COMMERCIAL EXECUTION
SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
Sales grew by 24% measured in Danish kroner and by 18% at CER the first three months of 2022, driven by growth across all therapy areas with Diabetes care sales growth of 16% (CER), Obesity care sales growth of 107% (CER) and Rare disease sales growth of 3% (CER).
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Sales split per therapy | Sales Q1 2022 DKK million | Sales Q1 2021 DKK million | | Growth as reported | Growth at CER | Share of growth at CER |
Diabetes and Obesity care segment | | | | | | |
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Rybelsus® | 2,063 | | 729 | | | 183 | % | 167 | % | 20 | % |
Ozempic® | 12,035 | | 6,662 | | | 81 | % | 70 | % | 77 | % |
Victoza® | 3,322 | | 3,909 | | | (15 | %) | (20 | %) | (13 | %) |
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Total GLP-1 | 17,420 | | 11,300 | | | 54 | % | 45 | % | 84 | % |
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Long-acting insulin | 4,796 | | 4,822 | | | (1 | %) | (4 | %) | (3 | %) |
| - Tresiba® | 2,564 | | 2,365 | | | 8 | % | 4 | % | 2 | % |
| - Xultophy® | 717 | | 681 | | | 5 | % | 3 | % | 0 | % |
| - Levemir® | 1,515 | | 1,776 | | | (15 | %) | (18 | %) | (5 | %) |
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Premix insulin | 3,012 | | 2,953 | | | 2 | % | (3 | %) | (2 | %) |
| - Ryzodeg® | 637 | | 420 | | | 52 | % | 48 | % | 3 | % |
| - NovoMix® | 2,375 | | 2,533 | | | (6 | %) | (12 | %) | (5 | %) |
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Fast-acting insulin | 4,842 | | 4,556 | | | 6 | % | 2 | % | 1 | % |
| - Fiasp® | 497 | | 402 | | | 24 | % | 20 | % | 1 | % |
| - NovoRapid® | 4,345 | | 4,154 | | | 5 | % | 0 | % | 0 | % |
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Human insulin | 2,312 | | 2,535 | | | (9 | %) | (14 | %) | (6 | %) |
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Total insulin | 14,962 | | 14,866 | | | 1 | % | (4 | %) | (10 | %) |
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Other Diabetes care1 | 884 | | 1,110 | | | (20 | %) | (25 | %) | (4 | %) |
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Total Diabetes care | 33,266 | | 27,276 | | | 22 | % | 16 | % | 70 | % |
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Wegovy® | 1,404 | | — | | | — | | — | | 21 | % |
Saxenda® | 1,998 | | 1,551 | | | 29 | % | 23 | % | 6 | % |
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Total Obesity care | 3,402 | | 1,551 | | | 119 | % | 107 | % | 27 | % |
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Diabetes and Obesity care total | 36,668 | | 28,827 | | | 27 | % | 20 | % | 97 | % |
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Rare disease segment | | | | | | |
Rare blood disorders2 | 3,077 | | 2,678 | | | 15 | % | 9 | % | 4 | % |
| - Haemophilia A | 565 | | 497 | | | 14 | % | 10 | % | 1 | % |
| - Haemophilia B | 177 | | 147 | | | 20 | % | 18 | % | 0 | % |
| - NovoSeven® | 2,271 | | 1,980 | | | 15 | % | 8 | % | 3 | % |
Rare endocrine disorders3 | 1,820 | | 1,920 | | | (5 | %) | (8 | %) | (2 | %) |
Other Rare disease4 | 466 | | 379 | | | 23 | % | 18 | % | 1 | % |
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Rare disease total | 5,363 | | 4,977 | | | 8 | % | 3 | % | 3 | % |
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Total sales | 42,031 | | 33,804 | | | 24 | % | 18 | % | 100 | % |
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1) Primarily NovoNorm®, needles and GlucaGen® HypoKit®. | | | | |
2) Comprises NovoSeven®, NovoEight®, Esperoct®, Refixia® and NovoThirteen®. | | |
3) Primarily Norditropin®. | | | | |
4) Primarily Vagifem® and Activelle®. |
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
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Financial report for the period 1 January 2022 to 31 March 2022 | |
DIABETES AND OBESITY CARE
Diabetes care, sales and market share development
Sales in Diabetes care increased by 22% measured in Danish kroner and by 16% at CER to DKK 33,266 million driven by GLP-1 growth. Novo Nordisk has improved the global diabetes value market share over the last 12 months from 29.3% to 30.5% in line with the aspiration of strengthening the Diabetes care leadership, aiming at reaching a global value market share of more than one third in 2025. The market share increase was driven by market share gains in both International Operations and North America Operations.
In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from February 2021 and February 2022 provided by the independent data provider IQVIA. EMEA covers Europe, the Middle East and Africa; Region China covers mainland China, Hong Kong and Taiwan, and Rest of World covers all other countries except for North America. | | | | | | | | | | | | | | | | | |
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Diabetes care, development per geographical area | Novo Nordisk’s share of the total diabetes market (value, MAT) | Diabetes care, sales development |
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| | February | February | Sales Q1 2022 DKK million | Growth at CER |
| | 2022 | 2021 |
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Global | 30.5 | % | 29.3 | % | 33,266 | | 16 | % |
International Operations | 25.4 | % | 23.6 | % | 17,532 | | 13 | % |
| - EMEA * | 28.9 | % | 27.8 | % | 8,416 | | 15 | % |
| - Region China ** | 33.1 | % | 31.7 | % | 4,656 | | 0 | % |
| - Rest of World *** | 16.4 | % | 13.7 | % | 4,460 | | 27 | % |
North America Operations | 32.3 | % | 31.5 | % | 15,734 | | 18 | % |
| - The US | 32.2 | % | 31.5 | % | 14,740 | | 17 | % |
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Source: IQVIA, February 2022 data. *Data for EMEA available for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk Diabetes care sales in the area. **Data for mainland China, excluding Hong Kong and Taiwan. *** Data for Rest of World available for seven markets representing approximately 70% of total Novo Nordisk’s Diabetes care sales in the area.
GLP-1 therapy for type 2 diabetes
Sales of GLP-1 products for type 2 diabetes (Rybelsus®, Ozempic® and Victoza®) increased by 54% measured in Danish kroner and by 45% at CER to DKK 17,420 million. The GLP-1 segment’s value share of the total diabetes market has increased to 27.8% compared with 22.8% 12 months ago. Novo Nordisk continues to be the global market leader in the GLP-1 segment with a 53.6% value market share, an increase of 2.8 percentage points compared to 12 months ago. | | | | | | | | | | | | | | | | | |
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GLP-1, development per geographical area | Novo Nordisk's share of the diabetes GLP-1 market (value, MAT) | GLP-1, sales development |
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| | February | February | Sales Q1 2022 DKK million | Growth at CER |
| | 2022 | 2021 |
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Global | 53.6 | % | 50.8 | % | 17,420 | | 45 | % |
International Operations | 60.1 | % | 54.9 | % | 5,874 | | 60 | % |
| - EMEA * | 58.9 | % | 56.0 | % | 3,249 | | 38 | % |
| - Region China ** | 67.3 | % | 88.9 | % | 888 | | 101 | % |
| - Rest of World *** | 61.8 | % | 45.3 | % | 1,737 | | 104 | % |
North America Operations | 52.6 | % | 50.2 | % | 11,546 | | 38 | % |
| - The US | 51.8 | % | 49.5 | % | 10,861 | | 37 | % |
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Source: IQVIA, February 2022 data. *Data for EMEA available for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk GLP-1 sales in the area. **Data for mainland China, excluding Hong Kong and Taiwan. ***Data for Rest of World available for seven markets representing approximately 70% of total Novo Nordisk Diabetes care sales in the area.
Rybelsus® sales increased by 183% measured in Danish kroner and by 167% at CER to DKK 2,063 million. Sales growth was driven by North America Operations as well as EMEA and Rest of World. Rybelsus® has now been launched in 34 countries.
Ozempic® sales increased by 81% measured in Danish kroner and by 70% at CER to DKK 12,035 million. Sales growth was driven by both North America Operations and International Operations. Ozempic® has been launched in 72 countries.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
Victoza® sales decreased by 15% measured in Danish kroner and by 20% at CER to DKK 3,322 million as the GLP-1 market is moving towards once-weekly and tablet-based treatments. The sales decline was driven by both North America Operations and International Operations.
International Operations
Sales of GLP-1 diabetes products in International Operations increased by 66% measured in Danish kroner and by 60% at CER. Sales growth is driven by all geographical areas. The value share of the GLP-1 class of the total diabetes market has increased to 14.5% from 11.2% 12 months ago. Novo Nordisk is the market leader with a value market share of 60.1%.
EMEA
Sales in EMEA increased by 40% measured in Danish kroner and by 38% at CER. The sales growth reflects the uptake of Ozempic® and Rybelsus®, partially offset by lower sales of Victoza®. Rybelsus® has been launched in 24 countries in EMEA. Novo Nordisk remains the market leader in EMEA with a value market share of 58.9%.
Region China
Sales in Region China increased by 120% measured in Danish kroner and by 101% at CER. The sales growth reflects the uptake of Ozempic®. As of 1 January 2022, Ozempic® has been included on the National Reimbursement List in China. The GLP-1 class' share of the overall diabetes market value in Region China increased to 6.8% from 3.4% 12 months ago.
Rest of World
Sales in Rest of World increased by 113% measured in Danish kroner and by 104% at CER. The sales growth reflects increased sales of Ozempic® and Rybelsus®, following the launch in Japan, partially offset by Victoza®. Novo Nordisk remains the market leader with a value market share of 61.8%.
North America Operations
Sales of GLP-1 diabetes products in North America Operations increased by 49% measured in Danish kroner and by 38% at CER. Novo Nordisk is the market leader with a 52.6% value market share compared to 50.2% 12 months ago. The value market share of the GLP-1 class of the total North American diabetes market has increased to 32.5% compared to 27.0% 12 months ago.
Sales growth in the US is driven by a prescription volume growth of the GLP-1 class of more than 30% in the first quarter of 2022 compared to the first quarter of 2021 as well as market share gains for Ozempic® and Rybelsus®. During 2022, the weekly-new-to-brand scripts for Ozempic® has increased from around 20,000 to around 28,000. The weekly new-to-brand market share for Ozempic® is 48.2% and 12.5% for Rybelsus®. The combined Novo Nordisk GLP-1 new-to-brand prescription market share is now 65.7%. Novo Nordisk is the market leader with 54.2% measured on total monthly prescriptions for the combined GLP-1 portfolio.
Sales of GLP-1 in the US increased by 37% at CER. The sales increase was driven by continued uptake of Ozempic® and Rybelsus®, partially offset by declining Victoza® sales. GLP-1 sales growth was negatively impacted by rebate enhancements as well as unfavourable channel and payer mix.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
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Financial report for the period 1 January 2022 to 31 March 2022 | |
Insulin
Sales of insulin increased by 1% measured in Danish kroner and decreased by 4% at CER to DKK 14,962 million. Sales decline at CER was driven by declining sales in the US.
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Insulin, development per geographical area | Novo Nordisk’s share of the total insulin market (volume, MAT) | Insulin, sales development |
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| | February | February | Sales Q1 2022 DKK million | Growth at CER |
| | 2022 | 2021 |
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Global | 47.0 | % | 47.2 | % | 14,962 | | (4 | %) |
International Operations | 50.1 | % | 50.2 | % | 10,996 | | 1 | % |
| - EMEA * | 47.4 | % | 47.5 | % | 4,992 | | 4 | % |
| - Region China ** | 50.8 | % | 50.6 | % | 3,427 | | (6 | %) |
| - Rest of World *** | 57.1 | % | 57.3 | % | 2,577 | | 2 | % |
North America Operations | 38.6 | % | 39.4 | % | 3,966 | | (15 | %) |
| - The US | 38.1 | % | 39.1 | % | 3,691 | | (16 | %) |
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Source: IQVIA, February 2022 data. *Data for EMEA available for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk insulin sales in the area. **Data for mainland China, excluding Hong Kong and Taiwan. ***Data for Rest of World available for seven markets representing approximately 70% of total Novo Nordisk Diabetes care sales in the area.
International Operations
Sales of insulin in International Operations increased by 5% measured in Danish kroner and by 1% at CER. Sales growth at CER was driven by all insulin products except for human insulin, NovoMix® and Levemir®.
EMEA
Sales of insulin in EMEA increased by 5% measured in Danish kroner and by 4% at CER. The sales growth at CER was mainly driven by Tresiba®, NovoRapid®, Levemir® and Fiasp®, partially countered by NovoMix® and human insulin. Novo Nordisk has a volume market share of 47.4% of the total insulin market.
Region China
Sales of insulin in Region China increased by 3% measured in Danish kroner and decreased by 6% at CER. The sales decline at CER was driven by NovoMix®, human insulin and Levemir®, partially countered by Ryzodeg® and Tresiba®. Xultophy® was launched in February 2022. Insulin sales were negatively affected by supply chain impacts related to the implementation of Volume Based Procurement in May 2022. Novo Nordisk has a volume market share of 50.8% of the total insulin market.
Rest of World
Sales of insulin in Rest of World increased by 6% measured in Danish kroner and by 2% at CER. The sales growth at CER was driven by all insulin products except for human insulin and Levemir®. Novo Nordisk has a volume market share of 57.1% of the total insulin market.
North America Operations
Sales of insulin in North America Operations decreased by 9% measured in Danish kroner and by 15% at CER. The sales decrease in the US was driven by lower realised prices due to rebate enhancements and channel and payer mix as well as a decline in volume with the US insulin volume market declining 1% compared to the first quarter of 2021. Novo Nordisk has a volume market share of 38.6% of the total insulin market.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
Obesity care, sales development
Sales of Obesity care products, Saxenda® and Wegovy® increased by 119% measured in Danish kroner and by 107% at CER to DKK 3,402 million. Sales growth was driven by both North America Operations and International Operations. Saxenda® has been launched in 65 countries, and Wegovy® was launched in the US in June 2021. | | | | | | | | | | | |
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Obesity care, development per geographical area | Obesity care, sales development |
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| | Sales Q1 2022 DKK million | Growth at CER |
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Global | 3,402 | | 107 | % |
International Operations | 1,193 | | 63 | % |
| - EMEA | 726 | | 94 | % |
| - Region China | 37 | | — |
| - Rest of World | 430 | | 22 | % |
North America Operations | 2,209 | | 146 | % |
| - The US | 2,108 | | 158 | % |
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International Operations
Sales of Saxenda® in International Operations increased by 67% measured in Danish kroner and by 63% at CER driven by increased sales in EMEA and Rest of World. Novo Nordisk currently has a value market share of 54.3% in the branded obesity prescription drug market.
EMEA
Sales of Saxenda® in EMEA increased by 96% measured in Danish kroner and by 94% at CER. Novo Nordisk currently has a value market share of 73.5% in the branded obesity prescription drug market.
Rest of World
Sales of Saxenda® in Rest of World increased by 28% measured in Danish kroner and by 22% at CER. Saxenda® has been launched in 19 countries in Rest of World. Novo Nordisk currently has a value market share of 42.7% in the branded obesity prescription drug market.
North America Operations
Sales of Obesity care products in North America Operations increased by 164% measured in Danish kroner and by 146% at CER. Novo Nordisk now has a value market share of 91.5% in the branded anti-obesity prescription drug market in North America. Wegovy® was made available to patients in June 2021 and market access has progressed and commercial formulary access is now around 80%. Feedback from prescribers and patients has been encouraging and demand from patients exceeded supply.
In December 2021, Novo Nordisk announced that a contract manufacturer filling syringes for Wegovy® pens for the US market has temporarily stopped deliveries and manufacturing following issues with current Good Manufacturing Practices. Focus is on ensuring continuity of care to patients that have already initiated treatment, and in March 2022 Novo Nordisk had to stop supply of the lower Wegovy® doses (0.25 and 0.50 mg) to prevent new patients from initiating treatment. In addition, the 1.0 mg dose is currently out of stock.
The contract manufacturer has reinitiated commercial production and Novo Nordisk expects to make all Wegovy® dose strengths available in the US during the second half 2022.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
Rare disease
Rare disease, sales development
Sales of Rare disease products increased by 8% measured in Danish kroner and by 3% at CER to DKK 5,363 million in line with the strategic aspiration of sustained growth in Rare disease. The sales growth at CER was driven by both International Operations and North America Operations. Sales growth was driven by Rare blood disorders. | | | | | | | | | | | |
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Rare disease, development per geographical area | Rare disease, sales development |
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| | Sales Q1 2022 DKK million | Growth at CER |
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Global | 5,363 | | 3 | % |
International Operations | 3,316 | | 3 | % |
| - EMEA | 1,682 | | (13 | %) |
| - Region China | 148 | | 155 | % |
| - Rest of World | 1,486 | | 21 | % |
North America Operations | 2,047 | | 3 | % |
| - The US | 1,905 | | 4 | % |
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Rare blood disorders
Sales of Rare blood disorder products increased by 15% measured in Danish kroner and by 9% at CER to DKK 3,077 million. The increasing sales were driven by NovoSeven® as well as the launch products Esperoct® and Refixia®.
Sales of haemophilia A products increased by 14% measured in Danish kroner and by 10% at CER to DKK 565 million. The sales increase was driven by International Operations. Esperoct® has now been launched in 27 countries.
Sales of haemophilia B products increased by 20% measured in Danish kroner and by 18% at CER to DKK 177 million. The sales increase was driven by International Operations. Refixia® has now been launched in 25 countries.
Sales of NovoSeven® increased by 15% measured in Danish kroner and by 8% at CER to DKK 2,271 million. The sales development was driven by increasing sales in both North America Operations and International Operations.
Rare endocrine disorders
Sales of Rare endocrine disorder products decreased by 5% measured in Danish kroner and by 8% at CER to DKK 1,820 million. The sales development was driven by North America Operations' sales decreasing by 20% at CER and by International Operations sales decreasing by 2% at CER. Novo Nordisk continues being the leading company in the global human growth disorder market with a value market share of 36.4% compared to 36.1% a year ago.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
FINANCIALS
GEOGRAPHIC SALES DEVELOPMENT
Sales increased by 24% measured in Danish kroner and by 18% at CER to DKK 42,031 million in the first three months of 2022. Sales in International Operations increased by 18% measured in Danish kroner and by 13% at CER. The strategic aspiration for International Operations is sales growth between 6-10%. Sales in North America Operations increased by 33% measured in Danish kroner and by 24% at CER. The strategic aspiration of transforming 70% of sales in the US has progressed, and 67% of sales are now derived from products launched since 2015.
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Sales split per geographical area | Sales Q1 2022 DKK million | Growth as reported | Growth at CER | Share of growth at CER |
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International Operations | 22,041 | | 18 | % | 13 | % | 42 | % |
| - EMEA | 10,824 | | 14 | % | 12 | % | 20 | % |
| - Region China | 4,841 | | 12 | % | 2 | % | 1 | % |
| - Rest of World | 6,376 | | 30 | % | 26 | % | 21 | % |
North America Operations | 19,990 | | 33 | % | 24 | % | 58 | % |
| - The US | 18,753 | | 32 | % | 23 | % | 54 | % |
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Total sales | 42,031 | | 24 | % | 18 | % | 100 | % |
International Operations
Sales in International Operations increased by 18% measured in Danish kroner and by 13% at CER. Sales growth was driven by all therapy areas with GLP-1 sales growing by 60% at CER, insulin sales growing by 1% at CER, Obesity care sales growing by 63% at CER and Rare disease sales growing by 3% at CER.
EMEA
Sales in EMEA increased by 14% measured in Danish kroner and by 12% at CER. Sales growth was driven by Diabetes care growing by 15% at CER driven by increased GLP-1 sales. Obesity care sales increased by 94% at CER and Rare disease sales decreased by 13% at CER.
Region China
Sales in Region China increased by 12% measured in Danish kroner and by 2% at CER. Sales growth was driven by GLP-1 sales growing 101% at CER partially offset by Other diabetes care declining 43% at CER and insulin sales declining 6% at CER. Insulin sales were negatively impacted by supply chain impacts related to the implementation of Volume Based Procurement in May 2022
Rest of World
Sales in Rest of World increased by 30% measured in Danish kroner and by 26% at CER. Sales growth was driven by Diabetes care growing by 27% at CER, reflecting increased GLP-1 and insulin sales, Obesity care sales growing by 22% at CER and Rare disease growing by 21% at CER.
North America Operations
Sales in North America Operations increased by 33% measured in Danish kroner and by 24% at CER. The sales increase reflects GLP-1 diabetes sales growing by 38% at CER, Obesity care sales growing by 146% at CER and Rare disease sales growing by 3% at CER. This was partially offset by insulin sales decreasing by 15% at CER driven by lower realised prices due to rebate enhancements and channel and payer mix as well as a decline in volume.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
DEVELOPMENT IN COSTS AND OPERATING PROFIT
The cost of goods sold increased by 19% measured in Danish kroner and by 17% at CER to DKK 6,917 million, resulting in a gross margin of 83.5% measured in Danish kroner compared with 82.8% in 2021. The increase in gross margin reflects a positive product mix, driven by increased GLP-1 sales, a positive currency impact of 0.5 percentage point and productivity improvements. This is partially countered by lower realised prices mainly in the US.
Sales and distribution costs increased by 23% measured in Danish kroner and by 18% at CER to DKK 10,183 million. The increase in costs is driven by both International Operations and North America Operations. In International Operations, promotional spend is related to launch activities for Ozempic® and Rybelsus® as well as Obesity care market development activities. In North America Operations, the cost increase is driven by promotional activities for Rybelsus® and Ozempic® as well as market development activities for Obesity care, partially offset by lower promotional spend related to insulin.
Research and development costs increased by 32% measured in Danish kroner and by 29% at CER to DKK 5,206 million reflecting increased late-stage clinical trial activity compared to the first three months of 2021. Increased activities within Other serious chronic diseases are driving the cost increase reflecting the progression of the pipeline within cardiovascular disease and NASH as well as the operating costs and amortisations related to acquisition of Dicerna Pharmaceuticals Inc.
Administration costs increased by 4% measured in Danish kroner and by 2% at CER to DKK 970 million.
Other operating income and expenses (net) was DKK 392 million compared with DKK 121 million in 2021, driven by income from partnerships related to Dicerna Pharmaceuticals Inc.
Operating profit increased by 28% measured in Danish kroner and by 18% at CER to DKK 19,147 million. Operating profit growth was negatively impacted by around 2 percentage points from the acquisition of Dicerna Pharmaceuticals Inc. in 2021.
Financial items (net) showed a net loss of DKK 1,228 million compared with a net gain of DKK 956 million in 2021.
In line with Novo Nordisk’s treasury policy, the most significant foreign exchange risks for Novo Nordisk have been hedged, primarily through foreign exchange forward contracts. The foreign exchange result was a net loss of DKK 777 million compared with a net gain of DKK 947 million in 2021. This reflects losses on hedged currencies, primarily the US dollar.
As per the end of March 2022, a negative market value of financial contracts of approximately DKK 1.8 billion has been deferred for recognition later in 2022 and 2023.
The effective tax rate was 20.7% in the first three months of 2022 compared with an effective tax rate of 20.8% in 2021.
Net profit increased by 13% to DKK 14,210 million and diluted earnings per share increased by 14% to DKK 6.22.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
CASH FLOW AND CAPITAL ALLOCATION
FREE CASH FLOW IN THE FIRST THREE MONTHS OF 2022 AND CAPITAL EXPENDITURE
Free cash flow was DKK 21.6 billion compared with DKK 9.5 billion in 2021 supporting the strategic aspiration to deliver attractive capital allocation to shareholders. The increase is driven by higher net profit, higher provisions for rebates in the US and a positive impact from change in working capital.
Capital expenditure for property, plant and equipment was DKK 1.5 billion compared with DKK 1.4 billion in 2021.
Novo Nordisk’s financial reserves were DKK 31.1 billion by end of March 2022 comprising cash at bank, marketable securities (measured at fair value based on active market data) and undrawn credit facilities less overdrafts and loans repayable within 12 months.
EQUITY AND CAPITAL ALLOCATION
Total equity was DKK 66,550 million at the end of the first three months of 2022, equivalent to 33.8% of total assets, compared with 41.4% at the end of the first three months of 2021. Please refer to appendix 5 for further elaboration of changes in equity.
Reduction in share capital
At the Annual General Meeting of Novo Nordisk A/S, held on 24 March 2022, a 1.3% reduction in the total share
capital was approved. The reduction was effectuated by a cancellation of 30,000,000 treasury B shares of DKK 0.20
at a nominal value of DKK 6,000,000. After the legal implementation of the share capital reduction on 27 April
2022, Novo Nordisk’s share capital now amounts to DKK 456,000,000 divided into an A share capital of DKK
107,487,200 and a B share capital of DKK 348,512,800.
2022 share repurchase programme
On 2 February 2022, Novo Nordisk announced an overall share repurchase programme of up to DKK 22 billion to be executed during a 12-month period beginning 2 February 2022. Under the programme, Novo Nordisk has as of 22 April 2022 repurchased 5,595,250 B shares for an amount of DKK 4.0 billion.
Based on the increased expectations for cash flow generation in 2022, the Board of Directors has approved an expansion of the 2022 share repurchase programme by DKK 2 billion to DKK 24 billion.
As announced in February 2022, Novo Nordisk’s majority shareholder Novo Holdings A/S, a holding company fully owned by the Novo Nordisk Foundation, has informed Novo Nordisk that it intends to consider its participation in the Novo Nordisk share repurchase programme on a year-by-year basis. For 2022, Novo Holdings A/S has informed Novo Nordisk that it plans to participate in the share repurchase programme. Novo Holdings A/S has an ownership of 28.4% of the Novo Nordisk share capital after the implementation of the share capital decrease, and Novo Holdings A/S currently intends to maintain its ownership of the Novo Nordisk share capital around 28%
Issuance of Eurobonds
On 24 March 2022, Novo Nordisk announced the successful Eurobond issuance in an aggregate principal amount of EUR 1.5 billion under its EUR 5 billion Euro Medium Term Note Programme. The first tranche maturing on 31 March 2025 was issued in an aggregate principal amount of EUR 500 million with a coupon of 0.750%. The second tranche maturing on 30 September 2027 was issued in an aggregate principal amount of EUR 500 million with a coupon of 1.125%.The third tranche maturing on 31 March 2030 was issued in an aggregate principal amount of EUR 500 million with a coupon of 1.375%. Net proceeds of the issuances will be used by Novo Nordisk for general corporate purposes. Further, part of the net proceeds have been used for refinancing of the bridge loan facility established in connection with Novo Nordisk’s acquisition of Dicerna Pharmaceuticals, Inc. in 2021. The bonds are recognised as borrowings measured at amortised cost.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
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Financial report for the period 1 January 2022 to 31 March 2022 | |
OUTLOOK
OUTLOOK 2022
The current expectations for 2022 are summarised in the table below: | | | | | | | | |
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Expectations are as reported, if not otherwise stated | Expectations 29 April 2022 | Expectations 2 February 2022 |
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Sales growth | | |
at CER | 10% to 14% | 6% to 10% |
as reported | Around 7 percentage points higher than at CER | Around 5 percentage points higher than at CER |
| | |
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Operating profit growth | | |
at CER | 9% to 13% | 4% to 8% |
as reported | Around 11 percentage points higher than at CER | Around 7 percentage points higher than at CER |
| | |
| | |
Financial items (net) | Loss of around DKK 4.1 billion | Loss of around DKK 2.8 billion |
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Effective tax rate | 20% to 22% | 20% to 22% |
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Capital expenditure (PP&E) | Around DKK 12.0 billion | Around DKK 12.0 billion |
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Depreciation, amortisation and impairment losses | Around DKK 6.5 billion | Around DKK 6.5 billion |
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Free cash flow (excluding impact from business development) | DKK 55-60 billion | DKK 50-55 billion |
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| | |
For 2022, sales growth is now expected to be 10% to14% at CER. Given the current exchange rates versus the Danish krone, sales growth reported in DKK is now expected to be around 7 percentage points higher than at CER. The guidance reflects expectations for sales growth in both International Operations and North America Operations, mainly driven by Diabetes and Obesity care. Intensifying competition within both Diabetes care and Rare disease as well as an estimated negative impact on global sales growth of around 3 percentage points from Volume Based Procurement of insulin in China are also reflected in the guidance. Furthermore, continued pricing pressure within Diabetes care, especially in the US, is expected to negatively impact sales development. Following higher than expected volume growth of GLP-1-based products, including Ozempic®, the outlook also reflects expected periodic supply constraints. Finally, the outlook also reflects the expectation of making all dose strengths of Wegovy® available in the US during the second half of 2022.
Operating profit growth is now expected to be 9% to 13% at CER. Given the current exchange rates versus the Danish krone, growth reported in DKK is now expected to be around 11 percentage points higher than at CER. The expectation for operating profit growth primarily reflects the updated sales growth outlook and continued investments in current and future growth drivers within Research and development and Commercial. Across the operating units, commercial investments are related to the continued roll-out of Ozempic® and Rybelsus® as well as global investments in building the anti-obesity market and the launch of Wegovy®. Furthermore, resources are allocated to both early and late-stage pipeline activities. The acquisition of Dicerna Pharmaceuticals Inc. is negatively impacting operating profit growth by around 3 percentage points due to higher operating costs and amortisations of intangible assets.
The potential wider consequences of Russia's invasion of Ukraine, including impacts on energy supply and supply chains, could cause uncertainty to the outlook and the business performance of Novo Nordisk.
For 2022, Novo Nordisk now expects financial items (net) to amount to a loss of around DKK 4.1 billion, mainly reflecting losses associated with foreign exchange hedging contracts.
The effective tax rate for 2022 is still expected to be in the range of 20-22%.
Capital expenditure is still expected to be around DKK 12 billion in 2022 primarily relating to investments in additional capacity for active pharmaceutical ingredient (API) production at existing manufacturing sites.
Depreciation, amortisation and impairment losses are still expected to be around DKK 6.5 billion.
The free cash flow is now expected to be DKK 55-60 billion reflecting higher sales and net profit expectations.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
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Financial report for the period 1 January 2022 to 31 March 2022 | |
All of the above expectations are based on assumptions that the global or regional macroeconomic and political environment will not significantly change business conditions for Novo Nordisk during 2022, including energy and supply chain disruptions, the potential implications from major healthcare reforms and legislative changes as well as outcome of legal cases including litigations related to the 340B Drug Pricing Programme in the US, and that the currency exchange rates, especially the US dollar, will remain at the current level versus the Danish krone. Neither does the guidance include the financial implications of any significant business development transactions during the remainder of 2022. | | | | | | | | | | | | | | | | | |
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FX (average rates) | | | | Q1 2022 | Q1 2021 | % change | Spot rate 26 April 2022 |
| | | | | | | |
USD | | | | 664 | | 617 | | 8 | % | 697 | |
CNY | | | | 105 | | 95 | | 11 | % | 107 | |
JPY | | | | 5.70 | | 5.82 | | (2 | %) | 5.46 | |
CAD | | | | 524 | | 488 | | 7 | % | 546 | |
GBP | | | | 890 | | 851 | | 5 | % | 884 | |
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Novo Nordisk has hedged expected net cash flows in a number of invoicing currencies and, all other things being equal, movements in key invoicing currencies will impact Novo Nordisk’s operating profit as outlined in the table below. | | | | | | | | |
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Key invoicing currencies | Impact on Novo Nordisk's operating profit in the next 12 months of a 5% movement in currency | Hedging period (months)1 |
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USD | DKK 2,600 million | 12 | |
CNY2 | DKK 360 million | 0 |
JPY | DKK 220 million | 12 |
CAD | DKK 210 million | 9 |
GBP | DKK 120 million | 11 | |
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1) As of 28 April 2022.
2) Chinese yuan traded offshore (CNH) used as proxy when hedging Novo Nordisk’s CNY currency exposure.
The financial impact from foreign exchange hedging is included in Financial items (net).
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
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Financial report for the period 1 January 2022 to 31 March 2022 | |
INNOVATION AND THERAPEUTIC FOCUS
Diabetes care
Ozempic® 2.0 mg approved in the US for the treatment of adults with type 2 diabetes
On 28 March, Ozempic® 2.0 mg was approved by the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes in adults. Ozempic® is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults. Further, Ozempic® is indicated to reduce the risk of major cardiovascular events such as heart attack, stroke or cardiovascular death in adults with type 2 diabetes and known heart disease. Novo Nordisk expects to launch Ozempic® 2.0 mg in the United States in the second quarter of 2022. For further information, please see the company announcement: https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=108096 (the contents of the company's website do not form a part of this Form 6-K).
Once-weekly insulin icodec demonstrates superior reduction in HbA1c in ONWARDS 2 phase 3 trial
On 28 April, Novo Nordisk announced headline results from the ONWARDS 2 trial, a phase 3a, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec in people with type 2 diabetes. The remainder of trials in the ONWARDS programme will read out during the rest of 2022. For information, please see the company announcement: https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=112839 (the contents of the company's website do not form a part of this Form 6-K).
Phase 1 trial with Ideal Pump insulin (insulin 119) successfully completed
In February 2022, Novo Nordisk successfully completed a phase 1 trial with insulin 119. The trial investigated safety,
tolerability, pharmacokinetics and pharmacodynamics of insulin 119 compared to faster-acting insulin aspart in people
with type 1 diabetes. In March 2022, a phase 1 formulation guidance trial was initiated designed to identify the formulation suitable for further clinical development.
Phase 1b trial with insulin 965 completed and development terminated
During the first quarter of 2022, Novo Nordisk successfully completed a phase 1b trial investigating biomarkers of functional selective insulin 965. Following the completion of the trial, development of insulin 965 has been terminated due to portfolio considerations.
Phase 1 trial initiated with an oral once-daily GLP-1/GIP co-agonist
In April 2022, Novo Nordisk initiated a phase 1 trial with a once-daily GLP-1/GIP co-agonist. The trial is investigating safety, tolerability, pharmacokinetics and pharmacodynamics of different doses of once-daily GLP-1/GIP.
Rare disease
Phase 3 trial with concizumab successfully completed
In February 2022, Novo Nordisk successfully completed the pivotal phase 3 trial with concizumab, explorer 7. The trial investigated subcutaneous concizumab prophylaxis treatment in people with haemophilia A and B with inhibitors. The trial met its primary endpoint by showing concizumab prophylaxis was effective in reducing the annual bleeding rate (ABR) by 86% compared to no prophylaxis treatment in people with haemophilia A with inhibitors (HAwI) and haemophilia B with inhibitors (HBwI). The overall median ABR on concizumab prophylaxis was 0, and the median ABR was 0 in the HAwI and HBwI subgroups, respectively. The estimated mean ABR was 1.7 for concizumab prophylaxis and 11.8 for people not receiving prophylaxis treatment . Concizumab appeared to have a safe and well tolerated profile with no thromboembolic events reported after the restart of the phase 3 in August 2020. Novo Nordisk expects to submit concizumab for regulatory approval in the second half of 2022.
Technology platforms
Phase 1 trial initiated with SOMA oral Device (DV3395)
In March 2022, Novo Nordisk initiated a phase 1 trial with the DV3395 oral device concept. The trial is investigating safety and gastrointestinal transit of the DV3395 device, without active pharmaceutical ingredient, in around 60 people.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
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Financial report for the period 1 January 2022 to 31 March 2022 | |
Purpose and sustainability
Environment
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ENVIRONMENTAL PERFORMANCE | Q1 2022 | Q1 2021 | Q1 2019 (pre-COVID)4 | | | | % change Q1 2022 to Q1 2021 | % change Q1 2022 to Q1 2019 |
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Emissions | | | | | | | | |
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CO2 emissions from operations and transportation (1,000 tonnes) | 60 | 41 | 80 | | | | 46 | % | (25 | %) |
- Scope 1 emissions1 | 20 | 18 | 22 | | | | 11 | % | (9 | %) |
- Scope 2 emissions2 | 6 | 5 | 20 | | | | 20 | % | (70 | %) |
- Scope 3 emissions3 | 34 | 18 | 38 | | | | 89 | % | (11 | %) |
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1. Scope 1: Direct emissions from company owned and controlled resources (including emissions from production processes and transport. 2. Scope 2: Indirect emissions from the generation of energy purchased from a utility provider (including electricity, steam, heat and cooling). 3. Scope 3: Emissions are limited to CO2 emissions from business flights and product distribution. 4. In 2019, some emission categories were only reported at an annual basis. For these categories, the quarterly emissions have been estimated based on the full-year results
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Emissions
Novo Nordisk's ambition is to have zero environmental impact. The environmental strategy is called Circular for Zero.
Carbon emissions from operations and transportation increased by 46% in the first three months of 2022 compared to the first three months of 2021, mainly reflecting COVID-19 impact on activities in 2021. Scope 3 emissions increased by 89% due to increased business travel and product distribution done by air freight. Compared with the first quarter of 2019, total carbon emissions decreased by 25%. Novo Nordisk has recently entered into a new partnership with SkyNRG enabling the use of sustainable aviation fuel, which is estimated to reduce carbon emissions from product distribution by around 25% as of 2025 compared to 2021.
Social
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SOCIAL PERFORMANCE | Q1 2022 | Q1 2021 | | | | % change Q1 2022 to Q1 2021 |
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Patients | | | | | | |
Patients reached with Novo Nordisk's Diabetes care products (estimate in million)1 | 34.9 | 33.0 | | | | 6 | % |
'- Hereof children reached through the Changing Diabetes® in Children programme (cumulative) | 33,209 | 29,052 | | | | 14 | % |
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Sustainable employer | | | | | | |
Gender in leadership positions2 (ratio men:women) | 57:43 | 58:42 | | | | N/A |
Gender in senior leadership positions3 (ratio men:women) | 63:37 | 65:35 | | | | N/A |
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1. Calculated as a moving annual total. 2. Defined as team leaders, managers, directors, vice presidents, corporate vice presidents, senior vice presidents and executive management. 3. Defined as vice presidents, corporate vice presidents, senior vice presidents and executive management. |
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Patients
Novo Nordisk continued to take action under the social responsibility strategy ‘Defeat Diabetes’ with a keen focus on access and affordability and prevention. The number of people with diabetes treated with Novo Nordisk products, calculated as a moving annual total, at the end of March 2022 was 34.9 million. This estimate represents a net increase of 1.9 million patients compared to the end of March 2021.
Novo Nordisk has an ambition that no child should die from type 1 diabetes. To achieve this, the Changing Diabetes® in Children programme aims to reach 100,000 children by 2030. By end of March 2022, more than 33,000 children were reached, an increase of 14% compared to the first quarter of 2021. Jordan, Lebanon, Malawi, Mozambique and Rwanda have been added to the programme which now includes 23 countries.
In April 2022, Novo Nordisk announced a positive scientific opinion from the European Medicines Agency (EMA) on human insulin with more flexible storage without refrigeration. EMA’s positive scientific opinion will now be used to support obtaining approval of the more flexible storage conditions by national health authorities in a number of relevant low- and middle-income countries. The new guidance aims to improve flexibility and convenience for many people with diabetes in low- and middle-income countries, who have limited access to reliable refrigeration, and who may live within long distances from a clinic or pharmacy.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
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Financial report for the period 1 January 2022 to 31 March 2022 | |
Sustainable employer
Novo Nordisk aspires to be a sustainable employer, and in 2021 two aspirational gender diversity targets were launched; achieve a balanced gender representation across all managerial level and achieve a minimum of 45% women and a minimum of 45% men in senior leadership positions by the end of 2025.
By the end of the first quarter in 2022, 43% of all leaders were women, and 37% of leaders in senior leadership positions were women compared to 35% the end of first quarter in 2021.
Employees
The number of full-time employees at the end of the first three months of 2022 increased by 9.0% compared to 12 months ago. The total number of full-time employees was 49,295. The increase is driven by Product Supply, International Operations, R&D and Global Business Services in India.
Russia's invasion of Ukraine
Following Russia's invasion of Ukraine, Novo Nordisk's key priorities have been to safeguard employees and continue the supply of essential medicines.
Although Novo Nordisk's offices in Kyiv, Ukraine, were shuttered on 24 February, the company remains in regular contact with the Ukrainian employees. Emergency funds have been provided to all affected employees to help meet the costs of evacuation. Further, Novo Nordisk has coordinated support to help any employee who wanted to relocate or leave Ukraine with the ability to do so. Novo Nordisk has to the extent possible continued supply of medicines in Ukraine. Moreover, Novo Nordisk has donated two months’ supply of diabetes and haemophilia medication to the Ukrainian Ministry of Health and together with humanitarian organisations Novo Nordisk continues to monitor the situation to be able to provide further support. In neighbouring countries hosting refugees from Ukraine, Novo Nordisk has provided donations to ensure access to insulin for people who have been forced to flee.
In Russia, Novo Nordisk has suspended further marketing investments, while maintaining supply of medicine to ensure that more than 700,000 patients can continue their treatment with essential medication. Within regulatory, Novo Nordisk has ceased filing for marketing authorisations of new medication, and within clinical development, Novo Nordisk has suspended further clinical investments in Russia. Consequently, no new clinical trials are initiated in Russia, and active enrolment of new patients in ongoing trials is halted. Currently, there are around 3,000 patients enrolled in Russia. Novo Nordisk's factory in Russia is still operating to supply insulin to patients in Russia only.
Sales in Russia and Ukraine constituted less than 1% of Novo Nordisk's global sales in 2021.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
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Financial report for the period 1 January 2022 to 31 March 2022 | |
LEGAL MATTERS
Abbreviated New Drug Applications have been filed for semaglutide with the U.S. FDA
In January 2022, four companies notified Novo Nordisk that they had filed Abbreviated New Drug Applications (ANDAs) for semaglutide, the active pharmaceutical molecule in Ozempic® with the U.S. Food and Drug Administration. Accordingly, these ANDAs contain Paragraph IV certifications to obtain approval to engage in the commercial manufacture, use or sale of Ozempic® before the expiration of some or all of the patents currently listed for Ozempic® in the Orange Book with expiration dates ranging from December 2023 until December 2033, including the drug substance patent expiring June 2032 (all expiration dates assume paediatric exclusivity extension). Subsequently, Dr. Reddy’s Laboratories, Ltd. (DRL), Mylan Pharmaceuticals Inc. (Mylan) and Alvogen Inc., (Alvogen) have provided similar notifications to Novo Nordisk, while
Aurobindo Pharma US Inc. (Aurobindo) has informed Novo Nordisk that they have withdrawn their ANDA application. Novo Nordisk has filed suit against the companies maintaining their ANDA application for patent infringement, asserting infringement of Novo Nordisk’s patents. Novo Nordisk does not expect these matters to have a material impact on Novo Nordisk’s financial position, operating profit or cash flow.
Abbreviated New Drug Application relating to Victoza®
On 22 March 2022, Novo Nordisk entered into a settlement with Sandoz Inc. (Sandoz) regarding the US patent litigation case for Victoza® (liraglutide), which was commenced in June 2020. Consequently, Sandoz is licensed to launch a generic version of Victoza® as of 22 June 2024, or earlier under certain circumstances. The agreement follows earlier agreements with Teva, Myland and Pfizer. The agreement is subject to review by the US Federal Trade Commission and the US Department of Justice.
Victoza® product liability litigation in the US
Numerous claims alleging pancreatic cancer, pancreatitis and thyroid cancer have been filed in U.S. courts against various incretin class manufacturers, including Victoza® and Novo Nordisk. As of 12 April 2022, 366 plaintiffs have filed product liability cases against Novo Nordisk, most alleging pancreatic cancer. In March and April of 2021, the California federal and state courts granted defendants’ motions for summary judgment on pre-emption and general causation grounds in all pancreatic cancer cases before those courts as of the time of the rulings. On 28 March 2022, the U.S. Court of Appeals for the Ninth Circuit affirmed the MDL court’s grant of summary judgment on general causation grounds.
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
MANAGEMENT STATEMENT
The Board of Directors and Executive Management have reviewed and approved the financial report of Novo Nordisk A/S
for the first three months of 2022. The financial report has not been audited or reviewed by the company’s
independent auditors.
The financial report for the first three months of 2022 has been prepared in accordance with IAS 34 'Interim Financial
Reporting' and additional Danish disclosure requirements for listed companies. The accounting policies adopted in the
preparation are consistent with those applied in the Annual Report 2021 of Novo Nordisk.
In our opinion, the financial report for the first three months of 2022 gives a true and fair view of the Group’s assets,
liabilities and financial position at 31 March 2022, and of the results of the Group’s operations and cash flow for the
period 1 January 2022 to 31 March 2022. Furthermore, in our opinion, Management’s Review includes a true and fair
account of the development in the operations and financial circumstances of the results for the period and of the financial
position of the Group as well as a description of the most significant risks and elements of uncertainty facing the Group in
accordance with Danish disclosure requirements for listed companies.
Besides what has been disclosed in the quarterly financial report, no changes in the Group’s most significant risks and
uncertainties have occurred relative to what was disclosed in the consolidated Annual Report 2021.
Bagsværd, 29 April 2022 | | | | | | | | |
Executive Management: | | |
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Lars Fruergaard Jørgensen President and CEO | Karsten Munk Knudsen CFO | Monique Carter |
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Martin Holst Lange | Marcus Schindler | Camilla Sylvest |
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Henrik Wulff | | |
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Board of Directors: | | |
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Helge Lund Chair | Henrik Poulsen Vice chair | Jeppe Christiansen |
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Elisabeth Dahl Christensen | Laurence Debroux | Andreas Fibig |
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Sylvie Grégoire | Liselotte Hyveled | Mette Bøjer Jensen |
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Kasim Kutay | Christina Law | Martin Mackay |
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Thomas Rantzau | | |
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| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
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Financial calendar | |
5 June 2022 | Investor event at ADA in New Orleans |
4 August 2022 | Financial statement for the first six months of 2022 |
2 November 2022 | Financial statement for the first nine months of 2022 |
1 February 2023 | Financial statement for 2022 |
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Contacts for further information | |
Media: | | |
Ambre Brown Morley | +45 3079 9289 | abmo@novonordisk.com |
Natalia Salomao Abrahao (US) | +1 848 304 1027 | niaa@novonordisk.com |
| | |
Investors: | | |
Daniel Muusmann Bohsen | +45 3075 2175 | dabo@novonordisk.com |
Ann Søndermølle Rendbæk | +45 3075 2253 | arnd@novonordisk.com |
David Heiberg Landsted | +45 3077 6915 | dhel@novonordisk.com |
Jacob Martin Wiborg Rode | +45 3075 5956 | jrde@novonordisk.com |
Mark Joseph Root (US) | +1 848 213 3219 | mjhr@novonordisk.com |
Further information about Novo Nordisk is available on novonordisk.com.
Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including this document as well as the company’s statutory Annual Report 2021 and Form 20-F both filed with the SEC in February 2022 in continuation of the publication of the Annual Report 2021, 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.
In this document, examples of forward-looking statements can be found under the headings ‘Outlook’, ‘Research and Development update’ and 'Equity’.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo Nordisk cautions that a number of important factors, including those described in this document, could cause actual results to differ materially from those contemplated in any forward-looking statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, such as 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, including as a result of interruptions or delays affecting supply chains on which Novo Nordisk relies, 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 including the risk of cybersecurity breaches, 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, failure to maintain a culture of compliance, epidemics, pandemics or other public health crises, and the effects of domestic or international crises, civil unrest, war or other conflict, and factors related to the foregoing matters and other factors not specifically identified herein.
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 document, reference is made to the overview of risk factors in ‘Risk Management’ of the Annual Report 2021.
Unless required by law, Novo Nordisk is under no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of this document, whether as a result of new information, future events or otherwise.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
APPENDIX 1: QUARTERLY NUMBERS IN DKK | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | |
(Amounts in DKK million, except number of full-time equivalent employees, earnings per share and number of shares outstanding). |
| | | | | | | | | | | % change |
| | | | 2022 | | 2021 | | Q1 2022 vs. |
| | | | Q1 | | Q4 | Q3 | Q2 | Q1 | | Q1 2021 |
| | | | | | | | | | | |
| | | | | | | | | | | |
Net sales | | | | 42,031 | | 38,333 | 35,622 | 33,041 | 33,804 | | 24 | % |
| | | | | | | | | | | |
Gross profit | | | | 35,114 | | 32,092 | 29,563 | 27,494 | 27,993 | | 25 | % |
Gross margin | | | | 83.5% | | 83.7% | 83.0% | 83.2% | 82.8% | | |
| | | | | | | | | | | |
Sales and distribution costs | | | | (10,183) | | (11,632) | (9,119) | (8,001) | (8,256) | | 23 | % |
Percentage of sales | | | | 24.2% | | 30.3% | 25.6% | 24.2% | 24.4% | | |
Research and development costs | | | | (5,206) | | (5,632) | (4,252) | (3,944) | (3,944) | | 32 | % |
Percentage of sales | | | | 12.4% | | 14.7% | 11.9% | 11.9% | 11.7% | | |
Administrative costs | | | | (970) | | (1,190) | (1,024) | (904) | (932) | | 4 | % |
Percentage of sales | | | | 2.3% | | 3.1% | 2.9% | 2.7% | 2.8% | | |
Other operating income and expenses | | | | 392 | | (4) | 81 | 134 | 121 | | 224 | % |
| | | | | | | | | | | |
Operating profit | | | | 19,147 | | 13,634 | 15,249 | 14,779 | 14,982 | | 28 | % |
Operating margin | | | | 45.6% | | 35.6% | 42.8% | 44.7% | 44.3% | | |
| | | | | | | | | | | |
Financial income | | | | 210 | | 254 | 790 | 90 | 1,753 | | (88 | %) |
Financial expenses | | | | (1,438) | | (775) | (927) | 48 | (797) | | 80 | % |
Financial items (net) | | | | (1,228) | | (521) | (137) | 138 | 956 | | (228 | %) |
| | | | | | | | | | | |
Profit before income taxes | | | | 17,919 | | 13,113 | 15,112 | 14,917 | 15,938 | | 12 | % |
| | | | | | | | | | | |
Income taxes | | | | (3,709) | | (2,221) | (2,993) | (2,794) | (3,315) | | 12 | % |
| | | | | | | | | | | |
Net profit | | | | 14,210 | | 10,892 | 12,119 | 12,123 | 12,623 | | 13 | % |
| | | | | | | | | | | |
Depreciation, amortisation and impairment losses | | | | 1,650 | | 2,082 | 1,349 | 1,217 | 1,377 | | 20 | % |
Capital expenditure (PP&E) | | | | 1,520 | | 2,049 | 1,175 | 1,709 | 1,402 | | 8 | % |
Net cash generated from operating activities | | | | 23,586 | | (3,017) | 21,507 | 25,255 | 11,255 | | 110 | % |
Free cash flow | | | | 21,568 | | (22,993) | 19,616 | 23,164 | 9,532 | | 126 | % |
| | | | | | | | | | | |
Total assets | | | | 197,136 | | 194,508 | 174,084 | 158,095 | 141,387 | | 39 | % |
Total equity | | | | 66,550 | | 70,746 | 66,112 | 65,559 | 58,496 | | 14 | % |
Equity ratio | | | | 33.8% | | 36.4% | 38.0% | 41.5% | 41.4% | | |
| | | | | | | | | | | |
Full-time equivalent employees end of period | | | | 49,295 | | 47,792 | 46,982 | 45,971 | 45,157 | | 9 | % |
| | | | | | | | | | | |
Basic earnings per share/ADR (in DKK) | | | | 6.24 | | 4.77 | 5.29 | 5.26 | 5.47 | | 14 | % |
Diluted earnings per share/ADR (in DKK) | | | | 6.22 | | 4.76 | 5.27 | 5.26 | 5.45 | | 14 | % |
Average number of shares outstanding (million) | | | | 2,276.4 | | 2,284.0 | 2,291.9 | 2,300.8 | 2,309.6 | | (1 | %) |
Average number of diluted shares outstanding (million) | | | | 2,283.3 | | 2,290.6 | 2,297.3 | 2,306.3 | 2,315.6 | | (1 | %) |
| | | | | | | | | | | |
Sales by business segment: | | | | | | | | | | | |
Total GLP-1 | | | | 17,420 | | 16,372 | 13,848 | 12,077 | 11,300 | | 54 | % |
Long-acting insulin | | | | 4,796 | | 4,677 | 4,416 | 4,149 | 4,822 | | (1 | %) |
Premix insulin | | | | 3,012 | | 2,691 | 2,844 | 2,715 | 2,953 | | 2 | % |
Fast-acting insulin | | | | 4,842 | | 4,520 | 4,359 | 4,252 | 4,556 | | 6 | % |
Human insulin | | | | 2,312 | | 2,085 | 2,391 | 2,041 | 2,535 | | (9 | %) |
Total insulin | | | | 14,962 | | 13,973 | 14,010 | 13,157 | 14,866 | | 1 | % |
Other Diabetes care | | | | 884 | | 816 | 859 | 809 | 1,110 | | (20 | %) |
Total Diabetes care | | | | 33,266 | | 31,161 | 28,717 | 26,043 | 27,276 | | 22 | % |
Wegovy® | | | | 1,404 | | 782 | 519 | 85 | — | | N/A |
Saxenda® | | | | 1,998 | | 1,677 | 1,879 | 1,907 | 1,551 | | 29 | % |
Total Obesity care | | | | 3,402 | | 2,459 | 2,398 | 1,992 | 1,551 | | 119 | % |
Diabetes and Obesity care total | | | | 36,668 | | 33,620 | 31,115 | 28,035 | 28,827 | | 27 | % |
| | | | | | | | | | | |
Rare blood disorders | | | | 3,077 | | 2,490 | 2,326 | 2,723 | 2,678 | | 15 | % |
Rare endocrine disorders | | | | 1,820 | | 1,719 | 1,805 | 1,859 | 1,920 | | (5 | %) |
Other Rare disease | | | | 466 | | 504 | 376 | 424 | 379 | | 23 | % |
Rare disease total | | | | 5,363 | | 4,713 | 4,507 | 5,006 | 4,977 | | 8 | % |
| | | | | | | | | | | |
Sales by geographic segment: | | | | | | | | | | | |
International Operations | | | | 22,041 | | 18,216 | 18,337 | 18,237 | 18,747 | | 18 | % |
- EMEA | | | | 10,824 | | 9,427 | 9,170 | 9,579 | 9,530 | | 14 | % |
- Region China | | | | 4,841 | | 3,710 | 4,257 | 3,722 | 4,330 | | 12 | % |
- Rest of World | | | | 6,376 | | 5,079 | 4,910 | 4,936 | 4,887 | | 30 | % |
North America Operations | | | | 19,990 | | 20,117 | 17,285 | 14,804 | 15,057 | | 33 | % |
- The US | | | | 18,753 | | 18,902 | 16,181 | 13,754 | 14,172 | | 32 | % |
| | | | | | | | | | | |
Segment operating profit: | | | | | | | | | | | |
Diabetes and Obesity care | | | | 16,379 | | 11,861 | 13,052 | 12,155 | 12,470 | | 31 | % |
Rare disease | | | | 2,768 | | 1,773 | 2,197 | 2,624 | 2,512 | | 10 | % |
| | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
APPENDIX 2: INCOME STATEMENT AND STATEMENT OF COMPREHENSIVE INCOME | | | | | | | | | | | | | | | |
| | | | | | | |
| | | | | | | |
DKK million | Q1 2022 | | Q1 2021 | | | | |
| | | | | | | |
| | | | | | | |
Income statement | | | | | | | |
| | | | | | | |
Net sales | 42,031 | | 33,804 | | | | |
Cost of goods sold | (6,917) | | (5,811) | | | | |
| | | | | | | |
| | | | | | | |
Gross profit | 35,114 | | 27,993 | | | | |
| | | | | | | |
Sales and distribution costs | (10,183) | | (8,256) | | | | |
Research and development costs | (5,206) | | (3,944) | | | | |
Administrative costs | (970) | | (932) | | | | |
Other operating income and expenses | 392 | | 121 | | | | |
| | | | | | | |
| | | | | | | |
Operating profit | 19,147 | | 14,982 | | | | |
| | | | | | | |
Financial income | 210 | | 1,753 | | | | |
Financial expenses | (1,438) | | (797) | | | | |
| | | | | | | |
| | | | | | | |
Profit before income taxes | 17,919 | | 15,938 | | | | |
| | | | | | | |
Income taxes | (3,709) | | (3,315) | | | | |
| | | | | | | |
| | | | | | | |
NET PROFIT | 14,210 | | 12,623 | | | | |
| | | | | | | |
| | | | | | | |
Basic earnings per share (DKK) | 6.24 | | 5.47 | | | | |
Diluted earnings per share (DKK) | 6.22 | | 5.45 | | | | |
| | | | | | | |
Segment Information | | | | | | | |
| | | | | | | |
| | | | | | | |
Segment sales: | | | | | | | |
Diabetes and Obesity care | 36,668 | | 28,827 | | | | |
Rare disease | 5,363 | | 4,977 | | | | |
| | | | | | | |
Segment operating profit: | | | | | | | |
Diabetes and Obesity care | 16,379 | | 12,470 | | | | |
Operating margin | 44.7% | | 43.3% | | | | |
| | | | | | | |
Rare disease | 2,768 | | 2,512 | | | | |
Operating margin | 51.6% | | 50.5% | | | | |
| | | | | | | |
Total segment operating profit | 19,147 | | 14,982 | | | | |
| | | | | | | |
| | | | | | | |
Statement of comprehensive income | | | | | | | |
| | | | | | | |
Net profit for the period | 14,210 | | 12,623 | | | | |
| | | | | | | |
Other comprehensive income | | | | | | | |
Items that will not subsequently be reclassified to the Income statement | | | | | | | |
Remeasurements on defined benefit plans | 325 | | 213 | | | | |
| | | | | | | |
Items that will be reclassified subsequently to the Income statement | | | | | | | |
Exchange rate adjustments of investments in subsidiaries | 1,087 | | 603 | | | | |
Cash flow hedges, realisation of previously deferred (gains)/losses | 641 | | (976) | | | | |
Cash flow hedges, deferred gains/(losses) incurred during the period | (652) | | (1,573) | | | | |
Other items | (4) | | (2) | | | | |
Tax on other comprehensive income, income/(expense) | 125 | | 597 | | | | |
| | | | | | | |
Other comprehensive income for the period, net of tax | 1,522 | | (1,138) | | | | |
TOTAL COMPREHENSIVE INCOME FOR THE PERIOD | 15,732 | | 11,485 | | | | |
| | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
APPENDIX 3: CASH FLOW STATEMENT | | | | | | | | | | | |
| | | |
DKK million | Q1 2022 | | Q1 2021 |
| | | |
| | | |
Net profit | 14,210 | | | 12,623 | |
| | | |
Adjustment for non-cash items: | | | |
Income taxes in the Income Statement | 3,709 | | | 3,315 | |
Depreciation, amortisation and impairment losses | 1,650 | | | 1,377 | |
Other non-cash items | 7,388 | | | 1,034 | |
Change in working capital | 1,893 | | | (1,126) | |
Interest received | 48 | | | 13 | |
Interest paid | (52) | | | (50) | |
Income taxes paid | (5,260) | | | (5,931) | |
| | | |
| | | |
Net cash generated from operating activities | 23,586 | | | 11,255 | |
| | | |
| | | |
Purchase of intangible assets | (260) | | | (97) | |
| | | |
Purchase of property, plant and equipment | (1,520) | | | (1,402) | |
| | | |
Proceeds from other financial assets | — | | | 1 | |
Purchase of other financial assets | (7) | | | (4) | |
Purchase of marketable securities | (1,845) | | | (2,350) | |
Sale of marketable securities | 1,725 | | | 367 | |
| | | |
| | | |
Dividend received from associated company | — | | | 4 | |
| | | |
| | | |
Net cash used in investing activities | (1,907) | | | (3,481) | |
| | | |
| | | |
Purchase of treasury shares | (4,477) | | | (2,960) | |
Dividends paid | (15,690) | | | (13,495) | |
Proceeds from issue of bonds | 11,120 | | | — | |
Proceeds from borrowings | 30 | | | — | |
Repayment of borrowings | (12,855) | | | (349) | |
Withheld dividend tax | 2,737 | | | 2,329 | |
| | | |
| | | |
Net cash used in financing activities | (19,135) | | | (14,475) | |
| | | |
| | | |
NET CASH GENERATED FROM ACTIVITIES | 2,544 | | | (6,701) | |
| | | |
Cash and cash equivalents at the beginning of the year | 10,719 | | | 12,226 | |
| | | |
Exchange gain/(loss) on cash and cash equivalents | (55) | | | 154 | |
| | | |
| | | |
Cash and cash equivalents at the end of the period | 13,208 | | | 5,679 | |
| | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
APPENDIX 4: BALANCE SHEET | | | | | | | | | | | |
| | | |
DKK million | 31 Mar 2022 | | 31 Dec 2021 |
| | | |
| | | |
ASSETS | | | |
| | | |
Intangible assets | 43,344 | | | 43,171 | |
Property, plant and equipment | 56,399 | | | 55,362 | |
Investments in associated companies | 466 | | | 525 | |
Deferred income tax assets | 9,338 | | | 8,672 | |
Other receivables and prepayments | 239 | | | 267 | |
Other financial assets | 813 | | | 916 | |
| | | |
| | | |
TOTAL NON-CURRENT ASSETS | 110,599 | | | 108,913 | |
| | | |
Inventories | 20,289 | | | 19,621 | |
Trade receivables | 36,241 | | | 40,643 | |
Tax receivables | 3,101 | | | 1,119 | |
Other receivables and prepayments | 4,824 | | | 5,037 | |
Marketable securities | 6,752 | | | 6,765 | |
Derivative financial instruments | 1,936 | | | 1,690 | |
Cash at bank | 13,394 | | | 10,720 | |
| | | |
TOTAL CURRENT ASSETS | 86,537 | | | 85,595 | |
TOTAL ASSETS | 197,136 | | | 194,508 | |
| | | |
EQUITY AND LIABILITIES | | | |
| | | |
Share capital | 462 | | | 462 | |
Treasury shares | (7) | | | (6) | |
Retained earnings | 66,612 | | | 72,004 | |
Other reserves | (517) | | | (1,714) | |
| | | |
| | | |
TOTAL EQUITY | 66,550 | | | 70,746 | |
| | | |
Borrowings | 24,084 | | | 12,961 | |
Deferred income tax liabilities | 5,305 | | | 5,271 | |
Retirement benefit obligations | 950 | | | 1,280 | |
Other liabilities | 257 | | | 360 | |
Provisions | 4,388 | | | 4,374 | |
| | | |
| | | |
Total non-current liabilities | 34,984 | | | 24,246 | |
| | | |
Borrowings | 1,396 | | | 13,684 | |
Trade payables | 6,679 | | | 8,870 | |
Tax payables | 4,606 | | | 3,658 | |
Other liabilities | 21,831 | | | 19,600 | |
Derivative financial instruments | 2,286 | | | 2,184 | |
Provisions | 58,804 | | | 51,520 | |
| | | |
| | | |
Total current liabilities | 95,602 | | | 99,516 | |
| | | |
TOTAL LIABILITIES | 130,586 | | | 123,762 | |
| | | |
TOTAL EQUITY AND LIABILITIES | 197,136 | | | 194,508 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
APPENDIX 5: EQUITY STATEMENT | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | |
DKK million | Share capital | Treasury shares | Retained earnings | | | | Other reserves | | Total |
| | | | | | | | | |
| | | | | | | | | |
Q1 2022 | | | | | | | | | |
| | | | | | | | | |
Balance at the beginning of the period | 462 | | (6) | | 72,004 | | | | | (1,714) | | | 70,746 | |
Net profit for the period | | | 14,210 | | | | | | | 14,210 | |
Other comprehensive income for the period | | | 325 | | | | | 1,197 | | | 1,522 | |
| | | | | | | | | |
| | | | | | | | | |
Total comprehensive income for the period | | | 14,535 | | | | | 1,197 | | | 15,732 | |
| | | | | | | | | |
| | | | | | | | | |
Transactions with owners: | | | | | | | | | |
Dividends | | | (15,690) | | | | | | | (15,690) | |
Share-based payments | | | 246 | | | | | | | 246 | |
Tax related to restricted stock units | | | (7) | | | | | | | (7) | |
Purchase of treasury shares | | (1) | | (4,476) | | | | | | | (4,477) | |
| | | | | | | | | |
| | | | | | | | | |
Balance at the end of the period | 462 | | (7) | | 66,612 | | | | | (517) | | | 66,550 | |
| | | | | | | | | |
|
| | | | | | | | |
DKK million | Share capital | Treasury shares | Retained earnings | | | | Other reserves | | Total |
| | | | | | | | | |
| | | | | | | | | |
Q1 2021 | | | | | | | | | |
| | | | | | | | | |
Balance at the beginning of the period | 470 | | (8) | | 63,774 | | | | | (911) | | | 63,325 | |
Net profit for the period | | | 12,623 | | | | | | | 12,623 | |
Other comprehensive income for the period | | | 213 | | | | | (1,351) | | | (1,138) | |
| | | | | | | | | |
| | | | | | | | | |
Total comprehensive income for the period | | | 12,836 | | | | | (1,351) | | | 11,485 | |
| | | | | | | | | |
| | | | | | | | | |
Transactions with owners: | | | | | | | | | |
Dividends | | | (13,496) | | | | | | | (13,496) | |
Share-based payments | | | 175 | | | | | | | 175 | |
Tax related to restricted stock units | | | (33) | | | | | | | (33) | |
Purchase of treasury shares | | (1) | | (2,959) | | | | | | | (2,960) | |
| | | | | | | | | |
| | | | | | | | | |
Balance at the end of the period | 470 | | (9) | | 60,297 | | | | | (2,262) | | | 58,496 | |
| | | | | | | | | |
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
APPENDIX 6: SALES SPLIT PER AREA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | |
Q1 2022 sales split per area | | | | | | | |
| | | | | | | |
DKK million | Total | International Operations | EMEA | Region China | Rest of World | North America Operations | The US |
| | | | | | | |
Diabetes and Obesity care segment | | | | | | | |
| Rybelsus® | 2,063 | 513 | 274 | 7 | 232 | 1,550 | 1,525 |
| % change at CER | 167% | — | — | — | — | 128% | 129% |
| Ozempic® | 12,035 | 3,817 | 2,217 | 473 | 1,127 | 8,218 | 7,622 |
| % change at CER | 70% | 118% | 61% | — | — | 54% | 52% |
| Victoza® | 3,322 | 1,544 | 758 | 408 | 378 | 1,778 | 1,714 |
| % change at CER | (20%) | (15%) | (20%) | (4%) | (15%) | (23%) | (23%) |
| Total GLP-1 | 17,420 | 5,874 | 3,249 | 888 | 1,737 | 11,546 | 10,861 |
| % change at CER | 45% | 60% | 38% | 101% | 104% | 38% | 37% |
| Long-acting insulin | 4,796 | 3,161 | 1,965 | 574 | 622 | 1,635 | 1,486 |
| % change at CER | (4%) | 8% | 11% | 2% | 6% | (23%) | (25%) |
| | Tresiba® | 2,564 | 1,624 | 917 | 329 | 378 | 940 | 820 |
| | % change at CER | 4% | 17% | 20% | 36% | (1%) | (14%) | (17%) |
| | Xultophy® | 717 | 595 | 439 | 14 | 142 | 122 | 120 |
| | % change at CER | 3% | 9% | (4%) | — | 55% | (20%) | (21%) |
| | Levemir® | 1,515 | 942 | 609 | 231 | 102 | 573 | 546 |
| | % change at CER | (18%) | (4%) | 10% | (28%) | (13%) | (34%) | (35%) |
| Premix insulin | 3,012 | 2,849 | 646 | 1,550 | 653 | 163 | 158 |
| % change at CER | (3%) | (3%) | (15%) | (1%) | 7% | (7%) | (7%) |
| | Ryzodeg® | 637 | 637 | 130 | 232 | 275 | — | — |
| | % change at CER | 48% | 48% | 16% | — | 3% | — | — |
| | NovoMix® | 2,375 | 2,212 | 516 | 1,318 | 378 | 163 | 158 |
| | % change at CER | (12%) | (12%) | (21%) | (13%) | 11% | (7%) | (7%) |
| Fast-acting insulin | 4,842 | 3,080 | 1,819 | 660 | 601 | 1,762 | 1,660 |
| % change at CER | 2% | 7% | 10% | (2%) | 10% | (7%) | (7%) |
| | Fiasp® | 497 | 322 | 278 | — | 44 | 175 | 165 |
| | % change at CER | 20% | 25% | 20% | — | 63% | 13% | 13% |
| | NovoRapid® | 4,345 | 2,758 | 1,541 | 660 | 557 | 1,587 | 1,495 |
| | % change at CER | 0% | 5% | 8% | (2%) | 7% | (9%) | (9%) |
| Human insulin | 2,312 | 1,906 | 562 | 643 | 701 | 406 | 387 |
| % change at CER | (14%) | (14%) | (4%) | (24%) | (11%) | (17%) | (17%) |
| Total insulin | 14,962 | 10,996 | 4,992 | 3,427 | 2,577 | 3,966 | 3,691 |
| % change at CER | (4%) | 1% | 4% | (6%) | 2% | (15%) | (16%) |
| Other Diabetes care1 | 884 | 662 | 175 | 341 | 146 | 222 | 188 |
| % change at CER | (25%) | (25%) | 1% | (43%) | 19% | (23%) | (24%) |
| Total Diabetes care | 33,266 | 17,532 | 8,416 | 4,656 | 4,460 | 15,734 | 14,740 |
| % change at CER | 16% | 13% | 15% | 0% | 27% | 18% | 17% |
| Wegovy® | 1,404 | — | — | — | — | 1,404 | 1,404 |
| % change at CER | — | — | — | — | — | — | — |
| Saxenda® | 1,998 | 1,193 | 726 | 37 | 430 | 805 | 704 |
| % change at CER | 23% | 63% | 94% | — | 22% | (11%) | (14%) |
| Total Obesity care | 3,402 | 1,193 | 726 | 37 | 430 | 2,209 | 2,108 |
| % change at CER | 107% | 63% | 94% | — | 22% | 146% | 158% |
| Diabetes and Obesity care total | 36,668 | 18,725 | 9,142 | 4,693 | 4,890 | 17,943 | 16,848 |
| % change at CER | 20% | 16% | 19% | 0% | 27% | 26% | 26% |
| | | | | | | | | |
Rare disease segment | | | | | | | |
| Rare blood disorders2 | 3,077 | 1,803 | 885 | 97 | 821 | 1,274 | 1,212 |
| % change at CER | 9% | 6% | (21%) | — | 52% | 14% | 16% |
| | Haemophilia A | 565 | 449 | 283 | 17 | 149 | 116 | 110 |
| | % change at CER | 10% | 15% | (1%) | — | 46% | (6%) | (6%) |
| | Haemophilia B | 177 | 118 | 70 | 3 | 45 | 59 | 29 |
| | % change at CER | 18% | 28% | 9% | — | 61% | 0% | 35% |
| | NovoSeven® | 2,271 | 1,213 | 516 | 77 | 620 | 1,058 | 1,034 |
| | % change at CER | 8% | 2% | (32%) | — | 54% | 17% | 18% |
| Rare endocrine disorders3 | 1,820 | 1,218 | 553 | 49 | 616 | 602 | 596 |
| % change at CER | (8%) | (2%) | (3%) | 47% | (2%) | (20%) | (20%) |
| Other Rare disease4 | 466 | 295 | 244 | 2 | 49 | 171 | 97 |
| % change at CER | 18% | 4% | 5% | 0% | (2%) | 59% | 112% |
| Rare disease total | 5,363 | 3,316 | 1,682 | 148 | 1,486 | 2,047 | 1,905 |
| % change at CER | 3% | 3% | (13%) | 155% | 21% | 3% | 4% |
| | | | | | | | | |
Total sales | 42,031 | 22,041 | 10,824 | 4,841 | 6,376 | 19,990 | 18,753 |
| % change at CER | 18% | 13% | 12% | 2% | 26% | 24% | 23% |
| % change as reported | 24% | 18% | 14% | 12% | 30% | 33% | 32% |
| Share of growth | 100% | 42% | 20% | 1% | 21% | 58% | 54% |
1) Primarily NovoNorm®, needles and GlucaGen® HypoKit®.
2) Comprises NovoSeven®, NovoEight®, Refixia®, NovoThirteen® and Esperoct®.
3) Primarily Norditropin®.
4) Primarily Vagifem® and Activelle®.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
APPENDIX 7: ACQUISITION OF BUSINESSES
On 28 December 2021, Novo Nordisk acquired all outstanding shares of the publicly held US company Dicerna Pharmaceuticals, Inc. via a cash tender offer. Before the acquisition, Novo Nordisk held 2.9% of the shares in Dicerna Pharmaceuticals, Inc. at a fair value of DKK 573 million.
Details of the acquisition
The total purchase price amounts to DKK 22,034 million, which has been settled by the fair value of existing shareholdings of DKK 573 million, settlement of a pre-existing relationship of DKK 145 million and a cash consideration of DKK 21,316 million.
The purchase price allocation for the acquisition is considered provisional due to the fact that the transaction was closed on 28 December 2021, and the process of identifying and determine fair value of assets acquired and liabilities assumed is on-going. Adjustments may be applied to the purchase price allocation for a period of up to 12 months from the acquisition date.
No Changes during the first 3 months of 2022 have been made to the provisional purchase price allocation as presented in the 2021 Annual Report note 5.3. Acquisition of businesses.
The development in goodwill in the first three month of 2022 is as follows:
| | | | | |
DKK million | 31 Mar 2022 |
Goodwill as of 31 December 2021 | 4,346 |
Exchange rate adjustment | 89 |
Goodwill as of 31 March 2022 | 4,435 |
For further information regarding the acquisition please refer to the Annual Report for 2021.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
APPENDIX 8: NON-IFRS FINANCIAL MEASURES (ADDITIONAL INFORMATION)
In this Company Announcement, Novo Nordisk discloses certain financial measures of the Group’s financial performance, financial position and cash flows that reflect adjustments to the directly comparable measures calculated and presented in accordance with IFRS. These non-IFRS financial measures may not be defined and calculated by other companies in the same manner and may thus not be comparable with such measures. The non-IFRS financial measures presented in the Company Announcement are Sales and operating profit at CER, Free cash flow and Financial reserves.
Sales and operating profit growth at CER
'Growth at CER’ means that the effect of changes in exchange rates is excluded. It is defined as Net sales/Operating profit for the period measured at the average exchange rates for the same period prior year compared with Net sales/Operating profit for the same period prior year. Price adjustments within hyperinflation countries as defined in IAS 29 ‘Financial reporting in hyperinflation economies’ are excluded from the calculation to avoid growth at CER being artificially inflated.
Growth at CER is considered to be relevant information for investors in order to understand the underlying development in sales and operating profit by adjusting for the impact of currency fluctuations.
| | | | | | | | | | | | | | | |
Sales at CER | | | | | | | |
| | | | | | | |
DKK million | Q1 2022 | Q1 2021 | % change Q1 2022 to Q1 2021 | | | | |
| | | | | | | |
Net sales | 42,031 | | 33,804 | | 24 | % | | | | |
Effect of exchange rates | (2,161) | | — | | | | | | |
Sales at CER | 39,870 | | 33,804 | | 18 | % | | | | |
| | | | | | | |
Operating profit at CER | | | | | | | |
| | | | | | | |
DKK million | Q1 2022 | Q1 2021 | % change Q1 2022 to Q1 2021 | | | | |
| | | | | | | |
Operating profit | 19,147 | | 14,982 | | 28 | % | | | | |
Effect of exchange rates | (1,440) | | — | | | | | | |
Operating profit at CER | 17,707 | | 14,982 | | 18 | % | | | | |
Free cash flow
Novo Nordisk defines free cash flow as ’net cash generated from operating activities’, less ‘net cash used in investing activities’, less repayment on lease liabilities and excluding net change of marketable securities. Free cash flow is a measure of the amount of cash generated in the period which is available for the Board of Directors to allocate between Novo Nordisk's capital providers, through eg dividends, share repurchases and repayment of debt (excluding lease liability repayments) or for retaining in the business to fund future growth.
The following table shows a reconciliation of Free cash flow with Net cash generated from operating activities, the most directly comparable IFRS financial measure:
| | | | | | | | | | |
Free cash flow | | | | |
| | | | |
DKK million | Q1 2022 | Q1 2021 | | |
| | | | |
Net cash generated from operating activities | 23,586 | | 11,255 | | | |
Net cash used in investing activities | (1,907) | | (3,481) | | | |
Net purchase of marketable securities | 120 | | 1,983 | | | |
| | | | |
Repayment on lease liabilities | (231) | | (225) | | | |
Free cash flow | 21,568 | | 9,532 | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
| | | | | |
Financial report for the period 1 January 2022 to 31 March 2022 | |
Financial reserves
'Financial reserves' is defined as the sum of cash and cash equivalents at the end of the period, marketable securities with original term to maturity exceeding three months and undrawn committed credit and loan facilities, with a maturity of more than 12 months, less loans and bank overdrafts classified as liabilities arising from financing activities with obliged repayment within 12 months of the balance sheet date. The following table reconciles total financial reserves with cash and cash equivalents, the most directly comparable IFRS financial measure:
| | | | | | | | |
Financial reserves | | |
| | |
DKK million | Q1 2022 | Q1 2021 |
| | |
Cash and cash equivalents | 13,208 | | 5,679 | |
Marketable securities | 6,752 | | 1,983 | |
Undrawn committed credit facility | 11,529 | | 11,528 | |
Undrawn bridge facility | — | | 5,578 | |
Borrowings | (387) | | (471) | |
Financial reserves | 31,102 | | 24,297 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Strategic aspirations | Performance highlights | Commercial execution | Financials | Cash flow and capital allocation | Outlook | Innovation and therapeutic focus | Purpose and sustainability | Legal | Financial Information |
| | | | | Company announcement No 33 / 2022 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
Date: April 29, 2022
Novo Nordisk A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
Novo Nordisk (PK) (USOTC:NONOF)
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