Jazz Pharmaceuticals Announces Third Quarter 2015 Financial Results

DUBLIN, Nov. 9, 2015 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the third quarter of 2015 and updated financial guidance for 2015.

"During the quarter, we remained focused on our mission of delivering important and meaningful products to patients. We are pleased that we have received FDA Priority Review status on our defibrotide NDA, an important step toward our objective to bring defibrotide to patients in the U.S. for the treatment of hepatic veno-occlusive disease with evidence of multi-organ dysfunction, a rare and often fatal complication of hematopoietic stem cell transplantation," said Bruce C. Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. "We also advanced our research and development pipeline, implemented our approved Xyrem REMS, grew key product sales, and remain well-positioned to further diversify and expand our product portfolio through our corporate development efforts."

Adjusted net income attributable to Jazz Pharmaceuticals plc for the third quarter of 2015 was $159.3 million, or $2.52 per diluted share, compared to $143.9 million, or $2.30 per diluted share, for the third quarter of 2014.

GAAP net income attributable to Jazz Pharmaceuticals plc for the third quarter of 2015 was $88.0 million, or $1.39 per diluted share, compared to $25.8 million, or $0.41 per diluted share, for the third quarter of 2014. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included in this press release.

Third Quarter 2015 Revenues and Product Sales

Total revenues for the third quarter of 2015 were $340.9 million, an increase of 11% over total revenues of $306.6 million for the third quarter of 2014. The increase in total revenues was driven by higher net product sales of Xyrem® (sodium oxybate) oral solution and Erwinaze®/Erwinase® (asparaginase Erwinia chrysanthemi). Total revenues include net product sales, royalties and contract revenues.

Net product sales for the third quarter of 2015 were as follows:

• Xyrem: Xyrem net sales increased by 19% to $242.9 million in the third quarter of 2015 compared to $204.3 million in the third quarter of 2014. During the third quarter of 2015, the average number of active Xyrem patients in the U.S. was approximately 12,450.
• Erwinaze/Erwinase: Erwinaze/Erwinase net sales increased by 8% to $56.3 million in the third quarter of 2015 compared to $52.1 million in the third quarter of 2014.
• Defitelio® (defibrotide): Defitelio/defibrotide net sales increased to $19.6 million in the third quarter of 2015 compared to $18.9 million in the third quarter of 2014. Product volume was in line with expectations, but sales were impacted by unfavorable foreign currency exchange movements.
• Prialt® (ziconotide) intrathecal infusion: Prialt net sales were $6.0 million in the third quarter of 2015 compared to $6.3 million in the third quarter of 2014.
• Psychiatry products: Net sales of the company's psychiatry products were $9.9 million in the third quarter of 2015 compared to $10.8 million in the third quarter of 2014.
• Other: Net sales of other products in the third quarter of 2015 were $3.9 million compared to $11.9 million in the third quarter of 2014. In March 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. in 2012.

Tables showing actual net product sales for the three and nine months ended September 30, 2015 and 2014 and pro forma net product sales for the nine months ended September 30, 2014 are included in this press release.

Operating Expenses and Other

Operating expenses for the third quarter of 2015 were $209.3 million compared to $248.5 million for the third quarter of 2014. Operating expenses changed over the prior year period primarily due to the following:

• Cost of product sales for the third quarter of 2015 was $28.4 million compared to $27.0 million for the same period in 2014. Gross margin for the third quarter of 2015 was 91.6% compared to 91.1% for the same period in 2014.
• Selling, general and administrative (SG&A) expenses for the third quarter of 2015 on a GAAP basis were $104.0 million compared to $93.5 million for the same period in 2014. Adjusted SG&A expenses for the third quarter of 2015 were $84.5 million, or 25% of total revenues, compared to $78.7 million, or 26% of total revenues, for the same period in 2014.
  
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