Market Overview

Jazz Pharmaceuticals Announces First Quarter 2019 Financial Results

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DUBLIN, May 7, 2019 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced financial results for the first quarter of 2019 and reaffirmed 2019 financial guidance.

"In the first quarter of 2019, we delivered strong top- and bottom-line growth and continued our efforts to bring innovative and life-changing medicines to patients, with FDA approval of Sunosi for EDS associated with narcolepsy or OSA, launch of Xyrem in pediatric narcolepsy and announcement of positive top-line results from our Phase 3 study of JZP-258," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "As the year progresses, we are continuing to invest in our business to support the successful launch of Sunosi in the U.S. and pre-launch activities in the EU, to generate data for our existing products and to fuel further advancement and diversification of our pipeline."

Financial Highlights













Three Months Ended
March 31,



(In thousands, except per share amounts and percentages)

2019


2018


Change

Total revenues

$

508,186



$

444,613



14

%

GAAP net income

$

85,201



$

45,991



85

%

Adjusted net income

$

213,173



$

182,371



17

%

GAAP EPS

$

1.47



$

0.75



96

%

Adjusted EPS

$

3.67



$

2.98



23

%

GAAP net income for the first quarter of 2019 was $85.2 million, or $1.47 per diluted share, compared to $46.0 million, or $0.75 per diluted share, for the first quarter of 2018.

Adjusted net income for the first quarter of 2019 was $213.2 million, or $3.67 per diluted share, compared to $182.4 million, or $2.98 per diluted share, for the first quarter of 2018. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Key Regulatory/R&D Updates 

In March 2019, the company announced that the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA. Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA for this indication and was approved with strengths of 75 mg and 150 mg for patients with narcolepsy and 37.5 mg, 75 mg, and 150 mg for patients with OSA.

In March 2019, the company announced positive top-line results from the global, double-blind, placebo-controlled, randomized-withdrawal, multi-center Phase 3 study evaluating the efficacy and safety of JZP-258 for the treatment of cataplexy and EDS in adult patients with narcolepsy. JZP-258 is a novel oxybate product candidate with a 92% reduction in sodium content compared to Xyrem.

In March 2019, positive results from DEFIFrance, an observational, multi-center, post-marketing study in adult and pediatric patients treated with defibrotide at hematopoietic stem cell transplant centers in France, were presented at the European Society for Blood and Marrow Transplant (EBMT) meeting.

Select 2019 Milestones




Programs


2019 Milestones*

Xyrem® (sodium oxybate) oral solution

Launched in March for the treatment of cataplexy or EDS in pediatric narcolepsy

JZP-258

Announced positive top-line results in March from the Phase 3 narcolepsy study


-

Expect to submit top-line results from the Phase 3 narcolepsy study to a fall medical meeting


-

Pre-New Drug Application (NDA) meeting with FDA


-

Goal to submit NDA as early as year-end

Sunosi™ (solriamfetol)

FDA approval on March 20 for EDS in narcolepsy or OSA


-

Drug Enforcement Administration (DEA) scheduling decision by late second quarter


-

Initiate Sunosi launch following DEA scheduling decision


-

Announce new Phase 3 development program mid-year


-

Obtain EU approval for EDS in narcolepsy or OSA as early as year-end

Vyxeos® (daunorubicin and cytarabine) liposome for injection

-

Presentation by Children's Oncology Group at the American Society of Clinical Oncology (relapsed/refractory pediatric acute myeloid leukemia (AML) study data)


-

Potential interim combination data results from MD Anderson collaboration


-

Finalized protocol for Phase 1/2 study (low-dose Vyxeos in combination with venetoclax); patient enrollment is expected to begin in the second half of the year

Defitelio® (defibrotide sodium) / defibrotide

Presentation of positive results from DEFIFrance study at EBMT in March


-

Conduct interim analysis of the Phase 3 study for prevention of hepatic veno-occlusive disease (VOD)


-

Complete enrollment in prevention of acute graft-vs-host disease Phase 2 study


-

Initiate exploratory Phase 2 study in chimeric antigen receptor t-cell therapy associated neurotoxicity


-

Initiate Phase 2 study in transplant-associated thrombotic microangiopathy

Asparaginase

-

Provide informational update on early-stage recombinant crisantaspase program later this year

CombiPlex®

-

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