company
`announcement
`
`~ novo nordisk®
`
`Financial report for the period 1 January 2019 to 30 September 2019
`
`1 November 2019
`
`Novo Nordisk's operating profit increased by 11 % in Danish kroner and by 5%
`at constant exchange rates (CER) in the first nine months of 2019
`
`• Sales increased by 9% in Danish kroner and by 5% at CER to DKK 89.6 billion . Sales in International Operations
`increased by 13% in Danish kroner (11 % at CER), driven by growth in all regions. Sales in North America
`Operations increased by 6% in Danish kroner (decreased by 1 % at CER).
`
`• Sales within Diabetes and obesity increased by 9% to DKK 75.5 billion (6% at CER), driven by Diabetes growing
`4% at CER and Obesity growing 50% at CER. Sales within Biopharmaceuticals increased by 8% to DKK 14.1
`billion (4% at CER).
`
`• Sales of Ozempic® were DKK 6,872 million and Ozempic® thereby reached blockbuster status. Ozempic® has
`now been launched in 24 countries. In the USA, the new-to-brand prescription market share for Ozempic® is
`now 37%, bringing Novo Nordisk's combined GLP-1 new-to-brand prescription market share to 54% .
`
`•
`
`In September 2019, Novo Nordisk received the US Food and Drug Administration (FDA) approval of Rybelsus®
`(semaglutide tablets) for treatment of adults with type 2 diabetes and Rybelsus® has now been made available in
`the USA.
`
`• For the 2019 outlook, sales growth is now expected to be 5-6% at CER (previously 4-6% at CER), while
`operating profit growth is still expected to be 4-6% at CER.
`
`PROFIT AND LOSS
`
`DKK million
`
`Net sales
`
`Operating profit
`
`Net profit
`
`Diluted earnings per share (in DKK)
`
`• CER: Constant exchange rates (average 2018)
`
`9M 2019
`
`9M 2018
`
`Growth
`as reported
`
`Growth
`at CER*
`
`89,604
`
`40,610
`
`30,234
`
`12.68
`
`82,099
`
`36,465
`
`30,131
`
`12.40
`
`9%
`
`11%
`
`0%
`
`2%
`
`5%
`
`5%
`
`N/A
`
`N/A
`
`Lars Fruergaard J0rgensen, president and CEO: "We are very satisfied with the sales growth for the first nine
`months of 2019, which was driven by all regions in International Operations and growth across our therapy areas
`Diabetes, Obesity and Biopharmaceuticals. During the third quarter of 2019, we have reached two very important
`milestones: the US FDA approval of Rybelsus® and the blockbuster status of Ozempic® following the successful
`launch in the USA; two major events that emphasise the strength of our current and future GLP-1 franchise."
`
`On 1 November 2019 at 13.00 CET, corresponding to 8.00 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'.
`
`Novo Nordisk A/5
`Investor Relations
`
`Novo Alie
`2880 Bagsva,rd
`Denmark:
`
`Telephone:
`+45 4444 8888
`www.novonordisk.com
`
`CVR Number:
`24 25 67 90
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`Financial report for the period 1 January 2019 to 30 September 2019
`
`Page 2 of 28
`
`FINANCIAL PERFORMANCE
`
`CONSOLIDATED FINANCIAL STATEMENT FOR THE FIRST NINE 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
`
`9M 2019
`
`9M 2018
`
`% change9M
`2019 to 9M 2018
`
`89,604
`
`74,948
`83 .6%
`
`22,287
`24.9%
`
`9,836
`11 .0%
`
`2,772
`3.1%
`
`557
`
`40,610
`45.3%
`
`(3,136)
`
`37,474
`
`7,240
`19.3%
`
`30,234
`33 .7%
`
`4,263
`6,551
`
`41,617
`32,714
`
`124,908
`52,953
`42.4%
`
`2,383.8
`12.68
`
`42,158
`
`82,099
`
`69,13S
`84 .2%
`
`20,669
`25.2%
`
`10,261
`12.5%
`
`2,647
`3.2%
`
`907
`
`36,465
`44.4%
`
`780
`
`37,245
`
`7,114
`19.1%
`
`30,131
`36 .7%
`
`2,283
`6,213
`
`37,204
`29,223
`
`101,895
`47,512
`46.6%
`
`2,430.8
`12.40
`
`43,161
`
`9%
`
`8%
`
`8%
`
`(4%)
`
`5%
`
`(39%)
`
`11%
`
`NIA
`
`1%
`
`2%
`
`0%
`
`87%
`5%
`
`12%
`12%
`
`23%
`11%
`
`(2%)
`2%
`
`(2%)
`
`These unaudited consolidated financial statements for the first nine 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 nine
`months of 2019 and the Management's review, have been prepared in accordance with additional Danish disclosure
`requirements for interim reports of listed companies. From 1 January 2019, the term 'constant exchange rates' (CER)
`will be used instead of 'local currencies' . There is no difference between the two terms.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`Financial report for the period 1 January 2019 to 30 September 2019
`
`Page 3 of 28
`
`GEOGRAPHIC SALES DEVELOPMENT
`Sales increased by 9% measured in Danish kroner and by 5% at CER to DKK 89,604 million in the first nine months
`of 2019. Sales in International Operations increased by 13% measured in Danish kroner and by 11 % at CER. Sales in
`North America Operations increased by 6% measured in Danish kroner and decreased by 1 % at CER.
`
`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 9M 2019
`DKKmillion
`
`Growth
`as reported
`
`Growth Share of growth
`at CER
`at CER
`
`46,213
`17,105
`10,810
`9,825
`4,719
`3,754
`43,391
`41,234
`
`89,604
`
`13%
`6%
`18%
`15%
`13%
`24%
`6%
`5%
`
`9%
`
`11%
`6%
`16%
`13%
`6%
`26%
`(1%)
`(1%)
`
`5%
`
`105%
`22%
`33%
`26%
`6%
`18%
`(5%)
`(13%)
`
`100%
`
`International Operations
`Sales in International Operations increased by 13% measured in Danish kroner and by 11 % at CER. Sales growth
`was driven by all regions, with key growth regions being Region AAMEO growing 16% (CER), Region China
`growing 13% (CER), Region Europe growing 6% (CER) and Region Latin America growing 26% (CER). Sales growth
`was positively impacted by timing of shipments primarily in Region AAMEO and Region Latin America,
`predominantly related to first half of 2019. Sales growth was driven by all therapy areas.
`
`Region Europe
`Sales in Region Europe increased by 6% in both Danish kroner and at CER. Sales growth was driven by Diabetes
`growing 8% (CER) from increased GLP-1 and insulin sales, and Obesity growing 61 % (CER), partly offset by
`Biopharmaceuticals declining 2% (CER).
`
`Region AAMEO
`Sales in Region AAMEO increased by 18% measured in Danish kroner and by 16% at CER. Sales growth was driven
`by Diabetes growing 14% (CER) from increased insulin sales, Obesity growing 97% (CER) and Biopharmaceuticals
`growing 12% (CER). Sales were positively impacted by timing of shipments, mainly in Diabetes.
`
`Region China
`Sales in Region China increased by 15% measured in Danish kroner and by 13% at CER. Sales growth was driven by
`Diabetes growing 12% (CER) from increased modern insulin and GLP-1 sales.
`
`Region Japan & Korea
`Sales in Region Japan & Korea increased by 13% measured in Danish kroner and by 6% at CER. Sales growth was
`driven by Obesity following the introduction of Saxenda® in Korea in 2018 and Biopharmaceuticals growing 7%
`(CER) driven by Norditropin® following the launch of the Noonan Syndrome indication while Diabetes sales remained
`unchanged (CER).
`
`Region Latin America
`Sales in Region Latin America increased by 24% measured in Danish kroner and by 26% at CER. Sales growth was
`driven by Diabetes growing 21 % (CER) from increased insulin and GLP-1 sales, Obesity growing 90% (CER) and
`Biopharmaceuticals growing 16% (CER). Sales were positively impacted by timing of shipments.
`
`North America Operations
`Sales in North America Operations increased by 6% measured in Danish kroner and decreased by 1 % at CER, due to
`sales in the USA declining 1 % (CER). The sales development reflects GLP-1 sales growing 17% (CER), Obesity sales
`growing 29% (CER) and Biopharmaceuticals sales growing by 1 % (CER). This was offset by insulin sales declining
`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
`
`R&D
`
`Sustainability I Legal
`
`Financial
`Information
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Financial report for the period 1 January 2019 to 30 September 2019
`
`Page 4 of 28
`
`SALES DEVELOPMENT ACROSS THERAPEUTIC AREAS
`Sales growth in the first nine months of 2019 of 9% measured in Danish kroner and 5% at CER was driven by solid
`growth across all therapy areas with Diabetes sales growth of 4% (CER), Obesity sales growth of 50% (CER) and
`Biopharmaceuticals sales growth of 4% (CER).
`
`Sales split per therapy
`Diabetes and obesity segment
`
`Sales 9M 2019
`DKKmillion
`
`Sales 9M 2018
`DKKmillion
`
`Growth
`as reported
`
`Growth
`atCER
`
`Share of growth
`atCER
`
`Long-acting insulin
`Tresiba"
`- Xultophy'"
`- Levemi~
`Premix insulin
`- Ryzodeg®
`- NovoMix®
`Fast-acting insulin
`- Fiasp"
`- Novo Rapid®
`Human insulin
`
`Total insulin
`
`Victoza"
`Ozempic®
`Total GLP-1
`
`Other diabetes 11
`
`Total diabetes
`
`Obesity (Saxenda")
`
`Diabetes and obesity total
`
`Biopharmaceuticals segment
`Haemophilia21
`- NovoSeven'"
`- NovoEight'"
`Growth disorders (Norditropin®)
`Other biopharmaceuticals31
`Biopharmaceuticals total
`
`Total sales
`
`15,674
`6,948
`1,626
`7,100
`
`7,913
`747
`7,166
`
`14,367
`804
`13,563
`
`6,832
`
`44,786
`
`16,507
`6,872
`23,379
`
`3,230
`
`71,395
`
`4,115
`
`75,510
`
`7,727
`6,160
`1,119
`5,199
`1,168
`14,094
`
`89,604
`
`15,388
`5,863
`1,162
`8,363
`
`7,756
`515
`7,241
`
`14,323
`384
`13,939
`
`7,087
`
`44,554
`
`17,833
`804
`18,637
`
`3,176
`
`66,367
`
`2,640
`
`69,007
`
`7,098
`5,925
`958
`4,872
`1,122
`13,092
`
`82,099
`
`2%
`19%
`40%
`(15%)
`
`2%
`45%
`(1%)
`
`0%
`109%
`(3%)
`
`(4%)
`
`1%
`
`(7%)
`
`25%
`
`2%
`
`8%
`
`56%
`
`9%
`
`9%
`4%
`17%
`7%
`4%
`8%
`
`9%
`
`(2%)
`13%
`36%
`(18%)
`
`0%
`42%
`(2%)
`
`(3%)
`104%
`(6%)
`
`(6%)
`
`(2%)
`
`(11%)
`
`20%
`
`(1%)
`
`4%
`
`50%
`
`6%
`
`5%
`0%
`14%
`2%
`3%
`4%
`
`5%
`
`(7%)
`18%
`9%
`(34%)
`
`1%
`5%
`(4%)
`
`(9%)
`9%
`(18%)
`
`(9%)
`
`(24%)
`
`(46%)
`129%
`83%
`
`(1%)
`
`58%
`
`30%
`
`88%
`
`8%
`1%
`3%
`3%
`1%
`12%
`
`100%
`
`11 Primarily oral antidiabetic products, needles and GlucaGen" HypoKit".
`21 Comprises NovoSeven", NovoEight", Refixia". NovoThirteen" and Esperoct".
`31 Primarily Vagifem" and Activelle".
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`Financial report for the period 1 January 2019 to 30 September 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 71,395 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 27.6% to 28.4%, driven by improved global insulin market share and
`growth of the GLP-1 segment.
`
`In the following sections, unless otherwise noted, market data are based on moving annual total (MAT) from August
`2019 and August 2018 provided by the independent data provider IQVIA.
`
`Diabetes, regional development
`
`Novo Nordisk's share of the total
`diabetes market (value, MAn
`
`Diabetes, sales development
`
`Global
`International Operations
`- Region Europe
`- Region AAMEO *
`- Region China **
`- Region Japan & Korea
`- Region Latin America * * *
`North America Operations
`-USA
`
`August
`2019
`
`August
`2018
`
`Sales 9M 2019
`DKKmillion
`
`Growth
`atCER
`
`28.4%
`22.0%
`26.9%
`21.4%
`27.8%
`9.6%
`17.4%
`30.8%
`31.1%
`
`27.6%
`22.1%
`26.8%
`22 .1%
`28.6%
`10.1%
`16.1%
`29.8%
`30.1%
`
`71,395
`36,149
`13,184
`8,465
`9,564
`2,725
`2,211
`35,246
`33,698
`
`4%
`11%
`8%
`14%
`12%
`0%
`21%
`(2%)
`(4%)
`
`Source: IQVIA, August 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.
`
`Insulin
`Sales of insulin increased by 1 % measured in Danish kroner and decreased by 2 % at CER to DKK 44,786 million.
`Sales decline was driven by declining sales in the USA, partly offset by increased sales in International Operations.
`
`Sales of long-acting insulin increased by 2% measured in Danish kroner and decreased by 2% at CER to DKK 15,674
`million. Novo Nordisk has improved its global volume market share in the long-acting insulin segment from 31.3%
`to 32 .2. % 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 85 countries,
`while Xultophy® has been launched in 32 countries.
`
`Sales of premix insulin increased by 2% measured in Danish kroner, and remained unchanged at CER, to DKK 7,913
`million. Novo Nordisk is market leader in the segment and has improved its global volume market share in the
`premix insulin segment from 63.4% to 64.1 % in the last 12 months. The unchanged sales measured at CER were
`driven by increased sales of Ryzodeg®while sales of NovoMix® declined. Ryzodeg® has been launched in 28
`countries.
`
`Sales of fast-acting insulin remained unchanged in Danish kroner and decreased by 3% at CER to DKK 14,367
`million. Novo Nordisk is market leader in the fast-acting insulin segment with a global volume market share of
`50.5%, which has been broadly unchanged over the past 12 months. The decreasing sales measured at CER were
`driven by declining sales of NovoRapid®, offset by a positive impact from Fiasp®. Fiasp® has now been launched in
`31 countries.
`
`Sales of human insulin decreased by 4% measured in Danish kroner and by 6% at CER to DKK 6,832 million.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Financial report for the period 1 January 2019 to 30 September 2019
`
`Page 6 of 28
`
`Insulin, regional development
`
`Novo Nordisk's share of the total
`insulin market (volume, MAT)
`
`lnsuli n, sales development
`
`Global
`International Operations
`- Region Europe
`- Region AAMEO *
`- Region China **
`- Region Japan & Korea
`- Region Latin America** *
`North America Operations
`-USA
`
`August
`2019
`
`August
`2018
`
`Sales 9M 2019
`DKKmillion
`
`Growth
`atCER
`
`46.5%
`49.1%
`44.1%
`54.8%
`50.2%
`50.4%
`51.0%
`39.9%
`40.2%
`
`46.1%
`48.7%
`44 .1%
`54 .7%
`50 .6%
`50 .2%
`44.5%
`39.7%
`40 .1%
`
`44,786
`27,519
`9,246
`7,153
`7,629
`1,932
`1,559
`17,267
`16,513
`
`(2%)
`8%
`3%
`14%
`12%
`(1%)
`11%
`(16%)
`(17%)
`
`Source: IQVIA, August 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 Taiw an . *** 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 8% 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% in both Danish kroner and at CER. Sales growth was driven by the
`penetration of Tresiba®, Fiasp® and Xultophy®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 16% measured in Danish kroner and by 14% at CER. The sales
`growth was driven by the overall diabetes market, market share gains and increased sales across all insulin
`categories.
`
`Region China
`Sales of insulin in Region China increased by 13% measured in Danish kroner and by 12 % at CER. The sales growth
`was driven by NovoMix®, NovoRapid® and Levemir®. In August 2019, Tresiba® was admitted to the National
`Reimbursement Drug List effective from January 2020.
`
`Region Japan & Korea
`Sales of insulin in Region Japan & Korea increased by 5% measured in Danish kroner and decreased by 1 % at CER.
`The decline in sales at CER was driven by NovoMix® and NovoRapid®, as both products reached the 15-year price
`protection limit 1 April 2018 in Japan, leading to significant mandatory price reductions as well as lower human
`insulin sales, partly offset by positive contributions from market share gains for Tresiba® and Ryzodeg® in both Japan
`and Korea . In September 2019, Xultophy® was launched in Japan .
`
`Region Latin America
`Sales of insulin in Region Latin America increased by 8% measured in Danish kroner and by 11 % at CER. The sales
`growth was driven by the overall diabetes market growth, market share gains as well as increased sales of
`NovoRapid®, Tresiba® and Xultophy®.
`
`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
`expanded its volume market share from 39.7% to 39.9% in the last 12 months, due to continued market share
`gains in the basal insulin segment.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Financial report for the period 1 January 2019 to 30 September 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 25% measured in Danish kroner
`and by 20% at CER to DKK 23,379 million. Sales of Ozempic® were DKK 6,872 million and Ozempic® thereby
`reached blockbuster status. Ozempic® has now been launched in 24 countries in North America Operations, Region
`Europe and Region Latin America. Sales growth was driven by both North America Operations and International
`Operations. The GLP-1 segment's value share of the total diabetes market has increased to 17.0% compared with
`13.7% 12 months ago. Novo Nordisk continues to be the global market leader in the GLP-1 segment with a 46.8%
`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
`
`August
`2019
`
`August
`2018
`
`Sales 9M 2019
`DKKmillion
`
`Growth
`atCER
`
`46.8%
`50.3%
`52.9%
`39.3%
`92.4%
`29.8%
`68.3%
`46.3%
`45.8%
`
`46.6%
`52.9%
`55.5%
`45.1%
`82.2%
`34.3%
`68.9%
`45.4%
`45.0%
`
`23,379
`6,019
`3,516
`787
`655
`461
`600
`17,360
`16,676
`
`20%
`28%
`26%
`14%
`67%
`(3%)
`61%
`17%
`16%
`
`Source: IQVIA, August 2019 data MAT. • Novo Nordisk's GLP-1 diabetes products comprise Victoza® and Ozempic® •• Data for 9 selected private markets
`representing approximately 60% of Novo Nordisk 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 29% measured in Danish kroner and by 28% at CER. Sales
`growth is driven by all regions except for Region Japan & Korea. The value share of the GLP-1 class of the total
`diabetes market has increased to 8.6% from 7.3% 12 months ago. Novo Nordisk is the market leader with a 50.3%
`value market share.
`
`Region Europe
`Sales in Region Europe increased by 26% in both Danish kroner and at CER. The sales development reflects the
`positive impact from the introduction of Ozempic® in 20 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 52.9% value market share.
`
`Region AAMEO
`Sales in Region AAMEO increased by 19% measured in Danish kroner and by 14% at CER. The value share of the
`GLP-1 class of the total diabetes market remains low and Novo Nordisk has a value market share of 39.3% across
`Region AAMEO.
`
`Region China
`Sales in Region China increased by 69% measured in Danish kroner and by 67% at CER. The increase in sales
`reflects broad market access and continued commercial investments, which have driven the expansion of the GLP-1
`class of the overall diabetes market value to 1.9% from 1.2% 12 months ago and increased the Victoza® GLP-1
`value market share to 92.4%.
`
`Region Japan & Korea
`Sales in Region Japan & Korea increased by 5% measured in Danish kroner and decreased by 3% at CER. The
`development in sales reflects an underlying volume growth, partly offset by the timing of inventory adjustments and
`the intensified competition from a once-weekly product. Novo Nordisk currently holds a value market share of
`29.8% .
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`Financial report for the period 1 January 2019 to 30 September 2019
`
`Page 8 of 28
`
`Region Latin America
`Sales in Region Latin America increased by 53% measured in Danish kroner and by 61 % at CER. The sales growth
`reflects the continued expansion of the GLP-1 segment across the region and the introduction of Ozempic® in Brazil.
`Novo Nordisk remains the market leader in the region with a value market share of 68.3%.
`
`North America Operations
`Sales of GLP-1 diabetes products in North America Operations increased by 24% measured in Danish kroner and by
`17% at CER. Novo Nordisk is the market leader with a 46.3% value market share. The value share of the GLP-1 class
`of the total North American diabetes market has increased to 20.1 %.
`
`Sales growth in the USA is driven by an underlying prescription volume growth of the GLP-1 class of around 30%,
`driven by once-weekly GLP-1 products. In February 2018, Novo Nordisk launched Ozempic® in the USA and the
`weekly new-to-brand prescription market share for Ozempic® has now reached 37%, bringing Novo Nordisk's
`combined GLP-1 new-to-brand prescription market share to 54%. Consequently Novo Nordisk's GLP-1 is now
`market leader measured on monthly prescriptions.
`
`Sales of GLP-1 in the USA increased by 16% at CER. The increase in sales was driven by continued uptake of
`Ozempic®, partly offset by declining sales of Victoza®. The declining Victoza® 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 Victoza® were negatively impacted by the launch of Ozempic® and a
`competing once-weekly product.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`Financial report for the period 1 January 2019 to 30 September 2019
`
`Page 9 of 28
`
`Obesity, sales development
`Sales of Saxenda® increased by 56% measured in Danish kroner and by 50% at CER to DKK 4,115 million. Sales
`growth of Saxenda® was driven by both International Operations and North America Operations. Saxenda® has now
`been launched in 45 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 9M 2019
`DKKmillion
`
`Growth
`atCER
`
`4,115
`1,611
`234
`648
`6
`220
`503
`2,504
`2,323
`
`50%
`98%
`61%
`97%
`
`206%
`90%
`29%
`30%
`
`International ocerations
`Sales of Saxenda
`in International Operations increased by 98% in both Danish kroner and at CER driven by
`increased sales in all regions. Novo Nordisk currently has a value market share of 35% in the Obesity market in
`International Operations.
`
`Region Europe
`Sales of Saxenda® in Region Europe increased by 61 % in both Danish kroner and at CER. Saxenda® has now been
`launched in 19 countries in Region Europe. Novo Nordisk currently has a value market share of 47% in the obesity
`market in Region Europe.
`
`Region AAMEO
`Sales of Saxenda® in Region AAMEO increased by 102% measured in Danish kroner and by 97% at CER. Saxenda®
`has now been launched in 17 countries in Region AAMEO. Novo Nordisk currently has a value market share of 44%
`in the obesity market in Region AAMEO.
`
`Region Japan & Korea
`Sales of Saxenda® in Region Japan & Korea were driven by Korea following the launch in early 2018.
`
`Region Latin America
`Sales of Saxenda® in Region Latin America increased by 82% measured in Danish kroner and by 90% at CER.
`Saxenda® has been launched in 5 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 37% measured in Danish kroner and by 29% at CER
`and were driven by increased sales in both the USA and Canada. Sales in the USA were negatively impacted by
`inventory reductions in first quarter of 2019. Novo Nordisk currently has a value market share of 67% in the obesity
`market in North America Operations.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`Financial report for the period 1 January 2019 to 30 September 2019
`
`Page 10 of 28
`
`BIOPHARMACEUTICALS
`Biopharmaceuticals, sales development
`Sales of biopharmaceutical products increased by 8% measured in Danish kroner and by 4% at CER to DKK 14,094
`million. The sales development was driven by sales growth in International Operations and North America
`Operations. Sales growth in International Operations was driven by Region AAMEO, Region Latin America, Region
`Japan & Korea and Region China, partly offset by declining sales in Region Europe.
`
`Biopharmaceuticals, regional development
`
`Global
`International Operations
`- Region Europe
`- Region AAMEO
`- Region China
`- Region Japan & Korea
`- Region Latin America
`North America Operations
`-USA
`
`Biopharmaceuticals, sales
`development
`
`Sales 9M 2019
`DKKmillion
`
`Growth
`atCER
`
`14,094
`8,453
`3,687
`1,697
`255
`1,774
`1,040
`5,641
`5,213
`
`4%
`6%
`(2%)
`12%
`53%
`7%
`16%
`1%
`1%
`
`Haemophilia
`Sales of haemophilia products increased by 9% measured in Danish kroner and by 5% at CER to DKK 7,727 million.
`The increasing sales were driven by the continued global roll-out of Refixia® and NovoEight®. Novo Nordisk
`continues to expand its broad global haemophilia presence.
`
`Sales of NovoSeven® increased by 4% measured in Danish kroner, and remained unchanged at CER, to DKK 6,160
`million, reflecting the solid position of NovoSeven® as a haemostatic agent in critical treatment settings 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 NovoEight® increased by 17% measured in Danish kroner and by 14% at CER to DKK 1,119 million. Sales
`growth was driven by Region AAMEO, Region Europe, Region Latin America and North America Operations.
`NovoEight® has now been launched in 49 countries.
`
`Sales of Refixia® increased to DKK 263 million. Sales growth was driven by the product launches in Region Europe,
`Region Japan & Korea and North America Operations. Refixia® has been launched in 14 countries.
`
`During the third quarter of 2019, Esperoct® (the brand name for N8-GP) was launched in Germany and Switzerland.
`
`Growth disorders (Norditropin41)
`Sales of growth disorder products increased by 7% measured in Danish kroner and by 2 % at CER to DKK 5,199
`million. The increasing sales were driven by positive contributions from International Operations increasing by 3% at
`CER and by North America Operations increasing by 1 % at CER. Novo Nordisk is the leading company in the global
`human growth disorder market with a market share measured in value of around 32% and focusing on the
`continued market presence expansion driven by new indications and the introduction of the next-generation device.
`
`Financial
`Performance
`
`Equity
`
`Outlook
`
`R&D
`
`Sustainability
`
`Legal
`
`Financial
`Information
`
`Company announcement No 62 / 2019
`
`Novo Nordisk Exhibit 2500
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`

`

`Financial report for the period 1 January 2019 to 30 September 2019
`
`Page 11 of 28
`
`DEVELOPMENT IN COSTS AND OPERATING PROFIT
`The cost of goods sold increased by 13% measured in both Danish kroner and at CER to DKK 14,656 million,
`resulting in a gross margin of 83.6% measured in Danish kroner, compared with 84.2 % in 2018. The decrease in
`gross margin reflects a negative impact from lower realised prices in the USA and impairment of intangible assets,
`partly countered by a positive product mix driven by increased GLP-1 sales and a positive currency impact of 0.5
`percentage point.
`
`Sales and distribution costs increased by 8% measured in Danish kroner and by 5% at CER to DKK 22,287
`million . The increase in sales and distribution costs was 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® and Saxenda® as well as prelaunch activities
`for Rybelsus®.
`
`Research and development costs decreased by 4% measured in Danish kroner and by 6% at CER to DKK 9,836
`million, reflecting reversal of write-downs of prelaunch inventory in first quarter of 2019 following the filing of oral
`semaglutide to the US FDA and severance costs in third quarter of 2018 offset by impairment of intangible assets.
`The underlying development in R&D 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, offset by
`increasing costs for the semaglutide in obesity clinical programmes STEP and SELECT.
`
`Administration costs increased by 5% measured in Danish kroner and by 3% at CER to DKK 2,772 million,
`reflecting growth across the regions in International Operations.
`
`Other operating income (net) was DKK 557 million compared with DKK 907