EX-99 3 a171024-99_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 Q3 and 9M 2017 Condensed Interim Financial Report – Supplementary Data

INDEX
Page
GROUP AND DIVISIONAL OPERATING PERFORMANCE Q3 and 9M 2017
 
Group
2
Innovative Medicines
5
Sandoz
13
Alcon
15
CASH FLOW AND GROUP BALANCE SHEET
17
INNOVATION REVIEW
20
CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
 
Consolidated income statements
29
Condensed consolidated statements of comprehensive income
31
Condensed consolidated balance sheets
32
Condensed consolidated changes in equity
33
Condensed consolidated cash flow statements
34
Notes to condensed interim consolidated financial statements, including update on legal proceedings
36
SUPPLEMENTARY INFORMATION
44
CORE RESULTS
 
Reconciliation from IFRS to core results
46
Group
48
Innovative Medicines
50
Sandoz
52
Alcon
54
Corporate
56
ADDITIONAL INFORMATION
 
Condensed consolidated changes in net debt / Share information
58
Free cash flow
59
Net sales of the top 20 Innovative Medicines products
60
Innovative Medicines sales by business franchise
62
Net sales by region
64
Currency translation rates
66
Income from associated companies
67
DISCLAIMER
68
 
 
1
 

GROUP AND DIVISIONAL OPERATING PERFORMANCE


Key figures1
   
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
 
 
USD m
   
USD m
   
USD
   
cc 1
   
USD m
   
USD m
   
USD
   
cc 1
 
Net sales to third parties
   
12 413
     
12 126
     
2
     
2
     
36 194
     
36 196
     
0
     
1
 
Divisional operating income
   
2 519
     
2 324
     
8
     
11
     
6 926
     
7 134
     
- 3
     
0
 
Corporate income & expense, net
   
- 162
     
- 55
   
nm
   
nm
     
- 367
     
- 321
     
- 14
     
- 24
 
Operating income
   
2 357
     
2 269
     
4
     
6
     
6 559
     
6 813
     
- 4
     
- 1
 
    As % of net sales
   
19.0
%
   
18.7
%
                   
18.1
%
   
18.8
%
               
Income from associated companies
   
262
     
217
     
21
     
21
     
692
     
547
     
27
     
26
 
Interest expense
   
- 197
     
- 174
     
- 13
     
- 17
     
- 569
     
- 539
     
- 6
     
- 8
 
Other financial income and expense
   
14
     
- 38
   
nm
   
nm
     
16
     
- 82
   
nm
   
nm
 
Taxes
   
- 353
     
- 329
     
- 7
     
- 10
     
- 971
     
- 977
     
1
     
- 2
 
Net income
   
2 083
     
1 945
     
7
     
10
     
5 727
     
5 762
     
- 1
     
2
 
Basic earnings per share (USD)
   
0.89
     
0.81
     
10
     
12
     
2.43
     
2.42
     
0
     
3
 
Cash flows from operating activities
   
3 586
     
3 231
     
11
             
9 213
     
7 884
     
17
         
Free cash flow1
   
3 064
     
2 591
     
18
             
7 972
     
6 479
     
23
         
Core1
                                                               
Core operating income
   
3 382
     
3 381
     
0
     
1
     
9 627
     
9 974
     
- 3
     
- 1
 
    As % of net sales
   
27.2
%
   
27.9
%
                   
26.6
%
   
27.6
%
               
Core net income
   
3 017
     
2 938
     
3
     
4
     
8 573
     
8 656
     
-1
     
1
 
Basic core earnings per share (USD)
   
1.29
     
1.23
     
5
     
6
     
3.64
     
3.63
     
0
     
2
 
nm = not meaningful


Third quarter

Net sales
Net sales were USD 12.4 billion (+2%, +2% cc) in the third quarter, as volume growth of 7 percentage points, including growth from Cosentyx, Entresto and Alcon, was partly offset by the negative impacts of generic competition (-4 percentage points) and pricing (-1 percentage point).

Corporate income and expense, net
Corporate income and expense, which includes the cost of Group management and central services, amounted to a net expense of USD 162 million in third quarter of 2017 compared to USD 55 million in prior year mainly due to lower gains from divestments of real estate, lower realized net gains from investments in the Novartis Venture Fund and a fair value adjustment to contingent liabilities.

Operating income
Operating income was USD 2.4 billion (+4%, +6% cc) mainly driven by growth drivers, productivity and a gain from a Swiss pension plan amendment, which were partly offset by generic erosion. Operating income margin in constant currencies increased 0.7 percentage points; currency had a negative impact of 0.4 percentage points, resulting in a net increase of 0.3 percentage points to 19.0% of net sales.

Core adjustments amounted to USD 1.0 billion (2016: USD 1.1 billion). Core operating income was USD 3.4 billion (0%, +1% cc) as growth drivers and productivity offset generic erosion. Core operating income margin in constant currencies decreased 0.2 percentage points; currency had a negative impact of 0.5 percentage points, resulting in a net decrease of 0.7 percentage points to 27.2% of net sales.

Income from associated companies
Income from associated companies amounted to USD 262 million, compared to USD 217 million in the prior year quarter. The increase is due to a higher estimated income contribution from GSK Consumer Healthcare Holdings Ltd. of USD 119 million compared to USD 91 million in prior year, as well as to an



1 Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 44. Unless otherwise noted, all growth rates in this document refer to same period in prior year.
 
 
2
 

increased estimated income contribution from Roche Holding AG (Roche) of USD 142 million compared to USD 125 million in prior year.

Core income from associated companies increased to USD 359 million from USD 295 million in prior year, in line with reported income from associated companies and as core income contribution from both GSK Consumer Healthcare Holdings Ltd. and Roche increased compared to prior year.

Interest expense and other financial income/expense
Interest expense increased to USD 197 million from USD 174 million in prior year due to higher outstanding debt. Other financial income and expense amounted to an income of USD 14 million compared to an expense of USD 38 million in the prior year quarter, mainly due to lower currency losses of USD 11 million compared to USD 44 million in prior year.

Taxes
The tax rate was 14.5% in line with prior year. The core tax rate was 15.2% in line with prior year.

Net income and EPS
Net income was USD 2.1 billion (+7%, +10% cc), driven by the strong operating income and higher income from associated companies.

EPS was USD 0.89 (+10%, +12% cc), driven by growth in net income and the benefit from the share buyback program.

Core net income was USD 3.0 billion (+3%, +4% cc), driven by growth in core operating income and higher core income from associated companies.

Core EPS was USD 1.29 (+5%, +6% cc), driven by growth in core net income and the benefit from the share buyback program.

Free cash flow amounted to USD 3.1 billion (+18% USD) compared to USD 2.6 billion in prior year. The increase of USD 0.5 billion was mainly driven by improved cash flows from operating activities and lower net investments in intangible assets.

Nine months

Net sales
Net sales were USD 36.2 billion (0%, +1% cc) in the first nine months, as volume growth of 6 percentage points, including growth from Cosentyx, Entresto, Promacta/Revolade and Tafinlar + Mekinist, was offset by the negative impacts of generic competition (-3 percentage points) and pricing (-2 percentage points).

Corporate income and expense, net
Corporate income and expense, which includes the cost of Group management and central services, amounted to a net expense of USD 367 million compared to USD 321 million in prior year mainly due to lower gains from divestments of real estate.

Operating income
Operating income was USD 6.6 billion (-4%, -1% cc) as generic erosion and higher impairments were mostly offset by growth drivers, productivity and lower amortization. Core adjustments amounted to USD 3.1 billion (2016: USD 3.2 billion). Operating income margin in constant currencies decreased 0.4 percentage points; currency had a negative impact of 0.3 percentage points, resulting in a net decrease of 0.7 percentage points to 18.1% of net sales.

Core adjustments amounted to USD 3.1 billion (2016: USD 3.2 billion). Core operating income was USD 9.6 billion (-3%, -1% cc). Core operating income margin in constant currencies decreased 0.7 percentage points, mainly due to generic erosion of Gleevec/Glivec partly offset by growth drivers and productivity; currency had a negative impact of 0.3 percentage points, resulting in a net decrease of 1.0 percentage points to 26.6% of net sales.

Income from associated companies
Income from associated companies increased to USD 692 million from USD 547 million in prior year mainly due to higher income from the investment in GSK Consumer Healthcare Holdings Ltd. The share of income from GSK Consumer Healthcare Holdings Ltd. increased to USD 338 million from
 
3
 

USD 198 million in prior year. The increase was due to an estimated income from GSK Consumer Healthcare Holdings Ltd. of USD 291 million compared to USD 220 million in 2016, as well as the recognition of a positive prior year true up of USD 47 million based on the actual audited results for 2016, compared to a negative prior year true up of USD 22 million recognized in 2016 for 2015.

Core income from associated companies increased to USD 1.0 billion from USD 854 million in the prior year period. The core income contribution from GSK Consumer Healthcare Holdings Ltd. increased to USD 368 million from USD 282 million in the first nine months of 2016, and the core income contribution from Roche increased to USD 645 million from USD 567 million in the first nine months of 2016.

Interest expense and other financial income/expense
Interest expense increased to USD 569 million from USD 539 million in the prior year period due to higher outstanding debt. Other financial income and expense amounted to an income of USD 16 million compared to an expense of USD 82 million in the prior year period, mainly due to lower currency losses of USD 44 million compared to USD 117 million in prior year.

Taxes
The tax rate was 14.5% in line with prior year. The core tax rate was 15.2% in line with prior year.

Net income and EPS
Net income was USD 5.7 billion (-1%, +2% cc), due to higher income from associated companies.

EPS was USD 2.43 (0%, +3% cc), driven by net income growth and the benefit from the share buyback program.

Core net income was USD 8.6 billion (-1%, +1% cc), due to higher core income from associated companies.

Core EPS was USD 3.64 (0%, +2% cc), with growth in core net income and the benefit from the share buyback program.

Free cash flow amounted to USD 8.0 billion (+23% USD) compared to USD 6.5 billion in the prior year. The increase of USD 1.5 billion was mainly driven by improved cash flows from operating activities.
 
4
 

Innovative Medicines
     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
   
8 302
     
8 173
     
2
     
2
     
24 269
     
24 289
     
0
     
2
 
Operating income
   
2 179
     
2 020
     
8
     
11
     
5 975
     
6 066
     
-2
     
2
 
  As % of net sales
   
26.2
     
24.7
                     
24.6
     
25.0
                 
Core operating income
   
2 657
     
2 676
     
-1
     
1
     
7 659
     
7 947
     
-4
     
-1
 
  As % of net sales
   
32.0
     
32.7
                     
31.6
     
32.7
                 

Third quarter

Net sales
Net sales were USD 8.3 billion (+2%, +2% cc) in the third quarter. Volume contributed 8 percentage points to sales growth. Generic competition had a negative impact of 6 percentage points largely due to Gleevec/Glivec genericization in Europe and the US. Pricing impact was negligible.

Regionally, US sales (USD 2.8 billion, +4% cc) grew as Cosentyx, Entresto, Promacta/Revolade, Tasigna and Afinitor more than offset the generic competition, largely for Gleevec/Glivec. Europe sales (USD 2.9 billion, -1% cc) slightly declined mainly driven by Gleevec/Glivec genericization, partly offset by Cosentyx, Tafinlar + Mekinist, Jakavi, and Entresto growth. Japan sales (USD 0.6 billion, +1% cc) grew slightly mainly driven by Lucentis. Emerging Growth Markets sales increased 5% (cc) to USD 2.1 billion.

Novartis Pharmaceuticals business unit sales were USD 5.2 billion (+6% cc). Immunology and Dermatology (USD 1.1 billion, +37% cc) sales increased, driven by strong growth of Cosentyx (USD 556 million, +83% cc) across all indications, mainly in US and Europe. In Cardio-Metabolic, Entresto (USD 128 million, +138% cc) continued to grow, benefitting from the impact of improved access and sales force expansion in the US and from broad reimbursement in Europe. Respiratory (USD 415 million, +6% cc) performance was driven by strong growth of Xolair (USD 245 million, +12% cc). In Neuroscience, Gilenya (USD 801 million, 0% cc) was in line with prior year. Ophthalmology sales (USD 1.3 billion, -3% cc) declined mainly driven by generic impact of Pataday in the US, partly offset by Lucentis (USD 481 million, +5% cc).

Novartis Oncology business unit sales were USD 3.1 billion (-4% cc) declining due to Gleevec/Glivec (USD 445 million, -47% cc) generic impact in Europe and the US. Excluding Gleevec/Glivec, sales grew 11% (cc) driven by Promacta/Revolade (USD 227 million, +36% cc), Tasigna (USD 482 million, +12% cc), Tafinlar + Mekinist (USD 224 million, +27% cc), Jakavi (USD 201 million, +31% cc), Votrient (USD 213 million, +15% cc), Exjade (USD 264 million, +11% cc) and Kisqali (USD 26 million).

Operating income
Operating income was USD 2.2 billion (+8%, +11% cc), mainly driven by higher sales, productivity, a gain from a Swiss pension plan amendment and lower amortization, which were partly offset by generic erosion, growth investments and lower divestment gains. Operating income margin in constant currencies increased 2.1 percentage points; currency had a negative impact of 0.6 percentage points, resulting in a net increase of 1.5 percentage points to 26.2% of net sales.

Core adjustments totaled USD 478 million, including USD 516 million for amortization of intangible assets, partly offset by a gain from a Swiss pension plan amendment. Prior year core adjustments were USD 656 million. Core operating income was USD 2.7 billion (-1%, +1% cc). Core operating income margin in constant currencies decreased by 0.3 percentage points; currency had a negative impact of 0.4 percentage points, resulting in a net decrease of 0.7 percentage points to 32.0% of net sales.
 
Core gross margin as a percentage of net sales increased by 0.3 percentage points (cc), mainly due to higher revenues from the Xolair profit sharing in the US. Core R&D expenses decreased by 0.9 percentage points (cc), mainly reflecting continued productivity and resource allocation from the creation of the Global Drug Development unit. Core SG&A expenses increased by 1.5 percentage points (cc), largely due to growth investments for Kisqali, Cosentyx and Entresto. Core Other Income and Expense impact was negligible.
 
5
 

Nine months

Net sales
Innovative Medicines delivered net sales of USD 24.3 billion (0%, +2% cc) in the first nine months, as volume growth (+7 percentage points) more than offset the negative impact of generic competition (-5 percentage points). Pricing impact was negligible.

In the US (USD 8.2 billion, +1% cc), the strong performance of Cosentyx, Entresto, and Promacta/Revolade was partly offset by generic competition, largely for Gleevec/Glivec. Europe sales (USD 8.3 billion, 0% cc) were in line with prior year as Cosentyx, Jakavi, Tafinlar + Mekinist and Entresto growth was fully offset by generic competition, largely for Gleevec/Glivec. Japan sales (USD 1.8 billion, -2% cc) declined versus the prior year, mainly due to generic competition. Emerging Growth Markets sales increased 7% (cc) to USD 6.2 billion.

Operating income
Operating income was USD 6.0 billion (-2%, +2% cc) mainly due to higher sales, productivity, lower amortization, partly offset by generic erosion, growth investments and the RLX030 net charge. Operating income margin in constant currencies increased 0.1 percentage points; currency had a negative impact of 0.5 percentage points, resulting in a net decrease of 0.4 percentage points to 24.6% of net sales.

Core adjustments amounted to USD 1.7 billion, mainly due to USD 1.6 billion of amortization of intangible assets. Prior year core adjustments were USD 1.9 billion. Core adjustments decreased compared to prior year mainly due to lower amortization. Core operating income was USD 7.7 billion  (-4%, -1% cc). Core operating income margin in constant currencies decreased by 0.8 percentage points; currency had a negative impact of 0.3 percentage points, resulting in a net decrease of 1.1 percentage points to 31.6% of net sales.

Core gross margin as a percentage of net sales increased by 0.5 percentage points (cc) mainly driven by higher revenues from the Xolair profit sharing in the US. Core R&D expenses decreased by 0.9 percentage points (cc), mainly reflecting continued productivity and resource allocation from the creation of the Global Drug Development unit. Core SG&A expenses increased by 1.8 percentage points (cc), largely due to launch investments. Core Other Income and Expense, net decreased the margin by 0.4 percentage points (cc).

Innovative Medicines product review

All comments below focus on third quarter movements in constant currencies.

ONCOLOGY BUSINESS UNIT
     
Q3 2017
     
Q3 2016
 
% change
     
9M 2017
     
9M 2016
  % change  
 
 
USD m
   
USD m
 
USD
 
cc
   
USD m
   
USD m
 
USD
 
cc
 
Gleevec/Glivec
   
445
     
834
     
-47
     
-47
     
1 495
     
2 559
     
-42
     
-41
 
Tasigna
   
482
     
441
     
9
     
12
     
1 356
     
1 281
     
6
     
9
 
Sandostatin
   
402
     
413
     
-3
     
-1
     
1 191
     
1 238
     
-4
     
-2
 
Afinitor/Votubia
   
389
     
393
     
-1
     
0
     
1 118
     
1 125
     
-1
     
1
 
Exjade/Jadenu
   
264
     
242
     
9
     
11
     
778
     
719
     
8
     
10
 
Tafinlar + Mekinist1
   
224
     
172
     
30
     
27
     
627
     
494
     
27
     
28
 
Promacta/Revolade
   
227
     
168
     
35
     
36
     
612
     
457
     
34
     
35
 
Votrient
   
213
     
183
     
16
     
15
     
595
     
537
     
11
     
11
 
Jakavi
   
201
     
149
     
35
     
31
     
549
     
419
     
31
     
32
 
Kisqali
   
26
     
0
 
nm
 
nm
     
41
     
0
 
nm
 
nm
 
Other
   
228
     
240
     
-5
     
-3
     
669
     
754
     
-11
     
-9
 
Total Oncology business unit
   
3 101
     
3 235
     
-4
     
-4
     
9 031
     
9 583
     
-6
     
-4
 

1Majority of sales for Tafinlar and Mekinist are combination, but both can be used as a monotherapy
nm = not meaningful


Tasigna (USD 482 million, +12% cc) showed solid growth driven by the US and phasing in Emerging Growth Markets. Tasigna is approved for the treatment of adult patients newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase, and is also approved for the treatment of adult patients with Ph+ CML in the chronic or accelerated phase who are resistant or intolerant to at least one prior therapy including Gleevec/Glivec. In Q2, the European Commission approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna
 
6
 

Summary of Product Characteristics (SmPC). In Q3, a supplemental New Drug Application (sNDA) for Tasigna (nilotinib) in TFR was accepted for review by the FDA and granted priority review.

Gleevec/Glivec (USD 445 million, -47% cc) continued to decline, driven by generic imatinib competition in most major markets. Gleevec/Glivec is approved in more than 110 countries for the treatment of adult patients in all phases of Ph+ CML, for the treatment of patients with KIT (CD117)-positive gastrointestinal tumors (KIT+ GIST), which cannot be surgically removed and/or have metastasized, and for the treatment of adult patients following complete surgical removal of KIT+ GIST. Not all indications are available in every country.

Sandostatin (USD 402 million, -1% cc) declined slightly due to competitive pressure. Sandostatin is a somatostatin analogue available in immediate and long-acting release injectable formulations and is indicated for the treatment of acromegaly and NET. In NET, Sandostatin LAR is used for patients with symptoms of carcinoid syndrome from gastro-entero-pancreatic NET as well as for tumor control in patients with advanced NET of the midgut or unknown primary tumor location.

Afinitor/Votubia (USD 389 million, 0% cc) were in line with prior year as competitive pressure in the breast cancer and renal cell carcinoma indications was offset by growth in NET and TSC. Afinitor is approved in combination with exemestane for the treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer after recurrence or progression following a non-steroidal aromatase inhibitor (in the US, specifically after failure of treatment with letrozole or anastrozole), for patients with advanced renal cell carcinoma whose disease has progressed on or after treatment with VEGF-targeted therapy (in the US, specifically after failure of treatment with sunitinib and sorafenib), for progressive, metastatic or unresectable well- or moderately-differentiated pancreatic NET, and for the treatment of progressive, metastatic or unresectable, well-differentiated, nonfunctional GI or lung NET. Afinitor is also approved for treatment of patients with subependymal giant cell astrocytoma associated with TSC that requires therapeutic intervention but cannot be curatively resected and for treatment of patients with renal angiomyolipoma associated with TSC who do not require immediate surgery. Everolimus, the active ingredient in Afinitor/Votubia, is available under the trade names Zortress/Certican for use in other non-oncology indications and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

Exjade/Jadenu (USD 264 million, +11% cc) showed solid growth in most major markets, driven by continued uptake of Film-Coated Tablet (FCT). Exjade is a once-daily dispersible tablet for chronic transfusional iron overload, as well as for chronic iron overload in patients with non-transfusion-dependent thalassemia. Jadenu, a once-daily oral film-coated tablet formulation, which provides a simpler administration for patients, is approved in the US, Canada, Switzerland and other markets for the same indications as Exjade. In the EU, the film-coated tablet formulation is approved as Exjade FCT. Regulatory applications for FCT have been submitted in several other countries worldwide. In addition to the FCT, the film-coated tablet formulation has been developed as Granules for patients who cannot swallow tablets, using the same composition as the FCT. Jadenu Sprinkle granules were approved by the US FDA in May 2017, and Jadenu granules were approved in Japan, in July 2017. A regulatory application for granules also has been submitted under the name Exjade in the EU and regulatory approval is expected in 2017.

Promacta/Revolade (USD 227 million, +36% cc) grew at a strong double-digit rate in all regions, driven by continued worldwide uptake as well as growth of the thrombopoietin (TPO) class for chronic immune (idiopathic) thrombocytopenic purpura (ITP). It is the only approved once-daily oral TPO receptor agonist and the only TPO receptor agonist with multiple indications in different disease states and leads the market globally in the TPO class. It is approved in more than 100 countries for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an inadequate response or are intolerant to other treatments. In the US and EU, Promacta/Revolade is approved for patients one year and older with chronic ITP who have had an insufficient response to other treatments. It is approved in Japan for aplastic anemia as first-line therapy and for patients who are refractory to other treatments. It is also approved in 45 countries for the treatment of patients with severe aplastic anemia who are refractory to other treatments, and in more than 50 countries for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.

Tafinlar + Mekinist (USD 224 million, +27% cc) performance was driven by double-digit growth across all regions. Tafinlar + Mekinist is the first combination of its kind for the treatment of patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma, as detected by a
 
7
 

validated test, and continues to be the market leader globally across targeted therapy options. It is also the first combination of BRAF and MEK inhibitors to report three years of follow-up survival data in a Phase III study and five years of follow up in a separate Phase II study in BRAF V600+ unresectable or metastatic melanoma patients. Tafinlar and Mekinist are also approved as single agents for the treatment of patients with unresectable or metastatic melanoma in more than 60 countries worldwide. The combination of Tafinlar + Mekinist is also approved for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation in the US and advanced NSCLC with a BRAF V600 mutation in the EU.

Votrient (USD 213 million, +15% cc) showed solid growth driven mainly by the US and phasing in Emerging Growth Markets. Votrient is a small molecule tyrosine kinase inhibitor (TKI) that inhibits a number of intracellular proteins to limit tumor growth and cell survival, which is approved in the US for the treatment of patients with aRCC, and in the EU for first-line treatment of adult patients with aRCC as well as patients who have received prior cytokine therapy for advanced disease. Votrient is also indicated for the treatment of patients with selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy or have progressed within 12 months after neoadjuvant therapy (efficacy in adipocytic STS or gastrointestinal stromal tumors has not been demonstrated).

Jakavi (USD 201 million, +31% cc) showed continued double-digit growth across all regions driven by myelofibrosis (MF) and reimbursement of the second-line polycythemia vera (PV) indication in additional countries. Jakavi, an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases, is the first JAK inhibitor indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary MF (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF. Jakavi is currently approved in 101 countries for the MF indication, including EU countries, Japan and Canada. More than 75 countries have also approved Jakavi for the treatment of adult patients with PV who are resistant to or intolerant of hydroxyurea, including EU countries, Switzerland, Canada and Japan, and regulatory applications have been submitted in other countries. Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization in the areas of oncology, hematology and graft-versus-host disease outside the US. Ruxolitinib is marketed in the US by Incyte under the brand name Jakafi®.

Kisqali (USD 26 million), US launch progressed in the third quarter and EU approval was obtained. The full US promotional launch occurred at the end of August, and by the end of September, the vast majority of patient lives had payor access. Germany is currently the only major market in the EU where the product is launched and reimbursed. Other major markets in the EU are expected to gain reimbursement over the next 12 months. Additional filings are underway with other health authorities worldwide. Kisqali is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting the proteins cyclin-dependent kinase 4 and 6. Kisqali was approved in combination with an aromatase inhibitor by the FDA and launched in the US in March 2017 as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. In May 2017, FDA approved Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets), the first-of-its-kind in Oncology, as initial endocrine-based therapy for the treatment of HR+/HER2- advanced or metastatic breast cancer in postmenopausal women.
 
 
8
 

PHARMACEUTICAL BUSINESS UNIT

OPHTHALMOLOGY
     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Lucentis
   
481
     
456
     
5
     
5
     
1 403
     
1 383
     
1
     
4
 
Travoprost Group
   
149
     
151
     
-1
     
-1
     
439
     
458
     
-4
     
-3
 
Systane Group
   
100
     
96
     
4
     
2
     
292
     
277
     
5
     
5
 
Topical Olopatadine Group
   
49
     
81
     
-40
     
-39
     
225
     
280
     
-20
     
-19
 
Other
   
544
     
586
     
-7
     
-7
     
1 663
     
1 746
     
-5
     
-4
 
Total Ophthalmology
   
1 323
     
1 370
     
-3
     
-3
     
4 022
     
4 144
     
-3
     
-2
 
 
Lucentis (USD 481 million, +5% cc) sales continued to grow driven by market expansion in Europe, Japan and Emerging Growth Markets, and reimbursement listing in China for nAMD indication. Lucentis is approved for six indications and is the only treatment available for all types of choroidal neovascularization (CNV). Lucentis is an anti-VEGF therapy specifically designed for the eye, minimizing systemic exposure. The Lucentis pre-filled syringe has launched in 33 countries so far. Lucentis is licensed from Genentech, and Novartis holds the rights to commercialize the product ex-US. Genentech holds the rights to commercialize Lucentis in the US. 

Travoprost Group (USD 149 million, -1% cc) sales declined mainly due to loss of exclusivity in Europe. Travoprost Group includes Travatan, TravatanZ and DuoTrav, which are indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or who have ocular hypertension. Single agent travoprost products (Travatan, TravatanZ, Travatan BAK-Free and Izba) are prescribed as first-line agents. DuoTrav (travoprost and timolol) is a fixed-dose combination solution approved as a second-line treatment.

Systane Group (USD 100 million, +2% cc) sales grew in the US, partly offset by a slowdown in Europe. The Systane portfolio is a group of ocular health products, most of which are indicated for the temporary relief of burning and irritation due to dryness of the eye. The Systane portfolio includes Systane Ultra, Systane Balance, and Systane Hydration, and includes treatments for daily and nighttime relief, as well as products for everyday lid hygiene, and for discomfort associated with contact lens wear.

Topical Olopatadine Group (USD 49 million, -39% cc) sales declined mainly due to the loss of exclusivity of Pataday in the US. Patanol, Pataday and Pazeo are olopatadine hydrochloride ophthalmic solutions of different concentrations that are approved to treat the signs and symptoms of allergic conjunctivitis (Patanol), as well as ocular itching associated with allergic conjunctivitis (Pataday and Pazeo).

IMMUNOLOGY and DERMATOLOGY
     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Cosentyx
   
556
     
301
     
85
     
83
     
1 456
     
737
     
98
     
98
 
Neoral/Sandimmun(e)
   
126
     
130
     
-3
     
-2
     
364
     
389
     
-6
     
-4
 
Zortress/Certican
   
107
     
101
     
6
     
6
     
298
     
294
     
1
     
3
 
Ilaris
   
107
     
73
     
47
     
47
     
287
     
208
     
38
     
39
 
Myfortic
   
94
     
97
     
-3
     
-1
     
274
     
292
     
-6
     
-1
 
Other
   
73
     
68
     
7
     
3
     
207
     
204
     
1
     
1
 
Total Immunology and Dermatology
   
1 063
     
770
     
38
     
37
     
2 886
     
2 124
     
36
     
38
 
Xolair sales for all indications are reported in the Respiratory franchise

Cosentyx (USD 556 million, +83% cc) showed strong growth across all indications, driven by the US and Europe, with more than 100,000 patients treated since launch. Cosentyx is the first and only fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), the key cytokine in the pathogenesis of psoriasis (PsO), ankylosing spondylitis (AS) and psoriatic arthritis (PsA), and is approved to treat PsO, AS, PsA and in Japan – pustular PsO. In clinical trials, Cosentyx has also shown superiority over Enbrel® and Stelara®, providing rapid and sustainable efficacy for patients with PsO. The Cosentyx EU label was also updated to include additional hard-to-treat areas including palmoplantar, nail and scalp PsO.

Xolair continued its strong growth globally as a treatment for chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU). CSU is a distressing skin condition that appears
 
 
9
 

spontaneously and causes persistent hives and/or painful deeper swelling of the skin for 6 weeks or more. Xolair is also a treatment for moderate-to-severe or severe persistent allergic asthma (SAA), which is addressed in the Respiratory section. All Xolair sales are booked in the Respiratory franchise. Novartis co-promotes Xolair with Genentech in the US and shares a portion of the operating income, but does not book US sales.

Neoral/Sandimmun(e) (USD 126 million, -2% cc) is an immunosuppressant to prevent organ rejection following a kidney, liver, heart, lung or bone marrow transplant. It is also indicated for the treatment of selected autoimmune disorders, such as endogenous uveitis, nephrotic syndrome, psoriasis, rheumatoid arthritis and atopic dermatitis. Sales are declining slightly due to generic competition and mandatory price reductions, mainly in Europe and Japan. The decrease is not as rapid as has been the case in other therapeutic areas, due to the special characteristics of the solid organ transplant market.

Zortress/Certican (USD 107 million, +6% cc), approved in more than 100 countries to prevent organ rejection in adult heart and kidney transplant patients, continued to show growth. It is also approved for liver transplant patients in over 70 countries, including EU countries and the US. Everolimus, the active ingredient in Zortress/Certican, is marketed for other indications under the trade names Afinitor/Votubia. For use in drug-eluting stents Everolimus is exclusively licensed to Abbott and sublicensed to Boston Scientific.

Ilaris (USD 107 million, +47% cc) continued to grow strongly. Ilaris is a selective, high-affinity, fully human monoclonal antibody that inhibits IL-1β, a key cytokine in the inflammatory pathway, by blocking the action of IL-1β for a sustained period of time, therefore inhibiting inflammation that is caused by its over-production. Ilaris is approved in over 70 countries as a treatment for various inflammatory conditions, especially for adults and children with cryopyrin-associated periodic syndrome (CAPS), systemic juvenile idiopathic arthritis (SJIA), and the symptomatic treatment of refractory acute gouty arthritis. In 2016, Ilaris received approval for patients with Adult-Onset Still’s Disease in Europe, and for three rare and distinct types of Periodic Fever Syndromes, also known as Hereditary Periodic Fevers, in the US and Japan. The European Commission approved Ilaris for the same three Periodic Fever Syndromes in February 2017.

Myfortic (USD 94 million, -1% cc), a transplantation medicine, declined slightly due to loss of exclusivity in several markets. Myfortic continued to grow in geographies where generic competition has not yet begun.

NEUROSCIENCE

     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Gilenya
   
801
     
790
     
1
     
0
     
2 360
     
2 299
     
3
     
3
 
Other
   
26
     
30
     
-13
     
-11
     
77
     
94
     
-18
     
-17
 
Total Neuroscience
   
827
     
820
     
1
     
0
     
2 437
     
2 393
     
2
     
3
 

Gilenya (USD 801 million, 0% cc), was in line with prior year in the US, while Europe’s solid growth was partly offset by phasing in Emerging Growth Markets. Gilenya is indicated to treat relapsing forms of multiple sclerosis (RMS) and is approved in over 80 countries. Gilenya has been used to treat more than 217,000 patients with long-term data now out to 10 years, with the total patient exposure now at more than 480,000 patient years. Gilenya is licensed from Mitsubishi Tanabe Pharma.

RESPIRATORY

     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Ultibro Breezhaler
   
101
     
95
     
6
     
3
     
291
     
273
     
7
     
8
 
Seebri Breezhaler
   
37
     
37
     
0
     
2
     
109
     
111
     
-2
     
2
 
Onbrez Breezhaler
   
27
     
37
     
-27
     
-16
     
83
     
107
     
-22
     
-15
 
COPD portfolio
   
165
     
169
     
-2
     
-1
     
483
     
491
     
-2
     
2
 
Xolair1
   
245
     
215
     
14
     
12
     
673
     
619
     
9
     
12
 
Other
   
5
     
6
     
-17
     
-29
     
16
     
23
     
-30
     
-18
 
Total Respiratory
   
415
     
390
     
6
     
6
     
1 172
     
1 133
     
3
     
7
 
1Revenue, which is ex-US only, reflects Xolair sales for all indications (including CSU/CIU, which is managed by the Immunology and Dermatology franchise)
 
 
10
 

The COPD portfolio, which consists of Ultibro Breezhaler, Onbrez Breezhaler and Seebri Breezhaler, declined -1% (cc) to USD 165 million. All three products in the COPD portfolio are delivered via the low-resistance Breezhaler inhalation device. In the US, Sunovion Pharmaceuticals Inc. has assumed as of December 21, 2016 US commercialization rights for these US products under the names Utibron Neohaler, Arcapta Neohaler and Seebri Neohaler. Novartis will continue to bring Ultibro Breezhaler, Onbrez Breezhaler and Seebri Breezhaler to patients with COPD outside of the US.

Ultibro Breezhaler (USD 101 million, +3% cc), a LABA/LAMA, grew driven by positive FLAME study  results and the GOLD guidelines, which recommended LABA/LAMA as the preferred option in the majority of symptomatic patients regardless of their exacerbation risk. Ultibro Breezhaler, a first-in-class dual bronchodilator, is approved in over 90 countries, including Japan and EU countries. It is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide, and in the EU is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

Seebri Breezhaler (USD 37 million, +2% cc), an inhaled LAMA is approved in over 100 countries and indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with COPD. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura.

Onbrez Breezhaler (USD 27 million, -16% cc), an inhaled LABA, declined, due in part to a focus of resources on Ultibro Breezhaler. Onbrez Breezhaler is indicated as a maintenance of airflow obstruction in adult patients with COPD, and is approved in over 100 countries.

Xolair (USD 245 million, +12% cc), currently approved in more than 90 countries as a treatment for moderate-to-severe or severe persistent allergic asthma, continued to grow strongly. In July 2016, the FDA approved an expanded age range for Xolair to include children six to 11 years of age with moderate to severe persistent asthma. Worldwide, Xolair is the first biologic approved for adults and children with moderate-to-severe allergic asthma. In August 2017, Xolair was approved in China for moderate to severe persistent allergic asthma in adults & adolescents > 12 years of age. This approval makes Xolair the first & only biologic approved for asthma in China. Xolair as a treatment for CSU/CIU is addressed earlier in the Immunology and Dermatology section. Novartis co-promotes Xolair with Genentech in the US and shares a portion of the operating income, but does not book US sales.

CARDIO-METABOLIC

     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Entresto
   
128
     
53
     
142
     
138
     
322
     
102
     
216
     
215
 
Other
   
5
     
4
     
25
     
21
     
12
     
10
     
20
     
21
 
Total Cardio-Metabolic
   
133
     
57
     
133
     
130
     
334
     
112
     
198
     
198
 
Entresto (USD 128 million, +138% cc) (sacubitril/valsartan) continued to grow, benefitting from the impact of improved access and sales force expansion in the US and from broad reimbursement in Europe. Entresto is now approved in 92 countries and launched in nearly 50 countries to date, and has been used to treat more than 360,000 patients with heart failure with reduced ejection fraction worldwide since July 2015. Entresto, a combination of valsartan, an angiotensin receptor blocker, and sacubitril, a neprilysin inhibitor, demonstrated significant superiority in mortality (20%) over and above enalapril in the PARADIGM-HF trial, representing the first major advance in heart failure in over two decades. Entresto has been granted a class I recommendation in both US and EU guidelines in 2016.
ESTABLISHED MEDICINES
     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Galvus
   
310
     
306
     
1
     
3
     
906
     
895
     
1
     
3
 
Diovan/Co-Diovan
   
231
     
261
     
-11
     
-10
     
713
     
816
     
-13
     
-10
 
Exforge
   
244
     
232
     
5
     
4
     
711
     
689
     
3
     
5
 
Voltaren/Cataflam
   
118
     
131
     
-10
     
-2
     
346
     
389
     
-11
     
-1
 
Exelon/Exelon Patch
   
95
     
104
     
-9
     
-10
     
293
     
330
     
-11
     
-11
 
Ritalin/Focalin
   
44
     
62
     
-29
     
-32
     
162
     
209
     
-22
     
-24
 
Other
   
398
     
435
     
-9
     
-6
     
1 256
     
1 472
     
-15
     
-12
 
Total Established Medicines
   
1 440
     
1 531
     
-6
     
-4
     
4 387
     
4 800
     
-9
     
-6
 
 
 
 
11
 

Galvus Group (USD 310 million, +3% cc) showed continued growth. The Group includes Galvus, an oral treatment for type-2 diabetes, and Eucreas, a single-pill combination of vildagliptin (the active ingredient in Galvus) and metformin. Galvus is mainly promoted for the treatment of patients whose diabetes is uncontrolled on metformin as well as for special patient segments, such as elderly and renal-impaired patients. Earlier this year, Galvus was listed in the National Reimbursement Drug List (NRDL) in China. The Galvus Group is currently approved in more than 125 countries.

Diovan Group (USD 231 million, -10% cc), consisting of Diovan monotherapy and the combination product Co-Diovan/Diovan HCT, saw sales decline due to loss of exclusivity including in the US, EU and Japan.

Exforge Group (USD 244 million, +4% cc), which includes Exforge and Exforge HCT, grew despite ongoing generic competition in the US and Japan, and beginning in Europe in 2017. Both Exforge and Exforge HCT grew strongly in Emerging Growth Markets.

Voltaren/Cataflam (USD 118 million, -2% cc) is a leading international brand by sales in the non-steroidal anti-inflammatory drugs (NSAIDs) market for the relief of symptoms in rheumatic diseases, such as rheumatoid arthritis and osteoarthritis, and for various other inflammatory and pain conditions. This product is subject to generic competition.

Exelon/Exelon Patch (USD 95 million, -10% cc) declined due to generic competition for Exelon Patch in the US and EU. Exelon Patch is approved for the treatment of mild-to-moderate Alzheimer’s disease dementia (AD) in more than 85 countries, and severe AD in 14 countries, including the US. Exelon Patch is also indicated for the treatment of Parkinson’s disease dementia in more than 20 countries.

Ritalin/Focalin (USD 44 million, -32% cc) is a treatment for attention deficit hyperactivity disorder (ADHD). Ritalin and Ritalin LA are available in more than 70 and 30 countries, respectively, and are also indicated for narcolepsy. Ritalin and Focalin are subject to generic competition in the US.
 
12
 

Sandoz
     
Q3 2017
     
Q3 2016
   
% change
   
YTD 2017
   
YTD 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
   
2 584
     
2 517
     
3
     
1
     
7 465
     
7 539
     
-1
     
-1
 
Operating income
   
390
     
354
     
10
     
9
     
1 063
     
1 080
     
-2
     
-3
 
  As % of net sales
   
15.1
     
14.1
                     
14.2
     
14.3
                 
Core operating income
   
580
     
530
     
9
     
8
     
1 537
     
1 550
     
-1
     
-1
 
  As % of net sales
   
22.4
     
21.1
                     
20.6
     
20.6
                 

Third quarter

Net sales
Sandoz net sales were USD 2.6 billion (+3%, +1% cc) in the third quarter, as volume growth of 8 percentage points was partially offset by 7 percentage points of price erosion. Excluding the US, net sales grew by 9% (cc).

Sales in the US were USD 798 million (-13% cc), driven by increased pricing pressure from competition in retail generics and continued customer consolidation. Sales in Europe were USD 1.2 billion (+8% cc), driven by continuing strong growth in Italy, Russia, Switzerland and Turkey. Sales in Asia / Africa / Australasia were USD 354 million (+8% cc). Sales in Latin America were USD 110 million (+12% cc), mainly driven by Brazil.

Global sales of Biopharmaceuticals (biosimilars, biopharmaceutical contract manufacturing and Glatopa 20mg) grew 9% (cc) to USD 292 million. By region, Europe continued double-digit growth supported by the recent launches of biosimilars Rixathon (rituximab) and Erelzi (etanercept). US Biopharmaceuticals declined primarily due to competitive pressures on Glatopa 20mg from ongoing market conversion to the 40mg version of the reference medicine. Zarxio, the first US biosimilar approved under the BPCIA pathway, continues to grow after two years on the market.

Retail sales were USD 2.2 billion (0% cc), as the decline in the US (-13% cc) was offset by growth ex-US (+7% cc). Total Anti-Infectives franchise sales were USD 359 million (+3% cc). Growth in finished dosage forms sold under the Sandoz name (USD 221 million, +7% cc), was partly offset by a decline in Anti-Infectives sold to third parties for sale under their own name (USD 137 million -3% cc).

Operating income
Operating income was USD 390 million (+10%, +9% cc) mainly driven by higher sales and strong gross margin expansion from product mix and productivity, partly offset by higher M&S growth investments. Operating income margin in constant currencies increased by 1.1 percentage points; currency had a negative impact of 0.1 percentage points resulting in a net increase of 1.0 percentage points to 15.1% of net sales.

Core adjustments amounted to USD 190 million, mainly due to USD 184 million of amortization, and impairments of tangible and intangible assets. Prior year core adjustments were USD 176 million, including USD 167 million for amortization, and impairments of tangible and intangible assets. Core operating income was USD 580 million (+9%, +8% cc). Core operating income margin increased by 1.5 percentage points (cc); currency had a negative impact of 0.2 percentage points, resulting in a net increase of 1.3 percentage points to 22.4% of net sales.

Core gross margin as a percentage of net sales increased by 2.0 percentage points (cc), driven by a favorable sales mix and ongoing productivity improvements, which more than offset the impact of price erosion in the US. Core R&D expenses decreased by 0.4 percentage points (cc). Core SG&A expenses increased by 1.6 percentage points (cc) mainly due to higher M&S investments in key ex-US markets and biosimilars launches. Core Other Income and Expense, had a positive margin contribution of 0.7 points (cc) mainly due to gains from the divestment of non-strategic assets.
 
13
 

Nine months

Net sales
Sandoz net sales were USD 7.5 billion (-1%, -1% cc) in the first nine months, as volume growth of 6 percentage points was more than offset by 7 percentage points of price erosion.

Sales in the US were USD 2.5 billion (-10% cc) mainly due to increased pricing pressure in retail generics, partly offset by growth in Biopharmaceuticals. Sales in Europe were USD 3.4 billion (+4% cc), driven by growth in Italy and Switzerland partly offset by pressure on pricing in the Nordics. Sales in Asia / Africa / Australasia were USD 1.0 billion (0% cc).

Global sales of Biopharmaceuticals grew 14% (cc) to USD 826 million, driven by Zarxio (filgrastim), Binocrit (epoetin alfa) and the launch of Rixathon (rituximab) in selected European markets. Sandoz now has five approved and marketed biosimilars in Europe, more than any other company. Retail Generics sales were USD 6.3 billion (-2% cc), as the decline in the US (-12% cc) more than offset growth outside the US (+3% cc). Total Anti-Infectives franchise sales were USD 1.0 billion (+1% cc). Growth in finished dosage forms sold under the Sandoz name (USD 646 million, +5% cc), was offset by a decline in Anti-Infectives sold to third parties for sale under their own name (USD 379 million -5% cc), reflecting the discontinuation of low-margin products impacting the first quarter.

Operating income
Operating income was USD 1.1 billion (-2%, -3% cc) mainly due to US pricing pressure and M&S growth investments, partly offset by sales growth in the rest of world and gross margin improvement due to sales mix and productivity. Operating income margin in constant currencies decreased 0.3 percentage points; currency had a positive impact of 0.2 percentage points, resulting in a net decrease of 0.1 percentage points to 14.2% of net sales.

Core adjustments amounted to USD 474 million, mainly due to USD 451 million of amortization, and impairments of tangible and intangible assets and USD 26 million of net restructuring charges.Prior year core adjustments were USD 470 million, including USD 415 million for amortization, and impairments of tangible and intangible assets and USD 61 million of net restructuring charges. Core operating income was USD 1.5 billion (-1%, -1% cc). Core operating income margin in constant currencies decreased by 0.1 percentage points, mainly due to higher M&S investment in key ex-US markets and biosimilars; currency had a positive impact of 0.1 percentage points, resulting in an unchanged ratio of 20.6% of net sales.

Core gross margin as a percentage of net sales increased by 1.3 percentage points (cc), driven by a favorable sales mix and ongoing productivity improvements, which more than offset the impact of price erosion in the US. Core R&D expenses decreased by 0.2 percentage points (cc). Core SG&A expenses increased by 1.5 percentage points (cc), due to higher M&S investments behind growth drivers. Core Other Income and Expense, net decreased the margin by 0.1 percentage points (cc).
 
14
 

Alcon
     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
   
1 527
     
1 436
     
6
     
7
     
4 460
     
4 368
     
2
     
3
 
Operating loss
   
-50
     
-50
     
0
     
19
     
-112
     
-12
   
nm
   
nm
 
  As % of net sales
   
-3.3
     
-3.5
                     
-2.5
     
-0.3
                 
Core operating income
   
238
     
206
     
16
     
23
     
636
     
687
     
-7
     
-2
 
  As % of net sales
   
15.6
     
14.3
                     
14.3
     
15.7
                 
nm = not meaningful

Third quarter

Net sales
Alcon net sales were USD 1.5 billion (+6%, +7% cc) in the third quarter, driven by growth in most market segments. Alcon delivered strong performance in the third quarter as a result of the actions taken to strengthen customer relationships and improve the efficiency and effectiveness of operations, along with increased promotional investment and new launches. The Alcon results of the third quarter partly benefit from stock in trade movements, contributing approximately 2% (cc) of growth.

All regions grew, with growth in both franchises. Sales in the US grew 3% (cc), Europe Middle East and Africa grew 4% (cc) and Asia sales, including Japan, grew double-digit (cc). Emerging Growth Markets grew 21% (cc).

Operating loss/income
Operating loss was USD 50 million, in line with prior year, as sales growth and gross margin improvements were offset by impairments related to business development activities. Operating income margin in constant currencies grew 1.1 percentage points; currency had a negative impact of 0.9 percentage points, resulting in a net increase of 0.2 percentage points to negative 3.3% of net sales.

Core adjustments amounted to USD 288 million, driven by amortization and impairments of intangible assets. Prior year core adjustments were USD 256 million mainly due to amortization of intangible assets and restructuring. Core operating income was USD 238 million (+16%, +23% cc), driven by higher sales. Core operating income margin in constant currencies increased by 2.1 percentage points; currency had a negative impact of 0.8 percentage points, resulting in a net increase of 1.3 percentage points to 15.6% of net sales.

Core gross margin as a percentage of net sales increased 1.0 percentage points (cc) versus the prior year quarter mainly driven by higher sales. Core R&D expenses increased by 0.1 percentage points (cc). Core SG&A expenses decreased by 1.7 percentage points (cc) driven by sales uptake. Core Other Income and Expense, net decreased the margin by 0.5 percentage points (cc).

Nine months

Net sales
Alcon net sales were USD 4.5 billion (+2%, +3% cc) in the first nine months. Surgical sales grew +3% (cc), driven by strong performance of the vitreoretinal portfolio and cataract consumables. Vision Care sales grew +3% (cc), driven by continued double-digit growth of Dailies Total1.

Operating loss/income
Operating loss was USD 112 million in the first nine months, compared to a loss of USD 12 million in the prior year period, impacted by the growth plan and impairment charges related to business development activities. Operating income margin in constant currencies decreased 1.5 percentage points; currency had a negative impact of 0.7 percentage points, resulting in a net decrease of 2.2 percentage points to negative 2.5% of net sales.

Core adjustments amounted to USD 748 million, primarily due to amortization and impairments of intangible assets. Prior year core adjustments were USD 699 million mainly due to amortization of intangible assets and restructuring. Core operating income was USD 636 million (-7%, -2% cc), primarily impacted by continued investments behind the growth plan. Core operating income margin in constant currencies decreased by 0.9 percentage points; currency had a negative impact of 0.5 percentage points, resulting in a net decrease of 1.4 percentage points to 14.3% of net sales.
 
15
 

Core gross margin as a percentage of net sales was in line with prior year. Core R&D expenses decreased 0.2 percentage points (cc). Core SG&A expenses increased by 0.5 percentage points (cc) behind investments to drive growth. Core Other Income and Expense, net decreased the margin by 0.6 percentage points (cc).

Alcon product review

All comments below focus on third quarter movements in constant currencies.

SURGICAL
     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Cataract products
   
667
     
648
     
3
     
4
     
2 006
     
2 016
     
0
     
1
 
Consumables
   
344
     
345
     
0
     
2
     
1 054
     
1 036
     
2
     
3
 
IOLs
   
243
     
234
     
4
     
4
     
723
     
747
     
-3
     
-1
 
Equipment
   
80
     
69
     
16
     
13
     
229
     
233
     
-2
     
-1
 
Vitreoretinal products
   
177
     
151
     
17
     
18
     
507
     
455
     
11
     
12
 
Refractive/Other
   
64
     
46
     
39
     
37
     
165
     
160
     
3
     
3
 
Total Surgical
   
908
     
845
     
7
     
9
     
2 678
     
2 631
     
2
     
3
 

Surgical sales were USD 908 million (+9% cc) in the third quarter, driven by continued growth of vitreoretinal (+18% cc), IOLs (+4% cc) and cataract consumables (+2% cc). Refractive/Other (+37% cc) included growth of CyPass Micro-Stent in the US. Surgical sales partly benefit from stock in trade movements, contributing approximately 3% (cc) of growth.

VISION CARE
     
Q3 2017
     
Q3 2016
   
% change
     
9M 2017
     
9M 2016
   
% change
 
   
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Contact lenses
   
481
     
456
     
5
     
5
     
1 390
     
1 342
     
4
     
4
 
Contact lens care
   
138
     
135
     
2
     
1
     
392
     
395
     
-1
     
-1
 
Total Vision Care
   
619
     
591
     
5
     
4
     
1 782
     
1 737
     
3
     
3
 

Vision Care sales were USD 619 million (+4% cc) in the third quarter. Contact lenses grew +5% (cc), as double-digit growth of Dailies Total1 globally was partially offset by the weekly/monthly portfolio. Contact lens care grew +1% (cc), driven by growth in Europe and Asia.
 
16
 

CASH FLOW AND GROUP BALANCE SHEET

Cash flow

Third quarter
Cash flows from operating activities amounted to USD 3.6 billion in the third quarter, compared to USD 3.2 billion in prior year. The increase of USD 0.4 billion was mainly driven by higher net income adjusted for non-cash items and favorable net working capital changes.

Cash flows used in investing activities from continuing operations amounted to USD 0.6 billion. This amount included cash outflows of USD 0.4 billion for the purchase of property, plant and equipment, USD 0.3 billion for intangible assets, USD 0.1 billion for financial and other non-current assets and USD 0.1 billion net for acquisitions and divestments of businesses offset by USD 0.3 billion proceeds from the sale of property, plant and equipment, intangible and financial assets.

In prior year, the cash flows used in investing activities from continuing operations amounted to USD 0.7 billion, primarily for the purchase of property, plant and equipment, intangible, financial and other non-current assets.

Cash flows used in investing activities from discontinued operations, which consists of payments out of provisions related to the portfolio transformation transactions, amounted to USD 40 million in the third quarter, compared to USD 63 million in prior year.

The cash flows used in financing activities amounted to USD 1.9 billion, compared to USD 0.3 billion in prior year. The current year quarter amount is mainly due to net cash outflows for treasury share transactions of USD 1.4 billion and for the net reduction in current financial debts of USD 0.6 billion.

The prior year amount included the issuance of two euro denominated bonds for total proceeds of USD 1.9 billion, reduction of short-term borrowings of USD 1.9 billion and cash outflows of USD 0.4 billion, net for treasury share transactions.

Free cash flow amounted to USD 3.1 billion (+18% USD) compared to USD 2.6 billion in prior year. The increase of USD 0.5 billion was mainly driven by improved cash flows from operating activities and lower net investments in intangible assets.

Nine months
Cash flows from operating activities amounted to USD 9.2 billion in the first nine months, compared to USD 7.9 billion in prior year. The increase of USD 1.3 billion was mainly driven by favorable working capital changes and a higher dividend received from GSK Consumer Healthcare Holdings Ltd., more than offsetting the decrease in net income adjusted for non-cash items.

Cash flows used in investing activities from continuing operations amounted to USD 2.0 billion in the first nine months of 2017. This amount included cash outflows of USD 1.1 billion for the purchase of property, plant and equipment, USD 0.7 billion for intangible assets, USD 0.3 billion for financial and other non-current assets and USD 0.8 billion for acquisitions and divestments of businesses, net (mainly the Ziarco Group Limited and Encore Vision, Inc. acquisitions), offset by USD 0.9 billion proceeds from the sale of property, plant and equipment, intangible and financial assets.

In prior year, cash flows used in investing activities from continuing operations amounted to USD 1.8 billion. This amount included cash outflows of USD 1.3 billion for the purchase of property, plant and equipment, USD 0.8 billion for intangible assets, USD 0.3 billion for financial and other non-current assets, as well as a net amount of USD 0.5 billion for acquisitions and divestments of businesses, mainly for the acquisition of Transcend Medical, Inc., offset by USD 1.0 billion proceeds from the sale of property, plant and equipment, intangible and financial assets.

Cash flows used in investing activities from discontinued operations, which consists of payments out of provisions related to the portfolio transformation transactions, amounted to USD 0.1 billion, compared to USD 0.5 billion in prior year.

The cash flows used in financing activities amounted to USD 5.3 billion in the first nine months, compared to USD 3.0 billion in prior year. The current year amount included cash outflows of USD 6.5 billion for the dividend payment and USD 4.3 billion, net for treasury share transactions. The net cash inflows from the increase in current and non-current financial debts of USD 5.4 billion were mainly due
 
 
17
 

to the issuance of bonds denominated in US dollar and euro for a total notional amount of USD 5.0 billion and the increase in short-term borrowings of USD 0.7 billion. The repayment of a non-current financial debt amounted to USD 0.2 billion.

The prior year amount included mainly cash outflows of USD 6.5 billion for the dividend payment and USD 0.7 billion, net for treasury share transactions, offset by cash inflows from a USD 4.2 billion net increase in current and non-current financial debts.

Free cash flow amounted to USD 8.0 billion (+23% USD) compared to USD 6.5 billion in prior year. The increase of USD 1.5 billion was mainly driven by improved cash flows from operating activities, which included a higher dividend received from GSK Consumer Healthcare Holdings Ltd., as well as lower investments in property, plant and equipment.

Balance sheet

Assets
Total non-current assets of USD 107.5 billion at September 30, 2017 increased by USD 2.3 billion compared to December 31, 2016. Property, plant and equipment increased by USD 0.6 billion to USD 16.3 billion, mainly due to the favorable currency translation adjustments, as net additions were offset by depreciation. Goodwill increased by USD 0.7 billion to USD 31.7 billion, mainly due to USD 0.6 billion favorable currency translation adjustments. Intangible assets other than goodwill decreased by USD 0.5 billion to USD 30.8 billion, as net additions of USD 2.1 billion and favorable currency translation adjustments of USD 0.8 billion were more than offset by amortization and impairment charges totaling USD 3.4 billion. Financial and other non-current assets increased by USD 1.5 billion to USD 28.7 billion, mainly due to favorable currency translation adjustments.

Total current assets increased by USD 2.5 billion to USD 27.5 billion at September 30, 2017, compared to December 31, 2016 due to increase in cash and cash equivalents, marketable securities, commodities and derivatives of USD 1.6 billion and Inventories of USD 0.7 billion. Trade receivables and other current assets were broadly in line with prior year end.

Liabilities
Total non-current liabilities of USD 37.2 billion at September 30, 2017 increased by USD 4.2 billion compared to December 31, 2016. Long-term financial debt increased by USD 5.3 billion to USD 23.2 billion at September 30, 2017, mainly due to the issuance, in the first quarter, of bonds denominated in US dollar and euro for a total notional amount of USD 3.0 billion and USD 2.0 billion respectively. Other non-current liabilities decreased by USD 1.1 billion to USD 14.1 billion at September 30, 2017, compared to December 31, 2016, mainly due to a reduction of the pension obligations of USD 1.2 billion resulting from actuarial gains and a change in the accounting for a component of the Swiss pension plan from defined benefit to defined contribution plan.

Total current liabilities increased by USD 3.2 billion to USD 25.4 billion at September 30, 2017. Trade payables at USD 4.7 billion were broadly in line with prior year end. Current financial debts and derivatives increased by USD 1.1 billion to USD 7.0 billion, mainly due to higher short-term borrowings. Other current liabilities increased by USD 2.3 billion to USD 13.7 billion, mainly due to the repurchase commitment under the share buyback trading plan of USD 1.3 billion, which will be credited to equity once the shares are repurchased or the obligation to repurchase own shares is settled.

Group equity
The Group’s equity decreased by USD 2.5 billion to USD 72.4 billion at September 30, 2017, compared to USD 74.9 billion at December 31, 2016. The decrease was mainly on account of USD 6.5 billion for the dividend payment, net treasury share purchases of USD 4.5 billion and the recognition of the repurchase commitment under the share buyback trading plan of USD 1.3 billion. These amounts resulting from transactions with shareholders were partially offset by net income of USD 5.7 billion, favorable currency translation differences of USD 2.3 billion, net actuarial gains from defined benefit plans of USD 1.1 billion and Equity-based compensation of USD 0.5 billion.

Net debt and debt/equity ratio
The Group’s liquidity amounted to USD 9.4 billion at September 30, 2017 compared to USD 7.8 billion at December 31, 2016, and the total of the non-current and current financial debt, including derivatives, amounted to USD 30.2 billion at September 30, 2017, compared to USD 23.8 billion at December 31, 2016. The net debt increased to USD 20.7 billion at September 30, 2017 compared to
 
 
18
 

USD 16.0 billion at December 31, 2016. The debt/equity ratio increased to 0.42:1 at September 30, 2017 compared to 0.32:1 at December 31, 2016.
 
 
 
 
 
 
19
 

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.

Key developments from the third quarter of 2017 include:

New approvals and regulatory opinions

·
Kisqali (ribociclib), in combination with an aromatase inhibitor, was approved by the European Commission (EC) for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy. Kisqali is the first CDK4/6 inhibitor approved in Europe based on a first-line Phase III trial that met its primary endpoint of progression-free survival (PFS) at interim analysis.

·
Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell (CAR-T) therapy, was approved by the US Food and Drug Administration (FDA) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is a novel immunocellular therapy designed as a one-time treatment that uses a patient's own T cells to fight cancer. Kymriah is the first therapy based on gene transfer approved by the FDA.

·
Rydapt (midostaurin) was approved by the EC for two indications in rare, hard-to-treat diseases.  Rydapt is approved for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. It was also cleared for use as monotherapy for the treatment of adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia.

·
Alcon Clareon AutonoMe IOL was approved in the EU in October, with the most advanced optic material available in an automated, disposable and pre-loaded delivery system. AutonoMe IOL delivery system is easy, intuitive and enhances control for precise IOL insertion during cataract surgery.

Regulatory submissions and filings

·
The FDA confirmed that it has accepted for review the Biologics License Application (BLA) for AMG 334 (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, erenumab is expected to be the first and only fully human monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, specifically designed for the prevention of migraine. Novartis and Amgen will co-commercialize erenumab in the US. Amgen has exclusive commercialization rights in Japan and Novartis has exclusive commercialization rights in rest of world. The companies will continue global co-development.

·
A supplemental New Drug Application (sNDA) for Tasigna (nilotinib) was accepted for review by the FDA in September and granted priority review. The sNDA seeks the addition of attempting Treatment-Free Remission (TFR) into the product label. If added, Tasigna would be the first and only tyrosine kinase inhibitor to include information on stopping therapy in Ph+ CML-CP patients in the US product information.

·
The FDA confirmed in September that it had accepted for regulatory review a Sandoz marketing authorization application for biosimilar rituximab (Roche’s Rituxan®). The Sandoz biosimilar would be used, if approved, to treat blood cancers including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis. The submission comprises a comprehensive data package including analytical, pre-clinical and clinical data. The European Commission approved Sandoz biosimilar rituximab in June 2017 for use in all indications of the reference medicine.
 
 
20
 

Results from ongoing trials and other highlights

·
Results from a Phase III adjuvant study of Tafinlar (dabrafenib) + Mekinist (trametinib) in patients with stage III BRAF V600E/K mutation-positive melanoma after complete surgical resection were presented at ESMO. Findings from the COMBI-AD study, which met its primary endpoint, found a statistically significant 53% reduction in the risk of death or recurrence in patients treated with the BRAF and MEK inhibitor combination therapy versus placebo. The results were also simultaneously reported in NEJM. Additionally, Tafinlar + Mekinist received FDA Breakthrough Therapy designation for the adjuvant treatment of patients with Stage III melanoma with a BRAF V600 mutation following complete resection.

·
Results from a Phase II study of Tafinlar + Mekinist, showing efficacy for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy when treated with the combination were also presented at ESMO. Findings from the study demonstrated a 64% overall response rate and a median duration of response of 10.4 months (after a median follow-up of 15.9 months). Median overall survival was 24.6 months, with a two-year overall-survival rate of 51%. The study findings were simultaneously published in The Lancet Oncology.

·
Data from CANTOS, a Phase III study evaluating quarterly injections of ACZ885 (canakinumab) in people with a prior heart attack and inflammatory atherosclerosis, was presented in August at the European Society of Cardiology Congress. The results were published simultaneously in The New England Journal of Medicine and The Lancet. CANTOS met its primary endpoint with a statistically significant 15% reduction of Major Adverse Cardiovascular Events (MACE) in people with a prior heart attack and inflammatory atherosclerosis who were treated with 150mg of ACZ885 in addition to standard of care including lipid-lowering therapy. This effect was driven by 24% relative reduction in risk of heart attack. A non-significant 10% reduction in risk of cardiovascular death was also observed. A sub-group of study participants, in the 150 mg arm, whose inflammation was reduced below the median hsCRP, measured at three months after one dose of treatment, saw a 27% relative risk reduction on the primary MACE end-point. A review of a blinded, pre-planned oncology safety analyses revealed a 77% reduction in lung cancer mortality and 67% reduction in lung cancer cases in patients treated with 300 mg of ACZ885. Novartis is discussing the CANTOS study findings with health authorities and plans to submit the cardiovascular data for regulatory approval, as well as begin evaluation of the lung cancer findings in additional Phase III confirmatory studies.

·
Phase III 5-year data for Cosentyx presented at EADV showed high and long-lasting skin clearance in patients with moderate-to-severe plaque psoriasis and demonstrating that the safety of this biologic was sustained over the 5-year treatment period. By specifically targeting interleukin-17A (IL-17A), Cosentyx addresses the key cytokine involved in the development of psoriasis, which plays a significant role in the pathogenesis of plaque psoriasis, PsA and AS.

·
OPTIMA data for Xolair also presented at EADV re-confirmed that almost two thirds of chronic spontaneous urticaria (CSU) patients treated with Xolair 300 mg for 6 months are well-controlled. In addition, data showed that after a treatment pause almost 90% of patients – previously well controlled – regained effective symptom control within 12 weeks of re-treatment on Xolair.

·
Novartis announced positive topline results from the Phase III PARADIGMS study, investigating the safety and efficacy of oral once-daily Gilenya (fingolimod) in children and adolescents (ages 10 to 17) with multiple sclerosis (MS). PARADIGMS is the first ever randomized, controlled Phase III study of a disease-modifying therapy (DMT) in pediatric MS. Data show that oral fingolimod resulted in a significant and clinically meaningful reduction in the number of relapses (annualized relapse rate) in this patient population over a period of up to two years, compared to interferon beta-1a intramuscular injections. The safety profile of fingolimod was consistent with that seen in other clinical trials, with overall more adverse events reported in the interferon group.

·
A new analysis from a pivotal Phase II study of AMG 334 (erenumab) presented at the Congress of the International Headache Society (IHC) showed reduced monthly migraine days in patients with chronic migraine for whom previous preventive treatments have failed. In these patients, erenumab cut the average number of migraine days by at least five days and up to a week per month, depending on treatment dose. Additionally presented at IHC, were new data assessing the safety of erenumab 140 mg IV in a cardiovascular population with stable angina who are at increased risk for myocardial ischemia. This is the only such study evaluating the safety of a
 
 
21
 

 
monoclonal antibody targeting the CGRP pathway. Results of this study showed that inhibition of the CGRP receptor with erenumab had no impact on exercise capacity as measured by an exercise stress test.

·
Data from a long-term study of patients continuously treated with Sandoz proposed biosimilar adalimumab of reference medicine Humira® showed that efficacy and safety profiles of the two medicines matched throughout 51 weeks of treatment in patients with moderate-to-severe chronic plaque psoriasis. Results were presented in September at EADV. ADACCESS is a Phase III confirmatory randomized, double-blind, controlled, 51-week study to compare efficacy and safety between Sandoz biosimilar adalimumab and the reference medicine. The study consists of three treatment periods.

·
Novartis and Medicines for Malaria Venture (MMV) launched a phase IIb trial of KAF156, a next-generation antimalarial compound with the potential to treat drug-resistant strains of the malaria parasite. The trial will test multiple dosing combinations and dosing schedules of KAF156 and lumefantrine, including the feasibility of a single dose therapy in adults, adolescents and children. Seventeen centers across nine countries in Africa and Asia will participate.

·
Novartis exclusively licensed global commercial rights to gevokizumab from XOMA. Gevokizumab is a potent humanized, monoclonal antibody targeting IL1β with unique allosteric modulating properties and has the potential to treat patients in a variety of diseases where inflammation is a component. In a separate agreement, XOMA has granted Novartis a license to its intellectual property covering the use of IL1β antibodies.

·
Promacta/Revolade data showed long-term disease control for chronic/persistent immune thrombocytopenia (ITP). Nearly 70% of patients maintained platelet counts of ≥30×109/L without rescue therapy for prolonged periods. More than one-third of patients permanently stopped one or more concomitant ITP medications. The data was published in Blood in October.
 
·
Novartis’ continuous manufacturing facility in Basel was granted a license by Swissmedic to produce drugs for the use in clinical trials, following a successful inspection by the Regional Drug Inspection Agency, RHI, on behalf of Swissmedic. Continuous manufacturing is an innovative process spearheaded by a Novartis collaboration with the Massachusetts Institute of Technology, in which medicines are manufactured in a single ‘flow’ with all steps of chemical and pharmaceutical production integrated into a seamless process. Novartis will look to implement continuous manufacturing in Novartis’ development portfolio in a stepwise manner, with patients in clinical trials expected to start receiving medicines made by this method in 2018.
 
 
22
 

Selected Innovative Medicines approvals: US, EU and Japan
Product
Active ingredient/
Descriptor
Indication
Approval date
Kymriah
(CTL019)
tisagenlecleucel
Suspension for intravenous infusion, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.
- US – Aug 2017
Rydapt (PKC412)
midostaurin
FLT3-mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM): aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia
- EU – Sep 2017
Kisqali
ribociclib
In combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.
- EU – Aug 2017
Signifor
pasireotide
Long-acting release formulation approved in EU as a once-monthly treatment for adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed
- EU – Sep 2017
 
 
23
 

Selected Innovative Medicines projects awaiting regulatory decisions
   
Completed submissions
 
Product
Indication
US
EU
Japan
News update
AMG 334
Migraine prophylaxis
Q3 2017
Q2 2017
 
- First anti-CGRP monoclonal antibody to receive both FDA & EMA regulatory filing acceptance
- New analysis from a pivotal Phase II study presented at IHC (September) shows erenumab reduced monthly migraine days in patients with chronic migraine for whom previous preventive treatments have failed
- Results from dedicated cardiovascular safety study also presented at IHC and confirm erenumab has no impact on cardiovascular function
Jadenu/Exjade granules
Chronic iron overload
Approved
Q4 2016
Approved
 
Promacta/ Revolade
Aplastic anemia (moderate and severe)
   
Q4 2016
 
Signifor LAR
Cushing’s disease
Q3 2017
Approved
Q2 2017
- Working with FDA on data formatting for planned resubmission.
Tafinlar + Mekinist
BRAF V600+ non-small cell lung cancer (NSCLC)
Approved
Approved
Q4 2016
Results were published in The Lancet Oncology showing efficacy for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy when treated with the combination. The results were also presented at ESMO 2017.

Selected Innovative Medicines pipeline projects
Project/ Compound
Potential indication/ Disease area
First planned submissions
Current Phase
News update
ABL001
Chronic myeloid leukemia 1st line
2025
I
- Start of pivotal trials planned for 2017
Chronic myeloid leukemia 3rd line
2020
I
 
ACZ885
(canakinumab)
   
Secondary prevention of cardiovascular events
2017
III
- Positive Phase III results (CANTOS) announced in June
- An anti-inflammatory therapy trial with canakinumab published in NEJM showed that anti-inflammatory therapy with canakinumab (150 mg) resulted in a statistically lower rate of CV events in comparison to placebo.
- Analysis published in The Lancet revealed canakinumab (300 mg) reduced lung cancer mortality by 77% in the CANTOS study with further studies planned
Adjuvant NSCLC
≥2021
III
 
1st Line NSCLC
≥2021
III
 
2nd Line NSCLC
≥2021
III
 
Arzerra
Non-Hodgkin’s lymphoma (refractory)
2019
III
- Study endpoint is event driven
 
BAF312
Secondary Progressive Multiple Sclerosis
2018
III
 
 
 
24
 

BYL719 + fulvestrant
HR+/HER2- postmenopausal aBC 2nd line
2018
III
 
BYM338
Hip fracture recovery
≥2021
II
 
Sarcopenia
≥2021
II
 
CAD106
Alzheimer’s disease
≥2021
II / III
- Generation study 1 ongoing
- Phase II/III in cognitively healthy people at risk of Alzheimer’s disease
CFZ533
Kidney and Liver Transplantation
≥2021
II
 
CNP520
Alzheimer’s disease
≥2021
II / III
- Generation study 1 ongoing
- Generation study 2 opened enrollment in June 2017
- Phase II/III in cognitively healthy people at risk of Alzheimer’s disease
- In partnership with Amgen
- FDA Fast Track designation
Cosentyx
Non-radiographic axial spondyloarthritis
2019
III
 
Psoriatic arthritis head-to-head vs. adalimumab
2020
III
- First Patient, First Visit (FPFV) achieved in April 2017
Ankylosing spondylitis head-to-head vs. adalimumab
≥2021
III
 
ECF843
Dry eye
≥2021
II
- Acquired worldwide ophthalmic rights (ex-EU) from Lubris in April 2017
EMA401
Peripheral neuropathic pain
≥2021
II
- Phase IIb initiated
Entresto
Chronic heart failure with preserved ejection fraction
2019
III
- PARAGON-HF trial enrollment completed
Post-acute myocardial infarction
2020
III
 
FTY720
(fingolimod)
Pediatric multiple sclerosis
2017
III
- Positive topline results from Phase III PARADIGMS study announced
- Full results will be presented at the 7th joint ECTRIMS-ACTRIMS meeting
INC280
NSCLC (cMET amp and mut)
2018
II
 
NSCLC (EGFRm)
≥2021
II
- FPFV achieved in 2017
Jakavi
Acute graft-versus-host disease (GvHD)
2020
III
 
Chronic graft-versus-host disease (GvHD)
2020
III
 
KAE609
Malaria
≥2021
II
 
KAF156
Malaria
≥2021
II
 
Kisqali (LEE011) + tamoxifen + goserelin or
NSAI + goserelin
HR+/HER2- premenopausal aBC 1st line
2018
III
- Fully enrolled
Kisqali (LEE011) + fulvestrant
HR+/HER2- postmenopausal aBC 1st/2nd line
2018
III
- Fully enrolled
Kisqali (LEE011)
+ adjuvant endocrine therapy
HR+/HER2- BC (adjuvant, high risk)
≥2021
III
- FPFV achieved in 2017
HR+/HER2- BC (adjuvant, intermediate risk)
≥2021
III
 
Kymriah (CTL019, tisagenlecleucel)
 
Adult r/r DLBCL
Q4 2017
(US and EU)
II
(pivotal)
 
 
 
25
 

 
B-ALL (children/young adults)
Q4 2017 (EU)
II
(pivotal)
- FDA approval received
- EU planned submission
 
Folicular Lymphoma
2020
II
 
LAM320
Multi-drug resistant tuberculosis
2018
III
 
LCI699
Cushing’s disease
2018
III
- Fully enrolled; additional registration trial for US currently enrolling
LHW090
Resistant Hypertension
≥2021
II
 
LIK066
Weight loss
≥2021
II
 
LJN452
Non-alcoholic steatohepatitis (NASH)
≥2021
II
- FDA Fast Track designation
LMI070
Spinal muscular atrophy
≥2021
II
 
Lucentis
Retinopathy of prematurity
2018
III
- Phase III PIP study enrolling
MAA868
Stroke prevention in atrial fibrillation
≥2021
II
 
OMB157 (ofatumumab)
Relapsing multiple sclerosis
2019
III
- Trials ongoing
PDR001 + Tafinlar + Mekinist
Metastatic BRAF V600+ melanoma
2019
III
- COMBI-I study ongoing: Part 3 FPFV achieved in September 2017
PDR001
NET
2019
II
- Fully enrolled
- FDA orphan drug designation
PIM447
Hematologic cancers
≥2021
I
 
Promacta / Revolade
Severe aplastic anemia 1st line
2018
III
 
QAW039
Asthma
2019
III
- Phase III program recruiting
QBW251
COPD
≥2021
II
 
QGE031
Chronic spontaneous urticaria / chronic
idiopathic urticaria
2020
II
 
QMF149
Asthma
2019
III
 
QVM149
Asthma
2019
III
 
RTH258
nAMD
2018
III
- Positive Phase III results (HAWK, HARRIER) announced in June 2017
- Presentation at AAO planned for Nov 2017
Diabetic macular edema
2020
III
 
Rydapt (PKC412)
Acute myeloid leukemia (FLT3 wild type)
≥2021
III
 
SEG101
Sickle cell pain crises
2018
II/III
 
Tafinlar + Mekinist
BRAF V600+ melanoma (adjuvant)
2017
III
- Fully enrolled
- Positive results meeting Phase III adjuvant study endpoints were presented at ESMO and published in NEJM
- FDA Breakthrough Therapy designation received Oct 2017
UNR844
Presbyopia
≥2021
II
 
VAY736
Auto-Immune Hepatitis
≥2021
II
 
Primary Sjoegren’s syndrome
≥2021
II
- FDA Fast Track designation
VAY785 (emricasan)
Non-alcoholic steatohepatitis (NASH)
≥2021
II
- Conatus transaction announced in May 2017
Xolair
Nasal Polyps
2020
 III  
ZPL389
Atopic dermatitis
≥2021
II
 

 
 
26
 

Selected Sandoz approvals and pipeline projects (biosimilars)
Project/ Compound
Potential indication/
Disease area
Submission status
Current Phase
News update
GP2015 (etanercept)
Arthritides (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), plaque psoriasis and others (same as originator)
US
EU
Approved
Approved
- EU approval for Erelzi in June 2017
GP2013 (rituximab)
Follicular lymphoma, diffuse large B cell lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis (same as originator)
US
EU
Submitted
Approved
- ASSIST-FL results presented at ASH
- EU approval for Rixathon in June 2017
- US filed September 2017
GP2017 (adalimumab)
Arthritides (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), plaque psoriasis and others (same as originator)
US
EU
III
Submitted
- EU filing in May 2017
GP1111 (infliximab)
Autoimmune diseases including rheumatoid arthritis and psoriasis (same as originator)
EU
Submitted
- EU filing in May 2017
LA-EP2006 (pegfilgrastim)
Chemotherapy-induced neutropenia and others (same as originator)
 
III
 
- Resubmission planned for 2019 to address FDA complete response letter
- Withdrawal of EU filing in January 2017 with planned re-filing in 2017
 
 
27
 

Selected Alcon pipeline projects
Project/ Compound
Potential indication/ Disease area
Planned submissions
Current Phase
News update
SURGICAL
AcrySof IQ PanOptix IOL
Trifocal IOL
US 2019
Advanced
- Received CE Mark in Europe in Q2 2015
AcrySof IQ PanOptix Toric IOL
Trifocal IOL for astigmatism
US 2019
Advanced
- Received CE Mark in Europe in Q4 2016
A02238
Mid-tier phacoemulsification device
US 2018
EU 2018
Advanced
Advanced
 
Clareon Monofocal IOL
Next-generation IOL
US 2019
JP 2017
Advanced
Submitted
- Received CE Mark in Europe in Q2 2017
CyPass Micro-Stent
Minimally invasive surgical glaucoma device for implant during cataract surgery
JP 2018
Advanced
- Received US approval in Q3 2016
- Received CE Mark in Europe in Q1 2017
 
VISION CARE
A00717
Daily disposable line extension
EU 2018
JP 2018
Advanced
Advanced
 
A01660
New daily disposable lens
US 2018
EU 2018
JP 2019
Advanced
Advanced
Advanced
 
 
 
28
 

CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

Consolidated income statements

Third quarter (unaudited)



(USD millions unless indicated otherwise) Q3 2017 Q3 2016 Change
Net sales 12 413 12 126 287
Other revenues 279 215 64
Cost of goods sold -4 323 -4 368 45
Gross profit 8 369 7 973 396
Marketing & Sales -3 168 -2 944 -224
Research & Development -2 239 -2 224 -15
General & Administration -510 -456 -54
Other income 424 530 -106
Other expense -519 -610 91
Operating income 2 357 2 269 88
Income from associated companies 262 217 45
Interest expense -197 -174 -23
Other financial income and expense, net 14 -38 52
Income before taxes 2 436 2 274 162
Taxes -353 -329 -24
Net income 2 083 1 945 138
Attributable to:
Shareholders of Novartis AG
2 081 1 940 141
Non-controlling interests
2 5 -3
Weighted average number of shares outstanding – Basic (million) 2 335 2 379 -44
Basic earnings per share (USD)1 0.89 0.81 0.08
Weighted average number of shares outstanding – Diluted (million) 2 359 2 401 -42
Diluted earnings per share (USD)1 0.88 0.81 0.07
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

29

 
Consolidated income statements

Nine months to September 30 (unaudited)



(USD millions unless indicated otherwise) 9M 2017 9M 2016 Change
Net sales 36 194 36 196 -2
Other revenues 777 634 143
Cost of goods sold -12 686 -13 031 345
Gross profit 24 285 23 799 486
Marketing & Sales -9 397 -8 752 -645
Research & Development -6 470 -6 455 -15
General & Administration -1 559 -1 602 43
Other income 1 349 1 546 -197
Other expense -1 649 -1 723 74
Operating income 6 559 6 813 -254
Income from associated companies 692 547 145
Interest expense -569 -539 -30
Other financial income and expense, net 16 -82 98
Income before taxes 6 698 6 739 -41
Taxes -971 -977 6
Net income 5 727 5 762 -35
Attributable to:
Shareholders of Novartis AG
5 727 5 755 -28
Non-controlling interests
0 7 -7
Weighted average number of shares outstanding – Basic (million) 2 353 2 380 -27
Basic earnings per share (USD)1 2.43 2.42 0.01
Weighted average number of shares outstanding – Diluted (million) 2 375 2 402 -27
Diluted earnings per share (USD)1 2.41 2.40 0.01
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

30

 
Condensed consolidated statements of comprehensive income

Third quarter (unaudited)



(USD millions) Q3 2017 Q3 2016 Change
Net income 2 083 1 945 138
Other comprehensive income to be eventually recycled into the consolidated income statement:
Fair value adjustments on financial instruments, net of taxes
153 66 87
Novartis share of other comprehensive income recognized by associated companies, net of taxes
7 -96 103
Net investment hedge
-69 -69
Translation effects
55 732 -677
Total of items to eventually recycle
146 702 -556
Other comprehensive income never to be recycled into the consolidated income statement:
Net actuarial gains from defined benefit plans, net of taxes
359 281 78
Comprehensive income 2 588 2 928 -340
Attributable to:
Shareholders of Novartis AG
2 587 2 922 -335
Non-controlling interests
1 6 -5



Nine months to September 30 (unaudited)



(USD millions) 9M 2017 9M 2016 Change
Net income 5 727 5 762 -35
Other comprehensive income to be eventually recycled into the consolidated income statement:
Fair value adjustments on financial instruments, net of taxes
159 -34 193
Novartis share of other comprehensive income recognized by associated companies, net of taxes
166 -95 261
Net investment hedge
-207 -207
Translation effects
2 309 198 2 111
Total of items to eventually recycle
2 427 69 2 358
Other comprehensive income never to be recycled into the consolidated income statement:
Net actuarial gains/(losses) from defined benefit plans, net of taxes
1 081 -1 251 2 332
Comprehensive income 9 235 4 580 4 655
Attributable to:
Shareholders of Novartis AG
9 234 4 574 4 660
Non-controlling interests
1 6 -5



31

 
Condensed consolidated balance sheets


(USD millions)
Sep 30,
2017
(unaudited)
Dec 31,
2016
(audited)


Change
Assets
Non-current assets
Property, plant & equipment 16 263 15 641 622
Goodwill 31 715 30 980 735
Intangible assets other than goodwill 30 836 31 340 -504
Financial and other non-current assets 28 692 27 232 1 460
Total non-current assets 107 506 105 193 2 313
Current assets
Inventories 6 954 6 255 699
Trade receivables 8 482 8 202 280
Other current assets 2 609 2 697 -88
Cash and cash equivalents, marketable securities, commodities and derivatives 9 421 7 777 1 644
Total current assets 27 466 24 931 2 535
Total assets 134 972 130 124 4 848
Equity and liabilities
Equity attributable to Novartis AG shareholders 72 311 74 832 -2 521
Non-controlling interests 59 59 0
Total equity 72 370 74 891 -2 521
Non-current liabilities
Financial debts 23 163 17 897 5 266
Other non-current liabilities 14 060 15 127 -1 067
Total non-current liabilities 37 223 33 024 4 199
Current liabilities
Trade payables 4 685 4 873 -188
Financial debts and derivatives 6 997 5 905 1 092
Other current liabilities 13 697 11 431 2 266
Total current liabilities 25 379 22 209 3 170
Total liabilities 62 602 55 233 7 369
Total equity and liabilities 134 972 130 124 4 848
 

32

 
Condensed consolidated changes in equity 

Third quarter (unaudited)



(USD millions) Q3 2017 Q3 2016 Change
Consolidated equity at July 1 69 978 72 532 -2 554
Comprehensive income 2 588 2 928 -340
Purchase of treasury shares -1 336 -492 -844
Equity-based compensation 166 105 61
Decrease of treasury share repurchase obligation under a share buyback trading plan 975 975
Impact of change in ownership of consolidated entities -7 7
Change in non-controlling interests -1 0 -1
Consolidated equity at September 30 72 370 75 066 -2 696
 



Nine months to September 30 (unaudited)



(USD millions) 9M 2017 9M 2016 Change
Consolidated equity at January 1 74 891 77 122 -2 231
Comprehensive income 9 235 4 580 4 655
Purchase of treasury shares -4 690 -870 -3 820
Increase of treasury share repurchase obligation under a share buyback trading plan -1 312 -1 312
Exercise of options and employee transactions 235 214 21
Equity-based compensation 507 502 5
Dividends to shareholders of Novartis AG -6 495 -6 475 -20
Impact of change in ownership of consolidated entities -7 7
Change in non-controlling interests -1 0 -1
Consolidated equity at September 30 72 370 75 066 -2 696
 



33

 
Condensed consolidated cash flow statements

Third quarter (unaudited)



(USD millions) Q3 2017 Q3 2016 Change
Net income 2 083 1 945 138
Reversal of non-cash items
Taxes
353 329 24
Depreciation, amortization and impairments
1 478 1 508 -30
Change in provisions and other non-current liabilities
-29 249 -278
Income from associated companies
-262 -217 -45
Net financial expense
183 212 -29
Other
103 -195 298
Net income adjusted for non-cash items 3 909 3 831 78
Interest and other financial receipts 28 9 19
Interest and other financial payments -296 -170 -126
Taxes paid1 -221 -339 118
Cash flows before working capital changes 3 420 3 331 89
Payments out of provisions and other net cash movements in non-current liabilities -215 -339 124
Change in net current assets and other operating cash flow items 381 239 142
Cash flows from operating activities 3 586 3 231 355
Purchase of property, plant & equipment -382 -443 61
Purchase of intangible assets -287 -478 191
Proceeds from sales of intangible assets 157 209 -52
Purchase of financial and other non-current assets -123 -58 -65
Proceeds from sales of property, plant & equipment and financial assets 113 130 -17
Acquisitions and divestments of businesses, net -105 -104 -1
Change in marketable securities and commodities -18 55 -73
Cash flows used in investing activities from continuing operations -645 -689 44
Cash flows used in investing activities from discontinued operations 1 -40 -63 23
Total cash flows used in investing activities -685 -752 67
Change in current and non-current financial debts -576 82 -658
Treasury share transactions, net -1 398 -410 -988
Impact of change in ownership of consolidated enities -6 6
Other financing cash flows 37 -8 45
Cash flows used in financing activities -1 937 -342 -1 595
Effect of exchange rate changes on cash and cash equivalents -10 1 -11
Change in cash and cash equivalents 954 2 138 -1 184
Cash and cash equivalents at July 1 7 856 5 036 2 820
Cash and cash equivalents at September 30 8 810 7 174 1 636
 
In Q3 2016, the total tax payment amounted to USD 350 million, of which USD 11 million was included in the cash flows used in investing activities from discontinued operations.
 

34

 
Condensed consolidated cash flow statements

Nine months to September 30 (unaudited)



(USD millions) 9M 2017 9M 2016 Change
Net income 5 727 5 762 -35
Reversal of non-cash items
Taxes
971 977 -6
Depreciation, amortization and impairments
4 608 4 343 265
Change in provisions and other non-current liabilities
3 737 -734
Income from associated companies
-692 -547 -145
Net financial expense
553 621 -68
Other
-63 -223 160
Net income adjusted for non-cash items 11 107 11 670 -563
Interest and other financial receipts 934 705 229
Interest and other financial payments -642 -677 35
Taxes paid1 -1 125 -1 320 195
Cash flows before working capital changes 10 274 10 378 -104
Payments out of provisions and other net cash movements in non-current liabilities -505 -1 352 847
Change in net current assets and other operating cash flow items -556 -1 142 586
Cash flows from operating activities 9 213 7 884 1 329
Purchase of property, plant & equipment -1 058 -1 276 218
Purchase of intangible assets -718 -822 104
Proceeds from sales of intangible assets 540 668 -128
Purchase of financial and other non-current assets -343 -265 -78
Proceeds from sales of property, plant & equipment and financial assets 338 290 48
Acquisitions and divestments of businesses, net -760 -530 -230
Change in marketable securities, commodities and divestments of interests in associated companies 5 89 -84
Cash flows used in investing activities from continuing operations -1 996 -1 846 -150
Cash flows used in investing activities from discontinued operations 1 -127 -522 395
Total cash flows used in investing activities -2 123 -2 368 245
Dividends related to shareholders of Novartis AG -6 495 -6 475 -20
Change in current and non-current financial debts 5 439 4 163 1 276
Treasury share transactions, net -4 331 -690 -3 641
Impact of change in ownership of consolidated entities -6 6
Other financing cash flows 50 -3 53
Cash flows used in financing activities -5 337 -3 011 -2 326
Effect of exchange rate changes on cash and cash equivalents 50 -5 55
Change in cash and cash equivalents 1 803 2 500 -697
Cash and cash equivalents at January 1 7 007 4 674 2 333
Cash and cash equivalents at September 30 8 810 7 174 1 636
 
In 9M 2016, the total tax payment amounted to USD 1 503 million, of which USD 183 million was included in the cash flows used in investing activities from discontinued operations.

35

 
Notes to the Condensed Interim Consolidated Financial Statements for the three- and nine-month period ended September 30, 2017 (unaudited)

1. Basis of preparation

These Condensed Interim Consolidated Financial Statements for the three- and nine-month period ended September 30, 2017, were prepared in accordance with International Accounting Standard 34 Interim Financial Reporting and accounting policies set out in the 2016 Annual Report published on January 25, 2017.

2. Selected critical accounting policies

The Group’s principal accounting policies are set out in Note 1 to the Consolidated Financial Statements in the Annual Report 2016 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 discussed in the 2016 Annual Report, goodwill, Alcon brand name 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 under IFRS 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.

36

 
3. Significant transactions

Significant transactions in 2017

Innovative Medicines – Acquisition of Ziarco Group Limited
On January 20, 2017, Novartis acquired Ziarco Group Limited, a privately held company focused on the development of novel treatments in dermatology. This acquisition adds a once daily oral H4 receptor antagonist in development for atopic dermatitis (AD), commonly known as eczema, to complement the Novartis dermatology portfolio and pipeline. The fair value of the total purchase consideration was USD 420 million. The amount consisted of an initial cash payment of USD 325 million and the net present value of the contingent consideration of USD 95 million, due to the Ziarco shareholders, which they are eligible to receive upon achievement of specified development milestones. The purchase price allocation resulted in net identifiable assets of USD 395 million and goodwill of USD 25 million. Results of operations since the date of acquisition were not material.

Innovative Medicines – Acquisition of Encore Vision, Inc.
On January 20, 2017, Novartis acquired Encore Vision, Inc., a privately-held company in Fort Worth, Texas, USA, focused on the development of a novel treatment in presbyopia. The fair value of the total purchase consideration was USD 456 million. The amount consisted of an initial cash payment of USD 366 million and the net present value of the contingent consideration of USD 90 million, due to the Encore shareholders, which they are eligible to receive upon achievement of specified development and commercialization milestones. The purchase price allocation resulted in net identifiable assets of USD 389 million and goodwill of USD 67 million. Results of operations since the date of acquisition were not material.

Significant transactions in 2016

Alcon – Acquisition of Transcend Medical, Inc.
On February 17, 2016, Alcon entered into an agreement to acquire Transcend Medical, Inc. (Transcend), a privately-held, US-based company focused on developing minimally-invasive surgical devices to treat glaucoma. The transaction closed on March 23, 2016, and the fair value of the total purchase consideration was USD 332 million. The amount consisted of an initial cash payment of USD 240 million and the net present value of the contingent consideration of USD 92 million due to the Transcend shareholders, which they are eligible to receive upon achievement of specified development and commercialization milestones. The purchase price allocation resulted in net identifiable assets of USD 294 million and goodwill of USD 38 million. Results of operations since the date of acquisition were not material.

Innovative Medicines – Acquisition of Reprixys Pharmaceuticals Corporation
On November 18, 2016, Novartis acquired Reprixys Pharmaceuticals Corporation (Reprixys), a privately held, US-based company specializing in development of therapeutics in certain hematologic and inflammatory disorders following receipt of results of the SUSTAIN study. The initial interest of 19% was adjusted to its fair value of USD 64 million through the consolidated income statement at acquisition date. This re-measurement resulted in a gain of USD 53 million.

The fair value of the total purchase consideration for acquiring the 81% stake Novartis did not already own amounted to USD 268 million. The amount consisted of an initial cash payment of USD 194 million and the net present value of the contingent consideration of USD 74 million due to the Reprixys shareholders, which they are eligible to receive upon achievement of specified development and commercialization milestones. The purchase price allocation resulted in net identifiable assets of USD 332 million. No goodwill was recognized. Results of operations since the date of acquisition were not material.

37

 
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)
2017 2016 Change 9M 2017 9M 2016 Change
Balance at beginning of year 2 374.1 2 373.9 0.2 74 832 77 046 -2 214
Shares acquired to be cancelled -56.8 -8.8 -48.0 -4 473 -681 -3 792
Other share purchases -2.8 -2.4 -0.4 -217 -189 -28
Exercise of options and employee transactions 4.2 4.1 0.1 235 214 21
Equity-based compensation 8.6 8.7 -0.1 507 502 5
Increase of treasury share repurchase obligation under a share buyback trading plan -1 312 -1 312
Dividends to shareholders of Novartis AG -6 495 -6 475 -20
Net income of the period attributable to shareholders of Novartis AG 5 727 5 755 -28
Impact of change in ownership of consolidated entities -7 7
Other comprehensive income attributable to shareholders of Novartis AG 3 507 -1 181 4 688
Balance at September 30 2 327.3 2 375.5 -48.2 72 311 74 984 -2 673
 

In 2017, Novartis entered into an irrevocable, non-discretionary arrangement with a bank to repurchase own shares on the second trading line under its up to USD 5 billion share buyback, as well as to mitigate dilution from equity-based participation plans. The commitment under this arrangement amounted to USD 1.3 billion as of September 30, 2017, reflecting the expected purchases by the bank under such trading plan over a rolling 90 days period.

38

 
5. Consolidated income statements – Segmentation

The businesses of Novartis are divided operationally on a worldwide basis into three identified reporting segments, Innovative Medicines, Sandoz and Alcon. 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.

Innovative Medicines researches, develops, manufactures, distributes and sells patented prescription medicines. The Innovative Medicines Division is organized into two global business units: Novartis Oncology, which consists of the global business franchises Oncology and Novartis Pharmaceuticals, which consists of the global business franchises Ophthalmology, Neuroscience, Immunology and Dermatology, Respiratory, Cardio-Metabolic and Established Medicines.

Sandoz develops, manufactures, distributes and sells prescription medicines, as well as pharmaceutical active substances, that are not protected by valid and enforceable third-party patents. Sandoz is organized globally in 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 dermatology, respiratory, oncology, ophthalmics, cardiovascular, metabolism, central nervous system, pain, gastrointestinal, and hormonal therapies, as well as finished dosage form anti-infectives sold to third parties. In Anti-Infectives, Sandoz manufactures 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.

Alcon researches, discovers, develops, manufactures, distributes and sells eye care products. Alcon is the global leader in eye care with product offerings in eye care devices and vision care. Alcon is organized into two global business franchises: Surgical and Vision Care. The Surgical franchise includes technologies and devices for cataract, retinal, glaucoma and refractive surgery, as well as intraocular lenses to treat cataract and refractive errors, like presbyopia and astigmatism. Alcon also provides viscoelastics, surgical solutions, surgical packs, and other disposable products for cataract and vitreoretinal surgery. The Vision Care franchise comprises daily disposable, monthly replacement, and color-enhancing contact lenses, as well as a complete line of contact lens care products including multi-purpose and hydrogen-peroxide based solutions, rewetting drops and daily protein removers.

The divisions are supported by Novartis Institute for BioMedical Research, Novartis Business Services, Global Drug Development and Novartis Technical Operations. Corporate activities include Group headquarter functions 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 2016.

39

 
Segmentation –Third quarter (unaudited)

Innovative Medicines Sandoz Alcon Corporate (including eliminations) Group
(USD millions) Q3 2017 Q3 2016 Q3 2017 Q3 2016 Q3 2017 Q3 2016 Q3 2017 Q3 2016 Q3 2017 Q3 2016
Net sales to third parties 8 302 8 173 2 584 2 517 1 527 1 436 12 413 12 126
Sales to other segments 171 158 20 29 1 -192 -187
Net sales 8 473 8 331 2 604 2 546 1 528 1 436 -192 -187 12 413 12 126
Other revenues 241 193 8 10 2 28 12 279 215
Cost of goods sold -2 261 -2 280 -1 481 -1 540 -795 -764 214 216 -4 323 -4 368
Gross profit 6 453 6 244 1 131 1 016 735 672 50 41 8 369 7 973
Marketing & Sales -2 227 -2 047 -438 -399 -503 -498 -3 168 -2 944
Research & Development -1 861 -1 889 -195 -204 -183 -131 -2 239 -2 224
General & Administration -232 -246 -74 -60 -94 -86 -110 -64 -510 -456
Other income 247 264 70 62 17 19 90 185 424 530
Other expense -201 -306 -104 -61 -22 -26 -192 -217 -519 -610
Operating income 2 179 2 020 390 354 -50 -50 -162 -55 2 357 2 269
as % of net sales 26.2% 24.7% 15.1% 14.1% -3.3% -3.5% 19.0% 18.7%
Income from associated companies 1 262 216 262 217
Interest expense -197 -174
Other financial income and expense, net 14 -38
Income before taxes 2 436 2 274
Taxes -353 -329
Net income 2 083 1 945
 
 

40

 
Segmentation –Nine months to September 30 (unaudited)

Innovative Medicines Sandoz Alcon Corporate (including eliminations) Group
(USD millions) 9M 2017 9M 2016 9M 2017 9M 2016 9M 2017 9M 2016 9M 2017 9M 2016 9M 2017 9M 2016
Net sales to third parties 24 269 24 289 7 465 7 539 4 460 4 368 36 194 36 196
Sales to other segments 502 464 82 71 3 -587 -535
Net sales 24 771 24 753 7 547 7 610 4 463 4 368 -587 -535 36 194 36 196
Other revenues 678 559 27 31 3 4 69 40 777 634
Cost of goods sold -6 667 -6 896 -4 286 -4 466 -2 382 -2 310 649 641 -12 686 -13 031
Gross profit 18 782 18 416 3 288 3 175 2 084 2 062 131 146 24 285 23 799
Marketing & Sales -6 619 -6 133 -1 320 -1 236 -1 458 -1 383 -9 397 -8 752
Research & Development -5 468 -5 465 -576 -605 -426 -385 -6 470 -6 455
General & Administration -715 -744 -225 -218 -300 -309 -319 -331 -1 559 -1 602
Other income 804 870 121 136 38 46 386 494 1 349 1 546
Other expense -809 -878 -225 -172 -50 -43 -565 -630 -1 649 -1 723
Operating income 5 975 6 066 1 063 1 080 -112 -12 -367 -321 6 559 6 813
as % of net sales 24.6% 25.0% 14.2% 14.3% -2.5% -0.3% 18.1% 18.8%
Income from associated companies -1 22 5 671 542 692 547
Interest expense -569 -539
Other financial income and expense, net 16 -82
Income before taxes 6 698 6 739
Taxes -971 -977
Net income 5 727 5 762
 
 
 

41

 
6. Financial instruments



The following table illustrates the three hierarchical levels for valuing financial instruments at fair value and also those measured at amortized cost or at cost as of September 30, 2017 and December 31, 2016. For additional information on the hierarchies and other matters, please refer to the Consolidated Financial Statements in the 2016 Annual Report, published on January 25, 2017.

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

(USD millions)
Sep 30,
2017
Dec 31,
2016
Sep 30,
2017
Dec 31,
2016
Sep 30,
2017
Dec 31,
2016
Sep 30,
2017
Dec 31,
2016
Sep 30,
2017
Dec 31,
2016
Debt securities 304 284 24 22 328 306
Equity securities 5 5
Fund investments 33 31 33 31
Total available-for-sale marketable securities 342 315 24 22 366 337
Time deposits with original maturity more than 90 days 117 108 117 108
Derivative financial instruments 22 230 22 230
Accrued interest on debt securities 1 1 1 1
Total marketable securities, time deposits and derivative financial instruments 342 315 46 252 118 109 506 676
Financial investments and long-term loans
Available-for-sale financial investments 850 513 442 476 1 292 989
Fund investments 128 107 128 107
Contingent consideration receivables 609 586 609 586
Long-term loans and receivables from customers and finance lease, advances, security deposits 542 514 542 514
Financial investments and long-term loans 850 513 1 179 1 169 542 514 2 571 2 196
Associated companies at fair value through profit or loss 35 158 188 193 188
Contingent consideration payables -889 -889 -889 -889
Other financial liabilities -80 -129 -80 -129
Derivative financial instruments -140 -116 -140 -116
Total financial liabilities at fair value -140 -116 -969 -1 018 -1 109 -1 134

There were no changes in the first nine months of the year in the valuation techniques used for financial instruments nor significant transfers from one level to the other nor significant transactions associated with level 3 financial instruments. During 2017, there were several individually non-significant transfers of equity securities from level 3 to level 1 for USD 73 million due to Initial Public Offerings.

The fair value of straight bonds amounted to USD 23.8 billion at September 30, 2017 (USD 17.9 billion at December 31, 2016) compared to the balance sheet value of USD 22.9 billion at September 30, 2017 (USD 17.3 billion at December 31, 2016). 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 2.6 billion at September 30, 2017 (USD 2.2 billion at December 31, 2016) is included in line “financial and other non-current assets” of the condensed consolidated balance sheets.

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.

42

 


7. 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 20 to the Consolidated Financial Statements in our 2016 Annual Report and 2016 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 October 23, 2017 of significant developments in those proceedings, as well as any new significant proceedings commenced since the date of the 2016 Annual Report and 2016 Form 20-F.

Investigations and related litigations

Asia/Russia investigation
In the second quarter of 2017, Novartis Group companies received document requests and subpoenas from the US Department of Justice and the US Securities and Exchange Commission requesting information concerning Alcon’s business practices in Asia and Russia, both before and after Alcon became part of the Novartis Group. Novartis is cooperating with this investigation.



In addition to the matter described above, there have been other developments in the other legal matters described in Note 20 to the Consolidated Financial Statements contained in our 2016 Annual Report and 2016 Form 20-F. These do not significantly affect the assessment of management concerning the adequacy of the total provisions recorded for legal proceedings.





43

 
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, and certain acquisition 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

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

44

 
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. The definition of free cash flow used by Novartis does not include amounts related to changes in investments in associated companies nor related to acquisitions or divestments of subsidiaries. Free cash flow is not intended to be a substitute measure for cash flow from operating activities as determined under IFRS.

45

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

Innovative Medicines Sandoz Alcon Corporate Group
(USD millions) Q3 2017 Q3 2016 Q3 2017 Q3 2016 Q3 2017 Q3 2016 Q3 2017 Q3 2016 Q3 2017 Q3 2016
IFRS Operating income 2 179 2 020 390 354 -50 -50 -162 -55 2 357 2 269
Amortization of intangible assets 516 612 117 115 227 225 860 952
Impairments
Intangible assets
63 84 20 54 57 140 138
Property, plant & equipment related to the Group-wide rationalization of manufacturing sites
-1 46 45
Other property, plant & equipment
11 7 1 -2 12 5
Financial assets
1 20 22 21 42 22
Total impairment charges 73 92 67 52 77 22 21 239 165
Acquisition or divestment of businesses and related items
- Income
-1 -4 -26 -54 -27 -58
- Expense
5 17 30 51 35 68
Total acquisition or divestment of businesses and related items, net 4 13 4 -3 8 10
Other items
Divestment gains
-28 -232 -6 -48 -28 -286
Restructuring and related items
- Income
-17 -6 -4 -11 -1 -1 -22 -18
- Expense
36 82 13 26 20 6 17 55 145
Legal-related items
- Income
-1 -1
- Expense
9 69 10 19 69
Additional income
-170 -3 -45 -37 -10 -255 -10
Additional expense
56 26 20 12 74 47 150 85
Total other items -115 -61 6 9 -16 31 43 6 -82 -15
Total adjustments 478 656 190 176 288 256 69 24 1 025 1 112
Core operating income 2 657 2 676 580 530 238 206 -93 -31 3 382 3 381
as % of net sales 32.0% 32.7% 22.4% 21.1% 15.6% 14.3% 27.2% 27.9%
Income from associated companies 1 262 216 262 217
Core adjustments to income from associated companies, net of tax 97 78 97 78
Interest expense -197 -174
Other financial income and expense 14 -38
Taxes (adjusted for above items) -541 -526
Core net income 3 017 2 938
Core net income attributable to shareholders of Novartis AG 3 015 2 933
Core basic EPS (USD)1 1.29 1.23
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

46

 
CORE RESULTS –Reconciliation from IFRS results to core results – Group – Nine months to September 30

Innovative Medicines Sandoz Alcon Corporate Group
(USD millions) 9M 2017 9M 2016 9M 2017 9M 2016 9M 2017 9M 2016 9M 2017 9M 2016 9M 2017 9M 2016
IFRS Operating income 5 975 6 066 1 063 1 080 -112 -12 -367 -321 6 559 6 813
Amortization of intangible assets 1 600 1 835 340 345 676 672 2 616 2 852
Impairments
Intangible assets
566 89 51 60 57 4 674 153
Property, plant & equipment related to the Group-wide rationalization of manufacturing sites
-1 46 2 45 2
Other property, plant & equipment
3 67 14 8 17 75
Financial assets
11 20 72 71 92 82
Total impairment charges 568 167 111 70 77 4 72 71 828 312
Acquisition or divestment of businesses and related items
- Income
-2 -14 -95 -184 -97 -198
- Expense
18 30 114 178 132 208
Total acquisition or divestment of businesses and related items, net 16 16 19 -6 35 10
Other items
Divestment gains
-368 -570 -6 -48 -368 -624
Restructuring and related items
- Income
-32 -26 -6 -31 -2 -2 -4 -40 -63
- Expense
197 280 32 92 17 26 19 42 265 440
Legal-related items
- Income
-2 -99 -2 -99
- Expense
25 205 10 35 205
Additional income
-513 -11 -3 -50 -13 -37 -20 -603 -44
Additional expense
193 84 20 12 89 76 302 172
Total other items -500 -137 23 55 -5 23 71 46 -411 -13
Total adjustments 1 684 1 881 474 470 748 699 162 111 3 068 3 161
Core operating income 7 659 7 947 1 537 1 550 636 687 -205 -210 9 627 9 974
as % of net sales 31.6% 32.7% 20.6% 20.6% 14.3% 15.7% 26.6% 27.6%
Income from associated companies -1 22 5 671 542 692 547
Core adjustments to income from associated companies, net of tax 1 343 307 344 307
Interest expense -569 -539
Other financial income and expense 16 -82
Taxes (adjusted for above items) -1 537 -1 551
Core net income 8 573 8 656
Core net income attributable to shareholders of Novartis AG 8 573 8 649
Core basic EPS (USD)1 3.64 3.63
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

47

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


(USD millions)


Q3 2017
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items 3


Other
items 4


Q3 2017
Core results


Q3 2016
Core results
Gross profit 8 369 844 20 11 9 244 8 971
Operating income 2 357 860 239 8 -82 3 382 3 381
Income before taxes 2 436 944 239 8 -69 3 558 3 464
Taxes5 -353 -541 -526
Net income 2 083 3 017 2 938
Basic EPS (USD)6 0.89 1.29 1.23
The following are adjustments to arrive at Core Gross Profit
Cost of goods sold -4 323 844 20 11 -3 448 -3 370
The following are adjustments to arrive at Core Operating Income
Research & Development -2 239 16 140 34 -2 049 -2 080
Other income 424 -1 -27 -268 128 158
Other expense -519 80 35 141 -263 -296
The following are adjustments to arrive at Core Income before taxes
Income from associated companies 262 84 13 359 295
Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms; Income from associated companies includes USD 84 million for the Novartis share of the estimated Roche core items.
Impairments: Cost of goods sold and Research & Development include impairment charges related to intangible assets; Research & Development and Other expense include impairment charges related to financial assets; Other income and Other expense include reversals and charges related to the impairment of property, plant and equipment.
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: Cost of goods sold and Other expense include net restructuring and other charges related to the Group-wide rationalization of manufacturing sites; Research & Development includes fair value adjustments to contingent consideration liabilities; Research & Development, Other income and Other expense include other restructuring income and charges and related items; Other income also includes a gain from a Swiss pension plan amendment as well as product and financial asset divestment gains; Other expense also includes legal-related items, a provision for contract termination costs and a fair value adjustment to a contingent consideration liability; Income from associated companies includes an adjustment of USD 13 million for the Novartis share of the estimated GSK Consumer Healthcare Holdings Ltd. core 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. 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 188 million. The average tax rate on the adjustments is 16.8%, since the estimated full year core tax charge of 15.2% has been applied to the pre-tax income of the period.
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

48

 
CORE RESULTS – Reconciliation from IFRS results to core results – Group – Nine months to September 30


(USD millions)


9M 2017
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items 3


Other
items 4


9M 2017
Core results


9M 2016
Core results
Gross profit 24 285 2 559 82 39 26 965 26 740
Operating income 6 559 2 616 828 35 -411 9 627 9 974
Income before taxes 6 698 2 929 829 35 -381 10 110 10 207
Taxes5 -971 -1 537 -1 551
Net income 5 727 8 573 8 656
Basic EPS (USD)6 2.43 3.64 3.63
The following are adjustments to arrive at Core Gross Profit
Cost of goods sold -12 686 2 559 82 39 -10 006 -10 090
The following are adjustments to arrive at Core Operating Income
Research & Development -6 470 57 612 -261 -6 062 -6 229
Other income 1 349 -10 -97 -672 570 531
Other expense -1 649 144 132 483 -890 -769
The following are adjustments to arrive at Core Income before taxes
Income from associated companies 692 313 1 30 1 036 854
Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms; Income from associated companies includes USD 313 million for the Novartis share of the estimated Roche core items.
Impairments: Cost of goods sold and Research & Development include impairment charges related to intangible assets; Research & Development and Other expense include impairment charges related to financial assets; Other income and Other expense include reversals and charges related to the impairment of property, plant and equipment.
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: Cost of goods sold and Other expense include net restructuring and other charges related to the Group-wide rationalization of manufacturing sites; Research & Development, Other income and Other expense include other restructuring income and charges and related items; Other income and Other expense include legal-related items; Research & Development includes fair value adjustments to contingent consideration liabilities; Other income also includes a gain from a Swiss pension plan amendment, product and financial asset divestment gains, a partial reversal of a prior period charge and an income from a settlement of a contract dispute; Other expense also includes a charge for onerous contracts, a provision for contract termination costs and a fair value adjustment to a contingent consideration liability; Income from associated companies includes an adjustment of USD 30 million for the Novartis share of the estimated GSK Consumer Healthcare Holdings Ltd. core 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. 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 3.4 billion, to arrive at the core results before tax, amounts to USD 566 million. The average tax rate on the adjustments is 16.6%, since the estimated full year core tax charge of 15.2% has been applied to the pre-tax income of the period.
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

49

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


(USD millions)


Q3 2017
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items 3


Other
items 4


Q3 2017
Core results


Q3 2016
Core results
Gross profit 6 453 503 7 6 963 6 850
Operating income 2 179 516 73 4 -115 2 657 2 676
The following are adjustments to arrive at Core Gross Profit
Cost of goods sold -2 261 503 7 -1 751 -1 674
The following are adjustments to arrive at Core Operating Income
Research & Development -1 861 13 63 52 -1 733 -1 771
Other income 247 -1 -1 -216 29 22
Other expense -201 11 5 42 -143 -132
Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms.
Impairments: Research & Development includes impairment charges related to intangible assets; Other income and Other expense include reversals and charges related to the impairment of property, plant and equipment.
Acquisition or divestment of businesses and related items, including restructuring and integration charges: Other income and Other expense includes transitional service-fee expenses and other items related to the portfolio transformation.
Other items: Cost of goods sold and Other expense include net restructuring and other charges related to the Group-wide rationalization of manufacturing sites; Research & Development, Other income and Other expense include other restructuring income and charges and related items; Research & Development includes fair value adjustments to contingent consideration liabilities; Other income also includes a gain from a Swiss pension plan amendment, as well as product and financial asset divestment gains; Other expense also includes a provision for contract termination costs, legal-related items and other charges.

50

 
CORE RESULTS – Reconciliation from IFRS results to core results – Innovative Medicines – Nine months to September 30


(USD millions)


9M 2017
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items 3


Other
items 4


9M 2017
Core results


9M 2016
Core results
Gross profit 18 782 1 551 31 30 20 394 20 264
Operating income 5 975 1 600 568 16 -500 7 659 7 947
The following are adjustments to arrive at Core Gross Profit
Cost of goods sold -6 667 1 551 31 30 -5 055 -5 048
The following are adjustments to arrive at Core Operating Income
Research & Development -5 468 49 535 -243 -5 127 -5 277
Other income 804 -10 -2 -612 180 150
Other expense -809 12 18 325 -454 -313
Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms.
Impairments: Cost of goods sold and Research & Development include impairment charges related to intangible assets; Other income and Other expense include reversals and charges related to the impairment of property, plant and equipment.
Acquisition or divestment of businesses and related items, including restructuring and integration charges: Other income and Other expense includes transitional service-fee income and expenses and other items related to the portfolio transformation.
Other items: Cost of goods sold and Other expense include net restructuring and other charges related to the Group-wide rationalization of manufacturing sites; Research & Development, Other income and Other expense include other restructuring income and charges and related items; Other income and Other expense include legal-related items; Research & Development includes fair value adjustments to contingent consideration liabilities; Other income also includes a gain from a Swiss pension plan amendment, an income from a settlement of a contract dispute, as well as product and financial asset divestment gains; Other expense also includes a provision for contract termination costs, a charge for onerous contracts and other charges.

51

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


(USD millions)


Q3 2017
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items


Other
items 3


Q3 2017
Core results


Q3 2016
Core results
Gross profit 1 131 117 20 4 1 272 1 187
Operating income 390 117 67 6 580 530
The following are adjustments to arrive at Core Gross Profit
Cost of goods sold -1 481 117 20 4 -1 340 -1 369
The following are adjustments to arrive at Core Operating Income
Other income 70 -7 63 45
Other expense -104 47 9 -48 -47
Amortization of intangible assets: Cost of goods sold includes recurring 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 expense includes 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; Other income and Other expense include other restructuring income and charges and related items. Other income also includes a gain from a Swiss pension plan amendment.

52

 
CORE RESULTS – Reconciliation from IFRS results to core results – Sandoz – Nine months to September 30


(USD millions)


9M 2017
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items


Other
items 3


9M 2017
Core results


9M 2016
Core results
Gross profit 3 288 340 51 9 3 688 3 619
Operating income 1 063 340 111 23 1 537 1 550
The following are adjustments to arrive at Core Gross Profit
Cost of goods sold -4 286 340 51 9 -3 886 -4 022
The following are adjustments to arrive at Core Operating Income
Other income 121 -9 112 99
Other expense -225 60 23 -142 -119
Amortization of intangible assets: Cost of goods sold includes recurring 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 expense includes 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; Other income and Other expense include other restructuring income and charges and related items. Other income also includes a gain from a Swiss pension plan amendment.

53

 
CORE RESULTS – Reconciliation from IFRS results to core results – Alcon – Third quarter


(USD millions)


Q3 2017
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items


Other
items 3


Q3 2017
Core results


Q3 2016
Core results
Gross profit 735 224 959 893
Operating loss/income -50 227 77 -16 238 206
The following are adjustments to arrive at Core Gross Profit
Cost of goods sold -795 224 -571 -543
The following are adjustments to arrive at Core Operating Income
Research & Development -183 3 77 -18 -121 -113
Other income 17 -8 9 18
Other expense -22 10 -12 -8
Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms.
Impairments: Research & Development includes impairment charges related to intangible and financial assets.
Other items: Research & Development includes fair value adjustments to contingent consideration liabilities; Other income includes a gain from a Swiss pension plan amendment and restructuring income and related items; Other expense also includes legal-related items.

54

 
CORE RESULTS – Reconciliation from IFRS results to core results – Alcon – Nine months to September 30


(USD millions)


9M 2017
IFRS results


Amortization of
intangible assets 1



Impairments 2
Acquisition or
divestment of
businesses
and related items


Other
items 3


9M 2017
Core results


9M 2016
Core results
Gross profit 2 084 668 2 752 2 711
Operating loss/income -112 676 77 -5 636 687
The following are adjustments to arrive at Core Gross Profit
Cost of goods sold -2 382 668 -1 714 -1 661
The following are adjustments to arrive at Core Operating Income
Research & Development -426 8 77 -18 -359 -357
Other income 38 -14 24 44
Other expense -50 27 -23 -19
Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms.
Impairments: Research & Development includes impairment charges related to intangible and financial assets.
Other items: Research & Development includes fair value adjustments to contingent consideration liabilities and other items; Other income and Other expense include restructuring income and charges and related items; Other income also includes a gain from a Swiss pension plan amendment and the partial reversal of a prior period charge; Other expense also includes legal-related items.

55

 
CORE RESULTS – Reconciliation from IFRS results to core results – Corporate – Third quarter


(USD millions)


Q3 2017
IFRS results


Amortization of
intangible assets



Impairments 1
Acquisition or
divestment of
businesses
and related items 2


Other
items 3


Q3 2017
Core results


Q3 2016
Core results
Gross profit 50 50 41
Operating loss -162 22 4 43 -93 -31
The following are adjustments to arrive at Core Operating Loss
Other income 90 -26 -37 27 73
Other expense -192 22 30 80 -60 -109
Impairments: Other expense includes impairment charges related to financial assets.
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 includes a gain from a Swiss pension plan amendment and other items; Other expense includes a fair value adjustment to a contingent consideration liability, restructuring charges and related items, and other costs.

56

 
CORE RESULTS – Reconciliation from IFRS results to core results – Corporate – Nine months to September 30


(USD millions)


9M 2017
IFRS results


Amortization of
intangible assets



Impairments 1
Acquisition or
divestment of
businesses
and related items 2


Other
items 3


9M 2017
Core results


9M 2016
Core results
Gross profit 131 131 146
Operating loss -367 72 19 71 -205 -210
The following are adjustments to arrive at Core Operating Loss
Other income 386 -95 -37 254 238
Other expense -565 72 114 108 -271 -318
Impairments: Other expense includes impairment charges related to financial assets.
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 includes a gain from a Swiss pension plan amendment and other items; Other expense includes a fair value adjustment to a contingent consideration liability, restructuring charges and related items, and other costs.

57

 
Condensed consolidated changes in net debt 

Third quarter



(USD millions) Q3 2017 Q3 2016
Change in cash and cash equivalents 954 2 138
Change in marketable securities, commodities, financial debt and financial derivatives 431 -291
Reduction in net debt 1 385 1 847
Net debt at July 1 -22 124 -20 628
Net debt at September 30 -20 739 -18 781



Nine months to September 30



(USD millions) 9M 2017 9M 2016
Change in cash and cash equivalents 1 803 2 500
Change in marketable securities, commodities, financial debt and financial derivatives -6 517 -4 797
Increase in net debt -4 714 -2 297
Net debt at January 1 -16 025 -16 484
Net debt at September 30 -20 739 -18 781





Components of net debt


(USD millions)
Sep 30,
2017
Sep 30,
2016
Current financial debts and derivative financial instruments -6 997 -8 307
Non-current financial debts -23 163 -18 259
Less liquidity:
Cash and cash equivalents 8 810 7 174
Marketable securities, commodities and derivative financial instruments 611 611
Net debt at September 30 -20 739 -18 781



Share information

Sep 30,
2017
Sep 30,
2016
Number of shares outstanding 2 327 339 772 2 375 517 359
Registered share price (CHF) 82.90 76.40
ADR price (USD) 85.85 78.96
Market capitalization (USD billions) 198.9 187.8
Market capitalization (CHF billions) 192.9 181.5

58

 
Free cash flow

Third quarter



(USD millions) Q3 2017 Q3 2016 Change
Operating income 2 357 2 269 88
Reversal of non-cash items
Depreciation, amortization and impairments
1 478 1 508 -30
Change in provisions and other non-current liabilities
-29 249 -278
Other
103 -195 298
Operating income adjusted for non-cash items 3 909 3 831 78
Interest and other financial receipts 28 9 19
Interest and other financial payments -296 -170 -126
Taxes paid -221 -339 118
Payments out of provisions and other net cash movements in non-current liabilities -215 -339 124
Change in inventory and trade receivables less trade payables -100 -140 40
Change in other net current assets and other operating cash flow items 481 379 102
Cash flows from operating activities 3 586 3 231 355
Purchase of property, plant & equipment -382 -443 61
Purchase of intangible assets -287 -478 191
Proceeds from sales of intangible assets 157 209 -52
Purchase of financial and other non-current assets -123 -58 -65
Proceeds from sales of property, plant & equipment and financial assets 113 130 -17
Free cash flow 3 064 2 591 473



Nine months to September 30



(USD millions) 9M 2017 9M 2016 Change
Operating income 6 559 6 813 -254
Reversal of non-cash items
Depreciation, amortization and impairments
4 608 4 343 265
Change in provisions and other non-current liabilities
3 737 -734
Other
-63 -223 160
Operating income adjusted for non-cash items 11 107 11 670 -563
Interest and other financial receipts 934 705 229
Interest and other financial payments -642 -677 35
Taxes paid -1 125 -1 320 195
Payments out of provisions and other net cash movements in non-current liabilities -505 -1 352 847
Change in inventory and trade receivables less trade payables -871 -1 664 793
Change in other net current assets and other operating cash flow items 315 522 -207
Cash flows from operating activities 9 213 7 884 1 329
Purchase of property, plant & equipment -1 058 -1 276 218
Purchase of intangible assets -718 -822 104
Proceeds from sales of intangible assets 540 668 -128
Purchase of financial and other non-current assets -343 -265 -78
Proceeds from sales of property, plant & equipment and financial assets 338 290 48
Free cash flow 7 972 6 479 1 493

59

 
Net sales of the top 20 Innovative Medicines products in 2017 – Third quarter

US Rest of world Total

Brands


Business Franchise


Indication


USD m
% change
in constant
currencies


USD m
% change
in constant
currencies


USD m

% change
in USD
% change
in constant
currencies
Gilenya Neuroscience Relapsing multiple sclerosis 428 0 373 2 801 1 0
Gleevec/Glivec Oncology Chronic myeloid leukemia and GIST 141 -53 304 -43 445 -47 -47
Cosentyx Immunology and Dermatology Psoriasis, ankylosing spondylitis and psoriatic arthritis 346 69 210 110 556 85 83
Lucentis Ophthalmology Age-related macular degeneration 481 5 481 5 5
Tasigna Oncology Chronic myeloid leukemia 212 16 270 9 482 9 12
Sandostatin Oncology Carcinoid tumors and Acromegaly 203 -3 199 1 402 -3 -1
Afinitor/Votubia Oncology Breast cancer / TSC 212 11 177 -11 389 -1 0
Galvus Established Medicines Diabetes 310 3 310 1 3
Exjade/Jadenu Oncology Chronic iron overload 132 16 132 5 264 9 11
Diovan/Co–Diovan Established Medicines Hypertension 19 -39 212 -6 231 -11 -10
Exforge Established Medicines Hypertension 7 40 237 4 244 5 4
Xolair1 Respiratory Asthma 245 12 245 14 12
Tafinlar + Mekinist Oncology Melanoma 87 13 137 39 224 30 27
Promacta/Revolade Oncology Immune thrombocytopenic purpura 119 47 108 25 227 35 36
Votrient Oncology Renal cell carcinoma 109 21 104 10 213 16 15
Jakavi Oncology Myelofibrosis 201 31 201 35 31
Travoprost Group Ophthalmology Reduction of elevated intraocular pressure 55 20 94 -11 149 -1 -1
Neoral/Sandimmun(e) Immunology and Dermatology Transplantation 11 22 115 -3 126 -3 -2
Voltaren/Cataflam Established Medicines Inflammation/pain 118 -2 118 -10 -2
Entresto Cardio-Metabolic Chronic Heart Failure 74 111 54 198 128 142 138
Top 20 products total 2 155 8 4 081 2 6 236 4 4
Rest of portfolio 651 -8 1 415 -1 2 066 -4 -3
Total Division sales 2 806 4 5 496 1 8 302 2 2
Net sales reflect Xolair sales for all indications (e.g. including Xolair SAA and Xolair CSU, which is managed by the Immunology and Dermatology franchise).
nm = not meaningful

60

 
Net sales of the top 20 Innovative Medicines products in 2017 – Nine months to September 30

US Rest of world Total

Brands


Business Franchise


Indication


USD m
% change
in constant
currencies


USD m
% change
in constant
currencies


USD m

% change
in USD
% change
in constant
currencies
Gilenya Neuroscience Relapsing multiple sclerosis 1 276 3 1 084 4 2 360 3 3
Gleevec/Glivec Oncology Chronic myeloid leukemia and GIST 498 -48 997 -37 1 495 -42 -41
Cosentyx Immunology and Dermatology Psoriasis, ankylosing spondylitis and psoriatic arthritis 912 80 544 139 1 456 98 98
Lucentis Ophthalmology Age-related macular degeneration 1 403 4 1 403 1 4
Tasigna Oncology Chronic myeloid leukemia 599 13 757 7 1 356 6 9
Sandostatin Oncology Carcinoid tumors and Acromegaly 618 -3 573 -1 1 191 -4 -2
Afinitor/Votubia Oncology Breast cancer / TSC 603 5 515 -3 1 118 -1 1
Galvus Established Medicines Diabetes 906 3 906 1 3
Exjade/Jadenu Oncology Chronic iron overload 376 10 402 10 778 8 10
Diovan/Co–Diovan Established Medicines Hypertension 63 -43 650 -5 713 -13 -10
Exforge Established Medicines Hypertension 23 nm 688 3 711 3 5
Xolair1 Respiratory Asthma 673 12 673 9 12
Tafinlar + Mekinist Oncology Melanoma 246 11 381 41 627 27 28
Promacta/Revolade Oncology Immune thrombocytopenic purpura 318 45 294 26 612 34 35
Votrient Oncology Renal cell carcinoma 305 16 290 7 595 11 11
Jakavi Oncology Myelofibrosis 549 32 549 31 32
Travoprost Group Ophthalmology Reduction of elevated intraocular pressure 161 5 278 -7 439 -4 -3
Neoral/Sandimmun(e) Immunology and Dermatology Transplantation 31 3 333 -5 364 -6 -4
Voltaren/Cataflam Established Medicines Inflammation/pain 346 -1 346 -11 -1
Entresto Cardio-Metabolic Chronic Heart Failure 197 190 125 269 322 216 215
Top 20 products total 6 226 6 11 788 3 18 014 2 4
Rest of portfolio 1 975 -12 4 280 -1 6 255 -6 -5
Total Division sales 8 201 1 16 068 2 24 269 0 2
 
Net sales reflect Xolair sales for all indications (e.g. including Xolair SAA and Xolair CSU, which is managed by the Immunology and Dermatology franchise).
nm = not meaningful

61

 
Innovative Medicines net sales by business franchise – Third quarter

Q3 2017 Q3 2016 % change % change
USD m USD m USD cc
Oncology
Gleevec/Glivec 445 834 -47 -47
Tasigna 482 441 9 12
Sandostatin 402 413 -3 -1
Afinitor/Votubia 389 393 -1 0
Exjade/Jadenu 264 242 9 11
Tafinlar + Mekinist 224 172 30 27
Promacta/Revolade 227 168 35 36
Votrient 213 183 16 15
Jakavi 201 149 35 31
Kisqali 26 0 nm nm
Other 228 240 -5 -3
Total Oncology business unit 3 101 3 235 -4 -4
Ophthalmology
Lucentis 481 456 5 5
Travoprost Group 149 151 -1 -1
Systane Group 100 96 4 2
Topical Olopatadine Group 49 81 -40 -39
Other 544 586 -7 -7
Total Ophthalmology 1 323 1 370 -3 -3
Immunology and Dermatology
Cosentyx 556 301 85 83
Neoral/Sandimmun(e) 126 130 -3 -2
Zortress/Certican 107 101 6 6
Ilaris 107 73 47 47
Myfortic 94 97 -3 -1
Other 73 68 7 3
Total Immunology and Dermatology 1 063 770 38 37
Neuroscience
Gilenya 801 790 1 0
Other 26 30 -13 -11
Total Neuroscience 827 820 1 0
Respiratory
Ultibro Breezhaler 101 95 6 3
Seebri Breezhaler 37 37 0 2
Onbrez Breezhaler 27 37 -27 -16
Subtotal COPD1 portfolio 165 169 -2 -1
Xolair2 245 215 14 12
Other 5 6 -17 -29
Total Respiratory 415 390 6 6
Cardio-Metabolic
Entresto 128 53 142 138
Other 5 4 25 21
Total Cardio-Metabolic 133 57 133 130
Established Medicines
Galvus 310 306 1 3
Diovan/Co-Diovan 231 261 -11 -10
Exforge 244 232 5 4
Voltaren/Cataflam 118 131 -10 -2
Exelon/Exelon Patch 95 104 -9 -10
Ritalin/Focalin 44 62 -29 -32
Other 398 435 -9 -6
Total Established Medicines 1 440 1 531 -6 -4
Total Pharmaceuticals business unit 5 201 4 938 5 6
Total Division net sales 8 302 8 173 2 2
Chronic Obstructive Pulmonary Disease
Net sales reflect Xolair sales for all indications (e.g. including Xolair SAA and Xolair CSU, which is managed by the Immunology and Dermatology franchise).
 
 
 
nm = not meaningful

62

 
Innovative Medicines net sales by business franchise – Nine months to September 30

9M 2017 9M 2016 % change % change
USD m USD m USD cc
Oncology
Gleevec/Glivec 1 495 2 559 -42 -41
Tasigna 1 356 1 281 6 9
Sandostatin 1 191 1 238 -4 -2
Afinitor/Votubia 1 118 1 125 -1 1
Exjade/Jadenu 778 719 8 10
Tafinlar + Mekinist 627 494 27 28
Promacta/Revolade 612 457 34 35
Votrient 595 537 11 11
Jakavi 549 419 31 32
Kisqali 41 0 nm nm
Other 669 754 -11 -9
Total Oncology business unit 9 031 9 583 -6 -4
Ophthalmology
Lucentis 1 403 1 383 1 4
Travoprost Group 439 458 -4 -3
Systane Group 292 277 5 5
Topical Olopatadine Group 225 280 -20 -19
Other 1 663 1 746 -5 -4
Total Ophthalmology 4 022 4 144 -3 -2
Immunology and Dermatology
Cosentyx 1 456 737 98 98
Neoral/Sandimmun(e) 364 389 -6 -4
Zortress/Certican 298 294 1 3
Ilaris 287 208 38 39
Myfortic 274 292 -6 -1
Other 207 204 1 1
Total Immunology and Dermatology 2 886 2 124 36 38
Neuroscience
Gilenya 2 360 2 299 3 3
Other 77 94 -18 -17
Total Neuroscience 2 437 2 393 2 3
Respiratory
Ultibro Breezhaler 291 273 7 8
Seebri Breezhaler 109 111 -2 2
Onbrez Breezhaler 83 107 -22 -15
Subtotal COPD1 portfolio 483 491 -2 2
Xolair2 673 619 9 12
Other 16 23 -30 -18
Total Respiratory 1 172 1 133 3 7
Cardio-Metabolic
Entresto 322 102 216 215
Other 12 10 20 21
Total Cardio-Metabolic 334 112 198 198
Established Medicines
Galvus 906 895 1 3
Diovan/Co-Diovan 713 816 -13 -10
Exforge 711 689 3 5
Voltaren/Cataflam 346 389 -11 -1
Exelon/Exelon Patch 293 330 -11 -11
Ritalin/Focalin 162 209 -22 -24
Other 1 256 1 472 -15 -12
Total Established Medicines 4 387 4 800 -9 -6
Total Pharmaceuticals business unit 15 238 14 706 4 6
Total Division net sales 24 269 24 289 0 2
Chronic Obstructive Pulmonary Disease
Net sales reflect Xolair sales for all indications (e.g. including Xolair SAA and Xolair CSU, which is managed by the Immunology and Dermatology franchise).
 
 
 
nm = not meaningful

63

 
Net sales by region1 – Third quarter

Q3 2017 Q3 2016 % change Q3 2017 Q3 2016
USD m USD m USD cc % of total % of total
Innovative Medicines
Europe
2 887 2 797 3 -1 35 34
US
2 806 2 710 4 4 34 33
Asia/Africa/Australasia
1 925 1 929 0 3 23 24
Canada and Latin America
684 737 -7 1 8 9
Total 8 302 8 173 2 2 100 100
Of which in Established Markets
6 227 6 102 2 1 75 75
Of which in Emerging Growth Markets
2 075 2 071 0 5 25 25
Sandoz
Europe
1 233 1 087 13 8 48 43
US
798 917 -13 -13 31 36
Asia/Africa/Australasia
354 341 4 8 14 14
Canada and Latin America
199 172 16 14 7 7
Total 2 584 2 517 3 1 100 100
Of which in Established Markets
1 881 1 894 -1 -3 73 75
Of which in Emerging Growth Markets
703 623 13 12 27 25
Alcon
Europe
382 352 9 4 25 25
US
648 628 3 3 42 44
Asia/Africa/Australasia
379 333 14 16 25 23
Canada and Latin America
118 123 -4 7 8 8
Total 1 527 1 436 6 7 100 100
Of which in Established Markets
1 176 1 138 3 3 77 79
Of which in Emerging Growth Markets
351 298 18 21 23 21
Group
Europe
4 502 4 236 6 2 36 35
US
4 252 4 255 0 0 34 35
Asia/Africa/Australasia
2 658 2 603 2 6 21 21
Canada and Latin America
1 001 1 032 -3 4 9 9
Total 12 413 12 126 2 2 100 100
Of which in Established Markets
9 284 9 134 2 0 75 75
Of which in Emerging Growth Markets
3 129 2 992 5 8 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.
 
 

64

 
Net sales by region1 – Nine months to September 30

9M 2017 9M 2016 % change 9M 2017 9M 2016
USD m USD m USD cc % of total % of total
Innovative Medicines
Europe
8 280 8 385 -1 0 34 35
US
8 201 8 101 1 1 34 33
Asia/Africa/Australasia
5 760 5 736 0 3 24 24
Canada and Latin America
2 028 2 067 -2 6 8 8
Total 24 269 24 289 0 2 100 100
Of which in Established Markets
18 108 18 231 -1 0 75 75
Of which in Emerging Growth Markets
6 161 6 058 2 7 25 25
Sandoz
Europe
3 398 3 241 5 4 46 43
US
2 482 2 747 -10 -10 33 36
Asia/Africa/Australasia
1 014 1 054 -4 0 14 14
Canada and Latin America
571 497 15 12 7 7
Total 7 465 7 539 -1 -1 100 100
Of which in Established Markets
5 482 5 639 -3 -3 73 75
Of which in Emerging Growth Markets
1 983 1 900 4 4 27 25
Alcon
Europe
1 150 1 130 2 3 26 26
US
1 902 1 889 1 1 43 43
Asia/Africa/Australasia
1 069 995 7 8 24 23
Canada and Latin America
339 354 -4 5 7 8
Total 4 460 4 368 2 3 100 100
Of which in Established Markets
3 482 3 479 0 1 78 80
Of which in Emerging Growth Markets
978 889 10 14 22 20
Group
Europe
12 828 12 756 1 1 35 35
US
12 585 12 737 -1 -1 35 35
Asia/Africa/Australasia
7 843 7 785 1 4 22 22
Canada and Latin America
2 938 2 918 1 7 8 8
Total 36 194 36 196 0 1 100 100
Of which in Established Markets
27 072 27 349 -1 0 75 76
Of which in Emerging Growth Markets
9 122 8 847 3 7 25 24
 
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.
 
 

65

 
Principal currency translation rates

Third quarter


Average
rates
Q3 2017

Average
rates
Q3 2016
Period-end
rates
Sep 30,
2017
Period-end
rates
Sep 30,
2016
1 CHF 1.039 1.025 1.031 1.035
1 CNY 0.150 0.150 0.150 0.150
1 EUR 1.175 1.116 1.180 1.121
1 GBP 1.309 1.314 1.342 1.295
100 JPY 0.901 0.976 0.888 0.991
100 RUB 1.696 1.548 1.725 1.577



Nine months to September 30


Average
rates
9M 2017

Average
rates
9M 2016
Period-end
rates
Sep 30,
2017
Period-end
rates
Sep 30,
2016
1 CHF 1.017 1.020 1.031 1.035
1 CNY 0.147 0.152 0.150 0.150
1 EUR 1.113 1.116 1.180 1.121
1 GBP 1.275 1.393 1.342 1.295
100 JPY 0.893 0.923 0.888 0.991
100 RUB 1.716 1.468 1.725 1.577





66

 
Income from associated companies

(USD millions) Q3 2017 Q3 2016 9M 2017 9M 2016
Share of estimated Roche reported results
180 162 509 522
Prior-year adjustment
-67 -68
Amortization of additional intangible assets recognized by Novartis on initial accounting for the equity interest
-38 -37 -110 -110
Net income effect from Roche Holding AG 142 125 332 344
Share of estimated GSK Consumer Healthcare Holdings Ltd. reported results
120 95 296 229
Prior-year adjustment
47 -22
Amortization of additional intangible assets recognized by Novartis on initial accounting for the equity interest
-1 -4 -5 -9
Net income effect from GlaxoSmithKline Consumer Healthcare Holdings Ltd. 119 91 338 198
Others 1 1 22 5
Income from associated companies 262 217 692 547
 

Core income from associated companies

(USD millions) Q3 2017 Q3 2016 9M 2017 9M 2016
Income from associated companies 262 217 692 547
Share of estimated Roche core adjustments 84 79 243 187
Roche prior year adjustment 70 36
Share of estimated GSK Consumer Healthcare Holdings Ltd. core adjustments 13 -1 49 69
GSK Consumer Healthcare Holdings Ltd. prior year adjustment -19 15
Others 1
Core income from associated companies 359 295 1 036 854

67

 


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 “growing,” “driven,” “continued,” “growth drivers,” “momentum,” “progress,” “launches,” “launched,” “strategic review,” “outlook,” “on track,” “guidance,” “confidence,” “growth phase,” “expect,” “expected,” “growth plan,” “launch trajectory,” “launch,” “continued focus,” “pipelines,” “option,” “priority review,” “seeks,” “proposed,” “ongoing,” “discussing,” “plans,” “under review,” “to accelerate,” “to strengthen,” “for the future,” “continues,” “continue,” “priorities,” “improving,” “reviewing,” “strategies,” “enabling,” “strategy,” “remains a priority,” “to be executed,” “aims,” “re-confirm,” “would,” “estimated,” “will,” “potential,” “pipeline,” “initiate,” “recommended,” “recommendation,” “next-generation,” “investigating,” “evaluating,” “begin evaluation,” “commitment,” “planned,” “subject to,” “Fast Track designation,” “underway,” “submitted,” “can,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; potential shareholder returns or credit ratings; or regarding the potential outcome of the strategic review being undertaken to maximize shareholder value of the Alcon Division; or regarding the potential financial or other impact on Novartis or any of our divisions of the significant reorganizations of recent years, including the creation of the Pharmaceuticals and Oncology business units to form the Innovative Medicines Division, the creation of the Global Drug Development organization and Novartis Operations (including Novartis Technical Operations and Novartis Business Services), the transfer of the Ophthalmic Pharmaceuticals products of our Alcon Division to the Innovative Medicines Division, the transfer of selected mature, non-promoted pharmaceutical products from the Innovative Medicines Division to the Sandoz Division, and the transactions with GSK, Lilly and CSL; or regarding the potential impact of the share buyback plan; or regarding potential future sales or earnings of the Novartis Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward looking statements are based on our current beliefs and expectations 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. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee that the strategic review being undertaken to maximize shareholder value of the Alcon Division will reach any particular results, or at any particular time. Neither can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the significant reorganizations of recent years, including the creation of the Pharmaceuticals and Oncology business units to form the Innovative Medicines Division, the creation of the Global Drug Development organization and Novartis Operations (including Novartis Technical Operations and Novartis Business Services), the transfer of the Ophthalmic Pharmaceuticals products of our Alcon Division to the Innovative Medicines Division, the transfer of selected mature, non-promoted pharmaceutical products from the Innovative Medicines Division to the Sandoz Division, and the transactions with GSK, Lilly and CSL. Neither can there be any guarantee that shareholders will achieve any particular level of shareholder returns. Nor can there be any guarantee that the Group, or any of its divisions, will be commercially successful in the future, or achieve any particular credit rating or financial results. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the significant reorganizations of recent years, including the creation of the Pharmaceuticals and Oncology business units to form the Innovative Medicines Division, the creation of the Global Drug Development organization and Novartis Operations (including Novartis Technical Operations and Novartis Business Services), the transfer of the Ophthalmic Pharmaceuticals products of our Alcon Division to the Innovative Medicines Division, the transfer of selected mature, non-promoted pharmaceutical products from the Innovative Medicines Division to the Sandoz Division, and the transactions with GSK, Lilly and CSL may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; 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 which commenced in prior years and will continue this year; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; the particular prescribing preferences of physicians and patients; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes and government investigations generally; general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and 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. Jakafi® is a registered trademark of Incyte Corporation. Enbrel® is a registered trademark of Amgen Inc. Stelara® is a trademark of Janssen Biotech, Inc. Rituxan® is a registered trademark of Biogen. Humira® is a registered trademark of AbbVie Inc.
 
 
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About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 121,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

Important dates
November 13, 2017   R&D update and investor event in London
January 24, 2018    Fourth quarter and full year results 2017
March 2, 2018     Annual General Meeting
April 19, 2018      First quarter results 2018
May 15-16, 2018    Meet Novartis Management investor event in Basel
July 18, 2018       Second quarter results 2018
October 18, 2018      Third quarter results 2018
 
 
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