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`Financial report for the period 1 January 2022 to 30 September 2022
`
`2 November 2022
`
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`Novo Nordisk's sales increased by 26% in Danish kroner and by 16% at constant
`exchange rates to DKK 128.9 billion in the first nine months of 2022
`
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`• Operating profit increased by 28% in Danish kroner and by 14% at constant exchange rates (CER) to DKK 57.7 billion.
`• Sales in North America Operations increased by 37% in Danish kroner (22% at CER), and sales in International
`Operations increased by 16% in Danish kroner (11% at CER).
`• Sales within Diabetes and Obesity care increased by 29% in Danish kroner to DKK 113.2 billion (18% at CER), mainly
`driven by GLP-1 diabetes sales growth of 59% in Danish kroner (44% at CER). Rare disease sales increased by 8%
`measured in Danish kroner (2% at CER).
`• Obesity care sales grew by 91% in Danish Kroner (75% at CER). Novo Nordisk expects to make all Wegovy® dose
`strengths available in the US towards the end of 2022.
`• Within R&D, Novo Nordisk successfully completed a phase 2 trial with CagriSema in people with type 2 diabetes and the
`last phase 3a trial with once-weekly insulin icodec.
`
`• For the 2022 outlook, sales growth is now expected to be 14-17% at CER and operating profit growth is now expected
`to be 13-16% at CER. Sales and operating profit growth reported in Danish kroner are now expected to be 10 and 15
`percentage points higher than at CER, respectively.
`
`PROFIT AND LOSS
`
`DKK million
`Net sales
`Operating profit
`
`Net profit
`Diluted earnings per share (in DKK)
`* CER: Constant exchange rates (average 2021).
`
`9M 2022
`
`9M 2021
`
`Growth
`as reported
`
`Growth
`at CER*
`
`
`
`
`
`
`
`128,862
`57,722
`
`41,933
`18.42
`
`102,467
`45,010
`
`36,865
`15.98
`
` 26%
` 28%
`
` 14%
` 15%
`
` 16%
` 14%
`
`N/A
`N/A
`
`Lars Fruergaard Jørgensen, president and CEO: "We are very pleased with the sales growth in the first nine months of 2022
`which has enabled us to raise the outlook for the full year. The growth is driven by increasing demand for GLP-1-based
`diabetes treatments, especially Ozempic®. Within R&D, the encouraging phase 2 data with CagriSema in type 2 diabetes
`and the successful completion of the phase 3 programme for once-weekly insulin icodec support our aspiration of further
`raising the innovation bar for diabetes treatments."
`
`On 2 November 2022 at 13.00 CET, corresponding to 08.00 pm EDT, 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 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 2 of 32
`
`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 the first nine months of 2022 (blue indicates third-quarter development):
`
`Purpose and sustainability
`Progress towards zero environmental impact:
`•
`Carbon emissions from operations and transportation
`decreased by 18% compared to the first nine months of
`2019
`
`◦
`
`Adding value to society:
`•
`Progress on 'Defeat Diabetes' strategy:
`◦ Medical treatment provided to 35.7 million people living
`with diabetes
`Reaching more than 37,000 children in Changing
`Diabetes® in Children programme
`Five months’ supply of 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 has
`increased to 38% from 36% in the first nine months of 2021
`
`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 trial 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 trial 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
`
`Commercial execution
` Strengthen diabetes leadership to more than one-third:
`• Diabetes value market share increased by 1.7 percentage
`points to 31.6% (MAT)
`
` More than DKK 25 billion in Obesity care sales by 2025:
`• Obesity care sales increased by 75% (CER) to DKK 11.4
`billion
`
` Secure a sustained growth outlook for Rare disease:
`•
`Rare disease sales increased by 2% (CER) to DKK 15.7 billion
`
`Financials
`Deliver solid sales and operating profit growth:
`•
`Sales growth at 16% (CER)
`International Operations sales growth of 11% (CER)
`•
`• US sales growth of 21% (CER) with 72% of sales coming
`from products launched since 2015
`• Operating profit growth of 14% (CER)
`
` Drive operational efficiencies:
`•
`Continued productivity gains in Product Supply
`
`Enable attractive capital allocation to shareholders:
`•
`Free cash flow of DKK 62.5 billion
`• DKK 41.9 billion returned to shareholders during the first
`nine months of 2022
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Financial
`Information
`
` Company announcement No 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 3 of 32
`
`PERFORMANCE HIGHLIGHTS
`FINANCIAL HIGHLIGHTS FOR THE FIRST NINE MONTHS OF 2022
`
`PROFIT AND LOSS
`
`9M 2022
`
`9M 2021
`
`(Amounts are in DKK million, except for earnings per share and employees)
`
` % change
` 9M 2022 to
` 9M 2021
`
` % change
` 9M 2022 to
` 9M 2021 at
`CER
`
`Net sales
`
`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
`
`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
`Average number of diluted shares outstanding (million)
`Diluted earnings per share / ADR (in DKK)
`Full-time equivalent employees end of period
`
` 128,862
`
` 102,467
`
` 108,676
` 84.3%
`(32,474)
` 25.2%
`(15,962)
` 12.4%
`(3,119)
` 2.4%
`601
`
`
`
`
`
`
`
`
`
` 85,050
` 83.0%
`(25,376)
` 24.8%
`(12,140)
` 11.8%
`(2,860)
` 2.8%
`336
`
`
`
`
`
`
`
`
`
` 57,722
` 44.8%
`(4,976)
`
`
`
` 52,746
`(10,813)
`
` 20.5%
` 41,933
` 32.5%
`
`5,327
`
`7,185
`
` 71,786
` 62,490
` 242,836
` 76,680
` 31.6%
` 2,276.0
`
`18.42
` 52,696
`
` 45,010
` 43.9%
`957
`
`
`
` 45,967
`(9,102)
`
` 19.8%
` 36,865
` 36.0%
`
`3,943
`
`4,286
`
` 58,017
` 52,312
` 174,084
` 66,112
` 38.0%
` 2,306.4
`
`15.98
` 46,982
`
` 26%
`
` 28%
`
` 28%
`
` 31%
`
` 9%
`
` 79%
`
` 28%
`
` (620%)
`
` 15%
` 19%
`
` 14%
`
` 35%
` 68%
` 24%
` 19%
` 39%
` 16%
`
` (1%)
` 15%
` 12%
`
` 16%
`
` 17%
`
` 19%
`
` 26%
`
` 5%
`
` 58%
`
` 14%
`
`N/A
`
`N/A
`N/A
`
`N/A
`
`N/A
`N/A
`N/A
`N/A
`N/A
`N/A
`
`N/A
`N/A
`N/A
`
`These unaudited consolidated financial statements for the first nine months of 2022 have been prepared in accordance
`with IAS 34 ‘Interim Financial Reporting’ and additional Danish disclosure requirements for listed companies. The
`accounting policies adopted in the preparation are consistent with those applied in the Annual Report 2021 of Novo
`Nordisk.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Financial
`Information
`
` Company announcement No 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 4 of 32
`
`COMMERCIAL EXECUTION
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales grew by 26% measured in Danish kroner and by 16% at CER in the first nine months of 2022, driven by Diabetes care
`sales growth of 14% (CER) and Obesity care sales growth of 75% (CER). Rare disease sales growth of 2% (CER). Sales growth
`has resulted in periodic supply constraints and related drug shortage notifications in some countries.
`
`Sales split per therapy
`Diabetes and Obesity care segment
`
` Sales 9M 2022
`DKK million
`
` Sales 9M 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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`7,246
`42,774
`8,999
`59,019
`12,839
`7,106
`2,113
`3,620
`8,219
`2,159
`6,060
`12,992
`1,498
`11,494
`6,216
`40,266
`2,512
`101,797
`3,742
`7,634
`11,376
`113,173
`
`8,825
`1,696
`533
`6,397
`5,536
`1,328
`15,689
`
`3,015
`22,989
`11,221
`37,225
`13,387
`6,998
`1,984
`4,405
`8,512
`1,287
`7,225
`13,167
`1,253
`11,914
`6,967
`42,033
`2,778
`82,036
`604
`5,337
`5,941
`87,977
`
`7,727
`1,531
`475
`5,531
`5,584
`1,179
`14,490
`
`128,862
`
`102,467
`
`1) Primarily NovoNorm®, needles and GlucaGen® HypoKit®.
`2) Comprises NovoSeven®, NovoEight®, Esperoct®, Refixia® and NovoThirteen®.
`3) Primarily Norditropin®.
`4) Primarily Vagifem® and Activelle®.
`
` 140%
` 86%
` (20%)
` 59%
` (4%)
` 2%
` 7%
` (18%)
` (3%)
` 68%
` (16%)
` (1%)
` 20%
` (4%)
` (11%)
` (4%)
` (10%)
` 24%
`—
` 43%
` 91%
` 29%
`
` 14%
` 11%
` 12%
` 16%
` (1%)
` 13%
` 8%
`
` 26%
`
`
`
` 120%
` 69%
` (26%)
` 44%
` (10%)
` (5%)
` 3%
` (24%)
` (10%)
` 59%
` (22%)
` (8%)
` 13%
` (10%)
` (18%)
` (11%)
` (15%)
` 14%
`—
` 33%
` 75%
` 18%
`
` 6%
` 6%
` 9%
` 6%
` (6%)
` 7%
` 2%
`
` 16%
`
` 22%
` 97%
` (18%)
` 101%
` (8%)
` (2%)
` 0%
` (6%)
` (5%)
` 5%
` (10%)
` (6%)
` 1%
` (7%)
` (8%)
` (27%)
` (3%)
` 71%
` 16%
` 11%
` 27%
` 98%
`
` 3%
` 1%
` 0%
` 2%
` (2%)
` 1%
` 2%
`
` 100%
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Financial
`Information
`
` Company announcement No 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 5 of 32
`
`DIABETES AND OBESITY CARE
`Diabetes care, sales and market share development
`Sales in Diabetes care increased by 24% measured in Danish kroner and by 14% at CER to DKK 101,797 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 29.9% to 31.6% 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 August 2021
`and August 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
`
`August
`2022
` 31.6%
` 26.1%
` 29.0%
` 32.5%
` 18.6%
` 33.3%
` 33.2%
`
`August
`2021
` 29.9%
` 24.5%
` 28.4%
` 32.9%
` 14.7%
` 31.8%
` 31.8%
`
` Sales 9M 2022
`DKK million
`101,797
`50,629
`24,976
`12,002
`13,651
`51,168
`47,478
`
`Growth
`at CER
` 14%
` 9%
` 12%
` (9%)
` 25%
` 20%
` 18%
`
`Source: IQVIA, August 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 59% measured in Danish
`kroner and by 44% at CER to DKK 59,019 million. The GLP-1 segment’s value share of the total diabetes market has
`increased to 31.1% compared with 25.3% 12 months ago. Novo Nordisk continues to be the global market leader in the
`GLP-1 segment with a 55.7% value market share, an increase of 3.6 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
`
`August
`2022
` 55.7%
` 62.6%
` 60.0%
` 62.5%
` 69.6%
` 54.6%
` 53.7%
`
`August
`2021
` 52.1%
` 57.5%
` 57.5%
` 79.1%
` 52.2%
` 51.3%
` 50.5%
`
` Sales 9M 2022
`DKK million
`59,019
`18,886
`10,661
`2,737
`5,488
`40,133
`37,398
`
`Growth
`at CER
` 44%
` 55%
` 39%
` 87%
` 86%
` 39%
` 37%
`
`Source: IQVIA, August 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 140% measured in Danish kroner and by 120% at CER to DKK 7,246 million. Sales growth was
`driven by North America Operations as well as Rest of World and EMEA. Rybelsus® has now been launched in 43 countries.
`
`Ozempic® sales increased by 86% measured in Danish kroner and by 69% at CER to DKK 42,774 million. Sales growth was
`driven by both North America Operations and International Operations. Ozempic® has been launched in 75 countries.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Financial
`Information
`
` Company announcement No 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 6 of 32
`
`Victoza® sales decreased by 20% measured in Danish kroner and by 26% at CER to DKK 8,999 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 62% measured in Danish kroner and by 55% 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 16.5% from 12.7% 12 months ago. Novo Nordisk is the market leader with a value market share of 62.6%.
`
`EMEA
`Sales in EMEA increased by 42% measured in Danish kroner and by 39% 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 60.0%.
`
`Region China
`Sales in Region China increased by 106% measured in Danish kroner and by 87% 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 9.5% from 5.0% 12 months ago.
`
`Rest of World
`Sales in Rest of World increased by 97% measured in Danish kroner and by 86% 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 69.6%.
`
`North America Operations
`Sales of GLP-1 diabetes products in North America Operations increased by 57% measured in Danish kroner and by 39%
`at CER. Novo Nordisk is the market leader with a 54.6% value market share compared to 51.3% 12 months ago. The value
`market share of the GLP-1 class of the total North American diabetes market has increased to 35.8% compared to 29.8%
`12 months ago.
`
`Sales growth in the US is driven by a prescription volume growth of the GLP-1 class of more than 40% in the third quarter
`of 2022 compared to the third 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 42.8% driven by Ozempic® with 34.0% and Rybelsus®
`with 6.5%. Novo Nordisk is the market leader with 52.4% measured on total monthly prescriptions for the combined GLP-1
`portfolio.
`
`Sales of GLP-1 in the US increased by 37% at CER. The sales increase was driven by continued uptake of Ozempic® and
`Rybelsus®, partially offset by declining Victoza® sales. GLP-1 sales growth was negatively impacted by rebate
`enhancements as well as unfavourable channel and payer mix.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Financial
`Information
`
` Company announcement No 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 7 of 32
`
`Insulin
`Sales of insulin decreased by 4% measured in Danish kroner and by 11% at CER to DKK 40,266 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
`
`August
`2022
` 46.8%
` 49.9%
` 47.6%
` 49.5%
` 57.1%
` 38.2%
` 37.7%
`
`August
`2021
` 47.3%
` 50.3%
` 47.6%
` 50.7%
` 57.4%
` 39.1%
` 38.8%
`
` Sales 9M 2022
`DKK million
`40,266
`29,830
`13,779
`8,305
`7,746
`10,436
`9,589
`
`Growth
`at CER
` (11%)
` (7%)
` (2%)
` (21%)
` 3%
` (20%)
` (22%)
`
`Source: IQVIA, August 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 2% 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 2% 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 13% measured in Danish kroner and by 21% at CER. The sales decline was
`driven by NovoMix®, human insulin, Levemir® and NovoRapid® 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 49.5% of the total insulin market.
`
`Rest of World
`Sales of insulin in Rest of World increased by 8% measured in Danish kroner and by 3% 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 10% measured in Danish kroner and by 20% 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 the first nine months of 2021. Novo
`Nordisk has a volume market share of 37.7% 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
`
`Financial
`Information
`
` Company announcement No 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 8 of 32
`
`Obesity care, sales development
`Sales of Obesity care products, Saxenda® and Wegovy® increased by 91% measured in Danish kroner and by 75% at CER
`to DKK 11,376 million. Sales growth was driven by both North America Operations and International Operations. Saxenda®
`has now been launched in 71 countries, and Wegovy® was launched in the US in June 2021. The volume growth of the
`global branded obesity market was 63%.
`
`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 9M 2022
`DKK million
`11,376
`4,141
`2,575
`110
`1,456
`7,235
`6,891
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 75%
` 73%
` 96%
` 168%
` 38%
` 77%
` 81%
`
`International Operations
`Sales of Saxenda® in International Operations increased by 80% measured in Danish kroner and by 73% at CER driven by
`increased sales in EMEA and Rest of World. Novo Nordisk currently has a value market share of 61.0% in the branded
`obesity prescription drug market.
`
`EMEA
`Sales of Saxenda® in EMEA increased by 100% measured in Danish kroner and by 96% at CER. Novo Nordisk currently has
`a value market share of 80.8% in the branded obesity prescription drug market.
`
`Rest of World
`Sales of Saxenda® in Rest of World increased by 48% measured in Danish kroner and by 38% at CER. Saxenda® has now
`been launched in 22 countries in Rest of World. Novo Nordisk currently has a value market share of 47.0% in the branded
`obesity prescription drug market.
`
`North America Operations
`Sales of Obesity care products in North America Operations increased by 99% measured in Danish kroner and by 77% at
`CER. Novo Nordisk now has a value market share of 93.5% in the branded anti-obesity prescription drug market in North
`America. Wegovy® was 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. The
`1.7 mg and the 2.4 mg doses of Wegovy® are currently available in the market and Novo Nordisk expects to make all
`Wegovy® dose strengths available in the US towards the end of 2022.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Financial
`Information
`
` Company announcement No 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 9 of 32
`
`Rare disease
`Rare disease, sales development
`Sales of Rare disease products increased by 8% measured in Danish kroner and by 2% at CER to DKK 15,689 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 9M 2022
`DKK million
`15,689
`9,645
`5,171
`733
`3,741
`6,044
`5,519
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 2%
` 4%
` (3%)
` 131%
` 5%
` (3%)
` (4%)
`
`Rare blood disorders
`Sales of Rare blood disorder products increased by 14% measured in Danish kroner and by 6% at CER to DKK 8,825 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 1,696 million. The
`sales increase was driven by International Operations and North America Operations. Esperoct® has been launched in 27
`countries.
`
`Sales of haemophilia B products increased by 12% measured in Danish kroner and by 9% at CER to DKK 533 million. The
`sales increase was driven by International Operations, partially countered by North America Operations. Refixia® has now
`been launched in 27 countries.
`
`Sales of NovoSeven® increased by 16% measured in Danish kroner and by 6% at CER to DKK 6,397 million. The sales
`development was driven by increasing sales in International Operations.
`
`Rare endocrine disorders
`Sales of Rare endocrine disorder products decreased by 1% measured in Danish kroner and by 6% at CER to DKK 5,536
`million. The sales decline was driven by North America Operations' sales decreasing by 13% at CER and by International
`Operations' sales decreasing by 2% at CER. The sales decline was driven by lower realised prices in the US. Novo Nordisk
`continues being the leading company in the global human growth disorder market with a value market share of 36.3%.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Financial
`Information
`
` Company announcement No 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 10 of 32
`
`FINANCIALS
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 26% measured in Danish kroner and by 16% at CER to DKK 128,862 million in the first nine months of
`2022. Sales growth has resulted in periodic supply constraints and related drug shortage notifications in some countries.
`Sales in International Operations increased by 16% measured in Danish kroner and by 11% at CER. The strategic aspiration
`for International Operations is sales growth between 6-10%. Sales in North America Operations increased by 37%
`measured in Danish kroner and by 22% at CER. Compared to the strategic aspiration of transforming 70% of sales in the
`US, 72% 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 9M 2022
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`
`
`
`
`
`
`
`
`
`64,415
`32,722
`12,845
`18,848
`64,447
`59,888
`
`128,862
`
` 16%
` 16%
` 4%
` 28%
` 37%
` 36%
`
` 26%
`
` 11%
` 13%
` (5%)
` 22%
` 22%
` 21%
`
` 16%
`
` 38%
` 23%
` (4%)
` 19%
` 62%
` 55%
`
` 100%
`
`International Operations
`Sales in International Operations increased by 16% measured in Danish kroner and by 11% at CER. Sales growth was
`driven by most therapy areas with GLP-1 sales growing by 55% at CER, Obesity care sales growing by 73% at CER and Rare
`disease sales growing by 4% at CER, partially countered by insulin sales decreasing by 7%.
`
`EMEA
`Sales in EMEA increased by 16% measured in Danish kroner and by 13% at CER. Sales growth was driven by Diabetes care
`growing by 12% 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 3% at CER.
`
`Region China
`Sales in Region China increased by 4% measured in Danish kroner and decreased by 5% at CER. Sales were driven by
`insulin sales declining by 21% at CER. Insulin sales were negatively impacted by the implementation of Volume Based
`Procurement from May 2022. GLP-1 sales were growing by 87% at CER and Other diabetes care sales decreased by 24% at
`CER. Rare disease sales increased by 131% at CER reflecting timing of shipments.
`
`Rest of World
`Sales in Rest of World increased by 28% measured in Danish kroner and by 22% at CER. Sales growth was driven by
`Diabetes care growing by 25% at CER, reflecting increased GLP-1 and insulin sales, Obesity care sales growing by 38% at
`CER and Rare disease growing by 5% at CER.
`
`North America Operations
`Sales in North America Operations increased by 37% measured in Danish kroner and by 22% at CER. The sales increase
`reflects GLP-1 diabetes sales growing by 39% at CER and Obesity care sales growing by 77% at CER. This was partially
`offset by insulin sales decreasing by 20% at CER driven by lower realised prices due to rebate enhancements and channel
`and payer mix as well as a decline in volume. Rare disease sales decreased by 3% at CER.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Financial
`Information
`
` Company announcement No 79 / 2022
`
`Novo Nordisk Exhibit 2512
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`

`

`Financial report for the period 1 January 2022 to 30 September 2022
`
`Page 11 of 32
`
`DEVELOPMENT IN COSTS AND OPERATING PROFIT
`The cost of goods sold increased by 16% measured in Danish kroner and by 13% at CER to DKK 20,186 million, resulting in
`a gross margin of 84.3% measured in Danish kroner compared with 83.0% in 2021. The increase in gross margin reflects a
`positive product mix, driven by increased GLP-1 sales, a positive currency impact of 0.9 percentage point and productivity
`improvements. This is partially countered by lower realised prices mainly in the US and Region China.
`
`Sales and distribution costs increased by 28% measured in Danish kroner and by 19% at CER to DKK 32,474 million. The
`increase in costs is driven by both International Operations and North America Operations. In International Operations,
`promotional spend is related to promotional activities for Ozempic® and Rybelsus® as well as Obesity care market
`development activities. In North America Operations, the cost increase is driven by promotional activities for Ozempic® and
`market development activities for Obesity care. The cost increase is reflecting low activity level in 2021 due to COVID-19
`and higher distribution costs.
`
`Research and development cost