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`
`
`
`
`
`
`
`
`
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`4 May 2023
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`
`
`Novo Nordisk's sales increased by 27% in Danish kroner and by 25% at constant
`exchange rates to DKK 53.4 billion in the first three months of 2023
`
`
`
`
`
`
`
`
`
`
`
`
`
`• Operating profit increased by 31% in Danish kroner and by 28% at constant exchange rates (CER) to DKK 25.0 billion.
`• Sales in North America Operations increased by 47% in Danish kroner (41% at CER). Wholesaler inventory movements in
`the US positively impacted sales growth. Sales in International Operations increased by 9% in Danish kroner (10% at
`CER).
`
`• Sales within Diabetes and Obesity care increased by 33% in Danish kroner to DKK 48.8 billion (31% at CER), mainly
`driven by GLP-1 diabetes sales growth of 54% in Danish kroner (50% at CER). Rare disease sales decreased by 15%
`measured in Danish kroner (16% at CER) reflecting a temporary reduction in manufacturing output.
`
`• Obesity care sales grew by 131% in Danish Kroner to DKK 7.8 billion (124% at CER) mainly driven by the uptake of
`Wegovy® in the US. A second contract manufacturer for Wegovy® initiated production in April 2023.
`
`• Within R&D, Novo Nordisk successfully completed the PIONEER PLUS phase 3 trial with oral semaglutide 25 mg and 50
`mg demonstrating superior reductions in HbA1c and body weight versus 14 mg in people with type 2 diabetes.
`• On 13 April 2023, the 2023 outlook was raised with sales and operating profit growth at CER now expected to be
`24-30% and 28-34%, respectively. Sales and operating profit growth reported in Danish kroner are now expected to be
`6 and 9 percentage points lower than at CER, respectively. The ongoing share repurchase programme is expanded by
`DKK 2 billion to DKK 30 billion.
`
`PROFIT AND LOSS
`
`DKK million
`Net sales
`Operating profit
`
`Net profit
`Diluted earnings per share (in DKK)
`* CER: Constant exchange rates (average 2022).
`
`Q1 2023
`
`Q1 2022
`
`Growth
`as reported
`
`Growth
`at CER*
`
`
`
`
`
`
`
`53,367
`25,007
`
`19,814
`8.78
`
`42,031
`19,147
`
`14,210
`6.22
`
` 27%
` 31%
`
` 39%
` 41%
`
` 25%
` 28%
`
`N/A
`N/A
`
`Lars Fruergaard Jørgensen, president and CEO: "We are very pleased with the sales growth in the first three months of
`2023. The growth is driven by increasing demand for our GLP-1-based diabetes and obesity treatments, particularly in the
`US where the prescription trend for Wegovy® highlights the high unmet need for people living with obesity. The sales
`momentum and continued expansion of the supply capacity have enabled us to raise the outlook for the full year."
`
`On 4 May 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 30 / 2023
`
`Novo Nordisk Exhibit 2514
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`Page 2 of 29
`
`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 three months of 2023
`
`PERFORMANCE HIGHLIGHTS
`
`Purpose and sustainability (ESG)
`Progress towards zero environmental impact:
`–
`Carbon emissions from operations and transportation decreased by
`21% compared to first quarter of 2019 (increased by 5% compared to
`the first quarter of 2022)
`
`Adding value to society:
`–
`Medical treatment provided to 37.2 million people living with
`diabetes
`Reaching more than 42,000 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
`
`Commercial execution
`Strengthen diabetes leadership to more than one-third:
`–
`Diabetes value market share increased by 1.7 percentage points to
`32.2% (MAT)
`
`Financials
`Deliver solid sales and operating profit growth:
`–
`Sales growth at 25% (CER)
`–
`Operating profit growth of 28% (CER)
`
`–
`
`Human insulin with more flexible storage without refrigeration
`now approved in 11 countries
`
`Being recognised as a sustainable employer:
`–
`Share of women in senior leadership positions has increased to
`39% from 37% end of March 2022
`
`Strengthen and progress Rare disease pipeline:
`–
`Somapacitan approved in the US 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 124% (CER) to DKK 7.8 billion
`
`Secure a sustained growth outlook for Rare Disease:
`–
`Rare disease sales decreased by 16% at (CER) at DKK 4.6 billion
`
`Drive operational efficiencies:
`–
`Operational leverage reflecting sales growth
`
`Enable attractive capital allocation to shareholders:
`–
`Free cash flow of DKK 24.8 billion
`–
`DKK 23.5 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 30 / 2023
`
`Novo Nordisk Exhibit 2514
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`Page 3 of 29
`
`PERFORMANCE HIGHLIGHTS
`FINANCIAL HIGHLIGHTS FOR THE FIRST THREE 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
`
`Q1 2023
`
`Q1 2022
`
` 53,367
`
` 42,031
`
` 45,185
` 84.7%
`(12,412)
` 23.3%
`(6,728)
` 12.6%
`(1,071)
` 2.0%
`33
`
`
`
`
`
`
`
`
`
` 35,114
` 83.5%
`(10,183)
` 24.2%
`(5,206)
` 12.4%
`(970)
` 2.3%
`392
`
`
`
`
`
`
`
`
`
` 25,007
` 46.9%
`(270)
`
`
`
` 24,737
`(4,923)
`
` 19.9%
` 19,814
` 37.1%
`
`1,719
`
`4,693
`
` 29,814
` 26,726
` 24,764
` 2,256.6
`8.78
`
` 57,089
`
` 19,147
` 45.6%
`(1,228)
`
`
`
` 17,919
`(3,709)
`
` 20.7%
` 14,210
` 33.8%
`
`1,650
`
`1,520
`
` 23,586
` 20,797
` 21,568
` 2,283.3
`6.22
`
` 49,295
`
` % change
` Q1 2023 to
` Q1 2022
`
` % change
` Q1 2023 to
` Q1 2022 at
`CER
`
` 27%
`
` 29%
`
` 22%
`
` 29%
`
` 10%
`
` (92%)
`
` 31%
`
` 25%
`
` 26%
`
` 20%
`
` 28%
`
` 9%
`
` (92%)
`
` 28%
`
` (78%)
`
` N/A
`
` 38%
` 33%
`
` N/A
` N/A
`
` 39%
`
` N/A
`
` 4%
` 209%
` 26%
` 29%
` 15%
` (1%)
` 41%
` 16%
`
` N/A
` N/A
` N/A
` 26%
` N/A
` N/A
` N/A
` N/A
`
`These unaudited consolidated financial statements for the first three 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.
`
`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 30 / 2023
`
`Novo Nordisk Exhibit 2514
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`Page 4 of 29
`
`COMMERCIAL EXECUTION
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales grew by 27% measured in Danish kroner and by 25% at CER in the first three months of 2023, driven by Diabetes
`care sales growth of 21% (CER) and Obesity care sales growth of 124% (CER). Rare disease sales decreased by 16% (CER).
`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 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 Q1 2023
`DKK million
`
` Sales Q1 2022
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`22,455
`19,640
`2,815
`4,356
`26,811
`4,133
`2,776
`4,488
`2,012
`13,409
`729
`40,949
`4,563
`3,279
`7,842
`48,791
`
`3,049
`1,128
`399
`4,576
`
`15,357
`12,035
`3,322
`2,063
`17,420
`4,796
`3,012
`4,842
`2,312
`14,962
`884
`33,266
`1,404
`1,998
`3,402
`36,668
`
`3,077
`1,820
`466
`5,363
`
`53,367
`
`42,031
`
` 46%
` 63%
` (15%)
` 111%
` 54%
` (14%)
` (8%)
` (7%)
` (13%)
` (10%)
` (18%)
` 23%
` 225%
` 64%
` 131%
` 33%
`
` (1%)
` (38%)
` (14%)
` (15%)
`
` 27%
`
` 43%
` 59%
` (17%)
` 107%
` 50%
` (14%)
` (7%)
` (9%)
` (11%)
` (11%)
` (21%)
` 21%
` 211%
` 63%
` 124%
` 31%
`
` (3%)
` (38%)
` (12%)
` (16%)
`
` 25%
`
` 63%
` 68%
` (5%)
` 21%
` 84%
` (6%)
` (2%)
` (4%)
` (3%)
` (15%)
` (2%)
` 67%
` 29%
` 12%
` 41%
` 108%
`
` (1%)
` (7%)
` 0%
` (8%)
`
` 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®.
`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 30 / 2023
`
`Novo Nordisk Exhibit 2514
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`Page 5 of 29
`
`DIABETES AND OBESITY CARE
`Diabetes care, sales and market share development
`Sales in Diabetes care increased by 23% measured in Danish kroner and by 21% at CER to DKK 40,949 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 32.2% from 30.5% 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 February 2022
`and February 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 ***
`
`February
`2023
` 32.2%
` 33.9%
` 33.6%
` 26.6%
` 29.1%
` 32.0%
` 20.4%
`
`February
`2022
` 30.5%
` 32.3%
` 32.2%
` 25.4%
` 28.9%
` 33.2%
` 16.5%
`
` Sales Q1 2023
`DKK million
`40,949
`21,545
`19,838
`19,404
`10,050
`4,225
`5,129
`
`Growth
`at CER
` 21%
` 32%
` 29%
` 12%
` 19%
` (7%)
` 17%
`
`Source: IQVIA, February 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 54% measured in Danish
`kroner and by 50% at CER to DKK 26,811 million. The estimated global GLP-1 share of total diabetes prescriptions has
`increased to 4.9% compared with 3.4% 12 months ago. Novo Nordisk continues to be the global market leader in the
`GLP-1 segment with a 54.4% value market share, an increase of 0.8 percentage point 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
`North America Operations
` - The US
`International Operations
` - EMEA *
` - Region China **
` - Rest of World ***
`
`February
`2023
` 54.4%
` 53.0%
` 52.1%
` 65.2%
` 61.1%
` 66.9%
` 75.6%
`
`February
`2022
` 53.6%
` 52.6%
` 51.8%
` 60.1%
` 58.9%
` 66.7%
` 61.8%
`
` Sales Q1 2023
`DKK million
`26,811
`17,978
`16,536
`8,833
`5,048
`1,349
`2,436
`
`Growth
`at CER
` 50%
` 50%
` 45%
` 52%
` 57%
` 56%
` 40%
`
`Source: IQVIA, February 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 111% measured in Danish kroner and by 107% at CER to DKK 4,356 million. Sales growth was
`driven by North America Operations as well as EMEA and Rest of World.
`
`Ozempic® sales increased by 63% measured in Danish kroner and by 59% at CER to DKK 19,640 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 30 / 2023
`
`Novo Nordisk Exhibit 2514
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`Page 6 of 29
`
`Victoza® sales decreased by 15% measured in Danish kroner and by 17% at CER to DKK 2,815 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 56% measured in Danish kroner and by 50%
`at CER. Wholesaler inventory movements in the US positively impacted sales growth. Novo Nordisk is the market leader
`with a 53.0% value market share compared to 52.6% 12 months ago. The estimated GLP-1 share of total diabetes
`prescriptions has increased to 12.0% compared with 8.4% 12 months ago.
`
`Sales of GLP-1 in the US increased by 45% 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 of around 60% in the first quarter of
`2023 compared to the first quarter of 2022 as well as market share gains for Ozempic® and Rybelsus®. The combined
`Novo Nordisk GLP-1 new-to-brand prescription market share is now 63.4% driven by Ozempic® with 52.8% and Rybelsus®
`with 7.6%. Novo Nordisk is the market leader with 52.9% measured by total monthly prescriptions for the combined GLP-1
`portfolio.
`
`International Operations
`Sales of GLP-1 diabetes products in International Operations increased by 50% measured in Danish kroner and by 52% at
`CER. Sales growth is driven by all geographical areas. The estimated GLP-1 share of total diabetes prescriptions has
`increased to 3.2% compared with 2.3% 12 months ago. Novo Nordisk is the market leader with a value market share of
`65.2%.
`
`EMEA
`Sales in EMEA increased by 55% measured in Danish kroner and by 57% 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 61.1%. The estimated GLP-1 share of total diabetes prescriptions has increased to 4.5% compared
`with 3.3% 12 months ago.
`
`Region China
`Sales in Region China increased by 52% measured in Danish kroner and by 56% at CER. The sales growth reflects the
`uptake of Ozempic®. The GLP-1 share of total diabetes prescriptions has increased to 2.7% compared with 1.4% 12 months
`ago.
`
`Rest of World
`Sales in Rest of World increased by 40% in both Danish kroner and 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
`75.6%. The estimated GLP-1 share of total diabetes prescriptions has increased to 1.9% compared with 1.3% 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 30 / 2023
`
`Novo Nordisk Exhibit 2514
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`Page 7 of 29
`
`Insulin
`Sales of insulin decreased by 10% measured in Danish kroner and by 11% at CER to DKK 13,409 million. Sales decline at
`CER was driven by declining sales in Region China, the US 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 ***
`
`February
`2023
` 46.3%
` 38.1%
` 37.7%
` 49.2%
` 47.4%
` 46.0%
` 57.5%
`
`February
`2022
` 47.1%
` 38.6%
` 38.1%
` 50.1%
` 47.5%
` 50.6%
` 57.1%
`
` Sales Q1 2023
`DKK million
`13,409
`3,406
`3,155
`10,003
`4,837
`2,587
`2,579
`
`Growth
`at CER
` (11%)
` (18%)
` (18%)
` (8%)
` (5%)
` (22%)
` 4%
`
`Source: IQVIA, February 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 14% measured in Danish kroner and by 18% 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 three months of 2022. Novo
`Nordisk has a volume market share of 37.7% of the total US insulin market.
`
`International Operations
`Sales of insulin in International Operations decreased by 9% measured in Danish kroner and by 8% 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 3% measured in Danish kroner and by 5% at CER. The sales decline at CER was
`mainly driven by short-acting and long-acting insulin, partially countered by pre-mix insulin. Novo Nordisk has a volume
`market share of 47.4% of the total insulin market.
`
`Region China
`Sales of insulin in Region China decreased by 25% measured in Danish kroner and by 22% 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 Xulthopy®. Novo Nordisk has a volume market share of 46.0% of the total insulin market.
`
`Rest of World
`Sales of insulin in Rest of World remained unchanged in Danish kroner and increased by 4% at CER. The sales growth at
`CER was driven by long-acting insulin and human insulin, partially countered by fast-acting insulin and premix insulin.
`Novo Nordisk has a volume market share of 57.5% 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 30 / 2023
`
`Novo Nordisk Exhibit 2514
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`Page 8 of 29
`
`Obesity care, sales development
`Sales of Obesity care products, Wegovy® and Saxenda®, increased by 131% measured in Danish kroner and by 124% at
`CER to DKK 7,842 million. Sales growth was driven by both North America Operations and International Operations.
`Wegovy® has been launched in the US, Denmark and Norway. A second contract manufacturer for Wegovy® has initiated
`production. The volume growth of the global branded obesity market was 53.8%.
`
`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
`
`February
`2023
` 53.8%
` 43.1%
` 47.1%
` 65.4%
` 100.6%
`N/A
` 33.6%
`
` Sales Q1 2023
`DKK million
`7,842
`5,911
`5,789
`1,931
`1,216
`53
`662
`
`Growth
`at CER
` 124%
` 156%
` 162%
` 65%
` 71%
` 46%
` 57%
`
`Source: IQVIA, February 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 225% measured in Danish kroner and by 211% at CER to DKK 4,563 million. Sales of Saxenda®
`increased by 64% measured in Danish kroner and by 63% at CER to DKK 3,279 million.
`
`North America Operations
`Sales of Obesity care products in North America Operations increased by 168% measured in Danish kroner and by 156% at
`CER to DKK 5,911 million. Sales of Wegovy® increased by 215% measured in Danish kroner and by 201% at CER to DKK
`4,425 million reflecting the commercial relaunch in January 2023. Broad commercial formulary access has been achieved.
`Sales of Saxenda® increased by 85% measured in Danish kroner and by 77% at CER to DKK 1,486 million. The volume
`growth of the branded obesity market in the US was 47.1%.
`
`International Operations
`Sales of Obesity care products in International Operations increased by 62% measured in Danish kroner and by 65% at
`CER to DKK 1,931 million driven by increased sales in EMEA and Rest of World. Sales of Saxenda® in International
`Operations increased by 50% measured in Danish kroner and by 53% at CER to DKK 1,793 million and sales of Wegovy®
`reached DKK 138 million. Wegovy® has been launched in two countries in International Operations. The volume growth of
`the branded obesity market in International Operations was 65.4%.
`
`EMEA
`Sales of Obesity care products in EMEA increased by 67% measured in Danish kroner and by 71% at CER. Wegovy® has
`been launched in Denmark and Norway. The volume growth of the branded obesity market in EMEA was 100.6%.
`
`Rest of World
`Sales of Saxenda® in Rest of World increased by 54% measured in Danish kroner and by 57% at CER. The volume growth of
`the branded obesity market in Rest of World was 33.6%.
`
`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 30 / 2023
`
`Novo Nordisk Exhibit 2514
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`Page 9 of 29
`
`Rare disease, sales development
`Rare disease sales decreased by 15% measured in Danish kroner and by 16% at CER to DKK 4,576 million. Sales of Rare
`blood disorder products decreased by 1% measured in Danish kroner and by 3% at CER to DKK 3,049 million driven by
`NovoSeven®, partially offset by the launch products in haemophilia A and B. Sales of Rare endocrine disorders products
`decreased by 38% in both Danish kroner and CER to DKK 1,128 million reflecting a temporary reduction in manufacturing
`output. Novo Nordisk has a value market share of 33.0% 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 Q1 2023
`DKK million
`4,576
`1,841
`1,695
`2,735
`1,476
`183
`1,076
`
`
`
`
`
`
`
`
`
`Growth
`at CER
` (16%)
` (14%)
` (15%)
` (17%)
` (12%)
` 27%
` (27%)
`
`North America Operations
`Rare disease sales in North America Operations decreased by 10% measured in Danish kroner and by 14% at CER. The
`sales decline was driven by lower sales of Rare endocrine disorders products decreasing by 30% measured in Danish
`kroner and by 33% at CER reflecting a temporary reduction in manufacturing output and lower realised prices in the US.
`Sales of Rare blood disorders products increased by 1% measured in Danish kroner and decreased by 3% 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 disorders products decreasing by 42% measured in Danish kroner and
`by 41% at CER reflecting a temporary reduction in manufacturing output. Sales of Rare blood disorders products
`decreased by 2% in both Danish kroner and CER driven by lower sales of NovoSeven®, partially countered by growth of
`haemophilia A and B products.
`
`EMEA
`Rare disease sales decreased by 12% in both Danish kroner and CER driven by a decrease of Rare endocrine disorders
`products by 69% measured in Danish kroner and by 71% at CER reflecting a temporary reduction in manufacturing output.
`Sales of Rare blood disorder products increased by 24% in both Danish kroner and at CER, primarily driven by NovoSeven®
`and haemophilia A products.
`
`Region China
`Rare disease sales increased by 24% measured in Danish kroner and by 27% at CER driven by sales of both Rare blood
`disorder, especially haemophilia A following the launch of NovoEight®, and Rare endocrine disorders products.
`
`Rest of World
`Rare disease sales decreased by 28% measured in Danish kroner and by 27% at CER. The sales decline was driven by both
`sales of Rare blood disorder and Rare endocrine disorders products. Sales of Rare blood disorder products decreased by
`34% measured in Danish kroner and by 35% at CER driven by NovoSeven® and haemophilia A products. Sales of Rare
`endocrine disorders products decreased by 22% measured in Danish kroner and by 19% 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 30 / 2023
`
`Novo Nordisk Exhibit 2514
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`
`
`Financial report for the period 1 January 2023 to 31 March 2023
`
`Page 10 of 29
`
`FINANCIALS
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 27% measured in Danish kroner and by 25% at CER to DKK 53,367 million in the first three 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 47% measured in Danish kroner and by 41% at CER. Sales in International Operations
`increased by 9% measured in Danish kroner and by 10% at CER.
`
`Sales split per geographical area
`
` Sales Q1 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
`
`
`
`
`
`
`
`
`
`
`29,297
`27,322
`24,070
`12,742
`4,461
`6,867
`
`53,367
`
` 47%
` 46%
` 9%
` 18%
` (8%)
` 8%
`
` 27%
`
` 41%
` 39%
` 10%
` 18%
` (5%)
` 9%
`
` 25%
`
` 78%
` 71%
` 22%
` 18%
` (2%)
` 6%
`
` 100%
`
`North America Operations
`Sales in North America Operations increased by 47% measured in Danish kroner and by 41% at CER. Wholesaler inventory
`movements in the US positively impacted sales growth. The sales increase reflects GLP-1 diabetes sales growing by 50% at
`CER and Obesity care sales growing by 156% at CER. This was partially offset by insulin sales decreasing by 18% 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 14% at CER reflecting a temporary reduction in manufacturing output.
`
`International Operations
`Sales in International Operations increased by 9% measured in Danish kroner and by 10% at CER. Sales growth was driven
`by GLP-1 sales growing by 52% at CER and Obesity care sales growing by 65% at CER, partially countered by insulin sales
`decreasing by 8% 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% in both Danish kroner and at CER. Sales growth was driven by Diabetes care growing by
`19% at CER driven by increased GLP-1 sales, partially countered by decreased insulin sales. Obesity care sales increased by
`71% at CER and Rare disease sales decreased by 12% at CER.
`
`Region China
`Sales in Region China decreased by 8% measured in Danish kroner and by 5% at CER. The sales decline at CER was driven
`by insulin sales declining by 22% at CER. Insulin sales were negatively impacted by the implementation of Volume Based
`Procurement from May 2022. GLP-1 sales were growing by 56% at CER and Other diabetes care sales decreased by 13% at
`CER. Rare disease sales increased by 27% at CER.
`
`Rest of World
`Sales in Rest of World increased by 8% measured in Danish kroner and by 9% at CER. Sales growth was driven by Diabetes
`care growing by 17% at CER, reflecting increased GLP-1 and insulin sales, Obesity care sales growing by 57% at CER and
`Rare disease decreasing by 27% at CER