NEW YORK (Reuters) - Eli Lilly and Co <LLY.N> on Thursday forecast 2008 earnings above Wall Street expectations and said it remained on track to seek U.S. approval this month for prasugrel, a blood clot preventer, which posted mixed results in a recent large clinical trial.
By Ransdell Pierson and Lewis Krauskopf
NEW YORK (Reuters) - Eli Lilly and Co <LLY.N> on Thursday forecast 2008 earnings above Wall Street expectations and said it remained on track to seek U.S. approval this month for prasugrel, a blood clot preventer, which posted mixed results in a recent large clinical trial.
The Indianapolis-based drug maker expects earnings of $3.85 to $4 per share next year, excluding special items.
The outlook translates into profit growth of 8 percent to 14 percent from anticipated 2007 earnings and exceeds the analysts' average forecast of $3.81 per share compiled by Reuters Estimates.
!ADVERTISEMENT!"Clearly the 2008 forecast is much better than expected," said Lehman Brothers analyst Tony Butler. "Lilly is showing the strength of their brands and cost or expense discipline."
Lilly expects compound annual earnings-per-share growth through 2011 in the "low-double digits" percentage range. It expects its Cymbalta depression treatment to overtake schizophrenia drug Zyprexa as its biggest U.S. product in 2008.
Industry analysts have questioned whether Lilly will have enough new products to make up for expected plunging sales of several drugs set to lose U.S. patent protection in coming years, including chemotherapy agent Gemzar in 2010, Zyprexa in 2011 and Cymbalta in 2013.
"There's no question we will face the biggest challenge of our history at the beginning of the next decade, but we're confident we can meet that challenge based on new products being launched before and during that period," Lilly's chief operating officer John Lechleiter told Reuters.
Toward that end, Lechleiter said Lilly aims to launch on average two new drugs per year beginning in 2011, increasing to three per year by 2014.
The company also has financial strength to license or buy more drugs, said Lechleiter, whose company was hosting a meeting on Thursday in New York with investors and industry analysts.
"The only drug in Lilly's pipeline with potential to lessen that looming (patent) pothole is prasugrel," said Trevor Polischuk, global pharmaceuticals analyst with OrbiMed Advisors.
Lilly's other experimental drugs, while interesting, do not have enough sales potential to fill the gap, Polischuk said.
"Investors are keen on grasping the pipeline," Lehman's Butler said. "It is critical to understand 'life after Zyprexa."' The schizophrenia drug has annual global sales approaching $5 billion.
The company said dependence on Zyprexa - whose tendency to cause weight gains has hurt its U.S. sales - will diminish as sales increase for its other drugs, including Alimta for cancer, and a long-acting form of its diabetes drug Byetta.
Prasugrel, the most important drug in Lilly's pipeline, recently proved better able to prevent heart problems than Plavix, the huge-selling blood-clot treatment from Bristol-Myers Squibb Co <BMY.N> and Sanofi-Aventis <SASY.PA>.
But prasugrel caused a higher incidence of serious bleeding, raising doubts whether U.S. regulators will approve the drug before a large planned new safety trial is completed.
Lechleiter acknowledged that prasugrel had limited benefit for 16 percent of the patients taking it in the large study, namely those over 75 years old or those weighing under 132 pounds.
A smaller "tailored" dose of prasugrel could prove safer for these two populations, he said.
"But among 80 percent of patients, there was a very clear benefit of prasugrel over Plavix," Lechleiter said.
He said that made him optimistic U.S. regulators will approve the drug, which it licensed from Daiichi Sankyo Co Ltd <4568.T> and which analysts think could become a multi-billion-dollar product.
(Reporting by Ransdell Pierson, Lewis Krauskopf and Edward Tobin; Editing by Derek Caney)
