Nov. 28, 2014, 10:45 AM
- Medtronic (MDT +1.3%) secures EU approval for its $43B acquisition of Covidien plc (COV +1%) contingent on, as expected, Covidien selling Stellarex, its drug-coated angioplasty balloon. Spectranetics (SPNC +1.9%) agreed to purchase Stellarex several weeks ago for $30M. The FTC recently gave its blessing to the transaction as well.
- Previously: FTC clears Medtronic/Covidien marriage
- Previously: Spectranetics buys Covidien's DCB platform
Nov. 26, 2014, 3:57 PM
- The Federal Trade Commission approves the merger between Medtronic (MDT +1%) and Covidien plc (COV +1.2%) with the proviso that Covidien divest its drug-coated catheter business before completing the transaction. Covidien agreed to sell the business for $30M to Spectranetics (SPNC +1%) several weeks ago.
- Previously: Medtronic buying Covidien for $42.9B
Nov. 18, 2014, 8:07 AM
- Medtronic (NYSE:MDT) fiscal Q2 results ($M): Revenues: 4,366 (+4.1%); COGS: 1,142 (+4.8%); Operating Expenses: 1,881 (+3.9%); Net Income: 828 (-7.2%); EPS: 0.83 (-6.7%); CF Ops (6 mo.): 1,223 (-39.4%).
- Revenue by group ($M): Cardiac Rhythm & Heart Failure: 1,320 (+3.7%); Coronary & Structural Heart: 743 (+4.9%); Aortic & Peripheral Vascular: 223 (+2.3%); Spine: 746 (unch); Neuromodulation: 494 (+3.1%); Surgical Technologies: 410 (+8.8%); Restorative Therapies: 1,650 (+3.0%); Diabetes Group: 430 (+9.4%).
- 2015 Guidance: Revenue growth: 4 - 5% from 3 - 5%; non-GAAP EPS: $4.00 - 4.10 (unch).
- Previously: Medtronic EPS and revenue in-line
Nov. 18, 2014, 7:43 AM
Nov. 17, 2014, 5:30 PM
Nov. 17, 2014, 8:24 AM
- At American Heart Association meeting in Chicago, Medtronic (NYSE:MDT) presented new data supporting the clinical and economic value of its cardiac resynchronization therapy (CRT) devices for the treatment of heart failure (HF).
- Over 1M HF patients are hospitalized each year. 25% of them are re-admitted within 30 days and 50% are re-admitted within six months. The mortality rate is ~30%.
- In an effort to determine whether CRT reduces the rate of all-cause readmission within 30 days of a heart failure hospitalization, a meta-analysis of pooled data from five randomized trials involving 3,872 patients was completed. In the group of 678 patients with an index heart failure hospitalization, there was a 26% relative reduction in hospital readmissions in patients treated with CRT. The benefit was higher, 31%, in patients with more advance heart failure (Class III/IV) than Class II at 10%.
- Separately, researchers found that patients who improved or remained unchanged six months after CRT were projected to live longer and consumed fewer hospital resources than patients who worsened.
Nov. 12, 2014, 4:53 AM
- Medtronic (NYSE:MDT) submitted concessions last Friday in a bid to secure regulatory approval for its $43B acquisition of Covidien (NYSE:COV), says the European Commission.
- The EU antitrust authority will decide by Nov. 28 whether to clear the deal.
- A takeover of its Irish rival would reduce Medtronic's overall global tax burden, although it has said that the takeover is not an "inversion" deal for tax reasons.
Nov. 10, 2014, 4:47 PM
Nov. 10, 2014, 10:49 AM
- The Japanese Ministry of Health, Labour and Welfare approves Medtronic's (MDT +0.1%) Evera SureScan implantable cardioverter-defibrillator (ICD) for magnetic resonance imaging (MRI) scans positioned on any region of the body. The commercial launch is underway.
- Evera MRI is available in both single chamber and dual chamber ICDs.
- Until the availability of MR-Conditional ICDs, patients with the devices had been contraindicated from receiving MRI scans because of the potential interactions between the MRI and device function.
- Evera MRI is not yet approved in the U.S.
- Related tickers: (STJ +0.7%)(BSX +1.6%)
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. 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. 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
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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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