SAN DIEGO, March 15 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. , a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, today reported financial results for the fourth quarter and year ended December 31, 2009.
“Our third party manufacturer has now submitted its response to the FDA’s observations, and we will be prepared to re-submit our NDA for OFIRMEV at the earliest possible opportunity,” stated Ted Schroeder, President and CEO. “We believe it is important to note that no safety or efficacy deficiencies were noted in the Complete Response letter and the FDA did not request that any additional clinical trials be completed in order to obtain approval of the NDA. As a result, we believe that we have sufficient capital resources to fund our operations through re-submission of the NDA and approval of OFIRMEV.”
For the year ended December 31, 2009, Cadence reported a net loss of $45.5 million, or $0.93 per share, compared to a net loss of $57.1 million, or $1.55 per share, for 2008. Operating expenses for 2009 were $44.5 million, a decrease of $12.0 million from the $56.5 million reported for 2008. The decrease in the current year expenses is primarily due to a reduction in research and development costs as a result of the company’s discontinuation of its omiganan development program and the completion of its clinical development program and submission of an NDA for OFIRMEV. Further, the impairment charge taken in 2008 on the company’s omiganan manufacturing equipment was significantly greater than the restructuring charges taken in 2009 as a result of the discontinuation of the omiganan program. Partially offsetting these reductions was an increase in sales and marketing expenses in 2009 as the company began establishing its commercial and supply functions in preparation for the potential commercial launch of OFIRMEV, including an increase in sales and marketing staff from 2 at the end of 2008 to 40 at the end of 2009.
Conference Call and Webcast on March 15, 2010 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time)
Cadence management will host a conference call on March 15, 2010 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) and interested investors may participate in the conference call by dialing 877-303-9145 (domestic) or 760-536-5203 (international). To access the webcast, please visit the company’s website at www.cadencepharm.com and go to the Investor Relations page. A replay of the webcast will be available approximately two hours after the call and remain available on the company’s website until the next quarterly financial results call.
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting. For more information about Cadence, please visit www.cadencepharm.com.
Cadence(TM) and OFIRMEV(TM) are trademarks of Cadence Pharmaceuticals, Inc. Perfalgan(R) is a registered trademark of Bristol-Myers Squibb Company.
Cadence Pharmaceuticals, Inc.
