Boston Scientific 10-Q 2024-09-30

Filed 2024-11-01. 8 sections, 273K characters. Original on sec.gov · Markdown · JSON

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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 September 30, 2024

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

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 October 29, 2024 was 1,473,827,485.

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)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 Operations38
ITEM 3.Quantitative and Qualitative Disclosures About Market Risk58
ITEM 4.Controls and Procedures59
PART IIOTHER INFORMATION60
ITEM 1.Legal Proceedings60
ITEM 1A.Risk Factors60
ITEM 5.Other Information60
ITEM 6.Exhibits60
SIGNATURE62

PART I

FINANCIAL INFORMATION

Item 1. CONSOLIDATED FINANCIAL STATEMENTS

BOSTON SCIENTIFIC CORPORATION AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

Three Months Ended September 30,Nine Months Ended September 30,
(in millions, except per share data)2024202320242023
Net sales$4,209$3,527$12,186$10,515
Cost of products sold1,3121,1013,7913,198
Gross profit2,8972,4268,3957,317
Operating expenses:
Selling, general and administrative expenses1,5621,2424,3723,811
Research and development expenses4073561,1561,051
Royalty expense5112435
Amortization expense205208631620
Intangible asset impairment charges—127658
Contingent consideration net expense (benefit)(23)12(4)43
Restructuring net charges (credits)8151251
Litigation-related net charges (credits)—(111)—(111)
2,1641,7336,4675,558
Operating income (loss)7336931,9281,759
Other income (expense):
Interest expense(79)(66)(225)(200)
Other, net14(18)(7)(78)
Income (loss) before income taxes6696101,6971,480
Income tax expense (benefit)200105413392
Net income (loss)4685041,2841,088
Preferred stock dividends———(23)
Net income (loss) attributable to noncontrolling interests(0)(0)(4)(0)
Net income (loss) attributable to Boston Scientific common stockholders$469$505$1,288$1,065
Net income (loss) per common share — basic$0.32$0.34$0.88$0.74
Net income (loss) per common share — diluted$0.32$0.34$0.87$0.73
Weighted-average shares outstanding
Basic1,472.71,464.51,470.61,448.8
Diluted1,487.41,475.01,484.51,459.1

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 September 30,Nine Months Ended September 30,
(in millions)2024202320242023
Net income (loss)$468$504$1,284$1,088
Other comprehensive income (loss), net of tax:
Foreign currency translation adjustment(181)21(79)(7)
Net change in derivative financial instruments(100)3(95)(25)
Net change in defined benefit pensions and other items(0)(0)0(5)
Other comprehensive income (loss)(282)23(173)(37)
Comprehensive income (loss)$187$528$1,110$1,051
Net income (loss) attributable to noncontrolling interests(0)—(4)—
Other comprehensive income (loss) attributable to noncontrolling interests10(16)4(16)
Comprehensive income (loss) attributable to noncontrolling interests10(16)0(16)
Comprehensive income attributable to Boston Scientific common stockholders$177$511$1,110$1,035

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)September 30, 2024December 31, 2023
ASSETS
Current assets:
Cash and cash equivalents$2,502$865
Trade accounts receivable, net2,5012,228
Inventories2,7532,484
Prepaid income taxes332315
Other current assets674621
Total current assets8,7616,514
Property, plant and equipment, net3,0722,859
Goodwill1

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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. We advance science for life by providing a broad range of high performance solutions to address unmet patient needs and reduce the cost of health care. When used in this report, the terms "we," "us," "our" and "the Company" mean Boston Scientific Corporation and its divisions and subsidiaries.

Financial Summary

Three Months Ended September 30, 2024

Our net sales for the third quarter of 2024 were $4.209 billion, compared to $3.527 billion for the third quarter of 2023. This increase of $683 million, or 19.4 percent, included operational1 net sales growth of 19.5 percent and the negative impact of 10 basis points from foreign currency fluctuations. Operational net sales growth included organic2 net sales growth of 18.2 percent and the positive impact of 130 basis points from the acquisitions of Relievant Medsystems, Inc. (Relievant), the endoluminal vacuum therapy portfolio of B. Braun Medical Inc. (Braun) and Silk Road Medical, Inc. (Silk Road Medical) during the fourth quarter of 2023, and first and third quarters of 2024, respectively, for which there is less than a full period of comparable net sales. The increase in our net sales was primarily driven by strong commercial execution across our businesses, led by the rapid adoption of our Farapulse™ Pulsed Field Ablation System following U.S. launch in early 2024. Refer to Quarterly Results and Business Overview for a discussion of our net sales by business.

Our reported net income attributable to Boston Scientific common stockholders for the third quarter of 2024 was $469 million, or $0.32 per diluted share. Our reported results for the third quarter of 2024 included certain charges and/or credits totaling $469 million (after-tax), or $0.32 per diluted share. Excluding these items, adjusted net income attributable to Boston Scientific common stockholders3 was $937 million, or $0.63 per diluted share.

Our reported net income attributable to Boston Scientific common stockholders for the third quarter of 2023 was $505 million, or $0.34 per diluted share. Our reported results for the third quarter of 2023 included certain charges and/or credits totaling $227 million (after-tax), or $0.15 per diluted share. Excluding these items, adjusted net income attributable to Boston Scientific common stockholders3 was $732 million, or $0.50 per diluted share.

1Operational net sales growth excludes the impact of foreign currency fluctuations.

2Organic 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.

3Adjusted measures, including operational and organic net sales growth and adjusted net income attributable to Boston Scientific common stockholders, exclude certain items required by generally accepted accounting principles in the United States (GAAP), are not prepared in accordance with 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 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 September 30, 2024
(in millions, except per share data)Income (Loss) Before Income TaxesIncome Tax Expense (Benefit)Net Income (Loss)Net Income (Loss) Attributable to Noncontrolling InterestsNet Income (Loss) Attributable to Boston Scientific Common StockholdersImpact per Share
Reported$669$200$468$(0)$469$0.32
Non-GAAP adjustments:
Amortization expense2052817721750.12
Acquisition/divestiture-related net charges (credits)144(56)200—2000.13
Restructuring and restructuring-related net charges (credits)52745—450.03
Investment portfolio net losses (gains) and impairments(1)0(1)—(1)(0.00)
European Union (EU) Medical device regulation (MDR) implementation costs13212—120.01
Deferred tax expenses (benefits)—(38)38—380.03
Adjusted$1,082$143$939$2$937$0.63
Three Months Ended September 30, 2023
(in millions, except per share data)Income (Loss) Before Income TaxesIncome Tax Expense (Benefit)Net Income (Loss)Net Income (Loss) Attributable to Noncontrolling InterestsNet Income (Loss) Attributable to Boston Scientific Common StockholdersImpact per Share
Reported$610$105$504$(0)$505$0.34
Non-GAAP adjustments:
Amortization expense208

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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 $6.471 billion as of September 30, 2024 and $5.899 billion as of December 31, 2023. A ten percent appreciation in the U.S. dollar’s value relative to the hedged currencies would increase the derivative instruments’ fair value by $367 million as of September 30, 2024 compared to $236 million as of December 31, 2023. A ten percent depreciation in the U.S. dollar’s value relative to the hedged currencies would decrease the derivative instruments’ fair value by $449 million as of September 30, 2024 compared to $288 million as of December 31, 2023. 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 and euro-denominated 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 September 30, 2024 or December 31, 2023. As of September 30, 2024, $10.924 billion in aggregate principal amount of our outstanding debt obligations was at fixed interest rates, representing approximately 100 percent of our total debt, on an amortized cost basis. As of September 30, 2024, 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 Part I 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 President and Chief Executive Officer (CEO) and our Executive Vice President and Chief Financial Officer (CFO), evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2024 pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended. 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 Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and ensure 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 September 30, 2024, our disclosure controls and procedures were effective.

Changes in Internal Control over Financial Reporting

During 2022, we began a multi-year implementation of a new global enterprise resource planning (ERP) system, which will replace our existing system. The implementation is expected to occur in phases over the next several years. The portion of the transition to the new ERP system which we have completed to date resulted in changes in our internal control over financial reporting in 2023. No changes occurred during the first nine months of 2024. As future phases are implemented, we expect the changes to have a material impact on our internal controls over financial reporting and we will evaluate whether these process changes necessitate further changes in the design of and testing for effectiveness of internal controls over financial reporting.

PART II

OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

Refer to Note H – Commitments and Contingencies to our unaudited consolidated financial statements contained in Item 1 of Part I 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 on Form 10-K, which could materially affect our business, financial condition or future results.

Item 5. OTHER INFORMATION

(c)

On August 9, 2024, John B. "Brad" Sorenson, our Executive Vice President, Global Operations, entered into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c). Mr. Sorenson’s plan covers the sale of up to 67,198 shares of our common stock including up to 20,383 shares to be acquired upon determination and/or vesting of performance share units and restricted share units and 17,362 shares to be acquired upon exercise of stock options. Transactions under Mr. Sorenson’s plan are based upon pre-established dates and stock price thresholds and will only occur upon the expiration of the applicable mandatory cooling-off period. Mr. Sorenson’s plan will terminate on the earlier of May 16, 2025, or the date all shares subject to the plan have been sold.

On August 9, 2024, Arthur C. Butcher, our Executive Vice President and Group President, MedSurg and Asia Pacific, entered into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c). Mr. Butcher’s plan covers the sale of 69,253 shares of our common stock to be acquired upon exercise of stock options. Transactions under Mr. Butcher’s plan are based upon pre-established dates and stock price thresholds and will only occur upon the expiration of the applicable mandatory cooling-off period. Mr. Butcher’s plan will terminate on the earlier of January 30, 2026, or the date all shares subject to the plan have been sold.

On August 26, 2024, Daniel J. Brennan, our Executive Vice President and Chief Financial Officer, entered into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c). Mr. Brennan’s plan covers the sale of up to 120,672 shares of our common stock including up to 45,062 shares to be acquired upon determination and/or vesting of performance share units and restricted share units and 75,610 shares to be acquired upon exercise of stock options. Transactions under Mr. Brennan’s plan are based upon pre-established dates and stock price thresholds and will only occur upon the expiration of the applicable mandatory cooling-off period. Mr. Brennan’s plan will terminate on the earlier of June 2, 2025, or the date all shares subject to the plan have been sold.

Item 6. EXHIBITS ( documents filed or furnished with this report; # compensatory plans or arrangements)

22Subsidiary Issuer of Guaranteed Securities (incorporated herein by reference to Exhibit 22 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed on May 1, 2024, File No. 1-11083).
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*Inline XBRL Taxonomy Extension Schema Document.
101.CAL*Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*Inline 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 November 1, 2024.

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