National Editor

Synagis and Ethyol helped MedImmune to handsome earnings for 2003 - allowing the company to record more than $1 billion in revenues for the year - but the company said the fate of its once-ballyhooed influenza vaccine, FluMist, is uncertain.

"The MedImmune organization, as a whole, is strong and continuing to build for the future," David Mott, CEO, told investors during a conference call. Revenues rose 24 percent to top out at $1.1 billion. Cash and marketable securities increased 34 percent to $1.9 billion. And Gaithersburg, Md.-based MedImmune's stock (NASDAQ:MEDI) rose $1.48 Thursday to close at $23.71, after rising as high as $24.29.

But then there is FluMist. Once considered a potential blockbuster, FluMist has so far proved "disappointing," Mott said, given that the current estimates for the 2003-2004 flu season show the product might only bring in $30 million in sales revenue for MedImmune.

Growth in 2003 was due mainly to Synagis (palivizumab), MedImmune's flagship product to block respiratory syncytial virus in high-risk infants. Worldwide sales in 2003 totaled $849 million, a 26 percent increase over 2002 sales of $672 million. For the 2003 fourth quarter, sales rose 14 percent to $358 million, up from $314 million in the same quarter of 2002.

Sales of Ethyol (amifostine), a selective cytoprotective agent used to reduce some toxicities associated with chemotherapy and radiotherapy, added up to about $100 million for the year, increasing 23 percent over worldwide sales of $81 million in 2002. For the fourth quarter, Ethyol sales grew 12 percent to $29 million.

Other revenues for the year were $62 million, including $46 million as milestone and reimbursement payments from partner Wyeth, of Madison, N.J., for FluMist, the nasal flu vaccine approved by the FDA after a rocky history in June and launched in September.

In the fourth quarter alone, other revenues totaled $9 million, of which $8 million was associated with FluMist revenues not related to sales. In 2002, the other revenues column amounted to $62 million for the year and $33 million for the fourth quarter.

MedImmune also markets CytoGam, an intravenous immune globulin indicated for prophylaxis against cytomegalovirus disease associated with the transplantation of a kidney, lung, liver, pancreas or heart.

FluMist yielded no sales-related revenue, defined as royalties or transfer payments, since the quantity and timing of doses sold, returned and discounted for the entire 2003-2004 influenza season were not sufficiently determinable. Still, MedImmune does figure it might be able to tally $30 million for the season in sales-related revenues for the drug.

Lota Zoth, chief financial officer for MedImmune, said in the conference call that the $30 million is a "somewhat rough estimate, because those variables are still moving around a bit."

Meanwhile, Mott said, no decisions have been made about what to do next with FluMist.

"Everything is on the table," he said. "We need to rethink about the product and how we position it, and where we are seeking to expand the label and in what time frame. We need to re-evaluate which responsibilities MedImmune has and which ones Wyeth has, and try to come up with the right formula going forward. We don't yet have answers to that."

Mott allowed that the options include everything "from us continuing to go forward together under the basic structure we have in place now," to Wyeth bailing out, to MedImmune bailing out, "or perhaps both of us declaring defeat and getting out."

He said the companies are "evaluating all possible scenarios, and really trying to come up with a clean strategy going forward for how to do the best job with the asset we have. Quite frankly, I probably listed those [options] in the order of likelihood."

The company is holding off providing much more guidance about 2004 until March 1, though Mott said MedImmune believes FluMist is a good product.

"We need to get that goodness described better in the label," he said. Various sponsored trials are ongoing, as well as talks with the FDA.

"We continue to think that there is a pony there," Mott said.

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