Cadence Pharmaceuticals, Inc.’s (CADX) fourth quarter fiscal 2009 net loss per share came in at 30 cents, wider than the Zacks Consensus Estimate by a penny. The year-ago loss was 37 cents.
 
Quarterly Results
 
The company reported no revenues for the quarter. Operating expenses for the reported quarter climbed to $15.1 million from $13.5 million in the year-ago quarter due to the rise in sales and marketing expenses.

This can be attributed to the establishment of infrastructure in preparation for the launch of Ofirmev on approval. Ofirmev is an intravenous drug for the treatment of pain and fever for which the company is seeking approval.

The rise in sales and marketing expenses was partially offset by a reduction in the research and development spend in the quarter because of the completion of the clinical development program for Ofirmev in early 2009 in addition to the discontinuation of the development program for omiganan in Mar 2009.
 
We note that the lower net loss per share in the reported quarter compared to the year-ago quarter despite higher operating expenses was primarily because of an increase in the number of shares. Total net loss increased to $15.31 million during the reported quarter compared to $14.04 million in the year ago period.
 
Yearly Results
 
For 2009, the company suffered a loss of $45.5 million, or 93 cents per share, as against a loss of $57.1 million, or $1.55 for 2008. The company reported no revenues in 2009.
 
The lower loss in 2009 was attributable to the 27% year-over-year decrease in operating expenses. The 105% reduction in research and development costs contributed mainly to the decrease in operating expenses.

The massive decline in research and development costs was triggered by the discontinuation of the company’s omiganan development program, the completion of the clinical development program for Ofirmev and the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the pain drug during the year.
 
However, Cadence suffered a setback in Feb 2010 when the FDA refused to approve Ofirmev because of deficiencies in the company’s third-party manufacturing facility. The manufacturer of the intravenous painkiller has already responded to the Complete Response letter from the FDA. Cadence intends to resubmit the NDA to the U.S. agency once the problems are resolved.
 
Cadence ended the year with cash, cash equivalents and short-term investments of $82 million.
 

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