Cholecystitis, Acute

MARLBOROUGH, Mass., Oct. 26, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) generated net sales of $3.527 billion during the third quarter of 2023, growing 11.2 percent on a reported basis, 11.1 percent on an operational1 basis and 10.2 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income attributable to Boston Scientific common stockholders of $505 million or $0.34 per share (EPS), compared to $174 million or $0.12 per share a year ago, and achieved adjusted3 EPS of $0.50 for the period, compared to $0.43 a year ago. "We achieved another quarter of strong performance, thanks to the hard work of our talented global team and our differentiated medical technologies that improve the lives of patients across the globe," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "As we shared at our recent Investor Day meeting, we are well-positioned for the long term, backed by our category leadership strategy, strong pipeline of innovation and track record of strong commercial execution." Third quarter financial results and recent developments: Reported net sales of $3.527 billion, representing an increase of 11.2 percent on a reported basis, compared to the company's guidance range of 8.5 to 10.5 percent; 11.1 percent on an operational basis; and 10.2 percent on an organic basis, compared to the company's guidance range of 7 to 9 percent, all compared to the prior year period. Reported GAAP net income attributable to Boston Scientific common stockholders of $0.34 per share, compared to the company's guidance range of $0.21 to $0.25 per share, and achieved adjusted EPS of $0.50 per share, compared to the guidance range of $0.46 to $0.48 per share. Achieved the following net sales growth in each reportable segment, compared to the prior year period: MedSurg: 10.6 percent reported, 10.0 percent operational and 9.4 percent organic Cardiovascular: 11.6 percent reported, 11.7 percent operational and 10.6 percent organic Achieved the following net sales growth in each region, compared to the prior year period: United States (U.S.): 8.5 percent reported and operational Europe, Middle East and Africa (EMEA): 14.7 percent reported and 10.9 percent operational Asia-Pacific (APAC): 14.8 percent reported and 19.5 percent operational Latin America and Canada (LACA): 22.0 percent reported and 16.1 percent operational Emerging Markets4: 14.4 percent reported and 19.0 percent operational Announced positive 12-month results from the ADVENT pivotal clinical trial of the FARAPULSE™ Pulsed Field Ablation (PFA) System,5 which met the primary safety and efficacy endpoints, and demonstrated the FARAPULSE PFA System is noninferior to standard-of-care therapies. Completed enrollment in the first phase of the ADVANTAGE AF clinical trial studying the FARAPULSE PFA System for the treatment of patients with persistent atrial fibrillation (AF) and commenced enrollment in an extension arm of the study to evaluate the safety and effectiveness of adjunctive use of the FARAPOINT™ PFA Catheter for cavotricuspid isthmus (CTI) ablations, a procedure used to treat atrial flutter. Received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablation System, which includes the POLARx FIT Cryoablation Balloon Catheter and is used to treat patients with paroxysmal AF. Announced the U.S. FDA approval of the latest-generation WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device, which is designed to improve visualization during device placement, reduce device-related thrombus post-implant and treat a broader range of patient anatomies. Received U.S. FDA 510(k) clearance and launched the next-generation LUX-Dx II/II+™ Insertable Cardiac Monitor (ICM) System for long-term monitoring of arrhythmias. Received CE Mark, U.S. FDA clearance and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval for the AVVIGO™+ Multi-Modality Guidance System, a next-generation technology that provides high-quality intravascular ultrasound (IVUS) imaging and physiologic assessment of coronary vessels and lesions. Announced positive data at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium demonstrating statistical superiority of the AGENT™ Drug Coated Balloon5 versus uncoated balloon angioplasty for the treatment of patients with in-stent restenosis, meeting the primary endpoint of target lesion failure (TLF) at 12 months (17.9% vs. 28.7%, P=0.006) for the AGENT IDE clinical trial. Presented at TCT were study results demonstrating statistically significant lower major bleeding rates in patients with pulmonary embolism (PE) who were treated with the EKOS™ Endovascular System compared to the Inari FlowTriever® System as analyzed in the REAL-PE study. Received U.S. FDA De Novo classification grant and marketing authorization for an expanded indication for the AXIOS™ Stent and Electrocautery-Enhanced Delivery System. The new indication allows for use of the device to facilitate endoscopic drainage of the gallbladder for patients with acute cholecystitis who are at high risk for surgery. Announced U.S. FDA approval for an expanded indication of the WaveWriter Alpha™ Spinal Cord Stimulator (SCS) Systems for the treatment of painful diabetic peripheral neuropathy (DPN). Announced agreement to acquire Relievant Medsystems, Inc., a privately held medical technology company that has developed and commercialized the only U.S. FDA-cleared system, the Intracept® Intraosseous Nerve Ablation System, for vertebrogenic pain, subject to customary closing conditions. Net sales for the third quarter by business and region: Guidance for Full Year and Fourth Quarter 2023 The company now estimates net sales growth for the full year 2023, versus the prior year period, to be approximately 11 percent on both a reported basis and organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company now estimates EPS on a GAAP basis in a range of $1.00 to $1.04 and estimates adjusted EPS, excluding certain charges (credits), of $1.99 to $2.02. The company estimates net sales growth for the fourth quarter of 2023, versus the prior year period, to be in a range of approximately 9 to 11 percent on a reported basis, and approximately 8 to 10 percent on an organic basis. Fourth quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.26 to $0.30 and adjusted EPS, excluding certain charges (credits), of $0.49 to $0.52. Conference Call Information Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: investors.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website. About Boston Scientific Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit and connect on Twitter and Facebook. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "may," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our expected net sales; reported, operational and organic revenue growth rates; reported and adjusted EPS for the fourth quarter and full year 2023; our financial performance; acquisitions; clinical trials; our business plans and product performance, and new and anticipated product approvals and launches. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Risks and uncertainties that may cause such differences include, among other things: the impact of foreign currency fluctuations; future U.S. and global economic, political, competitive, reimbursement and regulatory conditions; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by extreme weather or other climate change-related events; disruptions caused by pandemics on our operations and financial results; labor shortages and increases in labor costs; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property; litigation; financial market conditions; the execution and effect of our business strategy, including our cost-savings and growth initiatives; and future business decisions made by us and our competitors. New risks and uncertainties may arise from time to time and are difficult to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A - Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this press release. Note: Amounts reported in millions within this press release are computed based on the amounts in thousands. As a result, the sum of the components reported in millions may not equal the total amount reported in millions due to rounding. Certain columns and rows within tables may not add due to the use of rounded numbers. Percentages presented are calculated from the underlying unrounded amounts. Use of Non-GAAP Financial Information A reconciliation of the company's non-GAAP financial measures to the corresponding GAAP measures, and an explanation of the company's use of these non-GAAP financial measures, is included in the exhibits attached to this press release. BOSTON SCIENTIFIC CORPORATION Q4 and FY 2023 GUIDANCE RECONCILIATIONS (Unaudited) Net Sales Earnings per Share Use of Non-GAAP Financial Measures To supplement our unaudited consolidated financial statements presented on a GAAP basis, we disclose certain non-GAAP financial measures, including adjusted net income (loss), adjusted net income (loss) attributable to Boston Scientific common stockholders and adjusted net income (loss) per share (EPS) that exclude certain charges (credits); operational net sales, which exclude the impact of foreign currency fluctuations; and organic net sales, which exclude the impact of foreign currency fluctuations as well as the impact of acquisitions and divestitures with less than a full period of comparable net sales. These non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States and should not be considered in isolation from or as a replacement for the most directly comparable GAAP financial measures. Further, other companies may calculate these non-GAAP financial measures differently than we do, which may limit the usefulness of those measures for comparative purposes. To calculate adjusted net income (loss), adjusted net income (loss) attributable to Boston Scientific common stockholders and adjusted net income (loss) per share we exclude certain charges (credits) from GAAP net income and GAAP net income attributable to Boston Scientific common stockholders, which include amortization expense, goodwill and intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio gains and losses, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), EU MDR implementation costs, debt extinguishment charges, deferred tax expenses (benefits) and discrete tax items. Amounts are presented after-tax using the company's effective tax rate, unless the amount is a significant unusual or infrequently occurring item in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 740-270-30, "General Methodology and Use of Estimated Annual Effective Tax Rate." Please refer to Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our most recent Annual Report filed on Form 10-K filed with the Securities and Exchange Commission or Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations in any Quarterly Report on Form 10-Q that we have filed or will file thereafter for an explanation of each of these adjustments and the reasons for excluding each item. The GAAP financial measures most directly comparable to adjusted net income (loss), adjusted net income (loss) attributable to Boston Scientific common stockholders and adjusted net income (loss) per share are GAAP net income (loss), GAAP net income (loss) attributable to Boston Scientific common stockholders and GAAP net income (loss) per common share – diluted, respectively. To calculate operational net sales growth rates, which exclude the impact of foreign currency fluctuations, we convert actual net sales from local currency to U.S. dollars using constant foreign currency exchange rates in the current and prior periods. To calculate organic net sales growth rates, we also remove the impact of acquisitions and divestitures with less than a full period of comparable net sales. The GAAP financial measure most directly comparable to operational net sales and organic net sales is net sales on a GAAP basis. Reconciliations of each of these non-GAAP financial measures to the corresponding GAAP financial measure are included in the accompanying schedules. Management uses these supplemental non-GAAP financial measures to evaluate performance period over period, to analyze the underlying trends in our business, to assess our performance relative to our competitors and to establish operational goals and forecasts that are used in allocating resources. In addition, management uses these non-GAAP financial measures to further its understanding of the performance of our operating segments. The adjustments excluded from our non-GAAP financial measures are consistent with those excluded from our operating segments' measures of net sales and profit or loss. These adjustments are excluded from the segment measures reported to our chief operating decision maker that are used to make operating decisions and assess performance. We believe that presenting adjusted net income (loss), adjusted net income (loss) attributable to Boston Scientific common stockholders, adjusted net income (loss) per share, operational net sales growth rates and organic net sales growth rates, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for its operational decision-making and allows investors to see our results "through the eyes" of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance. SOURCE Boston Scientific Corporation

System is Designed to Deliver Triple Impact: Clinical Benefit to Patients, Better Visualization and Control to Surgeons, and Higher Efficiency to Hospitals The Levita Robotic Platform is intended to deliver the clinical benefits of the company’s first commercial product, the Levita Magnetic Surgical System, including less pain, faster recovery and fewer scars for patients. (Credit: Business Wire) Levita Magnetics, a company with a mission to improve access to better surgery for more patients, today announced that the first ever robotic-assisted surgical procedures have been performed using the company’s newest system in development, the Levita® Robotic Platform. The first case was a reduced-incision laparoscopic cholecystectomy (gallbladder removal) completed by Dr. Ignacio Robles, a minimally invasive surgeon at Clínica INDISA in Santiago, as part of a current clinical study of the system in Chile. The new robotic platform is intended to deliver the clinical benefits of the company’s first commercial product, the Levita® Magnetic Surgical System, including less pain, faster recovery and fewer scars for patients.1,2 The platform is intended to improve visualization, maintain surgeon control of instruments, and increase hospital efficiency with fewer assistive personnel required to conduct the procedures. With its compact footprint, the robotic platform is specially designed for high volume ambulatory or same-day discharge abdominal surgeries. The aim of these combined benefits is to increase the volume of high-quality, efficiently performed procedures while improving surgical access to patients. “I am pleased to have the opportunity to perform the world’s first procedures using this innovative robotic platform. The first surgery was a challenging acute cholecystitis, nevertheless, the procedure went very smoothly and the patient had an outstanding recovery with no complications reported at 30 days post-procedure. Since then, we have performed two additional acute cholecystectomies using the robotic platform, with both patients enrolled and treated on the same day,” said Dr. Robles. “The combination of Levita’s magnetic technology within a robotic platform shows great promise to improve surgeon control and efficiency during surgical procedures. I’m excited to continue participating in this clinical study to further support the development of this platform.” “Levita’s original Magnetic Surgical System has been reported to improve surgical outcomes for patients with less pain and fewer incisions,” said Steven D. Schwaitzberg, MD, FACS, Professor and Chair of the Department of Surgery at Jacobs School of Medicine and Biomedical Sciences, University at Buffalo. “Further advancing this technology into a robotic surgery platform has the potential to be useful in many procedures by providing a stable visualization platform without the need for an additional assistant.” “We are taking Magnetic Surgery to the next level with this disruptive approach. Our robotic platform is designed to be the first to enable the clinical benefits of a less invasive procedure with fewer incisions, while allowing the surgeon full control of the platform and surgical instruments directly beside the patient,” said Dr. Alberto Rodriguez-Navarro, minimally invasive surgeon, founder and CEO of Levita Magnetics. “We believe enabling timely access to needed surgery has a direct impact on the quality of life for patients and may reduce the risk of complications or death due to the underlying disease. Our ultimate goal is to globally increase the ability of surgeons and hospitals to provide more patients access to better surgical procedures within their communities. We are advancing our clinical study and plan to submit the Levita Robotic Platform to the U.S. FDA for clearance in late 2021. We aim to deliver what society is expecting from surgical robotics.” The Levita Robotic Platform is an investigational system. It is not available for commercial sale in the United States and has not been cleared by the Food and Drug Administration (FDA). The Levita Magnetic Surgical System enables reduced-port laparoscopic surgical procedures designed to minimize the footprint of surgery. The system, which consists of an external magnet placed on the skin that controls a shaftless detachable grasper, enables instruments to move without the constraints of a fixed-position pivot point. The Levita Magnetic Surgical System is indicated in the U.S. to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures; the liver in bariatric procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and peri-colorectal tissue in colorectal procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a body mass index (BMI) range of 20 to 60 kg/m2. Source: Company Press Release