said Thursday it expects a delay in approval for its breakthrough cancer-fighting drug, Zevalin.
The disappointing drug development news overshadowed strong first-quarter net income of $20.8 million, or 12 cents per share, which matched Wall Street estimates and was well above results from the year-ago quarter.
Wall Street observers were counting on the
U.S. Food and Drug Administration
to review Zevalin at a June advisory committee meeting, which would have put the drug in the slot for a mid-to-late summer approval.
But Thursday night, IDEC dashed those hopes. Company executives acknowledged that the FDA has asked for additional information on Zevalin. Responding to the requests, combined with the rapidly approaching cutoff for the June meeting, "makes it unlikely that we will present at the June meeting," a company executive said on the analyst conference call.
Company executives added that the company has no idea when it will be scheduled for an FDA advisory committee hearing, or when the drug will be approved.
Investors reacted accordingly. Shares in IDEC closed Thursday down $2.40, or 4.4%, to $52.14, ahead of the earnings release. The stock fell to $49 in after-hours trading on
Several analysts were expecting Zevalin to kick in more than $20 million in sales for IDEC in 2001. If the drug's approval is delayed, those estimates will have to be adjusted downward, which will hurt IDEC's bottom line.
And IDEC can ill afford a reduction in revenue and earnings estimates because it's an expensive stock compared with its peers. At Thursday's close, the company was trading at 93 times 2001 earnings and 61 times 2002 earnings.
Back to IDEC's quarterly results, the company's first-quarter earnings matched Wall Street estimates and were up sharply from a year ago, when the San Diego company lost $4.3 million, or 3 cents per share. Past results have been restated to reflect the adoption of new accounting standards.
IDEC reported first-quarter revenue of $56.5 million, compared with $27 million in the year-ago quarter.
Revenue in the quarter included $48.6 million from sales of Rituxan, the cancer-fighting drug IDEC co-markets with
. Earlier this week, Genentech reported stronger-than-expected first-quarter Rituxan sales of $168 million.