Earnings release
Page 1
Boston Scientific Boston Scientific Announces Results For Second Quarter 2021 MARLBOROUGH , Mass . , July 27 , 2021 / PRNewswire / -- Boston Scientific Corporation ( NYSE : BSX ) generated net sales of $ 3.077 billion during the second quarter of 2021 , growing 53.6 percent on a reported basis , 49.6 percent on an operational¹ basis and 52.4 percent on an organic² basis , all compared to the prior year period . The company reported GAAP net income available to common stockholders of $ 172 million or $ 0.12 per share ( EPS ) , compared to a GAAP net loss available to common shareholders of $ 153 million or $ ( 0.11 ) per share a year ago , and achieved adjusted EPS of $ 0.40 for the period , compared to $ 0.08 a year ago . " We delivered excellent results this quarter , with strong momentum throughout our portfolio and faster - than - market growth in most segments , fueled by our team's dedication to customers and patients all over the world , " said Mike Mahoney , chairman and chief executive officer , Boston Scientific . " We are confident that our focus on meeting customers ' needs today , and our innovative pipeline to solve tomorrow's challenges , will continue to deliver value for patients , customers and shareholders . " Second quarter financial results and recent developments : • Reported net sales of $ 3.077 billion , representing an increase of 53.6 percent on a reported basis , exceeding the company's guidance range of 46 to 50 percent ; 49.6 percent on an operational basis ; and 52.4 percent on an organic basis , exceeding the company's guidance range of 44 to 48 percent , all compared to the prior year period . • Reported GAAP net income available to common stockholders of $ 0.12 per share , compared to the company's guidance range of $ 0.16 to $ 0.18 per share and achieved adjusted EPS of $ 0.40 exceeding the guidance range of $ 0.36 to $ 0.38 per share . • Achieved net sales growth in each reportable segment4 , compared to the prior year period : MedSurg : 64.6 percent reported , 60.6 percent operational and 60.7 percent organic • Rhythm and Neuro : 65.0 percent reported , 60.6 percent operational and 51.4 percent organic • Cardiovascular : 51.4 percent reported , 47.2 percent operational and organic • Achieved the following regional5 net sales growth , compared to the prior year period : o U.S .: 70.1 percent reported and operational o EMEA ( Europe , Middle East and Africa ) : 59.3 percent reported and 47.1 percent operational • APAC ( Asia - Pacific ) : 27.0 percent reported and 21.1 percent operational • Emerging Markets³ : 33.8 percent reported and 25.8 percent operational Completed European CE Mark for the EXALT ™ Model B Single - Use Bronchoscope for use in bronchoscopy procedures such as secretion management , airway intubation , percutaneous tracheostomy , double lumen endotracheal tube placement and biopsies in the intensive care unit and operating room . • Following successful U.S. launch , initiated European launch of SpaceOAR Vue ™ Hydrogel , a next - generation spacer designed to reduce side effects of prostate radiation therapy . SpaceOAR Vue Hydrogel allows physicians to see the spacer on computerized tomography ( CT ) scans , which would otherwise require magnetic resonance imaging ( MRI ) . Radiotherapy is a highly effective therapy for prostate cancer , the most common cancer affecting men in Europe with more than 400,000 new cases diagnosed each year . • Exercised option to acquire the remaining shares of Farapulse , Inc. The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation System a non - thermal ablation system for the treatment of atrial fibrillation and other cardiac arrhythmias . The transaction is anticipated to close in the third quarter of 2021 , subject to customary closing conditions.6 • Presented findings at the European Society of Cardiology's Heart Failure 2021 Congress from MANAGE - HF Phase 1 - a prospective , observational study , which sought to evaluate and optimize the clinical integration and alert management process of the HeartLogic ™ Heart Failure Diagnostic . Data suggests the HeartLogic diagnostic was safely integrated into clinical practice and clinician intervention following an alert , and was associated with more rapid recovery of patients compared to those who received no change in treatment . • Announced at TVT : The Structural Heart Summit positive 24 - month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the WATCHMAN FLX ™ Left Atrial Appendage Closure ( LAAC ) Device for patients with non - valvular atrial fibrillation ( NVAF ) . The trial met its key secondary effectiveness endpoint with a 3.4 % rate of ischemic stroke or systemic embolism at 24 months compared to the performance goal of 8.7 % . • Completed patient enrollment in the OPTION clinical trial - a randomized controlled study comparing the WATCHMAN FLX device to first - line oral anticoagulants ( OAC ) for 1,600 patients with NVAF who also undergo a cardiac ablation procedure . • Presented as late - breaking clinical science at TVT were results from the Early Neo2 Registry of the ACURATE neo2TM Aortic Valve System that demonstrated excellent procedural outcomes , including a low permanent pacemaker implementation ( PPI ) rate and low rate of paravalvular leakage ( PVL ) which was assessed by an independent core lab , following late - breaking site - reported results also presented at the EuroPCR 2021 congress . • Began enrollment in the AGENT IDE trial , the first randomized study in the U.S. designed to assess safety and effectiveness of the AGENT ™ Drug Coated Balloon vs. plain old balloon angioplasty ( POBA ) in patients with in - stent restenosis , which accounts for approximately 10 % of percutaneous coronary interventions ( PCIS ) . • Initiated an early feasibility study in the U.S. for the Millipede Transcatheter Annuloplasty Ring System , which will assess the safety and feasibility of the system in 7 patients with severe functional mitral regurgitation . • Commenced enrollment in the ELEGANCE registry , a post - market study gathering real - world clinical evidence to assess long - term outcomes of patients following treatment with either the Ranger ™ Drug - Coated Balloon or the Eluvia ™ Drug - Eluting Stent . The registry is focused on enrolling women and members of Black and Hispanic communities , who have historically been underrepresented in clinical trials . • Announced one - year follow - up results of the COMBO randomized controlled clinical trial at the North American Neuromodulation Society ( NANS ) Mid - Year Meeting , demonstrating that Combination Therapy delivered by the Spectra WaveWriter ™ Spinal Cord Stimulator ( SCS ) System achieved a sustained , high level of clinical and functional success with an 84 % responder rate . This evidence supports the hypothesis that providing multimodal therapy can produce effective clinical outcomes . • Announced the election of David S. Wichmann , former chief executive officer of UnitedHealth Group , to the company's board of directors . 1. Operational net sales growth excludes the impact of foreign currency fluctuations . 2. Organic net sales growth excludes the impact of foreign currency fluctuations as well as net sales from the acquisition of Preventice Solutions , Inc. ( Preventice ) in Q1 2021 , as well as prior period net sales from the intrauterine health franchise and Specialty Pharmaceuticals business , divested in Q2 2020 and Q1 2021 , respectively . 3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions , healthcare sectors and our global capabilities . Periodically , we assess our list of Emerging Markets countries , and effective January 1 , 2021 , modified our list to include the following countries : Brazil , Chile , China , Colombia , Czech Republic , India , Indonesia , Malaysia , Mexico , Philippines , Poland , Russia , Saudi Arabia , Slovakia , South Africa , South Korea , Taiwan , Thailand , Turkey and Vietnam . We have revised prior period amounts to conform to the current year's presentation which had an immaterial impact on previously reported Emerging Markets net sales . 4. We have three historical reportable segments comprised of Medical Surgical ( MedSurg ) , Rhythm and Neuro , and Cardiovascular , which represent an aggregation of our operating segments that generate revenues from the sale of medical devices ( Medical Devices ) . 5. On March 1 , 2021 , we completed the sale of the Specialty Pharmaceuticals business . Our consolidated net sales include Specialty Pharmaceuticals up to the date of the closing of the transaction . Specialty Pharmaceuticals net sales were substantially U.S. based and presented as a stand - alone operating segment alongside our Medical Device reportable segments .. 6. Caution : the FARAPULSE platform is an investigational device . Limited by U.S. law to investigational use only . Not available for sale . 7. Caution : Millipede is an investigational device . Limited by U.S. law to investigational use only . Not available for sale . Net sales for the second quarter by business and region : ( in millions ) Endoscopy $ Three Months Ended June 30 , 2021 551 $ 2020 348 Reported Basis 58.5 % Less : Impact of Foreign Currency Fluctuations 4.4 % Increase / ( Decrease ) Operational Basis 54.1 % Less : Impact of Recent Acquisitions / Divestitures - % Organic Basis 54.1 %