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`Financial report for the period 1 January 2022 to 31 December 2022
`
`1 February 2023
`
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`Novo Nordisk's sales increased by 26% in Danish kroner and by 16% at constant
`exchange rates to DKK 177.0 billion in 2022
`
`
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`• Operating profit increased by 28% in Danish kroner and by 15% at constant exchange rates (CER) to DKK 74.8 billion.
`• Sales in North America Operations increased by 35% in Danish kroner (21% at CER), and sales in International
`Operations increased by 17% in Danish kroner (13% at CER).
`• Sales within Diabetes and Obesity care increased by 29% in Danish kroner to DKK 156.4 billion (19% at CER), mainly
`driven by GLP-1 diabetes sales growth of 56% in Danish kroner (42% at CER). Rare disease sales increased by 7%
`measured in Danish kroner (1% at CER).
`• Obesity care sales grew by 101% in Danish Kroner (84% at CER). All Wegovy® dose strengths were made available again
`in the US in December 2022.
`• Within R&D, Novo Nordisk initiated two phase 1 trials in NASH based on the siRNA technology platform.
`
`• For the 2023 outlook, both sales and operating profit growth are expected to be 13-19% at CER. Sales and operating
`profit growth reported in Danish kroner are expected to be 4 and 5 percentage points lower than at CER, respectively.
`• At the Annual General Meeting on 23 March 2023, the Board of Directors will propose a final dividend of DKK 8.15 for
`2022 per share. The expected total dividend for 2022 is DKK 12.40 per share, of which DKK 4.25 was paid as interim
`dividend in August 2022. The Board of Directors has decided to initiate a new 12-month share repurchase programme
`of up to DKK 28 billion.
`
`PROFIT AND LOSS
`
`DKK million
`Net sales
`Operating profit
`
`Net profit
`Diluted earnings per share (in DKK)
`* CER: Constant exchange rates (average 2021).
`
`2022
`
`2021
`
`Growth
`as reported
`
`Growth
`at CER*
`
`
`
`
`
`
`
`176,954
`74,809
`
`55,525
`24.44
`
`140,800
`58,644
`
`47,757
`20.74
`
` 26%
` 28%
`
` 16%
` 18%
`
` 16%
` 15%
`
`N/A
`N/A
`
`Lars Fruergaard Jørgensen, president and CEO: "We are very pleased with the double-digit sales growth in 2022 driven by
`our innovative GLP-1-based diabetes and obesity treatments, and more than 36 million people living with diabetes are now
`benefiting from our treatments. We continued to make progress on our Strategic aspirations and in 2023, we will continue
`our focus on strong commercial execution, expanding and progressing our innovative pipeline and investing significantly
`in the expansion of production capacity for current and future portfolio."
`
`On 1 February 2023 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 Alle 1
`2880 Bagsværd
`Denmark
`
`Telephone:
`+45 4444 8888
`www.novonordisk.com
`
`CVR Number:
`24 25 67 90
`
` Company announcement No 5 / 2023
`
`Novo Nordisk Exhibit 2513
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`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.
`
`Within "Financials", the strategic aspiration of transforming 70% of US sales has been achieved, and sales growth in
`International Operations has surpassed the aspiration of "6-10% growth". Consequently, the regional aspirations are
`removed.
`
`Performance highlights for 2022 (blue indicates fourth-quarter development):
`
`Purpose and sustainability
`Progress towards zero environmental impact:
`•
`Carbon emissions from operations and transportation
`decreased by 29% compared to 2019
`
`◦
`
`Adding value to society:
`•
`Progress on 'Defeat Diabetes' strategy:
`◦ Medical treatment provided to 36.3 million people living
`with diabetes
`Reached more than 41,000 children in Changing
`Diabetes® in Children programme
`• Diabetes and haemophilia medication donated to the
`Ukrainian Ministry of Health
`Positive scientific opinion from EMA on human insulin with
`more flexible storage without refrigeration
`
`•
`
`Being recognised as a sustainable employer:
`•
`Share of women in senior leadership positions increased to
`39% from 36% in 2021
`
`Commercial execution
` Strengthen diabetes leadership to more than one-third:
`• Diabetes value market share increased by 1.8 percentage
`points to 31.9% (MAT)
`
` More than DKK 25 billion in Obesity care sales by 2025:
`• Obesity care sales increased by 84% (CER) to DKK 16.9
`billion
`
` Secure a sustained growth outlook for Rare disease:
`•
`Rare disease sales increased by 1% (CER) to DKK 20.5 billion
`
`Innovation and therapeutic focus
`Further raise innovation bar for diabetes treatment:
`Approval of Ozempic® 2.0 mg in the US
`•
`•
`Successful completion of phase 3a trials with once-weekly
`insulin icodec
`Successful completion of phase 2 trial with CagriSema in
`people with type 2 diabetes
`Phase 1 trials with Ideal Pump insulin successfully
`completed
`Phase 1 trial initiated with a once-daily oral GLP-1/GIP
`agonist and once-weekly oral semaglutide
`
`•
`
`•
`
`•
`
`Stre Develop superior treatment solutions for obesity:
`•
`STEP TEENs phase 3 trial successfully completed
`•
`Phase 3a initiation with CagriSema in people with obesity
`•
`Phase 1 initiation with oral amycretin
`
`the
`
`Strengthen and progress Rare disease pipeline:
`•
`Concizumab phase 3 trials completed in people with
`haemophilia A and B with inhibitors and in people without
`inhibitors
`• Dosing initiated in phase 3a trial with Mim8
`•
`Phase 2 trial initiated with NDec in sickle cell disease
`•
`Acquisition of Forma Therapeutics to expand pipeline in
`sickle cell disease
`
`Establish presence in Other serious chronic diseases:
`•
`Phase 2 trial initiated with NNC6019 in cardiomyopathy
`•
`Phase 1 trials initiated in NASH utilising the siRNA platform
`
`Financials
`Deliver solid sales and operating profit growth:
`•
`Sales growth at 16% (CER)
`International Operations sales growth of 13% (CER)
`•
`• US sales growth of 19% (CER) with 73% of sales coming
`from products launched since 2015
`• Operating profit growth of 15% (CER)
`
` Drive operational efficiencies:
`•
`Continued productivity gains in Product Supply
`
`Enable attractive capital allocation to shareholders:
`•
`Free cash flow of DKK 57.4 billion
`• DKK 49.4 billion returned to shareholders in 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 5 / 2023
`
`Novo Nordisk Exhibit 2513
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`Page 3 of 33
`
`PERFORMANCE HIGHLIGHTS
`FINANCIAL HIGHLIGHTS FOR 2022
`
`PROFIT AND LOSS
`(Amounts are in DKK million, except for earnings per
`share)
`
`2022
`
`2021
`
`2020
`
`2019
`
`2018
`
` % change
` 2022 to
` 2021
`
` % change
` 2022 to
` 2021 at CER
`
`Net sales
`
` 176,954
`
` 140,800
`
` 126,946
`
` 122,021
`
` 111,831
`
` 26%
`
` 27%
`
` 25%
`
` 35%
`
` 10%
`
` 16%
`
` 17%
`
` 16%
`
` 29%
`
` 6%
`
` 211%
`
` 178%
`
`
`
` 148,506
` 83.9%
`(46,217)
` 26.1%
`(24,047)
` 13.6%
`(4,467)
` 2.5%
`1,034
`
`
`
`
`
`
`
`
`
` 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
`
`
`
`
`
`
`
`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
`
`Operating profit
`Operating margin
`Financial items (net)
`
`Profit before income taxes
`Income taxes
`Effective tax rate
`Net profit
`Net profit margin
`
` 74,809
` 42.3%
`(5,747)
`
`
`
` 69,062
`(13,537)
`
` 19.6%
` 55,525
` 31.4%
`
` 58,644
` 41.7%
`436
`
`
`
` 54,126
` 42.6%
`(996)
`
`
`
` 52,483
` 43.0%
`(3,930)
`
`
`
` 47,248
` 42.2%
`367
`
`
`
` 59,080
`(11,323)
`
` 19.2%
` 47,757
` 33.9%
`
` 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%
`
` 28%
`
`N/A
`
` 17%
` 20%
`
` 16%
`
`7,362
`
` 12,146
` 78,887
` 57,362
` 241,257
` 83,486
` 34.6%
`
`
`
`6,025
`
`6,335
`
` 55,000
` 29,319
` 194,508
` 70,746
` 36.4%
`
`5,753
`
`5,825
`
` 51,951
` 28,565
` 144,922
` 63,325
` 43.7%
`
`5,661
`
`8,932
`
` 46,782
` 34,451
` 125,612
` 57,593
` 45.8%
`
`
`
`
`
`
`
`
` 15%
`
`N/A
`
`N/A
`N/A
`
`N/A
`
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`
`N/A
`N/A
`
`3,925
`
`9,636
`
` 44,616
` 32,536
` 110,769
` 51,839
` 46.8%
`
`
`
` 22%
` 92%
` 43%
` 96%
` 24%
` 18%
`
` 18%
` 19%
`
`OTHER KEY NUMBERS
`Depreciation, amortisation and
`impairment losses
`Capital expenditure (PP&E)
`Net cash generated from operating
`activities
`Free cash flow
`Total assets
`Equity
`Equity ratio
`Diluted earnings per share / ADR (in
`15.93
`16.38
`18.01
`20.74
`24.44
`DKK)
`Total dividend per share 1)
`8.15
`8.35
`9.10
`10.40
`12.40
`Payout ratio 2)
` 50.6%
` 50.5%
` 50.0%
` 49.6%
` 50.3%
`1) Total dividend for the financial year 2022 including proposed final dividend of DKK 8.15 per share and interim dividend paid in August 2022 of DKK 4.25 per share.
`2) Total dividend for the year as a percentage of net profit.
`
`The Board of Directors and Executive Management have approved the Annual Report 2022 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 2022. 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 5 / 2023
`
`Novo Nordisk Exhibit 2513
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`Page 4 of 33
`
`COMMERCIAL EXECUTION
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales grew by 26% measured in Danish kroner and by 16% at CER in 2022, driven by Diabetes care sales growth of 14%
`(CER) and Obesity care sales growth of 84% (CER). Rare disease sales growth of 1% (CER). Sales growth has resulted in
`periodic supply constraints and related drug shortage notifications across a number of products and geographies.
`
`Sales split per therapy
`Diabetes and Obesity care segment
`
` Sales 2022
`DKK million
`
` Sales 2021
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`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
`Wegovy®
`Saxenda®
`Total Obesity care
`Diabetes and Obesity care total
`Rare disease segment
`Rare blood disorders2
` - Haemophilia A
` - Haemophilia B
` - NovoSeven®
`Rare endocrine disorders3
`Other Rare disease4
`Rare disease total
`
`Total sales
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`11,299
`59,750
`12,322
`83,371
`16,741
`9,353
`2,809
`4,579
`10,562
`2,889
`7,673
`17,463
`2,003
`15,460
`8,186
`52,952
`3,225
`139,548
`6,188
`10,676
`16,864
`156,412
`
`11,706
`2,338
`759
`8,308
`7,138
`1,698
`20,542
`
`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
`1,386
`7,014
`8,400
`121,597
`
`10,217
`2,112
`637
`7,221
`7,303
`1,683
`19,203
`
`176,954
`
`140,800
`
`1) Primarily NovoNorm®, needles and GlucaGen® HypoKit®.
`2) Comprises NovoSeven®, NovoEight®, Esperoct®, Refixia® and NovoThirteen®.
`3) Primarily Norditropin®.
`4) Primarily Vagifem® and Activelle®.
`
` 134%
` 77%
` (18%)
` 56%
` (7%)
` (4%)
` 6%
` (19%)
` (6%)
` 69%
` (19%)
` (1%)
` 15%
` (3%)
` (10%)
` (5%)
` (10%)
` 23%
` 346%
` 52%
` 101%
` 29%
`
` 15%
` 11%
` 19%
` 15%
` (2%)
` 1%
` 7%
`
` 26%
`
` 114%
` 61%
` (24%)
` 42%
` (13%)
` (10%)
` 3%
` (25%)
` (10%)
` 62%
` (23%)
` (7%)
` 9%
` (9%)
` (16%)
` (11%)
` (15%)
` 14%
` 297%
` 42%
` 84%
` 19%
`
` 7%
` 6%
` 16%
` 6%
` (6%)
` (3%)
` 1%
`
` 16%
`
` 24%
` 90%
` (16%)
` 98%
` (10%)
` (4%)
` 0%
` (6%)
` (5%)
` 4%
` (9%)
` (6%)
` 1%
` (7%)
` (6%)
` (27%)
` (2%)
` 69%
` 18%
` 12%
` 30%
` 99%
`
` 3%
` 1%
` 0%
` 2%
` (2%)
` 0%
` 1%
`
` 100%
`
`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 5 / 2023
`
`Novo Nordisk Exhibit 2513
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`Page 5 of 33
`
`DIABETES AND OBESITY CARE
`Diabetes care, sales and market share development
`Sales in Diabetes care increased by 23% measured in Danish kroner and by 14% at CER to DKK 139,548 million driven by
`growth of GLP-1-based products. Novo Nordisk has improved the global diabetes value market share over the last 12
`months from 30.1% to 31.9% 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 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.
`
`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
`2022
` 31.9%
` 26.3%
` 29.0%
` 32.2%
` 19.6%
` 33.5%
` 33.3%
`
`November
`2021
` 30.1%
` 24.9%
` 28.7%
` 33.2%
` 15.5%
` 31.9%
` 31.9%
`
` Sales 2022
`DKK million
`139,548
`67,384
`33,790
`15,220
`18,374
`72,164
`66,881
`
`Growth
`at CER
` 14%
` 10%
` 13%
` (9%)
` 26%
` 18%
` 16%
`
`Source: IQVIA, November 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 56% measured in Danish
`kroner and by 42% at CER to DKK 83,371 million. The GLP-1 segment’s value share of the total diabetes market has
`increased to 33.5% compared with 26.5% 12 months ago. Novo Nordisk continues to be the global market leader in the
`GLP-1 segment with a 54.9% value market share, an increase of 2.2 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
`2022
` 54.9%
` 64.0%
` 60.5%
` 64.4%
` 73.2%
` 53.6%
` 52.7%
`
`November
`2021
` 52.7%
` 58.8%
` 58.3%
` 73.1%
` 56.9%
` 51.8%
` 51.0%
`
` Sales 2022
`DKK million
`83,371
`26,196
`14,855
`3,737
`7,604
`57,175
`53,167
`
`Growth
`at CER
` 42%
` 57%
` 43%
` 88%
` 78%
` 36%
` 33%
`
`Source: IQVIA, November 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 134% measured in Danish kroner and by 114% at CER to DKK 11,299 million. Sales growth
`was driven by North America Operations as well as Rest of World and EMEA. Rybelsus® has been launched in 43 countries.
`
`Ozempic® sales increased by 77% measured in Danish kroner and by 61% at CER to DKK 59,750 million. Sales growth was
`driven by both North America Operations and International Operations. Ozempic® has been launched in 75 countries.
`Sales growth has resulted in periodic supply constraints and related drug shortage notifications across geographies.
`
`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 5 / 2023
`
`Novo Nordisk Exhibit 2513
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`Page 6 of 33
`
`Victoza® sales decreased by 18% measured in Danish kroner and by 24% at CER to DKK 12,322 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 63% measured in Danish kroner and by 57% at
`CER. Sales growth is driven by all geographical areas. The GLP-1 segment’s value share of the total diabetes market has
`increased to 17.6% from 13.5% 12 months ago. Novo Nordisk is the market leader with a value market share of 64.0%.
`
`EMEA
`Sales in EMEA increased by 46% measured in Danish kroner and by 43% at CER. The sales growth reflects the uptake of
`Ozempic® and Rybelsus®, partially offset by lower sales of Victoza®. Rybelsus® has been launched in 32 countries in EMEA.
`Novo Nordisk remains the market leader in EMEA with a value market share of 60.5%.
`
`Region China
`Sales in Region China increased by 102% measured in Danish kroner and by 88% at CER. The sales growth reflects the
`uptake of Ozempic®, partially offset by lower sales of Victoza®. As of 1 January 2022, Ozempic® has been included on the
`National Drug Reimbursement List in China. The GLP-1 segment’s value share of the total diabetes market in Region China
`has increased to 11.6% from 5.8% 12 months ago.
`
`Rest of World
`Sales in Rest of World increased by 88% measured in Danish kroner and by 78% 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 73.2%.
`
`North America Operations
`Sales of GLP-1 diabetes products in North America Operations increased by 53% measured in Danish kroner and by 36%
`at CER. Novo Nordisk is the market leader with a 53.6% value market share compared to 51.8% 12 months ago. The value
`market share of the GLP-1 class of the total North American diabetes market has increased to 38.2% compared to 31.0%
`12 months ago.
`
`Sales growth in the US is driven by a prescription volume growth of the GLP-1 class of around 50% in the fourth quarter of
`2022 compared to the fourth quarter of 2021 as well as market share gains for Ozempic® and Rybelsus®. The combined
`Novo Nordisk GLP-1 new-to-brand prescription market share is now 50.1% driven by Ozempic® with 37.1% and Rybelsus®
`with 9.4%. Novo Nordisk is the market leader with 50.3% measured on total monthly prescriptions for the combined GLP-1
`portfolio.
`
`Sales of GLP-1 in the US increased by 33% 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 5 / 2023
`
`Novo Nordisk Exhibit 2513
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`Page 7 of 33
`
`Insulin
`Sales of insulin decreased by 5% measured in Danish kroner and by 11% at CER to DKK 52,952 million. Sales decline at CER
`was driven by declining sales in the US, Region China and EMEA.
`
`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
`2022
` 46.7%
` 49.6%
` 47.4%
` 48.5%
` 57.1%
` 38.4%
` 38.0%
`
`November
`2021
` 47.1%
` 50.2%
` 47.5%
` 50.7%
` 57.3%
` 38.6%
` 38.2%
`
` Sales 2022
`DKK million
`52,952
`38,760
`18,218
`10,302
`10,240
`14,192
`13,054
`
`Growth
`at CER
` (11%)
` (7%)
` (3%)
` (22%)
` 5%
` (21%)
` (22%)
`
`Source: IQVIA, November 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 decreased by 3% measured in Danish kroner and by 7% at CER. The sales
`decline at CER was driven by lower insulin sales in Region China due to implementation of Volume Based Procurement as
`well as lower sales in EMEA.
`
`EMEA
`Sales of insulin in EMEA remained unchanged in Danish kroner and decreased by 3% at CER. The sales decline at CER was
`mainly driven by NovoMix®, human insulin, NovoRapid® and Levemir®, partially countered by Tresiba®, Fiasp® and
`Ryzodeg®. Novo Nordisk has a volume market share of 47.6% of the total insulin market.
`
`Region China
`Sales of insulin in Region China decreased by 16% measured in Danish kroner and by 22% at CER. The sales decline was
`driven by NovoMix®, human insulin, Levemir®, NovoRapid® and Tresiba® due to the implementation of Volume Based
`Procurement from May 2022. The sales decline was partially countered by Ryzodeg® and Xulthopy®. Novo Nordisk has a
`volume market share of 48.5% of the total insulin market.
`
`Rest of World
`Sales of insulin in Rest of World increased by 8% measured in Danish kroner and by 5% at CER. The sales growth at CER
`was driven by all insulin products except for human insulin, NovoMix® 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 12% measured in Danish kroner and by 21% 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 3% compared to 2021. Novo Nordisk has a volume market
`share of 38.0% of the total US 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 5 / 2023
`
`Novo Nordisk Exhibit 2513
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`Page 8 of 33
`
`Obesity care, sales development
`Sales of Obesity care products, Saxenda® and Wegovy®, increased by 101% measured in Danish kroner and by 84% at CER
`to DKK 16,864 million. Sales growth was driven by both North America Operations and International Operations. Saxenda®
`has now been launched in 71 countries, and Wegovy® has been launched in the US, Denmark and Norway. The volume
`growth of the global branded obesity market was 53%.
`
`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 2022
`DKK million
`16,864
`5,886
`3,615
`133
`2,138
`10,978
`10,502
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 84%
` 82%
` 96%
` 105%
` 61%
` 85%
` 90%
`
`Sales of Saxenda® increased by 52% measured in Danish kroner and by 42% at CER to DKK 10,676 million. Wegovy® sales
`increased by 346% measured in Danish kroner and by 297% at CER to DKK 6,188 million. Sales were impacted by supply
`chain pipeline filling in the US in December 2022.
`
`International Operations
`Sales of Saxenda® in International Operations increased by 87% measured in Danish kroner and by 80% at CER driven by
`increased sales in EMEA and Rest of World. Novo Nordisk currently has a value market share of 63.8% in the branded
`obesity prescription drug market. Wegovy® has been launched in two countries in International Operations.
`
`EMEA
`Sales of Saxenda® in EMEA increased by 97% measured in Danish kroner and by 93% at CER. Novo Nordisk currently has a
`value market share of 82.4% in the branded obesity prescription drug market. Wegovy® was launched in Denmark in
`December 2022.
`
`Rest of World
`Sales of Saxenda® in Rest of World increased by 71% measured in Danish kroner and by 61% at CER. Saxenda® has been
`launched in 22 countries in Rest of World. Novo Nordisk currently has a value market share of 50.3% in the branded
`obesity prescription drug market.
`
`North America Operations
`Sales of Obesity care products in North America Operations increased by 108% measured in Danish kroner and by 85% at
`CER. Sales were impacted by supply chain pipeline filling in the US in December 2022. Novo Nordisk now has a value
`market share of 94.0% in the branded anti-obesity prescription drug market in North America. Wegovy® was first made
`available to patients in June 2021 and broad commercial formulary access has been achieved.
`
`In December 2021, Novo Nordisk announced that a contract manufacturer filling syringes for Wegovy® pens for the US
`market temporarily stopped deliveries and manufacturing, following issues with current Good Manufacturing Practices. All
`Wegovy® dose strengths were made available again in the US in December 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 5 / 2023
`
`Novo Nordisk Exhibit 2513
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`Page 9 of 33
`
`Rare disease
`Rare disease, sales development
`Sales of Rare disease products increased by 7% measured in Danish kroner and by 1% at CER to DKK 20,542 million.
`
`Rare disease, development per geographical area
`
`Rare disease, sales development
`
`Global
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
` Sales 2022
`DKK million
`20,542
`12,577
`6,831
`856
`4,890
`7,965
`7,273
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 1%
` 5%
` (1%)
` 101%
` 5%
` (5%)
` (6%)
`
`Rare blood disorders
`Sales of Rare blood disorder products increased by 15% measured in Danish kroner and by 7% at CER to DKK 11,706
`million. The increasing sales were driven by NovoSeven® as well as the launch products Esperoct® and Refixia®.
`
`Sales of haemophilia A products increased by 11% measured in Danish kroner and by 6% at CER to DKK 2,338 million. The
`sales increase was driven by International Operations and North America Operations. Esperoct® has now been launched in
`29 countries.
`
`Sales of haemophilia B products increased by 19% measured in Danish kroner and by 16% at CER to DKK 759 million. The
`sales increase was driven by International Operations, partially countered by North America Operations. Refixia® has been
`launched in 27 countries.
`
`Sales of NovoSeven® increased by 15% measured in Danish kroner and by 6% at CER to DKK 8,308 million. The sales
`development was driven by increasing sales in International Operations.
`
`Rare endocrine disorders
`Sales of Rare endocrine disorder products decreased by 2% measured in Danish kroner and by 6% at CER to DKK 7,138
`million. The sales decline was driven by North America Operations' sales decreasing by 18% at CER and by International
`Operations' sales decreasing by 1% at CER. The sales decline was driven by lower realised prices in the US as well as supply
`constraints in the fourth quarter of 2022. Novo Nordisk continues to be the leading company in the global human growth
`disorder market with a value market share of 35.1%.
`
`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 5 / 2023
`
`Novo Nordisk Exhibit 2513
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`Page 10 of 33
`
`FINANCIALS
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 26% measured in Danish kroner and by 16% at CER to DKK 176,954 million in 2022. Sales growth has
`resulted in periodic supply constraints and related drug shortage notifications across a number of products and
`geographies. Sales in International Operations increased by 17% measured in Danish kroner and by 13% at CER. Sales in
`North America Operations increased by 35% measured in Danish kroner and by 21% at CER. Compared to the strategic
`aspiration of transforming 70% of sales in the US by 2022, 73% 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 2022
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`
`
`
`
`
`
`
`
`
`85,847
`44,236
`16,209
`25,402
`91,107
`84,656
`
`176,954
`
` 17%
` 17%
` 1%
` 28%
` 35%
` 34%
`
` 26%
`
` 13%
` 15%
` (6%)
` 24%
` 21%
` 19%
`
` 16%
`
` 40%
` 24%
` (4%)
` 20%
` 60%
` 53%
`
` 100%
`
`International Operations
`Sales in International Operations increased by 17% measured in Danish kroner and by 13% at CER. Sales growth was
`driven by most therapy areas with GLP-1 sales growing by 57% at CER, Obesity care sales growing by 82% at CER and Rare
`disease sales growing by 5% at CER, partially countered by insulin sales decreasing by 7%.
`
`EMEA
`Sales in EMEA increased by 17% measured in Danish kroner and by 15% at CER. Sales growth was driven by Diabetes care
`growing by 13% at CER driven by increased GLP-1 sales, partially countered by decreased insulin sales. Obesity care sales
`increased by 96% at CER and Rare disease sales decreased by 1% at CER.
`
`Region China
`Sales in Region China increased by 1% measured in Danish kroner and decreased by 6% at CER. The sales decline at CER
`was driven by insulin sales declining by 22% at CER. Insulin sales were negatively impacted by the implementation of
`Volume Based Procurement from May 2022. GLP-1 sales were growing by 88% at CER and Other diabetes care sales
`decreased by 24% at CER. Rare disease sales increased by 101% at CER reflecting timing of shipments.
`
`Rest of World
`Sales in Rest of World increased by 28% measured in Danish kroner and by 24% at CER. Sales growth was driven by
`Diabetes care growing by 26% at CER, reflecting increased GLP-1 and insulin sales, Obesity care sales growing by 61% at
`CER and Rare disease growing by 5% at CER.
`
`North America Operations