ImClone Narrows Loss but Misses

Updated from 8:06 a.m. EST

Shares of ImClone Systems ( IMCL) slipped Monday after the company said it had narrowed fourth-quarter and full-year losses, but the results fell below analysts' estimates

The company also declined to give sales and earnings guidance for 2004's first quarter or for the full year, saying it needed more time to assess sales trends of its recently-approved colon cancer drug Erbitux.

Without such guidance, Wall Street's estimates -- exacerbated by the fact that few analysts follow the company -- are all over the place. According to Thomson One Analytics, first-quarter estimates range from a profit of 28 cents a share to a loss of 39 cents. The average for the three analysts polled by the firm is a loss of 11 cents.

For the full year, the average Thomson estimate is a profit of 11 cents, with the range careening from a loss of 82 cents to a gain of 90 cents.

Analysts polled by the research firm had expected ImClone to lose 32 cents a share for 2003's fourth quarter and to lose $1.48 for the full year. Instead, the New York-based biotechnology company lost 35 cents for the quarter and $1.52 for the year.

Still, those results were better than the previous year. For 2003's fourth quarter, ImClone lost $26.3 million, or 35 cents a share, compared with a loss of $39.4 million, or 54 cents a share, for the same period in 2002. Quarterly revenue rose to $19.8 million from $14.9 million.

Last year, ImClone lost $112.5 million, or $1.52 a share, compared with 2002's loss of $157.9 million, or $2.15 a share. Total revenue grew to $80.8 million from $60 million.

Last year's results exclude the impact of the Food and Drug Administration's approval of Erbitux four weeks ago, the drug's launch two weeks later and the receipt last week of a $250 million milestone payment from marketing partner Bristol-Myers Squibb ( BMY).

Daniel S. Lynch, the company's chief executive, said Monday that ImClone's major goals this year are not only to sell Erbitux as a late-stage colon cancer drug but also to pursue research to determine if the drug is suitable as a treatment for earlier-stage colon cancer as well as for other cancers. (Erbitux is approved as a combination treatment with a chemotherapy product called irinotecan -- or as a single treatment in patients for whom irinotecan doesn't work -- in cases where colorectal cancer has spread to other parts of the body).

The most promising prospect is for cancers of the head and neck. The company has completed a phase III clinical trial testing Erbitux plus radiation on these cancers. Phase III tests represent the final clinical trial step before a drug is submitted for approval to the FDA. Lynch said the results will be presented at a major cancer conference in June. If the results are significant, ImClone will seek FDA approval, Lynch said.

Other clinical tests involving Erbitux include using the drug and chemotherapy during earlier stages of colorectal cancer and combining the drug with Genentech's ( DNA) recently approved Avastin to treat colorectal cancer. ImClone is also testing Erbitux plus chemotherapy as a treatment for certain lung cancers. Lynch said the company will give a broader discussion of its research efforts during the next fiscal quarter.

In late trading, the stock was down $1.26 cents, or 2.7%, to $45.25.

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