Jazz Pharmaceuticals plc today announced financial results for the first quarter ended March 31, 2015 and reaffirmed financial guidance for 2015.
“We are pleased with our strong top-line performance during the first quarter, driven by sales growth of our key products,” says Bruce C. Cozadd, chairman and CEO of Jazz Pharmaceuticals, in a release. “For 2015, we will remain focused on execution of our key objectives, including advancing our development pipeline, completing the rolling NDA submission for defibrotide, preparing for the potential launch of defibrotide in the US, and continuing our efforts to further diversify our business through corporate development activities.”
Adjusted net income attributable to Jazz Pharmaceuticals for the first quarter of 2015 was $125.1 million, or $1.99 per diluted share, compared to $99.5 million, or $1.59 per diluted share, for the first quarter of 2014.
GAAP net income attributable to Jazz Pharmaceuticals for the first quarter of 2015 was $70.7 million, or $1.12 per diluted share, compared to GAAP net loss attributable to Jazz Pharmaceuticals of $92.7 million, or $1.58 per diluted share, for the first quarter of 2014. GAAP net loss attributable to Jazz Pharmaceuticals for the first quarter of 2014 included acquired in-process research and development expense of $127.0 million.
Total revenues for the first quarter of 2015 were $309.3 million, an increase of 25% over total revenues of $246.9 million for the first quarter of 2014. The increase in total revenues was driven primarily by higher net product sales of Xyrem (sodium oxybate) oral solution, Erwinaze/Erwinase (asparaginase Erwinia chrysanthemi), and Defitelio (defibrotide). Total revenues include net product sales, royalties, and contract revenues.
Net product sales for the first quarter of 2015 were as follows:
Xyrem: Xyrem net sales increased by 33% to $212.7 million in the first quarter of 2015 compared to $160.4 million in the first quarter of 2014. During the first quarter of 2015, the average number of active Xyrem patients in the U.S. increased to approximately 12,375.
Erwinaze/Erwinase: Erwinaze/Erwinase net sales increased by 7% to $50.4 million in the first quarter of 2015 compared to $46.9 million in the first quarter of 2014.
Defitelio/defibrotide: Defitelio/defibrotide net sales increased by 15% to $17.4 million in the first quarter of 2015 compared to pro forma net sales of $15.1 million in the first quarter of 2014. The pro forma information represents net sales of Defitelio/defibrotide as if the acquisition of Gentium SpA. (Gentium), which closed on January 23, 2014, had closed on January 1, 2014.
Prialt (ziconotide) intrathecal infusion: Prialt net sales were $6.8 million in the first quarter of 2015 compared to $4.3 million in the first quarter of 2014. The increase in net sales was primarily due to lower sales in the first quarter of 2014 resulting from the timing of shipments to the exclusive wholesale distributor and central pharmacy for Prialt.
Psychiatry products: Net sales of the company’s psychiatry products were $9.1 million in the first quarter of 2015 compared to $9.9 million in the first quarter of 2014.
Other: Net sales of other products in the first quarter of 2015 were $10.8 million compared to pro forma net sales of $11.7 million in the first quarter of 2014. On a pro forma basis, net sales of other products included net sales of active pharmaceutical ingredients by Gentium as if the Gentium acquisition had closed on January 1, 2014. On March 20, 2015, the company completed the sale of certain products and the related business that the company acquired as part of the acquisition of EUSA Pharma Inc (EUSA Pharma) in 2012.
Karen Smith, MD, PhD joined the company as the global head of research and development and chief medical officer on April 13, 2015. Smith brings more than 20 years of experience in the industry, and a track record of success in global development, medical affairs, and lifecycle management. Smith has held positions of increasing responsibility with Merck, Pfizer, Bristol-Myers Squibb, AstraZeneca and most recently, Allergan, where she was senior vice president, global medical affairs and therapeutic area head (dermatology), research and development.
“We are pleased to have Dr Karen Smith join Jazz Pharmaceuticals at this exciting time of expansion of our R&D activities,” says Russell Cox, executive vice president and chief operating officer of Jazz Pharmaceuticals. “Karen brings expertise in multiple therapeutic areas, including oncology, and has deep experience across pharmaceuticals, devices and biologics. Her strong leadership, global R&D and regulatory experience, and results-driven approach will bring significant value to our organization.”