MedImmune reports GAAP net loss of $63 million for second quarter

By Jennifer Lanning Drey

Eugene, Ore., July 20 - MedImmune, Inc. reported a GAAP net loss of $63 million, or $0.26 per share, on $73 million in revenues for the second quarter, according to a company news release.

The loss includes share-based compensation expense.

MedImmune reported a net loss of $44 million, or $0.18 per share, on revenues of $88 million for the comparable period in 2005, according to the release.

The company's cash and marketable securities were $2.3 billion on June 30, compared to $1.5 billion on Dec. 31, 2005, according to the release.

Highlights for the second quarter include two Food and Drug Administration approvals that will financially benefit the company, said Jim Young, president of research and development for MedImmune, during a company conference call held Thursday.

In early July, the company received FDA approval for its reverse genetics technology for use in development of influenza vaccines.

The company now owns or has exclusive licenses to all of the key intellectual property in the field of recombinant influenza, virus products and reverse genetics, Young said.

"As such, we have offered licenses for our reverse genetics technology to other vaccine manufacturers developing influenza vaccines," he said.

In addition, MedImmune will receive royalties and milestone revenues based on intellectual property rights from a newly approved vaccine to prevent cervical cancer.

"We are starting to see some of the fruits of our labors over the last couple of years to bring things through the development cue and to the market," said Young.

The company also hopes to gain FDA approval of a new formulation of FluMist (influenza virus vaccine live, intranasal) for the current approved indication in 2007.

MedImmune has filed a supplemental Biologics License Application and recently received a complete response letter from the FDA.

Young said MedImmune plans to answer all of the FDA's questions and is confident that it will ultimately receive FDA approval of a refrigerator-stable form of FluMist.

MedImmune also plans to file another supplemental Biologics License Application for the new indication to include children as young as one year old if they do not have a history of wheezing, Young said.

"In this population in particular, we have an excellent risk-benefit profile versus the injectable vaccine," Young said.

Numax advancing

MedImmune is also advancing Numax, an investigational humanized monoclonal antibody being evaluated for its potential to prevent serious respiratory tract caused by human respiratory syncytial virus (RSV) in pediatric patients.

During the second quarter, the company completed a pivotal phase 3 study comparing Numax to Synagis (palivizumab), one of its already commercialized products indicated for the prevention of RSV in pediatric patients.

MedImmune is currently analyzing the data from the study, which involved 6,600 children, and expects to announce top line results in the fourth quarter.

The company also plans to begin an RSV feasibility treatment study that will use Numax to treat approximately 300 infants who already have an RSV infection.

"MedImmune has made very substantial progress during the 2006 second quarter, advancing its development stage pipeline products," said Young.

The company now has 40 products and product candidates, 14 of which are in the clinic. MedImmune expects to submit up to eight Investigational New Drug applications over the next 12 to 18 months, Young said.

MedImmune, based in Gaithersburg, Md., is focused on the areas of infectious diseases, cancer and inflammatory diseases.

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