Biotech Values

[DewDiligence]

ZGEN -16% AH on FDA delay for rThrombin.
This 8K report was just filed:

http://biz.yahoo.com/e/070822/zgen8-k.html

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On August 22, 2007, ZymoGenetics, Inc. (the "Company") provided a status report on the regulatory review process for rThrombin. The Company reported in a conference call that it has received notification from the U.S. Food and Drug Administration ("FDA") that the submission of additional manufacturing related information has been determined by the FDA to be a major amendment to the rThrombin Biologics License Application. Accordingly, the goal date for completion of FDA review under the Prescription Drug User Fee Act has been extended by three months, from October 18, 2007 to January 17, 2008.

The Company also reported certain updates to financial guidance, including the following:

• a $40 million milestone payment due from Bayer Healthcare upon approval of rThrombin by the FDA is now expected to be received in the first quarter of 2008;

• delay of the $40 million milestone payment will reduce the amount of revenue recorded under the Bayer Healthcare license agreement in 2007 from $5 - 8 million, as previously guided, to approximately $3 million;

• no revenues from sale of rThrombin are anticipated until 2008; and

• approximately $8 million of costs related to rThrombin commercial drug supply, previously assumed to be recorded as inventory, are now expected to be expensed to research and development in the fourth quarter of 2007.
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