AstraZeneca Earnings Rise, FDA Panel Approves Brillinta AstraZeneca (AZN) reported Thursday that its core earnings per share rose 9% in the second quarter, helped by a strong performance in emerging markets and sales of key drugs such as cholesterol medicine Crestor. While the British pharmaceutical warned that the second half of the year will be more "challenging," it also raised its earnings forecast for 2010 for the third time this year.

Second-quarter earnings per share excluding items rose to $1.79 from $1.64, beating analysts' estimates of $1.53, according to Thomson Reuters. Net income gained 23% to $2.11 billion from $1.71 billion a year earlier. AstraZeneca's revenue rose 3% to $8.18 from $7.96 in the same quarter last year, or 1% at a constant exchange rate. Analysts forecast sales of $8.1 billion.

"Our second quarter performance reflects continued strong growth in our Emerging Markets and good performance for key brands Crestor, Seroquel and Symbicort. While revenue and Core EPS comparisons become more challenging in the second half of the year, we have increased our full year financial targets," said CEO David Brennan in a statement.

The company's U.S. revenue declined by 4% due to the impact of generic competition for several of its drugs. This issue is expected only to worsen in the second half. Revenue comparisons also will be impacted by reduced sales of AstraZeneca's H1N1 pandemic flu vaccine.

Still, AstraZeneca last month managed to stave off one looming danger when a U.S. court upheld its patent on Crestor, removing a threat to the $4.5 billion in revenue the company earns from the drug. AstraZeneca therefore raised its earnings estimate for the full year to $6.35 to $6.65 a share excluding items, up from a previous goal of $6.05 to $6.35 a share. And following the strong performance, it also doubled its 2010 share repurchasing program to $2 billion.

FDA Panel Gives a Big Boost to Blood Thinner


But the big story this week is the backing an FDA advisory panel gave to the company's blood thinner, Brilinta, on Wednesday. Brilinta is a potential blockbuster and rival to Sanofi-Aventis's (SNY) and Bristol-Myers Squibb's (BMY) Plavix, which had $9.8 billion in sales last year.

Plavix and Brilinta both work by stopping blood platelets from sticking together and forming clots that can lead to heart attacks and strokes.

The FDA panel voted 7-1 to recommend approval of Brilinta to reduce the risk of heart attacks, strokes and death in patients who have suffered from heart attacks or chest pain, and who are either managed medically or need an artery-clearing procedure. The FDA is scheduled to decide on Brilinta by Sept. 16, and while the agency does not have to follow the panel's advice, it usually does. Brilinta sales could reach $1.47 billion by 2016, according to analysts surveyed by Bloomberg.

Getting a thumbs up from the panel was no foregone conclusion: In the international clinical trial AstraZeneca performed with 18,624 patients, the relatively small group from North America saw no benefit. Still, there was a sharp reduction in deaths, strokes and heart attacks in patients on Brilinta compared to those on Plavix, and the drug did not increase the chances of major bleeding.

With AstraZeneca facing a major patent cliff, Brillinta is one big key to its future growth. The drugmaker also aims to boost sales in emerging economies, it said.

AstraZeneca shares, which surged Wednesday to finish 3.2% higher, are down about 1.7% in Thursday's trading.

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