Mon, Mar. 30, 1:03 PM
- According to Bloomberg, privately-held Rome-based drug firm Sigma-Tau Group is attracting interest from prospective bidders for its rare diseases business. The unit, valued as high as $1B, could be nice fit with Jazz Pharmaceuticals (JAZZ -0.3%) or Shire plc (SHPG -1%). Last year, Jazz acquired the rights to Sigma-Tau's defibrotide in the Americas for as much as $250M. No formal negotiations are underway, though, and the Cavazza family that owns the business may choose not to sell.
- Sigma-Tau, founded in 1957, generated sales of €697M ($757M) in 2013, with the rare diseases unit contributing €165M. The 220-employee unit focuses on blood diseases and cancer.
- Previously: Jazz kicks off Fast Track review process for VOD med (Dec. 12, 2014)
- Previously: Jazz secures rights to defibrotide in the Americas (July 2, 2014)
Tue, Feb. 24, 4:39 PM
- Jazz Pharmaceuticals (NASDAQ:JAZZ) Q4 results ($M): Total Revenues: 328.1 (+39.1%); Product Sales: 324.2 (+38.7%); Operating Expenses: 169.4 (+46.4%); Operating Income: 129.9 (+37.5%); Net Income: 81.6 (+47.6%); EPS: 1.30 (+44.4%); Quick Assets: 684.0 (+7.5%).
- Key product sales: Xyrem: 222.5 (+35.5%); Erwinaze/Erwinase: 52.8 (+21.4%); Defitelio/defibrotide: 19.2; Prialt: 10.0 (+56.3%).
- 2015 Guidance: Revenues: $1.31B - 1.37B; Net Product Sales: $1.303B - 1.363B; Xyrem: $950M - 970M; Erwinaze/Erwinase: $200M - 215M; Defitelio/defibrotide: $73M - 83M; EPS: $5.17 - 5.70; Non-GAAP EPS: $9.45 - 9.75.
Tue, Feb. 24, 4:17 PM| Comment!
Mon, Feb. 23, 5:35 PM
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Mon, Feb. 9, 12:21 PM
- The following are healthcare companies whose after-tax margins have expanded the past three quarters and trade at least 500K shares per day:
- (ACOR -0.7%)(BCR -1.5%)(BIIB -0.2%)(CAH -1.2%)(CPHD +1.3%)(EVHC -1.6%)(ILMN +0.7%)(JAZZ -1.7%)(LCI +7.3%)(MNK -0.5%)(SHPG -2.9%)(SYK -0.2%)(TMO -0.7%)(UTHR +1.4%)(VRX).
- This is not a list of "Buy" recommendations, but rather a targeted list of firms that may be suitable for more in-depth research.
Wed, Jan. 14, 11:51 AM
- Flamel Technologies (FLML -25%) drops on a 6x surge in volume in apparent response a favorable ruling from the USPTO for Jazz Pharmaceuticals (JAZZ +3.1%) and against the petitions from Par Pharmaceuticals, Roxane Labs and Amneal Pharmaceuticals. The decision reaffirmed the validity of four patents related to Xyrem (#'s 7,895,059, 8,457,988, 7,668,730, 8,589,182).
- In October, Canaccord Genuity analyst John Newman published a research report reiterating his Buy recommendation on Jazz Pharmaceuticals (JAZZ +3.8%) with a $163 price target based on his view that Flamel's NDA for its once-daily version of Xyrem (sodium oxybate), to be filed under the 505(NYSE:B)(2) paragraph IV pathway, will reference Jazz's orange book-listed patents. This will trigger a lawsuit and and an automatic 30-month stay of approval.
- The delay will give Jazz more time to develop its once-daily version, JZP-386, which should enter Phase 2 this year.
Wed, Jan. 14, 11:13 AM
- At JPM15, Jazz Pharmaceuticals (JAZZ +4.5%) Chairman and CEO Bruce Cozadd said that he expects 2014 revenues to come in at the upper range of previously-reported guidance of $1.15B - 1.17B.
- Also, he sees Xyrem sales at the upper end of $765M - 780M and Erwinaze/Erwinase at the upper end of $190M - 200M.
Dec. 19, 2014, 1:13 PM
- Thinly-traded small cap Flamel Technologies (FLML +12%) heads north in response to its announcement that it achieved its objective of a single before-bedtime dose of sodium oxybate using its proprietary Micropump technology. A single dose option for sufferers of narcolepsy would eliminate a second dose 2.5 to 4 hours later that is necessary with the current standard of care, Jazz Pharmaceuticals' (JAZZ -0.9%) Xyrem (sodium oxybate). This would be more convenient and would eliminate the disruption in sleep.
- Flamel plans to meet with the FDA before mid-2015 to clarify a regulatory path.
Dec. 12, 2014, 1:28 PM
- Jazz Pharmaceuticals (JAZZ -3.4%) initiates its rolling submission of its New Drug Application (NDA) to the FDA for Fast Track-designated defibrotide for the treatment of severe hepatic veno-occlusive disease (VOD). The company expects to complete its filing in the first half of next year.
- The Fast Track process allows for a company to submit individual sections of its NDA in order to expedite regulatory review. The FDA has also tagged defibrotide an Orphan Drug for VOD so it will have a seven-year period of market exclusivity if approved.
- Jazz obtained the U.S. rights to defibrotide from Sigma-Tau Pharmaceuticals that obtained the rights from Gentium S.p.A. Jazz acquired Gentium a year ago.
- Previously: Jazz to acquire Gentium in $1B deal (Dec. 19, 2013)
Dec. 2, 2014, 4:50 PM
- Jazz Pharmaceuticals (NASDAQ:JAZZ) enrolls the first patients in a Phase 3 clinical trial evaluating the safety and efficacy of Xyrem (sodium oxybate) in young patients aged seven to 17 who have narcolepsy with cataplexy.
- Xyrem is currently approved for use in adults with the same condition.
- The 52-week randomized, double-blind study will enroll up to 100 pediatric patients at sites in the U.S. and several countries in Europe. The press release also states that the trial is open label (both patients and investigators know what is being administered) which is impossible if it is double-blind (neither know).
- The primary efficacy endpoint is the change in cataplexy attacks over two weeks (double-blind). Safety will be measured over 52 weeks in what may be the open label portion.
Nov. 4, 2014, 4:22 PM| Comment!
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| Comment!
Aug. 4, 2014, 5:35 PM
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