Jazz Pharmaceuticals plc’s (JAZZ) second-quarter 2013 adjusted earnings of $1 per share were well above the year-ago earnings of 81 cents. Excluding one-time items, stock-based compensation expense and amortization, second quarter 2013 earnings per share were $1.43, up 31.2%. The Zacks Consensus Estimate was $1.37 per share.
Quarterly revenues increased 67.7% year over year to $208.3 million. The year-over-year increase in revenues was attributable to the addition of Erwinaze. Strong sales of Xyrem also contributed to revenue growth. Revenues were marginally below the Zacks Consensus Estimate of $209 million.
Quarter in Detail
In the reported quarter, Xyrem sales increased 50% to $133.7 million. Jazz Pharma stated that during the quarter approximately 10,700 patients were on Xyrem compared to 9,850 in the year-ago quarter.
Erwinaze generated revenues of $44.9 million, up 36.5% year over year. Prialt revenues were $4.7 million compared with $5.6 million a year ago. Prialt’s second quarter 2013 sales reflect the effect of Jazz’s transition to its Navigator Reimbursement and Access Program for Prialt. Meanwhile, psychiatry products generated sales of $11.8 million compared with $19.8 million a year ago. The decline was due to generic competition.
Jazz Pharma’s selling, general and administrative expenses during the quarter shot up 57.39% to $73 million. The increase was due to higher headcount resulting from the EUSA acquisition. Research and development expenses during the quarter stood at $9.2 million.
An intravenous formulation of Erwinaze is currently being evaluated. 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 slated to begin later this year. In Jun 2013, the U.S. Food and Drug Administration (:FDA) had granted fast track designation to Asparec, which is being evaluated for the treatment of ALL in patients who are hypersensitive to E. coli asparaginase.
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 a regulatory filing by the end of 2013 for JZP-386.
2013 Guidance Up
Jazz Pharma raised its 2013 guidance. For 2013, Jazz Pharma expects adjusted earnings in the range of $6.20 to $6.40 per share, up from the earlier guidance of $6.10 to $6.30. Share based compensation expense is expected in the range of $45–$47 million.
Jazz Pharma raised its revenue guidance to $860–$880 million from the earlier range of $830–$860 million. Xyrem net sales are now expected in the range of $560–$570 million, above the earlier guidance of $540–$555 million. Erwinaze net sales are now expected in the range of $170–$180 million compared to the earlier guidance of $150–$175 million.
Jazz Pharma carries a Zacks Rank #2 (Buy). Currently, companies which look well- positioned include like Actelion Ltd. (ALIOF) and Gilead Sciences Inc. (GILD) with a Zacks Rank #1 (Strong Buy), and Aegerion Pharmaceuticals, Inc. (AEGR) with a Zacks Rank #2.
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