The FDA approves St Jude's (STJ -1.9%) next-generation Merlin.net Patient Care Network (PCN), a system for cardiac patients with implanted medical devices that allows doctors to monitor them via the Internet and "detect heart failure symptoms earlier than ever before." Information is sent to doctors via the "Merlin@home" Transmitter and a patient's Internet connection. (PR)
Boston Scientific (BSX +2.5%) hits a 16-month high today after Credit Suisse upped the stock to Outperform, citing a better top-line and improved visibility. On those catalysts, the firm reduces the valuation discount it thinks the stock should trade at versus rivals St. Jude (STJ) and Medtronic (MDT) to 10%. The stock currently trades at around a 20% discount to its peers.
The FDA has sent St Jude Medical (STJ) a warning about defects at the company's factory in California where it makes heart defibrillators, the wires for which have had no end of problems. The FDA won't authorize new product lines at the facility until the faults have been corrected but it's not seeking any product recalls or a shutdown of operations. St Jude doesn't expect the warning to hurt its earnings.
St. Jude Medical (STJ) raises its preliminary Q4 results, now expecting an EPS of around $0.90 - $0.92, up from its prior view of $0.86 - $0.88 and better than Street estimates of $0.87. The firm cites better sales results along with cost savings initiatives during the quarter. Q4 sales are approximately $1.372B, slightly better than consensus estimates of $1.37B.
St. Jude Medical (STJ +0.2%) has reportedly pledged to improve training and quality procedures, and correct flaws the FDA found during an inspection of the company's Sylmar facility in California, which manufactures a key heart-rhythm device. The inspection focused on the Durata wires that connect defibrillators to the heart and which have had no end of problems.
Volcano (VOLC) CEO Scott Huennekens has predicted that the market for a test that shows whether patients need heart stents could increase ten-fold to $2B within a decade. That would be a boon not only to Volcano, which sells the tests and could become a takeover target, but also to St. Jude Medical (STJ), which is the only other company in the game. Doctors are enthusiastic as data indicates they've been over-stenting.
A group of Democratic Senators have signed a letter urging for a delay in implementing a tax on the medical device industry that is scheduled to go into effect January 1, saying the industry has received little guidance about how to comply with the tax, and is causing significant uncertainty and confusion. The Senators are requesting that a delay be included in the fiscal cliff bill Congress is currently negotiating.
St. Jude Medical (STJ -0.5%) slips on a downgrade by TheStreet Ratings to Hold. The firm says that the stock's reasonable valuations are more than offset by deteriorating net income, weak operating cash flow and disappointing return on equity.
St. Jude Medical (STJ +1.4%) gains on the back of yesterday's $1B buyback announcement and an upgrade to Buy at Mizuho. The firm says that concerns about a Durata recall are overblown, and that any impact on its EPS from market share loss in implanted defibrillators should be "more than offset" by yesterday's buyback announcement.
Boston Scientific (BSX +2.7%) bucks a down tape this morning on an upgrade to Buy at Citigroup. The firm says BSX is positioned to be the biggest winner from St. Jude Medical's (STJ -1%) Durata troubles. Citi expects it will be taken off the market within six months, and the ripple effects are likely to cost STJ around $820M in annual sales. BSX could easily take 41% of that market share, with Medtronic (MDT -0.9%) absorbing around 29%. Citi's upgrade differs widely from comments made on Friday by BofA Merrill, which put the risk of a Durata recall well below 50%.
St. Jude Medical (STJ -1%) says the first patient implant using its Portico Transcatheter heart valve has been made, using a Transapical Delivery System. The Portico Transcatheter heart valve is made of bovine pericardial tissue and is designed to increase physicians' control and placement accuracy during valve deployment. The valve has the ability to be completely re-sheathed and repositioned, which allows the physician to retrieve the valve, if necessary.
Shares of St. Jude Medical (STJ +3%) claw back a bit of their 12% pummeling taken on Wednesday following the FDA's release of a report citing serious flaws in STJ's oversight of Durata. BofA Merrill Lynch notes that the report found no new safety issues and the probability of a recall stands well below 50%, which is already priced into the stock. It reiterates a Buy with a potential downside to $24 and an upside peaking around $40.
St. Jude Medical, Inc., develops, manufactures and distributes cardiovascular medical devices for global cardiac rhythm management, cardiovascular, atrial fibrillation therapy areas and neurostimulation medical devices for the management of chronic pain.