EX-99 3 a120719-99_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


INTERIM FINANCIAL REPORT – SUPPLEMENTARY DATA

Novartis Q2 and First Half 2012 Interim Financial Report – Supplementary Data

INDEX
Page
GROUP AND DIVISIONAL OPERATING PERFORMANCE Q2 2012 and H1 2012
 
Group
2
Pharmaceuticals
6
Alcon
12
Sandoz
14
Vaccines and Diagnostics
16
Consumer Health
17
GROUP BALANCE SHEET AND CASH FLOW
19
INNOVATION REVIEW
21
CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
 
Consolidated income statements
30
Consolidated statements of comprehensive income
32
Condensed consolidated balance sheets
33
Condensed consolidated changes in equity
34
Condensed consolidated cash flow statements
35
Notes to Condensed Interim Consolidated Financial Statements, including update on legal proceedings
37
SUPPLEMENTARY INFORMATION
43
CORE RESULTS
 
Reconciliation from IFRS to core results
44
Group
46
Pharmaceuticals
48
Alcon
50
Sandoz
52
Vaccines and Diagnostics
54
Consumer Health
56
Corporate
57
ADDITIONAL INFORMATION
 
Condensed consolidated changes in net debt
58
Free cash flow / Share information / Summary of equity movements
59
Net sales of top 20 Pharmaceuticals Division products
61
Pharmaceuticals Division sales by therapeutic area
63
Net sales by region
65
Income from associated companies
67
DISCLAIMER
68


 
 
 

 


GROUP AND DIVISIONAL OPERATING PERFORMANCE

Key figures
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
      14 303       14 915       -4       1       28 038       28 942       -3       0  
Divisional operating income
      3 323       3 456       -4       1       6 225       7 017       -11       -8  
Corporate income & expense, net
      -135       -134       1       8       -222       -287       -23       -20  
Group operating income
      3 188       3 322       -4       1       6 003       6 730       -11       -7  
    As % of net sales
      22.3       22.3                       21.4       23.3                  
Income from associated companies
      176       130       35       36       304       247       23       23  
Interest expense
      -183       -190       -4       3       -347       -379       -8       -6  
Other financial income and expense
      34       -16    
nm
   
nm
      -7       6    
nm
      -49  
Taxes
      -482       -520       -7       -3       -893       -1 057       -16       -12  
Net income
      2 733       2 726       0       5       5 060       5 547       -9       -5  
EPS (USD)
      1.12       1.13       -1       4       2.07       2.33       -11       -7  
Free cash flow
      2 311       3 297       -30               4 367       4 919       -11          
 
Core1
                                                                 
Operating income
      3 911       4 235       -8       -3       7 597       8 247       -8       -5  
    As % of net sales
      27.3       28.4                       27.1       28.5                  
Net income
      3 356       3 564       -6       -2       6 449       6 940       -7       -4  
EPS (USD)
      1.38       1.48       -7       -3       2.65       2.88       -8       -5  
nm = not meaningful

Second quarter

Group net sales
Group net sales reached USD 14.3 billion (-4%, +1% cc) in the second quarter, with growth from recently launched products more than offsetting the loss associated with the Diovan patent expiration. Currency had a negative impact of 5 percentage points as a result of the strengthening of the dollar against most major currencies.

The rejuvenation of our portfolio is key to our long-term growth. Products launched since 2007, which include Lucentis, Gilenya, Afinitor and Tasigna, continued to perform strongly. These recently launched products grew 8% to USD 4.1 billion and now comprise 29% of Group net sales, up from 25% a year ago.

Corporate income and expense, net
Corporate income and expense, net, which includes the costs of Group management and central services, remained constant compared to the prior year and amounted to a net expense of USD 135 million.



 
1 The Group’s core results – including core operating income, core net income and core earnings per share – exclude amortization of intangible assets, impairment charges, expenses relating to the integration of acquisitions as well as other items that are, or are expected to accumulate within the year to be, over a USD 25 million threshold that management deems exceptional. See further information and definition of core results on page 43.

2
 
 

 


Group operating income
In the second quarter of 2012, the adjustments made to Group operating income to arrive at core operating income amounted to a net expense of USD 723 million (2011 USD 913 million). These adjustments included the amortization of intangible assets (USD 711 million, mainly related to Alcon, compared to USD 744 million in the 2011 period) and exceptional items (net expense of USD 12 million, compared to USD 169 million in 2011). Exceptional expenses included USD 68 million of acquisition-related expenses related to Alcon and USD 63 million related to impairment charges in various divisions. These were offset by exceptional gains of USD 191 million, of which the principal items were USD 79 million of provision reductions in the Pharmaceuticals Division and a favorable settlement gain of USD 56 million in the Vaccines and Diagnostics Division. The previous year benefited from exceptional income of USD 338 million arising from a product divestment in the Pharmaceuticals Division offset by a number of exceptional expense items totaling USD 507 million, principally impairment charges in the Pharmaceuticals and Vaccines and Diagnostics Divisions of USD 107 million and USD 62 million, respectively, and a USD 150 million legal settlement in the Sandoz Division.

As a result, Group core operating income decreased 8% (-3% cc) to USD 3.9 billion. Core operating income margin in constant currencies decreased by 1.2 percentage points. Together with a positive currency impact of 0.1 percentage points it resulted in a net decrease in core operating income margin of 1.1 percentage points to 27.3% of net sales.

Income from associated companies
Income from associated companies increased to USD 176 million from USD 130 million in the year-ago period. This income comprises mainly the Novartis share of the estimated net result in Roche AG of USD 151 million (including amortization of intangible assets of USD 38 million).

The core income from associated companies increased to USD 204 million from USD 170 million in the prior-year period.

Interest expense and other financial income/expense
The interest expense decreased to USD 183 million in the second quarter of 2012 from USD 190 million in the prior-year quarter as a result of lower average gross financial debt compared to the prior year and lower interest rates. Other financial income and expense was a net income of USD 34 million, mainly resulting from currency gains compared to a net expense of USD 16 million in the prior-year period.

Taxes
The tax rate (taxes as percentage of pre-tax income) decreased in the second quarter to 15.0% from 16.0% in the prior-year period, principally due to the impact of the debt restructuring in June 2011 following the Alcon merger, and due to lower income in higher tax jurisdictions.

The core tax rate (taxes as a percentage of core pre-tax income) increased to 15.4% in the second quarter 2012 from 15.1% in the same period a year ago.

Net income and EPS
Group net income remained at USD 2.7 billion as the decline in operating income was offset by higher income from associated companies, better financial results and a lower tax rate. The EPS of USD 1.12 is marginally lower compared to the prior year figure of USD 1.13 as a result of the Alcon merger-related higher number of average outstanding shares.

Core net income decreased by USD 0.2 billion to USD 3.4 billion or 6% (-2% cc) largely in line with the decline in core operating income. Core EPS declined 7% (-3% cc) to USD 1.38.

Free cash flow
Free cash flow of USD 2.3 billion in the second quarter was 30% below the previous year (USD 3.3 billion). Lower divestment proceeds (USD 0.4 billion) and higher payment of tax (USD 0.3 billion) primarily accounted for most of the decline.


3
 
 

 


First half

Group net sales
Group net sales amounted to USD 28.0 billion (-3%, 0% cc), with strong sales of recently launched products offsetting the negative impact of the Diovan patent expiration. Currency depressed results by 3 percentage points.

Across the Group’s diversified healthcare portfolio, products launched since 2007 continued to perform strongly with 12% growth over the previous year. These recently launched products now comprise 28% of Group net sales, up from 24% a year ago.

Corporate income and expense, net
Corporate income and expense, net, amounted to a net expense of USD 222 million in the first six months of 2012, lower than the prior-year amount of USD 287 million principally due to the current year including an exceptional gain from the sale of a financial asset of USD 51 million.

Group operating income
In the first half year of 2012, the adjustments made to Group operating income to arrive at core operating income amounted to a net expense of USD 1.6 billion (2011 USD 1.5 billion). These adjustments included the amortization of intangible assets (USD 1.4 billion, mainly related to Alcon, compared to USD 1.5 billion in the 2011 period) and exceptional items (net expense of USD 169 million, compared to a net income of USD 8 million in 2011). Exceptional expenses included USD 149 million for a US restructuring in the Pharmaceuticals Division and USD 123 million of acquisition-related expenses related to Alcon. These were offset by exceptional gains of USD 330 million, of which the principal items were USD 137 million of provision reductions in the Pharmaceuticals Division, a settlement gain of USD 56 million in the Vaccines and Diagnostics Division and a gain from the sale of financial assets of USD 51 million. The previous year benefited from exceptional income of USD 714 million, of which USD 338 million arose from a product divestment gain in the Pharmaceuticals Division; USD 230 million from a legal settlement in the Alcon Division and USD 102 million from divestments required to complete the Alcon merger, offset by a number of exceptional expense items totaling USD 706 million, principally impairment charges in the Pharmaceuticals and Vaccines and Diagnostics Divisions of USD 107 million and USD 81 million, respectively, and USD 178 million of legal settlements in the Sandoz Division.

As a result, Group core operating income decreased 8% (-5% cc) to USD 7.6 billion. Core operating income margin in constant currencies decreased by 1.5 percentage points to 27.1% of net sales.

Income from associated companies
Income from associated companies increased by 23% to USD 304 million, primarily due to a higher estimated income contribution from Roche.

The core income from associated companies increased to USD 379 million from USD 366 million in the prior-year period.

Interest expense and other financial income/expense
Interest expense decreased to USD 347 million in the first half of 2012 from USD 379 million in the prior-year period as a result of lower average gross financial debt compared to the prior year and lower interest rates. Other financial income and expense was a net expense of USD 7 million, mainly resulting from currency losses compared to a net income of USD 6 million in the prior-year period.

Taxes
The tax rate (taxes as percentage of pre-tax income) decreased in the first half of 2012 to 15.0% from 16.0% in the prior-year period, principally due to the impact of the debt restructuring in June 2011, following the Alcon merger, and due to lower income in higher tax jurisdictions.

The core tax rate (taxes as a percentage of core pre-tax income) decreased to 15.4% in first half 2012 from 15.8% in the same period a year ago.

Net income and EPS
Group net income declined 9% (-5% cc) to USD 5.1 billion following the decline in operating income and was only partially offset by better financial results, higher income from associated companies and a lower tax rate. EPS declined 11% (-7% cc) to USD 2.07 at a slightly higher rate than net income as a result of the Alcon merger-related higher number of average outstanding shares.

4
 
 

 


Core net income decreased by USD 0.5 billion to USD 6.4 billion or 7% (-4% cc) largely in line with the decline in core operating income. Core EPS declined 8% (-5% cc) to USD 2.65.

Free cash flow
Free cash flow of USD 4.4 billion in the first half was 11% lower than the previous year (USD 4.9 billion). Lower operating income (USD 0.7 billion) and lower divestment proceeds (USD 0.5 billion) were partially offset by lower payments of tax and provisions (USD 0.4 billion) and lower working capital (USD 0.3 billion).


5
 
 

 




Pharmaceuticals
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
      8 255       8 338       -1       4       16 094       16 036       0       4  
Operating income
      2 741       2 791       -2       3       5 143       5 252       -2       1  
  As % of net sales
      33.2       33.5                       32.0       32.8                  
Core operating income
      2 746       2 699       2       6       5 335       5 241       2       5  
  As % of net sales
      33.3       32.4                       33.1       32.7                  

Second quarter

Net sales
Net sales of USD 8.3 billion (-1%, +4% cc) were driven by 9 percentage points of volume growth, partly offset by the impact of generic entries of 4 percentage points and a negative pricing impact of 1 percentage point. Products launched since 2007 generated USD 2.8 billion of net sales, growing 28% in cc over the same period last year. These recently launched products – Lucentis, Exforge, Exelon Patch, Exjade, Reclast/Aclasta, Tekturna/Rasilez, Tasigna, Afinitor, Arcapta Neohaler/Onbrez Breezhaler, Ilaris, Fanapt and Gilenya – now comprise 34% of division sales, compared to 28% in the same period last year.

Europe (USD 2.6 billion, -6% cc) was impacted by generic competition, mainly for Diovan following the loss of exclusivity in November 2011, which offset the strong performance of recently launched products now contributing 44% of net sales for the region. US sales (USD 2.8 billion, +10% cc) benefited from continued strong performance for Tasigna and Gilenya, which offset generic competition for Femara. Latin America and Canada (USD 0.8 billion, +10% cc) and Japan (USD 1.0 billion, +6% cc) achieved strong growth rates, fueled by new product launches. The Emerging Growth Markets (USD 1.9 billion, +5% cc) were led by particularly strong growth in China and India.

Excluding the impact from generic competition for Femara in the US and Europe, Oncology (USD 2.7 billion, +3% cc) delivered strong underlying growth of 9% (cc). Growth was driven by the continued strong performance of Gleevec/Glivec and Tasigna (combined sales of USD 1.4 billion, +9% cc), as well as Sandostatin (USD 370 million, +6% cc) and Afinitor, which contributed USD 175 million (+80% cc). Primary Care franchise performance (USD 2 billion, -6% cc) was impacted by the expected sales decline in Diovan (USD 1.3 billion, -15% cc) due to the loss of exclusivity in Europe and Canada. Excluding Diovan, the Primary Care franchise grew 15% (cc), underpinned by the continued strong uptake of Galvus (USD 224 million, +47% cc) and Exforge (USD 352 million, +20% cc). In Specialty Care, the Neuroscience franchise (USD 0.7 billion, +39% cc) saw strong growth from Gilenya (USD 283 million), following successful launches in both the US and Europe. The Ophthalmics franchise (USD 0.6 billion, +20% cc) benefited from the strong performance of Lucentis (USD 604 million, +20% cc).

Operating income
Operating income was USD 2.7 billion (-2%, +3% cc). The operating income margin decreased by 0.4 percentage points in cc, with a positive currency impact of 0.1 percentage points resulting in an operating income margin of 33.2% of net sales. Included in the operating income in 2012 were USD 79 million of provision reductions mainly related to aliskiren inventory, whereas the second quarter of 2011 included divestment income from Elidel® (USD 324 million, net) and intangible asset impairment charges of USD 107 million.

Core operating income increased 2% (+6% cc) to USD 2.7 billion. Core operating income margin in constant currencies increased 0.8 percentage points. An additional positive currency impact of 0.1 percentage points resulted in a core operating income margin of 33.3% of net sales. Gross margin declined by 2.3 percentage points due to increased royalties (-0.7 percentage points), mainly for Lucentis and Gilenya, and unfavorable product mix. R&D expenses decreased by 0.7 percentage points of net sales in constant currencies. Marketing & Sales and General & Administration expenses improved margin by 1.5 percentage points (cc), benefiting from continuing productivity efforts despite significant investments in new product launches. Other Income and Expense, net, improved margin by 0.9 percentage point (cc).


6
 
 

 


First half

Net sales
Net sales expanded +4% in constant currencies (0% USD) to USD 16.1 billion, driven by 9 percentage points of volume growth, partly offset by the impact of generic entries of 5 percentage points and flat pricing. Recently launched products provided USD 5.5 billion of net sales, representing 34% of total net sales for the division compared to 27% in the 2011 period.

Europe (USD 5.1 billion, -6% cc) was impacted by generic competition but benefited from recently launched products, which generated 43% of net sales. The US (USD 5.4 billion, +9% cc) contributed 33% of total sales for the division. Japan’s performance (USD 1.9 billion, 4% cc) improved versus prior year due to new launches. Latin America and Canada (USD 1.5 billion, +10% cc) maintained solid growth rates despite the Diovan generic impact in Canada. The Emerging Growth Markets (USD 3.6 billion, +6% cc) were led by double-digit growth from China and India.

Operating income
Operating income was USD 5.1 billion (-2%, +1% cc). The operating income margin decreased by 0.7 percentage points in cc with a negative currency impact of 0.1 percentage point resulting in an operating income margin of 32.0% of net sales. Included in the operating income in 2012 were restructuring charges of USD 149 million related to the US General Medicine business announced in January and USD 137 million of provision reductions mainly related to aliskiren inventory, whereas the first half of 2011 included divestment income from ophthalmic products related to the Alcon acquisition (USD 81 million) and Elidel® (USD 324 million, net), as well as intangible asset impairment charges of USD 107 million.

Core operating income grew 2% (+5% cc) to USD 5.3 billion. In constant currencies, core operating income margin improved by 0.6 percentage points due to continuing productivity efforts. Currency movements negatively impacted core operating income margin by 0.2 percentage points resulting in a core operating income margin of 33.1% of net sales. The underlying gross margin decreased by 2.1 percentage points (cc), mainly driven by royalties and product mix. R&D expenses decreased by 0.8 percentage points (cc). Marketing & Sales and General & Administration expenses improved operating income margin by 0.9 percentage points (cc). Other Income and Expense, net decreased by 1.0 percentage point (cc).

Pharmaceuticals product review

All comments below focus on second quarter movements.

PRIMARY CARE
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Hypertension medicines
                                                         
Diovan
      1 266       1 513       -16       -15       2 456       2 918       -16       -15  
Exforge
      352       308       14       20       655       569       15       19  
  Subtotal Valsartan Group
      1 618       1 821       -11       -9       3 111       3 487       -11       -10  
Tekturna/Rasilez
      98       159       -38       -35       227       290       -22       -19  
Subtotal Hypertension
      1 716       1 980       -13       -11       3 338       3 777       -12       -10  
Galvus
      224       165       36       47       425       297       43       52  
Arcapta Neohaler/Onbrez Breezhaler
      33       26       27       44       62       46       35       47  
Total strategic franchise products
      1 973       2 171       -9       -6       3 825       4 120       -7       -5  
Established medicines
      411       438       -6       -2       784       885       -11       -9  
Total
      2 384       2 609       -9       -5       4 609       5 005       -8       -6  

Diovan Group (USD 1.3 billion, -15% cc), consisting of Diovan and Diovan HCT, saw worldwide sales decline due to the loss of exclusivity in the EU and Canada. Diovan Group remains a top-selling anti-hypertensive medication worldwide, with 12.8% share of the global hypertension market (Apr. 2012 MAT, IMS PADDS), and sustained performance in key Emerging Growth Markets such as China, as well as select countries in Latin America, Asia Pacific, Middle East and Africa.


7
 
 

 


Exforge Group (USD 352 million, +20% cc), which includes Exforge and Exforge HCT, showed strong worldwide growth, fueled by continued demand in the US, Asia Pacific and Middle East as well as ongoing Exforge HCT launches in Asia and Latin America. Exforge, a single-pill combination of Diovan and the calcium channel blocker amlodipine, delivered double-digit growth globally and is now available for patients in over 80 countries. Exforge HCT, which consists of Exforge with a diuretic (hydrochlorothiazide) in a single pill, is now available in over 40 countries, with additional launches expected in 2012.

Tekturna/Rasilez (USD 98 million, -35% cc) sales were down in the second quarter following requested label updates in the EU, US and Japan. The label updates followed our decision in December 2011 to halt the ALTITUDE study. Novartis continues to have discussions with health authorities worldwide regarding aliskiren and aliskiren-containing products. Novartis voluntarily ceased to market Valturna, a single pill combination containing aliskiren and the angiotensin receptor blocker (ARB) valsartan, in the US as of April 2012.

Galvus Group (USD 224 million, +47% cc), which includes oral treatments with vildagliptin for type 2 diabetes, continued to show strong growth in key markets, particularly in Europe, as well as Japan, China, Latin America and Asia Pacific. This performance was driven by new indications (as a monotherapy in patients who cannot take metformin) and use of vildagliptin in an expanded patient population (moderate and severe renal impairment). Vildagliptin is now approved in more than 100 countries.

Arcapta Neohaler/Onbrez Breezhaler (USD 33 million, +44% cc) continues to grow strongly as a once-daily long-acting beta2-agonist (LABA) for the maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). Onbrez Breezhaler (indacaterol) is now approved in more than 85 countries, most recently in China and South Africa. Indacaterol was launched in the US in March 2012 under the name Arcapta Neohaler and in Japan in December 2011 through a co-promotion agreement with Eisai Co. Ltd. under the name Onbrez Inhalation Capsules.

ONCOLOGY
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Gleevec/Glivec
      1 194       1 203       -1       4       2 324       2 279       2       5  
Tasigna
      237       170       39       45       446       323       38       42  
Subtotal Bcr-Abl franchise
      1 431       1 373       4       9       2 770       2 602       6       10  
Sandostatin
      370       365       1       6       740       702       5       9  
Zometa
      336       376       -11       -7       663       749       -11       -9  
Exjade
      219       232       -6       0       435       411       6       10  
Afinitor
      175       102       72       80       318       192       66       71  
Femara
      115       241       -52       -50       222       595       -63       -61  
Other
      37       39       -5       10       70       75       -7       0  
Total
      2 683       2 728       -2       3       5 218       5 326       -2       1  

Our Bcr-Abl franchise, consisting of Gleevec/Glivec and Tasigna, grew strongly, reaching USD 1.4 billion (+9% cc) in the second quarter.

Gleevec/Glivec (USD 1.2 billion, +4% cc) continued to grow as a targeted therapy for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), as a treatment for adult patients with metastatic and/or unresectable KIT+ gastrointestinal stromal tumors (GIST), and as an adjuvant treatment for certain adult patients following resection of KIT+ GIST. In the second quarter, Novartis filed marketing authorizations with the EMA and FDA for Gleevec/Glivec in pediatric Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL).

Tasigna (USD 237 million, +45% cc) is growing rapidly as a next-generation targeted therapy for certain adult patients with Ph+ CML. It has received regulatory approval in newly diagnosed Ph+ CML in the chronic phase in 70 markets globally, including the US, EU, Japan and Switzerland, with additional submissions pending worldwide. Tasigna is also approved as a second-line treatment for patients with Ph+ CML in chronic and accelerated phases in more than 95 countries. Tasigna market share continues to rise in both the first-line and second-line Ph+ CML settings.


8
 
 

 


Sandostatin (USD 370 million, +6% cc) continued to benefit from increasing use of Sandostatin LAR in key markets to treat the symptoms of patients with neuroendocrine tumors. Based on data from the Phase IIIb PROMID study, approvals have been granted in more than 30 countries for the delay of disease progression in patients with midgut carcinoid tumors. These data are currently under review for inclusion in the label in more than 20 additional countries. A total of 14 countries have approved a new presentation of Sandostatin LAR, which includes a new diluent, safety needle and vial adapter improving the mixing and administration of Sandostatin LAR, with additional filings underway.

Zometa (USD 336 million, -7% cc) is a leading bisphosphonate treatment used in the oncology setting to reduce or delay skeletal-related events in patients with bone metastases from solid tumors and multiple myeloma. Worldwide sales declined as anticipated in the second quarter due to new competition.

Exjade (USD 219 million, 0% cc), a once-daily oral therapy for transfusional iron overload, approved in more than 100 countries, was flat in the second quarter. Worldwide regulatory filings are underway for use in patients with non-transfusion-dependent thalassemia, a genetic disorder that affects red blood cell production, causing anemia.

Afinitor (USD 175 million, +80% cc), an oral inhibitor of the mTOR pathway used across multiple diseases, is now approved across four indications in the US. In the second quarter, Afinitor was approved by the FDA for patients with renal angiomyolipomas associated with tuberous sclerosis complex (TSC). In the second quarter, the EMA’s CHMP adopted a positive opinion for Afinitor (everolimus) in combination with the aromatase inhibitor exemestane for the treatment of postmenopausal women with HR+, HER2/neu- negative (HER2-) advanced breast cancer. The indication is currently also under review with the FDA. Afinitor is also approved for the treatment of patients with advanced renal cell carcinoma following VEGF-targeted therapy; advanced pancreatic neuroendocrine tumors; and subependymal giant cell astryocytomas associated with TSC (as Votubia in the EU). Everolimus, the active ingredient in Afinitor, 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.

Femara (USD 115 million, -50% cc) is a treatment for early stage and advanced breast cancer in postmenopausal women. Worldwide sales continued to decline in the second quarter due to competition from multiple generic entries in the US, Europe and other key markets.

SPECIALTY CARE

Neuroscience
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Gilenya
      283       79       258       268       530       138       284       292  
Exelon/Exelon Patch
      258       264       -2       4       529       515       3       7  
Comtan/Stalevo
      137       160       -14       -9       292       306       -5       -2  
Extavia
      38       44       -14       -4       75       78       -4       3  
Other (including Fanapt)
      19       8       138       139       35       17       106       108  
Total strategic franchise products
      735       555       32       39       1 461       1 054       39       43  
Established medicines
      126       142       -11       -5       247       278       -11       -7  
Total
      861       697       24       30       1 708       1 332       28       33  

Gilenya (USD 283 million, +268% cc), a once-daily oral therapy for relapsing remitting and/or relapsing forms of multiple sclerosis (MS) in adult patients, continued to show rapid growth. EU and US regulatory reviews of Gilenya concluded in the second quarter confirmed a positive benefit-risk profile when used in accordance with the updated labels announced earlier this year. Gilenya is now approved in more than 60 countries, and more than 38,000 patients have been prescribed the commercial product. Approximately 41,000 patients have been treated in clinical trials and in a post-marketing setting, and there are currently approximately 42,000 patient years of exposure. On April 25, 2012, the UK’s National Institute for Health and Clinical Excellence (NICE) confirmed its recommendation of Gilenya as a treatment option for patients with highly active relapsing-remitting MS in England and Wales. Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.


9
 
 

 


Exelon/Exelon Patch (USD 258 million, +4% cc) combined sales continued to grow. Exelon Patch, the transdermal form of the medicine, grew 14% cc and generated 85% of total Exelon sales in the second quarter. Exelon Patch is approved for the treatment of mild-to-moderate Alzheimer’s disease dementia in more than 80 countries, including more than 20 countries where it is also approved for Parkinson's disease dementia.

Ophthalmics
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Lucentis
      604       541       12       20       1 171       985       19       25  
Other
      26       25       4       7       48       62       -23       -19  
Total
      630       566       11       20       1 219       1 047       16       22  

Lucentis (USD 604 million, +20% cc), showed continued strong growth as the only anti-VEGF therapy licensed across three ocular indications: wet age-related macular degeneration (wet AMD), visual impairment due to diabetic macular edema (DME), and visual impairment due to macular edema secondary to retinal vein occlusion (RVO). In wet AMD, Lucentis is the standard of care and the only medicine approved in more than 100 countries to significantly improve vision in the majority of patients with this disease. Lucentis is approved for the treatment of visual impairment due to DME in more than 70 countries and macular edema secondary to RVO in more than 60 countries. In the second quarter, two year results of the publicly-funded CATT study, comparing treatments for macular degeneration, confirmed that there is an overall significantly higher risk of serious systemic adverse events with the use of unlicensed intravitreal Avastin® versus Lucentis. Since its launch in 2006, there are more than one million patient-treatment years of exposure for Lucentis. Genentech/Roche holds the rights to Lucentis in the US.

Integrated Hospital Care
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Neoral/Sandimmun
      209       227       -8       -4       407       441       -8       -5  
Myfortic
      134       135       -1       5       267       255       5       8  
Zortress/Certican
      52       50       4       13       98       92       7       13  
Ilaris
      20       12       67       68       35       23       52       58  
Other
      99       93       6       14       197       179       10       14  
Total strategic franchise products
      514       517       -1       5       1 004       990       1       5  
Everolimus stent drug
      81       80       1       10       167       163       2       5  
Established medicines
      294       321       -8       -5       579       619       -6       -5  
Total
      889       918       -3       2       1 750       1 772       -1       2  

Zortress/Certican (USD 52 million, +13% cc) is a transplantation medicine available in more than 85 countries to prevent organ rejection in adult heart and kidney transplant patients. It continues to generate solid growth, including in the US market. Everolimus, the active ingredient in Zortress/Certican, is marketed for other indications under the trade names Afinitor and Votubia. Everolimus is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

Ilaris (USD 20 million, +68% cc) is approved in over 60 countries for the treatment of adults and children who suffer from cryopyrin-associated periodic syndrome (CAPS), a group of rare auto-inflammatory disorders.


10
 
 

 


Critical Care
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Xolair
      127       125       2       10       239       232       3       9  
TOBI
      76       70       9       14       152       141       8       11  
Total
      203       195       4       11       391       373       5       10  

Xolair (USD 127 million, +10% cc), approved for severe persistent allergic asthma in Europe and for moderate-to-severe persistent allergic asthma in the US, gained blockbuster status in 2011 when annual global sales reached USD 1 billion (including US sales booked by Genentech/Roche). Xolair is approved in more than 90 countries and continues to grow strongly in Europe, major Latin American markets and Japan. Novartis co-promotes Xolair with Genentech/Roche in the US, and shares a portion of the operating income, but does not book US sales.

TOBI (USD 76 million, +14% cc, including TOBI nebulizer solution) continued to show robust growth, driven by ongoing launches of TOBI Podhaler in selected European, Latin American and Middle Eastern markets. Additional launches are planned for the second half of 2012. TOBI Podhaler, a novel inhaled dry powder formulation of the antibiotic tobramycin, is approved in the EU, Canada and other countries for cystic fibrosis patients aged six years and older. In the US, the New Drug Application (NDA) for TOBI Podhaler will be reviewed by the FDA’s Anti-Infective Drugs Advisory Committee in September.

11
 
 

 

 
Alcon
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
      2 648       2 625       1       5       5 189       5 041       3       6  
Operating income
      419       371       13       25       782       895       -13       -7  
  As % of net sales
      15.8       14.1                       15.1       17.8                  
Core operating income
      974       947       3       7       1 876       1 787       5       8  
  As % of net sales
      36.8       36.1                       36.2       35.4                  

Second quarter

Net sales
Net sales rose 1% (+5% cc) to USD 2.6 billion in the second quarter. This continued solid performance was led by Surgical sales growth of 3% (+8% cc) and contact lens sales growth of 2% (+6%), underpinned by a robust uptake of new products such as the LenSx femtosecond refractive cataract laser and Dailies Total1 silicone hydrogel daily disposable contact lens. Ophthalmic Pharmaceuticals declined 1% (+4% cc) in the quarter, impacted by a significant drop in ocular allergy incidence in the US.

Emerging Growth Markets had another quarter of strong growth, with net sales expanding 5% (+14% cc) over the previous-year period. In Japan, sales growth of 12% (+10% cc) benefitted from a strong Surgical and Ophthalmic Pharmaceuticals performance. US sales rose 4% (+4% cc), led by the robust performance of the Surgical franchise, dry eye products, and contact lenses, partially offset by weaker Travatan and ocular allergy season sales. European sales declined 8% (+2% cc) due to a slowdown in market growth, particularly in the cataract segment and Vision Care.

Operating income
Operating income of USD 419 million rose 13% (+25% cc), and included amortization of intangible assets (USD 477 million) and integration costs (USD 68 million).

Core operating income of USD 974 million increased by 3% (+7% cc). Alcon delivered operating leverage through productivity gains and the realization of post-integration synergies (USD 73 million), while continuing to invest in Emerging Growth Markets and R&D. Core operating income margin in constant currencies increased by 0.8 percentage points, with a negative currency impact of 0.1 percentage points, resulting in a net increase of 0.7 percentage points to 36.8% of net sales. Gross margin increased 1.0 percentage point to 75.3% of net sales. Marketing & Sales expenses, which represented 23.9% of net sales, improved by 1.3 percentage points (cc) despite increased investments in Emerging Growth Markets. General & Administration expenses remained at 5.0% of net sales in the 2012 period. Investments in R&D represented 9.0% of net sales, up 0.9 percentage points (cc) from the prior-year period. Starting in January 2012, R&D costs include an allocation of the Novartis Institutes for BioMedical Research (NIBR) ophthalmic research expenditures. Excluding the NIBR allocation, core operating income grew 5% (+10% cc).

First half

Net sales
Net sales rose 3% (+6% cc) to USD 5.2 billion, driven by strong Surgical growth of 6% (+9% cc) and solid Ophthalmic Pharmaceuticals growth of 2% (+5% cc), overcoming the impact of a mild US ocular allergy season.

Operating income
Operating income of USD 782 million declined 13% (-7% cc) due to the inclusion of exceptional settlement and divestment income in 2011. Operating income in the first half of 2012 included amortization of intangible assets (USD 954 million) and integration costs (USD 123 million).

Core operating income increased by 5% (+8% cc) to USD 1.9 billion. Core operating income margin in constant currencies increased by 0.6 percentage points, with a positive currency impact of 0.2 percentage points, resulting in a net increase of 0.8 percentage points to 36.2% of net sales. Excluding the NIBR allocation, core operating income grew 7% (+10% cc).



12
 
 

 


Alcon product review

All comments below focus on second quarter movements.

Surgical
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Cataract products
      757       746       1       6       1 470       1 427       3       6  
          Cataract IOLs
      335       336       0       5       654       645       1       5  
Vitreoretinal products
      140       130       8       11       281       252       12       14  
Refractive/Other
      60       51       18       24       124       93       33       37  
Total
      957       927       3       8       1 875       1 772       6       9  

In the second quarter, global Surgical sales were USD 957 million (+3%, +8% cc). Emerging Growth Markets and US cataract product sales grew strongly. The intraocular lens (IOL) category benefitted from an increasing shift to advanced technology IOLs, which rose 5% (+9% cc), mostly due to solid sales of the AcrySof IQ Toric and AcrySof IQ ReSTOR+3.0 intraocular lenses. Additionally, new approvals of expanded ranges of Acrysof IQ ReSTOR and AcrySof IQ Toric were achieved in the EU. LenSx femtosecond refractive cataract lasers continued to show solid uptake, with units installed in over 30 countries since rollout began in 2011. Strong growth in the Refractive segment was driven by sales of Wavelight equipment in the US, Europe and Asia. The Vitreoretinal portfolio showed strong growth, led by Constellation equipment sales, particularly in non-US markets.

Ophthalmic Pharmaceuticals
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Glaucoma
      335       335       0       6       641       646       -1       3  
Allergy/Otic/Nasal
      243       261       -7       -6       507       519       -2       -2  
Infection/Inflammation
      267       260       3       7       517       488       6       9  
Dry Eye/Other
      216       212       2       8       425       400       6       11  
Total
      1 061       1 068       -1       4       2 090       2 053       2       5  

Global sales of Ophthalmic Pharmaceuticals products totaled USD 1.1 billion (-1%, +4% cc) in the second quarter. US allergy sales of Pataday products were suppressed by a significant drop in seasonal ocular allergy incidence in the second quarter versus previous year. Travatan/DuoTrav sales grew at a mid-teen rate in non-US markets, offset by the impact of generic prostaglandin competition in the US. A New Drug Application (NDA) was filed in US in the second quarter for a novel fixed combination of Brinzolamide/Brimonidine tartrate to treat ocular hypertension. Infection/Inflammation product sales grew 3% (+7% cc), led by strong growth of ophthalmic suspension products Durezol, which gained a new indication for anterior uveitis in the US in the second quarter, and Nevanac. Systane Ultra and Systane Balance were key growth drivers in the Dry Eye segment.

Vision Care
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Contact lenses
      446       439       2       6       870       852       2       5  
Contact lens care
      184       191       -4       -1       354       364       -3       -1  
Total
      630       630       0       4       1 224       1 216       1       3  

Vision Care global product sales were USD 630 million (0%, +4% cc). Contact lens growth was driven by the ongoing strong performance of Air Optix, which continued to lead the marketplace in the multifocal segment and achieved 17% (cc) growth over the previous-year quarter, and strong Dailies growth in the US. The launch of Dailies Total1 in the silicone hydrogel daily disposable contact lens category in select European markets, including France and Italy in the second quarter, was well received, and resulted in significant market share gains. Contact lens solution sales were below the previous year, with double-digit growth of the Aosept/Clear Care hydrogen peroxide solution more than offset by weakness in multi-purpose solution sales.

13
 
 

 

 
Sandoz
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
      2 147       2 466       -13       -7       4 271       4 839       -12       -7  
Operating income
      259       283       -8       -5       557       695       -20       -19  
  As % of net sales
      12.1       11.5                       13.0       14.4                  
Core operating income
      349       533       -35       -31       731       1 067       -31       -30  
  As % of net sales
      16.3       21.6                       17.1       22.1                  

Second quarter

Net sales
Sandoz net sales declined 13% (-7% cc) to USD 2.1 billion, driven by 7 percentage points of price erosion. Volume was flat as double-digit sales growth in Western Europe, Asia and biosimilars was offset by declining volumes in both the US and Germany versus the prior-year quarter.

US retail generics and biosimilars sales (USD 629 million, -26% cc) declined as a result of increased competition and lower pricing on enoxaparin (generic Lovenox®, USD 156 million), as well as nearly USD 70 million of prior-year sales of gemcitabine and lansoprazole authorized generics. German sales of retail generics and biosimilars (USD 279 million, -8% cc) declined, primarily as a result of the continued penetration of low-priced statutory health insurance tenders. Western Europe (which excludes Germany) retail generics and biosimilars grew strongly (+10% cc), driven by double-digit growth in France, Italy, the United Kingdom and the Nordics. Japan grew 14% (cc) in the quarter. Emerging Growth Markets performed strongly, led by Asia (+24% cc), which was driven by double-digit growth in China and Southeast Asia, and Central and Eastern Europe (+14% cc), with high double-digit growth in Russia, Poland and Turkey.
 
 
Sandoz continued to strengthen its number one global position in biosimilars (USD 84 million, +28%, +39% cc), and saw strong momentum across all three of its products – Omnitrope (human growth hormone), Binocrit (epoetin alfa) and Zarzio (filgrastim) – each of which is the leading biosimilar in its respective market segment.

Operating income
Operating income decreased by 8% (-5% cc) to USD 259 million. The operating income margin increased by 0.3 percentage points in constant currencies compared to the second quarter of 2011, with a favorable currency impact of 0.3 percentage points, to 12.1% of net sales. Operating income margin increased by 5.9 percentage points more than core operating income margin, primarily as a result of provisions relating to a legal settlement in the US in the prior-year quarter.

Core operating income declined 35% (-31% cc) to USD 349 million. Core operating income margin in constant currencies decreased by 5.8 percentage points. This declined from the exceptionally high level of 21.6% in the second quarter of 2011 as a result of lower sales and the impact of higher quality and manufacturing costs as well as increased investment into Sandoz’s biosimilars and respiratory pipeline. A favorable currency impact of 0.5 percentage points improved the core operating income margin to 16.3% of net sales. Gross margin decreased by 1.3 percentage points (cc), driven primarily by continued investments in quality assurance and manufacturing. Marketing & Sales expenses as a percent of net sales increased by 1.4 percentage points (cc) due to declining sales in the quarter together with investments into growing businesses in Western Europe. R&D expenses increased by 2.0 percentage points (cc) or USD 35 million as a result of development investments in biosimilars and respiratory products. General & Administration expenses decreased by 0.1 percentage points (cc) due to cost management and productivity improvements. Other Income and Expense, net, had a negative impact of 1.2 percentage points (cc) due to lower other income and higher healthcare contributions to the US government.

14
 
 

 


First half

Net sales
Net sales decreased in the first six months by 12% (-7% cc) to USD 4.3 billion, driven by declines in the US (-23% cc) and Germany (-8% cc), which were partly offset by double-digit sales growth in Western Europe (+10% cc) and Asia (+21%), as well as growth in Central and Eastern Europe (+3% cc) in declining markets, and continued strong results from biosimilars (+46% cc). Total sales volume was flat as a result of competition on US sales of enoxaparin, lost US authorized generics of gemcitabine and lansoprazole in the prior year, and lower sales in Germany. Price erosion was 7 percentage points in the first half.

Operating income
Operating income in the first six months decreased by 20% (-19% cc) to USD 557 million. The operating margin fell by 1.7 percentage points, partly offset by a positive currency impact of 0.3 percentage points, to 13.0% of net sales as a result of price erosion and investments into quality assurance and manufacturing as well as investments into the development of future biosimilars and respiratory products. The operating income margin decreased by 3.6 percentage points less than the core operating income margin, primarily as a result of provisions for legal cases in the US in the prior-year period.

Core operating income decreased by 31% (-30% cc) to USD 731 million. Core operating income margin in constant currencies decreased by 5.4 percentage points to 16.7% of net sales. This declined from the exceptionally high level of 22.1% in the first half of 2011 as a result of declining prices, lower high-margin sales in the US and Germany, and higher investments in quality assurance, manufacturing and the development of promising biosimilars and respiratory products. A favorable currency impact of 0.4 percentage points improved the core operating income margin to 17.1% of net sales. Gross margin decreased by 1.5 percentage points (cc), driven primarily by continued investments in quality assurance and manufacturing. Marketing & Sales expenses as a percent of net sales increased by 1.7 percentage points (cc) due to declining sales in the first half and investments into growing businesses in Western Europe. R&D expenses increased by 2.0 percentage points (cc) or USD 65 million as a result of development investments in biosimilars and respiratory products. General & Administration expenses increased by 0.1 percentage points (cc) due to declining sales in the first six months. Other Income and Expense, net, had a negative impact of 0.1 percentage points (cc) due to declining sales in the first half.

15
 
 

 

 
Vaccines and Diagnostics
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
      349       299       17       21       648       670       -3       -1  
Operating loss
      -96       -214       55       47       -269       -315       15       7  
  As % of net sales
      -27.5       -71.6                       -41.5       -47.0                  
Core operating loss
      -90       -89       -1       -15       -208       -113    
nm
   
nm
 
  As % of net sales
      -25.8       -29.8                       -32.1       -16.9                  
nm = Not meaningful

Second quarter

Net sales
Net sales were USD 349 million for second quarter (+17%, +21% cc) compared to USD 299 million in the prior-year period. Sales growth was driven by pre-pandemic contracts and Menveo, which grew at a double-digit rate in the US.

Operating loss
Reported operating loss was USD 96 million for the quarter compared to a loss of USD 214 million for the prior-year period. The second quarter of 2011 included an impairment charge of USD 62 million related to a financial asset, while the 2012 quarter included a licensing settlement benefit of USD 56 million. Excluding these items, the operating loss was in line with the prior-year quarter, with the benefit of higher sales offset by continued investment in the manufacturing network and the investment in anticipation of the expected approval of Bexsero.

Core operating loss for the period was USD 90 million compared to a loss of USD 89 million for the same period in 2011.

First half

Net sales
Net sales were USD 648 million (-3%, -1% cc) for first half of 2012 compared to USD 670 million for the year-ago period. The first half of 2011 was impacted by the release of bulk pediatric shipments which had been delayed from the fourth quarter of 2010 due to production issues. Excluding the impact of these shipments, the underlying business showed solid growth, driven by Menveo and the Diagnostics business, partially offset by higher late season northern hemisphere flu sales in the first half of 2011.

Operating loss
Reported operating loss was USD 269 million for first half of 2012 compared to a loss of USD 315 million for the same period in 2011. The first half of 2011 included an impairment charge of USD 81 million related to a financial asset and the 2012 period included a licensing settlement benefit of USD 56 million. Excluding these items, operating loss increased, with flat net sales offset by continued investment in the manufacturing network and the investment in anticipation of the expected approval of Bexsero.

Core operating loss for the period was USD 208 million compared to a loss of USD 113 million for the same period in 2011.

16
 
 

 

 
Consumer Health
        Q2 2012       Q2 2011    
% change
      H1 2012       H1 2011    
% change
 
     
USD m
   
USD m
   
USD
   
cc
   
USD m
   
USD m
   
USD
   
cc
 
Net sales
      904       1 187       -24       -18       1 836       2 356       -22       -18  
Operating income
      0       225    
nm
      -95       12       490       -98       -92  
  As % of net sales
      0       19.0                       0.7       20.8                  
Core operating income
      18       239       -92       -88       59       479       -88       -82  
  As % of net sales
      2.0       20.1                       3.2       20.3                  
nm = Not meaningful

Second quarter

Net sales
Net sales declined 24% (-18% cc) to USD 0.9 billion from USD 1.2 billion in the prior-year quarter mainly due to the suspension of production at our US manufacturing facility in Lincoln, Nebraska, which supplies products for both Consumer Health businesses, in December 2011. We made progress in the remediation of quality issues at the Lincoln site, resuming production for the Animal Health product Sentinel and the OTC product Excedrin in the second quarter.

OTC sales in the second quarter declined versus the same period last year, largely due to manufacturing issues. Slow growth in several markets, particularly in Europe, where there was a weak summer season and trade de-stocking in Germany following legislation changes earlier in the year, also negatively impacted sales performance. Despite these relatively weak market conditions, OTC continued to drive growth and market share gains in key global brands such as Voltaren, Nicotinell and Otrivin through sustained investment, improved commercial execution and new launches such as Voltaren 12h,a new stronger formulation for the number one topical analgesic, which is currently being rolled out in several markets. In Russia, OTC’s third largest business, sales continued to grow with strong market share gains.

Animal Health reported a sales decline versus the second quarter of 2011 due to limited sales of companion animal products manufactured at the Lincoln, Nebraska facility, mainly impacting the US and Canada. Excluding the Lincoln brands, Animal Health delivered strong single-digit growth, well ahead of the market. Emerging Growth Markets delivered high single-digit growth, led by India and Russia where sales grew at a strong double-digit rate. In Europe, the business generated single-digit growth and Milbemax continued to be the number one de-wormer for cats and dogs. Denagard, an oral anti-infective for pigs and poultry, continued to drive growth across several markets with particularly strong results in the US. Recent launches of Atopica for atopic dermatitis in cats, and Onsior for managing pain in cats and dogs, continued to gain market share in their respective categories.

Operating income
There was zero operating income for the second quarter versus a prior-year operating income of USD 225 million largely due to the impact of the suspension of production at Lincoln and investment in quality upgrades at the facility. Prior-year income from divestments in OTC also contributed to the decrease.

Core operating income declined 92% (-88% cc) to USD 18 million and core operating income margin declined by 17.2 percentage points in constant currencies. Disruption in supply and one-time costs to upgrade quality at the Lincoln facility generated a gross margin decline of 9.5 percentage points (cc). The decline was partially offset by robust cost savings, the optimization of discounts and promotional offers and a positive product mix. Marketing & Sales expenses as a percent of net sales increased by 4.0 percentage points (cc), R&D expenses increased by 1.7 percentage points (cc), and General & Administration expenses increased by 0.5 percentage points (cc) as strong cost containment initiatives across the organization could not offset the significant sales and margin impact of the production disruption. Other Income and Expense, net, declined by 1.5 percentage points (cc) due to prior-year income from small brand and asset divestments.


17
 
 

 


First half

Net sales
Consumer Health sales declined 22% (-18% cc) to USD 1.8 billion in the first half of 2012 from USD 2.4 billion in the 2011 period mainly due to the impact of the suspension of production at Lincoln.

OTC’s net sales declined sharply versus the first half of last year primarily due to the impact of the manufacturing suspension. Also contributing to the sales decline was the impact of a weak cough-and-cold season earlier in the year across Europe. Sustained investment in key global brands like Voltaren, Otrivin and Nicotinell, the launch of line extensions, and the improvement of commercial execution continued to drive growth and market share gains in several key markets.

Animal Health reported a sales decline versus the first half of 2011 as a result of limited sales of companion animal products manufactured at the Lincoln facility, which mainly impacted the US and Canada. Excluding the Lincoln brands, Animal Health growth was well ahead of the market. The US continued to show strong momentum with double-digit sales growth excluding the Lincoln brands. Emerging Growth Markets posted double-digit sales growth with particularly good performances in China, India and Russia.

Operating income
Consumer Health reported an operating income of USD 12 million in the first half of 2012 versus prior-year operating income of USD 490 million largely due to the impact of the suspension of production and quality upgrade investments at the Lincoln facility. Prior-year income from OTC divestments also contributed to the decrease. Operating income margin declined by 20.1 percentage points to 0.7% with a negative currency impact of 1.2 percentage points.

Core operating income declined 88% (-82% cc) to USD 59 million and core operating income margin declined by 15.9 percentage points in constant currencies. Gross margin decreased by 9.2 percentage points (cc) in the first half mainly due to disruptions in supply, idle capacity charges at the Lincoln site as well as one-time quality upgrade investments at the facility. Marketing & Sales expenses as a percent of net sales increased by 4.1 percentage points (cc). R&D expenses increased by 1.4 percentage points (cc) and General & Administration expenses increased by 0.8 percentage points (cc), all largely due to lower sales that more than offset the positive impact of cost savings programs. Other Income and Expense, net, declined by 0.4 percentage points (cc) mainly due to prior-year income from small brand and asset divestments.

18
 
 

 

 
GROUP BALANCE SHEET AND CASH FLOW

Balance sheet

Assets
Total assets amounted to USD 118.5 billion at June 30, 2012 compared to USD 117.5 billion at December 31, 2011. Total non-current assets of USD 92.4 billion decreased by USD 1.0 billion over the first six months driven by amortization of intangible assets of USD 1.4 billion and a reduction in property, plant and equipment and goodwill of USD 0.2 billion. This was partially offset by additions to intangible assets of USD 0.3 billion and an increase in financial and other non-current assets of USD 0.3 billion.

Current assets of USD 26.1 billion increased by USD 2.0 billion during the first six months driven by an increase in liquidity of USD 1.0 billion and a total additional USD 1.0 billion in inventories, trade receivables and other current assets.

Financial debt
Total short-term and long-term financial debt including derivatives amounted to USD 22.6 billion at June 30, 2012 compared to USD 20.2 billion at December 31, 2011. Long-term debt remained at USD 13.8 billion and consisted of bonds and Euro Medium Term Notes of USD 12.7 billion and other long-term financial debt of USD 1.1 billion. Short-term debt including derivatives increased from USD 6.4 billion at December 31, 2011 to USD 8.9 billion at June 30, 2012 and consisted of commercial paper of USD 5.9 billion and other short-term borrowings of USD 3.0 billion. Commercial paper increased in the first half of 2012 by USD 3.7 billion from USD 2.2. billion at December 31, 2011 and other short-term borrowings decreased by USD 1.2 billion from USD 4.2 billion at December 31, 2011, mainly due to the repayment of a 3.5% Swiss franc bond of CHF 700 million.

Group equity
The Group’s equity fell by USD 1.7 billion to USD 64.2 billion at June 30, 2012 compared to USD 65.9 billion at December 31, 2011. This reduction was driven by the dividend payment of USD 6.0 billion which was only partially offset by the comprehensive income of USD 4.0 billion (mainly consisting of the net income of the period of USD 5.1 billion, offset by pension plan actuarial losses of USD 0.8 billion and negative translation differences of USD 0.3 billion) and other equity movements of USD 0.3 billion related to share-based compensation transactions and the purchase of treasury shares.

Liquidity and debt/equity ratio
The Group’s debt/equity ratio increased to 0.35:1 at June 30, 2012 compared to 0.31:1 at the beginning of the year. This was a result of the lower equity due to the dividend payment and higher net financial debts. The Group’s liquidity increased from USD 5.1 billion at the end of 2011 to USD 6.1 billion at June 30, 2012 and net debt increased in the same period from USD 15.2 billion to USD 16.5 billion.

Cash flow

Cash flow from operating activities decreased 13% in the second quarter of 2012, mainly due to the 4% fall in operating income, higher income tax payments and lower non-cash expenses, and amounted to USD 3.0 billion compared to USD 3.4 billion in the prior-year period.

The cash flow used in investing activities amounted to USD 0.7 billion in the second quarter of 2012, mainly for investments in property, plant and equipment. In the prior year period, there was a net inflow from investing activities as the outflows for the investments in tangible and intangible assets were more than offset by the proceeds from the sale of various assets.

The cash outflow for financing activities amounted to USD 1.7 billion in the second quarter of 2012 compared to USD 6.6 billion in the prior-year period as a result of repayments of financial debt and repurchase of treasury shares in both periods.
 
 
Free cash flow of USD 2.3 billion in the second quarter was 30% below the previous year of USD 3.3 billion. Lower divestment proceeds (USD 0.4 billion) and higher payment of tax (USD 0.3 billion) primarily accounted for most of the decline.

The cash flow from operating activities in the first six months of 2012 increased by 3% to USD 5.5 billion from USD 5.4 billion in the prior-year period. The improvement is mainly due to higher payments out of provisions and other liabilities in the prior-year period of USD 0.8 billion compared to USD 0.5 billion in the current period.

19
 
 

 



The cash flow used in investing activities amounted to USD 1.2 billion in the first six months of 2012 compared to an inflow of USD 0.6 billion in the prior-year period. This amount consists mainly of investments in property, plant and equipment of USD 1.0 billion and in other assets of USD 0.4 billion. The proceeds from the sale of assets amounted to USD 0.2 billion in the first six months of 2012 compared to USD 0.7 billion in the prior-year period.

The cash outflow for financing activities amounted to USD 3.4 billion in the first six months of 2012 compared to USD 7.0 billion in the prior-year period. This change is due to an increased dividend payment of USD 0.7 billion and the absence of the 2011 payment of USD 3.2 billion for acquiring additional interests in Alcon.

Free cash flow of USD 4.4 billion in the first half was 11% lower than the previous year of USD 4.9 billion. Lower operating income (USD 0.7 billion) and lower divestment proceeds (USD 0.5 billion) were partially offset by lower payments of tax and provisions (USD 0.4 billion) and lower working capital (USD 0.3 billion).

20
 
 

 



Innovation Review

Benefiting from our continued focus on innovation, Novartis has one of the industry’s most competitive pipelines with more than 130 projects in clinical development.

Key developments in the second quarter of 2012 include:

New approvals and positive opinions

·  
The EMA’s CHMP adopted a positive opinion for Afinitor (everolimus) in combination with the aromatase inhibitor therapy exemestane for the treatment of postmenopausal women with HR+, HER2/neu- negative (HER2-) advanced breast cancer without symptomatic visceral disease after failure or progression following treatment with a non-steroidal aromatase inhibitor.

·  
The FDA approved Afinitor for the treatment of adult patients with renal angiomyolipomas and tuberous sclerosis complex (TSC) who do not require immediate surgery. With this approval, which followed a priority review, Afinitor became the first medical treatment in this patient population.
 
 
·  
Jakavi (ruxolitinib) received a positive CHMP opinion for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Globally, there are few available treatments for myelofibrosis, a rare, life-threatening blood cancer characterized by bone marrow failure, enlarged spleen and shortened survival.

·  
Signifor (pasireotide) was approved by the European Commission for the treatment of adult patients with Cushing’s disease, an endocrine disorder caused by excessive cortisol, for whom surgery is not an option or has failed. Signifor is the first pituitary-targeted medicine for Cushing’s disease to be approved in the EU.

·  
Seebri Breezhaler (glycopyrronium) 44 mcg delivered dose (50 mcg glycopyrronium per capsule) was recommended for approval by CHMP as a once-daily inhaled maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease (COPD). The positive opinion was underpinned by data from three of the Novartis Phase III GLOW trials. If approved, Seebri Breezhaler will offer patients an alternative once-daily therapy in the long-acting muscarinic antagonist (LAMA) class with the potential to reduce breathlessness, increase the capacity to exercise and help improve quality of life.

·  
Onbrez Breezhaler (indacaterol maleate) 150 mcg was approved in China and South Africa as a once-daily maintenance bronchodilator treatment for patients with COPD.

·  
Alcon received approval to market AcrySof IQ ReSTOR +2.5D Toric Multifocal intraocular lenses (IOLs) with a CE mark in the EU. The 2.5 diopter lens, which builds on Alcon’s existing portfolio of IOLs, provides enhanced distance vision and improved functional near vision while correcting for astigmatism. As a toric multifocal lens, it will be an improved option for cataract patients with astigmatism who also wish to have presbyopia correction.

·  
Alcon also received approval for Durezol in the indication of anterior uveitis in the US. Originally, the product was indicated for use as an anti-inflammatory following eye surgery. The new indication allows for the treatment of inflammation in the uvea near the middle of the eye. If left untreated, uveitis can lead to other eye disorders, including cataracts and glaucoma.

·  
Dailies Total1, Alcon’s first silicone hydrogel daily disposable contact lens, achieved approval in the US, following its EU launch in late 2011. Dailies Total1 is the industry’s first water-gradient silicone hydrogel contact lens, increasing the water content at the core of the lens from 33% to more than 80% and representing a major advancement in patient comfort. The new lens also has the highest oxygen transmissibility of any daily disposable lens.

21
 
 

 



Regulatory updates

·  
Novartis submitted marketing authorizations for Gleevec/Glivec (imatinib) in pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) to the FDA and EMA.

·  
Following the CHMP’s positive opinion in April on the EU label update for Gilenya (fingolimod), the first oral treatment for multiple sclerosis (MS), the European Commission announced its decision to make the label update effective throughout the EU and formally concluded the Article 20 review of Gilenya that was initiated in January 2012. In May, the FDA issued a Drug Safety Communication (DSC) on the previously announced US label update for Gilenya. In the DSC, the FDA confirmed that the overall benefit-risk profile of Gilenya remained positive for MS patients when used in accordance with the updated label. The updates to the Gilenya label in the US and EU include patient selection parameters to aid in the identification of patients suitable for Gilenya treatment and more specific recommendations for treatment initiation.

·  
The Japanese Ministry of Health, Labour and Welfare, following the Novartis decision in December 2011 to halt the ALTITUDE study, requested that an update to the Rasilez product information in Japan include a contraindication against the combined use of aliskiren with an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) in patients with diabetes, with an exception for those patients whose blood pressure is poorly controlled by any available treatment including an ACE inhibitor or ARB. The update also included a precaution against the combined use of aliskiren with an ACE inhibitor or ARB in patients with renal impairment.

·  
Alcon filed a US New Drug Application (NDA) for Brinzolamide-Brimonidine, the first fixed combination product not containing a beta blocker for the treatment of intraocular pressure in patients with glaucoma.

Results from ongoing trials

·  
An 18-month analysis from the Phase III BOLERO-2 study presented at the American Society of Clinical Oncology confirmed that Afinitor plus exemestane more than doubled the time postmenopausal women with HR+/HER2- advanced breast cancer lived without tumor growth (progression-free survival, or PFS). The updated results showed that treatment with Afinitor plus exemestane resulted in a median PFS of 7.8 months compared to 3.2 months with hormonal therapy plus placebo (hazard ratio=0.45 [95% confidence interval: 0.36 to 0.54]; p<0.0001) by local investigator assessment and significantly reduced the risk of cancer progression by 55% versus plus placebo.

·  
Results from the Phase III study of Signifor (pasireotide) long-acting release (LAR) were presented at the joint International Congress of Endocrinology and European Congress of Endocrinology meeting. The study found that pasireotide LAR was significantly more effective at inducing full biochemical control in patients with acromegaly, chronic hormonal disorder that occurs when excess growth hormone is produced, compared to the current standard of care, Sandostatin LAR (octreotide/IM injection).

·  
Novartis presented new data from two trials of ACZ885 (canakinumab) at the European League Against Rheumatism Congress in Germany: a pivotal Phase III study in patients with systemic juvenile idiopathic arthritis (SJIA); and a Phase II study in patients with tumor necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS). SJIA and TRAPS are both rare and serious autoinflammatory diseases that usually start in childhood. In the Phase III study, 62% of SJIA patients treated with ACZ885 were symptom-free at the end of the placebo-controlled period. In addition, 33% of SJIA patients treated with ACZ885 were able to completely discontinue corticosteroids within five months. In the Phase II study, 90% of TRAPS patients treated with ACZ885 experienced clinical remission after only one week of treatment.

22
 
 

 


·  
The first four Phase III studies of QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) in the treatment of chronic obstructive pulmonary disease (COPD) met their respective primary endpoints of efficacy, safety, exercise endurance and superiority to Seretide® (a fixed dose combination of fluticasone 500 mcg and salmeterol 50 mcg). The studies – ILLUMINATE, SHINE, BRIGHT, and ENLIGHTEN – are part of the IGNITE clinical trial program intended to form the basis for a filing in COPD in the EU, Japan and other countries. Three more QVA149 Phase III studies (SPARK, BLAZE and ARISE) are expected to reach completion in 2012.

·  
A Phase II study conducted by the independent Type 1 Diabetes TrialNet group showed that ACZ885 did not provide an efficacy benefit compared to placebo after 12 months of treatment in newly diagnosed patients with type 1 diabetes. There was no significant difference in the number and severity of adverse events between the ACZ885 and placebo groups.

·  
Data from the RESTORE extension study in diabetic macular edema patients presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting showed that an average of 3.7 Lucentis (ranibizumab) injections in the second year and 2.7 in the third year of treatment were sufficient to fully maintain the mean visual acuity gained in the core study. At month 36, the mean change in best corrected visual acuity (BCVA) in patients previously treated with Lucentis alone was 8.0 letters from baseline with a mean of 13.9 injections. These results confirmed the utility of an individualized treatment with Lucentis according to a regimen consistent with the EU label.

·  
Also presented at ARVO, a retrospective analysis of data on nearly 4,500 patients with wet age related macular degeneration confirmed the well-characterized safety profile of Lucentis. The analysis was conducted as part of the five-year LUMINOUS study, which is expected to recruit more than 30,000 patients from clinics across Asia, Australia, Europe, North and South America, making it one of the largest observational studies in ophthalmology. The study is expected to provide additional long-term evidence on the effectiveness of individualized treatment with Lucentis and reinforce its safety profile in licensed indications and real-world settings.

·  
New results from an extension of the Phase III head-to-head TRANSFORMS study reinforcing the long-term efficacy and safety of Gilenya were presented at the European Neurological Society annual meeting. Additional data from 7-year Phase II extension studies showing sustained improvements in patients with relapsing multiple sclerosis who continued treatment with Gilenya were presented at the American Academy of Neurology annual meeting.

·  
A Phase II study of the investigational compound LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor (ARNI), showed evidence of superiority over the ARB valsartan in its ability to lower blood pressure with a favorable safety and tolerability profile. LCZ696 is the only ARNI in late stage clinical development.




23
 
 

 


Q2 2012 selected approvals: US, Europe and Japan
Product
Active ingredient
Indication
Approval date
Afinitor/Votubia
everolimus
Treatment of postmenopausal women with HR+ advanced breast cancer in combination with exemestane after treatment with letrozole or anastrozole
FDA decision expected in H2 2012
   
Treatment of adult patients with renal angiomyolipomas and tuberous sclerosis complex who do not require immediate surgery
US-April
Signifor
pasireotide
Treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed
EU-April


Selected projects awaiting regulatory decisions
   
Completed submissions
 
Product
Indication
US
EU
Japan
News update
ACZ885
Gouty arthritis
Q1 2011
Q4 2010
 
- EMA review ongoing; feedback expected in late 2012
- Novartis is working with the FDA on next steps, following the Agency’s request for additional clinical data to evaluate the benefit-risk profile in gouty arthritis refractory patients
Afinitor/Votubia
Tuberous sclerosis complex angiomyolipoma
Approved
Q1 2012
Q1 2012
- FDA approved in Apr. 2012
- Japan filing achieved in Feb. 2012
- EU filing achieved in Jan. 2012
 
 
HR+ breast cancer
Q4 2011
Q4 2011
 
- Positive CHMP recommendation granted in Jun. 2012
- FDA, EMA decisions expected in 2012
Exelon Patch15cm2
Alzheimer’s disease
Q4 2011
Q4 2011
 
- Submission dossiers currently under review by FDA and CHMP
Exjade
Non-transfusion-dependent thalassemia
Q4 2011
Q4 2011
 
- FDA, EMA decisions expected in
2012
Jakavi
Myelofibrosis
 
Q2 2011
 
- Positive CHMP recommendation granted in Apr. 2012
Lucentis
Visual impairment due to diabetic macular edema
   
Q1 2012
- Japan filing achieved in Mar. 2012
NVA237
Chronic obstructive pulmonary disease
 
Q3 2011
Q4 2011
- CHMP issued a positive opinion in Jun. 2012; EMA approval decision expected within three months
- GLOW-2 data versus placebo and open-label tiotropium 18 mcg presented at American Thoracic Society International Conference in May 2012
- Japan filing achieved in Q4 2011; dossier under review by Pharmaceuticals and Medical Devices Agency
- Phase III agreed with FDA; filing expected beginning of 2014

24
 
 

 


QTI571
Pulmonary arterial hypertension
Q1 2012
Q1 2012
Q2 2012
- Japan filing achieved in Apr. 2012
 
Signifor
Cushing’s disease
Q1 2012
Approved
 
- EMA approved in Apr. 2012
- FDA decision expected in H2 2012
TOBI Podhaler
Pseudomonas aeruginosa lung infection in cystic fibrosis
Q4 2011
Approved
 
- FDA Advisory Committee in September
Zortress/
Certican
Prevention of organ rejection – liver transplant
Q4 2011
Q4 2011
 
- US action date and EU decision on liver indication expected by Q3 and Q4 2012, respectively


Selected Pharmaceuticals pipeline projects
Project/ Compound
Potential indication/ Disease area
First planned submissions
Current Phase
News update
 
ACZ885
 
Systemic juvenile idiopathic arthritis
2012
III
- New Phase III data presented at the Annual European Congress of Rheumatology showed that 62% of SJIA patients treated with ACZ885 were symptom-free at the end of the placebo-controlled period; in addition, 33% of SJIA patients treated with ACZ885 were able to completely discontinue corticosteroids within five months
Secondary prevention of cardiovascular events
≥2016
III
 
Afinitor/
Votubia
HER2+ breast cancer 1st line
2013
III
 
HER2+ breast cancer 2nd/3rd line
2013
III
 
Hepatocellular cancer
2013
III
 
Gastrointestinal/lung neuroendocrine tumors
2015
III
 
Lymphoma
2015
III
 
AFQ056
Fragile X syndrome
2014
II
 
Parkinson’s disease, L-dopa induced dyskinesia
2014
 
II
 
AIN457
Psoriasis
2013
III
- All pivotal trials involving more than 3,000 patients fully recruited ahead of schedule
Arthritides (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
2014
III
 
 
Multiple sclerosis
≥2016
II
 
AUY922
Solid tumors
≥2016
II
 
BAF312
Multiple sclerosis
≥2016
II
- Phase III expected to start in H2 2012
BCT197
Chronic obstructive pulmonary disease
≥2016
II
 
BEZ235
Solid tumors
≥2016
II
 
BGS649
Obese hypogonadotropic hypogonadism
≥2016
II
 
BKM120
Solid tumors
2015
II
 
BYL719
Solid tumors
≥2016
I
 
BYM338
Sporadic inclusion body myositis
>2016
II
 
CAD106
Alzheimer’s disease
≥2016
II
 

25
 
 

 


DEB025
Hepatitis C
>2016
III
- FDA provided clarification that the clinical program is on partial hold due to a small number of cases of pancreatitis, which included one patient fatality
- Although treatment with DEB025 is currently stopped in all clinical trials, trials are still ongoing with peginterferon alpha and ribavirin, without the addition of DEB025
- Novartis is working closely with the FDA to determine next steps
Gilenya
Chronic inflammatory demyelinating neuropathy
≥2016
II
 
Jakavi (INC424)
Polycythemia vera
2014
III
 
LBH589
Relapsed or relapsed-and-refractory multiple myeloma
2013
III
- Phase II PANORAMA-2 study showed clinical benefit of LBH589 in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma, presented at the American Society of Clinical Oncology (ASCO) annual meeting
 
Hematological cancers
≥2016
II
 
LCI699
Cushing’s
≥2016
II
 
LCQ908
Metabolic diseases
2014
III
 
LCZ696
Heart failure
2014
III
- A Phase III outcome study (PARADIGM) in heart failure with reduced ejection fraction is ongoing to assess the superiority of LCZ696 to the ACE inhibitor enalapril in delaying the time to first occurrence of either cardiovascular mortality or heart failure hospitalization
 
Hypertension
2014
III
- In Q2, LCZ696 entered Phase III for the indication of 1st line treatment of hypertension
LDE225
Advanced basal cell carcinoma
2014
II
 
 
 
Solid tumors
≥2016
I
- Data presented at ASCO from a Phase I/II study of LDE225 demonstrated efficacy in pediatric patients with recurrent medulloblastoma
- Correlative analysis supports use of the 5-gene hedgehog assay as a pre-selection tool in future trials
LDK378
ALK-positive advanced non-small cell lung cancer
2015
I
- First-in-human Phase I study of LDK378 showed preliminary clinical response in patients
- Pivotal studies to start end 2012
LFF571
Clostridium difficile infection
≥2016
II
 
LGT209
Hypercholesterolemia
≥2016
II
 
LGX818
Solid tumors
≥2016
I
 
Lucentis
Pathological myopia
2012
III
- Data and submission expected in H2 2012
 
Choroidal neovascularization and macular edema1
≥2016
II
 

26
 
 

 


MEK162
Solid tumors
≥2016
II
- Phase II study of MEK162 presented at ASCO showed clinical activity in patients with BRAF and NRAS-mutated advanced melanoma
- MEK162 is the first targeted therapy to show activity in patients with NRAS-mutated melanoma
PKC412
Aggressive systemic mastocytosis
2014
II
 
Acute myeloid leukemia
2014
III
 
QAW039
Asthma
≥2016
II
 
QGE031
Severe allergic diseases
≥2016
II
- Development being evaluated in a number of severe allergic conditions including food allergy and atopic dermatitis
QMF149
Chronic obstructive pulmonary disease
2015
II
- Currently in Phase II with ex-US filings planned for 2015
Asthma
2015
II
 
QVA149
Chronic obstructive pulmonary disease
2012
III
- Submission on track for H2 2012 in EU and other countries including Japan
- Phase III agreed with FDA; filing expected end of 2014
RLX030
Acute heart failure
2013
III
- Data expected for late 2012
Signifor (SOM230)
Acromegaly
2012
III
- Full results of Phase III head-to-head study comparing SOM230 LAR (pasireotide) to Sandostatin LAR (octreotide) were presented at European Congress of Endocrinology in May 2012
Tasigna
cKIT melanoma
2014
II
 
TKI258
Renal cell carcinoma
2013
III
 
 
Solid tumors
≥2016
II
 
Xolair
Chronic idiopathic urticaria
2013
III
- Phase III recruitment on track
1 Choroidal neovascularization and macular edema secondary to conditions other than age related macular degeneration, diabetic macular edema, retinal vein occlusion and pathologic myopia.


 
Selected Alcon pipeline projects
 
Project/ Compound
Potential indication/ Disease area
Planned submissions
Current Phase
News update
 
SURGICAL
AcrySof IQ ReSTOR IOL (new design)
 
Cataract
EU 2012
US 2013
JP 2013
Approved
Advanced
Advanced
 
- CE marked in Feb. 2012
- Launch rollout began in Apr. 2012 with full EU launch planned for Sep. 2012
AcrySof IQ ReSTOR Toric IOL (new design)
Cataract
EU 2012
US 2013
JP 2015
Approved
Advanced
Advanced
 
 
AcrySof IQ ReSTOR Toric IOL
Cataract
US 2014
JP 2014
Advanced
Advanced
 
AcrySof IQ ReSTOR Toric IOL diopter range expansion
Cataract
US 2013
JP 2014
Advanced
Advanced
 
AcrySof IQ Toric IOL low diopter range expansion
Cataract
US 2013
JP 2013
Advanced
Advanced
 
AcrySof Cachet angle-supported phakic lens
Refractive
US 2013
JP 2013
Advanced
Advanced
 
Infiniti system upgrade
Cataract
US filed
JP 2012
Approved
Advanced
 

27
 
 

 


Next generation Phaco system
Cataract
US 2012
EU 2013
JP 2013
Filed
Advanced
Advanced
 
Allegretto EX-500 laser, new indication
Refractive
US 2014
Advanced
 
OPHTHALMIC PHARMACEUTICALS
Azarga solution
Glaucoma
JP 2012
Phase III
 
Brinzolamide/Brimonidine fixed combination
Glaucoma
US 2012
EU 2013
Filed
Phase III
- Timolol-free fixed combination
Travatan, new formulation
Glaucoma
US 2012
EU 2012
JP 2013
Phase III
Phase III
Phase III
 
Jetrea
Retina
EU 2011
Filed
- New in-licensed technology
Nevanac, new formulation
Anti-inflammatory
US 2011
EU 2012
Filed
Filed
- FDA has accepted filing
Nevanac, new indication
Anti-inflammatory
EU 2011
Approved
- Post-surgical macular edema indication approved late Dec. 2011
Durezol emulsion, new indication
Anti-inflammatory
US 2011
Approved
- FDA approved new indication in Q2 2012
AL-2354A
Dry eye
US 2012
Phase III
 
Patanol, new formulation
Ocular allergy
US >2014
EU >2014
Phase III
 
Cilodex
Otic infections
EU 2011
Approved
- Completed de-centralized procedure; ratification at local level occurring over next few months
AL-60371
Otic infections
US 2013
Phase III
- Infections associated with swimmer’s ear approved in Q2 2012
VISION CARE
Dailies Total1 lens
Contact lens
US 2011
JP 2012
Approved
Filed
- Approved in the US in Q2 2012
New color lens design
Contact lens
EU 2011
JP 2011
Approved
Approved
- Dailies Limbal Ring
New toric lens design
Contact lens
US 2012
EU 2012
JP 2012
Advanced
Advanced
Advanced
- Dailies Aqua Comfort Plus Toric
New multi-focal design
Contact lens
US 2014
EU 2014
JP 2014
Advanced
Advanced
Advanced
- Dailies Aqua Comfort Plus Multifocal
New color lens design
Contact lens
US 2013
EU 2013
Advanced
Advanced
- Silicone Hydrogel Colors
New lens solution
Lens solution
US 2013
EU 2013
Advanced
Advanced
 


Selected Vaccines and Diagnostics pipeline projects
Project/ Compound
Potential indication/ Disease area
Planned submissions
Current Phase
News update
Menveo
 
Prevention of meningococcal disease (serogroups A, C, Y and W-135) in infants, toddlers and young children
Complete
Registration
- US resubmission planned in H2 2012 following FDA Complete Response Letter
- EU approval received for children 2-10 years of age
Optaflu
 
Seasonal influenza (cell culture subunit vaccine)
Complete
Registration
(US)
- US submission completed in Q4 2011 for 18+ years of age
Fluad
Seasonal influenza (subunit vaccine with MF59 adjuvant)
2012
III
- US Phase III study for older adults (65 years and older) complete
- Phase III study in children underway

28
 
 

 


Agriflu pediatric
Seasonal influenza (subunit vaccine) pediatric indication
2012
III
- US filing for pediatric age extension planned in 2012
Bexsero (EU)
 
Multi-component vaccine for prevention of meningococcal disease (serogroup B)
Complete
 
Registration
- EU filing achieved in 2010; currently under EMA review
 
Bexsero (US) or MenABCWY (US)
 
Prevention of meningococcal disease (serogroup B or combined serogroups A, B, C, Y and W-135)
≥2013
 
II
- Phase III strategy under evaluation; start planned in 2013
 
 
Group B streptococcus
Prevention of group B streptococcus
≥2013
II
 
Staph. aureus
 
Prevention of Staphylococcus aureus
≥2013
I
 
TdaP
Prevention of Tetanus, Diphtheria, Pertussis
≥2013
I
 


29
 
 

 
CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

Consolidated income statements  (unaudited)

Second quarter

Q2 2012
USD m
Q2 2011
USD m
Change
USD m
Net sales 14 303 14 915 -612
Other revenues 238 208 30
Cost of Goods Sold -4 610 -4 619 9
Gross profit 9 931 10 504 -573
Marketing & Sales -3 613 -3 904 291
Research & Development -2 285 -2 397 112
General & Administration -737 -738 1
Other income 265 502 -237
Other expense -373 -645 272
Operating income 3 188 3 322 -134
Income from associated companies 176 130 46
Interest expense -183 -190 7
Other financial income and expense 34 -16 50
Income before taxes 3 215 3 246 -31
Taxes -482 -520 38
Net income 2 733 2 726 7
Attributable to:
Shareholders of Novartis AG
2 706 2 704 2
Non-controlling interests
27 22 5
Average number of shares outstanding – Basic (million) 2 420.7 2 399.0 21.7
Basic earnings per share (USD)1 1.12 1.13 -0.01
Average number of shares outstanding – Diluted (million) 2 441.2 2 426.0 15.2
Diluted earnings per share (USD)1 1.11 1.11 0.00
 
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG

30






Consolidated income statements  (unaudited)

First half

H1 2012
USD m
H1 2011
USD m
Change
USD m
Net sales 28 038 28 942 -904
Other revenues 416 403 13
Cost of Goods Sold -9 094 -9 077 -17
Gross profit 19 360 20 268 -908
Marketing & Sales -7 108 -7 428 320
Research & Development -4 520 -4 585 65
General & Administration -1 456 -1 432 -24
Other income 616 1 051 -435
Other expense -889 -1 144 255
Operating income 6 003 6 730 -727
Income from associated companies 304 247 57
Interest expense -347 -379 32
Other financial income and expense -7 6 -13
Income before taxes 5 953 6 604 -651
Taxes -893 -1 057 164
Net income 5 060 5 547 -487
Attributable to:
Shareholders of Novartis AG
5 011 5 474 -463
Non-controlling interests
49 73 -24
Average number of shares outstanding – Basic (million) 2 417.0 2 353.0 64.0
Basic earnings per share (USD)1 2.07 2.33 -0.26
Average number of shares outstanding – Diluted (million) 2 438.6 2 378.7 59.9
Diluted earnings per share (USD)1 2.05 2.30 -0.25
Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG

31






Consolidated statements of comprehensive income  (unaudited)

Second quarter

Q2 2012
USD m
Q2 2011
USD m
Change
USD m
Net income 2 733 2 726 7
Fair value adjustments on financial instruments, net of taxes -2 39 -41
Net actuarial losses from defined benefit plans, net of taxes -369 -344 -25
Novartis share of other items recorded in comprehensive income recognized by associated companies, net of taxes -7 3 -10
Translation effects -1 171 1 410 -2 581
Comprehensive income 1 184 3 834 -2 650
Attributable to:
Shareholders of Novartis AG
1 161 3 848 -2 687
Non-controlling interests
23 -14 37

First half

H1 2012
USD m
H1 2011
USD m
Change
USD m
Net income 5 060 5 547 -487
Fair value adjustments on financial instruments, net of taxes 33 39 -6
Net actuarial losses from defined benefit plans, net of taxes -762 -345 -417
Novartis share of other items recorded in comprehensive income recognized by associated companies, net of taxes -69 11 -80
Translation effects -261 2 324 -2 585
Comprehensive income 4 001 7 576 -3 575
Attributable to:
Shareholders of Novartis AG
3 954 7 522 -3 568
Non-controlling interests
47 54 -7

32






Condensed consolidated balance sheets

June 30,
2012
(unaudited)
USD m
Dec 31,
2011
(audited)
USD m


Change
USD m
Assets
Non-current assets
Property, plant & equipment 15 584 15 627 -43
Goodwill 29 831 29 943 -112
Intangible assets other than goodwill 30 735 31 969 -1 234
Financial and other non-current assets 16 220 15 873 347
Total non-current assets 92 370 93 412 -1 042
Current assets
Inventories 6 420 5 930 490
Trade receivables 10 487 10 323 164
Other current assets 3 109 2 756 353
Cash, short-term deposits and marketable securities 6 106 5 075 1 031
Total current assets 26 122 24 084 2 038
Total assets 118 492 117 496 996
Equity and liabilities
Equity attributable to Novartis AG shareholders 64 130 65 844 -1 714
Non-controlling interests 111 96 15
Total equity 64 241 65 940 -1 699
Non-current liabilities
Financial debts 13 754 13 855 -101
Other non-current liabilities 15 577 14 553 1 024
Total non-current liabilities 29 331 28 408 923
Current liabilities
Trade payables 4 585 4 989 -404
Financial debts and derivatives 8 878 6 374 2 504
Other current liabilities 11 457 11 785 -328
Total current liabilities 24 920 23 148 1 772
Total liabilities 54 251 51 556 2 695
Total equity and liabilities 118 492 117 496 996

33






Condensed consolidated changes in equity  (unaudited)

Second quarter

Q2 2012
USD m
Q2 2011
USD m
Change
USD m
Consolidated equity at April 1 63 201 65 340 -2 139
Comprehensive income 1 184 3 834 -2 650
Purchase of treasury shares, net -265 -1 709 1 444
Fair value of Novartis shares used to acquire outstanding non-controlling interests in Alcon, Inc. 9 163 -9 163
Excess of the consideration exchanged for acquiring Alcon non-controlling interests compared to their recorded values -4 539 4 539
Equity-based compensation 132 244 -112
Dividends -3 -16 13
Change in non-controlling interests -8 -5 224 5 216
Consolidated equity at June 30 64 241 67 093 -2 852

First half

H1 2012
USD m
H1 2011
USD m
Change
USD m
Consolidated equity at January 1 65 940 69 769 -3 829
Comprehensive income 4 001 7 576 -3 575
Purchase of treasury shares, net -53 -2 291 2 238
Fair value of Novartis shares used to acquire outstanding non-controlling interests in Alcon, Inc. 9 163 -9 163
Excess of the consideration exchanged for acquiring Alcon non-controlling interests compared to their recorded values -5 634 5 634
Equity-based compensation 415 415 0
Dividends -6 030 -5 368 -662
Change in non-controlling interests -32 -6 537 6 505
Consolidated equity at June 30 64 241 67 093 -2 852

34






Condensed consolidated cash flow statements  (unaudited)

Second quarter

Q2 2012
USD m
Q2 2011
USD m
Change
USD m
Net income 2 733 2 726 7
Reversal of non-cash items
Taxes
482 520 -38
Depreciation, amortization and impairments
1 194 1 383 -189
Change in provisions and other non-current liabilities
41 505 -464
Net financial income
149 207 -58
Other
-20 -329 309
Net income adjusted for non-cash items 4 579 5 012 -433
Interest and other financial receipts 110 21 89
Interest and other financial payments -232 -426 194
Taxes paid -972 -674 -298
Cash flows before working capital changes 3 485 3 933 -448
Payments out of provisions and other net cash movements in non-current liabilities -324 -212 -112
Change in net current assets and other operating cash flow items -176 -275 99
Cash flows from operating activities 2 985 3 446 -461
Purchase of property, plant & equipment -604 -453 -151
Purchase of intangible, financial and other non-current assets -110 -171 61
Proceeds from sales of property, plant & equipment, intangible, financial and other non-current assets 40 475 -435
Acquisitions and divestments of businesses -43 20 -63
Change in marketable securities and investment in associated companies -6 239 -245
Cash flows used in / from investing activities -723 110 -833
Change in current and non-current financial debts -1 479 -4 046 2 567
Dividends paid to shareholders of Novartis AG -20 -16 -4
Treasury share transactions -266 -1 742 1 476
Acquisition of non-controlling interests -6 -741 735
Other financing cash flows 99 -12 111
Cash flows used in financing activities -1 672 -6 557 4 885
Translation effect on cash and cash equivalents -33 58 -91
Change in cash and cash equivalents 557 -2 943 3 500
Cash and cash equivalents at April 1 4 041 7 174 -3 133
Cash and cash equivalents at June 30 4 598 4 231 367

35






Condensed consolidated cash flow statements  (unaudited)

First half

H1 2012
USD m
H1 2011
USD m
Change
USD m
Net income 5 060 5 547 -487
Reversal of non-cash items
Taxes
893 1 057 -164
Depreciation, amortization and impairments
2 338 2 588 -250
Change in provisions and other non-current liabilities
403 627 -224
Net financial income
354 374 -20
Other
-54 -406 352
Net income adjusted for non-cash items 8 994 9 787 -793
Interest and other financial receipts 557 416 141
Interest and other financial payments -372 -628 256
Taxes paid -1 319 -1 444 125
Cash flows before working capital changes 7 860 8 131 -271
Payments out of provisions and other net cash movements in non-current liabilities -538 -810 272
Change in net current assets and other operating cash flow items -1 821 -1 968 147
Cash flows from operating activities 5 501 5 353 148
Purchase of property, plant & equipment -1 016 -872 -144
Purchase of intangible, financial and other non-current assets -322 -258 -64
Proceeds from sales of property, plant & equipment, intangible, financial and other non-current assets 204 696 -492
Acquisitions and divestments of businesses -43 -569 526
Change in marketable securities and investment in associated companies 9 1 604 -1 595
Cash flows used in / from investing activities -1 168 601 -1 769
Change in current and non-current financial debts 2 704 3 672 -968
Dividends paid to shareholders of Novartis AG -6 030 -5 368 -662
Treasury share transactions -55 -2 134 2 079
Acquisition of non-controlling interests -6 -3 178 3 172
Other financing cash flows -27 -36 9
Cash flows used in financing activities -3 414 -7 044 3 630
Translation effect on cash and cash equivalents -30 2 -32
Change in cash and cash equivalents 889 -1 088 1 977
Cash and cash equivalents at January 1 3 709 5 319 -1 610
Cash and cash equivalents at June 30 4 598 4 231 367

36






Notes to the Condensed Interim Consolidated Financial Statements for the three- and six-month periods ended June 30, 2012 

1. Basis of preparation

These Condensed Interim Consolidated Financial Statements for the three- and six-month periods ended June 30, 2012, were prepared in accordance with International Accounting Standard 34 Interim Financial Reporting and accounting policies set out in the 2011 Annual Report published on January 25, 2012.

2. Selected critical accounting policies

The Group’s principal accounting policies are set out in note 1 to the Consolidated Financial Statements in the 2011 Annual Report and conform with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board. The presentation of financial statements requires management to make subjective and complex judgments that affect the reported amounts. Because of the inherent uncertainties, actual outcomes and results may differ from management’s assumptions and estimates. In particular, as discussed in note 11 of the 2011 Annual Report, investments in intangible assets (including goodwill and acquired In-Process Research & Development projects) are reviewed for impairment at least annually, or 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 recent 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 financial results.

The determination of the contingent consideration in respect of acquisitions also requires management to make assumptions on the probability and amount of potential payments due to previous owners. If actual payments are different to the estimated amounts recorded for contingent consideration there could be a significant impact, either positive or negative, on the Group’s financial results.

3. Significant transactions

No significant acquisition or divestment transactions occurred during the six-month period up to June 30, 2012. Note 3 to the 2011 Annual Report describes in detail the significant acquisition or divestment transactions that occurred during 2011.

On May 2, 2012 the Sandoz Division signed a definitive agreement to acquire specialty dermatology generics company Fougera Pharmaceuticals based in Melville, New York, for USD 1.5 billion in an all-cash transaction. Fougera is a specialty dermatology business with 2011 net sales of USD 429 million, and employs approximately 700 people. The transaction is expected to be completed in the third quarter of 2012.

37






4. Principal currency translation rates

Second quarter


Average
rates
Q2 2012
USD

Average
rates
Q2 2011
USD
Period-end
rates
June 30,
2012
USD
Period-end
rates
June 30,
2011
USD
1 CHF 1.068 1.149 1.047 1.201
1 EUR 1.283 1.439 1.258 1.450
1 GBP 1.583 1.630 1.564 1.608
100 JPY 1.249 1.225 1.257 1.244

First half


Average
rates
H1 2012
USD

Average
rates
H1 2011
USD
Period-end
rates
June 30,
2012
USD
Period-end
rates
June 30,
2011
USD
1 CHF 1.077 1.105 1.047 1.201
1 EUR 1.297 1.403 1.258 1.450
1 GBP 1.577 1.616 1.564 1.608
100 JPY 1.256 1.220 1.257 1.244

38






5. Consolidated income statements – Segmentation – Second quarter  (unaudited)

Pharmaceuticals Alcon Sandoz Vaccines and Diagnostics Consumer Health Corporate (incl. eliminations) Total Group
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Net sales to third parties 8 255 8 338 2 648 2 625 2 147 2 466 349 299 904 1 187 14 303 14 915
Sales to other segments 77 66 13 3 70 85 8 18 5 4 -173 -176
Net sales of segments 8 332 8 404 2 661 2 628 2 217 2 551 357 317 909 1 191 -173 -176 14 303 14 915
Other revenues 116 111 9 14 2 111 80 1 5 1 -4 238 208
Cost of Goods Sold -1 689 -1 529 -1 148 -1 173 -1 259 -1 407 -310 -282 -408 -413 204 185 -4 610 -4 619
Gross profit 6 759 6 986 1 522 1 469 958 1 146 158 115 502 783 32 5 9 931 10 504
Marketing & Sales -2 149 -2 309 -633 -661 -382 -416 -86 -96 -362 -426 -1 4 -3 613 -3 904
Research & Development -1 650 -1 800 -248 -214 -196 -179 -118 -129 -73 -75 -2 285 -2 397
General & Administration -264 -249 -138 -135 -80 -93 -37 -36 -65 -76 -153 -149 -737 -738
Other income 180 376 3 14 9 19 2 7 29 71 57 265 502
Other expense -135 -213 -87 -102 -50 -194 -15 -75 -2 -10 -84 -51 -373 -645
Operating income 2 741 2 791 419 371 259 283 -96 -214 0 225 -135 -134 3 188 3 322
as % of net sales 33.2% 33.5% 15.8% 14.1% 12.1% 11.5% -27.5% -71.6% 0.0% 19.0% 22.3% 22.3%
Income from associated companies -1 16 2 3 3 3 155 125 176 130
Interest expense -183 -190
Other financial income and expense 34 -16
Income before taxes 3 215 3 246
Taxes -482 -520
Net income 2 733 2 726

39






Consolidated income statements – Segmentation – First half  (unaudited)

Pharmaceuticals Alcon Sandoz Vaccines and Diagnostics Consumer Health Corporate (incl. eliminations) Total Group
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
Net sales to third parties 16 094 16 036 5 189 5 041 4 271 4 839 648 670 1 836 2 356 28 038 28 942
Sales to other segments 149 126 28 6 141 150 19 35 10 9 -347 -326
Net sales of segments 16 243 16 162 5 217 5 047 4 412 4 989 667 705 1 846 2 365 -347 -326 28 038 28 942
Other revenues 227 223 20 21 1 5 170 154 2 6 -4 -6 416 403
Cost of Goods Sold -3 260 -2 959 -2 294 -2 321 -2 497 -2 736 -602 -581 -833 -826 392 346 -9 094 -9 077
Gross profit 13 210 13 426 2 943 2 747 1 916 2 258 235 278 1 015 1 545 41 14 19 360 20 268
Marketing & Sales -4 210 -4 359 -1 247 -1 271 -761 -799 -168 -173 -726 -832 4 6 -7 108 -7 428
Research & Development -3 261 -3 422 -496 -424 -384 -344 -239 -250 -140 -145 -4 520 -4 585
General & Administration -528 -495 -268 -261 -166 -182 -72 -71 -132 -146 -290 -277 -1 456 -1 432
Other income 344 527 6 266 31 41 3 11 12 83 220 123 616 1 051
Other expense -412 -425 -156 -162 -79 -279 -28 -110 -17 -15 -197 -153 -889 -1 144
Operating income 5 143 5 252 782 895 557 695 -269 -315 12 490 -222 -287 6 003 6 730
as % of net sales 32.0% 32.8% 15.1% 17.8% 13.0% 14.4% -41.5% -47.0% 0.7% 20.8% 21.4% 23.3%
Income from associated companies -1 -1 16 3 4 3 3 283 241 304 247
Interest expense -347 -379
Other financial income and expense -7 6
Income before taxes 5 953 6 604
Taxes -893 -1 057
Net income 5 060 5 547

40






6. Legal proceedings update

A number of Novartis subsidiaries are, and will likely continue to be, subject to various legal proceedings, including governmental investigations, that arise from time to time. As a result, the Group may become subject to substantial liabilities that may not be covered by insurance. Litigation is inherently unpredictable. As a result, Novartis 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. See note 20 in the Group’s Consolidated Financial Statements in the 2011 Annual Report for a summary of major legal proceedings. The following is a non-exhaustive update, also relating to cases reported in the 2011 Annual Report and in the press release for the first quarter of 2012, and includes information as of July 18, 2012:

WDKY investigation
In the first quarter of 2012, Novartis Pharmaceuticals Corporation (NPC) received a subpoena from the United States Attorney’s Office (USAO) for the Western District of Kentucky (WDKY) requesting the production of documents relating to marketing practices, including remuneration of healthcare providers, in connection with certain NPC products (including Tekturna and its combination products).NPC is cooperating with the investigation, which is civil and criminal in nature.

SDNY specialty pharmacy investigation
In the first quarter of 2012, NPC received a civil investigative demand from the USAO for the Southern District of New York (SDNY) requesting information regarding its interactions with specialty pharmacies concerning certain NPC products (including Gleevec and Gilenya). NPC is cooperating with the investigation, which is civil in nature.

Zometa/Aredia product liability litigation
NPC together with other Novartis subsidiaries are defendants in more than 700 cases brought in US courts, in which plaintiffs claim to have experienced osteonecrosis of the jaw after treatment with Zometa or Aredia, which are used to treat patients whose cancer has spread to the bones.

The majority of the US cases are consolidated in two venues – a federal multidistrict litigation proceeding and a separate state court proceeding in New Jersey. The first trial out of the state court consolidated proceedings held in New Jersey in September and October 2010 resulted in a defense verdict in favor of NPC. On June 13, 2012, the New Jersey Court of Appeals affirmed the judgment in favor of NPC. Plaintiffs have petitioned the New Jersey Supreme Court for further review, which is discretionary.

A prior state court case unrelated to the consolidated proceedings held in October 2009 resulted in a plaintiff’s verdict, which the Montana Supreme Court affirmed on appeal.

The first federal trial took place in November 2010 in the US District Court for the Middle District of North Carolina and resulted in a plaintiffs’ verdict. NPC filed an appeal against this verdict which remains pending. The second federal trial took place in May 2011 in the US District Court for the Eastern District of New York and resulted in a defense verdict in favor of NPC. This verdict is also currently on appeal.

The next federal trial began in the US District Court for the Western District of Kentucky on January 9, 2012. On January 31, 2012, the jury returned a verdict in favor of NPC, which was not appealed by plaintiff and which is therefore final. The second federal trial of 2012 began in the US District Court for the Eastern District of Missouri on January 23, 2012. On February 1, 2012, the jury returned a verdict in favor of NPC. On March 5, 2012, plaintiff filed a notice of appeal. On April 11, 2012, the US Court of Appeals for the Eighth Circuit dismissed the appeal; judgment has been entered for NPC. The third federal trial of 2012 began in the US District Court for the Western District of Missouri on March 20, 2012. On April 6, 2012, it resulted in a plaintiff’s verdict for compensatory damages of USD 0.2 million. No punitive damages were awarded. NPC filed a motion for judgment as a matter of law on May 7, 2012, which remains pending.

Further state and federal trials are scheduled for the remaining part of 2012.

41






Average Wholesale Price litigation
Claims have been brought against various pharmaceutical companies, including certain Sandoz entities and NPC, alleging that they fraudulently overstated the Average Wholesale Price (AWP) which is or has been used by state Medicaid agencies to calculate reimbursements to healthcare providers.

In the fourth quarter of 2011, Sandoz Inc. (Sandoz) reached an agreement in principle to settle the state portion of the New York City and New York Counties federal and state court cases for USD 22 million and the state portion of the Iowa case for USD 3 million. The settlement amount of USD 25 million for the Iowa and the New York settlements together was fully provisioned for in the fourth quarter of 2011. The settlement agreements have been executed by all parties and payments of the Iowa and the New York settlements were made in the first half of 2012. All related cases have been dismissed.

A bench trial against Sandoz in Mississippi Chancery Court ended on April 15, 2011. On September 2, 2011, the court rendered an opinion in favor of Sandoz on the false claims, conspiracy, and anti-kickback provisions but against Sandoz on the other causes of action and awarded plaintiff a total of USD 38.2 million (USD 23.7 million in compensatory damages, USD 2.7 million in civil penalties and USD 11.8 million in punitive damages). On October 4, 2011, the court granted Sandoz’ motion to amend the opinion and withdrew the punitive damages award. On March 30, 2012, an evidentiary hearing took place in order to determine whether punitive damages are appropriate and, if so, in what amount punitive damages should be awarded. On June 19, 2012, the court limited the punitive damages award to USD 3.75 million.

On July 13, 2012, the Alabama Supreme Court rendered judgment in Sandoz’ favor and overturned the February 2009 Montgomery County, Alabama Circuit Court jury verdict against Sandoz in the amount of USD 78 million (compensatory damages of USD 28 million and punitive damages of USD 50 million).

Lucentis patent litigation
Novartis Group companies have been sued by and have sued MedImmune in several European countries, including the United Kingdom, Germany, Switzerland, France and the Netherlands. MedImmune alleges that the sale of Lucentis in these countries infringes its patents and its rights under its Supplementary Protection Certificates (SPC).

In the UK, a trial took place in May 2011. On July 5, 2011, the UK court issued its decision and held that Novartis did not infringe MedImmune’s patents and that MedImmune’s patents were invalid. MedImmune has filed an appeal against this decision. A separate trial to hear Novartis’ challenge against the validity of MedImmune’s UK SPC took place on February 3, 2012, and the UK court found the SPC to be invalid. MedImmune appealed this decision. On July 11, 2012, the UK Court of Appeal held that MedImmune’s patent was invalid (and thereby also the SPC extension), upholding the first instance decision. In Germany, the infringement trial took place on October 18, 2011. On November 10, 2011, the German court found that the import and sale of Lucentis infringes one of the two MedImmune patents in dispute and the related SPC right in Germany. This decision is being appealed. The German invalidity trial on the other MedImmune patent took place on January 24, 2012, and the Federal Patent Court found this patent to be invalid. The trial on the validity of MedImmune’s German SPC took place on May 2, 2012, and the Federal Patent Court found the SPC to be invalid. On June 26, 2012, the European Patent Office also held that the MedImmune patent, which forms the basis for the SPCs, is invalid.

Wage and hour litigation
As previously reported, certain pharmaceutical sales representatives filed suit in a state court in California and in the US District Court for the Southern District of New York against NPC alleging that NPC violated wage and hour laws by misclassifying the pharmaceutical sales representatives as “exempt” employees, and by failing to pay overtime compensation. These actions are part of a number of lawsuits against pharmaceutical companies that challenge the industry’s long-term practice of treating pharmaceutical sales representatives as salaried employees. NPC has agreed with the plaintiffs to end the ongoing proceedings and to provide a payment of up to USD 99 million for eligible class members; the full amount of USD 99 million has been provisioned for in the third quarter of 2011 and in the first quarter of 2012. This settlement resolves the wage and hour claims brought in 2006, as well as additional wage and hour claims covering a more recent time period. On May 31, 2012, the judge granted final approval of the settlement and dismissed the case with prejudice.

42






SUPPLEMENTARY INFORMATION



Non-IFRS disclosures

Core results

The Group’s core results – including core operating income, core net income and core earnings per share – exclude the amortization of intangible assets, impairment charges, expenses relating to the integration of acquisitions as well as other items that are, or are expected to accumulate within the year to be, over a USD 25 million threshold that management deems exceptional.

Novartis believes that investor understanding of the Group’s performance is enhanced by disclosing core measures of performance because, since they exclude these exceptional items which can vary significantly from year to year, the core measures enable better comparison 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 that include targets 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 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 or amortization of purchased intangible assets.

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 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 usage 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. Novartis uses free cash flow in internal comparisons of results from the Group’s divisions. Free cash flow of the divisions uses the same definition as for the Group. No tax or financial receipts or payments are included in the division calculations. 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.



43






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

Pharmaceuticals Alcon Sandoz Vaccines and Diagnostics Consumer Health Corporate Total
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Q2 2012
USD m
Q2 2011
USD m
Operating income 2 741 2 791 419 371 259 283 -96 -214 0 225 -135 -134 3 188 3 322
Amortization of intangible assets 78 97 477 474 89 99 52 59 14 14 1 1 711 744
Impairments
Intangible assets
22 107 5 2 27 109
Property, plant & equipment related to the Group-wide rationalization of manufacturing sites 1
5 5
Other property, plant & equipment
17 14 1 3 20 15
Financial assets
1 10 62 15 3 16 75
Total impairment charges 40 131 5 1 8 62 2 15 3 63 204
Acquisition-related items
- Expense
68 80 2 3 2 4 72 87
Total acquisition-related items, net 68 80 2 3 2 4 72 87
Other exceptional items
Exceptional divestment gains
-26 -338 -1 -26 -339
Restructuring items
- Income
-17 -17
- Expense1
9 18 6 22 1 1 1 -2 17 39
Legal-related items
- Expense
-4 150 146
Additional exceptional income
-79 -56 -135
Additional exceptional expense
4 3 31 32 38 32
Total other exceptional items -113 -320 10 17 1 150 -56 1 4 -2 31 32 -123 -122
Total adjustments 5 -92 555 576 90 250 6 125 18 14 49 40 723 913
Core operating income 2 746 2 699 974 947 349 533 -90 -89 18 239 -86 -94 3 911 4 235
as % of net sales 33.3% 32.4% 36.8% 36.1% 16.3% 21.6% -25.8% -29.8% 2.0% 20.1% 27.3% 28.4%
Income from associated companies -1 16 2 3 3 3 155 125 176 130
Core adjustments to income from associated companies, net of tax -16 44 40 28 40
Interest expense -183 -190
Other financial income and expense 34 -16
Taxes (adjusted for above items) -610 -635
Core net income 3 356 3 564
Core net income attributable to shareholders 3 329 3 542
Core EPS (USD) 1.38 1.48
The Group-wide projects of rationalizing manufacturing sites resulted in restructuring charges of USD 18 million (2011 USD 44 million).

44






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

Pharmaceuticals Alcon Sandoz Vaccines and Diagnostics Consumer Health Corporate Total
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
H1 2012
USD m
H1 2011
USD m
Operating income 5 143 5 252 782 895 557 695 -269 -315 12 490 -222 -287 6 003 6 730
Amortization of intangible assets 156 219 954 967 178 193 106 115 29 29 2 2 1 425 1 525
Impairments
Intangible assets
23 107 1 5 2 29 109
Property, plant & equipment related to the Group-wide rationalization of manufacturing sites 1
5 5
Other property, plant & equipment
14 14 1 3 1 1 18 16
Financial assets
1 14 81 16 3 17 98
Total impairment charges 38 135 1 5 1 8 82 1 2 16 3 64 228
Acquisition-related items
- Gains
-81 -21 -102
- Expense
123 92 3 3 4 15 130 110
Total acquisition-related items, net -81 123 71 3 3 4 15 130 8
Other exceptional items
Exceptional divestment gains
-26 -338 -44 -51 -77 -382
Restructuring items
- Income1
-60 -6 -66
- Expense1
188 54 9 36 2 2 1 2 200 94
Legal-related items
- Income
-230 -230
- Expense
19 43 178 19 221
Additional exceptional income
-137 -56 -193
Additional exceptional expense
14 7 16 55 53 92 53
Total other exceptional items -2 -284 16 -151 -4 178 -56 2 17 -42 4 53 -25 -244
Total adjustments 192 -11 1 094 892 174 372 61 202 47 -11 26 73 1 594 1 517
Core operating income 5 335 5 241 1 876 1 787 731 1 067 -208 -113 59 479 -196 -214 7 597 8 247
as % of net sales 33.1% 32.7% 36.2% 35.4% 17.1% 22.1% -32.1% -16.9% 3.2% 20.3% 27.1% 28.5%
Income from associated companies -1 -1 16 3 4 3 3 283 241 304 247
Core adjustments to income from associated companies, net of tax -16 91 119 75 119
Interest expense -347 -379
Other financial income and expense -7 6
Taxes (adjusted for above items) -1 173 -1 300
Core net income 6 449 6 940
Core net income attributable to shareholders 6 400 6 782
Core EPS (USD) 2.65 2.88
The Group-wide projects of rationalizing manufacturing sites resulted in a net restructuring charge of USD 33 million including a divestment income of USD 6 million (2011 USD 99 million).

45






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




Q2 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges3


Other
exceptional
items4



Q2 2012
Core results



Q2 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 9 931 688 2 -38 10 583 11 253
Operating income 3 188 711 63 72 -123 3 911 4 235
Income before taxes 3 215 755 63 56 -123 3 966 4 199
Taxes5 -482 -610 -635
Net income 2 733 3 356 3 564
EPS (USD)6 1.12 1.38 1.48
The following are adjustments to arrive at Core Gross Profit
Other revenues 238 -56 182 208
Cost of Goods Sold -4 610 688 2 18 -3 902 -3 870
The following are adjustments to arrive at Core Operating Income
Research & Development -2 285 22 27 -1 -2 237 -2 262
General & Administration -737 4 -733 -735
Other income 265 -123 142 160
Other expense -373 1 36 70 35 -231 -277
The following are adjustments to arrive at Core Income before taxes
Income from associated companies 176 44 -16 204 170
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; Other expense includes amortization of intangible assets; Income from associated companies includes the recurring amortization of the purchase price allocation related to intangible assets included in the Novartis equity-method accounting for Roche of USD 38 million and USD 6 million for the Novartis share of the estimated Roche core items.
Impairments: Research & Development and Other expense include principally impairments of intangible assets and property, plant & equipment; Other expense also includes impairments of financial assets.
Acquisition or divestment related items, restructuring and integration charges: Cost of Goods Sold includes an acquisition related inventory step-up adjustment; Other expense relates to Alcon integration costs; Income from associated companies includes a USD 16 million revaluation gain on the initial interest in an acquired company.
Other exceptional items: Other revenues include an income of USD 56 million related to an intellectual property settlement and license agreement; Cost of Goods Sold relates primarily to restructuring charges related to the Group-wide rationalization of manufacturing sites; Research & Development, Other income and Other expense include restructuring charges related to the Group-wide rationalization of manufacturing sites; General & Administration includes exceptional IT-related costs; Other income includes a provision reduction of USD 79 million mainly related to Tekturna/Rasilez inventories, a reversal of prior year restructuring charges of USD 30 million, and a product divestment gain of USD 26 million; Other expense includes primarily charges for IT and finance restructuring of USD 31 million, a restructuring charge of USD 12 million related to the European Business and a reclassification from income to expense related to the prior quarter.
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 exceptional items although this is not the case for items arising from criminal 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 751 million to arrive at the core results before tax amounts to USD 128 million. This results in the average tax rate on the adjustments being 17.0%.
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 – First half  (unaudited)




H1 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges3


Other
exceptional
items4



H1 2012
Core results



H1 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 19 360 1 381 1 3 -17 20 728 21 794
Operating income 6 003 1 425 64 130 -25 7 597 8 247
Income before taxes 5 953 1 516 64 114 -25 7 622 8 240
Taxes5 -893 -1 173 -1 300
Net income 5 060 6 449 6 940
EPS (USD)6 2.07 2.65 2.88
The following are adjustments to arrive at Core Gross Profit
Other revenues 416 -56 360 403
Cost of Goods Sold -9 094 1 381 1 3 39 -7 670 -7 551
The following are adjustments to arrive at Core Operating Income
Research & Development -4 520 42 28 -4 450 -4 425
General & Administration -1 456 7 -1 449 -1 426
Other income 616 -282 334 334
Other expense -889 2 35 127 267 -458 -602
The following are adjustments to arrive at Core Income before taxes
Income from associated companies 304 91 -16 379 366
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; Other expense includes amortization of intangible assets; Income from associated companies includes the recurring amortization of the purchase price allocation related to intangible assets included in the Novartis equity-method accounting for Roche of USD 77 million and USD 14 million for the Novartis share of the estimated Roche core items.
Impairments: Research & Development and Other expense include principally impairments of intangible assets and property, plant & equipment; Other expense also includes impairments of financial assets.
Acquisition or divestment related items, restructuring and integration charges: Cost of Goods Sold includes an acquisition related inventory step-up adjustment; Other expense relates to Alcon integration costs; Income from associated companies includes a USD 16 million revaluation gain on the initial interest in an acquired company.
Other exceptional items: Other revenues include an income of USD 56 million related to an intellectual property settlement and license agreement; Cost of Goods Sold relates primarily to restructuring charges related to the Group-wide rationalization of manufacturing sites; Research & Development, Other income and Other expense include restructuring charges related to the Group-wide rationalization of manufacturing sites; General & Administration includes exceptional IT-related costs; Other income includes a provision reduction of USD 137 million mainly related to Tekturna/Rasilez inventories, a reversal of prior year restructuring charges of USD 60 million, a gain on divestment related to the Novartis Venture Funds of USD 51 million, and a product divestment gain of USD 26 million; Other expense includes a restructuring charge of USD 149 million related to the US business, an additional legal settlement provision of USD 19 million and an additional provision of USD 14 million related to Tekturna/Rasilez clinical studies; Other expense also includes charges for IT and finance restructuring of USD 55 million, additional charges of USD 13 million for product recalls and additional charges of USD 5 million for inventories both related to a US production plant, and a restructuring charge of USD 12 million related to the European Business.
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 exceptional items although this is not the case for items arising from criminal 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 1 669 million to arrive at the core results before tax amounts to USD 280 million. This results in the average tax rate on the adjustments being 16.8%.
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 – Pharmaceuticals – Second quarter  (unaudited)




Q2 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges


Other
exceptional
items3



Q2 2012
Core results



Q2 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 6 759 65 13 6 837 7 085
Operating income 2 741 78 40 -113 2 746 2 699
The following are adjustments to arrive at Core Gross Profit
Cost of Goods Sold -1 689 65 13 -1 611 -1 430
The following are adjustments to arrive at Core Operating Income
Research & Development -1 650 13 22 -1 -1 616 -1 677
Other income 180 -123 57 35
Other expense -135 18 -2 -119 -186
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 principally impairment charges related to In Process Research & Development; Other expense includes impairments primarily of property, plant & equipment.
Other exceptional items: Cost of Goods Sold, Research & Development, Other income, and Other expense include restructuring charges related to the Group-wide rationalization of manufacturing sites; Other income includes a provision reduction of USD 79 million mainly related to Tekturna/Rasilez inventories, a reversal of prior year restructuring charges of USD 30 million, and a product divestment gain of USD 26 million; Other expense includes a restructuring charge of USD 12 million related to the European Business and a reclassification from income to expense related to the prior quarter.
 

48






CORE RESULTS – Reconciliation from IFRS results to core results – Pharmaceuticals – First half  (unaudited)




H1 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges


Other
exceptional
items3



H1 2012
Core results



H1 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 13 210 131 30 13 371 13 640
Operating income 5 143 156 38 -2 5 335 5 241
The following are adjustments to arrive at Core Gross Profit
Cost of Goods Sold -3 260 131 30 -3 099 -2 745
The following are adjustments to arrive at Core Operating Income
Research & Development -3 261 25 23 -3 213 -3 284
Other income 344 -225 119 105
Other expense -412 15 193 -204 -366
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 principally impairment charges related to In Process Research & Development; Other expense includes impairments primarily of property, plant & equipment.
Other exceptional items: Cost of Goods Sold, Other income and Other expense include restructuring charges related to the Group-wide rationalization of manufacturing sites; Other income includes a provision reduction of USD 137 million mainly related to Tekturna/Rasilez inventories, a reversal of prior year restructuring charges of USD 60 million, and a product divestment gain of USD 26 million; Other expense includes a restructuring charge of USD 149 million related to the US business, an additional legal settlement provision of USD 19 million and an additional provision of USD 14 million related to Tekturna/Rasilez clinical studies; Other expense also includes a restructuring charge of USD 12 million related to the European business.
 

49






CORE RESULTS – Reconciliation from IFRS results to core results – Alcon – Second quarter  (unaudited)




Q2 2012
IFRS results



Amortization of
intangible assets1




Impairments
Acquisition or
divestment related
items, restructuring
and integration
charges2


Other
exceptional
items3



Q2 2012
Core results



Q2 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 1 522 474 3 1 999 1 951
Operating income 419 477 68 10 974 947
The following are adjustments to arrive at Core Gross Profit
Cost of Goods Sold -1 148 474 3 -671 -691
The following are adjustments to arrive at Core Operating Income
Research & Development -248 3 -245 -213
General & Administration -138 4 -134 -132
Other expense -87 68 3 -16 -12
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.
Acquisition or divestment related items, restructuring and integration charges: Other expense relates to Alcon integration costs.
Other exceptional items: Cost of Goods Sold and Other expense include restructuring charges related to the Group-wide rationalization of manufacturing sites; General & Administration includes other exceptional IT costs.
 

50






CORE RESULTS – Reconciliation from IFRS results to core results – Alcon – First half  (unaudited)




H1 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges3


Other
exceptional
items4



H1 2012
Core results



H1 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 2 943 950 1 6 3 900 3 734
Operating income 782 954 1 123 16 1 876 1 787
The following are adjustments to arrive at Core Gross Profit
Cost of Goods Sold -2 294 950 1 6 -1 337 -1 334
The following are adjustments to arrive at Core Operating Income
Research & Development -496 4 -492 -422
General & Administration -268 7 -261 -255
Other expense -156 123 3 -30 -15
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 includes impairments of intangible assets.
Acquisition or divestment related items, restructuring and integration charges: Other expense relates to Alcon integration costs.
Other exceptional items: Cost of Goods Sold and Other expense include restructuring charges related to the Group-wide rationalization of manufacturing sites; General & Administration includes other exceptional IT costs.

51






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




Q2 2012
IFRS results



Amortization of
intangible assets1




Impairments
Acquisition or
divestment related
items, restructuring
and integration
charges


Other
exceptional
items2



Q2 2012
Core results



Q2 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 958 87 1 1 046 1 242
Operating income 259 89 1 349 533
The following are adjustments to arrive at Core Gross Profit
Cost of Goods Sold -1 259 87 1 -1 171 -1 311
The following are adjustments to arrive at Core Operating Income
Research & Development -196 2 -194 -175
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.
Other exceptional items: Cost of Goods Sold includes restructuring charges related to the Group-wide rationalization of manufacturing sites.
 

52






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




H1 2012
IFRS results



Amortization of
intangible assets1




Impairments
Acquisition or
divestment related
items, restructuring
and integration
charges


Other
exceptional
items2



H1 2012
Core results



H1 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 1 916 174 2 2 092 2 444
Operating income 557 178 -4 731 1 067
The following are adjustments to arrive at Core Gross Profit
Cost of Goods Sold -2 497 174 2 -2 321 -2 550
The following are adjustments to arrive at Core Operating Income
Research & Development -384 4 -380 -336
Other income 31 -6 25 40
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.
Other exceptional items: Cost of Goods Sold includes restructuring charges related to the Group-wide rationalization of manufacturing sites; Other income includes a USD 6 million gain on sales of assets related to the Group-wide rationalization of manufacturing sites.
 
 

53






CORE RESULTS – Reconciliation from IFRS results to core results – Vaccines and Diagnostics – Second quarter  (unaudited)




Q2 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges3


Other
exceptional
items4



Q2 2012
Core results



Q2 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 158 48 2 -56 152 173
Operating income -96 52 8 2 -56 -90 -89
The following are adjustments to arrive at Core Gross Profit
Other revenues 111 -56 55 80
Cost of Goods Sold -310 48 2 -260 -224
The following are adjustments to arrive at Core Operating Income
Research & Development -118 4 5 -109 -124
Other expense -15 3 -12 -13
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 impairments of intangible assets; Other expense includes a facility impairment charge.
Acquisition or divestment related items, restructuring and integration charges: Cost of Goods Sold includes an acquisition related inventory step-up adjustment.
Other exceptional items: Other revenues include an income of USD 56 million related to an intellectual property settlement and license agreement.
 

54






CORE RESULTS – Reconciliation from IFRS results to core results – Vaccines and Diagnostics – First half  (unaudited)




H1 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges3


Other
exceptional
items4



H1 2012
Core results



H1 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 235 97 3 -56 279 388
Operating income -269 106 8 3 -56 -208 -113
The following are adjustments to arrive at Core Gross Profit
Other revenues 170 -56 114 154
Cost of Goods Sold -602 97 3 -502 -471
The following are adjustments to arrive at Core Operating Income
Research & Development -239 9 5 -225 -240
Other expense -28 3 -25 -28
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 impairments of intangible assets; Other expense includes a facility impairment charge.
Acquisition or divestment related items, restructuring and integration charges: Cost of Goods Sold includes an acquisition related inventory step-up adjustment.
Other exceptional items: Other revenues include an income of USD 56 million related to an intellectual property settlement and license agreement.

55






CORE RESULTS – Reconciliation from IFRS results to core results – Consumer Health – Second quarter  (unaudited)




Q2 2012
IFRS results



Amortization of
intangible assets1




Impairments
Acquisition or
divestment related
items, restructuring
and integration
charges


Other
exceptional
items2



Q2 2012
Core results



Q2 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 502 14 1 517 797
Operating income 0 14 4 18 239
The following are adjustments to arrive at Core Gross Profit
Cost of Goods Sold -408 14 1 -393 -399
The following are adjustments to arrive at Core Operating Income
Other expense -2 3 1 -12
Amortization of intangible assets: Cost of Goods Sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets.
Other exceptional items: Other expense includes principally additional charges for inventory provisions related to a US production plant.
 

CORE RESULTS – Reconciliation from IFRS results to core results – Consumer Health – First half  (unaudited)




H1 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges


Other
exceptional
items3



H1 2012
Core results



H1 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 1 015 29 1 1 045 1 574
Operating income 12 29 1 17 59 479
The following are adjustments to arrive at Core Gross Profit
Cost of Goods Sold -833 29 1 -803 -797
The following are adjustments to arrive at Core Operating Income
Other expense -17 1 16 0 -13
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: Other expense includes impairment charges related to the US activities.
Other exceptional items: Other expense includes principally additional charges of USD 13 million for product recalls and additional charges of USD 5 million for inventory provisions, both related to a US production plant.

56






CORE RESULTS – Reconciliation from IFRS results to core results – Corporate – Second quarter  (unaudited)




Q2 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges3


Other
exceptional
items4



Q2 2012
Core results



Q2 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 32 32 5
Operating income -135 1 15 2 31 -86 -94
The following are adjustments to arrive at Core Operating Income
Other expense -84 1 15 2 31 -35 -11
Amortization of intangible assets: Other expense includes amortization of intangible assets.
Impairments: Other expense includes impairments of financial assets.
Acquisition or divestment related items, restructuring and integration charges: Other expense includes Alcon-related legal entity reorganization charges.
Other exceptional items: Other expense includes charges for IT and finance restructuring projects.

CORE RESULTS – Reconciliation from IFRS results to core results – Corporate – First half  (unaudited)




H1 2012
IFRS results



Amortization of
intangible assets1




Impairments2
Acquisition or
divestment related
items, restructuring
and integration
charges3


Other
exceptional
items4



H1 2012
Core results



H1 2011
Core results
USD millions USD millions USD millions USD millions USD millions USD millions USD millions
Gross profit 41 41 14
Operating income -222 2 16 4 4 -196 -214
The following are adjustments to arrive at Core Operating Income
Other income 220 -51 169 123
Other expense -197 2 16 4 55 -120 -80
Amortization of intangible assets: Other expense includes amortization of intangible assets.
Impairments: Other expense includes impairments for financial assets.
Acquisition or divestment related items, restructuring and integration charges: Other expense includes Alcon-related legal entity reorganization charges.
Other exceptional items: Other income includes a gain on divestment related to the Novartis Venture Funds; Other expense includes charges for IT and finance restructuring projects.

57






Condensed consolidated changes in net debt  (unaudited)

Second quarter

Q2 2012
USD m
Q2 2011
USD m
Change in cash and cash equivalents 557 -2 943
Change in marketable securities, financial debt and financial derivatives 2 123 3 391
Change in net debt 2 680 448
Net debt at April 1 -19 206 -22 349
Net debt at June 30 -16 526 -21 901

First half

H1 2012
USD m
H1 2011
USD m
Change in cash and cash equivalents 889 -1 088
Change in marketable securities, financial debt and financial derivatives -2 261 -5 960
Change in net debt -1 372 -7 048
Net debt at January 1 -15 154 -14 853
Net debt at June 30 -16 526 -21 901



Components of net debt

H1 2012
USD m
H1 2011
USD m
Current financial debts and derivative financial instruments -8 878 -13 581
Non-current financial debts -13 754 -13 924
Less liquidity:
Cash and cash equivalents 4 598 4 231
Marketable securities and derivative financial instruments 1 508 1 373
Net debt at June 30 -16 526 -21 901



58






Free cash flow  (unaudited)

Second quarter

Q2 2012
USD m
Q2 2011
USD m
Change
USD m
Operating income 3 188 3 322 -134
Reversal of non-cash items
Depreciation, amortization and impairments
1 194 1 383 -189
Change in provisions and other non-current liabilities
41 505 -464
Other
156 -198 354
Total reversal of non-cash items
1 391 1 690 -299
Interest and other financial receipts 110 21 89
Interest and other financial payments -232 -426 194
Taxes paid -972 -674 -298
Payments out of provisions and other net cash movements in non-current liabilities -324 -212 -112
Change in inventory and accounts receivable less accounts payable -83 -29 -54
Change in other net current assets and other operating cash flow items -93 -246 153
Cash flows from operating activities 2 985 3 446 -461
Purchase of property, plant & equipment -604 -453 -151
Purchase of intangible, financial and other non-current assets -110 -171 61
Proceeds from sales of property, plant & equipment, intangible, financial and other non-current assets 40 475 -435
Free cash flow 2 311 3 297 -986

First half

H1 2012
USD m
H1 2011
USD m
Change
USD m
Operating income 6 003 6 730 -727
Reversal of non-cash items
Depreciation, amortization and impairments
2 338 2 588 -250
Change in provisions and other non-current liabilities
403 627 -224
Other
250 -158 408
Total reversal of non-cash items
2 991 3 057 -66
Interest and other financial receipts 557 416 141
Interest and other financial payments -372 -628 256
Taxes paid -1 319 -1 444 125
Payments out of provisions and other net cash movements in non-current liabilities -538 -810 272
Change in inventory and accounts receivable less accounts payable -1 236 -1 546 310
Change in other net current assets and other operating cash flow items -585 -422 -163
Cash flows from operating activities 5 501 5 353 148
Purchase of property, plant & equipment -1 016 -872 -144
Purchase of intangible, financial and other non-current assets -322 -258 -64
Proceeds from sales of property, plant & equipment, intangible, financial and other non-current assets 204 696 -492
Free cash flow 4 367 4 919 -552

59






Share information  (unaudited)

June 30,
2012
June 30,
2011
Number of shares outstanding (million) 2 417.9 2 426.5
Registered share price (CHF) 52.90 51.50
ADS price (USD) 55.90 61.11
Market capitalization (USD billion) 133.9 150.1
Market capitalization (CHF billion) 127.9 125.0

Summary of equity movements  (unaudited)

Number of outstanding shares (in millions) Issued share capital and reserves attributable to Novartis AG shareholders

2012

2011

Change
HY 2012
USD m
HY 2011
USD m
Change
USD m
Balance at beginning of year 2 407 2 289 118 65 844 63 196 2 648
Shares issued in connection with the merger with Alcon 108 -108 6 009 -6 009
Treasury shares exchanged in connection with the merger with Alcon 57 -57 3 154 -3 154
Excess of the purchase price for acquiring non-controlling interests compared to the recorded amounts and other impacts of change of ownership in consolidated entities -5 634 5 634
Share buy-backs:
Shares acquired to be cancelled
-39 39 -2 360 2 360
Shares acquired to be held in Group Treasury
-5 -5 -240 -240
Equity-based compensation 10 7 3 415 415 0
Other treasury shares movements 6 5 1 187 69 118
Dividends -6 030 -5 368 -662
Net income of the period attributable to shareholders of Novartis AG 5 011 5 474 -463
Other comprehensive income attributable to shareholders of Novartis AG -1 057 2 048 -3 105
Balance at June 30 2 418 2 427 -9 64 130 67 003 -2 873

60






Supplementary tables: Second quarter 2012  – Net sales of top 20 pharmaceutical products  (unaudited)

US Rest of world Total

Brands




USD m
% change
in constant
currencies


USD m
% change
in constant
currencies


USD m

% change
in USD
% change
in constant
currencies
Diovan/Co–Diovan Hypertension 658 4 608 -29 1 266 -16 -15
Gleevec/Glivec Chronic myeloid leukemia 432 17 762 -1 1 194 -1 4
Lucentis Age-related macular degeneration 604 20 604 12 20
Sandostatin Acromegaly 154 6 216 6 370 1 6
Zometa Cancer complications 146 -9 190 -5 336 -11 -7
Exforge Hypertension 100 27 252 19 352 14 20
Gilenya Relapsing multiple sclerosis 181 170 102 nm 283 258 268
Exelon/Exelon Patch Alzheimer's disease 103 18 155 -3 258 -2 4
Tasigna Chronic myeloid leukemia 84 45 153 46 237 39 45
Exjade Iron chelator 60 -14 159 6 219 -6 0
Top ten products total 1 918 15 3 201 1 5 119 1 6
Galvus Diabetes 224 47 224 36 47
Neoral/Sandimmun Transplantation 16 -11 193 -3 209 -8 -4
Voltaren (excl. OTC) Inflammation/pain 191 2 191 -5 2
Afinitor Advanced renal cell carcinoma 86 139 89 47 175 72 80
Reclast/Aclasta Osteoporosis 99 -1 61 9 160 -1 3
Comtan/Stalevo Parkinson’s disease 40 -27 97 0 137 -14 -9
Ritalin/Focalin Attention deficit/hyperactive disorder 108 16 40 19 148 13 17
Myfortic Transplantation 60 22 74 -5 134 -1 5
Xolair Asthma 0 nm 127 18 127 2 10
Tekturna/Rasilez Hypertension 37 -45 61 -28 98 -38 -35
Top 20 products total 2 364 13 4 358 3 6 722 2 6
Rest of portfolio 400 -4 1 133 -7 1 533 -11 -6
Total Division sales 2 764 10 5 491 1 8 255 -1 4
nm = not meaningful

61






Supplementary tables: First half 2012  – Net sales of top 20 pharmaceutical products  (unaudited)

US Rest of world Total

Brands




USD m
% change
in constant
currencies


USD m
% change
in constant
currencies


USD m

% change
in USD
% change
in constant
currencies
Diovan/Co–Diovan Hypertension 1 252 5 1 204 -29 2 456 -16 -15
Gleevec/Glivec Chronic myeloid leukemia 816 19 1 508 0 2 324 2 5
Lucentis Age-related macular degeneration 1 171 25 1 171 19 25
Sandostatin Acromegaly 318 16 422 4 740 5 9
Zometa Cancer complications 288 -14 375 -5 663 -11 -9
Exforge Hypertension 178 16 477 20 655 15 19
Gilenya Relapsing multiple sclerosis 348 188 182 nm 530 284 292
Exelon/Exelon Patch Alzheimer's disease 212 20 317 1 529 3 7
Tasigna Chronic myeloid leukemia 160 37 286 45 446 38 42
Exjade Iron chelator 124 2 311 13 435 6 10
Top ten products total 3 696 16 6 253 2 9 949 4 7
Galvus Diabetes 425 52 425 43 52
Neoral/Sandimmun Transplantation 34 -3 373 -6 407 -8 -5
Voltaren (excl. OTC) Inflammation/pain 1 0 379 2 380 -2 2
Afinitor Advanced renal cell carcinoma 151 125 167 41 318 66 71
Reclast/Aclasta Osteoporosis 182 -2 119 14 301 2 4
Comtan/Stalevo Parkinson’s disease 102 -5 190 0 292 -5 -2
Ritalin/Focalin Attention deficit/hyperactive disorder 204 6 75 12 279 6 8
Myfortic Transplantation 115 22 152 0 267 5 8
Xolair Asthma 0 nm 239 15 239 3 9
Tekturna/Rasilez Hypertension 93 -25 134 -15 227 -22 -19
Top 20 products total 4 578 15 8 506 4 13 084 4 7
Rest of portfolio 791 -15 2 219 -9 3 010 -14 -10
Total Division sales 5 369 9 10 725 1 16 094 0 4
nm = not meaningful

62






Pharmaceuticals Division net sales by therapeutic area – Second quarter  (unaudited)

Q2 2012
USD m
Q2 2011
USD m
% change
USD
% change
cc
Primary Care
Hypertension medicines
Diovan 1 266 1 513 -16 -15
Exforge 352 308 14 20
Subtotal Valsartan Group 1 618 1 821 -11 -9
Tekturna/Rasilez 98 159 -38 -35
Subtotal Hypertension 1 716 1 980 -13 -11
Galvus 224 165 36 47
Arcapta Neohaler/Onbrez Breezhaler 33 26 27 44
Total strategic franchise products 1 973 2 171 -9 -6
Established medicines 411 438 -6 -2
Total Primary Care products 2 384 2 609 -9 -5
Oncology
Gleevec/Glivec 1 194 1 203 -1 4
Tasigna 237 170 39 45
Subtotal Bcr-Abl franchise 1 431 1 373 4 9
Sandostatin 370 365 1 6
Zometa 336 376 -11 -7
Exjade 219 232 -6 0
Afinitor 175 102 72 80
Femara 115 241 -52 -50
Other 37 39 -5 10
Total Oncology products 2 683 2 728 -2 3
Specialty - Neuroscience
Gilenya 283 79 258 268
Exelon/Exelon Patch 258 264 -2 4
Comtan/Stalevo 137 160 -14 -9
Extavia 38 44 -14 -4
Other (including Fanapt) 19 8 138 139
Total strategic franchise products 735 555 32 39
Established medicines 126 142 -11 -5
Total Neuroscience products 861 697 24 30
Specialty - Ophthalmics
Lucentis 604 541 12 20
Other 26 25 4 7
Total Opthalmics products 630 566 11 20
Specialty - Integrated Hospital Care (IHC)*
Neoral/Sandimmun 209 227 -8 -4
Myfortic 134 135 -1 5
Zortress/Certican 52 50 4 13
Ilaris 20 12 67 68
Other 99 93 6 14
Total strategic franchise products 514 517 -1 5
Everolimus stent drug 81 80 1 10
Established medicines 294 321 -8 -5
Total IHC products 889 918 -3 2
Specialty - Critical Care
Xolair 127 125 2 10
TOBI 76 70 9 14
Total Critical Care products 203 195 4 11
Additional products
Voltaren (excl. OTC) 191 201 -5 2
Ritalin/Focalin 148 131 13 17
Tegretol 89 90 -1 5
Trileptal 66 66 0 7
Foradil 64 83 -23 -13
Other 47 54 -13 -13
Total additional products 605 625 -3 3
Total strategic franchise products 6 738 6 732 0 5
Total established medicines and additional products 1 517 1 606 -6 0
Total Division net sales 8 255 8 338 -1 4
* includes Transplantation

63






Pharmaceuticals Division net sales by therapeutic area – First half  (unaudited)

H1 2012
USD m
H1 2011
USD m
% change
USD
% change
cc
Primary Care
Hypertension medicines
Diovan 2 456 2 918 -16 -15
Exforge 655 569 15 19
Subtotal Valsartan Group 3 111 3 487 -11 -10
Tekturna/Rasilez 227 290 -22 -19
Subtotal Hypertension 3 338 3 777 -12 -10
Galvus 425 297 43 52
Arcapta Neohaler/Onbrez Breezhaler 62 46 35 47
Total strategic franchise products 3 825 4 120 -7 -5
Established medicines 784 885 -11 -9
Total Primary Care products 4 609 5 005 -8 -6
Oncology
Gleevec/Glivec 2 324 2 279 2 5
Tasigna 446 323 38 42
Subtotal Bcr-Abl franchise 2 770 2 602 6 10
Sandostatin 740 702 5 9
Zometa 663 749 -11 -9
Exjade 435 411 6 10
Afinitor 318 192 66 71
Femara 222 595 -63 -61
Other 70 75 -7 0
Total Oncology products 5 218 5 326 -2 1
Specialty - Neuroscience
Gilenya 530 138 284 292
Exelon/Exelon Patch 529 515 3 7
Comtan/Stalevo 292 306 -5 -2
Extavia 75 78 -4 3
Other (including Fanapt) 35 17 106 108
Total strategic franchise products 1 461 1 054 39 43
Established medicines 247 278 -11 -7
Total Neuroscience products 1 708 1 332 28 33
Specialty - Ophthalmics
Lucentis 1 171 985 19 25
Other 48 62 -23 -19
Total Opthalmics products 1 219 1 047 16 22
Specialty - Integrated Hospital Care (IHC)*
Neoral/Sandimmun 407 441 -8 -5
Myfortic 267 255 5 8
Zortress/Certican 98 92 7 13
Ilaris 35 23 52 58
Other 197 179 10 14
Total strategic franchise products 1 004 990 1 5
Everolimus stent drug 167 163 2 5
Established medicines 579 619 -6 -5
Total IHC products 1 750 1 772 -1 2
Specialty - Critical Care
Xolair 239 232 3 9
TOBI 152 141 8 11
Total Critical Care products 391 373 5 10
Additional products
Voltaren (excl. OTC) 380 389 -2 2
Ritalin/Focalin 279 264 6 8
Tegretol 174 175 -1 4
Trileptal 141 127 11 16
Foradil 129 155 -17 -9
Other 96 71 35 38
Total additional products 1 199 1 181 2 6
Total strategic franchise products 13 118 12 910 2 5
Total established medicines and additional products 2 976 3 126 -5 -2
Total Division net sales 16 094 16 036 0 4
* includes Transplantation

64






Net sales by region1 – Second quarter  (unaudited)

Q2 2012 Q2 2011 % change Q2 2012 Q2 2011
USD m USD m USD cc % of total % of total
Pharmaceuticals
Europe
2 585 3 076 -16 -6 31 37
US
2 764 2 512 10 10 34 30
Asia/Africa/Australasia
2 131 1 971 8 10 26 24
Canada and Latin America
775 779 -1 10 9 9
Total 8 255 8 338 -1 4 100 100
Of which in Established Markets
6 398 6 423 0 3 78 77
Of which in Emerging Growth Markets
1 857 1 915 -3 5 22 23
Alcon
Europe
701 759 -8 2 26 29
US
1 076 1 040 3 4 41 40
Asia/Africa/Australasia
579 534 8 11 22 20
Canada and Latin America
292 292 0 9 11 11
Total 2 648 2 625 1 5 100 100
Of which in Established Markets
2 017 2 017 0 3 76 77
Of which in Emerging Growth Markets
631 608 4 14 24 23
Sandoz
Europe
1 047 1 117 -6 5 49 45
US
676 883 -23 -24 31 36
Asia/Africa/Australasia
271 297 -9 -4 13 12
Canada and Latin America
153 169 -9 -2 7 7
Total 2 147 2 466 -13 -7 100 100
Of which in Established Markets
1 592 1 874 -15 -10 74 76
Of which in Emerging Growth Markets
555 592 -6 5 26 24
Vaccines and Diagnostics
Europe
124 101 23 34 36 34
US
157 128 23 22 45 43
Asia/Africa/Australasia
43 43 0 5 12 14
Canada and Latin America
25 27 -7 -6 7 9
Total 349 299 17 21 100 100
Of which in Established Markets
283 228 24 29 81 76
Of which in Emerging Growth Markets
66 71 -7 -4 19 24
Consumer Health
Europe
449 503 -11 -1 50 42
US
167 368 -55 -54 18 31
Asia/Africa/Australasia
189 201 -6 -2 21 17
Canada and Latin America
99 115 -14 -6 11 10
Total 904 1 187 -24 -18 100 100
Of which in Established Markets
596 855 -30 -26 66 72
Of which in Emerging Growth Markets
308 332 -7 1 34 28
Group Total
Europe
4 906 5 556 -12 -2 34 37
US
4 840 4 931 -2 -2 34 33
Asia/Africa/Australasia
3 213 3 046 5 8 22 20
Canada and Latin America
1 344 1 382 -3 7 10 10
Total 14 303 14 915 -4 1 100 100
Of which in Established Markets
10 886 11 397 -4 -1 76 76
Of which in Emerging Growth Markets
3 417 3 518 -3 6 24 24
Net sales from operations by location of third party customer. Emerging Growth Markets are all markets other than the Established Markets of the US, Canada, Japan, Australia, New Zealand and Western Europe.

65






Net sales by region1 – First half  (unaudited)

H1 2012 H1 2011 % change H1 2012 H1 2011
USD m USD m USD cc % of total % of total
Pharmaceuticals
Europe
5 106 5 890 -13 -6 32 37
US
5 369 4 926 9 9 33 31
Asia/Africa/Australasia
4 085 3 734 9 9 25 23
Canada and Latin America
1 534 1 486 3 10 10 9
Total 16 094 16 036 0 4 100 100
Of which in Established Markets
12 493 12 435 0 3 78 78
Of which in Emerging Growth Markets
3 601 3 601 0 6 22 22
Alcon
Europe
1 392 1 463 -5 2 27 29
US
2 053 1 933 6 6 40 38
Asia/Africa/Australasia
1 196 1 093 9 10 23 22
Canada and Latin America
548 552 -1 6 10 11
Total 5 189 5 041 3 6 100 100
Of which in Established Markets
3 984 3 907 2 4 77 78
Of which in Emerging Growth Markets
1 205 1 134 6 13 23 22
Sandoz
Europe
2 097 2 231 -6 2 49 46
US
1 348 1 728 -22 -22 32 36
Asia/Africa/Australasia
512 549 -7 -4 12 11
Canada and Latin America
314 331 -5 0 7 7
Total 4 271 4 839 -12 -7 100 100
Of which in Established Markets
3 146 3 616 -13 -10 74 75
Of which in Emerging Growth Markets
1 125 1 223 -8 0 26 25
Vaccines and Diagnostics
Europe
220 238 -8 -2 34 36
US
253 233 9 9 39 35
Asia/Africa/Australasia
96 109 -12 -12 15 16
Canada and Latin America
79 90 -12 -10 12 13
Total 648 670 -3 -1 100 100
Of which in Established Markets
480 474 1 4 74 71
Of which in Emerging Growth Markets
168 196 -14 -12 26 29
Consumer Health
Europe
931 991 -6 1 51 42
US
328 761 -57 -57 18 32
Asia/Africa/Australasia
369 373 -1 1 20 16
Canada and Latin America
208 231 -10 -5 11 10
Total 1 836 2 356 -22 -18 100 100
Of which in Established Markets
1 212 1 723 -30 -27 66 73
Of which in Emerging Growth Markets
624 633 -1 5 34 27
Group Total
Europe
9 746 10 813 -10 -3 35 37
US
9 351 9 581 -2 -2 33 33
Asia/Africa/Australasia
6 258 5 858 7 7 22 20
Canada and Latin America
2 683 2 690 0 6 10 10
Total 28 038 28 942 -3 0 100 100
Of which in Established Markets
21 315 22 155 -4 -1 76 77
Of which in Emerging Growth Markets
6 723 6 787 -1 5 24 23
Net sales from operations by location of third party customer. Emerging Growth Markets are all markets other than the Established Markets of the US, Canada, Japan, Australia, New Zealand and Western Europe.
 

66






Income from associated companies

Q2 2012
USD m
Q2 2011
USD m
H1 2012
USD m
H1 2011
USD m
Share of estimated Roche reported net income 189 163 362 360
Restructuring impact (2011 includes USD 41 million from 2010) -41
Amortization of intangible assets -38 -41 -77 -79
Net income effect from Roche 151 122 285 240
Net income from other associated companies 25 8 19 7
Income from associated companies 176 130 304 247

67








 

Disclaimer
This press release contains forward-looking statements that can be identified by terminology such as “prospects,” “recommendations,” “on track,” “momentum,” “positive opinion,” “expected,” “recommendation,” “recommended,” “expectations,” “pipeline,” “strategy,” “long-term,” “sustainable,” “future,” “commitment,” “potentially,” “would,” “predicted,” “will,” “plans,” “planned,” “expect,” “outlook,” “unforeseen events,” “potential,” “filing,” “launch,” “submission,” “filed,” 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 outcomes of our efforts to improve the quality standards at any or all of our manufacturing sites, 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 reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such 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 Group will be successful in its efforts to improve the quality standards at any or all of our manufacturing sites, or that we will succeed in restoring or maintaining production at any particular sites.  Neither can there be any guarantee that the Group, or any of its divisions, will achieve any particular financial results. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including additional analyses of existing clinical data or unexpected new clinical data; the Group's ability to obtain or maintain patent or other proprietary intellectual property protection, including the ultimate extent of the impact on the Group of the loss of patent protection on key products which commenced last year and will continue this year; unexpected product manufacturing and quality issues, including the potential outcomes of the Warning Letter issued to us with respect to three Sandoz manufacturing facilities, and the potential outcome of efforts to restart production at the Consumer Health manufacturing facility at Lincoln, Nebraska; government, industry, and general public pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, shareholder litigation, government investigations and intellectual property disputes; competition in general; uncertainties regarding the effects of the ongoing global financial and economic crisis, including the financial troubles in certain Eurozone countries; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; the impact that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this presentation 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.

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, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 126,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Important dates
October 25, 2012                                Third quarter results 2012
November 2012                                  Novartis Investor Day (including R&D update)
January 23, 2013                                Fourth quarter and full year results 2012

68