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Summary of Significant Accounting Policies (Policies) | 12 Months Ended
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Sep. 28, 2024
Accounting Policies [Abstract] |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The Company assesses the terms of its strategic investments to determine if they meet the definition of a variable interest entity (VIE) and if so, whether the Company has a controlling financial interest. A controlling financial interest occurs if the Company has both the power to direct activities of the VIE that most significantly impact the VIE’s economic performance and an obligation to absorb the losses of or the right to receive the benefits from the VIE that could potentially be significant to the VIE. The Company’s strategic investments did not meet the controlling financial interest criteria, and therefore the Company did not consolidate any VIEs during fiscal 2024, 2023 or 2022. The Company’s fiscal year ends on the last Saturday in September. Fiscal 2024, 2023 and 2022 ended on September 28, 2024, September 30, 2023 and September 24, 2022, respectively. Fiscal 2023 was a 53-week year and fiscal 2024 and 2022 were 52-week years.
Subsequent Events Consideration | Subsequent Events Consideration The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for certain estimates or to identify matters that may require additional disclosure. Subsequent events have been evaluated as required. There were no material recognized or unrecognized subsequent events recorded in the consolidated financial statements as of and for the year ended September 28, 2024, except as noted below. On October 11, 2024, the Company entered into a definitive agreement to acquire Gynesonics, Inc. (“Gynesonics”) for a purchase price of approximately $350.0 million, subject to working capital and other customary adjustments. Gynesonics, located in Redwood, California, develops a technology intended for diagnostic intrauterine imaging and transcervical treatment of certain symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. Completion of the acquisition is subject to customary closing conditions, including receipt of required regulatory approvals. Gynesonics will be included in the GYN Surgical reportable segment. On November 19, 2024, the Company executed an accelerated share repurchase agreement (ASR) with JPMorgan Chase & Co., (“JP Morgan”) pursuant to which the Company agreed to repurchase $250 million of the Company’s common stock. Refer to Note 12 for further discussion.
Management's Estimates | Management’s Estimates and Uncertainties The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions by management affect the Company’s revenue recognition for multiple performance obligation arrangements, valuations, purchase price allocations and contingent consideration related to business combinations, expected future cash flows including growth rates, discount rates, terminal values and other assumptions and estimates used to evaluate the recoverability of long-lived assets and goodwill, estimated fair values of intangible assets and goodwill, amortization methods and periods, accounts receivable reserves, inventory excess and obsolescence reserves, warranty reserves, certain accrued expenses, restructuring and other related charges, contingent liabilities, tax reserves, deferred tax rates and the recoverability of the Company’s net deferred tax assets and related valuation allowances, and stock-based compensation. Although the Company regularly assesses these estimates, actual results could differ materially from these estimates. Changes in estimates are recorded in the period in which they become known. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances. The Company is subject to a number of risks similar to those of other companies of similar size in its industry, including dependence on third-party reimbursements to support the markets of the Company’s products, early stage of development of certain products, rapid technological changes, recoverability of long-lived assets (including intangible assets and goodwill), competition, stability of world financial markets, ability to obtain regulatory approvals, changes in the regulatory environment, limited number of suppliers, customer concentration, integration of acquisitions, substantial indebtedness, government regulations, management of international activities, protection of proprietary rights, patent and other litigation, dependence on contract manufacturers, supply chain constraints, inflation and interest rates, and dependence on key individuals.
Cash Equivalents | Cash Equivalents The Company classifies all highly liquid investments with stated maturities of three months or less from the date of purchase as cash equivalents. Cash equivalents are highly liquid investments with insignificant interest rate risk and maturities of three months or less at the time of acquisition.
Investments and Strategic Investments | Investments Investments in debt securities are classified as available-for-sale and are reported at estimated fair value with unrealized gains and losses recorded as a component of accumulated other comprehensive income. The Company determines the appropriate classification of its investment in debt securities at the time of purchase and re-evaluates such determination at each balance sheet date. The Company reviews its investments for impairment and adjusts these investments to fair value through earnings, as required. Strategic Investments The majority of the Company’s strategic investments are in non-marketable equity securities, which are measured at cost, less any impairment, adjusted to fair value for any observable price changes in orderly transactions for identical or similar investments of the same issuer. Investments in entities for which the Company has the ability to exercise significant influence are accounted for under the equity method if the Company holds less than 50 percent of the voting stock and the entity is not a VIE in which the Company is the primary beneficiary in accordance with Accounting Standards Codification (“ASC”) Topic 323, Investments - Equity Method and Joint Ventures. The Company records these investments initially at cost and adjusts the carrying amount to reflect its proportional share of the earnings or losses of the investee. Refer to Note 6 for additional details on strategic investment balances.
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents, available-for-sale debt securities, equity investments and trade accounts receivable. The Company invests its cash, cash equivalents and available-for-sale debt securities with high credit quality financial institutions. The Company’s customers are principally located in the U.S., Europe and Asia. The Company performs ongoing credit evaluations of the financial condition of its customers and generally does not require collateral. Although the Company is directly affected by the overall financial condition of the healthcare industry, as well as global economic conditions, management does not believe significant credit risk exists as of September 28, 2024. The Company generally has not experienced any material losses related to receivables from individual customers or groups of customers in the healthcare industry. The Company maintains an allowance for doubtful accounts based on accounts past due and historical collection experience. There were no customers with a balance greater than 10% of accounts receivable as of September 28, 2024 and September 30, 2023. There were no customers that represented greater than 10% of consolidated revenues for fiscal years 2024, 2023 and 2022
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value on a first-in, first-out basis. Work-in-process and finished goods inventories consist of materials, labor and manufacturing overhead. The valuation of inventory requires management to estimate excess and obsolete inventory. The Company employs a variety of methodologies to determine the net realizable value of its inventory. Provisions for excess and obsolete inventory are primarily based on management’s estimates of forecasted sales, usage levels and expiration dates, as applicable for certain disposable products. A significant change in the timing or level of demand for the Company’s products compared to forecasted amounts may result in recording additional charges for excess and obsolete inventory in the future. The Company records charges for excess and obsolete inventory within cost of product revenues. Inventories consisted of the following:
|  | September 28, 2024 |  | September 30, 2023
Raw materials |  | $ | 251.4 |  |  | $ | 238.6 |
Work-in-process |  | 62.0 |  |  | 66.3 |
Finished goods |  | 366.4 |  |  | 312.7 |
|  | $ | 679.8 |  |  | $ | 617.6 |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment is recorded at cost less accumulated depreciation and impairments. The straight-line method of depreciation is used for all property and equipment. Property, plant and equipment consisted of the following:
| Estimated Useful Life |  | September 28, 2024 |  | September 30, 2023
Equipment | 3–10 years |  | $ | 378.1 |  |  | $ | 380.0 |
Equipment under customer usage agreements | 3–8 years |  | 523.1 |  |  | 508.1 |
Buildings and improvements | 20–35 years |  | 247.1 |  |  | 230.0 |
Leasehold improvements | Shorter of the Original Lease Term or Estimated Useful Life |  | 44.0 |  |  | 44.4 |
Land |  |  | 40.8 |  |  | 41.1 |
Furniture and fixtures | 5–7 years |  | 24.6 |  |  | 19.2 |
Finance lease right-of-use asset |  |  | 8.8 |  |  | 8.2 |
|  |  | 1,266.5 |  |  | 1,231.0 |
Less - accumulated depreciation and amortization |  |  | (728.7) |  |  | (714.0) |
|  |  | $ | 537.8 |  |  | $ | 517.0 |
Equipment under customer usage agreements primarily consists of diagnostic instruments located at customer sites but owned by the Company. Generally, the customer has the right to use the equipment for a period of time provided they meet certain agreed to conditions. The Company recovers the cost of providing the equipment from the sale of disposables, primarily assays, tests and handpieces. The depreciation costs associated with equipment under customer usage agreements are charged to cost of product revenues over the estimated useful life of the equipment. The costs to maintain the equipment in the field are charged to cost of product revenue as incurred. In September 2020 and October 2020, the Company was awarded grants of $7.6 million and $119.3 million, respectively, from the Department of Defense Joint Acquisition Task Force (“DOD”) to expand production capacity for the Company's two SARS-CoV-2 assays. These grants were specifically to fund capital equipment and labor investments to increase manufacturing capacity to enable the Company to provide a certain amount of COVID-19 tests per month for the U.S. market. The Company accounted for the funds received under these grants as a reimbursement of the purchased capital equipment. The Company procured and paid for the capital equipment and necessary resources to build out its facility and construct the manufacturing lines to meet the requirements specified in the grant agreement. Subsequent to the Company paying for the capital equipment, the DOD reimbursed the Company upon it meeting certain requirements. However, the DOD retained title to the assets purchased under the agreement, and title was transferred to the Company upon meeting certain milestones of the manufacturing efforts and obtaining approval from the DOD that the respective milestone had been met. As of the end of fiscal 2022, the Company had completed all milestones under the agreement and was awaiting approval by the DOD. During the second quarter of fiscal 2023, the Company received the final DOD approvals and the final payment from the DOD of $20.5 million, which was recorded as a reduction of the cost basis of the purchased equipment. As of September 30, 2023, no amounts were awaiting approval and all defined milestones were completed. In fiscal 2022, the Company received $75.0 million from the DOD for reimbursement of capital equipment, which was recorded as a reduction of the cost basis of the purchased equipment. In addition, a portion of the DOD grant funded expenditures in connection with the project that did not qualify for capitalization and was recorded as a reduction to expenses, which was $7.6 million in fiscal 2022. During the third quarter of fiscal 2023, the Company identified indicators of impairment related to the long-lived assets of its Mobidiag business and based on the fair value of the asset group recorded an impairment charge of $12.1 million related to property, plant and equipment. In addition, during the third quarter of fiscal 2023, the Company identified indicators of impairment related to the long-lived assets of its SSI ultrasound imaging business and recorded an impairment charge of $5.8 million related to property, plant and equipment.
Long-Lived Assets | Long-Lived Assets The Company reviews its long-lived assets, which includes property, plant and equipment and identifiable intangible assets (see below for discussion of intangible assets), for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable in accordance with ASC 360-10-35-15, Property, Plant and Equipment—Impairment or Disposal of Long-Lived Assets (ASC 360). Recoverability of these assets is evaluated by comparing the carrying value of the assets to the undiscounted cash flows estimated to be generated by those assets over their remaining economic life. If the undiscounted cash flows are not sufficient to recover the carrying value of the assets, the assets are considered impaired. The impairment loss is measured by comparing the fair value of the assets to their carrying value. Fair value is determined by either a quoted market price, if any, or a value determined by a discounted cash flow technique.
Business Combinations and Acquisition of Intangible Assets | Business Combinations and Acquisition of Intangible Assets The Company accounts for the acquisition of a business in accordance with ASC 805, Business Combinations (ASC 805). Amounts paid to acquire a business are allocated to the assets acquired and liabilities assumed based on their fair values at the date of acquisition. Contingent consideration not deemed to be linked to continuing employment is recorded at fair value on the date of acquisition. The value recorded is based on estimates of future financial projections under various potential scenarios using a Monte Carlo simulation. These cash flow projections are discounted with an appropriate risk adjusted rate. Each quarter until such contingent amounts are earned, the fair value of the liability is remeasured and adjusted as a component of operating expenses based on changes to the underlying assumptions. The estimates used to determine the fair value of the contingent consideration liability are subject to significant judgment and actual results are likely to differ from the amounts originally recorded. The Company determines the fair value of acquired intangible assets based on detailed valuations that use certain information and assumptions provided by management. The Company allocates any excess purchase price over the fair value of the net tangible and intangible assets acquired to goodwill. The Company uses the income approach to determine the fair value of developed technology and in-process research and development (“IPR&D”) acquired in a business combination. This approach determines fair value by estimating the after-tax cash flows attributable to the respective asset over its useful life and then discounting these after-tax cash flows back to a present value. The Company bases its revenue assumptions on estimates of relevant market sizes, expected market growth rates, expected trends in technology and expected product introductions by competitors. Developed technology represents patented and unpatented technology and know-how. The value of the in-process projects is based on the project's stage of completion, the complexity of the work completed as of the acquisition date, the projected costs to complete, the contribution of core technologies and other acquired assets, the expected introduction date, the estimated cash flows to be generated upon commercial release and the estimated useful life of the technology. The Company believes that the estimated developed technology and IPR&D amounts represent the fair value at the date of acquisition and do not exceed the amount a third-party would pay for the assets. The significant assumptions used to estimate the fair value of intangible assets include discount rates and certain assumptions that form the basis of the forecasted results, specifically revenue growth rates. These significant assumptions are forward looking and could be affected by future economic and market conditions. The Company also uses the income approach, as described above, to determine the estimated fair value of certain other identifiable intangible assets including customer relationships and trade names. Customer relationships represent established relationships with customers, which provide a ready channel for the sale of additional products and services. Trade names represent acquired company and product names
Intangible Assets and Goodwill | Intangible Assets and Goodwill Intangible Assets Intangible assets are initially recorded at fair value and stated net of accumulated amortization and impairments. The Company amortizes its intangible assets that have finite lives using either the straight-line method, or if reliably determinable, based on the pattern in which the economic benefit of the asset is expected to be utilized. Amortization is recorded over the estimated useful lives ranging from 5 to 30 years. The Company evaluates the recoverability of its definite lived intangible assets whenever events or changes in circumstances or business conditions indicate that the carrying value of these assets may not be recoverable based on expectations of future undiscounted cash flows for each asset group. If the carrying value of an asset or asset group exceeds its undiscounted cash flows, the Company estimates the fair value of the assets, generally utilizing a discounted cash flow analysis based on the present value of after-tax cash flows to be generated by the assets using a risk-adjusted discount rate. To estimate the fair value of the assets, the Company uses market participant assumptions pursuant to ASC 820, Fair Value Measurements. Indefinite lived intangible assets, such as IPR&D assets, are initially recorded at fair value and are required to be tested for impairment annually, or more frequently if indicators of impairment are present. The Company’s annual impairment test date is as of the first day of its fourth quarter. Intangible assets consisted of the following:
|  | September 28, 2024 |  | September 30, 2023
Description |  | Gross Carrying Value |  | Accumulated Amortization |  | Gross Carrying Value |  | Accumulated Amortization
Acquired intangible assets: |  |  |  |  |  |  |  |
Developed technology |  | $ | 4,567.0 |  |  | $ | 3,834.0 |  |  | $ | 4,411.0 |  |  | $ | 3,649.5 |
In-process research and development |  | 25.1 |  |  | — |  |  | 25.7 |  |  | — |
Customer relationships |  | 609.7 |  |  | 569.8 |  |  | 600.0 |  |  | 550.6 |
Trade names |  | 260.3 |  |  | 224.5 |  |  | 253.6 |  |  | 212.8 |
Total acquired intangible assets |  | $ | 5,462.1 |  |  | $ | 4,628.3 |  |  | $ | 5,290.3 |  |  | $ | 4,412.9 |
Internal-use software |  | 25.7 |  |  | 20.5 |  |  | 24.0 |  |  | 17.8 |
Capitalized software embedded in products |  | 30.2 |  |  | 24.6 |  |  | 27.7 |  |  | 22.7 |
Total intangible assets |  | $ | 5,518.0 |  |  | $ | 4,673.4 |  |  | $ | 5,342.0 |  |  | $ | 4,453.4 |
During the second quarter of fiscal 2024, in connection with commencing its company-wide annual strategic planning process, the Company identified indicators of impairment in its BioZorb product line, which was part of the Focal acquisition. As a result, the Company performed an undiscounted cash flow analysis pursuant to ASC 360 to determine if the cash flows expected to be generated by the BioZorb product line over the remaining estimated useful life of the primary asset were sufficient to recover the carrying value of the asset group. Based on this analysis, the undiscounted cash flows were not sufficient to recover the carrying value of the long-lived assets. Therefore, the Company was required to perform Step 3 of the impairment test and determine the fair value of the asset group. To estimate the fair value of the asset group, the Company utilized the income approach, which is based on a discounted cash flow (DCF) analysis and calculated the fair value by estimating the after-tax cash flows attributable to the asset group and then discounting the after-tax cash flows to present value using a risk-adjusted discount rate. Based on this analysis, the fair value of the BioZorb asset group was below its carrying value and the Company recorded an impairment charge of $26.8 million during the second quarter of fiscal 2024. The impairment charge was allocated to the long-lived assets on a pro-rata basis as follows: $25.9 million to developed technology and $0.9 million to trade names, which reduced the carrying value of the assets to $13.9 million and $0.5 million respectively. During the third quarter of fiscal 2024, the Federal Drug Administration classified a prior safety notice for the BioZorb Marker as a Class I recall. This was the technical classification of a prior safety notice only, not a product removal. Following this, the Company lowered its forecasts for this product line, which is an indicator of impairment. Accordingly, the Company performed an undiscounted cash flow analysis, and the cash flows were not sufficient to recover the carrying value of the asset group. The Company performed a fair value analysis and determined that the fair value of the asset group was de minimus. As a result, the Company recorded an impairment charge of $13.3 million and $0.4 million to developed technology and trade names, respectively, to fully write-off the assets. During the first quarter of fiscal 2024, the Company assessed its only in-process research and development intangible asset from its Mobidiag acquisition for impairment. The Company determined the fair value of this indefinite-lived asset utilizing the DCF model and recorded a $4.3 million impairment charge, reducing the fair value of this asset to $22.4 million. The reduction in the fair value of this asset was primarily due to a reduction in forecasted revenues and a delay in the timing of completing the project. In addition, the Company determined that the useful life of the customer relationship and trade name intangible assets from its Mobidiag acquisition should be shortened and recorded accelerated amortization expense of $7.3 million to bring the net carrying values to zero. During the third quarter of fiscal 2023, in connection with its company-wide annual budgeting and strategic planning process as well as evaluating the current operating performance of its Mobidiag business, including product design and manufacturing requirements, the Company reassessed its short-term and long-term commercial plans for this business. The Company made certain operational and strategic decisions to invest and focus more on the long-term success of this business, which resulted in the Company significantly reducing its forecasted revenues and operating results. As a result, the Company identified indicators of impairment and performed an undiscounted cash flow analysis pursuant to ASC 360 to determine if the cash flows expected to be generated by the Mobidiag business over the estimated remaining useful life of its primary assets were sufficient to recover the carrying value of the asset group. Based on this analysis the undiscounted cash flows were not sufficient to recover the carrying value of the long-lived assets. As a result, the Company was required to perform Step 3 of the impairment test and determine the fair value of the asset group. To estimate the fair value of the asset group, the Company utilized the income approach, which was based on a DCF analysis. Assumptions used in the DCF require significant judgment, including judgment about appropriate discount rates, growth rates, and the amount and timing of expected future cash flows. The forecasted cash flows were based on the Company's most recent strategic plan at that time and for periods beyond the strategic plan, the Company's estimates were based on assumed growth rates expected as of the measurement date. The Company believed its assumptions were consistent with the plans and estimates that a market participant would use to manage the business. The discount rate used was intended to reflect the risks inherent in future cash flow projections and was based on an estimate of the weighted average cost of capital (WACC) of market participants relative to the asset group. The Company used a discount rate of 17.0%. Based on this analysis, the fair value of the Mobidiag asset group was below its carrying value. Prior to calculating and allocating the impairment charge, the Company assessed the only in-process research and development intangible asset in this asset group for impairment. The Company determined the fair value of this indefinite-lived asset utilizing the DCF model and recorded a $10.5 million impairment charge, reducing the fair value of this asset to $26.5 million. The reduction in fair value of this asset was primarily due to a reduction in forecasted revenues and a delay in the timing of completing the project to focus on other projects. To record the asset group to fair value, the Company recorded an impairment charge of $186.9 million during the third quarter of fiscal 2023. The impairment charge was allocated to the long-lived assets on a pro-rata basis as follows: $153.7 million to developed technology, $10.4 million to customer relationships, $10.7 million to trade names, and $12.1 million to equipment. The Company believed its assumptions used to determine the fair value of the asset group were reasonable. The Company also re-evaluated the remaining useful lives of the intangible assets and concluded no changes were necessary at that time. During the third quarter of fiscal 2023, the Company also identified indicators of impairment associated with its SSI ultrasound imaging asset group. The Company determined that the fair value of this asset group was approximately zero and the carrying value of the long-lived assets was fully impaired. As a result, the Company recorded an impairment charge of $26.4 million, of which $20.6 million was allocated to intangible assets, primarily developed technology, and $5.8 million was allocated to equipment. During the fourth quarter of fiscal 2022, the Company performed its annual impairment test of its Mobidiag IPR&D intangible asset. The Company determined the fair value of the asset utilizing a DCF model and recorded a $27.7 million impairment charge. The reduction in fair value was due to an increase in the discount rate from higher interest rates, a reduction in forecasted revenues and timing of completing the project. During the fourth quarter of fiscal 2022, the Company identified a certain product line associated with the Focal Therapeutics, Inc. acquisition that would no longer be commercially sold. As a result, the Company recorded an impairment charge to write-off a developed technology asset of $8.2 million. During the third quarter of fiscal 2022, the Company identified certain product lines associated with the Faxitron Bioptics, LLC acquisition that would no longer be commercially sold. As a result, the Company recorded an impairment charge to write-off the developed technology assets of $9.2 million. Amortization expense related to developed technology is classified as cost of product revenues—amortization of intangible assets. Amortization expense related to customer relationships and trade names is classified as a component of amortization of intangible assets within operating expenses. The estimated amortization expense at September 28, 2024 for each of the five succeeding fiscal years was as follows:
Fiscal 2025 | $ | 199.3 |
Fiscal 2026 | $ | 169.2 |
Fiscal 2027 | $ | 82.1 |
Fiscal 2028 | $ | 79.0 |
Fiscal 2029 | $ | 72.9 |
Goodwill In accordance with ASC 350, Intangibles—Goodwill and Other (ASC 350), the Company tests goodwill for impairment annually at the reporting unit level and between annual tests if events and circumstances indicate it is more likely than not that the fair value of a reporting unit is less than its carrying value. Events that could indicate impairment and trigger an interim impairment assessment include, but are not limited to, current economic and market conditions, including a decline in market capitalization, a significant adverse change in legal factors, business climate, operational performance of the business or key personnel, and an adverse action or assessment by a regulator. In performing the impairment test, the Company utilizes the single-step approach prescribed under Accounting Standards Update No. 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (ASU 2017-04). This approach requires a comparison of the carrying value of each reporting unit to its estimated fair value and to the extent the carrying value exceeds the fair value a charge is recorded up to the amount of goodwill in the reporting unit. To estimate the fair value of its reporting units, the Company primarily utilizes the income approach. The income approach is based on a DCF analysis and calculates the fair value by estimating the after-tax cash flows attributable to a reporting unit and then discounting the after-tax cash flows to present value using a risk-adjusted discount rate. Assumptions used in the DCF require significant judgment, including judgment about appropriate discount rates and terminal values, growth rates, and the amount and timing of expected future cash flows. The forecasted cash flows are based on the Company’s most recent budget and strategic plan and for years beyond this period, the Company’s estimates are based on assumed growth rates expected as of the measurement date. The Company believes its assumptions are consistent with the plans and estimates used to manage the underlying businesses. The discount rates used are intended to reflect the risks inherent in future cash flow projections and are based on estimates of the weighted-average cost of capital (“WACC”) of market participants. The market approach considers comparable market data based on multiples of revenue or earnings before interest, taxes, depreciation and amortization (“EBITDA”) and is primarily used as a corroborative analysis to the results of the DCF analysis. The Company believes its assumptions used to determine the fair value of its reporting units are reasonable. If different assumptions were used, particularly with respect to forecasted cash flows, terminal values, WACCs, or market multiples, different estimates of fair value may result and there could be the potential that an impairment charge could result. Actual operating results and the related cash flows of the reporting units could differ from the estimated operating results and related cash flows. The Company conducted its fiscal 2024 impairment test for its reporting units on the first day of the fourth quarter, and as noted above used DCF and market approaches to estimate the fair value of its reporting units as of June 30, 2024, and ultimately used the fair value determined by the DCF approach in making its impairment test conclusions. As a result of completing this analysis, all of the Company's reporting units had fair values exceeding their carrying values. At September 28, 2024, the Company believes that its reporting units, with goodwill aggregating $3.4 billion, were not at risk of failing the goodwill impairment test based on its current forecasts and qualitative assessment. The Company conducted its fiscal 2023 and 2022 impairment tests for its reporting units on the first day of the fourth quarter of its respective fiscal year, and as noted above used DCF and market approaches to estimate the fair value of its reporting units as of the measurement date, and ultimately used the fair value determined by the DCF approach in making its impairment test conclusions. As a result of completing these analyses, all of the Company's reporting units had fair values exceeding their carrying values. A rollforward of goodwill activity by reportable segment from September 30, 2023 to September 28, 2024 is as follows:
| Diagnostics |  | Breast Health |  | GYN Surgical |  | Skeletal Health |  | Total |  |
Balance at September 30, 2023 | $ | 1,351.6 |  |  | $ | 787.8 |  |  | $ | 1,133.9 |  |  | $ | 8.0 |  |  | $ | 3,281.3 |  |  |
Endomag acquisition | — |  |  | 138.9 |  |  | — |  |  | — |  |  | 138.9 |  |  |
Foreign currency and other adjustments | 14.2 |  |  | 7.9 |  |  | 0.8 |  |  | — |  |  | 22.9 |  |  |
Balance at September 28, 2024 | $ | 1,365.8 |  |  | $ | 934.6 |  |  | $ | 1,134.7 |  |  | $ | 8.0 |  |  | $ | 3,443.1 |  |  |
Other Assets | Other Assets Other assets consisted of the following:
|  | September 28, 2024 |  | September 30, 2023
Other Assets |  |  |  |
Tax receivable |  | $ | 37.5 |  |  | $ | 33.0 |
Operating lease right of use assets |  | 92.2 |  |  | 62.7 |
Life insurance contracts |  | 71.0 |  |  | 56.1 |
Deferred tax assets |  | 128.8 |  |  | 56.6 |
Strategic investments |  | 54.3 |  |  | 15.5 |
Other |  | 27.0 |  |  | 44.0 |
|  | $ | 410.8 |  |  | $ | 267.9 |
Life insurance contracts were purchased in connection with the Company’s Nonqualified Deferred Compensation Plan (“DCP”) and are recorded at their cash surrender value (see Note 14 for further discussion).
Research and Software Development Costs | Research and Software Development Costs Costs incurred for the research and development of the Company’s products are expensed as incurred. Nonrefundable advance payments for goods or services to be received in the future by the Company for use in research and development activities are deferred. The deferred costs are expensed as the related goods are delivered or the services are performed. The Company accounts for the development costs of software embedded in the Company’s products in accordance with ASC 985, Software. Costs incurred in the research, design and development of software embedded in products to be sold to customers are charged to expense until technological feasibility of the ultimate product to be sold is established. The Company’s policy is that technological feasibility is achieved when a working model, with the key features and functions of the product, is available for customer testing. Software development costs incurred after the establishment of technological feasibility and until the product is available for general release are capitalized, provided recoverability is reasonably assured. Capitalized software development costs are amortized over their estimated useful life and recorded within cost of revenues - product.
Foreign Currency Translation | Foreign Currency Translation The financial statements of the Company’s foreign subsidiaries are translated in accordance with ASC 830, Foreign Currency Matters. The reporting currency for the Company is the U.S. dollar. The functional currency of the Company’s foreign subsidiaries is determined based on the guidance in ASC 830. The majority of the Company's foreign subsidiaries' functional currency is the applicable local currency, although certain of the Company's foreign subsidiaries' functional currency is the U.S. dollar based on the nature of their operations or functions. Assets and liabilities of subsidiaries whose functional currency is the local currency are translated at the exchange rate in effect at each balance sheet date. Before translation, the Company re-measures foreign currency denominated assets and liabilities, including inter-company accounts receivable and payable, into the functional currency of the respective entity, resulting in unrealized gains or losses recorded in other income (expense), net, in the Consolidated Statements of Income. Revenues and expenses are translated using average exchange rates during the respective period. Foreign currency translation adjustments are accumulated as a component of other comprehensive income (loss), which is a separate component of stockholders’ equity. Gains and losses arising from transactions denominated in foreign currencies are included in other income (expense), net, in the Consolidated Statements of Income. During fiscal years 2024, 2023 and 2022, the Company recorded net foreign exchange (losses) gains of $(21.0) million, $(7.9) million, and $48.5 million, respectively.
Accumulated Other Comprehensive Income | Accumulated Other Comprehensive Income (Loss) Other comprehensive income (loss) includes certain transactions that have generally been reported in the statement of stockholders’ equity. The following tables summarize the components and changes in accumulated balances of other comprehensive loss for the periods presented:
| Year Ended September 28, 2024 |  | Year Ended September 30, 2023
| Foreign Currency Translation |  | Pension Plan |  | Available-for-sale debt securities |  | Hedged Interest Rate Swaps |  | Total |  | Foreign Currency Translation |  | Pension Plan |  |  |  | Hedged Interest Rate Swaps |  | Total
Beginning Balance | $ | (168.0) |  |  | $ | 0.3 |  |  | $ | — |  |  | $ | 20.1 |  |  | $ | (147.6) |  |  | $ | (267.2) |  |  | $ | (0.3) |  |  |  |  | $ | 29.3 |  |  | $ | (238.2) |
Other comprehensive income (loss) before reclassifications | 53.1 |  |  | (0.3) |  |  | 1.6 |  |  | (18.3) |  |  | 36.1 |  |  | 99.2 |  |  | 0.6 |  |  |  |  | (9.2) |  |  | 90.6 |
Ending Balance | $ | (114.9) |  |  | $ | — |  |  | $ | 1.6 |  |  | $ | 1.8 |  |  | $ | (111.5) |  |  | $ | (168.0) |  |  | $ | 0.3 |  |  |  |  | $ | 20.1 |  |  | $ | (147.6) |
Derivatives | Derivatives Interest Rate Risk - Cash Flow Hedge The Company is exposed to certain risks arising from both its business operations and economic conditions. The Company manages its exposure to some of its interest rate risk through the use of interest rate swaps, which are derivative financial instruments. The Company does not use derivatives for speculative purposes. For a derivative that is designated as a cash flow hedge, changes in the fair value of the derivative are recognized in accumulated other comprehensive income (“AOCI”) to the extent the derivative is effective at offsetting the changes in the cash flows being hedged until the hedged item affects earnings. In fiscal 2019, the Company entered into an interest rate swap contract with an effective date of December 23, 2020 and a termination date of December 17, 2023 to hedge a portion of its variable rate debt. On August 25, 2022, the interest rate swap agreement was restructured (consistent with the 2021 Credit Agreement; see Note 9) to convert the benchmark interest rate from LIBOR to the SOFR rate effective September 23, 2022 with a termination date of December 17, 2023. The Company applied the practical and optional expedients in ASC 848, Reference Rate Reform, in evaluating the impact of modifying the contract, which resulted in no change to the accounting for this derivative contract. The notional amount of this swap was $1.0 billion. The restructured interest rate swap fixed the SOFR component of the variable interest rate on $1.0 billion of the notional amount under the 2021 Credit Agreement at 1.23%. The critical terms of the restructured interest rate swap were designed to mirror the terms of the Company’s SOFR-based borrowings under the 2021 Credit Agreement and therefore were highly effective at offsetting the cash flows being hedged. The Company designated this derivative as a cash flow hedge of the variability of the SOFR-based interest payments on $1.0 billion of principal. Therefore, changes in the fair value of the swap were recorded in AOCI. The contract expired during the first quarter of fiscal 2024. On March 23, 2023, the Company entered into two consecutive interest rate swap contracts with the first contract having an effective date of December 17, 2023 and terminating on December 27, 2024, and the second contract having an effective date of December 27, 2024 and terminating on September 25, 2026. The notional amount of these swaps is $500 million, and the first interest rate swap fixes the SOFR component of the variable interest rate at 3.46%, and the second interest rate swap fixes the SOFR component of the variable interest rate at 2.98%. The critical terms of the interest rate swaps are designed to mirror the terms of the Company’s SOFR-based borrowings under the 2021 Credit Agreement and therefore are highly effective at offsetting the cash flows being hedged. The Company designated this derivative as a cash flow hedge of the variability of the SOFR-based interest payments on $500 million of principal. The changes in the fair value of the swaps are recorded in AOCI and net of taxes were a loss of $18.3 million, a loss of $9.2 million and a gain of $44.0 million, respectively, for fiscal years 2024, 2023, and 2022, respectively. The fair value of these derivative instruments was in an asset position of $2.9 million as of September 28, 2024. Forward Foreign Currency Contracts, Foreign Currency Option Contracts The Company enters into forward foreign currency exchange contracts and foreign currency option contracts (including collars) to mitigate certain operational exposures from the impact of changes in foreign currency exchange rates. Such exposures result from the portion of the Company's cash and operations that are denominated in currencies other than the U.S. dollar, primarily the Euro, the U.K. Pound, the Australian dollar, the Canadian dollar, the Chinese Yuan and the Japanese Yen. These foreign currency exchange contracts are entered into to support transactions made in the ordinary course of business and are not speculative in nature. The Company uses collars and forward contracts as part of its foreign currency hedging strategy to manage the risk associated with fluctuations in foreign currency exchange rates. Collars, which are a combination of a put and call option, limit the range of possible positive or negative returns on an underlying exposure to a specific range. The contracts are generally for periods of one year or less. The Company did not elect hedge accounting for these contracts. The change in the fair value of these contracts is recognized directly in earnings as a component of other income (expense), net. Realized and unrealized gains and losses from these contracts, which were the only derivative contracts not designated for hedge accounting, for the years ended September 28, 2024, September 30, 2023, and September 24, 2022 were as follows:
| Years Ended
| September 28, 2024 |  | September 30, 2023 |  | September 24, 2022
Amount of realized gain (loss) recognized in income |  |  |  |  |
Forward foreign currency contracts | $ | 3.9 |  |  | $ | 1.3 |  |  | $ | 68.5 |
Foreign currency option contracts | — |  |  | (4.0) |  |  | — |
| $ | 3.9 |  |  | $ | (2.7) |  |  | $ | 68.5 |
Amount of unrealized (loss) gain recognized in income |  |  |  |  |
Forward foreign currency contracts | $ | (20.9) |  |  | $ | (7.5) |  |  | $ | 14.7 |
Foreign currency option contracts | 0.8 |  |  | (5.5) |  |  | 5.5 |
| $ | (20.1) |  |  | $ | (13.0) |  |  | $ | 20.2 |
Amount of gain (loss) recognized in income |  |  |  |  |
Total | $ | (16.2) |  |  | $ | (15.7) |  |  | $ | 88.7 |
As of September 28, 2024, the Company had outstanding forward foreign currency contracts that were not designated for hedge accounting and are used to hedge forecasted transactions denominated in the Euro, U.K. pound, Australian dollar, Canadian dollar, Chinese Yuan and Japanese Yen with an aggregate notional amount of $378.5 million. Financial Instrument Presentation The table below presents the fair value of the Company's derivative financial instruments as well as their classification on the balance sheet as of September 28, 2024:
| Balance Sheet Location |  | September 28, 2024 |  | September 30, 2023
Assets: |  |  |  |  |
Derivative instrument designated as a cash flow hedge: |  |  |  |  |
Interest rate swap contracts | Prepaid expenses and other current assets |  | $ | 3.1 |  |  | $ | 16.2 |
Interest rate swap contracts | Other assets |  | — |  |  | 10.7 |
|  |  | $ | 3.1 |  |  | $ | 26.9 |
Derivatives not designated as hedging instruments: |  |  |  |  |
Forward foreign currency contracts | Prepaid expenses and other current assets |  | $ | — |  |  | $ | 8.4 |
Foreign currency option contracts | Prepaid expenses and other current assets |  | 0.8 |  |  | — |
|  |  | $ | 0.8 |  |  | $ | 8.4 |
Liabilities: |  |  |  |  |
Derivative instruments designated as a cash flow hedge: |  |  |  |  |
Interest rate swap contracts | Other long-term liabilities |  | 0.2 |  |  | — |
Total |  |  | $ | 0.2 |  |  | $ | — |
Derivatives not designated as hedging instruments: |  |  |  |  |
Forward foreign currency contracts | Accrued expenses |  | $ | 12.6 |  |  | $ | — |
The following table presents the unrealized gain (loss) recognized in AOCI related to the interest rate caps and interest rate swap for the following reporting periods:
| Years Ended
| September 28, 2024 |  | September 30, 2023 |  | September 24, 2022
Amount of (loss) gain recognized in other comprehensive income (loss), net of taxes: |  |  |  |  |
Interest rate swap | $ | (18.3) |  |  | $ | (9.2) |  |  | $ | 44.0 |
Total | $ | (18.3) |  |  | $ | (9.2) |  |  | $ | 44.0 |
Accounts Receivable and Reserves | Trade Receivables and Allowance for Credit Losses The Company applies ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326) to its trade receivables and allowances for credit losses, which requires that financial assets measured at amortized cost be presented at the net amount expected to be collected. The expected credit losses are developed using an estimated loss rate method that considers historical collection experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The estimated loss rates are applied to trade receivables with similar risk characteristics such as the length of time the balance has been outstanding and the location of the customer. In certain instances, the Company may identify individual trade receivable assets that do not share risk characteristics with other trade receivables, in which case the Company records its expected credit losses on an individual asset basis. For example, potential adverse changes to customer liquidity from new macroeconomic events, such as pandemics and inflation, must be taken into consideration. To date, the Company has not experienced significant customer payment defaults, or identified other significant collectability concerns. In connection with assessing credit losses for individual trade receivable assets, the Company considers significant factors relevant to collectability including those specific to the customer such as bankruptcy, length of time an account is outstanding, and the liquidity and financial position of the customer. If a trade receivable asset is evaluated on an individual basis, the Company excludes those assets from the portfolios of trade receivables evaluated on a collective basis. The following is a rollforward of the allowance for credit losses for fiscal 2024, 2023 and 2022:
|  | Balance at Beginning of Period |  | Charged to Costs and Expenses |  |  |  | Write- offs and Payments |  | Balance at End of Period
Period Ended: |  |  |  |  |  |  |  |  |  |
September 28, 2024 |  | $ | 38.5 |  |  | $ | 5.7 |  |  |  |  | $ | (2.8) |  |  | $ | 41.4 |
September 30, 2023 |  | $ | 37.7 |  |  | $ | 3.7 |  |  |  |  | $ | (2.9) |  |  | $ | 38.5 |
September 24, 2022 |  | $ | 40.5 |  |  | $ | 4.2 |  |  |  |  | $ | (7.0) |  |  | $ | 37.7 |
Cost of Service and Other Revenues | Cost of Service and Other Revenues Cost of service and other revenues primarily represents payroll and related costs associated with the Company’s professional services, employees, consultants, infrastructure costs and overhead allocations, including depreciation, rent and materials consumed in providing the service.
Stock-Based Compensation | Stock-Based Compensation The Company accounts for share-based payments in accordance with ASC 718, Stock Compensation (ASC 718). As such, all share-based payments to employees, including grants of stock options, restricted stock units, performance stock units and market stock units and shares issued under the Company’s employee stock purchase plan, are recognized in the Consolidated Statements of Income based on their fair values on the date of grant. In addition, all excess tax benefits and deficiencies are recognized as a component of the provision for income taxes on a discrete basis in the period in which the equity awards vest and/or are settled.
Net Income Per Share | Net Income Per Share Basic net income per share is computed by dividing net income by the weighted average number of common shares outstanding. Diluted net income per share is computed by dividing net income by the weighted average number of common shares and the dilutive effect of potential future issuances of common stock from outstanding stock options and restricted stock units for the period outstanding determined by applying the treasury stock method. In accordance with ASC 718, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of in-the-money stock options and restricted stock units. This results in the assumed buyback of additional shares, thereby reducing the dilutive impact of equity awards.
Product Warranties | Product Warranties The Company generally offers a one-year warranty for its products. The Company provides for the estimated cost of product warranties at the time product revenue is recognized. Factors that affect the Company’s warranty reserves include the number of units sold, historical and anticipated rates of warranty repairs and the cost per repair. The Company periodically assesses the adequacy of the warranty reserve and adjusts the amount as necessary. Product warranty activity for fiscal 2024 and 2023 was as follows:
|  | Balance at Beginning of Period |  | Provisions |  | Acquired |  |  |  | Settlements/ Adjustments |  | Balance at End of Period
Period ended: |  |  |  |  |  |  |  |  |  |  |  |
September 28, 2024 |  | $ | 8.3 |  |  | $ | 9.0 |  |  | $ | 0.1 |  |  |  |  | $ | (7.5) |  |  | $ | 9.9 |
September 30, 2023 |  | $ | 8.0 |  |  | $ | 6.8 |  |  | $ | 0.8 |  |  |  |  | $ | (7.3) |  |  | $ | 8.3 |
Advertising Costs | Advertising Costs Advertising costs are charged to operations as incurred. The Company does not have any direct-response advertising. Advertising costs, which include trade shows and conventions, were approximately $22.6 million, $31.4 million and $78.1 million for fiscal 2024, 2023 and 2022, respectively, and were included in selling and marketing expense in the Consolidated Statements of Income. The higher advertising costs in fiscal 2022 was primarily due to the Company's agreement to be a sponsor of the Women's Tennis Association and related structure of the arrangement and the production and airing of its Super Bowl commercial in February 2022.
Recently Issued Accounting Pronouncements | New Accounting Pronouncements In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) Improvements to Reportable Segment Disclosures. The guidance requires entities to provide enhanced disclosures about significant segment expenses. For entities that have adopted the amendments in Update 2023-07, the updated guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, and is applicable to the Company in fiscal 2025. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of ASU 2023-07 on its consolidated financial position and results of operations. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740) Improvements to Income Tax Disclosures. The FASB issued this Update to enhance income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The amendments in this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2024, and is applicable to the Company in fiscal 2025. Early adoption is permitted. The Company is currently evaluating the impact of the adoption of ASU 2023-09 on its consolidated financial position and results of operations. In March 2024, the SEC issued its final climate disclosure rule, which requires the disclosure of Scope 1 and Scope 2 greenhouse gas emissions and other climate-related topics in annual reports and registration statements, when material. Disclosure requirements were to begin phasing in for fiscal years beginning on or after January 1, 2025, however on April 4, 2024, the SEC issued an order staying the rule pending the completion of an ongoing judicial review. The Company is monitoring SEC developments and evaluating the impact of the new rule to its financial statements.

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