Boston Scientific 10-Q 2022-06-30

Filed 2022-08-04. 7 sections, 265K characters. Original on sec.gov · Markdown · JSON

Cover and table of contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☑QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2022

OR

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File No. 1-11083

BOSTON SCIENTIFIC CORPORATION

(Exact name of registrant as specified in its charter)

Delaware04-2695240
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)

300 Boston Scientific Way**,** Marlborough**,** Massachusetts 01752-1234

(Address of Principal Executive Offices) (Zip Code)

508 683-4000

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.01 per shareBSXNew York Stock Exchange
0.625% Senior Notes due 2027BSX27New York Stock Exchange
5.50% Mandatory Convertible Preferred Stock, Series A, par value $0.01 per shareBSX PR ANew York Stock Exchange

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer☑Accelerated filer☐
Non-accelerated filer☐Smaller reporting company☐
Emerging growth company☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑

The number of shares outstanding of Common Stock, $0.01 par value per share, as of July 29, 2022 was 1,431,614,313.

TABLE OF CONTENTS

Page No.
PART IFINANCIAL INFORMATION3
ITEM 1.Consolidated Financial Statements3
Consolidated Statements of Operations (Unaudited)3
Consolidated Statements of Comprehensive Income (Loss) (Unaudited)4
Consolidated Balance Sheets (Unaudited as of June 30 2022)5
Consolidated Statements of Stockholders' Equity (Unaudited)6
Consolidated Statements of Cash Flows (Unaudited)7
Notes to the Consolidated Financial Statements (Unaudited)9
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations36
ITEM 3.Quantitative and Qualitative Disclosures About Market Risk57
ITEM 4.Controls and Procedures58
PART IIOTHER INFORMATION59
ITEM 1.Legal Proceedings59
ITEM 1A.Risk Factors59
ITEM 6.Exhibits59
SIGNATURE61

PART I

FINANCIAL INFORMATION

Item 1. CONSOLIDATED FINANCIAL STATEMENTS

BOSTON SCIENTIFIC CORPORATION AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

Three Months Ended June 30,Six Months Ended June 30,
(in millions, except per share data)2022202120222021
Net sales$3,244$3,077$6,270$5,829
Cost of products sold1,0119451,9661,839
Gross profit2,2332,1324,3043,990
Operating expenses:
Selling, general and administrative expenses1,1651,1212,2252,139
Research and development expenses335298654574
Royalty expense11122324
Amortization expense204180402365
Intangible asset impairment charges745745
Contingent consideration net expense (benefit)36(85)48(91)
Restructuring net charges (credits)113148
Litigation-related net charges (credits)4229842302
Gain on disposal of businesses and assets—(2)—(9)
1,8101,8703,4153,358
Operating income (loss)423262889632
Other income (expense):
Interest expense(64)(86)(343)(168)
Other, net(14)(26)(46)11
Income (loss) before income taxes345149501474
Income tax expense (benefit)85(37)131(53)
Net income (loss)260186370527
Preferred stock dividends(14)(14)(28)(28)
Net income (loss) available to common stockholders$246$172$342$500
Net income (loss) per common share — basic$0.17$0.12$0.24$0.35
Net income (loss) per common share — assuming dilution$0.17$0.12$0.24$0.35
Weighted-average shares outstanding
Basic1,429.71,421.31,428.81,420.0
Assuming dilution1,437.81,432.51,438.11,431.7

Refer to notes to the unaudited consolidated financial statements. Amounts may not foot due to rounding.

BOSTON SCIENTIFIC CORPORATION AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED)

Three Months Ended June 30,Six Months Ended June 30,
(in millions)2022202120222021
Net income (loss)$260$186$370$527
Other comprehensive income (loss), net of tax:
Foreign currency translation adjustment77213(81)
Net change in derivative financial instruments134(18)157111
Net change in defined benefit pensions and other items0001
Total other comprehensive income (loss)211(16)17030
Total comprehensive income (loss)$471$170$540$558

Refer to notes to the unaudited consolidated financial statements. Amounts may not foot due to rounding.

BOSTON SCIENTIFIC CORPORATION AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS (UNAUDITED)

As of
(in millions, except share and per share data)June 30, 2022December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents$276$1,925
Trade accounts receivable, net1,9171,778
Inventories1,7521,610
Prepaid income taxes264205
Other current assets874799
Total current assets5,0836,317
Property, plant and equipment, net2,2462,252
Goodwill12,88311,988
Other intangible assets, net6,3496,121
Deferred tax assets4,0594,142
Other long-term assets1,5691,410
TOTAL ASSETS$32,189$32,229
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current debt obligations$170$261
Accounts payable732794
Accrued expenses2,1972,436
Other current liabilities784783
Total current liabilities3,8834,274

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Introduction

Boston Scientific Corporation is a global developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. Our mission is to transform lives through innovative medical solutions that improve the health of patients around the world. As a medical technology leader for more than 40 years, we have advanced the practice of less-invasive medicine by helping physicians and other medical professionals diagnose and treat a wide range of diseases and medical conditions and improve patients’ quality of life by providing alternatives to surgery and other medical procedures that are typically traumatic to the body. Our net sales have increased substantially since our formation, fueled in part by strategic acquisitions designed to improve our ability to take advantage of growth opportunities in the medical device industry and to build diversified portfolios within our core businesses. We advance science for life by providing a broad range of high performance solutions to address unmet patient needs and reduce the cost of healthcare. When used in this report, the terms "we," "us," "our" and "the Company" mean Boston Scientific Corporation and its divisions and subsidiaries.

COVID-19 Pandemic

In March 2020, the World Health Organization declared COVID-19, including all additional variations and strains thereof, a global pandemic (COVID-19 pandemic). Procedural delays from the further resurgence of COVID-19 infections and the emergence of new, more contagious variant strains of COVID-19, as well as staffing shortages within healthcare facilities, have and may continue to negatively impact demand for our products, net sales, gross profit margin and operating expenses as a percentage of net sales.

While we expect the COVID-19 pandemic and related impacts will continue to negatively impact our performance to an extent, we continue to believe our long-term fundamentals remain strong and we intend to manage through these challenges with strategic focus and the winning spirit of our global team.

Economic Trends

Economic conditions created in part by the COVID-19 pandemic, have had, and are expected to continue to have, a negative impact on our business. We face and expect to continue to face, increases in the cost and limited availability of raw materials, components, and other inputs necessary to manufacture and distribute our products due to constraints and inflation within the global supply chain, as well as increases in the cost and time to distribute our products. Further, other macroeconomic factors have led to a challenging labor market in which we compete, which impacts in some cases, our ability to retain and attract new talent as well as put inflationary pressure on certain operational costs due to wage increases. Uncertainty around inflationary pressures, rising interest rates and monetary policy, could potentially cause new, or exacerbate existing, economic challenges that we may face. These conditions could worsen, or others could arise, if the U.S. and global economies were to enter recessionary periods, triggered or exacerbated by monetary policy designed to curb inflation.

Corporate Sustainability

Our sustainable environmental, social and governance practices underpin all aspects of our global business. Our approach is aligned with the United Nations Sustainable Development Goals and our material topics and practices are informed by a broad range of internal and external stakeholders – locally, nationally and globally. Our employees around the world work with suppliers and other organizations that share our commitment to these practices that help address issues related to health inequity, economic disparity, climate change and environmental protection. These efforts are supported by our cross-functional Corporate Social Responsibility Steering Committee, our Corporate Social Responsibility Council, our Environmental Health and Safety teams and policies, our Global Council for Inclusion, as well as our local, regional and national employee and community engagement programs. In addition, our 2021 annual bonus plan included performance measured against environmental targets, employee engagement goals and human capital metrics targets, including global gender and U.S. (inclusive of Puerto Rico) multicultural goals. In 2022 we were named to the Forbes 2022 list of America's Best Employers for Diversity, as well as ranked number one among Health Care Equipment companies on renewable energy use by JUST Capital. We were also ranked on the list of 100 best Corporate Citizens of 2022 by 3BL Media. For additional information on our sustainability efforts, as well as our Diversity, Equity and Inclusion (DE&I) initiatives, refer to our most recent Annual Report on Form 10-K. For additional information on our annual bonus plan, refer to our Proxy Statement for the 2022 Annual Meeting of Shareholders.

Financial Summary

Three Months Ended June 30, 2022

Our net sales for the second quarter of 2022 were $3.244 billion, as compared to $3.077 billion for the second quarter of 2021. This increase of $167 million, or 5.4 percent, included operational1 net sales growth of 9.6 percent and the negative impact of 420 basis points from foreign currency fluctuations. The increase in our net sales was primarily driven by recent acquisitions as well as the strength and diversity of our product portfolio coupled with growth in the underlying markets in which we compete and strong commercial execution. Refer to Quarterly Results and Business Overview for a discussion of our net sales by global business.

Our reported net income available to common stockholders for the second quarter of 2022 was $246 million, or $0.17 per diluted share. Our reported results for the second quarter of 2022 included certain charges and/or credits totaling $389 million (after-tax), or $0.27 per diluted share. Excluding these items, adjusted net income available to common stockholders1 was $635 million, or $0.44 per diluted share.

Our reported net income available to common stockholders for the second quarter of 2021 was $172 million, or $0.12 per diluted share. Our reported results for the second quarter of 2021 included certain charges and/or credits totaling $405 million (after-tax), or $0.28 per diluted share. Excluding these items, adjusted net income available to common stockholders1 was $577 million, or $0.40 per diluted share.

1Operational net sales growth rates, which exclude the impact of foreign currency fluctuations, and other adjusted measures, which exclude certain items required by generally accepted accounting principles in the United States (U.S. GAAP) are not prepared in accordance with U.S. GAAP and should not be considered in isolation from, or as a replacement for, the most directly comparable GAAP measure. Refer to Additional Information for a discussion of management’s use of these non-GAAP financial measures.

The following is a reconciliation of our results of operations prepared in accordance with U.S. GAAP to those adjusted results considered by management. Refer to Quarterly Results and Business Overview and Additional Information for a discussion of these reconciling items:

Three Months Ended June 30, 2022
(in millions, except per share data)Income (Loss) Before Income TaxesIncome Tax Expense (Benefit)Net Income (Loss)Preferred Stock DividendsNet Income (Loss) Available to Common Stockholders

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Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We develop, manufacture and sell medical devices globally and our earnings and cash flows are exposed to market risk from changes in currency exchange rates and interest rates. We address these risks through a risk management program that includes the use of derivative financial instruments. We operate the program pursuant to documented corporate risk management policies. We do not enter derivative transactions for speculative purposes. Gains and losses on derivative financial instruments substantially offset losses and gains on underlying hedged exposures. Furthermore, we manage our exposure to counterparty risk on derivative instruments by entering into contracts with a diversified group of major financial institutions and by actively monitoring outstanding positions.

Our currency risk consists primarily of foreign currency denominated firm commitments, forecasted foreign currency denominated intercompany and third-party transactions and net investments in certain subsidiaries. We use both nonderivative (primarily European manufacturing operations) and derivative instruments to manage our earnings and cash flow exposure to changes in currency exchange rates. We had currency derivative instruments outstanding in the contract amount of $6.920 billion as of June 30, 2022 and $8.381 billion as of December 31, 2021. A ten percent appreciation in the U.S. dollar’s value relative to the hedged currencies would increase the derivative instruments’ fair value by $264 million as of June 30, 2022 as compared to $298 million as of December 31, 2021. A ten percent depreciation in the U.S. dollar’s value relative to the hedged currencies would decrease the derivative instruments’ fair value by $323 million as of June 30, 2022 as compared to $364 million as of December 31, 2021. Any increase or decrease in the fair value of our currency exchange rate sensitive derivative instruments would be substantially offset by a corresponding decrease or increase in the fair value of the hedged underlying asset, liability or forecasted transaction, resulting in minimal impacts on our unaudited consolidated statements of operations.

Our interest rate risk relates primarily to U.S. dollar borrowings partially offset by U.S. dollar cash investments. We have historically used interest rate derivative instruments to manage our earnings and cash flow exposure to changes in interest rates. We had no interest rate derivative instruments outstanding as of June 30, 2022 and December 31, 2021. As of June 30, 2022, $8.878 billion in aggregate principal amount of our outstanding debt obligations was at fixed interest rates, representing approximately 98 percent of our total debt, on an amortized cost basis. As of June 30, 2022, our outstanding debt obligations at fixed interest rates were comprised of senior notes.

Refer to Note D – Hedging Activities and Fair Value Measurements to our unaudited consolidated financial statements contained in Item 1 of this Quarterly Report on Form 10-Q for further information regarding our derivative financial instruments.

Item 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer (CEO) and our Chief Financial Officer (CFO), evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2022 pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended (the Exchange Act). Disclosure controls and procedures are designed to ensure that material information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such material information is accumulated and communicated to our management, including our CEO and CFO, as appropriate, to allow timely decisions regarding required disclosure. Based on their evaluation, our CEO and CFO concluded that, as of June 30, 2022, our disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting in the second quarter or first six months of 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

A multi-year implementation of a new global enterprise resource planning (ERP) system is in progress and will replace our existing ERP system. The implementation is expected to occur in phases over the next several years. As the phased implementation occurs, it will result in changes to our processes and procedures which will include changes to our internal controls over financial reporting. As such changes occur, we will evaluate quarterly whether they materially affect our internal control over financial reporting.

PART II

OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

Refer to Note G – Income Taxes and Note H – Commitments and Contingencies to our unaudited consolidated financial statements contained in Item 1 of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.

Item 1A. RISK FACTORS

In addition to other information contained elsewhere in this report, you should carefully consider the factors discussed in Part I, Item 1A. Risk Factors in our most recent Annual Report filed on Form 10-K, which could materially affect our business, financial condition or future results.

Item 6. EXHIBITS ( documents filed or furnished with this report)

4.1Indenture dated as of March 8, 2022, among American Medical Systems Europe B.V., Boston Scientific Corporation and U.S. Bank Trust Company, National Association, as Trustee (incorporated by reference to Exhibit 4.1, Current Report on Form 8-K dated March 8, 2022, File No. 1-11083)
4.20.750% Senior Notes due March 8, 2025 (incorporated herein by reference to Exhibit 4.2, Current Report on Form 8-K dated March 8, 2022, File No. 1-11083)
4.31.375% Senior Notes due March 8, 2028 (incorporated herein by reference to Exhibit 4.3, Current Report on Form 8-K dated March 8, 2022, File No. 1-11083)
4.41.625% Senior Notes due March 8, 2031 (incorporated herein by reference to Exhibit 4.4, Current Report on Form 8-K dated March 8, 2022, File No. 1-11083)
4.51.875% Senior Notes due March 8, 2034 ((incorporated herein by reference to Exhibit 4.5, Current Report on Form 8-K dated March 8, 2022, File No. 1-11083)
10.1Form of EC Non-CEO Change in Control Agreement (incorporated herein by reference to Exhibit 10.1, Current Report on Form 8-K dated May 6, 2022, File No. 1-11083)
10.2Boston Scientific Corporation Employee Stock Purchase Plan, Amended and Restated Effective as of July 1, 2022 (incorporated by reference herein to Exhibit 10.2, Current Report on Form 8-K dated May 6, 2022, File No. 1-11083)
22Subsidiary Issuer of Guaranteed Securities
31.1*Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.SCH*XBRL Taxonomy Extension Schema Document.
101.CAL*XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*XBRL Taxonomy Extension Presentation Linkbase Document.
104Cover Page Interactive Data File (embedded within the Inline XBRL document and contained in Exhibit 101).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized on August 4, 2022.

BOSTON SCIENTIFIC CORPORATION
By:/s/ Daniel J. Brennan
Name:Daniel J. Brennan
Title:Executive Vice President and Chief Financial Officer