetes
|
for diabetes
|
Tomorrow: Continued rollout of
|
Tomorrow: Normalise living with
|
injectable diabetes portfolio and
|
diabetes supported by digital
|
launch of Rybelsus®
|
solutions
|
API: Active pharmaceutical ingredient
Investor presentation
|
First nine months of 2020
|
STRENGTHEN LEADERSHIP
by offering innovative
|
1.
|
Disease and market
|
33
|
|
|
|
|
medicines and driving
|
2.
|
Insulin segment
|
41
|
|
|
|
|
patient outcomes
|
3. GLP-1 segment
|
44
|
33
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Diabetes - the inability to manage blood sugar levels appropriately
Facts about diabetes
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin produced by the pancreas
Primary classifications:
Type 1 diabetes: Complete insulin deficiency due to destruction of beta- cells in the pancreas
Type 2 diabetes: Characterised by some degree of insulin resistance and insulin deficiency
Insulin:
-
Facilitates uptake of blood sugar into cells
-
Inhibits glucose release from the liver
Fat cell
LiverPancreas
Insulin action profiles
Fast-acting
Premix
Long-acting
6:00
|
10:00
|
14:00
|
18:00
|
22:00
|
2:00
|
6:00
|
|
|
|
|
|
Time of day
|
|
Breakfast
|
Lunch
|
Dinner
|
|
|
|
34
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
GLP-1s have positive effects beyond glycaemic control and treatment guidelines now reflect the CV risk benefits
Medications for treatment of type 2 diabetes
Class
|
HbA1C
|
Hypoglycaemia
|
Weight
|
CV risk
|
change
|
|
change
|
risk
|
reduction
|
Metformin
|
1.5
|
No
|
Neutral
|
Minimal
|
|
|
|
|
|
Sulfonylurea
|
1.5
|
Yes
|
Gain
|
None
|
ADA/EASD diabetes treatment guidelines for second-line
treatment with established ASCVC or CKD
First-line therapy is metformin and lifestyle management.
If HbA1c above target, proceed as below
NO Without
Established ASCVD or CKDestablished ASCVD or CKD
YES
TZDs
|
0.5 - 1.4
|
No
|
Gain
|
Varies
|
DPP-IV inhibitors
|
|
No
|
Neutral
|
Neutral
|
0.6 - 0.8
|
|
|
|
|
|
SGLT-2 inhibitors
|
0.5 - 0.9
|
No
|
Loss
|
Varies
|
|
|
|
|
|
GLP-1
|
1.0 - 1.8
|
No
|
Loss
|
Varies
|
|
|
|
|
|
Long-acting insulin
|
1.5 - 2.5
|
Yes
|
Gain
|
TG and HDL
|
Fast-acting insulin
|
1.5 - 2.5
|
Yes
|
Gain
|
TG and HDL
|
|
|
|
|
|
ASCVD predominates
GLP-1
|
|
SGLT-2
|
|
with proven CVD
|
with proven CVD
|
|
|
benefit*,
|
benefit*
|
|
|
if eGFR adequate
|
|
|
|
EITHER/OR
|
|
|
|
If HbA1c above target
If further intensification is required or patient is now unable to tolerate GLP-1 and/or SGLT-2, choose agents demonstrating CV safety…
*Proven CVD benefit means it has label indication of reducing CVD events. For GLP-1 strongest evidence for liraglutide>semaglutide>exenatide extended release. For SGLT-2 evidence modestly stronger for empagliflozin>canagliflozin. ASCVD: atherosclerotic cardiovascular disease; CKD: chronic kidney disease; CV: cardiovascular; CVD: cardiovascular disease; CVOT: cardiovascular outcome trial; DPP-4: dipeptidyl peptidase-4 inhibitor; eGFR: estimated glomerular filtration rate; GLP-1:glucagon-likepeptide-1 receptor agonist; HF: heart failure; SGLT-2: sodium glucose co-transporter-2 inhibitor
Sources: Adapted from: Nathan DM, et al. Diabetes Care. 2006; 29: 1963-1972; Nathan DM, et al. 2007;30:753- 759; Nathan DM, et al. Diabetes Care. 2008;31:173-175. ADA. Diabetes Care. 2008; 31:S12-S54. WelChol PI. 1/2008. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)
35
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
People with diabetes have increased mortality risk with eight years shorter life expectancy, highlighting the importance of innovation
Diabetes is associated with shorter life expectancy
|
|
|
The unmet need remains large within diabetes
|
|
and lower quality of life
|
|
|
|
|
|
|
|
|
|
|
|
|
Untreated (million)
|
|
|
|
|
|
|
|
|
|
|
463
|
|
|
Treated with competitors' products (million)
|
|
|
|
|
|
|
•
|
Life expectancy 8 years shorter1
|
|
|
Treated with Novo Nordisk' products (million)
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes •
|
Driven by 200% increased risk of all
|
|
|
101
|
|
|
|
|
|
|
|
|
cause mortality1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
70% of people with diabetes die from
CVD
|
atherosclerotic CVD2
|
183
|
|
|
|
|
• 150% increase in risk of stroke3
|
56
|
|
|
|
|
Organs
|
• Higher likelihood of neuropathy,
|
retinopathy, limb amputation, cancer
|
|
and cognitive dysfunction4
|
|
|
|
|
|
24
|
|
|
|
30
|
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
Diabetic
|
Other OAD
|
Insulin Branded OAD
|
GLP-1
|
|
population5
|
|
|
|
|
|
36
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Global diabetes prevalence is increasing and 700 million people are expected to have diabetes by 2045
The number of people with diabetes is expected to
increase 51% by 2045
Of the 463 million, around 30 million1 people are currently treated
with Novo Nordisk diabetes products
800
700
600
500
400
300
200
100
0
1.9 mio treated with GLP-1
2.4 mio treated with new-generation insulin
mio treated13.0 mio treated with generationmodern insulin
treated with
10.9 mio treated with human insulins
2019
|
|
|
2030
|
2045
|
|
EMEA
|
|
Region China
|
|
|
RoW
|
|
North America
|
|
|
|
|
|
|
|
|
Source: International Diabetes Federation: Diabetes Atlas 1st Edition 2000 and Diabetes Atlas 9th Edition 2019
|
1 In addition to the above-mentioned product classes, oral anti-diabetics constitutes the remainder of people treated with Novo
|
EMEA: Europe, Middle East, Africa; RoW: Asia Pacific, Latin America;
|
Nordisk products
|
37
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Diabetes is a chronic disease requiring treatment intensification over time
Distribution of patients and value across treatment classes
Diet and exercise
|
|
|
|
100%
|
|
|
|
|
|
|
|
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OAD
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80%
|
|
|
44%
|
|
|
|
|
18%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GLP-1
|
|
|
|
|
|
|
|
|
|
13%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18%
|
|
|
|
|
20%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Insulin
|
40%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8%
|
|
|
|
|
|
|
|
|
|
|
20%
|
|
|
26%
|
|
|
|
|
43%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
Time
|
|
|
|
Patients
|
|
|
|
|
Value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Insulin
|
|
GLP-1
|
|
SGLT2i
|
|
DPP-IV
|
|
Traditional OADs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: Patient distribution across treatment classes is indicative and based on data for the USA, Germany and France. Other OADs covers: metformin, sulfonylurea, thiazolidinediones.
Source: IQVIA PharMetrix claims data, IQVIA disease analyser, IQVIA MIDAS; value figures based on IQVIA MAT, Aug 2020
OAD: Oral anti-diabetic
38
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Diabetes volume growth remains solid with 4% growth in a large USD 50 billion diabetes market
The number of treated patients1 is expected to
|
The diabetes realised value2 is expected to grow by
|
grow by 4% annually towards 2026
|
3% annually towards 2026
|
CAGR: +4%
|
CAGR: +3%
|
|
|
|
|
|
|
ILLUSTRATIVE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ILLUSTRATIVE
|
|
206M
|
50bn
|
|
|
|
2019
|
|
|
2026
|
|
|
2019
|
2026
|
|
|
Other OAD
|
|
|
DPP-4i
|
|
SGLT-2i
|
|
GLP-1
|
|
Insulin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Key trends in diabetes
-
Innovation focused on oral GLP-1 and combinations
-
Biosimilar competition and loss of exclusivity
-
Diabetes technology with digital health
-
Patients outcome beyond glucose control
-
Evolving payer dynamics and market access hurdles
-
Access and affordability of medicine
1 Patient data: Novo Nordisk forecast; 2 Value data: 2018 data based on company reported sales and 2025 is based on a projection of diabetes market realised sales;
Note: GLP-1+basal insulin combination sales are included in insulin; Other OAD includes metformin, SU and TZDs; DPP-4i+SGLT-2i products are included in the SGLT-2i group. Growth rates are compound annual growth rates (CAGR).
39
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
The total branded diabetes market for the first half of 2020, annualised, had a global value of DKK ~300 billion
DKK billion
350
300
250
200
150
100
50
0
Global diabetes market
|
|
-3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
130 128
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-2%
|
|
|
|
|
|
|
|
|
|
|
|
73
|
|
|
|
|
|
|
|
|
|
|
|
60
|
60
|
|
|
|
|
|
|
|
58
|
|
19%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28
|
34
|
Total
|
Insulin
|
GLP-1
|
DPP-IV
|
SGLT-2
|
DKK billion 150
100
50
0
DKK billion
150
100
50
0
|
|
|
|
|
|
|
|
|
|
The USA
|
|
|
|
|
|
|
|
|
|
|
|
|
-1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143 145
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-13%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
+21%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
61
|
54
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
54
|
|
|
|
-13%
|
|
|
|
|
|
|
|
|
|
43
|
|
|
|
|
|
+3%
|
|
|
|
|
|
|
|
|
|
|
|
|
23
|
21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
|
16
|
|
|
Total
|
Insulin
|
GLP-1
|
DPP-IV
|
SGLT-2
|
|
|
|
|
|
|
|
|
|
Rest of world
|
|
|
|
|
|
|
|
|
+12%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
134 150
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
+6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
+4%
|
|
|
|
|
|
|
|
|
|
|
|
69
|
73
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
+33%
|
|
37
|
39
|
|
+37%
|
|
|
|
|
|
|
|
|
|
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
|
13
|
18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
Insulin
|
GLP-1
|
DPP-IV
|
SGLT-2
|
2018/19: Covers the four quarters from Q3 2018 to Q2 2019, except for Boehringer Ingelheim share of Trajenta which covers full year; 20182019/20: Covers the four quarters from Q3 2019 to Q2 2020, except for Boehringer Ingelheim share of Trajenta which
covers full year 2019; Note: Constant exchange rates between periods and Boehringer Ingelheim's regional split is based on regional split from 2019 Annual report for prescription medicine; Source: Company reported sales
40
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk has a strong leadership position within the growing diabetes market
Global diabetes market by treatment class1
|
Novo Nordisk remains global diabetes
|
|
value market leader
|
DKK
|
|
|
|
|
|
|
|
billion
|
|
|
|
|
|
|
|
350
|
Market CAGR2: 8.5%
|
|
|
35%
|
29%
|
300
|
|
|
|
|
|
30%
|
|
|
|
|
|
|
250
|
|
|
CAGR: 6.7%
|
|
25%
|
|
|
|
|
|
|
|
200
|
|
|
CAGR: 192.7%
|
|
20%
|
|
150
|
|
|
CAGR: 29.5%
|
|
15%
|
|
100
|
|
|
CAGR: 0.4%
|
|
10%
|
|
50
|
|
|
|
|
|
5%
|
|
0
|
|
|
|
|
|
0%
|
Aug
|
14FY
|
15FY
|
16FY
|
17FY
|
18FY
|
19FY
|
Aug
|
2010
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
Novo Nordisk
|
Takeda
|
|
Insulin
|
GLP-1
|
SGLT2
|
DPP-4
|
|
Sanofi
|
Eli Lilly
|
|
|
|
|
|
|
Merck
|
BI
|
|
|
|
|
|
|
AstraZeneca
|
Novartis
|
|
|
|
|
|
|
J&J
|
|
Novo Nordisk market share and
share of growth
60%
|
|
|
50%
|
|
|
40%
|
|
36%
|
30%
|
|
29%
|
20%
|
|
|
|
10%
|
|
|
0%
|
|
|
Aug
|
|
Aug
|
2017
|
NN market share
|
2020
|
|
|
NN share of growth
-
Data is based on company reported sales from Sanofi, Eli Lilly, AstraZeneca, GSK, Novartis, Johnson & Johnson, and Merck. Data does not include generic metformin, sulphonylureas or thiazolidinedione
-
CAGR for 5-year period
OAD: Oral anti-diabetic; NN: Novo Nordisk ; Source: IQVIA MAT, Aug 2020 value figures Note: IQVIA data can be inflated due to use of list prices in the US ; BI: Boehringer Ingelheim
41
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk global insulin market leadership expanded to 46.9% and the global insulin volume market grew by 2.8%
Global
North America Operations
|
|
Market growth: 2.8%
|
International Operations
|
|
Market growth: 0.2%
|
|
MS: 46.9%
|
|
Market growth: 3.8%
|
|
MS: 39.6%
|
|
MS gain/loss1: 0.4%-p
|
|
MS: 49.7%
|
|
MS gain/loss1: -0.3%-p
|
|
Sales growth: -3%
|
|
MS gain/loss1: 0.6%-p
|
|
Sales growth: -22%
|
|
|
|
Sales growth: 10%
|
USA
Market growth: 0.2%
MS: 39.5%
MS gain/loss1: -0.6%-p
Sales growth: -23%
Source: IQVIA MAT, Aug 2020 volume figures
Note: Sales growth for first nine months of 2020 at constant exchange rates; Market shares are for Novo Nordisk and market growth for the total insulin market
1MS gain/loss compared with Aug 2019 reported MS
EMEA: Europe, Middle East, Africa; MS: Market share; RoW: Asia Pacific; Latin America;
|
Region China
|
|
Market growth: 5.1%
|
|
MS: 49.5%
|
|
MS gain/loss1: -0.6%-p
|
EMEA
|
Sales growth: 14%
|
RoW
|
Market growth: 2.7%
|
MS: 47.2%
|
Market growth: 6.2%
|
MS gain/loss1: 0.4%-p
|
MS: 57.0%
|
Sales growth: 6%
|
MS gain/loss1: 1.1%-p
|
|
Sales growth: 12%
|
NN market share NN share of growth Market growth (right axis) NN growth (right axis)
42
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Insulin market size and volume share of growth and market share
|
Insulin market share and market size (DKK billion)
|
|
Market
|
Market
|
|
|
|
|
|
|
|
|
|
growth
|
share
|
Total
|
|
|
45%
|
|
|
|
268
|
2%
|
+0.3%
|
Long-
|
|
38%
|
133
|
|
|
4%
|
+0.0%
|
Acting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fast-
|
|
53%
|
93
|
|
|
|
0.1%
|
+1.3%
|
Acting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
66%
|
|
|
|
|
|
|
|
|
Premix
|
|
18
|
|
|
|
|
|
|
-3.1%
|
+0.7%
|
|
|
36%
|
|
|
|
|
|
|
|
|
Human
|
|
24
|
|
|
Novo Nordisk
|
|
Competitors
|
|
0.8%
|
-0.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Insulin volume: Share of growth and
market share
80%
|
|
|
10%
|
60%
|
|
62%
|
8%
|
|
|
|
|
|
47%
|
6%
|
40%
|
|
|
|
|
|
|
4%
|
20%
|
|
|
2%
|
|
|
|
0%
|
Aug
|
Aug
|
0%
|
|
2017
|
2020
|
|
Source: IQVIA, Aug 2020, LHS graph - Value, RHS Graph - Volume, MAT, all countries; NN: Novo Nordisk
43
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Icodec, a once-weekly insulin, improved PPG control, HbA1c, and increased the number of patients reaching target in a phase 2 trial
Icodec showed statistically significant
|
Numerical improvement in HbA1c
|
The proportion of patients on icodec
|
|
post prandial blood glucose control
|
|
over 26 weeks
|
|
reaching HbA1c targets was higher
|
FPG
|
|
|
Icodec
|
|
Glargine U100
|
Change
|
|
|
Icodec
|
|
|
Glargine U100
|
Proportion
|
|
Icodec
|
|
Glargine U100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(mmol/L)
|
|
|
in HbA1c
|
|
|
|
|
of patients
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
|
|
0.0
|
|
|
|
|
|
|
100%
|
|
|
*
|
*
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
|
|
-0.2
|
|
|
|
|
|
|
|
72% 68%
|
|
-0.4
|
|
|
|
|
|
|
75%
|
|
|
|
|
|
|
|
|
7
|
|
-0.6
|
|
|
|
|
|
|
|
|
49%
|
|
|
-0.8
|
|
|
|
|
|
|
50%
|
|
6
|
|
|
|
|
|
|
|
|
39%
|
|
-1.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-1.15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25%
|
|
|
5
|
|
-1.2
|
|
|
|
|
-1.33
|
|
|
|
|
-1.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
-1.6
|
|
|
|
|
|
|
0%
|
|
|
|
|
0
|
4
|
8
|
12
|
16
|
20
|
26
|
|
< 7.0%
|
≤ 6.5%
|
|
|
|
|
|
Weeks
|
|
|
|
|
|
HbA1c target
|
*Statistically significant at week 26
PPG: Post-prandial control; FPG: Fasting plasma glucose
44
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
GLP-1 effect dependent on blood glucose level
GLP-1 mechanism of action when blood
sugar levels increase
-
Increases insulin secretion in the pancreas
-
Reduces glucagon secretion in the liver
-
Slows gastric emptying in the gut
-
Creates sense of satiety in the brain
Brain
Pancreas
Diabetes
CVD
Obesity
NASH
CKD
Brain
disorders
Semaglutide holds a plethora of
therapeutic opportunities FORTE - Semaglutide 2.0 mg
Semaglutide s.c. ~961 patients, T2D
FOCUS - Diabetic retinopathy outcomes trial
Semaglutide s.c; ~1,500 patients, T2D ≥10 years
SOUL - Cardiovascular outcomes trial
Oral semaglutide; ~9,600 patients, T2D, established CVD or
CKD
SELECT - Cardiovascular outcomes trial
Semaglutide 2.4 mg, ~17,500 patients with obesity and without diabetes, event driven
Semaglutide in NASH
Semaglutide s.c.; phase 2 trials
FLOW - Chronic kidney disease outcomes trial
Semaglutide 1.0 mg; ~3,200 patients, T2D, moderate to severe CKD
Investigator initiated trials
-
Alzheimer's disease
-
Parkinson's disease
S.c: Subcutaneous; T2D: Type 2 diabetes; CVD: Cardiovascular disease; CKD: Chronic kidney disease
45
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
The global GLP-1 market penetration varies across regions with Novo Nordisk having a best-in-class portfolio
GLP-1 market growth and Novo Nordisk market share
|
GLP-1 value and patient share1 of the total diabetes market
|
70%
|
|
|
25%
|
|
|
|
60%
|
|
57.7%
|
|
50%
|
|
47.6%
|
20%
|
|
|
|
|
|
40%
|
|
38.6%
|
15%
|
30%
|
|
|
10%
|
|
|
|
20%
|
|
|
|
10%
|
|
|
5%
|
|
|
|
0%
|
Aug
|
Aug
|
0%
|
|
2017
|
2020
|
|
|
NN market share
|
NN share of growth
|
|
|
Market growth
|
NN growth
|
|
24%
20%
14%
|
7%
|
5%
|
7%
|
|
|
|
|
|
2%
|
|
|
|
|
|
World
|
North
|
EMEA Region
|
RoW
|
|
America
|
China
|
|
GLP-1 value share of total diabetes
GLP-1 patient share of total diabetes
Source: 1Patient share based on data for the USA, the UK, Germany and France only. IQVIA MAT value, Aug 2020; EMEA: Europe, Middle East, Africa; RoW: Rest of World
46
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
GLP-1 sourcing is primarily from outside the class but GLP-1s are still typically used after failure on other products
US 'line of usage' across product classes
100%
80%
60%
40%
20%
0%
Metformin
|
SU
|
DPP-4i
|
SGLT-2i
|
GLP-1
|
Share of patients on OADs achieving
HbA1c below 7% in major European countries
HbA1c >7%
43%
57%
HbA1c <7%
GLP-1 source of business
(new-to-brand prescription market share)
Insulin and Treatment
GLP-1 naive
5% 5%
Insulin
25%
50%
11%
GLP-1OAD
Note: Data based on data from France, Germany, the UK and the USA only
OAD: Oral anti-diabetic (includes but is not limited to DPP-IV,SGLT-2, metformin and sulfonylurea)
Source: IQVIA Disease Analyser (France, Germany and the UK) and IQVIA LRx (USA), Jun 2018
47
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
SUSTAIN trials with subcutaneous semaglutide
SUSTAIN
|
1
|
2
|
3
|
4
|
5
|
|
6
|
|
7
|
Baseline
|
8.1%
|
8.1%
|
8.3%
|
8.2%
|
8.4%
|
|
8.7%
|
|
8.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-0.1
|
|
|
|
|
|
|
-0.5
|
|
|
|
|
-0.4
|
|
|
Change in
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-0.8
|
|
|
|
|
|
HbA1c (%)
|
|
|
|
-0.9
|
|
|
-1.1
|
|
-1.1
|
|
|
|
-1.3
|
|
-1.2
|
|
|
|
|
|
|
|
-1.8-1.4
|
-1.4
|
|
|
-01
|
|
|
-1.5
|
-1.5
|
|
|
|
|
-1.6
|
-1.6
|
-1.6
|
|
-1.8-1.5
|
|
|
|
|
|
1.2
|
|
|
|
|
|
Baseline
|
92 kg
|
89 kg
|
96 kg
|
93 kg
|
92 kg
|
|
92 kg
|
|
95 kg
|
|
|
|
|
|
|
|
|
|
|
|
|
-1
|
|
|
|
|
-1.4
|
-0.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-1.9
|
-1.9
|
|
|
|
|
|
Change in
|
|
|
|
|
|
|
|
-2.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-3.0
|
weight (kg)
|
|
|
|
|
-3.5
|
-3.7
|
|
-3.6
|
|
|
-3.7
|
|
|
|
|
|
|
|
-4.3
|
|
|
|
|
|
-4.5
|
|
|
-5.2
|
|
-4.9
|
|
|
-4.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-5.6
|
|
|
|
|
|
|
|
|
-6.1
|
|
-6.4
|
|
|
-6.5
|
|
|
|
|
|
|
|
|
|
|
semaglutide 1.0 mg
|
semaglutide 0.5 mg
|
placebo
|
sitagliptin 100 mg
|
exenatide ER
|
glargine U100
|
dulaglutide 1.5 mg
|
dulaglutide 0.75 mg
|
-
Statistically significant; SUSTAIN 1: QW sema vs placebo in drug-naïve people with T2D; SUSTAIN 2: QW sema vs sitagliptin 100 mg QD in people with T2D added to 1-2 OADs; SUSTAIN 3: QW sema vs QW exenatide ER 2.0 mg in people with T2D added to 1-2 OADs; SUSTAIN 4: QW sema vs QD insulin glargine in people with T2D added to 1-2 OADs; SUSTAIN 5: QW sema vs placebo in people with T2D added to insulin; SUSTAIN 6: QW sema vs placebo, added to standard-of-care; SUSTAIN 7: QW sema vs QW dulaglutide 75 mg and 150 mg in people with T2D added to 1-2 OADs: ER: Extended-release; QW: once weekly; QD: once daily; sema: semaglutide; T2D: type 2 diabetes, OAD: oral anti-diabetics
48
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
PIONEER programme with oral semaglutide
PIONEER
|
1
|
|
2
|
3
|
4
|
5
|
7
|
8
|
Baseline
|
8.0%
|
|
8.1%
|
8.3%
|
8.0%
|
8.0%
|
8.3%
|
8.2%
|
|
|
|
|
|
|
|
|
|
|
-0.1
|
|
|
-0.1
|
-0.1
|
|
|
Change in
|
|
|
|
-0.5
|
|
|
-0.7
|
-0.6
|
HbA1c (%)
|
|
|
|
|
|
|
|
-0.8
|
|
|
-0.8
|
|
|
|
-1.0
|
|
|
-0.9
|
-1.1
|
-1.1
|
|
|
|
|
|
|
|
|
-1.3
|
|
|
-1.1
|
-1.3
|
|
-1.4
|
-1.4
|
|
|
-1.4
|
-1.4
|
|
|
|
|
|
|
|
|
|
|
|
|
88 kg
|
|
92kg
|
91 kg
|
94 kg
|
91 kg
|
89 kg
|
0.6
|
Baseline
|
|
86 kg
|
|
|
|
|
|
|
|
|
|
|
|
|
-0.7
|
-0.7
|
-1.1
|
-0.8
|
-1.0
|
|
-1.7
|
-1.5
|
|
-1.2
|
|
|
|
|
|
|
|
|
|
|
|
|
-2.2
|
|
|
|
|
Change in
|
-2.5
|
|
|
|
|
-2.9
|
-2.9
|
|
|
|
-3.2
|
|
weight (kg)
|
|
|
|
-3.3
|
|
|
|
-4.2-3.8
|
-3.7
|
|
|
|
-4.1
|
|
|
|
-4.3
|
|
|
-4.7
|
|
|
|
|
|
|
|
|
|
|
oral semaglutide 3 mg
|
|
oral semaglutide 7 mg
|
|
oral semaglutide 14 mg
|
|
placebo
|
|
sitagliptin 100 mg
|
|
empagliflozin 25 mg
|
|
Victoza® 1.8 mg
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: PIONEER 9 and PIONEER 10 were Japanese studies and PIONEER 6 was a CV safety study. * Statistically significant based on the hypothetical treatment policy; PIONEER 1: QD oral sema vs placebo in people with T2D treated with diet and exercise only;
PIONEER 2: QD oral sema vs empagliflozin 25 mg in people with T2D; PIONEER 3: QD oral sema vs sitagliptin 100 mg in people with T2D; PIONEER 4: QD oral sema vs Victoza® 1.8 mg and placebo in people with T2D; PIONEER 5: QD oral sema vs placebo in people
with T2D and moderate renal impairment; PIONEER 7: QD oral sema using a flexible dose adjustment based on clinical evaluation vs sitagliptin 100 mg in people with T2D; PIONEER 8: Effects of QD oral sema vs placebo in people with long duration of T2D
treated with insulin ER: Extended-release; QW: once weekly; QD: once daily; oral sema: oral semaglutide; T2D: type 2 diabetes, OAD: oral anti-diabetics; CV: Cardiovascular
Investor presentation First nine months of 2020
STRENGTHEN TREATMENT OPTIONS
THROUGH MARKET DEVELOPMENT
AND BY OFFERING INNOVATIVE
MEDICINES AND DRIVING PATIENT
OUTCOMES
1. Obesity disease and market
|
50
|
|
|
2. Obesity market development
|
52
|
|
|
|
|
3. Innovation
|
53
|
|
|
50
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
People with obesity are at an increased risk of developing severe comorbidities that are life-threatening and costly for society
Diabetes
CVD
Heart
failure
Sleep
apnoea
Osteo-
arthritis
Increased risk of type 2 diabetes
Increased risk of CVD
Increased risk of heart failure
Increased severity of sleep apnoea
Increased risk of osteoarthritis
Only 2% of the 650 million people with obesity
are treated with prescription medication
650 million people with obesity
Visit the doctor
Discussion and
|
|
evaluation of
|
|
next steps Actively
|
|
managed1
|
2% treated2
|
Global healthcare cost related to obesity
expected to increase by 50% by 2025
|
|
|
|
USD ~1.2
|
|
|
|
|
|
|
|
|
|
|
USD ~1.0
|
|
trillion
|
USD ~0.8
|
|
trillion
|
|
|
trillion
|
|
|
|
|
|
|
|
|
|
2017 2020 2025
CVD: Cardiovascular disease; AOM: Anti-obesity medication, TRx SU Volume.
The figure illustrates some of the intervention points to treat obesity with prescription medication
-
Attempt to manage weight through lifestyle modification or surgery
-
2% of people with obesity are estimated to be treated with anti-obesity medication
Source: World Obesity Federation, 2017; IQVIA Xponent MAT, May 2020 and NSP MAT, May 2020; IQVIA MIDAS 2017
51
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Saxenda® addresses a global unmet need for medical weight management
Global obesity prevalence
|
Saxenda® launched countries
|
Global reimbursement status
|
<10% <10-19.9%<20-29.9%>30%
Saxenda® now launched in 54 countries
70% access in commercial channel, but due to employer opt-in, effective access is around 20%
Reimbursement in IO is predominantly out-of-pocket
NICE has recommended Saxenda® for use by NHS in select patient populations
~60% coverage by private insurance, 20% of which includes restricted/unrestricted coverage
Saxenda® reimbursed April 2020 in selected patient groups
NAO: North America Operations; IO: International Operations; EMEA: Europe, Middle East, Africa; RoW: Rest of World;
CER: Constant exchange rates
52
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Global obesity market share, market growth, and US volume and value market
Obesity market growth and Novo Nordisk
|
Obesity market size and growth
|
US obesity care market remains small at
|
market share
|
|
around USD 853 million
|
|
|
|
DKK
|
|
|
|
TRx SU
|
|
mUSD/value
|
|
80%
|
|
60%
|
billion
|
~3%
|
|
|
market share
|
|
market share
|
|
|
|
|
|
100
|
|
900
|
|
|
|
|
|
|
|
|
|
|
|
|
10
|
1
|
|
10
|
|
|
|
63%
|
50%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60%
|
|
40%
|
|
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
|
600
|
|
|
|
|
|
|
|
|
60
|
|
|
40%
|
|
30%
|
|
|
|
|
|
|
|
|
|
~18%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20%
|
|
|
|
|
40
|
|
300
|
|
|
|
|
|
|
63%
|
|
|
|
20%
|
|
|
|
|
|
|
|
|
3%
|
|
55%
|
|
|
20
|
|
|
|
|
10%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0%
|
NN market share
|
0%
|
Aug
|
Saxenda®
|
Others
|
Aug
|
0
|
Volume
|
0
|
Value
|
|
|
|
|
|
Market growth (right axis)
|
|
2019
|
|
|
2020
|
Generic
|
Other branded AOM
|
Saxenda®
|
Source: IQVIA, Aug 2020, Value MAT, all countries; IQVIA Xponent MAT, May 2020 and NSP MAT, May 2020.
53
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Making obesity a healthcare priority requires stakeholder engagement
HCPs take action by referring or managing obesity as any other chronic disease
Stigma is socially unacceptable
Willingness to pay for chronic obesity care
Treatment guidelines in place
PwO seek medical support
Obesity recognised as a serious chronic disease
Healthcare system funds obesity prevention
Future
Addressing market development barriers
-
Activate people with obesity to seek treatment
TruthAboutWeight
Social media awareness campaigns
-
Engage more and stable HCP's
Medical journals and congresses ReThinkObesity
-
Ensure access to care
Increased quality of life for patients Long-term benefits for healthcare stystems
Develop a leading portfolio of superior treatment solutions
PwO: People with obesity; HCP: Healthcare professional
54
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Across the STEP 1, 3, and 4 trials, a weight loss of 16.9% to 18.2% was reported for people treated with semaglutide 2.4 mg
|
STEP 1
|
STEP 3
|
STEP 4
|
|
STEP 2
|
|
Weight
|
Weight management
|
Sustained weight management
|
Weight management with
|
|
management
|
with IBT
|
From initiation
|
From randomisation
|
T2DM
|
Baseline body
|
|
|
to 68 weeks
|
to 68 weeks1
|
|
105.3
|
105.8
|
107.2
|
96.1
|
99.8
|
weight (kg)
|
|
|
|
|
|
|
10
|
Sema
|
Placebo
|
Sema
|
IBT
|
Sema
|
Placebo
|
Sema
|
Placebo
|
Sema
|
Placebo
|
|
|
|
|
+ IBT
|
|
|
|
|
6.5
|
|
|
from baseline
|
5
|
|
|
|
|
|
|
|
|
|
|
0
|
|
|
|
|
|
|
|
|
|
|
-5
|
|
-2.4
|
|
|
|
|
|
|
|
-3.1
|
BW(%)
|
|
|
|
-5.0
|
|
-5.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-10
|
|
|
|
|
|
|
-8.8*
|
|
-10.6*
|
|
Change
|
in
|
|
|
|
|
|
|
|
|
|
|
-15
|
|
|
|
|
|
|
|
|
|
|
|
-20
|
-16.9*
|
|
-17.6*
|
|
-18.2 *
|
|
|
|
|
|
1 The primary endpoint was measured as the change in weight from randomisation (after a 20-weekrun-in) to week 68.
*Statistically significant, based on the trial product estimand (secondary statistical approach): treatment effect if all people adhered to treatment and did not initiate other anti-obesity therapies
IBT: Intensive behavioural therapy; Sema: Semaglutide; BW: Body weight; T2D: Type 2 diabetes
55
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
In STEP 1, people treated with semaglutide had a superior weight loss of up to 16.9%
The pivotal STEP 1 trial showed greater than 16% weight loss
0
|
|
|
|
|
|
|
|
|
|
|
|
-2
|
|
|
|
|
|
|
|
|
|
Placebo: -2.4%
|
-4
|
|
|
|
|
|
|
|
|
|
|
|
-6
|
|
|
|
|
|
|
|
|
|
|
|
-8
|
|
|
|
|
|
|
|
|
|
|
|
-10
|
|
|
|
|
|
|
|
|
|
|
|
-12
|
|
|
|
|
|
|
|
|
|
|
|
-14
|
|
|
|
|
|
|
|
|
|
|
|
-16
|
|
|
|
|
|
|
|
|
|
|
|
-18
|
|
|
|
|
|
|
|
|
Semaglutide: -16.9%
|
|
-20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0
|
4
|
8
|
12
|
16
|
20
|
28
|
36
|
44
|
52
|
60
|
68
|
|
|
|
|
|
Time since initiation (weeks)
|
|
|
|
Data from STEP 1
-
Average age 46
-
74.1% women
-
Average BMI - 37.9 kg/m2
Improvements in lipid profiles as well as C-reactive protein
Semaglutide improved health-related quality of life as measured by SF-36 and IWQoL-lite-CT
Change in body weight in % depicts observed means since time of randomisation; trial product estimand.
BMI: body mass index; SF-36: Short Form (36) Health Survey; IWQoL-lite-CT: Impact of Weight on Quality of Life-Lite questionnaire
56
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
In STEP 1, 34.8% of patients treated with semaglutide reached ≥20% weight loss and reported improved quality of life versus placebo
Categorical weight loss
Proportion of patients
100%
|
|
92.4%
|
|
|
Sema 2.4 mg
|
|
|
Placebo
|
|
|
|
|
|
80%
|
|
74.8%
|
|
|
|
|
|
|
|
|
|
|
60%
|
|
|
|
54.8%
|
|
|
|
40%
|
|
33.1%
|
|
|
|
34.8%
|
|
|
|
|
|
|
|
|
20%
|
|
|
11.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.0%
|
2.0%
|
|
|
|
|
|
|
0%
|
|
|
|
|
|
|
|
|
|
≥5%
|
≥10%
|
|
≥15%
|
|
|
≥20%
|
|
|
|
|
|
Weight loss
Descriptive statistic only. Based on the on-treatment data, i.e. data for subjects that are on-treatment at week 68 Sema: semaglutide
Sema 2.4 mg showed a statistically significant treatment difference
versus placebo in the IWQoL-Lite-CT PRO
IQWoL-Lite-CT
|
|
|
|
ETD [95% CI]
|
|
|
|
|
|
Physical function
|
|
|
|
9.43 [7.50 : 11.35] *
|
|
|
|
|
|
|
|
|
|
|
|
Physical
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9.14 [7.31 : 10.96] *
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Psychological
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.50 [8.81 : 12.19] *
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.02 [8.42 : 11.62] *
|
|
|
Favours placebo
|
|
Favours semaglutide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-2
|
0
|
2
|
4
|
6
|
8
|
|
|
10
|
|
12
|
14
|
|
|
-
statistically significant; p-values other than physical function were not controlled for multiplicity
PRO: patient reported outcome; CI: confidence interval, ETD: estimated treatment difference, IWQoL-Lite-CT: Impact of Weight on Quality of Life- lite:
57
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
The AM833 phase 2 monotherapy trial and phase 1 combination with semaglutide trial decreased weight by 10.8% and 17.1%
Weight loss for AM833 plus lifestyle intervention1
0
|
|
|
Mean baseline: 107.4 kg
|
-4
|
|
|
|
|
-8
|
|
|
|
|
|
|
|
|
- 10.8%
|
-12
|
|
|
|
|
0
|
|
Weeks
|
|
26
|
|
|
|
|
AM833
|
AM833
|
AM833
|
AM833
|
AM833
|
0.3mg
|
0.6mg
|
1.2mg
|
2.4mg
|
4.5mg
|
Placebo
|
Lira
|
|
|
|
|
3.0mg
|
|
|
|
Weight loss for AM833 and semaglutide in phase 12
0
|
|
Mean baseline: 95.1 kg
|
-4
|
|
|
-8
|
|
- 9.5%
|
|
|
-12
|
|
|
-16
|
|
- 17.1%
|
|
|
-20
|
|
|
0
|
Weeks
|
20
|
|
|
AM833 0.3 mg
|
AM833 0.16 mg
|
AM833 0.6 mg
|
AM833 1.2 mg
|
AM833 2.4 mg
|
sema 2.4 mg
|
sema 2.4 mg
|
sema 2.4 mg
|
sema 2.4 mg
|
sema 2.4 mg
|
sema 2.4 mg
|
|
|
|
|
-
Lifestyle intervention is defined as counselling for a reduced-calorie diet and increased physical activity. Data is based on the trial product estimand: treatment effect if all people adhered to treatment and did not initiate other anti-obesity therapies
-
Data are observed means, 20 week phase 1b trial dosing increments with semaglutide and AM833 once-weekly with a 16 week dose-escalation regimen. Data is based on the trial product estimand.
58
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk obesity pipeline supports efforts to close the treatment gap
Innovation curve
Body weight set-point and counter regulation
Novo Nordisk's current pipeline is closing the treatment gap
%
0
Weight loss prediction for patient groups
Oral product
20-30% weight loss
Increase weight loss towards 15-
|
|
Today's marketed
|
5
|
30%
|
treatment options
|
Investigate product
|
|
10
|
|
combinations
|
Semaglutide 2.4 mg
|
15
|
Provide data applicable for
|
individualised treatment
|
20
|
Pipeline
|
Targeted treatment solutions
Saxenda®
|
10-15% weight loss
|
Today
1 Long-term Drug Treatment for Obesity: A Systematic and Clinical Review; Susan Z. Yanovski, MD; Jack A. Yanovski, MD, PHD JAMA.2014; 311(1):74-86.2 Treatment of Obesity: Weight Loss and Bariatric Surgery; Bruce M. Wolfe, Elizaveta Kvach and Robert H. Eckel; Circulation Research. 2016; 118:1844-1855
Investor presentation
|
First nine months of 2020
|
SECURE A LEADING POSITION BY
LEVERAGING FULL PORTFOLIO AND
EXPANDING INTO ADJACENT AREAS
|
1. Haemophilia
|
61
|
|
|
|
|
|
|
2. Growth hormone disorders
|
62
|
|
|
|
|
|
|
|
|
|
|
3. Biopharm innovation
|
64
|
|
|
Biopharm
|
|
60
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Biopharm sustained growth outlook is supported by innovation and utilisation of core capabilities
Internal and external innovation to drive
|
Core capabilities within research and
|
long-term growth
|
development to drive long-term growth
|
Bringing
|
Ensuring future
|
Exploring new
|
Leveraging
|
internal
|
growth by
|
technologies by
|
deep biological
|
innovation to
|
leveraging
|
utilising added
|
understanding
|
market by
|
external
|
research
|
for future
|
pipeline
|
innovation
|
platforms
|
growth
|
progression
|
|
|
|
61
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Haemophilia is a rare disease with severe unmet medical needs and the market is highly competitive
Low diagnosis and treatment rates
Number ofwithin haemophilia people (000)
500
400
300
200
100
0
|
People with
|
Diagnosed
|
Inhibitor
|
haemophilia
|
|
|
|
|
|
|
Haemophilia A
|
|
Haemophilia B
|
|
|
|
|
|
Note: The inhibitor segment includes acquired haemophilia patients, patients with low titre inhibitors or with transient inhibitors, and patients on immune tolerance induction.
Source: World Federation of Haemophilia (WFH) - Annual survey 2018; WFH: Closing the gap - achieving optimal care, Haemophilia 2012.
Sales of recombinant haemophilia products
DKK billion
40
30
20
10
0
2015
|
2019
|
2015
|
2019
|
2015
|
2019
|
Haemophilia
|
Haemophilia A
|
|
Haemophilia B
|
with inhibitors
|
|
|
|
|
|
|
|
|
NovoSeven®
|
|
NovoEight®
|
|
|
Refixia®/Rebinyn®
|
|
|
|
|
|
|
|
Advate/Adynovate
|
|
|
Idelvion
|
|
Coagil VII
|
|
|
|
|
|
Obizur1
|
|
Kogenate/Kovaltry/Jivi
|
|
|
Rixubis
|
|
|
|
|
|
Feiba2
|
|
Xyntha/Refacto
|
|
|
Alprolix
|
|
|
|
|
|
Hemlibra3
|
|
Eloctate/Elocta
|
|
|
Benefix
|
|
|
|
|
|
|
|
|
|
|
Helixate/Afstyla
Hemlibra
1 Obizur only indicated for acquired haemophilia; 2 Plasma-derived;3 Part of the Hemlibra sales is used for treatment of haemophilia A patients in 2019
Source: Company reported sales and Evaluate
62
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Biopharm sales growth of 4% driven by solid commercial execution with key brands being NovoSeven® and Norditropin®
|
|
|
NovoSeven® and Norditropin®
|
|
|
|
DKK
|
|
|
account for 80% of Biopharm sales
|
|
|
|
|
|
|
|
|
|
|
|
|
billion
|
|
|
|
|
|
|
|
|
|
|
|
|
25
|
6%
|
|
4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20
|
|
|
|
|
-16%
|
|
-1%
|
|
|
4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
0
2015
|
2016
|
2017
|
2018
|
2019
|
9M 2020
|
Added sales in the haemophilia product portfolio
DKK
|
|
|
|
|
billion
|
|
|
|
|
7.7
|
|
|
|
|
|
|
|
|
7.5
|
9M 2019
|
NovoSeven®
|
NovoEight®
|
Other
|
9M 2020
|
|
NovoSeven®
|
|
Other haemophilia products
|
|
|
|
Norditropin®
|
|
Other biopharm
|
|
|
|
|
|
|
|
Growth at CER
|
Note: Company reported sales; CER: Constant exchange rates
63
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Solid commercial execution is driving 13% Norditropin® sales growth in the first nine months of 2020
Historic reported sales
for Norditropin®
DKK billion
6
3
0
2015 2016 2017 2018 2019 9M Norditropin® Growth at CER 2020
Norditropin® value leadership maintained
despite increasing competition
20%
10%
0%
Aug
|
|
Novo Nordisk
|
|
Pfizer
|
Aug
|
|
|
2015
|
|
Eli Lilly
|
|
Roche
|
2020
|
|
|
|
|
|
|
Merck Kgaa
|
|
Sandoz
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
Continue frequent launches with new
indications and device upgrades
Device portfolio
|
Current
|
Towards
|
|
launches
|
2022
|
Noonan syndrome,
|
16
|
30
|
EU device upgrades
|
Note: Company reported sales; CER: Constant exchange rates
|
Note: IQVIA, MAT value DKK, Aug 2020
|
64
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Scientific excellence ensures an innovative and competitive pipeline with therapeutic solutions for severe conditions
Innovation in haemophilia
1986
More than 35 years of innovation
Curative therapy
Non-invasive therapy
Mim8
Concizumab
Esperoct®
Refixia®
NovoEight®
NovoThirteen®
NovoSeven®
TodayFuture
Biopharm pipeline
Current
|
2018
|
2019
|
2020
|
………2021 …..
|
phases
|
|
|
|
|
Phase 3a
|
|
|
Concizumab
|
|
|
|
HA and HB1
|
|
Phase 3a
|
|
|
Concizumab
|
|
|
|
HAwI/HBwI1
|
|
|
|
|
|
Phase 1
|
|
EPI01 (SCD)
|
|
Phase 1/2
|
|
|
Mim8
|
|
Phase 3
|
|
|
Somapacitan GHD
|
Phase 2
|
|
|
Somapacitan SGA
|
1 The convizumab phase 3 programme was resumed in August 2020.
SCD: Sickle-cell disease; SGA: Short of gestational age; HwI: Haemophilia A or B patients with inhibitors; SGA: small for gestational age; GHD: Growth hormone deficiency
65
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Phase 3 programme on-going investigating concizumab for haemophilia A and B irrespective of inhibitor status
Phase 3 trials with data expected first half of 2021
Exp7 and Exp8: On-demandtreatment
Exp7 and Exp8:
Phase 2 patients on concizumab prophylaxis
Exp7 (with inhibitors): Prophylaxis with bypassing or on-demand
Exp8 (without inhibitors): Prophylaxis with factor replacement or on-demand
Arm 1: No prophylaxis
Arm 2: Concizumab
prophylaxis
Arm 3: Concizumab
prophylaxis
Arm 4: Concizumab
prophylaxis
Main part:
24 weeks treatment
Extension with
concizumab prophylaxis
Extension:
Up to 136 weeks treatment
Characteristics and next steps
-
High affinity, humanised monoclonal IgG4 antibody
-
First-in-classanti-TFPI boosting the initiation phase to restore haemostasis
-
Delivered once-daily in a convenient Flextouch® pen
-
Safe and well-tolerated in phase 2 and efficacy comparable to factor replacement
66
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Next-generation FVIII mimentic, Mim8, is a bispecific antibody for SC prophylaxis treatment in people with haemophilia A
|
|
|
Thrombin generation assay
|
|
|
Thromboelastography
|
|
|
|
400
|
HA plasma + FVIII
|
|
|
|
|
150
|
|
|
|
HA
|
|
|
|
|
|
|
|
|
|
|
|
(nM)
|
300
|
|
|
|
|
|
(min)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peak
|
|
|
Mim8
|
|
|
|
-time
|
100
|
|
|
emicizumab1
|
|
200
|
|
|
|
|
|
|
|
|
Thrombin
|
|
|
|
|
|
Clottime, R
|
|
|
|
|
|
|
100
|
|
|
|
emicizumab1
|
50
|
Mim8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HA
|
|
Normal control
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0
|
|
|
|
|
|
|
0
|
|
|
|
|
|
|
|
0.1
|
1
|
10
|
100
|
1000
|
|
0.01
|
0.1
|
1
|
10
|
100
|
1000
|
|
|
|
Antibody (nM)
|
|
|
|
|
|
Antibody (nM)
|
|
|
Mim8 potently stimulates FX activation resulting in efficacious haemostasis in vitro and in vivo
Mim8 effectively stops severe bleeds in mouse models
Characteristics
-
Strong activity at site of bleeding
-
Minimised target binding in circulation
-
Delivered in an innovative device
Phase 1/2 trial
-
Initiated in January 2020
-
Phase 1 is a single ascending dose part with 40 treated people
-
Phase 2 is a multiple ascending dose part with 32 treated people
-
Trial investigates safety, tolerability, PK/PD of single sc injections
1 Sequence-identical-analogue (SIA) of the FVIII-mimicking bispecific antibody emicizumab; PK: pharmacokinetics; PD: pharmacodynamics; SC: subcutaneous
67
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Once-weekly, biodegradable somapacitan has entered phase 3 for GHD and is approved in the US for AGHD indication
Phase 2 trial in GHD with 1-year efficacy and safety
|
Somapacitan
|
|
|
|
16
|
|
|
*
|
|
|
|
|
|
|
|
14
|
|
|
11.5
|
|
|
|
|
|
|
|
|
|
|
10.01
|
|
|
|
|
|
|
12
|
|
9.7
|
|
Growth hormone with a
|
Albumin binding side
|
|
velocityheight
|
|
|
|
|
Mean
|
(cm/year)
|
|
|
|
|
single amino acid
|
chain securing
|
|
7.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
substitution
|
reversible binding to
|
|
|
|
|
|
|
|
|
|
|
8
|
|
|
|
|
|
|
endogenous albumin
|
|
|
|
|
|
|
|
Next steps
|
|
|
|
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Somapacitan in children (GHD)
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
•
|
Phase 3 trial (REAL 4) has been initiated
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
|
|
|
•
|
Somapacitan dose 0.16 mg/kg/week
|
|
|
|
0
|
|
|
|
|
|
Somapacitan in children (SGA)
|
|
|
|
|
|
|
|
•
|
Phase 2 trial (REAL 5) has been initiated
|
|
|
|
|
0.04
|
0.08
|
0.16
|
0.034
|
|
|
|
|
|
Somapacitan in adults (AGHD)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Somapacitan
|
|
Norditropin®
|
•
|
Has been approved in the US under tradename
|
|
|
|
|
|
(mg/kg/week)
|
|
(mg/day)
|
|
Sogroya®
|
|
|
|
|
|
|
|
|
|
•
|
Has been submitted in the EU and Japan
|
Data are mean height velocity (cm/year) ± SD at week (wk) 52. Doses are mg/kg/time. * Denotes statistical significance difference compared to once-daily Norditropin®. GHD: Growth hormone deficiency; AGHD: Adult-onset growth hormone deficiency; FDA: Food and Drug Administration; EMA; European Medicines Agency; 1Value was 9.8 for the full analysis set. Value of 10.0 is from a post-hoc analysis that excluded 4 visits of one patient who discontinued prematurely at week 6
68
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk and bluebird bio join forces in next-generation genome editing for children and adult patients with haemophilia A
Potential curative treatment in
haemophilia A
-
mRNA-basedmegaTAL™-driven gene editing
-
Highly specific and efficient way to silence, edit or insert genetic components.
-
Allows for gene editing in all age groups
bluebird bio/Novo Nordisk's joint
approach
-
megaTAL™: Proprietary, patented technology, broad IP
-
Correcting FVIII-clotting factor deficiency
-
Potential lifelong effect
-
Possibility to explore additional therapeutic targets
AAV: Adenovirus vector; BDD: B-domain deleted; hFVIII: human factor VIII; LNP: Lipid nanoparticle; mRNA: messenger ribonucleic acid; TAL: transcription activator-like.
Investor presentation
|
First nine months of 2020
|
ESTABLISH PRESENCE BY BUILDING
COMPETITIVE PIPELINE AND
SCIENTIFIC LEADERSHIP
|
1. The unmet needs
|
70
|
|
|
|
|
|
|
|
|
|
|
|
|
2. Cardiovascular disease
|
71
|
|
|
|
|
|
|
|
|
|
|
|
|
3. Non-alcoholic steatohepatitis
|
73
|
|
|
|
|
|
|
|
4. Stem cells
|
|
74
|
|
|
|
|
|
Other serious
|
|
|
|
chronic diseases
70
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk is expanding into other serious chronic diseases
Serious chronic diseases are often associated with diabetes and obesity
|
New therapeutic areas represent patient populations with high
|
|
unmet medical needs
|
• 70% of people with diabetes die
CVD
|
|
from atherosclerotic CVD
|
•
|
40% of people hospitalised for
|
|
|
|
heart failure have diabetes
|
NASH
|
• 80% of people with NASH live with
|
obesity and 35% have diabetes
|
|
|
|
-
40% of people with diabetes have
CKD diabetic nephropathy and 50% have obesity
|
Estimated patients
|
Number of related deaths
|
CVD
|
~420 million
|
~20 million annually
|
|
Estimated patients
|
Diagnosis rate
|
NASH
|
~15-40 million1
|
~20%2
|
CKD
|
~200 million
|
~20%
|
1 Internal forecast comprising the USA, Europe and Japan; 2 Diagnosis rate is considered a major uncertainty to the forecast CVD: Cardiovascular disease; NASH: Non-alcoholic Steatohepatitis; CKD: Chronic kidney disease
Source: Source: Diabetes Care 2005 Jan; 28(1): 164-176; Abera SF et al. Global, Regional, and National Burden of Cardiovascular Diseases for 10 Causes, 1990 to 2015, 2017; Heart Disease and Stroke Statistics, American Heart Association, 2017; Williams CD et al. Prevalence of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis among a largely middle-aged population utilizing ultrasound and liver biopsy, 2011; Addressing the global burden of chronic kidney disease through clinical and translational research, 2014
71
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Novo Nordisk's ambition within cardiovascular disease
In-licensing/acquisition
of mid-stage assets
Accelerate internal pipeline
Subcutaneous PCSK9i - successful
phase 1 results
At least one product launched between 2024-2028targeting atherosclerotic cardiovascular disease or heart failure with a highly innovative, first to market product serving a significant unmet need in a large patient population
72
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Acquisition of Corvidia Therapeutics supports Novo Nordisk's ambition within cardiovascular disease
Data from a phase 2a trial using ziltivekimab in CKD stage 5 patients with inflammation
|
Placebo
|
|
Ziltivekimab
|
|
|
|
2 mg
|
6 mg
|
20 mg
|
|
|
N=61
|
12
|
16
|
16
|
17
|
|
|
|
|
|
|
|
% of patients
|
|
hsCRP<2.0
|
14.3
|
43.8
|
60.0
|
90.9*
|
mg/L, Week 12
|
|
|
|
|
Conclusions:
-
Ziltivekimab effectively reduces C-reactive protein (CRP) in patients with CKD on dialysis
-
Ziltivekimab substantially reduced markers of inflammation with a trend towards improving NT-proBNP without adversely affecting lipoprotein lipids, neutrophils or platelets
Trial design of the phase 2b (RESCUE)
|
|
|
|
|
7.5 mg Q4W (66 patients)
|
|
|
|
|
|
CKD stage
|
|
|
15 mg Q4W (66 patients)
|
|
|
3-5 hsCRP
|
|
|
|
|
|
|
|
|
|
>2 mg/L
|
|
|
30 mg Q4W (66 patients)
|
|
|
|
|
|
|
|
Placebo Q4W (66 patients)
|
|
|
|
|
|
|
|
|
|
24-week treatment
|
Primary endpoint
-
Reduction of inflammation measured as reduction in C-reactive protein
Purpose/timing
-
Determine a dose for a potential phase 3 CVOT
73
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Semaglutide showed significant improvements in NASH resolution and could play a role in preventing disease progression
Semaglutide showed resolution of NASH with no worsening of
|
|
|
Proportion
|
fibrosis versus placebo in the phase 2 trial1
|
•
|
NASH resolution without worsening of
|
|
|
|
of patients
|
|
|
|
|
fibrosis is one of two critical endpoints
|
100%
|
|
|
|
|
defined by the FDA and EMA2
|
80%
|
|
|
|
• For prevention of NASH disease progression,
|
|
|
66.7% *
|
|
NASH resolution could be the more relevant
|
|
|
|
|
endpoint
|
60%
|
47.3% *
|
|
*
|
• To date, semaglutide NASH results are
|
|
46.9%
|
|
|
arguably the most convincing NASH
|
|
|
|
|
|
40%
|
|
|
|
|
resolution data shown
|
|
|
|
|
|
22.9%
|
|
|
|
• Semaglutide in NASH was granted
|
20%
|
|
|
|
|
Breakthrough Therapy designation in the US
|
0%
|
|
|
|
• Phase 3 programme expected to begin in
|
|
|
|
|
2021
|
Placebo
|
0.1 mg
|
0.2 mg
|
0.4 mg
|
|
|
*statistically significant at 72 weeks (p<0.05 vs placebo). Based on a complete case analysis using people with an evaluable biopsy at end of trial
-
Analysis included patients with fibrosis stage 1, 2 or 3 at baseline
-
FDA guidance on developing treatment for NASH: "Noncirrhotic Non-alcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment Guidance for Industry". EMA guidance on developing treatment for NASH: "Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)"
NASH: non-alcoholic steatohepatitis.
74
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
The stem cell platform has the potential to solve unmet needs for people with serious chronic diseases
STEM CELL TECHNOLOGY
|
|
|
|
|
Cell bank of
|
Differentiate
|
Treatment
|
Patient
|
Blastocyst
|
|
Pluripotent
|
transplanted at
|
|
undifferentiated
|
stem cells to
|
|
centres
|
|
|
embryonic
|
|
stem cells
|
specific cell
|
|
|
|
|
treatment centres
|
|
|
stem cells
|
|
|
|
|
|
|
|
|
|
|
|
types
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PartnersPartners
COMPLEMENTARY COMPETENCIES
Parkinson's disease
Collaboration with Lund University and partnership with Biolamina
Type 1 diabetes Encapsulation device in collaboration with universities
Chronic kidney disease
Partnership with Mayo Clinic
GMP-grade production capability in US facility utilising Novo Nordisk's core CMC capabilities
Ethical stem cell practices
IP positions on differentiation protocols
Academic collaborations with stem
cell technology experts
Dry age-related macular degeneration Partnership with Biolamina
Chronic heart failure
Partnership with Biolamina
Investor presentation
|
First nine months of 2020
|
1.
|
International Operations growth
|
76
|
|
|
|
|
|
|
2.
|
International Operations at a glance
|
78
|
|
|
|
|
|
|
3. EMEA
|
83
|
|
|
|
|
4. Region China
|
88
|
|
|
|
|
|
5. RoW
|
92
|
|
|
|
76
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Growth momentum has increased driven by demographics and the Market Fit approach
International Operations is diverse and
covers 190 markets
430M live with diabetes
570M live with obesity
IO's share of revenue 9M 2020
NAO 47%
53% IO
Historic growth has been in the
range of 4-6%
12%
20139M
Growth momentum has benefitted from
the Market Fit approach
40%
|
|
|
|
30%
|
|
|
30%
|
|
|
|
20%
|
|
|
23%
|
|
|
|
13%
|
10%
|
|
|
|
|
|
|
9%
|
0%
|
Aug
|
Market Fit
|
Aug
|
|
|
2017
|
approach
|
2020
|
|
introduced
|
-
Diabetes market share NN Diabetes SOG Market growth
NN Diabetes growth
NAO: North America Operations; IO: International Operations; SOG: Share of Growth
77
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
The medium-term growth is expected to be 6-10% annually driven by securing the base and three future growth enablers
Sales have increased by 5% since 2013, while
|
ILLUSTRATIVE
|
medium-term growth is expected to be 6-10%
|
6-10%
5%
|
2013
|
2014
|
2015
|
2016
|
2017
|
2018
|
2025
|
|
|
Future growth drivers
|
|
Base sales with mature therapy areas
|
|
|
|
Secure the sales base by leveraging biopharm and portfolio of short-acting and premix insulin
Drive additional growth through three future growth enablers
Establish basal market leadership
Drive GLP-1 market growth
Expand the obesity market
78
|
Investor presentation
|
First nine months of 2020
|
International Operations at a glance
|
|
Diabetes trend
|
|
|
Diabetes market by value and Novo
|
|
Million
|
|
|
|
DKK
|
Nordisk market share
|
|
700
|
|
22%
|
|
billion
|
|
|
|
|
|
200
|
|
|
|
80%
|
|
|
|
|
|
|
600
|
|
26%
|
|
|
|
|
|
|
500
|
|
|
|
150
|
|
29%1
|
GLP-1
|
60%
|
|
|
|
|
|
|
|
400
|
|
|
|
100
|
|
|
Insulin
|
40%
|
300
|
|
|
637
|
|
4%1
|
|
|
522
|
|
|
|
|
200
|
415
|
|
|
|
|
|
|
|
|
50
|
|
|
|
20%
|
|
|
|
|
|
|
|
100
|
|
|
|
|
|
9%1
|
OAD
|
|
0
|
2019
|
2030
|
2045
|
0
|
Aug
|
|
Aug
|
0%
|
|
|
2015
|
|
2020
|
|
|
|
Population with diabetes
|
|
|
|
|
|
|
|
|
GLP-1 MS
|
Insulin MS
|
OAD MS
|
|
|
Diabetes growth rate
|
|
|
|
|
|
|
|
|
|
|
Novo Nordisk®
Novo Nordisk reported sales
First nine months
|
Sales
|
Growth2
|
2020
|
(mDKK)
|
|
Long-acting insulin3
|
7,590
|
14%
|
Premix insulin4
|
7,799
|
8%
|
Fast-acting insulin5
|
8,170
|
8%
|
Human insulin
|
5,872
|
8%
|
Total insulin
|
29,431
|
10%
|
GLP-16
|
8,087
|
37%
|
Other Diabetes care7
|
2,250
|
(12%)
|
Diabetes care
|
39,768
|
13%
|
Obesity care
|
1,611
|
8%
|
(Saxenda®)
|
|
|
Diabetes & Obesity
|
41,379
|
12%
|
care
|
|
|
Biopharm8
|
9,020
|
8%
|
|
|
|
Total
|
50,399
|
12%
|
|
|
|
Diabetes trend estimates based on the following International Diabetes Foundation defined regions: Africa, Europe, Middle East and North Africa, South and Central America, South East Asia and Western Pacific Source: International Diabetes Federation: Diabetes Atlas 1th Edition 2000 and Diabetes Atlas 9th Edition 2019
1 CAGR calculated for 5-year period; Competitor insulin value market shares, as of Aug 2020: Novo Nordisk 49%, Sanofi 29% and Eli Lilly 15%; Competitor GLP-1 value market shares, as of Aug 2020: Novo Nordisk 52%, Eli Lilly 43% and AstraZeneca 5%; OAD: Oral anti-diabetic; MS: Market share; Source: IQVIA MAT, Aug 2020 value figures
2 At Constant exchange rates; 3 Comprises Tresiba®, Xultophy® and Levemir®; 4 Comprises Ryzodeg® and NovoMix®; 5 Comprises Fiasp® and NovoRapid®; 6 Comprises Victoza® and Ozempic®; 7 Comprises NovoNorm® and needles; 8 Comprises primarily NovoSeven®, NovoEight®, NovoThirteen®, Refixia®, Norditropin®, Vagifem® and Activelle®
79
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Diabetes market share and market growth in International Operations
Diabetes market growth and Novo Nordisk market share
10%
12%
0% Aug
|
NN market share
|
NN share of growth
|
Aug
|
2017
|
Market growth
|
NN growth
|
2020
|
|
|
Diabetes market size and growth
DKK
|
|
~9%
|
|
|
billion
|
|
7
|
171
|
|
4
|
3
|
157
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
~13%
|
|
|
|
|
|
|
|
|
|
|
|
22.7%
|
|
|
22.0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aug
|
Novo Nordisk
|
BI
|
|
Others
|
Aug
|
|
|
2019
|
|
|
Novo Nordisk
|
|
Competitors
|
2020
|
|
|
|
|
|
|
Source: IQVIA, Aug 2020, Value, MAT, all countries; NN: Novo Nordisk; BI: Boehringer Ingelheim
80
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Insulin market size and volume share of growth and market share in International Operations
|
Insulin market share and market size (DKK billion)
|
|
Market
|
Market
|
|
|
|
|
|
|
|
|
|
growth
|
share
|
Total
|
|
|
49%
|
|
|
59
|
5%
|
+0.8%
|
|
|
|
|
Long-
|
|
35%
|
27
|
|
|
|
7%
|
+1.2%
|
Acting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fast-
|
|
59%
|
15
|
|
|
|
6%
|
+0.9%
|
acting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Premix
|
75%
|
8
|
|
|
|
|
|
4%
|
+1.4%
|
|
|
49%
|
|
|
|
|
|
|
|
|
Human
|
|
|
8
|
|
|
|
|
|
-1.1%
|
-0.3%
|
|
|
|
|
|
Novo Nordisk
|
|
Competitors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Insulin volume: Share of growth and
market share
80%
|
|
|
10%
|
60%
|
|
66%
|
8%
|
|
|
|
|
|
50%
|
6%
|
40%
|
|
|
|
|
|
|
4%
|
20%
|
|
|
2%
|
|
|
|
0%
|
Aug
|
Aug
|
0%
|
|
2017
|
2020
|
|
|
NN market share
|
NN share of growth
|
|
Market growth
|
NN growth
|
|
Source: IQVIA, Aug 2020, LHS graph - Value, RHS Graph - Volume, MAT, all countries; NN: Novo Nordisk
81
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
GLP-1 market share and market growth
|
GLP-1 market growth and Novo Nordisk market share
|
80%
|
|
60%
|
60%
|
|
|
53%
|
40%
|
37%
|
31%
20%
0% Aug
|
NN market share
|
NN share of growth
|
Aug
|
2017
|
2020
|
|
Market growth
|
NN growth
|
|
GLP-1 market size and growth
DKK
billion~31%
218
30
14
|
|
~37%
|
|
|
50.3%
|
|
|
|
52.7%
|
|
|
|
|
Aug
|
Novo Nordisk
|
Eli Lilly
|
Others
|
Aug
|
2019
|
Novo Nordisk
|
Competitors
|
2020
|
|
|
Source: IQVIA, Aug 2020, Value, MAT, all countries; NN: Novo Nordisk
82
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Obesity market share and market growth in International Operations
Obesity market growth and Novo Nordisk market share
|
Obesity market size and growth
|
|
|
|
|
|
|
DKK
|
|
~1%
|
|
|
|
|
|
|
|
billion
|
|
|
|
|
|
|
|
|
|
|
4
|
|
|
|
|
|
|
4
|
0
|
|
50%
|
|
|
|
|
60%
|
|
|
|
|
|
|
|
|
|
|
|
40%
|
|
|
|
39%
|
50%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30%
|
|
|
|
|
40%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30%
|
|
|
|
|
20%
|
|
|
|
|
20%
|
|
|
~12%
|
|
|
|
|
|
|
|
|
|
|
10%
|
|
|
|
10%
|
10%
|
36%
|
|
|
40%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0%
|
Aug
|
NN market share
|
Market growth
|
Aug
|
0%
|
Aug
|
Saxenda®
|
Others
|
Aug
|
|
2017
|
|
|
2020
|
|
2019
|
|
|
2020
|
Source: IQVIA, Aug 2020, Value MAT, all countries
83
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Diabetes market by value and Novo
Novo Nordisk reported sales
First nine months
|
Sales
|
Growth2
|
2020
|
(mDKK)
|
|
200
|
28%
|
150
|
|
100
|
223
|
171
|
|
50
|
134
|
|
0
2019 2030 2045
Population with diabetes Diabetes growth rate
100
|
|
|
|
80%
|
80
|
|
27%1
|
GLP-1
|
60%
|
|
|
|
60
|
|
4%1
|
Insulin
|
|
|
|
40%
|
40
|
|
|
|
|
20
|
|
11%1
|
OAD
|
20%
|
|
|
|
0
|
Aug
|
|
Aug
|
0%
|
|
2015
|
|
2020
|
|
|
GLP-1 MS
|
Insulin MS
|
OAD MS
|
Long-acting insulin3
|
4,916
|
12%
|
Premix insulin4
|
2,275
|
(1%)
|
Fast-acting insulin5
|
4,968
|
6%
|
Human insulin
|
1,823
|
0%
|
Total insulin
|
13,982
|
6%
|
GLP-16
|
5,547
|
35%
|
Other Diabetes care7
|
547
|
(31%)
|
Diabetes care
|
20,076
|
11%
|
Obesity care
|
834
|
8%
|
(Saxenda®)
|
|
|
Diabetes & Obesity
|
20,910
|
11%
|
care
|
|
|
Biopharm8
|
5,249
|
10%
|
Total
|
26,159
|
11%
|
Diabetes trend estimates based on the following International Diabetes Foundation defined regions: Africa, Europe, Middle East and North Africa, South and Central America, South East Asia and Western Pacific Source: International Diabetes Federation: Diabetes Atlas 1th Edition 2000 and Diabetes Atlas 9th Edition 2019; EMEA: Europe, Middle East and Africa
1 CAGR calculated for 5-year period; Competitor insulin value market shares, as of Aug
|
2 At constant exchange rates; 3 Comprises Tresiba®, Xultophy® and Levemir®; 4
|
2020: Novo Nordisk 47%, Sanofi 33% and Eli Lilly 16%; Competitor GLP-1 value market
|
Comprises Ryzodeg® and NovoMix®; 5 Comprises Fiasp® and NovoRapid®; 6
|
shares, as of Aug 2020: Novo Nordisk 54%, Eli Lilly 41% and AstraZeneca 5%; OAD: Oral
|
Comprises Victoza® and Ozempic®; 7 Comprises NovoNorm® and needles; 8
|
anti-diabetic; MS: Market share; Source: IQVIA MAT, Aug 2020 value figures
|
Comprises primarily NovoSeven®, NovoEight®, NovoThirteen®, Refixia®,
|
|
Norditropin®, Vagifem® and Activelle®
|
84
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Diabetes market share and market growth in EMEA
Diabetes market growth and Novo Nordisk market share
20%
9%
0%
-20%
|
|
|
|
|
Aug
|
|
Aug
|
2017
|
|
2020
|
|
|
|
NN market share
|
|
NN share of growth
|
|
|
|
|
|
|
|
Market growth (right axis)
|
|
NN growth (right axis)
|
|
|
|
|
|
Diabetes market size and growth
|
|
DKK
|
|
~9%
|
|
|
billion
|
|
3
|
91
|
3
|
2
|
|
83
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
~12%
|
|
|
|
|
|
|
|
|
|
|
|
27.4%
|
|
|
26.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aug
|
Novo Nordisk
|
BI
|
|
Others
|
Aug
|
|
|
2019
|
|
|
|
|
|
|
2020
|
|
|
|
|
|
Novo Nordisk
|
|
Competitors
|
|
|
|
|
|
|
|
|
|
Source: IQVIA, Aug 2020, Value, MAT; NN: Novo Nordisk; BI- Boehringer Ingelheim
85
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Insulin market size and volume market share in EMEA
Insulin market share and market size (DKK billion)
Total
|
47%
|
|
|
37
|
Long-
|
38%
|
18
|
|
|
acting
|
|
|
|
|
|
|
|
Fast-
|
56%
|
11
|
|
|
acting
|
|
|
|
|
|
|
|
|
71%
|
|
|
|
|
Premix
|
4
|
|
|
|
|
|
44%
|
|
|
|
|
Human
|
4
|
|
|
|
|
|
|
|
Novo Nordisk
|
|
Competitors
|
|
|
|
|
|
|
Market Market
growth share
3% +1.0%
6% +1.7%
4% +0.9%
-0.6%+1.6%
-8% -0.7%
|
Insulin volume: market share
|
|
80%
|
|
|
|
12%
|
|
|
|
|
10%
|
60%
|
|
|
|
8%
|
|
|
|
47%
|
6%
|
40%
|
|
|
|
4%
|
|
|
|
4%
|
2%
|
20%
|
|
|
|
0%
|
|
|
|
|
-2%
|
0%
|
Aug
|
|
Aug
|
-4%
|
|
2017
|
NN market share
|
2020
|
|
|
|
Market growth (right axis)
|
|
NN growth (right axis)
Source: IQVIA, Aug 2020, LHS graph - Value, RHS Graph - Volume, MAT, Europe, Middle East & Africa, Share of growth not depicted due to too high numbers; NN: Novo Nordisk
86
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
GLP-1 market share and market growth in EMEA
GLP-1 market growth and Novo Nordisk market share
80%
54%
50%
34%
-10%
-40%
|
|
|
|
|
Aug
|
|
Aug
|
2017
|
|
2020
|
|
|
|
NN market share
|
|
NN share of growth
|
|
|
|
|
|
|
|
Market growth (right axis)
|
|
NN growth (right axis)
|
|
|
|
|
|
GLP-1 market size and growth
|
DKK
|
~30%
|
|
billion
|
|
1
|
13
|
|
|
2
|
|
0
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
~34%
|
|
|
52.9%
|
|
|
|
54.4%
|
|
|
|
|
Aug
|
Novo Nordisk
|
Eli Lilly
|
Others
|
Aug
|
2019
|
|
|
|
2020
|
Source: IQVIA, Aug 2020, Value, MAT, Europe, Middle East & Africa; NN: Novo Nordisk
87
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Obesity market share and market growth in EMEA
Obesity market growth and Novo Nordisk market share
|
Obesity market size and growth
|
70%
60%
50%
40%
30%
20%
10%
0%
65%
|
|
|
8%
|
Aug
|
NN Market Share
|
Market Growth
|
Aug
|
2017
|
2020
|
|
DKK
|
|
~8%
|
|
50%
|
billion
|
|
0.9
|
|
|
0.9
|
0.1
|
|
|
|
|
40%
|
|
|
|
|
30%
|
|
|
~14%
|
|
20%
|
|
|
|
|
|
62%
|
|
|
65%
|
10%
|
|
|
|
|
|
|
|
0%
|
Aug
|
Saxenda®
|
Others
|
Aug
|
|
|
2019
|
|
|
2020
|
Source: IQVIA, Aug 2020, Value, MAT, Europe, Middle East & Africa; NN: Novo Nordisk
88
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
|
Diabetes trend
|
|
|
Diabetes market by value and Novo
|
|
Million
|
|
|
|
|
Nordisk market share
|
|
|
|
|
|
DKK
|
|
|
|
250
|
|
|
|
billion
|
|
|
|
|
8%
|
|
25
|
|
|
|
100%
|
|
21%
|
|
|
|
|
|
|
|
|
|
|
|
200
|
|
|
|
|
|
|
|
|
|
|
20
|
|
|
|
80%
|
|
|
|
|
|
|
GLP-1
|
|
|
|
|
|
|
|
|
150
|
|
|
|
15
|
|
42%1
|
|
60%
|
100
|
|
197
|
212
|
10
|
|
9%1
|
Insulin
|
40%
|
|
|
|
163
|
|
|
|
|
|
|
|
|
50
|
|
|
|
5
|
|
10%1
|
OAD
|
20%
|
|
|
|
|
|
|
|
0
|
|
2030
|
2045
|
0
|
Aug
|
|
Aug
|
0%
|
2019
|
|
|
2015
|
|
2020
|
|
Population with diabetes
|
|
|
|
|
|
|
GLP-1 MS
|
Insulin MS
|
OAD MS
|
Diabetes growth rate
|
|
|
|
|
|
|
|
|
Novo Nordisk reported sales
First nine months
|
Sales
|
Growth2
|
2020
|
(mDKK)
|
|
|
|
|
Long-acting insulin3
|
1,120
|
39%
|
Premix insulin4
|
3,662
|
13%
|
Fast-acting insulin5
|
1,563
|
18%
|
Human insulin
|
2,178
|
2%
|
Total insulin
|
8,523
|
14%
|
GLP-16
|
799
|
24%
|
Other Diabetes care7
|
1,204
|
(5%)
|
Diabetes care
|
10,526
|
12%
|
Obesity care
|
6
|
(17%)
|
(Saxenda®)
|
|
|
Biopharm8
|
304
|
19%
|
|
|
|
Total
|
10,836
|
12%
|
|
|
|
Source: International Diabetes Federation: Diabetes Atlas 1th Edition 2000 and Diabetes Atlas 9th Edition 2019
1 CAGR calculated for last 5-year period
|
2 At constant exchange rates; 3 Comprises Tresiba® and Levemir®; 4 Comprises
|
Competitor insulin value market shares, as of Aug 2020: Novo Nordisk 47%, Sanofi
|
NovoMix®;5 Comprises NovoRapid®; 6 Comprises Victoza®; 7 Comprises
|
19%, Gan & Lee 13% and Eli Lilly 10%; Competitor GLP-1 value market shares, as of
|
NovoNorm® and needles; 8 Comprises primarily NovoSeven®, NovoEight® and
|
Aug 2020: Novo Nordisk 92% and AstraZeneca 3%
|
Norditropin®
|
OAD: Oral anti-diabetic; MS: Market share; Source: IQVIA MAT, Aug 2020 value figures
|
|
89
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Diabetes market share and market growth in Region China
Diabetes market growth and Novo Nordisk market share
40%
36%
30%
29%
20%
|
|
14%
|
10%
|
|
|
|
|
11%
|
0%
|
Aug
|
Aug
|
|
2017
|
2020
|
|
NN market share
|
NN share of growth
|
|
Market growth (right axis)
|
NN growth (right axis)
|
|
Diabetes market size and growth
|
|
DKK
|
~11%
|
1
|
21
|
billion
|
0
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
~14%
|
|
|
|
|
|
|
|
|
|
28.5%
|
|
|
27.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aug
|
Novo Nordisk
|
Merck
|
Others
|
Aug
|
|
|
2019
|
|
|
|
|
|
|
2020
|
|
|
|
|
|
Novo Nordisk
|
|
Competitors
|
|
|
|
|
|
|
|
|
|
Source: IQVIA, Aug 2020, Value, MAT, NN: Novo Nordisk
90
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Insulin market size and volume share of growth and market share in Region China
Insulin market share and market size (DKK billion)
Total
|
|
|
47%
|
11
|
|
17%
|
|
|
|
|
Long-
|
|
|
4
|
|
|
acting
|
|
|
|
|
|
|
|
|
|
|
80%
|
|
|
|
|
Fast-
|
1
|
|
|
|
acting
|
|
|
|
|
|
|
|
|
Premix
|
77%
|
3
|
|
|
Human
|
44%
|
|
2
|
|
|
|
|
|
Novo Nordisk
|
|
Competitors
|
|
|
|
|
|
|
|
|
Market Market
growth share
13% -0.3%
19% +1.9%
17% +0.3%
11% +0.2%
5% -2.5%
Insulin volume: market share
|
|
80%
|
|
|
50%
|
60%
|
|
|
40%
|
|
50%
|
|
|
|
30%
|
|
|
|
40%
|
|
|
|
|
|
37%
|
20%
|
20%
|
|
4%
|
10%
|
|
|
0% Aug
|
NN market share
|
Aug
|
0%
|
2017
|
2020
|
|
NN share of growth
|
|
|
|
|
Market growth (right axis)
NN growth (right axis)
Source: IQVIA, Aug 2020, LHS graph - Value, RHS Graph - Volume, MAT; NN: Novo Nordisk
91
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
GLP-1 market share and market growth in Region China
GLP-1 market growth and Novo Nordisk market share
100%
|
|
|
|
92%
|
80%
|
|
|
|
|
60%
|
|
|
|
|
40%
|
|
|
|
56%
|
|
|
|
|
|
|
|
|
56%
|
20%
|
|
|
|
|
0%
|
Aug
|
NN market share
|
Market growth
|
Aug
|
|
2017
|
2020
|
|
NN growth (right axis)
|
|
|
|
|
|
GLP-1 market size and growth
DKK
|
|
~56%
|
|
|
billion
|
|
|
|
|
0.0
|
0.0
|
0.6
|
|
0.2
|
|
|
|
|
0.4
|
|
|
|
|
|
|
~56%
|
|
|
|
|
|
|
92%
|
92%
|
|
|
|
|
Aug
|
Novo Nordisk
|
Eli Lilly
|
Others
|
Aug
|
2019
|
Novo Nordisk
|
Competitors
|
2020
|
|
|
Source: IQVIA, Aug 2020, Value, MAT; Share of growth not depicted due to too high numbers; NN: Novo Nordisk
92
|
Investor presentation
|
First nine months of 2020
|
Rest of World at a glance
|
|
Diabetes trend
|
|
|
|
Diabetes market by value and
|
|
Million
|
|
|
|
DKK
|
Novo Nordisk market share
|
|
|
|
|
|
|
|
|
|
|
30%
|
|
billion
|
|
|
|
200
|
|
|
|
|
|
|
|
|
|
|
|
70
|
|
|
|
|
80%
|
|
|
|
|
|
|
|
|
150
|
|
30%
|
|
60
|
|
|
32%1
|
GLP-1
|
|
|
|
|
50
|
|
|
60%
|
|
|
|
|
|
|
|
Insulin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2%1
|
|
|
|
|
|
40
|
|
|
|
|
100
|
|
|
202
|
|
|
|
|
40%
|
|
|
30
|
|
|
|
|
|
|
155
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
119
|
|
|
|
|
|
OAD
|
|
50
|
|
|
20
|
|
|
7%1
|
20%
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
0
|
2019
|
2030
|
2045
|
0
|
Aug
|
|
Aug
|
0%
|
|
|
2015
|
|
2020
|
|
|
Population with diabetes
|
|
|
|
|
|
|
|
|
GLP-1 MS
|
Insulin MS
|
OAD MS
|
|
Diabetes growth rate
|
|
|
|
|
|
|
|
|
|
|
|
Novo Nordisk®
Novo Nordisk reported sales
First nine months
|
Sales
|
Growth2
|
2020
|
(mDKK)
|
|
Long-acting insulin3
|
1,554
|
8%
|
Premix insulin4
|
1,862
|
11%
|
Fast-acting insulin5
|
1,639
|
5%
|
Human insulin
|
1,871
|
25%
|
Total insulin
|
6,926
|
12%
|
GLP-16
|
1,741
|
51%
|
Other Diabetes care7
|
499
|
(2%)
|
Diabetes care
|
9,166
|
17%
|
Obesity care
|
771
|
7%
|
(Saxenda®)
|
|
|
Diabetes & Obesity
|
9,937
|
16%
|
care
|
|
|
Biopharm8
|
3,467
|
5%
|
|
|
|
Total
|
13,404
|
13%
|
|
|
|
Diabetes trend estimates based on the following International Diabetes Foundation defined regions: South & Central America, Southeast Asia
International Diabetes Federation: Diabetes Atlas 1th Edition 2000 and Diabetes Atlas 9th Edition 2019
1 CAGR calculated for last 5-year period
Competitor insulin value market shares, as of Aug 2020: Novo Nordisk 56%, Sanofi
24% and Eli Lilly 16%; Competitor GLP-1 value market shares, as of Aug 2020: Novo Nordisk 42%, Eli Lilly 53% and AstraZeneca 4%
OAD: Oral anti-diabetic; MS: Market share; Source: IQVIA MAT, Aug 2020 value figures
-
At constant exchange rates 3 Comprises Tresiba®, Xultophy® and Levemir®; 4 Comprises NovoMix® and Ryzodeg®; 5 Comprises NovoRapid®; 6 Comprises Victoza® and Ozempic®;7 Comprises NovoNorm® and needles;
-
Comprises primarily NovoSeven®, NovoEight® and Norditropin®
93
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Diabetes market share and market growth in Rest of World
Diabetes market growth and Novo Nordisk market share
20%
|
|
|
14%
|
15%
|
13%
|
|
10%
|
|
5%
|
8%
|
|
0%
|
|
-5%
|
|
-10%Aug
|
Aug
|
2017
|
2020
|
NN market share
|
Market growth (right axis)
|
NN growth (right axis)
|
|
Diabetes market size and growth
|
|
|
|
~8%
|
2
|
59
|
|
1
|
1
|
55
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
~14%
|
|
|
|
|
|
|
|
|
|
|
|
13.3%
|
|
|
12.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aug
|
Novo Nordisk
|
BI
|
|
Others
|
Aug
|
|
|
2019
|
|
|
|
|
|
|
2020
|
|
|
|
|
|
Novo Nordisk
|
|
Competitors
|
|
|
|
|
|
|
|
|
|
Source: IQVIA, Aug 2020, Value, MAT, Rest of world; NN: Novo Nordisk BI: Boehringer Ingelheim
94
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Insulin market size and volume market share in Rest of World
Insulin market share and market size (DKK billion)
Market
|
Market
|
Insulin volume: market share
|
growth
|
share
|
|
Total
|
|
56%
|
|
|
Fast-
|
38%
|
4
|
|
|
acting
|
|
|
|
|
|
|
|
|
Long-
|
60%
|
2
|
|
|
|
acting
|
|
|
|
|
|
|
|
|
|
Premix
|
80%
|
2
|
|
|
|
|
Human
|
63%
|
2
|
|
|
|
|
|
|
|
Novo Nordisk
|
|
Competitors
|
|
|
|
|
|
4% +0.6%
6% +0.7%
5% +2.1%
4% 1.6%
0%
|
|
|
|
|
0%
|
Aug
|
|
|
Aug
|
2017
|
|
NN market share
|
2020
|
|
|
|
|
Market growth (right axis)
|
|
|
|
|
|
|
|
|
|
|
NN growth (right axis)
|
|
|
|
|
|
|
|
Source: IQVIA, Aug 2020, LHS graph - Value, RHS Graph - Volume, MAT; ; Share of growth not depicted due to too high numbers; NN: Novo Nordisk
95
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
GLP-1 market share and market growth in Rest of World
GLP-1 market growth and Novo Nordisk market share
80%
|
|
60%
|
47%
|
|
40%
|
42%
|
|
|
30%
|
20%
|
|
0%
|
|
-20%Aug
|
Aug
|
2017
|
2020
|
NN market share
|
NN share of growth
|
Market growth (right axis)
|
NN growth (right axis)
|
|
|
GLP-1 market size and growth
|
|
|
|
~31%
|
|
DKK
|
|
0.5
|
4.2
|
billion
|
0.6
|
-0.1
|
|
3.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
~47%
|
37.7%
|
|
|
|
|
|
|
42.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aug
|
Novo Nordisk
|
Eli Lilly
|
|
Others
|
Aug
|
|
2019
|
|
|
|
|
|
|
2020
|
|
|
|
|
Novo Nordisk
|
|
Competitors
|
|
|
|
|
|
|
|
Source: IQVIA, Aug 2020, Value, MAT; NN: Novo Nordisk
96
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Obesity market share and market growth in Rest of World
Obesity market growth and Novo Nordisk market share
40%
|
|
|
|
25%
|
|
|
|
31%
|
20%
|
30%
|
|
|
|
|
|
|
|
|
15%
|
20%
|
|
|
|
10%
|
|
|
|
|
5%
|
10%
|
|
|
|
|
|
|
|
|
0%
|
|
|
|
-1%
|
|
0%
|
Aug
|
NN market share
|
Aug
|
-5%
|
|
2017
|
Market growth (Right Axis)
|
2020
|
|
|
|
Obesity market size and growth
|
|
DKK
|
~(1%)
|
|
|
billion
|
|
|
|
|
|
|
|
|
2.9
|
|
|
|
|
|
|
|
2.9
|
|
|
0.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
~10%
|
|
28%
|
|
|
31%
|
Aug
|
Saxenda®
|
Others
|
Aug
|
2019
|
|
|
2020
|
Source: IQVIA, Aug 2020, Value, MAT,; NN: Novo Nordisk
Investor presentation
|
First nine months of 2020
|
|
1.
|
US growth drivers
|
98
|
|
|
|
|
|
|
|
|
2. US healthcare system
|
99
|
|
|
|
|
North America
|
3.
|
North America operations at glance
|
102
|
|
|
Operations
|
|
98
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
Innovation drives largest transition in the history of Novo Nordisk USA, turning around 70% of sales in just seven years
Directional growth drivers and catalysts
|
GLP-1
|
|
|
Obesity
|
|
|
Insulin
|
|
|
Biopharm
|
|
|
|
|
|
|
|
|
|
|
|
•
|
Ozempic® launch
|
|
•
|
Semaglutide obesity
|
|
•
|
Continued price
|
|
•
|
Competitive
|
•
|
Rybelsus® launch
|
|
|
launch
|
|
|
pressure
|
|
|
pressure
|
|
•
|
Saxenda® LoE
|
|
•
|
Biosimilar
|
|
•
|
New product
|
•
|
Victoza® LoE
|
|
|
|
|
|
|
|
|
competition
|
|
|
launches
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Relative sales composition - 47% transformation complete
100%
80%
60%
40%
30%
20%
0%
2015
|
|
|
2022
|
Biopharm
|
|
Mature insulin1
|
|
Victoza®
|
|
|
Obesity
|
|
New GLP-1
|
|
New insulin
|
|
|
|
|
launches2
|
|
launches3
|
1 Modern insulin, human insulin, Prandin®, devices and needles; 2 Ozempic® and Rybelsus®; 3 Tresiba®, Xultophy®, Fiasp® and follow-on brand insulin LoE: Loss of exclusivity
99
|
Investor presentation
|
First nine months of 2020
|
Novo Nordisk®
|
US insulin net prices have declined in recent years, yet some patients still struggle with affordability
The US population by health
|
|
List price and net price
|
Novo Nordisk insulin affordability
|
insurance coverage
|
|
development for NovoLog® vial
|
offerings in the US
|
Private insurance schemes
|
|
Uninsured
|
|
List price1
|
Net price1
|
|
|
|
|
Government insurance schemes
|
|
|
|
|
|
|
|
|
|
|
|
8%
44%
48%
333 million people
Note: Government insurance schemes cover Medicare, Medicaid and public exchanges - some of these with high deductibles
Source: Census.gov; Congressional Budget Office Health Insurance Coverage 2016- 2026; Medicare Enrollment Dashboard; CMS Health Insurance Enrollment Projection 2015-2025; Medicaid and CHIP Enrollment Report Oct 2017; CMS Insurance Marketplace Fact sheet 2017; CDC.gov
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
• Follow-onbrand fast-acting (Novolog®) and premix
|
600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
insulin (Novolog® Mix) with 50% list price discount vs.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
branded versions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
•
|
My$99Insulin 30-day supply of a combination of Novo
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nordisk insulin products (up to 3 vials or 2 packs of
|
400
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pens) for USD 99
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
• Patient Assistance Program free diabetes medication
|
300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
to people in need, annual income <400% above
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
government defined poverty. Program expanded
|
200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
during COVID-19 outbreak if job loss and limited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
coverage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|