PALO ALTO, Calif., March 3 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. today announced financial results for the fourth quarter and full year ended December 31, 2009.
XYREM(R) (sodium oxybate) oral solution net sales increased 100% to $31.6 million for the quarter ended December 31, 2009, compared to net sales of $15.8 million for the quarter ended December 31, 2008. XYREM net sales for the year ended December 31, 2009 increased 80% to $96.8 million, compared with $53.8 million for the year ended December 31, 2008. Net sales of once-daily LUVOX CR(R) (fluvoxamine maleate) Extended-Release Capsules, launched in April 2008, increased 86% to $5.7 million for the quarter ended December 31, 2009, compared to $3.1 million for the quarter ended December 31, 2008. LUVOX CR net sales for the year ended December 31, 2009 increased 220% to $18.3 million, compared with $5.7 million for the year ended December 31, 2008.
Research and development expenses for the quarter ended December 31, 2009 were $6.3 million, compared to $14.7 million for the quarter ended December 31, 2008. For the year ended December 31, 2009, research and development expenses were $36.6 million, compared to $70.0 million for the year ended December 31, 2008. Research and development expenses in both 2009 and 2008 primarily reflect the expenses relating to Phase III clinical activities for the company’s JZP-6 product candidate, sodium oxybate for the treatment of fibromyalgia. In 2009, the company completed the second of two Phase III clinical studies and submitted a New Drug Application (NDA) for JZP-6 to the U.S. Food and Drug Administration (FDA) in December. The NDA for JZP-6 was filed by the FDA in February 2010 and the target date for the FDA to complete its review under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.
Jazz Pharmaceuticals’ net income for the quarter ended December 31, 2009 was $5.7 million, or $0.17 per diluted share, compared to a net loss of $56.9 million, or $2.04 per share, for the quarter ended December 31, 2008. For the year ended December 31, 2009, the net loss was $6.8 million, or $0.23 per share, compared to a net loss of $184.3 million, or $7.19 per share, for the year ended December 31, 2008. Contributing to the net loss in 2008 was a fourth quarter non-cash impairment charge of $29.8 million relating to the company’s LUVOX CR intangible asset.
Jazz Pharmaceuticals’ cash, cash equivalents and marketable securities as of December 31, 2009 totaled $15.6 million, excluding restricted cash of $3.0 million.
Jazz Pharmaceuticals will host an investor conference call and live audio webcast to give a company update, as well as to discuss financial results and guidance, today (March 3, 2010) commencing at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The live webcast may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.JazzPharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing 1-800-591-6923 in the U.S., or 1-617-614-4907 outside the U.S., and entering passcode 79845734.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information see www.JazzPharmaceuticals.com.
Non-GAAP Financial Measures
CONTACT: Shawn Mindus, Senior Director, Financial Planning, Analysis, and
Strategy of Jazz Pharmaceuticals, Inc., +1-650-496-2800,
investorinfo@jazzpharmaceuticals.com; or Karen L. Bergman, +1-650-575-1509,
or Michelle Corral, +1-415-794-8662, both of BCC Partners, for Jazz
Pharmaceuticals, Inc.
Web site: http://www.jazzpharmaceuticals.com/
