Wed, Nov. 11, 5:48 PM
- Boston Scientific (NYSE:BSX) slid today, -4.2%, following proposed government guidelines that would limit coverage of the company's new Watchman heart implant.
- The company had hit a new nine-year high of $19.06 last Thursday; shares today closed at $18.01, 5.5% off that high.
- The Centers for Medicare and Medicaid Services is proposing limits to the use of percutaneous left atrial appendage closure (LAAC) therapy, with a memo that concludes applying the therapy using an implanted device is "not reasonable and necessary to diagnose or treat an illness or injury or to improve the functioning of a malformed body member," which would make it ineligible for broad reimbursement.
- The memo is just a proposal for the moment, and it does suggest conditions under which Watchman could qualify for coverage, but it's a blow to long-term hopes. Leerink's Danielle Antalffy says the product is a key long-term growth driver (expectations to ramp to $500M market opportunity by 2019), while RBC Capital Markets' Glenn Novarro wonders if the CMS just needs better data via an outcomes registry.
Tue, Nov. 10, 10:41 AM
- In an effort to expand its footprint in interventional oncology, Boston Scientific (BSX +0.1%) acquires privately-held CeloNova Biosciences' interventional radiology portfolio for $70M plus potential regulatory- and sales-based milestones. The assets include drug-eluting microspheres designed to be loaded with chemotherapy drugs for delivery to tumors and spherical embolic products for the treatment of uterine fibroids and other conditions.
- The deal, expected to close by year end, includes CeloNova's Embozene TANDEM Drug-Eluting Microspheres that can be embedded with drugs to treat liver cancer and ONCOZENE and Embozene Microspheres, technologies that can be used to treat hypervascular tumors, arteriovenous malformations and hepatoma.
- Microspheres are small spherical particles used by interventional radiologists to slow or stop the blood supply to a tumor. They are delivered via a pre-loaded syringe in a catheter-based approach.
Wed, Oct. 28, 8:58 AM
- Boston Scientific (BSX) Q3 results: Revenues: $1,888M (+2.3%); COGS: $539M (-2.0%); R&D Expense: $221M (+4.2%); SG&A: $729M (-1.6%); Operating Loss: ($299M) (-567.2%); Net Loss: ($198M) (-560.5%); Loss Per Share: ($0.15) (-600.0%); Quick Assets: $350M (-40.4%).
- 2015 Guidance: Total Revenues: $7.470B - 7.510B from $7.275B - 7.375B; EPS: $0.02 - 0.05 from $0.28 - 0.34; Non-GAAP EPS: $0.90 - 0.92 from $0.88 - 0.92.
- Q4 Guidance: Total Revenues: $1.970B - 2.010B; EPS: $0.10 - 0.13; Non-GAAP EPS: $0.23 - 0.25.
Wed, Oct. 28, 6:37 AM
Tue, Oct. 27, 5:30 PM
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Wed, Oct. 14, 10:28 AM
- In a partial victory for Boston Scientific (BSX +0.1%), a Delaware court reduces a $100M verdict award in to a woman in May for injuries allegedly suffered from the company's transvaginal mesh device to $10M. Judge Mary Johnston referred to the original award as "grossly disproportionate to the injuries suffered and shocks the court's conscience and sense of justice." The company wanted the entire verdict set aside and a new trial, but the judge denied the request. It intends to appeal the decision.
- In April, it settled 2,970 mesh-related lawsuits for $119M. Many more remain outstanding, however, for the company and fellow mesh manufacturers Johnson and Johnson (JNJ -1.3%) an C.R. Bard (BCR -0.1%).
- Previously: Boston Scientific on the hook for $100M in Delaware transvaginal mesh trial (May 28)
Thu, Oct. 8, 9:19 AM
- Boston Scientific (NYSE:BSX) closes an additional round of financing with Israel-based MValve Technologies Ltd., which it has supported since 2012. MValve is developing a percutaneous mitral valve replacement system that is designed to work with BSX's Lotus Valve, creating a unique treatment solution for mitral regurgitation (MR).
- The new investment will fund a first-in-human clinical trial for the MValve docking system for transcatheter mitral valve replacement (TMVR) in patients with MR, which is the leakage of blood backward through the heart's mitral valve each time the left ventricle contracts. It is the most common heart valve disorder.
- The Lotus Aortic Valve System is a second-generation valve replacement technology, consisting of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. It is designed for precise placement as well as bi-directional repositioning and retrieval at any time prior to the release of the implant. The Lotus Valve also features an Adaptive Seal which conforms the patient's specific anatomy and minimizes paravalvular leak which, if significant, could be fatal.
- BSX also has an exclusive option to acquire MValve.
Mon, Oct. 5, 7:07 AM
- The FDA approves Boston Scientific's (NYSE:BSX) SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease. Both the drug coating and polymer which modulates drug release are fully absorbed shortly after drug elution is complete at three months. SYNERGY is designed to enable more rapid and complete arterial healing via synchronized drug and polymer absorption while reducing the risk of complications such as inflammation associated with long-term exposure to polymer from traditional drug-eluting stents.
- The data supporting the company's regulatory application was generated by the EVOLVE II study, a randomized, single-blind, non-inferiority pivotal trial that showed 0% definite stent thrombosis after 24 hours (no blood clotting). Four-year data showed a continued 0% stent thrombosis rate and a low 1.1% rate of lesion revascularization.
- A study assessing SYNERGY in patients at high risk of bleeding who are undergoing percutaneous coronary intervention (PCI) is expected to commence in Q1.
- Commercialization of the first and only BP-DES in the U.S. will begin immediately.
- SYNERGY received CE Mark clearance in 2012.
Sun, Oct. 4, 8:23 PM
- Ralph Lauren (NYSE:RL) is tapped for more even more gains after rallying sharply following last week's announcement of the resignation of CEO Ralph Lauren. New CEO Stefan Larsson is seen adding some fast-fashion punch to the luxury mindset at the company.
- Tenet Healthcare (NYSE:THC) could rise as much as 70% with mergers expected to start feeding the bottom line, observes Barclays. Concerns over Tenet's debt load has driven shares down sharply to levels seen as attractive.
- Margins at Boston Scientific (NYSE:BSX) are expected to improve with new products looking promising. The consensus price target on Wall Street implies close to a 20% gain is in store.
Mon, Aug. 31, 4:08 PM
- PTC Therapeutics (PTCT -6.2%) initiated with Buy rating and $90 (135% upside) price target by Citi.
- Patterson Companies (PDCO -1.1%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $54 (18% upside) from $48.
- Acadia Pharmaceuticals (ACAD -4.1%) upgraded to Overweight from Neutral with a price target of $48 (30% upside) by Piper Jaffray.
- Boston Scientific (BSX -1.9%) upgraded to Buy from Neutral with a $20 (19% upside) price target by Goldman Sachs.
- CR Bard (BCR -1.8%) upgraded to Buy from Neutral with a $220 (14% upside) price target by Goldman Sachs.
- Sarepta Therapeutics (SRPT -2.7%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $48 (34% upside) from $28.
- Bristol-Myers Squibb (BMY -1.8%) upgraded to Neutral from Underweight by Piper Jaffray. Price target maintained at $61 (2% upside).
- MacroCure (MCUR -3.7%) downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $5 (63% upside) from $15.
Thu, Jul. 23, 9:20 AM
- Boston Scientific (NYSE:BSX) Q2 results ($M): Total Revenues: 1,843 (-1.6%); Cardiovascular: 743 (+0.5%); Rhythm Management: 517 (-6.5%); MedSurg: 583 (+0.5%).
- Net Income: 102 (+999%); EPS: 0.08 (+999%).
- 2015 Guidance: Total Revenues: $7.275B - 7.375B from $7.225B - 7.375B; EPS: $0.28 - 0.34 from $0.32 - 0.38; Non-GAAP EPS: $0.88 - 0.92 (unch).
- Q3 Guidance: Total Revenues: $1.79B - 1.84B; EPS: $0.10 - 0.13; Non-GAAP EPS: $0.21 - 0.23.
Thu, Jul. 23, 7:05 AM
Wed, Jul. 22, 5:30 PM
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Tue, Jul. 7, 10:27 AM
- Biotie (BITI +0.6%) initiated with Buy rating and $26 (33% upside) price target by Roth Capital and a Buy rating with $30 (53% upside) price target by Stifel Nicolaus.
- Boston Scientific (BSX -0.1%) initiated with Overweight rating and $21 (20% upside) price target by Stephens & Co.
- Ophthotech (OPHT +1.9%) initiated with Outperform rating and $80 (49% upside) price target by Cowen & Co.
- Teva Pharmaceutical Industries (TEVA -0.5%) initiated with Buy rating and $77 (25% upside) price target by BTIG Research.
- Axovant Sciences (AXON -1.1%) initiated with Buy rating and $31 (64% upside) price target by Jefferies.
- PRA Heath Sciences (PRAH) initiated with Sector Weight rating and $36.06 (0% upside) price target by KeyBanc.
- Baxalta (BXLT -0.4%) initiated with Neutral rating and $36 (14% upside) price target by Goldman Sachs.
Thu, May 28, 12:42 PM
- Boston Scientific (BSX +1.8%) loses another product liability lawsuit related to its transvaginal mesh. A Delaware court has ordered the company to pay plaintiff Deborah Barba $25M in compensatory damages plus $75M in punitive damages, according to the law firm that represented Ms. Barba.
- Last month, the company announced that it reached agreements to settle 2,970 mesh-related suits for $119M. In November, it lost a suit brought by four women who claimed they were injured from the use of the product. The award was $26.7M.
- Lawyers are having a field day suing mesh manufacturers. Boston Scientific, Johnson & Johnson (JNJ -0.3%) and C.R. Bard (BCR -0.5%) still face close to 70K product liability lawsuits alleging poor design. The mesh, implanted in women for the treatment of incontinence and/or to support internal organs, had a tendency to erode over time causing organ damage and pain.
- Previously: Boston Sci loses first federal case over vaginal mesh product (Nov. 14, 2014)
Sun, May 10, 6:46 PM
- The FDA approves Nevro's (NYSE:NVRO) Senza spinal cord stimulation system (NYSE:SCS) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza system's value proposition is the reduction of pain without paresthesia or tingling sensation, which typically characterizes SCS therapy and that many patients find uncomfortable. Senza avoids paresthesia by delivering high frequency stimulation (10 KHz) and low stimulation amplitudes.
- The FDA also clears Senza for stimulation below 10KHz, which requires paresthesia.
- Related tickers: (NYSE:MDT) (NYSE:BSX) (NYSE:STJ)
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