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Nov. 5, 2014, 9:27 AM
- Covidien (COV -0.4%) FQ4 results: Revenues: $2,734M (+6.8%),Advanced Surgical: $951M (+17.1%), Surgical Solutions: $1,334M (+11.0%), Vascular Therapies: $426M (+3.1%), Respiratory and Patient Care: $974M (+3.1%); COGS: $1031M (-0.2%); R&D Expense: $149M (+2.1%); SG&A: $855M (+4.4%); Operating Income: $513M (+8.7%); Net Income: $517M (+39.0%); EPS: $1.13 (+41.3%).
- FY 14 results : Revenues: $10,659M (+4.1%), Advanced Surgical: $3,553M (+11.5%), Surgical Solutions: $5,113M (+7.1%), Vascular Therapies: $1,677M (+1.5%), Respiratory and Patient Care: $3,869M (+1.6%); COGS: $4,173M (+4.6%); R&D Expense: $546M (+7.5%); SG&A: $3,580M (+9.2%); Operating Income: $1,992M (-6.6%); Net Income: $1,662M (-2.2%); EPS: $3.65 (+1.1%).
- No guidance given.
Nov. 5, 2014, 6:01 AM
- Covidien (NYSE:COV): FQ4 EPS of $1.15 beats by $0.13.
- Revenue of $2.73B (+6.6% Y/Y) beats by $40M.
Nov. 4, 2014, 5:30 PM
- ACT, ANSS, ARIA, ATHM, AVA, AWR, AXAS, BBEP, BPI, BSFT, CBB, CCC, CEQP, CHK, CLH, CNP, COV, CSTE, CTSH, DAVE, DNR, DUK, EE, ENB, ENDP, FSS, GLDD, GTN, HFC, HL, HRC, INXN, KELYA, LAMR, LPX, LVLT, MDLZ, MEMP, MGA, MNTA, MVIS, NICE, NRG, NUS, OGE, PWE, PWR, RDC, RLGY, ROC, RRD, RTI, SBGI, SE, SEP, SMG, SSYS, STWD, SWC, THI, TMHC, TRGT, TW, TWX, VG, VOYA, WCG, WIX, YORW
Nov. 3, 2014, 8:11 AM
- Spectranetics (NASDAQ:SPNC) acquires Covidien's (NYSE:COV) Stellarex drug coated angioplasty balloon (DCB) platform for $30M. The company expects it to be a revenue catalyst beginning in 2015 and has the potential to deliver $100M to the top line within 2-3 years of commercialization in the U.S. Management expects it to be accretive to non-GAAP operating income, ex-items, in the first year following the start of the U.S. launch.
- Research and development related to Stellarex will dilute 2015 earnings $28M - 32M or $0.65 - 0.75 per share, however.
Oct. 27, 2014, 11:41 AM
- The FDA approves St. Jude Medical's (STJ -0.3%) TactiCath Quartz irrigated ablation catheter. The product gives physicians a real-time objective measure of the force that the catheter applies to a patient's heart wall during an ablation procedure. The technology is associated with a reduction in the rate of atrial fibrillation recurrence when optimal treatment measures are used.
- Related tickers: (BCR +1.2%)(MDT -0.1%)(JNJ +0.9%)(BSX +0.8%)(HNSN +2.1%)(ABT -0.6%)
Oct. 21, 2014, 10:52 AM
- The FDA accepts Eli Lilly's NDA for empagliflozin plus immediate-release metformin hydrochloride for the treatment of adults with type 2 diabetes (T2D). The product is part of the Lilly/Boehringer Ingelheim Diabetes alliance portfolio.
- Empagliflozin is a sodium glucose co-transporter-2 inhibitor which removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilize glucose.
- The FDA approved Jardiance (empagliflozin) as an adjunct to diet and exercise to improve glycemic control in adults with T2D in August 2014. Metformin has been in clinical use for many years.
- Diabetes-related tickers: (JNJ +0.4%)(OTCQB:ISLT)(OTCQB:BTHE +20%)(VTAE +2.5%)(NVO +0.5%)(MRK +0.9%)(NASDAQ:VKTX)(HPTX +0.4%)(ABT +1.2%)(OTCPK:TKPHF)(OTCPK:TKPYY -0.5%)(MDT +1.7%)(SNY -0.2%)(OTCQB:SNYNF -0.5%)(MNKD +2.4%)(ALR +1.4%)(TNDM +3%)
Oct. 17, 2014, 8:34 AM
- The U.S. District Court for the District of Connecticut grants a preliminary injunction against Ethicon Endo-Surgery (NYSE:JNJ) preventing it from manufacturing, marketing and selling its Harmonic ACE +7 ultrasonic energy device. The injunction is the result of Covidien's (NYSE:COV) lawsuit that alleges the product infringes on three of its patents.
- Ethicon's Harmonic devices were found to infringe the same patents in a prior suit in the same court. Ethicon is currently appealing the court's damages award of $175M.
Oct. 15, 2014, 10:02 AM
- Luminex (LMNX -7.3%) President and CEO Patrick J. Balthrop, Sr. retires. Mr. Nachum "Homi" Shamir replaces him. Mr. Balthrop will serve as a consultant through April 14, 2015 to assist in the transition.
- Mr. Shamir was formerly President and CEO of Given Imaging before it was acquired by Covidien (COV -3.8%).
Oct. 3, 2014, 10:19 AM
- Shaking off the potential flak from Uncle Sam for using its foreign cash to buy Covidien (COV +5.2%), Medtronic (MDT +3.5%) instead will rely on $16B in external financing to complete the transaction. Covidien shareholders will still receive $35.19 per share in cash plus 0.956 of an ordinary share of Medtronic.
- All terms and conditions of the definitive agreement signed by the two firms in June remain unchanged.
Oct. 1, 2014, 10:05 AM
- In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
- The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
- ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
- Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)
Oct. 1, 2014, 8:21 AM
- Yesterday, the U.S. Government released the first comprehensive disclosure of payments made by medical companies to doctors. Over the first five months of 2013, med firms paid $3.5B to doctors to fund items such as research, consulting, royalties to hospitals to help develop products and fees for speaking engagements. The monies were disbursed in two broad categories: research funding and fees to doctors for consulting and other non-research services.
- Roche's (OTCQX:RHHBY) Genentech unit led the way in the non-research category with $135M. Most of this (90%) went to a Southern California hospital network for royalties.
- Bristol-Myers Squibb (NYSE:BMY) was #1 in the research category with $329M which, according to the company, was largely the value of experimental medicines used in studies.
- Medtronic (NYSE:MDT) paid one unidentified doctor ~$3M who was among a group of six physicians paid at least $500K by the device maker. The company's total outlay for the period was $30.1M.
- Johnson & Johnson (NYSE:JNJ) paid $68M for non-research expenses.
- The disclosures, mandated by Obamacare, cover 4.4M payments to ~550K doctors and 1,360 teaching hospitals from August to December 2013.
- The disclosures are a bit controversial. Physicians complained that the government did not give them enough time to review the data to correct mistakes.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
Sep. 25, 2014, 9:05 AM
- Covidien (NYSE:COV) will report fiscal Q4 and fiscal year results before the open on November 5. Its conference call will start at 8:30 am ET.
- Consensus views for fiscal Q4 and fiscal 2014 are EPS of $1.02 on revenues of $2.7B and EPS of $4.02 on revenues of $10.6B, respectively.
Sep. 23, 2014, 7:45 AM
- U.S. Treasury Secretary Jack Lew says that the Obama Administration is prepared to institute rules to stop tax inversion deals. If so, it will do so without a sliver of Republican support. Barclays analyst Michael Leuchten says, "Washington is playing for time. It makes them look good and it allows Congress to maybe get its act together and maybe do something on the legislative side."
- Mr. Lew's comments have spooked the market a bit. European companies already involved in deals or rumored to be targets are all under pressure due to the perception that some of the deals already announced may be at risk.
- The U.S. firm in the best position is Horizon Pharma (NASDAQ:HZNP). It completed its tax inversion transaction with Ireland-based Vidara Therapeutics last week.
- Related tickers: (MDT -0.4%)(COV -0.5%)(ABBV -0.6%)(SHPG -0.7%)(OTCQB:SHPGF -1.5%)(PFE -0.7%)(AZN -0.1%)(SNN +0.1%)(SYK -0.8%)
Sep. 23, 2014, 3:45 AM
- Under Treasury Secretary Jack Lew’s crackdown on inversions, the Treasury Department announced new tax rules late yesterday to deter U.S. companies from moving their domicile to countries with lower tax rates.
- The tax changes make it harder for companies to complete overseas mergers, and should they choose to invert, companies will face a hard time using the cash accumulated abroad.
- The new rules are effective immediately and apply to all deals that have not closed by yesterday.
- Related M&A: MDT, COV, SLXP, MYL, CQB, OTC:FYFFF,BKW, THI
Sep. 17, 2014, 4:17 PM
- Covidien (NYSE:COV) declares $0.36/share quarterly dividend, 12.5% increase from prior dividend of $0.32.
- Forward yield 1.58%
- Payable Nov. 6; for shareholders of record Oct. 7; ex-div Oct. 3.
Sep. 16, 2014, 2:01 PM
- Results from the 331-patient randomized controlled IN.PACT SFA trial show Medtronic's (MDT +0.3%) IN.PACT Admiral drug-coated balloon (DCB) peripheral artery intervention device outperformed standard percutaneous transluminal angioplasty (PTA) both clinically and economically.
- The 12-month clinically-driven target lesion revascularization (CD-TLR) rate was 2.4% for the IN.PACT Admiral DCB compared to 20.6% for standard PTA. In other words, only 2.4% required another procedure within one year compared to one in five PTA patients.
- In an economic analysis from the U.S. phase of the SFA trial, the follow-up target limb-related medical care costs from discharge to one year were $750/patient lower in the DCB group versus the PTA group, despite higher initial hospital costs. This translates into an incremental cost-effectiveness ratio (ICER) of about $2,900 per repeat revascularization avoided, which is similar to other cardiovascular therapies, including coronary drug-eluting stents.
Medtronic PLC is engaged in providing medical technology alleviating pain, restoring health, and extending life of people. It currently functions in three operating segments that manufacture and sell device-based medical therapies.
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