On July 27, 2021 Boston Scientific Corporation (NYSE: BSX) reported that 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 (Press release, Boston Scientific, JUL 27, 2021, View Source [SID1234585248]). 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.
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"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:
U.S.: 70.1 percent reported and operational
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 neo2 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 patients with severe functional mitral regurgitation.7
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.
Guidance for Full Year and Third Quarter 2021
The company now estimates net sales growth for the full year 2021, versus the prior year period, to be in a range of approximately 21 to 22 percent on a reported basis, and approximately 19 to 20 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and the Q1 2021 acquisition of Preventice Solutions, Inc., as well as the intrauterine health franchise and the Specialty Pharmaceuticals business, which were divested in Q2 2020 and Q1 2021, respectively. The company now estimates EPS on a GAAP basis in a range of $0.79 to $0.83 and estimates adjusted EPS, excluding certain charges (credits), of $1.58 to $1.62.
The company estimates net sales growth for the third quarter of 2021, versus the prior year period, to be in a range of approximately 12 to 14 percent on both a reported and organic basis. Third quarter organic net sales guidance excludes the impact of foreign currency fluctuations and the Q1 2021 acquisition of Preventice, as well as the Specialty Pharmaceuticals business, which we divested in Q1 2021. The company estimates EPS on a GAAP basis in a range of $0.20 to $0.22 and adjusted EPS, excluding certain charges (credits), of $0.39 to $0.41.
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: www.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.