DUBLIN, May 9, 2017 /PRNewswire/ --
Total Revenues Increased 12% to $376 Million
Settled Xyrem Patent Litigation with First ANDA Filer
Completed Rolling NDA Submission for Vyxeos (CPX-351)
Announced Positive Top-Line Data for JZP-110 in Obstructive Sleep Apnea and Narcolepsy and for Xyrem in Pediatric Narcolepsy
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2017 and updated financial guidance for 2017.
“The first part of 2017 has been an exceptionally productive period for us in R&D as we announced top-line data for our three JZP-110 Phase 3 studies and our Xyrem Phase 2/3 pediatric study, completed the Vyxeos NDA submission while preparing for potential FDA approval and launch, started additional clinical programs and advanced other key development projects,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “With increased clarity around Xyrem longevity, we remain focused on delivering on our growth strategy, including preparing for the launch of additional products, such as Vyxeos, and investing in corporate development activities with the goal of further diversifying and expanding our product portfolio and offering important new therapeutic options to patients while increasing shareholder value.”
GAAP net income for the first quarter of 2017 was $86.5 million, or $1.41 per diluted share, compared to $75.8 million, or $1.21 per diluted share, for the first quarter of 2016.
Adjusted net income for the first quarter of 2017 was $141.2 million, or $2.31 per diluted share, compared to $134.6 million, or $2.15 per diluted share, for the first quarter of 2016. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
Financial Highlights
Three Months Ended March 31, | ||||||||||
(In thousands, except per share amounts and percentages) | 2017 | 2016 | Change | |||||||
Total revenues | $ | 376,053 | $ | 336,010 | 11.9 | % | ||||
GAAP net income | $ | 86,511 | $ | 75,812 | 14.1 | % | ||||
Adjusted net income | $ | 141,222 | $ | 134,568 | 4.9 | % | ||||
GAAP EPS | $ | 1.41 | $ | 1.21 | 16.5 | % | ||||
Adjusted EPS | $ | 2.31 | $ | 2.15 | 7.4 | % | ||||
Total Revenues
Three Months Ended | |||||||
(In thousands) | 2017 | 2016 | |||||
Xyrem® (sodium oxybate) oral solution | $ | 272,326 | $ | 249,537 | |||
Erwinaze® / Erwinase® (asparaginase Erwinia chrysanthemi) | 51,388 | 51,173 | |||||
Defitelio® (defibrotide sodium) / defibrotide | 35,900 | 17,897 | |||||
Prialt® (ziconotide) intrathecal infusion | 7,717 | 6,209 | |||||
Other | 6,347 | 9,100 | |||||
Product sales, net | 373,678 | 333,916 | |||||
Royalties and contract revenues | 2,375 | 2,094 | |||||
Total revenues | $ | 376,053 | $ | 336,010 | |||
Net product sales increased 12% in the first quarter of 2017 compared to the same period in 2016 primarily due to higher net product sales of Xyrem and Defitelio.
Xyrem net product sales increased 9% in the first quarter of 2017 compared to the same period in 2016.
Erwinaze/Erwinase net product sales in the first quarter of 2017 were consistent with net product sales in the same period in 2016. During the quarter, the company continued to experience supply challenges, which resulted in fluctuations in inventory levels and temporary disruptions to the company’s ability to supply certain markets. The company expects that temporary supply disruptions will continue in 2017, including in the U.S.
Defitelio/defibrotide net product sales increased 101% in the first quarter of 2017 compared to the same period in 2016 primarily due to the launch of Defitelio in the U.S. in April 2016 and strong growth in sales in other markets. Net product sales in the U.S. were $11.6 million in the first quarter of 2017.
Operating Expenses
Three Months Ended | |||||||
(In thousands, except percentages) | 2017 | 2016 | |||||
GAAP: | |||||||
Cost of product sales | $ | 25,065 | $ | 23,439 | |||
Gross margin | 93.3 | % | 93.0 | % | |||
Selling, general and administrative | $ | 144,255 | $ | 128,765 | |||
% of total revenues | 38.4 | % | 38.3 | % | |||
Research and development | $ | 44,928 | $ | 31,252 | |||
% of total revenues | 11.9 | % | 9.3 | % | |||
Acquired in-process research and development | $ | $ | 8,750 | ||||
Three Months Ended | |||||||
(In thousands, except percentages) | 2017 | 2016 | |||||
Non-GAAP adjusted: | |||||||
Cost of product sales | $ | 23,819 | $ | 22,640 | |||
Gross margin | 93.6 | % | 93.2 | % | |||
Selling, general and administrative | $ | 118,450 | $ | 102,611 | |||
% of total revenues | 31.5 | % | 30.5 | % | |||
Research and development | $ | 40,786 | $ | 27,962 | |||
% of total revenues | 10.8 | % | 8.3 | % | |||
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 2017 compared to the same period in 2016 on a GAAP and on a non-GAAP adjusted basis primarily due to higher headcount and other expenses resulting from the expansion of the company’s business, including expenses related to the potential U.S. launch of Vyxeos (cytarabine and daunorubicin liposome injection).
To read full press release, please click here.
