On October 26, 2023 Boston Scientific Corporation (NYSE: BSX) reported 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 (Press release, Boston Scientific, OCT 26, 2023, View Source;_gl=1*1muje07*_ga*MTgxMjY3ODM0OS4xNzAyMzU3ODg1*_ga_759NN7RMMK*MTcwMjM1Nzg4NC4xLjEuMTcwMjM1NzkxNS4wLjAuMA.. [SID1234638411]). 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.
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"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.
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 attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales.
3. Adjusted EPS excludes the impacts of certain charges (credits) which may 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.
4. Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2023, modified our list to include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada. We have revised prior year amounts to conform to the current year’s presentation.
5. The FARAPULSE PFA System and the AGENT DCB are investigational devices. Restricted by Federal law to investigational use only. Not available for sale in the U.S.
Net sales for the third quarter by business and region:
Increase/(Decrease)
Three Months Ended
September 30,
Reported
Basis
Impact of
Foreign
Currency
Fluctuations
Operational
Basis
Impact of
Recent
Acquisitions /
Divestitures
Organic
Basis
(in millions)
2023
2022
Endoscopy
$ 629
$ 559
12.6 %
(0.7) %
11.9 %
(1.4) %
10.6 %
Urology
483
433
11.5 %
(0.5) %
11.1 %
— %
11.1 %
Neuromodulation
229
221
3.7 %
(0.4) %
3.2 %
— %
3.2 %
MedSurg
1,341
1,213
10.6 %
(0.5) %
10.0 %
(0.6) %
9.4 %
Cardiology
1,647
1,479
11.4 %
(0.1) %
11.4 %
— %
11.4 %
Peripheral Interventions
538
479
12.3 %
0.6 %
12.9 %
(4.5) %
8.4 %
Cardiovascular
2,185
1,958
11.6 %
0.1 %
11.7 %
(1.1) %
10.6 %
Net Sales
$ 3,527
$ 3,170
11.2 %
(0.1) %
11.1 %
(0.9) %
10.2 %
Increase/(Decrease)
Three Months Ended
September 30,
Reported
Basis
Impact of
Foreign
Currency
Fluctuations
Operational
Basis
(in millions)
2023
2022
U.S.
$ 2,099
$ 1,934
8.5 %
— %
8.5 %
EMEA
671
585
14.7 %
(3.8) %
10.9 %
APAC
611
532
14.8 %
4.7 %
19.5 %
LACA
146
119
22.0 %
(5.9) %
16.1 %
Net Sales
$ 3,527
$ 3,170
11.2 %
(0.1) %
11.1 %
Emerging Markets4
$ 594
$ 519
14.4 %
4.6 %
19.0 %
Amounts may not add due to the use of rounded numbers. Growth rates are based on actual, unrounded amounts and may not recalculate precisely.
Growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions/divestitures are not prepared in accordance with U.S. GAAP.
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.