`
`
`
`Financial report for the period 1 January 2019 to 31 March 2019
`
`3 May 2019
`
`Novo Nordisk's operating profit increased by 14% in Danish kroner and by 8%
`at constant exchange rates (CER) in the first three months of 2019
`
`• Sales increased by 9% in Danish kroner and by 4% at CER to DKK 29.3 billion. Operating profit growth of 8%
`at CER was positively impacted by a reversal of write-downs of oral semaglutide prelaunch inventory.
`
`
`• Sales in International Operations increased by 13% in Danish kroner (13% at CER), driven by growth in all
`regions and positively impacted by timing of shipments. Sales in North America Operations increased by 4% in
`Danish kroner (decreased 4% at CER), negatively impacted by inventory reductions.
`
`
`• Sales within Diabetes and obesity increased by 10% to DKK 24.8 billion (5% at CER), driven by Diabetes
`growing 4% at CER and Obesity growing 51% at CER. Sales within biopharmaceuticals increased by 3% to DKK
`4.5 billion (unchanged at CER).
`
`• Sales of Ozempic® were DKK 1,425 million and it has now been launched in 19 countries. In the USA, the new-
`to-brand prescription market share for Ozempic® has now exceeded 30% bringing Novo Nordisk's combined
`GLP-1 new-to-brand prescription market share to 50%.
`
`
`• Oral semaglutide has been filed for regulatory approval of glycaemic control in both the USA and the EU.
`Furthermore, oral semaglutide and Ozempic® have been filed for regulatory approval for CV risk reduction in the
`USA.
`
`
`
`• For the 2019 outlook, sales growth is still expected to be 2-5% at CER, and operating profit growth is still
`expected to be 2-6% at CER.
`
`
`
`PROFIT AND LOSS
`DKK million
`
`Net sales
`
`Operating profit
`
`Net profit
`
`Diluted earnings per share
`
`* CER: Constant exchange rates (average 2018)
`
`Q1 2019
`
`Growth
`as reported
`
`Growth
`at CER*
`
`29,291
`
`14,239
`
`10,445
`
`4.36
`
`9%
`
`14%
`
`(3%)
`
`(1%)
`
`4%
`
`8%
`
`N/A
`
`N/A
`
`Lars Fruergaard Jørgensen, president and CEO: "We delivered very solid performance in International
`Operations, driven by sales growth in all regions, meanwhile, sales in the USA were negatively impacted by
`inventory reductions. The global launch of Ozempic®, our new once-weekly GLP-1, is well on track and continues
`to gain market share. From a regulatory perspective, we achieved important milestones with the filing of oral
`semaglutide both in the USA and the EU. Based on the progress we made in the first quarter of 2019, we are on
`track to deliver on our outlook for the full-year.”
`
`On 3 May 2019 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.
`
`Novo Nordisk A/S
`Investor Relations
`
`Novo Allé
`2880 Bagsværd
`Denmark
`
`Telephone:
`+45 4444 8888
`www.novonordisk.com
`
`CVR Number:
`24 25 67 90
`
`Company Announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 2 of 28
`
`FINANCIAL PERFORMANCE
`
`CONSOLIDATED FINANCIAL STATEMENT FOR THE FIRST THREE MONTHS OF 2019
`
`PROFIT AND LOSS
`DKK million
`
`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
`
`Q1 2019
`
`Q1 2018
`
` % change Q1 2019
`to Q1 2018
`
`29,291
`
`24,559
`83.8%
`
`6,946
`23.7%
`
`2,678
`9.1%
`
`911
`3.1%
`
`215
`
`14,239
`48.6%
`
`(1,017)
`
`13,222
`
`2,777
`21.0%
`
`10,445
`35.7%
`
`1,058
`2,101
`
`9,890
`6,655
`
`110,135
`47,319
`43.0%
`
`2,394.6
`4.36
`
`42,453
`
`26,930
`
`22,733
`84.4%
`
`6,451
`24.0%
`
`3,321
`12.3%
`
`864
`3.2%
`
`351
`
`12,448
`46.2%
`
`1,161
`
`13,609
`
`2,858
`21.0%
`
`10,751
`39.9%
`
`732
`2,310
`
`9,815
`7,241
`
`93,558
`44,238
`47.3%
`
`2,442.3
`4.40
`
`42,688
`
`9%
`
`8%
`
`8%
`
`(19%)
`
`5%
`
`(39%)
`
`14%
`
`N/A
`
`(3%)
`
`(3%)
`
`(3%)
`
`45%
`(9%)
`
`1%
`(8%)
`
`18%
`7%
`
`(2%)
`(1%)
`
`(1%)
`
`These unaudited consolidated financial statements for the first three months of 2019 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 2018 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 2019. This includes IFRS 16 'Leases' applied on a modified retrospective basis, see
`appendix 7. Furthermore, the financial report, including the consolidated financial statements for the first three
`months of 2019 and the Management’s review, have been prepared in accordance with additional Danish disclosure
`requirements for interim reports of listed companies. Going forward, the term 'constant exchange rates' (CER) will
`be used in stead of 'local currencies'. There is no difference between the two terms.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 3 of 28
`
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 9% measured in Danish kroner and by 4% at CER to DKK 29,291 million in the first three months
`of 2019. Sales in International Operations increased by 13% in both Danish kroner and at CER, positively impacted
`by timing of shipments primarily in Region AAMEO and Region Latin America. Sales in North America Operations
`increased by 4% measured in Danish kroner and decreased by 4% at CER, negatively impacted by inventory
`reductions.
`
`Sales split per region
`
`International Operations
` - Region Europe
` - Region AAMEO
` - Region China
` - Region Japan & Korea
` - Region Latin America
`North America Operations
` - USA
`
`Total sales
`
` Sales Q1 2019
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of growth
`at CER
`
`15,387
`5,505
`3,738
`3,375
`1,458
`1,311
`13,904
`13,211
`
`29,291
`
`13%
`5%
`29%
`11%
`16%
`14%
`4%
`3%
`
`9%
`
`13%
`5%
`29%
`9%
`9%
`20%
`(4%)
`(5%)
`
`4%
`
`143%
`22%
`70%
`22%
`10%
`19%
`(43%)
`(59%)
`
`100%
`
`International Operations
`Sales in International Operations increased by 13% in both Danish kroner and at CER. Sales growth was driven by
`growth in all regions, and key drivers being Region AAMEO growing 29% (CER), Region Europe growing 5% (CER)
`and Region China growing 9% (CER). Sales growth was driven by increasing insulin, GLP-1 and obesity sales while
`sales in Biopharm were broadly unchanged.
`
`Region Europe
`Sales in Region Europe increased by 5% in both Danish kroner and at CER. Sales growth was driven by Diabetes
`growing 7% (CER) from increased GLP-1 and new-generation insulin sales, and Obesity growing 74% (CER), partly
`offset by Biopharm declining by 4% (CER).
`
`Region AAMEO
`Sales in Region AAMEO increased by 29% in both Danish kroner and at CER. Sales growth was driven by Diabetes
`growing 27% (CER) from increased insulin sales, Obesity growing 149% (CER) and Biopharm growing by 18%
`(CER). Sales were positively impacted by timing of shipments, mainly in Diabetes.
`
`Region China
`Sales in Region China increased by 11% measured in Danish kroner and by 9% at CER. Sales growth was driven by
`Diabetes growing 8% (CER) from increased modern insulin and GLP-1 sales.
`
`Region Japan & Korea
`Sales in Region Japan & Korea increased by 16% measured in Danish kroner and by 9% at CER. Sales growth was
`driven by Obesity following the introduction of Saxenda® in Korea in 2018 and Biopharm growing by 9% (CER),
`while Diabetes sales were unchanged at CER.
`
`Region Latin America
`Sales in Region Latin America increased by 14% measured in Danish kroner and by 20% at CER. Sales growth was
`driven by Diabetes growing 37% (CER) from increased insulin and GLP-1 sales, and Obesity growing 90% (CER),
`partly offset by Biopharm declining by 17% (CER) reflecting timing of tender shipments.
`
`North America Operations
`Sales in North America Operations increased by 4% measured in Danish kroner and decreased by 4% at CER. Sales
`decline was driven by the USA declining by 5% (CER) negatively impacted by inventory reductions, adjusted hereof,
`sales are broadly unchanged, which reflects increased GLP-1 sales, partly offset by declining insulin sales as well as
`increased Obesity sales, partly offset by declining Biopharm sales.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 4 of 28
`
`SALES DEVELOPMENT ACROSS THERAPEUTIC CATEGORIES
`Total sales growth in the first three months of 2019 of 9% in Danish kroner and 4% measured at CER was driven by
`solid growth in Diabetes of 4% (CER) and Obesity growth of 51% (CER), partly offset by unchanged Biopharm sales
`when measured at CER.
`
`Sales split per therapy
`Diabetes and obesity segment
`
` Sales Q1 2019
`DKK million
`
` Sales Q1 2018
`DKK million
`
`Growth
`as reported
`
`Growth
`at CER
`
`Share of
`growth
`at CER
`
`Long-acting insulin
`-   Tresiba®
`-   Xultophy®
`-   Levemir®
`
`Premix insulin
`-   Ryzodeg®
`-   NovoMix®
`
`Fast-acting insulin
`-   Fiasp®
`-   NovoRapid®
`
`Human insulin
`
`Total insulin
`
`Victoza®
`Ozempic®
`Total GLP-1
`Other diabetes1)
`
`Total diabetes
`
`Obesity (Saxenda®)
`
`Diabetes and obesity total
`
`Biopharmaceuticals segment
`Haemophilia2)
`-   NovoSeven®
`-   NovoEight®
`Growth disorders (Norditropin®)
`Other biopharmaceuticals3)
`Biopharmaceuticals total
`
`5,244
`2,147
`477
`2,620
`
`2,757
`212
`2,545
`
`4,977
`231
`4,746
`
`2,415
`
`15,393
`
`5,722
`1,425
`7,147
`
`1,067
`
`23,607
`
`1,211
`
`24,818
`
`2,533
`2,012
`393
`1,555
`385
`4,473
`
`4,873
`1,755
`338
`2,780
`
`2,642
`141
`2,501
`
`4,778
`83
`4,695
`
`2,366
`
`14,659
`
`5,989
`69
`6,058
`
`1,121
`
`21,838
`
`770
`
`22,608
`
`2,503
`2,154
`296
`1,481
`338
`4,322
`
`Total sales
`
`29,291
`
`26,930
`
`1) Primarily oral antidiabetic products, needles and GlucaGen® HypoKit®.
`2) Comprises NovoSeven®, NovoEight®, NovoThirteen® and Refixia®.
`3) Primarily Vagifem® and Activelle®.
`
`8%
`22%
`41%
`(6%)
`
`4%
`50%
`2%
`
`4%
`178%
`1%
`
`2%
`
`5%
`
`(4%)
`-
`18%
`
`(5%)
`
`8%
`
`57%
`
`10%
`
`1%
`(7%)
`33%
`5%
`14%
`3%
`
`9%
`
`3%
`16%
`38%
`(10%)
`
`3%
`49%
`0%
`
`0%
`167%
`(3%)
`
`0%
`
`2%
`
`(10%)
`-
`11%
`
`(7%)
`
`4%
`
`51%
`
`5%
`
`(3%)
`(11%)
`29%
`1%
`13%
`0%
`
`4%
`
`11%
`23%
`11%
`(23%)
`
`6%
`6%
`0%
`
`2%
`12%
`(10%)
`
`0%
`
`19%
`
`(48%)
`104%
`56%
`
`(7%)
`
`68%
`
`33%
`
`101%
`
`(6%)
`(19%)
`7%
`1%
`4%
`(1%)
`
`100%
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 5 of 28
`
`DIABETES AND OBESITY
`Diabetes, sales development
`Sales in Diabetes increased by 8% measured in Danish kroner and by 4% at CER to DKK 23,607 million driven by
`solid GLP-1 and insulin growth. Novo Nordisk has improved the global diabetes value market share over the last 12
`months from 27.5% to 28.1%, driven by improved global insulin market share and growth of the GLP-1 segment,
`partly offset by declining GLP-1 market share.
`
`In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from
`February 2019 and February 2018 provided by the independent data provider IQVIA.
`
`Diabetes, regional development
`
`Novo Nordisk’s share
`of the total diabetes market (value, MAT)
`
`Diabetes, sales development
`
`Global
`International Operations
` - Region Europe
` - Region AAMEO *
` - Region China **
` - Region Japan & Korea
` - Region Latin America ***
`North America Operations
` - USA
`
`February
`2019
`
`28.1%
`22.1%
`26.7%
`21.8%
`28.1%
`9.8%
`16.4%
`30.4%
`30.7%
`
`February
`2018
`
`27.5%
`22.3%
`26.9%
`21.9%
`30.1%
`10.4%
`15.7%
`29.6%
`29.9%
`
` Sales Q1 2019
`DKK million
`
`Growth
`at CER
`
`23,607
`12,039
`4,226
`2,925
`3,291
`833
`764
`11,568
`11,105
`
`4%
`13%
`7%
`27%
`8%
`0%
`37%
`(5%)
`(6%)
`
`Source: IQVIA, February 2019 data. * 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.
`
`Insulin
`Total sales of insulin increased by 5% measured in Danish kroner and by 2% at CER to DKK 15,393 million. Sales
`growth was driven by International Operations, partly offset by declining sales in the USA.
`
`Sales of long-acting insulin increased by 8% measured in Danish kroner and by 3% at CER to DKK 5,244 million.
`Novo Nordisk has improved its global volume market share in the long-acting insulin segment from 30.9% to 32.1%
`the last 12 months. Sales were driven by Tresiba® and Xultophy®, partly offset by Levemir®. Tresiba® has now been
`launched in 79 countries, while Xultophy® now has been launched in 32 countries.
`
`Sales of premix insulin increased by 4% measured in Danish kroner and by 3% at CER to DKK 2,757 million. Novo
`Nordisk is market leader in the segment and has improved its global volume market share in the premix insulin
`segment from 63.6% to 64.3% the last 12 months. The increase in sales was driven by Ryzodeg® while sales of
`NovoMix® were broadly unchanged. Ryzodeg® has been launched in 27 countries.
`
`Sales of fast-acting insulin increased by 4% measured in Danish kroner, and remained unchanged at CER, to DKK
`4,977 million. Novo Nordisk is market leader in the segment and the global volume market share in the fast-acting
`insulin segment of 51.0% has been unchanged over the past 12 months. The unchanged sales measured at CER
`were positively impacted by Fiasp®, offset by declining sales of NovoRapid®. Fiasp® has now been launched in 27
`countries.
`
`Sales of human insulin increased by 2% measured in Danish kroner, and remained unchanged at CER, to DKK 2,415
`million.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 6 of 28
`
`Insulin, regional development
`
`Novo Nordisk’s share
`of the total insulin market (volume, MAT)
`
`Insulin, sales development
`
`Global
`International Operations
` - Region Europe
` - Region AAMEO *
` - Region China **
` - Region Japan & Korea
` - Region Latin America ***
`North America Operations
` - USA
`
`February
`2019
`
`46.7%
`49.4%
`43.9%
`57.0%
`50.7%
`50.4%
`47.8%
`40.2%
`40.6%
`
`February
`2018
`
`46.1%
`49.1%
`44.4%
`55.6%
`52.7%
`49.8%
`42.5%
`39.2%
`39.5%
`
` Sales Q1 2019
`DKK million
`
`Growth
`at CER
`
`15,393
`9,333
`3,041
`2,479
`2,640
`582
`591
`6,060
`5,828
`
`2%
`13%
`3%
`30%
`9%
`(5%)
`40%
`(13%)
`(14%)
`
`Source: IQVIA, February 2019 data. * 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.
`
`International Operations
`Sales of insulin in International Operations increased by 13% in both Danish kroner and at CER. Sales growth
`measured at CER was driven by long-acting, premix and fast-acting insulin as well as increasing human insulin sales.
`
`Region Europe
`Sales of insulin in Region Europe increased by 4% measured in Danish kroner and by 3% at CER. Sales growth was
`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 human insulin and NovoMix® sales.
`
`Region AAMEO
`Sales of insulin in Region AAMEO increased by 29% measured in Danish kroner and by 30% at CER. The sales
`growth was driven by increased sales of NovoRapid®, human insulin and NovoMix®.
`
`Region China
`Sales of insulin in Region China increased by 12% measured in Danish kroner and by 9% at CER. The sales growth
`was driven by NovoMix®, NovoRapid® and Levemir®, partly offset by lower human insulin sales.
`
`Region Japan & Korea
`Sales of insulin in Region Japan & Korea increased by 1% measured in Danish kroner and decreased by 5% at CER.
`The decline in sales at CER was driven by NovoRapid® and NovoMix®, 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® in Japan.
`
`Region Latin America
`Sales of insulin in Region Latin America increased by 30% measured in Danish kroner and by 40% at CER. The sales
`growth was driven by growth of the overall diabetes market, market share gains, inflationary price effects and
`increased sales of human insulin, NovoRapid® and Tresiba®.
`
`North America Operations
`Sales of insulin in North America Operations decreased by 6% measured in Danish kroner and by 13% at CER. The
`sales were negatively impacted by inventory reductions, impacting all insulin segments. Novo Nordisk expanded its
`volume market share from 39.2% to 40.2% measured over the last 12 months, and the expansion was driven by
`continued market share gains in the basal insulin segment. In addition to the inventory reductions, the decline in
`sales in the USA was driven by lower realised prices, including negative impact from changes in the payer mix in
`short-acting insulin and the changes in the coverage gap legislation.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 7 of 28
`
`GLP-1 therapy for type 2 diabetes
`Sales of GLP-1 products for type 2 diabetes (Victoza® and Ozempic®) increased by 18% measured in Danish kroner
`and by 11% at CER to DKK 7,147 million. Ozempic® has now been launched in 19 countries in North America
`Operations and Region Europe. Sales growth was driven by both International Operations and North America
`Operations. The GLP-1 segment’s value share of the total diabetes market has increased to 15.3% compared with
`12.3% 12 months ago. Novo Nordisk continues to be the global market leader in the GLP-1 segment with a 46.1%
`value market share.
`
`GLP-1, regional development
`
`Novo Nordisk's share of the diabetes
`GLP-1 market (value, MAT)*
`
`GLP-1, sales development
`
`Global
`International Operations
` - Region Europe
` - Region AAMEO **
` - Region China ***
` - Region Japan & Korea
` - Region Latin America ****
`North America Operations
` - USA
`
`February
`2019
`
`46.1%
`50.6%
`53.9%
`41.8%
`89.3%
`31.7%
`66.7%
`46.1%
`44.8%
`
`February
`2018
`
`48.5%
`54.9%
`57.2%
`47.6%
`72.2%
`38.1%
`72.5%
`47.3%
`46.8%
`
` Sales Q1 2019
`DKK million
`
`Growth
`at CER
`
`7,147
`1,842
`1,050
`272
`214
`147
`159
`5,305
`5,109
`
`11%
`25%
`21%
`11%
`90%
`10%
`35%
`7%
`6%
`
`Source: IQVIA, February 2019 data MAT. * Novo Nordisk's GLP-1 diabetes products comprise Victoza® and Ozempic® ** Data for 11 selected private markets
`representing approximately 70% of Novo Nordisk’s total diabetes sales in the region. *** Data for mainland China, excluding Hong Kong and Taiwan. **** Data for
`three selected private markets representing approximately 70% of Novo Nordisk’s total diabetes sales in the region.
`
`
`International Operations
`Sales of GLP-1 in International Operations increased by 25% in both Danish kroner and at CER. Sales growth is
`driven by all regions. The value share of the GLP-1 class of the total diabetes market has increased to 7.9% from
`6.8% in 2018. Novo Nordisk is the market leader with a 50.6% value market share.
`
`Region Europe
`Sales in Region Europe increased by 21% in both Danish kroner and at CER. The sales development reflects the
`positive impact from the expanded CV label for Victoza® and the introduction of Ozempic® in 17 countries, partly
`offset by competition from a once-weekly product. The initial feedback from the launch of Ozempic® has been
`positive. Novo Nordisk remains the market leader in Region Europe with a 53.9% value market share.
`
`Region AAMEO
`Sales in Region AAMEO increased by 15% measured in Danish kroner and by 11% at CER. The value share of the
`GLP-1 class of the total diabetes market remains low and Novo Nordisk is the GLP-1 market leader across Region
`AAMEO with a value market share of 41.8%.
`
`Region China
`Sales in Region China increased by 95% measured in Danish kroner and by 90% at CER. The increase in sales
`reflects the inclusion of Victoza® in the Chinese National Reimbursement Drug List in July 2017 as well as continued
`investments, which have driven the expansion of the GLP-1 category and increased the Victoza® GLP-1 value market
`share to 89.3%. The share of the GLP-1 class of the total diabetes market still remains low.
`
`Region Japan & Korea
`Sales in Region Japan & Korea increased by 17% measured in Danish kroner and by 10% at CER. The sales growth
`reflects the continued expansion of the GLP-1 market in Japan, partly offset by intensified competition from a once-
`weekly product. Novo Nordisk currently holds a value market share of 31.7%.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 8 of 28
`
`Region Latin America
`Sales in Region Latin America increased by 25% measured in Danish kroner and by 35% at CER. The sales growth
`reflects the continued expansion of the GLP-1 markets across the region. Novo Nordisk remains the market leader in
`the region with a value market share of 66.7%.
`
`North America Operations
`Sales of Novo Nordisk's GLP-1 diabetes products in North America Operations increased by 16% measured in Danish
`kroner and by 7% at CER. Novo Nordisk is the market leader with a 46.1% value market share. The value share of
`the GLP-1 class of the total North American diabetes market has increased to 18.1%.
`
`Sales growth in the USA is driven by an underlying prescription volume growth of the GLP-1 segment of more than
`25%. In February 2018, Novo Nordisk launched Ozempic® in the USA and broad formulary coverage has been
`obtained. The weekly new-to-brand prescription market share for Ozempic® has now reached 30% bringing Novo
`Nordisk's combined GLP-1 new-to-brand prescription market share to 50%, consequently the decline in the total
`Novo Nordisk GLP-1 market share has stabilised when measured on monthly prescriptions.
`
`Sales of total GLP-1 in the USA increased by 6% at CER. The increase in sales was driven by continued uptake of
`Ozempic®, partly offset by declining sales of Victoza®. The declining sales of Victoza® reflects a negative impact from
`inventory reductions, changes in the payer and channel mix and the changes in the coverage gap legislation,
`impacting average realised prices negatively. Furthermore, Victoza® was impacted by the continued competition
`from a once-weekly product, as well as the impact from the launch of Ozempic®.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 9 of 28
`
`Obesity, sales development
`Sales of Saxenda® increased by 57% measured in Danish kroner and by 51% at CER to DKK 1,211 million. Sales
`growth of Saxenda® was driven by both International Operations and North America Operations. Saxenda® has been
`launched in 41 countries.
`
`Obesity, regional development
`
`Global
`International Operations
` - Region Europe
` - Region AAMEO
` - Region China
` - Region Japan & Korea
` - Region Latin America
`North America Operations
` - USA
`
`Obesity, sales development
`
` Sales Q1 2019
`DKK million
`
`Growth
`at CER
`
`1,211
`540
`66
`236
`2
`77
`159
`671
`616
`
`51%
`146%
`74%
`149%
`—
`—
`90%
`13%
`13%
`
`International Operations
`Sales of Saxenda® in International Operations increased by 145% measured in Danish kroner and by 146% at CER
`driven by increased sales in all regions where Saxenda® has been introduced. Novo Nordisk currently has a value
`market share of 38% in the obesity market in International Operations.
`
`Region Europe
`Sales of Saxenda® in Region Europe increased by 74% in both Danish kroner and at CER. Saxenda® has now been
`launched in 18 countries in Region Europe. Novo Nordisk currently has a value market share of 45% in the obesity
`market in Region Europe.
`
`Region AAMEO
`Sales of Saxenda® in Region AAMEO increased by 157% measured in Danish kroner and by 149% at CER. Saxenda®
`has now been launched in 14 countries in Region AAMEO. Novo Nordisk currently has a value market share of 52%
`in the obesity market in Region AAMEO.
`
`Region Japan & Korea
`Sales of Saxenda® in Region Japan & Korea were driven by sales in South Korea following the launch in early 2018.
`
`Region Latin America
`Sales of Saxenda® in Region Latin America increased by 77% measured in Danish kroner and by 90% at CER.
`Saxenda® has now been launched in five countries in Region Latin America. Novo Nordisk currently has a value
`market share of 33% in the obesity market in Region Latin America.
`
`North America Operations
`Sales of Saxenda® in North America Operations increased by 22% measured in Danish kroner and by 13% at CER
`and were driven by increased sales in both the USA and Canada. Sales in the USA were negatively impacted by
`inventory reductions. Novo Nordisk currently has a value market share of 68% in the obesity market in North
`America Operations.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 10 of 28
`
`BIOPHARMACEUTICALS
`Biopharmaceuticals, sales development
`Sales of biopharmaceutical products increased by 3% measured in Danish kroner, and remained unchanged at CER,
`to DKK 4,473 million. The sales development measured at CER was driven by declining sales in North America
`Operations as well as Region Latin America and Region Europe offset by sales growth in Region AAMEO, Region
`Japan & Korea and Region China.
`
`Biopharmaceuticals, regional development
`
`Biopharmaceuticals, sales development
`
`Global
`International Operations
` - Region Europe
` - Region AAMEO
` - Region China
` - Region Japan & Korea
` - Region Latin America
`North America Operations
` - USA
`
` Sales Q1 2019
`DKK million
`
`Growth
`at CER
`
`4,473
`2,808
`1,213
`577
`82
`548
`388
`1,665
`1,490
`
`0%
`1%
`(4%)
`18%
`41%
`9%
`(17%)
`(3%)
`(9%)
`
`Haemophilia
`Sales of haemophilia products increased by 1% measured in Danish kroner and decreased by 3% at CER to DKK
`2,533 million. Declining sales were driven by lower NovoSeven® sales, partly offset by increased NovoEight® and
`Refixia® sales.
`
`Sales of NovoSeven® decreased by 7% measured in Danish kroner and by 11% at CER to DKK 2,012 million,
`reflecting the continued competitive pressure from a recently introduced product. The development in sales is driven
`by declining sales in Region Europe and Region Latin America as well as in North America Operations.
`
`Sales of NovoEight® increased by 33% measured in Danish kroner and by 29% at CER to DKK 393 million. Sales
`growth was driven by Region AAMEO and Region Europe. NovoEight® has now been launched in 46 countries.
`
`Sales of Refixia® increased to DKK 77 million. Sales growth was driven by the product launches in North America
`Operations and Region Europe. Refixia® has now been launched in 14 countries.
`
`Growth disorders (Norditropin®)
`Sales of growth disorder products increased by 5% measured in Danish kroner and by 1% at CER to DKK 1,555
`million. The sales growth measured at CER was driven by positive contribution from International Operations, partly
`offset by declining sales in North America Operations impacted by inventory reductions in the USA. Novo Nordisk is
`the leading company in the global human growth disorder market with a 33% market share measured in value.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 30 / 2019
`
`Novo Nordisk Exhibit 2498
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`

`

`Financial report for the period 1 January 2019 to 31 March 2019
`
`Page 11 of 28
`
`DEVELOPMENT IN COSTS AND OPERATING PROFIT
`The cost of goods sold increased by 13% in Danish kroner and by 12% at CER to DKK 4,732 million, resulting in a
`gross margin of 83.8% measured in Danish kroner, compared with 84.4% in 2018. The decrease in gross margin
`reflects a negative impact from growth of lower margin insulin products and lower prices, primarily related to the
`insulin segment in the USA, partly countered by improved productivity and a positive currency impact of 0.6
`percentage point.
`
`Sales and distribution costs increased by 8% in Danish kroner and by 3% at CER to DKK 6,946 million. The
`increase in sales and distribution costs is driven by International Operations reflecting resource allocation to growth
`markets and promotional activities for Victoza® and Saxenda® as well as launch activities for Ozempic®. In the USA,
`promotional activities are focusing on Ozempic®, Saxenda® and Tresiba®.
`
`Research and development costs decreased by 19% in Danish kroner and by 21% at CER to DKK 2,678 million,
`reflecting reversal of write-downs on clinical prelaunch inventory of approximately DKK 500 million, following the
`filing of oral semaglutide to the US FDA. Adjusted for the reversal of write-downs, research and development costs
`declined by 6%. The decline in costs is driven by the completion of the oral semaglutide phase 3a development
`programme and the completion of the head-to-head study between Tresiba® and insulin glargine U300, partly offset
`by increasing costs for the semaglutide in obesity clinical programmes STEP and SELECT.
`
`Administration costs increased by 5% in Danish kroner and by 3% at CER to DKK 911 million, reflecting growth
`across the regions in International Operations.
`
`Other operating income (net) was DKK 215 million compared with DKK 351 million in 2018. In 2018, Novo
`Nordisk received milestone payments from partners related to out-licensed clinical assets, and Novo Nordisk recorded
`a net gain of DKK 122 million following the disposal of 2 million shares in NNIT A/S to Novo Holdings A/S.
`
`Operating profit increased by 14% in Danish kroner and by 8% at CER to DKK 14,239 million. Adjusting for the
`positive impact from the reversal of write-downs of oral semaglutide prelaunch inventory operating profit growth
`was 4% at CER.
`
`FINANCIAL ITEMS (NET)
`Financial items (net) showed a net loss of DKK 1,017 million compared with a net gain of DKK 1,161 million in
`2018.
`
`In line with Novo Nordisk’s treasury policy, the most significant foreign exchange risks for the Group have been
`hedged, primarily through foreign exchange forward contracts. The foreign exchange result was a loss of DKK 876
`million compared with a gain of DKK 1,107 million in 2018. This development reflects a loss on foreign exchange
`hedging, involving especially the US dollar versus the Danish krone.
`
`As per the end of March 2019, a negative market value of financial contracts of approximately DKK 1.8 billion has
`been deferred for recognition later in 2019 and 2020.
`
`CAPITAL EXPENDITURE AND FREE CASH FLOW
`Net capital expenditure for property, plant and equipment was DKK 2.1 billion compared with DKK 2.3 billion in
`2018. Net capital expenditure was primarily related to investments in a new production facility for a range of
`diabetes active pharmaceutical ingredients in Clayton, North Carolina, USA, a new diabetes filling capacity in
`Hillerød, Denmark and an expansion