`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`4 August 2021
`
`
`Novo Nordisk's net profit increased by 10% in the first six months of 2021
`
`• Operating profit decreased by 1% in Danish kroner and increased by 9% at constant exchange rates (CER).
`
`• Sales increased by 5% in Danish kroner and by 12% at CER to DKK 66.8 billion. Sales in International Operations
`increased by 7% in Danish kroner (13% at CER), and sales in North America Operations increased by 1% in Danish
`kroner (11% at CER).
`
`• Sales within Diabetes and Obesity care increased by 5% in Danish kroner to DKK 56.9 billion (13% at CER), driven by
`GLP-1 growth of 21% in Danish kroner (30% at CER) reflecting the uptake of Ozempic® and Rybelsus®. Obesity care grew
`by 23% in Danish kroner (34% at CER) and Biopharm sales remained unchanged in Danish kroner (increased by 7% at
`CER).
`
`• In June 2021, Wegovy™, semaglutide 2.4 mg, was made available to patients in the US following the approval from the
`US Food and Drug Administration (FDA) for weight management in adults living with obesity.
`
`• For the 2021 outlook, sales growth is now expected to be 10-13% at CER (previously 6-10%), and operating profit growth
`is now expected to be 9-12% at CER (previously 5-9%). Sales growth reported in Danish kroner is still expected to be 4
`percentage points lower than at CER and operating profit growth reported in Danish kroner is now expected to be 5
`percentage points lower than at CER.
`
`PROFIT AND LOSS
`
`DKK million
`Net sales
`Operating profit
`
`Net profit
`Diluted earnings per share (in DKK)
`
`* CER: Constant exchange rates (average 2020).
`
`H1 2021
`
`H1 2020
`
`Growth
`as reported
`
`Growth
`at CER*
`
`
`
`
`
`
`
`66,845
`29,761
`
`24,746
`10.71
`
`
`
`
`
`
`
`63,881
`30,140
`
`22,522
`9.58
`
` 5%
` (1%)
`
` 10%
` 12%
`
` 12%
` 9%
`
`N/A
`N/A
`
`Lars Fruergaard Jørgensen, president and CEO: "We are pleased with the sales growth in the first half of 2021. The growth
`is driven by all geographical areas within International Operations as well as North America Operations, and by all therapy
`areas, in particular by our portfolio of GLP-1 treatments. Within R&D, we reached a very important milestone with the
`approval of Wegovy™ in the US, offering people living with obesity a new, efficacious treatment option. The strong financial
`performance in the first half of 2021 and the initial substantial demand for Wegovy™ in the US have enabled us to raise our
`outlook for the full year."
`
`
`On 4 August 2021 at 19.00 CEST, corresponding to 13.00 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 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 2 of 31
`
`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 six months of 2021 (second-quarter developments):
`
`Purpose and sustainability
`Adding value to society:
`•
`Progress on 'Defeat Diabetes' strategy:
`Collaboration with the University of Toronto focusing on
`◦
`prevention
`Initiation of 'Diabetes Compass' by the World Diabetes
`Foundation to improve access to diabetes care in low
`and middle-income countries
`Reaching 15 countries in Changing Diabetes in Children
`by including Ghana
`Launch of Prevention Accelerator inviting start-ups to
`submit ideas for how to predict or prevent obesity
`
`◦
`
`◦
`
`◦
`
`Innovation and therapeutic focus
`Further raise innovation bar for diabetes treatment:
`Approval of Ozempic® in China for the treatment of type 2
`•
`diabetes
`Resubmission of semaglutide 2.0 mg in the US
`Phase 2 initiation with cagrilintide in combination with
`semaglutide in people with type 2 diabetes
`
`•
`•
`
`Develop superior treatment solutions for obesity:
`• Decision to initiate phase 3a development with 50 mg oral
`semaglutide in obesity
`Approval of Wegovy™, semaglutide 2.4 mg, in the US
`
`•
`
`Strengthen and progress Biopharm pipeline:
`Sogroya®, somapacitan, approved in the EU for the
`•
`treatment of adults with growth hormone deficiency
`
`Establish presence in Other serious chronic diseases:
`•
`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
`
`Progress towards zero environmental impact:
`45% reduction in CO2 emissions compared to the first six
`•
`months of 2019
`Approximately 15% reduction in supplier CO2 emissions
`
`•
`
`Pro
` 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 0.5 percentage
`point to 29.6% (MAT)
`
` Strengthen obesity leadership and double sales:
`• Obesity care sales increased by 34% (CER) to DKK 3.5 billion
`
`Financials
`Deliver solid sales and operating profit growth:
`•
`Sales growth at 12% (CER)
`International Operations sales growth of 13% (CER)
`•
`• US sales growth of 10% with 56% of sales coming from
`products launched since 2015
`• Operating profit growth of 9% (CER)
`
` Secure a sustained growth outlook for Biopharm:
`•
`Biopharm sales increased by 7% (CER)
`
` Drive operational efficiencies:
`•
`Continued productivity gains in Product Supply
`
`Enable attractive capital allocation to shareholders:
`•
`Free cash flow of DKK 32.7 billion and DKK 21.9 billion
`returned to shareholders
`
`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 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 3 of 31
`
`PERFORMANCE HIGHLIGHTS
`FINANCIAL HIGHLIGHTS FOR THE FIRST SIX MONTHS OF 2021
`
`PROFIT AND LOSS
`(Amounts are in DKK million, except for numbers of shares, earnings per
`share and employees)
`
`H1 2021
`
`H1 2020
`
` % change H1
`2021 to H1 2020
`
`% change H1
`2021 to H1 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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`66,845
`
`55,487
` 83.0%
`16,257
` 24.3%
`7,888
` 11.8%
`1,836
` 2.7%
`255
`
`29,761
` 44.5%
`1,094
`
`30,855
`6,109
` 19.8%
`24,746
` 37.0%
`
`2,594
`3,111
`36,510
`32,696
`158,095
`65,559
` 41.5%
`2,310.9
`10.71
`45,971
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`63,881
`
`53,723
` 84.1%
`14,988
` 23.5%
`7,068
` 11.1%
`1,754
` 2.7%
`227
`
`30,140
` 47.2%
`(1,703)
`
`28,437
`5,915
` 20.8%
`22,522
` 35.3%
`
`2,244
`2,906
`34,273
`30,335
`136,121
`60,054
` 44.1%
`2,349.9
`9.58
`43,526
`
` 5%
`
` 3%
`
` 8%
`
` 12%
`
` 5%
`
` 12%
`
` (1%)
`
` (164%)
`
` 9%
` 3%
`
` 10%
`
` 16%
` 7%
` 7%
` 8%
` 16%
` 9%
`
` (2%)
` 12%
` 6%
`
` 12%
`
` 11%
`
` 15%
`
` 15%
`
` 8%
`
` 20%
`
` 9%
`
`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 six 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
`
`Financial
`Information
`
` Company announcement No 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 4 of 31
`
`COMMERCIAL EXECUTION
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales grew by 5% measured in Danish kroner and by 12% at CER the first six months of 2021, driven by growth across all
`therapy areas with Diabetes care sales growth of 11% (CER), Obesity care sales growth of 34% (CER) and Biopharm sales
`growth of 7% (CER). Sales growth is positively impacted by inventory changes and timing of shipments in 2021. Sales
`growth in the first six months of 2020 was positively impacted by COVID-19-related stocking, largely offset by fewer
`patients initiating treatment.
`
`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 H1 2021
`DKK million
`
` Sales H1 2020
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`1,674
`14,097
`7,606
`23,377
`8,971
`4,557
`1,326
`3,088
`5,668
`841
`4,827
`8,808
`837
`7,971
`4,576
`28,023
`1,919
`53,319
`3,543
`
`56,862
`
`5,401
`1,120
`309
`3,855
`3,779
`803
`9,983
`
`584
`9,591
`9,225
`19,400
`9,378
`4,618
`1,238
`3,522
`5,648
`671
`4,977
`9,493
`676
`8,817
`5,001
`29,520
`2,102
`51,022
`2,885
`
`53,907
`
`5,211
`845
`247
`4,009
`3,983
`780
`9,974
`
`66,845
`
`63,881
`
` 187%
` 47%
` (18%)
` 21%
` (4%)
` (1%)
` 7%
` (12%)
` 0%
` 25%
` (3%)
` (7%)
` 24%
` (10%)
` (8%)
` (5%)
` (9%)
` 5%
` 23%
`
` 5%
`
` 4%
` 33%
` 25%
` (4%)
` (5%)
` 3%
` 0%
`
` 5%
`
` 213%
` 58%
` (12%)
` 30%
` 2%
` 5%
` 12%
` (6%)
` 5%
` 34%
` 2%
` (1%)
` 30%
` (4%)
` (3%)
` 1%
` (5%)
` 11%
` 34%
`
` 13%
`
` 11%
` 39%
` 30%
` 3%
` 2%
` 5%
` 7%
`
` 12%
`
` 17%
` 75%
` (15%)
` 77%
` 2%
` 3%
` 2%
` (3%)
` 4%
` 3%
` 1%
` (2%)
` 2%
` (4%)
` (2%)
` 2%
` (1%)
` 78%
` 13%
`
` 91%
`
` 7%
` 4%
` 1%
` 2%
` 1%
` 1%
` 9%
`
` 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
`
`Financial
`Information
`
` Company announcement No 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 5 of 31
`
`DIABETES AND OBESITY CARE
`Diabetes care, sales and market share development
`Sales in Diabetes care increased by 5% measured in Danish kroner and by 11% at CER to DKK 53,319 million driven by
`GLP-1 growth. Novo Nordisk has improved the global diabetes value market share over the last 12 months from 29.1% to
`29.6% 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 May 2021 and
`May 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
`
`May
`2021
` 29.6%
` 24.0%
` 28.1%
` 32.4%
` 14.0%
` 31.6%
` 31.6%
`
`May
`2020
` 29.1%
` 22.5%
` 27.3%
` 27.8%
` 13.2%
` 31.5%
` 31.6%
`
` Sales H1 2021
`DKK million
`53,319
`29,294
`14,676
`7,866
`6,752
`24,025
`22,534
`
`Growth
`at CER
` 11%
` 13%
` 11%
` 13%
` 19%
` 9%
` 9%
`
`Source: IQVIA, May 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 21% measured in Danish
`kroner and by 30% at CER to DKK 23,377 million. The GLP-1 segment’s value share of the total diabetes market has
`increased to 24.0% compared with 20.0% 12 months ago. Novo Nordisk continues to be the global market leader in the
`GLP-1 segment with a 51.5% value market share, an increase of 2.4 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
`
`May
`2021
` 51.5%
` 56.1%
` 56.8%
` 84.9%
` 48.0%
` 50.8%
` 50.1%
`
`May
`2020
` 49.1%
` 52.1%
` 53.8%
` 92.9%
` 41.4%
` 48.6%
` 48.1%
`
` Sales H1 2021
`DKK million
`23,377
`7,527
`4,961
`833
`1,733
`15,850
`14,958
`
`Growth
`at CER
` 30%
` 46%
` 36%
` 68%
` 69%
` 24%
` 23%
`
`Source: IQVIA, May 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 187% measured in Danish kroner and by 213% at CER to DKK 1,674 million. Sales growth was
`driven by North America Operations as well as EMEA and Rest of World. Rybelsus® has now been launched in 18 countries.
`
`Ozempic® sales increased by 47% measured in Danish kroner and by 58% at CER to DKK 14,097 million. Sales growth was
`driven by both North America Operations and International Operations. Ozempic® has now been launched in 62 countries.
`
`Victoza® sales decreased by 18% measured in Danish kroner and by 12% at CER to DKK 7,606 million. The sales decline
`was driven by North America Operations and EMEA, partially offset by higher sales in Region China and Rest of World.
`Commercial
`Innovation and
`Purpose and
`Financial
`Cash flow and
`Performance
`Strategic
`execution
`therapeutic focus
`sustainability
`Information
`capital allocation
`aspirations
`highlights
`
`Financials
`
`Outlook
`
` Company announcement No 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 6 of 31
`
`International Operations
`Sales of GLP-1 diabetes products in International Operations increased by 40% measured in Danish kroner and by 46% 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 11.9% from 9.8% 12 months ago. Novo Nordisk is the market leader with a value market share of 56.1%.
`
`EMEA
`Sales in EMEA increased by 34% measured in Danish kroner and by 36% 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 15 countries in
`EMEA. Novo Nordisk remains the market leader in EMEA with a value market share of 56.8%.
`
`Region China
`Sales in Region China increased by 66% measured in Danish kroner and by 68% at CER. The sales growth reflects the
`uptake of Victoza® in mainland China and the launch of Ozempic® in Taiwan®. The GLP-1 class' share of the overall diabetes
`market value in Region China increased to 4.1% from 2.3% 12 months ago with a Victoza® market share of 88.6%.
`
`Rest of World
`Sales in Rest of World increased by 51% measured in Danish kroner and by 69% at CER. The sales growth reflects
`increased sales of Ozempic® , Rybelsus®, following the launch in Japan, and Victoza®. Novo Nordisk remains the market
`leader with a value market share of 48.0%.
`
`North America Operations
`Sales of GLP-1 diabetes products in North America Operations increased by 13% measured in Danish kroner and by 24%
`at CER. Novo Nordisk is the market leader with a 50.8% value market share compared to 48.6% 12 months ago. The value
`market share of the GLP-1 class of the total North American diabetes market has increased to 28.4% compared to 23.8%
`12 months ago.
`
`Sales growth in the US is driven by a prescription volume growth of the GLP-1 class of around 25% compared to the first
`six months of 2020. Rybelsus® weekly new-to-brand market share is 12.9%. The combined Novo Nordisk GLP-1 new-to-
`brand prescription market share is now 62.6%. Novo Nordisk is the market leader with 51.3% 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
`
`Financial
`Information
`
` Company announcement No 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 7 of 31
`
`Insulin
`Sales of insulin decreased by 5% measured in Danish kroner and increased by 1% at CER to DKK 28,023 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
`
`May
`2021
` 47.3%
` 50.3%
` 47.6%
` 50.8%
` 57.2%
` 39.2%
` 38.9%
`
`May
`2020
` 47.0%
` 49.7%
` 47.1%
` 50.4%
` 56.9%
` 39.7%
` 39.7%
`
` Sales H1 2021
`DKK million
`28,023
`20,340
`9,362
`6,199
`4,779
`7,683
`7,154
`
`Growth
`at CER
` 1%
` 6%
` 2%
` 10%
` 10%
` (11%)
` (11%)
`
`Source: IQVIA, May 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 1% measured in Danish kroner and by 6% at CER. Sales growth at
`CER was driven by long-acting insulin, premix insulin and fast-acting insulin, partially countered by human insulin.
`
`EMEA
`Sales of insulin in EMEA decreased by 3% 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 8% measured in Danish kroner and by 10% at CER. The sales growth was
`driven by Tresiba®, NovoMix®, NovoRapid® and Ryzodeg®, 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 remained unchanged in Danish kroner and increased 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
`57.2% of the total insulin market.
`
`North America Operations
`Sales of insulin in North America Operations decreased by 18% measured in Danish kroner and by 11% 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. Novo Nordisk has a volume market share of 39.2% 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
`
`Financial
`Information
`
` Company announcement No 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 8 of 31
`
`Obesity care, sales development
`Sales of Obesity care products, Saxenda® and Wegovy™, increased by 23% measured in Danish kroner and by 34% at CER
`to DKK 3,543 million. Sales growth was driven by International Operations and North America Operations. Saxenda® has
`been launched in 58 countries and Wegovy™ was launched in the US in June 2021. Novo Nordisk currently has a value
`market share of 66.9% 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 H1 2021
`DKK million
`3,543
`1,497
`839
`16
`642
`2,046
`1,874
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 34%
` 44%
` 55%
`—
` 30%
` 27%
` 27%
`
`International Operations
`Sales of Saxenda® in International Operations increased by 33% measured in Danish kroner and by 44% at CER, driven by
`increased sales in EMEA and Rest of World. Novo Nordisk currently has a value market share of 42.8% in the branded
`obesity prescription drug market.
`
`EMEA
`Sales of Saxenda® in EMEA increased by 46% measured in Danish kroner and by 55% at CER. Novo Nordisk currently has a
`value market share of 67.3% in the branded obesity prescription drug market.
`
`Rest of World
`Sales of Saxenda® in Rest of World increased by 18% measured in Danish kroner and by 30% at CER. Saxenda® has been
`launched in 19 countries in Rest of World. Novo Nordisk currently has a value market share of 33.5% in the branded
`obesity prescription drug market.
`
`North America Operations
`Sales of Obesity care products in North America Operations increased by 16% measured in Danish kroner and by 27% at
`CER. Novo Nordisk now has a value market share of 83.0% in the obesity prescription drug market in North America.
`Wegovy™ was made available to patients in June 2021 and market access has progressed. 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.
`
`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 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 9 of 31
`
`BIOPHARM
`Biopharm, sales development
`Sales of biopharm products remained unchanged in Danish kroner and increased by 7% at CER to DKK 9,983 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 both Rare blood disorders and Rare endocrine
`disorders.
`
`Biopharm, development per geographical area
`
`Biopharm, sales development
`
`Global
`International Operations
` - EMEA
` - Region China
` - Rest of World
`North America Operations
` - The US
`
` Sales H1 2021
`DKK million
`9,983
`6,193
`3,594
`170
`2,429
`3,790
`3,518
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` 7%
` 4%
` 5%
` (30%)
` 5%
` 12%
` 13%
`
`Rare blood disorders
`Sales of rare blood disorder products increased by 4% measured in Danish kroner and by 11% at CER to DKK 5,401 million.
`The increasing sales were driven by the launch products Esperoct® and Refixia® as well as NovoEight® and NovoSeven®.
`
`Sales of haemophilia A products increased by 33% measured in Danish kroner and by 39% at CER to DKK 1,120 million. The
`sales increase was driven by both International Operations and North America Operations. Esperoct® has now been
`launched 21 countries.
`
`Sales of haemophilia B products increased by 25% measured in Danish kroner and by 30% at CER to DKK 309 million. The
`sales increase was driven by both International Operations and North America Operations. Refixia® has now been
`launched in 20 countries.
`
`Sales of NovoSeven® decreased by 4% measured in Danish kroner and increased by 3% at CER to DKK 3,855 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 six months
`of 2020.
`
`Rare endocrine disorders
`Sales of rare endocrine disorder products decreased by 5% measured in Danish kroner and increased by 2% at CER to DKK
`3,779 million driven by Norditropin®. The sales growth at CER was driven by International Operations increasing by 4% at
`CER, partially offset by North America Operations decreasing by 2%. Novo Nordisk is the leading company in the global
`human growth disorder market with a value market share of 35.9% compared to 34.3% a year ago, driven by new
`indications and the 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
`
`Financial
`Information
`
` Company announcement No 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 10 of 31
`
`FINANCIALS
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 5% measured in Danish kroner and by 12% at CER to DKK 66,845 million in the first six months of 2021.
`Sales in International Operations increased by 7% 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 1% measured
`in Danish kroner and by 11% at CER. The strategic aspiration of transforming 70% of sales in the US has progressed, and
`56% 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 H1 2021
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`
`
`
`
`
`
`
`
`
`36,984
`19,109
`8,052
`9,823
`29,861
`27,926
`
`66,845
`
` 7%
` 7%
` 10%
` 6%
` 1%
` 0%
`
` 5%
`
` 13%
` 11%
` 12%
` 16%
` 11%
` 10%
`
` 12%
`
` 58%
` 27%
` 11%
` 20%
` 42%
` 39%
`
` 100%
`
`International Operations
`Sales in International Operations increased by 7% measured in Danish kroner and by 13% at CER. Sales growth was driven
`by all therapy areas with GLP-1 sales growing by 46% (CER), insulin sales growing by 6% (CER), Obesity care sales growing
`by 44% (CER) and Biopharm sales growing by 4% (CER).
`
`EMEA
`Sales in EMEA increased by 7% measured in Danish kroner and by 11% at CER. Sales growth was driven by Diabetes care
`growing by 11% (CER) driven by increased GLP-1 sales. Biopharm sales increased by 5% (CER) and Obesity care increased
`by 55% (CER).
`
`Region China
`Sales in Region China increased by 10% measured in Danish kroner and by 12% at CER. Sales growth was driven by
`Diabetes care growth of 13% (CER) reflecting increased insulin and GLP-1 sales, partially offset by Biopharm declining by
`30% (CER) reflecting increased distributor stock levels in the first six months of 2020.
`
`Rest of World
`Sales in Rest of World increased by 6% measured in Danish kroner and by 16% at CER. Sales growth was driven by
`Diabetes care growing by 19% (CER), reflecting increased GLP-1 and insulin sales, Obesity care growing by 30% (CER) and
`Biopharm growing by 5% (CER).
`
`North America Operations
`Sales in North America Operations increased by 1% measured in Danish kroner and by 11% at CER. Sales growth was
`positively impacted by inventory changes in 2021.
`
`The sales increase reflects GLP-1 sales growing by 24% (CER), Obesity care growing by 27% (CER) and Biopharm sales
`growing by 12% (CER). This was partially offset by insulin sales decreasing by 11% (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
`
`Financial
`Information
`
` Company announcement No 48 / 2021
`
`Novo Nordisk Exhibit 2507
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`
`
`Financial report for the period 1 January 2021 to 30 June 2021
`
`Page 11 of 31
`
`DEVELOPMENT IN COSTS AND OPERATING PROFIT
`The cost of goods sold increased by 12% measured in Danish kroner and by 14% at CER to DKK 11,358 million, resulting in
`a gross margin of 83.0% measured in Danish kroner compared with 84.1% in 2020. The decline in gross margin reflects
`lower realised prices in the US, a negative currency impact of 0.7% 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 8% measured in Danish kroner and by 15% at CER to DKK 16,257 million. The
`increase in costs is driven by both International Operations and North America Operations. In International Operations,
`promotional spend is related to launch activities for Rybelsus® and Ozempic®, field force expansion in China as well as
`Obesity care market development activities. In North America Operations, the cost increase is driven by promotional
`activities for Rybelsus® and Ozempic®, partially offset by lower promotional spend related to insulin. The cost increase was
`impacted by low activity level in the second quarter of 2020 due to COVID-19.
`
`Research and development costs increased by 12% measured in Danish kroner and by 15% at CER to DKK 7,888 million.
`Increased activities within Other serious chronic diseases are driving the cost increase reflecting the progression of the
`pipeline within cardiovascular disease and NASH as well as increased costs within Obesity care driven by the ongoing
`cardiovascular outcomes trials, SOUL and SELECT. The cost increase was impacted by low activity level in the second
`