SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 or 15d-16 OF

THE SECURITIES EXCHANGE ACT OF 1934

 

Report on Form 6-K dated July 17, 2008

(Commission File No. 1-15024)

 

This Report on Form 6-K shall be incorporated by reference in our Registration Statements on Form F-3 as filed with the Commission on May 11, 2001 (File No. 333-60712) and our Registration Statements on Form S-8 as filed with the Commission on September 5, 2006 (File No. 333-137112) and on October 1, 2004 (File No. 333-119475), in each case to the extent not superseded by documents or reports subsequently filed by us under the Securities Act of 1933 or the Securities Exchange Act of 1934, in each case as amended

 


 

Novartis AG

(Name of Registrant)

 

Lichtstrasse 35

4056 Basel

Switzerland

(Address of Principal Executive Offices)

 


 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F: x

     Form 40-F: o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

Yes: o

     Nox

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

Yes: o

     Nox

 

Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes: o

     Nox

 

Enclosure:                Novartis AG Announces Results for the First Half of 2008

 

 

 



 

 

Novartis International AG 

 

Novartis Global Communications

CH-4002 Basel

Switzerland
http://www.novartis.com

 

FINANCIAL REPORT   ·   RAPPORT TRIMESTRIEL   ·   QUARTALSBERICHT

 

Novartis gains momentum with strong performance in first half of 2008 from portfolio focused on growth areas of healthcare

 

·                  First-half results for continuing operations led by improving Pharmaceuticals performance ahead of expectations and expansion in Vaccines and Diagnostics

 

·                  Net sales rise 11% (+2% in local currencies) to USD 20.6 billion

 

·                  Operating income advances 12% to USD 4.9 billion on business expansion, productivity gains and currency benefits

 

·                  Net income up 13% to USD 4.6 billion; basic EPS rises 17% to USD 2.01

 

·                  Dynamic growth from new products – including Tekturna/Rasilez, Exforge, Lucentis, Exelon Patch and Aclasta/Reclast – provides USD 1.3 billion in first-half net sales

 

·                  Key R&D projects on track for 2008 submissions, particularly Afinitor (RAD001) for advanced kidney cancer and Menveo meningococcal meningitis vaccine

 

·                  25% stake in Alcon, the world leader in eye care, purchased in July; strategic acquisitions strengthen portfolio and complement internal growth drivers

 

·                  Novartis on track for record sales and earnings in 2008 from continuing operations

 

Key figures – Continuing operations

 

First half

 

 

 

H1 2008

 

H1 2007

 

% change

 

 

 

USD m

 

% of
net sales

 

USD m

 

% of
net sales

 

USD

 

lc

 

Net sales

 

20 635

 

 

 

18 528

 

 

 

11

 

2

 

Operating income

 

4 949

 

24.0

 

4 432

 

23.9

 

12

 

 

 

Net income

 

4 574

 

22.2

 

4 035

 

21.8

 

13

 

 

 

Basic earnings per share

 

USD

2.01

 

 

 

USD

1.72

 

 

 

17

 

 

 

 

Second quarter

 

 

 

Q2 2008

 

Q2 2007

 

% change

 

 

 

USD m

 

% of
net sales

 

USD m

 

% of
net sales

 

USD

 

lc

 

Net sales

 

10 726

 

 

 

9 400

 

 

 

14

 

5

 

Operating income

 

2 461

 

22.9

 

2 097

 

22.3

 

17

 

 

 

Net income

 

2 266

 

21.1

 

1 943

 

20.7

 

17

 

 

 

Basic earnings per share

 

USD

0.99

 

 

 

USD

0.83

 

 

 

19

 

 

 

 

All product names appearing in italics are trademarks owned by or licensed to Novartis Group Companies

 

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Basel, July 17, 2008 — Commenting on the results, Dr. Daniel Vasella, Chairman and  CEO of Novartis said: “The growth acceleration in the second quarter of 2008 and our R&D successes, especially in Pharmaceuticals and Vaccines, demonstrate that our strategy is delivering results and that we are heading towards a promising future despite a weak economy. Speed and productivity of operations are improving and growth in most countries is dynamic.”

 

OVERVIEW

 

First half

 

All businesses contributed to the strong performance, especially accelerating sales and profitability in Pharmaceuticals and sustained dynamic growth in Vaccines and Diagnostics that underpinned expectations for record results in 2008.

 

Net sales rose 11% (+2% in local currencies) to USD 20.6 billion as higher sales volumes contributed two percentage points of growth, while currency translation added nine points. Price changes and acquisitions had no significant impact.

 

Advancing faster than net sales, operating income was up 12% to USD 4.9 billion and driven by the solid business expansion as well as the Forward initiative, which also provided funds for major investments in new product development and expansion in fast-growing markets. The operating margin was slightly higher at 24.0% of net sales from 23.9% in the 2007 period.

 

Net income rose 13% to USD 4.6 billion on the increase in operating income as well as higher levels of financial income and income from associated companies. Basic earnings per share (EPS) rose faster, up 17% to USD 2.01 due to fewer outstanding shares.

 

Second quarter

 

Net sales for the quarter rose 14% (+5% lc) to USD 10.7 billion as Pharmaceuticals grew ahead of expectations and succeeded in overcoming the impact of 2007 challenges in the US. Vaccines and Diagnostics expanded at a fast rate, while difficult conditions in the US led to moderate growth in Sandoz and Consumer Health. Higher sales volumes provided five percentage points of growth, while positive currency translation added nine points.

 

Operating income advanced 17% to USD 2.5 billion on double-digit contributions from Pharmaceuticals and Consumer Health. As a result, the operating income margin rose to 22.9% of net sales from 22.3% in the 2007 period.

 

Net income also rose 17%, rising to USD 2.3 billion, benefiting from the ongoing business expansion and supported by higher levels of financial income and associated company income. Basic earnings per share (EPS) rose 19% to USD 0.99, above the 17% of net income growth reflecting the lower number of outstanding shares.

 

Underscoring the benefits of a strategic healthcare portfolio

 

The performance in the first half of 2008 shows how Novartis is fully leveraging growth opportunities and benefits from the Group’s strategic healthcare portfolio.

 

Recently launched pharmaceutical products contributed USD 1.3 billion to net sales in the first half of the year thanks to the ongoing rollout after 15 approvals in the US and EU in 2007. Top performers included Aclasta/Reclast (USD 103 million) as the only once-yearly

 

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therapy for osteoporosis and Lucentis (USD 437 million) as the only approved treatment shown to maintain and improve vision in people with age-related macular degeneration.

 

Sustained investments in innovation are delivering results. Afinitor (RAD001) is set for first regulatory submissions in 2008 as a breakthrough treatment for advanced kidney cancer, with studies underway in other cancers. Among other projects set for 2008 submissions is the meningococcal meningitis vaccine Menveo, which has the potential to become the first to protect from infancy to adulthood against four common serogroups associated with this often-fatal bacterial disease.

 

The Forward initiative is progressing well since its launch in December 2007 to improve speed, flexibility and productivity for enhanced competitiveness. Novartis is streamlining decision-making and freeing up resources to support future growth. About 65% of the anticipated 2008 cost savings of USD 670 million have been delivered. This initiative has a goal of pre-tax annual cost savings of USD 1.6 billion in 2010. The reduction of 2,500 full-time equivalent positions is underway, with nearly all affected associates notified.

 

The momentum of Pharmaceuticals in the first half confirmed plans for a new growth cycle starting in the second half of 2008, with quarterly net sales growth from Pharmaceuticals expected at a high-single-digit rate by the fourth quarter, in local currencies.

 

Strategic actions to strengthen healthcare portfolio

 

Complementing internal growth drivers, particularly new products from R&D investments and geographic expansion, Novartis has taken strategic actions during 2008 to further strengthen its healthcare portfolio with targeted acquisitions.

 

A 25% stake in Alcon Inc. (NYSE: ACL) was purchased on July 7 from Nestlé S.A. for USD 10.4 billion as part of an agreement that provides Novartis the opportunity to take majority ownership of the world leader in eye care. In an optional second step, Novartis has the right to acquire, and Nestlé the right to sell, the remaining 52% Alcon stake held by Nestlé between January 2010 and July 2011 for up to approximately USD 28 billion.

 

The acquisition of Protez Pharmaceuticals, a privately held US biotechnology company, will provide rights in the US and Europe to PZ-601, a promising antibiotic in Phase II development that has shown potential to treat life-threatening hospital infections.

 

Speedel Holding Ltd. (SWX: SPPN) became a majority-owned subsidiary on July 10 after the acquisition of an additional 51.7% stake. A mandatory public tender offer will start in August to buy remaining shares, with total acquisition costs estimated at CHF 907 million (or USD 880 million). Novartis has a long-standing collaboration with Speedel, whose R&D pipeline is a strong fit with the Group’s leading position in cardiovascular disease.

 

Group outlook

(Barring any unforeseen events)

 

Novartis reaffirms expectations for another year of record net sales and earnings in 2008 from continuing operations entirely focused on healthcare. Net sales from continuing operations for the Group are expected to rise at a mid-single-digit rate, and at a low-single-digit growth rate in the Pharmaceuticals Division, both in local currencies. Sandoz is now expected to achieve mid-single-digit net sales growth for the full year in local currencies.

 

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BUSINESS REVIEW

 

First half

 

Net sales

 

 

 

H1 2008

 

H1 2007

 

% change

 

 

 

USD m

 

USD m

 

USD

 

lc

 

Pharmaceuticals

 

13 192

 

11 988

 

10

 

1

 

Vaccines and Diagnostics

 

602

 

482

 

25

 

15

 

Sandoz

 

3 854

 

3 415

 

13

 

2

 

Consumer Health continuing operations

 

2 987

 

2 643

 

13

 

4

 

Net sales from continuing operations

 

20 635

 

18 528

 

11

 

2

 

 

Pharmaceuticals: +10% (+1% lc) to USD 13.2 billion

 

Dynamic growth from Oncology products and the flagship brand Diovan, along with increasing contributions from recently launched products, more than offset an 11% decline in the US, which was caused by the 2007 generic entries for four products (Lotrel, Lamisil, Trileptal and Famvir) and the Zelnorm suspension. Outside of North America, all other regions expanded, with Europe at USD 5.2 billion (+8% lc), Japan at USD 1.2 billion (+6% lc), Latin America at USD 0.9 billion (+8% lc) and the rest of the world at USD 1.4 billion (+19% lc).

 

Oncology (USD 4.0 billion, +14% lc) gained momentum and accounted for four of the five top-selling medicines. Gleevec/Glivec achieved sales of USD 1.8 billion (+17% lc), and Zometa, Sandostatin and Femara are all on track for over USD 1 billion in annual sales. Cardiovascular strategic products (USD 3.3 billion, +3% lc) benefited from sustained gains for Diovan (USD 2.9 billion, +12% lc) and increasing contributions from the new high blood pressure medicines Exforge and Tekturna/Rasilez.

 

Recently launched products added USD 1.3 billion in first-half net sales after 15 major US and EU approvals in 2007 and launches underway in 2008. Top performers included the once-yearly osteoporosis therapy Aclasta/Reclast (USD 103 million), Lucentis (USD 437 million) as a standard of care for age-related blindness and Exelon Patch as a new skin patch formulation for Alzheimer’s Disease and dementia linked to Parkinson’s Disease.

 

Net sales for the first half of 2008 included a one-time contribution of USD 104 million from a provision reversal following a Novartis review of accounting for rebate programs to US government health agencies.

 

Vaccines and Diagnostics: +25% (+15% lc) to USD 602 million

 

Strong growth driven by deliveries of tick-borne encephalitis (TBE) vaccines, geographic expansion outside the US in diagnostics and sales of H5N1 pandemic vaccines.

 

Sandoz: +13% (+2% lc) to USD 3.9 billion

 

Eastern Europe and improving positions in key markets helped mitigate the impact of a 7% lc decline in the US due to few new product launches. Russia solidified its position among the top five countries with 42% lc growth, while Germany gained market share and rose 1% lc. Poland, Canada, Brazil and Turkey provided important contributions.

 

5



 

Consumer Health continuing operations: +13% (+4% lc) to USD 3.0 billion

 

All businesses supported the improved performance, with CIBA Vision showing the strongest gains based on recent launches of new contact lens products and the benefits of full supplies following shortages in 2007.

 

Operating income

 

 

 

H1 2008

 

H1 2007

 

Change

 

 

 

USD m

 

% of
net
sales

 

USD m

 

% of 
net
sales

 

%

 

Pharmaceuticals

 

4 274

 

32.4

 

3 620

 

30.2

 

18

 

Vaccines and Diagnostics

 

–128

 

 

 

7

 

1.5

 

 

 

Sandoz

 

591

 

15.3

 

561

 

16.4

 

5

 

Consumer Health continuing operations

 

566

 

18.9

 

483

 

18.3

 

17

 

Corporate income & expense, net

 

–354

 

 

 

–239

 

 

 

 

 

Operating income from continuing operations

 

4 949

 

24.0

 

4 432

 

23.9

 

12

 

 

Pharmaceuticals: +18% to USD 4.3 billion

 

The double-digit advance was driven by the underlying business expansion in many regions that helped offset challenges in the US, strong contributions from productivity initiatives and a positive impact from one-time items. As a result, the operating income margin rose 2.2 percentage points to 32.4% of net sales from 30.2% in the 2007 period. Other Revenues provided 0.7 percentage points to the higher operating margin, mainly from royalty income for Betaseron®. Marketing & Sales expenses were 30.4% of net sales compared to 31.4% in the 2007 period on good productivity gains and effective reallocation of resources to support the rollout of new products including Exforge, Tekturna/Rasilez, Aclasta/Reclast, Lucentis and Exelon Patch. R&D investments rose in line with net sales, accounting for 20.2% of net sales. Priority areas included oncology compounds such as Afinitor, further support for Cardiovascular products and emerging late-stage compounds such as FTY720.

 

Vaccines and Diagnostics: operating loss of USD 128 million

 

The operating loss in the first half reflects the seasonal nature of this business, where seasonal flu vaccines sales mainly occur in the second half. Major investments were made in manufacturing and product quality as well as late-stage clinical trials and pre-launch activities for the two meningitis vaccines. The year-ago results also included a one-time legal settlement gain of USD 83 million. Excluding exceptional items and the amortization of intangible assets in both periods, the adjusted operating loss was USD 4 million in the first half compared to an adjusted operating income of USD 77 million in the 2007 period.

 

Sandoz: +5% to USD 591 million

 

Lower sales in the US and accelerated investments in R&D were among factors for the slowdown in operating income growth. Productivity gains supported an improvement in Costs of Goods Sold, which rose only 9%. However, R&D expenses rose 39% to support new projects, particularly for difficult-to-make generics. Marketing & Sales costs were higher on investments in emerging markets and to expand activities in follow-on biologics. The operating margin fell to 15.3% of net sales, a decline of 1.1 percentage points.

 

Consumer Health continuing operations: +17% to USD 566 million

 

An excellent double-digit expansion in operating income thanks to the overall business expansion and productivity benefits in all business units from the Forward initiative. Total Selling, General & Administration costs declined as a percentage of net sales, while R&D

 

6



 

investments expanded at a fast pace to support new product development. The operating income margin was 18.9% of net sales, up from 18.3% in the 2007 period.

 

Corporate income and expense, net

 

Among factors for the increased net corporate expenses were the negative impact of foreign exchange movements and additional investments in global IT infrastructure.

 

Second quarter

 

Net sales

 

 

 

Q2 2008

 

Q2 2007

 

% change

 

 

 

USD m

 

USD m

 

USD

 

lc

 

Pharmaceuticals

 

6 928

 

6 065

 

14

 

5

 

Vaccines and Diagnostics

 

322

 

251

 

28

 

19

 

Sandoz

 

1 948

 

1 719

 

13

 

2

 

Consumer Health continuing operations

 

1 528

 

1 365

 

12

 

3

 

Net sales from continuing operations

 

10 726

 

9 400

 

14

 

5

 

 

Pharmaceuticals: +14% (+5% lc) to USD 6.9 billion

 

A turnaround was achieved in the 2008 second quarter with higher sales in local currencies coming from the flagship cardiovascular and oncology brands as well as recently launched products. This more than compensated for the 3% decline in the US, which continued to be affected by 2007 generic entries for four products and the loss of Zelnorm.

 

Outside of North America, all regions showed strong performances: Europe (USD 2.7 billion, +8% lc), Japan (USD 664 million, +7% lc), Latin America (USD 466 million, +11% lc) and the rest of the world (USD 686 million, +18% lc).

 

Oncology (USD 2.1 billion, +13% lc) was the top-performing franchise, representing 30% of total net sales and driven by dynamic growth from Gleevec/Glivec, Femara and Exjade. The Cardiovascular franchise grew 9% lc on the leadership of Diovan (USD 1.5 billion, +13% lc) and increasing contributions from Tekturna/Rasilez and Exforge.

 

Recently launched products, including Tekturna/Rasilez, Exforge, Lucentis, Aclasta/Reclast and Exelon Patch, added USD 700 million of net sales in the second quarter as rollouts continued in key markets and new reimbursement decisions offered greater patient access. The 2008 second quarter included USD 104 million from a provision reversal following a Novartis review of accounting for rebate programs to US government health agencies.

 

Vaccines and Diagnostics: +28% (+19% lc) to USD 322 million

 

A H5N1 pandemic vaccine tender to the US government of USD 68 million was recorded in the 2008 second quarter. Higher deliveries of polio vaccines and blood testing diagnostics helped offset a modest decline in TBE vaccines, with sales limited by capacity.

 

Sandoz: +13% (+2% lc) to USD 1.9 billion

 

Key markets including Russia, Poland, Turkey, Canada and Switzerland delivered robust results, but the US continued to suffer as net sales fell 11% lc mainly from a lack of new product launches in 2008.

 

Consumer Health continuing operations: +12% (+3% lc) to USD 1.5 billion

 

CIBA Vision delivered strong growth from new products and full supplies after shortages in 2007. Emerging markets and strategic brands helped OTC offset lower sales in the US, which were hurt by an overall market shift in consumer spending toward unbranded, “private label” products. Animal Health saw solid growth in its companion animals business, more than offsetting a worldwide decline in demand for farm animal products.

 

7



 

Operating income

 

 

 

Q2 2008

 

Q2 2007

 

Change

 

 

 

USD m

 

% of
net
sales

 

USD m

 

% of
net
sales

 

%

 

Pharmaceuticals

 

2 178

 

31.4

 

1 767

 

29.1

 

23

 

Vaccines and Diagnostics

 

–75

 

 

 

–20

 

 

 

 

 

Sandoz

 

246

 

12.6

 

243

 

14.1

 

1

 

Consumer Health continuing operations

 

304

 

19.9

 

243

 

17.8

 

25

 

Corporate income & expense, net

 

–192

 

 

 

–136

 

 

 

 

 

Operating income from continuing operations

 

2 461

 

22.9

 

2 097

 

22.3

 

17

 

 

Pharmaceuticals: +23% to USD 2.2 billion

 

Strong operating income gains came from growing momentum in the underlying business, good progress of productivity initiatives that have delivered savings ahead of schedule and a net positive impact from one-time items. As a result, the operating income margin rose to 31.4% of net sales from 29.1% in the 2007 period. Cost of Goods Sold increased 18%, rising 0.6 percentage points as a percentage of net sales from an unfavorable product mix and currency effects. Other Revenues provided 0.6 percentage points to the improved operating income margin, mainly from royalty income for Betaseron®. R&D investments rose 12% on investments in projects including QAB149, QMF149, FTY720, Afinitor (RAD001), ACZ885 and Tekturna/Rasilez. Marketing & Sales declined to 30.4% of net sales as productivity initiatives supported major investments in new product launches that are rejuvenating the portfolio.

 

Vaccines and Diagnostics: operating loss of USD 75 million

 

Ongoing investments in R&D projects and manufacturing improvements were among key reasons for the operating loss expanding to USD 75 million in the second quarter from a loss of USD 20 million in the year-ago period. The second quarter of 2007 benefited from a gain of USD 16 million from legal settlements. Excluding exceptional items and the amortization of intangible assets in both periods, adjusted operating income was USD 16 million in the 2008 quarter compared to USD 39 million in the 2007 quarter.

 

Sandoz: +1% to USD 246 million

 

The sharp slowdown in operating income growth reflected reduced contributions from the US as well as significant investments in R&D for new products and expansion in key markets. The 2007 quarter included one-time charges of USD 28 million. The operating income margin fell to 12.6% from 14.1% in the 2007 period.

 

Consumer Health continuing operations: +25% to USD 304 million

 

CIBA Vision, Animal Health and OTC all contributed to operating income growing faster than sales, benefiting from the business expansion and productivity gains that supported investments in new products and expansion in key markets. The operating income margin rose to 19.9% of net sales in the 2008 quarter from 17.8% in the year-ago period.

 

Corporate income and expense, net

 

Higher corporate expenses included the impact of negative foreign exchange movements and additional investments in global IT infrastructure, which were partially offset by productivity gains from the Forward initiative.

 

8



 

FINANCIAL REVIEW

 

First half and second quarter

 

 

 

H1 2008

 

H1 2007

 

Change

 

Q2 2008

 

Q2 2007

 

Change

 

 

 

USD m

 

USD m

 

%

 

USD m

 

USD m

 

%

 

Operating income from continuing operations

 

4 949

 

4 432

 

12

 

2 461

 

2 097

 

17

 

Income from associated companies

 

256

 

192

 

33

 

119

 

95

 

25

 

Financial income

 

233

 

177

 

32

 

85

 

90

 

–6

 

Interest expense

 

–118

 

–110

 

7

 

–61

 

–57

 

7

 

Taxes

 

–746

 

–656

 

14

 

–338

 

–282

 

20

 

Net income from continuing operations

 

4 574

 

4 035

 

13

 

2 266

 

1 943

 

17

 

Net income from discontinued operations

 

9

 

152

 

 

 

–6

 

73

 

 

 

Total net income

 

4 583

 

4 187

 

9

 

2 260

 

2 016

 

12

 

 

Income from associated companies

 

Higher income contributions in the first half and the second quarter of 2008 represented largely the Novartis share of anticipated net income from the Roche investment.

 

Financial income, net

 

Improved net financial income in the first half came mainly from the significantly higher average net liquidity in the first half of 2008 (USD 5.9 billion vs. USD 0.4 billion in the year-ago period) and robust currency management. However, sharply lower US interest rates for short-term fixed income investments weighed on the second-quarter performance.

 

Taxes

 

The tax rate for continuing operations was 14.0% in the first half of 2008, in line with the year-ago period. In the second quarter of both years, the tax rate for continuing operations was lower than usual due to reductions of anticipated full-year tax rates. In the 2008 quarter, the tax rate was 13.0% compared to 12.7% in the 2007 quarter.

 

Net income from discontinued operations

 

Discontinued operations net income in the 2008 first half represent adjustments to various accruals related to the divestments of Medical Nutrition (as of July 1, 2007) and Gerber (as of September 1, 2007).

 

Balance sheet

 

Total equity rose to USD 51.6 billion as of June 30, 2008, compared to USD 49.4 billion at the end of 2007. This increase of USD 2.2 billion comes from net income of USD 4.6 billion and currency translation gains of USD 1.4 billion, which were partially offset by USD 3.3 billion for the 2008 dividend payment (which was 29% higher than the year-earlier payment in US dollar terms) and USD 0.2 billion in actuarial losses on defined-benefit pension plans. The launch of Swiss franc bond issues during the second quarter of 2008, which raised CHF 1.5 billion, and higher short-term financial debts mainly from the USD 3 billion Commercial Paper program in the US led to the debt/equity ratio rising to 0.21:1 from 0.12:1 at the end of 2007.

 

9



 

Proceeds from divestments completed in 2007 and ongoing cash flow contributions led to net liquidity of USD 5.5 billion at the end of the first half, which was significantly higher than net liquidity of USD 0.1 billion at the end of the year-ago period.

 

In the first half of 2008, six million shares were repurchased for USD 296 million after the start of the sixth share repurchase program in March via a second trading line on the Swiss Stock Exchange. This program was suspended in April 2008 after Novartis announced the Alcon agreement. Credit agencies reduced their ratings for Novartis while supporting the strategic intentions of this acquisition. Standard & Poor’s has now rated Novartis as AA- for long-term maturities and as A-1+ for short-term maturities. Moody’s has rated the Group as Aa2 and P-1, respectively, while Fitch has given a long-term rating of AA and a short-term rating of F1+. All three agencies maintained a “stable” outlook.

 

Cash flow

 

In the first half of 2008, cash flow from operating activities in continuing operations fell by USD 0.4 billion to USD 3.5 billion as higher operating income contributions were more than offset by investments in working capital and tax payments. Cash inflow from investing activities in continuing operations amounted to USD 4.5 billion, mainly from the sale of USD 5.5 billion in marketable securities that was offset by USD 1.0 billion in capital expenditures. Proceeds of the Swiss franc bond offerings in the 2008 second quarter and the US commercial paper program provided a cash inflow of USD 4.5 billion. This was partially offset by the dividend payment for 2007 of USD 3.3 billion and treasury share repurchases of USD 0.5 billion and other outflows of USD 0.2 billion, which resulted in a net cash inflow of USD 0.5 billion from financing activities in continuing operations.

 

PHARMACEUTICALS PRODUCT REVIEW

 

Note: Net sales data refer to first-half 2008 worldwide performance in local currencies

 

Diovan (USD 2.9 billion, +12% lc), the world’s top-selling branded medicine for high blood pressure, maintained solid growth worldwide and achieved its highest US share ever of 41% of the segment for angiotensin receptor blockers (ARBs). Although growth has slowed for the US antihypertensive segment, including the ARB class, Diovan has grown steadily in all key markets based on its status as the only medicine in its class approved to treat high blood pressure, high-risk heart attack survivors and patients with heart failure.

 

Gleevec/Glivec (USD 1.8 billion, +17% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), generated double-digit growth based on its status as the leading therapy for these and other life-threatening forms of cancer.

 

Zometa (USD 677 million, 0% lc), an intravenous bisphosphonate therapy for patients with cancer that has spread to the bones, was unchanged as fast expansion in some markets offset the US and Europe. Growth for this class of medicines began to slow in 2007 with patients receiving treatment less frequently and for shorter courses of therapy.

 

Femara (USD 561 million, +19% lc), an oral therapy for women with hormone-sensitive breast cancer, outpaced competitors and gained share in the aromatase inhibitor segment due to its unique benefits shown in major clinical trials. Growth in Europe was impacted slightly by the loss of patent protection earlier in 2008 in some markets, including Spain.

 

10



 

Sandostatin (USD 558 million, +5% lc), for acromegaly and various neuroendocrine and carcinoid tumors, has continued expanding around the world thanks to Sandostatin LAR, the long-acting once-monthly version that accounts for 85% of net sales.

 

Lucentis (USD 437 million), a biotechnology eye therapy, has experienced dynamic growth since its first launch in Europe in January 2007 and in more than 60 countries worldwide where Novartis has rights. Lucentis is the only treatment proven to maintain and improve vision in patients with “wet” age-related macular degeneration, the leading cause of blindness in people over age 50. Lucentis has been judged as cost-effective by a number of independent health agency assessments. The UK National Institute for Health and Clinical Excellence (NICE) issued a positive endorsement (FAD) in April, while the Canadian Drug Review recommended Lucentis for provincial drug plans. Genentech holds the US rights.

 

Exelon/Exelon Patch (USD 391 million, +20% lc), a therapy for mild to moderate forms of Alzheimer’s disease and dementia linked with Parkinson’s disease, experienced accelerated growth thanks to the once-daily Exelon Patch, which now represents more than 40% of US sales. First launched in 2007, this new formulation provides comparable efficacy to the highest dose of Exelon capsules, but with three times fewer reports of nausea or vomiting.

 

Exjade (USD 238 million, +42% lc) has grown quickly as the first and only once-daily oral therapy for iron overload, a potentially fatal condition linked to various blood disorders.

 

Lotrel (USD 195 million, –67% lc, only in the US), a single-tablet combination therapy for high blood pressure, has faced generic competition in the US for some strengths since May 2007 after an “at risk” launch despite a valid US patent until 2017.

 

Trileptal (USD 173 million, –59% lc), for epilepsy seizures, has seen sales decline following the start of generic competition after the end of US patent protection in October 2007 for some formulations, with US sales falling 77% in the first half of 2008.

 

Exforge (USD 173 million), a single-tablet combination of the angiotensin receptor blocker Diovan (valsartan) with the calcium channel blocker amlodipine, showed ongoing dynamic growth and continued to outperform launches of many previous high blood pressure combination therapies. Exforge is now available in over 30 countries.

 

Xolair (USD 95 million, +30% lc), an innovative therapy for moderate to severe allergic asthma, had a strong year-to-date performance in Europe and Latin America. Xolair Liquid was submitted in March for EU approval in a pre-filled safety syringe for patients with severe persistent allergic asthma. Studies are ongoing for the US submission. Novartis co-promotes Xolair with Genentech in the US and shares a portion of operating income. Genentech reported US sales of USD 246 million for Xolair in the first half of 2008.

 

Aclasta/Reclast (USD 103 million) is now available in more than 40 countries as a novel, once-yearly infusion for the treatment of postmenopausal osteoporosis, consistently outpacing benchmark launches since its first launch in August 2007. The use of Aclasta/Reclast was broadened in June with US approval for reducing the incidence of new clinical fractures in patients who have recently had a low-trauma hip fracture. Data in the New England Journal of Medicine, showed a significant 35% reduction in the risk of new clinical fractures in Aclasta/Reclast patients after surgery for this type of fracture.

 

Tekturna/Rasilez (USD 58 million), the first-in-class direct renin inhibitor, showed ongoing growth in a highly competitive environment. Launches are now underway in more

 

11



 

than 17 countries for this first new type of high blood pressure medicine in more than a decade, known as Tekturna in the US and Rasilez in other markets. The ASPIRE HIGHER clinical program is being expanded to 35,000 patients in 14 clinical trials, making it the largest cardio-renal outcomes program ever.

 

Tasigna (USD 29 million) continues to be well received with launches in over 45 countries since the end of 2007 as a new therapy for patients with a certain form of chronic myeloid leukemia (CML) resistant or intolerant to prior therapy including Gleevec/Glivec. A Phase III trial is comparing Tasigna and Gleevec/Glivec in newly diagnosed CML patients.

 

Galvus (vildagliptin), a new oral treatment for type 2 diabetes, is being launched after European approval in the first quarter of 2008. Also being launched is Eucreas, a single-tablet combination with the oral anti-diabetes medicine metformin. Some small clinical studies have started amid discussions with the FDA on overall steps needed for approval after an “approvable letter” in February 2007. However, resubmission for US approval is not currently planned.

 

R&D UPDATE

 

Pharmaceuticals

 

Oncology showcases potential at ASCO 2008

 

Novartis highlighted the potential of its oncology portfolio at the American Society of Clinical Oncology (ASCO) meeting in May 2008 with an unprecedented amount of research results drawing on a pipeline of investigational compounds and potential additional indications for marketed products. Among the highlights at ASCO:

 

·                  Afinitor (everolimus, RAD001), an oral inhibitor of mTOR (a key biological pathway involved in various cancers), more than doubled the time without tumor growth in patients with advanced kidney cancer after failure of standard treatment. The Phase III results from the RECORD-1 trial, which was stopped early based on these results presented at ASCO, will form the basis for global regulatory submissions in 2008 for approval in treating patients with advanced metastatic renal cell cancer. Registration trials in other cancers are underway. Early proof-of-concept studies presented at ASCO showed Afinitor may offer a novel treatment strategy for breast cancer by overcoming resistance and enhancing the efficacy of several commonly used breast cancer treatments. A new trial to explore the potential of Afinitor in breast cancer will be initiated in early 2009. Afinitor acts by directly inhibiting tumor cell growth and metabolism as well as the formation of new blood vessels (angiogenesis).

 

·                  Zometa demonstrated for the first time a significant benefit for premenopausal women with hormone-sensitive, early-stage breast cancer. The study showed that the addition of Zometa to hormone therapy after surgery significantly reduced the risk of recurrence or death by 36% beyond benefits achieved with hormone therapy alone. Many studies are underway examining the potential anticancer benefits of Zometa. Two studies, AZURE (pre-and post-menopausal breast cancer) and ZEUS (prostate cancer), have completed patient recruitment, and results are expected in the next two to three years.

 

·                  PKC412 entered Phase III development in the second quarter of 2008 in a trial evaluating the potential survival benefit of this protein kinase inhibitor in combination

 

12



 

with chemotherapy compared to the use of chemotherapy alone in treating patients with Acute Myeloid Leukemia (AML).

 

Other Specialty and General Medicine products

 

Extavia (interferon beta-1b, formerly NVF233) has received EU regulatory approval for use in treating various forms of multiple sclerosis (MS), while the US submission was completed in the second quarter of 2008. Extavia is exactly the same medicine as Betaferon®/Betaseron®, which is marketed by Bayer Schering and was the first beta interferon treatment for MS. Novartis gained rights to its own branded version in agreements with Bayer Schering related to Novartis acquiring Chiron. The US and European launches by the Pharmaceuticals Division are on track for first half of 2009, in line with an agreement with Bayer-Schering.

 

FTY720 (fingolimod) is progressing toward submissions at the end of 2009, with the potential to become the first once-daily oral therapy for MS. Various trials are underway in the largest Phase III program to be conducted in this debilitating neurological disease. About 3,200 people with MS are enrolled in five FTY720 trials worldwide, with a combined 2,300 patient-years of experience. In the second quarter of 2008 two infection-related incidents occurred among FTY720 patients, including one fatality (disseminated zoster). Information on these cases was shared with investigators and relevant health authorities, and reviewed by an independent Data Safety Monitoring Board. Patients in the FTY720 trials are being notified and studies are progressing as planned.

 

PZ-601, a novel broad-spectrum antibiotic in Phase II development, will be added to the Novartis development pipeline through an acquisition announced in June 2008 of Protez Pharmaceuticals, a private US biotechnology company. PZ-601 further strengthens the specialty medicines pipeline portfolio with its profile against potentially fatal drug-resistant infections. Antibiotic resistance is a growing public health problem and estimated to cause over 100,000 deaths annually in the US and Europe.

 

Vaccines and Diagnostics

 

Menveo (MenACWY-CRM) is set for regulatory submissions in the second half of 2008 as a new vaccine protecting against four common types of meningococcal meningitis known as A,C, W-135 and Y. This bacterial disease is a rare, but potentially fatal, infection that causes infection of the membranes around the brain and spinal cord. The initial submission is planned for use in vaccination of people ages 11-55, with submissions for children from age two months to 10 years planned for 2009. Recent Phase III data suggested Menveo has the potential to become the first vaccine to protect from infancy to adulthood against these four common serogroups.

 

A vaccine with the project name MenB is being developed to protect against a majority of global strains for the meningitis B serogroup, for which no vaccine is currently available. A Phase III trial in infants and children is underway as part of its development. The first regulatory submissions, for use in infants and children, are planned for 2010.

 

Sandoz

 

The FDA in July 2008 accepted for review an Abbreviated New Drug Application submitted by Sandoz in collaboration with Momenta Pharmaceuticals with a “Paragraph IV” certification for a generic version of glatiramer acetate injection (Copaxone®), which is

 

13



 

used to treat patients with the relapsing-remitting form of MS and is marketed by Teva. Another project being pursued with Momenta is enoxaparin, a technologically enabled generic version of Lovenox®. This medicine is a low-molecular-weight heparin marketed by Sanofi-aventis and used for the prevention and treatment of deep vein thrombosis and several cardiovascular conditions. A response to FDA guidance received in April 2008 after a constructive dialog is expected to be submitted in the third quarter of 2008 and a launch of this product is now expected in 2009.

 

Disclaimer

 

This release contains certain forward-looking statements relating to the Group’s business, which can be identified by terminology such as “momentum,” “on track,” “strategy,” “promising,” “anticipated,” “plans,” “expected,” “to further strengthen,” “opportunity,” “right to acquire… has the right to sell,” “potential,” “will,” “pipeline”, “outlook,” “expectations,” “planned,” “may,” “set”, “to explore”, “risk,” “progressing toward,” “potentially”, “estimated,” “being developed”, 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, or potential future sales or earnings of the Novartis Group or any of its divisions or business units; or by discussions of strategy, plans, expectations or intentions. 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 existing products in any market, or that such products will achieve any particular revenue levels. Nor can there be any guarantee that the Novartis Group, or any of its divisions or business units, will achieve any particular financial results. In particular, management’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays or government regulation generally; the Group’s ability to obtain or maintain patent or other proprietary intellectual property protection, including the uncertainties involved in the US litigation process; competition in general; government, industry, and general public pricing and other political pressures; 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 these materials 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 AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ

 

14



 

approximately 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

 

Important dates

 

September 3, 2008

Sandoz Day (Holzkirchen, Germany)

October 20, 2008

Third quarter and first nine months 2008 results

November 19, 2008

Pharmaceuticals research update (Cambridge, Massachusetts)

January 2009

Fourth quarter and full-year 2008 results

February 2009

Annual General Meeting (Basel)

April 2009

First quarter 2009 results

July 2009

Second quarter and first half 2009 results

October 2009

Third quarter and first nine months 2009 results

 

15



 

CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

Consolidated income statements (unaudited)

 

First half

 

 

 

H1 2008

 

H1 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Net sales from continuing operations

 

20 635

 

18 528

 

2 107

 

11

 

Other revenues

 

571

 

430

 

141

 

33

 

Cost of Goods Sold

 

-5 584

 

-4 985

 

-599

 

12

 

Of which amortization and impairments of product and patent rights and trademarks

 

-498

 

-482

 

-16

 

3

 

Gross profit

 

15 622

 

13 973

 

1 649

 

12

 

Marketing & Sales

 

-5 921

 

-5 399

 

-522

 

10

 

Research & Development

 

-3 441

 

-3 031

 

-410

 

14

 

General & Administration

 

-1 078

 

-1 000

 

-78

 

8

 

Other Income & Expense

 

-233

 

-111

 

-122

 

110

 

Operating income from continuing operations

 

4 949

 

4 432

 

517

 

12

 

Income from associated companies

 

256

 

192

 

64

 

33

 

Financial income

 

233

 

177

 

56

 

32

 

Interest expense

 

-118

 

-110

 

-8

 

7

 

Income before taxes from continuing operations

 

5 320

 

4 691

 

629

 

13

 

Taxes

 

-746

 

-656

 

-90

 

14

 

Net income from continuing operations

 

4 574

 

4 035

 

539

 

13

 

Net income from discontinued Consumer Health operations

 

9

 

152

 

-143

 

-94

 

Total net income

 

4 583

 

4 187

 

396

 

9

 

Attributable to:

 

 

 

 

 

 

 

 

 

Equity holders of Novartis AG

 

4 566

 

4 177

 

389

 

9

 

Minority interests

 

17

 

10

 

7

 

70

 

Average number of shares outstanding – Basic (million)

 

2 266.2

 

2 342.4

 

-76.2

 

-3

 

Basic earnings per share (USD)(1)

 

 

 

 

 

 

 

 

 

- Total

 

2.01

 

1.78

 

0.23

 

13

 

- Continuing operations

 

2.01

 

1.72

 

0.29

 

17

 

- Discontinued operations

 

0.00

 

0.06

 

-0.06

 

 

 

Average number of shares outstanding - Diluted (million)

 

2 285.2

 

2 355.6

 

-70.4

 

-3

 

Diluted earnings per share (USD)(1)

 

 

 

 

 

 

 

 

 

- Total

 

2.00

 

1.77

 

0.23

 

13

 

- Continuing operations

 

2.00

 

1.71

 

0.29

 

17

 

- Discontinued operations

 

0.00

 

0.06

 

-0.06

 

 

 

 


(1) Earnings per share (EPS) is calculated on the amount of net income attributable to the equity holders of Novartis AG

 

16



 

Consolidated income statements (unaudited)

 

Second quarter

 

 

 

Q2 2008

 

Q2 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Net sales from continuing operations

 

10 726

 

9 400

 

1 326

 

14

 

Other revenues

 

264

 

184

 

80

 

43

 

Cost of Goods Sold

 

-2 936

 

-2 497

 

-439

 

18

 

Of which amortization and impairments of product and patent rights and trademarks

 

-252

 

-240

 

-12

 

5

 

Gross profit

 

8 054

 

7 087

 

967

 

14

 

Marketing & Sales

 

-3 106

 

-2 812

 

-294

 

10

 

Research & Development

 

-1 767

 

-1 529

 

-238

 

16

 

General & Administration

 

-559

 

-517

 

-42

 

8

 

Other Income & Expense

 

-161

 

-132

 

-29

 

22

 

Operating income from continuing operations

 

2 461

 

2 097

 

364

 

17

 

Income from associated companies

 

119

 

95

 

24

 

25

 

Financial income

 

85

 

90

 

-5

 

-6

 

Interest expense

 

-61

 

-57

 

-4

 

7

 

Income before taxes from continuing operations

 

2 604

 

2 225

 

379

 

17

 

Taxes

 

-338

 

-282

 

-56

 

20

 

Net income from continuing operations

 

2 266

 

1 943

 

323

 

17

 

Net income from discontinued Consumer Health operations

 

-6

 

73

 

-79

 

 

 

Total net income

 

2 260

 

2 016

 

244

 

12

 

Attributable to:

 

 

 

 

 

 

 

 

 

Equity holders of Novartis AG

 

2 249

 

2 008

 

241

 

12

 

Minority interests

 

11

 

8

 

3

 

38

 

Average number of shares outstanding - Basic (million)

 

2 266.8

 

2 338.8

 

-72.0

 

-3

 

Basic earnings per share (USD)(1)

 

 

 

 

 

 

 

 

 

- Total

 

0.99

 

0.86

 

0.13

 

15

 

- Continuing operations

 

0.99

 

0.83

 

0.16

 

19

 

- Discontinued operations

 

0.00

 

0.03

 

-0.03

 

 

 

Average number of shares outstanding - Diluted (million)

 

2 285.6

 

2 351.6

 

-66.0

 

-3

 

Diluted earnings per share (USD)(1)

 

 

 

 

 

 

 

 

 

- Total

 

0.98

 

0.85

 

0.13

 

16

 

- Continuing operations

 

0.98

 

0.82

 

0.16

 

20

 

- Discontinued operations

 

0.00

 

0.03

 

-0.03

 

 

 

 


(1) Earnings per share (EPS) is calculated on the amount of net income attributable to the equity holders of Novartis AG

 

17



 

Consolidated statement of recognized income and expense (unaudited)

 

First half

 

 

 

H1 2008

 

H1 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income from continuing operations

 

4 574

 

4 035

 

539

 

Fair value adjustments on financial instruments

 

-77

 

6

 

-83

 

Actuarial losses/gains from defined benefit plans, net

 

-158

 

1 138

 

-1 296

 

Novartis share of equity recognized by associated companies

 

-13

 

92

 

-105

 

Revaluation of initial minority interests in Chiron

 

 

 

55

 

-55

 

Translation effects

 

1 365

 

305

 

1 060

 

Amounts related to discontinued operations

 

9

 

158

 

-149

 

Recognized income and expense

 

5 700

 

5 789

 

-89

 

 

Second quarter

 

 

 

Q2 2008

 

Q2 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income from continuing operations

 

2 266

 

1 943

 

323

 

Fair value adjustments on financial instruments

 

13

 

-10

 

23

 

Actuarial gains from defined benefit plans, net

 

506

 

1 072

 

-566

 

Novartis share of equity recognized by associated companies

 

 

 

5

 

-5

 

Translation effects

 

-11

 

188

 

-199

 

Amounts related to discontinued operations

 

-6

 

69

 

-75

 

Recognized income and expense

 

2 768

 

3 267

 

-499

 

 

18



 

Condensed consolidated balance sheets

 

First half

 

 

 

June 30,
2008

 

Dec 31,
2007

 

Change

 

June 30,
2007

 

 

 

(unaudited)

 

 

 

 

 

(unaudited)

 

 

 

USD m

 

USD m

 

USD m

 

USD m

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

 

Property, plant & equipment

 

13 727

 

12 633

 

1 094

 

11 352

 

Intangible assets

 

21 563

 

21 249

 

314

 

21 057

 

Financial and other non-current assets

 

16 024

 

14 140

 

1 884

 

14 235

 

Total non-current assets

 

51 314

 

48 022

 

3 292

 

46 644

 

Current assets

 

 

 

 

 

 

 

 

 

Inventories

 

6 450

 

5 455

 

995

 

5 022

 

Trade accounts receivable

 

7 142

 

6 648

 

494

 

6 233

 

Other current assets

 

2 295

 

2 126

 

169

 

1 834

 

Cash, short-term deposits and marketable securities

 

16 198

 

13 201

 

2 997

 

7 548

 

Total current assets from continuing operations

 

32 085

 

27 430

 

4 655

 

20 637

 

Assets held for sale related to discontinued operations

 

 

 

 

 

 

 

3 340

 

Total current assets

 

32 085

 

27 430

 

4 655

 

23 977

 

Total assets

 

83 399

 

75 452

 

7 947

 

70 621

 

 

 

 

 

 

 

 

 

 

 

Equity and liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total equity

 

51 605

 

49 396

 

2 209

 

43 664

 

Non-current liabilities

 

 

 

 

 

 

 

 

 

Financial debts

 

2 172

 

677

 

1 495

 

632

 

Other non-current liabilities

 

9 939

 

8 738

 

1 201

 

8 662

 

Total non-current liabilities

 

12 111

 

9 415

 

2 696

 

9 294

 

Current liabilities

 

 

 

 

 

 

 

 

 

Trade accounts payable

 

3 251

 

3 018

 

233

 

2 509

 

Financial debts and derivatives

 

8 559

 

5 117

 

3 442

 

6 819

 

Other current liabilities

 

7 873

 

8 506

 

-633

 

6 652

 

Total current liabilities from continuing operations

 

19 683

 

16 641

 

3 042

 

15 980

 

Liabilities related to discontinued operations

 

 

 

 

 

 

 

1 683

 

Total current liabilities

 

19 683

 

16 641

 

3 042

 

17 663

 

Total liabilities

 

31 794

 

26 056

 

5 738

 

26 957

 

Total equity and liabilities

 

83 399

 

75 452

 

7 947

 

70 621

 

 

19



 

Condensed consolidated changes in equity (unaudited)

 

First half

 

 

 

H1 2008

 

H1 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Consolidated equity at January 1

 

49 396

 

41 294

 

8 102

 

Recognized income and expense

 

5 700

 

5 789

 

-89

 

Purchase of treasury shares, net

 

-432

 

-1 095

 

663

 

Equity-based compensation

 

303

 

293

 

10

 

Dividends

 

-3 345

 

-2 598

 

-747

 

Changes in minority interests

 

-17

 

-19

 

2

 

Consolidated equity at June 30

 

51 605

 

43 664

 

7 941

 

 

Second quarter

 

 

 

Q2 2008

 

Q2 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Consolidated equity at April 1

 

49 266

 

40 502

 

8 764

 

Recognized income and expense

 

2 768

 

3 267

 

-499

 

Purchase of treasury shares, net

 

-554

 

-248

 

-306

 

Equity-based compensation

 

137

 

146

 

-9

 

Dividends

 

-3

 

 

 

-3

 

Changes in minority interests

 

-9

 

-3

 

-6

 

Consolidated equity at June 30

 

51 605

 

43 664

 

7 941

 

 

20



 

Condensed consolidated cash flow statements (unaudited)

 

First half

 

 

 

H1 2008

 

H1 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income from continuing operations

 

4 574

 

4 035

 

539

 

Reversal of non-cash items

 

 

 

 

 

 

 

Taxes

 

746

 

656

 

90

 

Depreciation, amortization and impairments

 

1 258

 

1 120

 

138

 

Change in provisions and other non-current liabilities

 

217

 

152

 

65

 

Net financial income

 

-115

 

-67

 

-48

 

Other

 

-84

 

70

 

-154

 

Net income adjusted for non-cash items

 

6 596

 

5 966

 

630

 

Interest and other financial receipts

 

571

 

300

 

271

 

Interest and other financial payments

 

-611

 

-81

 

-530

 

Taxes paid

 

-1 176

 

-973

 

-203

 

Cash flow before working capital changes

 

5 380

 

5 212

 

168

 

Payments out of provisions and other net cash movements in non-current liabilities

 

-307

 

-143

 

-164

 

Change in net current assets and other operating cash flow items

 

-1 532

 

-1 149

 

-383

 

Cash flow from operating activities from continuing operations

 

3 541

 

3 920

 

-379

 

Investments in property, plant & equipment

 

-967

 

-1 145

 

178

 

Acquisitions of subsidiaries

 

 

 

-52

 

52

 

Decrease/increase in marketable securities, intangible and financial assets

 

5 452

 

-778

 

6 230

 

Cash flow from investing activities from continuing operations

 

4 485

 

-1 975

 

6 460

 

Change in current and non-current financial debts

 

4 367

 

92

 

4 275

 

Dividends paid to shareholders of Novartis AG

 

-3 345

 

-2 598

 

-747

 

Treasury share transactions  and other financing cash flows

 

-532

 

-783

 

251

 

Cash flow from financing activities from continuing operations

 

490

 

-3 289

 

3 779

 

Cash flow from discontinued operations

 

69

 

168

 

-99

 

Translation effect on cash and cash equivalents

 

124

 

24

 

100

 

Change in cash and cash equivalents  from discontinued operations

 

 

 

-51

 

51

 

Change in cash and cash equivalents from continuing operations

 

8 709

 

-1 203

 

9 912

 

Cash and cash equivalents at January 1 from continuing operations

 

5 360

 

3 815

 

1 545

 

Cash and cash equivalents at June 30 from continuing operations

 

14 069

 

2 612

 

11 457

 

 

21



 

Condensed consolidated cash flow statements (unaudited)

 

Second quarter

 

 

 

Q2 2008

 

Q2 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income from continuing operations

 

2 266

 

1 943

 

323

 

Reversal of non-cash items

 

 

 

 

 

 

 

Taxes

 

338

 

282

 

56

 

Depreciation, amortization and impairments

 

624

 

580

 

44

 

Change in provisions and other non-current liabilities

 

130

 

84

 

46

 

Net financial income

 

-24

 

-33

 

9

 

Other

 

-4

 

21

 

-25

 

Net income adjusted for non-cash items

 

3 330

 

2 877

 

453

 

Interest and other financial receipts

 

120

 

58

 

62

 

Interest and other financial payments

 

-549

 

-44

 

-505

 

Taxes paid

 

-666

 

-690

 

24

 

Cash flow before working capital changes

 

2 235

 

2 201

 

34

 

Payments out of provisions and other net cash movements in non-current liabilities

 

-164

 

-64

 

-100

 

Change in net current assets and other operating cash flow items

 

-219

 

-268

 

49

 

Cash flow from operating activities from continuing operations

 

1 852

 

1 869

 

-17

 

Investments in property, plant & equipment

 

-564

 

-623

 

59

 

Acquisitions of subsidiaries

 

 

 

-4

 

4

 

Decrease/increase in marketable securities, intangible and financial assets

 

1 615

 

-181

 

1 796

 

Cash flow from investing activities from continuing operations

 

1 051

 

-808

 

1 859

 

Change in current and non-current financial debts

 

4 776

 

125

 

4 651

 

Dividends paid to shareholders of Novartis AG

 

-3

 

-806

 

803

 

Treasury share transactions and other financing cash flows

 

-594

 

-129

 

-465

 

Cash flow from financing activities from continuing operations

 

4 179

 

-810

 

4 989

 

Cash flow from discontinued operations

 

18

 

79

 

-61

 

Translation effect on cash and cash equivalents

 

38

 

41

 

-3

 

Change in cash and cash equivalents from discontinued operations

 

 

 

-49

 

49

 

Change in cash and cash equivalents from continuing operations

 

7 138

 

322

 

6 816

 

Cash and cash equivalents at April 1 from continuing operations

 

6 931

 

2 290

 

4 641

 

Cash and cash equivalents at June 30 from continuing operations

 

14 069

 

2 612

 

11 457

 

 

22



 

Consolidated income statements – First half – Divisional segmentation (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer Health
continuing
operations

 

Corporate

 

Total
continuing
operations

 

Discontinued
Consumer Health
operations

 

Total Group

 

 

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

 

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

Net sales to third parties

 

13 192

 

11 988

 

602

 

482

 

3 854

 

3 415

 

2 987

 

2 643

 

 

 

 

 

20 635

 

18 528

 

 

 

1 413

 

20 635

 

19 941

 

Sales to other Divisions

 

108

 

86

 

5

 

6

 

136

 

122

 

29

 

20

 

-278

 

-234

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales of Divisions

 

13 300

 

12 074

 

607

 

488

 

3 990

 

3 537

 

3 016

 

2 663

 

-278

 

-234

 

20 635

 

18 528

 

 

 

1 413

 

20 635

 

19 941

 

Other revenues

 

303

 

189

 

225

 

213

 

11

 

11

 

32

 

17

 

 

 

 

 

571

 

430

 

 

 

6

 

571

 

436

 

Cost of Goods Sold

 

-2 204

 

-2 024

 

-526

 

-401

 

-2 071

 

-1 905

 

-1 056

 

-885

 

273

 

230

 

-5 584

 

-4 985

 

 

 

-750

 

-5 584

 

-5 735

 

Of which amortization and impairments of product and patent rights and trademarks

 

-177

 

-179

 

-145

 

-139

 

-137

 

-126

 

-39

 

-38

 

 

 

 

 

-498

 

-482

 

 

 

-6

 

-498

 

-488

 

Gross profit

 

11 399

 

10 239

 

306

 

300

 

1 930

 

1 643

 

1 992

 

1 795

 

-5

 

-4

 

15 622

 

13 973

 

 

 

669

 

15 622

 

14 642

 

Marketing & Sales

 

-4 008

 

-3 768

 

-137

 

-91

 

-715

 

-571

 

-1 061

 

-969

 

 

 

 

 

-5 921

 

-5 399

 

 

 

-350

 

-5 921

 

-5 749

 

Research & Development

 

-2 665

 

-2 430

 

-183

 

-125

 

-348

 

-251

 

-154

 

-138

 

-91

 

-87

 

-3 441

 

-3 031

 

 

 

-22

 

-3 441

 

-3 053

 

General & Administration

 

-392

 

-368

 

-80

 

-78

 

-201

 

-164

 

-186

 

-184

 

-219

 

-206

 

-1 078

 

-1 000

 

 

 

-62

 

-1 078

 

-1 062

 

Other Income & Expense

 

-60

 

-53

 

-34

 

1

 

-75

 

-96

 

-25

 

-21

 

-39

 

58

 

-233

 

-111

 

30

 

2

 

-203

 

-109

 

Of which amortization and impairments of capitalized intangible assets included in function costs

 

-72

 

-40

 

-17

 

-4

 

-19

 

-18

 

-1

 

-3

 

-1

 

-3

 

-110

 

-68

 

 

 

-19

 

-110

 

-87

 

Operating income

 

4 274

 

3 620

 

-128

 

7

 

591

 

561

 

566

 

483

 

-354

 

-239

 

4 949

 

4 432

 

30

 

237

 

4 979

 

4 669

 

Income from associated companies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

256

 

192

 

 

 

 

 

256

 

192

 

Financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

233

 

177

 

 

 

 

 

233

 

177

 

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-118

 

-110

 

 

 

 

 

-118

 

-110

 

Income before taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5 320

 

4 691

 

30

 

237

 

5 350

 

4 928

 

Taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-746

 

-656

 

-21

 

-85

 

-767

 

-741

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4 574

 

4 035

 

9

 

152

 

4 583

 

4 187

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additions to:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

– Property, plant and equipment(1)

 

492

 

690

 

198

 

92

 

242

 

251

 

58

 

90

 

32

 

32

 

1 022

 

1 155

 

 

 

23

 

1 022

 

1 178

 

– Goodwill and other intangible assets(1)

 

70

 

221

 

3

 

 

 

14

 

15

 

8

 

2

 

1

 

4

 

96

 

242

 

 

 

71

 

96

 

313

 

 


(1) Excluding impact of business acquisitions

 

23



 

Consolidated income statements – Second quarter – Divisional segmentation (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer Health
continuing
operations

 

Corporate

 

Total
continuing
operations

 

Discontinued
Consumer Health
operations

 

Total Group

 

 

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

 

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

Net sales to third parties

 

6 928

 

6 065

 

322

 

251

 

1 948

 

1 719

 

1 528

 

1 365

 

 

 

 

 

10 726

 

9 400

 

 

 

722

 

10 726

 

10 122

 

Sales to other Divisions

 

55

 

43

 

2

 

2

 

73

 

56

 

14

 

10

 

-144

 

-111

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales of Divisions

 

6 983

 

6 108

 

324

 

253

 

2 021

 

1 775

 

1 542

 

1 375

 

-144

 

-111

 

10 726

 

9 400

 

 

 

722

 

10 726

 

10 122

 

Other revenues

 

145

 

89

 

99

 

78

 

5

 

9

 

15

 

8

 

 

 

 

 

264

 

184

 

 

 

4

 

264

 

188

 

Cost of Goods Sold

 

-1 197

 

-1 013

 

-266

 

-189

 

-1 081

 

-954

 

-531

 

-457

 

139

 

116

 

-2 936

 

-2 497

 

 

 

-386

 

-2 936

 

-2 883

 

Of which amortization and impairments of product and patent rights and trademarks

 

-90

 

-90

 

-72

 

-68

 

-70

 

-62

 

-20

 

-20

 

 

 

 

 

-252

 

-240

 

 

 

-3

 

-252

 

-243

 

Gross profit

 

5 931

 

5 184

 

157

 

142

 

945

 

830

 

1 026

 

926

 

-5

 

5

 

8 054

 

7 087

 

 

 

340

 

8 054

 

7 427

 

Marketing & Sales

 

-2 106

 

-1 959

 

-80

 

-49

 

-378

 

-298

 

-542

 

-506

 

 

 

 

 

-3 106

 

-2 812

 

 

 

-177

 

-3 106

 

-2 989

 

Research & Development

 

-1 355

 

-1 215

 

-97

 

-71

 

-186

 

-127

 

-81

 

-72

 

-48

 

-44

 

-1 767

 

-1 529

 

 

 

-12

 

-1 767

 

-1 541

 

General & Administration

 

-210

 

-196

 

-40

 

-37

 

-98

 

-87

 

-96

 

-93

 

-115

 

-104

 

-559

 

-517

 

 

 

-31

 

-559

 

-548

 

Other Income & Expense

 

-82

 

-47

 

-15

 

-5

 

-37

 

-75

 

-3

 

-12

 

-24

 

7

 

-161

 

-132

 

6

 

-1

 

-155

 

-133

 

Of which amortization and impairments of capitalized intangible assets included in function costs

 

-31

 

-19

 

-8

 

-4

 

-8

 

-11

 

-1

 

-1

 

-1

 

-2

 

-49

 

-37

 

 

 

-10

 

-49

 

-47

 

Operating income

 

2 178

 

1 767

 

-75

 

-20

 

246

 

243

 

304

 

243

 

-192

 

-136

 

2 461

 

2 097

 

6

 

119

 

2 467

 

2 216

 

Income from associated companies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

119

 

95

 

 

 

 

 

119

 

95

 

Financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

85

 

90

 

 

 

 

 

85

 

90

 

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-61

 

-57

 

 

 

 

 

-61

 

-57

 

Income before taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 604

 

2 225

 

6

 

119

 

2 610

 

2 344

 

Taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-338

 

-282

 

-12

 

-46

 

-350

 

-328

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 266

 

1 943

 

-6

 

73

 

2 260

 

2 016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additions to:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

– Property, plant and equipment(1)

 

277

 

361

 

99

 

48

 

154

 

161

 

35

 

43

 

20

 

8

 

585

 

621

 

 

 

17

 

585

 

638

 

– Goodwill and other intangible assets(1)

 

33

 

145

 

3

 

 

 

10

 

4

 

6

 

1

 

 

 

4

 

52

 

154

 

 

 

48

 

52

 

202

 

 


(1) Excluding impact of business acquisitions

 

24



 

Notes to the Condensed Interim Consolidated Financial Statements for the
six months ended June 30, 2008 (unaudited)

 

1. Basis of preparation

 

These condensed consolidated financial statements for the six-month period ended June 30, 2008, were prepared in accordance with International Accounting Standard 34 “Interim Financial Reporting” and accounting policies set out in the 2007 Annual Report, which was published on January 17, 2008.

 

2. Selected critical accounting policies

 

The principal accounting policies of Novartis are set out in note 1 to the consolidated financial statements in the 2007 Annual Report and conform with International Financial Reporting Standards (IFRS). 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 9 of the 2007 Annual Report, Novartis regularly reviews long-lived assets, including identifiable intangible assets and goodwill for impairment. Goodwill and acquired research and development projects not yet ready for use are subject to impairment review at least annually, or when events have occurred that require an assessment. Other intangible assets are reviewed for impairment whenever an event or decision occurs that raises concern about the 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 further impairment charges in the future.

 

3. Business combinations, divestments and other significant transactions

 

The following significant transactions occurred during 2008 and 2007:

 

Events until June 30, 2008

 

Corporate – Issuance of Swiss franc bonds

On June 26, Novartis issued two Swiss franc bonds totaling CHF 1.5 billion (USD 1.5 billion) in the Swiss capital market and that were listed individually on the SWX Swiss exchange. One was a 3.5% four-year bond for a total of CHF 700 million issued by Novartis Securities Investment Ltd. and guaranteed by Novartis AG. The other was a 3.625% seven-year bond of CHF 800 million issued by Novartis AG.

 

Events subsequent to June 30, 2008

 

Corporate – Alcon

On April 7, Novartis announced an agreement with Nestlé S.A. to acquire a 25% stake in Alcon Inc. (NYSE: ACL), and providing the option of acquiring an additional 52% stake. The potential value of these two transactions is approximately USD 39 billion.

 

On July 7, Novartis acquired the 25% stake from Nestlé for USD 10.4 billion in cash, which represented 74 million shares. This agreement reflects a price of USD 143.18 per share, which is Alcon’s volume-weighted average share price between January 7, 2008, and April 4, 2008. Alcon’s closing share price was USD 148.44 on April 4, the last trading day before

 

25



 

the signing of this agreement. This purchase price was reduced by approximately USD 200 million to account for the Alcon dividend paid in May 2008 on these shares to Nestlé rather than Novartis. Novartis financed the purchase of the 25% Alcon stake from internal cash reserves and external short-term financing.

 

In the optional second step, Novartis has the right to acquire Nestlé’s remaining 52% majority stake in Alcon between January 1, 2010, and July 31, 2011, for a fixed price of USD 181.00 per share, or approximately USD 28 billion. During this period, Nestlé has the right to require Novartis to buy its remaining stake at a 20.5% premium to Alcon’s share price at the time of exercise, but not exceeding USD 181.00 per share. Novartis has no obligation to purchase the remaining 23% of shares held by Alcon minority shareholders at any time.

 

Pharmaceuticals – Speedel

On July 10, Novartis announced the purchase of an additional 51.7% stake in Speedel Holding Ltd. (SWX: SPPN) and plans to acquire the remaining shares in the Swiss biopharmaceutical company through a mandatory public tender offer. Novartis acquired the 51.7% stake through off-exchange transactions with major Speedel shareholders for CHF 130 per share in cash. After these transactions, Novartis held 4.8 million shares of Speedel, or 61.4% of the outstanding Speedel shares. As of June 30, 2008, Speedel had 7.8 million registered outstanding shares (or a total of 7.9 million shares on a fully diluted basis). In accordance with Swiss law, Novartis will commence a mandatory tender offer to acquire the remaining shares. All participating shareholders will be offered the same price of CHF 130 per share in cash. This represents an 80% premium to the volume-weighted average price of Speedel’s shares for the 60 trading days prior to this announcement, which was CHF 72.19 per share. Total acquisition costs are estimated at CHF 907 million (or USD 880 million). This comprises CHF 928 million to acquire the fully diluted share capital of Speedel (excluding 9.7% already owned by Novartis) and costs to redeem Speedel’s convertible bonds at a required 16% premium to face value, less Speedel’s estimated current cash. Anticipated annual cost synergies are estimated at approximately USD 30 million.

 

Pharmaceuticals – Protez

On June 4, Novartis agreed to acquire Protez Pharmaceuticals, a privately-held US biopharmaceuticals company, gaining access to PZ-601, a broad-spectrum antibiotic in Phase II development against potentially fatal drug-resistant infections. Novartis agreed to acquire 100% of Protez for USD 100 million. Protez’s owners are eligible for additional payments of up to USD 300 million, which are contingent upon the future success of PZ-601. This transaction is expected to be completed in the third quarter of 2008.

 

2007

 

Pharmaceuticals – Betaseron® agreement related to Chiron acquisition

On September 14, Novartis and Bayer Schering Pharma AG completed an agreement related to regulatory, development, manufacturing and supply agreements for the multiple sclerosis medicine Betaseron®. The agreement was reached after the April 2006 acquisition of Chiron. As part of this agreement with Bayer Schering, Novartis received a one-time payment of USD 200 million primarily related to a transfer of manufacturing facilities to Bayer Schering as well as receiving rights to market its own branded version of Betaseron®, to be known as Extavia, starting in the first half of 2009 (pending regulatory approvals). As a result of this transaction, a final reassessment was made of the related assets from the Chiron acquisition as of April 20, 2006. This resulted in an increase of USD 235 million in identified net assets, which was adjusted in the 2007 first quarter.

 

26



 

Vaccines and Diagnostics – Intercell agreement

On September 28, Novartis entered into a strategic alliance with Intercell, an Austrian biotechnology company, focused on vaccines development. As a consequence of the agreement, Novartis paid USD 383 million (EUR 270 million) and recorded USD 207 million (EUR 146 million) of intangible assets. The payment also included the acquisition of an additional 4.8 million shares for USD 176 million (EUR 124 million), which increased the Novartis holding in Intercell to 15.9%. The equity investment is treated for accounting purposes as an “available-for-sale” marketable security recorded in the financial assets of the Division.

 

Consumer Health – Gerber Business Unit divestment

On September 1, Novartis completed the divestment of the Gerber infant products Business Unit for USD 5.5 billion to Nestlé S.A. A pre-tax divestment gain of USD 4.0 billion, and an after-tax gain of USD 3.6 billion, were recorded in the third quarter.

 

Consumer Health – Medical Nutrition Business Unit divestment

On July 1, Novartis completed the divestment of the remainder of the Medical Nutrition Business Unit for USD 2.5 billion to Nestlé S.A. A pre-tax divestment gain of USD 1.8 billion, and an after-tax gain of USD 1.6 billion, were recorded in the third quarter.

 

The Gerber and Medical Nutrition Business Units are disclosed as discontinued operations in all periods in the Group’s consolidated financial statements. Prior to their divestment, these businesses had combined 2007 net sales of USD 1.7 billion and operating income of USD 311 million.

 

4. Principal currency translation rates

 

First half

 

 

 

Average rates
H1 2008

 

Average rates
H1 2007

 

Period-end rates
June 30, 2008

 

Period-end rates
June 30, 2007

 

 

 

USD

 

USD

 

USD

 

USD

 

1 CHF

 

0.953

 

0.815

 

0.982

 

0.813

 

1 EUR

 

1.531

 

1.329

 

1.579

 

1.346

 

1 GBP

 

1.974

 

1.971

 

1.995

 

2.005

 

100 JPY

 

0.953

 

0.833

 

0.946

 

0.811

 

 

Second quarter

 

 

 

Average rates
Q2 2008

 

Average rates
Q2 2007

 

Period-end rates
June 30, 2008

 

Period-end rates
June 30, 2007

 

 

 

USD

 

USD

 

USD

 

USD

 

1 CHF

 

0.970

 

0.818

 

0.982

 

0.813

 

1 EUR

 

1.562

 

1.348

 

1.579

 

1.346

 

1 GBP

 

1.970

 

1.987

 

1.995

 

2.005

 

100 JPY

 

0.956

 

0.828

 

0.946

 

0.811

 

 

27



 

5. Legal proceedings update

 

A number of Novartis subsidiaries are the subject of various legal proceedings that arise from time to time. As a result, the Group may become subject to substantial liabilities that may not be covered by insurance. While Novartis does not currently expect that any of these proceedings will have a material adverse effect on its financial position, litigation is inherently unpredictable and large verdicts do occur. 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. The consolidated financial statements in the 2007 Annual Report in note 19 contain a summary of major legal proceedings. The following non-exhaustive list is limited to certain recent developments. Unless otherwise noted, all proceedings in the 2007 Annual Report remain outstanding.

 

Zometa/Aredia

A Novartis affiliate is now a defendant in more than 490 cases brought in US courts by more than 490 plaintiffs who claim to have experienced osteonecrosis of the jaw after treatment with Zometa/Aredia. Two of these cases purport to be class actions. Discovery is continuing in these cases.

 

Average Wholesale Price Litigation

Claims have been brought against various pharmaceutical companies, including Novartis subsidiaries, alleging they fraudulently overstated the Average Wholesale Price (AWP) used to calculate Medicare and Medicaid reimbursements, respectively. Discovery is ongoing in some cases. In a trial in Alabama against a Novartis subsidiary, the jury rejected the state’s claims for punitive damages but decided against the Novartis subsidiary on the state’s claims for compensatory damages of USD 33 million. The Novartis subsidiary will appeal the verdict to the Supreme Court of Alabama.

 

Zometa patent litigation

A generic manufacturer seeking approval to market a generic version of zoledronic acid in the US is challenging the validity and enforceability of the basic compound patent that expires in March 2013. This patent is listed for both Zometa and Aclasta/Reclast, assuring exclusivity for both of these products.

 

Lotrel patent litigation

In ongoing patent litigation on the US combination patent against generic manufacturers, the main trial against Teva is now expected in the first quarter of 2009.

 

J&J Nicolson patent litigation

Johnson & Johnson had filed suits seeking declaration that the Nicolson patents are invalid and/or that the launch of its Acuvue Oasys® and Advance® products do not infringe the Nicolson patents. The first trial on the Johnson & Johnson Oasys® product is scheduled to begin in April 2009.

 

Trileptal investigation

A Novartis subsidiary is fully cooperating with an investigation by the US Attorney’s Office for the Eastern District of Pennsylvania, which served an administrative subpoena pursuant to the Health Insurance Portability and Accountability Act. Novartis understands that the US Attorney’s Office is conducting parallel civil and criminal investigations into allegations of potential off-label promotion of Trileptal. The investigation has included requests for information and documents. Novartis is currently unable to express an opinion on the likely outcome of these investigations.

 

28



 

Supplementary information

 

Condensed consolidated change in liquidity (unaudited)

 

First half

 

 

 

H1 2008

 

H1 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Change in cash and cash equivalents

 

8 709

 

-1 203

 

9 912

 

Change in marketable securities, financial debt and financial derivatives

 

-10 649

 

644

 

-11 293

 

Change in net liquidity

 

-1 940

 

-559

 

-1 381

 

Net liquidity at January 1 from continuing operations

 

 7 407

 

656

 

6 751

 

Net liquidity from continuing operations at June 30

 

5 467

 

97

 

5 370

 

Net liquidity from discontinued operations

 

 

 

-8

 

8

 

Net liquidity at June 30

 

5 467

 

89

 

5 378

 

 

Second quarter

 

 

 

Q2 2008

 

Q2 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Change in cash and cash equivalents

 

7 138

 

322

 

6 816

 

Change in marketable securities, financial debt and financial derivatives

 

-6 042

 

168

 

-6 210

 

Change in net liquidity

 

1 096

 

490

 

606

 

Net liquidity at April 1 from continuing operations

 

4 371

 

-393

 

4 764

 

Net liquidity from continuing operations at June 30

 

5 467

 

97

 

5 370

 

Net liquidity from discontinued operations

 

 

 

-8

 

8

 

Net liquidity at June 30

 

5 467

 

89

 

5 378

 

 

29



 

Free cash flow (unaudited)

 

First half

 

 

 

H1 2008

 

H1 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Cash flow from operating activities from continuing operations

 

3 541

 

3 920

 

-379

 

Purchase of property, plant & equipment

 

-967

 

-1 145

 

178

 

Purchase of intangible and financial assets

 

-166

 

-322

 

156

 

Sale of property, plant & equipment, intangible and financial assets

 

166

 

256

 

-90

 

Dividends

 

-3 345

 

-2 598

 

-747

 

Free cash flow from continuing operations

 

-771

 

111

 

-882

 

Free cash flow from discontinued operations

 

-85

 

111

 

-196

 

Free cash flow

 

-856

 

222

 

-1 078

 

 

Second quarter

 

 

 

Q2 2008

 

Q2 2007

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Cash flow from operating activities from continuing operations

 

1 852

 

1 869

 

-17

 

Purchase of property, plant & equipment

 

-564

 

-623

 

59

 

Purchase of intangible and financial assets

 

-88

 

-210

 

122

 

Sale of property, plant & equipment, intangible and financial assets

 

19

 

233

 

-214

 

Dividends

 

-3

 

-806

 

803

 

Free cash flow from continuing operations

 

1 216

 

463

 

753

 

Free cash flow from discontinued operations

 

-14

 

15

 

-29

 

Free cash flow

 

1 202

 

478

 

724

 

 

Share information

 

 

 

 

 

June 30, 2008

 

June 30, 2007

 

Number of shares outstanding (million)

 

 

 

2 263.3

 

2 334.9

 

Registered share price (CHF)

 

 

 

56.25

 

69.00

 

ADS price (USD)

 

 

 

55.04

 

56.07

 

Market capitalization (USD billion)

 

 

 

125.0

 

131.0

 

Market capitalization (CHF billion)

 

 

 

127.3

 

161.1

 

 

30



 

Impact of intangible asset charges and significant exceptional items – First half (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer Health
continuing operations

 

Corporate

 

Total continuing
operations

 

 

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

H1 2008

 

H1 2007

 

 

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

Reported operating income

 

4 274

 

3 620

 

-128

 

7

 

591

 

561

 

566

 

483

 

-354

 

-239

 

4 949

 

4 432

 

Recurring amortization

 

201

 

205

 

161

 

143

 

156

 

144

 

40

 

41

 

1

 

3

 

559

 

536

 

Impairment of intangible assets

 

48

 

14

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

49

 

14

 

Intangible asset charges

 

249

 

219

 

162

 

143

 

156

 

144

 

40

 

41

 

1

 

3

 

608

 

550

 

Acquisition-related restructuring and integration expenses (including acquisition-related accounting impact of inventory adjustments), net

 

 

 

 

 

11

 

10

 

 

 

 

 

 

 

6

 

 

 

 

 

11

 

16

 

Restructuring expenses

 

47

 

 

 

 

 

 

 

4

 

7

 

-3

 

 

 

 

 

 

 

48

 

7

 

Impairment of property, plant & equipment

 

6

 

 

 

 

 

 

 

2

 

18

 

 

 

 

 

4

 

 

 

12

 

18

 

Exceptional restructuring and acquisition related integration expenses, net

 

53

 

 

 

11

 

10

 

6

 

25

 

-3

 

6

 

4

 

 

 

71

 

41

 

Exceptional gains from divesting brands, subsidiaries and financial investments

 

-141

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-141

 

 

 

Impairment of financial assets

 

21

 

3

 

 

 

 

 

 

 

10

 

 

 

 

 

6

 

4

 

27

 

17

 

Litigation and exceptional settlements

 

 

 

 

 

-49

 

-83

 

 

 

 

 

 

 

 

 

 

 

 

 

-49

 

-83

 

Suspension of Zelnorm

 

 

 

71

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

71

 

Release of pre-launch inventory provisions

 

-45

 

-107

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-45

 

-107

 

Release of US government health agency rebate provisions

 

-104

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-104

 

 

 

Other exceptional items

 

-128

 

-33

 

-49

 

-83

 

 

 

10

 

 

 

 

 

6

 

4

 

-171

 

-102

 

Total adjustments

 

33

 

186

 

124

 

70

 

162

 

179

 

37

 

47

 

11

 

7

 

367

 

489

 

Adjusted operating income

 

4 307

 

3 806

 

-4

 

77

 

753

 

740

 

603

 

530

 

-343

 

-232

 

5 316

 

4 921

 

Income from associated companies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

256

 

192

 

Recurring amortization related to income from associated companies, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

69

 

59

 

Net financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

115

 

67

 

Taxes (adjusted for above items)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-895

 

-834

 

Adjusted net income from continuing operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4 861

 

4 405

 

Adjusted net income attributable to shareholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4 844

 

4 395

 

Adjusted basic earnings per share from continuing operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2.14

 

1.88

 

 

31



 

Impact of intangible asset charges and significant exceptional items – Second quarter (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer Health
continuing operations

 

Corporate

 

Total continuing
operations

 

 

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

Q2 2008

 

Q2 2007

 

 

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

Reported operating income

 

2 178

 

1 767

 

-75

 

-20

 

246

 

243

 

304

 

243

 

-192

 

-136

 

2 461

 

2 097

 

Recurring amortization

 

100

 

103

 

80

 

72

 

78

 

73

 

21

 

21

 

1

 

2

 

280

 

271

 

Impairment of intangible assets

 

21

 

6

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

21

 

6

 

Intangible asset charges

 

121

 

109

 

80

 

72

 

78

 

73

 

21

 

21

 

1

 

2

 

301

 

277

 

Acquisition-related restructuring and integration expenses (including acquisition-related accounting impact of inventory adjustments), net

 

 

 

 

 

11

 

3

 

 

 

 

 

 

 

6

 

 

 

 

 

11

 

9

 

Restructuring expenses

 

8

 

 

 

 

 

 

 

 

 

 

 

-3

 

 

 

 

 

 

 

5

 

 

 

Impairment of property, plant & equipment

 

4

 

 

 

 

 

 

 

 

 

18

 

 

 

 

 

 

 

 

 

4

 

18

 

Exceptional restructuring and acquisition related integration expenses, net

 

12

 

 

 

11

 

3

 

 

 

18

 

-3

 

6

 

 

 

 

 

20

 

27

 

Exceptional gains from divesting brands, subsidiaries and financial investments

 

-26

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-26

 

 

 

Impairment of financial assets

 

6

 

2

 

 

 

 

 

 

 

10

 

 

 

 

 

1

 

 

 

7

 

12

 

Litigation and exceptional settlements

 

 

 

 

 

 

 

-16

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-16

 

Suspension of Zelnorm

 

 

 

19

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

19

 

Release of US government health agency rebate provisions

 

-104

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-104

 

 

 

Other exceptional items

 

-98

 

21

 

 

 

-16

 

 

 

10

 

 

 

 

 

1

 

 

 

-97

 

15

 

Total adjustments

 

9

 

130

 

91

 

59

 

78

 

101

 

18

 

27

 

2

 

2

 

198

 

319

 

Adjusted operating income

 

2 187

 

1 897

 

16

 

39

 

324

 

344

 

322

 

270

 

-190

 

-134

 

2 659

 

2 416

 

Income from associated companies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

119

 

95

 

Recurring amortization related to income from associated companies, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

35

 

31

 

Net financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

24

 

33

 

Taxes (adjusted for above items)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-416

 

-395

 

Adjusted net income from continuing operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 421

 

2 180

 

Adjusted net income attributable to shareholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 410

 

2 172

 

Adjusted basic earnings per share from continuing operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.06

 

0.93

 

 

32



 

Supplementary tables: First half 2008 – Net sales of top 20 pharmaceutical products (unaudited)

 

 

 

 

 

US

 

Rest of world

 

Total

 

Brands

 

Therapeutic area

 

USD m

 

% change
in local
currencies

 

USD m

 

% change
in local
currencies

 

USD m

 

% change
in USD

 

% change
in local
currencies

 

Diovan/Co–Diovan

 

Hypertension

 

1 183

 

11

 

1 695

 

14

 

2 878

 

20

 

12

 

Gleevec/Glivec

 

Chronic myeloid leukemia

 

422

 

27

 

1 408

 

14

 

1 830

 

29

 

17

 

Zometa

 

Cancer complications

 

313

 

-2

 

364

 

1

 

677

 

6

 

0

 

Femara

 

Breast cancer

 

235

 

18

 

326

 

20

 

561

 

28

 

19

 

Sandostatin

 

Acromegaly

 

205

 

4

 

353

 

7

 

558

 

14

 

5

 

Neoral/Sandimmun

 

Transplantation

 

55

 

-2

 

448

 

-1

 

503

 

10

 

-1

 

Lucentis

 

Age-related macular degeneration

 

 

 

 

 

437

 

285

 

437

 

333

 

285

 

Voltaren (Excl. OTC)

 

Inflammation/pain

 

3

 

50

 

415

 

6

 

418

 

17

 

6

 

Exelon/Exelon Patch

 

Alzheimer’s disease

 

124

 

27

 

267

 

16

 

391

 

32

 

20

 

Lescol

 

Cholesterol reduction

 

78

 

-27

 

259

 

-2

 

337

 

-1

 

-10

 

Top ten products total

 

 

 

2 618

 

10

 

5 972

 

16

 

8 590

 

24

 

14

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tegretol

 

Epilepsy

 

83

 

32

 

162

 

5

 

245

 

20

 

13

 

Comtan/Stalevo

 

Parkinson’s disease

 

96

 

10

 

149

 

15

 

245

 

23

 

13

 

Exjade

 

Iron chelator

 

96

 

13

 

142

 

76

 

238

 

52

 

42

 

Ritalin/Focalin

 

Attention deficit / hyperactive disorder

 

172

 

10

 

48

 

14

 

220

 

14

 

11

 

Foradil

 

Asthma

 

8

 

-20

 

201

 

2

 

209

 

16

 

1

 

Lotrel

 

Hypertension

 

195

 

-67

 

 

 

 

 

195

 

-67

 

-67

 

Trileptal

 

Epilepsy

 

70

 

-77

 

103

 

-3

 

173

 

-56

 

-59

 

Exforge

 

Hypertension

 

62

 

464

 

111

 

524

 

173

 

541

 

489

 

Tobramycin

 

Cystic fibrosis

 

91

 

7

 

54

 

-3

 

145

 

8

 

3

 

Myfortic

 

Transplantation

 

45

 

55

 

96

 

53

 

141

 

66

 

53

 

Top 20 products total

 

 

 

3 536

 

-7

 

7 038

 

18

 

10 574

 

16

 

7

 

Rest of portfolio

 

 

 

667

 

-29

 

1 951

 

-12

 

2 618

 

-9

 

-17

 

Total Division sales(1)

 

 

 

4 203

 

-11

 

8 989

 

10

 

13 192

 

10

 

1

 

 


(1)   Net sales for the first half of 2008 include a one-time contribution of USD 104 million from a brand-specific provision reversal following a Novartis review of accounting for rebate programs to US government health agencies. Individual brand sales may include contributions from the reversal of these provisions.

 

33



 

Supplementary tables: Second quarter 2008 – Net sales of top 20 pharmaceutical products (unaudited)

 

 

 

 

 

US

 

Rest of world

 

Total

 

Brands

 

Therapeutic area

 

USD m

 

% change
in local
currencies

 

USD m

 

% change
in local
currencies

 

USD m

 

% change
in USD

 

% change
in local
currencies

 

Diovan/Co-Diovan

 

Hypertension

 

613

 

12

 

896

 

14

 

1 509

 

22

 

13

 

Gleevec/Glivec

 

Chronic myeloid leukemia

 

216

 

22

 

726

 

13

 

942

 

26

 

15

 

Zometa

 

Cancer complications

 

160

 

0

 

186

 

1

 

346

 

7

 

0

 

Femara

 

Breast cancer

 

119

 

16

 

172

 

18

 

291

 

26

 

17

 

Sandostatin

 

Acromegaly

 

105

 

2

 

184

 

8

 

289

 

14

 

6

 

Neoral/Sandimmun

 

Transplantation

 

28

 

8

 

230

 

-1

 

258

 

11

 

-1

 

Lucentis

 

Age-related macular degeneration

 

 

 

 

 

242

 

198

 

242

 

236

 

198

 

Voltaren (Excl. OTC)

 

Inflammation/pain

 

1

 

0

 

215

 

5

 

216

 

17

 

5

 

Exelon/Exelon Patch

 

Alzheimer’s disease

 

65

 

35

 

138

 

17

 

203

 

34

 

23

 

Lescol

 

Cholesterol reduction

 

42

 

-18

 

139

 

4

 

181

 

8

 

-3

 

Top ten products total

 

 

 

1 349

 

11

 

3 128

 

16

 

4 477

 

24

 

14

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tegretol

 

Epilepsy

 

53

 

71

 

78

 

-2

 

131

 

25

 

19

 

Comtan/Stalevo

 

Parkinson’s disease

 

51

 

13

 

80

 

16

 

131

 

24

 

14

 

Exjade

 

Iron chelator

 

53

 

15

 

76

 

48

 

129

 

40

 

32

 

Ritalin/Focalin

 

Attention deficit/hyperactive disorder

 

87

 

21

 

27

 

16

 

114

 

24

 

20

 

Foradil

 

Asthma

 

4

 

0

 

100

 

-1

 

104

 

13

 

-2

 

Lotrel

 

Hypertension

 

100

 

-59

 

 

 

 

 

100

 

-59

 

-59

 

Trileptal

 

Epilepsy

 

30

 

-80

 

53

 

-2

 

83

 

-58

 

-61

 

Exforge

 

Hypertension

 

36

 

227

 

65

 

502

 

101

 

381

 

345

 

Tobramycin

 

Cystic fibrosis

 

45

 

10

 

27

 

0

 

72

 

11

 

5

 

Myfortic

 

Transplantation

 

24

 

60

 

53

 

49

 

77

 

64

 

52

 

Top 20 products total

 

 

 

1 832

 

-2

 

3 687

 

17

 

5 519

 

18

 

9

 

Rest of portfolio

 

 

 

386

 

-6

 

1 023

 

-9

 

1 409

 

0

 

-8

 

Total Division sales(1)

 

 

 

2 218

 

-3

 

4 710

 

10

 

6 928

 

14

 

5

 

 


(1) Net sales for the second quarter of 2008 include a one-time contribution of USD 104 million from a brand-specific provision reversal following a Novartis review of accounting for rebate programs to US government health agencies. Individual brand sales may include contributions from the reversal of these provisions.

 

34



 

First half – Pharmaceutical net sales by therapeutic area (unaudited)

 

 

 

H1 2008

 

H1 2007

 

% change

 

 

 

USD m

 

USD m

 

USD

 

Cardiovascular & Metabolism

 

 

 

 

 

 

 

Diovan

 

2 878

 

2 390

 

20

 

Lotrel

 

195

 

594

 

-67

 

Exforge

 

173

 

27

 

541

 

Tekturna/Rasilez

 

58

 

11

 

427

 

Other

 

14

 

2

 

NM

 

Total strategic franchise products

 

3 318

 

3 024

 

10

 

Mature products (including Lescol)

 

775

 

749

 

3

 

Total Cardiovascular & Metabolism products

 

4 093

 

3 773

 

8

 

 

 

 

 

 

 

 

 

Oncology & Hematology

 

 

 

 

 

 

 

Gleevec/Glivec

 

1 830

 

1 421

 

29

 

Zometa

 

677

 

636

 

6

 

Femara

 

561

 

439

 

28

 

Sandostatin

 

558

 

491

 

14

 

Exjade

 

238

 

157

 

52

 

Other

 

179

 

138

 

30

 

Total Oncology & Hematology products

 

4 043

 

3 282

 

23

 

 

 

 

 

 

 

 

 

Neuroscience & Ophthalmics

 

 

 

 

 

 

 

Lucentis

 

437

 

101

 

333

 

Exelon/Exelon Patch

 

391

 

297

 

32

 

Tegretol

 

245

 

204

 

20

 

Comtan/Stalevo

 

245

 

200

 

23

 

Ritalin/Focalin

 

220

 

193

 

14

 

Trileptal

 

173

 

396

 

-56

 

Other

 

425

 

533

 

-20

 

Total strategic franchise products

 

2 136

 

1 924

 

11

 

Mature products

 

211

 

212

 

0

 

Total Neuroscience & Ophthalmics products

 

2 347

 

2 136

 

10

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

Foradil

 

209

 

180

 

16

 

Tobramycin

 

145

 

134

 

8

 

Xolair

 

95

 

64

 

48

 

Other

 

52

 

40

 

30

 

Total strategic franchise products

 

501

 

418

 

20

 

Mature products

 

49

 

52

 

-6

 

Total Respiratory products

 

550

 

470

 

17

 

 

 

 

 

 

 

 

 

Immunology & Infectious Diseases (IID)

 

 

 

 

 

 

 

Neoral/Sandimmun

 

503

 

457

 

10

 

Aclasta/Reclast

 

103

 

5

 

NM

 

Elidel

 

83

 

94

 

-12

 

Other

 

309

 

202

 

53

 

Total strategic franchise products

 

998

 

758

 

32

 

Mature products

 

492

 

855

 

-42

 

Total IID products

 

1 490

 

1 613

 

-8

 

 

 

 

 

 

 

 

 

Additional mature products

 

 

 

 

 

 

 

Voltaren (Excluding OTC)

 

418

 

356

 

17

 

Enablex/Emselex

 

95

 

81

 

17

 

Prexige

 

23

 

52

 

-56

 

Zelnorm/Zelmac

 

5

 

91

 

-95

 

Other

 

128

 

134

 

-4

 

Total additional mature products

 

669

 

714

 

-6

 

 

 

 

 

 

 

 

 

Total strategic franchise products

 

10 996

 

9 406

 

17

 

Total mature products

 

2 196

 

2 582

 

-15

 

Total Division net sales(1)

 

13 192

 

11 988

 

10

 

 


NM – Not meaningful

 

(1) Net sales for the first half of 2008 include a one-time contribution of USD 104 million from a brand-specific provision reversal following a Novartis review of accounting for rebate programs to US government health agencies. Individual brand sales may include contributions from the reversal of these provisions.

 

35



 

Second quarter – Pharmaceutical net sales by therapeutic area (unaudited)

 

 

 

Q2 2008

 

Q2 2007

 

% change

 

 

 

USD m

 

USD m

 

USD

 

Cardiovascular & Metabolism

 

 

 

 

 

 

 

Diovan

 

1 509

 

1 239

 

22

 

Lotrel

 

100

 

241

 

-59

 

Exforge

 

101

 

21

 

381

 

Tekturna/Rasilez

 

30

 

1

 

NM

 

Other

 

8

 

2

 

300

 

Total strategic franchise products

 

1 748

 

1 504

 

16

 

Mature products (including Lescol)

 

398

 

372

 

7

 

Total Cardiovascular & Metabolism products

 

2 146

 

1 876

 

14

 

 

 

 

 

 

 

 

 

Oncology & Hematology

 

 

 

 

 

 

 

Gleevec/Glivec

 

942

 

747

 

26

 

Zometa

 

346

 

322

 

7

 

Femara

 

291

 

231

 

26

 

Sandostatin

 

289

 

253

 

14

 

Exjade

 

129

 

92

 

40

 

Other

 

98

 

69

 

42

 

Total Oncology & Hematology products

 

2 095

 

1 714

 

22

 

 

 

 

 

 

 

 

 

Neuroscience & Ophthalmics

 

 

 

 

 

 

 

Lucentis

 

242

 

72

 

236

 

Exelon/Exelon Patch

 

203

 

151

 

34

 

Tegretol

 

131

 

105

 

25

 

Comtan/Stalevo

 

131

 

106

 

24

 

Ritalin/Focalin

 

114

 

92

 

24

 

Trileptal

 

83

 

199

 

-58

 

Other

 

229

 

268

 

-15

 

Total strategic franchise products

 

1 133

 

993

 

14

 

Mature products

 

106

 

108

 

-2

 

Total Neuroscience & Ophthalmics products

 

1 239

 

1 101

 

13

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

Foradil

 

104

 

92

 

13

 

Tobramycin

 

72

 

65

 

11

 

Xolair

 

56

 

30

 

87

 

Other

 

25

 

20

 

25

 

Total strategic franchise products

 

257

 

207

 

24

 

Mature products

 

21

 

23

 

-9

 

Total Respiratory products

 

278

 

230

 

21

 

 

 

 

 

 

 

 

 

Immunology & Infectious Diseases (IID)

 

 

 

 

 

 

 

Neoral/Sandimmun

 

258

 

233

 

11

 

Aclasta/Reclast

 

64

 

3

 

NM

 

Elidel

 

41

 

47

 

-13

 

Other

 

165

 

110

 

50

 

Total strategic franchise products

 

528

 

393

 

34

 

Mature products

 

294

 

438

 

-33

 

Total IID products

 

822

 

831

 

-1

 

 

 

 

 

 

 

 

 

Additional mature products

 

 

 

 

 

 

 

Voltaren(Excluding OTC)

 

216

 

185

 

17

 

Enablex/Emselex

 

49

 

43

 

14

 

Prexige

 

13

 

31

 

-58

 

Zelnorm/Zelmac

 

3

 

-14

 

NM

 

Other

 

67

 

68

 

-1

 

Total additional mature products

 

348

 

313

 

11

 

 

 

 

 

 

 

 

 

Total strategic franchise products

 

5 761

 

4 811

 

20

 

Total mature products

 

1 167

 

1 254

 

-7

 

Total Division net sales(1)

 

6 928

 

6 065

 

14

 

 


NM – Not meaningful

 

(1) Net sales for the second quarter of 2008 include a one-time contribution of USD 104 million from a brand-specific provision reversal following a Novartis review of accounting for rebate programs to US government health agencies. Individual brand sales may include contributions from the reversal of these provisions.

 

36



 

Net sales by region (unaudited)

 

First half

 

 

 

 

 

 

 

% change

 

 

 

 

 

 

 

H1 2008

 

H1 2007

 

 

 

local

 

H1 2008

 

H1 2007

 

 

 

USD m

 

USD m

 

USD

 

currencies

 

% of total

 

% of total

 

Pharmaceuticals

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

4 203

 

4 744

 

-11

 

-11

 

32

 

40

 

Rest of world

 

8 989

 

7 244

 

24

 

10

 

68

 

60

 

Total

 

13 192

 

11 988

 

10

 

1

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccines and Diagnostics

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

224

 

146

 

53

 

53

 

37

 

30

 

Rest of world

 

378

 

336

 

13

 

-2

 

63

 

70

 

Total

 

602

 

482

 

25

 

15

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sandoz

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

898

 

953

 

-6

 

-7

 

23

 

28

 

Rest of world

 

2 956

 

2 462

 

20

 

5

 

77

 

72

 

Total

 

3 854

 

3 415

 

13

 

2

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consumer Health continuing operations

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

847

 

873

 

-3

 

-3

 

28

 

33

 

Rest of world

 

2 140

 

1 770

 

21

 

8

 

72

 

67

 

Total

 

2 987

 

2 643

 

13

 

4

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Group continuing operations

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

6 172

 

6 716

 

-8

 

-8

 

30

 

36

 

Rest of world

 

14 463

 

11 812

 

22

 

8

 

70

 

64

 

Total

 

20 635

 

18 528

 

11

 

2

 

100

 

100

 

 

37



 

Net sales by region (unaudited)

 

Second quarter

 

 

 

 

 

 

 

% change

 

 

 

 

 

 

 

Q2 2008

 

Q2 2007

 

 

 

local

 

Q2 2008

 

Q2 2007

 

 

 

USD m

 

USD m

 

USD

 

currencies

 

% of total

 

% of total

 

Pharmaceuticals

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

2 218

 

2 281

 

-3

 

-3

 

32

 

38

 

Rest of world

 

4 710

 

3 784

 

24

 

10

 

68

 

62

 

Total

 

6 928

 

6 065

 

14

 

5

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccines and Diagnostics

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

145

 

74

 

96

 

96

 

45

 

29

 

Rest of world

 

177

 

177

 

0

 

-13

 

55

 

71

 

Total

 

322

 

251

 

28

 

19

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sandoz

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

430

 

479

 

-10

 

-11

 

22

 

28

 

Rest of world

 

1 518

 

1 240

 

22

 

7

 

78

 

72

 

Total

 

1 948

 

1 719

 

13

 

2

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consumer Health continuing operations

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

428

 

443

 

-3

 

-3

 

28

 

32

 

Rest of world

 

1 100

 

922

 

19

 

7

 

72

 

68

 

Total

 

1 528

 

1 365

 

12

 

3

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Group continuing operations

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

3 221

 

3 277

 

-2

 

-2

 

30

 

35

 

Rest of world

 

7 505

 

6 123

 

23

 

8

 

70

 

65

 

Total

 

10 726

 

9 400

 

14

 

5

 

100

 

100

 

 

38



 

Quarterly analysis for continuing operations (unaudited)

 

Key figures by quarter

 

 

 

Q2 2008

 

Q1 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Net sales

 

10 726

 

9 909

 

817

 

8

 

Operating income

 

2 461

 

2 488

 

-27

 

-1

 

Financial income

 

85

 

148

 

-63

 

-43

 

Interest expense

 

-61

 

-57

 

-4

 

7

 

Taxes

 

-338

 

-408

 

70

 

-17

 

Net income

 

2 266

 

2 308

 

-42

 

-2

 

 

Net sales by region

 

 

 

Q2 2008

 

Q1 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

US

 

3 221

 

2 951

 

270

 

9

 

Europe

 

4 747

 

4 498

 

249

 

6

 

Rest of world

 

2 758

 

2 460

 

298

 

12

 

Total

 

10 726

 

9 909

 

817

 

8

 

 

Net sales by Division

 

 

 

Q2 2008

 

Q1 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Pharmaceuticals

 

6 928

 

6 264

 

664

 

11

 

Vaccines and Diagnostics

 

322

 

280

 

42

 

15

 

Sandoz

 

1 948

 

1 906

 

42

 

2

 

Consumer Health continuing operations

 

1 528

 

1 459

 

69

 

5

 

Total

 

10 726

 

9 909

 

817

 

8

 

 

Operating income by Division

 

 

 

Q2 2008

 

Q1 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Pharmaceuticals

 

2 178

 

2 096

 

82

 

4

 

Vaccines and Diagnostics

 

-75

 

-53

 

-22

 

42

 

Sandoz

 

246

 

345

 

-99

 

-29

 

Consumer Health continuing operations

 

304

 

262

 

42

 

16

 

Corporate income & expense, net

 

-192

 

-162

 

-30

 

19

 

Operating income from continuing operations

 

2 461

 

2 488

 

-27

 

-1

 

Discontinued Consumer Health operations

 

6

 

24

 

-18

 

-75

 

Total

 

2 467

 

2 512

 

-45

 

-2

 

 

39



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

 

Novartis AG

 

 

 

 

 

 

Date:

July 17, 2008

By:

 /s/ MALCOLM B. CHEETHAM

 

 

 

 

 

Name:

Malcolm B. Cheetham

 

 

Title:

Head Group Financial

 

 

 

Reporting and Accounting

 

40