MGI Pharma


slid 8% late Wednesday after the cancer-drug company posted a quarterly profit that was a shade lighter than Wall Street expected.

On the bright side, the Bloomington, Minn., company swung to a first-quarter profit, earning $11.6 million, or 15 cents a share, on sales of $63.2 million. That compares with a year-ago loss of $3.1 million, or a nickel a share, on revenue of $26.9 million.

Less pleasing to investors, though, was that latest-quarter numbers failed to meet the Wall Street analyst consensus estimate, which called for earnings of 16 cents a share on sales of $66 million. The company's Aloxi injection, now the No. 1 injectable treatment for chemotherapy-induced nausea and vomiting, showed solid sales gains except for a costly slowdown in January, MGI said.

The company also reaffirmed 2005 guidance, saying it expects to post revenue of $285 million, including Aloxi injection product sales of $260 million. Analysts surveyed by Thomson First Call had forecast 2005 revenue of $287 million.

MGI has completed a special protocol assessment with the Food and Drug Administration for Aloxi injection as treatment for postoperative nausea and vomiting, and for the development of an Aloxi oral formulation. Phase III trials are expected to begin within the next few weeks.

Two studies will enroll more than 1,000 patients across four treatment arms, receiving either a placebo or one of three dose levels of the Aloxi injection. MGI's Aloxi injection currently dominates the chemotherapy-induced nausea and vomiting injectable market only 18 months after its launch.

The company also announced an accelerated timeline for its new drug application for Saforis, its treatment for oral mucositis, the inflammation of the mouth and esophagus that occurs as a side effect of cancer treatment. MGI expects to submit a new drug application for Saforis oral suspension by the end of the third quarter, depending on the successful completion of its phase III trial. MGI also plans to expand the drug's labeling for other indications.

MGI is currently enrolling patients in its phase II clinical trial of Dacogen injection as front-line treatment for patients suffering from acute myeloid leukemia. The company plans to announce updated results from its Dacogen trials at the annual meeting of the American Society of Clinical Oncology in May.

In after-hours trading, the stock fell $2.02 to $23.90.