Haemonetics Corporation

08/07/2025 | Press release | Distributed by Public on 08/07/2025 04:11

Quarterly Report for Quarter Ending June 28, 2025 (Form 10-Q)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Management's Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") should be read in conjunction with both our interim condensed consolidated financial statements and notes thereto which appear elsewhere in this Quarterly Report on Form 10-Q and our annual consolidated financial statements, notes thereto and the MD&A contained in our Annual Report on Form 10-K for the fiscal year ended March 29, 2025. The following discussion may contain forward-looking statements and should be read in conjunction with the "Cautionary Statement Regarding Forward-Looking Information" in this discussion. When used in this report, the terms "we," "us," "our," "Haemonetics" and the "Company" mean Haemonetics Corporation.
Introduction
Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components.
We view our operations and manage our business in three principal reporting segments: Plasma, Blood Center and Hospital. For that purpose, "Plasma" includes plasma collection devices and disposables, donor management software and supporting software solutions sold to plasma customers. "Blood Center" includes blood collection and processing devices and disposables for plasma, red cells, and platelets. "Hospital" is comprised of Interventional Technologies, which includes Vascular Closure, Sensor-Guided Technologies and Esophageal Protection product lines, and Blood Management Technologies, which includes Hemostasis Management, Cell Salvage and Transfusion Management product lines.
We believe that Plasma and Hospital have the greatest growth potential and are well positioned to drive long-term value. Blood Center operates in more challenging markets, and we have sharpened our focus accordingly on targeted opportunities - particularly in plasma and platelets - while ensuring continued alignment of this business with our broader strategic objectives.
Recent Developments
2025 Share Repurchase Program
In April 2025, our Board of Directors (the "Board") approved a new three-year share repurchase program authorizing the repurchase of up to $500.0 million of our common stock, based on market conditions, through April 2028. This new share repurchase program will help to offset the dilutive impact of recent and future employee equity grants. The timing and amounts of activity under the share repurchase program will be at management's discretion. In addition to this share repurchase activity, our capital allocation strategy continues to prioritize funding of planned internal investments to support the business as well as inorganic opportunities to accelerate our long-term growth plans.
Market and Regional Alignment Initiative
In May 2025, the Board approved a new market and regional alignment initiative and delegated authority to our management to determine the details of the specific actions that will comprise the initiative. This strategic initiative, which is expected to continue through the end of fiscal 2027, is designed to improve operational performance and reduce costs by directing our resources toward the markets and geographies that offer the greatest growth and portfolio advancement opportunities. The amounts and timing of estimated costs and savings are subject to change until finalized. The actual amounts and timing may vary materially based on various factors.
Financial Summary
Three Months Ended
June 28, 2025 June 29, 2024 Reported growth
(Dollars in Thousands, Except Per Share Data)
Net revenues $ 321,394 $ 336,172 (4.4) %
Gross profit $ 192,244 $ 174,924 9.9 %
% of net revenues 59.8 % 52.0 %
Operating expenses $ 138,372 $ 135,168 2.4 %
Operating income $ 53,872 $ 39,756 35.5 %
% of net revenues 16.8 % 11.8 %
Interest and other (expense) income, net $ (8,703) $ 6,957 (225.1) %
Income before provision for income taxes $ 45,169 $ 46,713 (3.3) %
Provision for income taxes $ 11,138 $ 8,340 33.5 %
% of pre-tax income 24.7 % 17.9 %
Net income $ 34,031 $ 38,373 (11.3) %
% of net revenues 10.6 % 11.4 %
Net income per share - basic $ 0.71 $ 0.75 (5.3) %
Net income per share - diluted $ 0.70 $ 0.74 (5.4) %
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(1) Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency. See "Management's Use of Non-GAAP Measures."
Net revenues decreased 4.4% during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. Revenue decreases in Plasma and Blood Center, primarily driven by the previously announced customer transition of CSL and the divestiture of the Whole Blood product line in fiscal 2025, drove the overall decrease in net revenues, but was partially offset by an increase in Hospital, primarily attributable to the Hemostasis Management product line within the Blood Management Technologies franchise, during the three months ended June 28, 2025.
Operating income increased 35.5% during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The increase during the three months ended June 28, 2025 was primarily due to pricing benefits across all business units and product mix, as well as decreased restructuring costs related to portfolio rationalization initiatives and decreased amortization of fair value inventory step-up, partially offset by lower gains on sales of property, plant and equipment.
Management's Use of Non-GAAP Measures
Management uses non-GAAP financial measures, in addition to financial measures in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP"), to monitor the financial performance of the business, make informed business decisions, establish budgets and forecast future results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with U.S. GAAP. Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency conversion rate. We have provided this non-GAAP financial measure because we believe it provides meaningful information regarding our results on a consistent and comparable basis for the periods presented.
Results of Operations
Net Revenues by Geography
Three Months Ended
June 28, 2025 June 29, 2024 Reported growth Currency impact
Constant currency growth(1)
(Dollars in Thousands)
United States $ 242,404 $ 248,902 (2.6) % - % (2.6) %
International 78,990 87,270 (9.5) % 2.0 % (11.5) %
Total net revenues $ 321,394 $ 336,172 (4.4) % 0.5 % (4.9) %
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(1) Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency. See "Management's Use of Non-GAAP Measures."
Our principal operations are in the United States, Europe, Japan and other parts of Asia. We market and sell our products in approximately 96 countries through a combination of our direct sales force and independent distributors. During the three months ended June 28, 2025, our revenue generated outside the U.S. was 24.6% of total net revenues, as compared with 26.0% during the three months ended June 29, 2024. International sales are generally conducted in local currencies, primarily Japanese Yen, Euro and Chinese Yuan. Our results of operations are impacted by changes in foreign exchange rates, particularly in the value of the Yen and Euro, relative to the U.S. Dollar. We have placed foreign currency hedges on certain foreign currencies to mitigate our exposure to foreign currency fluctuations.
Please see the section entitled "Foreign Exchange" in this discussion for a more complete explanation of how foreign currency affects our business and our strategy for managing this exposure.
Net Revenues by Business Unit
Three Months Ended
June 28, 2025 June 29, 2024 Reported growth Currency impact
Constant currency growth(1)
(Dollars in Thousands)
Plasma
Plasma net revenues $ 129,897 $ 135,910 (4.4) % 0.3 % (4.7) %
Blood Center
Apheresis 51,822 49,094 5.6 % 1.2 % 4.4 %
Whole Blood 17 17,151 (99.9) % - % (99.9) %
Blood Center net revenues 51,839 66,245 (21.7) % 1.1 % (22.8) %
Hospital
Interventional Technologies(2)
58,483 63,044 (7.2) % 0.3 % (7.5) %
Blood Management Technologies(3)
81,175 70,973 14.4 % 0.6 % 13.8 %
Hospital net revenues 139,658 134,017 4.2 % 0.4 % 3.8 %
Total net revenues $ 321,394 $ 336,172 (4.4) % 0.5 % (4.9) %
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(1) Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency. See "Management's Use of Non-GAAP Measures."
(2) Interventional Technologies includes Vascular Closure, Sensor Guided Technologies and Esophageal Protection product lines of the Hospital business unit.
(3) Blood Management Technologies includes Hemostasis Management, Cell Salvage and Transfusion Management product lines of the Hospital business unit.
Plasma
Plasma revenue decreased by 4.4% on an as reported basis and by 4.7% without the effect of foreign exchange during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The decrease was driven by lower sales volumes in North America, primarily relating to the previously announced customer transition of CSL Plasma, which was partially offset by pricing benefits, share gains and upfront revenue recognition on execution of a renegotiated long-term software agreement with an existing software customer. We do not expect any North America disposable sales to CSL Plasma in fiscal 2026.
Blood Center
Blood Center revenue decreased by 21.7% on an as reported basis and by 22.8% without the effect of foreign exchange during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The decrease was primarily driven by the divestiture of our Whole Blood product line, which was completed in January 2025.
Hospital
Hospital revenue increased by 4.2% on an as reported basis and by 3.8% without the effect of foreign exchange during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The increase was primarily attributable to the Hemostasis Management product line within the Blood Management franchise, driven by volume growth, which was partially offset by lower volume in the Interventional Technologies franchise.
Gross Profit
Three Months Ended
June 28, 2025 June 29, 2024 Reported growth Currency impact
Constant currency growth(1)
(Dollars in Thousands)
Gross profit $ 192,244 $ 174,924 9.9 % 1.2 % 8.7 %
% of net revenues 59.8 % 52.0 %
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(1) Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency. See "Management's Use of Non-GAAP Measures."
Gross profit increased by 9.9% on an as reported basis and by 8.7% without the effect of foreign exchange during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The increase was driven primarily by pricing benefits across all business units and product mix, decreased restructuring costs related to portfolio rationalization initiatives and decreased amortization of fair value inventory step-up related to the Attune Medical acquisition.
Operating Expenses
Three Months Ended
June 28, 2025 June 29, 2024 Reported growth Currency impact
Constant currency growth(1)
(Dollars in Thousands)
Research and development $ 16,261 $ 14,449 12.5 % (0.2) % 12.7 %
% of net revenues 5.1 % 4.3 %
Selling, general and administrative $ 110,719 $ 108,248 2.3 % 0.4 % 1.9 %
% of net revenues 34.4 % 32.2 %
Amortization of acquired intangible assets $ 11,392 $ 12,471 (8.7) % (0.5) % (8.2) %
% of net revenues 3.5 % 3.7 %
Total operating expenses $ 138,372 $ 135,168 2.4 % 0.3 % 2.1 %
% of net revenues 43.1 % 40.2 %
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(1) Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency. See "Management's Use of Non-GAAP Measures."
Research and Development
Research and development expenses increased by 12.5% on an as reported basis and by 12.7% without the effect of foreign exchange during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The increase was primarily due to increased headcount as a result of recent acquisitions and continued focus on the development of new products.
Selling, General and Administrative
SG&Aexpenses increased by 2.3% on an as reported basis and by 1.9% without the effect of foreign exchange during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The increase was primarily driven by lower gains on sales of property, plant and equipment and higher performance-based compensation, partially offset by lower integration and transaction costs and lower freight costs.
Amortization of Acquired Intangible Assets
We recognized amortization expense related to our acquired intangible assets of $11.4 million during the three months ended June 28, 2025, as compared with $12.5 million during the three months ended June 29, 2024. The decrease was primarily due to certain intangible assets becoming fully amortized during fiscal 2025.
Interest and Other (Expense) Income, Net
Interest and other (expense) income, net decreased by $15.7 millionduring the three months ended June 28, 2025,as compared with the same period of fiscal 2025. The decrease was primarily driven by gains recognized in the first quarter of fiscal 2025 on the repurchase of $200.0 million of aggregate principal of the our 0.0% convertible senior notes due in 2026 (the "2026 Notes"). For further discussion on the 2026 Notes, refer to Note 12, Notes Payable and Long-Term Debtwithin these condensed consolidated financial statements.
Income Taxes
We conduct business globally and report our results of operations in a number of foreign jurisdictions in addition to the United States. Our reported tax rate differs from the statutory tax rate due to the jurisdictional mix of earnings in any given period as the foreign jurisdictions in which we operate have tax rates that differ from the U.S. statutory tax rate. Our effective tax rate is adversely impacted by non-deductible expenses including executive compensation and is favorably impacted by jurisdictional mix of earnings and research credits generated.
For the three months ended June 28, 2025, we reported income tax expense of $11.1 million, representing an effective tax rate of 24.7%. The effective tax rate for the three months ended June 28, 2025 includes $0.1 million of discrete tax expense, primarily related to stock compensation shortfalls.
For the three months ended June 29, 2024, we reported income tax expense of $8.3 million, representing an effective tax rate of 17.9%. The effective tax rate for the three months ended June 29, 2024 includes $3.6 million of discrete tax benefit, primarily related to stock compensation windfalls. The discrete benefit also includes other items such as provision to return differences.
The increase in the reported tax rate for the three months ended June 28, 2025, compared to the same period in fiscal 2025, relates primarily to the decrease in stock compensation windfall benefits.
Liquidity and Capital Resources
Resources
The following table contains certain key performance indicators we believe depict our liquidity and cash flow position:
June 28, 2025 March 29, 2025
(Dollars in Thousands)
Cash and cash equivalents $ 292,898 $ 306,763
Availability under revolving credit facility $ 750,000 $ 750,000
Working capital $ 381,753 $ 356,862
Current ratio 1.7 1.6
Net debt position(1)
$ (931,884) $ (918,025)
Days sales outstanding 56 55
Inventory turnover 1.2 1.4
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(1) Net debt position is the sum of cash and cash equivalents less total debt.
Our primary sources of liquidity are cash and cash equivalents, internally generated cash flow from operations and our senior unsecured revolving credit facility. We believe these sources are sufficient to fund our cash requirements over at least the next twelve months and to meet our known long-term cash requirements, including our 2026 Notes and 2.5%convertible senior notes due in 2029 (the "2029 Notes"). Our expected cash outlays relate primarily to acquisitions, investments, capital expenditures, share repurchases, the market and regional alignment initiative and cash principal and interest payments under our revised credit agreements.
As of June 28, 2025, we had $292.9 million in cash and cash equivalents, the majority of which is held in the U.S. or in countries from which it can be repatriated to the U.S.
Convertible Senior Notes
In the first quarter of fiscal 2025, we used a portion of its proceeds from the 2029 Notes to repurchase $200.0 million of the $500.0 million aggregate principal amount of our 2026 Notes for a total cost of $185.5 million, resulting in a gain of $14.5 million related to the discount on repurchase. As the repurchase of the 2026 Notes met the criteria for extinguishment accounting, $1.9 million of unamortized debt issuance costs were allocated to the repurchase, resulting in a net gain of $12.6 million. As of June 28, 2025, the $300.0 million remaining principal balance on the 2026 Notes was netted down by $1.1 million of remaining debt issuance costs, resulting in a net convertible note payable of $298.9 million. The 2026 Notes will mature on March 1, 2026, unless earlier converted, redeemed or repurchased. Interest expense related to the 2026 Notes was $0.4 million for the three months ended June 28, 2025 which is entirely attributable to the amortization of the debt issuance costs. The remaining debt issuance costs are amortized at an effective interest rate of 0.6%. For further discussion on the 2026 Notes, refer to Note 12, Notes Payable and Long-Term Debtwithin these condensed consolidated financial statements.
As of June 28, 2025, the $700.0 million principal balance of the 2029 Notes was netted down by $13.7 million of remaining debt issuance costs, resulting in a net convertible note payable of $686.3 million. The 2029 Notes will mature on June 1, 2029, unless earlier converted, redeemed or repurchased. Interest expense related to the 2029 Notes was $5.2 million for the three months ended June 28, 2025 which includes nominal interest expense and the amortization of the debt issuance costs. For further discussion on the 2029 Notes, refer to Note 12, Notes Payable and Long-Term Debtwithin these condensed consolidated financial statements.
Credit Facilities
On April 30, 2024, we entered into a second amended and restated credit agreement with certain lenders to refinance our 2022 unsecured credit facilities and extend their maturity date through April 2029. The second amended and restated credit agreement provides for a $250.0 million senior unsecured term loan, the proceeds of which, along with $12.5 million of cash on hand, were used to retire the balance of the term loan under our 2022 unsecured credit facilities, and a $750.0 million senior unsecured revolving credit facility (together, the "2024 Revised Credit Facilities"). Loans under the 2024 Revised Credit Facilities bear interest at an annual rate equal to the Adjusted Term SOFR Rate (as specified in the second amended and restated credit agreement), which is subject to a floor of 0.0%, plus an applicable rate ranging from 1.125% to 1.750% based on our consolidated net leverage ratio (as specified in the second amended and restated credit agreement) at the applicable measurement date. The revolving credit facility carries an unused fee that ranges from 0.125% to 0.250% annually based on our consolidated net leverage ratio at the applicable measurement date. The 2024 Revised Credit Facilities mature on April 30, 2029. The principal amount of the term loan under the 2024 Revised Credit Facilities amortizes quarterly through the maturity date at a rate of 2.5% for the first three years following the closing date, 5.0% for the fourth year following the closing date and 7.5% for the fifth year following the closing date, with the unpaid balance due at maturity. For further discussion on the 2029 Notes, refer to Note 12, Notes Payable and Long-Term Debtwithin these condensed consolidated financial statements.
At June 28, 2025, $243.8 million was outstanding under the term loan with an effective interest rate of 6.4%. There were no outstanding borrowings under the revolving credit facilities at June 28, 2025. We also had $19.5 million of uncommitted operating lines of credit to fund its global operations under which there were no outstanding borrowings as of June 28, 2025.
We have scheduled principal payments of $4.7 million required during the remainder of fiscal 2026 related to its term loan.
2025 Share Repurchase Program
In April 2025 our Board approved a new three-year share repurchase program authorizing the repurchase of up to $500.0 million of our common stock, based on market conditions, through April 2028. This new share repurchase program will help to offset the dilutive impact of recent and future employee equity grants. In addition to this share repurchase activity, our capital allocation strategy continues to prioritize funding of planned internal investments to support the business as well as inorganic opportunities to accelerate our long-term growth plans. Under the share repurchase program, we are authorized to repurchase, from time to time, outstanding shares of common stock in accordance with applicable laws on the open market, including under trading plans established pursuant to Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, and in privately negotiated transactions. The actual timing, number and value of shares repurchased will be determined by our discretion and will depend on a number of factors, including market conditions, applicable legal requirements and compliance with the terms of loan covenants. The share repurchase program may be suspended, modified or discontinued at any time, and we have no obligation to repurchase any amount of our common stock under the program.
Market and Regional Alignment Initiative
In May 2025, our Board approved a new market and regional alignment initiative and delegated authority to management to determine the details of the specific actions that will comprise the initiative. This strategic initiative is designed to improve operational performance and reduce costs by directing Company resources toward the markets and geographies that offer the greatest growth and portfolio advancement opportunities. During the three months ended June 28, 2025, we incurred $2.8 million of restructuring related costs under this initiative. Total cumulative charges under the market and regional alignment initiative are $3.4 million as of June 28, 2025. The amounts and timing of estimated costs and savings are subject to change until finalized. The actual amounts and timing may vary materially based on various factors.
Cash Flows
Three Months Ended
June 28, 2025 June 29, 2024
(Dollars in Thousands)
Net cash provided by (used in):
Operating activities $ 17,395 $ (27,421)
Investing activities (33,000) (139,197)
Financing activities (2,442) 333,692
Effect of exchange rate changes on cash and cash equivalents(1)
4,182 (1,445)
Net change in cash and cash equivalents $ (13,865) $ 165,629
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(1) The balance sheet is affected by spot exchange rates used to translate local currency amounts into U.S. Dollars. In accordance with U.S. GAAP, we have eliminated the effect of foreign currency throughout our cash flow statement, except for its effect on our cash and cash equivalents.
Operating Cash Flows
Net cash provided by operating activities increased by $44.8 million during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The fiscal 2026 period included cash inflows for net income of $34.0 million and increases in non-cash adjustments of $38.8 million, partially offset by unfavorable working capital adjustments of $55.5 million. The fiscal 2025 period included cash inflows for net income of $38.4 million being more than offset by cash outflows for non-cash adjustments related to a $12.6 million gain on the repurchase of convertible senior notes in the first quarter of fiscal 2025, a $14.3 million gain on the sale of property, plant and equipment, and unfavorable working capital adjustments of $79.0 million.
Investing Cash Flows
Net cash used in investing activities decreased by $106.2 million during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The fiscal 2026 period included cash outflows for strategic investments of $18.1 million and non-cash transfers from inventory of $11.5 million. The fiscal 2025 period included cash outflows for the acquisition of Attune Medical of $149.2 million and non-cash transfers from inventory of $4.2 million, partially offset by proceeds from the sale of property, plant and equipment of $20.4 million.
Financing Cash Flows
Net cash provided by financing activities decreased by $336.1 million during the three months ended June 28, 2025, as compared with the same period of fiscal 2025. The fiscal 2026 period included cash outflows for repayments of term loan borrowings and employee equity award settlements. The fiscal 2025 period included cash inflows relating to proceeds from the sale of the 2029 Notes of $700.0 million and proceeds from term loan borrowings of $250.0 million, partially offset by cash outflows for the repurchase of a portion of the 2026 Notes of $185.5 million, capped call purchases of $88.2 million, term loan redemptions of $262.5 million, payments on the revolving credit facility of $50.0 million, and debt issuance costs of $23.1 million.
Recent Accounting Pronouncements
Refer to Note 2, Recent Accounting Pronouncements, to the condensed consolidated financial statements for a discussion of recently issued accounting pronouncements.
Cautionary Statement Regarding Forward-Looking Information
Certain statements that we make from time to time, including statements contained in this Quarterly Report on Form 10-Q and incorporated by reference into this report, constitute "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 do not relate strictly to historical or current facts and reflect management's assumptions, views, plans, objectives and projections about the future. Forward-looking statements may be identified by the use of words such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "foresees," "potential" and other words of similar meaning in conjunction with, among other things: discussions of future operations; expected operating results and financial performance; our strategy for growth; product development, commercialization and anticipated performance and benefits; regulatory approvals; impacts of acquisitions or dispositions; and market position and expenditures.
Because forward-looking statements are based on current beliefs, expectations and assumptions regarding future events, they are subject to uncertainties, risks and changes that are difficult to predict and many of which are outside of our control. Investors should realize that if underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, our actual results and financial condition could vary materially from expectations and projections expressed or implied in its forward-looking statements. Investors are therefore cautioned not to rely on these forward-looking statements.
The following are some important factors that could cause our actual results to differ from our expectations in any forward-looking statements. For further discussion of these and other factors, see Item 1A. "Risk Factors" in our most recent Annual Report on Form 10-K.
•Our ability to achieve our long-term strategic and financial-improvement goals;
•Demand for and market acceptance risks for new and existing products, including material reductions in purchasing from or loss of a significant customer;
•Our ability to develop, manufacture and market new products and technologies successfully and in a timely manner and the ability of our competitors and other third parties to develop products or technologies that render our products or technologies noncompetitive or obsolete;
•Product quality or safety concerns, leading to product recalls, withdrawals, regulatory action by the FDA (or similar non-U.S. regulatory agencies), reputational damage, declining sales or litigation;
•Security breaches of our products or information technology systems, or those of our customers, suppliers or other business partners, which could impair our ability or our customers' ability to conduct business or compromise sensitive information of the Company or its customers, suppliers and other business partners, or of customers' patients;
•The potential that the expected strategic benefits and opportunities from completed or planned acquisitions, including our acquisitions of OpSens Inc. and Attune Medical, divestitures or other strategic investments by us may not be realized or may take longer to realize than expected;
•Pricing pressures resulting from trends toward healthcare cost containment, including the continued consolidation among healthcare providers and other market participants;
•Disruptions to the continuity, availability and pricing of plastic and other raw materials, finished goods and components used in the manufacturing of our products (including those purchased from sole-source suppliers) and the related continuity of our manufacturing, sterilization, supply chain and distribution operations, including disruptions caused by natural disasters, extreme weather and other conditions caused by or related to climate change, labor strikes, terrorism acts, cyber incidents or other adverse events;
•Our ability to obtain the anticipated benefits of restructuring programs that we have or may undertake, including our market and regional alignment and portfolio rationalization initiatives;
•The impact of enhanced requirements to obtain regulatory approval in the U.S. and around the world and the associated timing and cost of product approval;
•Our ability to comply with established and developing U.S. and foreign legal and regulatory requirements, including the U.S. Foreign Corrupt Practices Act, European Union Medical Device Regulation and In Vitro Diagnostic Regulation and similar laws in other jurisdictions, as well as the impact of U.S. and foreign export and import restrictions and tariffs;
•The impact of changes in U.S. and international tax laws, including with respect to the OBBBA;
•Our ability to meet our debt obligations and raise additional capital when desired on terms reasonably acceptable to us;
•The potential impact of our convertible senior notes and related capped call transactions;
•Geopolitical and economic conditions in China, Taiwan, Russia, Ukraine, the Middle East and other foreign jurisdictions where we do business;
•Our ability to execute and realize anticipated benefits from our investments in emerging economies;
•The potential effect of foreign currency fluctuations and interest rate fluctuations on our net revenues, expenses and resulting margins;
•Our ability to protect intellectual property and the outcome of patent litigation;
•Costs and risks associated with product liability and other litigation claims we may be subject to now or in the future;
•Our ability to retain and attract key personnel;
•Market conditions impacting our stock price and/or our share repurchase program, and the possibility that such share repurchase program may be delayed, suspended or discontinued;
•Our ability to achieve against our corporate responsibility initiatives and meet evolving stakeholder expectations concerning corporate responsibility matters; and
•The impact of actual or threatened public health crises.
Investors should understand that it is not possible to predict or identify all such factors and should not consider the risks described above and in Item 1A. "Risk Factors" in our Annual Report on Form 10-K to be a complete statement of all potential risks and uncertainties. We do not undertake to publicly update any forward-looking statement that may be made from time to time, whether as a result of new information or future events or developments.
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