Boston Scientific Announces Results For First Quarter 2021
Apr. 28, 2021
MARLBOROUGH, Mass., April 28, 2021 /PRNewswire/ -- Boston Scientific Corporation (BSX) generated net sales of $2.752 billion during the first quarter of 2021. This represents growth of 8.2 percent on a reported basis, 5.6 percent on an operational1 basis and 5.9 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income available to common stockholders of $327 million or $0.23 per share (EPS), compared to GAAP net income of $11 million or $0.01 per share a year ago, and achieved adjusted EPS of $0.37 for the period, compared to $0.28 a year ago.
"We are pleased by the trajectory of our recovery," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "Our global team remains committed to helping patients and our customers by delivering a robust portfolio of innovative solutions, and that commitment will continue to fuel our future growth."
First quarter financial results and recent developments:
Reported net sales of $2.752 billion, representing an increase of 8.2 percent on a reported basis, compared to the company's guidance range of 0 to 6 percent; 5.6 percent on an operational basis; and 5.9 percent on an organic basis, compared to the company's guidance range of (3) to 3 percent, all compared to the prior year period.
Reported GAAP net income available to common stockholders of $0.23 per share compared to the company's guidance range of $0.05 to $0.11 per share. Achieved adjusted EPS of $0.37 compared to the guidance range of $0.28 to $0.34 per share.
Achieved net sales growth in each reportable segment4, compared to the prior year period:
MedSurg: 11.1 percent reported, 8.6 percent operational and 9.5 percent organic
Rhythm and Neuro: 6.8 percent reported, 4.0 percent operational and 1.6 percent organic
Cardiovascular: 10.0 percent reported, 7.4 percent operational and organic
Achieved the following regional5 net sales growth, compared to the prior year period:
U.S.: 8.6 percent reported and operational
EMEA (Europe, Middle East and Africa): 9.4 percent reported and 1.9 percent operational
APAC (Asia-Pacific): 15.6 percent reported and 9.1 percent operational
Emerging Markets3: 16.0 percent reported and 13.2 percent operational
Received U.S. Food and Drug Administration (FDA) approval for the TheraSphere™ Y-90 Glass Microspheres for the treatment of patients with hepatocellular carcinoma, the most common type of primary liver cancer, and secured FDA Breakthrough Device designation for TheraSphere treatment for patients with glioblastoma, a type of brain cancer.6
Received approval for the Ranger™ Drug-Coated Balloon from Japan's Ministry of Health, Labor and Welfare (MHLW) and initiated a full launch in the region.
Launched Vercise Genus™ Deep Brain Stimulation (DBS) System in the U.S. Additionally, the system is being used with the world's first 16-channel directional leads—Cartesia™ X and HX leads—in the eXTend 3D Study in Europe.
Commenced U.S. launch of the WaveWriter Alpha™ portfolio of spinal cord stimulator (SCS) systems, consisting of four full-body MR conditional, Bluetooth-enabled devices, new FAST paresthesia-free therapy and all supported by Cognita™ Solutions—a suite of digital tools that helps physicians and patients navigate the pain management journey.
Surpassed 50,000 patients worldwide treated with the SENTINEL™ Cerebral Protection System, the first and only FDA-cleared device to protect patients from stroke risk during transcatheter aortic valve replacement (TAVR) procedures.
Published positive 12-month results from the PINNACLE FLX clinical trial in Circulation, demonstrating the next-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device is a safe and effective alternative to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation and increased risk of bleeding. The trial met its primary safety endpoint with a low adverse event rate of 0.5%, as well as its primary effectiveness endpoint with a 100% rate of LAA closure at 12 months.
Presented five-year outcomes from the EFFORTLESS study, the largest post-market registry of the Subcutaneous Implantable Defibrillator (S-ICD) System, further validating the long-term efficacy of the device. Results demonstrated 98% overall efficacy over five years, consistent with results of previous S-ICD studies and comparable to or higher than many large transvenous ICD studies.
Received FDA approval to modify the design of the ACURATE IDE trial—evaluating the ACURATE neo2™ Aortic Valve System—to an "all-risk" protocol to study patients with severe, symptomatic aortic stenosis who are at low risk of open-heart surgery, in addition to those at intermediate, high and extreme risk.
Initiated the NEwTON AF IDE clinical trial to evaluate the safety and effectiveness of the INTELLANAV STABLEPOINT™ Ablation Catheter enabled with DIRECTSENSE™ Technology in patients with paroxysmal atrial fibrillation.
Named eighth on the Forbes list of America's Best Employers for Diversity 2021, based on a survey of 50,000 Americans working for businesses with at least 1,000 employees.
Completed the acquisition of Preventice Solutions, Inc., a privately-held company which offers a full portfolio of mobile cardiac health solutions and services, for an upfront cash payment of ~$720 million, with up to an additional ~$230 million in a potential commercial milestone payment, given a preexisting 22 percent equity stake.
Completed the sale of the BTG Specialty Pharmaceuticals business to Stark International Lux S.A.R.L. and SERB SAS, affiliates of SERB, for ~$800 million in cash.
Announced a definitive agreement with an affiliate of Baring Private Equity Asia to acquire the global surgical business of Lumenis LTD. (LUME), a privately-held company that develops and commercializes energy-based medical solutions, for an upfront cash payment of ~$1.07 billion, subject to customary closing conditions and adjustments.
Announced plans to host a virtual Investor Day business review meeting for the investment community on Wednesday, September 22, 2021.
1. Operational net sales growth excludes the impact of foreign currency fluctuations.
2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales from the recent acquisition of Preventice Solutions, Inc. (Preventice). Organic net sales growth rates also exclude the intrauterine health franchise, which we divested in Q2 2020 and the Specialty Pharmaceuticals business, which we divested in Q1 2021.
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 year amounts to conform to the current year's presentation. The revision 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. Consistent with Section 515B of the FD&C Act, devices designated as Breakthrough Devices will receive prioritized review (Section II.F).
Guidance for Full Year and Second 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 16 to 19 percent on a reported basis, and approximately 15 to 18 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and the acquisition of Preventice Solutions, Inc., with no prior period related net sales, as well as the intrauterine health franchise, which we divested in Q2 2020 and the Specialty Pharmaceuticals business, which we divested in Q1 2021. The company now estimates earnings on a GAAP basis in a range of $0.81 to $0.88 per share and estimates adjusted earnings, excluding certain charges (credits), of $1.53 to $1.60 per share.
The company estimates net sales growth for the second quarter of 2021, versus the prior year period, to be in a range of approximately 46 to 50 percent on a reported basis and approximately 44 to 48 percent on an organic basis. Second quarter organic net sales guidance excludes the impact of foreign currency fluctuations and the acquisition of Preventice, with no prior period related net sales, as well as the intrauterine health franchise, which we divested in Q2 2020 and the Specialty Pharmaceuticals business, which we divested in Q1 2021. The company estimates earnings on a GAAP basis in a range of $0.16 to $0.18 per share and adjusted earnings, excluding certain charges (credits), of $0.36 to $0.38 per share.
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.
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