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 January 26, 2010

(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on September 5, 2006 (File No. 333-137112) and on October 1, 2004 (File No. 333-119475), in each case to the extent not superseded by documents or reports subsequently filed by us under the Securities Act of 1933 or the Securities Exchange Act of 1934, in each case as amended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 2009

 

 

 



 

Novartis International AG
Novartis Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com

 

FINANCIAL REPORT  ·  RAPPORT FINANCIER  ·  FINANZBERICHT

 

Novartis achieves record results in 2009 as momentum from recently launched products drives growth across its entire healthcare portfolio

 

Novartis completes CEO succession process with appointment of Joe Jimenez as new CEO and simplified leadership organization

 

·                  Group delivers sustained business expansion and profit improvement with all divisions contributing to strong performance in 2009

 

·                  Net sales rise 11% in local currencies (lc) to USD 44.3 billion (+7% in USD), as innovative  products drive Pharmaceuticals to industry-leading growth and Vaccines and Diagnostics sells over 100 million influenza A (H1N1) pandemic vaccine doses

 

·                  Core operating income grows 11% to USD 11.4 billion, as margin improves to 25.8% of net sales on business expansion and productivity gains

 

·                  Core net income rises 8% to USD 10.3 billion, at a lower pace than core operating income mainly due to Alcon-related financing costs

 

·                  Core EPS up 8% to USD 4.50

 

·                  Free cash flow before dividends advances 24% to USD 9.4 billion

 

·                  More than 30 drug approvals and full pipeline with 145 projects in pharmaceutical clinical development, of which 60 involve new molecular entities

 

·                  Forward productivity program exceeds savings goal by nearly 50% and a year ahead of schedule

 

·                  Access-to-medicine programs including medication for malaria and leprosy reach 80 million patients in 2009 with contributions valued at USD 1.5 billion, or 3% of sales

 

·                  New management in place for the next phase of growth

 

·                  Dr. Vasella to focus on strategic priorities as Chairman, Board names Joe Jimenez CEO and simplifies organizational structure completing the CEO succession process begun in 2008

 

·                  Novartis to become the first large, listed Swiss company to include a consultative vote on Compensation System in its Articles of Incorporation, further strengthening governance in wake of global financial crisis

 

·                  13th consecutive dividend increase: CHF 2.10 per share proposed for 2009

 

·                  2010 to be a year of significant progress in implementing strategic priorities with continued focus on innovation, growth and productivity

 

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

 

1



 

Key figures

 

 

 

Full year

 

 

 

 

 

Fourth quarter

 

 

 

2009

 

2008

 

% change

 

2009

 

2008

 

% change

 

 

 

USD m

 

USD m

 

USD

 

lc

 

USD m

 

USD m

 

USD

 

lc

 

Net sales

 

44 267

 

41 459

 

7

 

11

 

12 926

 

10 077

 

28

 

20

 

Operating income

 

9 982

 

8 964

 

11

 

 

 

2 637

 

1 680

 

57

 

 

 

Net income

 

8 454

 

8 163

 

4

 

 

 

2 323

 

1 507

 

54

 

 

 

Basic EPS (USD)

 

3.70

 

3.59

 

3

 

 

 

1.01

 

0.66

 

53

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Core(1)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

11 437

 

10 319

 

11

 

 

 

3 204

 

2 090

 

53

 

 

 

Net income

 

10 267

 

9 501

 

8

 

 

 

2 892

 

1 967

 

47

 

 

 

Basic EPS (USD)

 

4.50

 

4.18

 

8

 

 

 

1.26

 

0.86

 

47

 

 

 

 

Basel, January 26, 2010 — Commenting on the results, Dr. Daniel Vasella, Chairman and CEO of Novartis, said: “Novartis delivered an excellent performance in 2009 driven by strong underlying growth across our entire healthcare portfolio. Over the past 12 months, we sustained our lead in approvals for new products, achieving more than 30 major new product approvals in the US, Europe and Japan. Our productivity efforts improved profitability and allowed for continued investments in drug discovery. The planned acquisition of Alcon will propel Novartis to the global leadership position in eye-care and create a new growth platform. After 14 years as CEO it is the right time to complete the carefully planned CEO succession process, which started over a year ago. The Board appointed Joe Jimenez, currently division head of our pharmaceutical business as new CEO and also agreed to delayer and simplify the top leadership structure. The international experience in pharmaceuticals and consumer businesses together with an excellent track record destine Joe Jimenez to lead Novartis into a next phase of expansion and growth. I am convinced 2010 will be a year of significant progress.”

 

2



 

OVERVIEW

 

Full year

The underlying double-digit expansion in Pharmaceuticals, ranked as one of the industry’s fastest-growing businesses based on market share, led the Group’s healthcare portfolio in 2009 to another year of record results. Vaccines and Diagnostics achieved exceptionally high sales by rapidly developing and delivering influenza A (H1N1) pandemic vaccines to address the public health threat.

 

Net sales rose 7% (+11% in local currencies, lc) to USD 44.3 billion on the underlying expansion in all divisions: Pharmaceuticals (+12% lc), Vaccines and Diagnostics (+39% lc), Sandoz (+5% lc) and Consumer Health (+5% lc). Top-performing regions included Europe (USD 18.4 billion, +10% lc) and the United States (USD 14.3 billion, +11% lc) as well as the top six emerging markets (USD 4.0 billion, +17% lc) of Brazil, China, India, Russia, South Korea and Turkey. Higher volumes contributed 10 percentage points of growth, while acquisitions and price changes together added one percentage point of sales growth. The stronger US dollar compared to 2008 reduced full-year growth by four percentage points.

 

Operating income grew 11% to USD 10.0 billion in 2009, which resulted in the operating income margin rising to 22.5% of net sales from 21.6% in 2008. The stronger US dollar compared to 2008 reduced operating income growth by nine percentage points. Core operating income, which excludes exceptional items and amortization of intangible assets in both periods, grew 11% to USD 11.4 billion on improvements in Pharmaceuticals and Vaccines and Diagnostics as well as productivity gains in all divisions. The core operating income margin rose to 25.8% of net sales from 25.0% in 2008.

 

Net income rose 4% to USD 8.5 billion, while basic EPS was up 3% to USD 3.70. Core net income of USD 10.3 billion (+8%) rose at a slower pace than operating income as increased contributions from associated companies were partially reduced by Alcon-related financing costs. Core earnings per share were USD 4.50 in 2009, up from USD 4.18 in 2008.

 

Fourth quarter

Novartis ended 2009 strongly, delivering double-digit net sales and earnings growth that reflected operational progress in all divisions and more favorable currency conditions over the 2008 period.

 

Net sales grew 28% (+20% lc) to USD 12.9 billion. Pharmaceuticals (+13% lc) maintained its industry-leading performance based on growth of recently launched products. Results in Vaccines and Diagnostics (+166% lc) included USD 1.0 billion of A (H1N1) pandemic vaccine and adjuvant sales. Sandoz (+10% lc) benefited from the EBEWE Pharma specialty generics business acquisition in September, which added five percentage points to sales growth. Consumer Health (+13% lc) had better results in all businesses, particularly in OTC on the first-to-market OTC launch of Prevacid24HR in the US.

 

Operating income rose 57% to USD 2.6 billion, with favorable currency movements having a positive impact of five percentage points. The operating income margin improved to 20.4% in the 2009 quarter from 16.7% in 2008. Core operating income rose 53% to USD 3.2 billion in the 2009 quarter on double-digit contributions from all businesses, with the core operating income margin expanding to 24.8% of net sales in the 2009 period from 20.8% in the year-ago quarter.

 

Net income rose 54% to USD 2.3 billion, while basic EPS rose at the same pace to USD 1.01 in the 2009 period from USD 0.66 in 2008. Core net income was up 47% to USD 2.9 billion, which reflected higher financing charges and reduced income from associated companies. Core basic earnings per share (EPS) rose 47% to USD 1.26 in the 2009 quarter from USD 0.86 in the 2008.

 

3



 

More than 30 major approvals in 2009

Novartis is transforming its portfolio through long-term investments in innovation. More than 30 major regulatory approvals in 2009 included the new medicines Afinitor (cancer), Onbrez Breezhaler (chronic obstructive pulmonary disease) and Ilaris (CAPS); A (H1N1) pandemic flu vaccines; the first-ever biosimilars in Japan and Canada; and the Prevacid24HR OTC brand in the US. Among regulatory submissions completed in 2009 included Gilenia (FTY720, multiple sclerosis) in the US and Europe. Other key submissions involved new indications for Tasigna (first-line CML), Zometa (adjuvant breast cancer) and Lucentis (diabetic macular edema). Novartis gained approvals in Japan for six new medicines, while three more approvals were received in January 2010 for Equa (Galvus), Exforge (hypertension) and Afinitor. Many submissions are planned for 2010, with up to five in oncology: Afinitor (neuroendocrine tumors) and the development projects SOM230 (Cushing’s disease), LBH589 (Hodgkin’s lymphoma) and EPO906 (ovarian cancer).

 

Improving organizational productivity

Novartis is integrating the drive for greater productivity and increased efficiency into its operations, improving speed while freeing up resources to focus on customers and growth initiatives. This is expected to lead to further improvement in the Group’s operating income margin in 2010. Forward, the Group-wide initiative launched in late 2007 to simplify structures and redesign the way Novartis operates, has been completed a year ahead of schedule after progressing rapidly and achieving more than USD 2.3 billion of cumulative cost savings since 2007 and exceeding its 2010 goal of USD 1.6 billion.

 

Commitment to patients

Business success enables Novartis to continue its commitment to patients around the world, an integral part of the Group’s strategy. Medicines and vaccines from Novartis were used in 2009 to treat and protect more than 930 million people around the world, according to internal estimates. Novartis is helping patients in the developing world through key initiatives focused on neglected diseases, especially malaria, leprosy, dengue fever and treatment-resistant tuberculosis. Treatments worth USD 1.5 billion were contributed through Novartis access-to-medicine programs in 2009, reaching 79.5 million patients in need.

 

2010: Delivering on strategic priorities

Novartis expects 2010 to be a year of significant progress in implementing its strategy to meet the growing needs of patients and aging societies worldwide through its healthcare portfolio.

 

Industry-leading growth

Novartis expects to maintain momentum in 2010 and increase Group net sales at a mid-single-digit percentage rate in local currencies(1) based on the rapidly growing contributions of recently launched products and targeted investments in emerging growth markets.

 

Pharmaceuticals expects to continue the strong volume growth achieved in 2009 on the rapid expansion of recently launched products, implementing new commercial models to adapt to local market needs while expanding in high-growth markets. However, pricing conditions are uncertain given industry challenges that include healthcare reforms (particularly in the US and Turkey) and biennial price cuts in Japan, while therapeutic-class generic competition is also set to start for Diovan in 2010 ahead of the end of exclusivity in Europe (2011) and the US (September 2012). Reflecting these factors, Pharmaceuticals net sales in 2010 are expected to grow at a mid- to high-single digit rate in local currencies.

 

Vaccines and Diagnostics is preparing the launch of Menveo, a developmental vaccine against four serogroups of meningococcal meningitis. European approval is expected in early 2010 after a

 


(1)   Excluding Alcon acquisition

 

4



 

positive opinion in December 2009, while a US regulatory decision is also expected in the first half of the year. Novartis plans to continue delivering A (H1N1) pandemic influenza vaccines and adjuvants in 2010; however, sales estimates for the year are well below 2009 levels.

 

Sandoz expects to increase its pace of growth in 2010. The addition of EBEWE Pharma’s specialty injectables business in September 2009 has created a new global growth platform by improving access to price competitive quality oncology medicines.

 

Consumer Health aims to keep growing ahead of its markets in 2010. The late 2009 US launch of Prevacid24HR, the first OTC version of this drug for frequent heartburn pain, has created an important new brand. Novartis will launch an OTC version of pantoprazole, another proton pump inhibitor, in 14 European countries in the second quarter of 2010 after gaining rights from Nycomed.

 

The addition of Alcon, the global leader in eye care, will strengthen the Novartis healthcare portfolio and provide a greater presence in the fast-growing global eye care sector. Novartis announced on January 4 its intention to gain full ownership of Alcon by first completing the April 2008 agreement with Nestlé S.A. to acquire a 77% majority stake and subsequently entering into an all-share direct merger with Alcon for the remaining 23% minority stake. This merger, which will be implemented under the Swiss Merger Act, is in the interest of all stakeholders and will provide the needed clarity on Alcon’s future. Following the merger, Alcon will become a new Novartis division that incorporates CIBA Vision and certain Novartis ophthalmic medicines.

 

Board selects new CEO and simplifies the top leadership organization

The Board has accepted Dr. Daniel Vasella’s proposal to complete the CEO succession process after serving 14 years as CEO and 11 years as Chairman and CEO, by appointing Joe Jimenez, currently Head of the Pharmaceuticals Division as Novartis’ new CEO. Dr. Vasella will continue in his role as Chairman of the Board concentrating on strategic priorities. This completes the succession plan which began in 2008 with the creation of a transitional COO position and the appointment of new divisional management. The business portfolio has been successfully transformed to focus on healthcare, the research organization is highly respected and the pipeline is full and highly valued. Novartis’ reputation is among the best in its industry and beyond, led by a world-class leadership team. So, it is timely to transition to a new CEO.

 

The Board has selected Joe Jimenez with complete trust in his global leadership capabilities, based on his outstanding performance track record, broad international business experience and his ability to provide direction, align and engage people. These skills will be crucial for implementing Novartis’ strategy. Jimenez will take over the CEO responsibilities as of February 1, 2010.

 

David Epstein, currently Head of the Novartis Oncology business, the fastest growing unit in Pharmaceuticals, will become Head of the Pharmaceuticals Division. Jon Symonds will take over as CFO on February 1, 2010, from Raymund Breu, who will retire on March 31, having reached the mandatory retirement age.

 

Simplifying its leadership structure Novartis reduces the size of the Executive Committee from 12 to 9. They will be Joe Jimenez, CEO; Mark Fishman, M.D., Global Head of NIBR (The Novartis Institute for BioMedical Research); David Epstein, Division Head Pharmaceuticals; Jeff George, Division Head Generics; George Gunn, Division Head Consumer Health: Andrin Oswald, M.D., Division Head Vaccines and Diagnostics; Jon Symonds, CFO; Thomas Werlen, General Counsel; and Jürgen Brokatzky-Geiger, Global Head Human Resources.

 

Furthering the delayering efforts, three executive positions have been eliminated: COO, Head Corporate Affairs, and Head Group Quality/Technical Operations.

 

5



 

Two smaller units, Group Quality Assurance, headed by Juan Andres and Group Country Management/External Affairs, led by Joe Jimenez ad interim, report to the CEO. Corporate Audit and Compliance reports to the Chairman.

 

In the context of this new organizational structure Joerg Reinhardt, Andreas Rummelt and Thomas Wellauer have decided to pursue their careers outside of Novartis. We are thankful to each of them for their many contributions over the many years to the success of Novartis. All changes will be effective February 1, 2010.

 

 

6



 

AGM proposals for dividend rise and consultative vote on Compensation System to further strengthen governance in the wake of the global financial crisis, and against the mandatory separation of the responsibilities of Chairman and CEO

The Board proposes a dividend payment of CHF 2.10 per share for 2009, up 5% from CHF 2.00 per share for 2008 and representing the 13th consecutive dividend increase since the creation of Novartis in December 1996. The average annual dividend increased by 11.7% in CHF, while the annual total shareholder return since 1996 increased by 9%. Dividends paid for 2009 on outstanding shares will amount to USD 4.6 billion and the payout ratio is estimated at 55% of net income. Based on the year-end 2009 share price of CHF 56.50, the dividend yield is 3.7%. The payment date is March 5, 2010. All issued shares are dividend bearing, except 167.7 million treasury shares.

 

The Board further proposes that Novartis become the first large, listed Swiss company to include a consultative vote on its Compensation System in its Articles of Incorporation. Such a vote is to be held before every significant change in the Compensation System, but at least at every third Annual General Meeting (AGM). The three-year cycle for votes also allows shareholders to take a longer-term view when examining the sustainability of the Compensation System. Sustainable compensation systems are harmonized with multi-year business plans, and only attain their full effect when used unchanged for several years, in part since it takes time for them to be understood by employees. This proposal, if approved by shareholders, would be implemented following the upcoming AGM. The proposal complements the corporate governance initiatives that Novartis has instituted over the past year. In 2009 a new Risk Committee of the Board was established that oversees enterprise risk management processes for the Group while monitoring risk-adjusted decision-making. In addition, a “clawback provision” for incentive payments will be progressively included in employee contracts. This will allow Novartis to retract any unjustified payment to an employee if later it is found to be based on financial misstatements or unethical business behavior. This will further enhance Novartis’ governance in the wake of the global financial crisis, which revealed among some companies a lack of standards and oversight which eventually contributed to the worldwide recession.

 

The Board recommends to shareholders to vote against the proposal by a shareholder group to introduce a yearly separate consultative vote on the Compensation Report, stating that such a vote is retrospective as it relates only to the previous business year. This vote would not allow a true consultation since shareholders would only express their views on matters that had already occurred. Shareholders also do not have the essential basis for an informed opinion on compensation awarded, as this implies knowledge of the pre-agreed objectives and the degree to which these objectives have been met. For competitive reasons it would be against the interest of the corporation to disclose yearly and long-term objectives and individual performance assessments. Setting the compensation of executives is an essential management instrument of the Board that may not be rescinded. Swiss company law mandates that this duty must be allocated to the Board.

 

The Board also recommends to shareholders to vote against a mandatory separation of the Chairman of the Board and CEO functions, regarding such a rule as too rigid and not in the best interests of shareholders, as it would restrict freedom and prevent the flexible adaptation of the Group’s leadership structure to circumstances and strategic requirements. Novartis has long complied with international best practice based on the Board’s decision to combine the roles of Chairman and CEO with the appointments of a Lead Director and only Independent Directors for the most important Board Committees.

 

Finally, the Board proposes the re-election of Dr. Daniel Vasella and Marjorie M.T. Yang, each for a three-year term, and Hans-Joerg Rudloff for a one-year term (as he will reach the age limit).

 

Shareholders will vote on these and other proposals at the next Annual General Meeting scheduled for February 26, 2010.

 

7



 

BUSINESS REVIEW

 

Full year

 

Net sales

 

 

 

2009

 

2008

 

% change

 

 

 

USD m

 

USD m

 

USD

 

lc

 

Pharmaceuticals

 

28 538

 

26 331

 

8

 

12

 

Vaccines and Diagnostics

 

2 424

 

1 759

 

38

 

39

 

Sandoz

 

7 493

 

7 557

 

–1

 

5

 

Consumer Health

 

5 812

 

5 812

 

0

 

5

 

Net sales

 

44 267

 

41 459

 

7

 

11

 

 

Pharmaceuticals: USD 28.5 billion (+8%, +12% lc)

All geographic regions and therapeutic areas contributed to the double-digit expansion in local currencies, driven by recently launched products (USD 4.7 billion, +81% lc) that increased their share of net sales to 16% in 2009 from 10% in 2008. This group of rapidly growing products — including Lucentis, Exforge, Exjade, Exelon Patch, Reclast/Aclasta, Tekturna/Rasilez, Afinitor and Ilaris — provided eight percentage points of the division’s 12% lc net sales growth in 2009.

 

Oncology (USD 9.0 billion, +14% lc) remained the largest franchise and ranks No. 2 in the global oncology segment, led by sustained growth of Gleevec/Glivec (USD 3.9 billion, +12% lc) and three additional products — Zometa, Femara and Sandostatin — that each achieved more than USD 1 billion of sales. Exforge and Tekturna/Rasilez (high blood pressure) and Galvus (type 2 diabetes) drove expansion of Cardiovascular and Metabolism (USD 8.8 billion, +9% lc), complementing Diovan (USD 6.0 billion, +6% lc) as Novartis expanded its position as the global leader in hypertension. Lucentis (USD 1.2 billion, +47% lc) and Exelon (USD 954 million, +22% lc) fueled growth in Neuroscience and Ophthalmics (USD 4.9 billion, +12% lc).

 

All regions benefited from the product portfolio transformation, particularly Europe (USD 10.5 billion, +12% lc) as the largest region and generating more than 20% of sales from recently launched products. Also delivering top performances were Latin America and Canada (USD 2.5 billion, +13% lc), while the US (USD 9.5 billion, +11% lc) and Japan (USD 3.1 billion, +9% lc) both showed renewed growth. All six top emerging markets (USD 2.6 billion, +19% lc) — Brazil, China, India, Russia, South Korea and Turkey — advanced at robust double-digit rates.

 

Vaccines and Diagnostics: USD 2.4 billion (+38%, +39% lc)

A rapid response after the outbreak of the A (H1N1) pandemic in April 2009 enabled Vaccines and Diagnostics to deliver more than 100 million vaccine doses to governments around the world in only a few months, providing USD 1.0 billion of net sales from pandemic vaccines and adjuvants in 2009. Pediatric vaccines and strong growth in emerging markets helped offset price pressure on seasonal influenza vaccines and a decline in tick-borne encephalitis vaccines in Europe. Diagnostics sales were slightly lower.

 

Sandoz: USD 7.5 billion (—1%, +5% lc)

Consistent growth in 2009 at a stronger pace than in 2008 reflected the impact of new product launches, a sharper commercial focus in both mature and emerging markets, and the US returning to growth. To the benefit of customers, a price decline of seven percentage points from price erosion was more than offset by volume growth of 11 percentage points from new product launches. Retail generics and biosimilars in Germany (+4% lc) reached a leading 29% share from new product launches and volume growth in a challenging market. A total of 25 new product launches, eight more than 2008, underpinned US retail generics and biosimilars (+5%). Asia-Pacific (+17% lc) and Russia (+19% lc) were also among top performers. The EBEWE acquisition in September, which added one

 

8



 

percentage point to sales growth in 2009, provided a strong platform for growth in injectable oncology medicines.

 

Consumer Health: USD 5.8 billion (+0%, +5% lc)

All businesses achieved faster underlying growth than their respective markets despite the difficult economic conditions. CIBA Vision was the industry’s fastest-growing contact lens and lens care company on the strength of new product introductions. OTC delivered an increasingly positive performance, driven by portfolio innovation and the successful US launch of Prevacid24HR in November 2009. Animal Health grew ahead of the competition in the US.

 

Core operating income

 

 

 

2009

 

2008

 

 

 

 

 

USD m

 

% of
net
sales

 

USD m

 

% of
net
sales

 

Change
%

 

Pharmaceuticals

 

9 068

 

31.8

 

8 249

 

31.5

 

10

 

Vaccines and Diagnostics

 

719

 

29.7

 

309

 

18.1

 

133

 

Sandoz

 

1 395

 

18.6

 

1 421

 

18.8

 

–2

 

Consumer Health

 

1 118

 

19.2

 

1 125

 

19.4

 

–1

 

Corporate income and expenses, net

 

–863

 

 

 

–785

 

 

 

 

 

Core operating income

 

11 437

 

25.8

 

10 319

 

25.0

 

11

 

 

Pharmaceuticals

Operating income rose 11% to USD 8.4 billion and the operating income margin was 29.4% of net sales, up from 28.8% in 2008. Core operating income (USD 9.1 billion, +10%, including adverse currency impact of six percentage points) also grew well ahead of net sales on the strong volume expansion in local currencies and productivity gains of nearly USD 1 billion, which resulted in the core operating income margin rising 0.3 percentage points to 31.8% of net sales.

 

The improved core operating income performance also absorbed a dilution of 1.1 percentage points in lower Other Revenues, mainly due to the end of Betaseron® royalties in late 2008. The operational expansion, along with reinvestments of some productivity gains, enabled major investments in new product launches and rapid expansion of top emerging markets such as China. Marketing & Sales expenses fell 1.6 percentage points to 29.3% of net sales in 2009 as productivity improvements more than offset costs for the ongoing worldwide launches of many new products including Galvus, Exelon Patch, Valturna and the Tekturna/Rasilez portfolio. R&D investments supported the start of 14 new Phase III trials in 2009, with R&D representing 20.0% of net sales in 2009 compared to 20.3% in 2008. Among items excluded from core operating income in 2009 that totaled USD 676 million, which was largely unchanged from USD 670 million in 2008, were a USD 318 million increase in legal provisions as part of pending settlements to resolve US federal investigations into past marketing practices of Trileptal. Also in 2009, the ongoing strong sales performance of Famvir outside the US enabled the partial reversal of an impairment charge taken in 2007, providing a one-time gain of USD 100 million.

 

Vaccines and Diagnostics

Operating income of USD 372 million rose sharply from USD 78 million in 2008, with the operating income margin rising to 15.3% from 4.4% in 2008. Core operating income of USD 719 million in 2009 included substantial contributions from A (H1N1) pandemic flu vaccine sales enabled by significant development and manufacturing investments earlier in the year. Clinical trials for the pandemic vaccines and investments in the late-stage meningitis development vaccines led to R&D costs still rising as a percentage of net sales in 2009 compared to 2008. Results in 2008 included sales from major deliveries of A (H5N1) pandemic flu vaccines.

 

9



 

Sandoz

Operating income declined 1% to USD 1.1 billion, which included an adverse currency impact of 11 percentage points, with the operating income margin unchanged at 14.3% of net sales. Core operating income fell 2% to USD 1.4 billion. Improved business conditions in key markets and productivity gains, particularly in Marketing & Sales and R&D, reduced the total cost base while supporting investments in emerging markets and new products. However, the underlying improvements were more than offset by significant price erosion and the adverse currency impact, resulting in the core operating income margin falling 0.2 percentage points to 18.6% of net sales.

 

Consumer Health

Operating income fell 3% to USD 1.0 billion, which included an adverse currency impact of 10 percentage points, and the operating income margin in 2009 fell 0.5 percentage points to 17.5% of net sales. Core operating income benefited from the strong underlying business expansion and productivity gains. However, it declined 1% to USD 1.1 billion due to the adverse currency impact and major investments to launch the OTC product Prevacid24HR in the US, which resulted in the core operating income margin declining slightly to 19.2% of net sales in 2009 from 19.4% in 2008.

 

Corporate Income & Expense, net

Corporate income and expense, net, as well as related core measures, increased mainly due to higher pension expenses.

 

Fourth quarter

 

Net sales

 

 

 

Q4 2009

 

Q4 2008

 

% change

 

 

 

USD m

 

USD m

 

USD

 

lc

 

Pharmaceuticals

 

7 773

 

6 430

 

21

 

13

 

Vaccines and Diagnostics

 

1 387

 

491

 

182

 

166

 

Sandoz

 

2 143

 

1 804

 

19

 

10

 

Consumer Health

 

1 623

 

1 352

 

20

 

13

 

Net sales

 

12 926

 

10 077

 

28

 

20

 

 

Pharmaceuticals: USD 7.8 billion (+21%, +13% lc)

Sustained dynamic growth in the 2009 fourth quarter driven by rapid uptake of new products and ongoing expansion in all major markets. Recently launched products provided USD 1.4 billion of net sales in the 2009 quarter, rising to 18% of the division’s net sales from 12% in the 2008 quarter. These products also provided eight percentage points of the 13% lc net sales growth in the quarter. Among new product launches initiated in the 2009 quarter were Onbrez Breezhaler (COPD) in Germany following European regulatory approval in November.

 

Recently launched products provided important contributions in Oncology (USD 2.5 billion, +14% lc), which benefited from the new anti-cancer medicine Afinitor (USD 32 million) approved in 2009 and new clinical data supporting Tasigna (USD 68 million, +101% lc). Cardiovascular and Metabolism (USD 2.4 billion, +10% lc) benefited from rapid expansion of the diabetes medicine Galvus (USD 66 million, +211% lc), while Novartis expanded its share of the global branded anti-hypertension market on gains recorded for Diovan in all key markets as well as the rollout of new single-pill combination therapies involving Tekturna/Rasilez and Exforge. The ophthalmics medicine Lucentis (USD 374 million, +44% lc) also continued to show strong gains.

 

Europe (USD 2.9 billion, +14% lc) solidified its position as the largest region. Gains were also seen in the US (USD 2.5 billion, +12% lc), while Japan (USD 889 million, +9% lc) continued to benefit from new launches in 2009. The six top emerging markets (USD 712 million, +22% lc) advanced at a rapid pace, led by gains in China, Russia and India that more than offset recent governmental cost-

 

10



 

containment measures in Turkey.

 

Vaccines and Diagnostics: USD 1.4 billion (+182%, +166% lc)

USD 1.0 billion of net sales in the 2009 period came from deliveries of A (H1N1) pandemic flu vaccines and adjuvants. Seasonal flu vaccines were adversely impacted by a price decline, while pediatric vaccines helped offset lower sales of tick-borne encephalitis vaccines.

 

Sandoz: USD 2.1 billion (+19%, +10% lc)

Solid growth in key markets was in line with the consistent pace throughout 2009, with completion of the EBEWE Pharma acquisition in September adding five percentage points of growth in the 2009 quarter. US retail generics and biosimilars (+24%) achieved a third consecutive quarter of growth in 2009 with more new product launches than 2008. German retail generics and biosimilars (+1% lc) extended its lead in a deteriorating environment. Key emerging markets kept up their expansion, particularly in Asia-Pacific (+10% lc).

 

Consumer Health: USD 1.6 billion (+20%, +13% lc)

Very strong growth across all businesses was led by OTC expansion at a double-digit rate in local currencies on the strength of the US launch of Prevacid24HR in November and strong demand for “cough & cold” products. Continued momentum of new contact lens products supported CIBA Vision, while Animal Health advanced on market share gains in the US.

 

Core operating income

 

 

 

Q4 2009

 

Q4 2008

 

 

 

 

 

USD m

 

% of
net
sales

 

USD m

 

% of
net
sales

 

Change
%

 

Pharmaceuticals

 

2 215

 

28.5

 

1 803

 

28.0

 

23

 

Vaccines and Diagnostics

 

653

 

47.1

 

55

 

12.5

 

NM

 

Sandoz

 

356

 

16.6

 

296

 

16.4

 

20

 

Consumer Health

 

248

 

15.3

 

209

 

15.5

 

19

 

Corporate income and expenses, net

 

–268

 

 

 

–273

 

 

 

 

 

Core operating income

 

3 204

 

24.8

 

2 090

 

20.8

 

53

 

 

Pharmaceuticals

Operating income rose 22% to USD 1.9 billion, and the operating income margin improved 0.2 percentage points to 24.5% of net sales. Core operating income advanced 23%, well ahead of sales and included four percentage points of positive currency impact.

 

The strong business expansion, with net sales rising 13% lc, and benefits of productivity initiatives resulted in double-digit core operating income gains after investments in product launches, key development projects and geographic expansion. Marketing & Sales expenses were 30.3% of net sales, declining three percentage points from the 2008 period. R&D investments also benefited from productivity efforts, but remained largely steady at 21.0% of net sales amid investments in oncology, biologics and molecular diagnostics. As a result, the core operating income margin rose 0.5 percentage points to 28.5% of net sales. Cost of Goods Sold were 18.1% of net sales, an increase of 2.7 percentage points, reflecting higher Lucentis royalties and the short-term impact of an accelerated inventory reduction program in the quarter. Among exceptional items excluded in core operating income for 2009 that totaled USD 309 million were a USD 318 million increase in legal provisions as part of pending settlements to resolve US federal investigations into past marketing practices of Trileptal as well as a one-time gain of USD 100 million from the partial reversal of an impairment charge in 2007 for Famvir due to ongoing strong sales growth outside the US in the meantime. Core adjustments in 2008 excluded total exceptional items of USD 241 million.

 

11



 

Vaccines and Diagnostics

Operating income rose to USD 583 million from USD 26 million in the 2008 period, while core operating income of USD 653 million in the 2009 quarter reflected the recognition of exceptional contributions from sales of A (H1N1) pandemic flu vaccines during the period that were made possible by significant investments in development and manufacturing earlier in the year.

 

Sandoz

Operating income grew 11% to USD 221 million, which was reduced by seven percentage points of adverse currency impact. Core operating income improved on strong economies of scale and high growth in the US, advancing 20% to USD 356 million. As a result, the core operating income margin improved 0.2 percentage points to 16.6% of net sales. Core results excluded higher acquisition-related charges and exceptional items totaling USD 135 million in 2009 (including EBEWE acquisition costs and restructuring in Germany) compared to USD 96 million in 2008.

 

Consumer Health

Operating income was up 9% to USD 207 million in the 2009 quarter, which included nine percentage points of positive currency impact. However, the operating income margin declined 1.3 percentage points to 12.8% of net sales. Core operating income, which excluded higher impairment and other exceptional charges of USD 22 million in 2009 over the 2008 period, grew 19% to USD 248 million as productivity gains and cost controls helped free up resources for increased Marketing & Sales investments for the launch of Prevacid24HR in the US and R&D projects. As a result, the core operating income margin declined only 0.2 percentage points to 15.3% of net sales.

 

Corporate Income & Expense, net

Net corporate expenses in the fourth quarter of 2009 were slightly lower than in the 2008 period, as positive currency exchange movements and a gain on the sale of financial assets more than offset higher pension costs.

 

12



 

FINANCIAL REVIEW

 

Full year and fourth quarter

 

 

 

2009

 

2008

 

Change

 

Q4 2009

 

Q4 2008

 

Change

 

 

 

USD m

 

USD m

 

%

 

USD m

 

USD m

 

%

 

Core operating income

 

11 437

 

10 319

 

11

 

3 204

 

2 090

 

53

 

Income from associated companies

 

1 051

 

839

 

25

 

252

 

266

 

–5

 

Financial income

 

198

 

384

 

–48

 

104

 

58

 

79

 

Interest expense

 

–551

 

–290

 

90

 

–156

 

–76

 

105

 

Taxes

 

–1 868

 

–1 751

 

7

 

–512

 

–371

 

38

 

Core net income

 

10 267

 

9 501

 

8

 

2 892

 

1 967

 

47

 

Core basic EPS (USD)

 

4.50

 

4.18

 

8

 

1.26

 

0.86

 

47

 

 

Income from associated companies

For the fourth quarter of 2009, income from associated companies rose 10% to USD 107 million, but fell 34% to USD 293 million for the full year, mainly due to USD 189 million of exceptional charges in the third quarter of 2009 related to Roche’s restructuring of Genentech and Alcon’s decision to stop a development project. Core results in the fourth quarter declined 5% to USD 252 million due to losses from Idenix after it became an associated company when the Group’s shareholding fell below 50% in late 2009. Full-year core income from associated companies rose 25% to USD 1.1 billion on increased underlying contributions from Roche as well as full-year equity accounting of the 25% Alcon stake after the mid-2008 purchase.

 

Financial income and interest expense

Financial income rose 79% to USD 104 million in the fourth quarter of 2009, primarily from realized gains and lower impairment charges for marketable securities as well as average liquidity of USD 15.7 billion compared to USD 7.2 billion in the 2008 quarter. Interest expense more than doubled in the 2009 quarter to USD 156 million following the issuance of US dollar and euro bonds in the first half of the year. Reflecting these same factors for the full year, financial income declined 48% to USD 198 million, while interest expenses rose 90% to USD 551 million.

 

Taxes

The tax rate (taxes as a percentage of pre-tax income) in the fourth quarter of 2009 was 13.7% compared to 14.3% in the prior-year quarter, while the full-year tax rate rose to 14.8% from 14.1%. For core results, the tax rate in the fourth quarter of 2009 declined to 15.0% from 15.9% in the 2008 period. The core tax rate in 2009 was 15.4%, down from 15.6% in 2008.

 

Net income

In the fourth quarter of 2009, net income rose 54% to USD 2.3 billion, while net income for the full year rose 4% to USD 8.5 billion. Core net income advanced 47% to USD 2.9 billion in the fourth quarter of 2009. For the full year, core net income rose 8% to USD 10.3 billion.

 

Earnings per share

Basic earnings per share (EPS) in the fourth quarter were up 53% to USD 1.01 from USD 0.66 in the 2008 quarter, while full-year basic EPS rose 3% to USD 3.70 compared to USD 3.59 in 2008, at a slightly slower pace than net income in 2009 due to higher net income attributable to minority interests. For quarterly core results, basic EPS rose in line with core net income in the 2009 quarter, up 47% to USD 1.26 from USD 0.86 in the 2008 period, while full-year basic EPS grew 8% to USD 4.50 from USD 4.18 in 2008.

 

13



 

Balance sheet

The acquisition of EBEWE Pharma’s specialty generics business and USD 7.1 billion of investments in marketable securities with proceeds from bond issues in 2009 led to an increase in total assets, which rose to USD 95.6 billion in 2009 from USD 78.3 billion in 2008.

 

The Group’s equity rose to USD 57.5 billion at December 31, 2009, from USD 50.4 billion at the start of the year. The increase resulted mostly from USD 8.5 billion in net income in 2009, actuarial gains of USD 0.9 billion and currency translation gains of USD 0.8 billion. Other equity movements provided a net increase of USD 0.8 billion, mainly from share-based compensation of USD 0.6 billion. These contributions more than offset the dividend payment of USD 3.9 billion in the 2009 first quarter.

 

The Group’s debt/equity ratio rose to 0.24:1 at the end of 2009 compared to 0.15:1 at the end of 2008, reflecting issuance of a USD 5 billion bond (two tranches) in the US in the first quarter and a EUR 1.5 billion bond (USD 2.1 billion) in the second quarter. At the end of 2009, the Group’s financial debt of USD 14.0 billion consisted of USD 5.3 billion in current and USD 8.7 billion in non-current liabilities.

 

Overall liquidity rose to USD 17.4 billion at December 31, 2009, more than double the year-end 2008 level of USD 6.1 billion, underpinned by increasing cash flow from operations and proceeds from the bond issues. Novartis returned to a net liquidity position at the end of 2009, which stood at USD 3.5 billion compared to net debt (financial debt net of liquidity) of USD 1.2 billion at the end of 2008.

 

Credit agencies maintained their ratings of Novartis debt during 2009. Moody’s rated the Group as Aa2 for long-term maturities and P-1 for short-term maturities, and Standard & Poor’s had ratings of AA- for long-term and A-1+ for short-term maturities. Fitch had a long-term rating of AA and a short-term rating of F1+.

 

Cash flow

Cash flow from operating activities improved 25% in 2009 to USD 12.2 billion based on higher profitability and initiatives to reduce working capital requirements, which fell USD 1.3 billion from 2008 levels.

 

Cash outflows from investing activities amounted to USD 14.2 billion in 2009 compared to USD 10.4 billion in 2008, as lower capital expenditures of USD 1.9 billion (which declined to 4.3% of net sales in 2009 compared to 5.1% in 2008) was more than offset by investments in marketable securities and increased investments totaling USD 12.3 billion in intangible, non-current and financial assets, including the EBEWE Pharma generics acquisition.

 

Cash inflows from financing activities were a net USD 2.8 billion in 2009, as proceeds of USD 7.1 billion from the bond issues were partially offset by the dividend payment of USD 3.9 billion for 2008 and other items totaling USD 0.4 billion.

 

Free cash flow before dividends rose 24% to USD 9.4 billion in 2009, reflecting the strong focus on business performance and control of fixed and working capital.

 

14



 

PHARMACEUTICALS PRODUCT REVIEW

 

Note: Net sales growth data refer to full-year 2009 performance in local currencies.

 

Cardiovascular and Metabolism

 

Diovan (USD 6.0 billion, +6% lc) achieved solid worldwide growth based on its status as the only medicine in the angiotensin receptor blocker (ARB) class approved for all three indications to treat high blood pressure, high-risk heart attack survivors and heart failure. Japan now accounts for 20% of annual sales, while growth was seen in Europe, where the expected entry of generic versions of losartan, another medicine in the ARB segment, was delayed until the first half of 2010. In the US (+4%), Diovan increased its leadership of the ARB segment despite the overall shrinking of the branded anti-hypertension market due to increasing use of generic medicines in other anti-hypertensive classes.

 

Exforge (USD 671 million, +72% lc), a single-pill combination of the angiotensin receptor blocker Diovan (valsartan) and the calcium channel blocker amlodipine, has delivered above-market growth and set new standards for high blood pressure combination therapies since its launch in 2007. Exforge HCT, which adds a diuretic, was launched in the US in April 2009 as a single-pill therapy with three medicines. Exforge received approval in Japan in January 2010.

 

Tekturna/Rasilez (USD 290 million, +104% lc), the first in a new class of medicines known as direct renin inhibitors to treat high blood pressure, has been growing consistently since its launch in 2007 based on positive clinical data demonstrating its prolonged efficacy in lowering blood pressure for more than 24 hours and superiority in clinical trials over ramipril, a leading ACE inhibitor. Valturna — a single-pill combination with Diovan (valsartan) — was launched in the US in late 2009, joining the group of single-pill combinations that involve aliskiren, the active ingredient in Tekturna/Rasilez. A single-pill combination of aliskiren and amlodipine was submitted for US and European approvals in 2009, and a triple-combination with amlodipine and a diuretic is expected to be submitted in 2010.

 

Galvus/Eucreas (USD 181 million, +327% lc), oral treatments for type 2 diabetes, have achieved rapid success in many European, Latin American and Asia-Pacific markets since first launched in 2007. Galvus and Eucreas, a single-pill combination of Galvus with metformin that accounts for the majority of sales, have outperformed a competitor medicine in the DPP-4 segment in some countries. Galvus was approved in Japan in January 2010 with the brand name Equa.

 

Oncology

 

Gleevec/Glivec (USD 3.9 billion, +12% lc), a targeted therapy for some forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), achieved sustained double-digit growth based on its leadership position in treating these cancers backed by new clinical data and regulatory approvals. The latest approval in 2009 was for use in adjuvant (post-surgery) GIST patients, which is now approved in more than 55 countries in North America, Europe and Asia-Pacific.

 

Tasigna (USD 212 million, +145% lc), a second-line therapy for patients with a form of chronic myeloid leukemia (CML) resistant or intolerant to prior therapy, including Gleevec/Glivec, has gained rapid acceptance following its approval in more than 80 countries. In December 2009, Tasigna was submitted for US and European regulatory approvals for first-line use in CML after new data from the global ENESTnd trial, the largest head-to-head comparison of a targeted therapy against Glivec ever conducted, showed Tasigna produced faster and deeper responses than Glivec in newly diagnosed CML patients. Trials are underway examining the use of Tasigna in CML with suboptimal response to Glivec, as well as a Phase III trial in patients with GIST.

 

Zometa (USD 1.5 billion, +9% lc), an intravenous bisphosphonate therapy for patients with certain types of cancer that has spread to bones, is growing due to improved compliance and use in existing indications. US and European regulatory submissions were completed in late 2009 for the use of Zometa in adjuvant breast cancer in premenopausal women based on published anticancer data for this indication. Studies are underway to review potential benefits in other tumor types.

 

Femara (USD 1.3 billion, +16% lc), an oral therapy for postmenopausal women with hormone-sensitive breast cancer, saw strong sales growth in 2009 due to growth in the initial adjuvant (post-

 

15



 

surgery) setting. In August 2009, “The New England Journal of Medicine” published results from the landmark BIG 1-98 study affirming that the five-year upfront use of Femara after surgery was an optimal treatment approach for postmenopausal women with early-stage, hormone-receptor positive breast cancer. These data were submitted in the US and Europe for inclusion in product information.

 

Sandostatin (USD 1.2 billion, +7% lc), for patients with acromegaly and symptoms associated with neuroendocrine tumors of the gastrointestinal tract and pancreas, has grown from increasing use of Sandostatin LAR, the once-monthly version that accounts for nearly 90% of net sales. Recent clinical trial data demonstrated a significant delay in tumor progression in patients with metastatic neuroendocrine tumors of the midgut treated with Sandostatin LAR. These data formed the basis of a recent US National Comprehensive Cancer Network (NCCN) update on treatment guidelines for neuroendocrine tumors.

 

Exjade (USD 652 million, +27% lc), currently approved in more than 90 countries as the only once-daily oral therapy for transfusional iron overload, received regulatory approvals in 2009 in the US, Europe, Switzerland and other countries to extend the dose range to 40 mg/kg. This new dosing range provides a new option to patients who require dose intensification due to high iron burdens. Novartis submitted new safety information to health authorities worldwide in mid-2009. The new labeling was approved in Europe in November, providing new guidance on the selection of appropriate myelodysplastic syndrome (MDS) and malignant disease patients for Exjade therapy. US and Japanese regulatory authorities are also reviewing this data.

 

Afinitor (USD 70 million), an oral inhibitor of the mTOR pathway, was launched in the US, Europe and Switzerland after gaining regulatory approvals in 2009 as a treatment for advanced renal cell carcinoma (RCC, kidney cancer) following VEGF-targeted therapy. Afinitor is being studied in many cancer types. Phase III studies are underway in patients with neuroendocrine tumors (NET), breast cancer, lymphoma, tuberous sclerosis complex (TSC) and gastric cancer. Two potential regulatory submissions are planned for 2010 based on the outcome of clinical trials of this medicine in patients with neuroendocrine tumors (NET) as well as tuberous sclerosis complex (TSC). A late-stage trial is planned to start in patients with hepatocellular carcinoma (HCC) in early 2010. The active ingredient, everolimus, is the same as in the transplant therapy Certican.

 

Other Pharmaceuticals products

 

Lucentis (USD 1.2 billion, +47% lc), a biotechnology eye therapy now approved in more than 80 countries, delivered sustained growth on top performances in France, the United Kingdom, Australia and Japan. Lucentis is the only treatment proven to maintain and improve vision in patients with “wet” age-related macular degeneration, a leading cause of blindness in people over age 50. Lucentis was submitted in December 2009 for European regulatory approval for treatment of visual impairment due to diabetic macular edema (DME), an eye condition related to longstanding diabetes that may lead to blindness. Late-stage clinical trials are underway in other eye conditions. Genentech holds the US rights to this medicine.

 

Exelon/Exelon Patch (USD 954 million, +22% lc), a therapy for mild to moderate forms of Alzheimer’s disease dementia as well as dementia linked with Parkinson’s disease, achieved more than half of its sales from Exelon Patch, the novel skin patch launched in late 2007 that is now available in more than 60 countries worldwide.

 

Reclast/Aclasta (USD 472 million, +88% lc), a once-yearly infusion therapy for osteoporosis, continues to expand on increasing patient access to infusion centers and a broad range of use in patients with various types of this debilitating bone disease. Approvals have been received for up to six indications, including the treatment of osteoporosis in men and postmenopausal women.

 

Xolair (USD 338 million, +65% lc, Novartis sales), a biotechnology drug for moderate to severe persistent allergic asthma in the US and severe persistent allergic asthma in Europe, maintained solid growth due to its global presence and approvals in more than 80 countries, including Japan since early 2009. In August 2009, Xolair received European regulatory approval to treat children age six and older. Novartis co-promotes Xolair with Genentech in the US and shares a portion of operating income. In 2009, Genentech’s US sales were USD 571 million.

 

Certican (USD 118 million, +31% lc), a transplantation medicine, generated solid growth based on its availability in more than 70 countries. In the US, the FDA issued a Complete Response letter in

 

16



 

December 2009 for this medicine (under the brand name Zortress) for prevention of organ rejection in adult kidney transplant patients. The FDA discussions focus on product labeling and Risk Evaluation Mitigation Strategy (REMS) as well as a safety update, but no request for more clinical studies. This medicine, which has the same active ingredient as Afinitor (everolimus), has been shown to have good immunosuppressive efficacy and a manageable side-effect profile.

 

Extavia (USD 49 million), for relapsing forms of multiple sclerosis (MS), was launched in 2009 in the US and more than 20 other countries, marking the entry of Novartis into the field of MS. Extavia is the Novartis-branded version of Betaferon®/Betaseron®.

 

Ilaris, a fully human monoclonal antibody that blocks action of the inflammatory protein interleukin-1 beta, has been launched after receiving first approvals during 2009 in the US, Europe and some other markets for treatment of cryopyrin-associated periodic syndrome (CAPS), a group of rare lifelong auto-inflammatory disorders. Trials are ongoing in other diseases in which IL-1 beta is believed to play an important role. Other diseases include refractory gout, chronic obstructive pulmonary disease (COPD), type 2 diabetes and systemic juvenile idiopathic arthritis (SJIA).

 

R&D UPDATE

 

Novartis has one of the industry’s most competitive pipelines with 145 projects in pharmaceutical clinical development, of which 60 involve new molecular entities.

 

Pharmaceuticals

 

AIN457, a fully human monoclonal antibody that blocks action of interleukin-17A — a major trigger of inflammation involved in a variety of diseases such as uveitis, psoriasis and rheumatoid arthritis — has begun Phase III studies in November 2009 for use in treating a form of uveitis, an inflammation in the eye, with regulatory submissions possible in 2010.

 

Gilenia (FTY720, fingolimod), a once-daily oral compound in development for certain forms of multiple sclerosis, was submitted in December 2009 for US and European regulatory approvals. The clinical program provides safety experience in more than 2,300 MS patients, including some patients in their sixth year of therapy.

 

QAB149 (indacaterol), a once-daily long-acting bronchodilator for adult patients with chronic obstructive pulmonary disease (COPD), gained European regulatory approval in November 2009 as Onbrez Breezhaler and was launched in Germany in December. Onbrez Breezhaler has demonstrated greater improvements in lung function, breathlessness and quality of life compared to current therapies and is the first new inhaled compound in Europe for treatment of COPD in more than seven years. In the US, Novartis received a Complete Response letter from the FDA in October requesting additional information on the dosing proposed for QAB149. Novartis is working with the FDA to determine what clinical trials will be required.

 

Vaccines and Diagnostics

 

Menveo, a novel vaccine in development to protect against the four common A, C, W-135 and Y serogroups of meningococcal meningitis, is awaiting European regulatory approval in early 2010 after a positive opinion in December 2009 for initial use in adolescents (from age 11) and adults. A US regulatory decision is also expected in the first half of 2010. Trials are underway in other age groups.

 

MenB, in development as a vaccine to protect against the B serogroup of meningococcal meningitis, is in Phase III studies in Europe, where patient enrollment has been completed and a regulatory submission remains on track for 2010. The B serogroup is estimated to cause about 70% of meningococcal disease in Europe, with infants and toddlers most at risk. MenB has shown potential to

 

17



 

be the first to protect infants as young as six months based on Phase II trial results. In the US, discussions with the FDA are planned for 2010 to determine the scope of Phase III trials.

 

Disclaimer

These materials contain certain forward-looking statements relating to the Group’s business, which can be identified by terminology such as “strategic,” “proposes,” “to introduce,” “will,” “planned,” “expected,” “commitment,” “expects,” “set,” “preparing,” “plans,” “estimates,” “aims,” “would,” “potential,” “awaiting,” “estimated,” “proposal,” 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 regarding the potential acquisition and merger with Alcon; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for 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. Neither can there be any guarantee that the proposed acquisition and merger with Alcon will be completed in the expected form or within the expected time frame or at all. Nor can there be any guarantee that Novartis will be able to realize any of the potential synergies, strategic benefits or opportunities as a result of the proposed acquisition. In particular, management’s expectations could be affected by, among other things, 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; uncertainties regarding actual or potential legal proceedings, including, among others, product liability litigation, litigation regarding sales and marketing practices, government investigations and intellectual property disputes; competition in general; government, industry, and general public pricing and other political pressures; uncertainties regarding the after-effects of the recent global financial and economic crisis; uncertainties regarding future global exchange rates and uncertainties regarding future demand for our products; uncertainties involved in the development of new pharmaceutical products; the impact that the foregoing factors could have on the values attributed to the Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in 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 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 2009, the Group’s continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

 

18



 

Important dates

February 26, 2010

 

Annual General Meeting

April 20, 2010

 

First quarter 2010 results

July 15, 2010

 

Second quarter and first half 2010 results

October 21, 2010

 

Third quarter and first nine months 2010 results

 

19



 

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS(1)

 

Consolidated income statements

 

Full year (audited)

 

 

 

2009

 

2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Net sales

 

44 267

 

41 459

 

2 808

 

7

 

Other revenues

 

836

 

1 125

 

–289

 

–26

 

Cost of Goods Sold

 

–12 179

 

–11 439

 

–740

 

6

 

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

 

–869

 

–998

 

129

 

–13

 

Gross profit

 

32 924

 

31 145

 

1 779

 

6

 

Marketing & Sales

 

–12 050

 

–11 852

 

–198

 

2

 

Research & Development

 

–7 469

 

–7 217

 

–252

 

3

 

General & Administration

 

–2 281

 

–2 245

 

–36

 

2

 

Other income

 

782

 

826

 

–44

 

–5

 

Other expense

 

–1 924

 

–1 693

 

–231

 

14

 

Operating income

 

9 982

 

8 964

 

1 018

 

11

 

Income from associated companies

 

293

 

441

 

–148

 

–34

 

Financial income

 

198

 

384

 

–186

 

–48

 

Interest expense

 

–551

 

–290

 

–261

 

90

 

Income before taxes

 

9 922

 

9 499

 

423

 

4

 

Taxes

 

–1 468

 

–1 336

 

–132

 

10

 

Net income from continuing operations

 

8 454

 

8 163

 

291

 

4

 

Net income from discontinued Consumer Health operations

 

 

 

70

 

–70

 

 

 

Group net income

 

8 454

 

8 233

 

221

 

3

 

Attributable to:

 

 

 

 

 

 

 

 

 

Shareholders of Novartis AG

 

8 400

 

8 195

 

205

 

3

 

Non-controlling interests

 

54

 

38

 

16

 

42

 

Average number of shares outstanding – Basic (million)

 

2 267.9

 

2 265.5

 

2.4

 

0

 

Basic earnings per share (USD)(2)

 

 

 

 

 

 

 

 

 

– Continuing operations

 

3.70

 

3.59

 

0.11

 

3

 

– Discontinued operations

 

0.00

 

0.03

 

–0.03

 

 

 

– Total

 

3.70

 

3.62

 

0.08

 

2

 

Average number of shares outstanding – Diluted (million)

 

2 276.6

 

2 284.2

 

–7.6

 

0

 

Diluted earnings per share (USD)(2)

 

 

 

 

 

 

 

 

 

– Continuing operations

 

3.69

 

3.56

 

0.13

 

4

 

– Discontinued operations

 

0.00

 

0.03

 

–0.03

 

 

 

– Total

 

3.69

 

3.59

 

0.10

 

3

 

 


(1)

Full-year financial information in these Condensed Consolidated Financial Statements are derived from the audited Consolidated Financial Statements in the 2009 Annual Report published on January 26, 2010.

 

 

(2)

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

 

20



 

Consolidated income statements

 

Fourth quarter (unaudited)

 

 

 

Q4 2009

 

Q4 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Net sales

 

12 926

 

10 077

 

2 849

 

28

 

Other revenues

 

219

 

271

 

–52

 

–19

 

Cost of Goods Sold

 

–3 667

 

–2 834

 

–833

 

29

 

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

 

–160

 

–228

 

68

 

–30

 

Gross profit

 

9 478

 

7 514

 

1 964

 

26

 

Marketing & Sales

 

–3 476

 

–3 054

 

–422

 

14

 

Research & Development

 

–2 148

 

– 1 834

 

–314

 

17

 

General & Administration

 

–692

 

–629

 

–63

 

10

 

Other income

 

361

 

197

 

164

 

83

 

Other expense

 

–886

 

–514

 

–372

 

72

 

Operating income

 

2 637

 

1 680

 

957

 

57

 

Income from associated companies

 

107

 

97

 

10

 

10

 

Financial income

 

104

 

58

 

46

 

79

 

Interest expense

 

–156

 

–76

 

–80

 

105

 

Income before taxes

 

2 692

 

1 759

 

933

 

53

 

Taxes

 

–369

 

–252

 

–117

 

46

 

Net income from continuing operations

 

2 323

 

1 507

 

816

 

54

 

Net income from discontinued Consumer Health operations

 

 

 

42

 

–42

 

 

 

Group net income

 

2 323

 

1 549

 

774

 

50

 

Attributable to:

 

 

 

 

 

 

 

 

 

Shareholders of Novartis AG

 

2 305

 

1 539

 

766

 

50

 

Non-controlling interests

 

18

 

10

 

8

 

80

 

Average number of shares outstanding – Basic (million)

 

2 272.8

 

2 264.9

 

7.9

 

 

 

Basic earnings per share (USD)(1)

 

 

 

 

 

 

 

 

 

– Continuing operations

 

1.01

 

0.66

 

0.35

 

53

 

– Discontinued operations

 

0.00

 

0.02

 

–0.02

 

 

 

– Total

 

1.01

 

0.68

 

0.33

 

49

 

Average number of shares outstanding – Diluted (million)

 

2 286.7

 

2 282.6

 

4.1

 

 

 

Diluted earnings per share (USD)(1)

 

 

 

 

 

 

 

 

 

– Continuing operations

 

1.01

 

0.66

 

0.35

 

53

 

– Discontinued operations

 

0.00

 

0.01

 

–0.01

 

 

 

– Total

 

1.01

 

0.67

 

0.34

 

51

 

 


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

 

21



 

Consolidated statements of comprehensive income

 

Full year (audited)

 

 

 

2009

 

2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income from continuing operations

 

8 454

 

8 163

 

291

 

Fair value adjustments on financial instruments, net of taxes

 

93

 

–510

 

603

 

Net actuarial gains/losses from defined benefit plans, net of taxes

 

949

 

–2 140

 

3 089

 

Novartis share of equity recognized by associated companies, net of taxes

 

–43

 

–201

 

158

 

Revaluation of initial non-controlling interest in Speedel

 

 

 

38

 

–38

 

Translation effects

 

789

 

–1 122

 

1 911

 

Amounts related to discontinued operations

 

 

 

70

 

–70

 

Comprehensive income

 

10 242

 

4 298

 

5 944

 

Attributable to:

 

 

 

 

 

 

 

Shareholders of Novartis AG

 

10 180

 

4 275

 

5 905

 

Non-controlling interests

 

62

 

23

 

39

 

 

Fourth quarter (unaudited)

 

 

 

Q4 2009

 

Q4 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income from continuing operations

 

2 323

 

1 507

 

816

 

Fair value adjustments on financial instruments, net of taxes

 

–67

 

–212

 

145

 

Net actuarial gains/losses from defined benefit plans, net of taxes

 

1 737

 

–1 192

 

2 929

 

Novartis share of equity recognized by associated companies, net of taxes

 

6

 

–12

 

18

 

Revaluation of initial non-controlling interest in Speedel

 

 

 

2

 

–2

 

Translation effects

 

–110

 

–542

 

432

 

Amounts related to discontinued operations

 

 

 

42

 

–42

 

Comprehensive income

 

3 889

 

–407

 

4 296

 

Attributable to:

 

 

 

 

 

 

 

Shareholders of Novartis AG

 

3 871

 

–413

 

4 284

 

Non-controlling interests

 

18

 

6

 

12

 

 

22


 


 

Condensed consolidated balance sheets (audited)

 

 

 

Dec 31, 2009

 

Dec 31, 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Assets

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

Property, plant & equipment

 

14 075

 

13 100

 

975

 

Goodwill

 

12 039

 

11 285

 

754

 

Intangibles other than goodwill

 

10 331

 

9 534

 

797

 

Financial and other non-current assets

 

25 369

 

23 499

 

1 870

 

Total non-current assets

 

61 814

 

57 418

 

4 396

 

Current assets

 

 

 

 

 

 

 

Inventories

 

5 830

 

5 792

 

38

 

Trade receivables

 

8 310

 

7 026

 

1 284

 

Other current assets

 

2 102

 

1 946

 

156

 

Cash, short-term deposits and marketable securities

 

17 449

 

6 117

 

11 332

 

Total current assets

 

33 691

 

20 881

 

12 810

 

Total assets

 

95 505

 

78 299

 

17 206

 

Equity and liabilities

 

 

 

 

 

 

 

Total equity

 

57 462

 

50 437

 

7 025

 

Non-current liabilities

 

 

 

 

 

 

 

Financial debts

 

8 675

 

2 178

 

6 497

 

Other non-current liabilities

 

9 898

 

9 180

 

718

 

Total non-current liabilities

 

18 573

 

11 358

 

7 215

 

Current liabilities

 

 

 

 

 

 

 

Trade payables

 

4 012

 

3 395

 

617

 

Financial debts and derivatives

 

5 313

 

5 186

 

127

 

Other current liabilities

 

10 145

 

7 923

 

2 222

 

Total current liabilities

 

19 470

 

16 504

 

2 966

 

Total liabilities

 

38 043

 

27 862

 

10 181

 

Total equity and liabilities

 

95 505

 

78 299

 

17 206

 

 

23



 

Condensed consolidated changes in equity

 

Full year (audited)

 

 

 

2009

 

2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Consolidated equity at January 1

 

50 437

 

49 396

 

1 041

 

Comprehensive income

 

10 242

 

4 298

 

5 944

 

Sale/purchase of treasury shares, net

 

225

 

–430

 

655

 

Equity-based compensation

 

635

 

565

 

70

 

Dividends

 

–3 941

 

–3 345

 

–596

 

Changes in non-controlling interests

 

–136

 

–47

 

–89

 

Consolidated equity at December 31

 

57 462

 

50 437

 

7 025

 

 

Fourth quarter (unaudited)

 

 

 

Q4 2009

 

Q4 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Consolidated equity at October 1

 

53 313

 

50 737

 

2 576

 

Comprehensive income

 

3 889

 

–407

 

4 296

 

Sale/purchase of treasury shares, net

 

145

 

–24

 

169

 

Equity-based compensation

 

185

 

145

 

40

 

Changes in non-controlling interests

 

–70

 

–14

 

–56

 

Consolidated equity at December 31

 

57 462

 

50 437

 

7 025

 

 

24



 

Condensed consolidated cash flow statements

 

Full year (audited)

 

 

 

2009

 

2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income from continuing operations

 

8 454

 

8 163

 

291

 

Reversal of non-cash items

 

 

 

 

 

 

 

Taxes

 

1 468

 

1 336

 

132

 

Depreciation, amortization and impairments

 

2 341

 

2 760

 

–419

 

Change in provisions and other non-current liabilities

 

1 031

 

562

 

469

 

Net financial expense/income

 

353

 

–94

 

447

 

Other

 

255

 

–50

 

305

 

Net income adjusted for non-cash items

 

13 902

 

12 677

 

1 225

 

Interest and other financial receipts

 

613

 

659

 

–46

 

Interest and other financial payments

 

–654

 

–268

 

–386

 

Taxes paid

 

–1 623

 

–1 939

 

316

 

Cash flow before working capital changes

 

12 238

 

11 129

 

1 109

 

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

 

–735

 

–730

 

–5

 

Change in net current assets and other operating cash flow items

 

688

 

–630

 

1 318

 

Cash flow from operating activities

 

12 191

 

9 769

 

2 422

 

Investments in property, plant & equipment

 

–1 887

 

–2 106

 

219

 

Investments in intangible, financial and other non-current assets

 

–1 084

 

–346

 

–738

 

Sale of property, plant & equipment, intangible, financial and other non-current assets

 

226

 

329

 

–103

 

Acquisitions of subsidiaries

 

–925

 

–1 079

 

154

 

Increase in marketable securities, associated companies and non-controlling interests

 

–10 549

 

–7 165

 

–3 384

 

Cash flow used for investing activities

 

–14 219

 

–10 367

 

–3 852

 

Change in current and non-current financial debts

 

6 539

 

1 295

 

5 244

 

Dividends paid to shareholders of Novartis AG

 

–3 941

 

–3 345

 

–596

 

Treasury share transactions

 

224

 

–473

 

697

 

Other financing cash flows

 

–13

 

–50

 

37

 

Cash flow from/used for financing activities

 

2 809

 

–2 573

 

5 382

 

Cash flow from discontinued operations

 

 

 

–105

 

105

 

Translation effect on cash and cash equivalents

 

75

 

–46

 

121

 

Change in cash and cash equivalents

 

856

 

–3 322

 

4 178

 

Cash and cash equivalents at January 1

 

2 038

 

5 360

 

–3 322

 

Cash and cash equivalents at December 31

 

2 894

 

2 038

 

856

 

 

25



 

Condensed consolidated cash flow statements

 

Fourth quarter (unaudited)

 

 

 

Q4 2009

 

Q4 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income from continuing operations

 

2 323

 

1 507

 

816

 

Reversal of non-cash items

 

 

 

 

 

 

 

Taxes

 

369

 

252

 

117

 

Depreciation, amortization and impairments

 

629

 

641

 

–12

 

Change in provisions and other non-current liabilities

 

595

 

142

 

453

 

Net financial expense/income

 

52

 

18

 

34

 

Other

 

7

 

–48

 

55

 

Net income adjusted for non-cash items

 

3 975

 

2 512

 

1 463

 

Interest and other financial receipts

 

23

 

51

 

–28

 

Interest and other financial payments

 

–156

 

317

 

–473

 

Taxes paid

 

–406

 

–369

 

–37

 

Cash flow before working capital changes

 

3 436

 

2 511

 

925

 

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

 

–168

 

–249

 

81

 

Change in net current assets and other operating cash flow items

 

1 198

 

942

 

256

 

Cash flow from operating activities

 

4 466

 

3 204

 

1 262

 

Investments in property, plant & equipment

 

–619

 

–661

 

42

 

Investments in intangible, financial and other non-current assets

 

–613

 

–70

 

–543

 

Sale of property, plant & equipment, intangible, financial and other non-current assets

 

115

 

85

 

30

 

Acquisitions of subsidiaries

 

–35

 

–388

 

353

 

Increase in marketable securities, associated companies and non-controlling interests

 

–3 041

 

–695

 

–2 346

 

Cash flow used for investing activities

 

–4 193

 

–1 729

 

–2 464

 

Change in current and non-current financial debts

 

–271

 

–3 745

 

3 474

 

Treasury share transactions

 

144

 

10

 

134

 

Other financing cash flows

 

–14

 

–13

 

–1

 

Cash flow used for financing activities

 

–141

 

–3 748

 

3 607

 

Cash flow from discontinued operations

 

 

 

–26

 

26

 

Translation effect on cash and cash equivalents

 

–11

 

–112

 

101

 

Change in cash and cash equivalents

 

121

 

–2 411

 

2 532

 

Cash and cash equivalents at October 1

 

2 773

 

4 449

 

–1 676

 

Cash and cash equivalents at December 31

 

2 894

 

2 038

 

856

 

 

26



 

Notes to the Condensed Consolidated Financial Statements for 2009

 

1. Basis of preparation

These Condensed Consolidated Financial Statements for the three- and twelve-month periods ended December 31, 2009, were prepared in accordance with International Accounting Standard 34 Interim Financial Reporting and accounting policies set out in the 2009 Annual Report published on January 26, 2010. As of January 1, 2009, the Group adopted the revised IAS 1 Presentation of Financial Statements and IFRS 8 Operating Segments and the revised IAS 23 Borrowing Costs. These new accounting standards did not have a significant impact on the Group’s Condensed Consolidated Financial Statements.

 

2. Selected critical accounting policies

The Group’s principal accounting policies are set out in note 1 to the Consolidated Financial Statements in the 2009 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 notes 10 and 11 of the 2009 Annual Report, Novartis regularly reviews long-lived intangible and tangible assets, including identifiable intangible assets and goodwill for impairment. Goodwill and acquired In-Process Research & Development (IPR&D) projects not yet ready for use are subject to impairment review at least annually, or when events have occurred that require an assessment. As also discussed in notes 4 and 11 of the 2009 Annual Report, investments in associated companies and intangible assets are reviewed for impairment whenever an event or decision occurs that raises concern about their balance sheet carrying value. The amount of investments in associated companies, goodwill and other intangible assets on the Group’s consolidated balance sheet has risen significantly in recent years, primarily from recent acquisitions. Impairment testing under IFRS may lead to potentially significant impairment charges in the future that could have a materially adverse impact on the Group’s financial results.

 

3. Acquisitions, divestments and significant transactions

The following significant transactions occurred during 2009 and 2008:

 

Acquisitions in 2009

 

Sandoz — EBEWE Pharma

On May 20, Novartis announced a definitive agreement for Sandoz to acquire the specialty generic injectables business of EBEWE Pharma for EUR 925 million (USD 1.3 billion) in cash, to be adjusted for any cash or debt assumed at closing. This transaction was completed on September 22, 2009. The first payment of EUR 600 million (USD 0.9 billion) was made in 2009, with the balance to be paid in 2010. Based on a final purchase price allocation, EBEWE’s identified net assets were USD 0.7 billion, which resulted in goodwill of USD 0.5 billion in 2009. Results of operations from this acquisition, which were not material in 2009, were included from the completion date of this transaction.

 

Vaccines and Diagnostics — Zhejiang Tianyuan

On November 4, Novartis announced a definitive agreement to acquire an 85% stake in the Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. Terms call for Novartis to purchase an 85% majority interest for approximately USD 125 million in cash. The transaction, which is expected to be completed in 2010, is subject to certain closing conditions, including receipt of government and regulatory approvals in China.

 

Pharmaceuticals — Corthera

On December 23, Novartis announced a definitive agreement to acquire Corthera Inc, gaining worldwide rights to relaxin for the treatment of acute heart failure. Novartis will assume full responsibility for development and commercialization. The purchase price consists of an initial payment of USD 120 million. Corthera’s current shareholders are eligible to receive additional payments of up to USD 500 million contingent upon clinical milestones, regulatory approvals and the

 

27



 

achievement of commercialization targets. The transaction is expected to be completed in 2010.

 

Acquisitions in 2008

 

Corporate — Alcon

On April 7, Novartis announced an agreement with Nestlé S.A. under which Novartis obtained rights to acquire majority ownership of Alcon Inc. (NYSE: ACL), a Swiss-registered company listed only on the New York Stock Exchange. The potential total value of this transaction is up to approximately USD 38.5 billion. On July 7, 2008, Novartis acquired a 25% stake in Alcon, representing 74 million shares, from Nestlé for USD 10.4 billion in cash. At December 31, 2009, Alcon’s share price on the New York Stock Exchange (NYSE) was USD 164.35, which was above the Group’s carrying value of USD 136.88 per share for this strategic investment.

 

Pharmaceuticals — Speedel

On July 10, Novartis announced the all-cash purchase of an additional 51.7% stake in Speedel Holding AG (SIX: SPPN) through off-exchange transactions together with plans to buy all remaining shares in the Swiss biopharmaceuticals company in a mandatory public tender offer. In September 2009, Speedel shares were delisted from the SIX Swiss Exchange and Novartis holds now all shares. The price for the 90.5% interest not previously held was approximately CHF 939 million (USD 888 million) excluding USD 26 million of cash held by Speedel as of the July 2008 acquisition date of majority control. Speedel has been fully consolidated as a subsidiary since the July acquisition of a majority stake. Based on a final purchase price allocation, Speedel’s identified net assets were USD 472 million, which resulted in goodwill of USD 493 million in 2008. As a result of this purchase price allocation, the value of the initial 9.5% stake rose by USD 38 million, which was recorded in the consolidated statement of comprehensive income. The consolidation of Speedel resulted in immaterial amounts being included in the Group’s consolidated income and operating cash flow statements for 2008 and 2009.

 

Pharmaceuticals — Protez

On June 4, Novartis agreed to acquire Protez Pharmaceuticals, a privately held US biopharmaceuticals company, gaining access to PTZ601, a broad-spectrum antibiotic in Phase II development against potentially fatal drug-resistant bacterial infections. Novartis paid in total USD 102 million in cash to acquire 100% of Protez, whose owners are eligible for additional payments of up to USD 300 million contingent upon the future success of PTZ601. Protez has been consolidated since the transaction completion on July 17. Based on the purchase price allocation, identified net assets from Protez amounted to USD 72 million, which resulted in goodwill of USD 30 million. The consolidation of Protez resulted in immaterial amounts being included in the Group’s consolidated income and operating cash flow statements for 2008 and 2009.

 

Pharmaceuticals — Nektar pulmonary business

On October 21, Novartis agreed to acquire Nektar Therapeutics Inc.’s pulmonary business unit for USD 115 million in cash. In this transaction, which was completed on December 31, 2008, Novartis acquired research, development and manufacturing assets of Nektar’s pulmonary business unit, including tangible assets as well as intellectual property, intangible assets and related expertise. The full purchase price was allocated to the net assets acquired with no residual goodwill.

 

Other significant transactions in 2009

 

Corporate — Issuance of bond in US dollars

On February 5, Novartis issued a two-tranche bond totaling USD 5 billion registered with the US Securities and Exchange Commission as part of a shelf registration statement filed by Novartis in 2008. A 4.125% five-year tranche totaling USD 2 billion was issued by the Group’s US entity, Novartis Capital Corp., while a 5.125% 10-year tranche totaling USD 3 billion was issued by the Group’s Bermuda unit, Novartis Securities Investment Ltd. Both tranches are unconditionally guaranteed by Novartis AG.

 

Corporate — Issuance of bond in euros

On June 2, Novartis issued a EUR 1.5 billion bond (approximately USD 2.1 billion) with a coupon of 4.25% under its EUR 15 billion Euro Medium Term Note Programme. The seven-year bond, issued by Novartis Finance S.A., Luxembourg, has a maturity date of June 15, 2016, and is guaranteed by Novartis AG.

 

28



 

Corporate — Novartis India Ltd.

On June 8, Novartis completed a tender offer to acquire additional shares from public shareholders and increased its stake in the majority-owned Indian subsidiary, Novartis India Ltd., to 76.4% from 50.9% for approximately INR 3.8 billion (USD 80 million). Almost all large institutional investors and quasi-institutional shareholders participated in the offer. This transaction resulted in USD 57 million of goodwill.

 

Pharmaceuticals — Idenix

On August 5, Novartis did not participate in an underwritten public offering by Idenix Pharmaceuticals, which reduced the Group’s stake to 47% from the pre-offering level of 53%. As a result of this offering, Novartis no longer controls this company, so Idenix was deconsolidated with effect from September 1, 2009. Idenix has been accounted for on an equity basis since this date, which had no material impact on the Group’s consolidated income statement.

 

Other significant transaction in 2008

 

Corporate — Issuance of bonds in Swiss francs

On June 26, Novartis issued two Swiss franc bonds totaling CHF 1.5 billion (approximately USD 1.4 billion) in the Swiss capital market, with each listed on the SIX 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.

 

2009 subsequent event

 

Corporate — Alcon

In 2008, Novartis entered into an agreement to purchase Nestle’s 77% stake in Alcon Inc. for up to USD 38.5 billion, or an average price of USD 168 per share. Under the terms of the agreement, Novartis acquired a 25% Alcon stake from Nestlé in 2008 for USD 10.4 billion, or USD 143 per share. The purchase of the 25% stake was financed from internal cash reserves and external short-term financing.

 

On January 4, 2010, Novartis exercised its call option to acquire Nestlé’s remaining 52% Alcon stake for USD 28.1 billion (contains the 17% control premium for the 77% stake over Alcon’s share price of USD 143 at the time of the April 2008 announcement), or USD 180 per share. Upon completion of this transaction, Novartis will own a 77% majority stake in Alcon. The purchase of the 52% stake, which is subject to required regulatory approvals, is expected to be completed in the second half of 2010. Novartis will not control Alcon prior to the closing of the purchase of the 52% stake. This purchase will be funded from available liquidity and external debt financing.

 

On January 4, 2010, Novartis also announced its proposal to, upon completion of the Nestlé transaction, to enter into an all-share direct merger with Alcon for the remaining 23% minority stake. Novartis believes this merger, which is governed under the Swiss Merger Act, is in the interest of all stakeholders and will provide the needed clarity on Alcon’s future. Novartis proposed a fixed exchange ratio of 2.80 Novartis shares for each remaining Alcon share. Based on the Novartis closing share price of CHF 56.50 on December 30, 2009 (the last trading day on the SIX Swiss Stock Exchange before the announcement) and an exchange rate of CHF 1.04 = USD 1.00, this proposal represents an implied price of USD 153 per Alcon share and a 12% premium to Alcon’s unaffected publicly traded share price as determined by Novartis of USD 137 per share. Alcon’s closing share price was USD 164.35 on December 31, 2009 (the last trading day on the New York Stock Exchange before the announcement). The merger would be conditional on the closing of the 52% stake purchase from Nestlé and would require approval by the Boards of Directors of Novartis and Alcon. The merger would also require two-thirds approval by the shareholders of Novartis and Alcon voting at their respective meetings. Under Swiss law, Novartis has the right to vote its Alcon stake in favor of the proposed merger.

 

29



 

4. Principal currency translation rates

 

Full year

 

 

 

Average rates
2009
USD

 

Average rates
2008
USD

 

Period-end rates
Dec 31, 2009
USD

 

Period-end rates
Dec 31, 2008
USD

 

1 CHF

 

0.923

 

0.925

 

0.965

 

0.948

 

1 EUR

 

1.393

 

1.470

 

1.436

 

1.411

 

1 GBP

 

1.564

 

1.853

 

1.591

 

1.450

 

100 JPY

 

1.070

 

0.970

 

1.086

 

1.107

 

 

Fourth quarter

 

 

 

Average rates
Q4 2009
USD

 

Average rates
Q4 2008
USD

 

Period-end rates
Dec 31, 2009
USD

 

Period-end rates
Dec 31, 2008
USD

 

1 CHF

 

0.980

 

0.862

 

0.965

 

0.948

 

1 EUR

 

1.478

 

1.314

 

1.436

 

1.411

 

1 GBP

 

1.634

 

1.571

 

1.591

 

1.450

 

100 JPY

 

1.115

 

1.042

 

1.086

 

1.107

 

 

30


 


 

5. Consolidated income statements — Divisional segmentation — Full year (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer
Health

 

Corporate

 

Total
continuing
operations

 

Discontinued
Consumer
Health

operations

 

Total Group

 

 

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

 

 

2008

 

2009

 

2008

 

 

 

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

 

28 538

 

26 331

 

2 424

 

1 759

 

7 493

 

7 557

 

5 812

 

5 812

 

 

 

 

 

44 267

 

41 459

 

 

 

 

 

44 267

 

41 459

 

Sales to other Divisions

 

175

 

198

 

46

 

20

 

264

 

270

 

44

 

53

 

–529

 

–541

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales of Divisions

 

28 713

 

26 529

 

2 470

 

1 779

 

7 757

 

7 827

 

5 856

 

5 865

 

–529

 

–541

 

44 267

 

41 459

 

 

 

 

 

44 267

 

41 459

 

Other revenues

 

377

 

620

 

390

 

414

 

10

 

25

 

59

 

66

 

 

 

 

 

836

 

1 125

 

 

 

 

 

836

 

1 125

 

Cost of Goods Sold

 

–4 955

 

–4 481

 

–1 415

 

–1 270

 

–4 201

 

–4 119

 

–2 111

 

–2 071

 

503

 

502

 

–12 179

 

–11 439

 

 

 

 

 

–12 179

 

–11 439

 

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

 

–230

 

–353

 

–287

 

–286

 

–256

 

–283

 

–96

 

–76

 

 

 

 

 

–869

 

–998

 

 

 

 

 

–869

 

–998

 

Gross profit

 

24 135

 

22 668

 

1 445

 

923

 

3 566

 

3 733

 

3 804

 

3 860

 

–26

 

–39

 

32 924

 

31 145

 

 

 

 

 

32 924

 

31 145

 

Marketing & Sales

 

–8 369

 

–8 109

 

–297

 

–247

 

–1 330

 

–1 413

 

–2 054

 

–2 083

 

 

 

 

 

–12 050

 

–11 852

 

 

 

 

 

–12 050

 

–11 852

 

Research & Development

 

–5 840

 

–5 716

 

–508

 

–360

 

–613

 

–667

 

–346

 

–313

 

–162

 

–161

 

–7 469

 

–7 217

 

 

 

 

 

–7 469

 

–7 217

 

General & Administration

 

–870

 

–843

 

–176

 

–177

 

–385

 

–408

 

–376

 

–383

 

–474

 

–434

 

–2 281

 

–2 245

 

 

 

 

 

–2 281

 

–2 245

 

Other income

 

414

 

447

 

27

 

38

 

105

 

62

 

72

 

111

 

164

 

168

 

782

 

826

 

 

 

 70

 

782

 

896

 

Other expense

 

–1 078

 

–868

 

–119

 

–99

 

–272

 

–223

 

–84

 

–144

 

–371

 

– 359

 

–1 924

 

–1 693

 

 

 

 

 

–1 924

 

–1 693

 

Amortization and impairments of capitalized intangible assets included in above function costs

 

–125

 

–381

 

–43

 

–33

 

–10

 

–24

 

–1

 

–1

 

–3

 

–2

 

–182

 

–441

 

 

 

 

 

–182

 

–441

 

Operating income

 

8 392

 

7 579

 

372

 

78

 

1 071

 

1 084

 

1 016

 

1 048

 

–869

 

–825

 

9 982

 

8 964

 

 

 

70

 

9 982

 

9 034

 

Return on net sales

 

29.4

%

28.8

%

15.3

%

4.4

%

14.3

%

14.3

%

17.5

%

18.0

%

 

 

 

 

22.5

%

21.6

%

 

 

 

 

22.5

%

21.8

%

Income from associated companies

 

–14

 

 

 

 

 

 

 

7

 

4

 

 

 

 

 

300

 

437

 

293

 

441

 

 

 

 

 

293

 

441

 

Financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

198

 

384

 

 

 

 

 

198

 

384

 

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–551

 

–290

 

 

 

 

 

–551

 

–290

 

Income before taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9 922

 

9 499

 

 

 

70

 

9 922

 

9 569

 

Taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–1 468

 

–1 336

 

 

 

 

 

–1 468

 

–1 336

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8 454

 

8 163

 

 

 

70

 

8 454

 

8 233

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additions to:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

– Property, plant and equipment(1)

 

922

 

1 115

 

437

 

435

 

282

 

422

 

164

 

160

 

78

 

77

 

1 883

 

2 209

 

 

 

 

 

1 883

 

2 209

 

– Goodwill and other intangible assets(1)

 

809

 

98

 

12

 

42

 

35

 

21

 

101

 

22

 

10

 

5

 

967

 

188

 

 

 

 

 

967

 

188

 

 


(1) Excluding impact of business acquisitions

 

31



 

Consolidated income statements — Divisional segmentation — Fourth quarter (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer
Health

 

Corporate

 

Total
continuing
operations

 

Discontinued
Consumer
Health

operations

 

Total Group

 

 

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

 

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

 

 

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

 

7 773

 

6 430

 

1 387

 

491

 

2 143

 

1 804

 

1 623

 

1 352

 

 

 

 

 

12 926

 

10 077

 

 

 

 

 

12 926

 

10 077

 

Sales to other Divisions

 

38

 

39

 

20

 

11

 

74

 

62

 

13

 

12

 

–145

 

–124

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales of Divisions

 

7 811

 

6 469

 

1 407

 

502

 

2 217

 

1 866

 

1 636

 

1 364

 

–145

 

–124

 

12 926

 

10 077

 

 

 

 

 

12 926

 

10 077

 

Other revenues

 

93

 

160

 

108

 

86

 

2

 

8

 

16

 

17

 

 

 

 

 

219

 

271

 

 

 

 

 

219

 

271

 

Cost of Goods Sold

 

–1 382

 

–1 064

 

–552

 

–347

 

–1 253

 

–1 026

 

–614

 

–484

 

134

 

87

 

–3 667

 

–2 834

 

 

 

 

 

–3 667

 

–2 834

 

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

 

24

 

–76

 

–73

 

–70

 

–76

 

–64

 

–35

 

–18

 

 

 

 

 

–160

 

–228

 

 

 

 

 

–160

 

–228

 

Gross profit

 

6 522

 

5 565

 

963

 

241

 

966

 

848

 

1 038

 

897

 

–11

 

–37

 

9 478

 

7 514

 

 

 

 

 

9 478

 

7 514

 

Marketing & Sales

 

–2 356

 

–2 141

 

–109

 

–47

 

–396

 

–345

 

–615

 

–521

 

 

 

 

 

–3 476

 

–3 054

 

 

 

 

 

–3 476

 

–3 054

 

Research & Development

 

–1 632

 

–1 479

 

–199

 

–91

 

–172

 

–163

 

–102

 

–80

 

–43

 

–21

 

–2 148

 

–1 834

 

 

 

 

 

–2 148

 

–1 834

 

General & Administration

 

–261

 

–248

 

–61

 

–66

 

–109

 

–98

 

–120

 

–105

 

–141

 

–112

 

–692

 

–629

 

 

 

 

 

–692

 

–629

 

Other income

 

169

 

107

 

6

 

11

 

86

 

30

 

29

 

41

 

71

 

8

 

361

 

197

 

 

 

12

 

361

 

209

 

Other expense

 

–536

 

–242

 

–17

 

–22

 

–154

 

–72

 

–23

 

–42

 

–156

 

–136

 

–886

 

–514

 

 

 

 

 

–886

 

–514

 

Amortization and impairments of capitalized intangible assets included in above function costs

 

–40

 

–52

 

–25

 

–9

 

1

 

–3

 

–1

 

 

 

–1

 

 

 

–66

 

–64

 

 

 

 

 

–66

 

–64

 

Operating income

 

1 906

 

1 562

 

583

 

26

 

221

 

200

 

207

 

190

 

–280

 

–298

 

2 637

 

1 680

 

 

 

12

 

2 637

 

1 692

 

Return on net sales

 

24.5

%

24.3

%

42.0

%

5.3

%

10.3

%

11.1

%

12.8

%

14.1

%

 

 

 

 

20.4

%

16.7

%

 

 

 

 

20.4

%

16.8

%

Income from associated companies

 

–8

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

113

 

97

 

107

 

97

 

 

 

 

 

107

 

97

 

Financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

104

 

58

 

 

 

 

 

104

 

58

 

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–156

 

–76

 

 

 

 

 

–156

 

–76

 

Income before taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 692

 

1 759

 

 

 

12

 

2 692

 

1 771

 

Taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–369

 

–252

 

 

 

30

 

–369

 

–222

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 323

 

1 507

 

 

 

42

 

2 323

 

1 549

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additions to:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

– Property, plant and equipment(1)

 

309

 

374

 

143

 

136

 

104

 

91

 

66

 

67

 

28

 

28

 

650

 

696

 

 

 

 

 

650

 

696

 

– Goodwill and other intangible assets(1)

 

527

 

25

 

0

 

39

 

7

 

4

 

21

 

4

 

7

 

3

 

562

 

75

 

 

 

 

 

562

 

75

 

 


(1) Excluding impact of business acquisitions

 

32



 

6. Legal proceedings update

 

A number of Novartis subsidiaries are, and will likely continue to be, subject to 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. 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. See note 20 in the Group’s Consolidated Financial Statements in the 2009 Annual Report for a summary of major legal proceedings. The following is a non-exhaustive list relating to some cases reported in the 2009 Annual Report and includes information as of the 2009 fourth quarter:

 

Governmental investigations

 

In 2005 the US Attorney’s Office for the Eastern District of Pennsylvania (the EDPA) served an administrative subpoena pursuant to the Health Insurance Portability and Accountability Act on Novartis Pharmaceuticals Corporation (NPC), a Novartis subsidiary. NPC has been cooperating with parallel civil and criminal investigations by the EDPA into allegations of potential off-label marketing and promotion of the epilepsy therapy Trileptal as well as certain payments made to healthcare providers in connection with this medicine. NPC recently entered into a plea agreement with the EDPA, which is contingent on court approval, to resolve criminal allegations. Pursuant to the plea agreement, NPC will plead guilty to a misdemeanor violation of the US Food, Drug and Cosmetic Act and pay a fine of USD 185 million. NPC is currently negotiating with the EDPA to resolve civil claims relating to Trileptal. In the fourth quarter of 2009, Novartis increased provisions relating to the EDPA’s Trileptal investigations by USD 318 million. Total provisions at the end of 2009 relating to the EDPA’s civil and criminal Trileptal investigations were USD 397 million.

 

NPC is also cooperating with an investigation by the EDPA regarding potential off-label marketing and promotion as well as payments made to healthcare providers in connection with five other products: Diovan, Exforge, Sandostatin, Tekturna and Zelnorm. Novartis is unable to assess with reasonable certainty the outcome of the investigation related to these five products or the amounts, which could be material, that it might be required to pay to resolve this investigation.

 

The US Attorney’s Office for the Northern District of California in 2007 served an administrative subpoena pursuant to the Health Insurance Portability and Accountability Act covering several Novartis subsidiaries. The subpoena covered information regarding potential off-label marketing and promotion of TOBI (tobramycin), a treatment for patients with cystic fibrosis acquired through the purchase of Chiron Corporation in mid-2006. In September 2009, Novartis subsidiaries reached an agreement in principle with the US Department of Justice to pay USD 72.5 million to resolve all federal civil claims and state Medicaid claims relating to this investigation. Details of the agreement in principle are under discussion with relevant federal and state government offices.

 

In October 2009, the European Commission, together with the French competition authority, searched the French offices of Sandoz, alleging that Sandoz may have entered into anti-competitive price coordination practices with other generic pharmaceuticals companies and via the French trade association for generic pharmaceuticals companies. Sandoz is cooperating with the Commission and French authorities.

 

On January 12, 2010, the European Commission addressed a request for information to certain pharmaceutical companies, including Novartis International AG, asking them to submit copies of all of their patent settlement agreements as well as copies of all annexes, related agreements and amendments. The request covers patent settlement agreements concluded between originator and generic pharmaceutical companies in the period from July 1, 2008, to December 31, 2009, and

 

33



 

relating to the EU/EEA.

 

Zometa/Aredia litigation

 

Novartis Pharmaceuticals Corp. is a defendant in approximately 682 cases brought in US courts in which plaintiffs claim to have experienced osteonecrosis of the jaw after treatment with Zometa or Aredia, which are used to treat patients whose cancer has spread to the bones. All purported class actions have been dismissed. A trial that began in Montana in October 2009 resulted in a plaintiff’s verdict, and this verdict is currently under appeal. The next trial in a US state court is currently scheduled to begin in New Jersey in June 2010.

 

Zelnorm

 

Novartis subsidiaries are defendants in approximately 134 cases brought in US and Canadian courts in which plaintiffs claim to have experienced cardiovascular injuries after being treated with Zelnorm, a medicine for irritable bowel syndrome and chronic constipation. A purported national class action was filed against a Novartis subsidiary in Canada. A statement to defend was filed in this action. The first trial in the US is now expected to begin in Virginia in June 2010 after a case was dismissed that had been scheduled for trial in Louisiana in January 2010.

 

Contact lenses patent litigation

 

In the US, Johnson & Johnson (J&J) filed suits seeking a declaration that their Oasys® and Advance® products do not infringe CIBA Vision’s silicone hydrogel patents (Jump patents). CIBA Vision filed counter-claims for infringement of its Jump patents. Novartis has also filed infringement suits based on these patent rights in several European countries, including France, Germany, the Netherlands, Ireland, Italy, Spain and the United Kingdom. J&J filed an invalidation suit in Austria in January 2009. Courts in the Netherlands (February 2009), France (March 2009) and the US (August 2009) issued rulings holding that CIBA Vision’s patents were valid and infringed by J&J’s sales of Oasys® products. J&J appealed the rulings in the Netherlands, France and in the US. However, the trial court in the UK held in July 2009 that the Jump patents were invalid. CIBA Vision has filed an appeal. In December 2009, a trial court in Germany also decided that the German part of the Jump patents was invalid. CIBA Vision will appeal this decision.

 

Famvir

 

Famvir, a therapy for viral infections, is the subject of patent litigation against Teva and Roxane in the US. A trial against Teva in November 2009 resulted in a jury verdict in favor of Novartis that the compound patent was valid and enforceable, i.e., that there was no inequitable conduct (the jury’s verdict on inequitable conduct is advisory only). A hearing on a permanent injunction and inequitable conduct is scheduled for January 2010. The compound patent, which covers the active ingredient, expires in March 2011 and a method of use patent expires in 2015, including pediatric extensions. Teva had launched its generic version “at risk” in 2007 after the judge denied a request by Novartis for a preliminary injunction. Roxane could launch at risk in March 2011.

 

Average Wholesale Price litigation

 

Claims have been brought against various pharmaceutical companies, including Novartis subsidiaries, alleging that they fraudulently overstated the Average Wholesale Price and “best price”, which are, or have been, used by the US federal and state governments in the calculation of, respectively, Medicare reimbursements and Medicaid rebates. Discovery is ongoing in certain of these cases. Motions have been made to dismiss the complaint or for summary judgment in other cases. A Novartis subsidiary was defendant in a trial in Alabama in 2008. The jury rendered a verdict against the Novartis subsidiary and imposed USD 33 million of compensatory damages. No punitive damages were awarded. On October 16, 2009, the Supreme Court of the State of Alabama overturned this verdict, reversing the jury’s finding. In a second trial that took place in Alabama in February 2009, the jury rendered a verdict against a separate Novartis subsidiary and awarded

 

34



 

compensatory damages of USD 28 million and punitive damages of USD 50 million. The Novartis subsidiary is appealing the verdict. A third trial involving Novartis subsidiaries took place in Kentucky in June 2009. The jury rendered a verdict against a Novartis subsidiary and imposed USD 16 million of compensatory damages and USD 13.6 million in penalties. No punitive damages were awarded. The Novartis subsidiary has filed post-trial motions in December 2009. A fourth trial against a Novartis subsidiary scheduled to start in Texas in January 2010 has been postponed by the court. A new trial date is not expected before March 2010. A fifth trial against a Novartis subsidiary was scheduled to begin in Wisconsin in May 2010. The Wisconsin court has recently stayed the pre-trial proceedings (except for fact discovery) and postponed the trial to a date to be determined.

 

Wage and Hour litigation

 

A group of pharmaceutical sales representatives filed suit in a US state court in California and in a US federal court in New York against US Novartis subsidiaries alleging that the companies violated wage and hour laws by misclassifying the sales representatives as “exempt” employees, and by failing to pay overtime compensation. The lawsuits were consolidated and certified as a class action. In January 2009, the US federal district court for the Southern District of New York held the sales representatives were not entitled to overtime pay under the federal Fair Labor Standards Act and corresponding state wage and hour laws. Plaintiffs have appealed the judgment. Amicus briefs supporting the plaintiffs’ position were filed by the National Employment Lawyers Association and by the US Department of Labor. The US Chamber of Commerce filed a brief in support of Novartis on November 5, 2009.

 

Gender discrimination

 

Certain female pharmaceutical sales representatives brought a lawsuit in a US federal court in New York against, among others, several US Novartis subsidiaries, alleging they were discriminated against because of their gender. The district court granted, in part, plaintiffs’ motion for class certification against one of the US Novartis subsidiaries, but dismissed all other US Novartis subsidiaries from the case. Discovery was required to be completed by December 31, 2009, and the trial is scheduled to begin on April 7, 2010.

 

35



 

Supplementary information

 

Non-IFRS disclosures

 

Net liquidity/debt and free cash flow are non-IFRS financial measures, which means they should not be interpreted as measures determined under IFRS. Net liquidity/debt is presented as additional information since management believes it is a useful indicator of the Group’s ability to meet financial commitments and to invest in new strategic opportunities, including strengthening its balance sheet. Free cash flow is presented as additional information since management believes it is a useful indicator of the Group’s ability to operate without reliance on additional borrowing or usage of existing cash. Free cash flow is a measure of the net cash generated that is available for debt repayment and investment in strategic opportunities. Novartis uses free cash flow in internal comparisons of results from the Group’s divisions and business units. Free cash flow of the divisions and business units uses the same definition as for the Group. No dividends, tax or financial receipts or payments are included in the division and business unit calculations. The definition of free cash flow used by Novartis does not include amounts related to changes in investments in associated companies nor related to acquisitions or divestments of subsidiaries. Free cash flow is not intended to be a substitute measure for cash flow from operating activities as determined under IFRS.

 

Condensed consolidated change in net liquidity/debt (unaudited)

 

Full year

 

 

 

2009

 

2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Change in cash and cash equivalents

 

856

 

–3 322

 

4 178

 

Change in marketable securities, financial debt and financial derivatives

 

3 852

 

–5 332

 

9 184

 

Change in net liquidity/debt

 

4 708

 

–8 654

 

13 362

 

Net liquidity/debt at January 1

 

–1 247

 

7 407

 

–8 654

 

Net liquidity/debt at December 31

 

3 461

 

–1 247

 

4 708

 

 

Fourth quarter

 

 

 

Q4 2009

 

Q4 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Change in cash and cash equivalents

 

121

 

–2 411

 

2 532

 

Change in marketable securities, financial debt and financial derivatives

 

3 540

 

3 831

 

–291

 

Change in net liquidity/debt

 

3 661

 

1 420

 

2 241

 

Net liquidity/debt at October 1

 

–200

 

–2 667

 

2 467

 

Net liquidity/debt at December 31

 

3 461

 

–1 247

 

4 708

 

 

36



 

Free cash flow (unaudited)

 

Full year

 

 

 

2009

 

2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Cash flow from operating activities from continuing operations

 

12 191

 

9 769

 

2 422

 

Purchase of property, plant & equipment

 

–1 887

 

–2 106

 

219

 

Purchase of intangible, financial and other non-current assets

 

–1 084

 

–346

 

–738

 

Sale of property, plant & equipment, intangible, financial and other non-current assets

 

226

 

329

 

–103

 

Free cash flow before dividends

 

9 446

 

7 646

 

1 800

 

Dividends paid to shareholders of Novartis AG

 

–3 941

 

–3 345

 

–596

 

Free cash flow from continuing operations

 

5 505

 

4 301

 

1 204

 

Free cash flow from discontinued operations

 

 

 

–237

 

237

 

Free cash flow

 

5 505

 

4 064

 

1 441

 

 

Fourth quarter

 

 

 

Q4 2009

 

Q4 2008

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Cash flow from operating activities from continuing operations

 

4 466

 

3 204

 

1 262

 

Purchase of property, plant & equipment

 

–619

 

–661

 

42

 

Purchase of intangible, financial and other non-current assets

 

–613

 

–70

 

–543

 

Sale of property, plant & equipment, intangible, financial and other non-current assets

 

115

 

85

 

30

 

Free cash flow from continuing operations

 

3 349

 

2 558

 

791

 

Free cash flow from discontinued operations

 

 

 

–20

 

20

 

Free cash flow

 

3 349

 

2 538

 

811

 

 

Share information (unaudited)

 

 

 

December 31, 2009

 

December 31, 2008

 

Number of shares outstanding (million)

 

2 274.4

 

2 264.9

 

Registered share price (CHF)

 

56.50

 

52.70

 

ADS price (USD)

 

54.43

 

49.76

 

Market capitalization (USD billion)

 

124.0

 

113.2

 

Market capitalization (CHF billion)

 

128.5

 

119.4

 

 

37



 

Core results

 

The Group’s operating income, net income and earnings per share from continuing operations have been significantly affected by acquisition-related factors, including the amortization of intangible assets, impairment charges, expenses relating to the integration of acquisitions as well as other items over a USD 25 million threshold that management deems exceptional.

 

In order to improve transparency and better present the underlying performance of the business, Novartis decided in the fourth quarter of 2009 to introduce these core measures as an additional view of performance. Novartis believes that investor understanding of the Group’s performance is enhanced by disclosing these performance measures.

 

Novartis intends to use these core measures as important factors in assessing the Group’s performance in conjunction with other performance metrics. The following are examples of how these core measures will be utilized:

 

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

 

·                  Annual budgets will be prepared for both IFRS and core measures starting in 2010.

 

Despite the importance of these measures to management in setting goals and measuring the Group’s performance, these are non-IFRS measures that have no standardized meaning prescribed by IFRS. As a result, they have limits in usefulness to investors. Because of their non-standardized definitions, the core measures (unlike IFRS measures) may not be comparable to the calculation of similar measures of other companies. These core measures are presented solely to permit investors to more fully understand how the Group’s management assesses underlying performance. These core measures are not, and should not be viewed as, a substitute for IFRS measures.

 

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

 

38


 

 


 

CORE RESULTS

Reconciliation from IFRS results to core results — Full year 2009 (unaudited)

 

 

 

IFRS
results

USD m

 

Amortization
of intangible
assets(1)

USD m

 

Impairments(2)
USD m

 

Acquisition-related
restructuring and
integration items(3)

USD m

 

Exceptional
items(4)

USD m

 

Core
results

USD m

 

Net sales to third parties

 

44 267

 

 

 

 

 

 

 

 

 

44 267

 

Other revenues

 

836

 

 

 

 

 

 

 

–28

 

808

 

Cost of Goods Sold

 

–12 179

 

938

 

–69

 

18

 

 

 

–11 292

 

Gross profit

 

32 924

 

938

 

–69

 

18

 

–28

 

33 783

 

Marketing & Sales

 

–12 050

 

 

 

 

 

 

 

 

 

–12 050

 

Research & Development

 

–7 469

 

87

 

95

 

 

 

 

 

–7 287

 

General & Administration

 

–2 281

 

 

 

 

 

 

 

 

 

–2 281

 

Other income

 

782

 

 

 

 

 

 

 

–65

 

717

 

Other expense

 

–1 924

 

 

 

49

 

 

 

430

 

–1 445

 

Operating income

 

9 982

 

1 025

 

75

 

18

 

337

 

11 437

 

Income from associated companies

 

293

 

569

 

92

 

 

 

97

 

1 051

 

Financial income

 

198

 

 

 

 

 

 

 

 

 

198

 

Interest expense

 

–551

 

 

 

 

 

 

 

 

 

–551

 

Income before taxes

 

9 922

 

1 594

 

167

 

18

 

434

 

12 135

 

Taxes

 

–1 468

 

 

 

 

 

 

 

 

 

–1 868

(5)

Net income

 

8 454

 

 

 

 

 

 

 

 

 

10 267

 

Basic EPS (USD)(6)

 

3.70

 

 

 

 

 

 

 

 

 

4.50

 

Diluted EPS (USD)(6)

 

3.69

 

 

 

 

 

 

 

 

 

4.49

 

 


(1)

Amortization of intangible assets: Cost of Goods Sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; R&D includes the recurring amortization of acquired rights for core technology platforms; Income from associated companies includes the recurring amortization of the purchase price allocation related to intangible assets, primarily for the Roche and Alcon investments.

 

 

(2)

Impairments: Cost of Goods Sold includes impairments of acquired rights to in-market products and other production-related impairment charges, including a partial reversal of USD 100 million in Pharmaceuticals for an impairment taken in 2007 for Famvir; R&D includes write-offs related to in-process R&D; Other expense includes impairments, primarily for financial assets; Income from associated companies reflects the USD 92 million impairment charge taken for an Alcon pharmaceutical development project.

 

 

(3)

Acquisition-related restructuring and integration items: Cost of Goods Sold includes charges of USD 18 million related to the EBEWE Pharma specialty generics business acquisition.

 

 

(4)

Exceptional items: Other revenues reflects a USD 28 million gain from a settlement in Vaccines and Diagnostics; Other income reflects divestments gains in Pharmaceuticals; Other expense includes an increase of USD 345 million in legal provisions principally for the Trileptal and TOBI US government investigations; Income from associated companies reflects a USD 97 million one-time charge for the Novartis share of Roche’s restructuring charges for Genentech.

 

 

(5)

Taxes on the adjustments between IFRS and core results take into account the tax rate applicable in the jurisdiction where the adjustment arises.

 

 

(6)

Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

 

39


 


 

CORE RESULTS
Reconciliation of operating income to core operating income and net income — Full year
(unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer Health

 

Corporate

 

Total

 

 

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

 

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

Operating income

 

8 392

 

7 579

 

372

 

78

 

1 071

 

1 084

 

1 016

 

1 048

 

–869

 

–825

 

9 982

 

8 964

 

Amortization of intangible assets

 

366

 

414

 

312

 

318

 

260

 

284

 

84

 

77

 

3

 

2

 

1 025

 

1 095

 

Impairments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangible assets

 

–11

 

320

 

18

 

1

 

6

 

23

 

13

 

 

 

 

 

 

 

26

 

344

 

Property, plant & equipment

 

4

 

13

 

 

 

 

 

 

 

2

 

5

 

 

 

 

 

1

 

9

 

16

 

Financial assets

 

37

 

53

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

37

 

40

 

90

 

Total impairment charges

 

30

 

386

 

18

 

1

 

6

 

25

 

18

 

 

 

3

 

38

 

75

 

450

 

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

 

 

 

6

 

 

 

11

 

18

 

 

 

 

 

 

 

 

 

 

 

18

 

17

 

Exceptional items

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exceptional gains from divesting brands, subsidiaries and financial investments

 

–65

 

–141

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–65

 

–141

 

Other restructuring expenses

 

 

 

75

 

 

 

 

 

40

 

 

 

 

 

 

 

 

 

 

 

40

 

75

 

Legal provisions, litigations and exceptional settlements

 

345

 

79

 

17

 

–49

 

 

 

 

 

 

 

 

 

 

 

 

 

362

 

30

 

Other product recall costs

 

 

 

 

 

 

 

 

 

 

 

28

 

 

 

 

 

 

 

 

 

 

 

28

 

Release of pre-launch inventory provisions

 

 

 

–45

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–45

 

Release of US government rebate provisions

 

 

 

–104

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–104

 

Change in contractual terms triggering revenue recognition

 

 

 

 

 

 

 

–50

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–50

 

Total exceptional items

 

280

 

–136

 

17

 

–99

 

40

 

28

 

 

 

 

 

 

 

 

 

337

 

–207

 

Total adjustments

 

676

 

670

 

347

 

231

 

324

 

337

 

102

 

77

 

6

 

40

 

1 455

 

1 355

 

Core operating income

 

9 068

 

8 249

 

719

 

309

 

1 395

 

1 421

 

1 118

 

1 125

 

–863

 

–785

 

11 437

 

10 319

 

Core return on net sales

 

31.8

%

31.5

%

29.7

%

18.1

%

18.6

%

18.8

%

19.2

%

19.4

%

 

 

 

 

25.8

%

25.0

%

Income from associated companies

 

–14

 

 

 

 

 

 

 

7

 

4

 

 

 

 

 

300

 

437

 

293

 

441

 

Recurring amortization, exceptional impairments and restructuring expenses related to income from associated companies, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

758

 

398

 

Financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

198

 

384

 

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–551

 

–290

 

Taxes (adjusted for above items)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–1 868

 

–1 751

 

Core net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10 267

 

9 501

 

Core net income attributable to shareholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10 213

 

9 463

 

Core basic EPS (USD)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.50

 

4.18

 

 

40



 

CORE RESULTS

Divisional income statement segmentation — Full year (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer
Health

 

Corporate

 

Total

 

 

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

2009

 

2008

 

 

 

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

 

28 538

 

26 227

 

2 424

 

1 709

 

7 493

 

7 557

 

5 812

 

5 812

 

 

 

 

 

44 267

 

41 305

 

Sales to other Divisions

 

175

 

198

 

46

 

20

 

264

 

270

 

44

 

53

 

–529

 

–541

 

 

 

 

 

Sales of Divisions

 

28 713

 

26 425

 

2 470

 

1 729

 

7 757

 

7 827

 

5 856

 

5 865

 

–529

 

–541

 

44 267

 

41 305

 

Other revenues

 

377

 

620

 

362

 

365

 

10

 

25

 

59

 

66

 

 

 

 

 

808

 

1 076

 

Cost of Goods Sold

 

–4 725

 

–4 128

 

–1 128

 

–984

 

–3 927

 

–3 836

 

–2 015

 

–1 995

 

503

 

502

 

–11 292

 

–10 441

 

Gross profit

 

24 365

 

22 917

 

1 704

 

1 110

 

3 840

 

4 016

 

3 900

 

3 936

 

–26

 

–39

 

33 783

 

31 940

 

Marketing & Sales

 

–8 369

 

–8 109

 

–297

 

–247

 

–1 330

 

–1 413

 

–2 054

 

–2 083

 

 

 

 

 

–12 050

 

–11 852

 

Research & Development

 

–5 715

 

–5 335

 

–465

 

–327

 

–603

 

–643

 

–345

 

–312

 

–159

 

–159

 

–7 287

 

–6 776

 

General & Administration

 

–870

 

–843

 

–176

 

–177

 

–385

 

–408

 

–376

 

–383

 

–474

 

–434

 

–2 281

 

–2 245

 

Other income

 

349

 

261

 

27

 

38

 

105

 

62

 

72

 

111

 

164

 

168

 

717

 

640

 

Other expense

 

–692

 

–642

 

–74

 

–88

 

–232

 

–193

 

–79

 

–144

 

–368

 

–321

 

–1 445

 

–1 388

 

Core operating income

 

9 068

 

8 249

 

719

 

309

 

1 395

 

1 421

 

1 118

 

1 125

 

–863

 

–785

 

11 437

 

10 319

 

Income from associated companies

 

–14

 

 

 

 

 

 

 

7

 

4

 

 

 

 

 

1 058

 

835

 

1 051

 

839

 

Financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

198

 

384

 

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–551

 

–290

 

Income before taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12 135

 

11 252

 

Taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–1 868

 

–1 751

 

Core net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10 267

 

9 501

 

Core basic EPS (USD)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.50

 

4.18

 

 

41



 

CORE RESULTS

Reconciliation from IFRS results to core results — Fourth quarter 2009 (unaudited)

 

 

 

IFRS
results

USD m

 

Amortization
of intangible
assets(1)

USD m

 

Impairments(2)
USD m

 

Acquisition-related
restructuring and
integration items(3)

USD m

 

Exceptional
items(4)

USD m

 

Core
results

USD m

 

Net sales to third parties

 

12 926

 

 

 

 

 

 

 

 

 

12 926

 

Other revenues

 

219

 

 

 

 

 

 

 

–28

 

191

 

Cost of Goods Sold

 

–3 667

 

246

 

–86

 

18

 

 

 

–3 489

 

Gross profit

 

9 478

 

246

 

–86

 

18

 

–28

 

9 628

 

Marketing & Sales

 

–3 476

 

 

 

 

 

 

 

 

 

–3 476

 

Research & Development

 

–2 148

 

19

 

47

 

 

 

 

 

–2 082

 

General & Administration

 

–692

 

 

 

 

 

 

 

 

 

–692

 

Other income

 

361

 

 

 

 

 

 

 

–65

 

296

 

Other expense

 

–886

 

 

 

58

 

 

 

358

 

–470

 

Operating income

 

2 637

 

265

 

19

 

18

 

265

 

3 204

 

Income from associated companies

 

107

 

145

 

 

 

 

 

 

 

252

 

Financial income

 

104

 

 

 

 

 

 

 

 

 

104

 

Interest expense

 

–156

 

 

 

 

 

 

 

 

 

–156

 

Income before taxes

 

2 692

 

410

 

19

 

18

 

265

 

3 404

 

Taxes

 

–369

 

 

 

 

 

 

 

 

 

–512

(5)

Net income

 

2 323

 

 

 

 

 

 

 

 

 

2 892

 

Basic EPS (USD)(6)

 

1.01

 

 

 

 

 

 

 

 

 

1.26

 

Diluted EPS (USD)(6)

 

1.01

 

 

 

 

 

 

 

 

 

1.26

 

 


(1)   Amortization of intangible assets: Cost of Goods Sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; R&D includes the recurring amortization of acquired rights for core technology platforms; Income from associated companies includes the recurring amortization of the purchase price allocation related to intangible assets, primarily for the Roche and Alcon investments.

 

(2)   Impairments: Cost of Goods Sold includes impairments of acquired rights to in-market products and other production-related impairment charges, including a partial reversal of USD 100 million in Pharmaceuticals for an impairment taken in 2007 for Famvir; R&D includes write-offs related to in-process R&D; Other expense includes impairments, primarily for financial assets.

 

(3)   Acquisition-related restructuring and integration items: Cost of Goods Sold includes charges of USD 18 million related to the EBEWE Pharma specialty generics business acquisition.

 

(4)   Exceptional items: Other revenues reflects a USD 28 million gain from a settlement in Vaccines and Diagnostics; Other income reflects divestments gains in Pharmaceuticals; Other expense includes an increase of USD 318 million in legal provisions principally for the Trileptal US government investigation and a USD 40 million one-time charge in Sandoz for German commercial operations restructuring.

 

(5)   Taxes on the adjustments between IFRS and core results take into account the tax rate applicable in the jurisdiction where the adjustment arises.

 

(6)   Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.

 

42



 

CORE RESULTS

Reconciliation of operating income to core operating income and net income — Fourth quarter (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer Health

 

Corporate

 

Total

 

 

 

Q4 2009

 

Q4 2008

 

Q4 2009

 

Q4 2008

 

Q4 2009

 

Q4 2008

 

Q4 2009

 

Q4 2008

 

Q4 2009

 

Q4 2008

 

Q4 2009

 

Q4 2008

 

 

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

USD m

 

Operating income

 

1 906

 

1 562

 

583

 

26

 

221

 

200

 

207

 

190

 

–280

 

–298

 

2 637

 

1 680

 

Amortization of intangible assets

 

82

 

99

 

80

 

79

 

79

 

59

 

23

 

18

 

1

 

 

 

265

 

255

 

Impairments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intangible assets

 

–66

 

29

 

18

 

 

 

–4

 

8

 

13

 

 

 

 

 

 

 

–39

 

37

 

Property, plant & equipment

 

4

 

7

 

 

 

 

 

2

 

1

 

5

 

1

 

 

 

–3

 

11

 

6

 

Financial assets

 

36

 

27

 

 

 

 

 

 

 

 

 

 

 

 

 

11

 

28

 

47

 

55

 

Total impairment charges

 

–26

 

63

 

18

 

 

 

–2

 

9

 

18

 

1

 

11

 

–25

 

19

 

98

 

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

 

 

 

 

 

 

 

 

 

18

 

 

 

 

 

 

 

 

 

 

 

18

 

 

 

Exceptional items

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exceptional gains from divesting brands, subsidiaries and financial investments

 

–65

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–65

 

 

 

Other restructuring expenses

 

 

 

 

 

 

 

 

 

40

 

 

 

 

 

 

 

 

 

 

 

40

 

 

 

Legal provisions, litigations and exceptional settlements

 

318

 

79

 

–28

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

290

 

79

 

Other product recall costs

 

 

 

 

 

 

 

 

 

 

 

28

 

 

 

 

 

 

 

 

 

 

 

28

 

Change in contractual terms triggering revenue recognition

 

 

 

 

 

 

 

–50

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–50

 

Total exceptional items

 

253

 

79

 

–28

 

–50

 

40

 

28

 

 

 

 

 

 

 

 

 

265

 

57

 

Total adjustments

 

309

 

241

 

70

 

29

 

135

 

96

 

41

 

19

 

12

 

25

 

567

 

410

 

Core operating income

 

2 215

 

1 803

 

653

 

55

 

356

 

296

 

248

 

209

 

–268

 

–273

 

3 204

 

2 090

 

Core return on net sales

 

28.5

%

28.0

%

47.1

%

12.5

%

16.6

%

16.4

%

15.3

%

15.5

%

 

 

 

 

24.8

%

20.8

%

Income from associated companies

 

–8

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

113

 

97

 

107

 

97

 

Recurring amortization, exceptional impairments and restructuring expenses related to income from associated companies, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

145

 

169

 

Financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

104

 

58

 

Interest expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–156

 

–76

 

Taxes (adjusted for above items)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–512

 

–371

 

Core net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 892

 

1 967

 

Core net income attributable to shareholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 874

 

1 957

 

Core basic EPS (USD)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.26

 

0.86

 

 

43



 

CORE RESULTS

Divisional income statement segmentation – Fourth quarter (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer
Health

 

Corporate

 

Total

 

 

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

Q4
2009

 

Q4
2008

 

 

 

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

 

7 773

 

6 430

 

1 387

 

441

 

2 143

 

1 804

 

1 623

 

1 352

 

 

 

 

 

12 926

 

10 027

 

Sales to other Divisions

 

38

 

39

 

20

 

11

 

74

 

62

 

13

 

12

 

–145

 

–124

 

 

 

 

 

Sales of Divisions

 

7 811

 

6 469

 

1 407

 

452

 

2 217

 

1 866

 

1 636

 

1 364

 

–145

 

–124

 

12 926

 

10 027

 

Other revenues

 

93

 

160

 

80

 

86

 

2

 

8

 

16

 

17

 

 

 

 

 

191

 

271

 

Cost of Goods Sold

 

–1 406

 

–988

 

–479

 

–277

 

–1 159

 

–962

 

–579

 

–466

 

134

 

87

 

–3 489

 

–2 606

 

Gross profit

 

6 498

 

5 641

 

1 008

 

261

 

1 060

 

912

 

1 073

 

915

 

–11

 

–37

 

9 628

 

7 692

 

Marketing & Sales

 

–2 356

 

–2 141

 

–109

 

–47

 

–396

 

–345

 

–615

 

–521

 

 

 

 

 

–3 476

 

–3 054

 

Research & Development

 

–1 592

 

–1 427

 

–174

 

–82

 

–173

 

–160

 

–101

 

–80

 

–42

 

–21

 

–2 082

 

–1 770

 

General & Administration

 

–261

 

–248

 

–61

 

–66

 

–109

 

–98

 

–120

 

–105

 

–141

 

–112

 

–692

 

–629

 

Other income

 

104

 

107

 

6

 

11

 

86

 

30

 

29

 

41

 

71

 

5

 

296

 

194

 

Other expense

 

–178

 

–129

 

–17

 

–22

 

–112

 

–43

 

–18

 

–41

 

–145

 

–108

 

–470

 

–343

 

Core operating income

 

2 215

 

1 803

 

653

 

55

 

356

 

296

 

248

 

209

 

–268

 

–273

 

3 204

 

2 090

 

Income from associated companies

 

–8

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

258

 

266

 

252

 

266

 

Financial income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

104

 

58

 

Interest expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–156

 

–76

 

Income before taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3 404

 

2 338

 

Taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

–512

 

–371

 

Core net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2 892

 

1 967

 

Core basic EPS (USD)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.26

 

0.86

 

 

44


 


 

Supplementary tables: Full year 2009 — Net sales of top 20 pharmaceutical products (unaudited)

 

 

 

 

 

US

 

Rest of world

 

Total

 

Brands

 

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

 

2 492

 

4

 

3 521

 

7

 

6 013

 

5

 

6

 

Gleevec/Glivec

 

Chronic myeloid leukemia

 

1 088

 

21

 

2 856

 

9

 

3 944

 

7

 

12

 

Zometa

 

Cancer complications

 

718

 

8

 

751

 

9

 

1 469

 

6

 

9

 

Femara

 

Breast cancer

 

572

 

18

 

694

 

14

 

1 266

 

12

 

16

 

Lucentis

 

Age-related macular degeneration

 

 

 

 

 

1 232

 

47

 

1 232

 

39

 

47

 

Sandostatin

 

Acromegaly

 

458

 

6

 

697

 

8

 

1 155

 

3

 

7

 

Exelon/Exelon Patch

 

Alzheimer’s disease

 

362

 

30

 

592

 

18

 

954

 

17

 

22

 

Neoral/Sandimmun

 

Transplantation

 

90

 

–8

 

829

 

0

 

919

 

–4

 

–1

 

Voltaren (Excl. OTC)

 

Inflammation/pain

 

5

 

0

 

792

 

1

 

797

 

–2

 

1

 

Exforge

 

Hypertension

 

229

 

53

 

442

 

83

 

671

 

65

 

72

 

Top ten products total

 

 

 

6 014

 

11

 

12 406

 

13

 

18 420

 

9

 

12

 

Exjade

 

Iron chelator

 

247

 

16

 

405

 

34

 

652

 

23

 

27

 

Lescol

 

Cholesterol reduction

 

121

 

–21

 

442

 

–8

 

563

 

–13

 

–11

 

Comtan/Stalevo

 

Parkinson’s disease

 

217

 

9

 

337

 

17

 

554

 

10

 

14

 

Reclast/Aclasta

 

Osteoporosis

 

328

 

84

 

144

 

97

 

472

 

86

 

88

 

Ritalin/Focalin

 

Attention Deficit/Hyperactivity Disorder

 

343

 

–1

 

106

 

21

 

449

 

2

 

4

 

Tegretol

 

Epilepsy

 

91

 

–38

 

284

 

–1

 

375

 

–17

 

–13

 

Foradil

 

Asthma

 

14

 

0

 

343

 

3

 

357

 

–8

 

3

 

Myfortic

 

Transplantation

 

135

 

42

 

218

 

22

 

353

 

22

 

28

 

Xolair

 

Asthma

 

90

 

181

 

248

 

45

 

338

 

60

 

65

 

Lotrel

 

Hypertension

 

322

 

–17

 

 

 

 

 

322

 

–17

 

–17

 

Top 20 products total

 

 

 

7 922

 

10

 

14 933

 

13

 

22 855

 

9

 

12

 

Rest of portfolio

 

 

 

1 620

 

13

 

4 063

 

10

 

5 683

 

7

 

11

 

Total Division sales

 

 

 

9 542

 

11

 

18 996

 

12

 

28 538

 

8

 

12

 

 

45



 

Supplementary tables: Fourth quarter 2009 — Net sales of top 20 pharmaceutical products (unaudited)

 

 

 

 

 

US

 

Rest of world

 

Total

 

Brands

 

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

 

650

 

7

 

964

 

9

 

1 614

 

14

 

8

 

Gleevec/Glivec

 

Chronic myeloid leukemia

 

303

 

22

 

783

 

10

 

1 086

 

22

 

13

 

Zometa

 

Cancer complications

 

182

 

5

 

210

 

11

 

392

 

14

 

8

 

Femara

 

Breast cancer

 

150

 

22

 

191

 

10

 

341

 

22

 

15

 

Lucentis

 

Age-related macular degeneration

 

 

 

 

 

374

 

44

 

374

 

64

 

44

 

Sandostatin

 

Acromegaly

 

123

 

9

 

193

 

11

 

316

 

17

 

10

 

Exelon/Exelon Patch

 

Alzheimer’s disease

 

99

 

27

 

168

 

12

 

267

 

28

 

18

 

Neoral/Sandimmun

 

Transplantation

 

24

 

20

 

220

 

2

 

244

 

12

 

4

 

Voltaren (Excl. OTC)

 

Inflammation/pain

 

2

 

100

 

218

 

7

 

220

 

16

 

8

 

Exforge

 

Hypertension

 

63

 

43

 

133

 

56

 

196

 

66

 

52

 

Top ten products total

 

 

 

1 596

 

13

 

3 454

 

13

 

5 050

 

21

 

13

 

Exjade

 

Iron chelator

 

68

 

10

 

115

 

25

 

183

 

26

 

18

 

Lescol

 

Cholesterol reduction

 

31

 

–18

 

108

 

–10

 

139

 

–7

 

–13

 

Comtan/Stalevo

 

Parkinson’s disease

 

59

 

13

 

93

 

14

 

152

 

21

 

13

 

Reclast/Aclasta

 

Osteoporosis

 

100

 

69

 

47

 

54

 

147

 

73

 

65

 

Ritalin/Focalin

 

Attention Deficit/Hyperactivity Disorder

 

88

 

–10

 

32

 

23

 

120

 

0

 

–4

 

Tegretol

 

Epilepsy

 

18

 

–44

 

74

 

3

 

92

 

–5

 

–12

 

Foradil

 

Asthma

 

4

 

33

 

89

 

6

 

93

 

15

 

6

 

Myfortic

 

Transplantation

 

36

 

44

 

61

 

16

 

97

 

37

 

24

 

Xolair

 

Asthma

 

34

 

325

 

86

 

69

 

120

 

118

 

100

 

Lotrel

 

Hypertension

 

78

 

–13

 

 

 

 

 

78

 

–13

 

–13

 

Top 20 products total

 

 

 

2 112

 

13

 

4 159

 

14

 

6 271

 

21

 

13

 

Rest of portfolio

 

 

 

366

 

10

 

1 136

 

13

 

1 502

 

21

 

12

 

Total Division sales

 

 

 

2 478

 

12

 

5 295

 

14

 

7 773

 

21

 

13

 

 

46



 

Pharmaceutical net sales by therapeutic area — Full year (unaudited)

 

 

 

2009

 

2008

 

%
change

 

%
change

 

 

 

USD m

 

USD m

 

USD

 

lc

 

Cardiovascular and Metabolism

 

 

 

 

 

 

 

 

 

Diovan

 

6 013

 

5 740

 

5

 

6

 

Exforge

 

671

 

406

 

65

 

72

 

Lotrel

 

322

 

386

 

–17

 

–17

 

Tekturna/Rasilez

 

290

 

144

 

101

 

104

 

Galvus

 

181

 

43

 

321

 

327

 

Total strategic franchise products

 

7 477

 

6 719

 

11

 

13

 

Mature products (including Lescol)

 

1 319

 

1 464

 

–10

 

–7

 

Total Cardiovascular and Metabolism products

 

8 796

 

8 183

 

7

 

9

 

 

 

 

 

 

 

 

 

 

 

Oncology

 

 

 

 

 

 

 

 

 

Gleevec/Glivec

 

3 944

 

3 670

 

7

 

12

 

Zometa

 

1 469

 

1 382

 

6

 

9

 

Femara

 

1 266

 

1 129

 

12

 

16

 

Sandostatin

 

1 155

 

1 123

 

3

 

7

 

Exjade

 

652

 

531

 

23

 

27

 

Tasigna

 

212

 

89

 

138

 

145

 

Afinitor

 

70

 

1

 

NM

 

NM

 

Other

 

231

 

286

 

–19

 

–16

 

Total Oncology products

 

8 999

 

8 211

 

10

 

14

 

 

 

 

 

 

 

 

 

 

 

Neuroscience and Ophthalmics

 

 

 

 

 

 

 

 

 

Lucentis

 

1 232

 

886

 

39

 

47

 

Exelon/Exelon Patch

 

954

 

815

 

17

 

22

 

Comtan/Stalevo

 

554

 

502

 

10

 

14

 

Ritalin/Focalin

 

449

 

440

 

2

 

4

 

Tegretol

 

375

 

451

 

–17

 

–13

 

Trileptal

 

295

 

332

 

–11

 

–7

 

Extavia

 

49

 

 

 

NM

 

NM

 

Other

 

649

 

775

 

–16

 

–12

 

Total strategic franchise products

 

4 557

 

4 201

 

8

 

13

 

Mature products

 

384

 

404

 

–5

 

–1

 

Total Neuroscience and Ophthalmics products

 

4 941

 

4 605

 

7

 

12

 

 

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

 

 

Foradil

 

357

 

387

 

–8

 

3

 

Xolair

 

338

 

211

 

60

 

65

 

TOBI

 

300

 

295

 

2

 

4

 

Other

 

104

 

104

 

0

 

7

 

Total strategic franchise products

 

1 099

 

997

 

10

 

17

 

Mature products

 

88

 

87

 

1

 

–2

 

Total Respiratory products

 

1 187

 

1 084

 

10

 

15

 

 

 

 

 

 

 

 

 

 

 

Immunology and Infectious Diseases

 

 

 

 

 

 

 

 

 

Neoral/Sandimmun

 

919

 

956

 

–4

 

–1

 

Reclast/Aclasta

 

472

 

254

 

86

 

88

 

Myfortic

 

353

 

290

 

22

 

28

 

Certican

 

118

 

95

 

24

 

31

 

Other

 

232

 

177

 

31

 

36

 

Total strategic franchise products

 

2 094

 

1 772

 

18

 

22

 

Mature products

 

941

 

1 098

 

–14

 

–12

 

Total Immunology and Infectious Diseases products

 

3 035

 

2 870

 

6

 

9

 

 

 

 

 

 

 

 

 

 

 

Additional products

 

 

 

 

 

 

 

 

 

Voltaren (excluding OTC)

 

797

 

814

 

–2

 

1

 

Enablex/Emselex

 

223

 

201

 

11

 

13

 

Everolimus sales to stent manufacturers

 

215

 

 

 

NM

 

NM

 

Other

 

345

 

363

 

–5

 

–4

 

Total additional products

 

1 580

 

1 378

 

15

 

17

 

 

 

 

 

 

 

 

 

 

 

Total strategic franchise products

 

24 226

 

21 900

 

11

 

14

 

Total mature and additional products

 

4 312

 

4 431

 

–3

 

0

 

Total Division net sales(1)

 

28 538

 

26 331

 

8

 

12

 

 


NM — Not meaningful

 

(1) Full-year net sales in 2008 include a one-time contribution of USD 104 million in the second quarter of 2008. These brand-specific provision reversals were made 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.

 

47



 

Pharmaceutical net sales by therapeutic area — Fourth quarter (unaudited)

 

 

 

Q4 2009

 

Q4 2008

 

%
change

 

%
change

 

 

 

USD m

 

USD m

 

USD

 

lc

 

Cardiovascular and Metabolism

 

 

 

 

 

 

 

 

 

Diovan

 

1 614

 

1 419

 

14

 

8

 

Exforge

 

196

 

118

 

66

 

52

 

Lotrel

 

78

 

90

 

–13

 

–13

 

Tekturna/Rasilez

 

88

 

46

 

91

 

84

 

Galvus

 

66

 

17

 

288

 

211

 

Total strategic franchise products

 

2 042

 

1 690

 

21

 

14

 

Mature products (including Lescol)

 

322

 

328

 

–2

 

–9

 

Total Cardiovascular and Metabolism products

 

2 364

 

2 018

 

17

 

10

 

 

 

 

 

 

 

 

 

 

 

Oncology

 

 

 

 

 

 

 

 

 

Gleevec/Glivec

 

1 086

 

890

 

22

 

13

 

Zometa

 

392

 

345

 

14

 

8

 

Femara

 

341

 

279

 

22

 

15

 

Sandostatin

 

316

 

271

 

17

 

10

 

Exjade

 

183

 

145

 

26

 

18

 

Tasigna

 

68

 

32

 

113

 

101

 

Afinitor

 

32

 

1

 

NM

 

NM

 

Other

 

51

 

68

 

–25

 

–31

 

Total Oncology products

 

2 469

 

2 031

 

22

 

14

 

 

 

 

 

 

 

 

 

 

 

Neuroscience and Ophthalmics

 

 

 

 

 

 

 

 

 

Lucentis

 

374

 

228

 

64

 

44

 

Exelon/Exelon Patch

 

267

 

209

 

28

 

18

 

Comtan/Stalevo

 

152

 

126

 

21

 

13

 

Ritalin/Focalin

 

120

 

120

 

0

 

–4

 

Tegretol

 

92

 

97

 

–5

 

–12

 

Trileptal

 

68

 

73

 

–7

 

–13

 

Extavia

 

23

 

 

 

NM

 

NM

 

Other

 

165

 

162

 

2

 

–6

 

Total strategic franchise products

 

1 261

 

1 015

 

24

 

14

 

Mature products

 

98

 

91

 

8

 

–3

 

Total Neuroscience and Ophthalmics products

 

1 359

 

1 106

 

23

 

13

 

 

 

 

 

 

 

 

 

 

 

Respiratory

 

 

 

 

 

 

 

 

 

Xolair

 

120

 

55

 

118

 

100

 

Foradil

 

93

 

81

 

15

 

6

 

TOBI

 

81

 

76

 

7

 

4

 

Other

 

34

 

27

 

26

 

8

 

Total strategic franchise products

 

328

 

239

 

37

 

27

 

Mature products

 

23

 

21

 

10

 

1

 

Total Respiratory products

 

351

 

260

 

35

 

25

 

 

 

 

 

 

 

 

 

 

 

Immunology and Infectious Diseases

 

 

 

 

 

 

 

 

 

Neoral/Sandimmun

 

244

 

218

 

12

 

4

 

Reclast/Aclasta

 

147

 

85

 

73

 

65

 

Myfortic

 

97

 

71

 

37

 

24

 

Certican

 

36

 

23

 

57

 

39

 

Other

 

71

 

48

 

48

 

39

 

Total strategic franchise products

 

595

 

445

 

34

 

25

 

Mature products

 

234

 

245

 

–4

 

–10

 

Total Immunology and Infectious Diseases products

 

829

 

690

 

20

 

12

 

 

 

 

 

 

 

 

 

 

 

Additional products

 

 

 

 

 

 

 

 

 

Voltaren (excluding OTC)

 

220

 

190

 

16

 

8

 

Enablex/Emselex

 

59

 

52

 

13

 

14

 

Everolimus sales to stent manufacturers

 

32

 

 

 

NM

 

NM

 

Other

 

90

 

83

 

8

 

–2

 

Total additional products

 

401

 

325

 

23

 

14

 

 

 

 

 

 

 

 

 

 

 

Total strategic franchise products

 

6 695

 

5 420

 

24

 

16

 

Total mature and additional products

 

1 078

 

1 010

 

7

 

–1

 

Total Division net sales

 

7 773

 

6 430

 

21

 

13

 

 

NM — Not meaningful

 

48



 

Net sales by region(1) (unaudited)

 

Full year

 

 

 

 

 

 

 

% change

 

2009

 

 

 

 

 

2009
USD m

 

2008
USD m

 

USD

 

local
currencies

 

% of
total

 

2008
% of total

 

Pharmaceuticals

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

9 542

 

8 616

 

11

 

11

 

33

 

33

 

Europe

 

10 467

 

10 138

 

3

 

12

 

37

 

38

 

Asia / Africa / Australasia

 

6 079

 

5 231

 

16

 

13

 

21

 

20

 

Canada and Latin America

 

2 450

 

2 346

 

4

 

13

 

9

 

9

 

Total

 

28 538

 

26 331

 

8

 

12

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccines and Diagnostics

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

973

 

765

 

27

 

27

 

40

 

43

 

Europe

 

1 083

 

683

 

59

 

60

 

45

 

39

 

Asia / Africa / Australasia

 

303

 

281

 

8

 

9

 

12

 

16

 

Canada and Latin America

 

65

 

30

 

117

 

138

 

3

 

2

 

Total

 

2 424

 

1 759

 

38

 

39

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sandoz

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

1 847

 

1 766

 

5

 

5

 

25

 

24

 

Europe

 

4 271

 

4 481

 

–5

 

4

 

57

 

59

 

Asia / Africa / Australasia

 

820

 

764

 

7

 

11

 

11

 

10

 

Canada and Latin America

 

555

 

546

 

2

 

10

 

7

 

7

 

Total

 

7 493

 

7 557

 

–1

 

5

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consumer Health

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

1 892

 

1 714

 

10

 

10

 

33

 

29

 

Europe

 

2 541

 

2 732

 

–7

 

2

 

44

 

47

 

Asia / Africa / Australasia

 

883

 

863

 

2

 

2

 

15

 

15

 

Canada and Latin America

 

496

 

503

 

–1

 

7

 

8

 

9

 

Total

 

5 812

 

5 812

 

0

 

5

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Group

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

14 254

 

12 861

 

11

 

11

 

32

 

31

 

Europe

 

18 362

 

18 034

 

2

 

10

 

42

 

44

 

Asia / Africa / Australasia

 

8 085

 

7 139

 

13

 

11

 

18

 

17

 

Canada and Latin America

 

3 566

 

3 425

 

4

 

13

 

8

 

8

 

Total

 

44 267

 

41 459

 

7

 

11

 

100

 

100

 

 


(1) Net sales from operations by location of third party customer

 

49



 

Net sales by region(1) (unaudited)

 

Fourth quarter

 

 

 

 

 

 

 

% change

 

Q4 2009

 

 

 

 

 

Q4 2009
USD m

 

Q4 2008
USD m

 

USD

 

local
currencies

 

% of
total

 

Q4 2008
% of total

 

Pharmaceuticals

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

2 478

 

2 210

 

12

 

12

 

32

 

34

 

Europe

 

2 909

 

2 317

 

26

 

14

 

37

 

36

 

Asia / Africa / Australasia

 

1 696

 

1 348

 

26

 

15

 

22

 

21

 

Canada and Latin America

 

690

 

555

 

24

 

9

 

9

 

9

 

Total

 

7 773

 

6 430

 

21

 

13

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vaccines and Diagnostics

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

591

 

181

 

227

 

229

 

43

 

37

 

Europe

 

647

 

199

 

225

 

192

 

47

 

41

 

Asia / Africa / Australasia

 

127

 

105

 

21

 

6

 

9

 

21

 

Canada and Latin America

 

22

 

6

 

267

 

250

 

1

 

1

 

Total

 

1 387

 

491

 

183

 

166

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sandoz

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

536

 

439

 

22

 

21

 

25

 

24

 

Europe

 

1 196

 

1 044

 

15

 

4

 

56

 

58

 

Asia / Africa / Australasia

 

245

 

192

 

28

 

13

 

11

 

11

 

Canada and Latin America

 

166

 

129

 

29

 

14

 

8

 

7

 

Total

 

2 143

 

1 804

 

19

 

10

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Consumer Health

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

563

 

434

 

30

 

30

 

35

 

32

 

Europe

 

675

 

594

 

14

 

5

 

41

 

44

 

Asia / Africa / Australasia

 

239

 

202

 

18

 

5

 

15

 

15

 

Canada and Latin America

 

146

 

122

 

20

 

7

 

9

 

9

 

Total

 

1 623

 

1 352

 

20

 

13

 

100

 

100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Group

 

 

 

 

 

 

 

 

 

 

 

 

 

US

 

4 168

 

3 264

 

28

 

27

 

32

 

32

 

Europe

 

5 427

 

4 154

 

31

 

18

 

42

 

41

 

Asia / Africa / Australasia

 

2 307

 

1 847

 

25

 

13

 

18

 

19

 

Canada and Latin America

 

1 024

 

812

 

26

 

11

 

8

 

8

 

Total

 

12 926

 

10 077

 

28

 

20

 

100

 

100

 

 


(1) Net sales from operations by location of third party customer

 

50



 

Quarterly analysis (unaudited)

 

Key figures by quarter

 

 

 

Q4 2009

 

Q3 2009

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Net sales

 

12 926

 

11 086

 

1 840

 

17

 

Operating income

 

2 637

 

2 634

 

3

 

0

 

Financial income

 

104

 

51

 

53

 

104

 

Interest expense

 

–156

 

–173

 

17

 

–10

 

Taxes

 

–369

 

–379

 

10

 

–3

 

Net income

 

2 323

 

2 112

 

211

 

10

 

 

Net sales by region

 

 

 

Q4 2009

 

Q3 2009

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

US

 

4 168

 

3 508

 

660

 

19

 

Europe

 

5 427

 

4 607

 

820

 

18

 

Asia / Africa / Australasia

 

2 307

 

2 038

 

269

 

13

 

Canada and Latin America

 

1 024

 

933

 

91

 

10

 

Total

 

12 926

 

11 086

 

1 840

 

17

 

 

Net sales by division

 

 

 

Q4 2009

 

Q3 2009

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Pharmaceuticals

 

7 773

 

7 217

 

556

 

8

 

Vaccines and Diagnostics

 

1 387

 

543

 

844

 

155

 

Sandoz

 

2 143

 

1 850

 

293

 

16

 

Consumer Health

 

1 623

 

1 476

 

147

 

10

 

Total

 

12 926

 

11 086

 

1 840

 

17

 

 

Core operating income by division

 

 

 

Q4 2009

 

Q3 2009

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Pharmaceuticals

 

2 215

 

2 364

 

–149

 

–6

 

Vaccines and Diagnostics

 

653

 

102

 

551

 

NM

 

Sandoz

 

356

 

385

 

–29

 

–8

 

Consumer Health

 

248

 

323

 

–75

 

–23

 

Corporate Income & Expense, net

 

–268

 

–215

 

–53

 

25

 

Core operating income

 

3 204

 

2 959

 

245

 

8

 

 

NM — Not meaningful

 

51



 

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: January 26, 2010

By:

 /s/ MALCOLM B. CHEETHAM

 

 

 

Name:

Malcolm B. Cheetham

 

Title:

Head Group Financial

 

 

Reporting and Accounting

 

52