MARLBOROUGH, Mass., April 27, 2022 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) generated net sales of $3.026 billion during the first quarter of 2022, growing 10.0 percent on a reported basis, 12.6 percent on an operational¹ basis and 9.7 percent on an organic² basis, all compared to the prior year period. The company reported GAAP net income available to common stockholders of $97 million or $0.07 per share (EPS), compared to $327 million or $0.23 per share a year ago, and achieved adjusted EPS of $0.39 for the period, compared to $0.37 a year ago.

"Our growth this quarter was fueled by strong execution from our global team, our innovative portfolio and improved procedure volume," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We are pleased with our first quarter performance and outlook for the full year, despite the impact of macroeconomic headwinds, and we look forward to bringing meaningful innovation to customers and the patients we serve together."

First quarter financial results and recent developments:

• Reported net sales of $3.026 billion, representing an increase of 10.0 percent on a reported basis, compared to the company's guidance range of 5 to 8 percent; 12.6 percent on an operational basis; and 9.7 percent on an organic basis, compared to the company's guidance range of 5 to 8 percent, all compared to the prior year period.
  
  
• Reported GAAP net income available to common stockholders of $0.07 per share, compared to the company's guidance range of $0.16 to $0.20 per share, and achieved adjusted EPS of $0.39 per share, compared to the guidance range of $0.38 to $0.40 per share.
  
  
• Achieved net sales growth in each reportable segment⁴, compared to the prior year period:
• MedSurg: 9.1 percent reported, 11.1 percent operational and 8.0 percent organic
• Cardiovascular: 11.4 percent reported, 14.5 percent operational and 10.8 percent organic
  
  
• Achieved the following regional⁵ net sales growth, compared to the prior year period:
• U.S.: 12.8 percent reported and operational
• EMEA (Europe, Middle East and Africa): 3.3 percent reported and 12.0 percent operational
• APAC (Asia-Pacific): 9.3 percent reported and 13.6 percent operational
• Emerging Markets³: 22.8 percent reported and 28.7 percent operational
  
  
• Announced real-world data from the SURPASS 45-day analysis of more than 16,000 patients with the WATCHMAN FLX™ Left Atrial Appendage Closure Device from the National Cardiovascular Data (NCDR) Registry Left Atrial Appendage Occlusion (LAAO) Registry, as well as final one-year results from the FLXibility post-approval study with the device in Europe, both demonstrating low rates of adverse events and high rates of LAA closure in everyday clinical practice. Also received approval for the WATCHMAN FLX device in China by the National Medical Products Administration (NMPA) and will begin a limited market release in the coming months.
  
  
• Announced at the European Heart Rhythm Association (EHRA) annual meeting acute, real-world outcomes from the POLAR ICE study, which demonstrated that the POLARx™ Cryoablation System met safety and efficacy endpoints when used to perform pulmonary vein isolation (PVI) for the ablation treatment of atrial fibrillation. A low rate of procedure-related complications, a high rate of acute PVI, and short procedure and left-atrial dwell times was also observed.

• Received U.S. Food and Drug Administration (FDA) clearance for the EMBOLD™ Fibered Coil, a fully retractable coil indicated for arterial and venous embolization in the peripheral vasculature. The EMBOLD Fibered Coil enhances the existing Boston Scientific embolization portfolio.
  
  
• Received FDA investigational device exemption (IDE) to commence the FRONTIER study, a clinical trial assessing TheraSphere™ Y-90 Glass Microspheres as a treatment option for patients with recurrent glioblastoma, an aggressive type of cancer that can occur in the brain.
  
  
• Received FDA approval for next-generation Image Guided Programming Software for Deep Brain Stimulation Therapy. Vercise™ Neural Navigator with STIMVIEW™ XT enables clinicians to both visualize real-time lead placement and stimulation modeling of the brain anatomy in patients with Parkinson's disease or essential tremor.
  
  
• Received National Medical Products Administration (NMPA) approval in China for Rezūm™ Water Vapor Therapy. The Rezūm System is a minimally invasive treatment for benign prostatic hyperplasia (BPH), which affects up to 62 percent of men globally who have a prostate and are over 50 years of age.
  
  
• Received Health Canada approval for the first-of-its kind LithoVue™ Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring and StoneSmart™ Connect Console. The LithoVue Elite System is designed to allow physicians to monitor intrarenal pressure during ureteroscopy procedures to make pressure-related decisions in real time.
  
  
• Completed in mid-February the acquisition of Baylis Medical Company Inc., a company that offers advanced transseptal access solutions as well as guidewires, sheaths and dilators used to support catheter-based left-heart procedures.
  
  
• Completed a public offering of €3 billion ($3.3 billion) aggregate principal amount of EUR-denominated Senior Notes, and tender offer and early redemption of $3.3 billion aggregate principal amount of certain outstanding USD-denominated Senior Notes.

Guidance for Full Year and Second Quarter 2022 

The company now estimates net sales growth for the full year 2022, versus the prior year period, to be in a range of approximately 7 to 9 percent on a reported basis, and approximately 6.5 to 8.5 percent on an 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 $0.78 to $0.88 and estimates adjusted EPS, excluding certain charges (credits), of $1.74 to $1.79.

The company estimates net sales growth for the second quarter of 2022, versus the prior year period, to be in a range of approximately 3 to 6 percent on a reported basis and organic basis. Second 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 $0.19 to $0.23 and adjusted EPS, excluding certain charges (credits), of $0.41 to $0.43.

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.

About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world.  As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "may," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our expected net sales; reported, operational and organic revenue growth rates; reported and adjusted EPS for the second quarter and full year 2022; our financial performance; our business plans and product performance; and the impact of the COVID-19 pandemic on the company's results of operations. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Risks and uncertainties that may cause such differences include, among other things: the impact of the ongoing COVID-19 pandemic on our operations and financial results; future U.S. and global economic, political, competitive, reimbursement and regulatory conditions; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by extreme weather or other climate change-related events; labor shortages and increases in labor costs; new product introductions; expected procedural volumes; the closing and integration of acquisitions; demographic trends; intellectual property rights; litigation; financial market conditions; the execution and effect of our business strategy, including our cost-savings and growth initiatives; and future business decisions made by us and our competitors. New risks and uncertainties may arise from time to time and are difficult to predict, including those that have emerged or have increased in significance or likelihood as a result of the COVID-19 pandemic.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A - Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this press release.

Note: Amounts reported in millions within this press release are computed based on the amounts in thousands. As a result, the sum of the components reported in millions may not equal the total amount reported in millions due to rounding. Certain columns and rows within tables may not add due to the use of rounded numbers. Percentages presented are calculated from the underlying numbers in dollars.

Use of Non-GAAP Financial Information
A reconciliation of the company's non-GAAP financial measures to the corresponding GAAP measures, and an explanation of the company's use of these non-GAAP financial measures, is included in the exhibits attached to this press release.

Use of Non-GAAP Financial Measures

To supplement our unaudited consolidated financial statements presented on a GAAP basis, we disclose certain non-GAAP financial measures, including adjusted net income (loss), adjusted net income (loss) available to common stockholders and adjusted net income (loss) per share (EPS) that exclude certain amounts; operational net sales, which exclude the impact of foreign currency fluctuations; and organic net sales, which exclude the impact of foreign currency fluctuations as well as the impact of certain acquisitions and divestitures with less than a full period of comparable net sales. These non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States and should not be considered in isolation from or as a replacement for the most directly comparable GAAP financial measures. Further, other companies may calculate these non-GAAP financial measures differently than we do, which may limit the usefulness of those measures for comparative purposes.

To calculate adjusted net income (loss), adjusted net income (loss) available to common stockholders and adjusted net income (loss) per share we exclude certain charges (credits) from GAAP net income (loss) and GAAP net income (loss) available to common stockholders. Amounts are presented after-tax at the company's effective tax rate, unless the amount is a significant unusual or infrequently occurring item in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 740-270-30, "General Methodology and Use of Estimated Annual Effective Tax Rate." Please refer to Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our most recent Annual Report filed on Form 10-K filed with the Securities and Exchange Commission or any Quarterly Report on Form 10-Q that we file thereafter for an explanation of each of these adjustments and the reasons for excluding each item.

The GAAP financial measures most directly comparable to adjusted net income (loss), adjusted net income (loss) available to common stockholders and adjusted net income (loss) per share are GAAP net income (loss), GAAP net income (loss) available to common stockholders and GAAP net income (loss) per common share - assuming dilution, respectively. 

To calculate operational net sales growth rates, which exclude the impact of foreign currency fluctuations, we convert actual net sales from local currency to U.S. dollars using constant foreign currency exchange rates in the current and prior periods. To calculate organic net sales growth rates, we also remove the impact of acquisitions and divestitures with less than a full period of comparable net sales. The GAAP financial measure most directly comparable to operational net sales and organic net sales is net sales on a GAAP basis.

Reconciliations of each of these non-GAAP financial measures to the corresponding GAAP financial measure are included in the accompanying schedules.

Management uses these supplemental non-GAAP financial measures to evaluate performance period over period, to analyze the underlying trends in our business, to assess our performance relative to our competitors and to establish operational goals and forecasts that are used in allocating resources. In addition, management uses these non-GAAP financial measures to further its understanding of the performance of our operating segments. The adjustments excluded from our non-GAAP financial measures are consistent with those excluded from our operating segments' measures of net sales and profit or loss. These adjustments are excluded from the segment measures reported to our chief operating decision maker that are used to make operating decisions and assess performance.

We believe that presenting adjusted net income (loss), adjusted net income (loss) available to common stockholders, adjusted net income (loss) per share, operational net sales growth rates and organic net sales growth rates, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for its operational decision-making and allows investors to see our results "through the eyes" of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.

SOURCE Boston Scientific Corporation