company
`announcement
`
`"'1. e
`
`novo nord1sk
`
`Financial report for the period 1 January 2019 to 31 December 2019
`
`5 February 2020
`
`Novo Nordisk's operating profit increased by 11% in Danish kroner and by 6%
`at constant exchange rates (CER) in 2019
`
`• Sales increased by 9% in Danish kroner and by 6% at CER to DKK 122.0 billion. Sales in International Operations
`increased by 12% in Danish kroner (11 % at CER), driven by growth in all regions. Sales in North America
`Operations increased by 6% in Danish kroner (1 % at CER).
`
`• Sales within Diabetes and Obesity care increased by 10% to DKK 102.8 billion (6% at CER), driven by Diabetes
`care growing by 4% at CER and Obesity care growing by 42% at CER. Sales within Biopharm increased by 7%
`to DKK 19.2 billion (4% at CER).
`
`• Sales of GLP-1 increased by 27% in Danish kroner (22% at CER) reflecting the solid launch of Ozempic®.
`Following the US FDA approval, Rybelsus® was launched in the USA in the fourth quarter of 2019 and the initial
`feedback is encouraging.
`
`• In November 2019, Novo Nordisk introduced new strategic aspirations for 2025 in connection with its Capital
`Markets Day. The long-term financial targets were met with the full-year 2019 results.
`
`• In January 2020, Ozempic® was approved in the USA for CV risk reduction in people with type 2 diabetes and
`established cardiovascular diseases, and the Rybelsus® label in the USA was updated with additional information
`from the PIONEER 6 CV outcomes trial. Also in January 2020, Rybelsus® was recommended for approval for
`treatment of adults with type 2 diabetes by the European regulatory authorities.
`
`• For the 2020 outlook, sales growth is expected to be 3-6% at CER, and operating profit growth is expected to
`be 1-5% at CER. Growth reported in DKK is expected to be around 1 percentage point higher than at CER.
`
`• At the Annual General Meeting on 26 March 2020, the Board of Directors will propose a final dividend of DKK
`5.35 for 2019 per share of DKK 0.20. The expected total dividend for 2019 is DKK 8.35 per share, of which DKK
`3.00 per share was paid as interim dividend in August 2019. The Board of Directors intends to initiate a new 12-
`month share repurchase programme of up to DKK 17 billion.
`
`PROm AND LOSS
`DKKmillion
`
`Net sales
`
`Operating profit
`
`Net profit
`
`Diluted earnings per share (in DKK)
`
`• CER: Constant exchange rates (average 2018)
`
`2019
`
`2018
`
`Growth
`as reported
`
`Growth
`atCER*
`
`122,021
`
`52,483
`
`38,951
`
`16.38
`
`111,831
`
`47,248
`
`38,628
`
`15.93
`
`9%
`
`11%
`
`1%
`
`3%
`
`6%
`
`6%
`
`N/A
`
`N/A
`
`Lars Fruergaard Jergensen, president and CEO: "We are very satisfied with the financial performance in 2019.
`The results reflect an accelerated sales growth in International Operations and a strong launch of Ozempic9 in
`particular in North America Operations and Region Europe. The Rybelsus® launch in the USA is off to a good start,
`and we are pleased with the CV label indication for Ozempic® in the USA, and the EU recommendation to approve
`Rybelsus®, all for the benefit of patients.•
`
`On 5 February 2020 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'.
`
`Novo Nordisk A/S
`Investor Relations
`
`Novo Alie
`2880 Bagsvaerd
`Denmark
`
`Telephone:
`-+45 4444 8888
`www.novonordisk.com
`
`CVR Number:
`24 25 67 90
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 2501
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report for the period 1 January 2019 to 31 December 2019
`
`Page 2 of 34
`
`FINANCIAL PERFORMANCE
`
`CONSOLIDATED FINANCIAL STATEMENT FOR 2019
`
`PRORT AND LOSS
`(Amounts are in DKK million, except for
`earnings per share and dividend per share)
`
`r
`
`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, net11
`
`Operating profit
`Operating margin
`
`Financial items (net)
`
`Profit before income taxes
`
`2019
`
`2018
`
`2017
`
`2016
`
`2015
`
`% change
`2019to 2018
`
`122,021
`
`101,933
`83.5%
`
`31,823
`26.1%
`
`14,220
`11.7%
`
`4,007
`3.3%
`
`600
`
`52,483
`43.0%
`
`(3,930)
`
`48,553
`
`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%
`
`367
`
`94,064
`84.2%
`
`28,340
`25.4%
`
`14,014
`12.5%
`
`3,784
`3.4%
`
`1,041
`
`48,967
`43.8%
`
`(287)
`
`94,597
`84.6%
`
`28,377
`25.4%
`
`14,563
`13.0%
`
`3,962
`3.5%
`
`737
`
`48,432
`43.3%
`
`(634)
`
`91,739
`85.0%
`
`28,312
`26.2%
`
`13,608
`12.6%
`
`3,857
`3.6%
`
`3,482
`
`49,444
`45.8%
`
`(5,961)
`
`48,680
`
`47,798
`
`43,483
`
`9%
`
`8%
`
`8%
`
`(4%)
`
`2%
`
`(48%)
`
`11%
`
`NIA
`
`Income taxes
`Effective tax rate
`
`Net profit
`Net profit margin
`
`OTHER KEY NUMBERS
`
`Depreciation, amortisation and
`impairment losses
`Capital expenditure (Purchase of>
`property, plant and equipment)
`
`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) 31
`
`Payout ratio 41
`
`9,602
`19.8%
`
`38,951
`31.9%
`
`5,661
`
`8,932
`
`46,782
`34,451
`
`125,612
`57,593
`45.8%
`
`16.38
`8.35
`
`50.5%
`
`47,615
`
`8,987
`18.9%
`
`38,628
`34.5%
`
`3,925
`
`9,636
`
`44,616
`32,536
`
`110,769
`51,839
`46.8%
`
`15.93
`8.15
`
`50.6%
`
`10,550
`21.7%
`
`38,130
`34.1%
`
`3,182
`
`7,626
`
`41,168
`32,588
`
`102,355
`49,815
`48.7%
`
`15.39
`7.85
`
`50.4%
`
`9,873
`20.7%
`
`37,925
`33.9%
`
`3,193
`
`7,068
`
`48,314
`39,991
`
`97,539
`45,269
`46.4%
`
`14.96
`7.60
`
`50.2%
`
`8,623
`19.8%
`
`34,860
`32.3%
`
`2,959
`
`5,224
`
`38,287
`34,222
`
`91,799
`46,969
`51.2%
`
`13.52
`6.40
`
`46.6%
`
`2%
`
`7%
`
`1%
`
`44%
`
`(7%)
`
`5%
`6%
`
`13%
`11%
`
`3%
`2%
`
`11 01her operating income, net for 2015 indudes DKK 2,376 million for the partial divestment of =ociated company.
`~ Cash-based capital expenditure.
`
`"Total dividend for the financial year 2019 induding proposed final dividend of DKK 5.35 pershare and interim dividend paid in August 2019 of DKK 3.00 per share.
`
`"Total dividend for the year as a percentage of net profrt.
`
`The Board of Directors and Executive Management have approved the Annual Report 2019 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 2019. 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 2019.
`
`Financial I
`
`Performance
`
`Equity
`
`Outlook
`
`Strategic
`aspirations
`
`R&D
`
`I Sustainability I Corporate
`
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 2501
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2019 to 31 December 2019
`
`Page 3 of 34
`
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 9% measured in Danish kroner and by 6% at CER to DKK 122,021 million in 2019. Sales in
`International Operations increased by 12% measured in Danish kroner and by 11 % at CER. Sales in North America
`Operations increased by 6% measured in Danish kroner and by 1 % at CER. The sales growth is in line with the latest
`guidance of '5-6% sales growth at CER' provided in connection with the announcement in November 2019 for the
`financial results of the first nine months of 2019.
`
`Sales split per region
`
`International Operations
`- Region Europe
`- Region AAMEO
`- Region China
`- Region Japan & Korea
`- Region Latin America
`North America Operations
`-USA
`
`Total sales
`
`Sales2019
`DICK million
`
`Growth
`as reported
`
`Growth Share of growth
`atCER
`at CER
`
`61,564
`23,262
`14,089
`12,844
`6,453
`4,916
`60,457
`57,486
`
`122,021
`
`12%
`7%
`16%
`14%
`11%
`23%
`6%
`6%
`
`9%
`
`11%
`7%
`14%
`12%
`5%
`24%
`1%
`0%
`
`6%
`
`94%
`25%
`27%
`22%
`5%
`15%
`6%
`(1%)
`
`100%
`
`International Operations
`Sales in International Operations increased by 12 % measured in Danish kroner and by 11 % at C ER. Sales growth
`was driven by all regions, with key growth regions being Region AAMEO growing by 14% (CER), Region Europe
`growing by 7% (CER), Region China growing by 12% (CER) and Region Latin America growing by 24% (CER). Sales
`growth was driven by all therapy areas.
`
`Region Europe
`Sales in Region Europe increased by 7% in both Danish kroner and at CER. Sales growth was driven by Diabetes care
`growing by 9% (CER) from increased GLP-1 following the launch of Ozempic8 and insulin sales, and Obesity care
`growing by 60% (CER), while Biopharm sales were broadly unchanged.
`
`Region AAMEO
`Sales in Region AAMEO increased by 16% measured in Danish kroner and by 14% at CER. Sales growth was driven
`by Diabetes care growing by 12% (CER) from increased insulin sales, Obesity care growing by 87% (CER) and
`Biopharm growing by 8% (CER).
`
`Region China
`Sales in Region China increased by 14% measured in Danish kroner and by 12% at CER. Sales growth was driven by
`Diabetes care growing by 12% (CER) from increased modern insulin and GLP-1 sales and Biopharm growing by 43%
`(CER).
`
`Region Japan & Korea
`Sales in Region Japan & Korea increased by 11 % measured in Danish kroner and by 5% at CER. Sales growth was
`driven by Obesity care growing by 61 % (CER) following the introduction of Saxenda8 in Korea in 2018, Diabetes
`care growing by 3% (CER) and Biopharm growing by 4% (CER).
`
`Region Latin America
`Sales in Region Latin America increased by 23% measured in Danish kroner and by 24% at CER. Sales growth was
`driven by Diabetes care growing by 21 % (CER) from increased insulin and GLP-1 sales, Obesity care growing by 67%
`(CER) and Biopharm growing by 16% (CER).
`
`North America Operations
`Sales in North America Operations increased by 6% measured in Danish kroner and by 1 % at CER. The sales
`development reflects GLP-1 sales growing by 19% (CER), Obesity care sales growing by 28% (CER) and Biopharm
`sales growing by 2% (CER). This was offset by insulin sales dedining by 16% (CER), negatively impacted by lower
`realised prices following higher rebates, the changes in the coverage gap legislation as well as inventory reductions
`in the first quarter of 2019.
`
`Financial I
`
`Performance
`
`Equity
`
`Outlook
`
`Strategic
`aspirations
`
`R&D
`
`I Sustainability I Corporate I
`
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 2501
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for the period 1 January 2019 to 31 December 2019
`
`Page 4 of 34
`
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales growth in 2019 was 9% measured in Danish kroner and 6% at CER was driven by solid growth across all
`therapy areas with Diabetes care sales growth of 4% (CER), Obesity care sales growth of 42% (CER) and Biopharm
`sales growth of 4% (CER).
`
`Sales split per therapy
`Diabetes and Obesity care segment
`
`Sales 2019
`DKKmillion
`
`Sales 2018 DKK
`million
`
`Growth
`as reported
`
`Growth
`atCER
`
`Share of growth
`atCER
`
`Long-acting insulin
`- Tresiba•
`- Xultophy'-
`- Levemi,.
`
`Premix insulin
`- Ryzodeg"
`- NovoMiX-
`
`Fast-acting insulin
`- Fiasp•
`- NovoRapicP
`
`Human insulin
`
`Total insulin
`
`Victoza•
`OzempiC-
`Rybelsus•
`Total GLP-1
`Other Diabetes care 1>
`
`Total Diabetes care
`
`Obesity care (Saxenda•)
`
`20,776
`9,259
`2,210
`9,307
`
`10,578
`993
`9,585
`
`19,303
`1,243
`18,060
`
`9,036
`
`59,693
`
`21,934
`11,237
`50
`33,221
`
`4,247
`
`97,161
`
`5,679
`
`Diabetes and Obesity care total
`
`102,840
`
`Biophann segment
`Haemophilia2>
`- NovoSeven•
`- NovoEighi-
`Growth disorders (Norditropin•)
`Other Biopharm3>
`Biophann total
`
`10,281
`8,119
`1,525
`7,275
`1,625
`19,181
`
`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
`
`Total sales
`
`122,021
`
`111,831
`
`, needles and GlucaGen9 HypoKit9
`1> Primarily NovoNorm9
`.
`2> Comprises NovoSeven9
`, NovoEight9
`, Refixia9
`, NovoThirteen• and Esperoct•.
`3> Primarily Vagifem• and Activeue•.
`
`0%
`15%
`37%
`(17%)
`
`4%
`39%
`1%
`
`0%
`111%
`(4%)
`
`(2%)
`
`0%
`
`(10%)
`
`27%
`
`0%
`
`8%
`
`47%
`
`10%
`
`7%
`3%
`13%
`6%
`7%
`7%
`
`9%
`
`(4%)
`11%
`34%
`(20%)
`
`2%
`36%
`(1%)
`
`(3%)
`105%
`(7%)
`
`(5%)
`
`(3%)
`
`(13%)
`
`22%
`
`(2%)
`
`4%
`
`42%
`
`6%
`
`4%
`0%
`10%
`2%
`6%
`4%
`
`6%
`
`(12%)
`14%
`9%
`(35%)
`
`3%
`4%
`(1%)
`
`(10%)
`10%
`(20%)
`
`(7%)
`
`(26%)
`
`(52%)
`142%
`1%
`91%
`
`(1%)
`
`64%
`
`26%
`
`90%
`
`6%
`0%
`2%
`3%
`1%
`10%
`
`100%
`
`Financial I
`
`Performance
`
`Equity
`
`Outlook
`
`Strategic
`aspirations
`
`R&D
`
`I Sustainability I Corporate
`
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 2501
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financial report for the period 1 January 2019 to 31 December 2019
`
`Page 5 of 34
`
`DIABETES AND OBESITY CARE
`Diabetes care. sales development
`Sales in Diabetes care increased by 8% measured in Danish kroner and by 4% at CER to DKK 97,161 million driven
`by solid GLP-1 growth, partly offset by declining insulin sales. Novo Nordisk has improved its global diabetes value
`market share over the last 12 months from 27.8% to 28.6%, driven by improved global insulin market share and
`growth of the GLP-1 segment, reflecting an expansion of the diabetes value market share in North America
`Operations and a stabilisation of the value market share in International Operations.
`
`In the following sections, unless otherwise noted, market data are based on moving annual total (MAn from
`November 2019 and November 2018 provided by the independent data provider IQVIA.
`
`Diabetes care, regional development
`
`Novo Nordisk's share of the total
`diabetes market (value, MAl)
`
`Diabetes care, sales development
`
`Global
`International Operations
`- Region Europe
`- Region AAMEO *
`- Region China **
`- Region Japan & Korea
`- Region Latin America ***
`North America Operations
`- USA
`
`November
`2019
`
`November
`2018
`
`Sales2019
`DKKmlllion
`
`Growth
`atCER
`
`28.6%
`22.0%
`27.1%
`21.2%
`27.4%
`9.6%
`18.0%
`31.1%
`31.3%
`
`27.8%
`22.1%
`26.8%
`22.1%
`28.6%
`10.0%
`16.2%
`30.1%
`30.3%
`
`97,161
`48,188
`17,921
`11,039
`12,510
`3,781
`2,937
`48,973
`46,825
`
`4%
`10%
`9%
`12%
`12%
`3%
`21%
`(1%)
`(2%)
`
`Source: IQVIA, November 2019 data. • Data available for 9 private markets representing approximately 60% of total Novo Nordisk diabetes sales in the region. ••
`Data for mainland China, exduding Hong Kong and Taiwan. ••• Data available for three private markets representing approximately 70% of total Novo Nordisk's
`diabetes sales in the region.
`
`Insulin
`Sales of insulin remained unchanged in Danish kroner and decreased by 3% at CER to DKK 59,693 million. The
`decreased sales measured at CER were driven by declining sales in the USA, partly offset by increased sales in
`International Operations.
`
`Sales of long-acting insulin remained unchanged in Danish kroner and decreased by 4% at CER to DKK 20,776
`million. Novo Nordisk has improved its global volume market share in the long-acting insulin segment from 31.6%
`to 32.4% in the last 12 months. The decreased sales measured at CER were driven by declining Levemir® sales,
`partly offset by a positive impact from Tresiba® and Xultophy®. Tresiba® has now been launched in 86 countries,
`while Xultophy• has now been launched in 37 countries.
`
`Sales of premix insulin increased by 4% measured in Danish kroner and by 2% at CER to DKK 10,578 million. Novo
`Nordisk is market leader in the premix insulin segment with a global volume market share of 63.9%, which has been
`broadly unchanged over the past 12 months. The increased sales were driven by increased sales of Ryzodeg®_ partly
`offset by declining NovoMix® sales. Ryzodeg® has now been launched in 30 countries.
`
`Sales of fast-acting insulin remained unchanged in Danish kroner and decreased by 3% at CER to DKK 19,303
`million. Novo Nordisk is market leader in the fast-acting insulin segment with a global volume market share of
`50. 7%, which has been broadly unchanged over the past 12 months. The decreasing sales measured at CER were
`driven by declining sales of NovoRapid®, partly offset by a positive impact from Fiasp®. Fiasp® has now been
`launched in 33 countries.
`
`Sales of human insulin decreased by 2% measured in Danish kroner and by 5% at CER to DKK 9,036 million.
`
`Financial I
`
`Performance
`
`Equity
`
`Outlook
`
`Strategic
`aspirations
`
`R&D
`
`I Sustainability I Corporate I
`
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 2501
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2019 to 31 December 2019
`
`Page 6 of 34
`
`Insulin, regional development
`
`Novo Nordisk's share of the total
`insulin market (volume, MAn
`
`Insulin, sales development
`
`Global
`International Operations
`- Region Europe
`- Region AAMEO *
`- Region China **
`- Region Japan & Korea
`- Region Latin America ***
`North America Operations
`- USA
`
`November
`2019
`
`November
`2018
`
`Sales2019
`DKKmillion
`
`Growth
`atCER
`
`46.5%
`49.0%
`44.2%
`54.6%
`49.8%
`50.5%
`52.3%
`39.9%
`40.0%
`
`46.3%
`48.9%
`44.0%
`55.2%
`50.6%
`50.3%
`46.0%
`39.9%
`40.3%
`
`59,693
`36,407
`12,427
`9,339
`9,965
`2,612
`2,064
`23,286
`22,254
`
`(3%)
`7%
`2%
`13%
`11%
`0%
`11%
`(16%)
`(17%)
`
`Source: IQVIA, November 2019 data. • Data available for 9 private markets representing approximately 60% of total Novo Nordisk 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 9% measured in Danish kroner and by 7% at CER, sales
`growth was driven by long-acting, fast-acting and premix insulin.
`
`Region Europe
`Sales of insulin in Region Europe increased by 3% measured in Danish kroner and by 2% at CER. Sales growth was
`driven by the penetration of TresiballD, XultophyllDand FiaspllD across the region, partly offset by declining LevemirllD
`sales, reflecting the continued roll-out of TresiballD as well as declining human insulin and NovoMix® sales.
`
`Region AAMEO
`Sales of insulin in Region AAMEO increased by 15% measured in Danish kroner and by 13% at CER. The sales
`growth was driven by the overall diabetes market growth resulting in increased sales across all insulin segments.
`
`Region China
`Sales of insulin in Region China increased by 12 % measured in Danish kroner and by 11 % at CER. The sales growth
`was driven by NovoMixllD, NovoRapidllD and LevemirllD. In August 2019, Tresiba® was included into the National
`Reimbursement Drug List effective from January 2020.
`
`Region Japan & Korea
`Sales of insulin in Region Japan & Korea increased by 6% measured in Danish kroner, and remained unchanged at
`CER. The unchanged development in sales at CER was driven by declining sales of NovoRapidllD and NovoMixllD, offset
`by positive contributions from Ryzodeg® and Tresiba® in both Japan and Korea. In September 2019, XultophyllD was
`launched in Japan.
`
`Region Latin America
`Sales of insulin in Region Latin America increased by 10% measured in Danish kroner and by 11 % at CER. The sales
`growth was driven by the overall diabetes market growth and market share gains leading to growth in long-acting
`and short-acting insulin as well as human insulin.
`
`North America Operations
`Sales of insulin in North America Operations decreased by 11 % measured in Danish kroner and by 16% at CER. The
`decline in sales in the USA was driven by lower realised prices due to higher rebates across the insulin portfolio, the
`changes in the coverage gap legislation as well as inventory reductions in the first quarter of 2019. Novo Nordisk has
`a volume market share of 39.9% of the total insulin market, which has been stable the last 12 months.
`
`Financial I
`
`Performance
`
`Equity
`
`Outlook
`
`Strategic
`aspirations
`
`R&D
`
`I Sustainability I Corporate
`
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 2501
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2019 to 31 December 2019
`
`Page 7 of 34
`
`GLP-1 therapy for type 2 diabetes
`Sales of GLP-1 products for type 2 diabetes (Victoza41\ Ozempic® and Rybelsus~ increased by 27% measured in
`
`Danish kroner and by 22% at CER to DKK 33,221 million. Sales growth was driven by both North America
`Operations and International Operations. Sales of Ozempic® were DKK 11,237 million and Ozempic® has now been
`launched in 26 countries in North America Operations, Region Europe, Region Latin America and Region AAMEO.
`The GLP-1 segment's value share of the total diabetes market has increased to 18.0% compared with 14.4% 12
`months ago. Novo Nordisk continues to be the global market leader in the GLP-1 segment with a 47.5% value
`market share.
`
`GLP-1, regional development
`
`Novo Norcllsk's share of the diabetes
`GLP-1 market (value, MAn•
`
`GLP-1, sales development
`
`Global
`International Operations
`- Region Europe
`- Region AAMEO **
`- Region China***
`- Region Japan & Korea
`- Region Latin America ****
`North America Operations
`- USA
`
`November
`2019
`
`November
`2018
`
`Sales2019
`DKKmlllion
`
`Growth
`atCER
`
`47.5%
`50.6%
`52.8%
`38.6%
`92.8%
`30.0%
`70.8%
`46.9%
`46.5%
`
`46.2%
`52.0%
`54.7%
`43.5%
`86.6%
`32.9%
`67.8%
`45.2%
`44.7%
`
`33,221
`8,392
`4,932
`1,009
`898
`748
`805
`24,829
`23,866
`
`22%
`32%
`31%
`15%
`70%
`14%
`55%
`19%
`18%
`
`Source: IQVIA, November 2019 data MAT. • Novo Nordisk's GLP-1 diabetes products comprise Victoza•, Ozempic• and Rybelsus•. ** Data for 9 selected private
`markets representing approximately 60% of Novo Nordisk total diabetes 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 sales in the region.
`
`International Operations
`Sales of GLP-1 in International Operations increased by 34% measured in Danish kroner and by 32% 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 9.0%
`from 7.6% 12 months ago. Novo Nordisk is the market leader with a value market share of 50.6%.
`
`Region Europe
`Sales in Region Europe increased by 31 % in both Danish kroner and at CER. The sales development reflects the
`positive impact from the introduction of Ozempic® in 22 countries and the cardiovascular indication for Victoza•,
`partly offset by the impact from a competing once-weekly product. The initial feedback from the launch of
`Ozempic® has been positive and leading to a stabilisation of the market share in launch markets. Novo Nordisk
`remains the market leader in Region Europe with a value market share of 52.8%.
`
`Region AAMEO
`Sales in Region MMEO increased by 20% measured in Danish kroner and by 15% at CER. The value share of the
`GLP-1 class of the total diabetes market has expanded to 3.5% from 3.1 % 12 months ago. Novo Nordisk has a
`value market share of 38.6% across Region MMEO.
`
`Region China
`Sales in Region China increased by 72% measured in Danish kroner and by 70% at CER. The increase in sales
`reflects broad market access and continued commercial investments, which have driven the expansion of the GLP-1
`class' share of the overall diabetes market value to 2.1 % from 1.3% 12 months ago and increased the Victoza®
`GLP-1 value market share to 92.8%.
`
`Region Japan & Korea
`Sales in Region Japan & Korea increased by 22% measured in Danish kroner and by 14% at CER. The development
`in sales reflects continued market growth and the intensified competition from a once-weekly product. Novo Nordisk
`currently holds a value market share of 30.0%.
`
`Financial I
`
`Performance
`
`Equity
`
`Outlook
`
`Strategic
`aspirations
`
`R&D
`
`I Sustainability I Corporate I
`
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 2501
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financial report for the period 1 January 2019 to 31 December 2019
`
`Page 8 of 34
`
`Region Latin America
`Sales in Region Latin America increased by 48% measured in Danish kroner and by 55% at CER. The sales growth
`reflects the continued expansion of the GLP-1 segment across the region and the introduction of Ozempic111 in Brazil.
`Novo Nordisk remains the market leader in the region with a value market share of 70.8%.
`
`North America Operations
`Sales of GLP-1 diabetes products in North America Operations increased by 25% measured in Danish kroner and by
`19% at CER. Novo Nordisk is the market leader with a 46.9% value market share. The value market share of the
`GLP-1 class of the total North American diabetes market has increased to 21.3 % .
`
`Sales growth in the USA is driven by a prescription volume growth of the GLP-1 class of around 30%, driven by
`once-weekly GLP-1 products. In the USA, the weekly new-to-brand prescription market share for Ozempic111 has
`reached 37%. In October 2019, Novo Nordisk introduced Rybelsus8 and initial feedback has been positive and
`market access is progressing. The weekly new-to-brand prescription market share for Rybelsus• is 7% and the
`combined Novo Nordisk GLP-1 new-to-brand prescription market share is 57%. Novo Nordisk's GLP-1 is market
`leader measured on total monthly prescriptions.
`
`Sales of GLP-1 in the USA increased by 18% at CER. The increase in sales was predominantly driven by continued
`uptake of Ozempic8 and initial Rybelsus• sales reflecting pipeline filling, partly offset by declining sales of Victoza8
`.
`The declining Victoza111 sales reflect a negative impact from changes in the channel and payer mix and the changes in
`the coverage gap legislation, impacting average realised prices negatively. Furthermore, sales of Victoza111 were
`negatively impacted by the growth of the once-weekly GLP-1 product class.
`
`Financial I
`
`Performance
`
`Equity
`
`Outlook
`
`Strategic
`aspirations
`
`R&D
`
`I Sustainability I Corporate I
`
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 2501
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financial report for the period 1 January 2019 to 31 December 2019
`
`Page 9 of 34
`
`Obesity care, sales development
`Sales of Saxenda® increased by 47% measured in Danish kroner and by 42% at CER to DKK 5,679 million. Sales
`growth of Saxenda® was driven by both International Operations and North America Operations. Saxenda® has now
`been launched in 46 countries. Novo Nordisk currently has a value market share of 56% of the global obesity
`prescription drug market.
`
`Obesity care, regional development
`
`Global
`International Operations
`- Region Europe
`- Region AAMEO
`- Region China
`- Region Japan & Korea
`- Region Latin America
`North America Operations
`-USA
`
`Obesity care, sales development
`
`Sales2019
`DICK million
`
`Growth
`atCER
`
`5,679
`2,083
`334
`802
`9
`282
`656
`3,596
`3,348
`
`42%
`73%
`60%
`87%
`
`61%
`67%
`28%
`30%
`
`International O~ (ations
`Sales of Saxenda i n International Operations increased by 72% measured in Danish kroner and by 73% at CER
`driven by increased sales in all regions. Novo Nordisk currently has a value market share of 36% in the obesity
`prescription drug market in International Operations.
`
`Region Europe
`Sales of Saxenda® in Region Europe increased by 61 % measured in Danish kroner and by 60% at CER. Saxenda® has
`been launched in 19 countries in Region Europe. Novo Nordisk currently has a value market share of 49% in the
`obesity prescription drug market in Region Europe.
`
`Region AAMEO
`Sales of Saxenda9 in Region MMEO increased by 92% measured in Danish kroner and by 87% at CER. Saxenda9
`has now been launched in 18 countries in Region MMEO. Novo Nordisk currently has a value market share of 43%
`in the obesity prescription drug market in Region MMEO.
`
`Region Japan & Korea
`Sales of Saxenda® in Region Japan & Korea increased by 61 % in both Danish Kroner and at CER and were driven by
`Korea following the launch in early 2018.
`
`Region Latin America
`Sales of Saxenda8 in Region Latin America increased by 60% measured in Danish kroner and by 67% at CER.
`Saxenda® has been launched in 5 countries in Region Latin America. Novo Nordisk currently has a value market
`share of 35% in the obesity prescription drug market in Region Latin America.
`
`North America Operations
`Sales of Saxendae in North America Operations increased by 35% measured in Danish kroner and by 28% at CER
`and were driven by increased sales in both the USA and Canada. Novo Nordisk currently has a value market share of
`70% in the obesity prescription drug market in North America Operations.
`
`Financial I
`
`Performance
`
`Equity
`
`Outlook
`
`Strategic
`aspirations
`
`R&D
`
`I Sustainability I Corporate I
`
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 2501
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2019 to 31 December 2019
`
`Page 10 of 34
`
`BIOPHARM
`Biopharm. sales development
`Sales of biopharm products increased by 7% measured in Danish kroner and by 4% at CER to DKK 19,181 million.
`The sales development was driven by sales growth in both operating units as well as across both franchises:
`Haemophilia and Growth disorders. Sales growth in International Operations was driven by Region Latin America,
`Region AAMEO, Region China and Region Japan & Korea.
`
`Biophann, regional development
`
`Global
`International Operations
`- Region Europe
`- Region AAMEO
`- Region China
`- Region Japan & Korea
`- Region Latin America
`North America Operations
`-USA
`
`Biophann, sales development
`
`Sales2019
`DKKmlllion
`
`Growth
`atCER
`
`19,181
`11,293
`5,007
`2,248
`325
`2,390
`1,323
`7,888
`7,313
`
`4%
`5%
`0%
`8%
`43%
`4%
`16%
`2%
`2%
`
`Haemophilia
`Sales of haemophilia products increased by 7% measured in Danish kroner and by 4% at CER to DKK 10,281
`million. The increasing sales were driven by the continued global roll-out of Refixia 1111 and NovoEighte. Novo Nordisk
`continues to expand its broad global haemophilia presence.
`
`Sales of NovoSeven® increased by 3% measured in Danish kroner, and remained unchanged at CER, to DKK 8,119
`million, reflecting the solid position of NovoSeven® as a haemostatic agent in critical treatment settings and a wide
`range of labelled indications in an increasingly competitive environment. The sales development is driven by
`increased sales in Region Latin America, Region AAMEO and Region China as well as stable sales in North America
`Operations offset by declining sales in Region Europe and Region Japan & Korea.
`
`Sales of NovoEight1111 increased by 13% measured in Danish kroner and by 10% at CER to DKK 1,525 million. Sales
`growth was driven by Region Latin America, Region AAMEO, Region Europe and North America Operations.
`NovoEight1111 has now been launched in 52 countries.
`
`Sales of Refixia1111 increased to DKK 382 million. Sales growth was driven by the product launches in Region Europe,
`Region Japan & Korea and North America Operations. Refixia1111 has now been launched in 16 countries.
`
`Esperoct® has now been launched in nine countries and the initial feedback from patients and physicians is
`encouraging.
`
`Growth disorders (Norditropin•)
`Sales of growth disorder products increased by 6% measured in Danish kroner and by 2% at CER to DKK 7,275
`million. The increasing sales were driven by International Operations increasing by 3% at CER and by North America
`Operations increasing by 2% at CER. Novo Nordisk is the leading company in the global human growth disorder
`market with a market share measured in value of around 33% driven by new indications and the introduction of the
`next-generation device.
`
`Financial I
`
`Performance
`
`Equity
`
`Outlook
`
`Strategic
`aspirations
`
`R&D
`
`I Sustainability I Corporate I
`
`governance
`
`Legal
`
`Financial
`Information
`
`Company announcement No 7 / 2020
`
`Novo Nordisk Exhibit 250