May 14, 2014, 7:54 AM
- Surgical teams at Los Angeles' Cedar Sinai Hospital and New York's Lenox Hill Hospital successfully implant St. Jude Medical's (STJ) Portico Transcatheter Aortic Heart Valve signifying the start of the PORTICO clinical trial. The product is fully repositionable until fully deployed. Trial patients will be those who have a high or extreme surgical risk for open-heart surgery.
- The product is CE Mark-designated in Europe but investigational in the U.S.
May 7, 2014, 12:18 PM
- The FDA approves the Entovis pacemaker system with ProMRI technology made by Berlin, Germany's Biotronik. The device allows patients to undergo MRI scans with a limited exclusion zone. Entovis patients need only to alert radiology staff and they will verify that they are eligible to undergo the imaging. The company believes that this is a significant advantage over MRI-conditional pacers. The FDA's approval covers both single and dual chamber pacemakers when implanted with Setrox leads.
- Recent research finds that there is a 50 - 75% probability that patients implanted with a pacemaker or defibrillator will need an MRI at some point in their lives.
- (BSX) (MDT) (STJ)
Apr. 30, 2014, 6:41 PM
Apr. 16, 2014, 7:57 AM
- St. Jude Medical (STJ) Q1 net profit $249M vs $223M.
- Constant currency sales +4%.
- Sales breakdown: Cardiac Rhythm Management (CRM) +1% to $687M, with U.S. ICD sales +5%; Atrial Fibrillation (AF) +8% to $251M; Cardiovascular -1% to $326M; Neuromodulation flat at $99M.
- Outlook: Q2 adjusted EPS of $0.99-1.01 vs consensus of $1 and revenues of $1.38-1.46B vs $1.44B; FY EPS of $3.95-4.00 vs $4.30 and revenue of $5.61-5.76B vs $5.96B.
- St. Jude expects four new CRM product approvals in the U.S. to accelerate sales in H2. (PR)
Apr. 16, 2014, 7:32 AM
Apr. 16, 2014, 12:05 AM
Apr. 15, 2014, 5:30 PM
Apr. 9, 2014, 4:44 PM
- Some leading U.S. and European cardiologists favor curbs on sales or an outright moratorium on renal denervation devices.
- After Medtronic's (MDT +0.7%) Simplicity clinical trial failed to meet its efficacy endpoint doctors question the continued use of the product to treat high blood pressure in patients who fail to gain enough of a benefit from drugs.
- The therapy is currently approved in more than 80 countries. Analysts believe the U.S. market would be $3B if and when the FDA approves a device for the indication.
- The renal denervation procedure uses a catheter to insert the device through the groin and into the kidney where it applies RF pulses to the renal arteries to damage the nerve endings in the vascular wall. Physicians believe these nerves contribute to elevated blood pressure.
- (BSX) (STJ)
Feb. 24, 2014, 8:20 AM
Feb. 10, 2014, 11:19 AM
- St. Jude Medical (STJ +3.2%) enjoys lots of positive chatter following Friday's analyst day.
- Stifel upgrades shares to Buy from Hold with a $75 price target, touting the company's pipeline that spans several businesses and targets new and existing markets; the firm is convinced STJ is poised to show steadily accelerating sales growth and expanding margins during the next 2-3 years, yielding above consensus top- and-bottom line numbers in the process.
- Morgan Stanley says end-market stability and pipeline catalysts into H2 2014 suggest acceleration across the next several quarters; it reiterates an Overweight rating and $75 target.
- BofA is out positive too, calling the stock a "best idea" and seeing several potential catalysts through the rest of 2014; the firm tags an $80 target price.
Jan. 22, 2014, 9:18 AM
- St. Jude (STJ +0.4%) net profit edges up to $123M from $120M last year.
- Unfavorable currency fluctuations hurt sales by $27M. On a constant-currency basis, net sales +6%.
- Sales breakdown: cardiac rhythm-management +3%; implantable cardiac defibrillator +5%; pacemakers +1%.
- Q1 adjusted EPS of $0.94-0.96 vs consensus of $0.95, and revenue of $1.28-1.36B vs $1.38B.
- FY adjusted EPS of $3.94-3.99 vs $3.98, and revenue of $5.6-5.75B vs $5.64B. (PR)
Jan. 22, 2014, 7:32 AM
Jan. 22, 2014, 12:05 AM
Jan. 21, 2014, 5:30 PM
Jan. 13, 2014, 10:08 AM
- St. Jude (STJ +1.9%) estimates adjusted Q4 EPS of $0.97-0.99, with both ends of the range 2 cents above previous guidance. However, the figures exclude about $0.55 a share in charges, mainly related to restructuring and other corporate costs.
- St. Jude also expects revenue to have risen to $1.42B from $1.37B.
- Analysts project EPS of $0.96 and sales of $1.38B.
- Sales breakdown: Cardiac Rhythm Management +3% to $705M; Atrial Fibrillation +5% to $252M; Cardiovascular +4% to $350M; Neuromodulation +2% to $115M.
- St. Jude is due to give a presentation at the Annual JPMorgan Healthcare Conference in San Francisco at 11 PST. (PR)
Jan. 6, 2014, 2:09 PM
- McKesson (MCK -0.1%) upgraded to Strong Buy from Outperform at Raymond James.
- DaVita (DVA +0.4%) upgraded to Outperform from Market Perform at Raymond James.
- Idenix Pharmaceuticals (IDIX -0.3%) upgraded to Buy from Neutral at UBS.
- Abbott Labs (ABT +1.5%) upgraded to Overweight from Equalweight at Morgan Stanley.
- Medtronic (MDT +2%) upgraded to Overweight from Neutral at JPMorgan. Price target is $69.
- Vertex Pharmaceuticals (VRTX +2.5%) upgraded to Buy from Neutral at UBS.
- Ocera Therapeutics (OCRX +2.7%) upgraded to Outperform from Market Perform at BMO.
- Boston Scientific (BSX +3.2%) upgraded to Overweight from Equalweight at Morgan Stanley.
- Exelixis (EXEL +4.6%) upgraded to Overweight from Neutral at Piper.
- St. Jude Medical (STJ +3.8%) upgraded to Overweight from Equalweight at Morgan Stanley.
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.
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