Boston Scientific Corporation (NYSE: BSX) generated net sales of $2.932 billion during the third quarter of 2021, growing 10.3 percent on a reported basis, 9.7 percent on an operational1 basis and 10.6 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income available to common stockholders of $405 million or $0.28 per share (EPS), compared to a GAAP net loss available to common shareholders of $169 million or $(0.12) per share a year ago, and achieved adjusted EPS of $0.41 for the period, compared to $0.37 a year ago.
“We’ve seen this year that our strategy of category leadership, focus on high-growth markets and smart tuck-in M&A deals, combined with execution by our global team and an exciting pipeline, positions us well for the long term,” said Mike Mahoney, chairman and chief executive officer, Boston Scientific. “Despite some softness this quarter, including the ongoing impact of the COVID-19 pandemic, we’re confident that we will achieve our growth goals as the pandemic wanes.”
Third quarter financial results and recent developments:
•Reported net sales of $2.932 billion, representing an increase of 10.3 percent on a reported basis and 10.6 percent on an organic basis, both compared to the company's guidance range of 12 to 14 percent, all versus the prior year period.
•Reported GAAP net income available to common stockholders of $0.28 per share, compared to the company's guidance range of $0.20 to $0.22 per share and achieved adjusted EPS of $0.41 compared to the guidance range of $0.39 to $0.41 per share.
•Achieved net sales growth in each reportable segment4, compared to the prior year period:
◦MedSurg: 11.2 percent reported, 10.6 percent operational and 9.4 percent organic
◦Rhythm and Neuro: 8.2 percent reported, 7.8 percent operational and 1.5 percent organic
◦Cardiovascular: 19.4 percent reported, 18.5 percent operational and organic
•Achieved the following regional5 net sales growth, compared to the prior year period:
◦U.S.: 15.4 percent reported and operational
◦EMEA (Europe, Middle East and Africa): 9.3 percent reported and 7.9 percent operational
◦APAC (Asia-Pacific): 9.5 percent reported and 8.2 percent operational
◦Emerging Markets3: 21.9 percent reported and 17.8 percent operational
•Completed acquisitions of the global surgical business of Lumenis LTD., a privately held company that develops and commercializes energy-based medical solutions, and of Farapulse, Inc., the first company to commercialize a cardiac pulsed field ablation technology.
•Announced agreements to acquire Baylis Medical Company Inc. to expand Boston Scientific electrophysiology and structural heart product portfolios, and Devoro Medical Inc., to expand the company’s full suite of interventional strategies for thromboemboli. Both acquisitions are subject to customary closing conditions.
•Received U.S. Food & Drug Administration (FDA) clearance for the EXALT™ Model B Single-Use Bronchoscope for use in a wide range of bronchoscopy procedures in the intensive care unit (ICU) and operating room (OR), such as secretion management, airway intubation, percutaneous tracheostomy, double lumen endotracheal tube placement and biopsies. In the United States, more than 1.2 million bedside procedures6 involving a bronchoscope are performed in ICU and OR settings each year.
•Received a New Technology Add-on Payment (NTAP) designation from the U.S. Centers for Medicare and Medicaid Services (CMS) for the EXALT™ Model D Single-Use Duodenoscope, used to diagnose and treat pancreatic and biliary conditions during endoscopic retrograde cholangiopancreatography (ERCP) procedures.
•Initiated the SABRE randomized controlled trial, the first global study to examine the effectiveness of SpaceOAR Vue™ Hydrogel in reducing late gastrointestinal toxicity in patients receiving stereotactic body radiotherapy (SBRT) treatment for prostate cancer.
•Initiated the HI-PEITHO randomized trial, the first ever comparative study in the interventional field of PE treatment, evaluating the EkoSonic™ Endovascular System (EKOS system) in combination with anticoagulation versus anticoagulation alone, for the treatment of acute, intermediate-high-risk pulmonary embolism. Also presented at VIVA21 late-breaking clinical data from the KNOCOUT PE registry, which reaffirmed the safety and efficacy of the EKOS system for the treatment of patients with intermediate-high and high-risk pulmonary embolism (PE) and found zero intracerebral hemorrhages as well as low major bleeding rates among the patients in the analysis.
•Presented positive late-breaking clinical trial data for the Eluvia™ Drug-Eluting Vascular Stent System and the Ranger™ Drug-Coated Balloon at VIVA21, with the Eluvia stent exhibiting superiority compared to bare metal stents – the largest randomized trial of drug-eluting therapies in the field of peripheral artery disease – and the Ranger DCB demonstrating continued high rates of primary patency and a significant reduction in reinterventions at two years.
•Announced late-breaking results from the EPOCH clinical trial, which demonstrated improved progression-free survival in patients with metastatic colorectal cancer after treatment with TheraSphere™ Y-90 Glass Microspheres and represents the first positive phase 3 study for selective internal radiation therapy in any disease setting. Data from the trial was presented at the European Society for Medical Oncology (ESMO) Congress 2021, simultaneously published in the Journal of Clinical Oncology and is expected to support the company’s regulatory submission to the FDA for an expanded indication.
•Presented at Heart Rhythm 2021, the Heart Rhythm Society's Annual Meeting, positive real-world data supporting the next-generation WATCHMAN FLX™ and legacy WATCHMAN™ Left Atrial Appendage Closure Devices as alternatives to oral anticoagulation therapy for stroke risk reduction in people with non-valvular atrial fibrillation. Findings included patient follow-up visit data from the European FLXibility registry with the WATCHMAN FLX device demonstrating high rates of effective LAA closure and low rates of short-term complications through 120 days.
•Received Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval and commenced the Japanese launch of the POLARx™ Cryoablation System, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AF), an intermittent form of AF which causes an irregular and often abnormally fast heart rate.