Nov. 4, 2014, 4:22 PM
Nov. 3, 2014, 5:35 PM
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Aug. 19, 2014, 5:37 PM
Aug. 5, 2014, 5:55 PM
- Jazz Pharmaceuticals (JAZZ -1.5%) Q2 results: Total revenues: $291.2M (+39.8%); Operating Expenses: $216.9M (+65.3%); Operating Income: $74.3M (-3.6%); Net Income: $43.6M (+3.3%); EPS: $0.70 (+1.4%); Quick Assets: $268.3M (-57.8%).
- Product sales: Xyrem: $191.4M (+43.2%); Erwinaze/Erwinase: $47.9M (+6.7%); Defitelio/defibrotide: $20.2M.
- 2014 Guidance: Revenues: $1,125M - 1,165M; net product sales: $1,125M - 1,165M; Xyrem sales: $765M - 780M; GAAP EPS: $0.47 - 0.90; non-GAAP EPS: $8.00 - 8.25.
Aug. 5, 2014, 4:11 PM
Aug. 4, 2014, 5:35 PM
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Jul. 28, 2014, 8:35 AM
- CANbridge Life Sciences enters into an exclusive partnership with Jazz Pharmaceuticals' (NASDAQ:JAZZ) EUSA Pharma to commercialize Caphosol in China.
- Caphosol is an oral electrolyte solution designed to moisten, lubricate and clean the oral cavity. It is indicated for dryness of the mouth or throat regardless of the cause or whether the condition is temporary or permanent.
- Financial terms are not disclosed.
Jul. 2, 2014, 8:43 AM
- Jazz Pharmaceuticals (JAZZ) acquires the rights to defibrotide from Sigma-Tau Pharmaceuticals for the U.S. and all other countries in the Americas. Sigma-Tau held the rights on the basis of an agreement with Gentium S.p.A (GENTY) which Jazz acquired in December 2013.
- Jazz markets Defibrotide in Europe under the brand name Defitelio for the treatment of severe hepatic veno-occlusive disease (VOD) in patients over one month of age undergoing hematopoietic stem cell transplantation therapy. The company is working with the FDA on a regulatory pathway for defibrotide as a treatment for severe VOD.
- Under the terms of the agreement, Sigma-Tau receives an upfront payment of $75M when the transaction closes, $25M in milestone payments upon the FDA's acceptance of the NDA for VOD and up to $150M based on the timing of FDA clearance. Jazz expects to fund the deal with cash on hand. The transaction will close in Q3.
Jun. 2, 2014, 3:41 PM
- Jazz Pharmaceuticals' (JAZZ +0.1%) JZP-110 (formerly ADX-NO5), an investigational drug for the treatment of the symptoms of excessive daytime sleepiness in adults with narcolepsy, meets all primary and secondary endpoints in a Phase 2b clinical trial. The company plans to proceed with a Phase 3 trial after regulatory approval.
- In the 12-week Phase 2b study, 93 narcolepsy patients were randomized between placebo and a regimen of JZP-110 of 150 mg/day for four weeks followed by 300 mg/day for eight weeks.
- Sleep onset latency (SOL) was 1.4 minutes for placebo compared 9.5 minutes for JZP-110 at 4 weeks and 2.1 minutes for placebo compared to 12.8 minutes at 12 weeks. Clinical global impression change (symptoms "much improved" or "very much improved") was 51% for placebo compared to 80% at 4 weeks and 38% for placebo compared to 86% at 12 weeks. Epworth sleepiness scale (decrease in overall sleepiness) improved at 4 weeks (-5.6 vs -2.4 (placebo) and 8 weeks (-8.5 vs -2.5 (placebo).
- Jazz acquired the rights to the drug from Aerial BioPharma in early 2014.
May 19, 2014, 3:26 PM
May 9, 2014, 9:17 AM
May 8, 2014, 5:49 PM
May 8, 2014, 4:40 PM
- Jazz Pharmaceuticals (JAZZ): total revenues: $246.9 (+25.8%); product sales: $245M (+25.8%); operating expenses: $313.6M (+144.8%); operating loss: ($66.7M) vs $68.2M; loss/share: ($1.58) vs $0.71; cash & equiv: $245.9M (-61.4%).
- Sales by product: Xyrem: $160.4M (+36.5%); Erwinaze/Erwinase: $46.9M (+12.2%); Defitelio/Defibrotide: $12.2M; Prialt: $4.3M (-14%); Psychiatry: $9.9M (-44.1%); Other: $11.3M (-11%).
- 2014 guidance: total revenues: $1.1B - 1.16B; product revs: $1.093B - 1.153B; Xyrem: $755M - 775M; Erwinaze/Erwinase: $185M - 200M; Defitelio/Defibrotide: $42M - 52M; EPS: $1.81 - $2.30.
May 8, 2014, 4:08 PM
May 7, 2014, 5:35 PM
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Mar. 31, 2014, 10:44 AM
- Jazz Pharmaceuticals (JAZZ +3.5%) and its recent acquisition Gentium launch Defitelio (defibrotide) in Germany and Austria.
- The rollout will continue in 27 additional European countries in 2014 and 2015.
- Defitelio is the first licensed product for severe hepatic veno-occlusive disease in patients over one month of age undergoing haematopoietic stem cell transplantation therapy.
- The European Commission approved the product in October.
- Consensus Q1 and Q2 estimates are earnings of $1.91 on revenues of $259M and $1.97 on revenues of $276.3M, respectively.
- Consensus estimates for 2014 and 2015 are earnings of $8.21 on revenues of $1.14B and $10.16 on revenues of $1.36B, respectively.
- 574 mutual funds have positions, up from 448 a year earlier.
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