`
`
`
`
`
`
`
`
`
`
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`10 August 2023
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`Novo Nordisk's sales increased by 29% in Danish kroner and by 30% at constant
`exchange rates to DKK 107.7 billion in the first six months of 2023
`
`
`
`
`
`
`
`
`
`
`
`
`
`• Operating profit increased by 30% in Danish kroner and by 32% at constant exchange rates (CER) to DKK 48.9 billion.
`• Sales in North America Operations increased by 45% in Danish kroner (44% at CER). Sales in International Operations
`increased by 14% in Danish kroner (17% at CER).
`
`• Sales within Diabetes and Obesity care increased by 36% in Danish kroner to DKK 99.0 billion (37% at CER), mainly
`driven by GLP-1 diabetes sales growth of 49% in Danish kroner (50% at CER) and Obesity care growing by 158% in
`Danish Kroner to DKK 18.1 billion (157% at CER). Rare disease sales decreased by 18% in both Danish kroner and CER
`reflecting a temporary reduction in manufacturing output.
`
`• In August 2023, Novo Nordisk announced that semaglutide 2.4 mg statistically significantly reduced the risk of major
`adverse cardiovascular events in the SELECT cardiovascular outcomes trial. Further, the phase 3 obesity trials OASIS 1
`and STEP HFpEF were successfully completed.
`
`• For the 2023 outlook, sales and operating profit growth at CER are now expected to be 27-33% and 31-37%,
`respectively. Sales and operating profit growth reported in Danish kroner are expected to be 6 and 9 percentage points
`lower 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 2022).
`
`H1 2023
`
`H1 2022
`
`Growth
`as reported
`
`Growth
`at CER*
`
`
`
`
`
`
`
`107,667
`48,895
`
`39,242
`17.41
`
`83,296
`37,538
`
`27,528
`12.08
`
` 29%
` 30%
`
` 43%
` 44%
`
` 30%
` 32%
`
`N/A
`N/A
`
`Lars Fruergaard Jørgensen, president and CEO: "We are very pleased with the sales growth in the first half of 2023. The
`growth is driven by increasing demand for our GLP-1-based diabetes and obesity treatments, and we are serving more
`patients than ever before. The performance in the first six months has enabled us to raise the outlook for the full year.
`Within R&D, we are very excited about the results from the SELECT trial. Obesity is a serious chronic disease associated
`with many comorbidities and the results from SELECT demonstrate that comorbidities associated with the condition can be
`significantly reduced by treating people with semaglutide.
`
`On 10 August 2023 at 13.00 CEST, corresponding to 07.00 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 Alle 1
`2880 Bagsværd
`Denmark
`
`Telephone:
`+45 4444 8888
`www.novonordisk.com
`
`CVR Number:
`24 25 67 90
`
` Company announcement No 52 / 2023
`
`Novo Nordisk Exhibit 2515
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`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 six months of 2023 (blue indicates second quarter developments)
`
`PERFORMANCE HIGHLIGHTS
`
`Purpose and sustainability (ESG)
`Progress towards zero environmental impact:
`–
`Carbon emissions from operations and transportation decreased by
`28% compared to first half of 2019 (decreased by 10% compared to
`2022)
`
`Adding value to society:
`–
`Medical treatment provided to 39.1 million people living with
`diabetes (net increase of 4 million people)
`Reaching more than 45,000 children in Changing Diabetes® in
`Children programme
`
`–
`
`Innovation and therapeutic focus
`Further raise innovation bar for diabetes treatment:
`–
`Regulatory submission of once-weekly insulin icodec in the EU, the
`US and China
`Successful completion of phase 3 trial with higher doses of oral
`semaglutide
`Completion of phase 2 trial and first cohorts of phase 1 trial with
`GLP-1 and GIP combinations
`
`–
`
`–
`
`Develop superior treatment solutions for obesity:
`–
`Phase 3a trials REDEFINE 2 and 3 initiated with CagriSema in people
`with obesity
`Successful completion of phase 3 trial with 50 mg of oral semaglutide
`–
`Commercial execution
`Strengthen diabetes leadership to more than one-third:
`–
`Diabetes value market share increased by 1.7 percentage points to
`32.7% (MAT)
`
`Financials
`Deliver solid sales and operating profit growth:
`–
`Sales growth at 30% (CER)
`–
`Operating profit growth of 32% (CER)
`
`–
`
`Human insulin with more flexible storage without refrigeration
`now approved in 23 countries
`
`Being recognised as a sustainable employer:
`–
`Share of women in senior leadership positions has increased to
`40% from 38% end of June 2022
`
`–
`–
`–
`
`Successful completion of SELECT cardiovascular outcomes trial
`Successful completion of STEP HFpEF phase 3 trial
`Acquisition of Inversago Pharma
`
`Strengthen and progress Rare disease pipeline:
`–
`Somapacitan approved in the US, EU and Japan for the
`treatment of growth hormone deficiency in children
`Complete Response Letter received for concizumab in the US
`
`–
`
`Establish presence in other serious chronic diseases:
`–
`Phase 1 trials initiated with cell therapy treatment in heart failure
`and Parkinson's disease
`
`More than DKK 25 billion in Obesity sales by 2025:
`–
`Obesity care sales increased by 157% (CER) to DKK 18.1 billion
`
`Secure a sustained growth outlook for Rare Disease:
`–
`Rare disease sales decreased by 18% at (CER) at DKK 8.7 billion
`
`Drive operational efficiencies:
`–
`Operational leverage reflecting sales growth
`
`Enable attractive capital allocation to shareholders:
`–
`Free cash flow of DKK 45.5 billion
`–
`DKK 32.3 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 52 / 2023
`
`Novo Nordisk Exhibit 2515
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`Page 3 of 32
`
`PERFORMANCE HIGHLIGHTS
`FINANCIAL HIGHLIGHTS FOR THE FIRST SIX MONTHS OF 2023
`
`PROFIT AND LOSS
`
`(Amounts are in DKK million, except for earnings per share)
`
`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 (EBIT)
`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
`EBITDA
`Free cash flow
`Average number of diluted shares outstanding (million)
`Diluted earnings per share / ADR (in DKK)
`Full-time equivalent employees end of period
`
`H1 2023
`
`H1 2022
`
` 107,667
`
` 83,296
`
` 91,629
` 85.1%
`(26,754)
` 24.8%
`(13,855)
` 12.9%
`(2,143)
` 2.0%
`18
`
`
`
`
`
`
`
`
`
` 70,310
` 84.4%
`(21,023)
` 25.2%
`(10,329)
` 12.4%
`(1,961)
` 2.4%
`541
`
`
`
`
`
`
`
`
`
` 48,895
` 45.4%
`96
`
`
`
` 48,991
`(9,749)
`
` 19.9%
` 39,242
` 36.4%
`
`3,896
`
` 10,571
` 58,391
` 52,791
` 45,537
` 2,253.9
`17.41
`
` 59,337
`
` 37,538
` 45.1%
`(2,824)
`
`
`
` 34,714
`(7,186)
`
` 20.7%
` 27,528
` 33.0%
`
`3,286
`
`3,955
`
` 47,547
` 40,824
` 42,725
` 2,279.7
`12.08
`
` 50,816
`
` % change
` H1 2023 to
` H1 2022
`
` % change
` H1 2023 to
` H1 2022 at
`CER
`
` 29%
`
` 30%
`
` 27%
`
` 34%
`
` 9%
`
` (97%)
`
` 30%
`
` 30%
`
` 32%
`
` 28%
`
` 34%
`
` 10%
`
` (96%)
`
` 32%
`
` (103%)
`
` N/A
`
` 41%
` 36%
`
` N/A
` N/A
`
` 43%
`
` N/A
`
` 19%
` 167%
` 23%
` 29%
` 7%
` (1%)
` 44%
` 17%
`
` N/A
` N/A
` N/A
` 31%
` N/A
` N/A
` N/A
` N/A
`
`These unaudited consolidated financial statements for the first six months of 2023 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 2022 of Novo
`Nordisk. As of 23 May 2023, the International Accounting Standards Board (IASB) issued amendments to IAS 12 Income
`Taxes. Novo Nordisk has assessed the impact from the tax reform as immaterial.
`
`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 52 / 2023
`
`Novo Nordisk Exhibit 2515
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`Page 4 of 32
`
`COMMERCIAL EXECUTION
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales grew by 29% measured in Danish kroner and by 30% at CER in the first six months of 2023, driven by Diabetes care
`sales growth of 24% (CER) and Obesity care sales growth of 157% (CER). Rare disease sales decreased by 18% (CER). Sales
`growth has resulted in periodic supply constraints and related drug shortage notifications across a number of products
`and geographies.
`
`Sales split per therapy
`Diabetes and Obesity care segment
`
`Injectable GLP-1
` - Ozempic®
` - Victoza®
`Rybelsus®
`Total GLP-1
`Long-acting insulin1
`Premix insulin2
`Fast-acting insulin3
`Human insulin
`Total insulin
`Other Diabetes care4
`Total Diabetes care
`Wegovy®
`Saxenda®
`Total Obesity care
`Diabetes and Obesity care total
`Rare disease segment
`Rare blood disorders5
`Rare endocrine disorders6
`Other Rare disease7
`Rare disease total
`
`Total sales
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Sales H1 2023
`DKK million
`
` Sales H1 2022
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`46,392
`41,741
`4,651
`8,344
`54,736
`7,487
`5,232
`7,999
`3,979
`24,697
`1,396
`80,829
`12,081
`6,067
`18,148
`98,977
`
`5,885
`2,030
`775
`8,690
`
`107,667
`
`32,416
`26,384
`6,032
`4,235
`36,651
`8,900
`5,513
`8,729
`4,163
`27,305
`1,714
`65,670
`2,585
`4,460
`7,045
`72,715
`
`5,940
`3,743
`898
`10,581
`
`83,296
`
` 43%
` 58%
` (23%)
` 97%
` 49%
` (16%)
` (5%)
` (8%)
` (4%)
` (10%)
` (19%)
` 23%
` 367%
` 36%
` 158%
` 36%
`
` (1%)
` (46%)
` (14%)
` (18%)
`
` 29%
`
` 44%
` 59%
` (22%)
` 98%
` 50%
` (14%)
` (3%)
` (7%)
` 0%
` (7%)
` (19%)
` 24%
` 363%
` 38%
` 157%
` 37%
`
` (1%)
` (46%)
` (11%)
` (18%)
`
` 30%
`
` 57%
` 62%
` (5%)
` 16%
` 73%
` (5%)
` (1%)
` (2%)
` 0%
` (8%)
` (2%)
` 63%
` 37%
` 7%
` 44%
` 107%
`
` 0%
` (7%)
` 0%
` (7%)
`
` 100%
`
`1) Comprises Tresiba®, Xultophy® and Levemir®.
`2) Comprises Ryzodeg® and NovoMix®.
`3) Comprises Fiasp® and NovoRapid®.
`4) Primarily NovoNorm®, needles and GlucaGen® HypoKit®.
`5) Comprises NovoSeven®, NovoEight®, Esperoct®, Refixia® and NovoThirteen®.
`6) Primarily Norditropin® and Sogroya®
`7) 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 52 / 2023
`
`Novo Nordisk Exhibit 2515
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`Page 5 of 32
`
`DIABETES AND OBESITY CARE
`Diabetes care, sales and market share development
`Sales in Diabetes care increased by 23% measured in Danish kroner and by 24% at CER to DKK 80,829 million driven by
`growth of GLP-1-based products. Novo Nordisk has improved the global diabetes value market share over the last 12
`months to 32.7% from 31.0% 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 North America Operations and International Operations.
`
`In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from May 2022 and
`May 2023 provided by the independent data provider IQVIA. EMEA covers Europe, the Middle East and Africa; Region
`China covers mainland China, Hong Kong and Taiwan; 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
`North America Operations
` - The US
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`
`May
`2023
` 32.7%
` 34.2%
` 33.8%
` 27.1%
` 29.6%
` 31.8%
` 21.4%
`
`May
`2022
` 31.0%
` 32.8%
` 32.7%
` 25.8%
` 29.1%
` 33.0%
` 17.6%
`
` Sales H1 2023
`DKK million
`80,829
`41,379
`37,505
`39,450
`20,114
`8,445
`10,891
`
`Growth
`at CER
` 24%
` 28%
` 25%
` 20%
` 21%
` 11%
` 27%
`
`Source: IQVIA, May 2023 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 49% measured in Danish
`kroner and by 50% at CER to DKK 54,736 million. The estimated global GLP-1 share of total diabetes prescriptions has
`increased to 5.4% compared with 3.7% 12 months ago. Novo Nordisk continues to be the global market leader in the
`GLP-1 segment with a 54.1% value market share.
`
`GLP-1, development per geographical area
`
`Novo Nordisk's share of the
`diabetes GLP-1 market (value, MAT)
`
`GLP-1, sales development
`
`Global
`North America Operations
` - The US
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`
`May
`2023
` 54.1%
` 52.4%
` 51.4%
` 67.0%
` 62.0%
` 71.1%
` 78.8%
`
`May
`2022
` 54.8%
` 53.8%
` 52.9%
` 61.3%
` 59.4%
` 62.7%
` 66.2%
`
` Sales H1 2023
`DKK million
`54,736
`35,794
`32,454
`18,942
`10,407
`3,118
`5,417
`
`Growth
`at CER
` 50%
` 44%
` 39%
` 62%
` 55%
` 97%
` 58%
`
`Source: IQVIA, May 2023 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. Note: the estimated GLP-1 share of prescriptions is based on volume packs from IQVIA. Volume packs are converted into full-year patients/prescriptions
`based on WHO assumptions for average daily doses or if not available, Novo Nordisk assumptions.
`Rybelsus® sales increased by 97% measured in Danish kroner and by 98% at CER to DKK 8,344 million. Sales growth was
`driven by North America Operations as well as EMEA and Rest of World.
`
`Ozempic® sales increased by 58% measured in Danish kroner and by 59% at CER to DKK 41,741 million. Sales growth was
`driven by both North America Operations and International Operations. Sales growth has resulted in periodic supply
`constraints and related drug shortage notifications across geographies.
`
`Strategic
`aspirations
`
`Performance
`highlights
`
`Commercial
`execution
`
`Financials
`
`Cash flow and
`capital allocation
`
`Outlook
`
`Innovation and
`therapeutic focus
`
`Purpose and
`sustainability
`
`Financial
`Information
`
` Company announcement No 52 / 2023
`
`Novo Nordisk Exhibit 2515
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`Page 6 of 32
`
`Victoza® sales decreased by 23% measured in Danish kroner and by 22% at CER to DKK 4,651 million as the GLP-1 market
`is moving towards once-weekly and tablet-based treatments. The sales decline was driven by North America Operations.
`
`North America Operations
`Sales of GLP-1 diabetes products in North America Operations increased by 45% measured in Danish kroner and by 44%
`at CER. Wholesaler inventory movements in the US positively impacted sales growth. Novo Nordisk is the market leader
`with a 52.4% value market share compared to 53.8% 12 months ago. The estimated GLP-1 share of total diabetes
`prescriptions has increased to 13.3% compared with 9.0% 12 months ago.
`
`Sales of GLP-1 in the US increased by 39% 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.
`
`Sales growth in the US is driven by a prescription volume growth of the GLP-1 class above 60% in the second quarter of
`2023 compared to the second quarter of 2022. The combined Novo Nordisk GLP-1 new-to-brand prescription market
`share is now 62.3% driven by Ozempic® with 52.4% and Rybelsus® with 7.3%. Novo Nordisk is the market leader with 55.4%
`measured by total monthly prescriptions for the combined GLP-1 portfolio.
`
`International Operations
`Sales of GLP-1 diabetes products in International Operations increased by 58% measured in Danish kroner and by 62% at
`CER. Sales growth is driven by all geographical areas. The estimated GLP-1 share of total diabetes prescriptions has
`increased to 3.5% compared with 2.5% 12 months ago. Novo Nordisk is the market leader with a value market share of
`67.0% compared to 61.3% 12 months ago.
`
`EMEA
`Sales in EMEA increased by 53% measured in Danish kroner and by 55% at CER. The sales growth reflects the uptake of
`Ozempic® and Rybelsus®, partially offset by lower sales of Victoza®. Novo Nordisk remains the market leader in EMEA with
`a value market share of 62.0%. The estimated GLP-1 share of total diabetes prescriptions has increased to 4.8% compared
`with 3.6% 12 months ago.
`
`Region China
`Sales in Region China increased by 86% measured in Danish kroner and by 97% at CER. The sales growth reflects the
`uptake of Ozempic®. The GLP-1 share of total diabetes prescriptions has increased to 3.0% compared with 1.6% 12 months
`ago. Novo Nordisk is the market leader in Region China with a value market share of 71.1%.
`
`Rest of World
`Sales in Rest of World increased by 54% measured in Danish kroner and by 58% at CER. The sales growth reflects
`increased sales of Rybelsus® and Ozempic®, partially offset by Victoza®. Novo Nordisk remains the market leader with a
`value market share of 78.8%. The estimated GLP-1 share of total diabetes prescriptions has increased to 2.1% compared
`with 1.5% 12 months ago.
`
`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 52 / 2023
`
`Novo Nordisk Exhibit 2515
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`Page 7 of 32
`
`Insulin
`Sales of insulin decreased by 10% measured in Danish kroner and by 7% at CER to DKK 24,697 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
`North America Operations
` - The US
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`
`May
`2023
` 45.7%
` 37.9%
` 37.5%
` 48.5%
` 47.1%
` 43.3%
` 57.8%
`
`May
`2022
` 47.1%
` 38.4%
` 37.9%
` 50.3%
` 47.8%
` 50.4%
` 57.1%
`
` Sales H1 2023
`DKK million
`24,697
`5,284
`4,778
`19,413
`9,383
`4,783
`5,247
`
`Growth
`at CER
` (7%)
` (25%)
` (26%)
` (2%)
` (1%)
` (11%)
` 9%
`
`Source: IQVIA, May 2023 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.
`North America Operations
`Sales of insulin in North America Operations decreased by 24% measured in Danish kroner and by 25% 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 with the US insulin volume market declining 3% compared to the first six months of 2022. Novo
`Nordisk has a volume market share of 37.5% of the total US insulin market.
`
`International Operations
`Sales of insulin in International Operations decreased by 4% measured in Danish kroner and by 2% at CER. The sales
`decline at CER was driven by lower insulin sales in Region China due to the implementation of Volume Based Procurement
`in May 2022 as well as lower sales in EMEA.
`
`EMEA
`Sales of insulin in EMEA decreased by 2% measured in Danish kroner and by 1% at CER. The sales decline at CER was
`driven by long-acting insulin, pre-mix insulin and fast-acting insulin, partially countered by human insulin. Novo Nordisk
`has a volume market share of 47.1% of the total insulin market.
`
`Region China
`Sales of insulin in Region China decreased by 16% measured in Danish kroner and by 11% at CER. The sales decline was
`driven by all insulin products due to the implementation of Volume Based Procurement from May 2022 except for
`Ryzodeg® and Xultophy®. Novo Nordisk has a volume market share of 43.3% of the total insulin market.
`
`Rest of World
`Sales of insulin in Rest of World increased by 3% measured in Danish kroner and by 9% at CER. The sales growth at CER
`was driven by human insulin, long-acting insulin and fast-acting insulin, partially countered by premix insulin. Novo Nordisk
`has a volume market share of 57.8% 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 52 / 2023
`
`Novo Nordisk Exhibit 2515
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`Page 8 of 32
`
`Obesity care, sales development
`Sales of Obesity care products, Wegovy® and Saxenda®, increased by 158% measured in Danish kroner and by 157% at
`CER to DKK 18,148 million. Sales growth was driven by both North America Operations and International Operations.
`Wegovy® has been launched in the US, Denmark, Norway and Germany. The volume growth of the global branded obesity
`market was 75.9%.
`
`Obesity care, development per geographical area
`
`Global branded
`obesity market growth
`(Volume, MAT)
`
`Obesity care, sales development
`
`Global
`North America Operations
` - The US
`International Operations
` - EMEA
` - Region China
` - Rest of World
`
`May
`2023
` 75.9%
` 79.9%
` 87.8%
` 71.4%
` 101.6%
`N/A
` 40.2%
`
` Sales H1 2023
`DKK million
`18,148
`14,159
`13,906
`3,989
`2,640
`100
`1,249
`
`Growth
`at CER
` 157%
` 207%
` 216%
` 66%
` 79%
` 33%
` 47%
`
`Source: IQVIA, May 2023 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.
`
`Wegovy® sales increased by 367% measured in Danish kroner and by 363% at CER to DKK 12,081 million. Sales of
`Saxenda® increased by 36% measured in Danish kroner and by 38% at CER to DKK 6,067 million.
`
`North America Operations
`Sales of Obesity care products in North America Operations increased by 210% measured in Danish kroner and by 207% at
`CER to DKK 14,159 million. Sales of Wegovy® increased by 350% measured in Danish kroner and by 344% at CER to DKK
`11,621 million reflecting the commercial relaunch in January 2023. Demand for Wegovy® exceeds supply and to safeguard
`continuity of care, the supply of the lower Wegovy® dose strengths in the US was reduced in May 2023. Broad commercial
`formulary access has been achieved. Sales of Saxenda® increased by 28% measured in Danish kroner and by 27% at CER
`to DKK 2,538 million. The volume growth of the branded obesity market in the US was 87.8%.
`
`International Operations
`Sales of Obesity care products in International Operations increased by 61% measured in Danish kroner and by 66% at
`CER to DKK 3,989 million driven by increased sales in EMEA and Rest of World. Sales of Saxenda® in International
`Operations increased by 42% measured in Danish kroner and by 47% at CER to DKK 3,529 million and sales of Wegovy®
`reached DKK 460 million. Wegovy® has been launched in three countries in International Operations. The volume growth
`of the branded obesity market in International Operations was 71.4%.
`
`EMEA
`Sales of Obesity care products in EMEA increased by 74% measured in Danish kroner and by 79% at CER. The volume
`growth of the branded obesity market in EMEA was 101.6%.
`
`Rest of World
`Sales of Saxenda® in Rest of World increased by 41% measured in Danish kroner and by 47% at CER. The volume growth of
`the branded obesity market in Rest of World was 40.2%.
`
`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 52 / 2023
`
`Novo Nordisk Exhibit 2515
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`Page 9 of 32
`
`Rare disease, sales development
`Rare disease sales decreased by 18% in both Danish kroner and CER to DKK 8,690 million. Sales of rare blood disorder
`products decreased by 1% in both Danish kroner and CER to DKK 5,885 million driven by NovoSeven®, partially offset by
`the launch products in haemophilia A and B. Sales of rare endocrine disorder products decreased by 46% in both Danish
`kroner and CER to DKK 2,030 million reflecting a temporary reduction in manufacturing output. Novo Nordisk has a value
`market share of 29.5% (MAT) in the global human growth disorder market.
`
`Rare disease, development per geographical area
`
`Rare disease, sales development
`
`Global
`North America Operations
` - The US
`International Operations
` - EMEA
` - Region China
` - Rest of World
`
` Sales H1 2023
`DKK million
`8,690
`3,422
`3,120
`5,268
`2,844
`383
`2,041
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` (18%)
` (18%)
` (19%)
` (17%)
` (18%)
` 35%
` (23%)
`
`North America Operations
`Rare disease sales in North America Operations decreased by 17% measured in Danish kroner and by 18% at CER. The
`sales decline was driven by lower sales of rare endocrine disorder products decreasing by 44% measured in Danish kroner
`and by 45% at CER reflecting a temporary reduction in manufacturing output and lower realised prices in the US. Sales of
`rare blood disorders products decreased by 3% measured in Danish kroner and by 4% at CER driven by lower sales of
`NovoSeven®, partially countered by sales of haemophilia A and B products.
`
`International Operations
`Rare disease sales in International Operations decreased by 18% measured in Danish kroner and by 17% at CER. The sales
`decline was driven by lower sales of rare endocrine disorder products decreasing by 47% in both Danish kroner and CER
`reflecting a temporary reduction in manufacturing output. Sales of rare blood disorder products increased by 1%
`measured in Danish kroner and by 2% at CER driven by haemophilia A and B products, partially countered by NovoSeven®.
`
`EMEA
`Rare disease sales decreased by 18% in both Danish kroner and CER driven by a decrease of rare endocrine disorder
`products by 71% measured in Danish kroner and by 72% at CER reflecting a temporary reduction in manufacturing output.
`Sales of rare blood disorder products increased by 12% measured in Danish kroner and by 13% at CER, primarily driven by
`NovoSeven® and haemophilia A products.
`
`Region China
`Rare disease sales increased by 29% measured in Danish kroner and by 35% at CER driven by sales of both rare blood
`disorder products, especially haemophilia A following the launch of NovoEight®, and rare endocrine disorder products.
`
`Rest of World
`Rare disease sales decreased by 23% in both Danish kroner and CER. The sales decline was driven by sales of rare blood
`disorder products. Sales of rare blood disorder products decreased by 21% in both Danish kroner and CER driven by
`NovoSeven® and haemophilia A products. Sales of rare endocrine disorder products decreased by 29% measured in
`Danish kroner and by 28% at CER reflecting a temporary reduction in manufacturing output.
`
`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 52 / 2023
`
`Novo Nordisk Exhibit 2515
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`
`
`Financial report for the period 1 January 2023 to 30 June 2023
`
`Page 10 of 32
`
`FINANCIALS
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 29% measured in Danish kroner and by 30% at CER to DKK 107,667 million in the first six months of
`2023. Wholesaler inventory movements in the US positively impacted sales growth. Sales growth has resulted in periodic
`supply constraints and related drug shortage notifications across a number of products and geographies. Sales in North
`America Operations increased by 45% measured in Danish kroner and by 44% at CER. Sales in International Operations
`increased by 14% measured in Danish kroner and by 17% at CER.
`
`Sales split per geographical area
`
` Sales H1 2023
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`North America Operations
` - The US
`International Operations
` - EMEA
` - Region China
` - Rest of World
`
`Total sales
`
`
`
`
`
`
`
`
`
`
`58,960
`54,531
`48,707
`25,598
`8,928
`14,181
`
`107,667
`
` 45%
` 44%
` 14%
` 18%
` 6%
` 14%
`
` 29%
`
` 44%
` 42%
` 17%
` 19%
` 12%
` 18%
`
` 30%
`
` 71%
` 63%
` 29%
` 16%
` 4%
` 9%
`
` 100%
`
`North America Operations
`Sales in North America Operations increased by 45% measured in Danish kroner and by 44% at CER. Wholesaler inventory
`movements in the US positively impacted sales growth. The sales increase reflects GLP-1 diabetes sales growing by 44% at
`CER and Obesity care sales growing by 207% at CER. This was partially offset by insulin sales decreasing by 25% at CER
`driven by lower realised prices due to channel and payer mix, rebate enhancements as well as a decline in volume. Rare
`disease sales decreased by 18% at CER reflecting a temporary reduction in manufacturing output.
`
`International Operations
`Sales in International Operations increased by 14% measured in Danish kroner and by 17% at CER. Sales growth was
`driven by GLP-1 sales growing by 62% at CER and Obesity care sales growing by 66% at CER, partially countered by insulin
`sales decreasing by 2% at CER and Rare disease sales decreasing by 17% at CER reflecting a temporary reduction in
`manufacturing output.
`
`EMEA
`Sales in EMEA increased by 18% measured in Danish kroner and by 19% at CER. Sales growth was driven by Diabetes care
`growing by 21% at CER driven by increased GLP-1 sales, partially countered by decreased insulin sales. Obesity care sales
`increased by 79% at CER and Rare disease sales decreased by 18% at CER.
`
`Region China
`Sales in Region China increased by 6% measured in Danish kroner and by 12% at CER. The sales increase at CER was driven
`by GLP-1 sales growing by 97% at CER, partially countered by insulin sales declining by 11% at CER. Insulin sales were
`negatively impacted by the implementation of Volume Based Procurement from May 2022. Other diabetes care sales
`decreased by 17% at CER. Rare disease sales increased by 35% at CER.
`
`Rest of World
`Sales in Rest of World incr