PALO ALTO, Calif., May 13 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. today announced financial results for the quarter ended March 31, 2008.
Total revenues for the quarter ended March 31, 2008 were $14.6 million, compared to $14.1 million for the quarter ended March 31, 2007. XYREM(R) (sodium oxybate oral solution) net sales for the first quarter of 2008 increased 32 percent to $11.3 million, compared with $8.6 million for the first quarter of 2007.
Once-Daily LUVOX CR(R) (fluvoxamine maleate) Extended-Release Capsules was approved by the U.S. Food and Drug Administration (FDA) on February 28, 2008 for the treatment of both obsessive compulsive disorder (OCD) and social anxiety disorder (SAD), and the product was shipped to wholesalers late in the first quarter.
“The launch of LUVOX CR in the U.S. is progressing very well,” said Robert Myers, President of Jazz Pharmaceuticals. “Our commercial team is focused on introducing this important new treatment option to physicians for their patients with OCD and SAD.”
“We are off to a great start in 2008, with significant product development achievements in addition to our commercial success,” said Samuel Saks, M.D., Chief Executive Officer. “We recently completed screening of subjects in the first of our Phase III pivotal studies of JZP-6 for the treatment of fibromyalgia syndrome, a key milestone in this program. We look forward to obtaining results from this Phase III trial in the fourth quarter of 2008.”
Research and development expenses for the first quarter of 2008 were $21.2 million, compared to $14.9 million for first quarter of 2007. The increase primarily reflects higher expenses associated with later stage development programs, particularly JZP-6.
Selling, general and administrative expenses for first quarter of 2008 were $32.8 million, compared to $14.3 million for the first quarter of 2007. The increase was primarily due to spending in preparation for the launch of LUVOX CR, increased headcount and higher expenses to support the larger sales force.
Net loss for the first quarter of 2008 was $46.7 million, compared to a $19.6 million net loss for the first quarter of 2007.
Jazz Pharmaceuticals’ unrestricted cash and marketable securities balance as of March 31, 2008 was $105.2 million. During the quarter ended March 31, 2008, net cash used in operating activities was $38.2 million.
Jazz Pharmaceuticals will host an investor conference call and live audio webcast to discuss its financial results and provide a business update on its commercial and development activities on May 13, 2008 commencing at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The live webcast may be accessed on Jazz Pharmaceuticals’ website at http://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. An archived version of the webcast will be available through May 27, 2008. Investors may participate in the conference call by dialing 800-901-5259 in the U.S., or 617-786-4514 outside the U.S., and entering passcode 91585353. A replay of this call will be available until May 27, 2008 by phone at 888-286-8010 (U.S.), or 617-801-6888 (international), using the passcode 89402608.
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 http://www.JazzPharmaceuticals.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the commercial launch of LUVOX CR, the continued development of Jazz Pharmaceuticals’ product candidates and the timing of clinical study results. These forward-looking statements are based on the company’s current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the launch of LUVOX CR; risks related to the development of Jazz Pharmaceuticals’ product candidates, including the risk that study or clinical trial results may require Jazz Pharmaceuticals to discontinue the development of one or more product candidates; risks related to the uncertain and time-consuming regulatory approval process; and risks relating to the need for additional funds. These and other risk factors are discussed under “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2007 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on March 31, 2008. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
CONTACT: Matthew Fust, Chief Financial Officer 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/
