) third-quarter 2013 adjusted (including stock-based compensation
expense and depreciation) earnings of $1.61 per share were well
above the Zacks Consensus Estimate of $1.52 and the year-ago
adjusted earnings of $1.22 per share. Investors reacted
positively to the news.
Quarterly revenues increased 32.3% year over year to $232.2
million driven by strong sales of Xyrem (narcolepsy) and Erwinaze
(oncology). Revenues were above the Zacks Consensus Estimate of
Quarter in Detail
In the reported quarter, Xyrem sales increased 50% to $153.7
million. Jazz Pharma stated that during the quarter approximately
11,000 patients were on Xyrem compared to 10,200 in the year-ago
Erwinaze generated revenues of $44.1 million, up 39% year over
year. Prialt (for pain) revenues were $11 million compared with
$5.4 million a year ago. Prialt's third quarter 2013 sales
included a $5.7 million sale to the European distributor,
). Meanwhile, psychiatry products sales declined 49% to $10.7
million. The decline was due to generic competition.
Jazz Pharma's selling, general and administrative (SG&A)
expenses (on a reported basis) during the quarter increased 23.1%
to $75 million. Research and development (R&D) expenses (on a
reported basis) during the quarter shot up 85.2% to $12.8
million. The increase in SG&A and R&D expenses were due
to a higher headcount and related expenses resulting from the
EUSA Pharma acquisition in Jun 2012.
A study evaluating the intravenous formulation of Erwinaze met
its primary endpoint. The company submitted an amendment to the
biological license application (BLA) to the U.S. Food and Drug
Administration (FDA) to allow intravenous administration of
Erwinaze. Another study for the further use of Erwinaze in
adolescents and young adults with acute lymphoblastic leukemia
(ALL), who are hypersensitive to E. coli-derived asparaginase, is
expected to commence the process of identifying and recruiting
global study sites by year end.
In Jun 2013, the U.S. Food and Drug Administration (FDA) had
granted fast track designation to Asparec (phase I), which is
being evaluated for the treatment of ALL in patients who are
hypersensitive to E. coli asparaginase. The company is working on
evaluating Asparec in children.
Leukotac, an anti-CD25 monoclonal antibody, is in a phase III
study in Europe for the treatment of steroid-refractory acute
graft vs. host disease.
The company is planning to submit an investigational medicinal
product dossier by the end of 2013 for JZP-386 and initiate a
human trial in 2014.
For 2013, Jazz Pharma expects adjusted earnings in the range of
$6.30 to $6.40 per share (previous guidance: $6.20 to $6.40). The
Zacks Consensus Estimate currently stands at $5.67 per share.
Jazz Pharma tweaked its revenue guidance to $867-$877 million
from $860-$880 million expected earlier. Xyrem net sales are now
expected in the range of $565-$570 million (previous guidance:
$560-$570 million). Erwinaze net sales are now expected in the
range of $173-$178 million (previous guidance: $170-$180
Jazz Pharma carries a Zacks Rank #3 (Hold). Companies like
Isis Pharmaceuticals, Inc.
) appear to be well placed with a Zacks Rank #1 (Strong Buy).
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