boston scientific corp (BSX) Key Developments
Boston Scientific Reports Positive, Long-Term Data from the Evolve Trial of the Synergy Bioabsorbable Polymer Platinum Chromium Coronary Stent System
May 19 15
Boston Scientific reported positive, long-term data from the EVOLVE Trial of the SYNERGY Everolimus-Eluting Bioabsorbable Polymer Platinum Chromium Coronary Stent System, with no new major adverse cardiac events reported between years three and four. The study results were presented for the first time at EuroPCR 2015 by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia. Findings from year four of the EVOLVE Trial include the following key performance measures: the target lesion revascularization (TLR) rate was 1.1% compared to 6.1% for the PROMUS Element™ Plus Stent System (p=0.07); and no definite or probable stent thrombosis (ST) was observed. The EVOLVE Trial is the first human use, prospective, randomized, single-blind study evaluating the non-inferiority of the SYNERGY Stent, which employs an ultrathin bioabsorbable polymer coating applied to the abluminal (outer) surface of the stent. The comparator, the Boston Scientific PROMUS Element Plus Stent System,
utilizes a durable polymer coating applied to the entire stent (inner and outer) surface. EVOLVE is the first in a continuing cadence of clinical trials evaluating the performance of the SYNERGY Stent in a range of patients. In addition to these long-term data from the EVOLVE Trial, one-year findings from the EVOLVE II pivotal trial of 466 patients with diabetes treated with the SYNERGY Stent were presented by Stephan Windecker M.D., chief of cardiology and head of invasive cardiology at the Swiss Cardiovascular Center in Bern, Switzerland. Patients with diabetes face an increased risk of heart disease, stroke and myocardial infarction. The data
presented for patients with diabetes include the following: the TLR rate was 4.4%; and definite/probable ST was 1.1% at one year, with no definite/probable ST events after the first week post percutaneous coronary intervention (PCI). The EVOLVE II Trial includes a global, multi-center, randomized, single-blind, non-inferiority pivotal trial designed to evaluate the safety and performance of the SYNERGY Stent System compared to the durable polymer PROMUS Element Plus Stent System. The trial enrolled 1,684 patients in 125 sites worldwide. The EVOLVE II Trial is part of a rigorous clinical program designed to support the submission for U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the SYNERGY Stent. The EVOLVE II Trial also includes a non-randomized, single-arm diabetes study. The EVOLVE II Diabetes Substudy pooled patients with diabetes randomized to the SYNERGY arm in the EVOLVE II pivotal trial with patients enrolled in the non-randomized single-arm diabetes study as pre-specified in the study protocol. Patients in the EVOLVE II Trial demonstrated clinical and angiographic complexity to a degree not observed in prior U.S. pivotal trials for drug-eluting stents (DES). More than 25% of patients had non-ST elevation myocardial infarction (NSTEMI) and approximately 75 % of patients had AHA/ACC class B2/coronary lesions. As previously reported, EVOLVE II met its primary endpoint, demonstrating non-inferiority of SYNERGY versus the PROMUS Element Plus Stent for 12-month target lesion failure in the overall patient population.
Boston Scientific Prices USD 1.85 Billion Three Series of Senior Notes
May 8 15
Boston Scientific announced that it had priced three series of senior notes for an aggregate principal amount of USD 1.85 billion. Of these notes, USD 600 million will mature on May 15, 2020 and will bear a coupon of 2.850%, USD 500 million of 3.375% notes are maturing on May 15, 2022, and USD 750 million of 3.850% notes are due May 15, 2025. The company plans to use the net proceeds from the offering to finance the takeover of American Medical Systems' urology portfolio, and to repay debt. The portfolio acquisition is expected to close in the third quarter of 2015.
Boston Scientific Collaborates with MedAxiom and TogetherMD to Bring Value Based Solutions to Healthcare Systems
Apr 30 15
Boston Scientific announced the signing of two strategic agreements to advance the company's efforts to bring value based solutions aimed at improving outcomes and reducing the cost of cardiovascular care delivery to healthcare systems. As part of an agreement with MedAxiom, Boston Scientific will offer programs to help improve the way care is delivered to patients suffering from cardiovascular conditions including heart failure, atrial fibrillation, structural heart and ischemic heart disease. These programs will assist hospitals and ambulatory care sites in developing and implementing comprehensive clinical and operational strategies to drive efficiencies across the care continuum, from diagnosis to treatment and ongoing care. This agreement brings together Boston Scientific's strong expertise in lean practices, process improvement and supply chain optimization with MedAxiom's deep experience in cardiovascular program leadership. Additionally, Boston Scientific has signed an agreement with TogetherMD, to explore the integration of TogetherMD technology into the Boston Scientific cardiovascular portfolio and offer providers with access to actionable data in support of operational improvement and cost reduction initiatives. This includes robust industry benchmarking data and analysis of ongoing operational and financial performance, and billing and coding accuracy. TogetherMD has reported improved reimbursement and average service line cost savings of approximately $1.5 million from the introduction of similar initiatives in single hospital sites.1Boston Scientific will evaluate the use of this information technology platform across its businesses and regions. Boston Scientific will bring these and other comprehensive solutions to healthcare systems through its recently launched ADVANTICS™ solutions brand that emphasizes collaboration to meet unique customer needs. ADVANTICS programs include performance optimization, capital financing, care pathway transformation and patient management.
Boston Scientific Corporation Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015; Revised Earnings Guidance for the Year 2015; Provides Earnings Guidance for the Second Quarter of 2015
Apr 28 15
Boston Scientific Corporation reported unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported net sales of $1,768 million against $1,774 million a year ago. Operating income was $24 million against $197 million a year ago. Loss before income taxes was $51 million against income before income taxes of $146 million a year ago. Net loss was $1 million or $0.00 basic and diluted earnings per share against net income of $133 million or $0.10 basic and diluted loss per share a year ago. Adjusted net income was $286 million or $0.21 per diluted share against $268 million or $0.20 per diluted share a year ago. Adjusted net income pre-tax was $327 million against $304 million a year ago. The strong performance in first quarter of 2015 was driven primarily by operational revenue growth and gross margin expansion. Unfavorable foreign exchange impacted first quarter of 2015 adjusted EPS by $0.02 versus the $0.01. Excluding this unfavorable foreign exchange impact, First Quarter adjusted EPS grew 18% year-over-year. Adjusted free cash flow for the quarter was $118 million compared to $161 million last year. Capital expenditures were $46 million compared to $59 million a year ago.
The company now estimates revenue for the full year 2015 to be in a range of $7.225 to $7.375 billion compared to prior guidance of $7.300 to $7.500 billion, which versus the prior year period represents change in a range of negative 2 to flat on a reported basis and a growth range of approximately 4% to 6% on an operational basis. The company now estimates income on a GAAP basis in a range of $0.32 to $0.38 per share compared to prior guidance of $0.42 to $0.48, and continues to estimate adjusted earnings, excluding acquisition- and divestiture-, litigation, and restructuring-related charges, pension termination charges, and amortization expense, in a range of $0.88 to $0.92 per share. The company continue to expects full year 2015 adjusted tax rate to be in the range of 13% to 15%. The company expects full year 2015 adjusted operating margin to be between 22% and 22.5%, an improvement of roughly 200 basis points at the midpoint over full year 2014. Previously, the company assumed that unfavorable FX would negatively impact full year 2015 adjusted EPS by $0.04 or $0.01 per quarter. Based on current rates, the company now expects FX to impact full year 2015 adjusted EPS by $0.06 to $0.07 but are not changing adjusted EPS guidance.
The company estimates sales for the second quarter of 2015 in a range of $1.800 to $1.850 billion. The company estimates earnings on a GAAP basis in a range of $0.09 to $0.11 per share. Adjusted earnings, excluding acquisition- and divestiture-, and restructuring-related charges, and amortization expense, are estimated in a range of $0.20 to $0.22 per share. On an operational basis, the company expects consolidated sales to grow year-over-year in a range of 4% to 6%. The company expects adjusted gross margin for the second quarter to be in the range of 70.5% to 71.5% prior to key new product launches in the second half of the year. The company expects adjusted operating margin in the second quarter to be between 21% and 22%.
Boston Scientific Corporation Presents at Bank of America Merrill Lynch 2015 Health Care Conference, May-12-2015 10:00 AM
Apr 27 15
Boston Scientific Corporation Presents at Bank of America Merrill Lynch 2015 Health Care Conference, May-12-2015 10:00 AM. Venue: Encore at the Wynn, 3131 S Las Vegas Blvd, Las Vegas, Nevada, United States. Speakers: Daniel J. Brennan, Chief Financial Officer, Principal Accounting Officer and Executive Vice President, Susie Lisa, vice president, Investor Relations.