throbber

`
`
`
`
`
`
`
`
`
`
`
`
`
`Financial report for the period 1 January 2022 to 31 December 2022
`
`1 February 2023
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Novo Nordisk's sales increased by 26% in Danish kroner and by 16% at constant
`exchange rates to DKK 177.0 billion in 2022
`
`
`
`
`
`
`
`
`
`
`
`
`
`• 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

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket