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Novavax shares fall nearly 11%

THE BALTIMORE SUN

Shares of Novavax Inc. fell nearly 11 percent yesterday after the company said its third-quarter loss more than doubled as revenue plummeted and research spending rose.

The Columbia-based drug and vitamin company said its loss was $6.7 million, or 27 cents a share, on revenue of $2.5 million. That compares with a loss of $2.5 million, or 11 cents a share, on revenue of $5 million in the corresponding period last year.

Analysts had expected a loss of 20 cents a share, according to the average estimate of four analysts surveyed by Thomson Financial/First Call.

Shares of Novavax fell 41 cents, or 10.8 percent, to close at $3.40 yesterday.

The company said research and development costs rose to $3.7 million from $1.8 million.

Novavax interim Chief Executive Officer Mitchell J. Kelly described the company's third-quarter revenues in a statement as "clearly disappointing." The company blamed the decline on generic competition for Novavax's prenatal vitamins, as well as a sales shortfall caused by packaging problems for its vaginal infections cream.

The company said in August that it would lose up to $1.5 million in sales to distributors this year because of the packaging problems for AVC. A supplier discontinued the tube in which the cream was packaged, and Novavax said a new one leaked.

Neither Kelly nor Chief Financial Officer Dennis Genge could be reached yesterday for comment. But Kelly said in the statement that the company has "made significant strides on several key fronts," including resubmitting an application to have its Estrasorb estrogen replacement cream approved.

The revenue woes are only the latest bad news for Novavax, which replaced its CEO after a setback in attempts to get Estrasorb on the market. The company said yesterday that the Food and Drug Administration had accepted its Estrasorb application for review - the second time it has done so.

The company pulled the first application in April after the FDA said it would not approve the product without more information. The announcement came amid news that a nationwide study had put the merits of some kinds of hormone replacement therapy in doubt, linking long-term use with ovarian cancer, among other things.

(Novavax executives have emphasized that Estrasorb is different in part because it is designed for short-term use and is delivered in relatively low doses through the skin with a cream).

Novavax resubmitted the application in September. The same day, it said CEO John Spears had resigned and been replaced temporarily by Kelly, the CEO of Anaconda Capital Management LLC.

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