Thu, Jan. 29, 10:40 AM
- Alexion (ALXN +3.8%) Q4 results: Revenues: $599.5M (+35.7%); COGS: $49.4M (-4.3%); R&D Expense: $129.1M (+50.5%); SG&A: $183.8M (+36.4%); Operating Income: $203.7M (+47.5%); Net Income: $153.3M (+906.8%); EPS: $0.76 (+860.0%).
- FY2014 results: Revenues: $2,233.7M (+44.0%); COGS: $173.9M (-2.1%); R&D Expense: $513.8M (+62.0%); SG&A: $630.2M (+28.7%); Operating Income: $868.7M (+64.5%); Net Income: $656.9M (+159.7%); EPS: $3.26 (+156.7%); Quick Assets: $1961.6M (29.5%).
- FY2015 Guidance: Revenue: $2.55B - $2.6B; Non-GAAP EPS: $5.60 - $5.80.
Thu, Jan. 29, 8:59 AM
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Wed, Jan. 21, 10:11 AM
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Wed, Jan. 7, 5:03 PM
- A 102-patient Phase 2 clinical trial assessing Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab) for the prevention of antibody mediated rejection (AMR) in living-donor kidney transplant recipients requiring desensitization failed to achieve its primary efficacy endpoint of a statistically significant reduction in biopsy-proven AMR, graft loss, patient death or loss to follow-up at Week 9 post-transplant.
- Despite the setback, the company is planning a clinical trial to evaluate eculizumab for the treatment of patients with AMR after discussing the results with regulators.
Dec. 30, 2014, 7:17 AM
- Alexion Pharmaceuticals (NASDAQ:ALXN) finishes its rolling Biologics License Application (BLA) to the FDA for asfotase alfa for the treatment of hypophosphatasia (HPP), an ultra-rare metabolic disease that can lead to the destruction and deformity of bones, muscle weakness, seizures, respiratory failure and premature death. The overall mortality rate is 73% at five years. The incidence is 1:100,000 in a population of largely Anglo Saxon origin.
- Asfotase alfa is an enzyme replacement therapy that restores the genetically defective metabolic process that causes HPP.
- The FDA granted Breakthrough Therapy status to asfotase alfa in 2013. The company initiated its rolling BLA submission in April of this year.
Dec. 15, 2014, 7:01 AM
Dec. 10, 2014, 4:49 PM
- The Japanese Ministry of Health, Labour and Welfare (MHLW) grants Orphan Drug status to Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab) for the treatment of myasthenia gravis (MG), a rare, debilitating neurologic disorder.
- In Japan, Orphan Drugs pertain to those that treat diseases affecting fewer than 50K people.
Nov. 27, 2014, 12:11 PM
- Britain's National Institute for Health and Care Excellence (NICE), the advisory group for the National Health Service, recommends the commission of Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab) for the treatment of patients with atypical hemolytic uremic syndrome (aHUS), an ultra-rare life-threatening disorder characterized by renal failure and the formation of blood clots in the small blood vessels throughout the body (thrombotic microangiopathy or TMA). In the UK, the total number of potential patients, typically children five years old or less, is only ~25.
- 79% of patients with aHUS die within three years of diagnosis despite plasma exchange or plasma infusion. The majority of patients with aHUS who undergo a kidney transplant experience subsequent systemic TMA and face a 90% transplant failure rate.
- Soliris first achieved regulatory clearance in 2007 in the U.S. and EU for the treatment of another ultra-rare life-threatening blood disorder called paroxysmal nocturnal hemoglobinuria (PNH). It was approved for aHUS in the U.S. and EU in 2011. Soliris is also cleared for sale for both indications in Japan and selected other countries.
- A full regimen of Soliris costs ~$540,000, the world's most expensive drug until UniQure's Glybera (alipogene tiparvovec) leapfrogged it.
- NICE recommended funding for Soliris for aHUS in September.
- Previously: NICE recommends Soliris for aHUS
- Previously: UniQure sets price record with Glybera
Nov. 26, 2014, 3:33 PM
- Dutch biotech UniQure (QURE +22.6%) catapults into uncharted territory with the pricing of its gene therapy drug Glybera (alipogene tiparvovec). It is set to debut in Germany at €1.1M ($1.4M).
- Glybera treats an ultra-rare disease called lipoprotein lipase deficiency (LPLD), a condition that clogs the blood with fat. The European Commission approved it in November 2012 but the launch was delayed because the company needed to collect six-year follow up data on its benefits.
- UniQure's commercial partner, Italian firm Chiesi, has filed a pricing dossier with German regulators, who will issue an assessment of the drug's benefits by April 2015. Chiesi seeks a retail price of €53,000 per vial. Under German rules, the launch price will be valid for 12 months.
- At this price, the full regimen cost will be €1.1M for a typical LPLD patient weighing 62.5 kg, who will require 42 injections from 21 vials. The number of eligible patients is tiny, only 150 - 200 across Europe.
- Former #1 Soliris (eculizumab), made by Alexion Pharmaceuticals (ALXN +0.7%) is now a distant second at ~$540,000.
- ETFs: IBB, BIB, BIS
Nov. 25, 2014, 7:25 AM
- The Japanese Ministry of Health, Labour and Welfare grants Orphan Drug status to Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab) for the treatment of patents with neuromyelitis optica, a life-threatening ultra-rare neurologic disorder.
- The Japanese regulator grants Orphan Drug status to medicines that treat diseases afflicting less than 50K people in Japan. Among the benefits is a 10-year period of market exclusivity if approved.
Nov. 14, 2014, 12:00 PM| 41 Comments
Nov. 10, 2014, 8:04 AM
Oct. 23, 2014, 9:49 AM
- Alexion (ALXN +5%) Q3 results: Net Product Sales: $555.1M (+38.6%); COGS: $51.9M (+23.0%); R&D Expense: $100.7M (+14.2%); SG&A: $157.7M (+28.3%); Operating Income: $236.7M (+74.9%); Net Income: $177.7M (+89.4%); EPS: $0.88 (+87.2%); Quick Assets: $1781.7M (+17.6%).
- 2014 Guidance: Revenue: $2.22B - $2.23B from $2.18B - 2.20B; Non-GAAP EPS: $5.15 - $5.20 from $4.95 - 5.05.
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