Lilly 2008 Profit Forecast Eclipses Expectations

Eli Lilly 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.

Eli Lilly
Eli Lilly

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.

"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 said it 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 the Indianapolis-based company 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.

Lilly shares were little changed in morning trade despite the bullish 2008 forecast.

"The issue is not 2008; the issue is 2011 and beyond," said Morgan Stanley analyst Jami Rubin.

Lilly's chief operating officer, John Lechleiter, told Reuters, "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."

Toward that end, he said, Lilly aims to launch on average two new drugs per year beginning in 2011, increasing to three per year by 2014. It aims to move at least 10 additional drugs into late-stage studies by 2011.

The company also has financial strength to license or buy more drugs, said Lechleiter, whose company was hosting a meeting in New York on Thursday with investors and analysts.

Lilly said growing sales of its drugs in Japan and China would help it survive its patent protection problems, with company revenue in China likely to jump fivefold by 2015 to almost $1 billion.

"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.

Lilly said its dependence on Zyprexa -- whose tendency to cause weight gain has hurt its U.S. sales -- will diminish as sales increase for its other products, including Alimta for cancer and popular diabetes treatment Byetta.

The company said on Thursday that Byetta, sold in partnership with Amylin Pharmaceuticals, successfully controlled blood sugar levels in a trial involving patients taking it as a stand-alone treatment. Byetta is currently only approved for use with other diabetes medicines.

Lilly said the favorable results could help Byetta win approval as a monotherapy, an indication that U.S. regulators in 2005 refused to approve.

Prasugrel recently proved better able to prevent heart problems than Plavix, the huge-selling blood-clot treatment from Bristol-Myers Squibb and Sanofi-Aventis.

But prasugrel caused a higher incidence of serious bleeding, raising doubts about whether U.S. regulators will approve the drug before a planned new large trial is completed.

Lechleiter acknowledged that prasugrel had limited benefit for 16 percent of the patients taking it in the large study already completed -- namely, patients over 75 years old or weighing less than 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 that U.S. regulators will approve the drug, which Lilly licensed from Daiichi Sankyo and which analysts think could become a multibillion-dollar product.

Lilly shares were up 6 cents to $53.55 on the New York Stock Exchange amid a moderate decline for the drug sector.