said late Monday that it expects to receive Medicare reimbursement for its new cancer drug, Zevalin, in October, three months later than anticipated.
Idec has not given specific financial guidance for the current quarter or full year 2002, but on a conference call, Idec COO Bill Rohn told analysts that the company may want to "revisit their
Zevalin estimates for 2002," as a result of the delay in Medicare reimbursement.
Separately, the San Diego-based biotech firm has stopped all ongoing clinical trials of an experimental autoimmune drug, Idec-131, because of a newly identified safety risk.
Shares of Idec closed Monday up 13 cents, to $38.37, but were falling back after hours, down 6% to $36.
Zevalin, a new treatment for patients with advanced forms of non-Hodgkin's lymphoma, hit the market in March after being approved by U.S. drug regulators in late February. Zevalin is a monoclonal antibody that carries a payload of radioactive material that increases its tumor-killing power.
Medicare reimbursement for Zevalin, which is needed to jump-start the drug's sales, was expected in July. Monday, Idec said that it has received the necessary Medicare coding for patient claims and reimbursement, but that it won't take effect until October.
"We anticipated receiving pass-through status and corresponding C-codes for Zevalin in early July," said Rohn, "Nevertheless, we are gratified to learn that pass-through codes will be assigned to us in early October."
The Center for Medicare and Medicaid Services blamed the delay on "time constraints and systems issues," according to Rohn.
Idec's stock has been weak lately, in part on fears that slower-than-expected Zevalin sales -- hurt by the lack of Medicare reimbursement -- will force the company to miss Wall Street estimates for the second quarter, and force a reduction in sales estimates for the rest of the year.
Analysts expect the company to earn 20 cents a share in the second quarter and 87 cents a share for the full year 2002, according to consensus figures compiled by Thomson Financial/First Call. Analysts' estimates for Zevalin sales range from $6 million to $10 million in Zevalin sales for the current quarter.
"The lack of Medicare reimbursement is a hurdle to widespread adoption of Zevalin to date," said Rohn, on the conference call. "While we have 325
hospital sites licensed and trained to use Zevalin, many have chosen to hold off until the Medicare reimbursement issue is clarified."
Idec also said Monday that it was halting work on its experimental drug, Idec-131 because of an increased safety risk related to blood clots. The company said it was working with the Food and Drug Administration and its researchers to further analyze the potential problem.
Idec-131 is an experimental monoclonal antibody currently in phase II studies in patients with several autoimmune diseases, including Crohn's disease, psoriasis and multiple sclerosis.