May 6 2010
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced financial results for the first quarter ended March 31, 2010 and updated guidance for sales and expenses for 2010.
Total revenues for the quarter ended March 31, 2010 were $35.2 million, compared to $22.1 million for the quarter ended March 31, 2009, representing a 59% increase. XYREM® (sodium oxybate) net sales for the first quarter of 2010 were $28.7 million, compared to $17.7 million for the first quarter of 2009, representing a 62% increase. Net sales of once-daily LUVOX CR® (fluvoxamine maleate) extended-release capsules were $5.5 million for the first quarter of 2010, compared to $3.6 million for the first quarter of 2009, representing a 54% increase. Total revenues for the first quarter of 2010 also included $0.9 million in royalties and contract revenue compared to $0.8 million for the first quarter of 2009. The increase in XYREM product sales in the first quarter of 2010 compared to the first quarter of 2009 was due primarily to the impact of price increases taken in 2009, and to a lesser extent, a 5% increase in volume.
"In the first quarter, Jazz Pharmaceuticals continued in its mission to help improve patients' lives by providing therapies to address serious medical conditions. The commercial team delivered another quarter of solid performance in achieving year-over-year growth in sales and prescriptions for both of our products," said Bob Myers, President of Jazz Pharmaceuticals.
Research and development expenses for the quarter ended March 31, 2010 were $6.2 million, compared to $11.4 million for the quarter ended March 31, 2009. Research and development spending in the first quarter of 2010 was primarily focused on the prosecution of our new drug application for JZP-6, our product candidate for fibromyalgia, our long-term safety study for JZP-6, and development work on oral tablet forms of sodium oxybate, the active pharmaceutical ingredient in both XYREM and JZP-6. Research and development expenses were lower in the first quarter of 2010 compared to the first quarter of 2009 when we were actively conducting our second JZP-6 Phase III clinical trial and enrolling patients in the long-term safety study.
Selling, general and administrative expenses for the quarter ended March 31, 2010 were $16.8 million, compared to $14.2 million for the quarter ended March 31, 2009. Selling, general and administrative expenses were higher in the first quarter of 2010 compared to the first quarter of 2009, primarily due to pre-launch planning and preparation activities related to our JZP-6 product candidate and higher personnel expenses including stock-based compensation.
Net income for the quarter ended March 31, 2010 was $1.5 million, or $0.04 per diluted share, compared to a net loss of $13.0 million, or $0.45 per diluted share, for the quarter ended March 31, 2009.
Adjusted net income for the quarter ended March 31, 2010 was $6.1 million, or $0.18 per diluted share, compared to an adjusted loss of $9.9 million, or $0.34 per diluted share, for the same period of 2009. Adjusted net income/(loss) and adjusted net income/(loss) per diluted share are non-GAAP financial measures that exclude from GAAP net income/(loss) and GAAP net income/(loss) per diluted share revenue related to upfront and milestone payments, and certain expenses comprised of amortization and impairment of intangible assets, stock-based compensation and non-cash interest expense associated with a debt discount and debt issuance costs. A reconciliation of adjusted net income/(loss) and adjusted net income/(loss) per diluted share to GAAP net income/(loss) and GAAP net income/(loss) per diluted share, respectively, is available in a table included at the end of this press release.
Unrestricted cash, cash equivalents and marketable securities as of March 31, 2010 totaled $19.0 million, compared to $15.6 million as December 31, 2009. In the first quarter of 2010, we made the first scheduled amortization payment of $3.0 million on our senior secured notes.
"We are pleased to report our second successive quarter with positive earnings and cash flow," said Bruce Cozadd, Chairman and Chief Executive Officer of Jazz Pharmaceuticals. "We are focused as an organization on continuing to grow our existing business and investing for future growth, including preparing for potential approval and subsequent launch of JZP-6 in fibromyalgia. In the past few months, our NDA for JZP-6 was filed by the FDA with a PDUFA action date of October 11, 2010. In addition we signed a supply agreement to establish a new supplier for sodium oxybate."
Data from the JZP-6 Phase III clinical studies is being presented at appropriate scientific conferences this year. In April 2010, pain, fatigue, and patient improvement results from both Phase III studies were presented at the American Academy of Neurology (AAN) meeting in Toronto. Results from the second Phase III study will be presented at the upcoming Associated Professional Sleep Societies (APSS) and the European League Against Rheumatism (EULAR) meetings in June.
Jazz Pharmaceuticals is updating its full year 2010 guidance to increase Xyrem sales guidance and narrow the operating expense ranges as follows:
Expanding research and clinical options for children with cancer