throbber
company
`announcement
`
`~ novo nordisk"'
`
`Financia l report for the period 1 January 2021 to 31 March 2021
`
`5 May 2021
`
`Novo Nordisk's net profit increased by 6% in the first three months of 2021
`
`Operating profit decreased by 8% in Dan ish kroner and increased by 3% at constant exchange rates (CER).
`
`Sales remained unchanged in Dan ish kroner and increased by 7% at CER to DKK 33.8 billion. Sales in International
`Operations increased by 2% in Danish kroner (9% at CER), and sales in North America Operations decreased by 3% in
`Danish kroner (increased 6% at CER). Sales growth is negatively impacted by COVJD-19-related stocking in 2020, partially
`offset by inventory changes and timing of shipments in 2021 .
`
`Sales within Diabetes and Obesity care increased by 1 % in Danish kroner to DKK 28.8 bi ll ion (9% at CER), driven by GLP-1
`growth of 13% in Danish kroner (23% at CER) reflecting the uptake of Ozempic® and Rybelsus®. Biopharm sa les
`decreased by 6% in Danish kroner (increased by 1 % at CER).
`
`Within R&D, Novo Nordisk decided to initiate phase 3a development with 50 mg oral semaglutide in obesity. Fol lowing
`the Refusal to File letter in the US covering the label expansion application for once-weekly semaglutide 2.0 mg for the
`treatment of type 2 diabetes, Novo Nordisk is working towards resubmission in the second quarter of 2021 .
`
`For the 2021 outlook, sales growth is now expected to be 6-10% at CER, and operating profit growth is now expected to
`be 5-9% at CER. The ongoing share buyback programme will be expanded to DKK 18 bill ion.
`
`PROFIT AND LOSS
`
`DKK million
`Net sales
`
`Operating profit
`
`Net profit
`
`Diluted earnings per share (in DKK)
`
`* CER: Constant exchange rates (average 2020).
`
`- - - -
`
`Q1 2021
`
`Q1 2020
`
`Growth
`as reported
`
`Growth
`at CER*
`
`33,804
`
`14,982
`
`12,623
`
`5.4S
`
`33,875
`
`16,302
`
`11 ,897
`
`5.05
`
`0%
`
`(8%)
`
`6%
`
`8%
`
`7%
`
`3%
`
`N/A
`
`N/A
`
`Lars Fruergaard J0rgensen, presi dent and CEO: "We are very encouraged with the sa les growth in the first three months of
`2021 . Sales growth was driven by all thera py areas and across geograph ical areas within International Operations as well
`as North America Operations where growth has accelerated in the US. We were also pleased to announce plans to develop
`ora l semaglutide as a convenient and effective treatment option for people with obesity, complementing our injectable
`obesity medications. The solid fi nancia l performance in the first three months of 202 1 has enabled us to raise our outlook
`range for the ful l year."
`
`On 5 May 2021 at 13.00 CEST, corresponding to 7.00 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/5
`Investor Relations
`
`Novo Alie
`2880 Bagsv~rd
`Denmark
`
`Telephone:
`+45 4444 8888
`www.novonordisk.com
`
`CVR Number:
`24 25 67 90
`
`Company announcement No 30 I 2021
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report fo r the period 1 January 2021 to 31 March 2021
`
`Page 2 of 26
`
`STRATEGIC ASPIRATIONS
`
`STRATEGIC ASPIRATIONS 2025
`
`The strateg ic 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 2021:
`
`Purpose and sustainability
`Adding value to society:
`Progress on 'Defeat Diabetes' strategy:
`Collaboration with the University ofToronto focusing on
`prevention
`Initiation of 'Diabetes Compass' by the World Diabetes
`Foundation to improve access to diabetes care in low(cid:173)
`and middle-income countries
`
`Progress towards zero environmental impact:
`Progress on supplier target aiming at 100% renewable
`power across all suppliers by 2030 with around 15%
`reduction in supplier CO2 emissions
`48% reduction in CO2 emissions compared to the first three
`months 2019
`
`Innovation and therapeutic focus
`Further raise innovation bar for diabetes treatment:
`Ozempic® approved in China for the treatment of type 2
`diabetes
`Refusal to File letter received for semaglutide 2.0 mg
`
`Develop superior treatment solutions for obesity:
`Phase 3a clinical trial initiated with once-weekly semaglutide
`2.4 mg in people with heart failure with preserved ejection
`fraction (HFpEF)
`Decision to initiate phase 3a development with 50 mg oral
`semaglutide in obesity
`
`Strengthen and progress Biopharm pipeline:
`• SogroyaG!> approved in the EU for adults with growth
`hormone deficiency
`
`Establish presence in Other serious chronic diseases:
`Phase 3a development initiated with once-weekly
`semaglutide 2.4 mg for treatment of NASH
`Gilead Sciences and Novo Nordisk expanded NASH clinical
`collaboration
`
`Commercial execution
`
`Financials
`
`Strengthen diabetes leadership:
`Diabetes value market share increased by 0.6 percentage
`point to 29.3% (MAT)
`
`Strengthen obesity leadership and double sales:
`• Obesity care sales increased by 9% (CER) to DKK 1.6 billion
`
`Secure a sustained growth outlook for Biopharm:
`Biopharm sales increased by 1 % (CER)
`
`Deliver solid sales and operating profit growth:
`Sales growth at 7% (CER)
`International Operations sales growth at 9% (CER)
`In the US, sales grew 5% and 52% of sales came from
`products launched since 2015
`Operating profit growth of 3% (CER)
`
`Drive operational efficiencies:
`Gross margin positively impacted by productivity gains in
`Product Supply
`
`Enable attractive capital allocation to shareholders:
`Free cash flow of DKK 9.5 billion and DKK 16.5 billion
`returned to shareholders
`
`Strategic
`aspirations
`
`Financial
`Statement
`
`Commercial
`execution
`
`Financials I Cash flow and I
`
`capital allocation
`
`Purpose and I
`Outlook I Innovation and I
`
`therapeutic focus
`
`sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2021
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2021 to 31 March 2021
`
`Page 3 of 26
`
`FINANCIAL STATEMENT
`CONSOLIDATED FINANCIAL STATEMENT FOR THE FIRST THREE MONTHS OF 2021
`
`PROFIT AND LOSS
`
`(Amounts are in DKK million, except for earnings per share, d1v1dend per share and employees)
`
`Q1 2021
`
`Q1 2020
`
`% change Q1
`2021 to Q1 2020
`
`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
`
`33,804
`
`27,993
`82.896
`
`8,256
`24.4%
`
`3,944
`11 .7%
`
`932
`2.8%
`
`121
`
`14,982
`44.396
`
`956
`
`15,938
`
`3,315
`20.8%
`
`12,623
`37.3%
`
`1,377
`1.402
`11,255
`9,532
`
`141,387
`58,496
`41.4%
`
`2,315.6
`
`5.45
`
`45,157
`
`33,875
`
`28,489
`84.196
`
`7,590
`22.4%
`
`3,777
`11.1%
`
`927
`2.7%
`
`107
`
`16,302
`48.196
`
`{1,281)
`
`15,021
`
`3,124
`20.8%
`
`11,897
`35.1%
`
`1,086
`1,667
`10,012
`7,669
`
`126,256
`54,399
`43.1%
`
`2,354.8
`
`5.05
`
`43,158
`
`0%
`
`(2%)
`
`9%
`
`4%
`
`1%
`
`13%
`
`(8%)
`
`(175%)
`
`6%
`
`6%
`
`6%
`
`27%
`{16%)
`12%
`24%
`
`12%
`8%
`
`(2%)
`
`8%
`
`5%
`
`These unaudited consolidated financial statements for the first three months of 2021 have been prepared in accordance
`with !AS 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
`
`Financial
`Statement
`
`Commercial
`execution
`
`Finanoals I Cash now and I
`
`capital allocation
`
`Outlook I Innovation and I
`Purpose and I
`
`therapeutic focus
`
`sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2021
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for t he period 1 Janua ry 202 1 to 31 March 2021
`
`Page 4 of 26
`
`COMMERCIAL EXECUTION
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`
`Sales remained unchanged measured in Danish kroner and grew by 7% at CER the first three months of 2021 , driven by
`growth across all therapy areas with Diabetes care sales growth of 9% (CER}, Obesity care sales growth of 9% (CER) and
`Biopharm sales growth of 1 % (CER). Sales growth is negatively impacted by COVID-19-related stocking in the first three
`months of 2020, partially offset by inventory changes and tim ing of shipments in 2021 .
`
`Sales split per therapy
`
`Diabetes and Obesity ca re segment
`
`Sales Q1 2021
`DKKm illion
`
`Sales Q1 2020
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`Rybelsus®
`Ozempic®
`Victoza®
`Total GLP-1
`
`Long-acting insulin
`Tresiba®
`- Xultaphy®
`- Levemir®
`
`Prem ix insulin
`- Ryzodeg®
`- NovoMix®
`
`Fast-acti ng insulin
`- Fiasp®
`- NovoRapid®
`
`Human insul in
`
`Total insulin
`
`Other Di abetes ca re'
`
`Total Diabetes ca re
`
`Obesity ca re (Sa xenda®)
`
`Diabetes and Obesity care total
`
`Biopharm segment
`Rare blood disorders2
`- Haemophilia A
`- Haemophilia B
`- NovoSeven®
`Ra re endocri ne disord ers3
`Other Bi opharm 4
`Biopharm total
`
`729
`6,662
`3,909
`11,300
`
`4,822
`2,365
`681
`1,776
`
`2,953
`420
`2,533
`
`4,556
`402
`4,154
`
`2,535
`
`14,866
`
`1,110
`
`27,276
`
`1,551
`
`28,827
`
`2,678
`497
`147
`1,980
`1,920
`379
`4,977
`
`229
`4,755
`4,991
`9,975
`
`5,158
`2,460
`662
`2,036
`
`2,955
`337
`2,618
`
`5,1 14
`390
`4,724
`
`2,687
`
`15,914
`
`1,1 25
`
`27,014
`
`1,577
`
`28,591
`
`2,8 10
`452
`130
`2, 181
`2,031
`443
`5,284
`
`Total sales
`
`33,804
`
`33,875
`
`11 Pnmarily NovoNorm.,, needles and GlucaGene HypoKite_
`21 Comprises NovoSeven•, NovoE1ght*, Esperoct•, Reftxia131 and Nov0Th1rteeni»
`3
`> Pnmarily Norditropin•.
`"' Pnmarily Vagifemc, and Acttvellee.
`
`21 8%
`40%
`(22%)
`13%
`
`(7%)
`(4%)
`3%
`(13%)
`
`0%
`25%
`(3%)
`
`(1 1%)
`3%
`(12%)
`
`(6%)
`
`(7%)
`
`(1%)
`
`1%
`
`(2%)
`
`1%
`
`(5%)
`10%
`13%
`(9%)
`(5%)
`(1 4%)
`(6%)
`
`0%
`
`247%
`52%
`(16%)
`23%
`
`0%
`3%
`8%
`(696)
`
`6%
`34%
`296
`
`(4%)
`996
`(5%)
`
`2%
`
`0%
`
`4%
`
`9%
`
`9%
`
`9%
`
`2%
`1696
`18%
`(2%)
`2%
`(12%)
`1%
`
`7%
`
`22%
`99%
`(31 %)
`90%
`
`0%
`3%
`2%
`(5%)
`
`7%
`5%
`2%
`
`(9%)
`196
`(1096)
`
`3%
`
`1%
`
`1%
`
`92%
`
`6%
`
`98%
`
`3%
`396
`1%
`(2%)
`1%
`(2%)
`2%
`
`100%
`
`Strategic
`aspirations
`
`Financial
`Statement
`
`Com mercial
`execution
`
`Financials I Cash flow and I
`
`capital allocation
`
`Out look
`
`Purpose and I
`I Innovation and I
`
`therapeutic focus
`
`sustainability
`
`Legal
`
`Financial
`Information
`
`Company an nouncement No 30 / 2021
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financia l report for the period 1 January 2021 to 31 March 2021
`
`Page 5 of 26
`
`DIABETES AND OBESITY CARE
`
`Diabetes care, sales and market share development
`
`Sales in Diabetes care increased by 1 % measu red in Danish kroner and by 9% at CER to DKK 27,276 million driven by GLP-1
`growth. Novo Nordisk has improved the global diabetes value market share over the last 12 months from 28.8% to 29.3%
`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 (MAD from February 2021
`and February 2020 provided by the independent data provider IQVIA. EMEA covers Europe, the Middle East and Africa,
`Region China covers mainland China, Hong Kong and Ta iwan, and Rest of World covers all other countries except for North
`America .
`
`Diabetes care, development per geographical area
`
`February
`2021
`
`Novo Nord is k's share of the total
`diabetes market (value, MAn
`Diabetes care, sales development
`- - - - - -
`February
`2020
`
`Sales Q1 2021
`DKKmillion
`
`Growth
`at CER
`
`Global
`International Operations
`- EMEA *
`- Region China **
`- Rest of World ***
`North Ame rica Operation s
`- The US
`
`29.3%
`23.6%
`27.9%
`31.5%
`13.7%
`31.5%
`31.5%
`
`28.8%
`22.2%
`27.0%
`27.3%
`13.1%
`31 .2%
`31.4%
`- - -
`
`27,276
`14,898
`7,270
`4,270
`3,3S8
`12,378
`11,702
`
`9%
`10%
`2%
`21%
`18%
`7%
`6%
`- - - - - -
`
`Source: IQVIA February 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 Chma, excluding Hong Kong and Taiwan. ~* Data for Rest of World available for seven markets representing approximately 70% oftotal Novo
`Nordisl<s Diabetes care sales 1n the area
`
`GLP-1 therapy for type 2 diabetes
`
`Sales of GLP-1 products for type 2 diabetes (Rybelsus®, Ozempic® and Victoza®) increased by 13% measured in Danish
`kroner and by 23% at CER to DKK 11,300 mill ion. The GLP-1 segment's value share of the tota l diabetes market has
`increased to 22.8% compared with 18.9% 12 months ago. Novo Nordisk continues to be the global market leader in the
`GLP-1 segment with a 50.8% value market share, an increase of 2.5 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 Ame ri ca Operations
`- The US
`
`February
`2021
`
`February
`2020
`
`Sa les Q1 2021
`DKKmill ion
`
`50.8%
`54.8%
`56.0%
`88.6%
`45.3%
`50.2%
`49.5%
`
`48.3%
`51 .2%
`530%
`93.3%
`40.2%
`47.8%
`47.3%
`
`11,300
`3,537
`2,320
`403
`814
`7,763
`7,372
`
`Growth
`at CER
`
`23%
`31%
`18%
`86%
`54%
`19%
`18%
`- - - - -
`
`Source: IQVIA. February 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 . H* Data for Rest of World available for seven markets representing approximately 70% of total Novo Nordisk
`Diabetes care sales 1n the area
`
`Rybelsus® sales increased by 218% measured in Danish kroner and by 247% at CER to DKK 729 million. Sales growth was
`driven by North America Operations as well as EMEA and Rest of World . Rybelsus® has now been launched in 15 countries.
`
`Ozempic® sales increased by 40% measured in Danish kroner and by 52% at CER to DKK 6,662 million. Sales growth was
`driven by North America Operations and International Operations. Ozempic® has now been launched in 58 countries.
`Inventory changes in the US positively impacted sales growth.
`
`Strateg,c
`aspirations
`
`Financial
`Statement
`
`Commercial
`execution
`
`Financials I Cash now and I
`
`capital allocation
`
`Outlook I Innovation and I
`Purpose and I
`
`therapeutic focus
`
`sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2021
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2021 to 31 March 2021
`
`Page 6 of 26
`
`Victoza® sales decreased by 22% measured in Danish kroner and by 16% at CER to DKK 3,909 million. The sales decline
`was driven by North America Operations, EMEA and Rest of World, partially offset by higher sales in Reg ion China .
`
`International Operations
`
`Sales of GLP-1 diabetes products in International Operations increased by 25% measured in Danish kroner and by 31 % at
`CER. Sa les growth is driven by all geographical areas. The value share of the GLP-1 class of the total diabetes market has
`increased to 11.2% from 9.4% 12 months ago. Novo Nordisk is the market leader with a value market share of 54.8%.
`
`EMEA
`
`Sales in EMEA increased by 16% measured in Danish kroner and by 18% at CER. The sales growth reflects the uptake of
`Ozempic®, partially offset by lower sales of Victoza®. Rybelsus® has now been launched in 14 coun tries in EMEA. Novo
`Nordisk remains the market leader in EMEA with a value market share of 56.0%.
`
`Region China
`Sales in Region China increased by 82% measured in Danish kroner and by 86% at CER. The sales growth reflects the
`upt ake of Victoza® in main land Ch ina and the launch of Ozempic® in Taiwan®. The GLP-1 class' sha re of the overall diabetes
`market value in Region China increased to 3.4% from 2.2% 12 months ago with a Victoza® market share of 88.6%.
`
`Rest of World
`Sales in Rest of World increased by 33% measured in Danish kroner and by 54% at CER. The sales growth reflects
`increased sales of Ozempic® and the launch of Rybelsus in Japan®, partially offset by lower sales of Victoza®. Novo Nordisk
`remains the market leader with a va lue market share of 45 .3%.
`
`North America Operations
`
`Sales of GLP-1 diabetes products in North America Operations increased by 9% measured in Danish kroner and by 19% at
`CER. Novo Nordisk is the market leader with a 50.2% value market share compared to 47.8% 12 mont hs ago. The value
`market share of the GLP-1 class of the total North American diabetes market has increased to 27.3% compared to 22.8%
`12 months ago.
`
`Sales growth in the US is driven by a prescription volume growth of the GLP-1 class of around 20% in the quarter.
`Rybelsus® weekly new-to-brand market share is 12.5%. The combined Novo Nordisk GLP-1 new-to-brand prescription
`market share is now 58.0%. Novo Nordisk is the market leader measured on total monthly prescriptions for the combined
`GLP-1 portfolio.
`
`Sales of GLP-1 in the US increased by 18% at CER. The sales increase was driven by continued uptake of Ozempic® and
`Rybelsus®, partially offset by decl inin g Victoza® sales. GLP-1 sales growth was negatively impacted by rebate
`enhancements as well as unfavourable channel and payer mix, partially countered by inventory changes.
`
`Strategic
`aspirations
`
`Financial
`Statement
`
`Com mercial
`execution
`
`Financials I Cash flow and I
`
`capital allocation
`
`Outlook I Innovation and I
`Purpose and I
`
`therapeutic focus
`
`sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2021
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2021 to 31 March 2021
`
`Page 7 of 26
`
`Insulin
`Sales of insulin decreased by 7% measured in Dan ish kroner, and remained unchanged at CER to DKK 14,866 million. The
`unchanged sales at CER were driven by declini ng sales in t he US, offset by increased sa les in International Operations.
`
`I nsulin, development per geographical area
`
`Novo Nordisk's share of the total
`insulin market (volume, MAD
`
`Insulin, sales development
`
`- - - -
`Global
`International Operations
`• EMEA *
`• Reg ion China **
`• Rest of World ***
`North America Operations
`• The US
`
`February
`2021
`
`February
`2020
`
`Sales Q1 2021
`DKKmillion
`
`Growth
`at CER
`
`47.3%
`50.2%
`47.5%
`50.7%
`57.4%
`39.3%
`39.1%
`
`46.7%
`49.4%
`46.6%
`50.5%
`56.6%
`39.7%
`39.7%
`
`14,866
`10,520
`4,775
`3,322
`2,423
`4,346
`4,097
`
`0%
`5%
`(4%)
`16%
`12%
`(10%)
`(1 0%)
`
`Source. IQVIA February 2021 data. *Data for EMEA avadable for European markets and seven markets outside Europe representing approximately 90% of Novo Nordisk msuhn sales in
`the area. **Data for mainland China, exdudmg Hong Kong and Taiwan. * ** Data for Rest of World available for seven markets representing approximately 70% of total Novo Nord1sk's
`Diabetes care sales in the area.
`
`International Operations
`
`Sa les of insulin in International Operations decreased by 1 % measured in Danish kroner and increased by 5% at CER. Sales
`growth at CER was driven by long-acting and prem ix insu lin.
`
`EMEA
`Sales of insulin in EMEA decreased by 9% measured in Dani sh kroner and by 4% at CER. The sales decline was driven by
`fast-acting insulin, human insu lin and premix insulin, partially offset by long-acting insulin.
`
`Region China
`Sales of insulin in Region China increased by 13% measured in Dan ish kroner and by 16% at CER. The sa les growth was
`driven by all insul in products except for human insu lin.
`
`Rest of World
`Sales of insulin in Rest of World remained unchanged in Danish kroner and increased by 12% at CER. The sales growth was
`driven by human insulin, long-acting and fast-acting insulin.
`
`North America Operations
`
`Sales of insulin in North America Operations decreased by 18% measured in Danish kroner and by 1 0% at CER. The sales
`decrease in the US was driven by a decline in volume and rebate enhancements, partially offset by channel mix. Novo
`Nordisk has a volume market share of 39.1 % of the total insulin market.
`
`Strategic
`aspirations
`
`Financial
`Statement
`
`Commercial
`execution
`
`Financials I Cash flow and I
`
`capital allocation
`
`Purpose and I
`Outlook I Innovation and I
`
`therapeutic focus
`
`sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2021
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financia l report for the period 1 January 2021 to 31 March 2021
`
`Page 8 of 26
`
`Obesity care, sales development
`
`Sales of Saxenda® decreased by 2% measured in Danish kroner and increased by 9% at CER to DKK 1,551 million.
`Saxenda® sa les growth at CER was driven by International Operations and North America Operations. Saxenda® has now
`been launched in 58 countries. Novo Nordisk currently has a va lue market share of 66.1 % of the globa l 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 mi ll ion by 2025.
`
`Obesity care, development per geographical area
`
`Global
`International Operations
`- EMEA
`- Region Ch ina
`- Rest of World
`North America Operations
`- The US
`
`International Operations
`
`Obesity care, sales development
`
`Sales Q1 2021
`DKK million
`
`Growth
`at CER
`
`1,551
`715
`371
`7
`337
`836
`759
`
`9%
`18%
`18%
`
`17%
`2%
`0%
`
`Sales of Saxenda® in International Operations increased by 5% measured in Danish kroner and by 18% at CER, driven by
`increased sales in EMEA and Rest of World . Novo Nordisk currently has a va lue ma rket share of 41 .4% in the obesity
`prescription drug market.
`
`EMEA
`
`Sa les of Saxenda® in EMEA increased by 10% measured in Danish kroner and by 18% at CER. Novo Nordisk currently has a
`value market share of 67.0% in the obesity prescription drug market.
`
`Rest of World
`
`Sales of Saxenda® in Rest of World decreased by 1 % measured in Dan ish kroner and increased by 17% at CER. Saxenda®
`has been launched in 19 countries in Rest of World. Novo Nordisk currently has a va lue market share of 32.2% in the
`obesity prescription drug market.
`
`North America Operations
`
`Sales of Saxenda® in North America Operations decreased by 7% measured in Danish kroner and increased by 2% at CER.
`Saxenda® continues to grow in volume and Novo Nordisk now has a va lue market share of 82 .2% in the obesity
`prescri ption drug market in North America . Sa les were negatively impacted by unfavourable channel mix development.
`
`St rate gic
`aspirations
`
`Financial
`Statement
`
`Commercial
`execution
`
`Financials I Cash flow and I
`
`capital allocation
`
`Outlook I Innovation and I
`Purpose and I
`
`thera peutic focus
`
`sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcem ent No 30 / 202 1
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financia l report for the period 1 January 2021 to 31 March 2021
`
`Page 9 of 26
`
`BIOPHARM
`Biopharm, sales development
`
`Sales of biopharm products decreased by 6% measured in Dan ish kroner and increased by 1 % at CER to DKK 4,977 million
`in line with the strategic aspiration of sustained growth in Biopharm. The sales growth at CER was driven by North America
`Operations, partially offset by International Operations. Sales growth was driven by both rare blood disorders and rare
`endocrine disorders. Sales growth was negatively impacted by COVID-19-related stocking in 2020.
`
`Biopharm, development per geographical area
`
`Global
`International Operations
`- EMEA
`- Region China
`- Rest of World
`North Ame rica Opera tions
`- The US
`
`Rare blood disorders
`
`Biopharm, sales development
`
`Sales Q1 2021
`DKKmillion
`
`Growth
`at CER
`
`4,977
`3,134
`1,889
`53
`1,192
`1,843
`1,711
`
`1%
`0%
`6%
`(74%)
`2%
`3%
`3%
`
`- - -
`
`Sales of rare blood disorder products decreased by 5% measured in Danish kroner and increased by 2% at CER to DKK
`2,678 million. The increasing sa les at CER were driven by the launch products Esperoct® and Refixia®, partia lly offset by
`declining NovoSeven® sa les.
`
`Sales of haemophilia A products increased by 10% measured in Danish kroner and by 16% at CER to DKK 497 million. The
`sales increase was driven by International Operations and North America Operations. Esperoct® has been launched in 20
`countries.
`
`Haemophilia B products increased by 13% measured in Danish kroner and by 18% at CER to DKK 147 mi llion. The sales
`increase was driven by International Operations and North America Operations. Refixia® has been launched in 19
`countries.
`
`Sales of NovoSeven® decreased by 9% measured in Danish kroner and by 2% at CER to DKK 1,980 million. The sales
`development was driven by declin ing sales in Region China and Rest of World, partially offset by increasing sales in EM EA.
`The sales decline in Region China reflects increased distributor stock levels in 2020. Sa les in North America Operations
`were unchanged at CER.
`
`Rare endocrine disorders
`
`Sales of rare endocrine disorder products decreased by 5% measured in Danish kroner and increased by 2% at CER to DKK
`1,920 million driven by Norditropin®. The sales growth at CER was driven by North America Operations increasing by 2%
`and International Operations increasing by 1 % at CER. Novo Nordisk is the leading company in the global human growth
`disorder market with a value market share of 35.5% compared to 33 .1 % a year ago, driven by new indications and the
`global roll-out of the next-generation device.
`
`Strategic
`aspirations
`
`Rnancial
`Statement
`
`Commercial
`execution
`
`Financials I Cash now and I
`
`capital allocation
`
`Outlook I Innovation and I
`Purpose and I
`
`therapeutic focus
`
`sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2021
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2021 to 31 March 2021
`
`Page 10 of 26
`
`FINANCIALS
`GEOGRAPHIC SALES DEVELOPMENT
`
`Sa les remained unchanged in Dan ish kroner and increased by 7% at CER to DKK 33,804 million in the first three months of
`2021. Sales in International Operations increased by 2% measured in Danish kroner and by 9% at CER in line with the
`strategic aspiration of sales growth between 6-10%. Sa les in North America Operations decreased by 3% measured in
`Danish kroner and increased by 6% at CER. The strategic aspiration of transforming 70% of sa les in the US has progressed,
`and 52% of sales are now derived from products launched since 2015.
`
`Sales split per geographical area
`
`Sales Q1 2021
`DKKmillion
`
`Growth
`as reported
`
`Growth Share of growth
`at CER
`at CER
`
`Internation al Operations
`-EMEA
`- Region China
`- Rest of World
`North America Operations
`-The US
`
`Total sales
`
`International Operations
`
`18,747
`9, 530
`4,330
`4,887
`15,057
`14,172
`
`33,804
`
`2%
`(1%)
`14%
`2%
`(3%)
`(4%)
`
`0%
`
`9%
`3%
`16%
`14%
`6%
`5%
`
`7%
`
`64%
`13%
`24%
`27%
`36%
`32%
`
`100%
`
`Sa les in International Operations increased by 2% measured in Danish kroner and by 9% at CER. Sa les growth was driven
`by all geographical areas, with Rest of World growing by 14% (CER), Region China growing by 16% (CER) and EMEA growing
`by 3% (CER). Sa les growth was drive n by all therapy areas except for Biopharm. Sa les growth was negatively impacted by
`COVID-19-related stocking in 2020, partially offset by tim ing of shipments.
`
`EMEA
`Sa les in EMEA decreased by 1 % measu red in Dan ish kroner and increased by 3% at CER. Sa les growth was driven by
`Diabetes care growing by 2% (CER) driven by increased GLP-1 sa les. Biopharm sales increased by 6% (CER) and Obesity
`care increased by 18% (CER).
`
`Region China
`Sa les in Reg ion China increased by 14% measured in Danish kroner and by 16% at CER. Sales growth was driven by
`Diabetes care growth of 21 % (CER) refl ecting increased insu lin and GLP-1 sa les, partially offset by Biopharm decl ining by
`74% (CER) refl ecting increased distributor stock levels in t he first three months of 2020.
`
`Rest of World
`Sales in Rest of World increased by 2% measured in Danish kroner and by 14% at CER. Sales growth was driven by
`Diabetes care growing by 18% (CER) reflecting increased GLP-1 and insu lin sales, Obesity care growing by 17% (CER) and
`Biopharm growing by 2% (CER).
`
`North America Operations
`
`Sa les in North Am erica Operations decreased by 3% measured in Danish kroner and increased by 6% at CER. Sales growth
`was negatively impacted by COVID-19-related stocking in 2020, partially offset by inventory changes in 2021.
`
`The sales development at CER reflects GLP-1 sa les growing by 19% (CER}, Biopharm sa les growing by 3% (CER) and Obesity
`care growing by 2% (CER). Th is was partially offset by insulin sales decreasing by 10% (CER) driven by a decline in volume
`and rebate enhancements, partially offset by channel m ix.
`
`Strateg ic
`aspirati ons
`
`Financial
`Statement
`
`Commercial
`execution
`
`. . I Cash flow and I
`
`capital allocation
`
`Financials
`
`Purpose and I
`I Innovation and I
`
`therapeutic focus
`
`sustainability
`
`Outlook
`
`Legal
`
`Rnancial
`Inform ation
`
`Company an no uncem ent No 30 / 202 1
`
`Novo Nordisk Exhibit 2506
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`

`

`Financia l report for the period 1 January 2021 to 31 March 2021
`
`Page 11 of 26
`
`DEVELOPMENT IN COSTS AND OPERATING PROFIT
`
`The cost of goods sold increased by 8% measured in Danish kroner and by 11 % at CER to DKK 5,811 million, resulting in a
`gross margin of 82.8% 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 0.8% percentage point and amortisation of intangible assets
`related to the acquisition of Emisphere Techno logies 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 9% measured in Danish kroner and by 16% at CER to DKK 8,256 million. The
`increase in costs is driven by both International Operations and North America Operations. In International Operations,
`promotiona l spend is related to launch activities for Rybelsus® and Ozempic®, fie ld force expansion in China as well as
`obesity 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 and Biopharm.
`
`Research and development costs increased by 4% measured in Danish kroner and by 7% at CER to DKK 3,944 mill ion.
`Increased activities within Other serious chronic diseases are driving the cost increase reflecting the progression of the
`early pipeline with in cardiovascular disease and NASH as well as increased costs within obesity driven by the ongoing
`card iovascular outcomes trials, SOUL and SELECT.
`
`Administration costs increased by 1 % measured in Danish kroner and by 3% at CER to DKK 932 million, reflecting broadly
`unchanged spend across administrative areas.
`
`Other operating income (net) was DKK 121 mi ll ion compared with DKK 107 million in 2020.
`
`Operating profit decreased by 8% measured in Danish kroner and increased by 3% at CER to DKK 14,982 mill ion.
`
`FINANCIAL ITEMS (NET) AND TAX
`
`Financial items (net) showed a net gain of DKK 956 million compared with a net loss of DKK 1,281 million in 2020.
`
`In line with Novo Nordisk's treasury po

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket