Seeking Alpha
  • Saturday, April 19, 2014

  • 11:17 PM
    • With the injunction preventing Medtronic (MDT) from selling its CoreValve System taking effect in just a few days on April 23, the company asks the U.S. Court of Appeals to postpone the order until the firm can determine if the injunction was properly issued. The Court has yet to rule but it did grant its request for an expedited review of its appeal.
    • The firm and Edwards Lifesciences (EW) are currently negotiating a mechanism whereby clinicians currently trained on CoreValve can make patient-specific decisions regarding whether to implant Medtronic's device or Edwards' without being constrained by CoreValve's availability. The companies must report their status on the issue to the Court on May 21 although they can implement a plan earlier based on mutual agreement.
    • Medtronic believes that Edwards and the Court have inappropriately applied provisions of patent term extension regarding the Anderson '552 patent which expired in May 2012.
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  • 10:49 PM
    • The U.S. Department of Defense awards Express Scripts (ESRX) a seven-year contract to administer the TRICARE Pharmacy Program (4th Generation) covering ~10M beneficiaries. The company will run a retail pharmacy network, the TRICARE mail order pharmacy and will provide specialty pharmacy services.
    • ESRX has been providing home delivery to the DoD since 2003 and retail pharmacy services since 2004. Defense added specialty pharmacy in 2009.
    • The company will now provide pharmacy services to all the military worldwide including Military Treatment Facilities.
    • The contract will take effect May 1, 2015.
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  • 10:37 PM
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  • Friday, April 18, 2014

  • 4:03 AM
    • Eight million people have bought health insurance under Obamacare, President Obama said yesterday, easily surpassing earlier projections by the Congressional Budget Office for 6-7M signups by the end of March.
    • The high number of enrollments was achieved despite the technical problems that the online exchanges suffered, particularly when the Affordable Care Act was launched last year.
    • Around 35% of those who purchased coverage were people under 35, who are thought to be less likely need to treatment and so can help balance the cost of claims for those who need care.
    • However, Obama didn't provide details about the number of enrollees who already had insurance before Obamacare was introduced.
    • More on Obamacare
    • Health insurers: AET, HNT, HUM, UNH, WLP,
  • Thursday, April 17, 2014

  • 5:20 PM
    • EVP and Chief Operating Officer Ken Keller resigns to take a CEO job with another firm.
    • Joseph Turgeon replaces him as President and COO reporting to Chairman Dr. Rajesh C. Shrotriya.
    • Prior to joining Spectrum Pharmaceuticals (SPPI -2%) Mr. Turgeon was VP, Sales at Amgen (AMGN -0.1%).
    • VP, Corporate Accounts Tom Riga promoted to EVP and Chief Commercial Officer reporting to Mr. Turgeon.
    | 1 Comment
  • 5:05 PM
    • Total top line sales were $106.9M, up 16% yoy. Clinical Systems revenues were $17.3M (+38%) and Clinical Reagents revenues were $83.1M (+24%).
    • The North America business fell slightly (-1%) while the International business grew 56%.
    • Net loss was -$0.13/share compared to breakeven a year ago.
    • 503 GeneXpert systems placed globally.
    • GAAP gross margin was 50% compared to 53% yoy.
    • 2014 guidance range for revenues is $446M - $461M with a loss/share between -$0.38 and -$0.43.
    • (CPHD +0.7%)
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  • 4:44 PM
    • Actavis (ACT) buys four currently-marketed products from Akorn (AKRX) and one more under development for cash. The transaction is contingent on the consummation of Akorn's acquisition of Hi-Tech Pharmacal (HITK).
    • The products on the market are: Ciprofloxacin Hydrochloride Ophthalmic Solution, Levofloxacin Ophthalmic Solution, Lidocaine Hydrochloride Jelly and Lidocaine/Prilocaine Topical Cream.
    • The FTC stipulated that Akorn divest the products as a condition of its approval of the Hi-Tech transaction.
    • Financial terms are not disclosed.
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  • 4:23 PM
    • The FDA approves Glaxo (GSK) and Genmab's (GNMSF) monoclonal antibody Arzerra (ofatumumab) as a first-line therapy for patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
    • "Arzerra is the only therapeutic CD20 antibody approved in combination with chlorambucil for first-line CLL and as a monotherapy for CLL refractory to fludarabine and alemtuzumab," says Jan de Winkel, Ph.D., Genmab's CEO.
    • In the Phase 3 COMPLEMENT 1 clinical trial the ofatumumab plus chlorambucil group's progression-free survival (PFS) was 22.4 months compared to 13.1 months for the chlorambucil alone group.
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  • 3:41 PM
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  • 2:15 PM
    • Texas researchers predict that one in twenty or ~12M people in outpatient settings in the U.S. are misdiagnosed by doctors each year. About half could potentially harm patients.
    • They analyzed 3,000 patient records and found a misdiagnosis rate of 5%. Extrapolating the rate to the 80% of U.S. adults who receive outpatient medical care yields 12M people.
    • Faulty medical records and other potential flaws in the data could mean the real misdiagnosis rate is higher.
    • The study's lead author, Dr. Hardeep Singh of Baylor College of Medicine, hopes his team's findings give quality-of-care stakeholders a clearer sense of the problem.
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  • 1:49 PM
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  • 1:30 PM
    • Scientists create patient-specific cell lines from the skin cells of two adult men in a procedure called somatic cell nuclear transfer demonstrating that the technique can work for people of all ages. The embryonic cells are genetically identical to the donor and have profound therapeutic potential.
    • The cloning procedure is difficult, however. Only one in thirty-nine attempts was successful.
    • In therapeutic cloning, a jolt of electricity fuses a grown cell (e.g. skin cell) with an ovum whose DNA has been removed. After ~5 days of dividing and multiplying it develops into a hollow sphere-shaped embryo. The interior cells are pluripotent stem cells which can develop into many different kinds of cells. The goal is to coax them to develop into specialized cells for therapeutic purposes.
    • Complicating the ability to create patient-specific cell lines for millions of people are women's reticence over donating eggs, a sometimes painful process. Widespread donations may not be ultimately necessary since many people have genetically similar immune systems so 100 human embryonic stem cell lines would match over 50% of the U.S. population according to the co-author of the study, Dr. Robert Lanza.
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  • 12:25 PM
    • Q1 revenues of $31.7B up 5% yoy. Operating earnings were flat at $2.1B. Operating margin fell to 3.5% from 4.1%.
    • Optum revenues of $11.2B up 29% yoy but operating margin decreased to 5.8% compared to the comparable quarter's 6.2%.
    • 2.7M more people served yoy.
    • Consolidated medical care ratio decreased 20 basis points to 82.5%.
    • CF Ops was $1.4B.
    • EPS of $1.10 despite $0.35 negative impact from Affordable Care Act.
    • 2014 revenue guidance range is $128B - $129B. Net EPS range is $5.40 - $5.60.
    • (UNH -3.5%)
    • Press release
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  • 11:52 AM
    • Glaxo's (GSK -0.5%) once-daily long-term bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) Incruse Ellipta (umeclidinium bromide) receives marketing approval in Canada.
    • The product is a long-acting muscarinic antagonist monontherapy known as an anticholinergic. It delivers 62.5 micrograms of umeclidinium via a dry powder inhaler.
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  • 11:02 AM
    • TriVascular Technologies (TRIV +12%) holds onto its gain from yesterday's debut that ended at $13.79 (+14.9%) on turnover of 2.2M shares. Volume thus far in today's trading is light at 63K, however.
    • The medical device maker's lead product is its Ovation System, an endovascular stent graft for the repair of an abdominal aortic aneurysm. It received CE Mark approval in August 2010 and FDA approval in October 2012. Commercial sales began in the U.S. in November 2012.
    • Revenues for 2012 and 2013 were $5.4M and $19.5M, respectively.
    • Gross profit was -$3.6M and $7.8M.
    • Net loss was -$43.3M and -$50.3M.
    • Net loss/share was -$5.89 and -$5.01.
    • CF Ops was -$34M and -$46.9M.
    • Prospectus
    • (IPO) (FPX)
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  • 9:08 AM
    • Teve Pharmaceutical Industries (TEVA) and Pfizer (PFE) settle their patent suit related to the former's generic version of Celebrex.
    • Teva may launch its generic offerings in December of this year.
    • U.S. sales of the branded product were $2.2B in 2013 according to IMS Health.
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  • 8:58 AM
    • Q1 NI of $556M increased $4M (+0.7%) compared to Q1'13. NI ex-items was $652M up 8% from last year's $601M.
    • Total revenue for the quarter was $3.95B. Revenue ex-Gambro was $3.55B (+3%). Bioscience revenue was $1.61B (+5%). Medical Products revenue was $2.34B (+22%).
    • Q2 guidance calls for sales growth of 12% - 13% excluding foreign currency risk and EPS ex-items of $1.18 - $1.22.
    • 2014 guidance includes revenue growth of 9% - 10% ex foreign currency risk and EPS ex-items of $5.05 - $5.25.
    • (BAX)
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  • 8:39 AM
    • Aiming to capture a chunk of Janssen Pharmaceuticals' (JNJ) ORTHO EVRA (Norelgestromin/Ethinyl Estradiol Transdermal System 150/35 mcg/day) $150M U.S. sales, Mylan (MYL) launches its generic equivalent XULANE.
    • The product is indicated for the prevention of pregnancy in women who use a transdermal patch as a method of contraception.
    • According to IMS Health, Mylan has 300 ANDAs pending FDA approval representing $104.5B in branded sales. 42 are first-to-file submissions representing over $25B in branded sales.
    | 1 Comment
  • 8:25 AM
    • In a 28-2 vote, the Vermont Senate passes a bill that will require packaged food makers to label their products that contain genetically modified organisms ((GMOs)). If the State House of Representatives approves the Senates' changes to the version it passed before sending it the upper chamber, then the law will take effect July 1, 2016.
    • Vermont will be the first U.S. state to institute such mandatory labeling.
    • Predictably, food manufacturers oppose the bill saying GMOs are ubiquitous on grocery store shelves. The most popular GMO crops are corn, soybeans and canola which are found in almost every kind of packaged food. They say that GMOs are safe and the law, if enacted, will add unnecessary costs and complications for farmers and the food industry.
    • Consumer groups believe more safety testing needs to be done by independent researchers.
    • Vermont's bill would make it illegal to label a food product containing GMOs as "natural" or "all natural".
    • (MON) (PG)
    • ETFs: PBJ
  • 8:04 AM
    • In a novel cancer study funded with $42M by Cancer Research UK, scientists will test up to 14 different cancer drugs at the same time within one clinical trial. The objective is to identify the most effective treatments for advanced lung cancer by targeting specific rare genetic mutations.
    • The new approach will select a range of drugs for a specific patient instead of designing a study around a specific drug. In a profound change it eliminates randomization, the hallmark of clinical trial design.
    • Some mutations occur on only 1% - 2% of patients so the traditional method of clinical trial design is too expensive, time-consuming and inefficient.
    • AstraZeneca (AZN) will supply up to twelve experimental drugs that will be given to patients who do not show one of twenty-one sets of genetic abnormalities.
    • Pfizer (PFE) will supply its lung cancer drug Xalkori plus the experimental breast cancer drug palbociclib.
    • About 15-20 patients will be involved in the trial. Those drugs that show no benefit will be quickly dropped while those showing efficacy will be fast-tracked into larger-scale testing.
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