Drug maker Lilly to announce 2Q earnings Thursday

OVERVIEW: The Food and Drug Administration dealt Lilly a setback during the quarter when the company announced June 24 that regulators needed three more months to review the blood thinner prasugrel.

Lilly and its Japanese partner, Daiichi Sankyo Co., hope to gain approval of the drug prasugrel to treat patients with acute coronary syndromes, such as heart attacks or unstable angina, who are at risk of developing blood clots.

If approved, prasugrel would compete against the blockbuster Plavix, made by Bristol-Myers Squibb Co. and Sanofi-Aventis SA, and some analysts forecast annual revenue surpassing $1 billion for prasugrel.

The FDA did not ask for new clinical trials. It now plans to rule on the application by Sept. 26.

In July, a federal judge urged Lilly to settle a multibillion-dollar lawsuit filed by insurance companies, unions and others who claim the drug maker overpriced its top-selling product, the anti-psychotic Zyprexa, and exaggerated its usefulness.

U.S. District Judge Jack Weinstein said in court papers he was prepared to grant class-action status for the lawsuit brought by Mid-West National Life Insurance Co. of Tennessee and others. He set a hearing on the proposed order for July 31.

Lilly also announced in June that the FDA had approved the company's fastest-growing drug, Cymbalta, to treat fibromyalgia, a chronic pain disorder. The drug already is approved for diabetic nerve pain, major depressive disorder and generalized anxiety disorder.

Lilly launched Cymbalta in 2004. Its sales rose 37 percent in the first quarter to $605 million.

BY THE NUMBERS: Analysts polled by Thomson Financial, on average, forecast second-quarter earnings of $1 per share on $5 billion in revenue.

STOCK PERFORMANCE: Lilly shares started the second quarter trading above $50 but dipped down to $45.61 on June 27. The price had increased to $47.62 by Wednesday.

FIRST-QUARTER RECAP: Strong sales for Cymbalta and Cialis helped Lilly double its first-quarter profit, but the results missed Wall Street expectations. Lilly said earnings jumped to $1.06 billion, or 97 cents per share, from a 2007 first-quarter profit of $508.7 million, or 47 cents per share. The drugmaker's sales increased 14 percent to $4.81 billion from $4.23 billion.