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 April 20, 2010

(Commission File No. 1-15024)

 


 

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

 

1 Core results for operating income, net income and earnings per share (EPS) eliminate the amortization of intangible assets, the impact of acquisition-related factors and other significant exceptional items. See page 31 for further information.

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

 

 

 



 

 

 

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

 

 

 

 

 

 

- Investor Relations Release -

 

Novartis healthcare portfolio generates strong growth in first quarter of 2010, progress on delivering innovation, growth and productivity

 

·                  Portfolio rejuvenation underpins positive momentum in first quarter of 2010:

 

·                  Net sales up 25% (+18% in constant currencies, or cc) to USD 12.1 billion as Group’s recently launched products (USD 1.9 billion) contribute 16% of net sales, while sales recognition of A (H1N1) pandemic flu vaccine contracts adds USD 1.1 billion

 

·                  Operating income grows 50% (+42% cc) to USD 3.5 billion; core operating income up 48% (+41% cc) to USD 3.9 billion, core margin improves to 31.9% of net sales

 

·                  Net income rises 49% (+41% cc) to USD 2.9 billion; core net income grows 44% (+36% cc) to USD 3.3 billion

 

·                  EPS up 48% (+40% cc) to USD 1.29; core EPS rises 44% (+36% cc) to USD 1.45

 

·                  Free cash flow before dividends (USD 2.9 billion, +93%) nearly doubles on strong business performance and impact of initiatives to reduce cash conversion cycles

 

·                  Making progress in 2010 as new leadership team implements strategic priorities with continued focus on innovation, growth and productivity

 

·                  Extending innovation lead: Approvals for Menveo vaccine (US/EU) and three new medicines in Japan; US priority review status for Tasigna (cancer) and Gilenia (MS)

 

·                  Driving growth: Ongoing expansion in top emerging markets, EBEWE Pharma accelerating Sandoz, adapting commercial models in China and the US

 

·                  Improving productivity: All businesses driving productivity initiatives and targeted resource allocation to improve growth and profitability

 

·                  Alcon to be new growth platform: Completion of acquisition of 77% majority Alcon stake on track for second half of 2010; merger proposal in interest of all stakeholders

 

Key figures

First quarter

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Net sales

 

12 131

 

9 709

 

25

 

18

 

Operating income

 

3 511

 

2 347

 

50

 

42

 

Net income

 

2 948

 

1 975

 

49

 

41

 

EPS (USD)

 

1.29

 

0.87

 

48

 

40

 

Free cash flow
(before dividends)

 

2 903

 

1 506

 

93

 

 

 

Core(1)

 

 

 

 

 

 

 

 

 

Operating income

 

3 865

 

2 611

 

48

 

41

 

Net income

 

3 309

 

2 302

 

44

 

36

 

EPS (USD)

 

1.45

 

1.01

 

44

 

36

 

 

2



 

Basel, April 20, 2010Commenting on the results, Joseph Jimenez, CEO of Novartis, said: “I am pleased with the strong growth generated in the first quarter of 2010 across our entire healthcare portfolio. All of our businesses are making good progress, particularly the sustained expansion in Pharmaceuticals and the strong contributions from supply contracts for A (H1N1) pandemic flu vaccines. We are focusing on extending our lead in innovation, driving growth and improving productivity, which we believe will generate greater sustainable value from our portfolio. The growing contributions from products launched since 2007 are rejuvenating our portfolio and are the result of our commitment to innovation and successful R&D investments. We are intensifying productivity efforts to improve profitability as well as to enable continued investments in drug discovery and expansion into new markets. As we prepare for the integration of Alcon, which will create a new growth platform in eye care, we are building momentum in 2010 and achieving continued success.”

 

GROUP REVIEW

 

First quarter

Novartis delivered a strong performance in the first quarter of 2010 – particularly the rapid expansion of recently launched products and important regulatory approvals achieved for new medicines and vaccines – as the Group made progress with a sharp focus on innovation, growth and productivity.

 

Net sales rose 25% (+18% cc) to USD 12.1 billion on improvements in all businesses, particularly sales of A (H1N1) pandemic flu vaccines and rapid growth of recently launched products across the Group (USD 1.9 billion). Currency movements contributed seven percentage points to reported growth. Pharmaceuticals (USD 7.3 billion, +7% cc) advanced in all regions and maintained solid volume growth. Vaccines and Diagnostics (USD 1.4 billion, +436% cc) provided USD 1.1 billion from recognition of A (H1N1) pandemic vaccine sales. Sandoz (USD 2.0 billion, +9% cc) grew on successful new product launches and integration of EBEWE Pharma following the September 2009 acquisition. All Consumer Health businesses (USD 1.5 billion, +7% cc) had good performances and grew faster than their markets.

 

Operating income rose 50% (+42% cc) to USD 3.5 billion on the volume-driven sales expansion and significant contributions from Vaccines and Diagnostics, while also benefitting from eight percentage points of favorable currency movements. The operating income margin improved 4.7 percentage points to 28.9% of net sales from 24.2% in the 2009 period. Core operating income, which excludes exceptional items and amortization of intangible assets in both periods, rose 48% (+41% cc) to USD 3.9 billion, and the core operating income margin rose 5.0 percentage points to 31.9% of net sales from 26.9% in the year-ago quarter.

 

Net income advanced 49% (+41% cc) to USD 2.9 billion as contributions from associated companies and financial income more than offset increased interest expenses and a higher tax rate. Earnings per share (EPS) rose largely in line with net income to USD 1.29 from USD 0.87 in the 2009 period. Core net income grew 44% (+36% cc) to USD 3.3 billion, while core EPS was up 44% (+36% cc) in the first quarter to USD 1.45 from USD 1.01 in the year-ago period.

 

Delivering innovation, growth and productivity

 

Novartis continues to advance its strategy to meet the needs of patients everywhere with a broad healthcare portfolio that includes innovative medicines, preventive vaccines, cost-effective generics and self-care products. At the heart of this portfolio lies a sustained commitment to innovation, which has resulted in breakthrough products offering patients opportunities for improved health outcomes.

 

At a time of converging trends, which include rising global demand for medicines but also increasing cost-containment pressures, the new leadership team appointed in January 2010 has established priorities to deliver innovation, growth and productivity consistent with the Group’s aspiration to be the world’s most successful and respected healthcare company.

 

These priorities, aimed at creating greater value for patients, payors and physicians, include (1) extending the Group’s lead in innovation; (2) delivering sustainable growth through successful new product launches, investments to strengthen the business portfolio, and expansion in emerging markets; and (3) productivity initiatives that free up resources to improve profitability and support investments in innovation and growth.

 

3



 

Innovation

Innovation is the key driver of Novartis. The Group’s strong commercial position is the result of consistent R&D investments and a commitment to advancing treatment standards for patients.

 

An industry leader in new product approvals, Novartis achieved US and European Union approvals in the first quarter for Menveo, a new vaccine offering protection against four major serogroups of meningococcal meningitis, a potentially fatal bacterial disease. In Japan, three medicines – Afinitor (kidney cancer), Equa (type 2 diabetes) and Exforge (hypertension) – gained regulatory approvals in January. This follows approval of six medicines in 2009 in Japan, the Group’s second-largest market.

 

Two US regulatory submissions completed in late 2009 – Tasigna (cancer) and Gilenia (FTY720, multiple sclerosis) – were recognized in the first quarter of 2010 for their potential patient benefits. The US Food and Drug Administration granted these submissions priority review status, which accelerates the review of medicines that offer major advances or provide treatments where no adequate therapy exists. In the first quarter, a US filing was also made for Menveo to expand the use of this vaccine to children from age 2-10.

 

Many development projects are progressing toward regulatory submissions in 2010, with up to five in oncology: two additional indications for Afinitor as well as first submissions for the development projects SOM230 (Cushing’s disease), LBH589 (Hodgkin’s lymphoma) and EPO906 (ovarian cancer). Others include the first submission in Europe for MenB, which has the potential to become the first global vaccine against the B serogroup of meningococcal meningitis. However, one of the two Phase III trials involving ASA404 (cancer) was halted in March following an interim analysis of benefits for patients with non-small cell lung cancer (NSCLC). The Pharmaceuticals development project PTZ601 (infections) was also halted in the first quarter, resulting in a pre-tax impairment charge of USD 152 million (USD 57 million after release of deferred tax provisions).

 

Growth

New products, the result of successful R&D investments, are rejuvenating the Novartis portfolio together with initiatives to strengthen positions in emerging markets, build global businesses of scale, develop new commercial skills and improve talent. Contributions from recently launched products across the Group rose 68% to USD 1.9 billion in the first quarter, representing 16% of net sales compared to 12% in the 2009 period. In Pharmaceuticals, recently launched products provided USD 1.5 billion of net sales in the 2010 period, representing 20% of the division’s net sales compared to 14% in the 2009 quarter.

 

Targeted expansion in emerging markets is generating significant growth despite the financial crisis, which continues to impact some countries. In the first quarter, net sales from the top six emerging markets rose 38% (+22% cc) to USD 1.2 billion, driven by China and India. These six markets, which also include Brazil, Russia and South Korea, represented 9.6% of Group net sales, up from 8.7% in the 2009 period, more than offsetting cost-containment measures in Turkey.

 

Healthcare markets around the world are evolving rapidly, driven by factors such as intensifying cost-containment initiatives, a more challenging regulatory environment and the changing roles of physicians and payors. Novartis is constantly seeking ways to address these changes. Three important new initiatives were announced in the first quarter of 2010.

 

In China, a new regional operating structure is being implemented in Pharmaceuticals to recognize the diversity of China’s regions to better address local market needs as the government, and Novartis, make major long-term investments to improve healthcare access and quality.

 

In anticipation of changes to the product portfolio in the US, which includes expected approvals for a number of new specialty medicines but also the loss of market exclusivity for Diovan and other medicines in the next few years, Novartis has further streamlined its US business in Pharmaceuticals to maximize the potential of the changing portfolio in both primary care and specialty markets. This initiative, announced in April 2010, will create three national specialty businesses focused on multiple sclerosis, respiratory diseases and neuroscience to complement the existing Oncology business unit. In addition, a fourth business for primary care medicines, including the cardiovascular portfolio, will be consolidated into four regional units (reduction from the current five units). Approximately 383 full-time equivalent positions, primarily in headquarter-based functions, are to be reduced in a socially responsible manner, with 35% expected to be achieved by not filling vacant positions. A one-time charge of USD 24 million is planned to be taken in the second quarter of 2010, with annual cost savings of USD 56 million anticipated from 2011.

 

4



 

In addition, “Customers First” was launched in February 2010 after pilot programs to accelerate collaboration across the businesses in 45 countries – including the US, top European markets and Japan – that together represent 95% of Group net sales. Local cross-divisional teams are identifying ways to increase opportunities with key customers while increasing customer service and productivity.

 

Productivity

Novartis is now implementing a continuous focus on agility, efficiency, productivity and resource allocation throughout its operations, freeing up resources to improve profitability as well as to invest in future growth, particularly promising pipeline projects and emerging markets.

 

In the first quarter of 2010, the core operating income margin improved five percentage points to 31.9% of net sales over the 2009 period, supported by continuing improvements in productivity. Key areas of improvement in the 2010 quarter included Marketing & Sales in Pharmaceuticals, which declined to 27.9% of net sales in the first quarter of 2010 from 29.5% in the 2009 period, supported by the “geo-tailoring” strategy to adapt sales forces to local market needs while supporting new product launches. Offsetting these improvements was an increase in Cost of Goods Sold; this is partly the result of sustained reductions in inventory and productivity efforts, which has created excess capacity and lower fixed overhead absorption. Simplification of manufacturing operations is under review. Sandoz continues to improve manufacturing productivity, enabling it to absorb the impact of price erosion and improve its core operating income margin by 2.4 percentage points to 22.5% of net sales. Continuing improvements in gross margin have enabled Consumer Health to make significant investments in the launch of Prevacid24HR in the US without an adverse impact on the operating income margin.

 

Completion of the Alcon transactions will require a sharper focus on further improving free cash flow, which rose 93% to USD 2.9 billion in the first quarter of 2010 (before dividends). This improvement is a direct consequence of the strong sales of A (H1N1) pandemic vaccines as well as programs in the divisions to significantly reduce cash conversion cycles. The Group’s goal is to return to a net cash position within four years after completion of the Alcon transactions. Internal and external investments will continue to target growth opportunities offering potential to earn a premium on the Group’s cost of capital and strengthen the healthcare portfolio.

 

Alcon

The addition of Alcon, the global leader in eye care, will create a new growth platform in the fast-growing eye care sector. Novartis announced on January 4 plans to gain full ownership of Alcon by first completing the agreement to acquire a 77% majority stake – on track for completion in the second half of 2010 – and subsequently entering into an all-share direct merger with Alcon for the remaining 23% minority stake. Following the merger under Swiss law, Alcon will become a new division that incorporates CIBA Vision and certain Novartis ophthalmic medicines.

 

2010 outlook

Novartis is building momentum in 2010 and reaffirms expectations for Group net sales to grow at a mid-single-digit percentage rate in constant currencies (excluding Alcon) and for improvement in the Group’s operating income margin in 2010, driven by the business expansion and ongoing productivity gains. The strong sales and profit contributions in the first quarter of 2010 from fulfillment of agreed-upon government supply contracts for A (H1N1) pandemic vaccines, with sales approximately USD 400 million above the Group’s target at the beginning of the year, will further strengthen these prospects. If exchange rates remain at their current levels for the remainder of the year, reported and constant currency growth rates would be broadly similar.

 

Pharmaceuticals is continuing the strong volume growth from 2009 amid uncertain pricing conditions, with net sales reaffirmed to grow in 2010 at a mid- to high-single digit rate in constant currencies. In addition to the exceptional sales contributions from A (H1N1) pandemic vaccines, Vaccines and Diagnostics is launching the new Menveo vaccine in the US and Europe while expanding in targeted emerging markets. Sandoz is increasing its pace of sales growth in 2010 on contributions from all regions and the integration of EBEWE Pharma coupled with a renewed focus on productivity, while Consumer Health aims to keep growing ahead of its markets after a successful start to the year.

 

5



 

HEALTHCARE BUSINESS REVIEW

 

Pharmaceuticals

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Net sales

 

7 291

 

6 433

 

13

 

7

 

Operating income

 

2 327

 

2 062

 

13

 

7

 

As % of net sales

 

31.9

 

32.1

 

 

 

 

 

Core operating income

 

2 431

 

2 171

 

12

 

6

 

As % of net sales

 

33.3

 

33.7

 

 

 

 

 

 

First quarter

 

Net sales

Net sales expanded 13% to USD 7.3 billion (+7% in cc), driven by volume expansion. Recently launched products provided USD 1.5 billion of net sales in the 2010 period, representing 20% of net sales compared to 14% in the 2009 quarter. These products launched since 2007 – which include Lucentis, Exforge, Exelon Patch, Exjade, Reclast/Aclasta, Tekturna/Rasilez, Tasigna, Afinitor, Onbrez Breezhaler, Ilaris and Fanapt – contributed substantially to the division’s 7% cc net sales growth in the quarter.

 

All regions continued to benefit from the product portfolio transformation, particularly Europe (USD 2.8 billion, +10% cc) generating 25% of its net sales from recently launched products. Latin America and Canada maintained solid growth rates (USD 0.6 billion, +12% cc). Japan (USD 0.7 billion, -4% cc) was impacted by a slowdown in demand ahead of the biennial price cuts in April, masking underlying momentum from the regulatory approvals of nine new medicines since 2009. The six top emerging markets (USD 690 million, +9% cc) were led by double-digit gains in China, India, South Korea and Brazil, but more than offseting cost-containment measures in Turkey.

 

All therapeutic areas contributed to the business expansion. Oncology (USD 2.4 billion, +14% cc), the largest franchise, was led by sustained growth of Gleevec/Glivec (USD 1.0 billion, +8% cc) and Femara (USD 344 million, +15% cc), and important contributions from the recently launched products Exjade (USD 179 million, +39% cc), Tasigna (USD 75 million, +102% cc) and Afinitor (USD 41 million). Cardiovascular and Metabolism (USD 1.9 billion, +7% cc) was affected by Diovan (USD 1.4 billion, –1% cc), driven by the slowdown in demand ahead of the biennial price cut in Japan. Neuroscience and Ophthalmics (USD 901 million, +24% cc) saw rapid growth from Lucentis (USD 364 million, +43% cc) and Exelon/Exelon Patch (USD 251 million, +17% cc).

 

Operating income

Operating income rose 13% (+7% in cc) to USD 2.3 billion. The operating income margin of 31.9% of net sales was impacted by an impairment charge in R&D of USD 152 million after discontinuation of PTZ601, an anti-infective development project, while an asset write-up in Cost of Goods Sold of USD 100 million and an exceptional settlement gain in Other Income of USD 42 million were both related to the recent settlement with Teva regarding Famvir.

 

Core operating income grew 12% (+6% cc) to USD 2.4 billion. The core operating income margin of 33.3% of net sales was affected by lower Other Revenues and sales to other divisions (–0.7 percentage points) as well as higher Cost of Goods Sold (–1.0 percentage points) as a result of lower fixed overhead absorption and a devaluation of inventories to reflect lower standard costs, in addition to higher royalties. R&D improved 0.7 percentage points, mainly driven by phasing of clinical trial activities. Marketing & Sales and General & Administrative expenses benefited from continued productivity efforts, improving 1.7 percentage points compared to the same period in 2009. Higher net costs from Other Income and Expense (–1.1 percentage points) were mainly due to the 2009 period benefiting from provision reversals for launch product inventories.

 

6



 

Cardiovascular and Metabolism

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Hypertension medicines

 

1 735

 

1 590

 

9

 

5

 

Diovan

 

1 442

 

1 402

 

3

 

–1

 

Exforge

 

204

 

136

 

50

 

42

 

Tekturna/Rasilez

 

89

 

52

 

71

 

66

 

Galvus

 

76

 

26

 

192

 

176

 

Lotrel

 

73

 

83

 

–12

 

–12

 

Total strategic products

 

1 884

 

1 699

 

11

 

7

 

Mature products

 

295

 

331

 

–11

 

–16

 

Total

 

2 179

 

2 030

 

7

 

3

 

 

An expanding portfolio of high blood pressure medicines (USD 1.7 billion, +5% cc) has enabled Novartis to increase its leadership of the global branded hypertension market segment, achieving a 15.3% share in January 2010 compared to 14.4% in January 2009 (Source: IMS Health). Single-pill combinations based on valsartan (Diovan) and aliskiren (Tekturna/Rasilez) now provide over half of these sales, reflecting the continuing shift toward use of combination therapies.

 

Diovan (USD 1.4 billion, –1% cc) sales declined in the first quarter, mainly driven by a slowdown in the angiotensin receptor blocker (ARB) market in Japan ahead of the biennial price cut. In the US, Diovan reached sales of USD 588 million (+1% cc) in the first quarter, maintaining its leading share of the ARB segment with a 41.3% share in February 2010 (+1.1 percentage points vs. December 2009 and +0.9 percentage points vs. February 2009, Source: IMS Health). Diovan is the only medicine in the ARB class approved to treat the three major cardiovascular indications: high blood pressure, high-risk heart attack and heart failure.

 

Exforge (USD 204 million, +42% cc) continued to deliver strong growth on geographic expansion and the launch of Exforge HCT in the US and Europe. Exforge, a single-pill combination of Diovan (valsartan) and the calcium channel blocker amlodipine, has been consistently setting new standards for high blood pressure combination therapies since its first launch in 2007. Exforge received regulatory approval in Japan in January 2010, while Exforge HCT, which adds a diuretic in a single pill, has been a key growth driver in both the US and Europe.

 

Tekturna/Rasilez (USD 89 million, +66% cc) has a high growth rate supported by geographic expansion and launches of the single-pill combinations Tekturna/Rasilez HCT and Valturna. Tekturna/Rasilez is the only approved high blood pressure therapy in a new class of medicines known as direct renin inhibitors. The US is benefiting from the new growth driver Valturna, a single-pill therapy of aliskiren and valsartan launched in late 2009. Other single-pill combinations in development are a combination of aliskiren and amlodipine, currently under regulatory review in the US and Europe, and a triple-combination therapy with aliskiren, amlodipine and a diuretic expected to be submitted for US regulatory approval in 2010.

 

Galvus/Eucreas (USD 76 million, +176% cc), oral treatments for type 2 diabetes, has delivered sustained growth in many markets, particularly Germany, Spain, Brazil, Korea and India. Galvus was approved in Japan in January 2010 under the brand name Equa.

 

7



 

Oncology

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Gleevec/Glivec

 

1 032

 

894

 

15

 

8

 

Zometa

 

375

 

342

 

10

 

5

 

Femara

 

344

 

286

 

20

 

15

 

Sandostatin

 

310

 

258

 

20

 

14

 

Exjade

 

179

 

122

 

47

 

39

 

Tasigna

 

75

 

35

 

114

 

102

 

Afinitor

 

41

 

1

 

NM

 

NM

 

Other

 

49

 

59

 

–17

 

–22

 

Total

 

2 405

 

1 997

 

20

 

14

 

 


NM – Not meaningful

 

Gleevec/Glivec (USD 1.0 billion, +8% cc) has sustained growth through continued expansion in chronic myeloid leukemia (CML) as well as adjuvant treatment of gastrointestinal stromal tumors (GIST). Gleevec/Glivec, a targeted therapy for certain forms of CML and GIST, was most recently approved in 2009 for use in adjuvant (post-surgery) GIST patients, with approvals now achieved in more than 55 countries in North America, Europe and Asia-Pacific.

 

Tasigna (USD 75 million, +102% cc) has been growing rapidly on geographic expansion given the approvals in more than 80 countries and market penetration as a second-line therapy for patients with certain forms of CML resistant or intolerant to prior therapy including Gleevec/Glivec. In December 2009, Tasigna was submitted for US, European and other approvals worldwide for use in certain newly diagnosed chronic-phase CML patients based on data from the ENESTnd trial, the largest ever head-to-head comparison of a targeted therapy against Glivec. In February 2010, Tasigna received priority review status in the US for this submission. Trials are also underway examining the use of Tasigna in CML patients with suboptimal response to Glivec and in patients with metastatic GIST.

 

Zometa (USD 375 million, +5% cc) expansion has come from improved compliance and use of this intravenous bisphosphonate therapy in patients with certain types of cancer that has spread to bones, particularly in key European markets. US and European regulatory submissions were completed in late 2009 for use in adjuvant breast cancer in premenopausal women.

 

Femara (USD 344 million, +15% cc) achieved ongoing double-digit growth on market share gains in the US and key European markets, mainly Germany, France, Italy and Denmark. The use of Femara, an oral therapy for postmenopausal women with hormone sensitive breast cancer, has driven approximately 70% of overall aromatase inhibitor market segment growth around the world, particularly in the initial adjuvant (post-surgery) setting (Source: IMS Health Q4 2009).

 

Sandostatin (USD 310 million, +14% cc) benefited from increasing use of Sandostatin LAR in neuroendocrine tumors (NET).

 

Exjade (USD 179 million, +39% cc) has continued to expand on increased average dosing and improved adherence to therapy in the US, while also expanding in the Middle East. Exjade, currently approved in more than 100 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 extending the dose range to 40 mg/kg.

 

Afinitor (USD 41 million) has seen strong uptake following recent launches in key European markets. Afinitor, an oral inhibitor of the mTOR pathway, was launched in the US, Europe, Switzerland and Japan after first regulatory approvals in 2009 as a new treatment for advanced renal cell carcinoma (RCC, kidney cancer) following VEGF-targeted therapy. Afinitor, now approved in 49 countries, is being studied in many other 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 trials involving patients with neuroendocrine tumors (NET) as well as TSC. A late-stage trial in patients with hepatocellular carcinoma (HCC) will be initiated in the second quarter.

 

8



 

Neuroscience and Ophthalmics

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Lucentis

 

364

 

229

 

59

 

43

 

Exelon/Exelon Patch

 

251

 

203

 

24

 

17

 

Comtan/Stalevo

 

141

 

123

 

15

 

9

 

Fanapt

 

21

 

 

 

 

 

 

 

Extavia

 

20

 

3

 

NM

 

NM

 

Other

 

104

 

117

 

–11

 

–17

 

Total strategic products

 

901

 

675

 

33

 

24

 

Mature products

 

133

 

131

 

2

 

–7

 

Total

 

1 034

 

806

 

28

 

19

 

 


NM – Not meaningful

 

Lucentis (USD 364 million, +43% cc) continued to deliver strong growth, particularly in France, the UK, Australia and Japan, where it was launched in early 2009. This biotechnology eye therapy, which is approved in more than 80 countries for “wet” age-related macular degeneration, has now been used in more than 250,000 patients for this disease, a leading cause of blindness in people over age 50. A regulatory submission for this indication was accepted in April in China. In December 2009, a regulatory submission was filed in Europe for treatment of visual impairment due to diabetic macular edema (DME). Genentech holds the US rights to this medicine.

 

Exelon/Exelon Patch (USD 251 million, +17% cc) has been driven by Exelon Patch since its first launch in 2007, generating more than 60% of total Exelon sales in the first quarter of 2010 compared to 46% in the 2009 period. In February, this therapy for mild to moderate forms of Alzheimer’s disease dementia (approved in Europe) as well as dementia linked with Parkinson’s disease (approved in the US) was also submitted for regulatory approval in Japan.

 

Extavia (USD 20 million) has grown from geographic expansion in key markets, particularly Russia, Italy, Spain and the US, and expansion in Germany. Extavia, the Novartis-branded version of Betaferon®/Betaseron® for relapsing forms of multiple sclerosis, was launched in the US in 2009, and in over 20 other countries, including Canada and Russia, in 2010.

 

Respiratory

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Xolair

 

80

 

61

 

31

 

24

 

TOBI

 

65

 

74

 

–12

 

–14

 

Other

 

2

 

–1

 

NM

 

NM

 

Total strategic products

 

147

 

134

 

10

 

5

 

Mature products

 

49

 

53

 

–8

 

–15

 

Total

 

196

 

187

 

5

 

–1

 

 


NM – Not meaningful

 

Xolair (USD 80 million, +24% cc) has been growing in major European and Latin American markets as well as in Japan after its recent launch. The first quarter of 2010 also included lower sales to Genentech compared to the 2009 period for the US, where Novartis co-promotes Xolair with Genentech and shares a portion of operating income. Xolair, a biotechnology drug for moderate to severe persistent allergic asthma in the US and severe persistent allergic asthma in Europe, has a global presence with approvals in more than 80 countries. Phase III trials in China are planned to start in 2010 to support regulatory submissions in this country.

 

Onbrez Breezhaler (QAB149) (USD 3 million) a once-daily long-acting bronchodilator for adult patients with chronic obstructive pulmonary disease (COPD), was launched in Germany in December 2009 as well as Ireland and Denmark in March 2010 after European regulatory approval in November 2009. More than 20 launches are planned globally for the second half of 2010, including in the UK, Spain, Brazil and Mexico. Regulatory submissions are also planned for 2010 in Japan and China. In the US, all clinical studies to support resubmission have been started following a Complete Response letter from the FDA in October 2009 requesting additional data.

 

9



 

Immunology and Infectious Diseases

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Neoral/Sandimmun

 

212

 

221

 

–4

 

–10

 

Reclast/Aclasta

 

123

 

85

 

45

 

41

 

Myfortic

 

100

 

73

 

37

 

27

 

Certican

 

34

 

23

 

48

 

36

 

Other

 

71

 

46

 

54

 

43

 

Total strategic products

 

540

 

448

 

21

 

14

 

Mature products

 

207

 

220

 

–6

 

–11

 

Total

 

747

 

668

 

12

 

6

 

 

Reclast/Aclasta (USD 123 million, +41% cc) has maintained a strong growth pace driven by the US and geographic expansion. Reclast/Aclasta, a once-yearly infusion therapy for osteoporosis, has benefited from increasing patient access to infusion centers and a broad range of use in patients with various types of this debilitating bone disease.

 

Certican (USD 34 million, +36% cc), a transplantation medicine, is now available in more than 70 countries for use in the prevention of organ rejection based on its immunosuppressive efficacy and side-effect profile. Discussions are continuing with the FDA on product labeling and a Risk Evaluation Mitigation Strategy (REMS) to gain US regulatory approval (under the brand name Zortress) for prevention of organ rejection in adult kidney transplant patients. The FDA issued a Complete Response letter in December 2009, but did not request additional clinical trials.

 

Ilaris (ACZ885) (USD 4 million), a fully human monoclonal antibody that blocks action of the inflammatory protein interleukin-1 beta, has received additional regulatory approvals in Canada (February) and Brazil (March) following US and European regulatory approvals in 2009 for treatment of cryopyrin-associated periodic syndrome (CAPS), a group of rare auto-inflammatory disorders. Submissions of ACZ885 for use in the treatment of hard-to-treat gout are planned for late 2010. Trials are ongoing in other diseases in which IL-1 beta is believed to play an important role, including chronic obstructive pulmonary disease (COPD), type 2 diabetes and systemic juvenile idiopathic arthritis (SJIA).

 

10



 

Vaccines and Diagnostics

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Net sales

 

1 361

 

247

 

451

 

436

 

Operating income

 

839

 

–67

 

NM

 

NM

 

As % of net sales

 

61.6

 

 

 

 

 

 

 

Core operating income

 

923

 

9

 

NM

 

NM

 

As % of net sales

 

67.8

 

3.6

 

 

 

 

 

 


NM – Not meaningful

 

First quarter

 

Net sales

The further deliveries for many supply contracts with governments around the world for A (H1N1) pandemic flu vaccines and adjuvants generated net sales of USD 1.1 billion, resulting in the strong overall four-fold increase compared to the year-ago period. The vast majority came from recognition of sales for deliveries made during the first quarter as part of supply contracts reached in 2009. The new vaccine Menveo was also launched in March after US and European regulatory approvals for initial use from age 11 and older against four meningococcal meningitis serogroups. Sales in other areas, including diagnostics and tick-borne encephalitis vaccines, were broadly unchanged in the 2010 period compared to 2009.

 

Novartis has now largely finished deliveries of A (H1N1) pandemic vaccines and adjuvants to fulfill agreements with various governments, including the United States, following the pandemic outbreak in mid-2009, and production of A (H1N1) monovalent doses has been stopped.

 

Following the declaration of the pandemic in 2009, Novartis made significant investments that enabled the delivery of more than 150 million A (H1N1) pandemic vaccine doses through the end of the first quarter of 2010. More than 30,000 people were enrolled in A (H1N1) pandemic vaccine clinical trials, while three different technology platforms (traditional egg-based, cell-culture-based and MF-59 adjuvanted vaccines) received regulatory approvals to maximize the vaccine supply. Novartis also deployed more than 1,000 associates from other divisions within the Group to support these initiatives.

 

Operating income

Operating income in the first quarter of 2010 was USD 839 million compared to an operating loss of USD 67 million in the 2009 period based on contributions of A (H1N1) pandemic vaccines in the 2010 period, which were made possible by major investments in 2009.

 

Core operating income rose to USD 923 million from USD 9 million in the year-ago quarter. Significant investments were made in the first quarter of 2010 in R&D, including post-marketing commitments for A (H1N1) pandemic vaccines as well as the late-stage Menveo and MenB clinical development programs. Higher Marketing & Sales investments in the first quarter of 2010 over the 2009 period supported geographic expansion, particularly in emerging markets, and the build-up of sales and marketing infrastructure for the Menveo launch in the US.

 

11



 

Sandoz

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Net sales

 

2 001

 

1 726

 

16

 

9

 

Operating income

 

310

 

291

 

7

 

–1

 

As % of net sales

 

15.5

 

16.9

 

 

 

 

 

Core operating income

 

450

 

347

 

30

 

21

 

As % of net sales

 

22.5

 

20.1

 

 

 

 

 

 

First quarter

 

Net sales

All regions and businesses supported accelerating growth (USD 2.0 billion, +16%, +9% cc) compared to 2009 as 17 percentage points of volume expansion from new product launches, the inclusion of EBEWE Pharma’s specialty generics business since September 2009 and continued strong results from biosimilars more than offset price erosion of eight percentage points.

 

US retail generics and biosimilars (+19% cc) delivered successful new product launches (tacrolimus, lansoprazole and oxaliplatin) as well as improvements in sales of antibiotics and injectable oncology medicines. German retail generics and biosimilars (+5% cc) grew in a declining market, strengthening its leadership position while adapting its business model to compete effectively in the tender systems adopted by some major healthcare providers in 2009. In Western Europe (+11% cc), many markets grew at a double-digit pace, notably Italy, the UK, Austria, Switzerland, Belgium and the Nordic region, but France contracted strongly and lost market share due to fierce price competition. Emerging markets expanded at a rapid pace, particularly the Middle East, Turkey and Africa (+18% cc) and Asia-Pacific (+16% cc) and Central and Eastern Europe (+7% cc). Biosimilars (+81% cc) gained further momentum on contributions from the three launch brands Omnitrope, Binocrit and Filgrastim.

 

Operating income

Operating income grew 7% to USD 310 million, but down 1% cc, as the operating income margin fell 1.4 percentage points to 15.5% of net sales. Key factors for the reduction included acquisition-related charges for the EBEWE Pharma integration (–0.7 percentage points), exceptional costs for termination of a co-development agreement (–0.8 percentage points) and provisions for settlement of Average Wholesale Pricing litigation in the US (–1.9 percentage points).

 

Core operating income rose 30% (+21% cc) to USD 450 million, resulting in the core operating income margin rising 2.4 percentage points to 22.5% of net sales. Cost of Goods Sold (+0.1 percentage points) improved slightly as productivity improvement programs fully offset price erosion. Marketing & Sales costs (–0.9 percentage points) rose faster than sales on investments in biosimilars, Central & Eastern Europe and Asia-Pacific. R&D investments (+1.0 percentage points) were lower as productivity initiatives more than offset investments in development programs for biosimilars as well as other differentiated generics, including oncology injectables and respiratory products. General & Administrative costs (+0.8 percentage points) grew slower than net sales due to ongoing cost-containment measures, while Other Income & Expense (+1.4 percentage points) improved against the 2009 period due to lower legal fees.

 

12



 

Consumer Health

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Net sales

 

1 478

 

1 303

 

13

 

7

 

Operating income

 

264

 

235

 

12

 

3

 

As % of net sales

 

17.9

 

18.0

 

 

 

 

 

Core operating income

 

288

 

254

 

13

 

5

 

As % of net sales

 

19.5

 

19.5

 

 

 

 

 

 

First quarter

 

Net sales

All three Consumer Health businesses – OTC, Animal Health and CIBA Vision – contributed to higher net sales in the first quarter of 2010 (USD 1.5 billion, +13%, +7% cc), as these businesses grew ahead of their respective markets following challenges in 2009 posed by the financial crisis.

 

Pain medicines – particularly Voltaren in Europe and Excedrin in the US – were key contributors in OTC, while a weak “Cough & Cold” season slightly offset this performance. Prevacid24HR has achieved a 30% market share in the growing US over-the counter market for proton pump inhibitors since its launch in November 2009, propelled by a strong advertising and promotional campaign. CIBA Vision maintained its excellent growth pace from 2009, expanding in all regions on new product launches. The AirOptix contact lens franchise was among top performers, gaining share in all major markets. Animal Health grew ahead of its market in the US, helped by a strong competitive position for parasiticide products.

 

The US (+11%) delivered strong performances across all three businesses, while Europe (+5% cc) achieved robust growth with strong performances from Germany, France and Spain. Net sales in the top six emerging markets grew 27% (+11% cc), as all countries contributed to the positive results and led by double-digit gains in India and Turkey. Russia also delivered double-digit growth despite recent government price controls.

 

Operating income

Operating income rose 12% (+3% cc) to USD 264 million, at a slower pace than net sales as the operating income margin declined 0.1 percentage points in the first quarter of 2010 to 17.9% of net sales from the 2009 period.

 

Core operating income grew 13% (+5% cc) to USD 288 million, largely in line with net sales in constant currencies, as the core operating income margin was unchanged at 19.5% of net sales. Other Revenues and sales to other divisions (+0.3 percentage points) were higher, while Cost of Goods Sold (+0.5 percentage points) improved as a result of robust sales growth in key markets, optimized pricing and productivity gains. However, this was largely offset by higher Marketing & Sales expenses (–0.6 percentage points), primarily driven by significant promotional support for the 2009 launch of Prevacid24HR in the US as well as sales force expansion in emerging markets. R&D investments were flat as a percentage of net sales as investments were made in new product development across the businesses. General & Administrative costs (–0.3 percentage points) increased in the 2010 period as a result of a provision release in 2009, while Other Income & Expense (+0.1 percentage points) were largely unchanged compared to the 2009 period.

 

13



 

FINANCIAL REVIEW

 

First quarter

 

 

 

Q1 2010

 

Q1 2009

 

% change

 

 

 

USD m

 

USD m

 

USD

 

cc

 

Net sales

 

12 131

 

9 709

 

25

 

18

 

Divisional operating income

 

3 740

 

2 521

 

48

 

41

 

Corporate income & expense, net

 

229

 

174

 

 

 

 

 

Group operating income

 

3 511

 

2 347

 

50

 

42

 

Income from associated companies

 

103

 

83

 

24

 

17

 

Financial income

 

49

 

–48

 

NM

 

NM

 

Interest expense

 

–133

 

–86

 

–55

 

–52

 

Taxes

 

–582

 

–321

 

–81

 

–94

 

Net income

 

2 948

 

1 975

 

49

 

41

 

EPS (USD)

 

1.29

 

0.87

 

48

 

40

 

 

 

 

 

 

 

 

 

 

 

Core operating income

 

3 865

 

2 611

 

48

 

41

 

Core net income

 

3 309

 

2 302

 

44

 

36

 

Core EPS (USD)

 

1.45

 

1.01

 

44

 

36

 

 


NM – Not meaningful

 

Net sales

Net sales rose 25% (+18% cc) to USD 12.1 billion on improvements in all businesses, particularly sales of A (H1N1) pandemic flu vaccines and rapid growth of recently launched products across the Group (USD 1.9 billion). Currency movements contributed seven percentage points to reported growth. Pharmaceuticals (USD 7.3 billion, +7% cc) advanced in all regions and maintained solid volume growth. Vaccines and Diagnostics (USD 1.4 billion, +436% cc) provided USD 1.1 billion from recognition of A (H1N1) pandemic vaccine sales. Sandoz (USD 2.0 billion, +9% cc) grew on successful new product launches and integration of EBEWE Pharma following the September 2009 acquisition. All Consumer Health businesses (USD 1.5 billion, +7% cc) had good performances and grew faster than their markets. Higher volumes represented 19 percentage points of growth, while currency movements had a positive impact of seven points and acquisitions added one point. However, price changes reduced growth by two points. All regions achieved double-digit growth, led by Europe (USD 4.9 billion, +13% cc) and the US (USD 3.9 billion, +23% cc). Asia-Pacific (USD 2.2 billion, +18% cc) benefited from rapid expansion in key markets. Among the top six emerging markets (USD 1.2 billion, +22% cc), China, Brazil, India, Russia and South Korea maintained solid growth, but Turkey was hampered by cost-containment measures.

 

Corporate income & expense, net

Corporate expense rose in the first quarter to USD 229 million from USD 174 million in the 2009 period, mainly driven by an additional inter-divisional profit elimination and various one-time costs.

 

Group operating income

Operating income rose 50% (+42% cc) to USD 3.5 billion on the volume-driven sales expansion and significant contributions from Vaccines and Diagnostics, while also benefitting from eight percentage points of favorable currency movements. The operating income margin improved 4.7 percentage points to 28.9% of net sales from 24.2% in the 2009 period. Core operating income, which excludes exceptional items and amortization of intangible assets in both periods, rose 48% (+41% cc) to USD 3.9 billion, and the core operating income margin rose 5.0 percentage points to 31.9% of net sales from 26.9% in the year-ago quarter.

 

Income from associated companies

For the first quarter of 2010, income from associated companies rose 24% to USD 103 million from USD 83 million in the 2009 period on anticipated higher net income contributions from Alcon and Roche. Contributions from Roche for the 2010 quarter were reduced by USD 43 million after Roche took an additional Genentech-related exceptional restructuring charge in the second half of 2009. Core results, which exclude exceptional items and the amortization of intangible assets in both periods, increased 30% to USD 288 million.

 

14



 

Financial income and interest expense

Financial income was a positive USD 49 million in the first quarter from a negative USD 48 million in the 2009 period, mainly related to significantly higher average liquidity in the 2010 period and a positive currency result. Interest expenses rose 55% to USD 133 million following the issuance of US dollar bonds in February 2009 and March 2010 and a euro bond in June 2009.

 

Taxes

The tax rate (taxes as percentage of pre-tax income) rose to 16.5% in the first quarter from 14.0% in the 2009 period. A significant part of this increase was due to sales of A (H1N1) pandemic flu vaccines in higher-tax jurisdictions.

 

Net income

Net income rose 49% (+41% cc) to USD 2.9 billion as contributions from associated companies and financial income more than offset increased interest expenses and a higher tax rate. Core net income rose 44% (+36% cc) to USD 3.3 billion.

 

Earnings per share

Earnings per share (EPS) rose largely in line with net income to USD 1.29 in the first quarter from USD 0.87 in the 2009 period, while core EPS grew 44% (+36% cc) to USD 1.45 from USD 1.01. The average numer of shares outstanding rose 1% to 2,279.1 million from 2,265.9 million in the year-ago period, while a total of 2,287.9 million shares were oustanding at March 31, 2010.

 

Balance sheet

Total assets amounted to USD 95.8 billion at March 31, 2010, an increase of USD 0.3 billion compared to the end of 2009. Although cash and marketable securities rose by USD 2.4 billion as a result of reinvesting proceeds from the US dollar bond issued in March 2010, these were nearly offset by reductions due to currency changes (USD 2.0 billion) and lower underlying trade receivables (USD 0.3 billion).

 

Total liabilities increased by USD 2.5 billion to USD 40.6 billion as higher financial debts of USD 3.9 billion were partially offset by reductions in other non-financial liabilities. The Group’s equity fell by USD 2.2 billion to USD 55.2 billion at March 31, 2010, principally due to the dividend payment for 2009 of USD 4.5 billion (a 13% increase from the dividend payment for 2008 of USD 3.9 billion) and translation losses of USD 1.0 billion. These were partially offset by net income of USD 2.9 billion in the first quarter of 2010.

 

The Group’s debt/equity ratio rose to 0.32:1 at March 31, 2010, compared to 0.24:1 at the end of 2009, reflecting the higher financial debt following the issuance of the USD 5 billion bond in March 2010 and the lower equity. The Group’s financial debt of USD 17.9 billion consisted of USD 4.5 billion in current and USD 13.4 billion in non-current liabilities. Overall liquidity rose to USD 19.9 billion from USD 17.4 billion at the end of 2009. Net liquidity at March 31, 2010, fell to USD 2.0 billion from USD 3.5 billion at the end of the previous year following the USD 4.5 billion payment of the 2009 dividend.

 

Credit agencies maintained their ratings of Novartis debt during the first quarter of 2010. 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 rose 69% to USD 3.3 billion in the first quarter, driven by the strong business performance and in particular proceeds from A (H1N1) pandemic vaccines. Cash used for investing activities fell by USD 1.7 billion to USD 1.1 billion from the 2009 period, which included USD 2.4 billion of investments in marketable securities with proceeds from the 2009 US dollar bond. Among investments in the 2010 period were USD 0.4 billion for acquisitions, including USD 0.3 billion for completion of the EBEWE Pharma transaction. Cash flow from financing activities included a USD 4.2 billion increase in net financial debt due to the 2010 US dollar bond issuance and USD 0.4 billion arising from treasury share transactions, principally related to share-based compensation, but these were largely offset by the dividend payment of USD 4.5 billion .

 

Free cash flow before dividends rose 93% to USD 2.9 billion, with the USD 1.4 billion increase principally coming from the improved cash flow from operating activities.

 

15



 

INNOVATION REVIEW

 

Novartis has one of the industry’s most competitive pipelines with 135 projects in pharmaceutical clinical development, of which 58 involve new molecular entities.

 

Among developments in the first quarter of 2010:

 

·                  Approvals in Japan in January for Afinitor (kidney cancer), Equa (Galvus) (type 2 diabetes) and Exforge (hypertension) following approvals of six new medicines in this market in 2009.

 

·                  First approvals of the Menveo meningitis vaccine in the US (February) and Europe (March) from age 11 and older, and also the US filing for use from age 2-10.

 

·                  Submission for US approval of a triple combination therapy for hypertension in a single pill containing Tekturna/Rasilez, amlodipine and hydrochlorothiazide as well as Exelon Patch (Alzheimer’s disease) and Tasigna (cancer) for approval in Japan.

 

·                  Two US regulatory submissions completed in late 2009 – Tasigna (newly diagnosed CML) and Gilenia (FTY720, multiple sclerosis) – were given priority review status.

 

·                  Discontinuation of PTZ601 (complicated staphylococcal skin and soft tissue infections) after observation of a high rate of adverse events in a Phase I study and LCI699 (heart failure) after identification of a safety issue in form of an impaired stress response. One of the two Phase III trials involving ASA404 (non-small cell lung cancer) was halted in March following an interim analysis of benefits for patients with NSCLC.

 

2010 selected major approvals: US, Europe and Japan

 

Product

 

Active ingredient

 

Indication

 

Approval date

Afinitor

 

Everolimus

 

Kidney cancer

 

Japan – Q1

Equa (Galvus)

 

Vildagliptin

 

Type 2 diabetes

 

Japan – Q1

Exforge

 

Valsartan and amlodipine

 

Hypertension

 

Japan – Q1

Menveo

 

Quadrivalent meningococcal conjugate vaccine

 

Prevention of meningococcal meningitis (A, C, Y, W-135)

 

US, EU – Q1

 

Selected projects awaiting regulatory decisions

 

 

 

 

 

Completed submissions

 

 

Product

 

Indication

 

US

 

EU

 

Japan

 

News update

ABF656

 

Hepatitis C

 

Q4 2009

 

 

 

 

 

- EU submission withdrawn in April 2010 for technical reasons

Exelon Patch

 

Alzheimer’s disease

 

Approved

 

Approved

 

Q1 2010

 

 

FTY720
(Gilenia)

 

Multiple sclerosis

 

Q4 2009

 

Q4 2009

 

 

 

- FDA granted six-month priority review status; Advisory Committee meeting scheduled for June 10

Lucentis

 

Diabetic macular edema

 

 

 

Q4 2009

 

 

 

 

QAB149

 

COPD

 

Q4 2008

 

Approved

 

 

 

- Clinical trials underway to address FDA Complete Response letter (Q4 2009), resubmission planned for 2010

Tasigna

 

Newly diagnosed CML

 

Q4 2009

 

Q4 2009

 

Q1 2010

 

- FDA granted six-month priority review status

Tekturna and amlodipline

 

Hypertension

 

Q4 2009

 

Q4 2009

 

 

 

 

Tekturna, amlodipine and hydrochlorothiazide

 

Hypertension

 

Q1 2010

 

 

 

 

 

- US submission made in February 2010

- EU submission set for 2010

TOBI-TIP

 

Cystic fibrosis

 

 

 

Q4 2009

 

 

 

- US submission planned for 2010

Zometa

 

Adjuvant breast cancer

 

Q4 2009

 

Q4 2009

 

 

 

 

Zortress
(Certican)

 

Kidney transplantation

 

Q2 2009

 

Approved

 

 

 

-Addressing issues from FDA

 

16



 

Selected pharmaceutical pipeline projects

 

Project/
Compound

 

Potential indication/
Disease area

 

Planned
submissions

 

Current
Phase

 

News update

ACZ885

 

Refractory gout

 

2010

 

III

 

- On track for 2010 submission

 

 

SJIA

 

2011

 

III

 

 

 

 

Type 2 diabetes

 

2012

 

II

 

- Phase III start targeted for December 2010

AFQ056

 

Parkinson’s disease

 

2012

 

II

 

 

AG0178

 

Major depressive disorder

 

2012

 

III

 

 

AIN457

 

Behcet’s uveitis

 

2010

 

III

 

- On track for 2010 submission

 

 

Non-infectious uveitis

 

2011

 

III

 

 

 

 

Psoriasis

 

2013

 

II

 

- Phase III start planned for 2011

 

 

Rheumatoid arthritis

 

2013

 

II

 

- Phase III start planned for end of 2010

ASA404

 

Non-small cell lung cancer (NSCLC)

 

2012

 

III

 

- First-line Phase III NSCLC trial stopped in March 2010, second-line Phase III NSCLC trial ongoing (interim analysis in H2 2010)

BAF312

 

Multiple sclerosis

 

>2014

 

II

 

 

Certican

 

Prevention of organ rejection – liver

 

2011

 

III

 

 

DEB025

 

Hepatitis C

 

>2014

 

II

 

- In-licensed from Debiopharm in Q1 2010

EPO906

 

Ovarian cancer

 

2010

 

III

 

- On track for 2010 submission

Exjade

 

Non-transfusion-dependent Thalassemia (NTDT)

 

2011

 

II

 

 

INC424

 

Myelofibrosis

 

2011

 

III

 

 

LBH589

 

Hodgkin’s lymphoma

 

2010

 

II

 

- On track for 2010 submission

- Updated Phase II pivotal study data to be presented at ASCO

 

 

Multiple myeloma

 

2013

 

III

 

 

 

 

Hematological tumors

 

>2014

 

II

 

 

LCQ908

 

Type 2 diabetes

 

2013

 

II

 

- Phase II interim results expected in second half of 2010

LCZ696

 

Heart failure

 

2013

 

III

 

 

LDE225

 

Gorlin’s syndrome

 

2011

 

II

 

 

Lucentis

 

Retinal vein occlusion

 

2011

 

II

 

 

NVA237

 

COPD

 

2011

 

III

 

 

PKC412

 

Aggressive systemic mastocytosis

 

2011

 

II

 

 

 

 

Acute myeloid leukemia

 

2013

 

III

 

 

PRT128

 

Acute coronary syndrome (ACS)

 

2013

 

II

 

- First data from INNOVATE-PCI Phase II trial available in Q2 2010

 

 

Chronic coronary heart disease (CHD)

 

 

 

 

 

- Phase III start for CHD planned for H2 2010 and ACS for 2011

PTK796

 

Infections

 

2012

 

III

 

 

QAX028

 

COPD

 

>2014

 

II

 

 

QMF149

 

COPD

 

2013

 

II

 

 

 

 

Asthma

 

2013

 

II

 

 

QTI571
(Glivec)

 

Pulmonary arterial hypertension

 

2011

 

III

 

- Phase III recruitment ongoing

QVA149

 

COPD

 

2012

 

II

 

- Phase III planned start in 2010

 

17



 

Project/
Compound

 

Potential indication/
Disease area

 

Planned
submissions

 

Current
Phase

 

News update

RAD001

 

Neuroendocrine tumors

 

2010

 

III

 

- On track for 2010 submission

(Afinitor)

 

Tuberous sclerosis complex SEGA

 

2010

 

III

 

- On track for 2010 submission

 

 

Tuberous sclerosis complex AML

 

2011

 

III

 

 

 

 

ER+ breast cancer

 

2012

 

III

 

 

 

 

HER2+ breast cancer

 

2013

 

III

 

 

 

 

Gastric cancer

 

2012

 

III

 

 

 

 

Lymphoma

 

>2014

 

III

 

 

RLX030

 

Acute heart failure

 

2013

 

III

 

- Corthera acquisition in Q1 2010 (relaxin)

SBR759

 

Hyperphosphatemia

 

2011

 

III

 

 

SMC021

 

Osteoarthritis

 

2011

 

III

 

 

 

 

Osteoporosis

 

2011

 

III

 

 

SOM230

 

Cushing’s disease

 

2010

 

III

 

- On track for 2010 submission

 

 

Acromegaly

 

2011

 

III

 

 

 

 

Refractory / resistant carcinoid syndrome

 

2011

 

III

 

 

Tasigna

 

GIST

 

>2014

 

III

 

 

 

 

cKIT melanoma

 

2012

 

II

 

 

TKI258

 

Solid tumors

 

2013

 

II

 

 

 

Selected vaccine pipeline projects

 

Project/
Compound

 

Potential indication/
Disease area

 

Planned
submissions

 

Current
Phase

 

News update

Menveo
(A,C,W,Y meningitis serogroups)

 

Prevention of meningococcal disease (serogroups A, C, Y and W-135) in infants

 

2011 (EU/US)

 

III

 

 

 

 

Prevention of meningococcal disease (serogroups A, C, Y and W-135) from 2-10 years

 

 

 

 

 

- Submitted in the US in Q1 2010

MenB
(B meningitis serogroup)

 

Prevention of meningococcal disease (serogroup B) in infants

 

2010 (EU)

 

III

 

- End-of-Phase II meeting to be held with FDA in Q3 2010 to discuss Phase III requirements

 

18



 

Disclaimer

These materials contain certain forward-looking statements relating to the Group’s business, which can be identified by terminology such as “momentum,” “priority review,” “to be,” “on track,” “will,” “commitment,” “strategy,” “aspiration,” “priorities,” “potentially,” “potential,” “expected,” “to be,” “planned,” “anticipated,” “plans,” “outlook,” “aims,” “believed,” 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 analyses 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.

 

Important dates

July 15, 2010

Second quarter and first half 2010 results

October 21, 2010

Third quarter and first nine months 2010 results

January 2011

Fourth quarter and full-year 2010 results

 

19



 

CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

Consolidated income statements

 

First quarter (unaudited)

 

 

 

Q1 2010

 

Q1 2009

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

%

 

Net sales

 

12 131

 

9 709

 

2 422

 

25

 

Other revenues

 

225

 

217

 

8

 

4

 

Cost of Goods Sold

 

–3 096

 

–2 585

 

–511

 

20

 

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

 

–162

 

–223

 

61

 

–27

 

Gross profit

 

9 260

 

7 341

 

1 919

 

26

 

Marketing & Sales

 

–3 014

 

–2 721

 

–293

 

11

 

Research & Development

 

–2 037

 

–1 694

 

–343

 

20

 

General & Administration

 

–570

 

–505

 

–65

 

13

 

Other income

 

180

 

171

 

9

 

5

 

Other expense

 

–308

 

–245

 

–63

 

26

 

Operating income

 

3 511

 

2 347

 

1 164

 

50

 

Income from associated companies

 

103

 

83

 

20

 

24

 

Financial income

 

49

 

–48

 

97

 

–202

 

Interest expense

 

–133

 

–86

 

–47

 

55

 

Income before taxes

 

3 530

 

2 296

 

1 234

 

54

 

Taxes

 

–582

 

–321

 

–261

 

81

 

Net income

 

2 948

 

1 975

 

973

 

49

 

Attributable to:

 

 

 

 

 

 

 

 

 

Shareholders of Novartis AG

 

2 933

 

1 962

 

971

 

49

 

Non-controlling interests

 

15

 

13

 

2

 

15

 

Average number of shares outstanding – Basic (million)

 

2 279.1

 

2 265.9

 

13.2

 

1

 

Basic earnings per share (USD)(1)

 

1.29

 

0.87

 

0.42

 

48

 

Average number of shares outstanding – Diluted (million)

 

2 290.3

 

2 282.8

 

7.5

 

0

 

Diluted earnings per share (USD)(1)

 

1.28

 

0.86

 

0.42

 

49

 

 


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

 

20



 

Consolidated statements of comprehensive income

 

First quarter (unaudited)

 

 

 

Q1 2010

 

Q1 2009

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income

 

2 948

 

1 975

 

973

 

Fair value adjustments on financial instruments, net of taxes

 

5

 

–43

 

48

 

Net actuarial losses from defined benefit plans, net of taxes

 

–178

 

–665

 

487

 

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

 

–48

 

–67

 

19

 

Translation effects

 

–997

 

–1 403

 

406

 

Comprehensive income

 

1 730

 

–203

 

1 933

 

Attributable to:

 

 

 

 

 

 

 

Shareholders of Novartis AG

 

1 714

 

–212

 

1 926

 

Non-controlling interests

 

16

 

9

 

7

 

 

21



 

Condensed consolidated balance sheets

 

 

 

March 31,
2010

 

Dec 31,
2009

 

 

 

March 31,
2009

 

 

 

(unaudited)

 

(audited)

 

Change

 

(unaudited)

 

 

 

USD m

 

USD m

 

USD m

 

USD m

 

Assets

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

 

Property, plant & equipment

 

13 577

 

14 075

 

–498

 

12 516

 

Goodwill

 

11 688

 

12 039

 

–351

 

10 946

 

Intangibles other than goodwill

 

9 883

 

10 331

 

–448

 

9 031

 

Financial and other non-current assets

 

24 847

 

25 369

 

–522

 

22 995

 

Total non-current assets

 

59 995

 

61 814

 

–1 819

 

55 488

 

Current assets

 

 

 

 

 

 

 

 

 

Inventories

 

5 658

 

5 830

 

–172

 

5 764

 

Trade receivables

 

7 773

 

8 310

 

–537

 

6 751

 

Other current assets

 

2 471

 

2 102

 

369

 

2 128

 

Cash, short-term deposits and marketable securities

 

19 898

 

17 449

 

2 449

 

7 839

 

Total current assets

 

35 800

 

33 691

 

2 109

 

22 482

 

Total assets

 

95 795

 

95 505

 

290

 

77 970

 

Equity and liabilities

 

 

 

 

 

 

 

 

 

Total equity

 

55 216

 

57 462

 

–2 246

 

46 228

 

Non-current liabilities

 

 

 

 

 

 

 

 

 

Financial debts

 

13 445

 

8 675

 

4 770

 

6 978

 

Other non-current liabilities

 

9 702

 

9 898

 

–196

 

9 774

 

Total non-current liabilities

 

23 147

 

18 573

 

4 574

 

16 752

 

Current liabilities

 

 

 

 

 

 

 

 

 

Trade payables

 

3 561

 

4 012

 

–451

 

3 262

 

Financial debts and derivatives

 

4 484

 

5 313

 

–829

 

4 474

 

Other current liabilities

 

9 387

 

10 145

 

–758

 

7 254

 

Total current liabilities

 

17 432

 

19 470

 

–2 038

 

14 990

 

Total liabilities

 

40 579

 

38 043

 

2 536

 

31 742

 

Total equity and liabilities

 

95 795

 

95 505

 

290

 

77 970

 

 

Condensed consolidated changes in equity

 

First quarter (unaudited)

 

 

 

Q1 2010

 

Q1 2009

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Consolidated equity at January 1

 

57 462

 

50 437

 

7 025

 

Comprehensive income

 

1 730

 

–203

 

1 933

 

Sale/purchase of treasury shares, net

 

366

 

–240

 

606

 

Equity-based compensation

 

141

 

170

 

–29

 

Dividends

 

–4 468

 

–3 941

 

–527

 

Changes in non-controlling interests

 

–15

 

5

 

–20

 

Consolidated equity at March 31

 

55 216

 

46 228

 

8 988

 

 

22



 

Condensed consolidated cash flow statements

 

First quarter (unaudited)

 

 

 

Q1 2010

 

Q1 2009

 

Change

 

 

 

USD m

 

USD m

 

USD m

 

Net income

 

2 948

 

1 975

 

973

 

Reversal of non-cash items

 

 

 

 

 

 

 

Taxes

 

582

 

321

 

261

 

Depreciation, amortization and impairments

 

761

 

548

 

213

 

Change in provisions and other non-current liabilities

 

189

 

79

 

110

 

Net financial expense/income

 

84

 

134

 

–50

 

Other

 

75

 

60

 

15

 

Net income adjusted for non-cash items

 

4 639

 

3 117

 

1 522

 

Interest and other financial receipts

 

340

 

333

 

7

 

Interest and other financial payments

 

–137

 

–29

 

–108

 

Taxes paid

 

–469

 

–337

 

–132

 

Cash flow before working capital changes

 

4 373

 

3 084

 

1 289

 

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

 

–127

 

–262

 

135

 

Change in net current assets and other operating cash flow items

 

–939

 

–869

 

–70

 

Cash flow from operating activities

 

3 307

 

1 953

 

1 354

 

Investments in property, plant & equipment

 

–304

 

–368

 

64

 

Investments in intangible, financial and other non-current assets

 

–144

 

–136

 

–8

 

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

 

44

 

57

 

–13

 

Acquisitions of subsidiaries

 

–413

 

 

 

–413

 

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

 

–319

 

–2 395

 

2 076

 

Cash flow used for investing activities

 

–1 136

 

2 842

 

1 706

 

Change in current and non-current financial debts

 

4 234

 

4 705

 

–471

 

Dividends paid to shareholders of Novartis AG

 

–4 468

 

–3 931

 

–537

 

Treasury share transactions

 

368

 

–240

 

608

 

Other financing cash flows

 

–112

 

–82

 

–30

 

Cash flow from financing activities

 

22

 

452

 

–430

 

Translation effect on cash and cash equivalents

 

–21

 

–26

 

5

 

Change in cash and cash equivalents

 

2 172

 

–463

 

2 635

 

Cash and cash equivalents at January 1

 

2 894

 

2 038

 

856

 

Cash and cash equivalents at March 31

 

5 066

 

1 575

 

3 491

 

 

23



 

Notes to the Condensed Interim Consolidated Financial Statements for the three months ended March 31, 2010 (unaudited)

 

1. Basis of preparation

 

These Condensed Interim Consolidated Financial Statements for the three-month period ended March 31, 2010, 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, except as indicated below. As of January 1, 2010, the Group adopted IFRS 3 (revised) “Business Combinations.” The revised standard requires Novartis to include in the purchase consideration the estimated amount of any contingent considerations and the measurement to fair value, through the income statement of any interest in an acquired company that had been previously held. Furthermore, transaction costs are expensed as incurred and no longer form part of the acquisition price. The Group also adopted amendments to IAS 27: “Consolidated and Separate Financial Statements.”  This requires that the result of changes in the Novartis ownership percentage that do not result in a loss of control will be accounted for in equity. The Group also adopted amendments to IAS 39: “Financial instruments: Recognition and Measurement.” This revised standard requires that any options, including those concerning Alcon, related to acquisitions that up to December 31, 2009, did not require recognition, are recorded at their fair values, initially in opening equity at January 1, 2010, and subsequent fair value adjustments recorded in the income statement. These new accounting standards did not have a significant impact on the Group’s Condensed Interim 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 2010 and 2009:

 

Acquisitions in 2010

 

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 approximately USD 28 billion (containing 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

 

24



 

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, 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.

 

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 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 in the first quarter of 2010. Corthera’s current shareholders are eligible to receive additional payments of up to USD 500 million contingent upon clinical milestones, regulatory approvals and the achievement of commercialization targets. The transaction was completed on February 3, 2010, and the purchase price allocation is still preliminary. Results of operations since the acquisition date were not material.

 

Other significant transactions in 2010

 

Corporate – Issuance of bond in US dollars

On March 9, Novartis issued a three-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 1.9% three-year tranche totaling USD 2 billion, a 2.9% five-year tranche totaling USD 2 billion and a 4.4% 10-year tranche totaling USD 1 billion were issued by the Group’s US entity, Novartis Capital Corp. All tranches are unconditionally guaranteed by Novartis AG.

 

25



 

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.

 

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.

 

4. Principal currency translation rates

 

First quarter

 

 

 

Average rates
Q1 2010
USD

 

Average rates
Q1 2009
USD

 

Period-end rates
March 31, 2010
USD

 

Period-end rates
March 31, 2009
USD

 

1 CHF

 

0.946

 

0.870

 

0.937

 

0.872

 

1 EUR

 

1.385

 

1.303

 

1.342

 

1.324

 

1 GBP

 

1.562

 

1.434

 

1.507

 

1.431

 

100 JPY

 

1.102

 

1.070

 

1.073

 

1.018

 

 

26



 

5. Consolidated income statements — Divisional segmentation — First quarter (unaudited)

 

 

 

Pharmaceuticals

 

Vaccines and
Diagnostics

 

Sandoz

 

Consumer
Health

 

Corporate

 

Total Group

 

 

 

Q1
2010

 

Q1
2009

 

Q1
2010

 

Q1
2009

 

Q1
2010

 

Q1
2009

 

Q1
2010

 

Q1
2009

 

Q1
2010

 

Q1
2009

 

Q1
2010

 

Q1
2009

 

 

 

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

 

7 291

 

6 433

 

1 361

 

247

 

2 001

 

1 726

 

1 478

 

1 303

 

 

 

 

 

12 131

 

9 709

 

Sales to other Divisions

 

38

 

45

 

17

 

10

 

74

 

63

 

17

 

10

 

–146

 

–128

 

 

 

 

 

Sales of Divisions

 

7 329

 

6 478

 

1 378

 

257

 

2 075

 

1 789

 

1 495

 

1 313

 

–146

 

–128

 

12 131

 

9 709

 

Other revenues

 

84

 

102

 

123

 

97

 

4

 

4

 

14

 

14

 

 

 

 

 

225

 

217

 

Cost of Goods Sold

 

–1 206

 

–1 088

 

–392

 

–226

 

–1 118

 

–952

 

–518

 

–461

 

138

 

142

 

–3 096

 

–2 585

 

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

 

14

 

–80

 

–76

 

–70

 

–76

 

–54

 

–24

 

–19

 

 

 

 

 

–162

 

–223

 

Gross profit

 

6 207

 

5 492

 

1 109

 

128

 

961

 

841

 

991

 

866

 

–8

 

14

 

9 260

 

7 341

 

Marketing & Sales

 

–2 036

 

–1 898

 

–78

 

–59

 

–360

 

–296

 

–540

 

–468

 

 

 

 

 

–3 014

 

–2 721

 

Research & Development

 

–1 608

 

–1 343

 

–135

 

–88

 

–161

 

–141

 

–86

 

–76

 

–47

 

–46

 

–2 037

 

–1 694

 

General & Administration

 

–213

 

–194

 

–38

 

–33

 

–91

 

–91

 

–96

 

–81

 

–132

 

–106

 

–570

 

–505

 

Other income

 

120

 

121

 

18

 

3

 

25

 

7

 

5

 

13

 

12

 

27

 

180

 

171

 

Other expense

 

–143

 

–116

 

–37

 

–18

 

–64

 

–29

 

–10

 

–19

 

–54

 

–63

 

–308

 

–245

 

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

 

–261