Seeking Alpha
  • Today - Wednesday, April 23, 2014

  • 12:21 PM
    • The European Medicines Agency accepts Salix Pharmaceuticals' (SLXP -0.3%) and partner Progenics Pharmaceuticals' (PGNX -1.9%) submission for the use of Relistor (methylnaltrexone bromide) in patients with chronic non-cancer pain. The product is currently approved as a treatment for opioid-induced constipation in advanced illness patients.
    • Salix Relistor revenues for 2011 - 2013 were $27M, $33.2M and $39.4M, respectively.
    • Progenics' royalty income for the same years was $3.046M, $4.963M and $5.895M, respectively.
    • PGNX 10-K page 4
    | Comment!
  • 10:52 AM
    • San Francisco Assemblyman Tom Ammiano submits a bill to tighten the regulations governing the use of medical marijuana by adults. It would make it illegal for physicians to prescribe medical pot for patients they have not examined and bar prescriptions by doctors who have a financial stake in a pot dispensary.
    • The assembly Public Safety Committee passed the bill yesterday.
    • Somewhat controversial is the provision for the Department of Alcoholic Beverage Control to enforce the law. The California Narcotic Officers Association cites the irony in allowing an agency with regulatory responsibility over the use of recreational substances to regulate medical products. The senate version specifies the state health department as the regulator.
    • The bill, if passed, could lay the groundwork for a tax-and-control scheme for recreational pot use similar to Colorado and Washington.
    • (MDBX) (CANN) (AERO) (PHOT)
    | Comment!
  • 9:13 AM
    • Spectrum Pharmaceuticals' (SPPI) conditioning treatment in autologous transplants in multiple myeloma, Captisol-enabled (propylene glycol-free) Melphalan (CE Melphalan) meets its primary endpoint of determining the overall safety and toxicity profile in multiple myeloma patients receiving 200mg/m2 of CE Melphalan as myeloablative therapy prior to autologous stem cell transplantation.
    • Propylene glycol is associated with undesirable renal and cardiac side effects that limit the ability to deliver higher doses of therapeutic compounds.
    • A previous clinical trial established bioequivalence to the currently-available IV formulation of melphalan.
    • The company plans to file an NDA in Q3.
    • The FDA granted Orphan Drug Designation to the product for this indication.
    | 1 Comment
  • 8:44 AM
    • Top line revenues of $2.1B (+51%) driven by Avonex's $761M, Tecfidera's $506M, Tysabri's $441M and Rituxan & Gazyva's $297M.
    • Revenue growth has accelerated for five consecutive quarters.
    • The company recorded 100% of Tysabri revenues subsequent to its acquisition of the complete rights to the product in Q2.
    • GAAP diluted EPS was $2.02 (+13%) and net income $480M (+12%).
    • Full year guidance includes revenue growth of 26% - 28% and GAAP diluted EPS of $9.85 - $9.95.
    • (BIIB)
    | Comment!
  • 8:18 AM
    • Undeterred by a federal court smack down of his state-wide ban on Zogenix's (ZGNX) Zohydro, Governor Deval Patrick's Administration institutes restrictions on prescribing the product. Doctors will have to complete a risk assessment and pain treatment agreement before employing any opioid like Zohydro. The agreement covers drug screening, pill counts, safe storage and disposal and other safeguards against abuse.
    • The MA Board of Registration of Medicine approved the new requirements yesterday. Department of Public Health Commissioner Cheryl Bartlett issued an emergency order requiring physicians to use the state's Prescription Monitoring Program before prescribing Zohydro. The provides a mechanism for authorities to track where patients are receiving their medications.
    • Predictably, Zogenix is disappointed that state representatives did not accept the firm's offer to discuss the issue before announcing the new restrictions but welcomes the opportunity to do so at any time.
  • 7:40 AM
    • The European Commission designates Alexion Pharmaceuticals' (ALXN) Soliris (eculizumab) an orphan drug for the prevention of graft rejection following solid organ transplantation.
    • Soliris is currently approved in the U.S., European Union, Japan and other countries for the treatment of paroxysmal nocturnal hemoglobinuria and atypical uremic syndrome.
    • The company is currently investigating the product's use for the prevention of acute antibody-mediated rejection in kidney transplants and for the prevention of delayed graft function in patients receiving deceased donor kidney transplants.
    • The EC's orphan drug designation applies to medical products that treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 people. Like the U.S., the product will have a period of market exclusivity in the EU upon regulatory approval for the specific indication.
    | Comment!
  • 7:33 AM
    • Natus Medical (BABY): Q1 EPS of $0.26 beats by $0.03.
    • Revenue of $85.6M (-0.3% Y/Y) beats by $0.9M.
    • Press Release
    | Comment!
  • 7:15 AM
    • Neogenomics (NEO): FQ2 EPS of $0.00 in-line.
    • Revenue of $18.2M (+16.2% Y/Y) beats by $0.52M.
    • Press Release
    | Comment!
  • 7:08 AM
    • The Medicines (MDCO): Q1 EPS of -$0.08 misses by $0.01.
    • Revenue of $177.2M (+13.8% Y/Y) beats by $1.6M.
    • Press Release
    | Comment!
  • 7:04 AM
    • Biogen (BIIB): Q1 EPS of $2.47 misses by $0.09.
    • Revenue of $2.13B (+50.0% Y/Y) beats by $130M.
    • Press Release
    | Comment!
  • 6:03 AM
    • Thermo Fisher Scientific Inc. (TMO): Q1 EPS of $1.53 beats by $0.13.
    • Revenue of $3.9B (+22.3% Y/Y) beats by $160M.
    • Press Release
    | Comment!
  • 2:50 AM
    • Allergan (AGN) has adopted a one-year stockholder rights plan following a $47B hostile takeover bid from Valeant (VRX) and Bill Ackman's Pershing Square.
    • If any unapproved investor purchases 10% or more of Allergan's stock, other shareholders will have the right to acquire discounted shares. The plan would prevent Ackman from significantly increasing his 9.7% stake and it would stop Valeant from taking its offer directly to shareholders.
    • Allergan said the plan is not designed to prevent a takeover bid that directors are in favor of; rather it "aims to provide the board with adequate time to fully assess any proposal." (PR)
  • 1:38 AM
    • MSA Safety (MSA): Q1 EPS of $0.40 misses by $0.19.
    • Revenue of $265M (-6.4% Y/Y) misses by $15.16M.
    • Press Release
    | Comment!
  • Tuesday, April 22, 2014

  • 5:42 PM
    • While Intuitive Surgical's (ISRG) Q1 revenue was in-line with the forecast given in its April 8 warning, the company has cut its 2014 procedure growth guidance to 2%-8%, down from a prior 9%-12%.
    • Q1 procedure growth was 7%, down from a Q4 level of 12% and a full-year 2013 level of 16%.
    • As previously forecast, systems revenue fell 56% Y/Y in Q1 to $106M. Intuitive blames U.S. systems weakness on lower procedure growth, Obamacare-driven changes in hospital spending priorities, and "the impact that anticipation of a new system may have had on customer capital-spending decisions."
    • Q1 results, PR
    | Comment!
  • 4:35 PM
    • Product sales: $4.87B (+103.8%).
    • Net income: $2.23B (+209.7%)
    • EPS - Diluted: $1.33 (+209.3%)
    • Sovaldi sales: $2.27B.
    • Full year guidance: Net product sales: $11.3B - $11.5B, product gross margin: 75% - 77%, R&D: $2.2B - $2.3B, SG&A: $2.1B - $2.2B, EPS - Diluted: $0.63 - $0.66.
    • Press release
    • (GILD)
  • 4:29 PM
    • Amsurg Corp. (AMSG): Q1 EPS of $0.53 misses by $0.02.
    • Revenue of $263.1M (+1.2% Y/Y) misses by $8.62M.
    • Press Release
    | Comment!
  • 4:28 PM
    • Vascular Solutions, Inc. (VASC): Q1 EPS of $0.16 misses by $0.02.
    • Revenue of $29.91M (+14.8% Y/Y) in-line.
    • Press Release
    | Comment!
  • 4:24 PM
    • Product revenue: $4.36B (+4.9%).
    • Operating expenses: $3.16B (+12.9%).
    • Operating income: $1.36B (-5.4%).
    • Net Income: $1.07B (-25.2%).
    • EPS Basic: $1.42 (-25.7%).
    • CF Ops: $1.1B (+4.9%).
    • Neulasta/Neupogen: $1.38B (+3%).
    • Neulasta: $1.09B (+5%).
    • (AMGN)
    | Comment!
  • 4:15 PM
    • C. R. Bard, Inc. (BCR): Q1 EPS of $1.91 beats by $0.28.
    • Revenue of $799.3M (+8.0% Y/Y) beats by $12.2M.
    • Press Release
    | Comment!
  • 4:08 PM
    • Illumina (ILMN): Q1 EPS of $0.53 beats by $0.09.
    • Revenue of $421M (+27.2% Y/Y) beats by $29.5M.
    • Press Release
    | 1 Comment
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