company
`announcement
`
`• "'1. k"
`
`novo nord1s
`
`Financial report for the period 1 January 2018 to 30 June 2018
`
`8 August 2018
`
`Novo Nordisk's operating profit decreased by 8% in Danish kroner and
`increased by 4% in local currencies in the first six months of 2018
`
`Sales decreased by 5% in Danish kroner and increased by 4% in local currencies to DKK 54.3 billion.
`• Sales of Victoza• increased by 2% to DKK 11.7 billion (12% in local currencies).
`• Sales of Saxenda111 increased by 35% to DKK 1.7 billion (50% in local currencies).
`• Sales of Tresiba® were unchanged at DKK 3.7 billion (increased by 11 % in local currencies).
`• Sales of Xultophy® increased by 154% to DKK 720 million (165% in local currencies).
`• Sales in North America Operations decreased by 10% (unchanged in local currencies).
`• Sales in International Operations increased by 1 % (8% in local currencies).
`
`Sales within diabetes care and obesity decreased by 4% to DKK 45.6 billion (increased by 5% in local currencies).
`Sales within biopharmaceuticals decreased by 9% to DKK 8.7 billion (decreased by 1 % in local currencies).
`
`Operating profit decreased by 8% in Danish kroner and increased by 4% in local currencies to DKK 24. 7 billion,
`reflecting the significant depreciation of the US dollar and related currencies versus the Danish krone.
`
`Net profit increased by 5% to DKK 21.1 billion. Diluted earnings per share increased by 7% to DKK 8.66.
`
`In February 2018, Novo Nordisk launched Ozempic9 in the USA, a new once-weekly GLP-1, and the initial feedback
`from prescribers and payers is positive and the formulary coverage for Ozempic9 is progressing. The weekly new-to(cid:173)
`brand prescription market share for Ozempic® has reached 14%.
`
`During second quarter of 2018, Novo Nordisk announced the phase 3a results from four of the 10 clinical trials in
`the PIONEER programme with oral semaglutide, a new once-daily GLP-1 tablet for people with type 2 diabetes. The
`trials confirmed statistically significant reductions in both HbA1, and weight for oral semaglutide compared to
`empagliflozin, sitagliptin and Victoza•.
`
`The Board of Directors has approved an interim dividend for 2018 of DKK 3.00 per share of DKK 0.20 to be paid in
`August 2018.
`
`For 2018, sales growth is still expected to be 3-5% and operating profit growth is still expected to be 2-5%, both
`measured in local currencies. Sales growth and operating profit growth reported in Danish kroner are now
`expected to be 5 and 7 percentage points lower than in local currencies, respectively.
`
`For 2019, formulary negotiations with pharmacy benefit managers and managed care organisations in the USA are
`progressing. Subject to the final outcome of these negotiations, average prices after rebates are expected to be
`lower compared with the levels in 2018, predominantly due to basal insulin pricing and changed Medicare Part D
`coverage gap legislation. The market access for Novo Nordisk's key products is expected to remain broadly
`unchanged compared to 2018.
`
`Lars Fruergaard J0rgensen, president and CEO: "Sales growth in the first half of 2018 was driven by solid
`performance of our key innovative products: Victoza®, Tresiba9
`, Xultophy® and Saxenda®, and the launch of
`Ozempic9 is off to a good start in North America. We are encouraged about the clinical trial results for oral
`semaglutide and we are looking forward to making the first oral GLP-1 treatment available for people with type 2
`diabetes."
`
`Novo Nordisk A/5
`Investor Relations
`
`Novo Alie
`2880 Bagsvzrd
`Denmark
`
`Telephone:
`+45 4444 8888
`www.novonordisk.com
`
`CVR Number:
`24 25 67 90
`
`Company announcement No 60 / 2018
`
`Novo Nordisk Exhibit 2495
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report for the period 1 January 2018 to 30 June 2018
`
`Page 2 of 30
`
`About Novo Nordisk
`Novo Nordisk is a global healthcare company with 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 43,100 people in 79 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, YouTube.
`
`Conference call details
`On 8 August 2018 at 13.00 CEST, corresponding to 7.00 am EDT, 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 9 August 2018 at 13.30 CEST, corresponding to 7.30 am EDT, 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
`
`1 November 2018
`1 February 2019
`
`Financial statement for first nine months of 2018
`Financial statement for 2018
`
`Contacts for further Information
`
`Media:
`Katrine Sperling
`Ken lnchausti (USA)
`
`Investors:
`Peter Hugreffe Ankersen
`Anders Mikkelsen
`Valdemar Borum Svarrer
`
`+45 3079 6718
`+1609240 9429
`
`krsp@novonordisk.com
`kiau@novonordisk.com
`
`+45 3075 9085
`+45 3079 4461
`+45 3079 0301
`
`phak@novonordisk.com
`armk@novonordisk.com
`jvls@novonordisk.com
`
`Further information about Novo Nordisk is available on novonordisk.com.
`
`Company announcement No 60 / 2018
`
`Novo Nordisk Exhibit 2495
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2018 to 30 June 2018
`
`Page 3 of 30
`
`LIST OF CONTENTS
`
`FINANCIAL PERFORMANCE ...... .......................................................................... ........................ ......
`
`Consolidated financial statement for the first six months of 2018 ........................ ........................
`
`Sales development . . .. .. . ... .................... .. . . . . . . . . . . . .. . .. . . . . . . .. .. . . .. . . . . . ............. ... . . . . . . . .......................... ...
`
`Diabetes care and obesity, sales development .. . . .. . . .. . . .. .. .. .. .... .. .. . . .. .. . . .. .. . ... .... .. . ........ ....... .... . .. . . . ..
`
`Biopharmaceuticals, sales development . ........ .. . . . . . . ........... ... . . ............ .. .... .. .. .. .. ......... ........ ... . . . .. . . . .
`
`4
`
`4
`
`5
`
`6
`
`9
`
`Development in costs and operating profit ... .. . .. . .. . .. .. ... .. .. . . . . ....... ... . . . . . .. . ... . . .. ......... ... ... ... .. ... . . .. .. .. 10
`Financial items (net) .. .. .... .. .... .. .. ...... .. . .......... .. . . . .. . ....... ............. ... . . . . . .. .. . . .. . . . . .. .. .. ...... ... .......... .. ..... 1 O
`
`Capital expenditure and free cash flow . . . . . . . . .. . . . . .. ...... ... .. ......... .... . . . . .. .. . ... . . . . . . .......... .. . . .. ...... . .. .. .. .
`
`11
`
`OUTLOOK.................................................................. . . .............................................................. 12
`
`RESEARCH & DEVELOPMENT UPDATE.............................................................................................. 14
`
`SUSTAINABILITY UPDATE................................................................................................................ 17
`
`EQUITY............................................................................................................................................
`
`18
`
`LEGAL MATTERS.............................................................................................................................. 18
`
`MANAGEMENT STATEMENT............................................................................................................ 20
`
`FINANCIAL INFORMATION...............................................................................................................
`
`21
`
`Appendix 1: Quarterly numbers in DKK ........................................ ...................... ............. ............. 21
`
`Appendix 2: Income statement and statement of other comprehensive income ............................ 22
`
`Appendix 3: Cash flow statement .. ......... .. .. .. . . . . .. . ... . .. . .............. .. .... .. .. .. .... .. .. .. . . .. . .. . ... . . . ............ ... 23
`
`Appendix 4: Balance sheet ...... ....... .... .. .. .. . . . . .... . . .. . . .. .. .. . . .. . . . ....... . ....... ...... ...... .... .. .. .. . . . .. . . . . . . .. ....... 24
`
`Appendix 5: Equity statement .............................. ........................ .............................. ........... ....... 25
`
`Appendix 6: Regional sales split ............................................... ....................................................
`
`Appendix 7: Key currency assumptions ................ ......................... .. .............................................
`
`Appendix 8: New accounting standards in 2018 ................. .. .......................................................
`
`26
`
`28
`
`28
`
`Appendix 9: Quarterly numbers in USO (additional information) ............ .... .. .. .. .. .. ..... ..... .... .. . .. . ..... 29
`
`Appendix 1 O: Non-lFRS financial measures (additional information) . . .. ... .... .. .... .. ......... .......... .. . . . . . . 30
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Legal
`
`Financial
`Information
`
`Company announcement No 60 I 2018
`
`Novo Nordisk Exhibit 2495
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for the period 1 January 2018 to 30 June 2018
`
`Page 4 of 30
`
`FINANCIAL PERFORMANCE
`
`CONSOLIDATED FINANCIAL STATEMENT FOR THE FIRST SIX MONTHS OF 2018
`These unaudited consolidated financial statements for the first six months of 2018 have been prepared in
`accordance with IAS 34 'Interim Financial Reporting'. The accounting policies adopted in the preparation are
`consistent with those applied in the Annual Report 2017 of Novo Nordisk, except for the adoption of new,
`amended or revised standards and interpretations ('IFRSs') as published by the IASB that are endorsed by the EU and
`effective as of 1 January 2018. This includes IFRS 9 'Financial Instruments' applied prospectively and IFRS 15
`'Revenue from Contracts with Customers' applied on a modified retrospective basis, see appendix 8. Furthermore,
`the financial report including the consolidated financial statements for the first six months of 2018 and
`Management's review have been prepared in accordance with additional Danish disclosure requirements for interim
`reports of listed companies.
`
`Amounts are in DKK million, except for number of shares, earnings per share and full-time equivalent employees.
`
`PROFIT AND LOSS
`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
`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 (tangible assets)
`
`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
`
`H12018
`
`H1 2017
`
`% change
`H1 2017
`toH12018
`
`54.337
`
`45,788
`84.3%
`
`13,541
`24.9%
`
`6,617
`12.2%
`
`1,715
`3.2%
`
`737
`
`24,652
`45.4%
`
`1,455
`
`26,107
`
`5,013
`19.2%
`
`21,094
`38.8%
`
`1,500
`3,897
`
`25,585
`20,468
`
`103,248
`49,081
`47.5%
`
`2,436.6
`8.66
`
`43,105
`
`57,090
`
`48,430
`84.8%
`
`13,548
`23.7%
`
`6,703
`11 .7%
`
`1,770
`3.1%
`
`467
`
`26,876
`47.1%
`
`(1,229)
`
`25,647
`
`5,540
`21.6%
`
`20,107
`35.2%
`
`1,571
`3,538
`
`22,215
`18,792
`
`97,825
`48,436
`49.5%
`
`2,492.0
`8.07
`
`41,385
`
`(5%)
`
`(5%)
`
`0%
`
`(1%)
`
`(3%)
`
`58%
`
`(8%)
`
`NIA
`
`2%
`
`(10%)
`
`5%
`
`(5%)
`10%
`
`15%
`9%
`
`6%
`1%
`
`(2%)
`7%
`
`4%
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Legal
`
`Financial
`Information
`
`Company ann01.11cement No 60 / 2018
`
`Novo Nordisk Exhibit 2495
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financial report for the period 1 January 2018 to 30 June 2018
`
`Page 5 of 30
`
`SALES DEVELOPMENT
`Sales decreased by 5% measured in Danish kroner and increased by 4% in local currencies in the first six months of
`2018, reflecting a significant impact from the depreciation of the US dollar and related currencies versus the Danish
`krone. Sales growth in local currencies was realised within diabetes care and obesity with the majority of growth
`originating from Victoza®, Tresiba®, Xultophy®and Saxenda®, partly offset bl declining sales of Levemir®. Declining
`sales within biopharmaceuticals was driven by declining sales of NovoSeven and 'Other biopharmaceuticals' partly
`offset by increased sales of NovoEight® and Norditropin411
`.
`
`Sales split per therapy
`The diabetes care and obesity segment
`
`SalesH1
`2018 DKK
`million
`
`Sales H1
`2017 DKK
`million
`
`Growth
`as reported
`
`Growth
`in local
`currencies
`
`Share of
`growth
`in local
`currencies
`
`Long-acting insulin
`- Tresiba•
`- Xultophya
`- Levemi,.
`
`Premix insulin
`- Ryzodega
`- NovoMiX-
`
`Fast-acting insulin
`- Fiasp•
`- NovoRapi~
`
`Human insulin
`
`Total insulin
`
`Total GLP-1
`- Victoza•
`- OzempiC:-
`Other diabetes care 1l
`
`Total diabetes care
`
`Obesity (Saxenda•)
`
`Diabetes care and obesity total
`
`The blopharmaceuticals segment
`Haemophilia2>
`- NovoSeven•
`- NovoEigh,.-
`Growth disorders (Norditropin•)
`Other biopharmaceuticals3>
`Biopharmaceuticals total
`
`10,230
`3,707
`720
`5,803
`
`5,229
`320
`4,909
`
`9,714
`220
`9,494
`
`4,701
`
`29,874
`
`11,982
`11,718
`264
`
`2,132
`
`43,988
`
`1,653
`
`45,641
`
`4,797
`4,040
`635
`3,184
`715
`8,696
`
`11,582
`3,689
`284
`7,609
`
`5,565
`196
`5,369
`
`10,419
`16
`10,403
`
`4,971
`
`32,537
`
`11,525
`11,525
`
`2,244
`
`46,306
`
`1,225
`
`47,531
`
`5,315
`4,663
`576
`3,325
`919
`9,559
`
`Total sales
`
`54,337
`
`57,090
`
`1> Primarily NovoNorm•, needles and GlucaGen• HypoKit9
`.
`2> Comprises NovoSeven•, NovoEight9
`, Novo Thirteen• and Refixia9
`3> Primarily Vagifem• and Activelle8
`
`.
`
`.
`
`(12%)
`0%
`154%
`(24%)
`
`(6%)
`63%
`(9%)
`
`(7%)
`
`(9%)
`
`(5%)
`
`(8%)
`
`4%
`2%
`
`(5%)
`
`(5%)
`
`35%
`
`(4%)
`
`(10%)
`(13%)
`10%
`(4%)
`(22%)
`(9%)
`
`(5%)
`
`(3%)
`11%
`165%
`(16%)
`
`1%
`79%
`(2%)
`
`2%
`
`0%
`
`1%
`
`0%
`
`14%
`12%
`
`2%
`
`4%
`
`50%
`
`5%
`
`(2%)
`(6%)
`16%
`5%
`(18%)
`(1%)
`
`4%
`
`(17%)
`19%
`22%
`(58%)
`
`3%
`7%
`(4%)
`
`9%
`10%
`(1%)
`
`4%
`
`(1%)
`
`77%
`63%
`14%
`
`2%
`
`78%
`
`29%
`
`106%
`
`(6%)
`(13%)
`4%
`7%
`(7%)
`(6%)
`
`100%
`
`International Operations was the main driver of the sales growth, and the growth contributors were Region MMEO
`(Africa, Asia, Middle East and Oceania), Region Latin America, Region China and Region Europe, partly offset by
`Region Japan & Korea. Sales growth in Region Latin America of 46% measured in local currencies was positively
`impacted by 7 percentage points due to inflationary price effects in countries with high inflation.
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Legal
`
`Financial
`Information
`
`Company announcement No 60 / 2018
`
`Novo Nordisk Exhibit 2495
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2018 to 30 June 2018
`
`Page 6 of 30
`
`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 H1 2018
`DKKmllUon
`
`Growth
`as reported
`
`Growth
`in local currencies
`
`Share of growth
`in local currencies
`
`26,955
`25,830
`27,382
`10,693
`6,093
`5,780
`2,741
`2,075
`
`54,337
`
`(10%)
`(11%)
`1%
`1%
`1%
`2%
`(10%)
`19%
`
`(5%)
`
`0%
`0%
`8%
`2%
`15%
`6%
`(3%)
`46%
`
`4%
`
`1%
`(6%)
`99%
`8%
`42%
`16%
`(4%)
`37%
`
`100%
`
`Please refer to appendix 6 for further details on sales in the first six months of 2018.
`
`In the following sections, unless otherwise noted, market data are based on moving annual total (MAD from May
`2018 and May 2017 provided by the independent data provider IQVIA.
`
`DIABETES CARE AND OBESITY. SALES DEVELOPMENT
`Sales of diabetes care and obesity products decreased by 4% measured in Danish kroner and increased by 5% in
`local currencies to DKK 45,641 million. Novo Nordisk is the world leader in diabetes care with a global value market
`share of 27%.
`
`Insulin
`Sales of insulin decreased by 8% to DKK 29,874 million measured in Danish kroner and remained unchanged in
`local currencies. Measured in local currencies, sales growth was driven by International Operations, where all five
`regions apart from Region Japan & Korea contributed to growth, offset by lower sales in North America Operations.
`Novo Nordisk is the global leader with 46% of the total insulin market and 45% of the market for modem insulin
`and new-generation insulin, both measured in volume.
`
`Sales of long-acting insulin (Tresiba.,, Xultophy9 and Levemir~ decreased by 12% measured in Danish kroner and
`3% in local currencies to DKK 10,230 million.
`
`Sales of Tresiba® (insulin degludec), the once-daily new-generation insulin, reached DKK 3,707 million compared
`with DKK 3,689 million in 2017. The roll-out of Tresiba® continues and the product has now been launched in 70
`coul'ltries. Generally, Tresiba9 has shown solid penetration in markets with reimbursement at a similar level to insulin
`glargine U100, whereas penetration remains modest in markets with restricted market access.
`
`Sales of Xultophy®, a once-daily combination of insulin degludec (Tresiba~ and liraglutide (Victoza~, reached DKK
`720 million compared with DKK 284 million in 2017. Sales growth was driven by both International Operations,
`where predominantly Region Europe contributed to growth, and North America Operations. Xultophy9 has been
`launched in 22 countries.
`
`Sales of premix insulin (Ryzodeg• and NovoMix~ decreased by 6% measured in Danish kroner and increased by 1 %
`in local currencies to DKK 5,229 million.
`
`Sales of Ryzodeg®, a soluble formulation of insulin degludec and insulin aspart, reached DKK 320 million compared
`with DKK 196 million in 2017. Ryzodeg® has been marketed in 20 countries, and feedback from patients and
`prescribers is encouraging.
`
`Sales of fast-acting insulin (Fiasp® and NovoRapid~ decreased by 7% to DKK 9,714 million measured in Danish
`kroner and increased by 2% in local currencies.
`
`Sales of Rasp®, the novel mealtime fast-acting insulin aspart, were DKK 220 million. Fiasp® has now been launched
`in 18 countries.
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Legal
`
`Financial
`Information
`
`Company announcement No 60 / 2018
`
`Novo Nordisk Exhibit 2495
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2018 to 30 June 2018
`
`Page 7 of 30
`
`INSULIN MARKET SHARES
`(volume, MAD
`
`Novo Nordisk's share
`of the total insulin market
`
`Novo Nordisk's sha,-
`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****
`
`May
`2018
`
`46.1%
`39.6%
`39.9%
`48.9%
`43.8%
`56.0%
`51.9%
`50.0%
`43.4%
`
`May
`2017
`
`45.9%
`37.7%
`37.8%
`49A%
`44.6%
`56.5%
`53.4%
`49.3%
`41.8%
`
`May
`2018
`
`45.1%
`40.4%
`41.1%
`47.5%
`43.5%
`50.8%
`60.7%
`49.9%
`38.6%
`
`May
`2017
`
`44.6%
`38.5%
`38.9%
`47.9%
`44.2%
`51.3%
`61.1%
`48.6%
`39.8%
`
`Source: IQVIA, May 2018 data. * Modem insulin and new-generation insulin comprises the following Novo Nordisk products: Levemir•, NovoMix•, NovoRapid•,
`Tresiba•, Xultophy•, Ryzodeg• and Fiasp• •• Data available for 11 private markets representing approximately 70% of total Novo Nordisk's diabetes care 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 care sales in the region.
`
`North America Operations
`Sales of insulin in North America Operations decreased by 17% in Danish kroner and by 7% in local currencies. The
`decline in sales in the USA in the basal insulin segment was mainly driven by lower realised prices for Levemir9 and
`phasing of rebates in 2017 for Tresiba9 partly offset by higher sales of Tresiba9 following a net market share gain of
`approximately 3 percentage points in the basal insulin segment, underlying volume growth as well as increased sales
`of Xultophy9 100/3.6. The decline in sales decline in the USA in the short-acting insulin segment was driven by lower
`realised prices due to phasing of rebates in 2017 for Novolog9 partly offset by underlying volume growth.
`
`International Operations
`Sales of insulin in International Operations remained unchanged in Danish kroner and increased by 7% in local
`currencies. Sales growth measured in local currencies was driven by modern and new-generation, long-acting,
`premix and fast-acting insulin, partly offset by declining human insulin sales.
`
`Region Europe
`Sales of insulin in Region Europe increased by 1 % in Danish kroner and by 2% in local currencies. Sales were driven
`by the penetration of Xultophy9
`, Fiasp® and Tresiba9 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 AAMEO increased by 2% in Danish kroner and by 16% in local currencies. The sales
`growth measured in local currencies was driven by growth of the overall diabetes care market and 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 1 % in Danish kroner and by 5% 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, and Novo Nordisk has improved its market share in the long-acting insulin segment and broadly
`stabilised the modern insulin market share, partly offset by lower human insulin sales.
`
`Region Japan & Korea
`Sales of insulin in Region Japan & Korea decreased by 10% in Danish kroner and by 3% 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
`
`Legal
`
`Financial
`Information
`
`Company announcement No 60 / 2018
`
`Novo Nordisk Exhibit 2495
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financial report for the period 1 January 2018 to 30 June 2018
`
`Page 8 of 30
`
`Region Latin America
`Sales of insulin in Region Latin America decreased by 3% in Danish kroner and increased by 22% in local currencies.
`The sales growth measured in local currencies was driven by growth of the overall diabetes care market, inflationary
`price effects and positive volume contribution from all three insulin segments: long-acting, premix and fast-acting as
`well as human insulin.
`
`GLP-1 therapy for type 2 diabetes
`Sales of GLP-1 therapy for type 2 diabetes (Victoza• and Ozempic9) increased by 4 % in Danish kroner and by 14 %
`in local currencies to DKK 11,982 million. Sales growth is predominantly driven by North America Operations
`comprising 77% share of the GLP-1 growth. The GLP-1 segment's value share of the total diabetes care market has
`increased to 13.0% compared with 10.7% 12 months ago. Victoza• continues to be the market leader in the GLP-1
`segment with a 47% value market share.
`
`GLP-1 MARKET SHARES
`(value, MAl)
`
`GLP-1 share of total
`diabetes care market
`
`Vktoza• share
`of GLP-1 market
`
`Global
`North America Operations
`• USA
`International Operations
`- Region Europe
`- Region AAMEO*
`- Region China••
`- Region Japan & Korea
`- Region Latin America***
`
`May
`2018
`
`13.0%
`15A%
`15.5%
`7.1%
`11.1%
`2.9%
`1.0%
`5.2%
`5.7%
`
`May
`2017
`
`10.7%
`12.6%
`12.7%
`6.1%
`10.0%
`2.5%
`0.9%
`4.0%
`4.9%
`
`May
`2018
`
`47%
`46%
`45%
`54%
`56%
`46%
`78%
`36%
`70%
`
`May
`2017
`
`53%
`52%
`51%
`61%
`61%
`51%
`61%
`50%
`83%
`
`Source: IQVIA, May 2018 data MAT. • Data for 11 selected private markets representing approximately 70% of Novo Nordisk's total diabetes care sales in the region.
`•• Data for mainland China, exduding Hong Kong and Taiwan .... Data for three selected private markets representing approximately 70% of Novo Nordisk's total
`diabetes care sales in the region.
`
`North America Operations
`Sales of Novo Nordisk's GLP-1 diabetes products (Victoza• and Ozempic9) in North America Operations increased by
`3% in Danish kroner and increased by 15% in local currencies. Sales growth is driven by an underlying prescription
`volume growth of the GLP-1 class of more than 20%, and Novo Nordisk is the market leader with a 46% value
`market share. The value share of the GLP-1 class of the total North American diabetes care market has increased to
`15.4%.
`
`In February 2018, Novo Nordisk launched Ozempic• in the USA. a new once-weekly GLP-1, and the initial feedback
`from prescribers and payers is positive and the formulary coverage for Ozempic® is progressing well. The weekly
`new-to-brand prescription market share for Ozempic• has reached 14%. Sales of Victoza,. remained unchanged in
`Danish kroner and increased by 11 % in local currencies. Sales growth of Victoza• is driven by the positive impact
`from the updated label for Victoza• reflecting cardiovascular benefits, partly offset by rebate adjustments related to
`prior periods and an impact from the launch of Ozempic•.
`
`International Operations
`Sales of Victoza• in International Operations increased by 8% 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 International Operations diabetes care
`market has increased to 7 .1 % from 6.1 % in 2017. Victoza• is the market leader with a 54% value market share.
`
`Region Europe
`Sales in Region Europe increased by 9% in both Danish kroner and in local currencies. The sales development
`reflects positive impact from the expanded CV label for Victoza• as well as competition from a once-weekly product.
`In Region Europe, the value share of the GLP-1 class of the total diabetes care market has increased to 11.1 % .
`Victoza• remains the market leader in Region Europe with a 56% value market share.
`
`Financial
`Performance
`
`Outlook
`
`R&D
`
`I Sustainability I Equity
`
`Legal
`
`Financial
`Information
`
`Company announcement No 60 / 2018
`
`Novo Nordisk Exhibit 2495
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financial report for the period 1 January 2018 to 30 June 2018
`
`Page 9 of 30
`
`Region AAMEO
`Sales in Region MMEO decreased by 5% in Danish kroner and increased by 8% in local currencies. Sales growth is
`primarily driven by a number of countries in the Middle East. The value share of the GLP-1 class of the total diabetes
`care market increased to 2.9%. Victoza® is the GLP-1 market leader across Region MMEO with a value market
`share of 46%.
`
`Region China
`Sales in Region China increased by 50% in Danish kroner and by 57% in local currencies. The increase in sales
`reflects the indusion of Victoza® in the Chinese National Reimbursement Drug List in July 2017. In China, Victoza®
`has increased its GLP-1 value market share to 78%, however, the GLP-1 class only represents 1.0% of the total
`diabetes care market measured in value.
`
`Region Japan & Korea
`Sales in Region Japan & Korea decreased by 1 % in Danish kroner and increased by 6% in local currencies. The sales
`growth measured in local currencies 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 represents 5.2% of
`the total diabetes care market value compared with 4.0% in 2017. Victoza® holds a value market share of 36%.
`
`Region Latin America
`Sales in Region Latin America increased by 8% in Danish kroner and by 30% in local currencies. The sales growth
`reflects the continued expansion of the GLP-1 markets across the region. In Region Latin America, the GLP-1 class
`represents 5.7% of the total diabetes care market value compared with 4.9% in 2017. Victoza® remains the leader
`in the class with a value market share of 70% .
`
`Other diabetes care
`Sales of other diabetes care products, predominantly consisting of oral antidiabetic products, needles and
`GlucaGen®HypoKit®, declined by 5% to DKK 2, 132 million and increased by 2 % in local currencies. Increasing sales
`measured in local currencies were both seen in North America Operations and in International Operations, where
`Region Latin America and Region China contributed to sales growth.
`
`Saxenda• (obesity)
`Sales of Saxenda®, liraglutide 3 mg for weight management, increased by 35% in Danish kroner and by 50% in
`local currencies to DKK 1,653 million. Sales growth was driven by both North America Operations and International
`Operations, where Region MMEO, Region Latin America and Region Europe contributed to growth. Saxenda® was
`launched in May 2015 in the USA and has obtained broad commercial formulary market access, but generally with
`prior authorisation requirements. Saxenda® has now been launched in 30 countries.
`
`BIOPHARMACEUTICALS, SALES DEVELOPMENT
`Sales of biopharmaceutical products decreased by 9% measured in Danish kroner and by 1 % in local currencies to
`DKK 8,696 million. Decreasing sales were realised in North America Operations, partly offset by increased sales in
`International Operations.
`
`Haemophilia
`Sales of haemophilia products decreased by 10% measured in Danish kroner and by 2% in local currencies to DKK
`4,797 million. The sales decrease was primarily driven by lower NovoSeven® sales in the USA and Region Europe
`reflecting increased competition from a recently introduced product as well as increased clinical trial activity from
`competing products, partly offset by increased NovoSeven® sales in Region Latin America due to timing of tender
`deliveries. Furthermore, sales of NovoEight® in Region Europe and Region AAMEO contributed positively to the sales
`development.
`
`Growth disorders (Norditropin•)
`Sales of growth disorder products decreased by 4% to DKK 3, 184 million measured in Danish kroner and increased
`by 5% ~n local currencies. The sales development measured in local currencies was driven by positive contribution
`from North America Operations driven by higher realised prices in the USA, offset by declining sales in International
`Operations predominantly Region Europe and Region Japan & Korea. Novo Nordisk is the leading company in the
`global human growth disorder market with a 27% market share measured in volume.
`
`Financial I Outlook
`
`Performance
`
`R&D
`
`I Sustainability I Equity
`
`Legal
`
`Financial
`Information
`
`Company announcement No 60 / 2018
`
`Novo Nordisk Exhibit 2495
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2018 to 30 June 2018
`
`Page 10 of 30
`
`Other biopharmaceuticals
`Sales of other products within biopharmaceuticals, which predominantly consist of hormone replacement therapy(cid:173)
`related (HRn products, declined by 22% measured in Danish kroner and by 18% in local currencies to DKK 715
`million, primarily reflecting an effect from the launch of a generic version of Vagifem® in the USA.
`
`DEVELOPMENT IN COSTS AND OPERATING PROFIT
`The cost of goods sold declined by 1 % at DKK 8,549 million, resulting in a gross margin of 84.3% measured in
`Danish kroner, compared with 84.8% in 2017. The decline in gross margin refle