Seeking Alpha
  • Today - Tuesday, April 28, 2015

  • 1:31 PM
    • DaVita Healthcare Partners (DVA -0.2%) upgraded to Outperform with a $95 (14% upside) by Baird.
    • St. Jude Medical (STJ +0.5%) upgraded to Outperform with a $84 (15% upside) price target by Credit Suisse.
    • Omnicare (OCR -0.3%) downgraded to Sector Perform with a $82 (5% downside risk) price target by RBC Capital and to Neutral by Credit Suisse with a $91 (6% upside) price target.
    | Comment!
  • 1:16 PM
    • Retrophin (RTRX) initiated with a Buy rating and $50 (120% upside) price target by Deutsche Bank.
    • Stemline Therapeutics (STML -0.8%) initiated with Buy rating and $38 (146% upside) price target by H.C. Wainwright.
    • Trillium Therapeutics (TRIL -0.4%) initiated with Outperform rating and $29 (32% upside) price target by Leerink Swann.
    • Juniper Pharmaceuticals (JNP -0.5%) initiated with Buy rating and $15 (102% upside) by Roth Capital.
    • Radius Health (RDUS -2.8%) initiated with a Buy rating and $50 (35% upside) by Maxim Group.
    • DARA Biosciences (DARA +1.1%) initiated with Buy rating and $2 (138% upside) price target by H.C. Wainwright.
    • UniQure (QURE -2.5%) initiated with a Buy rating and $40 (60% upside) by Chardan Capital.
    • NeuroDerm (NDRM -1.7%) initiated with Buy rating and $21 (70% upside) price target by Jefferies.
    • Bluebird bio (BLUE +1.2%) initiated with Buy rating and $190 (42% upside) price target by Maxim Group.
    • Cidara Therapeutics (CDTX -1.9%) initiated with Sell rating and $13 (12% upside) price target by WBB.
    | Comment!
  • 12:53 PM
    • In this morning's earnings call, Merck (MRK +5.2%) reported that the FDA has again declined to approve Bridion (sugammadex) as a reversal agent for muscle relaxants used in surgery, citing the need to see more data on potential allergic reactions to the product. The decision was no surprise. The company expected to receive a Complete Response Letter (CRL), its second regarding sugammadex, by April 22. It originally submitted the New Drug Application (NDA) in 2008.
    • The product is sold in over 60 countries so the risk of allergic reactions appears to be manageable.
    | 1 Comment
  • 12:29 PM
    • May 2 is the PDUFA date for the FDA's decision on The Medicines Company's (MDCO +1.5%) Biologic License Application (BLA) for Raplixa, a dry powder formulation of fibrinogen and thrombin, for use as an aid to stop bleeding during surgery. The agency accepted the BLA for review a year ago.
    • The company obtained the rights to the product via its acquisition of ProFibrix in August 2013.
    • The European Commission approved Raplixa last month.
    | Comment!
  • 12:19 PM
    • April 30 is the PDUFA date for the FDA's decision on the approval of the use of the Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) inhaler in adult patients with asthma. The Ad Comm vote last month was 18 - 2 in favor of the new indication. Breo Ellipta is currently cleared for the treatment of chronic obstructive pulmonary disease.
    • Breo Ellipta was co-developed by Theravance (THRX +3.3%) and GlaxoSmithKline (GSK +0.2%).
    | Comment!
  • 11:42 AM
    • The FDA designates Bio-Path Holdings' (BPTH +5.9%) lead product candidate, Liposomal Grb-2, an Orphan Drug for the treatment of acute myeloid leukemia (AML). It is currently in Phase 2 development for the indication.
    • Liposomal Grb-2 (Growth factor Receptor Bound protein-2) suppresses the expression of Grb-2, which is an adaptor protein that links tyrosine kinases with their downstream signaling molecules. Tyrosine kinases function as "on" "off" switches in many cellular functions so interrupting their signaling may have an inhibitory effect on rapidly-growing cancer cells.
    • Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
    | Comment!
  • 11:11 AM
    • A Phase 3 trial, ZOE-50, evaluating the safety and efficacy GlaxoSmithKline's (GSK +0.4%) investigational shingles vaccine, HZ/su, showed that a two-dose schedule reduced the risk of herpes zoster by 97.2% in adults at least 50 years old compared to placebo. Efficacy was consistent across various age groups: 50 -59 years: 96.6%; 60 - 69 years: 97.4%; 60+ years: 97.6%; 70+ years: 98%.
    • HZ/su is non-live and combines gE, a protein found on the herpes zoster virus, with the adjuvant ASO1B, which boosts the immune response to gE.
    • Shingles is characterized by a painful, itchy rash caused by the reactivation of latent chicken pox virus, varicella zoster. The risk of developing shingles increases with age and altered immune system status.
    • HZ/su should be a formidable competitor to Merck's Zostavax, which is based on live virus and is less effective (64%: 60 - 69 years; 41%: 70 -79 years; 18%: 80+ years).
    | Comment!
  • 10:47 AM
    • Universal Health Services (UHS +0.7%) Q1 results: Revenues: $2,225.4M (+14.8%); Operating Income: $327.1M (+20.7%); Net Income: $174.3M (+26.2%); EPS: $1.73 (+25.4%); Quick Assets: $35.1M (+9.3%); CF Ops: $271.3M (+39.4%).
    • No guidance given.
    | Comment!
  • 10:37 AM
    • Icon plc (ICLR -4.3%) Q1 results: Revenues: $388.2M (+11.0%); SG&A: $79.6M (0.9%); Operating Income: $66.7M (+55.1%); Net Income: $55.9M (+54.4%); EPS: $0.9 (+57.9%); Quick Assets: $191.7M (-11.3%).
    • 2015 Guidance: Revenue: $1,600M - 1,650M from $1,160M - 1,675M; EPS: $3.60 - 3.70 from $3.45 - 3.60.
    | Comment!
  • 10:35 AM
    • The FDA designates Cerulean Pharma's (CERU +5.2%) lead nanoparticle-drug conjugate (NDC), CRLX101, for Fast Track review for the treatment, in combination with Avastin (bevacizumab), of metastatic renal cell carcinoma (RCC) following progression through two or three prior lines of therapy. CRLX101, currently in Phase 2 development for RCC, is a NDC that delivers the highly toxic topoisomerase 1 inhibitor, camptothecin, directly to a tumor.
    • Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the New Drug Application (NDA).
    | Comment!
  • 10:27 AM
    • CryoLife (CRY -0.5%) Q1 results: Revenues: $33.8M (-5.3%); COGS: $14.2M (+6.8%); R&D Expense: $2.3M (-8.0%); SG&A: $19M (+3.8%); Operating Loss: ($1.6M) (-194.1%); Net Loss: ($0.3M) (-127.3%); Loss Per Share: ($0.01) (-125.0%); Quick Assets: $38.2M (-2.8%).
    • 2015 Guidance: $148.5M - 150.5M from $151M - 153M; Gross Margin: ~60% (unch); R&D Expenses: $13M - 14M (unch); EPS: Breakeven from ($0.03).
    | Comment!
  • 10:20 AM
    | Comment!
  • 10:19 AM
    • MiMedx (MDXG -2.3%) Q1 results: Revenues: $40.8M (+108.2%); COGS: $5.1M (+70.0%); R&D Expense: $1.8M (+28.6%); SG&A: $29.3M (+84.3%); Operating Income: $4.2M (+566.7%); Net Income: $4.1M (+555.6%); EPS: $0.04 (+500.0%); Quick Assets: $44.7M (-14.5%); CF Ops: $4.2M (+362.5%).
    • Q2 Guidance: Revenue: $44M - 46M.
    • 2015 Guidance: $180M - 190M.
    | Comment!
  • 10:16 AM
    • It took more than a year, but the FDA finally sends a Complete Response Letter (CRL) to Amarin (AMRN -5.1%) to address its supplemental New Drug Application (sNDA) for an expanded label for Vascepa (icosapent ethyl) to include use as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with mixed dyslipidemia (one or more lipid disorders) and triglyceride levels from 200 to 499 mg/dL (ANCHOR population). Vascepa is currently cleared as an adjunct to diet to reduce TG levels in adult patients with severe (>=500 mg/dL) hypertriglyceridemia. Vaccepa's current labeling remains unchanged.
    • The original PDUFA date for the sNDA was December 20, 2013. In October, the FDA rescinded the Special Protocol Assessment after its advisory committee voted 9-2 against the expanded indication citing the need for "more clinically relevant measures of efficacy."
    • In the CRL, the FDA acknowledged that Vascepa demonstrated a treatment effect compared to placebo in reducing TG levels in the ANCHOR study but stated that there are insufficient data at present that support a drug-induced change in TGs as a surrogate for reducing CV risk, the rationale for the use of Vascepa in the ANCHOR population. The FDA did not determine that the effects of Vascepa, which go beyond lowering TGs, would not actually reduce CV risk. Despite Amarin proposing alternative indications and disclaimers, the agency has decided not to approve the expanded indication.
    • The company, with the support of the FDA, intends to complete the 8,000 patient REDUCE-IT CV outcomes study, which is currently 93% enrolled. The independent Data Monitoring Committee is expected conduct an interim review of the data in 2016. The study is projected to be completed in 2017 with final results available and published in 2018.
    | 7 Comments
  • 9:39 AM
    • The FDA designates Genzyme's (NYSE:SNY) investigational oral substrate reduction therapy, GZ/SAR402571, for Fast Track review for the treatment of Fabry disease. The product candidate is currently in Phase 2 development.
    • Fabry disease is an rare inherited disorder caused by mutations in the GLA gene. It is characterized by the buildup of a type of fat, called globotriaosylceramide, in the body's cells which leads to progressive kidney damage, heart attack and stroke. It affects 1 in 40K - 60K males, less frequently in females.
    • Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the New Drug Application (NDA).
    | Comment!
  • 9:33 AM
    • Neogenomics (NEO) Q1 results: Revenues: $23M (+26.4%); COGS: $13.5M (+42.1%); Operating Expenses: $10.1M (+21.7%); Operating Loss: ($0.6M) (-250.0%); Net Loss: ($0.8M) (-900.0%); Loss Per Share: ($0.01); Quick Assets: $31.2M (-7.4%); CF Ops: ($0.8M) (-180%).
    • 2015 Guidance: Revenues: $103M - 108M.
    | Comment!
  • 9:16 AM
    • Boston Scientific (NYSE:BSX) Q1 results ($M): Total Revenues: 1,768 (-0.3%); Cardiovascular: 712 (+1.7%); Rhythm Management: 514 (-1.9%); MedSurg: 542 (-1.1%).
    • Key Segment Sales: Interventional Cardiology: 495 (-0.4%); CRM: 456 (-2.1%); Defibrillator Systems: 335 (-1.2%); Endoscopy: 305 (-1.6%).
    • Net Income: (1) (-100.8%); EPS: 0.00 (-100.0%).
    • 2015 Guidance: Revenues: $7.225B - 7.375B from $7.300B - 7.500B; GAAP EPS: $0.32 - 0.38 from $0.42 - 0.48; Non-GAAP EPS: $0.88 - 0.92 (unch).
    • Q2 Guidance: Revenues: $1.80B - 1.85B; GAAP EPS: $0.09 - 0.11; Non-GAAP EPS: $0.20 - 0.22.
    | Comment!
  • 8:48 AM
    • Idexx Laboratories (IDXX -1.8%) Q1 results: Revenues: $382.5M (+6.2%); COGS: $166.9M (+5.6%); R&D Expense: $25M (+8.2%); SG&A: $117.7M (+8.1%); Operating Income: $72.8M (+4.0%); Net Income: $46.6M; EPS: $0.98 (+10.1%); Quick Assets: $321.4M (-0.3%); CF Ops: ($14.6M) (-143.6%).
    • 2015 Guidance: Revenue: $1,600M - 1,620M; EPS: $4.14 - 4.24; CAPEX: ~$100M.
    | Comment!
  • 8:47 AM
    • Bristol-Myers Squibb (NYSE:BMY) Q1 results ($M): Total Revenues: 4,041 (+6.0%); Net Product Sales: 3,059 (+9.0%); Alliance & Other: 982 (-2.2%); Mature Products & Other: 639 (-17.2%); Diabetes Alliance: 54 (-69.8%).
    • Net Income: 1,186 (+26.6%); GAAP EPS: 0.71 (+26.8%).
    • Key Product Sales: Abilify: 554 (+2.6%); Orencia: 400 (+10.2%); Sprycel: 375 (+9.6%); Eliquis: 355 (+234.9%); Baraclude: 340 (-16.3%); Yervoy: 325 (+19.9%); Reyataz: 294 (-14.5%); Sustiva Franchise: 290 (-9.1%); Hec C Franchise: 264; Erbitux: 165 (-2.4%).
    • 2015 Guidance: Revenues: $14.4B - 15.0B (unch); GAAP EPS: $0.96 - 1.06 from $1.55 - 1.70; Non-GAAP EPS: $1.60 - 1.70 from $1.55 - 1.70.
    • GAAP EPS guidance lowered due to upfront payments for business development transactions.
    | Comment!
  • 8:29 AM
    • Hospira (HSP -0.4%) Q1 results: Revenues: $1,174.9M (+11.8%); COGS: $651.4M (-4.4%); R&D Expense: $135.4M (+62.7%); SG&A: $223.6M (+20.2%); Operating Income: $133.4M (+33.9%); Net Income: $75.6M (+11.3%); EPS: $0.43 (+7.5%); Quick Assets: $643.7M (-19.8%); CF Ops: ($100.3M) (-648.1%).
    • Revenue by region: America: $976.9M (+16.0%); EMEA: $118.5M (-10.7%); APAC: $79.5M (+4.2%).
    • Revenue by business: Specialty Injectable Pharmaceuticals: $808.5M (+12.9%); Medication Management: $203.8M (-1.2%); Other Pharma: $162.6M (+26.7%).
    • No guidance given.
    | Comment!
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