`
`
`
`
`
`
`
`
`
`
`
`
`
`Financial report for the period 1 January 2021 to 30 September 2021
`
`3 November 2021
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Novo Nordisk's net profit increased by 12% in the first nine months of 2021
`
`
`
`
`
`
`
`
`
`
`
`
`
`• Operating profit increased by 5% in Danish kroner and by 12% at constant exchange rates (CER).
`
`• Sales increased by 8% in Danish kroner and by 13% at CER to DKK 102.5 billion. Sales in International Operations
`increased by 10% in Danish kroner (13% at CER), and sales in North America Operations increased by 6% in Danish
`kroner (13% at CER).
`
`• Sales within Diabetes and Obesity care increased by 10% in Danish kroner to DKK 88.0 billion (15% at CER), driven by
`GLP-1 growth of 24% in Danish kroner (30% at CER) reflecting the uptake of Ozempic® and Rybelsus®. Obesity care grew
`by 41% in Danish kroner (49% at CER) and Biopharm sales remained unchanged in Danish kroner (increased by 4% at
`CER).
`
`• Sales in the third quarter increased by 15% in Danish kroner (15% at CER) compared to the third quarter of 2020. Sales
`growth was driven by diabetes GLP-1 growth of 30% in Danish kroner (31% at CER) and Obesity care growth of 79% in
`Danish kroner (82% at CER) reflecting market expansion and the launch of Wegovy™ in the US.
`
`• Within R&D, Novo Nordisk initiated phase 3 development with both oral semaglutide 50 mg for the treatment of obesity
`and with ziltivekimab in cardiovascular disease during the third quarter.
`
`• On 29 October, the 2021 outlook was raised with sales growth and operating profit growth now both expected to be
`12-15% at CER. Sales and operating profit growth reported in Danish kroner is now expected to be 3 and 4 percentage
`points lower than at CER, respectively. The ongoing share buyback programme is expanded by DKK 2.0 billion to DKK 20
`billion.
`
`PROFIT AND LOSS
`
`DKK million
`Net sales
`Operating profit
`
`Net profit
`Diluted earnings per share (in DKK)
`
`* CER: Constant exchange rates (average 2020).
`
`9M 2021
`
`9M 2020
`
`Growth
`as reported
`
`Growth
`at CER*
`
`
`
`
`
`
`
`102,467
`45,010
`
`36,865
`15.98
`
`
`
`
`
`
`
`94,808
`42,948
`
`32,820
`14.00
`
` 8%
` 5%
`
` 12%
` 14%
`
` 13%
` 12%
`
`N/A
`N/A
`
`Lars Fruergaard Jørgensen, president and CEO: "We are very pleased with the sales growth in the first nine months of 2021
`which has enabled us to raise our outlook for the full year. The growth is driven by all geographical areas and by all therapy
`areas, in particular by accelerated growth of our portfolio of GLP-1 treatments for diabetes and obesity. In the US, the
`initial demand for Wegovy™ has significantly exceeded our expectations, underscoring the high unmet need for people
`living with obesity. With the initiation of two phase 3 programmes in the third quarter, we continue to expand our late-
`stage clinical pipeline."
`
`
`On 3 November 2021 at 13.00 CET, corresponding to 08.00 AM 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 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 2 of 30
`
`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 2021 (third-quarter developments):
`
`Purpose and sustainability
`Adding value to society:
`•
`Progress on 'Defeat Diabetes' strategy:
`46 new vulnerability assessments conducted enabling
`◦
`access to insulin to around 50,000 people with diabetes
`in Syria, Kenya, Nigeria, Ghana and Panama
`Reaching 18 countries in Changing Diabetes in Children
`by including Indonesia, Pakistan and Peru
`Collaboration with the University of Toronto focusing on
`prevention
`Partnership with the World Diabetes Foundation to
`initiate 'Diabetes Compass' to improve access to
`diabetes care
`
`◦
`
`◦
`
`◦
`
`Innovation and therapeutic focus
`Further raise innovation bar for diabetes treatment:
`Approval of Xulthopy® and Ozempic® in China for the
`•
`treatment of type 2 diabetes
`Resubmission of semaglutide 2.0 mg in the US
`Phase 1 trial completed with a glucose-sensitive insulin
`
`•
`•
`
`Develop superior treatment solutions for obesity:
`•
`Approval of Wegovy™, semaglutide 2.4 mg, in the US
`•
`Phase 3a development initiated with 50 mg oral
`semaglutide in obesity
`
`Strengthen and progress Biopharm pipeline:
`Sogroya®, somapacitan, approved in the EU for the
`•
`treatment of adults with growth hormone deficiency
`
`the
`
`Establish presence in Other serious chronic diseases:
`•
`Phase 3a development initiated with ziltivekimab in
`cardiovascular disease
`Phase 3a development initiated for treatment of NASH and
`Alzheimer's disease with semaglutide
`• New stem cell R&D licence agreement with Heartseed and
`acquisition of Prothena's ATTR amyloidosis programme
`
`•
`
`Financials
`Deliver solid sales and operating profit growth:
`•
`Sales growth at 13% (CER)
`International Operations sales growth of 13% (CER)
`•
`• US sales growth of 13% (CER) with 58% of sales coming
`from products launched since 2015
`• Operating profit growth of 12% (CER)
`
` Drive operational efficiencies:
`•
`Continued productivity gains in Product Supply
`
`Enable attractive capital allocation to shareholders:
`•
`Free cash flow of DKK 52.3 billion and DKK 33.5 billion
`returned to shareholders
`The ongoing share buyback programme is expanded by
`DKK 2.0 billion to DKK 20 billion
`
`•
`
`Progress towards zero environmental impact:
`44% reduction in CO2 emissions compared to the first nine
`•
`months of 2019
`Receipt of the RE100 Key Collaborator Award during Climate
`Week NYC
`
`•
`
` Evolve culture and ensure distinct core capabilities:
`•
`Launch of an aspirational gender diversity target
`
`Commercial execution
` Strengthen diabetes leadership:
`• Diabetes value market share increased by 0.7 percentage
`point to 29.9% (MAT)
`
` Strengthen obesity leadership and double sales:
`• Obesity care sales increased by 49% (CER) to DKK 5.9 billion
`
` Secure a sustained growth outlook for Biopharm:
`•
`Biopharm sales increased by 4% (CER) to DKK 14.5 billion
`
`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 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 3 of 30
`
`PERFORMANCE HIGHLIGHTS
`FINANCIAL HIGHLIGHTS FOR THE FIRST NINE MONTHS OF 2021
`
`PROFIT AND LOSS
`(Amounts are in DKK million, except for numbers of shares, earnings per share
`and employees)
`
`9M 2021
`
`9M 2020
`
` % change
` 9M 2021 to
` 9M 2020
`
` % change
` 9M 2021 to
` 9M 2020 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, net
`
`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
`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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`102,467
`
`85,050
` 83.0%
`25,376
` 24.8%
`12,140
` 11.8%
`2,860
` 2.8%
`336
`
`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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`94,808
`
`79,495
` 83.8%
`23,162
` 24.4%
`10,979
` 11.6%
`2,760
` 2.9%
`354
`
`42,948
` 45.3%
`(1,820)
`
`41,128
`8,308
` 20.2%
`32,820
` 34.6%
`
`4,374
`4,307
`51,779
`41,559
`139,947
`59,573
` 42.6%
`2,345.0
`14.00
`44,326
`
` 8%
`
` 7%
`
` 10%
`
` 11%
`
` 4%
`
` (5%)
`
` 5%
`
` (153%)
`
` 12%
` 10%
`
` 12%
`
` (10%)
` 0%
` 12%
` 26%
` 24%
` 11%
`
` (2%)
` 14%
` 6%
`
` 13%
`
` 12%
`
` 14%
`
` 13%
`
` 6%
`
` (1%)
`
` 12%
`
`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 2021 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 2020 of Novo
`Nordisk.
`
`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 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 4 of 30
`
`COMMERCIAL EXECUTION
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales grew by 8% measured in Danish kroner and by 13% at CER the first nine months of 2021, driven by growth across all
`therapy areas with Diabetes care sales growth of 13% (CER), Obesity care sales growth of 49% (CER) and Biopharm sales
`growth of 4% (CER).
`
`Sales split per therapy
`Diabetes and Obesity care segment
`
`Rybelsus®
`Ozempic®
`Victoza®
`Total GLP-1
`Long-acting insulin
` -   Tresiba®
` -   Xultophy®
` -   Levemir®
`Premix insulin
` -   Ryzodeg®
` -   NovoMix®
`Fast-acting insulin
` -   Fiasp®
` -   NovoRapid®
`Human insulin
`Total insulin
`Other Diabetes care1
`Total Diabetes care
`Obesity care (Saxenda® and Wegovy™)
`
`Diabetes and Obesity care total
`
`Biopharm segment
`Rare blood disorders2
` - Haemophilia A
` - Haemophilia B
` -  NovoSeven®
`Rare endocrine disorders3
`Other Biopharm4
`Biopharm total
`
`Total sales
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Sales 9M 2021
`DKK million
`
` Sales 9M 2020
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`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
`5,941
`
`87,977
`
`7,727
`1,531
`475
`5,531
`5,584
`1,179
`14,490
`
`102,467
`
`1,038
`15,023
`13,990
`30,051
`13,426
`6,720
`1,842
`4,864
`8,220
`967
`7,253
`14,082
`1,021
`13,061
`7,195
`42,923
`3,056
`76,030
`4,223
`
`80,253
`
`7,522
`1,286
`385
`5,683
`5,874
`1,159
`14,555
`
`94,808
`
` 190%
` 53%
` (20%)
` 24%
` 0%
` 4%
` 8%
` (9%)
` 4%
` 33%
` 0%
` (6%)
` 23%
` (9%)
` (3%)
` (2%)
` (9%)
` 8%
` 41%
`
` 10%
`
` 3%
` 19%
` 23%
` (3%)
` (5%)
` 2%
` 0%
`
` 8%
`
` 209%
` 61%
` (16%)
` 30%
` 4%
` 8%
` 11%
` (5%)
` 7%
` 39%
` 2%
` (2%)
` 27%
` (5%)
` 0%
` 2%
` (7%)
` 13%
` 49%
`
` 15%
`
` 7%
` 23%
` 26%
` 2%
` 0%
` 2%
` 4%
`
` 13%
`
` 18%
` 75%
` (18%)
` 75%
` 4%
` 4%
` 2%
` (2%)
` 4%
` 3%
` 1%
` (3%)
` 2%
` (5%)
` 0%
` 5%
` (2%)
` 78%
` 17%
`
` 95%
`
` 5%
` 2%
` 1%
` 1%
` 0%
` 0%
` 5%
`
` 100%
`
`1) Primarily NovoNorm®, needles and GlucaGen® HypoKit®.
`2) Comprises NovoSeven®, NovoEight®, Esperoct®, Refixia® and NovoThirteen®.
`3) Primarily Norditropin®.
`4) Primarily Vagifem® and Activelle®.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 5 of 30
`
`DIABETES AND OBESITY CARE
`Diabetes care, sales and market share development
`Sales in Diabetes care increased by 8% measured in Danish kroner and by 13% at CER to DKK 82,036 million driven by
`GLP-1 growth. Novo Nordisk has improved the global diabetes value market share over the last 12 months from 29.2% to
`29.9% 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 August 2021
`and August 2020 provided by the independent data provider IQVIA. EMEA covers Europe, the Middle East and Africa;
`Region China covers mainland China, Hong Kong and Taiwan, and Rest of World covers all other countries except for North
`America.
`
`Diabetes care, development per geographical area
`
`Novo Nordisk’s share of the total
`diabetes market (value, MAT)
`
`Diabetes care, sales development
`
`Global
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`North America Operations
` - The US
`
`August
`2021
` 29.9%
` 24.4%
` 28.4%
` 32.7%
` 14.7%
` 31.9%
` 31.8%
`
`August
`2020
` 29.2%
` 22.8%
` 27.4%
` 28.8%
` 13.3%
` 31.6%
` 31.7%
`
` Sales 9M 2021
`DKK million
`82,036
`44,056
`21,785
`11,980
`10,291
`37,980
`35,623
`
`Growth
`at CER
` 13%
` 14%
` 11%
` 13%
` 20%
` 11%
` 11%
`
`Source: IQVIA, August 2021 data. *Data for EMEA available for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk Diabetes care
`sales in the area. **Data for mainland China, excluding Hong Kong and Taiwan. *** Data for Rest of World available for seven markets representing approximately 70% of total Novo
`Nordisk’s Diabetes care sales in the area.
`
`GLP-1 therapy for type 2 diabetes
`Sales of GLP-1 products for type 2 diabetes (Rybelsus®, Ozempic® and Victoza®) increased by 24% measured in Danish
`kroner and by 30% at CER to DKK 37,225 million. The GLP-1 segment’s value share of the total diabetes market has
`increased to 25.3% compared with 21.0% 12 months ago. Novo Nordisk continues to be the global market leader in the
`GLP-1 segment with a 52.1% 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
`
`August
`2021
` 52.1%
` 57.5%
` 57.6%
` 79.8%
` 52.2%
` 51.3%
` 50.5%
`
`August
`2020
` 49.9%
` 52.8%
` 54.4%
` 92.0%
` 42.4%
` 49.4%
` 48.9%
`
` Sales 9M 2021
`DKK million
`37,225
`11,627
`7,522
`1,326
`2,779
`25,598
`24,151
`
`Growth
`at CER
` 30%
` 47%
` 37%
` 64%
` 73%
` 24%
` 23%
`
`Source: IQVIA, August 2021 data. *Data for EMEA available for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk GLP-1 sales in
`the area. **Data for mainland China, excluding Hong Kong and Taiwan. ***Data for Rest of World available for seven markets representing approximately 70% of total Novo Nordisk
`Diabetes care sales in the area.
`Rybelsus® sales increased by 190% measured in Danish kroner and by 209% at CER to DKK 3,015 million. Sales growth was
`driven by North America Operations as well as EMEA and Rest of World. Rybelsus® has now been launched in 23 countries.
`
`Ozempic® sales increased by 53% measured in Danish kroner and by 61% at CER to DKK 22,989 million. Sales growth was
`driven by North America Operations and International Operations. Ozempic® has now been launched in 67 countries.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 6 of 30
`
`Victoza® sales decreased by 20% measured in Danish kroner and by 16% at CER to DKK 11,221 million as the GLP-1 market
`is moving towards once-weekly and tablet-based treatments. The sales decline was driven by North America Operations,
`EMEA and Rest of World, partially offset by higher sales in Region China.
`
`International Operations
`Sales of GLP-1 diabetes products in International Operations increased by 44% measured in Danish kroner and by 47% at
`CER. Sales growth is driven by all geographical areas. The value share of the GLP-1 class of the total diabetes market has
`increased to 12.7% from 10.2% 12 months ago. Novo Nordisk is the market leader with a value market share of 57.5%.
`
`EMEA
`Sales in EMEA increased by 36% measured in Danish kroner and by 37% at CER. The sales growth reflects the uptake of
`Ozempic® and Rybelsus®, partially offset by lower sales of Victoza®. Rybelsus® has now been launched in 19 countries in
`EMEA. Novo Nordisk remains the market leader in EMEA with a value market share of 57.6%.
`
`Region China
`Sales in Region China increased by 66% measured in Danish kroner and by 64% at CER. The sales growth reflects the
`uptake of Victoza® and the launches of Ozempic® in Taiwan® and China following the approval in April 2021. The GLP-1
`class' share of the overall diabetes market value in Region China increased to 4.8% from 2.6% 12 months ago.
`
`Rest of World
`Sales in Rest of World increased by 60% measured in Danish kroner and by 73% 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 52.2%.
`
`North America Operations
`Sales of GLP-1 diabetes products in North America Operations increased by 17% measured in Danish kroner and by 24%
`at CER. Novo Nordisk is the market leader with a 51.3% value market share compared to 49.4% 12 months ago. The value
`market share of the GLP-1 class of the total North American diabetes market has increased to 29.8% compared to 24.9%
`12 months ago.
`
`Sales growth in the US is driven by a prescription volume growth of the GLP-1 class of around 30% in the third quarter of
`2021 compared to the third quarter of 2020. The weekly new-to-brand market share for Ozempic® is 43.9% and 13.0% for
`Rybelsus®. The combined Novo Nordisk GLP-1 new-to-brand prescription market share is now 63.7%. Novo Nordisk is the
`market leader with 52.3% measured on total monthly prescriptions for the combined GLP-1 portfolio.
`
`Sales of GLP-1 in the US increased by 23% 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 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 7 of 30
`
`Insulin
`Sales of insulin decreased by 2% measured in Danish kroner and increased by 2% at CER to DKK 42,033 million. Sales
`growth at CER was driven by increased sales in International Operations, partially offset by declining sales in the US.
`
`Insulin, development per geographical area
`
`Novo Nordisk’s share of the total
`insulin market (volume, MAT)
`
`Insulin, sales development
`
`Global
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`North America Operations
` - The US
`
`August
`2021
` 47.3%
` 50.3%
` 47.6%
` 50.8%
` 57.3%
` 39.1%
` 38.8%
`
`August
`2020
` 47.0%
` 49.9%
` 47.3%
` 50.4%
` 56.9%
` 39.6%
` 39.5%
`
` Sales 9M 2021
`DKK million
`42,033
`30,373
`13,728
`9,505
`7,140
`11,660
`10,855
`
`Growth
`at CER
` 2%
` 6%
` 2%
` 10%
` 10%
` (8%)
` (9%)
`
`Source: IQVIA, August 2021 data. *Data for EMEA available for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk insulin sales in
`the area. **Data for mainland China, excluding Hong Kong and Taiwan. ***Data for Rest of World available for seven markets representing approximately 70% of total Novo Nordisk’s
`Diabetes care sales in the area.
`International Operations
`Sales of insulin in International Operations increased by 3% measured in Danish kroner and by 6% at CER. Sales growth at
`CER was driven by all insulin products except for Levemir®.
`
`EMEA
`Sales of insulin in EMEA decreased by 2% measured in Danish kroner and increased by 2% at CER. The sales growth at CER
`was mainly driven by Tresiba® and Fiasp®. Novo Nordisk has a volume market share of 47.6% of the total insulin market.
`
`Region China
`Sales of insulin in Region China increased by 12% measured in Danish kroner and by 10% at CER. The sales growth was
`driven by Tresiba®, NovoRapid®, Ryzodeg® and NovoMix®, partially countered by human insulin and Levemir®. Novo
`Nordisk has a volume market share of 50.8% of the total insulin market.
`
`Rest of World
`Sales of insulin in Rest of World increased by 3% measured in Danish kroner and by 10% at CER. The sales growth at CER
`was driven by all insulin products except for Levemir® and NovoMix®. Novo Nordisk has a volume market share of 57.3% of
`the total insulin market.
`
`North America Operations
`Sales of insulin in North America Operations decreased by 14% measured in Danish kroner and by 8% at CER. The sales
`decrease in the US was driven by lower realised prices due to channel and payer mix and rebate enhancements as well as
`a decline in volume. Changes to the 340B Drug Programme positively impacted sales. Novo Nordisk has a volume market
`share of 39.1% of the total insulin market.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Legal
`
`Financial
`Information
`
` Company announcement No 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 8 of 30
`
`Obesity care, sales development
`Sales of Obesity care products, Saxenda® and Wegovy™, increased by 41% measured in Danish kroner and by 49% at CER
`to DKK 5,941 million. Sales growth was driven by North America Operations and International Operations. Saxenda® has
`been launched in 60 countries and Wegovy™ was launched in the US in June 2021. Novo Nordisk currently has a value
`market share of 73.0% of the global branded obesity prescription drug market. The strategic aspiration for Obesity care is
`to more than double reported sales from the base in 2019 of DKK 5,679 million by 2025.
`
`Obesity care, development per geographical area
`
`Obesity care, sales development
`
`Global
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
` Sales 9M 2021
`DKK million
`5,941
`2,303
`1,283
`38
`982
`3,638
`3,370
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 49%
` 51%
` 61%
`—
` 36%
` 48%
` 49%
`
`International Operations
`Sales of Saxenda® in International Operations increased by 43% measured in Danish kroner and by 51% at CER, driven by
`increased sales in EMEA and Rest of World. Novo Nordisk currently has a value market share of 50.2% in the branded
`obesity prescription drug market.
`
`EMEA
`Sales of Saxenda® in EMEA increased by 54% measured in Danish kroner and by 61% at CER. Novo Nordisk currently has a
`value market share of 70.8% in the branded obesity prescription drug market.
`
`Rest of World
`Sales of Saxenda® in Rest of World increased by 27% measured in Danish kroner and by 36% at CER. Saxenda® has been
`launched in 19 countries in Rest of World. Novo Nordisk currently has a value market share of 40.3% in the branded
`obesity prescription drug market.
`
`North America Operations
`Sales of Obesity care products in North America Operations increased by 39% measured in Danish kroner and by 48% at
`CER. Novo Nordisk now has a value market share of 85.4% in the obesity prescription drug market in North America.
`Wegovy™ was made available to patients in June 2021 and market access has progressed and commercial formulary
`access is now around 60%. The initial feedback from patients and prescribers has been encouraging. Initial demand has
`exceeded supply of Wegovy™ and patients may temporarily experience a delay in getting prescriptions filled. Novo Nordisk
`is gradually increasing supply and expects to be able to meet demand in early 2022, depending on the demand.
`
`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 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 9 of 30
`
`BIOPHARM
`Biopharm, sales development
`Sales of biopharm products remained unchanged in Danish kroner and increased by 4% at CER to DKK 14,490 million in
`line with the strategic aspiration of sustained growth in Biopharm. The sales growth at CER was driven by both North
`America Operations and International Operations. Sales growth was driven by Rare blood disorders.
`
`Biopharm, development per geographical area
`
`Biopharm, sales development
`
`Global
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
` Sales 9M 2021
`DKK million
`14,490
`8,962
`5,211
`291
`3,460
`5,528
`5,114
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 4%
` 3%
` 1%
` (5%)
` 5%
` 6%
` 7%
`
`Rare blood disorders
`Sales of rare blood disorder products increased by 3% measured in Danish kroner and by 7% at CER to DKK 7,727 million.
`The increasing sales were driven by the launch products Esperoct® and Refixia® as well as NovoSeven® and NovoEight®.
`
`Sales of haemophilia A products increased by 19% measured in Danish kroner and by 23% at CER to DKK 1,531 million. The
`sales increase was driven by both International Operations and North America Operations. Esperoct® has now been
`launched 24 countries.
`
`Sales of haemophilia B products increased by 23% measured in Danish kroner and by 26% at CER to DKK 475 million. The
`sales increase was driven by both International Operations and North America Operations. Refixia® has now been
`launched in 24 countries.
`
`Sales of NovoSeven® decreased by 3% measured in Danish kroner and increased by 2% at CER to DKK 5,531 million. The
`sales development was driven by increasing sales in North America Operations, partially offset by declining sales in
`International Operations. The sales decline in Region China reflects increased distributor stock levels in the first nine
`months of 2020.
`
`Rare endocrine disorders
`Sales of rare endocrine disorder products decreased by 5% measured in Danish kroner, and remained unchanged at CER,
`to DKK 5,584 million. The unchanged sales at CER was driven by International Operations increasing by 6% at CER, offset
`by North America Operations decreasing by 10% at CER. Novo Nordisk is the leading company in the global human growth
`disorder market with a value market share of 35.5% compared to 35.2% a year ago, driven by new indications and global
`roll-out of the next-generation device.
`
`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 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 10 of 30
`
`FINANCIALS
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 8% measured in Danish kroner and by 13% at CER to DKK 102,467 million in the first nine months of
`2021. Sales in International Operations increased by 10% measured in Danish kroner and by 13% at CER. The strategic
`aspiration for International Operations is sales growth between 6-10%. Sales in North America Operations increased by 6%
`measured in Danish kroner and by 13% at CER. The strategic aspiration of transforming 70% of sales in the US has
`progressed, and 58% 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 2021
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`
`
`
`
`
`
`
`
`
`55,321
`28,279
`12,309
`14,733
`47,146
`44,107
`
`102,467
`
` 10%
` 8%
` 14%
` 10%
` 6%
` 5%
`
` 8%
`
` 13%
` 11%
` 12%
` 17%
` 13%
` 12%
`
` 13%
`
` 53%
` 23%
` 11%
` 19%
` 47%
` 42%
`
` 100%
`
`International Operations
`Sales in International Operations increased by 10% measured in Danish kroner and by 13% at CER. Sales growth was
`driven by all therapy areas with GLP-1 sales growing by 47% at CER, insulin sales growing by 6% at CER, Obesity care sales
`growing by 51% at CER and Biopharm sales growing by 3% at CER.
`
`EMEA
`Sales in EMEA increased by 8% measured in Danish kroner and by 11% at CER. Sales growth was driven by Diabetes care
`growing by 11% at CER driven by increased GLP-1 sales. Obesity care increased by 61% at CER and Biopharm sales
`increased by 1% at CER.
`
`Region China
`Sales in Region China increased by 14% measured in Danish kroner and by 12% at CER. Sales growth was driven by
`Diabetes care growth of 13% at CER reflecting increased insulin and GLP-1 sales, partially offset by Biopharm declining by
`5% at CER reflecting increased distributor stock levels in the first nine months of 2020.
`
`Rest of World
`Sales in Rest of World increased by 10% measured in Danish kroner and by 17% at CER. Sales growth was driven by
`Diabetes care growing by 20% at CER, reflecting increased GLP-1 and insulin sales, Obesity care growing by 36% at CER
`and Biopharm growing by 5% at CER.
`
`North America Operations
`Sales in North America Operations increased by 6% measured in Danish kroner and by 13% at CER. Changes to the 340B
`Drug Pricing Programme positively impacted sales growth.
`
`The sales increase reflects GLP-1 diabetes sales growing by 24% at CER, Obesity care growing by 48% at CER and
`Biopharm sales growing by 6% at CER. This was partially offset by insulin sales decreasing by 8% at CER driven by lower
`realised prices due to channel and payer mix and rebate enhancements as well as a decline in volume.
`
`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 66 / 2021
`
`Novo Nordisk Exhibit 2508
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`

`

`Financial report for the period 1 January 2021 to 30 September 2021
`
`Page 11 of 30
`
`DEVELOPMENT IN COSTS AND OPERATING PROFIT
`The cost of goods sold increased by 14% measured in Danish kroner and by 15% at CER to DKK 17,417 million, resulting in
`a gross margin of 83.0% measured in Danish kroner compared with 83.8% in 2020. The decline in gross margin reflects
`lower realised prices in the US, a negative currency impact of 0.5% percentage point and amortisation of intangible assets
`related to the acquisition of Emisphere Technologies Inc. in 2020. This is countered by a positive product mix driven by
`increased GLP-1 sales and productivity improvements in line with the strategic aspiration of driving operational efficiencies.
`
`Sales and distribution costs increased by 10% measured in Danish kroner and by 14% at CER to DKK 25,376 million. The
`increase in costs is driven by North America Operations and International Operations. In North America Operations, the
`cost increase is driven by promotional activities for Rybelsus® and Ozempic® as well as market development activities for
`obesity, p