Replies to post #57569 on Biotech Values

[DewDiligence]

NVS is one company that evidently
believes in pay for performance:

http://blogs.wsj.com/health/2008/01/17/novartis-ceo-dan-vasella-less-pay-for-lower-performance

>>
January 17, 2008, 3:25 pm
by Jeanne Whalen

Dan Vasella, CEO of Swiss drug giant Novartis, has long been viewed as one of the industry’s more capable leaders. But Novartis’s less-than-stellar performance in 2007 led to steep pay cut for Vasella.

Vasella’s compensation in 2007 fell by about 20% from the previous year, to 17 million Swiss francs, according to Novartis’s annual report. How come? Novartis failed to meet some of its financial and business targets, Vasella told the Health Blog. The Novartis chief said it was his first pay cut since he took the helm of the drug maker more than a decade ago.

“This is the first year I have missed my objectives — or part of them,” Vasella said. “Normally I always meet or surpass the expectations.” Dr. Vasella said he sets these targets together with the board, which then reviews his performance and decides his compensation.

Novartis’s prescription drug unit had a tough year in the U.S., where it faced tough competition from generics. Novartis also suffered some setbacks with the FDA. The agency delayed a decision on diabetes pill Galvus, an important new drug that Novartis hoped to start selling in the U.S. last year. FDA also leaned on Novartis to withdraw the irritable bowel syndrome drug Zelnorm from the U.S. market due to safety concerns. The company complied. All of that contributed to a 45% drop in fourth-quarter net profit, the company reported today. Novartis has said it would cut 2,500 jobs, or about 2.5% of its workforce, to save money and reduce bureaucracy.

Vasella wasn’t alone in taking home less pay. Thomas Ebeling, who oversaw the pharmaceutical unit until October, when he was transferred to run the consumer health division, also suffered a big pay cut: his compensation fell by a whopping 65% last year, to 3.7 million Swiss francs.

Chief Financial Officer Raymund Breu and head of R&D Mark Fishman also took home fewer francs.

Bucking the trend was Andreas Rummelt, head of the generics unit Sandoz, whose pay rose 16% to 5.6 million Swiss francs. Sandoz had a good year, with sales up 20% to $7.2 billion and operating income up 41% to $1.04 billion.
<<

[Preciouslife1]

Novartis Damaged By U.S. Economy
Melanie Lindner, 01.17.08, 2:35 PM ET

http://www.forbes.com/markets/2008/01/17/novartis-pharmaceuticals-update-markets-equity-cx_ml_0117markets29.html?feed=rss_markets

U.S. economic woes have stretched across the Atlantic and are now weighing on Swiss pharmaceutical company, Novartis.

Novartis (nyse: NVS - news - people ) released its fourth-quarter and full-year results on Thursday, and blamed its 42.0% profit decline on weak performance in the U.S. and restructuring costs. The company said that cutting 2,500 jobs worldwide resulted in a $444.0 million charge to its fourth-quarter results. However, Novartis hopes that the job cuts will start saving the company $1.6 billion per year by 2010.

In the period ending Dec. 31, Novartis said its profits reached only $913.0, or 41 cents per share, compared with $1.66 billion, or 70 cents per share in the fourth quarter of 2006. But for the full year of 2007, profits jumped 66.0% to $11.9 billion, or $5.15 per share, compared with $7.2 billion, or $3.04 per share in the similar period of 2006.

Sales for the fourth quarter jumped to $9.9 billion from $9.4 billion in the prior year quarter, while sales for the full year reached $39.8 billion, compared with $37.2 billion in 2006.

It seems Novartis' problems are mainly in the U.S. According to Chief Executive Daniel Vasella: "The weak performance is exclusively due to the U.S. market." Joe Jimenez, head of Novartis' U.S. pharmaceutical division, said he expects the company's most important market to begin showing growth in the second half of 2008. However, he noted that "in total the U.S. will be down versus a year ago."

Novartis, which makes drugs like Diovan, used to treat hypertension, and Ritalin, used to treat attention deficit disorder, has been struggling to jump through the regulatory hoops of the U.S. Food and Drug Administration. The FDA has asked Novartis to perform further trials of its diabetes drug Galvus, causing the company to warn investors that the potential big seller would not be resubmitted for approval before 2010.

According to Citigroup analyst Amit Roy, Novartis offers "relatively low-risk long-term earnings growth." However, with the recent product suspension of Zelnorm, used to treat irritable bowel syndrome, and early generic erosion of Lotrel, a hyertension treatment, Lamasil, an anti-fungus treatment, and Famvir, an antivirus medication, sales growth will be limited in the near-term. Thus, due to the lack of neat-term catalysts, Roy rates Novartis "hold."

On the New York Stock Exchange, shares of Novartis dropped $2.38, or 4.3%, to $53.07, in Thursday midday trading. On the Swiss Exchange, Novartis closed down 2.05 Swiss francs, or 3.3%, to 59.20 francs.

[DewDiligence]

NVS Reports 1Q08 Results

[Quarterly results beat consensus expectation, but this was partly from the effect of the weak US dollar. Guidance for the rest of 2008 is unchanged and continues to be tepid: sales growth in the low single digits for the branded-pharma division and mid single digits for the overall company (measured in local currency).

The weak year-over-year growth in pharma is due in part to a reduction in US sales of Zelnorm, Lotrel, Trileptal, Lamisil, and Famvir; Zelnorm has been withdrawn from the US market while the other four are now subject to generic competition.

Among the most important drugs in the portfolio, there was good news and bad news. The good news: the two-largest drugs, Diovan +19% Y-o-Y and Gleevec +32% Y-o-Y, continued to perform well and Lucentis, in only its fifth quarter on the EU market, racked up $195M in sales, +15% vs 4Q07. Off-label Avastin is much less of a competitive threat in the EU than in the US. (Note that DNA books Lucentis sales in the U.S.) The bad news: Tekturna, the much ballyhooed hypertension drug that has been positioned as NVS’ Great Hope to supersede Diovan when Diovan goes off-patent in four years, is looking like a commercial bust; worldwide 1Q08 Tekturna sales were only $28M.

The first stage of the Alcon acquisition has not yet closed and hence there is no impact from the Alcon deal in the results reported here.

More detailed information, including sales figures for each of NVS’ top-20 drugs, may be found at http://hugin.info/134323/R/1211012/250787.pdf .]

http://biz.yahoo.com/iw/080421/0388578.html

>>
Monday April 21, 1:00 am ET

BASEL, SWITZERLAND--(MARKET WIRE)--Apr 21, 2008 --

* Net sales from continuing operations up 9% (+0% in local currencies) to USD 9.9 billion with double-digit contributions from Sandoz, Vaccines and Diagnostics and Consumer Health

* Operating income rises 7% to USD 2.5 billion, supporting major investments in new product launches, pipeline and emerging markets

* Net income up 10% to USD 2.3 billion; EPS advances 15% to USD 1.02

* Pharmaceuticals net sales up 6% (-3% lc) as flagship brands and key regions help offset 19% decline in US from ongoing impact of generics and Zelnorm marketing suspension:

* New products - including Tekturna/Rasilez, Exforge, Aclasta/Reclast, Exelon Patch, Exjade, Xolair, Lucentis and Tasigna - contribute more than USD 500 million of net sales in 2008 first quarter * Late-stage pipeline progressing well - particularly RAD001 (metastatic renal cancer), FTY720 (multiple sclerosis) and SOM230 (Cushing's disease) - amid plans for many regulatory submissions by end of 2010

* Sandoz benefits from fast-growing markets, particularly in Eastern Europe, as net sales rise 12% (+2% lc) and offset soft first-quarter sales in the US * Consumer Health with solid performance as net sales rise 14% (+5% lc) driven by growth in Animal Health, OTC and CIBA Vision

* Vaccines and Diagnostics achieves dynamic net sales growth of 21% (+10% lc) while boosting investments in new meningitis vaccines and product portfolio * Novartis expects record sales and earnings in 2008 from continuing operations

* Reaffirming outlook for Group net sales growth at a mid-single-digit rate and Pharmaceuticals at a low-single-digit rate, both in local currencies

Key figures - First quarter - Continuing operations

Q1 2008 Q1 2007 % change
% of % of
net net
USD m sales USD m sales USD lc
Net sales 9 909 9 128 9 0
Operating income 2 488 25.1 2 335 25.6 7
Net income 2 308 23.3 2 092 22.9 10
Basic earnings per share USD 1.02 USD 0.89 15
Key figures - First quarter - Total Group

Q1 2008 Q1 2007 % change
Net income - Continuing operations 2 308 2 092 10
Net income - Discontinued Consumer Health
operations 15 79 -81
Total net income 2 323 2 171 7
Total basic earnings per share USD 1.02 USD 0.92 11
Discontinued Consumer Health operations represent contributions from Medical Nutrition (divested as of July 1, 2007) and Gerber (divested as of September 1, 2007)

Basel, April 21, 2008 — Commenting on the results, Dr. Daniel Vasella, Chairman and CEO of Novartis said: "Our solid first quarter results show that Novartis is on track. I am especially pleased with the dynamic growth of Vaccines and Diagnostics and the new products in Pharmaceuticals. Our pipeline is also progressing well with promising results in innovative treatments in several areas, including cancer (e.g. RAD001) and multiple sclerosis (e.g. FTY720). Project Forward is beginning to deliver the desired improvements in efficiency, allowing for continuous high level investments in R&D. Our recently announced plans to acquire majority ownership of Alcon will create a new growth platform with the world leader in eye care, further strengthening our healthcare portfolio in a fast-changing healthcare environment. I am confident Novartis will once again achieve record sales and earnings in 2008 from continuing operations now fully focused on healthcare."

Overview

On track for solid growth in 2008, Novartis reported higher net sales and double-digit earnings growth in the first quarter of 2008 from the Group's continuing operations now entirely focused on healthcare and reaffirmed its outlook for record sales and earnings for the full year.

Net sales rose 9% to USD 9.9 billion, which were unchanged in local currencies (lc), thanks to the contributions from Sandoz, Consumer Health and Vaccines and Diagnostics. In Pharmaceuticals, net sales fell 3% lc to USD 6.3 billion as strong growth of key brands in all regions outside the US helped offset a 19% US decline from the negative impact of generic competition and the loss of Zelnorm that continued from 2007.

Operating income climbed at a slightly slower pace than net sales, rising 7% to USD 2.5 billion after taking into account significant investments in all Divisions in new product launches, late-stage development projects, and expansion in emerging markets. Currency movements had a net positive impact of approximately USD 185 million. The operating margin reached 25.1% of net sales after 25.6% in the year-ago period.

On the back of the solid operating performance, net income rose 10% to USD 2.3 billion, benefiting from business growth, productivity programs, higher levels of income from associated companies and net financial income. Basic earnings per share (EPS) advanced 15% to USD 1.02 from USD 0.89 in the 2007 first quarter, helped by a reduced level of outstanding shares.

FIRST QUARTER

Net sales

Q1 2008 Q1 2007 % change
USD m USD m USD lc
Pharmaceuticals 6 264 5 923 6 -3
Vaccines and Diagnostics 280 231 21 10
Sandoz 1 906 1 696 12 2
Consumer Health continuing operations 1 459 1 278 14 5
Net sales from continuing operations 9 909 9 128 9 0

Pharmaceuticals

Europe, Latin America, Japan and emerging markets all delivered significantly higher sales in local currencies, helping to partially offset a 19% decline in the US that reflected the ongoing impact from 2007 of generic competition for four products - Lotrel (high blood pressure), Lamisil (fungal infections), Trileptal (epilepsy) and Famvir (viral infections) - and the loss of Zelnorm. Excluding these five affected products, which had combined net sales of approximately USD 800 million in the 2007 first quarter, worldwide net sales rose 10% in local currencies.

Key growth drivers included the flagship high blood pressure medicine Diovan (USD 1.4 billion, +11% lc), with additional contributions from the ongoing rollout of the new high blood pressure medicines Exforge and Tekturna/Rasilez approved in 2007. Net sales in the Cardiovascular franchise fell 3% lc to USD 1.6 billion due to the loss of Lotrel to US generic competition since mid-2007, but were up 18% lc for the rest of the Cardiovascular portfolio.

Several new products provided significant incremental contributions to growth in the first quarter, particularly the rapid acceptance of Aclasta/Reclast as a once-yearly treatment for osteoporosis and Lucentis as the only approved treatment shown to maintain and improve vision in people with age-related macular degeneration. These new products, along with Tekturna/Rasilez, Exforge, Exelon Patch (Alzheimer's disease), Exjade (iron chelation), Xolair (asthma) and Tasigna (cancer), provided more than USD 500 million in combined quarterly net sales.

Vaccines and Diagnostics

Good performance thanks to the strong demand for TBE (tick-borne encephalitis) vaccines in Europe as well as ongoing market share gains outside of the US for NAT (nucleic acid testing) products used in diagnostic blood testing.

Sandoz

Fast-growing markets in Central and Eastern Europe - particularly Poland and Russia (now both among top five countries worldwide) - supported overall growth along with market share gains in Germany. In the US, net sales declined 2% lc as expansion of the overall portfolio helped to partially offset the lack of significant new product launches in the first quarter of 2008. The 2007 first quarter included contributions from the rollout of many "difficult-to-make" and authorized generics that now face competition.

Consumer Health continuing operations

OTC, Animal Health and CIBA Vision all supported the solid performance. CIBA Vision delivered strong growth thanks to new product launches for Dailies and AirOptix contact lenses and full product supplies following shortages in 2007. OTC benefited from sales of "cough and cold" products in the US and Europe as well as ongoing geographic expansion. Animal Health growth was driven by companion animal products, particularly in the US.

Operating income

Q1 2008 Q1 2007 Change
% of % of
net net
USD m sales USD m sales %
Pharmaceuticals 2 096 33.5 1 853 31.3 13
Vaccines and Diagnostics -53 -18.9 27 11.7
Sandoz 345 18.1 318 18.8 8
Consumer Health continuing operations 262 18.0 240 18.8 9
Corporate income & expense, net -162 -103
Operating income
from continuing operations 2 488 25.1 2 335 25.6 7
Pharmaceuticals

Rising faster than net sales, the 13% increase in operating income reflected the impact of recent productivity initiatives and a net positive impact of exceptional items. The operating income margin rose to 33.5% of net sales from 31.3% in the year-ago period. Cost of Goods Sold fell by 1.0 percentage point as a percentage of net sales, in part from lower royalty payments. Other Revenues increased by 0.8 percentage points mainly from royalty income for Betaseron®. R&D investments rose 8%, with investments made in late-stage trials for development compounds including QAB149, QMF149, FTY720 and ACZ885. Marketing & Sales rose roughly in line with net sales, as productivity initiatives helped offset expenses for new product launches. Other Income & Expenses provided 0.4 percentage points to the improved operating income margin, led by a one-time gain of USD 115 million from the divestment of some mature products to Amdipharm.

Vaccines and Diagnostics

Significant investments were among factors for the first-quarter operating loss. These included late-stage clinical trials and costs to prepare for the launches of two meningitis vaccines in development. The year-ago period also included a one-time gain of USD 67 million from a legal settlement. Excluding exceptional items and amortization of intangible assets in both periods, the adjusted operating loss was USD 20 million compared to operating income of USD 38 million in the 2007 period.

Sandoz

Productivity gains in manufacturing and product supply chain supported the improvement in operation income. R&D investments rose at a faster pace than net sales based on accelerated projects for various "difficult-to-make" generics and follow-on biotechnology drugs, which provide Sandoz a competitive advantage. As a result, the operating margin fell to 18.1% of net sales in the first quarter from 18.8% in the year-ago period.

Consumer Health continuing operations

All three business units generated higher operating income that supported investments in new product launches in CIBA Vision and ongoing geographic expansion in OTC, with Marketing & Sales costs up 12% over the prior-year period. Continued high R&D investments rose 11%, mainly in Animal Health. As a result, the operating income margin fell slightly to 18.0% of net sales.

Corporate income and expense, net

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

Corporate

Q1 2008 Q1 2007 Change
USD m USD m USD m %
Operating income from continuing operations 2 488 2 335 153 7
Income from associated companies 137 97 40 41
Financial income 148 87 61 70
Interest expense -57 -53 -4 8
Taxes -408 -374 -34 9
Net income from continuing operations 2 308 2 092 216 10
Net income from
discontinued Consumer Health operations 15 79 -64 -81
Total net income 2 323 2 171 152 7

Income from associated companies

Income from associated companies was USD 137 million in the 2008 first quarter from USD 97 million in the year-ago period and representing essentially the net contribution of anticipated 2008 first quarter results from the Roche investment.

Financial income, net

Average net liquidity in the 2008 first quarter was USD 6.4 billion, significantly higher than USD 0.9 billion in the year-ago period thanks to proceeds in the second half of 2007 from the divestments of Medical Nutrition and Gerber. This led to higher net financial income of USD 91 million, which was helped by currency gains on operating activities.

Taxes

The tax rate for continuing operations remained relatively stable at 15.0% in the 2008 first quarter compared to 15.2% in the year-ago period.

Balance sheet

Total equity was largely unchanged at USD 49.3 billion at the end of the 2008 first quarter compared to USD 49.4 billion at the end of 2007. The 2007 dividend payment of USD 3.3 billion, which rose 29% in US dollars from the 2006 dividend, and USD 0.7 billion in actuarial losses on defined-benefit pension plans were largely offset by USD 2.3 billion in first-quarter net income and currency translation gains of USD 1.4 billion. The balance sheet remained strong, with the debt/equity ratio at 0.13:1 at the end of the first quarter compared to 0.12:1 at the end of 2007.

Divestment proceeds and ongoing strong cash flow led to net liquidity reaching USD 4.4 billion at the end of the first quarter, significantly higher than net debt of USD 0.4 billion at the end of the year-ago period. However, net liquidity declined from USD 7.4 billion at the end of 2007 due mainly to the dividend payment.

Four million shares were repurchased for USD 194 million since the start of the sixth share repurchase program in March 2008 via a second trading line on the Swiss Stock Exchange. At the Annual General Meeting in February 2008, shareholders approved the cancellation of 85.3 million shares repurchased under the fourth and fifth share repurchase programs.

Cash flow

Higher tax payments and working capital requirements were among factors for the decline in cash flow from operating activities to USD 1.7 billion at the end of the 2008 first quarter compared to USD 2.1 billion in the year-ago period. Proceeds from the sale of marketable securities led to cash inflow from investing activities rising to USD 3.4 billion in the first quarter against cash outflow of USD 1.2 billion in the year-ago period. Free cash outflow of USD 2.1 billion in the 2008 first quarter included the full payment of the 2007 dividend of USD 3.3 billion, as compared to the 2006 dividend of USD 2.6 billion being split between the first (USD 1.8 billion) and second (USD 0.8 billion) quarters in 2007.

Well on the way to a new growth cycle in Pharmaceuticals Novartis Pharmaceuticals is on track for a new growth cycle to emerge in the second half of 2008, complementing the anticipated ongoing expansion of Sandoz, Vaccines and Diagnostics and Consumer Health that form the Group's portfolio focused on healthcare products. These businesses are expanding quickly and compete in areas that are expected to grow faster than the global pharmaceuticals market.

As in the first quarter, results of Pharmaceuticals in the second quarter of 2008 will be negatively affected by the full-year effect of having lost significant sales contributions from five products in the US during 2007. These products - Zelnorm, Lotrel, Trileptal, Lamisil and Famvir - had combined total net sales in the US of USD 3.1 billion in 2006, and net sales for this group of products fell to USD 1.7 billion in 2007. The year-on-year impact of lost sales from these medicines will only diminish later in 2008.

At the same time, growth of the unaffected product portfolio - driven by launches of many new products following 15 major US and EU approvals in 2007 and expansion of flagship cancer and cardiovascular products - is expected to support high-single digit net sales growth in the Pharmaceuticals Division by the fourth quarter of 2008, and net sales growth for the full year at a low-single-digit rate, both in local currencies.

Ahead of its new growth cycle, Novartis launched the "Forward" initiative in December 2007 to improve speed, simplicity and productivity for better competitiveness. More than 100 sub-projects are now underway amid expectations for pre-tax annual cost savings of USD 1.6 billion in 2010, with a pre-tax restructuring charge of USD 444 million taken in the 2007 fourth quarter. All site closures and other actions have been announced, with social plans being implemented and information already provided to nearly all associates affected by the reduction of approximately 2,500 full-time equivalent positions.

Strengthening healthcare portfolio with Alcon

Novartis reached an agreement in April 2008 with Nestlé S.A. providing the right to acquire majority ownership of Alcon Inc. (NYSE: ACL ) in two steps and add the world leader in eye care to its portfolio focused on growth areas of healthcare.

The first step to purchase a 25% stake in Alcon from Nestlé for approximately USD 11 billion is expected to be completed in the second half of 2008. The second step provides rights for Novartis to acquire, and Nestlé to sell, the remaining 52% Alcon stake held by Nestlé between January 2010 and July 2011 for up to approximately USD 28 billion. Completion of these steps would make Alcon a majority-owned subsidiary, furthering the Novartis strategy to access high-growth healthcare segments while limiting risks.

Alcon is the world's largest and most profitable eye care company with 2007 annual sales of USD 5.6 billion, operating income of USD 1.9 billion and net income of USD 1.6 billion. Alcon offers a range of pharmaceutical, surgical and consumer eye care products used to treat diseases, disorders and other conditions of the eye.

Group outlook

(Barring any unforeseen events) Novartis is on track for another year of record net sales and earnings in 2008 from continuing operations now entirely focused on healthcare. Net sales from continuing operations for the Group are expected to rise at a mid-single-digit rate, and at a low-single-digit growth rate in the Pharmaceuticals Division, both in local currencies.

Pharmaceuticals products performance review

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

Diovan (USD 1.4 billion, +11% lc), the No. 1 selling brand for high blood pressure in the world, maintained its strong pace in the first quarter after exceeding USD 5 billion in annual sales for the first time in 2007. Diovan has grown consistently thanks to its status as the only medicine in the angiotensin receptor blockers (ARBs) class approved to treat high blood pressure, high-risk heart attack survivors and patients with heart failure. In the US, Diovan has maintained its share above 40% among ARBs, with increasing use worldwide of Co-Diovan/Diovan HCT, a single-tablet combination with a diuretic.

Gleevec/Glivec (USD 888 million, +20% lc), a targeted therapy for certain forms of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), again delivered double digit growth and strengthened its leadership position in helping patients with these and other often-fatal forms of cancer. Data showing that 88% of Gleevec/Glivec patients with newly diagnosed Philadelphia chromosome-positive CML (Ph+ CML) were still alive after six years of treatment along with greater use in patients with metastatic GIST and various rare diseases led to strong growth in the US, where net sales rose 32%.

Zometa (USD 331 million, -1% lc), an intravenous bisphosphonate therapy for patients with cancer that has spread to the bones, experienced a modest slowdown, with US sales down 4% but rising 1% in the rest of the world. Growth for this class began to slow in 2007 with patients receiving treatment less frequently and for shorter courses of therapy.

Femara (USD 270 million, +22% lc), an oral treatment for women with hormone-sensitive breast cancer, continues to outpace competitors and gained share in the aromatase inhibitor segment due to its unique benefits. Publication of data in the Journal of Clinical Oncology in March showed treatment with Femara for up to seven years after standard tamoxifen therapy provided significant benefits in reducing the risk of recurrence in postmenopausal women with early breast cancer. Femara recently lost patent protection in several European markets, including Spain, that could negatively impact growth. In the US, a patent covering the active ingredient of Femara expires in June 2011. Novartis is vigorously defending its rights against a generic manufacturer challenging the patent.

Sandostatin (USD 269 million, +5% lc), for acromegaly and various neuroendocrine and carcinoid tumors, continued to generate strong growth based on increasing use of Sandostatin LAR, the long-acting once-monthly version that accounts for 85% of net sales.

Lucentis (USD 195 million), a biotechnology eye therapy, has now been launched in more than 60 countries following its initial launch in Europe in January 2007. Lucentis is the only treatment proved in clinical trials to maintain and improve vision in patients with the "wet" form of age-related macular degeneration, the leading cause of blindness in people over age 50. Genentech holds the US rights.

Exelon/Exelon Patch (USD 188 million, +17% lc), a treatment for mild to moderate forms of Alzheimer's disease and dementia associated with Parkinson's disease, has generated overall market segment gains after the US and European launches of Exelon Patch in late 2007. Nearly 40% of US net sales were for the Patch, a once-daily skin patch version that provides equivalent efficacy to the highest dose of Exelon capsules but with three times fewer reports of nausea or vomiting.

Exjade (USD 109 million, +55% lc) has benefited from its status as the first once-daily oral therapy for treating patients with iron overload - a potentially fatal condition - associated with various blood disorders.

Lotrel (USD 95 million, -73% lc, only in the US), a single-tablet high blood pressure combination therapy, has been severely impacted since May 2007 following the "at risk" launch of a generic copy by Teva Pharmaceuticals despite a valid US patent until 2017. Novartis is vigorously defending its patent rights. Sandoz also launched an authorized generic version.

Trileptal (USD 90 million, -57% lc), for epilepsy seizures, has experienced a significant decline in overall net sales following the start in October 2007 of generic competition in the US, where net sales fell 73% in the first quarter.

Exforge (USD 72 million), the first single-tablet combination of an angiotensin receptor blocker (Diovan) with the calcium channel blocker amlodipine, continues to outperform many previous combination therapy launches in the US and Europe. Exforge provides powerful reductions across all high blood pressure grades and is now available in more than 35 countries.

Xolair (USD 39 million, +2% lc), a biotechnology therapy for moderate to severe allergic asthma, experienced a slowdown mainly from the timing of supply sales to Genentech, but showed strong growth in Europe and Latin America. A Phase III study in pediatric patients with moderate-to-severe, persistent allergic asthma who were inadequately controlled met its primary endpoints, demonstrating a statistically significant reduction in exacerbations in Xolair-treated patients compared to those on placebo with no new safety signals reported. Xolair's adverse event profile was similar to placebo. Novartis co-promotes Xolair with Genentech in the US and shares a portion of operating income. Genentech reported US sales of USD 117 million for Xolair in the first quarter of 2008.

Aclasta/Reclast (USD 39 million) has experienced rapid growth as a 15-minute, once-yearly infusion for women with postmenopausal osteoporosis, outpacing benchmark launches since its launch in mid-2007. Aclasta/Reclast is now reimbursed on 100% of US Medicare formularies. Other indications are being pursued for prevention of clinical fractures after hip fracture as well as glucocorticoid-induced and male osteoporosis .

Tekturna/Rasilez (USD 28 million), the first new type of high blood pressure medicine in more than a decade, has now been launched in over 40 countries worldwide following US and European approvals during 2007. Known as Tekturna in the US and as Rasilez in other markets, this medicine has generated growth in a competitive environment. Tekturna HCT, a single-tablet combination with a diuretic, received US approval in January, while the EU submission as Rasilez HCT was completed in late 2007. Rasilez was also submitted ahead of schedule for approval in Japan.

Tasigna (USD 10 million) has been well-received following launches in more than 40 countries worldwide since the end of 2007 as a new therapy for patients with a certain form of chronic myeloid leukemia (CML) resistant or intolerant to prior therapy including Gleevec/Glivec (imatinib). A decision on approval in Japan is expected in 2008. A Phase III study is underway comparing Tasigna and Gleevec/Glivec in newly diagnosed CML patients. A registration study in patients with gastrointestinal stromal tumors (GIST) resistant or intolerant to prior treatment has completed enrollment.

Zelnorm/Zelmac (USD 2 million, -98% lc), for irritable bowel syndrome and chronic constipation, will not be resubmitted for US regulatory approval. This medicine was suspended in the US in March 2007, and subsequently in many other countries, to comply with a request from the FDA to review cardiovascular safety data. However, Zelnorm/Zelmac remains available in some countries, and Novartis will discuss next steps with local health authorities, as requested. An emergency treatment access program remains open in the US to provide Zelnorm to appropriate patients.

Research & Development update

Pharmaceuticals

Galvus (vildagliptin), a new oral treatment for type 2 diabetes, was launched in the first European markets in March, including the UK, with additional launches underway. The launches come after Galvus received European Union approval in the first quarter to prescribing information changes proposed by Novartis that reduced the recommended daily doses to 50 mg once-daily or 50 mg twice-daily in combination with various other oral anti-diabetes medicines. The first EU launches are also underway for Eucreas, a single-tablet combination of Galvus with the oral anti-diabetes medicine metformin. Novartis is continuing discussions with the FDA on steps needed for US approval to address requests for more data made in an "approvable letter" in February 2007. Resubmission for US approval is not expected before 2010.

RAD001 (everolimus), a once-daily oral inhibitor of the mTOR pathway, is on track for its first oncology regulatory submission in the second half of 2008. Results of the RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily) trial have been submitted as a late-breaking abstract for the American Society of Clinical Oncology meeting in May. An independent committee stopped this 400-patient trial in February after interim results met the primary endpoint and showed significantly better progression-free survival in patients with advanced kidney cancer who received RAD001 compared to placebo. Registration trials in other cancers are underway. RAD001 acts by directly inhibiting tumor cell growth and metabolism as well as formation of new blood vessels (angiogenesis).

FTY720 (fingolimod), with potential to become the first oral therapy for multiple sclerosis (MS), continued to demonstrate sustained benefits in patients with the relapsing-remitting form of MS after three years of treatment, according to results of an ongoing Phase II study extension presented in April. Data showed 68-73% of patients in the study remained free from relapses after three years of continuous treatment, depending on dosage. FTY720 is on track for regulatory submissions at the end of 2009, and is currently being investigated in the largest worldwide Phase III program to be conducted in MS.

SOM230 (pasireotide), a next-generation somatostatin analogue therapy, has completed Phase II studies for acromegaly, carcinoid tumors and Cushing's disease. A Phase III registration study for Cushing's disease, a rare hormone disorder for which there is no approved medical therapy, is enrolling patients. A Phase III trial in acromegaly began in the first quarter of 2008, with a Phase III trial in carcinoid tumors expected to begin this year.

Extavia (formerly NVF233, interferon beta-1b) has received a positive opinion supporting European Union approval for use in treating various forms of MS, with formal EU approval expected in the second quarter of 2008. Extavia is exactly the same medicine as Betaferon®/Betaseron®, which is marketed by Bayer Schering and was the first beta interferon treatment for MS. Novartis gained rights to its own branded version of this medicine in agreements with Bayer Schering related to Novartis acquiring Chiron. The submission for US approval is expected soon, with US/EU launches by the Pharmaceuticals Division on track for early 2009, its earliest contractually agreed launch date.

Vaccines and Diagnostics

Menveo (MenACWY-CRM) has completed recruitment in a Phase III trial involving infants as part of the overall development program for this vaccine against four common types of meningococcal meningitis known as A,C,W135 and Y. Phase II trial results showed Menveo may protect infants as young as two months old. Also in the first quarter of 2008, a Phase III study was started for a separate vaccine being developed against the B type of meningococcal meningitis. This bacterial disease is a rare, but potentially fatal, infection that causes an infection of the membranes around the brain and spinal cord. The first regulatory submissions for Menveo are planned for later in 2008.
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