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`Financial report for the period 1 January 2021 to 31 December 2021
`
`2 February 2022
`
`
`
`
`
`
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`Novo Nordisk's sales increased by 11% in Danish kroner and by 14% at constant
`exchange rates to DKK 140.8 billion in 2021
`
`
`
`
`
`
`
`
`
`• Operating profit increased by 8% in Danish kroner and by 13% at constant exchange rates (CER) to DKK 58.6 billion.
`• Sales in International Operations increased by 12% in Danish kroner (14% at CER), and sales in North America
`Operations increased by 10% in Danish kroner (14% at CER).
`• Sales within Diabetes and Obesity care increased by 13% in Danish kroner to DKK 121.6 billion (15% at CER), driven by
`GLP-1 sales growth of 28% in Danish kroner (32% at CER) reflecting the uptake of Ozempic® and Rybelsus®. Obesity care
`sales grew by 50% in Danish kroner (55% at CER), and Biopharm sales increased by 1% measured in Danish kroner (4%
`at CER).
`• Within R&D, Novo Nordisk in November 2021 successfully completed the first cohorts from the ongoing phase 1/2
`clinical trial with Mim8, and in December 2021 the acquisition of Dicerna Pharmaceuticals was completed.
`• In December 2021, a contract manufacturer filling syringes for Wegovy® temporarily stopped deliveries and
`manufacturing following issues with current Good Manufacturing Practices. Consequently, fewer new weekly patient
`initiations are expected in the first half of 2022 compared to fourth quarter of 2021. Novo Nordisk still expects to be
`able to meet demand in the US in the second half of 2022.
`• For the 2022 outlook, sales growth is expected to be 6-10% at CER and operating profit growth is expected to be 4-8%
`at CER. Sales and operating profit growth reported in Danish kroner is expected to be 5 and 7 percentage points higher
`than at CER, respectively.
`• At the Annual General Meeting on 24 March 2022, the Board of Directors will propose a final dividend of DKK 6.90 for
`2021 per share of DKK 0.20. The expected total dividend for 2021 is DKK 10.40 per share, of which DKK 3.50 was paid as
`interim dividend in August 2021. The Board of Directors intends to initiate a new 12-month share repurchase
`programme of up to DKK 22 billion.
`
`PROFIT AND LOSS
`
`DKK million
`Net sales
`Operating profit
`
`Net profit
`Diluted earnings per share (in DKK)
`
`* CER: Constant exchange rates (average 2020).
`
`2021
`
`2020
`
`Growth
`as reported
`
`Growth
`at CER*
`
`
`
`
`
`
`
`140,800
`58,644
`
`47,757
`20.74
`
`
`
`
`
`
`
`126,946
`54,126
`
`42,138
`18.01
`
` 11%
` 8%
`
` 13%
` 15%
`
` 14%
` 13%
`
`N/A
`N/A
`
`Lars Fruergaard Jørgensen, president and CEO: "We are very pleased with the double-digit sales growth in 2021 and the
`progress we have made on our Strategic Aspirations. The results reflect that almost 35 million people with diabetes are
`now benefiting from our treatments worldwide. In obesity, we are making progress in resolving the Wegovy® supply issue
`and we expect to be able to meet demand from people living with obesity in the US in the second half of 2022".
`
`On 2 February 2022 at 13.00 CET, corresponding to 07.00 am EST, an earnings call will be held. Investors will be able to listen in
`via a link on novonordisk.com, which can be found under ‘Investors’.
`
`Novo Nordisk A/S
`Investor Relations
`
`Novo Allé
`2880 Bagsværd
`Denmark
`
`Telephone:
`+45 4444 8888
`www.novonordisk.com
`
`CVR Number:
`24 25 67 90
`
` Company announcement No 7 / 2022
`
`Novo Nordisk Exhibit 2509
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report for the period 1 January 2021 to 31 December 2021
`
`Page 2 of 33
`
`STRATEGIC ASPIRATIONS
`
`STRATEGIC ASPIRATIONS 2025
`The strategic aspirations are objectives that Novo Nordisk intends to work towards and are not a projection of Novo
`Nordisk's financial outlook or expected growth. Novo Nordisk intends to describe how its activities develop in relation to
`each of the four dimensions on an ongoing basis.
`
`Performance highlights for 2021 (fourth-quarter developments):
`
`Purpose and sustainability
`Adding value to society:
`•
`Progress on 'Defeat Diabetes' strategy:
`◦ Medical treatment provided to 34.6 million people living
`with diabetes in 2021
`46 new vulnerability assessments conducted enabling
`access to insulin to around 82,000 people with diabetes
`Reaching 18 countries and around 32,000 children in
`Changing Diabetes® in Children
`
`◦
`
`◦
`
`Progress towards zero environmental impact:
`43% reduction in CO2 emissions compared to 2019
`•
`
` Evolve culture and ensure distinct core capabilities:
`•
`Launch of an aspirational gender diversity target
`
`Commercial execution
` Strengthen diabetes leadership to more than one-third
`• Diabetes value market share increased by 0.8 percentage
`point to 30.1% (MAT)
`
` Strengthen obesity leadership and double sales:
`• Obesity care sales increased by 55% (CER) to DKK 8.4 billion
`
` Secure a sustained growth outlook for Biopharm:
`•
`Biopharm sales increased by 4% (CER) to DKK 19.2 billion
`
`Innovation and therapeutic focus
`Further raise innovation bar for diabetes treatment:
`Approval of Xulthopy® and Ozempic® in China for the
`•
`treatment of type 2 diabetes
`Resubmission of semaglutide 2.0 mg in the US and approval
`in the EU in January 2022
`Phase 1 trial completed with a glucose-sensitive insulin
`
`•
`
`•
`
`Develop superior treatment solutions for obesity:
`Approval of Wegovy®, semaglutide 2.4 mg, in the US and
`•
`approval in the EU in January 2022
`Phase 3a development initiated with 50 mg oral
`semaglutide in obesity
`
`•
`
`Strengthen and progress Biopharm pipeline:
`Sogroya® phase 3 programme in children with growth
`•
`hormone deficiency successfully completed
`First Mim8 phase 1/2 trial cohorts successfully completed
`
`•
`
`Establish presence in Other serious chronic diseases:
`•
`Phase 3a development initiated with ziltivekimab in
`cardiovascular disease and semaglutide in NASH and
`Alzheimer's disease
`
`the
`
`
`
`Acquisition of Dicerna Pharmaceuticals and its RNAi platform to
`be applied across therapy areas
`
`Financials
`Deliver solid sales and operating profit growth:
`•
`Sales growth at 14% (CER)
`International Operations sales growth of 14% (CER)
`•
`• US sales growth of 13% (CER) with 60% of sales coming
`from products launched since 2015
`• Operating profit growth of 13% (CER)
`
` Drive operational efficiencies:
`•
`Continued productivity gains in Product Supply
`
`Enable attractive capital allocation to shareholders:
`•
`Free cash flow of DKK 29.3 billion
`•
`Share buyback of DKK 20 billion
`•
`Total dividend of DKK 10.40 per share and payout ratio of
`49.6%
`
`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 7 / 2022
`
`Novo Nordisk Exhibit 2509
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2021 to 31 December 2021
`
`Page 3 of 33
`
`PERFORMANCE HIGHLIGHTS
`FINANCIAL HIGHLIGHTS FOR 2021
`
`PROFIT AND LOSS
`(Amounts are in DKK million, except for earnings per
`share and dividend per share)
`
`2021
`
`2020
`
`2019
`
`2018
`
`2017
`
` % change
` 2021 to
` 2020
`
` % change
` 2021 to
` 2020 at CER
`
`Net sales
`
` 140,800
`
` 126,946
`
` 122,021
`
` 111,831
`
` 111,696
`
`Gross profit
`Gross margin
`Sales and distribution costs
`Percentage of sales
`Research and development costs
`Percentage of sales
`Administrative costs
`Percentage of sales
`Other operating income and expenses
`
`
`
`
`
` 117,142
` 83.2%
`(37,008)
` 26.3%
`(17,772)
` 12.6%
`(4,050)
` 2.9%
`332
`
`
`
`
`
`
`
`
`
` 106,014
` 83.5%
`(32,928)
` 25.9%
`(15,462)
` 12.2%
`(3,958)
` 3.1%
`460
`
`
`
`
`
`
`
`
`
` 101,933
` 83.5%
`(31,823)
` 26.1%
`(14,220)
` 11.7%
`(4,007)
` 3.3%
`600
`
`
`
`
`
`
`
`
`
` 94,214
` 84.2%
`(29,397)
` 26.3%
`(14,805)
` 13.2%
`(3,916)
` 3.5%
`1,152
`
`
`
`
`
`
`
`
`
` 94,064
` 84.2%
`(28,340)
` 25.4%
`(14,014)
` 12.5%
`(3,784)
` 3.4%
`1,041
`
`
`
`
`
` 48,967
` 43.8%
`(287)
`
` 11%
`
` 10%
`
` 12%
`
` 15%
`
` 2%
`
` (28%)
`
` 8%
`
` 14%
`
` 14%
`
` 15%
`
` 16%
`
` 4%
`
` (27%)
`
` 13%
`
`Operating profit
`Operating margin
`Financial items (net)
`
`Profit before income taxes
`Income taxes
`Effective tax rate
`Net profit
`Net profit margin
`
`OTHER KEY NUMBERS
`Depreciation, amortisation and
`impairment losses
`Purchase of intangible assets
`Capital expenditure
`Net cash generated from operating
`activities
`Free cash flow
`Total assets
`Equity
`Equity ratio
`Diluted earnings per share / ADR (in
`DKK)
`Total dividend per share 1)
`Payout ratio 2)
`
` 58,644
` 41.7%
`436
`
`
`
` 59,080
`(11,323)
`
` 19.2%
` 47,757
` 33.9%
`
`6,025
`
`1,050
`
`6,335
`
` 55,000
` 29,319
` 194,508
` 70,746
` 36.4%
`
` 54,126
` 42.6%
`(996)
`
`
`
` 52,483
` 43.0%
`(3,930)
`
`
`
` 47,248
` 42.2%
`367
`
`
`
`
`
` 53,130
`(10,992)
`
` 20.7%
` 42,138
` 33.2%
`
` 48,553
`(9,602)
`
` 19.8%
` 38,951
` 31.9%
`
` 47,615
`(8,987)
`
` 18.9%
` 38,628
` 34.5%
`
` 48,680
`(10,550)
`
` 21.7%
` 38,130
` 34.1%
`
`5,753
`
` 16,256
`5,825
`
` 51,951
` 28,565
` 144,922
` 63,325
` 43.7%
`
`5,661
`
`2,299
`
`8,932
`
` 46,782
` 34,451
` 125,612
` 57,593
` 45.8%
`
`3,925
`
`2,774
`
`9,636
`
` 44,616
` 32,536
` 110,769
` 51,839
` 46.8%
`
`3,182
`
`1,022
`
`7,626
`
` 41,168
` 32,588
` 102,355
` 49,815
` 48.7%
`
` (144%)
`
` 11%
` 3%
`
` 13%
`
` 5%
` (94%)
` 9%
` 6%
` 3%
` 34%
` 12%
`
`
`
`20.74
`
`
`
`18.01
`
`
`
`16.38
`
`
`
`15.93
`
`
`
`15.39
`
` 15%
`
`N/A
`
`N/A
`N/A
`
`N/A
`
`N/A
`
`N/A
`N/A
`N/A
`N/A
`N/A
`
`N/A
`
`7.85
`8.15
`8.35
`9.10
`10.40
` 50.4%
` 50.6%
` 50.5%
` 50.0%
` 49.6%
`1) Total dividend for the financial year 2021 including proposed final dividend of DKK 6.90 per share and interim dividend paid in August 2021 of DKK 3.50 per share.
`2) Total dividend for the year as a percentage of net profit.
`
`
`
` 14%
`
`The Board of Directors and Executive Management have approved the Annual Report 2021 of Novo Nordisk A/S
`including the audited consolidated financial statements. The Board of Directors and Executive Management also
`approved this unaudited financial statement containing condensed financial information for 2021. This financial
`statement is prepared in accordance with the recognition and measurement requirements of the International
`Financial Reporting Standards (IFRS) as issued by IASB and IFRS as endorsed by the EU.
`
`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 7 / 2022
`
`Novo Nordisk Exhibit 2509
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for the period 1 January 2021 to 31 December 2021
`
`Page 4 of 33
`
`COMMERCIAL EXECUTION
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales grew by 11% measured in Danish kroner and by 14% at CER 2021, driven by growth across all therapy areas with
`Diabetes care sales growth of 13% (CER), Obesity care sales growth of 55% (CER) and Biopharm sales growth of 4% (CER).
`
`Sales split per therapy
`Diabetes and Obesity care segment
`
`Rybelsus®
`Ozempic®
`Victoza®
`Total GLP-1
`Long-acting insulin
` -   Tresiba®
` -   Xultophy®
` -   Levemir®
`Premix insulin
` -   Ryzodeg®
` -   NovoMix®
`Fast-acting insulin
` -   Fiasp®
` -   NovoRapid®
`Human insulin
`Total insulin
`Other Diabetes care1
`Total Diabetes care
`Obesity care (Saxenda® and Wegovy®)
`
`Diabetes and Obesity care total
`
`Biopharm segment
`Rare blood disorders2
` - Haemophilia A
` - Haemophilia B
` -  NovoSeven®
`Rare endocrine disorders3
`Other Biopharm4
`Biopharm total
`
`Total sales
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Sales 2021
`DKK million
`
` Sales 2020
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`4,838
`33,705
`15,054
`53,597
`18,064
`9,729
`2,657
`5,678
`11,203
`1,711
`9,492
`17,687
`1,748
`15,939
`9,052
`56,006
`3,594
`113,197
`8,400
`
`121,597
`
`10,217
`2,112
`637
`7,221
`7,303
`1,683
`19,203
`
`1,873
`21,211
`18,747
`41,831
`18,439
`8,968
`2,444
`7,027
`10,925
`1,291
`9,634
`18,313
`1,385
`16,928
`8,873
`56,550
`4,031
`102,412
`5,608
`
`108,020
`
`9,662
`1,713
`518
`7,203
`7,707
`1,557
`18,926
`
`140,800
`
`126,946
`
` 158%
` 59%
` (20%)
` 28%
` (2%)
` 8%
` 9%
` (19%)
` 3%
` 33%
` (1%)
` (3%)
` 26%
` (6%)
` 2%
` (1%)
` (11%)
` 11%
` 50%
`
` 13%
`
` 6%
` 23%
` 23%
` 0%
` (5%)
` 8%
` 1%
`
` 11%
`
` 168%
` 64%
` (18%)
` 32%
` 0%
` 11%
` 11%
` (17%)
` 4%
` 37%
` (1%)
` (1%)
` 29%
` (3%)
` 4%
` 1%
` (10%)
` 13%
` 55%
`
` 15%
`
` 9%
` 25%
` 25%
` 4%
` (2%)
` 8%
` 4%
`
` 14%
`
` 18%
` 77%
` (19%)
` 76%
` 0%
` 6%
` 1%
` (7%)
` 2%
` 3%
` (1%)
` (1%)
` 2%
` (3%)
` 2%
` 3%
` (2%)
` 77%
` 18%
`
` 95%
`
` 5%
` 2%
` 1%
` 1%
` (1%)
` 1%
` 5%
`
` 100%
`
`1) Primarily NovoNorm®, needles and GlucaGen® HypoKit®.
`2) Comprises NovoSeven®, NovoEight®, Esperoct®, Refixia® and NovoThirteen®.
`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 7 / 2022
`
`Novo Nordisk Exhibit 2509
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financial report for the period 1 January 2021 to 31 December 2021
`
`Page 5 of 33
`
`DIABETES AND OBESITY CARE
`Diabetes care, sales and market share development
`Sales in Diabetes care increased by 11% measured in Danish kroner and by 13% at CER to DKK 113,197 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
`30.1% 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 November
`2021 and November 2020 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.
`
`Diabetes care, development per geographical area
`
`Novo Nordisk’s share of the total
`diabetes market (value, MAT)
`
`Diabetes care, sales development
`
`Global
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`North America Operations
` - The US
`
`November
`2021
` 30.1%
` 24.9%
` 28.7%
` 33.0%
` 15.5%
` 31.9%
` 31.9%
`
`November
`2020
` 29.3%
` 23.2%
` 27.7%
` 30.0%
` 13.5%
` 31.5%
` 31.6%
`
` Sales 2021
`DKK million
`113,197
`58,692
`29,136
`15,563
`13,993
`54,505
`51,197
`
`Growth
`at CER
` 13%
` 14%
` 12%
` 11%
` 24%
` 12%
` 11%
`
`Source: IQVIA, November 2021 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 28% measured in Danish
`kroner and by 32% at CER to DKK 53,597 million. The GLP-1 segment’s value share of the total diabetes market has
`increased to 26.5% compared with 21.9% 12 months ago. Novo Nordisk continues to be the global market leader in the
`GLP-1 segment with a 52.7% value market share, an increase of 2.3 percentage points compared to 12 months ago.
`
`GLP-1, development per geographical area
`
`Novo Nordisk's share of the
`diabetes GLP-1 market (value, MAT)
`
`GLP-1, sales development
`
`Global
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`North America Operations
` - The US
`
`November
`2021
` 52.7%
` 58.9%
` 58.3%
` 74.0%
` 56.9%
` 51.8%
` 51.0%
`
`November
`2020
` 50.4%
` 53.7%
` 55.1%
` 90.2%
` 43.6%
` 50.0%
` 49.3%
`
` Sales 2021
`DKK million
`53,597
`16,106
`10,209
`1,847
`4,050
`37,491
`35,442
`
`Growth
`at CER
` 32%
` 52%
` 38%
` 73%
` 85%
` 25%
` 24%
`
`Source: IQVIA, November 2021 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 158% measured in Danish kroner and by 168% at CER to DKK 4,838 million. Sales growth was
`driven by North America Operations as well as EMEA and Rest of World. Rybelsus® has now been launched in 29 countries.
`
`Ozempic® sales increased by 59% measured in Danish kroner and by 64% at CER to DKK 33,705 million. Sales growth was
`driven by both North America Operations and International Operations. Ozempic® has now been launched in 72 countries.
`
`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 7 / 2022
`
`Novo Nordisk Exhibit 2509
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2021 to 31 December 2021
`
`Page 6 of 33
`
`Victoza® sales decreased by 20% measured in Danish kroner and by 18% at CER to DKK 15,054 million as the GLP-1 market
`is moving towards once-weekly and tablet-based treatments. The sales decline was driven by North America Operations,
`EMEA and Rest of World, partially offset by higher sales in Region China.
`
`International Operations
`Sales of GLP-1 diabetes products in International Operations increased by 50% measured in Danish kroner and by 52% 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 13.6% from 10.7% 12 months ago. Novo Nordisk is the market leader with a value market share of 58.9%.
`
`EMEA
`Sales in EMEA increased by 38% in both Danish kroner and at CER. The sales growth reflects the uptake of Ozempic® and
`Rybelsus®, partially offset by lower sales of Victoza®. Rybelsus® has now been launched in 24 countries in EMEA. Novo
`Nordisk remains the market leader in EMEA with a value market share of 58.3%.
`
`Region China
`Sales in Region China increased by 77% measured in Danish kroner and by 73% at CER. The sales growth reflects the
`uptake of Victoza® in China and of Ozempic® in Taiwan as well as launch of Ozempic® in China following the approval in
`April 2021. 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 5.6% from 2.9% 12 months ago.
`
`Rest of World
`Sales in Rest of World increased by 74% measured in Danish kroner and by 85% 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 56.9%.
`
`North America Operations
`Sales of GLP-1 diabetes products in North America Operations increased by 21% measured in Danish kroner and by 25%
`at CER. Novo Nordisk is the market leader with a 51.8% value market share compared to 50.0% 12 months ago. The value
`market share of the GLP-1 class of the total North American diabetes market has increased to 31.1% compared to 26.0%
`12 months ago.
`
`Sales growth in the US is driven by a prescription volume growth of the GLP-1 class of around 30% in the fourth quarter of
`2021 compared to the fourth quarter of 2020. The weekly new-to-brand market share for Ozempic® is 44.9% and 12.7% for
`Rybelsus®. The combined Novo Nordisk GLP-1 new-to-brand prescription market share is now 63.9%. Novo Nordisk is the
`market leader with 53.4% measured on total monthly prescriptions for the combined GLP-1 portfolio.
`
`Sales of GLP-1 in the US increased by 24% 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 7 / 2022
`
`Novo Nordisk Exhibit 2509
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2021 to 31 December 2021
`
`Page 7 of 33
`
`Insulin
`Sales of insulin decreased by 1% measured in Danish kroner and increased by 1% at CER to DKK 56,006 million. Sales
`growth at CER was driven by increased sales in International Operations, partially offset by declining sales in the US.
`
`Insulin, development per geographical area
`
`Novo Nordisk’s share of the total
`insulin market (volume, MAT)
`
`Insulin, sales development
`
`Global
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`North America Operations
` - The US
`
`November
`2021
` 47.1%
` 50.3%
` 47.6%
` 50.9%
` 57.2%
` 38.6%
` 38.1%
`
`November
`2020
` 47.3%
` 50.1%
` 47.6%
` 50.6%
` 57.1%
` 39.6%
` 39.4%
`
` Sales 2021
`DKK million
`56,006
`39,942
`18,214
`12,284
`9,444
`16,064
`14,949
`
`Growth
`at CER
` 1%
` 6%
` 2%
` 8%
` 11%
` (9%)
` (9%)
`
`Source: IQVIA, November 2021 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 4% measured in Danish kroner and by 6% at CER. Sales growth at
`CER was driven by all insulin products except for Levemir® and NovoMix®.
`
`EMEA
`Sales of insulin in EMEA decreased by 1% measured in Danish kroner and increased by 2% at CER. The sales growth at CER
`was mainly driven by Tresiba® and Fiasp®, partially countered by Levemir®, NovoRapid® and human insulin. Novo Nordisk
`has a volume market share of 47.6% of the total insulin market.
`
`Region China
`Sales of insulin in Region China increased by 11% measured in Danish kroner and by 8% at CER. The sales growth was
`driven by Tresiba®, Ryzodeg® and NovoRapid®, partially countered by Levemir® and human insulin. Novo Nordisk has a
`volume market share of 50.9% of the total insulin market.
`
`Rest of World
`Sales of insulin in Rest of World increased by 6% measured in Danish kroner and by 11% at CER. The sales growth at CER
`was driven by all insulin products except for Levemir® and NovoMix®. Novo Nordisk has a volume market share of 57.2% of
`the total insulin market.
`
`North America Operations
`Sales of insulin in North America Operations decreased by 12% measured in Danish kroner and by 9% at CER. The sales
`decrease in the US was driven by lower realised prices due to channel and payer mix and rebate enhancements as well as
`a decline in volume. Changes to the 340B Drug Programme positively impacted sales. 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 7 / 2022
`
`Novo Nordisk Exhibit 2509
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financial report for the period 1 January 2021 to 31 December 2021
`
`Page 8 of 33
`
`Obesity care, sales development
`Sales of Obesity care products, Saxenda® and Wegovy®, increased by 50% measured in Danish kroner and by 55% at CER
`to DKK 8,400 million. Sales growth was driven by North America Operations and International Operations. Saxenda® has
`been launched in 65 countries, and Wegovy® was launched in the US in June 2021. Novo Nordisk currently has a value
`market share of 77.8% of the global branded obesity prescription drug market. The strategic aspiration for Obesity care is
`to more than double reported sales from the base in 2019 of DKK 5,679 million by 2025.
`
`Obesity care, development per geographical area
`
`Obesity care, sales development
`
`Global
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
` Sales 2021
`DKK million
`8,400
`3,117
`1,809
`61
`1,247
`5,283
`4,912
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 55%
` 52%
` 66%
`—
` 32%
` 57%
` 58%
`
`International Operations
`Sales of Saxenda® in International Operations increased by 47% measured in Danish kroner and by 52% at CER driven by
`increased sales in EMEA and Rest of World. Novo Nordisk currently has a value market share of 52.4% in the branded
`obesity prescription drug market.
`
`EMEA
`Sales of Saxenda® in EMEA increased by 61% measured in Danish kroner and by 66% at CER. Novo Nordisk currently has a
`value market share of 73.1% in the branded obesity prescription drug market.
`
`Rest of World
`Sales of Saxenda® in Rest of World increased by 27% measured in Danish kroner and by 32% at CER. Saxenda® has been
`launched in 19 countries in Rest of World. Novo Nordisk currently has a value market share of 41.7% in the branded
`obesity prescription drug market.
`
`North America Operations
`Sales of Obesity care products in North America Operations increased by 51% measured in Danish kroner and by 57% at
`CER. Novo Nordisk now has a value market share of 89.0% 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 more than 70%. The initial feedback from prescribers 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.
`As a consequence, Novo Nordisk does not expect to be able to meet the demand of Wegovy® in the US in the first half of
`2022 and fewer new weekly patient initiations are expected compared to the fourth quarter of 2021. Novo Nordisk still
`expects to be able to meet demand in the US in the second half of 2022.
`
`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 7 / 2022
`
`Novo Nordisk Exhibit 2509
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financial report for the period 1 January 2021 to 31 December 2021
`
`Page 9 of 33
`
`BIOPHARM
`Biopharm, sales development
`Sales of Biopharm products increased by 1% measured in Danish kroner and by 4% at CER to DKK 19,203 million in line
`with the strategic aspiration of sustained growth in Biopharm. The sales growth at CER was driven by both North America
`Operations and International Operations. Sales growth was driven by Rare blood disorders.
`
`Biopharm, development per geographical area
`
`Biopharm, sales development
`
`Global
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
` Sales 2021
`DKK million
`19,203
`11,728
`6,761
`395
`4,572
`7,475
`6,900
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 4%
` 3%
` 3%
` (11%)
` 5%
` 6%
` 7%
`
`Rare blood disorders
`Sales of Rare blood disorder products increased by 6% measured in Danish kroner and by 9% at CER to DKK 10,217 million.
`The increasing sales were driven by the launch products Esperoct® and Refixia® as well as NovoSeven® and NovoEight®.
`
`Sales of haemophilia A products increased by 23% measured in Danish kroner and by 25% at CER to DKK 2,112 million. The
`sales increase was driven by both International Operations and North America Operations. Esperoct® has now been
`launched in 25 countries.
`
`Sales of haemophilia B products increased by 23% measured in Danish kroner and by 25% at CER to DKK 637 million. The
`sales increase was driven by both International Operations and North America Operations. Refixia® has now been
`launched in 25 countries.
`
`Sales of NovoSeven® remained unchanged in Danish kroner and increased by 4% at CER to DKK 7,221 million. The sales
`development was driven by increasing sales in North America Operations, partially offset by declining sales in International
`Operations. The sales decline in Region China reflects increased distributor stock levels in 2020.
`
`Rare endocrine disorders
`Sales of Rare endocrine disorder products decreased by 5% measured in Danish kroner and by 2% at CER to DKK 7,303
`million. The sales development was driven by North America Operations' sales decreasing by 12% at CER, partially offset by
`International Operations sales increasing by 5% at CER. Novo Nordisk is the leading company in the global human growth
`disorder market with a value market share of 36.3% compared to 35.6% a year ago.
`
`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 7 / 2022
`
`Novo Nordisk Exhibit 2509
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2021 to 31 December 2021
`
`Page 10 of 33
`
`FINANCIALS
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 11% measured in Danish kroner and by 14% at CER to DKK 140,800 million in 2021. Sales in
`International Operations increased by 12% measured in Danish kroner and by 14% at CER. The strategic aspiration for
`International Operations is sales growth between 6-10%. Sales in North America Operations increased by 10% measured
`in Danish kroner and by 14% at CER. The strategic aspiration of transforming 70% of sales in the US has progressed, and
`60.3% of sales are now derived from products launched since 2015.
`
`Sales split per geographical area
`
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
`Total sales
`
` Sales 2021
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`
`
`
`
`
`
`
`
`
`73,537
`37,706
`16,019
`19,812
`67,263
`63,009
`
`140,800
`
` 12%
` 10%
` 14%
` 14%
` 10%
` 9%
`
` 11%
`
` 14%
` 12%
` 11%
` 19%
` 14%
` 13%
`
` 14%
`
` 51%
` 23%
` 9%
` 19%
` 49%
` 44%
`
` 100%
`
`International Operations
`Sales in International Operations increased by 12% measured in Danish kroner and by 14% at CER. Sales growth was
`driven by all therapy areas with GLP-1 sales growing by 52% at CER, insulin sales growing by 6% at CER, Obesity care sales
`growing by 52% at CER and Biopharm sales growing by 3% at CER.
`
`EMEA
`Sales in EMEA increased by 10% measured in Danish kroner and by 12% at CER. Sales growth was driven by Diabetes care
`growing by 12% at CER driven by increased GLP-1 sales. Obesity care sales increased by 66% at CER and Biopharm sales
`increased by 3% at CER.
`
`Region China
`Sales in Region China increased by 14% measured in Danish kroner and by 11% at CER. Sales growth was driven by
`Diabetes care growth of 11% at CER reflecting increased insulin and GLP-1 sales, partially offset by Biopharm sales
`declining by 11% at CER reflecting increased distributor stock levels in 2020.
`
`Rest of World
`Sales in Rest of World increased by 14% measured in Danish kroner and by 19% at CER. Sales growth was driven by
`Diabetes care growing by 24% at CER, reflecting increased GLP-1 and insulin sales, Obesity care sales growing by 32% at
`CER and Biopharm growing by 5% at CER.
`
`North America Operations
`Sales in North America Operations increased by 10% measured in Danish kroner and by 14% at CER. Changes to the 340B
`Drug Pricing Programme positively impacted sales growth.
`
`The sales increase reflects GLP-1 diabetes sales growing by 25% at CER, Obesity care sales growing by 57% at CER and
`Biopharm sales growing by 6% at CER. This was partially offset by insulin sales decreasing by 9% at CER driven by lower
`realised prices due to channel and payer mix and rebate enhancements