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Jazz (JAZZ) Q2 Earnings Up Y/Y, Lowers Earnings Outlook
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Jazz Pharmaceuticals plc (JAZZ - Free Report) reported second-quarter 2016 earnings of $1.80 per share, up 28.6% from the year-ago period. The Zacks Consensus Estimate was $1.71 per share. Excluding one-time items, second quarter 2016 earnings increased 15.4% to $2.63 per share.
Total revenues in the reported quarter increased 14.2% year over year to $381 million, mainly driven by Xyrem, Erwinaze and Defitelio. Revenues, however, fell short of the Zacks Consensus Estimate of $383 million.
The Quarter in Detail
In the reported quarter, Xyrem sales increased 13.4% to $280.9 million. The company reported 4% bottle volume growth in the quarter and expects mid to high single digit volume growth for 2016.
Xyrem is currently facing patent challenges from several companies – the Roxane Laboratories case will be tried in the second quarter of 2017. Meanwhile, a trial date for the other patent challenges is yet to be set.
Erwinaze/Erwinase generated revenues of $49.7 million, up 7.8% year over year. Jazz said that due to constrained manufacturing capacity, it has been facing issues in building sufficient inventory levels that can be used to absorb supply disruption. The company faced supply challenges in the reported quarter though it was able to meet patient demand. Jazz said that it continues to face inventory and supply challenges which could lead to further disruptions in its ability to supply certain markets including the U.S., from time to time.
Prialt revenues were $8.1 million, up 13.1% from the year-ago period. Meanwhile, psychiatry product sales decreased 58.7% to $3.9 million.
The company recorded Defitelio sales of $33.2 million in the second quarter of 2016, up 117.9% year over year. Sales benefited from the Apr 2016 launch of Defitelio in the U.S. where sales of $9.5 million was recorded. The company reported that 83 unique accounts ordered Defitileo during the second quarter with 75% reordering.
Jazz's adjusted selling, general and administrative (SG&A) expenses during the quarter increased 12% to $99 million. Adjusted research and development (R&D) expenses during the quarter increased 48% to $36 million.
JZP-110 is in phase III safety and efficacy studies for the treatment of excessive daytime sleepiness in patients suffering from narcolepsy or obstructive sleep apnea (OSA). Preliminary OSA data are expected in the first quarter of 2017. Meanwhile, with enrolment in the narcolepsy study progressing slower than expected, preliminary data for this indication is expected in mid-2017. Positive data from these studies would allow the company to file for approval in late 2017.
Meanwhile, Jazz is planning to start submitting a rolling NDA for Vyxeos for the treatment of acute myeloid leukemia (AML) later this quarter with the submission expected to complete in late 2016 or early 2017. Vyxeos, which became a part of the company’s pipeline following the Celator acquisition, has Fast Track designation in the U.S. Jazz intends to seek Priority Review.
During the second quarter of 2016, the company spent $28.9 million on share buybacks and has about $97 million left under its $300 million share repurchase program.
Revises 2016 Guidance
Jazz updated its 2016 guidance to reflect the Celator acquisition and the modification in the calculation of non-GAAP income tax provision.
The company now expects earnings in the range of $9.90 - $10.30 per share, (old guidance: $11.10 - $11.50 per share. The lowered guidance reflects higher SG&A and R&D expenses, higher net interest expense, the modification of the reported non-GAAP income tax provision, and the impact of global supply constraints for Erwinaze.
Jazz expects revenues in the range of $1,485–$1,530 million (old guidance: $1,490–$1,550 million). The Zacks Consensus Estimate is currently $1.53 billion. Total net product sales are now expected in the range of $1,477–$1,522 million (old guidance: 1,482–$1,542 million).
Xyrem sales are still expected in the range of $1,095–$1,130 million. Erwinaze/Erwinase sales guidance is in the range of $190–$215 million (old guidance: $200–$225 million). Defitelio is expected to generate revenues of $105–$125 million (old guidance: $100–$125 million) including U.S. sales of about $25 million - $35 million (old guidance: $20 million - $35 million).
Meanwhile, the company expects adjusted SG&A and R&D expenses in the range of $400–$415 million (old guidance: $390–$410 million) and $135–$145 million (old guidance: $115–$130 million), respectively.
Jazz is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector are Corcept Therapeutics Incorporated (CORT - Free Report) , Pacira Pharmaceuticals, Inc. (PCRX - Free Report) and Eisai Co., Ltd. . All three carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>
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Jazz (JAZZ) Q2 Earnings Up Y/Y, Lowers Earnings Outlook
Jazz Pharmaceuticals plc (JAZZ - Free Report) reported second-quarter 2016 earnings of $1.80 per share, up 28.6% from the year-ago period. The Zacks Consensus Estimate was $1.71 per share. Excluding one-time items, second quarter 2016 earnings increased 15.4% to $2.63 per share.
Total revenues in the reported quarter increased 14.2% year over year to $381 million, mainly driven by Xyrem, Erwinaze and Defitelio. Revenues, however, fell short of the Zacks Consensus Estimate of $383 million.
The Quarter in Detail
In the reported quarter, Xyrem sales increased 13.4% to $280.9 million. The company reported 4% bottle volume growth in the quarter and expects mid to high single digit volume growth for 2016.
Xyrem is currently facing patent challenges from several companies – the Roxane Laboratories case will be tried in the second quarter of 2017. Meanwhile, a trial date for the other patent challenges is yet to be set.
Erwinaze/Erwinase generated revenues of $49.7 million, up 7.8% year over year. Jazz said that due to constrained manufacturing capacity, it has been facing issues in building sufficient inventory levels that can be used to absorb supply disruption. The company faced supply challenges in the reported quarter though it was able to meet patient demand. Jazz said that it continues to face inventory and supply challenges which could lead to further disruptions in its ability to supply certain markets including the U.S., from time to time.
Prialt revenues were $8.1 million, up 13.1% from the year-ago period. Meanwhile, psychiatry product sales decreased 58.7% to $3.9 million.
The company recorded Defitelio sales of $33.2 million in the second quarter of 2016, up 117.9% year over year. Sales benefited from the Apr 2016 launch of Defitelio in the U.S. where sales of $9.5 million was recorded. The company reported that 83 unique accounts ordered Defitileo during the second quarter with 75% reordering.
Jazz's adjusted selling, general and administrative (SG&A) expenses during the quarter increased 12% to $99 million. Adjusted research and development (R&D) expenses during the quarter increased 48% to $36 million.
JZP-110 is in phase III safety and efficacy studies for the treatment of excessive daytime sleepiness in patients suffering from narcolepsy or obstructive sleep apnea (OSA). Preliminary OSA data are expected in the first quarter of 2017. Meanwhile, with enrolment in the narcolepsy study progressing slower than expected, preliminary data for this indication is expected in mid-2017. Positive data from these studies would allow the company to file for approval in late 2017.
Meanwhile, Jazz is planning to start submitting a rolling NDA for Vyxeos for the treatment of acute myeloid leukemia (AML) later this quarter with the submission expected to complete in late 2016 or early 2017. Vyxeos, which became a part of the company’s pipeline following the Celator acquisition, has Fast Track designation in the U.S. Jazz intends to seek Priority Review.
During the second quarter of 2016, the company spent $28.9 million on share buybacks and has about $97 million left under its $300 million share repurchase program.
Revises 2016 Guidance
Jazz updated its 2016 guidance to reflect the Celator acquisition and the modification in the calculation of non-GAAP income tax provision.
The company now expects earnings in the range of $9.90 - $10.30 per share, (old guidance: $11.10 - $11.50 per share. The lowered guidance reflects higher SG&A and R&D expenses, higher net interest expense, the modification of the reported non-GAAP income tax provision, and the impact of global supply constraints for Erwinaze.
Jazz expects revenues in the range of $1,485–$1,530 million (old guidance: $1,490–$1,550 million). The Zacks Consensus Estimate is currently $1.53 billion. Total net product sales are now expected in the range of $1,477–$1,522 million (old guidance: 1,482–$1,542 million).
Xyrem sales are still expected in the range of $1,095–$1,130 million. Erwinaze/Erwinase sales guidance is in the range of $190–$215 million (old guidance: $200–$225 million). Defitelio is expected to generate revenues of $105–$125 million (old guidance: $100–$125 million) including U.S. sales of about $25 million - $35 million (old guidance: $20 million - $35 million).
Meanwhile, the company expects adjusted SG&A and R&D expenses in the range of $400–$415 million (old guidance: $390–$410 million) and $135–$145 million (old guidance: $115–$130 million), respectively.
JAZZ PHARMACEUT Price
JAZZ PHARMACEUT Price | JAZZ PHARMACEUT Quote
Jazz is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector are Corcept Therapeutics Incorporated (CORT - Free Report) , Pacira Pharmaceuticals, Inc. (PCRX - Free Report) and Eisai Co., Ltd. . All three carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>