DUBLIN, May 10, 2016 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2016 and updated financial guidance for 2016.
"During the first quarter of 2016, we executed on our business model by delivering strong top- and bottom-line growth and commenced promotion of Defitelio in the U.S. immediately following FDA approval. Defitelio is the first and only approved treatment in the U.S. for patients who develop hepatic VOD with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation," said Bruce C. Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. "For 2016, we will continue to invest in the organic growth of our key products, including new indications, and the advancement of our development pipeline. Diversification of our product portfolio through internal and corporate development efforts remains a high priority as we seek to identify and acquire differentiated and long-lived therapeutic options for patients."
Adjusted net income for the first quarter of 2016 was $141.0 million, or $2.26 per diluted share, compared to $125.1 million, or $1.99 per diluted share, for the first quarter of 2015.
GAAP net income for the first quarter of 2016 was $74.1 million, or $1.19 per diluted share, compared to $70.7 million, or $1.12 per diluted share, for the first quarter of 2015. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included in this press release.
Financial Highlights | ||||||||||
Three Months Ended March 31, | ||||||||||
(In thousands, except per share amounts and percentages) | 2016 | 2015 | Change | |||||||
Total revenues | $ | 336,010 | $ | 309,303 | 8.6 | % | ||||
Adjusted net income | $ | 140,995 | $ | 125,068 | 12.7 | % | ||||
GAAP net income | $ | 74,121 | $ | 70,700 | 4.8 | % | ||||
Adjusted EPS | $ | 2.26 | $ | 1.99 | 13.6 | % | ||||
GAAP EPS | $ | 1.19 | $ | 1.12 | 6.3 | % | ||||
Total Revenues Total revenues were as follows: | |||||||
Three Months Ended March 31, | |||||||
(In thousands) | 2016 | 2015 | |||||
Xyrem® (sodium oxybate) oral solution | $ | 249,537 | $ | 212,690 | |||
Erwinaze® / Erwinase® (asparaginase Erwinia chrysanthemi) | 51,173 | 50,353 | |||||
Defitelio® (defibrotide sodium) / defibrotide | 17,897 | 17,363 | |||||
Prialt® (ziconotide) intrathecal infusion | 6,209 | 6,764 | |||||
Psychiatry | 7,002 | 9,093 | |||||
Other | 2,098 | 10,772 | |||||
Product sales, net | 333,916 | 307,035 | |||||
Royalties and contract revenues | 2,094 | 2,268 | |||||
Total revenues | $ | 336,010 | $ | 309,303 | |||
Net product sales increased by 9% in the first quarter of 2016 compared to the same period in 2015 primarily due to higher net product sales of Xyrem.
Erwinaze/Erwinase net product sales increased by 2% in the first quarter of 2016 compared to the same period in 2015. Although Erwinaze net product sales increased, as a consequence of constrained manufacturing capacity, the company has had a limited ability to build sufficient inventory levels that can be used to absorb supply disruptions. In the first quarter of 2016, the company experienced supply challenges that temporarily disrupted its ability to supply certain markets.
Defitelio/defibrotide product sales increased by 3% in the first quarter of 2016 compared to the same period in 2015. The increase in net product sales was partially offset by the impact of foreign exchange on sales made in euro.
Operating Expenses Operating expenses were as follows: | |||||||
Three Months Ended March 31, | |||||||
(In thousands, except percentages) | 2016 | 2015 | |||||
GAAP: | |||||||
Cost of product sales | $ | 23,439 | $ | 28,298 | |||
Gross margin | 93.0 | % | 90.8 | % | |||
Selling, general and administrative | $ | 128,765 | $ | 112,388 | |||
% of total revenues | 38.3 | % | 36.3 | % | |||
Research and development | $ | 31,252 | $ | 27,181 | |||
% of total revenues | 9.3 | % | 8.8 | % | |||
Acquired in-process research and development | $ | 8,750 | $ | ||||
Non-GAAP adjusted: | |||||||
Cost of product sales | $ | 22,640 | $ | 27,603 | |||
Gross margin | 93.2 | % | 91.0 | % | |||
Selling, general and administrative | $ | 102,611 | $ | 95,041 | |||
% of total revenues | 30.5 | % | 30.7 | % | |||
Research and development | $ | 27,962 | $ | 23,696 | |||
% of total revenues | 8.3 | % | 7.7 | % | |||
Operating expenses changed over the prior year period primarily due to the following:
- Selling, general and administrative (SG&A) expenses increased in the first quarter of 2016 compared to the same period in 2015, on a GAAP and non-GAAP adjusted basis, primarily due to higher headcount and other expenses resulting from the expansion of the company's business.
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