EX-99 3 a190718-99_2.htm 99.2 INTERIM FINANCIAL REPORT 99.2 Interim Financial Report
 
 
 
 
 
 
 
Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
 
http://www.novartis.com
 
CONDENSED INTERIM FINANCIAL REPORT – SUPPLEMENTARY DATA

Novartis Q2 and H1 2019 Condensed Interim Financial Report – Supplementary Data

INDEX
Page
GROUP AND DIVISIONAL OPERATING PERFORMANCE Q2 and H1 2019
 
Group
2
Innovative Medicines
6
Sandoz
11
CASH FLOW AND GROUP BALANCE SHEET
13
INNOVATION REVIEW
16
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
Consolidated income statements
19
Consolidated statements of comprehensive income
21
Consolidated balance sheets
23
Consolidated statements of changes in equity
24
Consolidated statements of cash flows
27
Notes to condensed interim consolidated financial statements, including update on legal proceedings
29
SUPPLEMENTARY INFORMATION
55
CORE RESULTS
 
Reconciliation from IFRS to core results
57
Group
59
Innovative Medicines
61
Sandoz
63
Corporate
65
Discontinued operations
66
ADDITIONAL INFORMATION
 
Income from associated companies
68
Condensed consolidated changes in net debt / Share information
69
Free cash flow
70
Currency translation rates
72
DISCLAIMER
73
 
 
 
1
 

 
Novartis Q2 and H1 2019 Condensed Interim Financial Report – Supplementary Data

Key figures 1
   
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
 
 
USD m
   
USD m
   
USD
   
cc 2
   
USD m
   
USD m
   
USD
   
cc 2
 
Net sales to third parties from continuing operations
   
11 764
     
11 339
     
4
     
8
     
22 870
     
22 254
     
3
     
8
 
Divisional operating income from continuing operations
   
2 846
     
2 580
     
10
     
18
     
5 228
     
5 124
     
2
     
11
 
Corporate income and expense, from continuing operations, net
   
- 183
     
- 149
     
- 23
     
- 28
     
- 323
     
- 322
     
0
     
-4
 
Operating income from continuing operations
   
2 663
     
2 431
     
10
     
17
     
4 905
     
4 802
     
2
     
11
 
    As % of net sales
   
22.6
     
21.4
                     
21.4
     
21.6
                 
Income from associated companies
   
176
     
5 932
   
nm
   
nm
     
256
     
6 084
   
nm
   
nm
 
Interest expense
   
- 205
     
- 237
     
14
     
12
     
- 431
     
- 455
     
5
     
4
 
Other financial income and expense
   
0
     
45
   
nm
   
nm
     
44
     
80
     
- 45
     
- 38
 
Taxes
   
- 525
     
- 443
     
- 19
     
- 26
     
- 797
     
- 813
     
2
     
- 6
 
Net income from continuing operations
   
2 109
     
7 728
     
- 73
     
- 71
     
3 977
     
9 698
     
- 59
     
- 56
 
Net income from discontinued  operations
   
4 691
     
40
   
nm
   
nm
     
4 590
     
98
   
nm
   
nm
 
Net income
   
6 800
     
7 768
     
- 12
     
- 10
     
8 567
     
9 796
     
- 13
     
- 8
 
Basic earnings per share from continuing operations (USD)
   
0.91
     
3.32
     
-73
     
-71
     
1.72
     
4.17
     
- 59
     
-55
 
Basic earnings per share from discontinued operations (USD)
   
2.03
     
0.02
   
nm
   
nm
     
1.98
     
0.04
   
nm
   
nm
 
Basic earnings per share (USD)
   
2.94
     
3.34
     
- 12
     
-10
     
3.70
     
4.21
     
- 12
     
-8
 
Cash flows from operating activities from continuing operations
   
3 111
     
3 512
     
-11
             
5 445
     
5 893
     
-8
         
Free cash flow from continuing operations 2
   
3 612
     
3 268
     
11
             
5 481
     
5 187
     
6
         
 
Core 2
                                                               
Core operating income from continuing operations
   
3 648
     
3 207
     
14
     
20
     
6 902
     
6 187
     
12
     
19
 
    As % of net sales
   
31.0
     
28.3
                     
30.2
     
27.8
                 
Core net income from continuing operations
   
3 096
     
2 735
     
13
     
19
     
5 907
     
5 419
     
9
     
16
 
Core net income from discontinued operations
           
276
   
nm
   
nm
     
278
     
574
   
nm
   
nm
 
Core net income
   
3 096
     
3 011
     
3
     
8
     
6 185
     
5 993
     
3
     
10
 
Core basic earnings per share from continuing operations (USD)
   
1.34
     
1.18
     
14
     
20
     
2.55
     
2.33
     
9
     
17
 
Core basic earnings per share from discontinued operations (USD)
           
0.11
   
nm
   
nm
     
0.12
     
0.25
   
nm
   
nm
 
Core basic earnings per share (USD)
   
1.34
     
1.29
     
4
     
9
     
2.67
     
2.58
     
3
     
11
 
nm = not meaningful
1 Continuing operations include the businesses of Innovative Medicines and Sandoz divisions and Corporate activities and discontinued operations include the business of Alcon. See page 42 for full explanation
2 Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 55. Unless otherwise noted, all growth rates in this release refer to same period in prior year.

Financials

In order to comply with International Financial Reporting Standards (IFRS), Novartis has separated the Group’s reported financial data for the current and prior years into “continuing” and “discontinued” operations. The results of the Alcon business are reported as discontinued operations. See page 42 and Notes 2, 3 and 11 for a full explanation.

Novartis continues to expect the previously-announced divestment of the Sandoz US oral solids and dermatology portfolio to be completed during 2019, pending closing conditions including regulatory approvals. Novartis remains fully committed to this business until it is divested to Aurobindo. The results of this business are included in continuing operations.

The commentary below focuses on continuing operations including the businesses of Innovative Medicines and Sandoz (including the US generic oral solids and dermatology portfolio), as well as the continuing Corporate functions. We also provide information on discontinued operations.
 
 
2
 

Continuing operations second quarter

Net sales
Net sales were USD 11.8 billion (+4%, +8% cc) in the second quarter driven by volume growth of 10 percentage points (cc), mainly from Cosentyx, Entresto and Lutathera. Strong volume growth was partly offset by the negative impacts of pricing (-1 percentage point cc) and generic competition (-1 percentage point cc).

Corporate income and expense, net
Corporate income and expense, which includes the cost of Group headquarter and coordination functions, amounted to an expense of USD 183 million in the second quarter compared to USD 149 million mainly on account of higher NBS restructuring costs. 

Operating income
Operating income was USD 2.7 billion (+10%, +17% cc) mainly driven by higher sales, improved gross margin, productivity programs and higher divestment gains, partly offset by growth investments and legal provisions. Operating income margin was 22.6% of net sales, increasing by 1.2 percentage points (+1.9 percentage points cc). Core adjustments amounted to USD 1.0 billion (2018: USD 0.8 billion).

Core operating income was USD 3.6 billion (+14%, +20% cc) mainly driven by higher sales, improved gross margin and productivity programs, partly offset by growth investments. Core operating income margin was 31.0% of net sales, increasing by 2.7 percentage points (+3.2 percentage points cc).

Income from associated companies
Income from associated companies decreased from USD 5.9 billion in prior year to USD 176 million in the second quarter of 2019. This decrease is mainly due to the pre-tax gain of USD 5.8 billion recognized on the divestment of the 36.5% stake in the GSK consumer healthcare joint venture in 2018.

The share of estimated reported income from Roche Holding AG increased from USD 146 million to USD 177 million.

Core income from associated companies increased to USD 253 million from USD 231 million in prior year due to a higher estimated core income contribution from Roche Holding AG.

Interest expense and other financial income/expense
Interest expense decreased to USD 205 million from USD 237 million in prior year, as the decrease in interest expense due to lower outstanding debts more than offset the additional interest expense on lease liabilities of USD 16 million, following the implementation of IFRS 16 Leases as of January 1, 2019.

Other financial income and expense were negligible in the quarter compared to an income of USD 45 million in the prior year quarter, as higher currency losses and financial expenses more than offset higher interest income.

Taxes
The tax rate in the second quarter was 19.9% compared to 5.4% in prior year. In May 2019, Swiss federal tax reform was enacted, which eliminated certain tax privileges, effective January 1, 2020. This required a revaluation of certain deferred tax assets and liabilities to the newly enacted tax rates. The impact of this revaluation was offset by the impact of a change to uncertain tax positions. The prior year tax rate was impacted by the divestment of the 36.5% stake in the GSK consumer healthcare joint venture.

Excluding the impacts of the Swiss federal tax reform and changes to uncertain tax positions in the second quarter and the GSK consumer healthcare joint venture divestment in prior year, the second quarter tax rate would have been 15.4% compared to 16.4% in the prior year. The decrease from prior year was mainly the result of a change in profit mix.

The core tax rate for continuing operations was 16.7% compared to 15.7% in prior year, mainly as a result of a change in profit mix.

Net income and EPS
Net income was USD 2.1 billion, declining compared to prior year which benefited from a USD 5.7 billion net gain recognized from the sale of our stake in the GSK consumer healthcare joint venture. EPS was USD 0.91.
 
 
 
3
 

Core net income was USD 3.1 billion (+13%, +19% cc) driven by growth in core operating income. Core EPS was USD 1.34 (+14%, +20% cc) in line with core net income.

Free cash flow from continuing operations amounted to USD 3.6 billion (+11% USD) compared to USD 3.3 billion in prior year, mainly driven by higher operating income adjusted for non-cash items, and higher divestment proceeds, partly offset by higher working capital, increased payments out of provisions and lower dividends received from the OTC JV which was divested in Q2 2018.

Continuing operations first half

Net sales
Net sales were USD 22.9 billion (+3%, +8% cc) in the first half driven by volume growth of 11 percentage points (cc), mainly from Cosentyx, Entresto and Lutathera. Strong volume growth was partly offset by the negative impacts of pricing (-2 percentage points cc) and generic competition (-1 percentage point cc).

Corporate income and expense, net
Corporate income and expense, which includes the cost of Group headquarter and coordination functions, amounted to an expense of USD 323 million in the first half year, in line with the prior year amount.

Operating income
Operating income was USD 4.9 billion (+2%, +11% cc) mainly driven by higher sales and improved gross margin, partly offset by growth investments and legal provisions. Operating income margin was 21.4% of net sales, decreasing by 0.2 percentage points (+0.7 percentage points cc). Core adjustments amounted to USD 2.0 billion (2018: USD 1.4 billion).

Core operating income was USD 6.9 billion (12%, +19% cc) mainly driven by higher sales, improved gross margin and productivity programs, partly offset by growth investments. Core operating income margin was 30.2% of net sales, increasing by 2.4 percentage points (+2.9 percentage points cc).

Income from associated companies
Income from associated companies amounted to USD 256 million in the first half compared to USD 6.1 billion in the prior year. This decrease is mainly due to the pre-tax gain of USD 5.8 billion recognized on the divestment of the 36.5% stake in the GSK consumer healthcare joint venture in 2018.

The share of income from Roche was USD 257 million compared to USD 171 million in prior year. The estimated income for Roche Holding AG, net of amortization, was USD 343 million compared to USD 296 million in prior year and was partly offset by the negative prior year true up of USD 129 million in the first quarter of 2019, compared to a negative prior year true up of USD 125 million recognized in the first quarter of 2018. In addition, a USD 43 million income from revaluation of deferred tax liability, recognized upon initial accounting of the Roche investment, was recorded in the first quarter of 2019, following a change in the enacted tax rate in February 2019 of the Swiss Canton Basel-Stadt, effective January 1, 2019.

Core income from associated companies in the first half decreased to USD 531 million compared to USD 606 million in prior year due to the discontinuation of core income from the GSK consumer healthcare joint venture. The core income contribution from Roche Holding AG increased to USD 532 million from USD 463 million in prior year, due to the recognition of a favorable prior year core income true up of USD 32 million compared to a favorable true up of USD 8 million in the first quarter of 2018, and higher estimated core income contribution from Roche for the current period.

Interest expense and other financial income/expense
Interest expense decreased to USD 431 million from USD 455 million in prior year, as the decrease in interest expense due to lower outstanding debts more than offset the additional interest expense on lease liabilities of USD 32 million, following the implementation of IFRS 16 Leases as of January 1, 2019.

Other financial income and expense amounted to an income of USD 44 million compared to USD 80 million in prior year, as higher currency losses and financial expenses more than offset higher interest income.
 
 
 
4
 

Taxes
The tax rate in the first half was 16.7% compared to 7.7% in prior year. In February 2019, the Swiss canton Basel-Stadt enacted a tax rate reduction effective January 1, 2019. In May 2019, Swiss federal tax reform was enacted, which eliminated certain tax privileges, effective January 1, 2020. This required a revaluation of certain deferred tax assets and liabilities to the newly enacted tax rates. The impact of this revaluation was offset by the impact of a change to uncertain tax positions. The prior year tax rate was significantly impacted by the divestment of the 36.5% stake in the GSK consumer healthcare joint venture.

Excluding the impacts of Swiss canton Basel-Stadt tax rate reduction, the Swiss federal tax reform and the changes to uncertain tax positions in the first half and the GSK consumer healthcare joint venture divestment in prior year, the tax rate in the first half would have been 15.4% compared to 16.1% in prior year. The decrease from prior year was mainly the result of a change in profit mix.

The core tax rate was 16.4% compared to 15.6% in prior year, mainly as a result of a change in profit mix.

Net income and EPS
Net income was USD 4.0 billion (-59%, -56% cc) as prior year benefited from a USD 5.7 billion net gain recognized from the sale of our stake in the GSK consumer healthcare joint venture. EPS was USD 1.72 (-59%, -55% cc) in line with net income.

Core net income was USD 5.9 billion (+9%, +16% cc) driven by growth in core operating income partly offset by the discontinuation of core income from the GSK consumer healthcare joint venture. Core EPS was USD 2.55 (+9%, +17% cc) in line with core net income.

Free cash flow from continuing operations amounted to USD 5.5 billion (+6% USD) compared to USD 5.2 billion in the prior year, mainly driven by higher operating income adjusted for non-cash items and higher divestment proceeds, partly offset by higher working capital, a sales milestone from the divested Vaccines business received in the prior year, increased payments out of provisions and lower dividends received from the OTC JV which was divested in Q2 2018.

Discontinued operations second quarter
Discontinued operations include the business of Alcon and certain Corporate costs directly attributable to Alcon up to the spin-off date. As the Alcon spin-off was completed on April 9, 2019, the operating results in the second quarter were not material. Net income in the second quarter 2019 includes the non-taxable non-cash net gain on distribution of Alcon Inc. to Novartis AG shareholders which amounted to USD 4.7 billion. The second quarter of prior year included the results from the operations of the Alcon Division and certain Corporate costs directly attributable to Alcon with sales of USD 1.8 billion and operating income of USD 53 million. For further details see Note 3 Significant transactions – Completion of the spin-off of the Alcon business through a dividend in kind distribution to Novartis shareholders.      

Discontinued operations first half
Discontinued operations net sales in the first half of 2019 were USD 1.8 billion compared to USD 3.6 billion in 2018 and operating income amounted to USD 71 million compared to USD 129 million in 2018. Net income from discontinued operations in the first half of 2019 amounted to USD 4.6 billion compared to USD 98 million in 2018 driven by the non-taxable non-cash net gain on distribution of Alcon Inc. to Novartis AG shareholders which amounted to USD 4.7 billion. For further details see Note 3 Significant transactions – Completion of the spin-off of the Alcon business through a dividend in kind distribution to Novartis shareholders.      

Total Group second quarter
For the total Group, net income amounted to USD 6.8 billion compared to USD 7.8 billion in the prior year, and basic earnings per share decreased to USD 2.94 from USD 3.34. Cash flow from operating activities for the total Group amounted to USD 3.1 billion and free cash flow to USD 3.6 billion.

Total Group first half
For the total Group, net income amounted to USD 8.6 billion compared to USD 9.8 billion in the prior year, and basic earnings per share decreased to USD 3.70 from USD 4.21. Cash flow from operating activities for the total Group amounted to USD 5.5 billion and free cash flow to USD 5.4 billion.
 
 
 
5
 

Innovative Medicines
     
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
   
9 326
     
8 876
     
5
     
9
     
18 106
     
17 274
     
5
     
10
 
Operating income
   
2 564
     
2 252
     
14
     
22
     
4 673
     
4 387
     
7
     
15
 
  As % of net sales
   
27.5
     
25.4
                     
25.8
     
25.4
                 
Core operating income
   
3 306
     
2 854
     
16
     
22
     
6 228
     
5 485
     
14
     
21
 
  As % of net sales
   
35.4
     
32.2
                     
34.4
     
31.8
                 

Second quarter

Net sales
Net sales were USD 9.3 billion (+5%, +9% cc) in the second quarter, as Pharmaceuticals grew 5% (+10% cc) and Oncology grew 5% (+9% cc). Volume contributed 10 (cc) percentage points to sales growth, mainly driven by Cosentyx, Entresto and Lutathera. Generic competition had a negative impact of 1 (cc) percentage points. Net pricing had a negligible impact.

Regionally, US sales (USD 3.3 billion, +10%) delivered a strong performance driven by Cosentyx, Entresto and Lutathera. Europe sales (USD 3.2 billion, +3%, +10% cc) benefited from continued strong performance of Entresto, Tafinlar + Mekinist, Jakavi and Lucentis. Japan sales were USD 0.6 billion (+1%, +2% cc). Emerging Growth Markets sales grew (+2%, +10% cc), led by double-digit cc growth in China.

Pharmaceuticals BU sales were USD 5.7 billion (+5%, +10% cc). Entresto (USD 421 million, +76%, +81% cc) continued to deliver strong double-digit performance, benefiting from the PIONEER data on hospital initiation and higher demand in ambulatory settings. Cosentyx (USD 858 million, +22%, +25% cc) grew double-digit across all indications. Xolair (USD 290 million, +11%, +18% cc) continued double-digit growth. Lucentis continued to grow (USD 536 million, +4%, +10% cc) and Gilenya (USD 825 million, -5%, -2% cc) declined.

Oncology BU sales were USD 3.6 billion (+5%, +9% cc). Growth was mainly driven by Lutathera (USD 109 million), Promacta/Revolade (USD 349 million, +20%, +23% cc), Tafinlar + Mekinist (USD 340 million, +20%, +25% cc), Kisqali (USD 111 million, +88%, +94% cc), Jakavi (USD 284 million, +19%, +26% cc) and Kymriah (USD 58 million).

Operating income
Operating income was USD 2.6 billion (+14%, +22% cc) mainly driven by continued strong sales growth, productivity, higher divestment gains and the pre-launch inventory provision releases, partly offset by legal provisions. Operating income margin was 27.5% of net sales increasing 2.1 percentage points (+2.8 percentage points in cc).

Core adjustments were USD 742 million, mainly USD 0.7 billion from legal provisions and USD 0.5 billion of amortization partly offset by USD 0.6 billion of net divestment gains, mainly from the sale and leaseback of real estate. Core adjustments increased compared to prior year mainly due to a legal provisions partly offset by higher divestment income.

Core operating income was USD 3.3 billion (+16%, +22% cc) mainly driven by higher sales, productivity programs and pre-launch provision releases, partly offset by higher growth investments. Core operating income margin was 35.4% of net sales, increasing 3.2 percentage points (+3.7 percentage points cc). Core gross margin increased by 0.3 percentage points (cc) driven by productivity. Core R&D expenses decreased by 1.4 percentage points (cc) mainly driven by sales leverage, productivity and portfolio prioritization. Core SG&A expenses declined by 1.0 percentage points (cc) mainly driven by productivity and sales leverage. Core Other Income and Expense, net increased the margin by 1.0 percentage points (cc) mainly due to Zolgensma pre-launch inventory provision release.
 
 
 
6
 

First half

Net sales
Innovative medicines delivered net sales of USD 18.1 billion (+5%, +10% cc) in the first half. Pharmaceuticals BU grew 5% (+10% cc) driven by Cosentyx reaching USD 1.6 billion and Entresto USD 778 million. Oncology grew 5% (+9% cc) driven by AAA including Lutathera, as well as Promacta/Revolade, Tafinlar + Mekinist and Kisqali. Volume contributed 11 (cc) percentage points to sales growth. Generic competition had a negative impact of 1 (cc) percentage points. Net pricing had a negligible impact.

Regionally, US sales (USD 6.3 billion, +12%) delivered a strong performance driven by Cosentyx, Entresto and Lutathera. Europe sales (USD 6.4 billion, +2%, +11% cc) benefited from continued strong performance of Entresto, Lucentis, Tafinlar + Mekinist and Cosentyx. Japan sales were USD 1.2 billion (0%, +1% cc). Emerging Growth Markets sales grew (+2%, +11% cc), led by double-digit cc growth in China.

Operating income
Operating income was USD 4.7 billion (+7%, +15% cc), mainly driven by continued strong sales growth, productivity and higher divestment gains, partly offset by growth investments and by legal provisions. Operating income margin was 25.8% of net sales, increasing 0.4 percentage points (+1.3 percentage points cc).

Core adjustments were USD 1.6 billion, mainly due to USD 1.0 billion of amortization. Core adjustments increased compared to prior year mainly driven by higher legal provisions and higher net impairment charges partly offset by higher net divestments (mainly from real estate).

Core operating income was USD 6.2 billion (+14%, +21% cc) mainly driven by higher sales and productivity programs, partly offset by higher growth investments. Core operating income margin was 34.4% of net sales, increasing 2.6 percentage points (+3.2 percentage points cc). Core gross margin increased by 0.6 percentage points (cc), mainly driven by productivity. Core R&D expenses decreased by 1.5 percentage points (cc) mainly driven by sales leverage, productivity and portfolio prioritization. Core SG&A expenses declined by 0.8 percentage points (cc) mainly driven by productivity and sales leverage. Core Other Income and Expense, net increased the margin by 0.3 percentage points (cc).

ONCOLOGY BUSINESS UNIT

     
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
 
 
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Tasigna
   
468
     
488
     
-4
     
-1
     
902
     
954
     
-5
     
-2
 
Sandostatin
   
403
     
399
     
1
     
4
     
795
     
799
     
-1
     
3
 
Afinitor/Votubia
   
401
     
408
     
-2
     
0
     
774
     
783
     
-1
     
1
 
Promacta/Revolade
   
349
     
292
     
20
     
23
     
656
     
549
     
19
     
24
 
Tafinlar + Mekinist1
   
340
     
284
     
20
     
25
     
637
     
551
     
16
     
21
 
Gleevec/Glivec
   
323
     
416
     
-22
     
-19
     
630
     
808
     
-22
     
-18
 
Jakavi
   
284
     
239
     
19
     
26
     
542
     
473
     
15
     
23
 
Exjade/Jadenu
   
253
     
289
     
-12
     
-10
     
491
     
550
     
-11
     
-8
 
Votrient
   
193
     
219
     
-12
     
-9
     
380
     
433
     
-12
     
-9
 
Lutathera
   
109
     
24
   
nm
   
nm
     
215
     
30
   
nm
   
nm
 
Kisqali
   
111
     
59
     
88
     
94
     
202
     
103
     
96
     
103
 
Kymriah
   
58
     
16
     
263
     
278
     
103
     
28
     
268
     
281
 
Other
   
314
     
300
     
5
     
9
     
600
     
563
     
7
     
11
 
Total Oncology business unit
   
3 606
     
3 433
     
5
     
9
     
6 927
     
6 624
     
5
     
9
 
 1Majority of sales for Mekinist and Tafinlar are combination, but both can be used as a monotherapy
 nm = not meaningful

Tasigna (USD 468 million, -4%, -1% cc) declined in the US, partially offset by modest growth in all other regions.
Sandostatin (USD 403 million, +1%, +4% cc) sales grew moderately driven by the US and EGM, partly offset by competitive pressure mainly in Europe.
Afinitor/Votubia (USD 401 million, -2%, 0% cc) was broadly in line with prior year as growth in the US was offset by the first generic competition in Europe. In the US, the Abbreviated New Drug Application (ANDA) challenges to the compound patent, and the ANDA and IPR challenges to the renal cell carcinoma use patent, have been resolved and the patents upheld. Novartis has resolved patent
 
 
 
7
 

litigation with certain generic manufacturers which may result in limited generic competition for Afinitor toward the end of 2019, and additional generic competition starting in mid-2020.
Promacta/Revolade (USD 349 million, +20%, +23% cc) continued to grow at a strong double-digit rate across all regions driven by increased use in chronic immune thrombocytopenia (ITP) and uptake as first-line treatment for severe aplastic anemia (SAA) in the US and Japan.
Tafinlar + Mekinist (USD 340 million, +20%, +25% cc) continued double-digit growth due to demand in metastatic melanoma and NSCLC, and strong uptake of the adjuvant melanoma indication in the US and Europe.
Gleevec/Glivec (USD 323 million, -22%, -19% cc) continued to decline due to generic competition in most major markets.
Jakavi (USD 284 million, +19%, +26% cc) continued double-digit growth across all regions driven by demand in the myelofibrosis and polycythemia vera indications.

Exjade/Jadenu (USD 253 million, -12%, -10% cc) declined mainly due to pressure from new generic competition in the US and generics in other regions.
Votrient (USD 193 million, -12%, -9% cc) sales declined, mainly driven by competitive pressure in the US.
Lutathera (USD 109 million) continued to grow led by the US with over 140 centers actively treating and the European launch progressing well. Sales from all AAA brands (including Lutathera and radiopharmaceutical diagnostic products) were USD 171 million.
Kisqali (USD 111 million, +88%, +94% cc) continued to grow in the US driven by use in first-line metastatic breast cancer patients, independent of menopausal status or combination partner, with strong uptake in Europe and other regions.
Kymriah (USD 58 million) strong demand continued and sales increased primarily driven by ongoing uptake in the US and Europe. There are over 130 qualified treatment centers and 19 countries worldwide that have coverage for at least one indication. Reimbursement for both Pediatric ALL and DLBCL was received in Japan, making Kymriah the only CAR-T available in Asia.

PHARMACEUTICAL BUSINESS UNIT

OPHTHALMOLOGY
     
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
 
 
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Lucentis
   
536
     
515
     
4
     
10
     
1 069
     
1 035
     
3
     
10
 
Travoprost Group
   
106
     
134
     
-21
     
-19
     
221
     
258
     
-14
     
-11
 
Other
   
532
     
531
     
0
     
4
     
1 045
     
1 044
     
0
     
4
 
Total Ophthalmology
   
1 174
     
1 180
     
-1
     
4
     
2 335
     
2 337
     
0
     
5
 

Lucentis (USD 536 million, +4%, +10% cc) delivered double-digit growth driven by commercial execution and strong market growth. 

Travoprost Group (USD 106 million, -21%, -19% cc) declined mainly due to increased competition in the US and generic competition in Europe.

NEUROSCIENCE

     
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
 
 
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Gilenya
   
825
     
866
     
-5
     
-2
     
1 591
     
1 687
     
-6
     
-2
 
Aimovig
   
24
           
nm
   
nm
     
42
           
nm
   
nm
 
Other
   
37
     
23
     
61
     
72
     
50
     
43
     
16
     
23
 
Total Neuroscience
   
886
     
889
     
0
     
3
     
1 683
     
1 730
     
-3
     
1
 
 
 
 
8
 

Gilenya (USD 825 million, -5%, -2% cc) declined in the US mainly due to competitive pressures. In the US, the ANDA (Abbreviated New Drug Application) proceedings challenging the compound patent and extensions expiring in 2019 have been resolved and the patent upheld.

Aimovig (USD 24 million), is the most prescribed anti-CGRP worldwide, with more than 250,000 patients prescribed in the post-trial setting. It has now been launched in 30 countries for the preventive treatment of migraine and additional launches are underway. Aimovig is co-commercialized with Amgen in the US, where Amgen records sales and Novartis has exclusive rights in all ex-US territories excluding Japan. The collaboration continues during the litigation between the companies and will remain in force unless a final court decision terminates the agreements.

Zolgensma previously known as AVXS-101, was approved and launched in the US in Q2 for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Administered as a single, one-time intravenous (IV) infusion, Zolgensma is the first and only gene therapy approved by the FDA for the treatment of all types of SMA, including those who are pre-symptomatic at diagnosis. One-time treatment with Zolgensma offers an alternative to lifetime chronic therapy for patients with SMA. Novartis is working closely with payers to offer pay-over-time options up to 5 years and outcomes-based agreements up to 5 years, as well as providing a patient program to support affordability and access. Zolgensma is currently under regulatory review in Europe and in Japan.

Mayzent was approved by the FDA on March 26th, 2019 and is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS, in adults. Mayzent is the only FDA approved oral therapy for active SPMS based on evidence from a pivotal prospective Phase III clinical trial (EXPAND) in a typical SPMS population.

IMMUNOLOGY, HEPATOLOGY and DERMATOLOGY
     
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
 
 
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Cosentyx
   
858
     
701
     
22
     
25
     
1 649
     
1 281
     
29
     
32
 
Ilaris
   
165
     
132
     
25
     
31
     
316
     
258
     
22
     
29
 
Total Immunology, Herpetology and Dermatology
   
1 023
     
833
     
23
     
26
     
1 965
     
1 539
     
28
     
32
 
Xolair sales for all indications are reported in the Respiratory franchise

Cosentyx (USD 858 million, +22%, +25% cc) delivered strong demand driven growth in the US and all other regions. In the US, Cosentyx (USD 534 million) sales grew 31%, in the rest of the world 11% (18% cc). In June, Novartis presented the first-of-its-kind MAXIMISE study, showing efficacy and safety of a biologic in the management of axial manifestations of PsA. As the first IL-17A inhibitor Cosentyx was launched in China in May, based on data which confirmed rapid response and high efficacy of Cosentyx in psoriasis patients. 

Ilaris (USD 165 million, +25%, +31% cc) sales were driven by strong double-digit volume growth, mostly in Europe and the US.

Xolair continued to grow in Chronic Spontaneous Urticaria (CSU, also known as Chronic Idiopathic Urticaria, CIU), a severe skin disease. Xolair on a global level is managed by the Respiratory franchise which reports all Xolair sales.

RESPIRATORY
     
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
 
 
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Ultibro Breezhaler
   
112
     
116
     
-3
     
1
     
216
     
222
     
-3
     
4
 
Seebri Breezhaler
   
34
     
39
     
-13
     
-9
     
65
     
77
     
-16
     
-9
 
Onbrez Breezhaler
   
20
     
27
     
-26
     
-18
     
42
     
54
     
-22
     
-15
 
Subtotal COPD Portfolio
   
166
     
182
     
-9
     
-4
     
323
     
353
     
-8
     
-2
 
Xolair
   
290
     
261
     
11
     
18
     
571
     
516
     
11
     
19
 
Other
   
5
     
6
     
-17
     
-2
     
12
     
13
     
-8
     
0
 
Total Respiratory
   
461
     
449
     
3
     
9
     
906
     
882
     
3
     
10
 
Xolair sales for all indications are reported in the Respiratory franchise

Xolair (USD 290 million, +11%, +18% cc) continued to grow in both indications, Severe Allergic Asthma (SAA) and Chronic Spontaneous Urticaria (CSU). Growth was mainly driven by the recent approval of Xolair
 
 
 
9
 

for home-use in Europe and strong performance in Emerging Growth Markets. We co-promote Xolair with Genentech in the US and share a portion of operating income, but we do not record any US sales.

Ultibro Breezhaler (USD 112 million, -3%, +1% cc) an inhaled LABA/LAMA, sales were broadly in line with prior year.
 
Seebri Breezhaler (USD 34 million, -13%, -9% cc) an inhaled LAMA, and Onbrez Breezhaler (USD 20 million, -26%, -18% cc) an inhaled LABA, declined due to competition in Europe.

CARDIOVASCULAR, RENAL AND METABOLISM

     
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
 
 
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Entresto
   
421
     
239
     
76
     
81
     
778
     
439
     
77
     
83
 
Other
   
6
     
6
     
0
     
14
     
12
     
10
     
20
     
20
 
Total Cardiovascular, Renal and Metabolism
   
427
     
245
     
74
     
79
     
790
     
449
     
76
     
81
 
Entresto (USD 421 million, +76%, +81% cc) delivered a strong quarter with continued growth momentum fueled by increased demand in both hospital and ambulatory settings across all territories/geographies. The Heart Failure Association of the European Society of Cardiology published a consensus paper in May that supports Entresto as a first line treatment option for patients hospitalized with new-onset HFrEF or decompensated congestive HFrEF. The paper also simplified treatment initiation and supported the use of Entresto in every patient stabilized in hospital.

ESTABLISHED MEDICINES
     
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
 
 
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Galvus Group
   
320
     
332
     
-4
     
2
     
635
     
650
     
-2
     
5
 
Diovan Group
   
283
     
244
     
16
     
23
     
544
     
509
     
7
     
14
 
Exforge Group
   
264
     
250
     
6
     
12
     
531
     
498
     
7
     
14
 
Zortress/Certican
   
124
     
115
     
8
     
12
     
240
     
224
     
7
     
12
 
Neoral/Sandimmun(e)
   
110
     
120
     
-8
     
-3
     
213
     
235
     
-9
     
-4
 
Voltaren/Cataflam
   
95
     
114
     
-17
     
-13
     
208
     
229
     
-9
     
-4
 
Other
   
553
     
672
     
-18
     
-13
     
1 129
     
1 368
     
-17
     
-12
 
Total Established Medicines
   
1 749
     
1 847
     
-5
     
0
     
3 500
     
3 713
     
-6
     
0
 

Galvus Group (USD 320 million, -4%, +2% cc) sales were broadly in line with prior year, with solid performance in Emerging Growth Markets including China.
Diovan Group (USD 283 million, +16%, +23% cc) grew in Europe, Emerging Growth Markets and the US mainly due to the recall of competitive generic products.
 
Exforge Group (USD 264 million, +6%, +12% cc) grew in Emerging Growth Markets and Europe mainly due to the recall of competitive generic products.
Zortress/Certican (USD 124 million, +8%, +12% cc) continued to grow in most regions.
Neoral/Sandimmun(e) (USD 110 million, -8%, -3% cc) declined due to generic competition and mandatory price reductions.
Voltaren/Cataflam (USD 95 million, -17%, -13% cc) declined due to generic competition.
 
 
 
10
 

Sandoz

     
Q2 2019
     
Q2 2018
   
% change
     
H1 2019
     
H1 2018
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
   
2 438
     
2 463
     
-1
     
3
     
4 764
     
4 980
     
-4
     
1
 
Operating income
   
282
     
328
     
-14
     
-7
     
555
     
737
     
-25
     
-17
 
  As % of net sales
   
11.6
     
13.3
                     
11.6
     
14.8
                 
Core operating income
   
501
     
480
     
4
     
10
     
962
     
979
     
-2
     
6
 
  As % of net sales
   
20.5
     
19.5
                     
20.2
     
19.7
                 

Sandoz US Generics Transaction

Novartis announced on September 6, 2018 that it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and US oral solids portfolio, to Aurobindo Pharma USA Inc. This transaction is expected to be completed during 2019. The results of this business are included in continuing operations.

Second quarter

Net sales
Net sales were USD 2.4 billion (-1%, +3% cc) driven by volume growth of 10 percentage points (cc) partially offset by 7 percentage points (cc) of price erosion mainly in the US. Excluding the US, net sales grew (+1%, +7% cc).

Sales in Europe were USD 1.3 billion (+3%, +9% cc). Sales in the US were USD 642 million declining 7% as continued industry-wide pricing pressure was partly offset by a lower prior year base. Sales in Asia / Africa / Australasia were USD 333 million (-2%, +1% cc). Sales in Canada and Latin America were USD 194 million (+1%, +7% cc).

Global sales of Biopharmaceuticals (biosimilars, biopharmaceutical contract manufacturing and Glatopa) grew to USD 401 million (+10%, +16% cc), driven by continued strong double-digit growth in Europe from Rixathon (rituximab), Hyrimoz (adalimumab) and Erelzi (etanercept). Launch roll-outs in Asia / Africa / Australasia also contributed to growth.

Retail sales were USD 1.9 billion (-3%, +2% cc) including sales from first-to-market launches. Total Anti-Infectives franchise sales were USD 320 million (-4%, +1% cc), including finished dosage forms sold under the Sandoz name and Anti-Infectives sold to third parties for sale under their own name (USD 134 million, -8%, -4% cc).

Operating income
Operating income was USD 282 million (-14%, -7% cc) as higher net changes in legal settlements and higher net restructuring expenses from the announced Sandoz transformation were partly offset by continued gross margin improvement. Operating income margin was 11.6% of net sales, declining 1.7 percentage points (-1.3 percentage points cc).

Core adjustments were USD 219 million, including USD 81 million of amortization. Prior year core adjustments were USD 152 million. The change in core adjustments compared to prior year was driven by higher net restructuring expenses from the announced Sandoz transformation.

Core operating income was USD 501 million (+4%, +10% cc) driven by gross margin improvements, sales growth and cost discipline, partly offset by price erosion and higher net changes in legal settlements. Core operating income margin was 20.5% of net sales, increasing 1.0 percentage point (1.4 percentage points cc). Core gross margin increased by 2.1 percentage points (cc), as favorable product and geographic mix and ongoing productivity improvements were partly offset by the impact of price erosion mainly in the US. Core R&D expenses increased by 0.1 percentage points (cc). Core SG&A expenses decreased by 1.6 percentage points (cc). Core Other Income and Expense decreased the margin by 2.2 percentage points (cc) mainly due to higher net changes in legal settlements.
 
 
 
11
 

First half

Net sales
Net sales were USD 4.8 billion (-4%, +1% cc) driven by volume growth of 9 percentage points (cc) partially offset by 8 percentage points (cc) of price erosion, mainly in the US. Excluding the US, net sales grew (-1%, +6% cc).

Sales in Europe were USD 2.5 billion (-1%, +7% cc). Sales in the US were USD 1.2 billion (-12%), mainly due to continued industry-wide pricing pressure. Sales in Asia / Africa / Australasia were USD 651 million (-2%, +2% cc). Sales in Canada and Latin America were USD 371 million (-4%, +3% cc).

Global sales of Biopharmaceuticals (biosimilars, biopharmaceutical contract manufacturing and Glatopa) grew to USD 752 million (+8%, +14% cc), driven by continued strong double-digit growth in Europe from Rixathon (rituximab), Hyrimoz (adalimumab) and Erelzi (etanercept). Launch roll-outs in Asia / Africa / Australasia also contributed to growth.

Retail sales were USD 3.8 billion (-6%, -1% cc), as the decline in the US (-8%) was mostly offset by growth in the rest of world. Excluding the US, retail sales were (-5%, +2% cc). Total Anti-Infectives franchise sales were USD 649 million (-8%, -3% cc), including finished dosage forms sold under the Sandoz name and Anti-Infectives sold to third parties for sale under their own name (USD 259 million, -9%, -5% cc).

Operating income
Operating income was USD 555 million (-25%, -17% cc) as higher net changes in legal settlements, higher restructuring expenses from the announced Sandoz transformation and lower divestment income were partially offset by continued gross margin improvement. Operating income margin was 11.6% of net sales, declining 3.2 percentage points (-2.6 percentage points cc).

Core adjustments were USD 407 million, including USD 160 million of amortization. Prior year core adjustments were USD 242 million. The change in core adjustments compared to prior year was driven by higher net restructuring expenses from the announced Sandoz transformation, lower divestment gains and higher net changes in legal settlements.

Core operating income was USD 962 million (-2%, +6% cc) as gross margin improvements, sales growth and lower SG&A costs were partly offset by price erosion, higher net legal settlements and lower divestment income. Core operating income was 20.2% of net sales, increasing 0.5 percentage points (+0.9 percentage points cc). Core gross margin increased by 1.9 percentage points (cc), as favorable product and geographic mix and ongoing productivity improvements, were partly offset by the impact of price erosion mainly in the US. Core R&D expenses increased by 0.3 percentage points (cc). Core SG&A expenses decreased by 0.6 percentage points (cc). Core Other Income and Expense decreased the margin by 1.3 percentage points (cc) mainly due to higher net legal settlements.
 
 
 
12
 

GROUP CASH FLOW AND BALANCE SHEET

Cash flow

Second quarter
Net cash flows from operating activities from continuing operations amounted to USD 3.1 billion, compared to USD 3.5 billion in the prior year quarter. Higher net income adjusted for non-cash items and other adjustments, including divestment gains, was more than offset by higher working capital, lower dividends from associated companies (OTC JV dividends received in the prior year quarter), and higher provision payments.

Net cash flows from operating activities from discontinued operations are not material on account of the completion of the Alcon spin-off on April 9, 2019, compared to USD 430 million in the prior year quarter.

Net cash inflows from investing activities from continuing operations amounted to USD 0.2 billion, compared to USD 4.5 billion in the prior year quarter. The current year period includes mainly cash inflows from the sale of property, plant and equipment (including proceeds from the sale and leaseback of real estate), intangible and financial assets of USD 1.0 billion, partly offset by cash outflows for the purchase of property, plant and equipment of USD 0.3 billion, for intangible assets of USD 0.2 billion, for financial assets and other non-current assets of USD 0.1 billion, and for the acquisitions of businesses of USD 0.3 billion for IFM Tre, Inc.

In the prior year quarter, net cash flows from investing activities from continuing operations were mainly related to the cash inflow of USD 13.0 billion from the divestment of our 36.5% stake in the GSK consumer healthcare joint venture. This was partly offset by cash outflows for the acquisitions of businesses of USD 8.4 billion, mainly for AveXis, Inc. of USD 8.3 billion, net (USD 8.7 billion, net of cash acquired USD 0.4 billion).

Net cash flows used in investing activities from discontinued operations amounted to USD 0.7 billion, compared to USD 0.1 billion in the prior year quarter. The current year period mainly includes the cash outflow of USD 0.6 billion due to the derecognized cash and cash equivalents following the completion of the spin-off of the Alcon business.

Net cash flows used in financing activities from continuing operations amounted to USD 2.7 billion, compared to USD 1.3 billion in the prior year quarter. The current year period mainly includes the cash outflows for net treasury share transactions of USD 2.4 billion, the net repayments of financial debts of USD 0.8 billion, partly offset by other net financing cash inflows of USD 0.5 billion.

In the prior year quarter, net cash flows used in financing activities from continuing operations included net repayments of financial debts of USD 0.9 billion, cash outflows for net treasury share transactions of USD 0.6 billion, partly offset by other net financing cash inflows of USD 0.3 billion.

Net cash inflows from financing activities from discontinued operations amounted to USD 2.7 billion, compared to a cash outflow of USD 0.3 billion in the prior year quarter. The current year period includes mainly the cash inflows of USD 3.2 billion from Alcon borrowings, partly offset by USD 0.1 billion payments for transaction costs.

Free cash flow from continuing operations amounted to USD 3.6 billion (+11% USD) compared to USD 3.3 billion in prior year, mainly driven by higher operating income adjusted for non-cash items, and higher divestment proceeds, partly offset by higher working capital, increased payments out of provisions and lower dividends received from the OTC JV which was divested in Q2 2018.

First half
Net cash flows from operating activities from continuing operations amounted to USD 5.4 billion, compared to USD 5.9 billion in the prior year period. Higher net income adjusted for non-cash items and other adjustments, including divestment gains, was more than offset by lower dividends from associated companies (OTC JV dividends received in the prior year period), higher provision payments and higher working capital, which in the prior year period included the receipt of a GSK sales milestone from the divested Vaccines business of USD 0.4 billion.

Net cash flows from operating activities from discontinued operations are USD 78 million, compared to USD 563 million in the prior year period.
 
 
 
13
 

Net cash inflows from investing activities from continuing operations amounted to USD 2.0 billion, compared to USD 0.5 billion in the prior year period. The current year mainly includes USD 2.3 billion net proceeds from the sales of marketable securities and commodities and cash inflows from the sale of property, plant and equipment (including the proceeds from the sale and leaseback of real estate), intangible and financial assets of USD 1.3 billion, partly offset by cash outflows for the purchase of property, plant and equipment of USD 0.6 billion, for intangible assets of USD 0.5 billion, for financial assets and other non-current assets of USD 0.2 billion, and for acquisitions and divestments of businesses, net of USD 0.4 billion including the acquisition of IFM Tre, Inc. (USD 0.3 billion).

In the prior year period, net cash flows from investing activities from continuing operations were mainly related to the cash inflow of USD 13.0 billion from the divestment of our 36.5% stake in the GSK consumer healthcare joint venture. This was partly offset by cash outflows for the acquisitions of businesses of USD 11.9 billion, mainly Advanced Accelerator Applications S.A. of USD 3.5 billion, net (USD 3.9 billion, net of cash acquired USD 0.4 billion) and AveXis, Inc. of USD 8.3 billion, net (USD 8.7 billion, net of cash acquired USD 0.4 billion).

Net cash flows used in investing activities from discontinued operations amounted to USD 1.1 billion, compared to USD 0.3 billion in the prior year period. The current year period includes mainly the cash outflow for the acquisition of PowerVision, Inc. of USD 0.3 billion and USD 0.6 billion due to the derecognized cash and cash equivalents following the completion of the Alcon spin-off, on April 9, 2019.

Net cash flows used in financing activities from continuing operations amounted to USD 13.0 billion, compared to USD 2.8 billion in the prior year period. The current year mainly includes the cash outflows for the dividend payment of USD 6.6 billion, the repayment at maturity of a US dollar bond of USD 3.0 billion and for net treasury share transactions of USD 2.4 billion. The net repayments of current financial debts amounted to USD 1.0 billion.

In the prior year period, net cash flows used in financing activities from continuing operations included cash outflows for the dividend payment of USD 7.0 billion, the repayment of non-current financial debts of USD 0.4 billion and for net treasury transactions of USD 0.3 billion. This was partly offset by cash inflows from the issuance of euro bonds totaling USD 2.8 billion (notional amount EUR 2.25 billion), the net increase in current financial debts of USD 1.8 billion, and other net financing cash inflows of USD 0.3 billion.

Net cash inflows from financing activities from discontinued operations amounted to USD 3.3 billion, compared to a cash outflow of USD 0.3 billion in the prior year period. The current year period includes mainly the cash inflows of USD 3.5 billion from Alcon borrowings, partly offset by USD 0.2 billion payments for transaction costs.

Free cash flow from continuing operations amounted to USD 5.5 billion (+6% USD) compared to USD 5.2 billion in the prior year, mainly driven by higher operating income adjusted for non-cash items, and higher divestment proceeds, partly offset by higher working capital, a sales milestone from the divested Vaccines business received in the prior year, increased payments out of provisions and lower dividends received from the OTC JV which was divested in Q2 2018.

Balance sheet

There has been a significant change on the balance sheet as a result of the completion of the spin-off of the Alcon business through the completion of the dividend in kind distribution to Novartis AG shareholders on April 9, 2019 (see Note 2, 3 and 11 for further details).

Assets
Total non-current assets of USD 88.0 billion at June 30, 2019 decreased by USD 22.0 billion compared to prior year end, mainly due to the derecognition of the Alcon business non-current assets as a result of the dividend in kind distribution to Novartis AG shareholders. Excluding the effect of the derecognition, total non-current assets increased by USD 1.6 billion. The reduction of USD 0.8 billion in intangible assets other than goodwill is due to amortization and impairments only partially offset by net additions and the impact of business combinations. Goodwill of USD 26.5 billion remained stable compared to December 31, 2018. Property, plant and equipment decreased by USD 0.5 billion to USD 12.3 billion mainly due to depreciation only partly offset by net additions. Right-of-use assets of USD 1.8 billion were recognized resulting from the implementation of IFRS 16 – Leases on January 1, 2019. Financial assets at USD 3.4 billion increased by USD 1.1 billion mostly due to the investments in
 
 
 
14
 

Alcon Inc. shares recognized by certain consolidated foundations through the Alcon spin-off. Investments in associated companies, deferred tax assets and other non-current assets were broadly in line with prior year end.

Total current assets of USD 28.3 billion at June 30, 2019 decreased by USD 7.2 billion. Excluding the effect of the derecognition of the Alcon business current assets, cash and cash equivalents decreased by USD 3.1 billion, mainly due to the repayment of financial debts and the dividend payment in Q1 2019. Marketable securities, commodities, time deposits and derivative financial instruments decreased by USD 2.3 billion. Inventories at USD 6.1 billion, and trade receivables at USD 8.0 billion increased by USD 0.6 billion and USD 0.5 billion respectively, while other current assets remained broadly in line with prior year end at USD 2.8 billion.
 
Liabilities
Total non-current liabilities of USD 34.7 billion decreased by USD 2.6 billion compared to December 31, 2018. Excluding the effect of the derecognition of the Alcon business non-current liabilities, total non-current liabilities remained broadly in line with prior year end. The recognition of the USD 1.8 billion lease liabilities, resulting from the implementation of IFRS 16 – Leases on January 1, 2019, was offset by the reduction of the non-current financial debt and the deferred tax liabilities by USD 2.0 billion and USD 0.2 billion respectively. Provisions and other non-current liabilities increased compared to prior year end by USD 0.4 billion to USD 6.8 billion.
 
Total current liabilities of USD 30.1 billion at June 30, 2019 increased by USD 0.5 billion. Excluding the effect of the derecognition of the Alcon business current liabilities, total current liabilities increased by USD 2.2 billion at June 30, 2019. Financial debts and derivatives decreased by USD 1.8 billion mainly due to repayment of USD 3.0 billion bond issued in February 2009. Lease liabilities of USD 0.3 billion were recognized resulting from the implementation of IFRS 16 – Leases on January 1, 2019. Provisions and other current liabilities increased by USD 3.5 billion mainly due to liabilities related to the treasury share repurchase obligation under a share buyback trading plan. Current income tax liabilities at USD 2.2 billion increased by USD 0.3 billion. Trade payable remained broadly in line with prior year end at USD 4.8 billion.

Net assets of disposal group held for sale of USD 0.8 billion are related to the pending divestment of the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo Pharma USA Inc., as announced on September 6, 2018 (see Note 3). 

Group equity
The Group’s equity decreased by USD 27.2 billion to USD 51.5 billion at June 30, 2019 compared to USD 78.7 billion at December 31, 2018. This decrease was mainly due to derecognition of the dividend in kind distribution liability of USD 23.4 billion upon the completion of the Alcon spin-off (see Note 2, 3 and 11 for further details), the cash-dividend payment of USD 6.6 billion, purchase of treasury shares of USD 3.0 billion, increase of treasury share repurchase obligation under a share buyback trading plan of USD 2.3 billion, net actuarial losses of USD 0.9 billion and transaction costs of USD 0.3 billion. This was partially offset by net income of USD 8.6 billion and the net effect of exercise of options and employee transactions of USD 0.7 billion.

Net debt and debt/equity ratio
The net debt increased to USD 17.9 billion at June 30, 2019 compared to USD 16.2 billion at December 31, 2018. The Group’s liquidity amounted to USD 10.3 billion at June 30, 2019 compared to USD 16.0 billion at December 31, 2018, and the total of the non-current and current financial debt, including derivatives, amounted to USD 28.2 billion at June 30, 2019, compared to USD 32.1 billion at December 31, 2018. The debt/equity ratio increased to 0.55:1 at June 30, 2019 compared to 0.41:1 at December 31, 2018.
 
 
 
15
 

Innovation Review

Benefitting from our continued focus on innovation, Novartis has one of the industry’s most competitive pipelines with more than 200 projects in clinical development.

Selected Innovative Medicines approvals: US, EU and Japan
Product
Active ingredient/Descriptor
Indication
Approval date
Piqray
alpelisib + fulvestrant
PIK3CA mutant HR+/HER2- postmenopausal advanced or metastatic BC
May 2019
Zolgensma
onasemnogene abepar-vovec-xioi
Spinal Muscular Atrophy (IV formulation)
May 2019

Selected Innovative Medicines projects awaiting regulatory decisions
      
Completed submissions
   
Product
Indication
 
US
   
EU
   
Japan
 
News update
Zolgensma (AVXS-101)
Spinal Muscular Atrophy Type 1 (IV formulation)
 
Approved
    Q4 2018
    Q4 2018
 
PRIME designation in EU
Sakigake designation in Japan
Mayzent (BAF312)
Secondary Progressive Multiple Sclerosis
 
Approved
    Q3 2018     Q1 2019    
BYL719
(Piqray in US, alpelisib)
+ fulvestrant
PIK3CA mutant HR+/HER2- postmenopausal advanced or metastatic BC
 
Approved
    Q4 2018

            
LCI699
Cushing’s disease
Q1 2019
 Q4 2018
- Announced plan to divest along with Signifor, in H2 2019
Lucentis
Retinopathy of prematurity
         Q4 2018     Q1 2019
Diabetic retinopathy          Q4 2018             
Promacta/ Revolade
Severe aplastic anemia, 1st line
 
Approved
    Q2 2018    
Approved
   
RTH258
nAMD
  Q1 2019     Q1 2019     Q2 2019    
SEG101
Sickle cell disease
  Q2 2019     Q2 2019          
- US Priority review
QMF149
Asthma
       Q2 2019          
QUARTZ study meets primary and key secondary endpoints
QVM149
Asthma
Q2 2019    
Xiidra
Dry eye
 
Approved
    Q4 2018          
- CHMP opinion anticipated Q4 2019

 
Selected Innovative Medicines pipeline projects
Project/ Compound
Potential indication/ Disease area
First planned submissions
Current Phase
News update
ABL001
Chronic myeloid leukemia 3rd  line
2021
III
 
Chronic myeloid leukemia 1st  line
≥2023
II
 
ACZ885
(canakinumab)
Adjuvant NSCLC
2022
III
Enrollment ongoing for Phase III studies
1st line NSCLC
2021
III
2nd line NSCLC
2021
III
Zolgensma
Spinal Muscular Atrophy Type 2/3 (IT formulation)
2020
I
- Interim data presented at AAN in May
AVXS-201
Rett Syndrome
2022
I
 
CAD106
Alzheimer’s disease
≥2023
II / III
 
 
16
 

 
BYL719
(Piqray in US)
 
  
HR- HER+ adv. breast cancer
≥2023
III
 
Triple negative breast cancer
≥2023
III
 
Head and neck squamous cell carcinoma
≥2023
III
 
Ovarian Cancer
≥2023
III
 
CFZ533
(iscalimab)
 
Solid organ transplantation
≥2023
II
- Enrollment has started in the phase IIb de novo and maintenance kidney transplant study
- Positive interim readout CIRRUS I trial June 2019
Sjoegren’s syndrome
≥2023
II
 
CNP520
Alzheimer’s disease
NA
II / III
- program discontinued in July 2019
Cosentyx
 
Non-radiographic axial spondyloarthritis
2019
III
- On track for readout in H2 2019
Psoriatic arthritis head-to-head vs. adalimumab
2020
III
 
Ankylosing spondylitis head-to-head vs. adalimumab
2022
III
 
Hidradenitis suppurativa
2022
III
 
CSJ117
Severe asthma
≥2023
II
 
ECF843
Dry eye
2022
II
 
Entresto
Chronic heart failure with preserved ejection fraction
2019
III
- PARAGON-HF topline results expected Q3-2019
Post-acute myocardial infarction
2020
III
 
HDM201
Acute myeloid leukemia
≥2023
II
 
INC280
(capmatinib)
NSCLC (cMET amp and mut)
2019
II
- Primary analysis in the GEOMETRY mono -1 study demonstrates promising efficacy – June 2019
- Breakthrough Therapy designation granted by FDA
- Orphan Drug designation granted by FDA (US) and MHLW (Japan)
Jakavi
Acute graft-versus-host disease (GvHD)
2020
III
 
Chronic graft-versus-host disease (GvHD)
2020
III
 
KAE609
(cipargamin)
Malaria
≥2023
II
 
KAF156
(ganaplacide)
Malaria
≥2023
II
 
Kisqali (LEE011)
+ endocrine therapy
HR+/HER2- early BC (adjuvant)
≥2023
III
- Translational Research In Oncology (TRIO) is collaborating with Novartis on an upcoming phase III clinical trial (called NATALEE)
- Positive read out MONALEESA-7 trial in advanced BC– June 2019
Kymriah (tisagenlecleucel)
 
r/r Follicular lymphoma
2021
II
 
Chronic lymphocytic leukemia
NA
II
 - program discontinued in Q2 2019
r/r DLBCL in 1st relapse
2021
III
 
+ pembrolizumab
r/r DLBCL
≥2023
I
 
LAM320
Multi-drug resistant tuberculosis
2021
III
- WHO pre-qualification submission achieved in April 2019
LJC242
Non-alcoholic steatohepatitis (NASH)
≥2023
II
 
LJN452
(tropifexor)
Non-alcoholic steatohepatitis (NASH)
≥2023
II
- FDA Fast Track designation
 
 
 
17
 

LMI070
Spinal Muscular Atrophy
≥2023
II
- FDA Orphan designation, EMA Orphan status obtained
- Dose ranging study ongoing
LNP023
IgA nephropathy
≥2023
II
 
Membranous nephropathy
≥2023
II
 
 
C3 glomerulopathy
≥2023
II
 
LOU064
Chronic spontaneous urticaria
≥2023
II
 
177Lu-PSMA-617
Metastatic castration-resistant prostate cancer
2020
III
 
MBG453
Myelodysplastic syndrome
2021
II
 
MOR106
Atopic dermatitis
≥2023
II
 
OMB157 (ofatumumab)
Relapsing multiple sclerosis
2019
III
- Phase III ASCLEPIOS studies fully recruited and on track for Q3 2019 readout
PDR001 + Tafinlar + Mekinist
Metastatic BRAF V600+ melanoma
2019
III
- On track for H2 2019 readout
PDR001 Combo
Metastatic melanoma
≥2023
II
- Enrollment ongoing
QAW039
(fevipiprant)
Asthma
2020
III
- Phase III LUSTER (1 and 2) and ZEAL (1 and 2) studies enrollment completed. On track for H2 2019 completion
QBW251
COPD
≥2023
II
 
QGE031
(ligelizumab)
Chronic spontaneous urticaria / chronic
idiopathic urticaria
2021
III
- Phase III trials initiated enrollment
RTH258 (brolucizumab)
Diabetic macular edema
2021
III
- DME trial started
Retinal vein occlusion
≥2023
III
 
Rydapt (PKC412)
Acute myeloid leukemia (FLT3 wild type)
2022
III
 
SAF312
Chronic ocular surface pain
≥2023
II
 
TQJ230
Secondary prevention of cardiovascular events in patients with elevated levels of lipoprotein (a)
≥2023
III
- Phase III planned to initiate in Q1 of 2020
UNR844
Presbyopia
2022
II
 
VAY736
(lanalumab)
Auto-immune hepatitis
≥2023
II
 
Primary Sjoegren’s syndrome
≥2023
II
- FDA Fast Track designation
- Phase II DRF study fully recruited
VAY785 (emricasan)
Non-alcoholic steatohepatitis (NASH)
≥2023
II
 
VPM087
1st line colorectal cancer / 1st line renal cell carcinoma
≥2023
I
 
Xolair
Nasal polyps
2019
III
- POLYP 1 and POLYP2 positive study read out – May 2019
ZPL389
(adriforant)
Atopic dermatitis
2022
II
- Phase IIb trial enrollment initiated

Selected Sandoz approvals and pipeline projects (biosimilars)
Project/ Compound
Potential indication/Disease area
Submission status
Current Phase
News update
LA-EP2006 (pegfilgrastim)
Chemotherapy-induced neutropenia and others (same as originator)
US
EU
Submitted
Approved
- Resubmitted to FDA in April
GP2411 (denosumab)
Osteoporosis, skeletal-related in bone met. pts (same as originator)
EU/US
III
 
 
 
 
18
 

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Consolidated income statements

Second quarter (unaudited)



(USD millions unless indicated otherwise) Note Q2 2019 Q2 2018 Change
Net sales to third parties from continuing operations 10 11 764 11 339 425
Sales to discontinued operations 20 -20
Net sales from continuing operations 11 764 11 359 405
Other revenues 10 260 294 -34
Cost of goods sold -3 406 -3 558 152
Gross profit from continuing operations 8 618 8 095 523
Selling, general and administration -3 585 -3 495 -90
Research and development -2 051 -2 126 75
Other income 989 481 508
Other expense -1 308 -524 -784
Operating income from continuing operations 2 663 2 431 232
Income from associated companies 176 5 932 -5 756
Interest expense -205 -237 32
Other financial income and expense 0 45 -45
Income before taxes from continuing operations 2 634 8 171 -5 537
Taxes -525 -443 -82
Net income from continuing operations 2 109 7 728 -5 619
Net income from discontinued operations before gain on distribution of Alcon Inc. to Novartis AG shareholders 11 40 -40
Gain on distribution of Alcon Inc. to Novartis AG shareholders 3, 11 4 691 4 691
Net income from discontinued operations 4 691 40 4 651
Net income 6 800 7 768 -968
Attributable to:
Shareholders of Novartis AG
6 799 7 768 -969
Non-controlling interests
1 1
Weighted average number of shares outstanding - Basic (million) 2 310 2 327 -17
Basic earnings per share from continuing operations (USD)1 0.91 3.32 -2.41
Basic earnings per share from discontinued operations (USD)1 2.03 0.02 2.01
Total basic earnings per share (USD)1 2.94 3.34 -0.40
Weighted average number of shares outstanding – Diluted (million) 2 333 2 346 -13
Diluted earnings per share from continuing operations (USD)1 0.90 3.29 -2.39
Diluted earnings per share from discontinued operations (USD)1 2.01 0.02 1.99
Total diluted earnings per share (USD)1 2.91 3.31 -0.40
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.





19

 
Consolidated income statements

First half (unaudited)



(USD millions unless indicated otherwise) Note H1 2019 H1 2018 Change
Net sales to third parties from continuing operations 10 22 870 22 254 616
Sales to discontinued operations 53 33 20
Net sales from continuing operations 22 923 22 287 636
Other revenues 10 556 529 27
Cost of goods sold -6 657 -7 009 352
Gross profit from continuing operations 16 822 15 807 1 015
Selling, general and administration -6 915 -6 779 -136
Research and development -4 350 -4 108 -242
Other income 1 192 869 323
Other expense -1 844 -987 -857
Operating income from continuing operations 4 905 4 802 103
Income from associated companies 256 6 084 -5 828
Interest expense -431 -455 24
Other financial income and expense 44 80 -36
Income before taxes from continuing operations 4 774 10 511 -5 737
Taxes -797 -813 16
Net income from continuing operations 3 977 9 698 -5 721
Net loss/income from discontinued operations before gain on distribution of Alcon Inc. to Novartis AG shareholders 11 -101 98 -199
Gain on distribution of Alcon Inc. to Novartis AG shareholders 3, 11 4 691 4 691
Net income from discontinued operations 4 590 98 4 492
Net income 8 567 9 796 -1 229
Attributable to:
Shareholders of Novartis AG
8 565 9 793 -1 228
Non-controlling interests
2 3 -1
Weighted average number of shares outstanding - Basic (million) 2 312 2 326 -14
Basic earnings per share from continuing operations (USD)1 1.72 4.17 -2.45
Basic earnings per share from discontinued operations (USD)1 1.98 0.04 1.93
Total basic earnings per share (USD)1 3.70 4.21 -0.52
Weighted average number of shares outstanding – Diluted (million) 2 336 2 347 -11
Diluted earnings per share from continuing operations (USD)1 1.70 4.13 -2.43
Diluted earnings per share from discontinued operations (USD)1 1.96 0.04 1.92
Total diluted earnings per share (USD)1 3.66 4.17 -0.51
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.   



20

 
Consolidated statements of comprehensive income

Second quarter (unaudited)



(USD millions) Q2 2019 Q2 2018 Change
Net income 6 800 7 768 -968
Other comprehensive income to be eventually recycled into the consolidated income statement:
Fair value adjustments on deferred cash flow hedges, net of taxes
6 -6
Total fair value adjustments on financial instruments, net of taxes
6 -6
Novartis share of other comprehensive income recognized by associated companies, net of taxes 1
-563 563
Net investment hedge
-27 124 -151
Currency translation effects2
525 -809 1 334
Total of items to eventually recycle 498 -1 242 1 740
Other comprehensive income never to be recycled into the consolidated income statement:
Actuarial (losses)/gains from defined benefit plans, net of taxes
-387 42 -429
Fair value adjustments on equity securities, net of taxes
-21 63 -84
Total of items never to be recycled -408 105 -513
Total comprehensive income 6 890 6 631 259
Attributable to:
Shareholders of Novartis AG
6 888 6 633 255
Continuing operations
2 298 6 553 -4 255
Discontinued operations
4 590 80 4 510
Non-controlling interests
2 -2 4
  
In 2018, Novartis share of other comprehensive income recognized by associated companies, net of taxes of USD 511 million was recycled into the consolidated income statement as a result of the divestment of the investment in GSK Consumer Healthcare Holdings Ltd. (see Note 3). 
In 2019, cumulative currency translation gains of USD 123 million were recycled into the consolidated income statement as a result of the Alcon spin-off (see Note 3 and 11). In 2018, cumulative currency translation losses of USD 946 million were recycled into the consolidated income statement as a result of the divestment of the investment in GSK Consumer Healthcare Holdings Ltd. 
  
 

21

 
Consolidated statements of comprehensive income

First half (unaudited)



(USD millions) H1 2019 H1 2018 Change
Net income 8 567 9 796 -1 229
Other comprehensive income to be eventually recycled into the consolidated income statement:
Fair value adjustments on debt securities, net of taxes
1 -2 3
Fair value adjustments on deferred cash flow hedges, net of taxes
1 9 -8
Total fair value adjustments on financial instruments, net of taxes
2 7 -5
Novartis share of other comprehensive income recognized by associated companies, net of taxes 1
-54 -528 474
Net investment hedge
12 59 -47
Currency translation effects2
189 233 -44
Total of items to eventually recycle 149 -229 378
Other comprehensive income never to be recycled into the consolidated income statement:
Actuarial (losses)/gains from defined benefit plans, net of taxes3
-890 224 -1 114
Fair value adjustments on equity securities, net of taxes
74 150 -76
Total of items never to be recycled -816 374 -1 190
Total comprehensive income 7 900 9 941 -2 041
Attributable to:
Shareholders of Novartis AG
7 898 9 941 -2 043
Continuing operations
3 321 9 786 -6 465
Discontinued operations
4 577 155 4 422
Non-controlling interests
2 0 2
In 2018, Novartis share of other comprehensive income recognized by associated companies, net of taxes of USD 511 million was recycled into the consolidated income statement as a result of the divestment of the investment in GSK Consumer Healthcare Holdings Ltd. (see Note 3).
In 2019, cumulative currency translation gains of USD 123 million were recycled into the consolidated income statement as a result of the Alcon spin-off (see Note 3 and 11). In 2018, cumulative currency translation losses of USD 946 million were recycled into the consolidated income statement as a result of the divestment of the investment in GSK Consumer Healthcare Holdings Ltd.
Included in 2019 is a USD -358 million impact related to the revaluation of deferred tax assets on Swiss pension plans that were previously recognized through other comprehensive income. This revaluation resulted from enactment of the Swiss canton Basel-Stadt tax rate reduction, effective on January 1, 2019.



22

 
Consolidated balance sheets


(USD millions)


Note
Jun 30,
2019
(unaudited)
Dec 31,
2018
(audited)


Change
Assets
Non-current assets
Property, plant and equipment 10 12 290 15 696 -3 406
Right-of-use assets 6 1 762 1 762
Goodwill 10 26 533 35 294 -8 761
Intangible assets other than goodwill 10 27 221 38 719 -11 498
Investments in associated companies 8 204 8 352 -148
Deferred tax assets 7 827 8 699 -872
Financial assets 3 434 2 345 1 089
Other non-current assets 703 895 -192
Total non-current assets 87 974 110 000 -22 026
Current assets
Inventories 6 094 6 956 -862
Trade receivables 7 973 8 727 -754
Income tax receivables 279 248 31
Marketable securities, commodities, time deposits and derivative financial instruments 344 2 693 -2 349
Cash and cash equivalents 9 991 13 271 -3 280
Other current assets 2 792 2 861 -69
Assets of disposal group held for sale 3 847 807 40
Total current assets 28 320 35 563 -7 243
Total assets 116 294 145 563 -29 269
Equity and liabilities
Equity
Share capital 936 944 -8
Treasury shares -67 -69 2
Reserves 50 557 77 739 -27 182
Issued share capital and reserves attributable to Novartis AG shareholders 51 426 78 614 -27 188
Non-controlling interests 78 78
Total equity 51 504 78 692 -27 188
Liabilities
Non-current liabilities
Financial debts 20 364 22 470 -2 106
Lease liabilities 6 1 752 1 752
Deferred tax liabilities 5 720 7 475 -1 755
Provisions and other non-current liabilities 6 843 7 319 -476
Total non-current liabilities 34 679 37 264 -2 585
Current liabilities
Trade payables 4 752 5 556 -804
Financial debts and derivative financial instruments 7 857 9 678 -1 821
Lease liabilities 6 294 294
Current income tax liabilities 2 196 2 038 158
Provisions and other current liabilities 14 962 12 284 2 678
Liabilities of disposal group held for sale 3 50 51 -1
Total current liabilities 30 111 29 607 504
Total liabilities 64 790 66 871 -2 081
Total equity and liabilities 116 294 145 563 -29 269
 

23

 
Consolidated statements of changes in equity 

Second quarter (unaudited)




(USD millions)




Share
capital




Treasury
shares




Retained
earnings




Total value
adjustments
Issued share
capital and
reserves
attributable
to Novartis
shareholders



Non-
controlling
interests




Total
equity
Total equity at April 1, 2019 944 -63 51 518 -5 170 47 229 78 47 307
Net income 6 799 6 799 1 6 800
Other comprehensive income 89 89 1 90
Total comprehensive income 6 799 89 6 888 2 6 890
Dividend in kind1 2 927 2 927 2 927
Purchase of treasury shares -16 -2 754 -2 770 -2 770
Reduction of share capital -8 12 -4
Equity-based compensation 175 175 175
Shares delivered to Alcon employees as a result of the Alcon spin-off 32 32 32
Taxes on treasury share transactions2 -185 -185 -185
Increase of treasury share repurchase obligation under a share buyback trading plan -2 573 -2 573 -2 573
Transaction costs3 -301 -301 -301
Fair value adjustments on financial assets sold 3 -3
Fair value adjustments related to divestments 4 -4
Impact of change in ownership of consolidated entities -3 -3 -2 -5
Other movements4 7 7 7
Total of other equity movements -8 -4 -2 672 -7 -2 691 -2 -2 693
Total equity at June 30, 2019 936 -67 55 645 -5 088 51 426 78 51 504
Fair value of the dividend-in-kind of the Alcon business distributed to Novartis AG shareholders and ADR (American Depositary Receipt) holders approved at the 2019 Annual General Meeting held on February 28, 2019. Distribution was effected on April 9, 2019, whereby each Novartis AG shareholders and ADR holder received 1 Alcon Inc, share for every 5 Novartis AG shares/ADRs they held on April 8, 2019, close of business (see Note 2, 3 and 11 for further details)
Included in Q2 2019 is a USD 69 million impact related to the revaluation of deferred tax liability on treasury shares that are recognized through retained earnings. This revaluation resulted from the Swiss Federal tax reform enacted in May 2019, effective January 1, 2020.
Transaction costs directly attributable to the distribution (spin-off) of the Alcon business to Novartis AG shareholders (see Note 2)
Impact of hyperinflationary economies


(USD millions)




Share
capital




Treasury
shares




Retained
earnings




Total value
adjustments
Issued share
capital and
reserves
attributable
to Novartis
shareholders



Non-
controlling
interests




Total
equity
Total equity at April 1, 2018 969 -93 73 498 -3 276 71 098 113 71 211
Net income 7 768 7 768 7 768
Other comprehensive income -563 -572 -1 135 -2 -1 137
Total comprehensive income 7 205 -572 6 633 -2 6 631
Purchase of treasury shares -4 -705 -709 -709
Reduction of share capital -25 34 -9
Equity-based compensation 169 169 169
Increase of treasury share repurchase obligation under a share buyback trading plan -363 -363 -363
Transaction costs1 -11 -11 -11
Fair value adjustments on financial assets sold 11 -11
Impact of change in ownership of consolidated entities -2 -2 -25 -27
Total of other equity movements -25 30 -910 -11 -916 -25 -941
Total equity at June 30, 2018 944 -63 79 793 -3 859 76 815 86 76 901
Transaction costs directly attributable to the distribution (spin-off) of the Alcon business to Novartis AG shareholders (see Note 2)



24

 
Consolidated statements of changes in equity 

First half 2019 (unaudited)




(USD millions)




Share
capital




Treasury
shares




Retained
earnings




Total value
adjustments
Issued share
capital and
reserves
attributable
to Novartis
shareholders



Non-
controlling
interests




Total
equity
Total equity at January 1, 2019, as previously reported 944 -69 82 191 -4 452 78 614 78 78 692
Impact of change in accounting policies1 3 3 3
Restated equity at January 1, 2019 944 -69 82 194 -4 452 78 617 78 78 695
Net income 8 565 8 565 2 8 567
Other comprehensive income -54 -613 -667 -667
Total comprehensive income 8 511 -613 7 898 2 7 900
Dividends -6 645 -6 645 -6 645
Dividend in kind2 -23 434 -23 434 -23 434
Purchase of treasury shares -17 -2 955 -2 972 -2 972
Reduction of share capital -8 12 -4
Exercise of options and employee transactions 3 197 200 200
Equity-based compensation 4 443 447 447
Shares delivered to Alcon employees as a result of the Alcon spin-off 32 32 32
Taxes on treasury share transactions3 -185 -185 -185
Increase of treasury share repurchase obligation under a share buyback trading plan -2 289 -2 289 -2 289
Transaction costs4 -253 -253 -253
Fair value adjustments on financial assets sold 19 -19
Fair value adjustments related to divestments 4 -4
Impact of change in ownership of consolidated entities -3 -3 -2 -5
Other movements5 13 13 13
Total of other equity movements -8 2 -35 060 -23 -35 089 -2 -35 091
Total equity at June 30, 2019 936 -67 55 645 -5 088 51 426 78 51 504
In H1 2019, the impact of change in accounting policy includes USD 3 million related to the implementation of IFRS 16 – Leases (see Notes 2 and 6 for further details).
Fair value of the dividend-in-kind of the Alcon business distributed to Novartis AG shareholders and ADR (American Depositary Receipt) holders approved at the 2019 Annual General Meeting held on February 28, 2019. Distribution was effected on April 9, 2019, whereby each Novartis AG shareholders and ADR holder received 1 Alcon Inc, share for every 5 Novartis AG shares/ADRs they held on April 8, 2019, close of business (see Note 2, 3 and 11 for further details)
Included in H1 2019 is a USD 69 million impact related to the revaluation of deferred tax liability on treasury shares that are recognized through retained earnings. This revaluation resulted from the Swiss Federal tax reform enacted in May 2019, effective January 1, 2020.
Transaction costs directly attributable to the distribution (spin-off) of the Alcon business to Novartis AG shareholders (see Note 2)
Impact of hyperinflationary economies

25

 
Consolidated statements of changes in equity 

First half 2018 (unaudited)




(USD millions)




Share
capital




Treasury
shares




Retained
earnings




Total value
adjustments
Issued share
capital and
reserves
attributable
to Novartis
shareholders



Non-
controlling
interests




Total
equity
Total equity at January 1, 2018, as previously reported 969 -100 77 639 -4 340 74 168 59 74 227
Impact of change in accounting policies1 237 -177 60 60
Restated equity at January 1, 2018 969 -100 77 876 -4 517 74 228 59 74 287
Net income 9 793 9 793 3 9 796
Other comprehensive income -528 676 148 -3 145
Total comprehensive income 9 265 676 9 941 0 9 941
Dividends -6 966 -6 966 -6 966
Purchase of treasury shares -5 -795 -800 -800
Reduction of share capital -25 34 -9
Exercise of options and employee transactions 4 429 433 433
Equity-based compensation 4 352 356 356
Increase of treasury share repurchase obligation under a share buyback trading plan -363 -363 -363
Transaction costs2 -11 -11 -11
Fair value adjustments on financial assets sold 18 -18
Impact of change in ownership of consolidated entities -3 -3 27 24
Total of other equity movements -25 37 -7 348 -18 -7 354 27 -7 327
Total equity at June 30, 2018 944 -63 79 793 -3 859 76 815 86 76 901
The impact of change in accounting policies includes USD 60 million relating to IFRS 15 implementation and USD 177 million relating to IFRS 9 implementation (see Note 1 and 29 of the 2018 Annual report).
Transaction costs directly attributable to the distribution (spin-off) of the Alcon business to Novartis AG shareholders (see Note 2).

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Consolidated statements of cash flows

Second quarter (unaudited)

(USD millions) Note Q2 2019 Q2 2018 Change
Net income from continuing operations 2 109 7 728 -5 619
Adjustments to reconcile net income from continuing operations to net cash flows from operating activities from continuing operations
Reversal of non-cash items and other adjustments 7 2 085 -4 084 6 169
Dividends received from associated companies and others 3 254 -251
Interest received 55 36 19
Interest paid -239 -228 -11
Other financial receipts 10 38 -28
Other financial payments 28 49 -21
Taxes paid1 -560 -501 -59
Net cash flows from operating activities from continuing operations before working capital and provision changes 3 491 3 292 199
Payments out of provisions and other net cash movements in non-current liabilities -323 -121 -202
Change in net current assets and other operating cash flow items -57 341 -398
Net cash flows from operating activities from continuing operations 3 111 3 512 -401
Net cash flows from operating activities from discontinued operations 1 430 -430
Total net cash flows from operating activities 3 111 3 942 -831
Purchase of property, plant and equipment -279 -257 -22
Proceeds from sales of property, plant and equipment 648 6 642
Purchase of intangible assets -161 -226 65
Proceeds from sales of intangible assets 210 222 -12
Purchase of financial assets -45 -39 -6
Proceeds from sales of financial assets 142 55 87
Purchase of other non-current assets -14 -9 -5
Proceeds from sales of other non-current assets 0 4 -4
Acquisitions and divestments of interests in associated companies, net -1 13 001 -13 002
Acquisitions and divestments of businesses, net 7 -286 -8 352 8 066
Purchase of marketable securities and commodities -75 -83 8
Proceeds from sales of marketable securities and commodities 69 139 -70
Net cash flows from investing activities from continuing operations 208 4 461 -4 253
Net cash flows used in investing activities from discontinued operations 2 -682 -136 -546
Total net cash flows used in/from investing activities -474 4 325 -4 799
Acquisition of treasury shares -2 368 -599 -1 769
Increase in non-current financial debts 91 -91
Repayments of non-current financial debts -7 -365 358
Change in current financial debts -793 -649 -144
Payments of lease liabilities, net -69 -69
Impact of change in ownership of consolidated entities -5 -2 -3
Dividends paid to non-controlling interests and other financing cash flows 532 256 276
Net cash flows used in financing activities from continuing operations -2 710 -1 268 -1 442
Net cash flows from/used in financing activities from discontinued operations 3 2 682 -262 2 944
Total net cash flows used in financing activities -28 -1 530 1 502
Net change in cash and cash equivalents 2 609 6 737 -4 128
Cash and cash equivalents of discontinued operations at March 31 4 499 499
Effect of exchange rate changes on cash and cash equivalents 76 -104 180
Total net change in cash and cash equivalents 3 184 6 633 -3 449
Cash and cash equivalents at April 1 6 807 5 813 994
Cash and cash equivalents at June 30 9 991 12 446 -2 455
In Q2 2018, the total net tax payment amounted to USD 516 million, of which USD 15 million was included in the “Net cash flows from operating activities from discontinued operations.”    
For additional information related to Q2 2019 Net cash flows used in investing activities from discontinued operations, refer to Note 11.
Including USD 119 million (Q2 2018: USD 8 million) transaction cost payments directly attributable to the distribution (spin-off) of the Alcon business to Novartis AG shareholders (see Note 2)
Cash and cash equivalents of discontinued operations at March 31 represents the amount of the Alcon business cash and cash equivalents included in the March 31, 2019 consolidated balance sheets in the line “Assets related to discontinued operations.”

27

 
Consolidated statements of cash flows

First half (unaudited)



(USD millions) Note H1 2019 H1 2018 Change
Net income from continuing operations 3 977 9 698 -5 721
Adjustments to reconcile net income from continuing operations to net cash flows from operating activities from continuing operations
Reversal of non-cash items and other adjustments 7 4 101 -2 619 6 720
Dividends received from associated companies and others 463 718 -255
Interest received 140 86 54
Interest paid -406 -372 -34
Other financial receipts 10 38 -28
Other financial payments -16 -14 -2
Taxes paid1 -960 -890 -70
Net cash flows from operating activities before working capital and provision changes from continuing operations 7 309 6 645 664
Payments out of provisions and other net cash movements in non-current liabilities -516 -264 -252
Change in net current assets and other operating cash flow items -1 348 -488 -860
Net cash flows from operating activities from continuing operations 5 445 5 893 -448
Net cash flows from operating activities from discontinued operations1 78 563 -485
Total net cash flows from operating activities 5 523 6 456 -933
Purchase of property, plant and equipment -561 -515 -46
Proceeds from sales of property, plant and equipment 812 51 761
Purchase of intangible assets -498 -642 144
Proceeds from sales of intangible assets 281 416 -135
Purchase of financial assets -154 -71 -83
Proceeds from sales of financial assets 177 64 113
Purchase of other non-current assets -24 -13 -11
Proceeds from sales of other non-current assets 3 4 -1
Acquisitions and divestments of interests in associated companies, net -3 13 000 -13 003
Acquisitions and divestments of businesses, net 7 -382 -11 859 11 477
Purchase of marketable securities and commodities -120 -223 103
Proceeds from sales of marketable securities and commodities 2 428 291 2 137
Net cash flows from investing activities from continuing operations 1 959 503 1 456
Net cash flows used in investing activities from discontinued operations 2 -1 105 -273 -832
Total net cash flows from investing activities 854 230 624
Dividends paid to shareholders of Novartis AG -6 645 -6 966 321
Acquisition of treasury shares -2 590 -774 -1 816
Proceeds from exercise options and other treasury share transactions 200 433 -233
Increase in non-current financial debts 2 856 -2 856
Repayments of non-current financial debts -3 008 -365 -2 643
Change in current financial debts -942 1 802 -2 744
Payments of lease liabilities, net -91 -91
Impact of change in ownership of consolidated entities -5 -7 2
Dividends paid to non-controlling interests and other financing cash flows 71 260 -189
Net cash flows used in financing activities from continuing operations -13 010 -2 761 -10 249
Net cash flows used in financing activities from discontinued operations 3 3 299 -315 3 614
Total net cash flows used in financing activities -9 711 -3 076 -6 635
Net change in cash and cash equivalents -3 334 3 610 -6 944
Effect of exchange rate changes on cash and cash equivalents 54 -24 78
Total net change in cash and cash equivalents -3 280 3 586 -6 866
Cash and cash equivalents at January 1 13 271 8 860 4 411
Cash and cash equivalents at June 30 9 991 12 446 -2 455
In 2019, the total net tax payment amounted to USD 998 million (2018: USD 983 million), of which USD 38 million (2018: USD 93 million) is included in the “Net cash flows from operating activities from discontinued operations.”     
For additional information related to H1 2019 Net cash flows used in investing activities from discontinued operations, refer to Note 11.
Including USD 170 million (2018: USD 8 million) transaction cost payments directly attributable to the distribution (spin-off) of the Alcon business to Novartis AG shareholders (see Note 2)

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Notes to the Condensed Interim Consolidated Financial Statements for the three-month and six-month period ended June 30, 2019 (unaudited)

1. Basis of preparation

These Condensed Interim Consolidated Financial Statements for the three-month and six-month period ended June 30, 2019, were prepared in accordance with International Accounting Standard 34 Interim Financial Reporting and accounting policies set out in the 2018 Annual Report published on January 30, 2019.

2. Selected critical accounting policies

The Group’s principal accounting policies are set out in Note 1 to the Consolidated Financial Statements in the 2018 Annual Report and conform with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board.

The presentation of financial statements requires management to make subjective and complex judgments that affect the reported amounts. Because of the inherent uncertainties, actual outcomes and results may differ from management’s assumptions and estimates.

As disclosed in the 2018 Annual Report, goodwill, and acquired In-Process Research & Development projects are reviewed for impairment at least annually and these, as well as all other investments in intangible assets, are reviewed for impairment whenever an event or decision occurs that raises concern about their balance sheet carrying value. The amount of goodwill and other intangible assets on the Group’s consolidated balance sheet has risen significantly in recent years, primarily from acquisitions. Impairment testing may lead to potentially significant impairment charges in the future that could have a materially adverse impact on the Group’s results of operations and financial condition.

During the first quarter of 2019, at the Annual General Meeting (AGM) of Novartis AG shareholders, held on February 28, 2019, the Novartis AG shareholders approved a special distribution by way of a dividend in kind to effect the spin-off of Alcon Inc. The shareholder approval required the recognition of a distribution liability at the fair value of the Alcon business to be distributed to Novartis AG shareholders. This required the use of valuation techniques for purposes of impairment testing of the Alcon business’ assets to be distributed and for the measurement of the fair value of the distribution liability. These valuations required the use of management assumptions and estimates related to the Alcon business’ future cash flows, market multiples to estimate day one market value and control premiums to apply in estimating the Alcon business fair value. These fair value measurements are classified as “Level 3” in the fair value hierarchy. Note 1 and Note 11 to the Consolidated Financial Statements in the 2018 Annual Report provide additional information on key assumptions that are highly sensitive in the estimation of fair values using valuation techniques. Due to these factors and inherent uncertainties in the use of estimates, actual outcomes and results could vary significantly.

The February 28, 2019, shareholder approval for the spin-off required the Alcon Division and selected portions of Corporate activities attributable to Alcon’s business (the “Alcon business”) to be reported as discontinued operations. Refer to Note 3 and Note 11 for further details.

Transaction costs recorded in Equity

Transaction costs that are directly attributable to the distribution (spin-off) of the Alcon business to the Novartis AG shareholders, and that would otherwise have been avoided, are recorded as a deduction from equity.

Non-current assets held for sale or held for distribution to owners

Non-current assets are classified as assets held for sale or related to discontinued operations when their carrying amount is to be recovered principally through a sale transaction or distribution to owners and a sale or distribution to owners is considered highly probable. They are stated at the lower of carrying amount and fair value less costs to sell with any resulting impairment recognized. Assets related to discontinued operations and assets of disposal group held for sale are not depreciated or amortized.

29

 
Distribution liability

The distribution liability was recorded at the date of shareholder approval for the distribution of the business assets to the shareholders. The Group has elected to measure the distribution liability at the fair value of the business assets taken as a whole to be distributed to shareholders. As a result, the distribution liability was recognized based on the fair value of the Alcon business. The distribution liability was recognized through a reduction in retained earnings. It is adjusted at each balance sheet date for changes in its estimated fair value, up to the date of the distribution to shareholders through retained earnings. Any resulting impairment of the business assets to be distributed is recognized in the consolidated income statements in “Other expense” of discontinued operations, at the date of initial recognition of the distribution liability or at subsequent dates resulting from changes of the distribution liability valuation. At the distribution settlement date, any resulting gain, which is measured as the excess amount of the distribution liability over the then carrying value of the assets of the business distributed, is recognized on the line “Gain on distribution of Alcon Inc. to Novartis AG shareholders” in the income statement of discontinued operations.

New IFRS standards effective as of January 1, 2019

IFRS 16 LEASES

IFRS 16 Leases substantially changed the financial statements as the majority of leases for which the company is the lessee became on-balance sheet liabilities with corresponding right-of-use assets also recognized on the balance sheet. The lease liability reflects the net present value of the remaining lease payments, and the right-of-use asset corresponds to the lease liability, adjusted for payments made before the commencement date, lease incentives and other items related to the lease agreement. The standard replaces IAS 17 Leases.

Upon adoption of the new standard, a portion of the annual operating lease costs, which was previously fully recognized as a functional expense, is recorded as interest expense. In addition, the portion of the lease payments which represents the reduction of the lease liability is recognized in the cash flow statement as an outflow from financing activities, which was previously fully recognized as an outflow from operating activities. Given the leases involved and the current low interest rate environment, these effects are not significant to the presentation of our consolidated income statement as well as consolidated cash flows from operating activities and from financing activities.

The Group implemented the new standard on January 1, 2019, and applied the modified retrospective method, with right-of-use assets measured at an amount equal to the lease liability, adjusted by the amount of the prepaid or accrued lease payments relating to those leases recognized in the balance sheet immediately before the date of initial application and will not restate prior years.

Results of our impact assessment:

The undiscounted operating lease commitments as of December 31, 2018, disclosed in Note 27 to the Consolidated Financial Statements in the Annual Report 2018, amounted to USD 3.6 billion. This includes approximately USD 0.1 billion of leases with a commencement date in 2019 and short-term leases, as well as low-value leases that are recognized from January 1, 2019, upon adoption of IFRS 16, on a straight-line basis as expense in profit and loss. This also includes USD 0.2 billion lease commitments related to the Alcon Division, which is attributable to discontinued operation in 2019. For the remaining lease commitments attributable to continuing operations of USD 3.3 billion, the Group recognized on January 1, 2019, lease liabilities of USD 1.74 billion and right-of-use assets USD 1.55 billion (after adjustments for the USD 0.18 billion prepayments and accrued lease payments recognized as at December 31, 2018). For the lease commitments attributable to discontinued operations, the Group recognized on January 1, 2019, lease liabilities and right-of-use assets of USD 0.2 billion. This does not include the discontinued operations right-of-use assets and lease liability on finance lease agreements of USD 75 million and USD 89 million, respectively. There was an insignificant impact to retained earnings upon adoption of IFRS 16 of USD 3 million that arose from subleases that were accounted for as operating lease agreements under IAS 17 and are accounted for as finance leases under IFRS 16.

As a lessor, the Group had no significant impact upon adoption.

30

 
For further information on the impact of adoption and additional disclosures of IFRS 16 Leases, see Note 6.

The Group has updated accounting policies, effective January 1, 2019, upon adoption of IFRS 16 – Leases are as follows:

Leases

As lessee, the Group assesses whether a contract contains a lease at inception of a contract. The Group recognizes a right-of-use asset and a corresponding lease liability for all arrangements in which it is a lessee, except for leases with a term of twelve months or less (short-term leases) and low value leases. For these short-term and low value leases, the Group recognizes the lease payments as an operating expense on a straight-line basis over the term of the lease.

The lease liability is initially measured at the present value of the future lease payments as from the commencement date of the lease. The lease payments are discounted using the interest rate implicit in the lease or, if not readily determinable, the Novartis incremental borrowing rate in the respective markets.

The right-of-use assets are initially recognized on the balance sheet at cost, which comprises the amount of the initial measurement of the corresponding lease liability, adjusted for any lease payments made at or prior to the commencement date of the lease, any lease incentive received and any initial direct costs incurred by Novartis, and expected costs for obligations to dismantle and remove right-of-use assets when they are no longer used.

Right-of-use assets are depreciated on a straight-line basis from the commencement date of the lease over the shorter of the useful life of the right-of-use asset or the end of the lease term.

Right-of-use assets are assessed for impairment whenever there is an indication that the balance sheet carrying amount may not be recoverable using cash flow projections for the useful life.

3. Significant transactions

Significant transaction in 2019

Completion of the spin-off of the Alcon business through a dividend in kind distribution to Novartis AG shareholders

On June 29, 2018, Novartis announced its intention to seek shareholder approval for the spin-off of the Alcon business into a separately traded standalone company, following the complete structural separation of the Alcon business into a standalone company (the Alcon business or Alcon Inc.).

The Novartis AG shareholders approved the spin-off of the Alcon business at the 2019 Annual General Meeting held on February 28, 2019, subject to completion of certain conditions precedent to the distribution. Upon shareholder approval, the Alcon business was reported as discontinued operations and the fair value of the Alcon business exceeded the carrying value of its net assets.

The conditions precedent to the spin-off were met and on April 8, 2019, the spin-off of the Alcon business was effected by way of a distribution of a dividend in kind of Alcon Inc. shares to Novartis AG shareholders and ADR (American Depositary Receipt) holders (the Distribution). Through the Distribution, each Novartis AG shareholder received 1 Alcon Inc. share for every 5 Novartis AG shares/ADRs they held on April 8, 2019, close of business. As of April 9, 2019, the shares of Alcon Inc. are listed on the SIX Swiss Exchange (SIX) and on the New York Stock Exchange (NYSE) under the symbol “ALC”.

The dividend in kind distribution liability to effect the spin-off of the Alcon business (the distribution liability) amounted to USD 26.4 billion at March 31, 2019, unchanged from its initial recognition on February 28, 2019, and was in excess of the carrying value of the Alcon business net assets as of February 28, 2019, and as of March 31, 2019. The net assets of the Alcon business amounted to USD 23.1 billion as at March 31, 2019.

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On March 6, 2019, Alcon entered into financing arrangements with a syndicate of banks under which it borrowed on April 2, 2019 a total amount of USD 3.2 billion. These borrowings consisted of approximately USD 2.8 billion and the equivalent of USD 0.4 billion in EUR in bridge and other term loans under such Alcon facilities agreement. In addition, approximately USD 0.3 billion of borrowings under a number of local bilateral facilities in different countries, with the largest share of borrowings in Japan, were raised. This resulted in a total gross debt of USD 3.5 billion. These outstanding borrowings of the Alcon legal entities were recorded in the balance sheet and financing cash flow from discontinued operations. Prior to the spin-off, through a series of intercompany transactions, Alcon legal entities paid approximately USD 3.1 billion in cash to Novartis and its affiliates.

At the April 8, 2019 Distribution, the fair value of the distribution liability of the Alcon business amounted to USD 23.4 billion, a decrease of USD 3.0 billion from March 31, 2019. As mentioned above, prior to the spin-off, through a series of intercompany transactions, Alcon legal entities incurred additional net financial debt and paid approximately USD 3.1 billion in cash to Novartis and its affiliates. This additional net debt and transactions resulted in a decrease in Alcon’s net assets to USD 20.0 billion at the date of the Distribution of the dividend in kind to Novartis AG shareholders on April 8, 2019. The distribution liability at April 8, 2019, remained in excess of the then carrying value of the Alcon business net assets.

Certain consolidated foundations own Novartis AG dividend bearing shares restricting their availability for use by the Group. These Novartis AG shares are accounted for as treasury shares. Through the Distribution, these foundations received Alcon Inc. shares representing an approximate 4.7% equity interest in Alcon Inc. Upon the loss of control of Alcon Inc. through the Distribution, the financial investment in Alcon Inc. was recognized at its fair value based on the opening traded share price of Alcon Inc. on April 9, 2019 (a Level 1 hierarchy valuation). At initial recognition, its fair value of USD 1.3 billion was reported on the Group’s consolidated balance sheet as a financial asset. Management has designated this investment at fair value through other comprehensive income.

The total non-taxable non-cash gain recognized at the completion of the spin-off of the Alcon business on April 9, 2019, amounted to USD 4.7 billion consisting of:

(USD millions) H1 2019
Net assets derecognized1 -20 025
Derecognition of distribution liability 23 434
Difference between net assets and distribution liability 3 409
Recognition of Alcon Inc. shares obtained through consolidated foundations 1 273
Currency translation gains recycled into the consolidated income statement 123
Transaction costs recognized in the consolidated income statement -114
Gain on distribution of Alcon Inc. to Novartis AG shareholders 4 691
See Note 11 for additional information.



Significant transaction closed on July 1, 2019

Innovative Medicines – Acquisition of Xiidra®.
On May 8, 2019, Novartis entered into an agreement with Takeda Pharmaceutical Company Limited (Takeda) to acquire the assets associated with Xiidra® (lifitegrast ophthalmic solution) 5% worldwide. Xiidra is the first and only prescription treatment approved to treat both signs and symptoms of dry eye by inhibiting inflammation caused by the disease. The transaction bolsters the Novartis front-of-the-eye portfolio and ophthalmic leadership. The transaction closed on July 1, 2019. The purchase price consists of an USD 3.4 billion upfront payment, customary purchase price adjustments of USD 0.1 billion and the potential milestone payments up to USD 1.9 billion, which Takeda is eligible to receive upon the achievement of specified commercialization milestones.

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Significant pending transaction

Sandoz – Divestment of US dermatology business and generic US oral solids portfolio
On September 6, 2018, Novartis announced it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids portfolio, to Aurobindo Pharma USA Inc. (Aurobindo), for USD 0.8 billion in cash and potential earn-outs.

The Sandoz US portfolios to be sold to Aurobindo include approximately 300 products as well as additional development projects. The sale includes the Sandoz US generic and branded dermatology businesses as well as its dermatology development center. As part of the transaction, Aurobindo will acquire the manufacturing facilities in Wilson, North Carolina, and in Hicksville and Melville, New York.

The transaction is expected to close in the course of 2019 following the completion of customary closing conditions. As the fair value of the consideration (USD 0.8 billion) less costs to sell was below the carrying value of the divested business (USD 1.0 billion, which includes an allocation of Sandoz goodwill of USD 0.2 billion), an impairment of the net assets to be divested in the amount of USD 0.2 billion was recognized as a reduction to goodwill.

In the Group’s consolidated balance sheet at June 30, 2019 and at December 31, 2018, the business assets and liabilities of the Sandoz US dermatology business and generic US oral solids portfolio are separately shown as assets and liabilities of disposal group held for sale.

The disposal group, assets and liabilities classified as held for sale consist of the following:


(USD millions)
Jun 30,
2019
Dec 31,
2018
Assets of disposal group classified as held for sale
Property, plant and equipment 158 148
Intangible assets other than goodwill 478 478
Deferred tax assets 8 8
Other non-current assets 1 1
Inventories 192 165
Other current assets 10 7
Total 847 807
Liabilities of disposal group classified as held for sale
Deferred tax liabilities 2 2
Provisions and other non-current liabilities 4 4
Provisions and other current liabilities 44 45
Total 50 51

There are no cumulative income or expenses included in other comprehensive income relating to the disposal group.

Significant transaction closed in 2019 – Continuing operations

Innovative Medicines – Acquisition of IFM Tre, Inc.
On May 7, 2019, Novartis acquired IFM Tre, Inc., a privately held, US based biopharmaceutical company focused on developing anti-inflammatory medicines targeting the NLRP3 inflammasome. The acquisition gives Novartis full rights to IFM Tre, Inc.’s portfolio of NLPR3 antagonists. The NLPR3 antagonists portfolio consists of one clinical and two pre-clinical programs: IFM-2427, a first-in-class, clinical stage systemic antagonist for an array of chronic inflammatory disorders including atherosclerosis and nonalcoholic steatohepatitis (NASH); a pre-clinical stage gutdirected molecule for the treatment of inflammatory bowel disease; and a pre-clinical stage central nervous system (CNS)-penetrant molecule.

The previously held interest of 9% is adjusted to its preliminary fair value of USD 34 million through the consolidated income statement at acquisition date. This remeasurement resulted in a gain of USD 16 million. The preliminary fair value of the total purchase consideration for acquiring the 91% stake

33

 
Novartis did not already own amounted to USD 373 million. The amount consisted of an initial cash payment of USD 285 million and the preliminary net present value of the contingent consideration of USD 88 million due to the IFM Tre, Inc. shareholders, which they are eligible to receive upon the achievement of specified development and commercialization milestones. The preliminary purchase price allocation resulted in net identifiable assets of USD 366 million and goodwill of USD 41 million. Results of operations since the date of acquisition were not material.

Significant transaction closed in 2019 – Discontinued operations

In March 2019, Alcon acquired PowerVision, Inc. (PowerVision), a privately-held, US-based medical device development company focused on developing accommodative, implantable intraocular lenses. The fair value of the total purchase consideration was USD 424 million. The amount consisted of an initial cash payment of USD 289 million and the net present value of the contingent consideration of USD 135 million, due to PowerVision shareholders, which they are eligible to receive upon the achievement of specified regulatory and commercialization milestones. The preliminary purchase price allocation resulted in net identifiable assets of USD 418 million, consisting of intangible assets, of USD 505 million, net deferred tax liabilities of USD 93 million, other net assets of USD 6 million, and goodwill of USD 6 million. The 2019 results of operations since the date of the acquisition are not material.

Significant transactions in 2018

Innovative Medicines – Acquisition of Advanced Accelerator Applications S.A.
On October 30, 2017, Novartis entered into a binding memorandum of understanding with Advanced Accelerator Applications S.A. (AAA), a company headquartered in Saint-Genis-Pouilly, France, under which Novartis agreed to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Novartis commenced the tender offer on December 7, 2017, to purchase all of the outstanding ordinary shares for a price of USD 41 per share and USD 82 per American Depositary Share (ADS), each representing two ordinary shares of AAA, which expired on January 19, 2018. The offer valued AAA’s equity at USD 3.9 billion, on a fully diluted basis.

As of January 19, 2018, the expiration date of the tender offer, approximately 97% of the then-outstanding fully diluted ordinary shares, including ordinary shares represented by ADSs (hereinafter collectively referred to as “the outstanding shares”), were validly tendered. On January 22, 2018, Novartis accepted and paid USD 3.9 billion for the outstanding shares tendered in the offer. On January 22, 2018, Novartis commenced a subsequent offering period that expired on January 31, 2018. As of the expiration of the subsequent offering period, an additional 1.8% of the outstanding shares were validly tendered. Novartis accepted and paid approximately USD 60 million, resulting in an increase in Novartis ownership in AAA to 98.7%.

The fair value of the total purchase consideration was USD 3.9 billion. The purchase price allocation resulted in net identifiable assets of approximately USD 1.9 billion, consisting of USD 2.5 billion intangible assets, USD 0.6 billion net deferred tax liabilities, and goodwill of approximately USD 2.0 billion. In 2018, from the date of the acquisition the business generated net sales of USD 0.4 billion. Management estimates net sales for the entire year 2018 would have amounted to USD 0.4 billion had AAA been acquired at the beginning of 2018. The 2018 results from operations since the date of the acquisition were not material.

As of December 31, 2018, Novartis held 99.1% of the then-outstanding fully diluted ordinary shares, including ordinary shares represented by ADSs.

AAA is a radiopharmaceutical company that develops, produces and commercializes molecular nuclear medicines – including Lutathera (USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide), a first-in-class radioligand therapy product for neuroendocrine tumors – and a portfolio of diagnostic products. Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes, which are used clinically for both diagnosis and therapy.

Innovative Medicines – Acquisition of AveXis, Inc.
On April 6, 2018, Novartis entered into an agreement and plan of merger with AveXis, Inc., a US-based clinical stage gene therapy company, under which Novartis commenced on April 17, 2018, a tender offer to purchase all outstanding common stock of AveXis, Inc. for USD 218 per share in cash. On May

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15, 2018, Novartis completed the acquisition of the common stock of AveXis, Inc. and paid a total of USD 8.7 billion.

The fair value of the total purchase consideration was USD 8.7 billion. The purchase price allocation resulted in net identifiable assets of approximately USD 7.2 billion, consisting of USD 8.5 billion intangible assets, USD 1.6 billion net deferred tax liabilities and other net assets of USD 0.3 billion, and goodwill of approximately USD 1.5 billion. The 2018 results of operations since the date of acquisition were not material.

AveXis, Inc. is focused on developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. AveXis, Inc.’s initial product candidate, AVXS-101, is a proprietary gene therapy currently in development for the treatment of spinal muscular atrophy (SMA) type 1 – the leading genetic cause of infant mortality – and SMA types 2 and 3. In addition, AveXis, Inc. has a pipeline of other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

Innovative Medicines – acquisition of Endocyte, Inc.
On October 18, 2018, Novartis entered into an agreement and plan of merger with Endocyte, a US-based bio-pharmaceutical company focused on developing targeted therapeutics for cancer treatment. The transaction was completed on December 21, 2018. Under the terms of the agreement, Novartis acquired all outstanding shares of Endocyte common stock for USD 24 per share. The total consideration amounted to USD 2.1 billion.

The fair value of the total purchase consideration was USD 2.1 billion. The preliminary purchase price allocation resulted in net identifiable assets of approximately USD 1.5 billion, consisting of USD 1.4 billion intangible assets, USD 0.2 billion net deferred tax liabilities and other net assets of USD 0.3 billion, and goodwill of approximately USD 0.6 billion. The purchase price allocation remains preliminary and will be finalized within the 12-month purchase price allocation measurement period, which started as of the acquisition date. Adjustments made to the December 31, 2018, preliminary purchase price allocation were not material and the Group currently does not expect any potential additional revisions to be material. The 2018 results from operations since the date of the acquisition were not material.

Endocyte uses drug conjugation technology to develop targeted therapies with companion imaging agents, including 177Lu-PSMA-617, a potential first-in-class investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

Corporate – Divestment of 36.5% stake in GlaxoSmithKline Consumer Healthcare Holdings Ltd.
On March 27, 2018, Novartis entered into an agreement with GlaxoSmithKline plc (GSK) to divest its 36.5% stake in GlaxoSmithKline Consumer Healthcare Holdings Ltd. to GSK for USD 13.0 billion in cash. As a result, Novartis discontinued the use of equity method accounting starting from April 1, 2018.

On June 1, 2018, the transaction closed and Novartis realized a pre-tax gain of USD 5.8 billion, recorded in income from associated companies.

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4. Summary of equity attributable to Novartis AG shareholders

Number of outstanding shares (in millions) Issued share capital and reserves attributable to Novartis AG shareholders (in USD millions)
2019 2018 Change H1 2019 H1 2018 Change
Balance at beginning of year 2 311.2 2 317.5 -6.3 78 614 74 168 4 446
Impact of change in accounting policy 1 3 60 -57
Restated equity at January 1 78 617 74 228 4 389
Shares acquired to be cancelled -32.8 -9.2 -23.6 -2 819 -700 -2 119
Other share purchases -1.6 -1.4 -0.2 -153 -100 -53
Exercise of options and employee transactions 5.5 7.7 -2.2 200 433 -233
Equity-based compensation 9.5 7.2 2.3 447 356 91
Shares delivered to Alcon employees as a result of the Alcon spin-off 32 32
Taxes on treasury share transactions 2 -185 -185
Increase of treasury share repurchase obligation under a share buyback trading plan -2 289 -363 -1 926
Dividends to shareholders of Novartis AG -6 645 -6 966 321
Dividend in kind3 -23 434 -23 434
Net income of the period attributable to shareholders of Novartis AG 8 565 9 793 -1 228
Other comprehensive income attributable to shareholders of Novartis AG -667 148 -815
Transaction costs4 -253 -11 -242
Impact of change in ownership of consolidated entities -3 -3
Other movements5 13 13
Balance at June 30 2 291.8 2 321.8 -30.0 51 426 76 815 -25 389
 
In H1 2019, the impact of change in accounting policy includes USD 3 million related to the implementation of IFRS 16 – Leases (see Notes 2 and 6 for further details). In H1 2018, the impact of change in accounting policy includes USD 60 million relating to the implementation of IFRS 15 – Revenue from Contracts with Customers implementation and USD 177 million relating to the implementation IFRS 9 - Financial instruments (see Note 1 and 29 of the 2018 Annual report)
Included in H1 2019 is a USD 69 million impact related to the revaluation of deferred tax liability on treasury shares that are recognized through retained earnings. This revaluation resulted from the Swiss Federal tax reform enacted in May 2019, effective January 1, 2020.
Fair value of the dividend-in-kind of Alcon Inc. shares to Novartis AG shareholders and ADR (American Depositary Receipt) holders approved at the 2019 Annual General Meeting held on February 28, 2019. Distribution was effected on April 8, 2019, whereby each Novartis AG shareholders and ADR holder received 1 Alcon Inc, share for every 5 Novartis AG shares/ADRs they held on April 8, 2019, close of business (see Note 2, 3 and 11 for further details)
Transaction costs directly attributable to the distribution (spin-off) of the Alcon business to Novartis AG shareholders (see Note 2)
Impact of hyperinflationary economies

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5. Financial instruments

Fair value by hierarchy

The following table illustrates the three hierarchical levels for valuing financial instruments at fair value and those measured at amortized cost as of June 30, 2019 and December 31, 2018. For additional information on the hierarchies and other matters, please refer to the Consolidated Financial Statements in the 2018 Annual Report, published on January 30, 2019.

Level 1 Level 2 Level 3 Valued at amortized cost or cost Total

(USD millions)
Jun 30,
2019
Dec 31,
2018
Jun 30,
2019
Dec 31,
2018
Jun 30,
2019
Dec 31,
2018
Jun 30,
2019
Dec 31,
2018
Jun 30,
2019
Dec 31,
2018
Debt securities 302 25 23 25 325
Fund investments 35 35 35 35
Total marketable securities 35 337 25 23 60 360
Time deposits and short term investments with original maturity more than 90 days 81 2 087 81 2 087
Derivative financial instruments 93 130 93 130
Accrued interest on debt securities 12 12
Total marketable securities, time deposits and derivative financial instruments 35 337 118 153 81 2 099 234 2 589
Financial investments and long-term loans
Financial investments 1 946 698 539 488 2 485 1 186
Fund investments 224 251 224 251
Contingent consideration receivables 408 396 408 396
Long-term loans and receivables from customers and finance lease, advances, security deposits 317 512 317 512
Financial investments and long-term loans 1 946 698 1 171 1 135 317 512 3 434 2 345
Associated companies at fair value through profit or loss 167 145 167 145
Contingent consideration payables -728 -907 -728 -907
Other financial liabilities -22 -10 -22 -10
Derivative financial instruments -189 -58 -189 -58
Total financial liabilities at fair value -189 -58 -750 -917 -939 -975

There were no significant transfers from one level to the other and no significant transactions associated with level 3 financial instruments. During the second quarter of 2019, there were several individually non-significant transfers of equity securities from level 3 to level 1 for USD 24 million due to Initial Public Offerings.

The fair value of straight bonds amounted to USD 23.6 billion at June 30, 2019 (USD 25.4 billion at December 31, 2018) compared to the balance sheet value of USD 22.3 billion at June 30, 2019 (USD 25.3 billion at December 31, 2018). For all other financial assets and liabilities, the carrying amount is a reasonable approximation of the fair value. The carrying amount of financial assets included in the line financial investments and long-term loans of USD 3.4 billion at June 30, 2018 (USD 2.3 billion at December 31, 2018) is included in line “financial and other non-current assets” of the consolidated balance sheets.

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During the second quarter of 2019, Alcon Inc. shares with a fair value of USD 113 million were sold and the USD 9 million gain on disposal was transferred from other comprehensive income to retained earnings.

The Group’s exposure to financial risks has not changed significantly during the period and there have been no major changes to the risk management department or in any risk management policies.

6. Lease liability and Right-of-use assets

Note 2 explains the changes and new accounting policy introduced on January 1, 2019, resulting from the adoption of the new accounting standards IFRS 16 – Leases.

The Group has entered into various fixed-term leases, mainly for vehicles and real estate.

The lease liability recorded in continuing operations on January 1, 2019, was USD 1 736 million and the right of use assets was USD 1 554 million.

Reconciliation of lease commitment disclosed on December 31, 2018, and lease liability recorded in continuing operations on January 1, 2019 is as follows:

(USD millions)
Operating lease commitments December 31, 20181 3 612
Operating lease commitments December 31, 2018 related to discontinued operations -222
Operating lease commitments December 31, 2018 related to continuing operations 3 390
Recognition exemption for short term leases -30
Recognition exception for low value leases -12
Lease arrangements with commencement date after December 31, 2018 -65
Undiscounted future lease payments continuing operations as of January 1, 2019 3 283
Effect of discounting -1 547
Lease liability as of January 1, 20192 1 736
    
As reported in Annual Report 2018 Note 27
Weighted average incremental borrowing rate of 3.5% was applied at January 1, 2019, the date of implementation of IFRS 16 - Leases.

The right-of-use assets of continuing operations at January 1, 2019, by underlying class of asset comprise the following:

(USD millions) January 1, 2019
Land 536
Buildings 848
Vehicles 147
Machinery & equipment and other assets 23
Right-of-use assets1 1 554
    
Right-of-use assets were lower than the lease liability at the date of implementation of IFRS 16 by USD 182 million, due to adjustments made for prepayments and accrued lease payments recognized at December 31, 2018.

The lease liability recorded in discontinued operations on January 1, 2019, was USD 286 million and the right-of-use asset was USD 276 million, including USD 89 million and USD 75 million, respectively, for the previously reported finance lease obligations.

As a result of applying the modified retrospective method at the date of implementation of IFRS 16 on January 1, 2019, whereby the right-of-use assets were measured at the amount equal to the lease liability, there is no impact to the reported deferred tax assets and deferred tax liabilities on the consolidated balance sheet, as the corresponding deferred tax assets and deferred tax liabilities attributable to the lease liability and right-of-use asset relate to income taxes levied by the same taxation authority within the same legal entity, and were therefore offset.

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The impact on retained earnings upon implementation of IFRS 16 was USD 3 million arising from subleases that were accounted for as operating lease agreements under IAS 17 and are accounted for as finance leases under IFRS 16.

The following table summarizes the movements of the right-of-use assets of continuing operations:

(USD millions)
Right-of-use assets at January 1, 2019 1 554
Additions1 399
Depreciation charge -149
Lease contract terminations2 -54
Currency translation effects 12
Total right-of-use assets at June 30, 2019 1 762
 No impairments were recorded in the period.
Additions in Q2 amounted to USD 143 millions.
Lease contract terminations represent modifications to existing leases that result in reductions to the right-of-use assets, which includes contract terminations.

The right-of-use assets carrying value and depreciation charge of continuing operations at June 30, 2019, are shown below by underlying class of asset:

Depreciation charge

(USD millions)
June 30, 2019
Carrying value

Q2 2019

H1 2019
Land 541 5 8
Buildings 1 076 47 97
Vehicles 122 21 41
Machinery & equipment and other assets 23 2 3
Total right-of-use assets 1 762 75 149

The lease liability of continuing operations at June 30, 2019, amounted to USD 2 billion and its breakdown by maturity is as follows:

(USD millions) June 30, 2019
Less than one year 294
Between one and two years 139
Between two and three years 170
Between three and four years 143
Between four and five years 129
After five years 1 171
Total lease liability 2 046

The following table provides additional disclosures related to right-of-use assets and lease liabilities of continuing operations:

(USD millions) Q2 2019 H1 2019
Interest expense on lease liabilities1 16 32
Expense on short-term leases 2 4
Expense on low-value leases 3 4
Total cash outflow for leases2 80 111
Thereof repayment of lease liability3
69 91
Gain arising from sale and leaseback transaction 468 468
Weighted average interest rate is 3.2% and 3.4% for Q2 2019 and H1 2019, respectively.
Reported as cash outflows used in financing activities
Net of lease incentives received of USD 29 million in H1 2019 (Q2 2019: nil)

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In the second quarter 2019, the Group completed a sale and leaseback transaction for certain property plant and equipment as part of its plans to consolidate sites. The transaction resulted in net cash flow inflows of USD 0.6 billion and the recognition of USD 86 million of lease liabilities, and USD 30 million of right-of-use assets. The right-of-use asset value reflects the proportion of the property, plant and equipment retained for a period of 1 to 5 years, with two 5 year extension periods for certain right-of-use assets, and the liability reflects the net present value of future lease payments. The net gain on the sale and leaseback transaction amounted to USD 0.5 billion.

The Group accounts for the expense of short-term leases of twelve months or less and underlying assets of low value leases on a straight-line basis over the lease term.

Variable lease payments were not significant. The income from subleasing right-of-use assets for the six months ended June 30, 2019, was not significant.

Following the completion of the Alcon Distribution (spin-off) on April 9, 2019, the right-of-use assets and lease liabilities classified as discontinued operations were derecognized (refer to Note 2, 3 and 11 for further details).

7. Details to the consolidated statements of cash flows

Reversal of non-cash items and other adjustments

(USD millions) Q2 2019 Q2 2018 Change
Depreciation, amortization and impairments on:
Property, plant and equipment
445 492 -47
Intangible assets
601 713 -112
Financial assets1
-32 -31 -1
Non-cash change in provisions and other non-current liabilities 958 109 849
Gains on disposal and other adjustments on property, plant and equipment; intangible assets; financial assets; and other non-current assets, net -615 -225 -390
Equity-settled compensation expense 174 155 19
Income from associated companies2 -176 -5 932 5 756
Taxes 525 443 82
Net financial expense 205 192 13
Total 2 085 -4 084 6 169
Includes fair value adjustments
Q2 2018 includes a reversal of a pre-tax gain (USD 5.8 billion) recognized from the divestment of the investment in GSK Consumer Healthcare Holdings Ltd. (see Note 3). The net cash proceed of USD 13.0 billion from the divestment was included in the consolidated statements of cash flows in line "Acquisitions and divestments of interests in associated companies, net."

(USD millions) H1 2019 H1 2018 Change
Depreciation, amortization and impairments on:
Property, plant and equipment
868 853 15
Intangible assets
1 619 1 357 262
Financial assets1
-20 -106 86
Non-cash change in provisions and other non-current liabilities 1 018 247 771
Gains on disposal and other adjustments on property, plant and equipment; intangible assets; financial assets; and other non-current assets, net -684 -411 -273
Equity-settled compensation expense 372 337 35
Income from associated companies2 -256 -6 084 5 828
Taxes 797 813 -16
Net financial expense 387 375 12
Total 4 101 -2 619 6 720
Includes fair value adjustments
2018 includes a reversal of a pre-tax gain (USD 5.8 billion) recognized from the divestment of the investment in GSK Consumer Healthcare Holdings Ltd. (see Note 3). The net cash proceed of USD 13.0 billion from the divestment was included in the consolidated statements of cash flows in line "Acquisitions and divestments of interests in associated companies, net."

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Cash flows arising from acquisitions and divestments of businesses,net

(USD millions) Q2 2019 Q2 2018 H1 2019 H1 2018
Net assets recognized as a result of business combinations -407 -8 318 -486 -11 848
Fair value of previously held equity interests 34 34
Receivables and payables contingent consideration, net 88 88 -5
Other payments and deferred consideration, net -3 2 -3 -37
Cash flows used for acquisitions of businesses -288 -8 316 -367 -11 890
Cash flows from/used in divestments of businesses 2 -36 -15 31
Cash flows used for acquisitions and divestments of businesses, net -286 -8 352 -382 -11 859

8. Acquisitions of businesses

(USD millions) H1 2019 H1 2018
Property, plant and equipment 44 135
Currently marketed products 2 230
Acquired research and development 449 8 545
Other intangible assets 0 1
Deferred tax assets 20 242
Financial and other assets 17
Inventories 6 17
Trade receivables and other current assets 4 81
Cash and cash equivalents 809
Deferred tax liabilities -101 -2 647
Current and non-current financial debts -2 -14
Trade payables and other liabilities -9 -431
Net identifiable assets acquired 411 8 985
Acquired cash and cash equivalents -809
Non-controlling interests -27
Goodwill 75 3 699
Net assets recognized as a result of business combinations 486 11 848

9. Legal proceedings update

A number of Novartis companies are, and will likely continue to be, subject to various legal proceedings, including litigations, arbitrations and governmental investigations, that arise from time to time. Legal proceedings are inherently unpredictable. As a result, the Group may become subject to substantial liabilities that may not be covered by insurance and may in the future incur judgments or enter into settlements of claims that could have a material adverse effect on its results of operations or cash flow. Note 19 to the Consolidated Financial Statements in our 2018 Annual Report and 2018 Form 20-F contains a summary as of the date of these reports of significant legal proceedings to which Novartis or its subsidiaries were a party. The following is a summary as of July 17, 2019 of significant developments in those proceedings, as well as any new significant proceedings commenced since the date of the 2018 Annual Report and 2018 Form 20-F.

INVESTIGATIONS AND RELATED LITIGATIONS
Southern District of New York (S.D.N.Y.) marketing practices investigation and litigation
In 2013, the US government filed a civil complaint in intervention to an individual qui tam action against Novartis Pharmaceuticals Corporation (NPC) in the United States District Court for the S.D.N.Y. The complaint, as subsequently amended, asserts federal False Claims Act and common law claims with respect to speaker programs and other promotional activities for certain NPC cardiovascular

41

 
medications (including Lotrel, Starlix and Valturna) allegedly serving as mechanisms to provide kickbacks to healthcare professionals from 2002 to 2011. It seeks damages and disgorgement of Novartis profits from the alleged unlawful conduct which, based on the government’s calculation, with trebling and penalties could exceed USD 1 billion. Also in 2013, New York State filed a civil complaint in intervention asserting similar claims. Neither government complaint in intervention adopted the individual relator’s claims with respect to off-label promotion of Valturna, which were subsequently dismissed with prejudice by the court. The individual relator continues to litigate the kickback claims on behalf of other states and municipalities. Novartis is engaged in settlement discussions to resolve the above-described claims and has recorded a provision in the amount of USD 0.7 billion in Q2 2019.

In addition to the matter described above, there have been other developments in the other legal matters described in Note 19 to the Consolidated Financial Statements contained in our 2018 Annual Report and 2018 Form 20-F.

The developments during the second quarter of 2019 do not significantly affect the assessment of management concerning the adequacy of the total provisions recorded for legal proceedings.

10. Segmentation of key figures

The businesses of Novartis are divided operationally on a worldwide basis into two identified reporting segments, Innovative Medicines and Sandoz. In addition, we separately report Corporate activities.

Reporting segments are presented in a manner consistent with the internal reporting to the chief operating decision maker which is the Executive Committee of Novartis. The reporting segments are managed separately because they each research, develop, manufacture, distribute and sell distinct products that require differing marketing strategies.

The Executive Committee of Novartis is responsible for allocating resources and assessing the performance of the reporting segments.

The reporting segments are as follows:

Innovative Medicines researches, develops, manufactures, distributes and sells patented prescription medicines. The Innovative Medicines Division is organized into two global business units: Novartis Oncology and Novartis Pharmaceuticals. Novartis Oncology consists of the global business franchise Oncology, and Novartis Pharmaceuticals consists of the global business franchises Ophthalmology; Neuroscience; Immunology, Hepatology and Dermatology; Respiratory; Cardiovascular, Renal and Metabolism; and Established Medicines.

Sandoz develops, manufactures and markets finished dosage form medicines as well as intermediary products including active pharmaceutical ingredients. Sandoz is organized globally into three franchises: Retail Generics, Anti-Infectives and Biopharmaceuticals. In Retail Generics, Sandoz develops, manufactures and markets active ingredients and finished dosage forms of pharmaceuticals to third parties. Retail Generics includes the areas of cardiovascular, central nervous system, dermatology, gastrointestinal and hormonal therapies, metabolism, oncology, ophthalmics, pain and respiratory, as well as finished dosage form anti-infectives sold to third parties. In Anti-Infectives, Sandoz manufactures and supplies active pharmaceutical ingredients and intermediates, mainly antibiotics, for internal use by Retail Generics and for sale to third-party customers. In Biopharmaceuticals, Sandoz develops, manufactures and markets protein- or other biotechnology-based products, including biosimilars, and provides biotechnology manufacturing services to other companies.

The divisions are supported by Novartis Institutes for BioMedical Research, Global Drug Development, Novartis Technical Operations and Novartis Business Services. Corporate includes the costs of the Group headquarters and those of corporate coordination functions in major countries, and items that are not specific to one segment. Further details are provided in Note 3 to the Consolidated Financial Statements of the Annual Report 2018.

Following the February 28, 2019, shareholders’ approval of the spin-off of the Alcon business (refer to Notes 2, 3 and 11 for further details), the Group reported its consolidated financial statements for the current and prior years as “continuing operations” and “discontinued operations.”

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Continuing operations comprise the activities of Innovative Medicines and Sandoz Divisions and the continuing Corporate activities.

Discontinued operations include the operational results from the Alcon eye care devices business and certain Corporate activities attributable to the Alcon business prior to the spin-off, the gain on distribution of Alcon Inc. to Novartis AG shareholders and certain other expenses related to the Distribution.

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Segmentation – Consolidated income statement – Second quarter

Innovative Medicines Sandoz Corporate (including eliminations) Group
(USD millions) Q2 2019 Q2 2018 Q2 2019 Q2 2018 Q2 2019 Q2 2018 Q2 2019 Q2 2018
Net sales to third parties from continuing operations 9 326 8 876 2 438 2 463 11 764 11 339
Sales to continuing and discontinued segments 177 177 37 34 -214 -191 20
Net sales from continuing operations 9 503 9 053 2 475 2 497 -214 -191 11 764 11 359
Other revenues 250 285 6 6 4 3 260 294
Cost of goods sold -2 327 -2 359 -1 315 -1 404 236 205 -3 406 -3 558
Gross profit from continuing operations 7 426 6 979 1 166 1 099 26 17 8 618 8 095
Selling, general and administration -2 911 -2 778 -550 -593 -124 -124 -3 585 -3 495
Research and development -1 853 -1 931 -198 -195 -2 051 -2 126
Other income 847 297 45 127 97 57 989 481
Other expense -945 -315 -181 -110 -182 -99 -1 308 -524
Operating income from continuing operations 2 564 2 252 282 328 -183 -149 2 663 2 431
as % of net sales 27.5% 25.4% 11.6% 13.3% 22.6% 21.4%
Income from associated companies 1 1 4 174 5 928 176 5 932
Interest expense -205 -237
Other financial income and expense, net 0 45
Income before taxes from continuing operations 2 634 8 171
Taxes -525 -443
Net income from continuing operations 2 109 7 728
Net income from discontinued operations before gain on distribution of Alcon Inc. to Novartis AG shareholders 40
Gain on distribution of Alcon Inc. to Novartis AG shareholders 4 691
Net income from discontinued operations 4 691 40
Net income 6 800 7 768
 
 
 

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Segmentation – Consolidated income statement – First half

Innovative Medicines Sandoz Corporate (including eliminations) Group
(USD millions) H1 2019 H1 2018 H1 2019 H1 2018 H1 2019 H1 2018 H1 2019 H1 2018
Net sales to third parties from continuing operations 18 106 17 274 4 764 4 980 22 870 22 254
Sales to continuing and discontinued segments 426 345 76 91 -449 -403 53 33
Net sales from continuing operations 18 532 17 619 4 840 5 071 -449 -403 22 923 22 287
Other revenues 511 508 34 10 11 11 556 529
Cost of goods sold -4 551 -4 632 -2 591 -2 802 485 425 -6 657 -7 009
Gross profit from continuing operations 14 492 13 495 2 283 2 279 47 33 16 822 15 807
Selling, general and administration -5 564 -5 333 -1 112 -1 195 -239 -251 -6 915 -6 779
Research and development -3 958 -3 714 -392 -394 -4 350 -4 108
Other income 922 508 82 240 188 121 1 192 869
Other expense -1 219 -569 -306 -193 -319 -225 -1 844 -987
Operating income from continuing operations 4 673 4 387 555 737 -323 -322 4 905 4 802
as % of net sales 25.8% 25.4% 11.6% 14.8% 21.4% 21.6%
Income from associated companies 1 1 4 254 6 080 256 6 084
Interest expense -431 -455
Other financial income and expense, net 44 80
Income before taxes from continuing operations 4 774 10 511
Taxes -797 -813
Net income from continuing operations 3 977 9 698
Net loss/income from discontinued operations before gain on distribution of Alcon Inc. to Novartis AG shareholders -101 98
Gain on distribution of Alcon Inc. to Novartis AG shareholders 4 691
Net income from discontinued operations 4 590 98
Net income 8 567 9 796
 
 
 

Segmentation – Additional balance sheet disclosure

Innovative Medicines Sandoz Corporate (including eliminations) Group

(USD millions)
Jun 30,
2019
Dec 31,
2018
Jun 30,
2019
Dec 31,
2018
Jun 30,
2019
Dec 31,
2018
Jun 30,
2019
Dec 31,
2018 1
Net operating assets 55 271 53 999 14 160 13 951 69 390 94 876
Included in net operating assets are:
Property, plant and equipment 9 701 10 098 2 062 2 159 527 561 12 290 15 696
Goodwill 18 698 18 551 7 828 7 837 7 7 26 533 35 294
Intangible assets other than goodwill 25 443 26 042 1 727 1 875 51 123 27 221 38 719
Group December 31, 2018 balances include the net operating assets of the Alcon segment amounting to USD 24.0 billion, including property, plant and equipment of USD 2.9 billion, Goodwill of USD 8.9 billion and intangible assets other than goodwill of USD 10.7 billion, that were deconsolidated on April 9, 2019, with the completion of the distribution (spin-off) of the Alcon business to Novartis AG shareholders (refer to Note 2, 3 and 11).   
 

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Segmentation – Net sales by region1 – Second quarter

Q2 2019 Q2 2018 % change Q2 2019 Q2 2018
USD m USD m USD cc 2 % of total % of total
Innovative Medicines
Europe
3 218 3 112 3 10 35 35
US
3 336 3 023 10 10 36 34
Asia/Africa/Australasia
2 106 2 060 2 6 23 23
Canada and Latin America
666 681 -2 10 6 8
Total 9 326 8 876 5 9 100 100
Of which in Established Markets
7 071 6 663 6 9 76 75
Of which in Emerging Growth Markets
2 255 2 213 2 10 24 25
Sandoz
Europe
1 269 1 237 3 9 52 50
US
642 692 -7 -7 26 28
Asia/Africa/Australasia
333 341 -2 1 14 14
Canada and Latin America
194 193 1 7 8 8
Total 2 438 2 463 -1 3 100 100
Of which in Established Markets
1 796 1 812 -1 3 74 74
Of which in Emerging Growth Markets
642 651 -1 5 26 26
Continuing operations
Europe
4 487 4 349 3 10 38 38
US
3 978 3 715 7 7 34 33
Asia/Africa/Australasia
2 439 2 401 2 5 21 21
Canada and Latin America
860 874 -2 9 7 8
Total 11 764 11 339 4 8 100 100
Of which in Established Markets
8 867 8 475 5 8 75 75
Of which in Emerging Growth Markets
2 897 2 864 1 9 25 25
Net sales from operations by location of third-party customer. Emerging Growth Markets comprise all markets other than the Established Markets of the US, Canada, Western Europe, Japan, Australia and New Zealand.
Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 55.
 

Segmentation – Net sales by region1 – First half

H1 2019 H1 2018 % change H1 2019 H1 2018
USD m USD m USD cc 2 % of total % of total
Innovative Medicines
Europe
6 352 6 204 2 11 35 36
US
6 329 5 675 12 12 35 33
Asia/Africa/Australasia
4 123 4 049 2 6 23 23
Canada and Latin America
1 302 1 346 -3 10 7 8
Total 18 106 17 274 5 10 100 100
Of which in Established Markets
13 638 12 873 6 9 75 75
Of which in Emerging Growth Markets
4 468 4 401 2 11 25 25
Sandoz
Europe
2 510 2 529 -1 7 53 51
US
1 232 1 400 -12 -12 26 28
Asia/Africa/Australasia
651 664 -2 2 14 13
Canada and Latin America
371 387 -4 3 7 8
Total 4 764 4 980 -4 1 100 100
Of which in Established Markets
3 491 3 668 -5 -1 73 74
Of which in Emerging Growth Markets
1 273 1 312 -3 5 27 26
Continuing operations
Europe
8 862 8 733 1 10 39 39
US
7 561 7 075 7 7 33 32
Asia/Africa/Australasia
4 774 4 713 1 5 21 21
Canada and Latin America
1 673 1 733 -3 8 7 8
Total 22 870 22 254 3 8 100 100
Of which in Established Markets
17 129 16 541 4 7 75 74
Of which in Emerging Growth Markets
5 741 5 713 0 9 25 26
Net sales from operations by location of third-party customer. Emerging Growth Markets comprise all markets other than the Established Markets of the US, Canada, Western Europe, Japan, Australia and New Zealand.
Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 55.
 





46

 
Segmentation – Net sales by business franchise

Innovative Medicines net sales by business franchise – Second quarter

Q2 2019 Q2 2018 % change % change
USD m USD m USD cc 3
Oncology
Tasigna 468 488 -4 -1
Sandostatin 403 399 1 4
Afinitor/Votubia 401 408 -2 0
Promacta/Revolade 349 292 20 23
Tafinlar + Mekinist 340 284 20 25
Gleevec/Glivec 323 416 -22 -19
Jakavi 284 239 19 26
Exjade/Jadenu 253 289 -12 -10
Votrient 193 219 -12 -9
Lutathera 109 24 nm nm
Kisqali 111 59 88 94
Kymriah 58 16 263 278
Other 314 300 5 9
Total Oncology business unit 3 606 3 433 5 9
Ophthalmology
Lucentis 536 515 4 10
Travoprost Group 106 134 -21 -19
Other 532 531 0 4
Total Ophthalmology 1 174 1 180 -1 4
Neuroscience
Gilenya 825 866 -5 -2
Aimovig 24 nm nm
Other 37 23 61 72
Total Neuroscience 886 889 0 3
Immunology, Hepatology and Dermatology
Cosentyx 858 701 22 25
Ilaris 165 132 25 31
Total Immunology, Hepatology and Dermatology 1 023 833 23 26
Respiratory
Ultibro Breezhaler 112 116 -3 1
Seebri Breezhaler 34 39 -13 -9
Onbrez Breezhaler 20 27 -26 -18
Subtotal COPD1 portfolio 166 182 -9 -4
Xolair2 290 261 11 18
Other 5 6 -17 -2
Total Respiratory 461 449 3 9
Cardiovascular, Renal and Metabolism
Entresto 421 239 76 81
Other 6 6 0 14
Total Cardiovascular, Renal and Metabolism 427 245 74 79
Established Medicines
Galvus Group 320 332 -4 2
Diovan Group 283 244 16 23
Exforge Group 264 250 6 12
Zortress/Certican 124 115 8 12
Neoral/Sandimmun(e) 110 120 -8 -3
Voltaren/Cataflam 95 114 -17 -13
Other 553 672 -18 -13
Total Established Medicines 1 749 1 847 -5 0
Total Pharmaceuticals business unit 5 720 5 443 5 10
Total Division net sales 9 326 8 876 5 9
Chronic Obstructive Pulmonary Disease
Xolair sales for all indications are reported in the Respiratory franchise.
Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 55.
 
 
nm = not meaningful

47

 
Innovative Medicines net sales by business franchise – First half

H1 2019 H1 2018 % change % change
USD m USD m USD cc 3
Oncology
Tasigna 902 954 -5 -2
Sandostatin 795 799 -1 3
Afinitor/Votubia 774 783 -1 1
Promacta/Revolade 656 549 19 24
Tafinlar + Mekinist 637 551 16 21
Gleevec/Glivec 630 808 -22 -18
Jakavi 542 473 15 23
Exjade/Jadenu 491 550 -11 -8
Votrient 380 433 -12 -9
Lutathera 215 30 nm nm
Kisqali 202 103 96 103
Kymriah 103 28 268 281
Other 600 563 7 11
Total Oncology business unit 6 927 6 624 5 9
Ophthalmology
Lucentis 1 069 1 035 3 10
Travoprost Group 221 258 -14 -11
Other 1 045 1 044 0 4
Total Ophthalmology 2 335 2 337 0 5
Neuroscience
Gilenya 1 591 1 687 -6 -2
Aimovig 42 nm nm
Other 50 43 16 23
Total Neuroscience 1 683 1 730 -3 1
Immunology, Hepatology and Dermatology
Cosentyx 1 649 1 281 29 32
Ilaris 316 258 22 29
Total Immunology, Hepatology and Dermatology 1 965 1 539 28 32
Respiratory
Ultibro Breezhaler 216 222 -3 4
Seebri Breezhaler 65 77 -16 -9
Onbrez Breezhaler 42 54 -22 -15
Subtotal COPD1 portfolio 323 353 -8 -2
Xolair2 571 516 11 19
Other 12 13 -8 0
Total Respiratory 906 882 3 10
Cardiovascular, Renal and Metabolism
Entresto 778 439 77 83
Other 12 10 20 20
Total Cardiovascular, Renal and Metabolism 790 449 76 81
Established Medicines
Galvus Group 635 650 -2 5
Diovan Group 544 509 7 14
Exforge Group 531 498 7 14
Zortress/Certican 240 224 7 12
Neoral/Sandimmun(e) 213 235 -9 -4
Voltaren/Cataflam 208 229 -9 -4
Other 1 129 1 368 -17 -12
Total Established Medicines 3 500 3 713 -6 0
Total Pharmaceuticals business unit 11 179 10 650 5 10
Total Division net sales 18 106 17 274 5 10
Chronic Obstructive Pulmonary Disease
Xolair sales for all indications are reported in the Respiratory franchise.
Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 55.
 
 
nm = not meaningful

48

 
Net sales of the top 20 Innovative Medicines products in 2019 – Second quarter

US Rest of world Total

Brands


Business franchise


Indication


USD m
%
change
USD/cc 2


USD m
%
change
USD
%
change
cc 2


USD m
%
change
USD
%
change
cc 2
Cosentyx Immunology, Hepatology and Dermatology Psoriasis, ankylosing spondylitis and psoriatic arthritis 534 31 324 11 18 858 22 25
Gilenya Neuroscience Relapsing multiple sclerosis 441 -6 384 -4 3 825 -5 -2
Lucentis Ophthalmology Age-related macular degeneration 536 4 10 536 4 10
Tasigna Oncology Chronic myeloid leukemia 204 -7 264 -2 3 468 -4 -1
Sandostatin Oncology Carcinoid tumors and acromegaly 218 5 185 -3 3 403 1 4
Entresto Cardiovascular, Renal and Metabolism Chronic heart failure 221 71 200 82 90 421 76 81
Afinitor/Votubia Oncology Breast cancer/TSC 259 7 142 -14 -10 401 -2 0
Promacta/Revolade Oncology Immune thrombocytopenic purpura 170 16 179 23 30 349 20 23
Tafinlar + Mekinist Oncology Melanoma 123 7 217 28 37 340 20 25
Galvus Group Established Medicines Diabetes 320 -4 2 320 -4 2
Gleevec/Glivec Oncology Chronic myeloid leukemia and GIST 96 -12 227 -26 -22 323 -22 -19
Xolair1 Respiratory Asthma 290 11 18 290 11 18
Diovan Group Established Medicines Hypertension 28 40 255 14 22 283 16 23
Jakavi Oncology Myelofibrosis 284 19 26 284 19 26
Exforge Group Established Medicines Hypertension 4 -20 260 6 12 264 6 12
Exjade/Jadenu Oncology Chronic iron overload 118 -14 135 -11 -7 253 -12 -10
Votrient Oncology Renal cell carcinoma 87 -19 106 -5 2 193 -12 -9
Ilaris Immunology, Hepatology and Dermatology Auto-inflammatory (CAPS, TRAPS, HIDS/MKD, FMF, SJIA, AOSD and gout) 77 26 88 24 34 165 25 31
Zortress/Certican Established Medicines Transplantation 44 29 80 -1 4 124 8 12
Travoprost Group Ophthalmology Reduction of elevated intraocular pressure 37 -26 69 -18 -15 106 -21 -19
Top 20 products total 2 661 8 4 545 4 10 7 206 6 10
Rest of portfolio 675 20 1 445 -3 4 2 120 3 8
Total division sales 3 336 10 5 990 2 9 9 326 5 9
Xolair sales for all indications are reported in the Respiratory franchise.
Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 55.

49

 
Net sales of the top 20 Innovative Medicines products in 2019 – First half

US Rest of world Total

Brands


Business franchise


Indication


USD m
%
change
USD/cc 2


USD m
%
change
USD
%
change
cc 2


USD m
%
change
USD
%
change
cc 2
Cosentyx Immunology, Hepatology and Dermatology Psoriasis, ankylosing spondylitis and psoriatic arthritis 1 008 38 641 16 24 1 649 29 32
Gilenya Neuroscience Relapsing multiple sclerosis 833 -6 758 -6 2 1 591 -6 -2
Lucentis Ophthalmology Age-related macular degeneration 1 069 3 10 1 069 3 10
Tasigna Oncology Chronic myeloid leukemia 384 -8 518 -4 3 902 -5 -2
Sandostatin Oncology Carcinoid tumors and acromegaly 433 7 362 -8 -1 795 -1 3
Entresto Cardiovascular, Renal and Metabolism Chronic heart failure 420 76 358 78 90 778 77 83
Afinitor/Votubia Oncology Breast cancer/TSC 493 9 281 -15 -8 774 -1 1
Promacta/Revolade Oncology Immune thrombocytopenic purpura 318 17 338 22 30 656 19 24
Tafinlar + Mekinist Oncology Melanoma 230 6 407 22 32 637 16 21
Galvus Group Established Medicines Diabetes 635 -2 5 635 -2 5
Gleevec/Glivec Oncology Chronic myeloid leukemia and GIST 175 -20 455 -23 -18 630 -22 -18
Xolair1 Respiratory Asthma 571 11 19 571 11 19
Diovan Group Established Medicines Hypertension 45 10 499 7 15 544 7 14
Jakavi Oncology Myelofibrosis 542 15 23 542 15 23
Exforge Group Established Medicines Hypertension 7 -22 524 7 14 531 7 14
Exjade/Jadenu Oncology Chronic iron overload 231 -9 260 -12 -7 491 -11 -8
Votrient Oncology Renal cell carcinoma 172 -19 208 -6 1 380 -12 -9
Ilaris Immunology, Hepatology and Dermatology Auto-inflammatory (CAPS, TRAPS, HIDS/MKD, FMF, SJIA, AOSD and gout) 142 21 174 23 35 316 22 29
Zortress/Certican Established Medicines Transplantation 82 24 158 0 8 240 7 12
Travoprost Group Ophthalmology Reduction of elevated intraocular pressure 84 -14 137 -14 -10 221 -14 -11
Top 20 products total 5 057 9 8 895 3 10 13 952 5 10
Rest of portfolio 1 272 22 2 882 -3 4 4 154 3 9
Total division sales 6 329 12 11 777 2 9 18 106 5 10
Xolair sales for all indications are reported in the Respiratory franchise.
Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 55.

50

 


Sandoz net sales by business franchise – Second quarter

Q2 2019 Q2 2018 % change % change
USD m USD m USD cc 2
Retail Generics1 1 903 1 955 -3 2
Biopharmaceuticals 401 363 10 16
Anti-Infectives 134 145 -8 -4
Total Division net sales 2 438 2 463 -1 3
Of which USD 186 million (2018: USD 187 million) represents Anti-Infectives sold under Sandoz name
Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 55.



Sandoz net sales by business franchise – First half

H1 2019 H1 2018 % change % change
USD m USD m USD cc 2
Retail Generics1 3 753 3 997 -6 -1
Biopharmaceuticals 752 698 8 14
Anti-Infectives 259 285 -9 -5
Total Division net sales 4 764 4 980 -4 1
Of which USD 390 million (2018: USD 417 million) represents Anti-Infectives sold under Sandoz name
Constant currencies (cc) is a non-IFRS measure. A definition of non-IFRS measures used by Novartis can be found starting on page 55.



The product portfolio of Sandoz is widely spread in 2019 and 2018.



51

 
Segmentation – Other revenue – Second quarter

Innovative Medicines Sandoz Corporate Group
(USD millions) Q2 2019 Q2 2018 Q2 2019 Q2 2018 Q2 2019 Q2 2018 Q2 2019 Q2 2018
Profit sharing income 181 170 1 1 182 171
Royalty income 15 42 4 2 6 3 25 47
Milestone income 47 70 2 47 72
Other1 7 3 1 1 -2 6 4
Total other revenues 250 285 6 6 4 3 260 294
Other includes revenue from activities such as manufacturing or other services rendered, to the extent such revenue is not recorded under net sales.
 

Segmentation – Other revenue – First half

Innovative Medicines Sandoz Corporate Group
(USD millions) H1 2019 H1 2018 H1 2019 H1 2018 H1 2019 H1 2018 H1 2019 H1 2018
Profit sharing income 350 330 1 1 351 331
Royalty income 49 85 7 3 13 11 69 99
Milestone income 98 78 23 3 121 81
Other1 14 15 3 3 -2 15 18
Total other revenues 511 508 34 10 11 11 556 529
Other includes revenue from activities such as manufacturing or other services rendered, to the extent such revenue is not recorded under net sales.

52

 




11. Discontinued operations

Consolidated income statement – Discontinued operations

(USD millions) Q2 2019 1 Q2 2018 H1 2019 H1 2018
Net sales to third parties of discontinued operations 1 819 1 777 3 598
Sales to continuing segments 32 3
Net sales of discontinued operations 1 819 1 809 3 601
Cost of goods sold -939 -860 -1 859
Gross profit of discontinued operations 880 949 1 742
Selling, general and administration -698 -638 -1 337
Research and development -150 -142 -288
Other income 62 15 81
Other expense -41 -113 -69
Operating income of discontinued operations 53 71 129
as % of net sales 2.9% 4.0% 3.6%
Interest expense -7 -10 -13
Other financial income and expense 2 -3 1
Income before taxes of discontinued operations 48 58 117
Taxes2 -8 -159 -19
Net loss/income from discontinued operations before gain on distribution of Alcon Inc. to Novartis AG shareholders 40 -101 98
Gain on distribution of Alcon Inc. to Novartis AG shareholders 3 4 691 4 691
Net income of discontinued operations 4 691 40 4 590 98
As the Alcon spin-off was completed on April 9, 2019, the Q2 2019 results of operations from the Alcon business were not material.
The tax rate on the net loss from discontinued operations before gain on distribution of Alcon Inc. to Novartis AG shareholders of 274% was impacted by prior period items, which the Group has concluded is not material to the current period or the prior periods to which they related, and changes in uncertain tax positions. Excluding these items, the tax rate would have been 15.5%.
See Note 3 for further details on the gain on distribution of Alcon Inc. to Novartis AG shareholders.



The following are included in net income from discontinued operations:

(USD millions) Q2 2019 1 Q2 2018 H1 2019 H1 2018
Interest income 2 1
Depreciation of property, plant and equipment -57 -42 -116
Amortization of intangible assets -264 -174 -530
Impairment charges on intangible assets -39 -39
Additions to restructuring provisions -4 -4
Equity-based compensation of Novartis equity plans -13 -9 -23
As the Alcon spin-off was completed on April 9, 2019, the Q2 2019 results of operations from the Alcon business were not material.

53

 
Supplemental cash flow disclosures related to the Alcon business distributed to Novartis AG shareholders



Net assets derecognized

(USD millions) H1 2019
Property, plant and equipment 2 858
Right-of-use assets 269
Goodwill 8 906
Intangible assets other than goodwill 11 121
Deferred tax assets 732
Financial and other non-current assets 526
Inventories 1 469
Trade receivables and other current assets 1 787
Cash and cash equivalents 628
Deferred tax liabilities -1 713
Current and non-current lease liabilities -269
Current and non-current financial debts -3 538
Trade payables, provisions and other liabilities -2 751
Net assets derecognized 20 025



Net cash flows used in investing activities from discontinued operations

(USD millions) Q2 2019 H1 2019
Payments out of provisions for transaction costs attributable to the spin-off of the Alcon business -14 -14
Divested cash and cash equivalents -628 -628
Cash flows attributable to the spin-off of the Alcon business -642 -642
Other cash flows used in investing activities, net -40 -463
Net cash flows used in investing activities from discontinued operations -682 -1 105

For additional information related to the distribution (spin-off) of the Alcon business to Novartis AG shareholders, effected through a dividend in kind distribution that was completed on April 9, 2019, refer to Note 2 and 3.



54

 
SUPPLEMENTARY INFORMATION (unaudited)

Non-IFRS disclosures

Core results

The Group’s core results – including core operating income, core net income and core earnings per share – exclude fully the amortization and impairment charges of intangible assets, excluding software, net gains and losses on fund investments and equity securities valued at fair value through profit and loss, and certain acquisition and divestment related items. The following items that exceed a threshold of USD 25 million are also excluded: integration and divestment related income and expenses, divestment gains and losses, restructuring charges/releases and related items, legal related items, impairments of property, plant and equipment and financial assets, as well as income and expense items that management deems exceptional and that are or are expected to accumulate within the year to be over a USD 25 million threshold.

Novartis believes that investor understanding of the Group’s performance is enhanced by disclosing core measures of performance because, since they exclude items which can vary significantly from year to year, the core measures enable better comparison of business performance across years. For this same reason, Novartis uses these core measures in addition to IFRS and other measures as important factors in assessing the Group’s performance.

The following are examples of how these core measures are utilized:

• In addition to monthly reports containing financial information prepared under International Financial Reporting Standards (IFRS), senior management receives a monthly analysis incorporating these core measures.

• Annual budgets are prepared for both IFRS and core measures.

Despite the use of these measures by management in setting goals and measuring the Group’s performance, these are non-IFRS measures that have no standardized meaning prescribed by IFRS. As a result, such measures have limits in usefulness to investors.

Because of their non-standardized definitions, the core measures (unlike IFRS measures) may not be comparable to the calculation of similar measures of other companies. These core measures are presented solely to permit investors to more fully understand how the Group’s management assesses underlying performance. These core measures are not, and should not be viewed as, a substitute for IFRS measures.

As an internal measure of Group performance, these core measures have limitations, and the Group’s performance management process is not solely restricted to these metrics. A limitation of the core measures is that they provide a view of the Group’s operations without including all events during a period, such as the effects of an acquisition, divestment, or amortization/impairments of purchased intangible assets and restructurings.

Constant currencies

Changes in the relative values of non-US currencies to the US dollar can affect the Group’s financial results and financial position. To provide additional information that may be useful to investors, including changes in sales volume, we present information about our net sales and various values relating to operating and net income that are adjusted for such foreign currency effects.

Constant currency calculations have the goal of eliminating two exchange rate effects so that an estimate can be made of underlying changes in the consolidated income statement excluding the impact of fluctuations in exchanges rates:

• the impact of translating the income statements of consolidated entities from their non-USD functional currencies to USD; and

55

 
• the impact of exchange rate movements on the major transactions of consolidated entities performed in currencies other than their functional currency.

We calculate constant currency measures by translating the current year’s foreign currency values for sales and other income statement items into USD using the average exchange rates from the prior year and comparing them to the prior year values in USD.

We use these constant currency measures in evaluating the Group’s performance, since they may assist us in evaluating our ongoing performance from year to year. However, in performing our evaluation, we also consider equivalent measures of performance which are not affected by changes in the relative value of currencies.

Growth rate calculation

For ease of understanding, Novartis uses a sign convention for its growth rates such that a reduction in operating expenses or losses compared to the prior year is shown as a positive growth.

Net debt and free cash flow

Net debt and free cash flow are non-IFRS financial measures, which means they should not be interpreted as measures determined under IFRS. Net debt is presented as additional information because management believes it is a useful supplemental indicator of the Group’s ability to pay dividends, to meet financial commitments and to invest in new strategic opportunities, including strengthening its balance sheet. Free cash flow is presented as additional information because management believes it is a useful supplemental indicator of the Group’s ability to operate without reliance on additional borrowing or use of existing cash. Free cash flow is a measure of the net cash generated that is available for debt repayment, investment in strategic opportunities and for returning to shareholders. Cash flows in connection with the acquisition or divestment of subsidiaries, associated companies and non-controlling interests in subsidiaries are not taken into account to determine free cash flow. Free cash flow is not intended to be a substitute measure for net cash flows from operating activities as determined under IFRS.

56

 
CORE RESULTS –Reconciliation from IFRS results to core results – Group – Second quarter

Innovative Medicines Sandoz Corporate Group
(USD millions unless indicated otherwise) Q2 2019 Q2 2018 Q2 2019 Q2 2018 Q2 2019 Q2 2018 Q2 2019 Q2 2018
IFRS operating income from continuing operations 2 564 2 252 282 328 -183 -149 2 663 2 431
Amortization of intangible assets 521 520 81 95 602 615
Impairments
Intangible assets
-17 61 2 20 -15 81
Property, plant and equipment related to the Group-wide rationalization of manufacturing sites
30 97 5 38 35 135
Other property, plant and equipment
7 6 6 7
Total impairment charges 13 165 13 58 26 223
Acquisition or divestment of businesses and related items
- Income
-4 -38 -8 -42 -8
- Expense
10 63 37 9 47 72
Total acquisition or divestment of businesses and related items, net 6 63 -1 1 5 64
Other items
Divestment gains
-598 -201 5 -14 -593 -215
Financial assets - fair value adjustments
-22 5 -10 14 -32 19
Restructuring and related items
- Income
-15 -5 -1 -2 -1 -2 -17 -9
- Expense
151 51 127 43 19 8 297 102
Legal-related items
- Income
-31 -63 -31 -63
- Expense
682 9 27 709 9
Additional income
-57 -8 -3 -5 -1 -65 -9
Additional expense
61 3 6 21 17 16 84 40
Total other items 202 -146 125 -1 25 21 352 -126
Total adjustments 742 602 219 152 24 22 985 776
Core operating income from continuing operations 3 306 2 854 501 480 -159 -127 3 648 3 207
as % of net sales 35.4% 32.2% 20.5% 19.5% 31.0% 28.3%
Income from associated companies 1 1 4 174 5 928 176 5 932
Core adjustments to income from associated companies, net of tax 77 -5 701 77 -5 701
Other financial income and expense 45
Core adjustments to other financial income and expense1 20
Taxes, adjusted for above items (core taxes) -620 -511
Core net income from continuing operations 3 096 2 735
Core net income from discontinued operations2 276
Core net income 3 096 3 011
Core net income attributable to shareholders of Novartis AG 3 095 3 011
Core basic EPS from continuing operations (USD)3 1.34 1.18
Core basic EPS from discontinued operations (USD)3 0.11
Core basic EPS (USD)3 1.34 1.29
Other financial income and expense includes fair value adjustments on financial assets.
For details on discontinued operations reconciliaton from IFRS to core net income, please refer to page 66.
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

57

 
CORE RESULTS –Reconciliation from IFRS results to core results – Group – First half

Innovative Medicines Sandoz Corporate Group
(USD millions unless indicated otherwise) H1 2019 H1 2018 H1 2019 H1 2018 H1 2019 H1 2018 H1 2019 H1 2018
IFRS operating income from continuing operations 4 673 4 387 555 737 -323 -322 4 905 4 802
Amortization of intangible assets 978 1 036 160 192 1 138 1 228
Impairments
Intangible assets
429 62 12 34 441 96
Property, plant and equipment related to the Group-wide rationalization of manufacturing sites
34 98 8 39 42 137
Other property, plant and equipment
1 9 6 7 9
Total impairment charges 464 169 26 73 490 242
Acquisition or divestment of businesses and related items
- Income
-5 -39 -16 -44 -16
- Expense
26 86 39 22 65 108
Total acquisition or divestment of businesses and related items, net 21 86 6 21 92
Other items
Divestment gains
-624 -277 -78 2 -45 -622 -400
Financial assets - fair value adjustments
-8 -78 -12 32 -20 -46
Restructuring and related items
- Income
-23 -8 -1 -2 -2 -2 -26 -12
- Expense
228 99 179 69 32 25 439 193
Legal-related items
- Income
-31 -63 -31 -63
- Expense
688 19 72 30 760 49
Additional income
-253 -30 -4 -6 -263 -30
Additional expense
84 82 6 21 21 29 111 132
Total other items 92 -193 221 -23 35 39 348 -177
Total adjustments 1 555 1 098 407 242 35 45 1 997 1 385
Core operating income from continuing operations 6 228 5 485 962 979 -288 -277 6 902 6 187
as % of net sales 34.4% 31.8% 20.2% 19.7% 30.2% 27.8%
Income from associated companies 1 1 4 254 6 080 256 6 084
Core adjustments to income from associated companies, net of tax 275 -5 478 275 -5 478
Other financial income and expense 44 80
Core adjustments to other financial income and expense1 20
Taxes, adjusted for above items (core taxes) -1 159 -999
Core net income from continuing operations 5 907 5 419
Core net income from discontinued operations2 278 574
Core net income 6 185 5 993
Core net income attributable to shareholders of Novartis AG 6 183 5 990
Core basic EPS from continuing operations (USD)3 2.55 2.33
Core basic EPS from discontinued operations (USD)3 0.12 0.25
Core basic EPS (USD)3 2.67 2.58
Other financial income and expense includes fair value adjustments on financial assets.
For details on discontinued operations reconciliaton from IFRS to core net income, please refer to page 67.
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

58

 
CORE RESULTS – Reconciliation from IFRS results to core results – Group – Second quarter


(USD millions unless indicated otherwise)


Q2 2019
IFRS results

Amortization
of intangible
assets 1



Impairments 2
Acquisition or
divestment of
businesses and
related items 3



Other items 4


Q2 2019
Core results


Q2 2018
Core results
Gross profit from continuing operations 8 618 592 2 65 9 277 8 820
Operating income from continuing operations 2 663 602 26 5 352 3 648 3 207
Income before taxes from continuing operations 2 634 679 26 5 372 3 716 3 246
Taxes from continuing operations5 -525 -620 -511
Net income from continuing operations 2 109 3 096 2 735
Net income from discontinued operations6 4 691 276
Net income 6 800 3 096 3 011
Basic EPS from continuing operations (USD)7 0.91 1.34 1.18
Basic EPS from discontined operations (USD)7 2.03 0.11
Basic EPS (USD)7 2.94 1.34 1.29
The following are adjustments to arrive at core gross profit
Other revenues 260 -24 236 294
Cost of goods sold -3 406 592 2 89 -2 723 -2 833
The following are adjustments to arrive at core operating income
Selling, general and administration -3 585 1 69 -3 515 -3 492
Research and development -2 051 10 -17 4 -2 054 -2 051
Other income 989 -2 -42 -731 214 171
Other expense -1 308 43 42 949 -274 -241
The following are adjustments to arrive at core income before taxes
Income from associated companies 176 77 253 231
Other financial income and expense8 20 20 45
Amortization of intangible assets: cost of goods sold includes amortization of acquired rights to in-market products, and other production-related intangible assets; research and development includes the amortization of acquired rights for technologies; income from associated companies includes USD 77 million for the Novartis share of the estimated Roche core items
Impairments: cost of goods sold and research and development include impairment charges related to intangible assets; research and development also contains the reversal of an impairment charge; other income and other expense include net impairment charges on property, plant and equipment
Acquisition or divestment of businesses and related items, including restructuring and integration charges: selling, general and administration, research and development and other expense include net charges related to acquisitions; other income and other expense include transitional service-fee income and expenses, and other items related to the portfolio transformation
Other items: other revenues includes an income related to an amendment of a collaboration agreement; cost of goods sold, other income and other expense include net restructuring and other charges related to the Group-wide rationalization of manufacturing sites; cost of goods sold, selling, general and administration, other income and other expense include other restructuring income and expense and related items; other income and other expense also include fair value adjustments and divestment gains and losses on financial assets and legal-related items; selling, general and administration also includes a receivable expected credit loss provision; other income also includes net gains from the divestment of property, plant and equipment and products and provision releases
Taxes on the adjustments between IFRS and core results take into account, for each individual item included in the adjustment, the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on other items, although this is not always the case for items arising from legal settlements in certain jurisdictions. Adjustments related to income from associated companies are recorded net of any related tax effect. Due to these factors and the differing effective tax rates in the various jurisdictions, the tax on the total adjustments of USD 1.1 billion to arrive at the core results before tax amounts to USD 95 million. The average tax rate on the adjustments is 8.8%.
For details on discontinued operations reconciliation from IFRS to core net income please refer to page 66.
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
Other financial income and expense includes fair value adjustments on financial assets

59

 
CORE RESULTS – Reconciliation from IFRS results to core results – Group – First half


(USD millions unless indicated otherwise)


H1 2019
IFRS results

Amortization
of intangible
assets 1



Impairments 2
Acquisition or
divestment of
businesses and
related items 3



Other items 4


H1 2019
Core results


H1 2018
Core results
Gross profit from continuing operations 16 822 1 116 12 99 18 049 17 230
Operating income from continuing operations 4 905 1 138 490 21 348 6 902 6 187
Income before taxes from continuing operations 4 774 1 413 490 21 368 7 066 6 418
Taxes from continuing operations5 -797 -1 159 -999
Net income from continuing operations 3 977 5 907 5 419
Net income from discontinued operations6 4 590 278 574
Net income 8 567 6 185 5 993
Basic EPS from continuing operations (USD)7 1.72 2.55 2.33
Basic EPS from discontined operations (USD)7 1.98 0.12 0.25
Basic EPS (USD)7 3.70 2.67 2.58
The following are adjustments to arrive at core gross profit
Other revenues 556 -66 490 529
Cost of goods sold -6 657 1 116 12 165 -5 364 -5 586
The following are adjustments to arrive at core operating income
Selling, general and administration -6 915 8 72 -6 835 -6 770
Research and development -4 350 22 429 13 -132 -4 018 -4 040
Other income 1 192 -2 -44 -812 334 260
Other expense -1 844 51 44 1 121 -628 -493
The following are adjustments to arrive at core income before taxes
Income from associated companies 256 275 531 606
Other financial income and expense8 44 20 64 80
Amortization of intangible assets: cost of goods sold includes amortization of acquired rights to in-market products, and other production-related intangible assets; research and development includes the amortization of acquired rights for technologies; income from associated companies includes USD 275 million for the Novartis share of the estimated Roche core items
Impairments: cost of goods sold and research and development include impairment charges and a reversal of impairment charges related to intangible assets; other income and other expense include net impairment charges related to property, plant and equipment
Acquisition or divestment of businesses and related items, including restructuring and integration charges: selling, general and administration, research and development and other expense include net charges related to acquisitions; other income and other expense include transitional service fee income and expenses, and other items related to the portfolio transformation
Other items: other revenues includes a net income from an outlicensing agreement and an income related to an amendment of a collaboration agreement; cost of goods sold, other income and other expense include net restructuring and other charges related to the Group-wide rationalization of manufacturing sites; cost of goods sold, selling, general and administration, other income and other expense include other restructuring income and expense and related items; selling, general and administration also includes a receivable expected credit loss provision and adjustments to provisions; research and development also includes fair value adjustments of contingent consideration liabilities; other income and other expense also include fair value adjustments and divestment gains and losses on financial assets and legal-related items; other income also includes net gains from divestments of products and property, plant & equipment and a provision release
Taxes on the adjustments between IFRS and core results take into account, for each individual item included in the adjustment, the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on other items, although this is not always the case for items arising from legal settlements in certain jurisdictions. Adjustments related to income from associated companies are recorded net of any related tax effect. Due to these factors and the differing effective tax rates in the various jurisdictions, the tax on the total adjustments for continuing operations of USD 2.3 billion to arrive at the core results before tax amounts to USD 362 million. The average tax rate on the adjustments is 15.8%, since the estimated full year core tax charge of 16.4% has been applied to the pre-tax income of the period.
For details on discontinued operations reconciliation from IFRS to core net income please refer to page 67.
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
Other financial income and expense includes fair value adjustments on financial assets

60

 
CORE RESULTS – Reconciliation from IFRS results to core results – Innovative Medicines – Second quarter


(USD millions)


Q2 2019
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items 3


Other
items 4


Q2 2019
Core results


Q2 2018
Core results
Gross profit 7 426 511 25 7 962 7 545
Operating income 2 564 521 13 6 202 3 306 2 854
The following are adjustments to arrive at core gross profit
Other revenues 250 -24 226 285
Cost of goods sold -2 327 511 49 -1 767 -1 793
The following are adjustments to arrive at core operating income
Selling, general and administration -2 911 1 62 -2 848 -2 775
Research and development -1 853 10 -17 4 -1 856 -1 856
Other income 847 -1 -4 -679 163 82
Other expense -945 31 5 794 -115 -142
Amortization of intangible assets: cost of goods sold includes amortization of acquired rights to in-market products and other production-related intangible assets; research and development includes the amortization of acquired rights for technologies
Impairments: research and development includes impairment charges and a reversal of impairment charges related to intangible assets; other income and other expense include net impairment charges related to property, plant and equipment
Acquisition or divestment of businesses and related items, including restructuring and integration charges: selling, general and administration, research and development and other expense include charges related to acquisitions and other income include transitional service-fee income related to the portfolio transformation
Other items: other revenues includes an income related to an amendment of a collaboration agreement; cost of goods sold and other expense include restructuring and other charges related to the Group-wide rationalization of manufacturing sites; cost of goods sold, selling, general and administration, other income and other expense include other restructuring income and charges and related items; other income and other expense also include fair value adjustments on financial assets; other income also includes net gains from the divestment of property, plant and equipment, products and financial assets and provision releases; other expense also includes legal-related items

61

 
CORE RESULTS – Reconciliation from IFRS results to core results – Innovative Medicines – First half


(USD millions)


H1 2019
IFRS results

Amortization
of intangible
assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items 3



Other items 4


H1 2019
Core results


H1 2018
Core results
Gross profit 14 492 956 23 15 471 14 623
Operating income 4 673 978 464 21 92 6 228 5 485
The following are adjustments to arrive at core gross profit
Other revenues 511 -66 445 508
Cost of goods sold -4 551 956 89 -3 506 -3 504
The following are adjustments to arrive at core operating income
Selling, general and administration -5 564 8 62 -5 494 -5 324
Research and development -3 958 22 429 13 -132 -3 626 -3 646
Other income 922 -1 -5 -717 199 127
Other expense -1 219 36 5 856 -322 -295
Amortization of intangible assets: cost of goods sold includes amortization of acquired rights to in-market products and other production-related intangible assets; research and development includes the amortization of acquired rights for technologies
Impairments: research and development includes impairment charges and a reversal of impairment charges related to intangible assets; other income and other expense include net impairment charges related to property, plant and equipment
Acquisition or divestment of businesses and related items, including restructuring and integration charges: selling, general and administration, research and development, other income and other expense include net charges related to acquisitions; other income also includes transitional service-fee income related to the portfolio transformation
Other items: other revenues includes a net income from an outlicensing agreement and an income related to an amendment of a collaboration agreement; cost of goods sold, other income and other expense include restructuring and other charges related to the Group-wide rationalization of manufacturing sites; cost of goods sold, selling, general and administration, research and development, other income and other expense include other restructuring income and charges and related items; research and development also includes fair value adjustments of contingent consideration liabilities; other income and other expense also include fair value adjustments on financial assets; other income also includes net gains from the divestment of property, plant and equipment, products and financial assets and provision releases; other expense also includes legal-related items

62

 
CORE RESULTS – Reconciliation from IFRS results to core results – Sandoz – Second quarter


(USD millions)


Q2 2019
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items


Other
items 3


Q2 2019
Core results


Q2 2018
Core results
Gross profit 1 166 81 2 40 1 289 1 258
Operating income 282 81 13 125 501 480
The following are adjustments to arrive at core gross profit
Cost of goods sold -1 315 81 2 40 -1 192 -1 245
The following are adjustments to arrive at core operating income
Selling, general and administration -550 7 -543 -593
Other income 45 -1 -32 12 62
Other expense -181 12 110 -59 -52
Amortization of intangible assets: cost of goods sold includes amortization of acquired rights to in-market products and other production-related intangible assets
Impairments: cost of goods sold includes impairment charges related to intangible assets; other income and other expense include net impairment charges related to property, plant and equipment
Other items: cost of goods sold and other expense include net restructuring and other charges related to the Group-wide rationalization of manufacturing sites; cost of goods sold, selling, general and administration, other income and other expense include restructuring income and charges and related items; selling, general and administration also includes a receivable expected credit loss provision; other expense and other income also include legal-related items

63

 
CORE RESULTS – Reconciliation from IFRS results to core results – Sandoz – First half


(USD millions)


H1 2019
IFRS results

Amortization
of intangible
assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items


Other
items 3


H1 2019
Core results


H1 2018
Core results
Gross profit 2 283 160 12 76 2 531 2 574
Operating income 555 160 26 221 962 979
The following are adjustments to arrive at core gross profit
Cost of goods sold -2 591 160 12 76 -2 343 -2 507
The following are adjustments to arrive at core operating income
Selling, general and administration -1 112 10 -1 102 -1 195
Other income 82 -1 -32 49 97
Other expense -306 15 167 -124 -103
Amortization of intangible assets: cost of goods sold includes amortization of acquired rights to in-market products and other production-related intangible assets
Impairments: cost of goods sold includes impairment charges related to intangible assets; other income and other expense include net impairment charges related to property, plant and equipment
Other items: cost of goods sold and other expense include net restructuring and other charges related to the Group-wide rationalization of manufacturing sites; cost of goods sold, selling, general and administration, other income and other expense include restructuring income and charges and related items; selling, general and administration also includes a receivable expected credit loss provision; other income and other expense also include legal-related items

64

 
CORE RESULTS – Reconciliation from IFRS results to core results – Corporate continuing – Second quarter


(USD millions)


Q2 2019
IFRS results


Amortization of
intangible assets



Impairments
Acquisition or
divestment of
businesses
and related items 1


Other
items 2


Q2 2019
Core results


Q2 2018
Core results
Gross profit 26 26 17
Operating income -183 -1 25 -159 -127
The following are adjustments to arrive at core operating income
Other income 97 -38 -20 39 27
Other expense -182 37 45 -100 -47
Acquisition or divestment of businesses and related items, including restructuring and integration charges: other income and other expense include transitional service fee income and expenses, and other items related to the portfolio transformation
Other items: other income and other expense include fair value adjustments and divestment gains and losses on financial assets, as well as restructuring charges and related items

CORE RESULTS – Reconciliation from IFRS results to core results – Corporate continuing – First half


(USD millions)


H1 2019
IFRS results


Amortization of
intangible assets



Impairments
Acquisition or
divestment of
businesses
and related items 1


Other
items 2


H1 2019
Core results


H1 2018
Core results
Gross profit 47 47 33
Operating income -323 35 -288 -277
The following are adjustments to arrive at core operating income
Other income 188 -39 -63 86 36
Other expense -319 39 98 -182 -95
Acquisition or divestment of businesses and related items, including restructuring and integration charges: other income and other expense include transitional service fee income and expenses, and other items related to the portfolio transformation
Other items: other income and other expense include fair value adjustments and divestment gains and losses on financial assets, as well as restructuring income and charges and related items

65

 
CORE RESULTS – Reconciliation from IFRS results to core results – Discontinued operations – Second quarter


(USD millions)


Q2 2019
IFRS results


Amortization of
intangible assets



Impairments
Acquisition or
divestment of
businesses
and related items 1


Other
items


Q2 2019
Core results


Q2 2018
Core results
Gross profit 1 169
Operating income of discontinued operations 334
Income before taxes of discontinued operations 329
Taxes -53
Net income from discontinued operations before gain on distribution of Alcon Inc. to Novartis AG shareholders 276
Gain on distribution of Alcon Inc. to Novartis AG shareholders 4 691 -4 691
Net income from discontinued operations 4 691 276
Basic EPS (USD)2 2.03 0.11
Acquisition or divestment of businesses and related items represents the non-taxable non-cash gain related to the distribution (spin-off) of Alcon Inc. to Novartis AG shareholders
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
 

66

 
CORE RESULTS – Reconciliation from IFRS results to core results – Discontinued operations – First half


(USD millions)


H1 2019
IFRS results


Amortization of
intangible assets 1



Impairments
Acquisition or
divestment of
businesses
and related items 2


Other
items 3


H1 2019
Core results


H1 2018
Core results
Gross profit 949 165 9 1 123 2 284
Operating income of discontinued operations 71 167 112 350 694
Income before taxes of discontinued operations 58 337 682
Taxes4 -159 -59 -108
Net loss/income from discontinued operations before gain on distribution of Alcon Inc. to Novartis AG shareholders -101 278 574
Gain on distribution of Alcon Inc. to Novartis AG shareholders 4 691 -4 691
Net income from discontinued operations 4 590 278 574
Basic EPS (USD)5 1.98 0.12 0.25
The following are adjustments to arrive at core gross profit
Cost of goods sold -860 165 9 -686 -1 317
The following are adjustments to arrive at core operating income
Selling, general and administration -638 14 -624 -1 337
Research and development -142 2 4 -136 -252
Other income 15 -3 12 19
Other expense -113 88 -25 -20
Amortization of intangible assets: cost of goods sold includes amortization of acquired rights to in-market products and other production-related intangible assets; research and development includes the amortization of acquired rights for technologies
Acquisition or divestment of businesses and related items represents the non-taxable non-cash gain related to the distribution of Alcon Inc. (spin-off) to Novartis AG shareholders
Other items: cost of goods sold, selling, general and administration, research and development and other expense include other restructuring charges and related items; research and development also includes amortization of option rights and the fair value adjustment of a contingent consideration liability; other income includes a fair value adjustments on a financial asset; other expense also includes legal-related items
Taxes on the adjustments between IFRS and core results take into account, for each individual item included in the adjustment, the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on other items, although this is not always the case for items arising from legal settlements in certain jurisdictions. Due to these factors and the differing effective tax rates in the various jurisdictions, the tax on the total adjustments, excluding the non-taxable non-cash gain on the distribution (spin-off) of Alcon Inc. to Novartis AG shareholders of USD 279 million to arrive at the core results before tax amounts to USD 100 million. The 2019 core tax rate excluding the effect of the gain on distribution of Alcon Inc. to Novartis AG shareholders is 17.5%.
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

67

 
Income from associated companies

(USD millions) Q2 2019 Q2 2018 H1 2019 H1 2018
Share of estimated Roche reported results
206 183 412 371
Prior-year adjustment
-129 -125
Amortization of additional intangible assets recognized by Novartis on initial accounting for the equity interest -29 -37 -69 -75
Partial release of deferred tax liability recognized
43
Net income effect from Roche Holding AG 177 146 257 171
Share of estimated GSK Consumer Healthcare Holdings Ltd. reported results
-8 119
Prior-year adjustment
4
Amortization of additional intangible assets recognized by Novartis on initial accounting for the equity interest
-3
Gain on divestment of GSK Consumer Healthcare Holdings Ltd., pre-tax 1 5 791 5 791
Net income effect from GlaxoSmithKline Consumer Healthcare Holdings Ltd. 1 5 783 5 911
Others -1 3 -1 2
Income from associated companies 176 5 932 256 6 084
 
On March 27, 2018, Novartis entered into the agreement to divest its 36.5% investment in GSK Consumer Healthcare Holdings Ltd. to GSK. As a result, equity accounting was discontinued starting from April 1, 2018. The transaction closed on June 1, 2018, see Note 3.

Core income from associated companies

(USD millions) Q2 2019 Q2 2018 H1 2019 H1 2018
Income from associated companies 176 5 932 256 6 084
Share of estimated Roche core adjustments 77 80 114 159
Roche prior year adjustment 161 133
Share of estimated GSK Consumer Healthcare Holdings Ltd. core adjustments 1 10 20
GSK Consumer Healthcare Holdings Ltd. prior year adjustment 1
Gain on divestment of GSK Consumer Healthcare Holdings Ltd., pre-tax 1 -5 791 -5 791
Core income from associated companies 253 231 531 606
 
On March 27, 2018, Novartis entered into the agreement to divest its 36.5% investment in GSK Consumer Healthcare Holdings Ltd. to GSK. As a result, equity accounting was discontinued starting from April 1, 2018. The transaction closed on June 1, 2018, see Note 3.



68

 
Condensed consolidated changes in net debt 

Second quarter

(USD millions) Q2 2019 Q2 2018
Change in cash and cash equivalents 3 184 6 633
Change in marketable securities, commodities, financial debts and financial derivatives 471 1 845
Reduction in net debt 3 655 8 478
Net debt at April 1 -21 541 -27 688
Net debt at June 30 -17 886 -19 210



First half

(USD millions) H1 2019 H1 2018
Change in cash and cash equivalents -3 280 3 586
Change in marketable securities, commodities, financial debts and financial derivatives 1 578 -3 749
Increase in net debt -1 702 -163
Net debt at January 1 -16 184 -19 047
Net debt at June 30 -17 886 -19 210



Components of net debt


(USD millions)
Jun 30,
2019
Jun 30,
2018
Non-current financial debts -20 364 -22 760
Current financial debts and derivative financial instruments -7 857 -9 596
Total financial debt -28 221 -32 356
Less liquidity:
Cash and cash equivalents
9 991 12 446
Marketable securities, commodities, time deposits and derivative financial instruments
344 700
Total liquidity 10 335 13 146
Net debt at June 30 -17 886 -19 210

Share information

Jun 30,
2019
Jun 30,
2018
Number of shares outstanding 2 291 765 401 2 321 740 340
Registered share price (CHF) 89.20 75.28
ADR price (USD) 91.31 75.54
Market capitalization (USD billions)1 209.7 175.7
Market capitalization (CHF billions)1 204.4 174.8
Market capitalization is calculated based on the number of shares outstanding (excluding treasury shares). Market capitalization in USD is based on the market capitalization in CHF converted at the quarter end CHF/USD exchange rate.

69

 
Free cash flow

Second quarter

(USD millions) Q2 2019 Q2 2018 Change
Operating income from continuing operations 2 663 2 431 232
Adjustments for non-cash items
Depreciation, amortization and impairments
1 014 1 174 -160
Change in provisions and other non-current liabilities
958 109 849
Other
-441 -70 -371
Operating income adjusted for non-cash items 4 194 3 644 550
Dividends received from associated companies and others 3 254 -251
Interest and other financial receipts 65 74 -9
Interest and other financial payments -211 -179 -32
Taxes paid -560 -501 -59
Payments out of provisions and other net cash movements in non-current liabilities -323 -121 -202
Change in inventory and trade receivables less trade payables -609 -99 -510
Change in other net current assets and other operating cash flow items 552 440 112
Net cash flows from operating activities from continuing operations 3 111 3 512 -401
Purchase of property, plant and equipment -279 -257 -22
Proceeds from sales of property, plant and equipment 648 6 642
Purchase of intangible assets -161 -226 65
Proceeds from sales of intangible assets 210 222 -12
Purchase of financial assets -45 -39 -6
Proceeds from sales of financial assets 142 55 87
Purchase of other non-current assets -14 -9 -5
Proceeds from sales of other non-current assets 0 4 -4
Free cash flow from continuing operations 3 612 3 268 344
Free cash flow from discontinued operations 294 -294
Total free cash flow 3 612 3 562 50

70

 
Free cash flow

First half

(USD millions) H1 2019 H1 2018 Change
Operating income from continuing operations 4 905 4 802 103
Adjustments for non-cash items
Depreciation, amortization and impairments
2 467 2 104 363
Change in provisions and other non-current liabilities
1 018 247 771
Other
-312 -74 -238
Operating income adjusted for non-cash items 8 078 7 079 999
Dividends received from associated companies and others 463 718 -255
Interest and other financial receipts 150 124 26
Interest and other financial payments -422 -386 -36
Taxes paid -960 -890 -70
Payments out of provisions and other net cash movements in non-current liabilities -516 -264 -252
Change in inventory and trade receivables less trade payables -1 306 -751 -555
Change in other net current assets and other operating cash flow items -42 263 -305
Net cash flows from operating activities from continuing operations 5 445 5 893 -448
Purchase of property, plant and equipment -561 -515 -46
Proceeds from sales of property, plant and equipment 812 51 761
Purchase of intangible assets -498 -642 144
Proceeds from sales of intangible assets 281 416 -135
Purchase of financial assets -154 -71 -83
Proceeds from sales of financial assets 177 64 113
Purchase of other non-current assets -24 -13 -11
Proceeds from sales of other non-current assets 3 4 -1
Free cash flow from continuing operations 5 481 5 187 294
Free cash flow from discontinued operations -62 290 -352
Total free cash flow 5 419 5 477 -58

71

 
Principal currency translation rates

Second quarter


(USD per unit)

Average
rates
Q2 2019

Average
rates
Q2 2018
Period-end
rates
Jun 30,
2019
Period-end
rates
Jun 30,
2018
1 CHF 0.998 1.015 1.026 1.005
1 CNY 0.147 0.157 0.146 0.151
1 EUR 1.124 1.192 1.138 1.163
1 GBP 1.285 1.361 1.268 1.311
100 JPY 0.910 0.916 0.929 0.904
100 RUB 1.548 1.612 1.583 1.595



First half


Average
rates
H1 2019

Average
rates
H1 2018
Period-end
rates
Jun 30,
2019
Period-end
rates
Jun 30,
2018
1 CHF 1.000 1.035 1.026 1.005
1 CNY 0.147 0.157 0.146 0.151
1 EUR 1.130 1.211 1.138 1.163
1 GBP 1.294 1.376 1.268 1.311
100 JPY 0.909 0.920 0.929 0.904
100 RUB 1.533 1.685 1.583 1.595

72

 




Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “guidance,” “focused,” “momentum,” “upcoming,” “transformative,” “continued,” “potential,” “launches,” “launch,” “growth drivers,”  “launched,” “on track” “filed,” “expected,” “to grow,” “will,” “enter,” “pipeline,” “committed,” “future,” “strategy,” “priority review,” “deliver,” “expect,” “to be completed,” “to become,” “to be presented,” “pending,” “closing conditions,” “continued,” “landmark,” “continues,” “submitted,” “resubmitted,” “submissions,” “filings,” “potentially,” “outlook,” “unforeseen,” “forecast,” “may,” “would,” “PRIME designation,” “Sakigake designation,” “enrollment,” “ongoing,” “planned,” “Fast Track designation,” “Orphan designation,” “Orphan status,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the potential outcome, or financial or other impact on Novartis, of the proposed divestiture of certain portions of our Sandoz Division business in the US; or regarding the potential impact of the share buyback plan; or regarding potential future sales or earnings of the Group or any of its divisions or potential shareholder returns; or by discussions of strategy, plans, expectations or intentions. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. In particular, our expectations could be affected by, among other things: global trends toward healthcare cost containment, including ongoing government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; regulatory actions or delays or government regulation generally, including potential regulatory actions or delays with respect to the proposed transactions or the development of the products described in this press release; the potential that the strategic benefits, synergies or opportunities expected from the Alcon and Sandoz transactions may not be realized or may be more difficult or take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns; the uncertainties inherent in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products that commenced in prior years and will continue this year; safety, quality or manufacturing issues; uncertainties regarding actual or potential legal proceedings, including, among others, product liability litigation, disputes and litigation with business partners or business collaborators, government investigations generally, litigation and investigations regarding sales and marketing practices, and intellectual property disputes; uncertainties involved in the development or adoption of potentially transformational technologies and business models; our performance on environmental, social and governance measures; general political, economic and trade conditions, including uncertainties regarding the effects of ongoing instability in various parts of the world; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

All product names appearing in italics are trademarks owned by or licensed to Novartis Group companies.
 
 
 
73
 

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.

Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 8:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting.
https://www.novartis.com/investors/event-calendar

Detailed financial results accompanying this press release are included in the condensed interim financial report at the link below. Additional information is provided on Novartis divisions and pipeline of selected compounds in late stage development and a copy of today's earnings call presentation can be found at.
https://www.novartis.com/investors/event-calendar

Important dates
September 9, 2019 ESG Investor day - London
October 22, 2019   Third quarter results 2019
December 5, 2019  R&D update 2019 - London
 
 
 
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