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Jazz Pharmaceuticals Announces First Quarter 2017 Financial Results

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PR Newswire

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."


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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
March 31,

(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
March 31,

(In thousands, except percentages)

2017


2016

GAAP:




Cost of product sales

$

25,065



$

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