company
`announcement
`
`Financial report for the period 1 January 2018 to 31 December 2018
`
`1 February 2019
`
`Novo Nordisk's operating profit decreased by 4% in Danish kroner and
`increased by 3% in local currencies in 2018
`Operating profit increased by 6% measured in local currencies when adjusted for the cost of severance
`and the priority review voucher for oral semaglutide
`
`Sales remained broadly unchanged in Danish kroner and increased by 5% in local currencies to DKK 111.8 billion.
`• Sales of Victoza411 increased by 5% to DKK 24.3 billion (9% in local currencies).
`• Sales of Ozempic411 were DKK 1. 796 million and total GLP-1 sales increased by 13 % (18 % in local currencies).
`• Sales of Saxenda411 increased by 51 % to DKK 3.9 billion (60% in local currencies).
`• Sales of Tresiba411 increased by 10% to DKK 8.0 billion (15% in local currencies).
`• Sales in International Operations increased by 2% (7% in local currencies).
`• Sales in North America Operations decreased by 2% (increased 3% in local currencies).
`• Sales within diabetes and obesity increased by 1 % to DKK 93.9 billion (6% in local currencies) and sales within
`biopharmaceuticals decreased by 5% to DKK 17.9 billion (1 % in local currencies).
`
`Operating profit decreased by 4% in Danish kroner and increased by 3% in local currencies to DKK 47.2 billion,
`impacted by the depreciation of the US dollar and related currencies versus the Danish krone. Adjusting for
`severance costs related to lay-offs in second half of 2018 and the expense related to the priority review voucher for
`the filing of oral semaglutide, operating profit increased by 6% in local currencies.
`
`Net profit increased by 1 % to DKK 38.6 billion and diluted earnings per share increased by 4% to DKK 15.93.
`
`In February 2018, Novo Nordisk launched Ozempic411
`, a new once-weekly GLP-1, in the USA. The weekly new-to(cid:173)
`brand prescription market share for Ozempic411 has now reached 26% and thereby stabilising the total Novo Nordisk
`GLP-1 market share. Ozempic9 has now been launched in 11 countries in Europe and North America.
`
`In November 2018, Novo Nordisk completed the phase 3a PIONEER programme for oral semaglutide, a new once(cid:173)
`daily GLP-1 tablet for people with type 2 diabetes, following successful completion of the remaining two trials,
`PIONEER 6 and 9. Novo Nordisk has decided to submit the oral semaglutide file around the end of first quarter
`2019 and has notified the US Food and Drug Administration (FDA) that Novo Nordisk will request priority review of
`the oral semaglutide filing based on a priority review voucher.
`
`For 2019, sales growth is expected to be 2-5% measured in local currencies. This includes the previously
`communicated negative impact from the changes in the funding of the Medicare Part D coverage by approximately
`DKK 2 billion. Sales growth reported in Danish kroner is expected to be 2 percentage points higher than in local
`currencies. Operating profit growth is expected to be 2-6% measured in local currencies. Operating profit growth
`reported in Danish kroner is expected to be 4 percentage points higher than in local currencies.
`
`The Board of Directors has adjusted the long-term financial target for OPAT/NOA from 125% to 80% to reflect the
`new accounting principles for handling of leases (IFRS 16) as well as the investment level in tangible and intangible
`assets. Further, to reflect the investment level, the cash to earnings target is adjusted from 90% to 85%. The long(cid:173)
`term financial target for operating profit growth remains unchanged.
`
`At the Annual General Meeting on 21 March 2019, the Board of Directors will propose a final dividend of DKK
`5.15 for 2018 per share of DKK 0.20. The expected total dividend for 2018 of DKK 8.15 per share, of which DKK
`3.00 per share was paid as interim dividend in August 2018, corresponds to an increase of 4% compared to 2017.
`The Board of Directors intends to initiate a new 12-month share repurchase programme of up to DKK 15 billion.
`
`Lars Fruergaard J0rgensen, president and CEO: "2018 was a year of change and significant progress for Novo
`Nordisk. We delivered on our targets for sales and operating profit and have successfully launched Ozempic411
`, our
`new once-weekly GLP-1 for people with type 2 diabetes, in several countries. The results from the broad PIONEER
`phase 3a programme for oral semaglutide are very encouraging for people with type 2 diabetes, and we are now
`close to submitting oral semaglutide for FDA approval."
`
`Novo Nordisk A/5
`Investor Relations
`
`Novo Alie
`2880 Bagsvaerd
`Denmark
`
`Telephone:
`+45 4444 8888
`www.novonordisk.com
`Company announcement No 6 / 2019
`
`CVR Number:
`24 25 67 90
`
`Novo Nordisk Exhibit 2497
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report for the period 1 January 2018 to 31 December 2018
`
`Page 2 of 36
`
`About Novo Nordisk
`Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes
`care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity,
`haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk
`employs approximately 43,200 people in 80 countries, and markets its products in more than 170 countries. Novo
`Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange
`(NVO). For more information, visit novonordisk.com, Facebook, Twitter, Linkedln and YouTube.
`
`Conference call details
`On 1 February 2019 at 13.00 CET, corresponding to 7 .00 am EST, a conference call will be held. Investors will be
`able to listen in via a link on novonordisk.com, which can be found under 'Investors'. Presentation material for the
`conference call will be available approximately one hour before on the same page.
`
`Webcast details
`On 4 February 2019 at 13.30 CET, corresponding to 7.30 am EST, management will give a presentation to
`institutional investors and sell-side analysts in London. A webcast of the presentation can be followed via a link on
`novonordisk.com, which can be found under 'Investors'. Presentation material for the webcast will be made
`available on the same page.
`
`Financial calendar
`
`05 March 2019
`
`21 March 2019
`03 May 2019
`09 August 2019
`01 November 2019
`
`Deadline for the company's receipts of shareholder proposals for the Annual General
`Meeting 2019
`Annual General Meeting 2019
`Financial statement for the first three months of 2019
`Financial statement for the first six months of 2019
`Financial statement for the first nine months of 2019
`
`Contacts for further information
`
`Media:
`Katrine Sperling
`Ken lnchausti (USA)
`
`Investors:
`Peter Hugreffe Ankersen
`Anders Mikkelsen
`Valdemar Borum Svarrer
`Kristoffer Due Berg
`Ann S0nderm0lle Rendb.ek
`
`+45 3079 6718
`+ 1 609 240 9429
`
`krsp@novonordisk.com
`kiau@novonordisk.com
`
`+45 3075 9085
`+45 3079 4461
`+45 3079 0301
`+45 3079 2849
`+45 3075 2253
`
`phak@novonordisk.com
`armk@novonordisk.com
`jvls@novonordisk.com
`krdb@novonordisk.com
`arnd@novonordisk.com
`
`Further information about Novo Nordisk is available on novonordisk.com.
`
`Company announcement No 6 / 2019
`
`Novo Nordisk Exhibit 2497
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2018 to 31 December 2018
`
`Page 3 of 36
`
`UST OF CONTENTS
`
`FINANCIAL PERFORMANCE..............................................................................................................
`
`4
`
`4
`Consolidated financial statement for 2018 ...................... ................................ ................. ............
`6
`Sales development .. . . . . . . ... . . . .. . . . . . . . . . . .... .. . . . . . . . . ........... ... .... . .......... ... ...............................................
`6
`Diabetes and obesity, sales development .....................................................................................
`9
`Biopharmaceuticals, sales development . ...... .. .. .............. ...................... ............ ........... ... .. . . . . .. . . . . ...
`11
`Development in costs and operating profit .......................................... .........................................
`11
`Financial items (net) .. . . . . .. ... . .. ................. .. .. .. .. .. .. .................. ...... . .......... .... . . . . . . . . . . . .. . . .. . .... . . . . . . . . .. . ..
`11
`Capital expenditure and free cash flow .... .. .. .. ...................... ...... ............ ..... ............. ... ... . .. .. .. .. ... ..
`OUTLOOK...........................................................................................
`........................................ 13
`
`RESEARCH & DEVELOPMENT UPDATE.............................................................................................. 15
`SUSTAINABILITY UPDATE.................................................................................................................
`18
`EQUITY............................................................................................................................................ 20
`
`21
`CORPORATE GOVERNANCE............................................................................................................
`LEGAL MATTERS.............................................................................................................................. 23
`MANAGEMENT STATEMENT............................................................................................................ 25
`FINANCIAL INFORMATION............................................................................................................... 26
`Appendix 1: Quarterly numbers in DKK . .. ... ... .. .. .......... ..... ........... .. ......... ..... .. .. .. .. .. .. ... ........ .......... 26
`Appendix 2: Income statement and statement of other comprehensive income ............................ 27
`Appendix 3: Cash flow statement .. ...... .......................................................... .. ............................ 28
`
`Appendix 4: Balance sheet . . .. . . . . . . .. . . . .... .................... ..... ........ ... .. .. . . .... . . ..... . ................... ............ ... 29
`Appendix 5: Equity statement .. .. .. . . .................... ........... ... .. .. ....... ............. ... . . . . . .. .. .. .. . .... . . . . . . . . . . .. . .. 30
`31
`Appendix 6: Regional sales split ........................................................ .. .............................. ...........
`
`Appendix 7: Key currency assumptions ........................................................................................ 33
`33
`Appendix 8: New accounting standards in 2018 ................ .......................................... ................
`Appendix 9: Quarterly numbers in USD (additional information) .. .. .. .. .. . ...... ............. .... ... .. .. . .. .... ... 34
`Appendix 10: Non-lFRS financial measures (additional information) .............................................. 35
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Corporate
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 6 /2019
`
`Novo Nordisk Exhibit 2497
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for the period 1 January 2018 to 31 December 2018
`
`Page 4 of 36
`
`FINANCIAL PERFORMANCE
`
`CONSOLIDATED FINANCIAL STATEMENT FOR 2018
`The Board of Directors and Executive Management have approved the Annual Report 2018 of Novo Nordisk NS
`including the audited consolidated financial statements. The Board of Directors and Executive Management also
`approved this unaudited financial statement containing condensed financial information for 2018. This financial
`statement is prepared in accordance with the recognition and measurement requirements of the International
`Financial Reporting Standards (IFRS) as issued by IASB and IFRS as endorsed by the EU. The accounting policies used
`in this financial statement are consistent with those used in the audited consolidated financial statements in the
`Annual Report 2018.
`
`2018
`
`2017
`
`2016
`
`2015
`
`2014
`
`% change
`2017to
`2018
`
`INCOME STATEMENT
`DKKmillion
`
`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
`Oe_erating_ marg_in
`
`Financial items (net)
`
`111,831
`
`111,696
`
`111,780
`
`107,927
`
`94,214
`84.2%
`
`29,397
`26.3%
`
`14,805
`13.2%
`
`3,916
`3.5%
`
`1,152
`
`47,248
`42.2%
`
`94,064
`84.2%
`
`28,340
`25.4%
`
`14,014
`12.5%
`
`3,784
`3.4%
`
`1,041
`
`48,967
`43.8%
`
`94,597
`84.6%
`
`28,377
`25.4%
`
`14,563
`13.0%
`
`3,962
`3.5%
`
`737
`
`48,432
`43.3%
`
`91,739
`85.0%
`
`28,312
`26.2%
`
`13,608
`12.6%
`
`3,857
`3.6%
`
`3,482
`
`49,444
`45.8%
`
`'
`
`367
`
`(287)
`
`(634)
`
`(5,961)
`
`88,806
`
`74,244
`83.6%
`
`23,223
`26.2%
`
`13,762
`15.5%
`
`3,537
`4.0%
`
`770
`
`34A92
`38.8%
`
`(396)
`
`34,096
`
`7,615
`22.3%
`
`26,481
`29.8%
`
`0%
`
`0%
`
`4%
`
`6%
`
`3%
`
`11%
`
`(4%)
`
`NIA
`
`(2%)
`
`(15%)
`
`1%
`
`Profit before income taxes
`
`47,615
`
`48,680
`
`47,798
`
`43,4113
`
`Income taxes
`Effective tax rate
`
`Net profit
`Net profit margin
`
`8,987
`18.9%
`
`38,628
`34.5%
`
`10,550
`21 .7%
`
`38,130
`34.1%
`
`9,873
`20.7%
`
`37,925
`33.9%
`
`8,623
`19.8%
`
`34,860
`32.3%
`
`"other operating income, net for 2015 indudes DKK 2,376 mil ion for the partial divestment of associated ccmpany.
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Corporate
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 6/ 2019
`
`Novo Nordisk Exhibit 2497
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financial report for the period 1 January 2018 to 31 December 2018
`
`Page 5 of 36
`
`CONSOLIDATED FINANCIAL STATEMENT FOR 2018 - CONTINUED
`
`OTHER KEY NUMBERS
`(Amounts are in DKK million, except for earnings per share
`and dividend per share)
`
`Depredfion, amortisation and impairment
`losses 1
`Capital expenditure, net (PP&E)
`
`Net cash generated from operating activities
`Free cash flow
`
`Total assets
`Equity
`Equity ratio
`
`Diluted earnings per share I ADR (in DKK)
`Total dividend per share (in DKK) 2l
`
`2018
`
`2017
`
`2016
`
`2015
`
`2014
`
`%change
`2017 to
`2018
`
`3,925
`9,524
`
`44,616
`32,536
`
`110,769
`51,839
`46.8%
`
`15.93
`8.15
`
`3,182
`8,679
`
`41,168
`32,588
`
`102,355
`49,815
`48.7%
`
`15.39
`7.85
`
`3,193
`7,061
`
`48,314
`39,991
`
`97,539
`45,269
`46.4%
`
`14.96
`7.60
`
`2,959
`5,209
`
`38,287
`34,222
`
`91,799
`46,969
`51.2%
`
`13.52
`6.40
`
`3,435
`3,986
`
`31,692
`27,396
`
`77,062
`40,294
`52.3%
`
`10.07
`5.00
`
`23%
`10%
`
`8%
`0%
`
`8%
`4%
`
`4%
`4%
`
`Payout ratio 3l
`
`50.6%
`
`50.4%
`
`50.2%
`
`46.6%
`
`48.7%
`
`"lndudlng impainments of around DKK 480 million in 2014 related to discontinuation of activities within inflammatory disorders.
`"Total dividend for the financial year 2018 induding proposed final dividend of DKK 5.15 per share and interim dividend paid in August 2018 of DKK 3.00 per share.
`
`~Total dividend for the year as a percentage of net profit.
`
`PERFORMANCE AGAINST LONG-TERM FINANOAL TARGETS
`
`2018
`(3.5%)
`(3.5%)
`
`2.8%
`
`2017
`1.1%
`1.1%
`
`4.8%
`
`2016
`(2.0%)
`3.9 %
`
`2015
`43.3%
`35.2%
`
`2014
`9.5%
`9.5%
`
`Target 21
`5%
`
`6.2 %
`
`12.7%
`
`12.7%
`
`Operating profit growth
`Operating profit growth adjusted 1i
`Operating profit growth adjusted in local
`currencies •J
`
`Operating profit after tax to net operating
`assets
`
`Cash to earnings
`Cash to earnings (three-year average)
`
`84.2%
`91.7 %
`
`85.5%
`96.4%
`
`105.4 %
`102.4 %
`
`98.2%
`96.8%
`
`103.5%
`93.1%
`
`116.7 %
`
`143.2%
`
`150.2 %
`
`148.7%
`
`101.0%
`
`125%
`
`90%
`
`"Growth in operating profn for 2015 and 2016 are adjusted for DKK 2,376 million for the partial divestment of associated company and DKK 449 million for the income related to the out(cid:173)
`licensing of mets for inflammatory disorders, both in 2015.
`21 Targets effective 31 December 2018. The long-term financial targets were adjusted in February 2019. Please roferto the outlook section.
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`Sustainability I Equity
`
`Corporate
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 612019
`
`Novo Nordisk Exhibit 2497
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2018 to 31 December 2018
`
`Page 6 of 36
`
`SALES DEVELOPMENT
`Sales remained unchanged in Danish kroner and increased by 5% in local currencies in 2018, reflecting a significant
`impact from the depreciation of the US dollar and related currencies versus the Danish krone. The sales growth is in
`line with the latest guidance of '4-5% sales growth measured in local currencies' provided in connection with the
`announcement in November 2018 for the first nine months of 2018. Sales growth in local currencies was realised
`within diabetes and obesity with the malority of growth originating from the GLP-1 diabetes products Victoza® and
`Ozempic®, the obesity product Saxenda , as well as long-acting insulin Tresiba® and Xultophy®, partly offset by
`declining sales of Levemir® and NovoRapid®. Declining sales within biopharmaceuticals were driven by NovoSeven®
`and 'Other biopharmaceuticals', partly offset by increased sales of NovoEight® and Norditropin®.
`
`Sales split per therapy
`The diabetes and obesity segment
`
`Sales2018
`DKKmillion
`
`Sales 2017
`DKKmillion
`
`Growth
`as reported
`
`Growth
`in local
`currencies
`
`Share of
`growth
`in local
`currencies
`
`Long-acting insulin
`- Tresiba•
`- Xultophy9
`- Levemi,.
`
`Premix insulin
`- Ryzodeg9
`- NovoMix9
`
`Fast-acting insulin
`- Fiasp•
`- NovoRapid9
`
`Human insulin
`
`Total insulin
`
`Victoza•
`Ozempic9
`Total GLP-1
`Other diabetes 11
`
`Total diabetes
`
`Obesity (Saxenda•)
`
`Diabetes and obesity total
`
`The biopharmaceuticals segment
`Haemophilia21
`- NovoSeven•
`- NovoEight_e
`Growth disorders (Norditropin•)
`Other biopharmaceuticals31
`Biopharrnaceuticals total
`
`20,844
`8,035
`1,614
`11,195
`
`10,194
`714
`9,480
`
`19,353
`590
`18,763
`
`9,265
`
`59,656
`
`24,333
`1,796
`26,129
`
`4,250
`
`90,035
`
`3,869
`
`93,904
`
`9,576
`7,881
`1,354
`6,834
`1,517
`17,927
`
`22,174
`7,327
`729
`14,118
`
`10,749
`492
`10,257
`
`20,124
`99
`20,025
`
`9,793
`
`62.840
`
`23,173
`
`23,173
`
`4,302
`
`90,315
`
`2,562
`
`92,877
`
`10,469
`9,206
`1,103
`6,655
`1,695
`18,819
`
`Total sales
`
`111,831
`
`111,696
`
`11 Primarily oral antidiabetic products, needles and GlucaGen• HypoKit9
`21 Comprises NovoSeven•, NovoEight•, NovoThirteen• and Refixia9
`31 Primarily Vagifem• and Activene•.
`
`.
`
`.
`
`(6%)
`70%
`121%
`(21%)
`
`(5%)
`45%
`(8%)
`
`(4%)
`
`(6%)
`
`(5%)
`
`(5%)
`
`5%
`
`13%
`
`(1%)
`
`0%
`
`51%
`
`1%
`
`(9%)
`(14%)
`23%
`3%
`(11%)
`(5%)
`
`0%
`
`(2%)
`15%
`126%
`(17%)
`
`0%
`54%
`(3%)
`
`1%
`
`(2%)
`
`(1%)
`
`(1%)
`
`9%
`
`18%
`
`3%
`
`4%
`
`60%
`
`6%
`
`(5%)
`(11%)
`26%
`7%
`(8%)
`(1%)
`
`5%
`
`(7%)
`21%
`18%
`(46%)
`
`0%
`6%
`(6%)
`
`3%
`10%
`(7%)
`
`(3%)
`
`(7%)
`
`42%
`36%
`78%
`
`2%
`
`73%
`
`30%
`
`103%
`
`(10%}
`(19%)
`5%
`9%
`(2%)
`(3%)
`
`100%
`
`International Operations was the main driver of sales growth and sales increased by 2% measured in Danish kroner
`and by 7% in local currencies. Sales in North America Operations decreased by 2% measured in Danish kroner and
`increased by 3% in local currencies.
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Corporate
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 6 / 2019
`
`Novo Nordisk Exhibit 2497
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2018 to 31 December 2018
`
`Page 7 of 36
`
`Sales split per region
`
`North America Operations
`- USA
`International Operations
`- Region Europe
`- Region AAMEO
`- Region China
`- Region Japan & Korea
`- Region Latin America
`
`Total sales
`
`Sales 2018
`DKKmillion
`
`Growth
`as reported
`
`Growth
`in local currencies
`
`Share of growth
`in local currencies
`
`S&,908
`54,488
`54,923
`21,679
`12,153
`11,285
`5,797
`4,oog
`
`111,831
`
`(2%)
`(2%)
`2%
`2%
`1%
`5%
`(5%)
`8%
`
`0%
`
`3%
`2%
`7%
`3%
`11%
`8%
`(2%)
`29%
`
`5%
`
`29%
`22%
`71%
`11%
`26%
`16%
`(2%)
`20%
`
`100%
`
`Please refer to appendix 6 for further details on sales in 2018.
`
`In the following sections, unless otherwise noted, market data are based on moving annual total (MA1) from
`November 2018 and November 2017 provided by the independent data provider IQVIA.
`
`DIABETES AND OBESITY, SALES DEVELOPMENT
`Sales of diabetes and obesity products increased by 1 % measured in Danish kroner and by 6% in local currencies to
`DKK 93,904 million. Novo Nordisk is the world leader in diabetes care with a global value market share of 27.9%
`compared with 27.4% in 2017.
`
`Insulin
`Sales of insulin decreased by 5% measured in Danish kroner and by 1 % in local currencies to DKK 59,656 million.
`The decline in sales measured in local currencies was driven by North America Operations declining by 7% driven by
`lower prices, partly offset by International Operations increasing sales with 5%, where all regions apart from Region
`Japan & Korea contributed to growth. Novo Nordisk is the global leader with 46.4% of the total insulin market and
`45.2% of the market for modern insulin and new-generation insulin, both measured in volume.
`
`Sales of long-acting insulin (Tresiba®, Xultophy8 and Levemir8
`2% in local currencies to DKK 20,844 million.
`
`) decreased by 6% measured in Danish kroner and by
`
`Sales of Tresiba1111 (insulin degludec), the once-daily new-generation insulin, reached DKK 8,035 million compared
`with DKK 7,327 million in 2017. Tresiba 1111 has now been launched in 76 countries.
`
`Sales of Xultophy®, a once-daily combination of insulin degludec (Tresiba®) and liraglutide (Victoza®), reached DKK
`1,614 million compared with DKK 729 million in 2017. Sales growth was driven by both International Operations,
`where predominantly Region Europe contributed to growth, and North America Operations. Xultophy® has now
`been launched in 26 countries.
`
`Sales of premix insulin (Ryzodeg8 and NovoMix®) decreased by 5% measured in Danish kroner and remained
`unchanged in local currencies to DKK 10,194 million.
`
`, a soluble formulation of insulin degludec and insulin aspart, reached DKK 714 million compared
`Sales of Ryzodeg1111
`with DKK 492 million in 2017. Ryzodeg® has now been launched in 27 countries.
`
`Sales of fast-acting insulin (Fiasp1111 and NovoRapid®) decreased by 4% measured in Danish kroner and increased by
`1 % in local currencies to DKK 19,353 million.
`
`Sales of Fiasp8
`, the novel mealtime fast-acting insulin aspart, reached DKK 590 million. Fiaspi» has now been
`launched in 25 countries.
`
`Financial I Outlook
`
`Performance
`
`I Sustainability I Equity
`
`R&D
`
`Corporate
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 6 / 2019
`
`Novo Nordisk Exhibit 2497
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financial report for the period 1 January 2018 to 31 December 2018
`
`Page 8 of 36
`
`INSULIN MARKET SHARES
`(volume, MAn
`
`Novo Nordisk's share
`of the total insulin market
`
`Novo Nordisk's share
`of the modern insulin and
`new-generation insulin market*
`
`Global
`North America Operations
`-USA
`International Operations
`- Region Europe
`- Region AAMEO**
`- Region China***
`- Region Japan & Korea
`- Region Latin America****
`
`November
`2018
`
`November
`2017
`
`November
`2018
`
`November
`2017
`
`46.4%
`40.0%
`40.4%
`49.1%
`43.5%
`57.0%
`50.8%
`50.3%
`46.1%
`
`45.9%
`38.8%
`39.0%
`48.9%
`44.1%
`55.5%
`52.9%
`49.6%
`42.2%
`
`45.2%
`41.1%
`41 .8%
`47.4%
`43.3%
`50.7%
`59.8%
`50.3%
`37.4%
`
`44.8%
`39.6%
`40.2%
`47.6%
`43.8%
`50.7%
`61.0%
`49.3%
`39.2%
`
`Source: IQVIA, November 2018 data. • Modern insulin and new-generation insulin comprises the following Novo Nordisk products: Levemir•, NovoMix•, NovoRapid•,
`Tresiba•, Xultoph~, Ryzodeg• and Fiasp• 0 Data available for 11 private markets representing approximately 70% of total Novo Nordisk's diabetes sales in the
`region. ••• Data for mainland China, excluding Hong Kong and Taiwan. •••• Data available for three private markets representing approximately 70% of total Novo
`Nordisk's diabetes sales in the region.
`
`North America Operations
`Sales of insulin in North America Operations decreased by 11 % measured in Danish kroner and by 7% in local
`currencies. The decline in sales in the USA was driven by Levemir• and NovoLog• and lower realised prices partly
`offset by higher sales of the new-generation insulin Xultophy• 100/3.6 and Tresiba• following a net market share
`gain of approximately 5 percentage points in the basal insulin segment and underlying volume growth. The sales
`decline in the USA in the short-acting insulin segment was driven by lower realised prices for Novolog®.
`
`International Operations
`Sales of insulin in International Operations remained unchanged in Danish kroner and increased by 5% in local
`currencies. Sales growth measured in local currencies was driven by long-acting, premix and fast-acting insulin,
`partly offset by declining human insulin sales.
`
`Region Europe
`Sales of insulin in Region Europe increased by 2% in both Danish kroner and local currencies. Sales were driven by
`the penetration of Xultophy®, Tresiba• and Fiasp® across the region, partly offset by contracting Levemir® sales
`reflecting the continued roll-out of Tresiba•, as well as declining NovoMix• and human insulin sales.
`
`Region AAMEO
`Sales of insulin in Region MMEO increased by 1 % measured in Danish kroner and by 11 % in local currencies. The
`sales growth measured in local currencies was driven by growth of the overall diabetes market and market share
`gains as well as a positive contribution from all three insulin segments: long-acting, premix and fast-acting as well as
`human insulin.
`
`Region China
`Sales of insulin in Region China increased by 3% measured in Danish kroner and by 6% in local currencies. The sales
`growth measured in local currencies was driven by continued growth in the three insulin segments: long-acting,
`premix and fast-acting, reflecting solid underlying volume growth, partly offset by lower human insulin sales.
`
`Region Japan & Korea
`Sales of insulin in Region Japan & Korea decreased by 10% measured in Danish kroner and by 7% in local
`currencies. The decline in sales was driven by NovoMix® and NovoRapid®, as both products reached the 15-year price
`protection limit 1 April 2018, leading to significant mandatory price reductions as well as lower human insulin sales,
`partly offset by positive contribution from market share gains for Ryzodeg• and Tresiba• in Japan.
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Corporate
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 6 / 2019
`
`Novo Nordisk Exhibit 2497
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financial report for the period 1 January 2018 to 31 December 2018
`
`Page 9 of 36
`
`Region Latin America
`Sales of insulin in Region Latin America decreased by 8% measured in Danish kroner and increased by 13% in local
`currencies. The sales growth measured in local currencies was driven by growth of the overall diabetes market,
`inflationary price effects and positive volume contribution from all three insulin segments: long-acting, premix and
`fast-acting.
`
`GLP-1 therapy for type 2 diabetes
`Sales of GLP-1 products for type 2 diabetes (Victoza® and Ozempic®) increased by 13% measured in Danish kroner
`and by 18% in local currencies to DKK 26, 129 million. Ozempic® has now been marketed in 11 countries in North
`America Operations and Region Europe and initial feedback is encouraging. Sales growth is predominantly driven by
`North America Operations comprising 81 % share of the GLP-1 growth. The GLP-1 segment's value share of the total
`diabetes market has increased to 14.5% compared with 11.8% 12 months ago. Novo Nordisk continues to be the
`market leader in the GLP-1 segment with a 46% value market share.
`
`GLP-1 MARKET SHARES
`(value, MAn
`
`GLP-1 share of total
`diabetes market
`
`Novo Nordisk's share of
`the diabetes GLP.1 market*
`
`Global
`North America Operations
`-USA
`International Operations
`- Region Europe
`- Region AAMEO**
`- Region China***
`- Region Japan & Korea
`- Region Latin America****
`
`November
`2018
`
`November
`2017
`
`November
`2018
`
`November
`2017
`
`14.5%
`17.1%
`17.3%
`7.7%
`11.9%
`3.2%
`1.3%
`5.9%
`6.2%
`
`11.8%
`13.9%
`14.1%
`6.6%
`10.5%
`2.7%
`0.9%
`4.6%
`5.2%
`
`46%
`45%
`45%
`52%
`55%
`43%
`87%
`33%
`68%
`
`50%
`48%
`48%
`56%
`58%
`48%
`68%
`41%
`75%
`
`Source: IQVlA. November 2018 data MAT.* Novo Nordisk's GLP-1 diabetes products comprise Victoza• and Ozemplc• ** Data for 11 selected private markets
`representing approximately 70% of Novo Nordisk's total diabetes sales in the region. * 0 Data for mainland China. exduding Hong Kong and Taiwan. **** Data for
`three selected private markets representing approximately 70% of Novo Nordisk's total diabetes sales in the region.
`
`North America Operations
`Sales of Novo Nordisk's GLP-1 diabetes products (Victoza® and Ozempic®) in North America Operations increased by
`14% measured in Danish kroner and by 19% in local currencies. Sales growth is driven by an underlying prescription
`volume growth of the GLP-1 class of more than 25%, driven by the launch of Ozempic9 and a competitive once(cid:173)
`weekly GLP-1, and Novo Nordisk is the market leader with a 45% value market share. The value share of the GLP-1
`class of the total North American diabetes market has increased to 17 .1 %.
`
`In February 2018, Novo Nordisk launched Ozempic9 in the USA, a new once-weekly GLP-1, and broad formulary
`coverage has been obtained. The weekly new-to-brand prescription market share for Ozempic® has now reached
`26% and thereby stabilising the total Novo Nordisk market share. Sales of Victoza® increased by 4% measured in
`Danish kroner and by 8% in local currencies. Sales growth of Victoza® is driven by the positive impact from the
`updated label for Victoza® reflecting cardiovascular benefits and the overall growth of the GLP-1 class, partly offset
`by the continued competition from a once-weekly product and the impact from the launch of Ozempic®.
`
`International Operations
`Sales of Victoza® in International Operations increased by 9% measured in Danish kroner and by 13% in local
`currencies. Sales growth is driven by all regions. The value share of the GLP-1 class of the total diabetes market has
`increased to 7. 7% from 6.6% in 2017. Novo Nordisk is the market leader with a 52 % value market share.
`
`Region Europe
`Sales in Region Europe increased by 9% in both Danish kroner and local currencies. The sales development reflects
`positive impact from the expanded CV label for Victoza®, partly offset by competition from a once-weekly product.
`In Region Europe, the value share of the GLP-1 class of the total diabetes market has increased to 11.9%. Novo
`Nordisk remains the market leader in Region Europe with a 55% value market share.
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Corporate
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 6 / 2019
`
`Novo Nordisk Exhibit 2497
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2018 to 31 December 2018
`
`Page 10 of 36
`
`Region AAMEO
`Sales in Region AAMEO decreased by 2% measured in Danish kroner and increased by 6% in local currencies. Sales
`growth measured in local currencies is primarily driven by a number of countries in the Middle East. The value share
`of the GLP-1 class of the total diabetes market increased to 3.2%. Novo Nordisk remains the GLP-1 market leader
`across Region AAMEO with a value market share of 43%.
`
`Region China
`Sales in Region China increased by 69% measured in Danish kroner and by 73% in local currencies. The increase in
`sales reflects the inclusion of Victod9 in the Chinese National Reimbursement Drug List in July 2017. In China,
`Victoza® has increased its GLP-1 value market share to 87% and accelerated the growth of the GLP-1 class, which
`now represents 1.3% of the total diabetes market measured in value.
`
`Region Japan & Korea
`Sales in Region Japan & Korea increased by 4% measured in Danish kroner and by 7% in local currencies. The sales
`growth reflects the continued expansion of the GLP-1 market in Japan, partly offset by intensified competition from
`a once-weekly product. In Region Japan & Korea, the GLP-1 class repre